Department of Health and Human Services: Vol. 80 Thursday, No. 180 September 17, 2015

Vol.
80 Thursday,
No. 180 September 17, 2015
Part II
Department of Health and Human Services

Food and Drug Administration
21 CFR Parts 1, 11, 16, 106, 110, et al.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food; Final Rule
tkelley on DSK3SPTVN1PROD with RULES2
VerDate Sep<11>2014 17:48 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17SER2.SGM 17SER2
55908 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations
DEPARTMENT OF HEALTH AND 117.435(d), 117.475(c)(2), and A. Title of Part 117

HUMAN SERVICES 117.475(c)(13). See section LVI for the B. Proposed Revisions for Consistency of
compliance dates. Terms
Food and Drug Administration C. Proposed Additions Regarding Allergen
FOR FURTHER INFORMATION CONTACT: Cross-Contact
Jenny Scott, Center for Food Safety and D. Proposed Revisions for Consistency
21 CFR Parts 1, 11, 16, 106, 110, 114, Applied Nutrition (HFS–300), Food and With the Definition of ‘‘Food’’
117, 120, 123, 129, 179, and 211 Drug Administration, 5100 Paint Branch E. Proposed Revisions To Address
[Docket No. FDA–2011–N–0920] Pkwy., College Park, MD 20740, 240– Guidance in Current Part 110
402–2166. F. Proposed Editorial Changes
Current Good Manufacturing Practice, G. General Comments on Current Part 110
SUPPLEMENTARY INFORMATION: (Final Part 117)
Hazard Analysis, and Risk-Based
Table of Contents VIII. Subpart A: Comments on Proposed
Preventive Controls for Human Food § 117.1—Applicability and Status
AGENCY: Food and Drug Administration, Executive Summary A. Comments on Proposed § 117.1(a)—
HHS. Purpose and Coverage of the Rule Applicability
Summary of the Major Provisions of the B. Comments on Proposed § 117.1(b)—
ACTION: Final rule. Rule Prohibited Act
Costs and Benefits C. Comments on Proposed § 117.1(c)—
SUMMARY: The Food and Drug
I. Background Specific CGMP Requirements
Administration (FDA or we) is A. FDA Food Safety Modernization Act IX. Subpart A: Comments on Proposed
amending our regulation for Current B. Stages in the Rulemaking for the Human § 117.3—Definitions
Good Manufacturing Practice In Preventive Controls Rule A. Redesignation
Manufacturing, Packing, or Holding C. Summary of the Major Provisions of B. Definitions in Current Part 110 That We
Human Food in two fundamental ways. Proposed Human Preventive Controls Proposed To Delete
First, we are modernizing the long- Rule C. Definitions That We Proposed To
standing current good manufacturing D. Draft Risk Assessment Establish in Part 117
practice requirements. Second, we are E. Definition of ‘‘Retail Food D. Comments Asking FDA To Establish
adding requirements for domestic and Establishment’’ Additional Definitions or Otherwise
F. Public Comments Clarify Terms Not Defined in the Rule
foreign facilities that are subject to our
II. Legal Authority E. Additional Definitions To Clarify Terms
regulation for Registration of Food A. Changes to Current 21 CFR Part 1, Not Defined in the Proposed Rule
Facilities to establish and implement Subparts H, I, and J X. Subpart A: Comments on Qualifications of
hazard analysis and risk-based B. Changes to Current 21 CFR Part 110 Individuals Who Manufacture, Process,
preventive controls for human food. We C. Hazard Analysis and Risk-Based Pack, or Hold Food
also are revising certain definitions in Preventive Controls A. Applicability and Qualifications of All
our regulation for Registration of Food D. Comments on Legal Authority Individuals Engaged in Manufacturing,
Facilities to clarify the scope of the III. General Comments on the Proposed Rule Processing, Packing, or Holding Food
exemption from registration IV. Comments on Proposed Revisions to the (Final § 117.4(a), (b), and (d))
requirements provided for ‘‘farms’’ and, Definitions in the Section 415 B. Additional Requirements Applicable to
Registration Regulations (21 CFR Part 1, Supervisory Personnel (Final § 117.4(c))
in so doing, to clarify which domestic
Subpart H) and the Section 414 XI. Subpart A: Comments on Proposed
and foreign facilities are subject to the Recordkeeping Regulations (21 CFR Part § 117.5—Exemptions
requirements for hazard analysis and 1, Subpart J) A. General Comments on the Proposed
risk-based preventive controls for A. Definitions That Impact a Determination Exemptions
human food. We are taking this action of Whether an Establishment Is a ‘‘Farm’’ B. Proposed § 117.5(a)—Exemption
as part of our announced initiative to B. Proposed Revisions to the Definition of Applicable to a Qualified Facility
revisit the current good manufacturing Farm C. Proposed § 117.5(b) and (c)—
practice requirements since they were C. Proposed New Definition of Harvesting Exemptions Applicable to Food Subject
last revised in 1986 and to implement D. Proposed Revision to the Definition of to HACCP Requirements for Fish and
new statutory provisions in the FDA Holding Fishery Products (21 CFR Part 123) or for
E. Proposed Revision to the Definition of Juice (21 CFR Part 120)
Food Safety Modernization Act. The Manufacturing/Processing D. Proposed § 117.5(d)—Exemption
rule is intended to build a food safety F. Proposed New Definition of Mixed-Type Applicable to Food Subject to Part 113—
system for the future that makes Facility Thermally Processed Low-Acid Foods
modern, science- and risk-based G. Proposed Revision to the Definition of Packaged In Hermetically Sealed
preventive controls the norm across all Packing Containers
sectors of the food system. V. Comments on the Organizing Principles E. Proposed § 117.5(e)—Exemption
DATES: This rule is effective November for How the Status of a Food as a Raw Applicable to a Facility That
Agricultural Commodity or as a Manufactures, Processes, Packages, or
16, 2015, except for the amendment to
Processed Food Affects the Requirements Holds a Dietary Supplement
part 110 in instruction 13, which is Applicable to a Farm Under Sections 415 F. Proposed § 117.5(f)—Exemption
effective September 17, 2018 and and 418 of the FD&C Act Applicable to Activities Subject to
paragraph (2) of the definition of VI. Rulemaking Required by Section 103(c) of Standards for Produce Safety in Section
‘‘qualified auditor’’ in § 117.3, and FSMA: On-Farm Activities 419 of the FD&C Act
§§ 117.5(k)(2), 117.8, 117.405(a)(2), A. Section 103(c)(1)(C) of FSMA G. Proposed §§ 117.5(g) and (h)—
117.405(c), 117.410(d)(2)(ii), 117.430(d), B. Comments on Qualitative Risk Exemptions Applicable to On-Farm Low-
117.435(d), 117.475(c)(2) and Assessment of On-Farm Activities Risk Activity/Food Combinations
117.475(c)(13). FDA will publish a Outside of the Farm Definition Conducted by a Small or Very Small
C. Comments Regarding an Exemption for Business

document in the Federal Register
Small and Very Small Farm Mixed-Type H. Proposed § 117.5(i)—Exemption Related
announcing the effective dates of Facilities Under Section 421 of the FD&C to Alcoholic Beverages
paragraph (2) of the definition of Act I. Proposed § 117.5(j)—Exemption
‘‘qualified auditor’’ in § 117.3, and VII. Comments on Proposed General Applicable to Facilities Solely Engaged
§§ 117.5(k)(2), 117.8, 117.405(a)(2), Revisions to Current Part 110 (Final Part in Storage of Raw Agricultural
117.405(c), 117.410(d)(2)(ii), 117.430(d), 117) Commodities Other Than Fruits and
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 55909
Vegetables Intended for Further XVIII. Subpart B: Comments on Proposed N. Proposed § 117.80(c)(14)—Food That
Distribution or Processing § 117.80(a)—General Processes and Relies on the Control of Water Activity
J. Proposed § 117.5(k)—Exemption Controls for Preventing the Growth of Undesirable
Applicable to Farms, Fishing Vessels, A. Proposed § 117.80(a)(1)—Adequate Microorganisms
Activities of ‘‘Farm Mixed-Type Sanitation Principles O. Proposed § 117.80(c)(15)—Food That
Facilities’’ Within the Definition of B. Proposed § 117.80(a)(2)—Quality Relies on the Control of pH for
‘‘Farm,’’ the Holding or Transportation of Control Operations Preventing the Growth of Undesirable
One or More Raw Agricultural C. Proposed § 117.80(a)(3)—Supervision of Microorganisms
Commodities, and Specified Activities Overall Sanitation P. Proposed § 117.80(c)(16)—Requirements
Conducted on Specified Raw D. Proposed § 117.80(a)(4)—Production for Ice Used in Contact With Food
Agricultural Commodities Procedures Q. Proposed Deletion of Current
K. Comments Requesting Additional E. Proposed § 117.80(a)(5)—Chemical, § 110.80(b)(17)—Food-Manufacturing
Exemptions Microbial, or Extraneous-Material Areas and Equipment
XII. Subpart A: Comments on Proposed Testing Procedures XXI. Subpart B: Comments on Proposed
§ 117.7—Applicability of Part 117 to a F. Proposed § 117.80(a)(6)—Contaminated § 117.93—Warehousing and Distribution
Facility Solely Engaged in the Storage of Food XXII. Subpart B: Comments on Proposed
Unexposed Packaged Food XIX. Subpart B: Comments on Proposed § 117.110—Natural or Unavoidable
XIII. Subpart B: Comments on Proposed § 117.80(b)—Processes and Controls for Defects in Food for Human Use That
§ 117.10—Personnel Raw Materials and Other Ingredients Present No Health Hazard
A. Proposed § 117.80(b)(1)—Inspection, XXIII. Subpart C: Comments on Overall
A. Management Responsibility for
Segregation and Handling of Raw Framework for Hazard Analysis and
Requirements Applicable to Personnel
Materials and Other Ingredients Risk-Based Preventive Controls
B. Proposed § 117.10(a)—Disease Control
B. Proposed § 117.80(b)(2)—Levels of XXIV. Subpart C: Comments on Proposed
C. Proposed § 117.10(b)—Cleanliness
Microorganisms in Raw Materials and § 117.126—Food Safety Plan
XIV. Subpart B: Comments on Proposed
Other Ingredients A. Proposed § 117.126(a)(1)—Requirement
§ 117.20—Plant and Grounds
C. Proposed § 117.80(b)(3)—Natural Toxins for a Food Safety Plan
A. Proposed § 117.20(a)—Grounds
in Raw Materials and Other Ingredients B. Proposed § 117.126(a)(2)—Preparation of
B. Proposed § 117.20(b)—Plant
D. Proposed § 117.80(b)(4)—Pests, the Food Safety Plan by a Preventive
Construction and Design
Undesirable Microorganisms and Controls Qualified Individual
XV. Subpart B: Comments on Proposed Extraneous Materials in Raw Materials C. Proposed § 117.126(b)—Contents of a
§ 117.35—Sanitary Operations and Other Ingredients Food Safety Plan
A. Proposed § 117.35(a)—General E. Proposed § 117.80(b)(5)—Holding Raw D. Proposed § 117.126(c)—Records
Maintenance Materials, Other Ingredients, and Rework E. Comments on Potential Requirements
B. Proposed § 117.35(b)—Substances Used in Bulk for Submission of a Facility Profile to
in Cleaning and Sanitizing; Storage of F. Proposed § 117.80(b)(7)—Liquid or Dry FDA
Toxic Materials Raw Materials and Other Ingredients XXV. Subpart C: Comments on Proposed
C. Proposed § 117.35(c)—Pest Control G. Proposed § 117.80(b)(8)—Raw Materials § 117.130—Hazard Analysis
D. Proposed § 117.35(d)—Sanitation of and Other Ingredients That Are Food A. Proposed § 117.130(a)—Requirement for
Food-Contact Surfaces Allergens a Written Hazard Analysis
E. Proposed § 117.35(d)(1)—Food-Contact XX. Subpart B: Comments on Proposed B. Proposed § 117.130(b)—Hazard
Surfaces Used for Manufacturing/ § 117.80(c)—Manufacturing Operations Identification
Processing or Holding A. Proposed § 117.80(c)(1)—Condition of C. Proposed § 117.130(c)—Evaluation of
F. Proposed § 117.35(d)(2)—Wet Cleaning Equipment, Utensils, and Finished Food Whether a Hazard Requires a Preventive
G. Proposed § 117.35(d)(3)—Single-Service Containers Control
Articles B. Proposed § 117.80(c)(2)—Conditions and XXVI. Subpart C: Comments on Proposed
H. Proposed § 117.35(e)—Sanitation of Controls for Food Manufacturing, § 117.135—Preventive Controls
Non-Food-Contact Surfaces Processing, Packing, and Holding A. Proposed § 117.135(a)—Requirement To
I. Proposed § 117.35(f)—Storage and C. Proposed § 117.80(c)(3)—Food That Can Identify and Implement Preventive
Handling of Cleaned Portable Equipment Support the Rapid Growth of Controls
and Utensils Undesirable Microorganisms B. Proposed § 117.135(b)—Requirement for
XVI. Subpart B: Comments on Proposed D. Proposed § 117.80(c)(4)—Measures To Written Preventive Controls
§ 117.37—Sanitary Facilities and Destroy or Prevent the Growth of C. Proposed § 117.135(c)(1)—Process
Controls Undesirable Microorganisms Controls
A. Proposed § 117.37(a)—Water Supply E. Proposed § 117.80(c)(5)—Work-in- D. Proposed § 117.135(c)(2)—Food
B. Proposed § 117.37(b)—Plumbing Process and Rework Allergen Controls
C. Proposed § 117.37(c)—Sewage Disposal F. Proposed § 117.80(c)(6)—Finished Food E. Proposed § 117.135(c)(3)—Sanitation
D. Proposed § 117.37(d)—Toilet Facilities G. Proposed § 117.80(c)(7)—Equipment, Controls
E. Proposed § 117.37(e)—Hand-Washing Containers, and Utensils F. Proposed § 117.135(c)(4)—Supply-Chain
Facilities H. Proposed § 117.80(c)(8)—Metal or Other Controls
XVII. Subpart B: Comments on Proposed Extraneous Material G. Proposed § 117.135(c)(5)—Recall Plan
§ 117.40—Equipment and Utensils I. Proposed § 117.80(c)(9)—Disposal of H. Proposed § 117.135(c)(6)—Other
A. Proposed § 117.40(a)—Design, Adulterated Food, Raw Materials, and Controls
Construction, Use, Installation, and Other Ingredients XXVII. Subpart C: Circumstances in Which
Maintenance of Equipment and Utensils J. Proposed § 117.80(c)(10)—Performing the Owner, Operator, or Agent in Charge
B. Proposed § 117.40(b)—Seams on Food- Manufacturing Steps of a Manufacturing/Processing Facility Is
Contact Surfaces K. Proposed § 117.80(c)(11)—Heat Not Required To Implement a Preventive
C. Proposed § 117.40(c)—Construction of Blanching and Growth and Control (Final §§ 117.136 and 117.137)
Equipment Contamination by Thermophilic XXVIII. Subpart C: Comments on Proposed
D. Proposed § 117.40(d)—Holding, Microorganisms During Manufacturing Requirements for a Recall Plan (Final
Conveying, and Manufacturing Systems Operations § 117.139)

E. Proposed § 117.40(e)—Freezer and Cold L. Proposed § 117.80(c)(12)—Batters, A. Proposed § 117.137(a)—Requirement for
Storage Compartments Breading, Sauces, Gravies, Dressings, a Written Recall Plan (Final § 117.139(a))
F. Proposed § 117.40(f)—Accurate and and Other Similar Preparations B. Proposed § 117.137(b)—Procedures That
Precise Instruments and Controls M. Proposed § 117.80(c)(13)—Filling, Describe the Steps To Be Taken, and
G. Proposed § 117.40(g)—Compressed Air Assembling, Packaging and Other Assign Responsibility for Taking Those
or Other Gases Operations Steps (Final § 117.139(b))
XXIX. Comments on Proposed § 117.140— G. Proposed § 117.165(b)—Written F. Proposed § 117.267—Procedure for

Preventive Control Management Procedures Requesting an Informal Hearing
Components XXXV. Subpart C: Comments on Proposed G. Proposed § 117.270—Requirements
A. Proposed § 117.140(a)—Flexible § 117.170—Reanalysis Applicable to an Informal Hearing
Requirements for Monitoring, Corrective A. Proposed § 117.170(a)—Circumstances H. Proposed § 117.287—Reinstatement of a
Actions and Corrections, and Requiring Reanalysis Qualified Facility Exemption That Was
Verification B. Proposed § 117.170(b)—Timeframe To Withdrawn
B. Proposed § 117.140(b)—Applicability of Complete Reanalysis I. Conforming Amendment to 21 CFR part
Preventive Control Management C. Proposed § 117.170(c)—Requirement To 16
Components to the Supply-Chain Revise the Written Food Safety Plan or J. Other Comments on the Withdrawal
Program Document Why Revisions Are Not Provisions
C. Proposed § 117.140(c)—Recall Plan is Needed XLI. Subpart F: Comments on Proposed New
Not Subject to Preventive Control D. Proposed § 117.170(d)—Requirement for Recordkeeping Requirements
Management Components Oversight of Reanalysis by a Preventive A. Proposed § 117.301—Records Subject to
XXX. Subpart C: Comments on Proposed Controls Qualified Individual the Requirements of Subpart F
§ 117.145—Monitoring E. Proposed § 117.170(e)—Reanalysis on B. Proposed § 117.305—General
A. Our Tentative Conclusion To Require the Initiative of FDA Requirements Applying to Records
Monitoring of the Performance of XXXVI. Subpart C: Comments on Proposed C. Proposed § 117.310—Additional
Preventive Controls § 117.180—Requirements Applicable to a Requirements Applying to the Food
B. Proposed § 117.145(a)—Flexibility in Preventive Controls Qualified Individual Safety Plan
Requirements for Monitoring and a Qualified Auditor D. Proposed § 117.315—Requirements for
C. Proposed § 117.145(b)—Records A. Proposed § 117.180(a) and (b)—What a Record Retention
XXXI. Subpart C: Comments on Proposed Preventive Controls Qualified Individual E. Proposed § 117.320—Requirements for
§ 117.150—Corrective Actions and or Qualified Auditor Must Do or Oversee Official Review
Corrections B. Proposed § 117.180(c)—Qualification F. Proposed § 117.325—Public Disclosure
A. Proposed § 117.150(a)(1)—Requirement Requirements G. Proposed § 117.330—Use of Existing
To Establish and Implement Corrective C. Proposed § 117.180(d)—Records Records
Action Procedures XXXVII. Subpart C: Comments on Proposed H. Final § 117.335—Special Requirements
B. Proposed § 117.150(a)(2)—Content of § 117.190—Implementation Records Applicable to a Written Assurance
Corrective Action Procedures A. Proposed § 117.190(a)—List of Required I. Other Comments on the Recordkeeping
C. Proposed § 117.150(b)—Corrective Records Requirements of Subpart F
B. Proposed § 117.190(b)—Applicability of
Action in the Event of an Unanticipated XLII. Subpart G: General Comments on
Subpart F
Problem Proposed Requirements for a Supply-
XXXVIII. Subpart D: Comments on Proposed
D. Proposed § 117.150(c)—Corrections Chain Program
§ 117.201—Modified Requirements That
E. Proposed § 117.150(d)—Records XLIII. Subpart G: Comments on Requirement
Apply to a Qualified Facility
XXXII. Subpart C: Comments on Proposed To Establish and Implement a Supply-
A. Comments on Submission of a
§ 117.155—Verification Certification Statement Chain Program
A. Flexibility in Requirements for B. General Comments on Modified A. Requirement for a Written Supply-Chain
Verification Requirements That Apply to a Qualified Program (Final § 117.405(a)(1) and (b))
B. Proposed § 117.155(a)—Verification Facility B. Circumstances That Do Not Require a
Activities C. Proposed § 117.201(a)—Documentation Written Supply-Chain Program (Final
C. Proposed § 117.155(b)—Documentation To Be Submitted § 117.405(a)(2))
of Verification Activities D. Proposed § 117.201(b)—Procedure for C. Exemption for Food Supplied for
D. Comments on Potential Requirements Submission Research or Evaluation (Final
Regarding Complaints E. Proposed § 117.201(c)—Frequency of § 117.405(a)(3))
XXXIII. Subpart C: Comments on Proposed Determination and Submission D. Additional Requirements for Non-
§ 117.160—Validation F. Proposed § 117.201(d)—Notification to Suppliers (Final § 117.405(c))
A. Flexibility in the Requirements To Consumers (Final § 117.201(e)) E. Proposed General Requirements for the
Validate Preventive Controls G. Proposed § 117.201(e)—Records (Final Supply-Chain Program That We Are Not
B. Proposed § 117.160(b)(1)—When § 117.201(f)) Including in the Final Rule (Proposed
Validation Must Be Performed and Role XXXIX. Subpart D: Comments on Proposed § 117.136(a)(4) and (5))
of the Preventive Controls Qualified § 117.206—Modified Requirements That XLIV. Subpart G: Comments on General
Individual in Validation Apply to a Facility Solely Engaged in the Requirements Applicable to a Supply-
C. Proposed § 117.160(b)(2)—What Storage of Unexposed Packaged Food Chain Program
Validation Must Include A. Proposed § 117.206(a)—Modified A. Description of What the Supply-Chain
D. Proposed § 117.160(b)(3)—Preventive Requirements for Unexposed Program Must Include (Final
Controls for Which Validation Is Not Refrigerated Packaged Food That § 117.410(a))
Required Requires Time/Temperature Controls B. Appropriate Supplier Verification
XXXIV. Subpart C: Comments on Proposed B. Proposed § 117.206(b)—Records Activities ((Final § 117.410(b))
§ 117.165—Verification of XL. Subpart E: Comments on Proposed New C. Purpose of Supplier Verification
Implementation and Effectiveness Provisions for Withdrawal of a Qualified Activities for Raw Materials and Other
A. Flexibility in the Requirements To Facility Exemption Ingredients (Final § 117.410(c))
Conduct Activities To Verify A. Proposed § 117.251—Circumstances D. Factors That Must Be Considered When
Implementation and Effectiveness That May Lead FDA To Withdraw a Approving Suppliers and Determining
B. Proposed § 117.165(a)(1)—Calibration Qualified Facility Exemption Appropriate Supplier Verification
C. Comments Directed to Proposed B. Proposed § 117.254—Issuance of an Activities for Raw Materials and Other
Requirements for Both Product Testing Order To Withdraw a Qualified Facility Ingredients (Final § 117.410(d))
(Proposed § 117.165(a)(2) and (b)(2)) and Exemption E. Supplier Non-Conformance (Final
Environmental Monitoring (Proposed C. Proposed § 117.257—Contents of an § 117.410(e))
§ 117.165(a)(3) and (b)(3)) Order To Withdraw a Qualified Facility XLV. Subpart G: New Requirement
D. Proposed § 117.165(a)(2)—Product Exemption Specifying Responsibilities of the
Testing D. Proposed § 117.260—Compliance With, Receiving Facility (Final § 117.415)
E. Proposed § 117.165(a)(3)— or Appeal of, an Order To Withdraw a XLVI. Subpart G: Comments on Using
Environmental Monitoring Qualified Facility Exemption Approved Suppliers and Determining
F. Proposed § 117.165(a)(4)—Review of E. Proposed § 117.264—Procedure for Appropriate Supplier Verification
Records Submitting an Appeal Activities
A. Using Approved Suppliers (Final Review of Hazard Analysis and clarified certain requirements within the
§ 117.420) Preventive Controls Programs in CGMP regulations, which were last
B. Determining Appropriate Verification Existence on the Date of Enactment of updated in 1986.
Activities (Final § 117.425) FSMA
Third, this rule clarifies the scope of
XLVII. Subpart G: Comments on Conducting LIV. Comments on Proposed Removal of 21
Supplier Verification Activities for Raw CFR part 110—Current Good the exemption for ‘‘farms’’ in FDA’s
Materials and Other Ingredients Manufacturing Practice in current food facility registration
A. Requirement to Conduct One or More Manufacturing, Packing, or Holding regulations and makes corresponding
Supplier Verification Activities (Final Human Food revisions to FDA’s current regulations
§ 117.430(a)) LV. Comments on Proposed Conforming for the establishment, maintenance, and
B. Requirement for an Onsite Audit as a Amendments availability of records. These revisions
Verification Activity When a Hazard Has LVI. Effective and Compliance Dates affect who is subject to the existing
a Reasonable Probability of Resulting in A. Effective and Compliance Dates for Part
regulations for registration and
Serious Adverse Health Consequences or 117
Death to Humans (Final § 117.430(b)) B. Effective and Compliance Dates for recordkeeping, as well as the new
C. Alternative Verification Activity When Revisions to Part 1 requirements for hazard analysis and
the Supplier Is a Qualified Facility (Final C. Effective Dates for Conforming risk-based preventive controls
§ 117.430(c)) Amendments requirements established here.
D. Alternative Verification Activity When D. Delayed Effective Dates for Provisions This final rule is the result of
the Supplier Is a Produce Farm That Is That Refer to the Forthcoming Rules for significant stakeholder engagement,
Not a ‘‘Covered Farm’’ for the Purposes Produce Safety and Third-Party beginning before the proposed rule. In
of the Future Produce Safety Rule (Final Certification response to extensive stakeholder input
§ 117.430(d)) LVII. Compliance and Enforcement
LVIII. Executive Order 13175
on the proposed rule, we revised key
E. Alternative Verification Activity When
the Supplier Is a Shell Egg Producer That LIX. Economic Analysis of Impacts provisions in a supplemental notice of
Has Less Than 3,000 Laying Hens (Final LX. Analysis of Environmental Impact proposed rulemaking. After the
§ 117.430(e)) LXI. Paperwork Reduction Act of 1995 supplemental notice of proposed
F. Independence of Persons Who Conduct LXII. Federalism rulemaking, we conducted even more
Supplier Verification Activities (Final LXIII. References outreach to the stakeholder community
§ 117.430(f)) to ensure that the risk-based, preventive
XLVIII. Subpart G: Comments on Onsite Executive Summary requirements in this final rule are
Audit practical and protective of public
Purpose and Coverage of the Rule
A. Requirements Applicable to an Onsite health.
Audit (Final § 117.435(a) and (b)) This rule is part of FDA’s
B. Substitution of Inspection by FDA or an implementation of the FDA Food Safety Summary of the Major Provisions of the
Officially Recognized or Equivalent Food Modernization Act (FSMA), which Rule
Safety Authority intends to better protect public health
C. Onsite Audit by a Third-Party Auditor The final rule implements the
by, among other things, adopting a requirements of FSMA for covered
Accredited for the Purposes of Section
808 of the FD&C Act
modern, preventive, and risk-based facilities to establish and implement a
XLIX. Subpart G: Comments on Records approach to food safety regulation. This food safety system that includes a
Documenting the Supply-Chain Program rule creates certain new requirements hazard analysis and risk-based
A. Applicability of the Recordkeeping for the production of human food by preventive controls. Specifically, the
Requirements of Subpart F (Final registered food facilities, and revises rule establishes requirements for:
§ 117.475(a)) previous requirements, in three key • A written food safety plan;
B. Requirement To Review Records of the ways. • Hazard analysis;
Supply-Chain Program (Final First, this rule creates new • Preventive controls;
§ 117.475(b))
C. Documentation Demonstrating Use of
requirements for certain domestic and • Monitoring;
the Written Procedures for Receiving
foreign facilities to establish and • Corrective actions and corrections;
Raw Materials and Other Ingredients
implement hazard analysis and risk- • Verification;
(Final § 117.475(c)(5)) based preventive controls for human • Supply-chain program;
D. Documentation of the Conduct of an food. In general, these requirements • Recall plan; and
Onsite Audit (Final § 117.475(c)(7)) apply to establishments that are • Associated records.
E. Documentation of Sampling and Testing required to register with FDA as a food We have added flexibility and clarity
(Final § 117.475(c)(8)) ‘‘facility.’’ This portion of the rule to these provisions in response to
F. Documentation of Other Appropriate requires registered food facilities to comments. Although there are
Supplier Verification Activity (Final maintain a food safety plan, perform a similarities between these requirements
§ 117.475(c)(10)) hazard analysis, and institute preventive of FSMA and the requirements of food
G. Documentation of an Alternative
controls for the mitigation of those safety systems known as Hazard
Verification Activity for a Supplier That
Is a Farm That Is Not a ‘‘Covered Farm’’ hazards, unless an exemption applies. Analysis and Critical Control Point
for the Purposes of the Future Produce Facilities must also monitor their (HACCP) systems, not every provision
Safety Rule (Final § 117.475(c)(13)) controls, conduct verification activities in FSMA is identical to the provisions
L. Holding Human Food By-Products to ensure the controls are effective, take of HACCP systems, and we have revised
Intended for Use in Animal Food appropriate corrective actions, and much of our terminology to distinguish
LI. Comments by Foreign Governments and maintain records documenting these FSMA’s requirements for hazard
Foreign Businesses actions. analysis and risk-based preventive
LII. Editorial and Conforming Changes Second, this rule modernizes FDA’s controls from HACCP requirements. A
LIII. Comments on FSMA’s Rulemaking

long-standing current good facility subject to the rule must conduct
Provisions
A. Comments on Requirements in Section manufacturing practice (CGMP) a hazard analysis to identify and
418(n)(3) of the FD&C Act Regarding regulations regarding the evaluate known or reasonably
Content manufacturing, processing, packing, or foreseeable hazards for each type of food
B. Comments on Requirements in Section holding of human food. We have manufactured, processed, packed, or
418(n)(5) of the FD&C Act Regarding updated, revised, and otherwise held at the facility to determine whether
there are any hazards requiring clarifies that corrections must be taken the distribution chain) will control the
preventive controls. The first step of a in a timely manner and must be hazard, then that facility can rely on its
hazard analysis is hazard identification, recorded when appropriate, but they do customer to provide written assurance
which must consider known or not, for example, need to be included in that the identified hazard will be
reasonably foreseeable hazards, a written plan or accompanied by a controlled by an entity in the
including biological, chemical, and reanalysis of the written food safety distribution chain, with flexibility for
physical hazards. The hazard analysis plan. how the customer provides that written
must consider hazards that may be As a third example, the final rule assurance depending on whether the
present in the food because they occur provides flexibility for which customer, or an entity subsequent to the
naturally, are unintentionally verification activities must occur. In customer, will control the hazard. We
introduced, or are intentionally general, a facility is required to conduct have identified four specific
introduced for purposes of economic verification activities, as appropriate to circumstances in which a
gain. We continue to believe that the nature of the preventive control and manufacturing/processing facility can
hazards that may be intentionally its role in the facility’s food safety rely on another entity in the distribution
introduced for economic gain will need system, including validation, chain to control a hazard, with practical
preventive controls in rare verification of monitoring, verification solutions explained further in section
circumstances, usually in cases where of corrective actions, verification of XXVII. We also have provided flexibility
there has been a pattern of economically implementation and effectiveness, and for a facility to establish, document, and
motivated adulteration in the past. reanalysis. Validation is not required for implement an alternative system that
Economically motivated adulteration all controls. For example, the rule ensures adequate control, at a later
that affects product integrity or quality, specifies that validation is not required distribution step, of the hazards in the
for example, but not food safety, is out for certain types of preventive controls food product distributed by a
of the scope of this rule. (i.e., food allergen controls, sanitation manufacturing/processing facility such
A facility subject to the rule must controls, supply-chain controls, and the that the facility would not need to
identify and implement preventive recall plan) and provides flexibility for implement a preventive control.
controls to provide assurances that any the facility to not validate other We revised the proposed provisions
hazards requiring a preventive control preventive controls with a written for a supplier program to add flexibility,
will be significantly minimized or justification based on factors such as the recognizing that the receiving facility
prevented and the food manufactured, nature of the hazard, and the nature of and the supplier may be separated by
processed, packed, or held by the the preventive control and its role in the several entities in a supply chain. We
facility will not be adulterated. The rule facility’s food safety system. Product are allowing entities such as
establishes preventive control testing and environmental monitoring distributors, brokers, and aggregators to
management components (monitoring, are listed as possible verification determine, conduct, and document
corrective actions and corrections, and activities, but, like other preventive appropriate supplier verification
verification) as appropriate to ensure the control management components in activities as a service to the receiving
effectiveness of the preventive controls. general, they are only required as facility, provided that the receiving
One way we have clarified the risk- appropriate to the food, facility, the facility reviews and assesses applicable
based flexibility of these requirements is nature of the preventive control, and the documentation provided by the other
by clearly stating in the final rule that preventive control’s role in the facility’s entity and documents that review and
a facility must take into account the food safety system. In many cases, assessment. However, because the
nature of the preventive control and the neither product testing nor approval of suppliers is ultimately the
facility’s food safety system when environmental monitoring will be responsibility of the receiving facility,
considering which activities are appropriate. For example, there would the rule specifies that only a receiving
appropriate for that facility. be little or no benefit to product testing facility can approve suppliers. To
We have also added flexibility and or environmental monitoring in improve clarity and readability we
made risk-based modifications for facilities that pack or hold produce raw redesignated the proposed provisions
specific preventive control management agricultural commodities that are rarely into eight distinct sections of regulatory
components. For example, the final rule consumed raw, such as potatoes. text in a newly established subpart G
allows flexibility for the specific records A facility must reanalyze the food (Supply-Chain Program).
required to document monitoring of safety plan as a whole at least once Each facility subject to the rule must
refrigeration controls during storage of a every three years. The final rule have a recall plan for a food with a
food that requires time/temperature provides the flexibility for a facility to hazard requiring a preventive control.
control for safety. These records can be only reanalyze the applicable portion of Many activities required by the final
either affirmative records demonstrating the food safety plan under certain other rule must be conducted (or overseen) by
temperature is controlled or ‘‘exception circumstances, such as when a facility a preventive controls qualified
records’’ demonstrating loss of becomes aware of new information individual, a new term we are coining
temperature control. As another about potential hazards associated with here. A preventive controls qualified
example, the rule includes tailored, less a food. individual is a qualified individual who
burdensome requirements for The final rule also adds flexibility to has successfully completed certain
corrections. A correction is defined in the preventive controls requirements training in the development and
this rule as an action to identify and and recognizes the reality of modern application of risk-based preventive
correct a problem that occurred during distribution chains by not requiring a controls or is otherwise qualified
the production of food, without other manufacturing/processing facility to through job experience to develop and
actions associated with a corrective implement a preventive control in apply a food safety system.
action procedure (such as actions to certain circumstances when the hazard The rule establishes several
reduce the likelihood that the problem requiring a preventive control will be exemptions (including modified
will recur, evaluate all affected food for controlled by another entity in the requirements in some cases) from the
safety, and prevent affected food from distribution chain. For example, if a requirements for hazard analysis and
entering commerce). The final rule facility’s customer (or another entity in risk-based preventive controls. All of
these exemptions are expressly food and that is required to register with and risk-based preventive controls
authorized by FSMA. A facility that FDA would be required to comply with unless it is covered by an exemption, as
manufactures, processes, packs, or holds the requirements for hazard analysis shown in the following table.
PROPOSED EXEMPTIONS FROM THE NEW REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE
CONTROLS
Who or what is exempt from the requirements for hazard analysis and Notes
risk-based preventive controls
‘‘Qualified Facility’’ as defined by FSMA: Modified requirements apply—i.e., a qualified facility is required to:
• Business with average annual sales of <$500,000 and at least • Notify FDA about its status; and
half the sales to consumers or local retailers or restaurants • Either:
(within the same state or within 275 miles); or. Æ Notify FDA that it is addressing hazards through preven-
• Very small business, which the rule defines as a business (in- tive controls and monitoring; or
cluding any subsidiaries and affiliates) averaging less than Æ Notify FDA that it complies with applicable non-Federal
$1,000,000, adjusted for inflation, per year, during the 3-year pe- food safety regulations, and notify consumers of the
riod preceding the applicable calendar year in sales of human name and complete business address of the facility
food plus the market value of human food manufactured, proc- where the food was manufactured or processed.
essed, packed, or held without sale (e.g., held for a fee). • The notification is in the form of an attestation, and must be
submitted every two years, during the same timeframe as the fa-
cility is required to update its facility registration.
• Low-risk, on-farm activities performed by small business (<500 full- Small and very small on-farm businesses conducting only the specified
time equivalent employees). low-risk activities are exempt from the requirements for hazard anal-
-or- ysis and risk-based preventive controls.
• Low-risk, on-farm activities performed by a very small business (dol- We define the low-risk, on-farm activities that qualify for the exemption,
lar threshold of $1,000,000, as described previously). including the specific foods to which they relate (such as making
jams, jellies, and preserves from acid fruits, and making milled grain
products such as cornmeal).
Activities that are subject to the seafood HACCP requirements of part The facility must be in compliance with part 123.
123 (21 CFR part 123).
Activities that are subject to the juice HACCP requirements of part 120 The facility must be in compliance with part 120.
(21 CFR part 120).
Activities that are subject to the ‘‘low-acid canned food’’ requirements • The exemption applies only with respect to microbiological hazards
of part 113 (21 CFR part 113). regulated under part 113.
• The facility must be in compliance with part 113.
The manufacturing, processing, packaging, or holding of a dietary sup- • The facility must be in compliance with part 111.
plement that is subject to the CGMP requirements of part 111 (21 • The facility must be in compliance with requirements for serious ad-
CFR part 111). verse event reporting for dietary supplements.
Activities of a facility that are subject to section 419 of the Federal These activities will be established in FDA’s forthcoming rule for
Food, Drug, and Cosmetic Act (Standards for Produce Safety). produce safety.
Alcoholic beverages at a facility that is required to obtain a permit from, The exemption also applies to food other than alcoholic beverages at
register with, or obtain approval of a notice or application from the such a facility, provided that the food is in prepackaged form and
Secretary of the Treasury as a condition of doing business in the constitutes not more than 5 percent of the overall sales of the facility.
United States.
Facilities that are solely engaged in the storage of raw agricultural A facility that stores raw agricultural commodities that are fruits and
commodities (other than fruits and vegetables) intended for further vegetables is not exempt.
distribution or processing.
A facility solely engaged in the storage of packaged food that is not ex- Modified requirements apply for the storage of unexposed packaged
posed to the environment. food that must be refrigerated for safety.
The rule includes procedures for The rule finalizes recordkeeping it is no longer FDA’s practice to include
withdrawing a qualified facility provisions associated with the new guidance in the regulatory text. The rule
exemption, in the event of an active provisions for hazard analysis and risk- finalizes some of the previously
investigation of a foodborne illness based preventive controls. These nonbinding provisions in the CGMPs as
outbreak that is directly linked to the records allow facilities to show, and binding requirements, including a
facility, or if FDA determines that it is FDA to determine, compliance with the requirement for education and training,
necessary to protect the public health new requirements. To meet these but deletes other nonbinding provisions.
and prevent or mitigate a foodborne requirements, a facility may use existing We have revised some key terms for
illness outbreak based on relevant records as appropriate. consistency and clarity. And we have
conditions or conduct associated with In addition to finalizing new clarified FDA’s long-standing position
the qualified facility. The final rule requirements for hazard analysis and that the CGMPs address allergen cross-
provides procedures for a facility to risk-based preventive controls as contact by making that explicit in the
appeal an order to withdraw a qualified required by FSMA, the rule does two regulatory text. Finally, the rule revises
facility exemption, for a facility to more key things. First, it modernizes the a long-standing exemption from the
request an informal hearing, for the existing CGMPs. Second, it revises the CGMP requirements regarding specific
conduct of an informal hearing, for an ‘‘farm’’ definition. activities conducted on raw agricultural
appeal, for revoking an order to The rule makes several revisions to commodities to reflect the contemporary
withdraw a qualified facility exemption, the CGMPs to update and clarify them. regulatory framework associated with
and for reinstating an exemption that For example, the final CGMPs do not the ‘‘farm’’ definition. In addition,
was withdrawn. include nonbinding provisions, because elsewhere in this issue of the Federal
Register, in a final rule that establishes crops, the harvesting of crops, the analysis, and to institute preventive
requirements for hazard analysis and raising of animals (including seafood), controls for the mitigation of those
risk-based preventive controls for food or any combination of these activities. A hazards. It also includes requirements
for animals, FDA is establishing an farm packs and holds raw agricultural for facilities to institute risk-based
additional revision to the human food commodities and may conduct certain environmental monitoring, product
CGMPs to address comments about the manufacturing/processing activities testing, and a supply-chain program as
practice of human food manufacturers (i.e., drying/dehydrating raw appropriate to the food, the facility, and
sending by-products to local farmers or agricultural commodities to create a the nature of the preventive controls, as
animal food manufacturers for use as distinct commodity (such as drying/ well as a requirement to institute
animal food. Because we proposed these dehydrating grapes to produce raisins), controls to help prevent hazards
requirements as part of the rulemaking treatment to manipulate the ripening of associated with economically motivated
for the animal preventive controls rule, raw agricultural commodities (such as adulteration. The total annualized
we are finalizing these provisions in the by treating produce with ethylene gas), domestic costs are estimated to be
final animal preventive controls rule and packaging and labeling). The term approximately $381 million per year,
rather than in this rule. farm also now includes a ‘‘secondary estimated with a 3 percent discount
activities farm,’’ which is an operation, rate, and $382 million per year,
Finally, the rule clarifies the ‘‘farm’’ not located on a primary production
definition that is central to the estimated at 7 percent when discounted
farm, devoted to the key farming
determination of whether certain over 10 years. We estimate that
operations of harvesting, packing, and/
entities must register as a food facility processed foods covered by this
or holding of raw agricultural
and, thus, become subject to the new commodities, provided that the primary rulemaking are responsible for
requirements for hazard analysis and production farm(s) that grow, harvest, approximately 903,000 foodborne
risk-based preventive controls. The final and/or raise the majority of the raw illnesses each year, at a total cost to the
‘‘farm’’ definition reflects current agricultural commodities harvested, American public of approximately $2.2
farming practices, differentiates between packed, and/or held by the secondary billion. Our break-even analysis shows
two types of farm operations (i.e., a activities farm owns, or jointly owns, a that for the rule to be cost effective, it
‘‘primary production farm’’ and a majority interest in the secondary would have to prevent $382 million
‘‘secondary activities farm’’), and allows activities farm. A secondary activities worth of foodborne illness;
for a consistent—although not farm may also conduct those additional approximately 17 percent of the total
identical—regulatory approach across activities allowed on a primary annual illnesses, or approximately
similar operations, to the extent production farm. 157,000 illnesses when using a discount
possible. In general, a ‘‘primary rate of 7 percent. For the rule to be cost
production farm’’ is an operation under Costs and Benefits effective using a discount rate of 3
one management in one general (but not This final regulation requires percent, it would have to prevent $381
necessarily contiguous) physical domestic and foreign facilities to adopt million worth of foodborne illness
location devoted to the growing of a food safety plan, perform a hazard (about 17 percent or 156,000 illnesses).
COSTS AND HEALTH BENEFITS

[$ millions]
One-time cost One-time cost

second yr compli- third yr compli- Annual cost
One-time cost ance period ance period (annually Total annualized Total Annualized
PCHF Provision first yr compliance (small (very small recurring cost at 7% cost at 3%
period businesses businesses costs)
<500 FTE’s) <$1 million)
Learn about Rule $6 $96 $21 $0 $16 $14

Total Costs Sub-
parts A & D ....... 17 148 88 15 43 41
Total Costs Sub-
parts C & G ...... 9 183 0 340 323 326
Total Domestic
Costs ................ 32 427 109 355 382 381
Total Foreign
Costs ................ 68 915 234 760 820 817
Total Costs ........... 100 1,342 344 1,115 1,202 1,198
Total Health Bene-

fits ..................... Not Quantified. Break-even occurs when 157,000 illnesses are prevented per year (based on domestic costs discounted at
7 percent).
TABLE OF ABBREVIATIONS AND ACRONYMS

Abbreviation/acronym What it means
Bioterrorism Act ............................... Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107–188).
CFSAN ............................................. Center for Food Safety and Applied Nutrition.
CGMP .............................................. Current Good Manufacturing Practice.
Codex ............................................... Codex Alimentarius Commission.
TABLE OF ABBREVIATIONS AND ACRONYMS—Continued

Abbreviation/acronym What it means
Codex Validation Guidelines. ........... Codex Guidelines for the Validation of Food Safety Control Measures.
CSA .................................................. Community Supported Agriculture.
CPG ................................................. Compliance Policy Guide.
EO .................................................... Executive Order.
EPA .................................................. U.S. Environmental Protection Agency.
EU .................................................... European Union.
FDA. ................................................. U.S Food and Drug Administration.
FD&C Act ......................................... Federal Food, Drug, and Cosmetic Act.
FSIS ................................................. Food Safety and Inspection Service of the U.S. Department of Agriculture.
FSIS Validation Guidelines .............. FSIS’ Compliance Guidelines on HACCP Systems Validation.
FSMA ............................................... FDA Food Safety Modernization Act.
FSPCA ............................................. Food Safety Preventive Controls Alliance.
GFSI ................................................. Global Food Safety Initiative.
HACCP ............................................. Hazard Analysis and Critical Control Point.
HIPAA .............................................. Health Insurance Portability and Accountability Act of 1996.
Infant formula rule ............................ Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Require-
ments, and Records and Reports, for Infant Formula, June 10, 2014 (79 FR 33057).
ISO ................................................... International Organization for Standardization.
LACF ................................................ Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (commonly called
‘‘Low-Acid Canned Foods’’).
N/A ................................................... Not Applicable.
NCIMS .............................................. National Conference on Interstate Milk Shipments.
NIFA ................................................. National Institute of Food and Agriculture.
NOP ................................................. National Organic Program.
OMB ................................................. Office of Management and Budget.
PHS Act ........................................... Public Health Service Act.
PMO ................................................. Pasteurized Milk Ordinance.
PMO facilities ................................... Facilities that comply with the PMO and are regulated under the NCIMS system.
PFP .................................................. Partnership for Food Protection.
PRA .................................................. Paperwork Reduction Act.
PSA .................................................. Produce Safety Alliance.
RAC .................................................. Raw agricultural commodity.
RFR .................................................. Reportable Food Registry.
Section 103(c)(1)(C) draft RA .......... Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm
Definition) Conducted in a Facility Co-Located on a Farm.
Section 103(c)(1)(C) RA .................. Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Defini-
tion) Conducted in a Facility Co-Located on a Farm (Final).
SBA .................................................. Small Business Administration.
SECG ............................................... Small Entity Compliance Guide.
TCS food .......................................... Time/Temperature Control for Safety Food.
USDA ............................................... U.S. Department of Agriculture.
I. Background on reacting to problems after they occur. and territorial authorities. A top priority
A. FDA Food Safety Modernization Act The law also provides new enforcement for FDA are those FSMA-required
authorities to help achieve higher rates regulations that provide the framework
The FDA Food Safety Modernization of compliance with risk-based, for industry’s implementation of
Act (FSMA) (Pub. L. 111–353), signed prevention-oriented safety standards preventive controls and enhance our
into law by President Obama on January and to better respond to and contain ability to oversee their implementation
4, 2011, is intended to allow FDA to
problems when they do occur. In for both domestic and imported food. To
better protect public health by helping
addition, the law contains important that end, we proposed the seven
to ensure the safety and security of the
food supply. FSMA enables us to focus new tools to better ensure the safety of foundational rules listed in table 1 and
more on preventing food safety imported foods and encourages requested comments on all aspects of
problems rather than relying primarily partnerships with State, local, tribal, these proposed rules.
TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

Title Abbreviation Publication
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2013 proposed human preventive 78 FR 3646, January 16, 2013
Based Preventive Controls for Human Food. controls rule.
Standards for the Growing, Harvesting, Packing, and Holding of 2013 proposed produce safety rule 78 FR 3504, January 16, 2013
Produce for Human Consumption.

Current Good Manufacturing Practice and Hazard Analysis and Risk- 2013 proposed animal preventive 78 FR 64736, October 29, 2013
Based Preventive Controls for Food for Animals. controls rule.
Foreign Supplier Verification Programs (FSVP) for Importers of Food 2013 proposed FSVP rule ............. 78 FR 45730, July 29, 2013
for Humans and Animals.
Accreditation of Third-Party Auditors/Certification Bodies to Conduct 2013 proposed third-party certifi- 78 FR 45782, July 29, 2013
Food Safety Audits and to Issue Certifications. cation rule.
TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA—Continued

Focused Mitigation Strategies To Protect Food Against Intentional 2013 proposed intentional adulter- 78 FR 78014, December 24, 2013
Adulteration. ation rule.
Sanitary Transportation of Human and Animal Food ............................. 2014 proposed sanitary transpor- 79 FR 7006, February 5, 2014
tation rule.
We also issued a supplemental notice listed in table 2 and requested in each supplemental notice of
of proposed rulemaking for the rules comments on specific issues identified proposed rulemaking.
TABLE 2—PUBLISHED SUPPLEMENTAL NOTICES OF PROPOSED RULEMAKING FOR THE FOUNDATIONAL RULES FOR
IMPLEMENTATION OF FSMA
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2014 supplemental human preven- 79 FR 58524, September 29, 2014
Based Preventive Controls for Human Food. tive controls notice.
Standards for the Growing, Harvesting, Packing, and Holding of 2014 supplemental produce safety 79 FR 58434, September 29, 2014
Produce for Human Consumption. notice.
Current Good Manufacturing Practice and Hazard Analysis and Risk- 2014 supplemental animal preven- 79 FR 58476, September 29, 2014
Based Preventive Controls for Food for Animals. tive controls notice.
Foreign Supplier Verification Programs (FSVP) for Importers of Food 2014 supplemental FSVP notice ... 79 FR 58574, September 29, 2014
for Humans and Animals.
As FDA finalizes these seven forward for food safety that will protect We issued a notice correcting several
foundational rulemakings, we are consumers into the future. typographical and stylistic errors in the
putting in place a framework for food B. Stages in the Rulemaking for the 2013 proposed human preventive
safety that is modern and brings to bear Human Preventive Controls Rule controls rule and a mistake in the date
the most recent science on provisions to of a reference (78 FR 17142, March 20,
enhance food safety, that is risk-based With regard to this rulemaking, we 2013). In that correction notice, we
and focuses effort where the hazards are published proposed provisions in the republished the Appendix in its entirety
2013 proposed human preventive (78 FR 17142 at 17143 through 17155;
reasonably likely to occur, and that is
controls rule and we published new and the corrected Appendix) because all the
flexible and practical given our current
re-proposed provisions in the 2014 references to the Appendix as published
knowledge of food safety practices. To
supplemental human preventive in the 2013 proposed human preventive
achieve this, FDA has engaged in a great controls notice. In the 2014
deal of outreach to the stakeholder controls rule (78 FR 3646 at 3812
supplemental human preventive through 3824) had been numbered
community to find the right balance in controls notice, we reopened the
these regulations of flexibility and incorrectly. We also extended the
comment period only with respect to comment periods for the 2013 proposed
accountability. specific proposed provisions. In human preventive controls rule, its
Since FSMA was enacted in 2011, we addition, we emphasized that the re- information collection provisions, and a
have been involved in approximately proposed provisions we included in the related risk assessment (see section I.D)
600 engagements on FSMA and the regulatory text were based on a in response to several requests that we
proposed rules, including public preliminary review of the comments. do so.
meetings, webinars, listening sessions, In this document, we use the broad
farm tours, and extensive presentations term ‘‘proposed human preventive C. Summary of the Major Provisions of
and meetings with various stakeholder controls rule’’ to refer to the complete Proposed Human Preventive Controls
groups (Ref. 1) (Ref. 2). As a result of proposed regulatory text, including both Rule
the proposed provisions we published
this stakeholder dialogue, FDA decided As part of our announced initiative
in the 2013 proposed human preventive
to issue the four supplemental notices of (Ref. 3) to revisit the CGMP
controls rule and the new and re-
proposed rulemaking to share our proposed provisions we published in requirements since they were last
current thinking on key issues and get the 2014 supplemental human revised in 1986, we proposed to amend
additional stakeholder input on those preventive controls notice. We use the our regulation for Current Good
issues. As we move forward into the narrow terms ‘‘2013 proposed human Manufacturing Practice In
next phase of FSMA implementation, preventive controls rule’’ and ‘‘2014 Manufacturing, Packing, or Holding
we intend to continue this dialogue and supplemental human preventive Human Food (currently established in
collaboration with our stakeholders, controls notice’’ to refer to specific text part 110 (21 CFR part 110)) to: (1)
through guidance, education, training, published in the Federal Register of Modernize it; (2) adjust and clarify what
and assistance, to ensure that everyone January 16, 2013 (78 FR 3646) and activities fall within the long-standing
understands and engages in their role in September 29, 2014 (79 FR 58524), exemption from the CGMP requirements
food safety. FDA believes these seven respectively. We use the terms ‘‘final for establishments engaged solely in the
foundational final rules, when human preventive controls rule’’ and harvesting, storage, or distribution of
implemented, will fulfill the paradigm ‘‘this rule’’ to refer to the regulations we one or more raw agricultural
shift toward prevention that was are establishing as a result of this commodities (RACs) based on
envisioned in FSMA and be a major step rulemaking. experience and changes in related areas
of the law since issuance of the CGMP controls, and related requirements in establishment’’ in the section 415
regulation; (3) delete some non-binding new part 117 as shown in table 3: registration regulations in the near
provisions of current part 110; and (4) future.
re-establish the provisions of current TABLE 3—PROPOSED SUBPARTS IN
part 110 in new part 117 (21 CFR part NEW PART 117 F. Public Comments
117). We also requested comment on: (1) We received more than 8,000 public
Additional proposed revisions or Sub- Title submissions on the 2013 proposed
clarifications to our CGMP regulations, part
human preventive controls rule, and
including whether to further implement
A ........ General Provisions. more than 1,300 public submissions on
opportunities for CGMP modernization, B ........ Current Good Manufacturing Prac-
such as on how best to revise the the 2014 preventive controls
tice. supplemental notice, each containing
current provisions for training; and (2) C ....... Hazard Analysis and Risk-Based
whether to revise some non-binding one or more comments. We received
Preventive Controls.
provisions to establish new D ....... Modified Requirements. submissions from diverse members of
requirements in proposed part 117, or to E ........ Withdrawal of an Exemption Applica- the public, including food facilities
simply retain them as useful provisions ble to a Qualified Facility. (including facilities co-located on a
of a comprehensive CGMP. F ........ Requirements Applying to Records farm); farms; cooperatives; coalitions;
As part of our implementation of new That Must Be Established and trade organizations; consulting firms;
statutory provisions in FSMA, we also Maintained. law firms; academia; public health
proposed to add, in newly established organizations; public advocacy groups;
part 117, requirements for certain D. Draft Risk Assessment consumers; consumer groups; Congress;
domestic and foreign facilities to We issued for public comment a Federal, State, local, and tribal
establish and implement hazard ‘‘Draft Qualitative Risk Assessment: Government Agencies; and other
analysis and risk-based preventive Risk of Activity/Food Combinations for organizations. Some submissions
controls for human food. As directed by Activities (Outside the Farm Definition) included signatures and statements from
FSMA (see section 418 of the Federal Conducted in a Facility Co-Located on multiple individuals. Comments
Food, Drug, and Cosmetic Act (FD&C a Farm’’ (the section 103(c)(1)(C) draft address virtually every provision of the
Act)), these new provisions would apply RA) (78 FR 3824, January 16, 2013). The proposed human preventive controls
to domestic and foreign facilities that purpose of the section 103(c)(1)(C) draft rule. In the remainder of this document,
are required to register under section RA was to provide a science-based risk we describe these comments, respond to
415 of the FD&C Act and our regulation analysis of those activity/food them, and explain any revisions we
for Registration of Food Facilities (21 combinations that would be considered made to the proposed human preventive
CFR part 1, subpart H; the section 415 low risk when conducted in a facility controls rule.
registration regulations). As directed by co-located on a farm. We used the
FSMA (see sections 418(l) and (m) of the tentative conclusions of the section Some comments address issues that
FD&C Act), we proposed to establish 103(c)(1)(C) draft RA to propose to are outside the scope of this rule. For
modified requirements for certain exempt food facilities that are small or example, some comments express
facilities. We requested comment on all very small businesses that are engaged concern over pesticides being used on
aspects of the proposed requirements, only in specific types of on-farm local crops being harmful to the
including an opportunity for public manufacturing, processing, packing, or honeybee population. Other comments
comment on potential requirements for holding activities from the requirements address the requirements of the
product testing, environmental for hazard analysis and risk-based proposed produce safety rule, such as
monitoring, a supply-chain program, preventive controls. We are including standards for water quality. Other
and hazards that may be intentionally the final risk assessment (the section comments express concern about the
introduced for purposes of economic 103(c)(1)(C) RA) in the docket use of bioengineered food ingredients,
gain. established for this document (Ref. 4). and ask that foods containing such
As directed by section 103 of FSMA, ingredients be labeled so that consumers
we proposed to clarify the scope of the E. Definition of ‘‘Retail Food
Establishment’’ can identify such foods and choose
exemption from the section 415 whether to consume them. Other
registration regulations for ‘‘farms’’ by An establishment that meets the comments assert that the rules should
revising the ‘‘farm’’ definition and by definition of ‘‘retail food establishment’’ address social issues. We do not discuss
adding or modifying the definitions for is exempt from the requirements of the such comments in this document.
certain activities (i.e., for ‘‘harvesting,’’ section 415 registration regulations and,
‘‘holding,’’ ‘‘manufacturing/processing,’’ thus, from FSMA’s requirements for II. Legal Authority
and ‘‘packing’’ activities) that govern, in hazard analysis and risk-based
part, whether a business that is devoted preventive controls. Section 102(c) of The proposed rule contained an
to the growing of crops, the raising of FSMA requires that we revise the explanation of its legal basis under
animals, or both is within the ‘‘farm’’ definition of ‘‘retail food establishment’’ authorities in the FDA Food Safety
definition. We also proposed to add or in § 1.227 to clarify its intent. We are Modernization Act, the FD&C Act, and
revise these definitions in our current addressing the requirements of section the Public Health Service Act. After
regulation (implementing section 414 of 102(c) of FSMA in a separate considering comments received in
the FD&C Act) for Establishment and rulemaking and issued a separate response to the 2013 proposed human
Maintenance of Records for Foods (21 proposed rule to amend the definition of preventive controls rule and 2014
CFR part 1, subpart J; the section 414 ‘‘retail food establishment’’ in the supplemental human preventive
recordkeeping regulations), which also section 415 registration regulations and controls notice, FDA made changes in
have an exemption for ‘‘farms.’’ the section 414 recordkeeping the final rule. The legal authorities
We proposed to establish the regulations (80 FR 19160, April 9, 2015). relied on for the final rule are the same
requirements for CGMPs, for hazard We intend to issue a final rule to amend as in the proposed rule unless otherwise
analysis and risk-based preventive the definition of ‘‘retail food described in the sections that follow.
A. Changes to Current 21 CFR Part 1, putrid, or decomposed substances, agent in charge of a facility to evaluate
Subparts H, I, and J being otherwise unfit for food, or being the hazards that could affect food
Sections 103(c)(2)(A) and (B) of FSMA prepared, packed, or held under manufactured, processed, packed, or
require that the Secretary adopt final insanitary conditions whereby it may held by the facility, identify and
rules for purposes of section 415 of the have become contaminated with filth, or implement preventive controls, monitor
FD&C Act (Registration of Food whereby it may have been rendered the performance of those controls, and
Facilities) with respect to ‘‘activities injurious to health. maintain records of the monitoring.
In addition to the FD&C Act, FDA’s Section 418(a) specifies that the purpose
that constitute on-farm packing or
legal authority for the changes to current of the preventive controls is to ‘‘prevent
holding of food that is not grown,
CGMP requirements derives from the the occurrence of such hazards and
raised, or consumed on such farm or
PHS Act to the extent such measures are provide assurances that such food is not
another farm under the same
related to communicable disease. adulterated under section 402 [of the
ownership’’ and ‘‘activities that
Authority under the PHS Act is derived FD&C Act] or misbranded under section
constitute on-farm manufacturing or from the provisions of sections 311, 361, 403(w) [of the FD&C Act]. . . .’’ In
processing of food that is not consumed and 368 (42 U.S.C. 243, 264, and 271) addition to the general requirements in
on that farm or on another farm under that relate to communicable disease. section 418(a) of the FD&C Act, sections
common ownership.’’ In section IV, we The PHS Act authorizes the Secretary to 418(b)–(i) contain more specific
discuss our revision of the section 415 make and enforce such regulations as requirements applicable to facilities.
registration regulations (21 CFR part 1, ‘‘are necessary to prevent the These include hazard analysis (section
subpart H) to clarify the types of introduction, transmission, or spread of 418(b)), preventive controls (section
activities that are included as part of the communicable diseases from foreign 418(c)), monitoring (section 418(d)),
definition of the term ‘‘facility’’ under countries into the States * * * or from corrective actions (section 418(e)),
section 415 of the FD&C Act and the one State * * * into any other State’’ verification (section 418(f)),
scope of the exemption for ‘‘farms’’ (section 361(a) of the PHS Act). (See sec. recordkeeping (section 418(g)), a written
provided by section 415 of the FD&C 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. plan and documentation (section
Act. The final rule also makes 202 for transfer of authority from the 418(h)), and reanalysis of hazards
corresponding changes in part 1, Surgeon General to the Secretary.) The (section 418(i)).
subpart I (Prior Notice of Imported revisions we are making to the current Section 103(c)(2)(C) of FSMA requires
Food) and in part 1, subpart J CGMP regulation are necessary to that the Secretary adopt a final rule with
(Establishment, Maintenance, and prevent the spread of communicable respect to the requirements under
Availability of Records). FDA’s legal disease. sections 418 and 421 of the FD&C Act
authority to modify these regulations is from which the Secretary may issue
derived from section 103(c) of FSMA C. Hazard Analysis and Risk-Based
exemptions or modifications of the
and sections 414, 415, 381(m) and Preventive Controls
requirements for certain types of
371(a) of the FD&C Act (21 U.S.C. 350c, Section 103 of FSMA, Hazard facilities. Sections 418(j)–(m) of the
350d, 801(m), and 701(a)). Analysis and Risk-Based Preventive FD&C Act and sections 103(c)(1)(D) and
Controls, amends the FD&C Act to (g) of FSMA provide authority for
B. Changes to Current 21 CFR Part 110
create a new section 418, which certain exemptions and modifications to
The changes to the current CGMP mandates rulemaking. Section the requirements of section 418 of the
regulation finalized in this document 418(n)(1)(A) of the FD&C Act requires FD&C Act. These include provisions
clarify the existing requirements of the that the Secretary issue regulations ‘‘to related to seafood and juice HACCP, and
regulation and update existing establish science-based minimum low-acid canned food (section 418(j));
requirements to reflect changes in the standards for conducting a hazard activities of facilities subject to section
food industry and in scientific analysis, documenting hazards, 419 of the FD&C Act (Standards for
understanding of food safety since implementing preventive controls, and Produce Safety) (section 418(k));
issuance of the current regulation. documenting the implementation of the qualified facilities (section 418(l));
FDA’s legal authority to require Current preventive controls. . . .’’ Section facilities that are solely engaged in the
Good Manufacturing Practices derives 418(n)(1)(B) of the FD&C Act requires production of food for animals other
from sections 402(a)(3), (a)(4) and 701(a) that the regulations define the terms than man, the storage of raw agricultural
of the FD&C Act (21 U.S.C. 342(a)(3), ‘‘small business’’ and ‘‘very small commodities (other than fruits and
342(a)(4), and 371(a)). Section 402(a)(3) business,’’ taking into consideration the vegetables) intended for further
of the FD&C Act provides that a food is study of the food processing sector distribution or processing, or the storage
adulterated if it consists in whole or in required by section 418(l)(5) of the of packaged foods that are not exposed
part of any filthy, putrid, or FD&C Act. Further, section 103(e) of to the environment (section 418(m));
decomposed substance, or if it is FSMA creates a new section 301(uu) in facilities engaged only in certain low-
otherwise unfit for food. Section the FD&C Act (21 U.S.C. 331(uu)) to risk on-farm activities on certain foods
402(a)(4) of the FD&C Act provides that prohibit ‘‘[t]he operation of a facility conducted by small or very small
a food is adulterated if it has been that manufactures, processes, packs, or businesses (section 103(c)(1)(D) of
prepared, packed, or held under holds food for sale in the United States FSMA), and dietary supplements
insanitary conditions whereby it may if the owner, operator, or agent in charge (section 103(g) of FSMA). In sections XI,
have become contaminated with filth, or of such facility is not in compliance XII, XXXVIII, and XXXIX, we discuss
whereby it may have been rendered with section 418 [of the FD&C Act].’’ provisions that implement these
injurious to health. Under section 701(a) In addition to rulemaking exemptions and modified requirements.
of the FD&C Act, FDA is authorized to requirements, section 418 contains In the 2014 supplemental human
issue regulations for the efficient requirements applicable to the owner, preventive controls notice, we included
enforcement of the FD&C Act. The operator, or agent in charge of a facility potential requirements for a supplier
revisions we are making to the current required to register under section 415. program, environmental monitoring,
CGMP regulation are necessary to Section 418(a) is a general provision and product testing. We are including
prevent food from containing filthy, that requires the owner, operator, or provisions for such activities in the final
rule. Section 418(o)(3) of the FD&C Act FDA concludes that the provisions in manufactures, processes, packs, or holds
provides supplier verification activities subpart C and related requirements in food for sale in the United States if the
and an environmental monitoring subparts A, D, F, and G should be owner, operator, or agent in charge of
program as examples of preventive applicable to activities that are intrastate such facility is not in compliance with
controls. Section 418(f)(4) of the FD&C in character. Facilities are required to section 418’’ is a prohibited act.
Act provides for the use of register under section 415 of the FD&C Notably, other subsections in section
environmental and product testing Act regardless of whether the food from 301 of the FD&C Act, and section 304
programs as part of required verification the facility enters interstate commerce of the FD&C Act (21 U.S.C. 334)
that the preventive controls are (§ 1.225(b)). The plain language of demonstrate that Congress has included
effectively and significantly minimizing section 418 of the FD&C Act applies to a specific interstate commerce nexus in
or preventing the occurrence of facilities that are required to register the provisions of the FD&C Act when
identified hazards. under section 415 (section 418(o)(2) of that is its intent. Accordingly, it is
In certain circumstances, the final the FD&C Act) and does not exclude a reasonable to interpret sections 418 and
rule does not require a manufacturing/ facility from the requirements because 301(uu) of the FD&C Act as not limiting
processing facility to implement a food from such a facility is not in the application of the rule only to those
preventive control for a hazard requiring interstate commerce. Further, the facilities with a direct connection to
a preventive control. Instead, the facility prohibited act provision associated with interstate commerce.
is permitted to rely on a subsequent section 418 (section 301(uu) of the FDA is mindful that its interpretation
entity in the distribution chain to FD&C Act) does not require interstate of FSMA and the FD&C Act should not
significantly minimize or prevent the commerce for a violation. cast doubt on their constitutionality.
FDA also is issuing the provisions in
hazard. In such a circumstance, a (See Solid Waste Agency of Northern
subpart C and related requirements in
facility must disclose in documents Cook County v. U.S., 531 U.S. 159
Subparts A, D, F, and G, under sections
accompanying the food, that the food is (2001)). FDA has considered the
402(a)(3), 402(a)(4), 403(w), and 701(a)
‘‘not processed to control [identified relevant provisions of FSMA and the
of the FD&C Act to the extent such
hazard].’’ This requirement is supported FD&C Act, FDA’s responsibilities in
requirements are necessary to prevent
by sections 418 and 701(a) of the FD&C implementing those laws, and the law
food from being held under insanitary
Act (21 U.S.C. 350g and 371(a)). The interpreting the commerce clause of the
conditions whereby it may become
requirement that facilities apply Constitution (Article I, section 8).
contaminated with filth or rendered
preventive controls to significantly injurious to health, or being unfit for Congress’ power to legislate under the
minimize or prevent hazards is food; and to the extent necessary to commerce clause is very broad.
fundamental to the public health prevent food from being misbranded However, such power is not without
benefits of the rule. To accommodate under section 403(w). FDA also is limits, see United States v. Lopez, 514
the realities of modern food production, finalizing those provisions under U.S. 549, 567 (1995); U.S. v. Morrison,
the rule allows a facility to rely on a sections 311, 361, and 368 of the PHS 529 U.S. 598, 618 (2000), and these
subsequent entity in the distribution Act relating to communicable disease to limits have been construed in light of
chain rather than requiring that facility the extent those provisions are relevant and enduring precedents. In
to apply the control. A food may pass necessary to prevent the interstate particular, in Lopez, supra, the Supreme
through multiple entities in the spread of communicable disease. Court acknowledged the continuing
distribution chain before it reaches vitality of Wickard v. Filburn, 317 U.S.
consumers. Further, ordinarily it is not D. Comments on Legal Authority 111 (1942), noting that ‘‘although
apparent from visual examination of the (Comment 1) One comment asserts Filburn’s own contribution to the
food whether a hazard requiring a that FDA does not have authority to demand for wheat may have been trivial
preventive control has been addressed. regulate intrastate commercial activities. by itself, that was not ‘enough to remove
Consequently, without labeling, a Another comment asserts that FDA does him from the scope of Federal
facility might not know that a facility not have authority to regulate farms that regulation where, as here, his
upstream in the supply chain has not are selling wholly intrastate. contribution, taken together with that of
applied a preventive control and is (Response 1) With regard to farms, many others similarly situated, is far
relying on a downstream entity to do so. this rule does not apply. With respect to from trivial.’ ’’ (514 U.S. at 556.) See also
Therefore, the agency concludes that farms that engage in activities outside Gonzales v. Raich, 545 U.S. 1, 17–25
information that food has not been the farm definition (i.e., farm mixed- (2005). This principle applies to the
processed to control an identified type facilities), this rule applies to the application of sections 418 and 301(uu)
hazard is necessary for a facility to fulfil non-farm portion of the operation. of the FD&C Act, as added by section
its obligation under section 418 when a FDA disagrees with the comments 104 of FSMA. Accordingly, given the
facility is relying on a subsequent entity regarding application of this rule to collective impact on commerce of
to control the hazard. The agency also activities that are intrastate in character. facilities that manufacture, process,
concludes that such labeling is Facilities are required to register under pack, or hold food that is sold in
necessary for the efficient enforcement section 415 of the FD&C Act regardless intrastate commerce, FDA concludes
of the Act because the labelling is of whether the food from the facility that such facilities should be subject to
critical for FDA to hold facilities enters interstate commerce (§ 1.225(b)). the rule. FDA notes that to the extent
responsible for their obligations under The plain language of section 418 of the these facilities are very small, they are
this regulatory scheme. Further, when FD&C Act applies to facilities that are subject to modified requirements under
the hazard can cause a communicable required to register under section 415 § 117.201. This outcome regarding
disease, FDA concludes that the (section 418(o)(2) of the FD&C Act) and intrastate commerce is consistent with
requirement is necessary to prevent the does not exclude a facility because food section 709 of the FD&C Act (21 U.S.C.
spread of communicable disease from from such a facility is not in interstate 379a), which states that in any action to
one state into another state and relies on commerce. Section 301(uu) of the FD&C enforce the act’s requirements
sections 311, 361, and 368 of the PHS Act (21 U.S.C. 331(uu)) provides that respecting foods, drugs, devices, and
Act. ‘‘the operation of a facility that cosmetics, any necessary connection
with interstate commerce is presumed. 10.115(g)). The public may submit emerged, and do not intend to convene
Likewise, this outcome is consistent comments on any guidance document at annual workgroups to assess that data
with FSMA’s risk-based, preventive any time (§ 10.115(g)(5)). and information.
approach to food safety because the risk We agree with comments that stress (Comment 3) Several comments ask
presented by unsafe food can be the importance of education and us to classify specific on-farm activities
significant, whether or not the food outreach. A central element of our as harvesting, packing, holding, or
moves from one state to another. strategy to gain industry compliance is manufacturing/processing so that an
to help make available to facilities operation that conducts these activities
III. General Comments on the Proposed subject to this rule the education and on a farm can determine whether
Rule technical assistance they need to conducting that specific activity is
(Comment 2) Several comments ask understand and implement the within, or outside, the ‘‘farm’’
us to develop guidance to accompany requirements (Ref. 6). Within the definition. These comments emphasize
the rule, particularly with respect to the Agency we are establishing a Food that a farm operation needs to know
new requirements for hazard analysis Safety Technical Assistance Network when a specific activity that it conducts
and risk-based preventive controls. For and seeking funding to increase FDA would be outside the ‘‘farm’’ definition
example, comments ask us to provide staffing to provide a central source of for the purposes of the requirements to
guidance on topics such as hazard information to support industry register as a food facility and, thus,
analysis, environmental monitoring, and understanding and implementation of require that the farm operation both
validation. Some of these comments ask FSMA standards (Ref. 6). This will register as a food facility and comply
that drafts of the guidance first be made allow us to respond in a timely and with the new requirements for hazard
available for public comment. consistent way to industry questions on analysis and risk-based preventive
Other comments emphasize the preventive controls technical and controls. Some of these comments focus
importance of education and outreach compliance issues (Ref. 6). on activities that we have previously
and ask us to provide support for We also are working in collaboration classified in more than one way (e.g.,
ongoing education and outreach, with the Food Safety Preventive ‘‘washing,’’ which we have previously
including an active role in providing Controls Alliance (FSPCA) to develop classified as both ‘‘harvesting’’ and
needed instructional examples and training materials and establish training ‘‘manufacturing/processing,’’ depending
lessons learned from current and technical assistance programs (Ref. on when the activity occurs) (See table
investigations and foodborne outbreaks. 5) and (Ref. 7). The Alliance includes 1 in the Appendix to the 2014
Some comments ask us to convene a members from FDA, State food supplemental human preventive
scientific workgroup that includes protection agencies, the food industry, controls rule, 79 FR 58524 at 58571–
experts in food and laboratory science, and academia. It is funded by a grant to 58572.) Other comments ask us to
public health, proficiency testing, the Illinois Institute of Technology’s periodically review our lists of
quality control, and other areas on at Institute for Food Safety and Health, a harvesting, packing, holding, and
least an annual basis to assess what nationally-recognized leader in food manufacturing/processing activities to
pathogens should be addressed in a food safety. In addition to developing a ensure that they reflect current
safety plan. standardized preventive controls practices. Some comments ask us to
Some comments ask that funding and training curriculum, the FSPCA is make a table of activities prominently
information on funding for training be developing selected sections of model available on our Internet site for easy
provided. Other comments assert that food safety plans for several food types access whenever the public seeks out
we must make available adequate that will provide needed instructional information regarding the forthcoming
resources to support outreach and examples. Although we have provided produce safety rule and the human
technical assistance delivered by State funding to the FSPCA to develop a preventive controls rule.
regulatory agencies, as well as standardized preventive controls (Response 3) We have added several
Cooperative Extension programs and training curriculum, we are unable to examples of ‘‘harvesting,’’ ‘‘packing,’’
non-governmental organizations that fund training for individual groups who ‘‘holding,’’ and ‘‘manufacturing/
work directly with farmers and might need particular training materials. processing’’ to the regulatory text (see
facilities. We also are partnering with the §§ 1.227, 1.328, and 117.3 and Response
(Response 2) We are developing National Institute of Food and 27, Response 28, Response 29, Response
several guidance documents, including Agriculture (NIFA) of the U.S. 31, Response 37, Response 38 and
general guidance on hazard analysis and Department of Agriculture (USDA) to Response 39). However, it is not
preventive controls, as well as guidance administer the FSMA-mandated practical to include every possible
on specific aspects such as National Food Safety Training, activity conducted by farm operations in
environmental monitoring and food Education, Extension, Outreach, and the regulatory text. Attempting to
allergen control (Ref. 5). We also intend Technical Assistance Program, a grant include a more extensive set of
to develop guidance specific to a variety program to provide technical assistance examples in the regulatory text has the
of food types based in part on technical for FSMA compliance to owners and potential to signal—incorrectly—that
information we obtained through a grant operators of small and medium-size any activity not specified in the
for this purpose, as well as on other farms and small food processors (Ref. 8). regulatory text cannot be considered to
topics, such as validation. We will Such efforts will help ensure be within the definition of that activity.
develop and issue this guidance in widespread voluntary compliance by In addition, we have not previously
accordance with our good guidance encouraging greater understanding and discussed our approach to classifying
practices regulation, which establishes adoption of established food safety some of the activities mentioned in the
criteria for when we issue a guidance standards, guidance, and protocols. comments, and we believe that we
document as an initial draft, invite At this time, we intend to rely on should provide an opportunity for
public comment, and prepare a final scientific publications and public comment on a more extensive list
version of the guidance document that epidemiological findings to assess the of activities classified as ‘‘harvesting,’’
incorporates suggested changes, when potential that new pathogens, or more packing,’’ ‘‘holding,’’ or
appropriate (§ 10.115(g)) (21 CFR virulent pathogenic strains, have ‘‘manufacturing/processing.’’
To address these comments, in the rather than through a separate adherence to organic standards). Some
near future we intend to issue a draft rulemaking. One comment notes that its comments express concern about the
guidance with our current thinking on farm has a store and a café that use time gap between the effective date of
the classification of activities as products from the farm, and it is not this rule and the time it will take to
‘‘harvesting,’’ packing,’’ ‘‘holding,’’ or clear if the store and café will be under incorporate applicable provisions into
‘‘manufacturing/processing.’’ In regulations while nearby restaurants State law.
accordance with our regulation on good and grocery stores are not. Some (Response 5) We are working through
guidance practices (§ 10.115(g)(1)), we comments ask us to define farmers’ the Partnership for Food Protection
will review any comments received and markets, CSA programs, roadside (PFP) (a group of dedicated
prepare the final version of the guidance stands, and other direct-to-consumer professionals from Federal, State, local,
document that incorporates suggested programs as retail food establishments tribal, and territorial governments with
changes, when appropriate; publish a not subject to registration as part of the roles in protecting the food supply and
notice in the Federal Register human preventive controls rulemaking public health) to develop and
announcing that the guidance document rather than through a separate implement a national Integrated Food
is available; and post the guidance rulemaking. Safety System consistent with FSMA’s
document on the Internet and make it (Response 4) Section 102(c) of FSMA emphasis on establishing partnerships
available in hard copy. Under our good requires that we revise the definition of for achieving compliance (see section
guidance practices regulation ‘‘retail food establishment’’ in § 1.227 to 209(b) of FSMA). For an example of our
(§ 10.115(g) and (h)), the public can clarify that, in determining the primary current thinking on establishing
comment on any guidance document at function of an establishment or a retail partnerships for achieving compliance,
any time, and we will revise guidance food establishment under the section see the ‘‘best practices’’ document made
documents in response to public 415 registration regulations, the sale of available by PFP (Ref. 10). This ‘‘best
comments when appropriate. food products directly to consumers by practices’’ document provides
In addition, our previously issued such establishments includes the sale of information to FDA field and State
‘‘Guidance for Industry: Questions and such food products or food directly to programs on a variety of issues,
Answers Regarding Food Facility consumers by such establishment at a including how to coordinate compliance
Registration’’ (Ref. 9) is in its sixth roadside stand or farmers’ market where activities. Our document entitled
edition, and we intend to update it in such stand or market is located other ‘‘Operational Strategy for Implementing
the near future to reflect the changes to than where the food was manufactured FSMA’’ also recognizes the importance
the definitions of ‘‘farm,’’ ‘‘harvesting,’’ or processed; the sale and distribution of developing operational partnerships
packing,’’ ‘‘holding,’’ and of such food through a CSA program; with States and other government
‘‘manufacturing/processing’’ that we are and the sale and distribution of such counterparts to optimize the
establishing in this rulemaking. food at any other such direct sales effectiveness, efficiency, and
(Comment 4) Some comments ask us platform as determined by the Secretary consistency of FSMA implementation
to prepare a table or flow chart of of HHS. As discussed in section I.E, we domestically (Ref. 11).
activities that make an operation a farm, have begun the process of amending the We are implementing a new
a retail food establishment, or a facility definition of ‘‘retail food establishment’’ inspection paradigm focused on
because food businesses will need to be in a separate rulemaking conducted whether firms are implementing
able to easily determine their regulatory under section 102(c) of FSMA, and are systems that effectively prevent food
classification to comply with the continuing that separate rulemaking by contamination, requiring fundamentally
applicable regulations. Other comments issuing a separate final rule. We intend different approaches to food safety
ask us to amend the definition of to issue a final rule to amend the inspection and compliance (Ref. 12).
‘‘manufacturing/processing’’ to ensure definition of ‘‘retail food establishment’’ This new paradigm involves a major
that community supported agriculture in the section 415 registration reorientation and retraining, for which
(CSA) programs will not become subject regulations in the near future. We also we are seeking funding, of more than
to the requirements for hazard analysis intend to update our previously issued 2,000 FDA inspectors, compliance
and risk-based preventive controls. ‘‘Guidance for Industry: Questions and officers, and other staff involved in food
Other comments ask us to clarify how Answers Regarding Food Facility safety activities, as well as thousands of
the revised definitions we are Registration’’ (Ref. 9) to reflect any State, local, and tribal inspectors (Ref.
establishing in the section 415 changes to a determination of whether 12).
registration regulations will affect an entity is a retail food establishment (Comment 6) Some comments ask us
entities classified as research and as a result of that rulemaking. In the to specify that the human preventive
development entities, pilot plants, test meantime, commenters may find our controls rule does not apply to activities
kitchens, shared use storage facilities, existing guidance helpful in addressing subject to the animal preventive
co-packers, sales offices, corporate their questions. controls rule.
offices, private residences, and (Comment 5) Some comments ask us (Response 6) The human preventive
registered foreign facilities that only to explain how we will enforce the rule, controls rule does not apply to activities
send samples to the United States. Some particularly with respect to coordination subject to the animal preventive
comments ask us to clarify how the with State and local authorities and controls rule. The title of the rule (i.e.,
revised definitions we are establishing with other Federal agencies. For Current Good Manufacturing Practice,
in the section 415 registration example, some comments ask whether Hazard Analysis, and Risk-Based
regulations will affect a determination FDA or the States will pay for Preventive Controls for Human Food)
of whether an entity or program (such inspections, whereas other comments narrows its applicability to human food.
as a farmers’ market, roadside stand, ask us to coordinate inspection of Moreover, regulations directed to food
CSA program, commissary kitchen, imports with USDA’s Food Safety and for animals are established in
community and incubator kitchens) is a Inspection Service (FSIS) or ask us to subchapter E of 21 CFR (i.e., Animal
retail food establishment that is not combine our inspections with those of Drugs, Feeds, And Related Products,
required to register as a food facility in USDA where possible (such as when parts 500–599), whereas regulations
the human preventive controls rule USDA conducts inspections for directed to human food are established
in subchapter B of 21 CFR (i.e., Food For in this rule, the animal preventive provisions applicable to a farm mixed-
Human Consumption, parts 100–199). controls rule, and the proposed produce type facility that is a small or very small
(Comment 7) Some comments ask us safety rule. However, the statutory business. Specifically, a small or very
to look to existing industry information direction is not the same for all the small business that is a farm mixed-type
technology solutions where possible to rules, and this difference in statutory facility is exempt from the requirements
lower the burden on industry for direction does lead to some differences for hazard analysis and risk-based
implementation. These comments also between the rules. For example, section preventive controls if the only activities
ask us to adopt a centralized 418(l) of the FD&C Act (which relates to that it conducts are the low-risk
information technology solution with this rule) provides for modified activity/food combinations listed in
robust functionality to facilitate tracking requirements for facilities that are very § 117.5(g) and (h). A very small business
stakeholders’ compliance with the rule. small businesses in addition to facilities that is a farm mixed-type facility, but
(Response 7) The rule allows for use that satisfy criteria for sales to qualified does not satisfy the criteria for the
of any available information technology end-users, but section 419(f) of the exemptions for only conducting low-
(e.g., in the creation and retention of FD&C Act (which relates to the risk activity/food combinations, is
records) that will allow industry to proposed produce safety rule) only eligible for modified requirements as a
comply with the rule, and we encourage provides for modified requirements for qualified facility, and we will enforce
the use of information technology to direct farm marketing. the modified requirements, rather than
streamline compliance. The long- Likewise, we have worked to align the the full requirements for hazard analysis
standing CGMP requirements allow for provisions of this rule with the and risk-based preventive controls, for
the use of automated systems (see provisions of the FSVP rule. Again, such very small businesses.
§ 117.40(d)). We are developing new however, there are statutory differences (Comment 12) Some comments
electronic systems to track compliance. that lead to some differences between express concern that we will enforce the
However, our internal procedures for the rules. For example, section 805 of rule more strictly for domestic facilities
tracking compliance are outside the the FD&C Act (21 U.S.C. 348a) applies than for foreign facilities—e.g., because
scope of this rule. to an importer whereas section 418 of we lack the funds and manpower to
(Comment 8) Some comments ask us the FD&C Act applies to a facility that enforce the rule for foreign facilities.
to re-evaluate the proposed human is required to register under section 415 Other comments assert that it is
preventive controls rule, compare it of the FD&C Act. unprecedented for importing countries
with existing programs, and identify a (Comment 10) Some comments ask us to regulate the production processes in
mechanism for integrating compliance to clarify how the requirements for exporting countries and that no
verification with existing industry and hazard analysis and risk-based scientific evidence supports such
governmental programs. These preventive controls will apply to an regulation. These comments express
comments note that many handlers/ establishment that supplies raw concern that this regulatory requirement
processors use and understand materials and other ingredients to a will greatly increase trading costs and
voluntary food safety management registered facility. might constitute a barrier to trade for
systems such as HACCP and HACCP- (Response 10) The requirements for exporting countries.
based certification programs (e.g., hazard analysis and risk-based (Response 12) We intend to enforce
certification to Global Food Safety preventive controls apply to facilities this rule in a consistent manner to
Initiative (GFSI) benchmark schemes) that are required to register under ensure that imported and domestically
and ask us why we proposed to create section 415 of the FD&C Act. If an produced foods are in full compliance
a separate inspection framework for establishment that supplies raw with the requirements of this rule. We
FSMA, without integrating that materials and other ingredients to a note that the forthcoming FSVP rule
inspection framework with existing registered facility is itself a facility that will require importers to help ensure
programs. is required to register under section 415 that food imported into the United
(Response 8) We decline this request. of the FD&C Act, that establishment is States is produced in compliance with
As previously discussed, we are subject to the requirements for hazard processes and procedures, including
establishing this rule as required by analysis and risk-based preventive reasonably appropriate risk-based
section 103 of FSMA (78 FR 3646 at controls. If that establishment is not preventive controls, that provide the
3657–3659 and 3668–3669). However, itself a facility that is required to register same level of public health protection as
where compliance with this rule mirrors under section 415 of the FD&C Act, that those required under this rule. The
compliance with existing regulatory establishment is not subject to the implementation of these supplier
requirements, there is no need to requirements for hazard analysis and verification programs by U.S. importers
duplicate existing records, which may risk-based preventive controls. will thus provide assurances that
be supplemented as necessary to However, such facilities may be subject imported food is in compliance with
include all of the required information. to verification activities of this regulation.
(See also Response 5 regarding manufacturers/processors that are We disagree that we are seeking to
implementation of a national Integrated required to verify controls implemented ‘‘regulate the production processes in
Food Safety System.) by their suppliers. exporting countries’’ inappropriately.
(Comment 9) Some comments ask us (Comment 11) Some comments This rule provides for a flexible set of
to make the various rules we are express concern about the potential for principles and a framework for hazard
establishing to implement FSMA unfair enforcement of the rule relating analysis and risk-based preventive
consistent with each other. to business size. Some comments assert controls to be applied to a given
(Response 9) We have aligned the that we should strictly enforce the rule production process in order to ensure
provisions of the various rules to the for big industry, but be lenient towards the production of safe food destined for
extent practicable. For example, we use small farms. the United States. Mandating that a
the same definitions of ‘‘farm’’ and the (Response 11) We intend to enforce finished food is manufactured under
same terms used in the definition of the rule in a fair and reasonable manner. general methods applicable to all foods
‘‘farm’’ (i.e., harvesting, packing, We note that farms are not covered by (e.g., good manufacturing practices) is a
holding, and manufacturing/processing) this rule, and the rule contains special widely accepted regulatory practice and
fundamentally different than mandating numbers on March 20, 2013, 78 FR respectively). The rule defines the terms
that food be produced in a certain way. 17142 at 17149–17151). ‘‘microorganism’’ and ‘‘pathogen,’’ and
We note that many countries have (Comment 13) Some comments assert the definition of ‘‘microorganism’’
adopted food safety regulations that that the rule should be more concise, explains that the term ‘‘undesirable
mandate certain principles and and that the average person without a microorganism’’ includes those
conditions be applied to food team of experts should be able to microorganisms that are pathogens, that
manufacturing. These include understand the rule and manage the subject food to decomposition, that
mandatory HACCP programs for seafood application of the rule. indicate that food is contaminated with
and other foods. For example, in a (Response 13) We agree the rule needs filth, or that otherwise may cause food
guidance document on food safety to be understandable. We have to be adulterated. The CGMP provisions
incorporated plain language directed to either preventing the growth
import requirements, the European
techniques—e.g., by using active voice of undesirable microorganisms or
Commission stated: ‘‘The EU rules on
in the new requirements for hazard preventing contamination with
food hygiene confirm that all food
analysis and risk-based preventive undesirable microorganisms are long-
businesses in third countries after controls. We also have established
primary production must put in place, standing, and these comments do not
additional definitions that enable us to provide any examples of how we have
implement and maintain a procedure improve readability (e.g., ‘‘qualified interpreted the CGMP requirements in
based on the HACCP principles.’’ The facility exemption,’’ ‘‘raw agricultural the past in a way that does not recognize
mandate that preventive controls be commodity,’’ ‘‘unexposed packaged that some bacteria have a role in food
applied to control hazards in the food,’’ and ‘‘you.’’) The comprehensive production or that creates practical
production of foods in this rule is nature of the new requirements for problems for the future. With regard to
similar to the European Union (EU) hazard analysis and risk-based biological hazards, the new
rules. Because the requirements being preventive controls reflects the requirements for hazard analysis and
implemented by FDA under this extensive statutory provisions they risk-based preventive controls focus on
regulation are flexible and not implement and the broad range of pathogens.
prescriptive, we do not agree that this activities and foods covered. We have (Comment 16) Some comments assert
regulation will significantly increase used examples in the regulatory text, that the rule will disproportionately
costs or impede trade. where relevant, and provided examples affect New England farmers because
We also disagree that there is no throughout the preamble to assist with they are small and production costs are
scientific evidence supporting this rule. understanding the requirements. higher compared to elsewhere in the
In the 2013 proposed preventive Likewise, the long-standing CGMP country and that the cost of the rule will
controls rule, we provided an extensive requirements need to be comprehensive, have negative consequences on New
background discussing the scientific because they are broadly directed to all England’s food supply. Other comments
evidence and international food safety stages of the production of food. We will assert that the rule will force small
standards upon which this rule is based be producing guidance documents that farmers out of business, forcing us to
(78 FR 3646 at 3659 through 3667, will be helpful in understanding the rely on foreign suppliers who are under
January 16, 2013). That discussion rule (see Response 2). very little FDA oversight, and that FDA
reviews a number of well documented We will issue a Small Entity oversight should be reduced so that the
food safety risks and how they can be Compliance Guide (SECG) in public can continue supporting small,
controlled by modern food safety accordance with section 212 of the local farmers. Other comments express
systems including the Codex HACCP Small Business Regulatory Enforcement concern that excessive rules will
principles contained in the HACCP Fairness Act (Pub. L. 104–121). A Small discourage farmers from supplying the
Entity Compliance Guide is a guidance Farm to School market.
Annex of the Codex General Principles
that explains the actions a small or very (Response 16) We believe that the
of Food Hygiene (78 FR 3646 at 3667, ‘‘farm’’ definition that we are
small business must take to comply
January 16, 2013). In that discussion we establishing in this rule greatly reduces
with a rule.
stated: ‘‘The proposed rule would the impact on farms of all size, because
(Comment 14) Some comments ask
require that a food safety system similar whether we will translate the rule into several operations that would have been
to HACCP be implemented in food foreign languages, such as Japanese. required to register as a food facility
facilities and would harmonize our (Response 14) We do not intend to under the section 415 registration
requirements with the recommendations translate the rule. As discussed in regulations as established in 2003 (68
and requirements of internationally Response 13, to help small and very FR 58894, October 10, 2003) will no
recognized food safety experts/ small businesses comply with a rule we longer be required to do so. (See the
authorities, such as experts/authorities issue a SECG. We are considering discussion of the changes to the ‘‘farm’’
in [Codex Alimentarius], [Food Safety whether to translate the SECG and definition in section IV.B) In addition,
Authority Australia New Zealand], outreach and technical assistance a farm mixed-type facility that is a small
[Canadian Food Inspection Agency], materials into additional languages. or very small business, and that only
and the European Union.’’ (78 FR 3646 (Comment 15) Some comments assert conducts low-risk activity/food
at 3663, January 16, 2013) In addition, that the rule incorrectly assumes that all combinations for manufacturing,
the Appendix to the 2013 proposed bacteria are harmful. processing, packing, and holding foods
preventive controls rule provided (Response 15) We have long that are not RACs, is exempt from the
additional scientific information on recognized that some bacteria have a new requirements for hazard analysis
activities such as product testing and role in food production, such as the and risk-based preventive controls. A
environmental monitoring to support lactic-acid producing bacteria that our farm mixed-type facility that does not
their role in ensuring safe food and how regulations explicitly acknowledge as satisfy these criteria for exemption, but
these align with international standards being added to yogurt (see, e.g., the is a very small business, is a qualified
such as those of Codex Alimentarius (78 standards of identity for yogurt, low fat facility that is subject to modified
FR 3646 at 3818–3820); republished in yogurt, and nonfat yogurt, in 21 CFR requirements. All of these factors will
its entirety with corrected reference 131.200, 131.203, and 131.206, reduce the burden on small farms.
(Comment 17) Some comments IV. Comments on Proposed Revisions to activity to be considered manufacturing/
express concern about contamination of the Definitions in the Section 415 processing (79 FR 58524 at 58530–
produce and other food in open Registration Regulations (21 CFR Part 58538). In the 2014 supplemental
containers by sulfuric hydrogen being 1, Subpart H) and the Section 414 human preventive controls notice, we
discharged from lead acid batteries that Recordkeeping Regulations (21 CFR proposed additional revisions to the
are used to operate forklifts. Part 1, Subpart J) definitions of ‘‘farm,’’ ‘‘harvesting,’’
A. Definitions That Impact a ‘‘packing,’’ and ‘‘holding’’ to address
(Response 17) The long-standing
Determination of Whether an these comments.
CGMP provisions require that the food
Establishment Is a ‘‘Farm’’ Even after the revisions we proposed
establishment must appropriately use
in the 2014 supplemental human
equipment to avoid the adulteration of We previously described section preventive controls notice, some
food with such contaminants (see 103(c) of FSMA (78 FR 3646 at 3674). comments assert that the overall ‘‘farm’’
§ 117.40(a)(2)). In brief, section 103(c) of FSMA directs definition still presents an unrealistic
(Comment 18) Some comments assert us to conduct rulemaking to clarify the and incomplete understanding of how
that we do not address comments on-farm manufacturing, processing, most farms in the United States are
submitted by individuals. packing, and holding activities that structured with regard to their physical
would trigger a requirement for a farm location(s) and business models. Most of
(Response 18) We address comments to register as a food facility and, thus,
on the provisions of the rule regardless the comments suggest alternative or
be subject to section 418 of the FD&C additional regulatory text (see, e.g.,
of who submits the comments. Act. We discussed the current legal and
However, we group similar comments Comment 22, Comment 23, Comment
regulatory framework for farms under
24, Comment 25, Comment 27,
together, and do not discuss the specific sections 415 and 418 of the FD&C Act,
Comment 37, Comment 39, and
text of each submitted comment letter and explained how the status of a food
Comment 50) or ask us to clarify how
when the point being made by one as a RAC or a processed food affects the
we will interpret the provisions (see,
comment letter can be included in a requirements applicable to a farm under
e.g., Comment 26, Comment 28,
general discussion of several comment sections 415 and 418 of the FD&C Act.
Comment 29, Comment 40, Comment
letters that express similar points of We then articulated a comprehensive set
41, Comment 42, Comment 43,
view. of organizing principles that formed the
Comment 44, Comment 47, and
basis for proposed revisions to the
(Comment 19) Some comments assert section 415 registration regulations. Comment 48).
that we need specific standards and Because these definitions also are As discussed in section I.A, there are
quantifiable guidelines for compressed established in the section 414 several FSMA-required regulations that
air. recordkeeping regulations, these provide the framework for industry’s
(Response 19) We agree that specific organizing principles also formed the implementation of preventive controls
standards and quantifiable guidelines basis for proposed revisions to and enhance our ability to oversee their
definitions in the section 414 implementation for both domestic and
for material such as compressed air
recordkeeping regulations. imported food (see the seven
could be useful to food establishments
Our previous description (78 FR 3646 foundational rules listed in table 1).
that use such material in the production Two of the proposed rules listed in table
of food. However, we disagree that such at 3675–3676) of the current legal and
regulatory framework that governs the 1 (i.e., the 2013 proposed animal
standards and guidelines need to be preventive controls rule and the 2013
determination of when an establishment
included in the rule. The rule is proposed intentional adulteration rule)
is required to register as a food facility
intended to establish procedures for the in accordance with the section 415 proposed to include a cross-reference to
safe manufacturing, processing, packing, registration regulations focused on the the ‘‘farm’’ definition in § 1.227, and a
and holding of food, and for hazard framework that governs whether an third proposed rule (i.e., the 2013
analysis and risk-based preventive establishment that grows and harvests proposed produce safety rule) proposed
controls in the production of food, crops or raises animals satisfies the to establish the same ‘‘farm’’ definition
rather than to set standards for specific definition of ‘‘farm,’’ because the facility as would be in § 1.227. A fourth
levels of contaminants in specific raw registration requirements of section 415 proposed rule (i.e., the 2013 proposed
materials and other ingredients. If a of the FD&C Act do not apply to FSVP rule) did not propose to establish
facility believes that its use of ‘‘farms.’’ Under that framework, a key the ‘‘farm’’ definition (or a cross-
compressed air should be addressed in factor in whether an establishment falls reference to the ‘‘farm’’ definition in
its food safety plan, then it should do within the definition of ‘‘farm,’’ even § 1.227), but under its proposed
so. with respect to crops it grows and definition of ‘‘foreign supplier’’ some
harvests itself, is whether the activities foreign suppliers would be farms—i.e.,
(Comment 20) Some comments ask us
conducted by the establishment fall establishments that harvest food that is
to address model laboratory standards
within definitions of ‘‘harvesting,’’ exported to the United States. As a
and accreditation to ensure that result, we received comments relevant
‘‘packing’’ or ‘‘holding’’ (which are
laboratories are using sound and reliable to the ‘‘farm’’ definition for all of these
within the ‘‘farm’’ definition). Another
test methods for detecting and key factor is whether activities rules. The majority of the comments
identifying pathogens. conducted by the establishment fall submitted to these other rulemakings
(Response 20) We decline this within the definition of manufacturing/ addressed issues that were the same as,
request. A separate section of FSMA processing (which have been outside the or similar to, the issues raised in the
addresses ‘‘Laboratory Accreditation For ‘‘farm’’ definition). comments submitted to this rulemaking.
Analyses Of Foods’’ (see section 202 of We previously described comments One comment submitted to the
FSMA). This rule focuses on section 103 regarding proposed revisions to the proposed rulemaking for the
of FSMA (section 418 of the FD&C Act). definitions of ‘‘farm,’’ ‘‘harvesting,’’ forthcoming FSVP rule requested
‘‘packing’’ and ‘‘holding,’’ as well as clarification regarding harvesting
comments regarding the triggers for an companies, and we are also providing
that clarification in this rulemaking. See comments noting that our proposed 52. We also are establishing a new
Response 32. technical amendment to § 1.361 was provision to allow off-farm
We proposed to redesignate all unnecessary because we had already establishments that package, pack, and
definitions in § 1.227 in the section 415 made this change in a different hold RACs that are produce as will be
registration regulations (i.e., current rulemaking (see 77 FR 10662, February defined in the produce safety rule to
§ 1.227) to eliminate paragraph 23, 2012). We are finalizing these comply with the CGMPs in part 117,
designations (such as (a) and (b)). We technical amendments and conforming subpart B by complying with the
received no comments that disagreed changes without change. applicable requirements for packing and
with our proposed redesignations and In the following sections, we discuss
holding that will be established in the
are finalizing them as proposed. comments that ask us to clarify the
final produce safety rule (see § 117.8
We proposed several technical proposed requirements or that disagree
amendments and conforming changes to with, or suggest one or more changes to, and Response 25). Because the new
the section 415 registration regulations the proposed requirements. After provision refers to provisions in a future
and to the section 414 recordkeeping considering these comments, we have produce safety rule, we will publish a
regulations. No comments opposed the revised the proposed definitions as document in the Federal Register
proposed technical amendments and shown in table 4, with editorial and announcing the effective date of § 117.8
conforming changes, except for conforming changes as shown in table once we finalize the produce safety rule.
TABLE 4—REVISIONS TO THE PROPOSED DEFINITIONS IN THE SECTION 415 REGISTRATION REGULATIONS AND THE
SECTION 414 RECORDKEEPING REGULATIONS
Definition Revision
Farm ............................................ • A farm is an ‘‘operation’’ rather than an ‘‘establishment.’’

• There are two types of farms: (1) Primary production farm; and (2) secondary activities Farm.
Primary production farm .............. • A primary production farm is ‘‘under one management’’ rather than ‘‘under one ownership.’’
• Although a primary production farm continues to be ‘‘in one general physical location,’’ we have clarified
that ‘‘one general physical location’’ is ‘‘not necessarily contiguous.’’
• A primary production farm is an operation devoted to the growing of crops, the harvesting of crops, the
raising of animals (including seafood), or any combination of these activities. Although some primary pro-
duction farms both grow and harvest crops, other primary production farms grow crops but do not harvest
them, and other primary production farms harvest crops but do not grow them.
• Treatment to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without ad-
ditional manufacturing/processing, is within the ‘‘farm’’ definition.
• We added an example of drying/dehydrating RACs to create a distinct commodity that would fall within the
‘‘farm’’ definition (i.e., drying/dehydrating grapes to produce raisins), as well as an example of additional
manufacturing/processing that would cause an operation that dries/dehydrates RACs to create a distinct
commodity to fall outside the ‘‘farm’’ definition (i.e., slicing).
• We added an example of additional manufacturing/processing that can cause an operation that packages
and labels RACs to fall outside the ‘‘farm’’ definition (i.e., irradiation).
Secondary activities farm ............ • A ‘‘secondary activities farm’’ is an operation, not located on a primary production farm, devoted to har-
vesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.
• A secondary activities farm may also conduct those additional activities allowed on a primary production
farm.
Harvesting ................................... • We added additional examples of harvesting activities.
Holding ........................................ • We added additional examples of holding activities.
Manufacturing/Processing ........... • We added additional examples of manufacturing/processing activities.
B. Proposed Revisions to the Definition requested comment on whether we leading to potential contamination of
of Farm should retain, remove, or modify the products from both farms, making it
phrase ‘‘in one general physical difficult to pinpoint the source of
We proposed to revise the ‘‘farm’’ location’’ in the ‘‘farm’’ definition. contamination in the event of a recall.
definition to: (1) Provide for on-farm (Comment 21) Most of the comments (2) Recall Plan. It is critical for everyone
packing and holding of RACs to remain support our proposed revision to in the produce supply chain to be
within the farm definition regardless of provide for on-farm packing and ‘‘recall ready,’’ especially those packing,
ownership of the RACs; (2) include, holding of RACs to remain within the commingling lots, and selling produce
within the ‘‘farm’’ definition, a farm definition regardless of ownership grown on another farm under different
description of packing activities that of the RACs. However, some comments ownership. (3) Traceability. It is
include packaging RACs grown or raised oppose this proposed revision. Some important that produce be traceable
on a farm without additional comments ask us to require that a farm from the specific farm where it was
manufacturing/processing; and (3) that packs, packs and sells, commingles grown to the end-user, and from the
provide for drying/dehydrating RACs to lots, and holds produce grown on a farm end-user back to the farm where it was
create a distinct commodity (such as the under different ownership comply with grown. (4) Exemptions. A covered
on-farm drying of grapes to produce the requirements of this rule for hazard farmer packing, packing and selling,
raisins), and packaging and labeling analysis and risk-based preventive commingling lots, or holding others’
such commodities, without additional controls for six reasons: (1) produce might be doing so from a farm
manufacturing/processing, to remain Commingling. Contamination from one that is exempt from the produce safety
within the farm definition. We also farm could find its way to another farm, rule. (5) Supplier program. Under the
human preventive controls rule a farmer name, complete business address, and ownership of the land on which crops
would be required to have a valid description of the produce in any are grown or animals are raised, noting
supplier program. (We note that a individual shipment, as well as respond that some farms are operated by
farmer might be a supplier to a facility to comments on whether it would be ‘‘tenant’’ farmers who do not own the
that is subject to the human preventive appropriate to also require the farm that land used in the farm’s operations.
controls rule, and could be subject to receives the shipment maintain such Some comments ask us to replace the
the facility’s supplier program, but record of information and, if so, for concept of ownership with the concept
would not itself be required to ‘‘have a what specified period of time. of a responsible party, such as a ‘‘farm
valid supplier program.’’) With this In the 2014 proposed sanitary operator’’ and to define a farm operator
requirement, receiving facilities could transportation rule, we explained our as ‘‘the person or entity that has
purchase in confidence knowing that if reasons for tentatively concluding that operational control over the farm and
the farm did pack others’ produce it was the sanitary transportation practices that benefits in whole or in part from the
produced in accordance with the rules would be required by that proposed rule farm’s normal operation. A farm
required by FSMA. (6) Conflict with the are not necessary to prevent RACs from operator may be an owner, a tenant, a
National Organic Program (NOP). Under becoming adulterated during partner, or an employee.’’
the NOP, a grower that purchases transportation by farms (79 FR 7006 at Some comments ask us to remove the
produce from another farm under 7016, February 5, 2014). For example, phrase ‘‘under one ownership’’ to allow
different ownership, packs produce we explained that we are not aware of sugar makers who share equipment and
from another farm, or mixes produce is instances in which insanitary sugarhouses to qualify as a farm. Other
no longer considered a crop producer conditions (e.g., improper temperature comments ask us to clarify how renting
and must seek certification as a control, improper equipment or leasing storage rooms or facilities
handler—an operation that has construction, inadequate equipment would affect the definition of a farm.
additional requirements to approve cleaning) with regard to transportation (Response 23) We have revised the
suppliers, segregate product, and operations conducted by farms ‘‘farm’’ definition by replacing the
maintain records necessary to involving the transportation of RACs phrase ‘‘under one ownership’’ with the
demonstrate compliance. Comments have contributed to foodborne illness, phrase ‘‘under one management.’’
assert that this NOP requirement is regardless of whether the farms are Although the original phrase ‘‘under
logical and is a practice that FDA conducting transportation operations for one ownership’’ was not referring to a
should take into consideration. their own RACs or for others’ RACs. We single owner, we agree that the ‘‘farm’’
Other comments assert that allowing will consider comments we receive on definition should reflect modern
a farm to pack produce from another our proposal to exempt farm vehicles business models (such as cooperatives,
farm must account for the problem transporting RACs from the sanitary on-farm packinghouses under
created by our proposal to exempt farm transportation rule when we issue a ownership by multiple growers, food
vehicles transporting RACs from the final sanitary transportation rule. We aggregators, and food hubs) and use
sanitary transportation rule. These will consider necessary guidance in language that the modern farming
comments argue that unless we revise light of the final sanitary transportation community understands. We decline the
that rule to prevent possible rule, but we note that good request to define and introduce a new
contamination during transport, we transportation practices are already term, such as ‘‘farm operator.’’ The term
should develop guidance for farms included in our 1998 guidance for ‘‘management’’ has a common meaning
packing produce that is transported industry entitled ‘‘Guide to Minimize that captures the request of these
from another farm, particularly where Microbial Food Safety Hazards for Fresh comments and is suitable for the
the commodity is high risk. Fruits and Vegetables’’ (Ref. 13). purposes of the farm definition.
(Response 21) The final ‘‘farm’’ (Comment 22) Some comments assert (Management. The person or persons
definition continues to provide for on- that farms are neither facilities nor controlling and directing the affairs of a
farm packing and holding of RACs to establishments. These comments ask us business, institution, etc.) (Ref. 14).
remain within the farm definition to revise the ‘‘farm’’ definition to use a Under either the previous or the
regardless of ownership of the RACs. term more suited to the nature of revised ‘‘farm’’ definition, leasing land
We have acknowledged that doing so farming. to grow or store crops or raise animals
would have consequences such as those (Response 22) We consider a farm to does not impact whether an operation is
described in these comments, as well as be a type of ‘‘establishment’’ but have within the ‘‘farm’’ definition. Under the
other consequences (see 79 FR 58524 at nonetheless revised the ‘‘farm’’ previous definition, ‘‘ownership’’
58532). Although comments pointed out definition to refer to an ‘‘operation’’ focused on ownership of the business
consequences that we had already rather than an ‘‘establishment’’ as entity conducting farm operations, not
considered, they did not point to any requested by these comments. ownership of the land. Leasing land is
other consequences. Therefore, we (Comment 23) Many comments a business practice common to a variety
affirm our tentative conclusion that address the role of ‘‘ownership’’ in the of business types, not just farms.
impacts such as these, while not always ‘‘farm’’ definition. Some of these Likewise, leasing buildings to store
optimal, are necessary to establish a comments emphasize that farming RACs does not impact whether an
sensible framework of risk-based operations are complex, with complex operation is within the ‘‘farm’’
regulations that both implement FSMA business structures, and are often not definition. See also Response 24
and reflect common farm activities. We held under sole ownership. Some regarding comments on ‘‘one general
intend to issue the final produce safety comments describe the role of multiple physical location.’’
rule in the near future and respond to business models (such as cooperatives, To the extent that sugar makers who
comments related to traceability of on-farm packinghouses under share equipment and sugarhouses only
produce, including whether to include a ownership by multiple growers, food conduct activities that are within the
requirement that a farm supplying aggregators, and food hubs) in modern ‘‘farm’’ definition, the revision from
produce to another farm that will pack farming and ask us to revise the ‘‘farm’’ ‘‘under one ownership’’ to ‘‘under one
or hold that produce should provide to definition to provide for such business management’’ should clarify that those
the farm that receives the produce its models. Other comments emphasize operations would be within the ‘‘farm’’
definition. However, when sugar makers definition of a ‘‘farm operator.’’ Some proximity to each other should not be
conduct operations outside the ‘‘farm’’ comments note that sugar makers rely considered the same ‘‘farm.’’
definition, they are facilities that are on sap from existing stands of trees that (Response 24) We have revised the
required to register under the section are often not concentrated in a single ‘‘farm’’ definition to specify that a farm
415 registration regulations, not ‘‘farms’’ area or even nearby the sugarhouse is ‘‘in one general (but not necessarily
that are exempt from that registration where the maple products are made. contiguous) physical location.’’ We have
requirement. A sugar maker that is a Some comments suggest that the term concluded that adding ‘‘not necessarily
small or very small farm mixed-type ‘‘reasonable distance’’ could be used to contiguous’’ makes it clear that farming
facility that only conducts the low-risk better define ‘‘general physical operations that are under one
activity/food combinations listed in the location.’’ Some comments ask us to management but have some physical
exemptions in § 117.5(g) and (h) (such issue guidance that will clarify and separation (e.g., with respect to the
as making syrup and sugar (e.g., making further designate the boundaries of ‘‘one location of packing operations) can
maple syrup from maple sap)) is exempt general physical location.’’ remain within the ‘‘farm’’ definition and
from the requirements of this rule. Some comments note that the ‘‘farm’’ that both in-line and off-line egg
However, a farm mixed-type facility that definition we proposed in the 2014 production facilities would be
is not a small or very small business as supplemental human preventive considered ‘‘farms.’’
those terms are defined in this rule, or controls notice correctly considers a We agree that separate locations that
that conducts activities in addition to farm operation to remain within the are not in close proximity to each other
the low-risk activity/food combinations ‘‘farm’’ definition even if it packs and should not be considered the same
listed in the exemptions in § 117.5(g) holds produce from another farm. ‘‘farm.’’ As the comments point out,
and (h), is subject to the requirements However, these comments state that it is there already is a framework of State
for hazard analysis and risk-based inspections for farms such as dairy
confusing that if the same two farms
preventive controls. Consistent with the farms, and we will need to work with
pack and hold produce together at an
discussion in Response 228, a farm our State regulatory partners to identify
off-farm location, using the exact same
mixed-type facility that must comply farms covered by the produce safety
practices, that packing location is
with the requirements for hazard rule. However, even without the new
considered a ‘‘facility’’ even though
analysis and risk-based preventive phrase ‘‘not necessarily contiguous,’’
there is no difference in risk. Other
controls and makes sugar from some situations would be complex. We
comments state that both in-line and off-
sugarcane or sugar beets can consider intend to address these types of
line egg production facilities should be
the findings of the section 103(c)(1)(C) situations with our State food safety
considered farms. According to these
partners. (See Response 5.)
RA (i.e., that this is a low-risk activity/ comments, off-line egg production We do not see that adding ‘‘not
food combination) in determining facilities receive eggs laid by hens at necessarily contiguous’’ creates a
whether there are any hazards requiring nearby farms, whereas in-line egg ‘‘farm’’ definition that is not ‘‘place-
a preventive control. A facility that production facilities receive eggs laid by based,’’ as was asserted by some
appropriately determines through its hens in henhouses adjacent to the plant comments, because the definition
hazard analysis that there are no and located on the same property. continues to specify ‘‘in one general
hazards requiring preventive controls Some comments ask us to retain ‘‘one physical location.’’ We also do not see
would document that determination in general physical location’’ in the ‘‘farm’’ that adding ‘‘not necessarily
its written hazard analysis but would definition because the word ‘‘farm,’’ and contiguous’’ presents any food safety
not need to establish preventive controls USDA’s definition of ‘‘farm,’ are ‘‘place- concerns, as asserted by comments
and associated management based.’’ Other comments assert that if noting that different locations may have
components. For additional information we delete the phrase ‘‘in one general different food safety risks, different
about the section 103(c)(1)(C) RA and physical location’’ then a fully water sources, different personnel, and
the exemptions for on-farm low-risk integrated operation could be a single different types of crops. For example, a
activity/food combinations for farm farm even though it was made up of farm that will be covered by the
mixed-type facilities that are small or numerous distinct farms possibly in forthcoming produce safety rule will be
very small businesses, see sections VI several different states. Other comments subject to standards for all of its water
and XI.G. ask us to retain ‘‘one general physical sources, all of its personnel, and all food
(Comment 24) Many comments location’’ in the ‘‘farm’’ definition subject to that rule. Likewise, we also do
address the role of ‘‘one general because different locations may have not believe that adding ‘‘not necessarily
physical location’’ in the ‘‘farm’’ different food safety risks, different contiguous’’ affects a determination of
definition and ask us to revise the water sources, different personnel, and whether a fully integrated operation
‘‘farm’’ definition to acknowledge that even different types of crops. Some could be a single farm.
farms may be composed of multiple comments assert that considering each (Comment 25) Some comments ask us
parcels, buildings, or structures that unique and individually State-permitted to consider revising the regulatory text
may or may not be contiguous. Some dairy farm to be an individual ‘‘farm’’ to ensure that similar activities would
comments point out that there are many regardless of common ownership or be treated the same way under either the
farming operations that may fall under geographic proximity will prevent produce safety rule or the human
the same management and ownership, conflict and interference with the preventive controls rule and be held to
but are separated by either a strip of permitting and inspection activities of the same risk-based requirements. These
land, body of water, or another the Grade ‘‘A’’ program while comments point out some of the
structure, particularly with respect to maintaining food safety. Other differences between the requirements
sites designated for packing and holding comments state that regardless of that would be established under the
operations. Some comments assert that whether we retain ‘‘one general physical proposed human preventive controls
as long as an economic unit is operating location’’ in the ‘‘farm’’ definition, we rule and the requirements that would be
a farm it should be irrelevant where the must interpret the term ‘‘farm’’ to cover established under the proposed produce
land is located, and state that this a very limited geographic area and that safety rule. For example, comments
interpretation is consistent with a USDA separate locations that are not in close state that the proposed human
preventive controls rule, but not the requirement for registration by making raises the majority of the RACs
proposed produce safety rule, would them subject to the requirements of the harvested, packed, and/or held by the
require off-farm packinghouses and off- produce safety rule for compliance secondary activities farm owns, or
farm cooling and storage facilities to purposes. Some comments ask us to jointly owns, a majority interest in the
have a written hazard analysis; written provide an exemption from, or waiver secondary activities farm. A secondary
preventive controls; written procedures for, the requirements of the human activities farm may also conduct those
for monitoring and corrective actions; preventive controls rule if a business additional activities allowed on a
validation of process controls; a written entity provides documentation that the primary production farm. With the
recall plan; environmental monitoring entity is following the standards of the added definition of ‘‘secondary
and product testing requirements; and a produce safety rule even though it is not activities farm,’’ off-farm packinghouses
written supplier program. As another on a farm. Other comments ask us to that are managed by a business entity
example, comments state that off-farm clarify that a farm can pack or hold (such as a cooperative) that is different
packing and holding operations would RACs that have already undergone from the business entity growing crops
be required to comply with the human packing or holding activities by another (such as individual farms) can be within
preventive controls rule one year earlier farm. the ‘‘farm’’ definition. We are making
than we proposed that similar sized on- Some comments ask to revise the these changes to reflect the current
farm packing and holding operations ‘‘farm’’ definition to include reality of what it means to be a farm.
would be required to comply with the establishments solely engaged in The changes will allow farms that use
forthcoming produce safety rule. ‘‘packing’’ and ‘‘holding’’ activities certain business models to harvest,
Some comments recommend options performed on RACs, regardless of pack, and/or hold produce to be able to
to achieve the goal of regulating on-farm whether the establishment grows crops. comply with the produce safety rule for
and off-farm packinghouses the same Other comments emphasize that any all of their operations. We believe that
way. These options include adding an revisions to the ‘‘farm’’ definition must this flexibility allows for the
exclusion to the ‘‘farm’’ definition in the allow genuine farm operators to carry requirements of the produce safety rule
produce safety rule; adding provisions out harvesting, packing, and holding to apply to a wider array of activities
to the human preventive controls rule to without opening loopholes for packing than our original proposal without
enable off-farm packinghouses to meet and processing businesses. Some opening the ‘‘farm’’ definition to
their obligation by complying with comments ask us to revise the ‘‘farm’’ operations that have no connection to
specified, applicable subparts of the definition to provide for a multi- the growing of crops or the raising of
produce safety rule; shortening the ownership operation provided that all of animals—the core activities of a farm.
‘‘farm’’ definition to simply state ‘‘Farm the partial owners are themselves By specifying that the farms that grow
means an establishment under one farmers. or raise the majority of the RACs
ownership devoted to the growing and/ Some comments ask us to provide harvested, packed, and/or held by the
or harvesting of crops, the raising of that off-farm packing and holding operation must own, or jointly own, a
animals (including seafood), or any or operations that do not change the status majority interest in the secondary
all of these activities;’’ addressing off- of a RAC into a processed food should activities farm, the revised ‘‘farm’’
farm establishments engaged solely in be able to comply with either the definition does, as requested by
‘‘low-risk’’ farming and harvesting produce safety rule or with the CGMPs comments, allow ‘‘farms’’ to carry out
activities by adding low-risk activities in subpart B of the human preventive harvesting, packing, and holding
such as hulling, shelling, and drying of controls rule. According to these activities in the same way as the
tree nuts; expanding the scope of the comments, we could simply apply the produce safety rule.
produce safety rule to include registered same logic that we applied when We are, as requested by some
facilities; and allowing modified providing that the packing and holding comments, establishing a new provision
requirements in the human preventive of RACs that have been dried/ to allow off-farm establishments that
controls rule to allow off-farm dehydrated to create a distinct package, pack, and hold RACs that are
packinghouses to be subject to commodity that is a processed food (i.e., produce as will be defined in the
requirements (and exemptions) of the no longer a RAC) may achieve produce safety rule to comply with the
produce safety rule within the compliance with the CGMP CGMPs in part 117, subpart B by
framework of the human preventive requirements by complying either with complying with the applicable
controls rule. subpart B of the human preventive requirements for packing and holding
Some comments emphasize that farm controls rule or by complying with the that will be established in the final
activities are farm activities, regardless applicable requirements for packing and produce safety rule (see § 117.8).
of where they happen. Some comments holding produce RACs in the produce Because the new provision refers to
assert that establishments that are safety rule (see § 117.5(k)(2)). provisions in a future produce safety
engaged solely in traditional harvesting, (Response 25) We have revised the rule, we will publish a document in the
holding, or packing activities associated ‘‘farm’’ definition to provide for two Federal Register announcing the
with a RAC that will be covered by the types of farms: (1) A primary production effective date of that provision once we
produce safety rule should be subject to farm and (2) a secondary activities farm finalize the produce safety rule.
the produce safety rule, rather than the (see § 117.3). We use the term ‘‘primary However, the revised ‘‘farm’’
human preventive controls rule, production farm’’ to refer to the ‘‘farm’’ definition does not, as requested by
regardless of physical location, definition as proposed, with the some comments, establish the exact
ownership, or legal ties to an operation revisions described in this final rule. We same regulatory framework for
devoted to the growing and harvesting use the term ‘‘secondary activities farm’’ operations, such as certain
of produce. Some comments assert that to mean an operation, not located on a packinghouses and hulling/shelling
an off-farm operation that packs and primary production farm, devoted to operations, that are within the ‘‘farm’’
holds RACs could be regulated in an harvesting (such as hulling or shelling), definition as for operations that conduct
identical fashion to an on-farm packing, and/or holding of RACs, similar activities but are outside the
operation that packs and holds RACs provided that the primary production ‘‘farm’’ definition by allowing off-farm
without changing the section 415 farm(s) that grows, harvests, and/or operations to be subject to the produce
safety rule rather than the requirements and harvested. The definition of ‘‘farm’’ referred to as ‘‘processing’’ in the
for hazard analysis and risk-based allows packing and holding of one’s context of a food’s status as a RAC or
preventive controls. We disagree that own RACs and other’s RACs, even if processed food) are not coextensive
the statutory framework provides they have been previously packed or with the activities described in our
flexibility for entities such as held by another farm that was not the definition of ‘‘manufacturing/
packinghouses and hulling/shelling farm on which the RACs were grown processing’’ (78 FR 3646 at 3679). When
operations that do not have a and harvested. we first established the section 415
connection to a farm to be subject to the (Comment 26) Some comments ask us registration regulations, a key criterion
requirements of the produce safety rule to clarify whether the ‘‘and’’ between in determining whether a business
for compliance purposes. (See the provisions that allow a farm to dry/ entity was a ‘‘farm’’ or a ‘‘facility’’ was
discussion at 79 FR 58524 at 58536.) We dehydrate RACs to create a distinct whether the operation conducted
continue to believe that an off-farm commodity, and provisions that allow a activities classified as ‘‘manufacturing/
packinghouse that is subject to this rule farm to package and label RACs, means processing.’’ Indeed, in the 2013
will be able to draw from the provisions that an operation must do both of these proposed preventive controls rule we
of the produce safety rule in developing activities to remain within the farm continued to rely on that key criterion
its food safety plan and establishing definition. These comments state that in proposing revisions to the ‘‘farm’’
preventive control management they do not think this is the intended (or definition. However, as already
components that are appropriate in light logical) outcome, which is to provide discussed, some changes to the ‘‘farm’’
of the nature of the preventive controls that farms can do either or both definition are necessary to establish a
and their role in the facility’s food safety activities and still be within the farm sensible framework of risk-based
system. For example, as previously definition and ask us to consider regulations that both implement FSMA
discussed (79 FR 58524 at 58536) we editorial changes (such as replacing and reflect common farm activities (see
expect that the food safety plan for an ‘‘and’’ with ‘‘or,’’ or adding a new Response 21). One of these changes is to
off-farm packinghouse would focus on a paragraph that would encompass both specify those manufacturing/processing
few key preventive controls, including activities). activities that are within the ‘‘farm’’
some that would have counterparts in (Response 26) The rule does not definition, rather than attempt to re-
the proposed produce safety rule, such require a farm to do both activities (i.e., classify an activity that arguably is
as maintaining and monitoring the drying/dehydrating RACs to create a manufacturing/processing as harvesting,
temperature of water used during distinct commodity, and packaging and packing, or holding in order to provide
packing (which would have labeling RACs) to remain within the for the activity to remain within the
counterparts under proposed § 112.46(c) farm definition. ‘‘farm’’ definition.
in the proposed produce safety rule). (Comment 27) Some comments ask us
to add artificial ripening of RACs as an (Comment 28) Some comments
We also expect that an off-farm
activity that is within the farm disagree that we should provide for
packinghouse would establish
definition. Some comments assert that drying/dehydrating RACs to create a
sanitation controls to address the
artificial ripening of RACs is not distinct commodity to be within the
cleanliness of food-contact surfaces
(including food-contact surfaces of manufacturing/processing because ‘‘farm’’ definition because this activity
utensils and equipment) and the artificial ripening does not transform a is a manufacturing/processing activity
prevention of cross-contamination from RAC into a processed food. and should be subject to the
insanitary objects and from personnel to (Response 27) We have revised the requirements for hazard analysis and
food, food-packaging material, and other ‘‘farm’’ definition to specify that risk-based preventive controls. Other
food-contact surfaces. On-farm treatment to manipulate the ripening of comments agree that we should provide
packinghouses would be subject to RACs (such as by treating produce with for this activity but assert that ‘‘drying/
similar, but not identical, requirements ethylene gas), and packaging and dehydrating RACs to create a distinct
(see e.g., proposed § 112.111(b) for labeling the treated RACs, without commodity’’ is confusing to the average
cleanliness of food-contact surfaces and additional manufacturing/processing, reader and ask us to add examples of
proposed § 112.113 for protection are within the ‘‘farm’’ definition. We what this means. Some comments ask
against contamination). agree that a treatment such as artificial us to clarify whether this activity
We acknowledge that some of the ripening does not transform a RAC into applies to specific situations, such as
provisions of the human preventive a processed food but disagree that such drying/baling of hops (because hops are
controls rule have no explicit a treatment is not manufacturing/ a low-risk product and beer brewing
counterparts in the proposed produce processing. To make that clearer, we should eliminate any pathogens on the
safety rule (e.g., the requirements for have added ‘‘treating to manipulate hops), drying plums to create prunes,
product testing and environmental ripening’’ to the list of examples of and concentrating maple sap into maple
monitoring as verification activities). As manufacturing/processing in the syrup, cream, and candy. Some
discussed in Response 525, we do not definition of that term. As discussed comments assert that maple syrup
expect either product testing or during the rulemaking to establish the should be considered a RAC because the
environmental monitoring to be section 415 registration regulations, process of producing maple syrup
common in facilities that process, pack, artificial ripening constitutes mirrors the regulatory text ‘‘drying/
or hold produce RACs. manufacturing/processing because it dehydrating RACs to create a distinct
Finally, in response to comments that involves treating, modifying, or commodity,’’ because maple syrup can
ask for a clarification that a farm can manipulating food (68 FR 58894 at only be produced through the
pack or hold RACs that have already 58912, October 10, 2003). See also our concentration of maple sap and the
undergone packing or holding activities previous statements about artificial process of that concentration is akin to
by another farm, we presume that the ripening in this rulemaking (78 FR 3646 the harvesting of other raw products.
commenter was asking about a case at 3683 and 79 FR 58524 at 58572). Other comments assert that the
where the farm that did the previous As previously discussed, the activities processing of sap is more appropriately
packing and holding activities was not that transform a RAC into a processed viewed as a harvesting activity (rather
the farm on which the RACs were grown food (and are sometimes therefore than food manufacturing).
Other comments ask us to clarify the on-farm low-risk activity/food grown by another farm, and washes the
specific methods of drying/dehydrating combinations (proposed § 117.5(h)), and produce before packing it, would be
that we would consider to be within the we have retained—and broadened—that conducting ‘‘additional manufacturing/
‘‘farm’’ definition—e.g., whether drying/ activity/food combination as an on- processing.’’
dehydrating is constrained to in situ, farm, low-risk manufacturing/ Other comments ask us to clarify
with no heat or mechanical air processing activity/food combination in whether packaged RACs are processed
circulation, because the example we the final human preventive controls rule food because ‘‘packaging’’ is defined as
discussed in the 2014 supplemental (see § 117.5(h), which includes making a manufacturing/processing operation.
preventive controls notice was ‘‘natural sugar and syrup from fruits and These comments also ask us to clarify
condition raisins.’’ These comments ask vegetables (e.g., dates), grains (e.g., rice, whether a farm would be precluded
us to specify the allowable methods of sorghum), other grain products (e.g., from holding RACs packaged in retail
drying to avoid confusion, and assert malted grains such as barley), saps (e.g., form because the packaged RACs are
that there is no food safety reason to agave, birch, maple, palm), sugar beets, processed food.
exclude use of heat or air, especially if and sugarcane). Processes such as (Response 29) See Response 27. We
sun and light are to be permitted. Other ‘‘boiling,’’ ‘‘concentrating,’’ and decline the request to reclassify
comments ask us to clarify what we ‘‘evaporating’’ are not ‘‘drying/ packaging and labeling so that they
mean by ‘‘without additional dehydrating’’ as the term ‘‘drying/ would not be considered
manufacturing/processing.’’ dehydrating’’ is used in this rule, and manufacturing/processing. Although we
(Response 28) We are retaining maple syrup is a processed food, not a classify packaging and labeling as
drying/dehydrating RACs to create a RAC. See also the discussion in manufacturing/processing, packaging
distinct commodity as an activity that is Response 23 regarding how a farm and labeling RACs do not transform the
within the ‘‘farm’’ definition even mixed-type facility that makes sugar RACs into processed food, and we
though it is manufacturing/processing. from sugarcane or sugar beets can classify ‘‘packaged RACs’’ as RACs.
As previously discussed, the processes consider the findings of the section We classify washing RACs as a
(described in comments to the 2013 103(c)(1)(C) RA (i.e., that this is a low- harvesting or packing activity when
proposed human preventive controls risk activity/food combination) in done on RACs before or during packing
rule) for drying grapes to ‘‘natural determining whether there are any or packaging, regardless of whether a
condition raisins’’ are akin to other hazards requiring a preventive control. farm is packing or packaging its own
harvesting activities traditionally A farm mixed-type facility that makes RACs or others’ RACs. As requested by
conducted by farms on RACs grown and maple products from maple sap could the comments, we have added an
harvested on farms, because they are follow the same approach. example of additional manufacturing/
traditionally performed by farms for the We have added ‘‘slicing’’ to the processing that would not be within the
purpose of removing RACs from the regulatory text as an example of ‘‘farm’’ definition—i.e., irradiating—to
place they were grown or raised and additional manufacturing/processing both the ‘‘farm definition’’ and to the
preparing them for use as food (79 FR that would be outside the ‘‘farm’’ definition of ‘‘manufacturing/
58524 at 58533). As also previously definition. We also have added ‘‘drying/ processing.’’ This example is different
discussed, the information provided by dehydrating grapes to produce raisins’’ from the example we used in the
the comments to the 2013 proposed to the regulatory text as an example of preamble of the 2014 supplemental
human preventive controls rule what we mean by ‘‘drying/dehydrating human preventive controls notice to
included information that ‘‘natural RACs to create a distinct commodity.’’ describe a limitation on activities within
condition raisins’’ are produced with Drying plums to produce prunes is the ‘‘farm definition’’—i.e., ‘‘modified
either sun-drying or artificial another example of drying/dehydrating atmosphere packaging’’ (see 79 FR
dehydration (79 FR 58524 at 58533). We RACs to create a distinct commodity. 58524 at 58532). We have decided to not
did not intend to limit the processes for Drying/baling hops is within the ‘‘farm’’ restrict the specific types of packaging
drying/dehydrating RACs to sun-drying, definition, but as a ‘‘holding’’ activity procedures that are within the ‘‘farm’’
and the regulatory text includes no such because drying/baling hops does not definition because doing so could be
limitation. We decline the request to create a distinct commodity. As confusing. Moreover, the specific safety
specify specific methods of drying/ discussed in Response 39, we have concern that can be associated with
dehydrating that would remain within revised the definition of ‘‘holding’’ to modified atmosphere packaging (i.e., the
the ‘‘farm’’ definition because doing so add drying/dehydrating RACs when the production of Clostridium botulinum
could imply that the list of methods was drying/dehydrating does not create a toxin), would be addressed by a
exhaustive and preclude use of new distinct commodity (such as drying/ proposed provision in the forthcoming
technology in the future. dehydrating hay or alfalfa) as an produce safety rule, if that provision is
However, we are adding ‘‘boiling’’ example of a holding activity. finalized (see proposed § 112.115; 78 FR
and ‘‘evaporating’’ to the list of (Comment 29) Some comments agree 3504 at 3589 and 3638). To clarify that
activities that we classify as that the activities of packaging and ‘‘modified atmosphere packaging’’ is a
manufacturing/processing to preclude labeling RACs should remain within the type of ‘‘packaging,’’ we have revised
interpretations, such as those expressed ‘‘farm’’ definition but ask us to the definition of ‘‘manufacturing/
in some of these comments, that the reclassify these activities so that they processing’’ to specify ‘‘packaging
processes to produce products such as are not considered manufacturing/ (including modified atmosphere
maple syrup, maple cream, and maple processing because they do not packaging)’’ as an example of a
candy are ‘‘drying/dehydrating.’’ In the transform a RAC into a processed food manufacturing/processing activity.
2013 proposed human preventive or change the nature of the RAC. These (Comment 30) Some comments assert
controls rule we included ‘‘Boiling/ comments ask us to add examples to that non-produce botanicals require
evaporation of maple sap to make maple regulatory text to explain what we mean treatments that do not create a new
syrup’’ as a low-risk manufacturing/ by ‘‘packaging and labeling without commodity and ask us to recognize
processing activity/food combination in additional manufacturing/processing.’’ these treatments as farm activities rather
the exemption for small and very small As an example, these comments ask than manufacturing/processing
businesses that only conduct specified whether a farm that packs produce activities. As examples, these comments
assert that activities such as cutting, activities listed in these comments, see separate contracts with the grower and
slicing, drying, freezing, wet or dry heat Response 3. the harvester. In another business
treating to kill plant tissues, and aging (Comment 31) Some comments assert model, a grower sells its crop to an
or fermenting are all activities that are that the ‘‘farm’’ definition is too limited entity that contracts with a separate
traditionally performed by farms on and ask us to include standard farm harvester to harvest the RACs and then
non-produce botanicals for the purpose activities such as culling, conveying, packs the RACs. There are variations on
of removing non-produce botanical sorting, waxing, labeling, storing, these business models, such as when a
RACs from the place where they were packaging and shipping of raw, whole grower sells its crop to an entity that
grown and preparing them for use as produce. These comments assert that both harvests and packs the RACs,
food. These comments also assert that these normal activities do not change without a contract with a separate
we have been inconsistent in our the shape or structure of RACs, or alter harvester.
activity classifications because we both the hazards, and should be covered Growing and harvesting operations
state that ‘‘heat treatment’’ is a food under the produce safety rule rather are not under the same management in
processing activity and state that than the human preventive controls some of these business models. As
activities traditionally performed by rule. discussed in Comment 23, comments
farmers to prepare crops for use are farm (Response 31) All of the activities emphasize that farming operations can
activities. These comments express described by these comments could be have complex business structures, and
concern that farmers won’t use heat within the ‘‘farm’’ definition (see 79 FR ask us to revise the ‘‘farm’’ definition to
treatments to control pests, based on a 58524 at 58571–58572), either because provide for these business models. To
misunderstanding of what constitutes they are specified in the ‘‘farm’’ explicitly include these business models
‘‘food processing.’’ definition itself or because they are in the ‘‘farm’’ definition, we have
examples of activities within the revised the ‘‘farm’’ definition to mean
(Response 30) We note that these
definition of ‘‘packing’’ or holding.’’ an operation under one management in
comments used the term ‘‘non-produce
Packaging and labeling RACs, without one general (but not necessarily
botanicals,’’ which is not a term we
additional manufacturing/processing, contiguous) physical location devoted to
have used or defined, and it is not clear
are specified in the regulatory text of the the growing of crops, the harvesting of
to us what the commenters intended
‘‘farm’’ definition. Sorting and culling crops, the raising of animals (including
this term to represent. In this document,
are included in the regulatory text of the seafood), or any combination of these
we are not addressing the question of
definition of ‘‘packing.’’ Storing is activities. With this revision, an
whether certain ‘‘botanicals’’ are or are
simply another term for ‘‘holding.’’ We operation can be within the ‘‘farm’’
not ‘‘produce.’’ The term ‘‘produce’’ was
had already included ‘‘weighing and definition if it grows crops but does not
proposed to be defined in the conveying’’ as an example of a low-risk harvest them or if it harvests crops but
forthcoming produce safety rule, and we packing or holding activity in the does not grow them.
intend to define it in that rule. exemption applicable to on-farm low- The ‘‘farm’’ definition established in
However, we can address in this rule risk activity/food combinations the section 415 registration regulations
these commenters’ questions about (§ 117.5(g)). To give more prominence to in 2003 (68 FR 58894), and the proposed
activity classification. Some of these this packing activity, we have added it revisions to the ‘‘farm’’ definition in the
activities are within the ‘‘farm’’ to the definition of ‘‘packing’’ as well. 2013 proposed human preventive
definition. For example, drying/ (Comment 32) One comment, controls rule and the 2014 supplemental
dehydrating a RAC without creating a submitted to Docket No. FDA–2011–N– human preventive controls notice, all
distinct commodity is part of ‘‘holding’’ 0143 for the FSVP rulemaking, notes describe a ‘‘farm’’ as an entity ‘‘devoted
and drying/dehydrating a RAC that that RACs often are harvested by a to the growing and harvesting of crops’’
creates a distinct commodity, without contract harvest company (Ref. 16). This (emphasis added). In light of the
additional manufacturing/processing, is comment asks us to clarify what is revision to the ‘‘farm’’ definition and as
manufacturing/processing that is meant by ‘‘establishment that harvests a discussed more fully in section IX.C.35,
included within the ‘‘farm’’ definition. food’’ in the definition of ‘‘foreign we have revised the ‘‘supplier’’
(See Response 28.) Cutting (or otherwise supplier’’ and whether, in such definition to include the establishment
separating) the edible portion of the circumstances, the supplier of the RAC that ‘‘grows the food’’ rather than the
RAC from the crop plant and removing would be the contract harvest company establishment that ‘‘harvests the food.’’
or trimming part of the RAC (e.g., or the establishment that owns the crop With this change in the ‘‘supplier’’
foliage, husks, roots or stems) are and sells it to an importer. definition, the supplier is the farm that
harvesting activities. (See Response 37.) (Response 32) The 2014 supplemental grows the food regardless of the
We have revised the definition of human preventive controls notice had business model for harvesting the food.
‘‘holding’’ to include the example of similar phrasing (‘‘establishment that (Comment 33) Some comments ask us
‘‘fumigating food during storage.’’ (See harvests the food’’) in the definition of to modify the ‘‘farm’’ definition to
Response 39.) We decided to include ‘‘supplier.’’ In the final rule the exclude feed mills that provide feed to
this example of a holding activity based definition of ‘‘supplier’’ has changed in more than 5 other farms. These
on previous discussions of how we relevant part to include the comments assert that egg farms are most
classify fumigating as a type of pest ‘‘establishment that grows the food,’’ likely to be company owned and the
control (see, e.g., 78 FR 3646 at 3682 consistent with changes to the farm median number of farms owned by a
and 79 FR 28524 at 28571). Although definition and as described in the company is under 8 and cite USDA as
we have not previously classified heat following paragraphs. the source of this information. These
treatment for purposes of pest control, There are several different business comments assert that setting the limit at
we agree that we should classify heat models in which RACs are harvested by 5 would not automatically exempt feed
treatment for purposes of pest control a contract harvester (Ref. 17). In one mills operated by these large egg laying
the same way that we have classified business model, a grower contracts with businesses from the animal preventive
fumigating for purposes of pest a harvester to perform harvesting on controls rule.
control—i.e., as a holding activity. behalf of the grower. In another business (Response 33) We decline this
Regarding classification of the other model, a third-party handler enters into request. The statutory exemption from
the section 415 registration regulations the RACs harvested, packed, and/or package form intended for direct human
(and, thus, from the requirements for held by the secondary activities farm consumption) or sold unpasteurized to
hazard analysis and risk-based owns, or jointly owns, a majority consumers within a State consistent
preventive controls) for ‘‘farms’’ is based interest in the secondary activities farm. with applicable State laws and
on the activities that an operation Drying/dehydrating RACs (such as regulations. Distributing raw milk in
conducts rather than on the size of the grapes and plums) to create a distinct interstate commerce would be unlawful,
operation. commodity, and packaging and labeling but would not form the basis for a
(Comment 34) Some comments assert such commodities, without additional decision that the business is ‘‘not a
that the hulling or dehydration of manufacturing/processing is within the farm.’’
walnuts should not be considered ‘‘farm’’ definition when conducted on a (Comment 36) Some comments
processing and, thus, that an farm or farm mixed-type facility. (See express concern that farmers who grow
establishment that conducts hulling or Response 28.) However, additional seed that is sold as animal feed must
dehydration activities on tree nuts such manufacturing/processing activities register as a food facility. These
as walnuts should not be considered a (such as removing pits from dried comments ask why sales of grain for
facility subject to the requirements for plums) are outside the ‘‘farm’’ animal feed are included in a rule that
hazard analysis and risk-based definition, and a farm or farm mixed- is focused on the safety of human food
preventive controls. These comments type facility that conducts such and ask us to exempt this category of
also assert that all growers who hull and activities becomes a facility that is farms and their sales of grain for animal
dry should operate under the same required to register and is subject to the feed from the registration rule.
rules, regardless of whether or not they requirements for hazard analysis and (Response 36) Establishments that
own their own crop. Some comments risk-based preventive controls for those satisfy the ‘‘farm’’ definition, including
assert that the hulling and shelling activities outside the farm definition. farms that grow seed that is sold as
operations in the nut industry are part The exception is when a farm is a small animal food, are not required to register
of the harvesting operation in which the or very small business eligible for the as a food facility. These comments may
outer shells are removed. These exemptions in § 117.5(g) and (h) for a mistakenly believe that we intended any
comments state that regardless of farm mixed-type facility that only food establishment that is required to
whether activities are conducted on the conducts low-risk activity/food register as a food facility to comply with
farm in which they are grown or at an combinations. Such a small or very the regulations we are establishing in
off-farm facility that provides hulling small business must still register as a part 117 regarding human food,
and shelling services, the food is a RAC, food facility, but will be exempt from regardless of whether the facility
the activity is low-risk and does not the requirements for hazard analysis produces food for consumption by
transform the RAC into a processed and risk-based preventive controls. (See humans or food for consumption by
food, and the product is delivered to a also the discussion in in the 2014 animals. This is not the case. We simply
processing facility and is not distributed supplemental human preventive proposed to revise definitions in the
in commerce. The comments argue that controls notice (79 FR 58524 at 58533– section 415 registration regulations
for all these reasons and because hulling 58534 and table 1 in the Appendix to relevant to the definition of ‘‘facility’’ in
and shelling activities are not subject to the 2014 supplemental human the same notice in which we proposed
subpart B, it is not appropriate to preventive controls notice (79 FR 58524 to modernize the current CGMPs for
subject facilities that conduct such at 58571–58572)). food and establish requirements for
activities to subpart C. Comments (Comment 35) Some comments assert hazard analysis and risk-based
request that hulling, shelling, and that we have referred to raw milk as preventive controls for human food,
drying of tree nuts be considered ‘‘on being ‘‘inherently dangerous’’ and because section 103 of FSMA addresses
farm’’ for the purposes of this rule. should not consider any activities that the definitions in the section 415
Other comments ask us to specify that result in the preparation of an registration regulations, as well as the
the production of ‘‘natural dried inherently unsafe product for sale to requirements for hazard analysis and
raisins,’’ dried plums, and dried hops consumers to be within the ‘‘farm’’ risk-based preventive controls. If a
are within the ‘‘farm’’ definition. definition (i.e., production of raw milk facility sells grain for use as animal
(Response 34) Hulling of tree nuts for direct human consumption should food, and is not exempt from the section
(such as walnuts, almonds, and not be considered ‘‘harvesting’’ or 415 registration regulations, that facility
pistachios) is a harvesting activity that ‘‘packing’’). These comments ask us to would be subject to the animal
is within the ‘‘farm’’ definition when re-consider the definition of ‘‘farm’’ as preventive controls rule, not the human
conducted on a farm or the farm part of it applies to the production of raw milk preventive controls rule that is the
a farm mixed-type facility. Drying/ for human consumption. Specifically, subject of this document.
dehydrating RACs without creating a these comments ask us to consider such
distinct commodity (such as drying activities to be outside the traditional C. Proposed New Definition of
walnuts and hops) is a holding activity business of a dairy farm and to subject Harvesting
that also is within the ‘‘farm’’ definition businesses that conduct such activities We proposed to define ‘‘Harvesting,’’
when conducted on a farm or farm to FSMA’s requirements for hazard as a new definition in §§ 1.227 and
mixed-type facility. As discussed in analysis and risk-based preventive 1.328, to apply to farms and farm
Response 25, we have revised the controls requirements as a means of mixed-type facilities and to mean
‘‘farm’’ definition to provide that an advancing public health. activities that are traditionally
operation, not located on a primary (Response 35) We decline this performed by farms for the purpose of
production farm, devoted to harvesting request. Producing milk is a traditional removing RACs from the place they
(such as hulling or shelling), packing, activity of a dairy farm, regardless of were grown or raised and preparing
and/or holding of RACs is within the whether the milk produced by that dairy them for use as food. We proposed that
‘‘farm’’ definition (as a ‘‘secondary farm is pasteurized and introduced into harvesting be limited to activities
activities farm’’), provided that the interstate commerce in accordance with performed on RACs on a farm, and that
primary production farm(s) that grows, § 1240.61 (Mandatory pasteurization for harvesting does not include activities
harvests, and/or raises the majority of all milk and milk products in final that transform a RAC into a processed
food. The proposed definition included waxing also has long been considered a does not create a distinct commodity
examples of activities that would be manufacturing/processing activity (such as drying/dehydrating hay or
harvesting. As noted in table 52 of this during the production of processed food alfalfa)). In table 1 in the Appendix to
document, we have reorganized the (because it involves making food from the 2014 supplemental human
listed examples of harvesting to present one or more ingredients, or preventive controls notice (79 FR 58524
them in alphabetical order. We also synthesizing, preparing, treating, at 58571–58572), we provided a more
have modified the proposal that modifying or manipulating food) (see 78 extensive list of examples of holding
harvesting be limited to activities FR 3646 at 3679). Artificial ripening of activities, including examples that are
performed on RACs on a farm to provide fruit is manufacturing/processing (not not in the regulatory text. We have
that harvesting can also be performed on harvesting), but is now within the previously classified some of these
processed foods created by drying/ ‘‘farm’’ definition (see § 117.3 and activities in more than one way (see 79
dehydrating a RAC without additional Response 27). Regarding classification FR 58524 at 58571–58572) depending
manufacturing/processing, because of the other activities listed in these on when the activity occurs. For
processed foods created by drying/ comments, see Response 3. example, sorting, culling, and grading
dehydrating RACs are within the ‘‘farm’’ (Comment 38) Some comments assert RACs can be either a holding activity or
definition. See Response 28 and 79 FR that fermenting cocoa beans and coffee a packing activity. Drying/dehydrating
58524 at 58533 regarding drying/ beans should be classified as RACs is holding when the drying/
dehydrating RACs to create a distinct ‘‘harvesting’’ rather than ‘‘holding.’’ dehydrating does not create a distinct
commodity. (Response 38) We agree that the commodity, but is manufacturing/
(Comment 37) Some comments ask us process of fermenting cocoa beans and processing when the drying/dehydrating
to provide more examples of harvesting coffee beans begins as a ‘‘harvesting’’ creates a distinct commodity (see
activities, in the regulatory text and in activity, when the pods are harvested Response 28). Regarding classification
guidance. Examples of the requested and the beans are removed; it continues of the other activities listed in these
activities include braiding; bunching; as ‘‘holding,’’ while the harvested beans comments, see Response 3.
cutting the edible portion of the crop ferment. Thus, fermenting cocoa beans (Comment 40) Some comments ask us
from the plant; hydro-cooling; and coffee beans has elements of both to clarify that mixing or blending intact
maintaining hydration of product; ‘‘harvesting’’ and ‘‘holding,’’ which are RACs is considered ‘‘holding’’
refrigerating; removing foliage; both within the ‘‘farm’’ definition. It is regardless of whether the RACs are the
removing free water from (e.g., not necessary to place the process of same or different.
spinning); removing or trimming roots; fermenting cocoa beans and coffee beans (Response 40) We use the term
trimming the tops of bunches of allium squarely in one activity or the other for ‘‘blending’’ when referring to RACs such
crops such as leeks, chives, or garlic and the regulatory purpose of determining as grain and when the RACs are the
root crops such as carrots, beets, whether an operation is within the same. For example, we consider the
turnips, parsnips, etc. to prepare them ‘‘farm’’ definition. See also Response 41. activity of ‘‘blending’’ different lots of
for sale; and trimming the lower stems the same grain to meet a customer’s
D. Proposed Revision to the Definition
of harvested herb crops such as parsley, quality specifications to be a practical
of Holding
basil, or cilantro, or the lower stems of necessity for product distribution and,
leafy greens. Other comments ask us to We proposed to revise the definition thus, to be within the definition of
specify that harvesting also of ‘‘Holding’’ in §§ 1.227 and 1.328 to ‘‘holding’’ (see 79 FR 58524 at 58537).
encompasses seed conditioning (i.e., add that holding also includes activities However, we use the term ‘‘mixing’’
cleaning the seed, including removal of performed incidental to storage of a when the RACs are different. For
leaves, stems, and husks to prepare for food, but does not include activities that example, we consider the activity of
marketing), ripening (artificial or transform a RAC into a processed food. ‘‘mixing’’ corn and oats in the
natural) of fruit, and waxing or coating Holding facilities could include production of animal food to be
of RACs. warehouses, cold storage facilities, manufacturing/processing, because
(Response 37) We have added or storage silos, grain elevators, and liquid mixing two different foods is ‘‘making
modified several examples of harvesting storage tanks. food from one or more ingredients’’
in the regulatory text (i.e., cutting (or (Comment 39) Some comments ask us (which is our definition of
otherwise separating) the edible portion to provide more examples of holding ‘‘manufacturing/processing’’), and the
of the RAC from the crop plant, activities, in the regulatory text and in animal food produced by mixing corn
removing or trimming part of the RAC guidance. Examples of the requested and oats is a processed food.
(e.g., foliage, husks, roots or stems), field activities include fumigating RACs; We classify ‘‘mixing’’ intact RACs that
coring, and hulling). In table 1 in the application of chemicals (including does not create a processed food as
Appendix to the 2014 supplemental fungicides, sanitizers, and anti- incidental to, and therefore part of,
human preventive controls notice (79 oxidants); application of ripening ‘‘packing’’ or ‘‘holding’’ as applicable.
FR 58524 at 58571–58572), we provided agents; using wax as a carrier of (Comment 41) Some comments ask us
a more extensive list of examples of fungicides or anti-oxidants applied to clarify whether the expanded
harvesting activities, including before storage; and waxing or coating of definition of holding that we proposed
examples that are not in the regulatory RACs, including ‘‘coating’’ grain RACs in the 2014 supplemental human
text. Although we have classified some with diatomaceous earth to control preventive controls notice would mean
of these activities in more than one way insects. According to these comments, that a warehouse that both stores cocoa
(see 79 FR 58524 at 58571–58572), in these activities are incidental to storage beans and fumigates the cocoa beans to
general these activities would fall and do not transform RACs into prevent pest infestation would be
within the ‘‘farm’’ definition when processed food. exempt from the requirements for
conducted on RACs that are not (Response 39) We have added or hazard analysis and risk-based
otherwise processed. For example, modified several examples of holding in preventive controls for a facility solely
coating RACs with wax/oil/resin for the the regulatory text (i.e., fumigating food engaged in the storage of RACs (other
purpose of storage or transport can be a during storage, and drying/dehydrating than fruits and vegetables) for further
packing (not harvesting) activity, but RACs when the drying/dehydrating distribution or processing (§ 117.5(j)).
(Response 41) Fumigating RACs such sampling activities does not remove a ‘‘manufacturing/processing’’ does not
as cocoa beans to prevent pest warehouse’s exemption altogether. create problems with determining the
infestation would be within the (Response 45) We consider that status of an operation as a ‘‘farm’’ or a
definition of ‘‘holding.’’ Therefore, such sampling food in the manner described ‘‘facility’’ and we are retaining examples
fumigation would not prevent a facility by this comment is a practical necessity in both definitions because doing so
that stores RACs (other than fruits and for the distribution of the food within reflects current practices on farms and
vegetables) from being eligible for the the definition of ‘‘holding,’’ and that the in manufacturing/processing facilities.
exemption in § 117.5(j), provided that exemption still applies to a facility that (Comment 47) Some comments ask us
the facility does not conduct other conducts such sampling. Importantly, to clarify that the traditional activities of
activities not classified as ‘‘holding.’’ the sampling must be in done in a packing shed—cleaning and packing
However, a threshold question for any accordance with CGMPs such that the intact fruits and vegetables—do not
facility solely engaged in the storage of exposure does not result in constitute ‘‘manufacturing/processing’’
RACs is whether the stored RACs are contamination of the food. that would trigger the requirement to
fruits or vegetables. We classify cocoa register as a facility.
E. Proposed Revision to the Definition of (Response 47) Packing activities are
beans within the category of ‘‘fruits and Manufacturing/Processing
vegetables’’ (78 FR 3646 at 3690) and, within the definition of ‘‘packing,’’ and
thus, a facility that stores cocoa beans is We proposed to revise the definition holding activities are within the
not eligible for the exemption in of ‘‘Manufacturing/Processing’’ in definition of ‘‘holding,’’ regardless of
§ 117.5(j). §§ 1.227 and 1.328 by adding to the whether the packing or holding
(Comment 42) Some comments ask us existing definition a criterion applicable activities take place on-farm or off-farm.
to clarify whether there is a timeframe to farms and farm mixed-type facilities. In other words, neither packing produce
associated with holding and to better As noted in table 52, we have nor holding produce would be classified
distinguish between ‘‘holding’’ and reorganized the listed examples of as manufacturing/processing merely
‘‘storage.’’ manufacturing/processing to present because the business entity conducting
(Response 42) There is no timeframe them in alphabetical order. the activity is a facility that is subject to
(maximum or minimum) associated (Comment 46) Some comments the section 415 registration regulations.
with holding. The definition of holding express concern that some activities As discussed in Response 25, we have
states ‘‘Holding means storage of food’’ included in the definition of revised the ‘‘farm’’ definition to provide
and, thus, there is no distinction ‘‘manufacturing/processing’’ overlap that an operation devoted to harvesting
between ‘‘holding’’ and ‘‘storing.’’ with activities (such as trimming, (such as hulling or shelling), packing,
(Comment 43) Some comments ask us washing, and cooling) included in the and/or holding of RACs is within the
to clarify how the definition of holding definition of ‘‘harvesting.’’ ‘‘farm’’ definition (as a ‘‘secondary
relates to practices, such as fumigation, (Response 46) We acknowledge that activities farm’’), provided that the
on almond hull stockpiles held on a there is some overlap in the activities primary production farm(s) that grows,
farm, a farm mixed-type facility, or off- that the regulatory text lists as examples harvests, and/or raises the majority of
farm. of both ‘‘manufacturing/processing’’ and the RACs harvested, packed, and/or
(Response 43) Practices that are ‘‘harvesting,’’ because some activities held by the secondary activities farm
incidental to storage of food, such as can occur during more than one owns, or jointly owns, a majority
fumigation of almond hull stockpiles, operation (see also the discussion at 79 interest in the secondary activities farm.
are holding, regardless of whether they FR 58524 at 58538 and table 1 in the With this revision, some off-farm
are conducted on-farm, on a farm Appendix to the 2014 supplemental packinghouses that are managed by a
mixed-type facility, or off-farm. human preventive controls notice (79 business entity (such as a cooperative)
(Comment 44) Some comments ask us FR 58524 at 58571–58572)). For that is different from the business entity
to clarify that value added activities example, ‘‘cutting’’ the core of the growing crops (such as individual
(such as repacking and blast freezing) lettuce from the crop plant can occur farms) can be within the ‘‘farm’’
conducted in facilities such as on-farm in the field where the lettuce is definition, provided that the primary
warehouses would be considered harvested, and ‘‘cutting’’ the core of the production farm(s) that grows, harvests,
holding when product is not exposed to lettuce from the rest of the harvested or raises the majority of the RACs
the environment. lettuce also can occur in a fresh-cut harvested, packed, and/or held by the
(Response 44) We consider the processing facility. An important secondary activities farm owns, or
activities described in these comments consequence of the multiple revisions jointly owns, a majority interest in the
to be activities performed as a practical we have made to the ‘‘farm’’ definition packing operation.
necessity for the distribution of the food in this rulemaking is that there are fewer (Comment 48) Some comments ask us
and, thus, to be within the definition of situations in which classification of a to make clear, in our response to
holding. particular activity is the only trigger for comments in the final rule, that any
(Comment 45) Some express concern an operation to be subject to the section adjustments we make to the definition
that the definition of holding would 415 registration regulations. For of manufacturing/processing in no way
prevent a facility that samples food example, the revised ‘‘farm’’ definition change the definitions of ‘‘raw
(such as sugar) for grading or quality no longer classifies the packing and agricultural commodity,’’ ‘‘processing,’’
control purposes from qualifying for the holding of others’ RACs to be a and ‘‘processed food,’’ which were
exemption for facilities engaged solely manufacturing/processing activity that mutually agreed to by EPA and FDA
in holding unexposed packaged food triggers the registration requirement. As (Ref. 15) to address regulatory
because they would temporarily expose another example, the revised ‘‘farm’’ responsibilities for antimicrobials
otherwise unexposed packaged food to definition specifies three applied to food, process water
the environment. These comments ask manufacturing/processing activities that contacting food, or hard food-contact
us to make clear that the requirements are within the ‘‘farm’’ definition. We surfaces.
for hazard analysis and risk-based conclude that the overlap in the (Response 48) The revisions we made
preventive controls only apply to the examples of activities listed in the to the ‘‘farm’’ definition, and to the
sampling activities and that engaging in definitions of ‘‘harvesting’’ and classification of activities relevant to the
‘‘farm’’ definition, do not change the risk activities specified in the ‘‘packing.’’ Some comments state that
statutory definitions of ‘‘raw agricultural exemptions for on-farm, low-risk when a RAC is packed in the field and/
commodity,’’ and ‘‘processed food,’’ or activity/food combinations (§ 117.5(g) or is placed into a clamshell container,
impact our interpretation of the and (h)). as a practical matter it is considered to
definition of ‘‘processing,’’ with respect (Response 51) We decline this have been ‘‘packed,’’ not ‘‘packaged.’’
to regulatory jurisdiction for request. Whether a particular (Response 53) We acknowledge that
antimicrobials applied to food, process establishment that falls within the farms traditionally refer to field packing,
water contacting food, or hard food- definition of ‘‘mixed-type facility’’ is including placing RACs into clamshell
contact surfaces. subject to the requirements for hazard containers that will serve as a consumer
analysis and risk-based preventive package, as ‘‘packing,’’ not ‘‘packaging.’’
F. Proposed New Definition of Mixed- controls is governed by the exemptions Indeed, in the 2013 human preventive
Type Facility established in this rule. controls rule we proposed to revise the
We proposed to define ‘‘Mixed-type definition of ‘‘packing’’ to specify that,
facility,’’ as a new definition in §§ 1.227 G. Proposed Revision to the Definition
for farms and farm mixed-type facilities,
and 1.328, to mean an establishment of Packing
‘‘packing’’ includes ‘‘packaging.’’
that engages in both activities that are We proposed to revise the definition However, in the 2014 supplemental
exempt from registration under section of ‘‘Packing’’ in §§ 1.227 and 1.328 by human preventive controls notice we
415 of the FD&C Act and activities that adding that packing includes activities proposed a simpler approach to
require the establishment to be performed incidental to packing a food, accommodate requests such as those in
registered. We specified in the but does not include activities that these comments, by simply specifying
regulatory text that an example of such transform a RAC into a processed food. in the ‘‘farm’’ definition that packaging
a facility is a ‘‘farm mixed-type facility,’’ We have revised the definition to clarify and labeling RACs, without additional
which is an establishment that grows that packing includes ‘‘re-packing.’’ manufacturing/processing, is within the
and harvests crops or raises animals and (Comment 52) Some comments ask us ‘‘farm’’ definition. We conclude that the
may conduct other activities within the to include minimal ‘‘manufacturing/ distinctions between the terms
farm definition, but also conducts processing’’ of RACs in the definition of ‘‘packing’’ and ‘‘packaging’’ do not
activities that require the establishment packing when the minimal create problems with determining the
to be registered. As a conforming change ‘‘manufacturing/processing’’ does not status of an operation as a ‘‘farm’’ or a
associated with the revisions to the transform the RAC into a processed ‘‘facility.’’ Further, we note that we have
‘‘farm’’ definition, we have revised the food. The comments describe waxing of given these terms identical meanings
example of a ‘‘farm mixed-type facility’’ fresh fruit (such as apples) and across multiple FDA regulations that are
to specify that it is an establishment that vegetables as examples of activities that applicable to facilities.
is a farm, but also conducts activities do not transform a RAC into a processed (Comment 54) Some comments refer
outside the farm definition that require food. to discussions at a ‘‘listening session’’
the establishment to be registered. (Response 52) As already discussed, regarding harvesting several varieties of
(Comment 49) Some comments assert the activities that transform a RAC into lettuce, washing them, and combining
that there is no scientific basis for the a processed food (and are sometimes heads or bunches of the different
definition of mixed-type facility. therefore referred to as ‘‘processing’’ in varieties in one bag that is sealed with
(Response 49) The proposed the context of a food’s status as a RAC a knot or twist tie. During these
definition is not a science-based or processed food) are not coextensive discussions, this type of activity was
definition. It is a descriptive term that with the activities described in our classified as being within the ‘‘farm’’
we are using to refer to certain food definition of ‘‘manufacturing/ definition. These comments ask how
establishments. We used this same term processing.’’ (See Response 27.) this activity can be classified as being
during the rulemaking to establish the Although waxing has long been within the ‘‘farm’’ definition when
section 415 registration regulations (see considered a manufacturing/processing mixing and washing are listed as
response to comment 46, 68 FR 58894 activity during the production of manufacturing/processing activities that
at 58906, October 10, 2003). processed food (because it involves trigger registration as a food facility and
(Comment 50) Some comments ask us making food from one or more whether there is a discrepancy between
to revise the definition to add more ingredients, or synthesizing, preparing, what the rule requires and what they
details about activities that are inside treating, modifying or manipulating heard at the listening session. Other
the farm definition and activities that food), we classify coating RACs with comments express the view that mixing
are outside the farm definition. wax/oil/resin for the purpose of storage RACs that have not been transformed
(Response 50) We decline the request or transport as a packing activity. (See into processed food (such as bagging
of these comments. Adding such details Response 37). mixed greens or different types of whole
would detract from the focus of the (Comment 53) Some comments ask us produce, such as potatoes, beets, and
definition—i.e., that it refers to a facility to clarify the distinction between carrots) should not put a farm in the
that conducts both activities that are ‘‘packing’’ and ‘‘packaging’’ because the category of a mixed-type facility.
inside the farm definition and activities terms are different but seem to be used (Response 54) Removing several
that are outside the farm definition. We interchangeably. These comments varieties of lettuce from the place in
have included additional examples of express concern that ‘‘placing food into which they were grown, washing them
‘‘harvesting,’’ ‘‘packing,’’ and ‘‘holding’’ containers’’ on farms that have on the farm, and combining heads or
activities in the regulatory text of the traditionally done so will be classified bunches of the different varieties in one
definitions for those terms (see §§ 1.227, as ‘‘manufacturing/processing’’ and bag that is sealed with a knot or twist
1.328 and 117.3 and Response 31, trigger the requirement to register as a tie on the farm are all activities within
Response 37 and Response 39). (See also food facility and ask us to reclassify the ‘‘farm’’ definition. We classify
Response 3.) ‘‘packaging’’ within the definition of ‘‘washing’’ and ‘‘mixing’’ in more than
(Comment 51) Some comments ask us ‘‘packing.’’ Other comments ask us to one way depending on when the
to revise the definition to exclude those remove the words ‘‘other than packaging activity occurs, and the ‘‘farm’’
establishments that only conduct low- of food’’ from the definition of definition now specifies that
‘‘packaging’’ RACs (without additional V. Comments on the Organizing the activity transforms a RAC into a
manufacturing/processing, such as Principles for How the Status of a Food processed food (as defined by these
slicing) is a farm activity, even though as a Raw Agricultural Commodity or as rules); (4) manufacturing/processing,
it is a type of ‘‘manufacturing/ a Processed Food Affects the packing, or holding food—whether
processing.’’ We have recognized Requirements Applicable to a Farm RACs or processed foods, from any
‘‘washing’’ as a harvesting activity since Under Sections 415 and 418 of the source—for consumption on the farm
we first issued the section 415 FD&C Act should remain within the farm
registration regulations (68 FR 58894 at In the 2014 supplemental human definition.
58961, October 10, 2003), even though preventive controls notice, we discussed (Response 55) We have revised the
we also classify ‘‘washing’’ RACs as comments on the organizing principles ‘‘farm’’ definition to refer to farms as
‘‘manufacturing/processing’’ when done that formed the basis for proposed ‘‘operations’’ rather than ‘‘facilities’’ or
in a food processing facility (such as a revisions to the section 415 registration ‘‘establishments’’; reflect modern
fresh-cut processing facility). We regulations and the section 414 business models (such as cooperatives,
recordkeeping regulations (79 FR 58524 on-farm packinghouses under
classify ‘‘mixing’’ intact RACs that does
at 58538). We also explained how our ownership by multiple growers, food
not create a processed food as incidental
proposed revisions to the ‘‘farm’’ aggregators, and some types of food
to, and therefore part of, ‘‘packing’’ or hubs (e.g., those that consolidate and
definition would require us to
‘‘holding’’ as applicable. Mixing heads distribute RACs but do not conduct
reconsider those organizing principles
or bunches of lettuce as described in the activities that transform the RACs into
(79 FR 58524 at 58538).
example does not create a processed (Comment 55) Some comments assert a processed food)); specify that a farm
food, because he mixing has not created that we should revise the organizing is in one general (but not necessarily
a distinct commodity, but only a set of principles to reflect the realities and contiguous) physical location; and
mixed RACs. On the other hand, mixing range of activities that farms conduct to provide that an operation devoted to
that creates a processed food is not prepare their crops for market and to harvesting (such as hulling or shelling),
‘‘packing’’ or ‘‘holding.’’ The definitions make the organizing principles packing, and/or holding of RACs is
of both ‘‘packing’’ and ‘‘holding’’ are consistent with FSMA’s risk-based within the ‘‘farm’’ definition as a
limited so that they do not include mandate. These comments ask us to secondary activities farm, provided that
activities that transform a RAC into revise the organizing principles as the primary production farm(s) that
processed food. Some kinds of mixing of follows: (1) The basic purpose of farms grows, harvests, and/or raises the
RACs do create a distinct commodity is to produce RACs and deliver them for majority of the RACs harvested, packed,
(for example, mixing corn and oats to sale to end-users or other buyers; (2) and/or held by the secondary activities
make animal food). In such cases, the activities that involve RACs and that farm owns, or jointly owns, a majority
mixing is manufacturing/processing and farms perform for the purposes of interest in the secondary activities farm
is not within the farm definition. selling their own RACs, including (e.g., an off-farm produce packinghouse
Likewise, although we classify placing growing them, harvesting them, owned by farmers or a farmer-owned
RACs in a plastic bag with a twist tie as preparing them for consumption in their tree nut hulling and drying operation).
‘‘packaging’’ rather than ‘‘packing’’ raw and unprocessed state, and packing, (See Response 22, Response 23,
when the plastic bag is the container sorting, grading, packaging, labeling, Response 24, and Response 25.) All of
holding, transporting, marketing, and these changes to the ‘‘farm’’ definition
that the consumer receives, we have
delivering them, should all be within do, as requested by these and other
provided for ’’packaging’’ RACs as an
the definition of ‘‘farm;’’ (3) even though comments, reflect the realities and range
activity within the ‘‘farm’’ definition.
farms traditionally also do a wide of activities that farms conduct. See
variety of activities that may be table 5 for organizing principles
considered processing, for the purpose regarding classification of activities on-
of these organizing principles, activities farm and off-farm in light of the changes
should be classified based on whether to the ‘‘farm’’ definition.
TABLE 5—ORGANIZING PRINCIPLES REGARDING CLASSIFICATION OF ACTIVITIES ON-FARM AND OFF-FARM
No. Organizing principle
1 ................... The basic purpose of farms is to produce RACs, and RACs are the essential products of farms.
2 ................... A farm is in one general (but not necessarily contiguous) location.
3 ................... Farm operations include business models such as cooperatives, on-farm packinghouses under ownership by multiple growers,
food aggregators, and some types of food hubs.
4 ................... Activities that involve RACs and that farms traditionally do for the purposes of growing RACs, removing them from the growing
areas, and preparing them for use as a food RAC, and for packing, holding, and transporting them, are all within the ‘‘farm’’
definition.
5 ................... Activities are classified based in part whether the activity transforms a RAC into a processed food.
6 ................... A limited number of traditional operations that farms do for the purpose of preparing RACs for use as a food RAC, but that are
classified as ‘‘manufacturing/processing,’’ are within the ‘‘farm’’ definition. These are: (1) Drying/dehydrating RACs to create a
distinct commodity, and packaging and labeling such commodities, without additional manufacturing/processing; (2) treatment
to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without additional manufacturing/proc-
essing; and (3) packaging and labeling RACs, when these activities do not involve additional manufacturing/processing.
7 ................... Manufacturing/processing, packing, or holding food—whether RACs or processed foods, from any source—for consumption on
the farm is within the farm definition.
VI. Rulemaking Required by Section a facility only engages in low-risk risks, and assert that it is likely that
103(c) of FSMA: On-Farm Activities activity/food combinations and is a many will be found to be low risk. Other
small or very small business and comments suggest that the Centers for
A. Section 103(c)(1)(C) of FSMA
requested comment on this tentative Disease Control and Prevention (CDC)
We previously described provisions of conclusion. expand its data analysis effort (Ref. 20)
FSMA that direct us to conduct a to separate out commodities to assess
science-based risk analysis to cover B. Comments on Qualitative Risk
attribution of foodborne illnesses for
specific types of on-farm packing, Assessment of On-Farm Activities
additional commodities.
holding, and manufacturing/processing Outside of the Farm Definition (Response 57) Because of changes we
activities that would be outside the (Comment 56) Some comments made to the farm definition, practices
‘‘farm’’ definition and, thus, subject to address the qualitative nature of the such as washing that are necessary to
the requirements for hazard analysis section 103(c)(1)(C) draft RA and assert move product from the field are within
and risk-based preventive controls (see that it is based on professional judgment the farm definition and are not
section 103(c)(1)(C) of FSMA and 78 FR rather than data. These comments ask us addressed in the section 103(c)(1)(C)
3646 at 3674 and 3689–3691). to update the section 103(c)(1)(C) draft RA. We disagree that we should re-
Consistent with this statutory direction, RA when more data become available. examine our data sources in assessing
we developed the section 103(c)(1)(C) Some comments assert that we should commodity-specific risks. As we
draft RA and made it available for not rely on data from the Food discussed in the section 103(c)(1)(C)
public comment (Ref. 18 and 78 FR Processing Sector Study (Ref. 19), but draft RA, we focused on considering the
3824). We are including the final risk instead collect data from large-scale risk of activity/food combinations rather
assessment (the section 103(c)(1)(C) RA) surveys of actual farm mixed-type than separately considering the risk of
in the docket established for this facilities and their activities. Other specific food categories because doing
document (Ref. 4). comments ask us to dedicate resources so would better enable us to focus on
We previously described provisions of and enter into agreements with whether a specific manufacturing,
FSMA that direct us to consider the agencies/organizations to collect, processing, packing, or holding activity
results of the science-based risk analysis analyze, and interpret data. Some conducted on food by a farm mixed-type
and exempt facilities that are small or comments ask us to consult with subject facility warranted an exemption from, or
very small businesses from the matter experts to ensure that the final modified requirements for, the
requirements for hazard analysis and risk assessment reflects sufficient provisions of section 418 of the FD&C
risk-based preventive controls (or geographic diversity. Act. The comments did not identify
modify these requirements, as we (Response 56) We have acknowledged additional data sources to use in
determine appropriate), if such facilities the limitations of the section assessing commodity-specific risks.
are engaged only in specific types of on- 103(c)(1)(C) draft RA (Ref. 18; see However, we did revise the section
farm activities that we determine to be section I.F in that document). Rather 103(c)(1)(C) draft RA by taking into
low risk involving specific foods that we than limit public input to subject matter consideration: (1) Comments submitted
determine to be low risk (see section experts, we requested comment from all to Docket FDA–2012–N–1258 on the
103(c)(1)(D) of FSMA and 78 FR 3646 at interested persons, and received a section 103(c)(1)(C) Draft RA; (2)
3675, 3691, and 3705–3707). Later in number of comments alerting us to comments submitted to Docket FDA–
this document (see section XI.G), we activity/food combinations conducted 2011–N–0920 on the proposed rule
discuss the provisions we are on farms and farm mixed-type facilities, relevant to activities conducted on foods
establishing in § 117.5(g) and (h), based including comments from diverse on farms; and (3) a revised Food
on the results of the section 103(c)(1)(C) geographic areas. We also received Processing Sector Study on domestic
RA, to exempt farm mixed-type facilities comments about activity/food establishments co-located on farms (Ref.
that are small or very small businesses combinations focused on botanicals that 21). This led us to include additional
from requirements for hazard analysis might be used in the production of activity/food combinations in our
and risk-based preventive controls if the dietary ingredients. We disagree that we evaluation, and many were found to be
only activities that the business need to conduct large scale surveys, or low risk. With respect to CDC
conducts that are subject to those enter into agreements with agencies/ expanding its data analysis effort, the
requirements are low-risk activity/food organizations, to collect additional CDC publication cited by the comments
combinations. information in light of the previous (Ref. 20) is the most up-to-date
We also previously described opportunity for broad public input publication available, and more finely
provisions of FSMA that direct us to: (1) regarding the activity/food grained data for additional commodities
Identify high risk-facilities and allocate combinations conducted on farms and are not currently available.
resources to inspect facilities according farm mixed-type facilities. (See also (Comment 58) Some comments assert
to the known safety risks of the facilities Response 139 regarding the Food that we should revise the section
(as determined by several factors) and Processing Sector Study.) 103(c)(1)(C) draft RA and then make it
immediately increase the frequency of (Comment 57) Some comments state available for additional public comment
inspection of all facilities (see the that it is not clear how certain high- or before finalizing the rule.
discussion of section 421 of the FD&C moderate-risk practices (e.g., washing), (Response 58) As we previously noted
Act at 78 FR 3646 at 3654–3655); and which are necessary to move product (78 FR 3824 at 3826, January 16, 2013),
(2) consider a possible exemption from from the field, will affect exemptions. we subjected the section 103(c)(1)(C)
or modification of requirements of These comments recommend that future draft RA to peer review in accordance
section 421 of the FD&C Act as we deem risk assessments examine the impact of with the requirements of the Final
appropriate (see the discussion of these practices by commodity and Information Quality Bulletin for Peer
section 103(c)(1)(D) of FSMA at 78 FR volume of intact fruits and vegetables Review (issued by the Office of
3646 at 3658). We tentatively concluded marketed through small and very small Management and Budget to implement
that we should not exempt or modify farm mixed-type facilities. Other the Information Quality Act (Pub. L.
the frequency requirements under comments ask us to re-examine our data 106–554)) before we made it available
section 421 based solely upon whether sources in assessing commodity-specific for broader public comment during a
time period that exceeded 10 months. 2. Request for Comment on an without change. For example, some
The additional iterative process Exemption From the Requirements of comments agree that there is no
recommended by these comments is not Section 421 of the FD&C Act meaningful distinction between
necessary and would go beyond the We received no comments that ‘‘manufacturing/processing,’’ ‘‘packing,’’
processes we routinely apply for public disagreed with our tentative conclusion and ‘‘holding’’ as defined in the
input on a risk assessment. that we should not exempt or modify proposed revisions to §§ 1.227 and
the inspection frequency requirements 1.328 and those terms as they have been
C. Comments Regarding an Exemption used in the long-standing CGMP
under section 421 based solely upon
for Small and Very Small Farm Mixed- requirements. These comments also
whether a facility only engages in low-
Type Facilities Under Section 421 of the agree that consistent use of these terms
risk activity/food combinations and is a
FD&C Act small or very small business. We are not throughout proposed part 117, in
establishing any exemption from, or reference to activities taking place in
1. Request for Comment on Data
modification to, the inspection food facilities, establishments, or plants,
Submission Requirements
frequency requirements under section would make the regulations more clear
We requested comment on whether 421 for facilities that only engage in and have no substantive effect on the
we should establish data submission low-risk activity/food combinations and current requirements. Other comments
requirements that would allow us to are a small or very small business. support the proposed replacement of the
identify types of facilities in order to term ‘‘facility’’ or ‘‘facilities’’ in the
VII. Comments on Proposed General CGMP requirements with the term
exempt them from the inspection Revisions to Current Part 110 (Final
frequencies, or modify the inspection ‘‘establishment’’ or ‘‘plant’’ whenever
Part 117) the term ‘‘facility’’ or ‘‘facilities’’ could
frequencies that apply to them, under
We proposed some general revisions be confused with the firms that are
section 421 of the FD&C Act. We
to the CGMP requirements in part 110, subject to the proposed requirements for
provided examples of such data hazard analysis and risk-based
elements, including identification of a including revising the title;
redesignating the provisions in part 117; preventive controls. Other comments
facility as a farm mixed-type facility, agree that it is appropriate to replace the
revising some terms for consistency
annual monetary value of sales, number word ‘‘shall’’ with the term ‘‘must.’’
within the rule; referring to the ‘‘owner,
of employees, and food category/activity operator, or agent in charge’’ rather than Some comments that support the
type. We also requested comment on to ‘‘plant management’’ or ‘‘operator’’; proposed provisions suggest alternative
any other criteria that may be revising provisions directed to or additional regulatory text (see, e.g.,
appropriate for the purposes of preventing contamination of food and Comment 59, Comment 63, and
allocating inspection resources to these food-contact substances so that they also Comment 65).
facilities. are consistently directed to preventing We received no comments that
Comments did not support these data contamination of food-packaging disagreed with our proposed
submission requirements. We are not materials; revising several provisions to redesignations and are finalizing them
establishing any data submission explicitly address allergen cross-contact, as proposed. In the following sections,
requirements that would allow us to as well as contamination; referring to we discuss comments that ask us to
identify types of facilities in order to ‘‘raw materials and ingredients’’ rather clarify the proposed requirements or
exempt them from the inspection than ‘‘raw materials and other that disagree with, or suggest one or
frequencies, or modify the inspection ingredients’’; deleting some non-binding more changes to, the proposed
frequencies that apply to them, under provisions; and making some editorial requirements. After considering these
revisions (78 FR 3646 at 3692 to 3693). comments, we have revised the
section 421 of the FD&C Act.
Some comments support one or more proposed provisions as shown in table
of these proposed general revisions 6.
TABLE 6—OUTCOME OF THE PROPOSED GENERAL REVISIONS TO PART 110
Proposed revision Outcome
Establish the title of part 117 .......... We have revised the title to read ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food.’’
Consistency of terms: Activities We are establishing in part 117 the same definitions for the terms ‘‘manufacturing/processing,’’ ‘‘packing,’’
subject to part 117. and ’’ holding’’ as we are establishing in the section 415 registration regulations and the section 414 rec-
ordkeeping regulations.
Consistency of terms: Facility ......... We have made the following changes to the proposed rule:
1. We have revised the definition of ‘‘plant’’ to focus it on the building, structure, or parts thereof, used for
or in connection with the manufacturing, processing, packing, or holding of human food.
2. We have revised applicable provisions to use ‘‘establishment’’ rather than ‘‘plant’’ when focusing on a
business entity rather than on buildings or other structures.
3. We have made conforming changes throughout the rule.
Consistency of terms: Owner, oper- We are: (1) Defining the term ‘‘you’’ to mean, for purposes of part 117, the owner, operator, or agent in
ator, or agent in charge. charge of a facility and (2) limiting use of the term ‘‘you’’ to provisions directed to ‘‘facilities’’ (i.e., provi-
sions in subparts C, D, E, and G).
Consistency of terms: Food-pack- We received no comments that disagreed with our proposal that provisions of current part 110 directed to
aging materials. preventing contamination of food and food-contact substances consistently be directed to preventing
contamination of food-packaging materials as well and are finalizing the applicable provisions as pro-
posed.
Additions regarding allergen cross- The CGMPs that we are establishing in subpart B explicitly address allergen cross-contact.
contact.
TABLE 6—OUTCOME OF THE PROPOSED GENERAL REVISIONS TO PART 110—Continued

Proposed revision Outcome
Revisions for consistency with the We have retained the current phrase ‘‘raw materials and other ingredients’’ (rather than the proposed
definition of ‘‘food’’. phrase ‘‘raw materials and ingredients’’) throughout the rule to make it clear that raw materials are ingre-
dients.
Revisions to delete some non-bind- We are deleting those nonbinding provisions of current part 110 that we proposed to delete. (For a list of
ing provisions. these deleted provisions, see table 8 in the 2013 proposed human preventive controls rule, 78 FR 3646
at 3714).
Revisions to re-establish some non- With one exception, we are, as proposed, re-establishing certain non-binding provisions of part 110 in part
binding provisions of part 110 as 117 as binding provisions. See table 11 in the 2013 proposed human preventive controls rule (78 FR
binding provisions in part 117. 3646 at 3728). The exception is one provision of § 110.80(b)(1) regarding inspecting containers of raw
materials on receipt, which we are deleting rather than re-establishing it as a requirement.
Editorial changes ............................ We are finalizing the proposed editorial changes regarding ‘‘Federal Food, Drug, and Cosmetic Act,’’ ‘‘in-
cludes, but is not limited to,’’ ‘‘must,’’ ‘‘adulteration,’’ and ‘‘when’’ as proposed, except that we are retain-
ing the term ‘‘such as’’ in place of the proposed term ‘‘including’’ in two provisions.
A. Title of Part 117 supplemental notice, we proposed disagree that the full regulatory text of
We proposed to re-establish the revisions to the definitions of ‘‘holding’’ the definitions for ‘‘packing’’ and
provisions of current part 110 in new and ‘‘packing’’ after considering ‘‘holding’’ are not adequate to provide a
part 117 and to establish the title of part comments submitted to the 2013 meaningful distinction between the two
117 as ‘‘Current Good Manufacturing proposed human preventive controls terms. ‘‘Packing’’ means, in part,
Practice and Hazard Analysis and Risk- rule. ‘‘placing food into a container’’ whereas
Based Preventive Controls for Human (Comment 60) Some comments ask us holding means, in part ‘‘storage of
Food’’ (78 FR 3646 at 3691). (Note that to clarify how we were ‘‘revising’’ the food.’’ ‘‘Placing food into a container’’ is
in the 2013 proposed human preventive definitions of the terms manufacturing, in no way similar to ‘‘storage of food.’’
controls rule, we described this as processing, packing, and holding (Comment 62) Some comments
revising the title of ‘‘current subpart B.’’ because these terms had not been disagree with our tentative conclusion
We should have described this as defined in the CGMPs in part 110. that there is no meaningful distinction
(Response 60) The comments are between ‘‘manufacturing/processing,’’
revising the title of current part 110.)
correct that these terms had not been ‘‘packing,’’ and ‘‘holding’’ as we would
defined in the CGMPs in part 110. We define them in the revised definitions
to revise the title to read ‘‘Current Good
proposed to ‘‘revise’’ these definitions and these terms as they had been used
Manufacturing Practice, Hazard
in the section 415 registration in the CGMPs. These comments ask us
Analysis, and Risk-Based Preventive
regulations and the section 414 to define these terms differently in the
Controls for Human Food.’’
(Response 59) We have revised the recordkeeping regulations and then human preventive controls rule. These
title of the rule as requested. establish in part 117 those revised comments state that although they do
definitions. not object to the consistent use of these
B. Proposed Revisions for Consistency of (Comment 61) Some comments from terms throughout part 117 in reference
Terms the produce industry state that it is to activities taking place in food
difficult to assess whether there is a facilities, establishments, or plants, they
1. Activities Subject to Proposed Part
meaningful distinction between believe there are significant distinctions
117
‘‘packing’’ and ‘‘holding’’ as would be in these terms that need to be
We noted that we had previously defined in the proposed human considered when finalizing the
described activities that may be preventive controls rule and as had been requirements of part 117.
considered ‘‘manufacturing, processing, used in the CGMPs in part 110 because (Response 62) These comments
packing, or holding’’ by establishing most harvesting and post-harvest provide neither specific suggestions for
definitions for these terms in the section handling activities of RACs had been how we should define these terms for
415 registration regulations and the excluded from the CGMP requirements the purpose of the human preventive
section 414 recordkeeping regulations under § 110.19. controls rule nor specific reasons for
(78 FR 3646 at 3692). We proposed to (Response 61) We assume that these their assertion that there are significant
revise these existing definitions (see comments are concerned about distinctions in these terms that need to
sections IV.D, IV.E, and IV.G) and to distinguishing ‘‘packing’’ from be considered when finalizing the
incorporate the revised definitions in ‘‘holding’’ because some exemptions requirements of part 117. Without more
part 117. We tentatively concluded that (e.g., the exemption in § 117.5(k) from specific information, we assume that the
there is no meaningful distinction the CGMP requirements for holding changes we have made to the definitions
between these terms as we would define RACs and the exemption in § 117.5(j) of ‘‘farm,’’ ‘‘holding,’’ and ‘‘packing’’
them in the revised definitions and from the requirements for hazard adequately address these comments.
these terms as they had been used in the analysis and risk-based preventive
CGMPs. We also tentatively concluded controls) apply to ‘‘holding’’ RACs. As 2. The Term ‘‘Facility’’
that consistent use of these terms previously discussed, we have We proposed to replace the term
throughout part 117, in reference to previously classified several on-farm ‘‘facility’’ or ‘‘facilities’’ in current part
activities taking place in food facilities, activities in more than one way (79 FR 110 with the term ‘‘establishment’’ or
establishments, or plants, would make 58524 at 58538 and 58571) depending ‘‘plant’’ in proposed part 117 whenever
the regulations more clear and have no on when the activity occurs. For the term ‘‘facility’’ or ‘‘facilities’’ could
substantive effect on the current example, sorting, culling, and grading be confused with the firms that are
requirements (78 FR 3646 at 3692). In RACs can occur during both packing subject to the proposed requirements for
the 2014 preventive controls and holding activities. However, we hazard analysis and risk-based
preventive controls required by section structures’’ when the term ‘‘plant’’ is the definition of the term ‘‘allergen
418 of the FD&C Act (78 FR 3646 at used. cross-contact’’ in this rule (see § 117.3).
3692). However, we tentatively As discussed in sections XIII–XXII, the
3. Owner, Operator, or Agent in Charge
concluded that it would not be CGMPs that we are establishing in
necessary to replace the use of the term In the 2013 proposed human subpart B explicitly address allergen
‘‘facilities’’ in current requirements preventive controls rule, we requested cross-contact, with some revisions
directed to specific functional parts of a comment on whether there is any requested by comments.
plant or establishment, such as ‘‘toilet meaningful difference between the (Comment 64) Some comments ask us
facilities’’ and ‘‘hand-washing persons identified in current part 110 to clarify that allergen cross-contact has
facilities,’’ because the use of the term and the ‘‘owner, operator, or agent in a meaning that is distinct from
‘‘facilities’’ in these contexts would not charge’’ identified in section 418 of the ‘‘contamination.’’
create confusion. FD&C Act. We also requested comment (Response 64) We previously noted
(Comment 63) Some comments state on whether it would be appropriate to that, in the past, inadvertent
that it would not be helpful to use refer to the ‘‘owner, operator, or agent in incorporation of an allergen into a food
‘‘plant’’ interchangeably with charge’’ of a plant, establishment, or was referred to as ‘‘contamination’’ or
‘‘establishment’’ when referring to a facility throughout proposed part 117 ‘‘cross-contamination,’’ but that more
business that is not required to register. and, if so, whether the requirements recently the term ‘‘cross-contact’’ (rather
These comments ask us to consistently would be clear if we revised the than ‘‘contamination’’ or ‘‘cross-
use one of these terms and to define a proposed rule to use pronouns (such as contamination’’) has been applied with
term that would mean ‘‘a business that ‘‘you’’ and ‘‘your’’) within proposed part respect to unintentional transfer of
is not required to register’’ to help 117 (78 FR 3646 at 3693). In the 2014 allergenic proteins from a food
distinguish such businesses from supplemental human preventive containing the proteins to one that does
‘‘facilities.’’ controls notice, we described comments not, because an allergen is a normal
(Response 63) We agree that it is on these issues and we tentatively component of food, and not itself a
appropriate to consistently use one term concluded that we could simplify the contaminant (78 FR 3646 at 3693).
when referring to a business entity. regulations directed to the ‘‘owner, Given this shift in the scientific
However, we disagree that it is operator, or agent in charge of a facility’’ literature distinguishing ‘‘cross-contact’’
necessary to establish a definition for a in provisions in subparts C, D, and E by from ‘‘contamination’’ and ‘‘cross-
business entity that is not required to using pronouns, without creating contamination,’’ we tentatively
register. A business that meets the confusion, if we (1) define the term concluded that we should begin using
definition of ‘‘facility’’ is required to ‘‘you’’ to mean, for purposes of part 117, the term ‘‘cross-contact’’ (now ‘‘allergen
register; a business that is not required the owner, operator, or agent in charge cross-contact’’) to describe inadvertent
to register is simply a business that does of a facility and (2) limit use of the term incorporation of an allergen into food,
not meet the definition of ‘‘facility.’’ ‘‘you’’ to provisions in proposed rather than the general term
To address these comments, we have subparts C, D, and E (79 FR 58524 at ‘‘contamination,’’ for purposes of
revised provisions of the rule in three 58556). clarity. In this final rule, we affirm that
ways. First, we have revised the We received no comments that tentative conclusion.
definition of ‘‘plant’’ to focus it on the disagreed with the proposed definition To further improve clarity, we
building, structure, or parts thereof, of ‘‘you’’ and are finalizing that reviewed the provisions of the rule
used for or in connection with the proposed definition without change. directed to preventing both allergen
manufacturing, processing, packing, or cross-contact and preventing
holding of human food, rather than on 4. Food-Packaging Materials contamination and made editorial
the ‘‘building or establishment.’’ We proposed that provisions of changes throughout. For example,
Second, we have revised applicable current part 110 directed to preventing § 117.10(b)(1) requires that hygienic
provisions of part 117 to use contamination of food and food-contact practices must include wearing outer
‘‘establishment’’ rather than ‘‘plant’’ surfaces consistently be directed to garments suitable to the operation in a
when focusing on a business entity preventing contamination of food- manner that protects against allergen
rather than on buildings or other packaging materials as well (78 FR 3646 cross-contact and against the
structures. Third, we have revised at 3693). We received no comments that contamination of food, food-contact
provisions that use the terms ‘‘plant,’’ disagreed with this proposal and are surfaces, or food-packaging materials.
‘‘establishment,’’ or both to conform to finalizing provisions directed to For additional provisions that include
the definition of ‘‘plant’’ and the preventing contamination of food- these editorial changes, see table 52.
described usage of ‘‘establishment.’’ For packaging materials as proposed. For
example, § 117.10 establishes D. Proposed Revisions for Consistency
additional discussion regarding the term
requirements for ‘‘the management of With the Definition of ‘‘Food’’
‘‘food-packaging materials,’’ see
the establishment’’ rather than ‘‘plant Comment 107. We proposed to retain the definition
management,’’ because ‘‘establishment’’ for ‘‘food’’ as already defined in § 110.3
is the term focusing on the business C. Proposed Additions Regarding (78 FR 3646 at 3693). Food means food
entity. As another example, Allergen Cross-Contact as defined in section 201(f) of the FD&C
§ 117.20(a)(1) establishes requirements We proposed to revise several CGMP Act and includes raw materials and
for properly storing equipment, provisions to explicitly address cross- ingredients. For consistency with the
removing litter and waste, and cutting contact (see 78 FR 3646 at 3693 and definition of food (which refers to ‘‘raw
weeds or grass within the immediate table 10 of the 2013 proposed human materials and ingredients’’ rather than
vicinity of the ‘‘plant’’ rather than preventive controls rule, 78 FR 3646 at ‘‘raw materials and other ingredients’’),
within the immediate vicinity of the 3718–3719). In the 2014 supplemental we proposed to change the title of
‘‘plant buildings or structures,’’ because human preventive controls notice, we current § 110.80(a) (which would be
the defined term ‘‘plant’’ focuses on the proposed to define and use the term proposed § 117.80(b)) to ‘‘Raw materials
buildings and structures, and it is not ‘‘allergen cross-contact’’ rather than and ingredients’’ rather than ‘‘Raw
necessary to repeat ‘‘buildings and ‘‘cross-contact,’’ and we are finalizing materials and other ingredients.’’ As a
companion change to this change in (see Comment 87, Comment 88, and other concerns. Likewise, some
title, we proposed to substitute Comment 89). comments ask us to retain any non-
‘‘ingredients’’ for ‘‘other ingredients’’ (Response 66) See Response 87, binding provisions that we proposed to
throughout provisions in current Response 88, and Response 89 for our re-establish as requirements if, after
§ 110.80 that refer to both raw materials reasons for declining to revise the considering comments, we do not
and ingredients (78 FR 3646 at 3693– definition of ‘‘food’’ in this rule. finalize these provisions as
3694). E. Proposed Revisions To Address requirements.
Guidance in Current part 110 (Response 67) We agree that the non-
to add a definition for ‘‘raw materials.’’
(Response 65) We decline this We proposed to delete some non- binding provisions we proposed to
request. During a previous rulemaking binding provisions of current part 110 delete, or considered re-establishing as
to revise the umbrella CGMPs, we (e.g., provisions using ‘‘should’’ or requirements, provide useful
explained that it is not possible to ‘‘compliance may be achieved by’’) (78 information for reasons such as those
categorically distinguish raw materials FR 3646 at 3694 and 3714–3717). We mentioned in the comments. However,
and other ingredients because raw also requested comment on whether to these provisions are more appropriately
materials are ingredients, and both raw revise other non-binding provisions to included in guidance, and we are
materials and ingredients are food establish new requirements in proposed deleting those non-binding provisions of
within the meaning of the FD&C Act (51 part 117 or to simply retain them as part 110 that we are not establishing as
FR 22458 at 22461, June 19, 1986). We useful provisions of a comprehensive requirements. We intend to transfer
have broadly defined ‘‘food’’ in this rule CGMP (78 FR 3646 at 3694 and 3728– some of the CGMP recommendations
to include both raw materials and 3729). that are currently in part 110, but that
ingredients. (Comment 67) Some comments ask us will be deleted from part 117, to
However, we have decided to retain to retain the provisions we proposed to guidance with editorial changes and
the current phrase ‘‘raw materials and delete—e.g., because the information changes that reflect current technology
other ingredients’’ (rather than the helps to clarify the intended effect of the and industry practices. For a list of non-
proposed phrase ‘‘raw materials and regulations, suggests means of binding provisions that we are deleting,
ingredients’’) throughout the rule to compliance with the requirements, and see table 7 in this document and table
make it clear that raw materials are can educate small, new, or foreign 8 in the 2013 proposed human
ingredients. See the regulatory text of companies. These comments assert that preventive controls rule (78 FR 3646 at
§§ 117.80(b), 117.80(c)(6), (7), and (9); the benefits to both the regulated 3714–3717). See Response 321 for a
and 117.130(c)(2)(iii). industry and to the general public of discussion of our reasons for deleting
(Comment 66) Some comments ask us retaining the information we proposed the recommendation listed in table 7 in
to revise the current definition of food to delete far outweigh any stylistic or this document.
TABLE 7—NONBINDING PROVISIONS THAT WE ARE DELETING IN ADDITION TO THE NON-BINDING PROVISIONS LISTED IN
TABLE 8 IN THE 2013 PROPOSED HUMAN PREVENTIVE CONTROLS RULE
Designation in part 110 Description
§ 110.80(a)(1) (Processes and con- Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has
trols—raw materials and ingredi- not contributed to the contamination or deterioration of food.
ents—final sentence).
F. Proposed Editorial Changes or replace ‘‘includes, but is not limited rule do use ‘‘such as’’ when that term is
to’’ with ‘‘such as,’’ to make clear that grammatically appropriate, such as in
We proposed to revise current part a following list is not complete. parenthetical phrases (see, e.g., the
110 to make five editorial changes: (1) (Response 68) The word ‘‘include’’ definitions of ‘‘holding’’ and ‘‘packing’’
Refer to the ‘‘Federal Food, Drug, and means to have (someone or something) in § 117.3).
Cosmetic Act’’ rather than to ‘‘the act’’; as part of a group or total; to contain
(2) replace the term ‘‘shall’’ with the G. General Comments on Current Part
(someone or something) in a group or as
term ‘‘must’’; (3) replace the phrase 110 (Final Part 117)
a part of something (Ref. 22). The word
‘‘includes, but is not limited to’’ with ‘‘includes’’ does not need to be followed We proposed specific revisions and
‘‘includes’’; (4) replace the phrase by ‘‘but is not limited to’’ to clearly deletions to our long-standing umbrella
‘‘adulteration within the meaning of the communicate that a following list is not CGMP requirements to modernize them.
act’’ with the single term ‘‘adulteration’’; complete. We also proposed to redesignate some of
and (5) replace the term ‘‘whenever’’ We proposed that two provisions these CGMP requirements. For example,
with ‘‘when.’’ (proposed § 117.80(c)(14) and (15)) we proposed to redesignate the
We received no comments that replace the term ‘‘such as’’ with the provisions found in six sentences that
disagreed with our proposed editorial term ‘‘including’’ (or variations of precede current § 110.80(a) by creating
changes regarding ‘‘Federal Food, Drug, ‘‘including’’). In light of the comment’s paragraph designations (a)(1) through
and Cosmetic Act,’’ ‘‘must,’’ view that ‘‘such as’’ would be clearer, (6) in new § 117.80. As corresponding
‘‘adulteration,’’ and ‘‘when’’ and are we have retained the term ‘‘such as’’ in changes, we proposed to redesignate
finalizing these editorial changes as those provisions. We decline the request current § 110.80(a) as § 117.80(b) and to
proposed. to more broadly revise the rule to redesignate current § 110.80(b) as
(Comment 68) Some comments ask us replace ‘‘includes’’ with ‘‘such as.’’ In § 117.80(c).
to either retain ‘‘includes, but is not many cases the term ‘‘such as’’ cannot Several comments suggest specific
limited to’’ wherever the list which replace ‘‘includes’’ when used as a verb. modifications to the umbrella CGMPs
follows is not intended to be exhaustive, We note that several provisions of the beyond what we proposed to revise. In
this section and in sections XIII through 22458, June 19, 1986), and the considered whether the comments
XXII, we address these specific comments do not provide examples of described a problem with the current
suggestions and have amended the how we have been interpreting these regulatory text, or instead focused on
regulatory text where warranted. provisions in a way that does not hypothetical problems that could occur
(Comment 69) Some comments ask us accomplish the goal of the umbrella in the future. Because most of these
to reorganize some of the current CGMPs. Furthermore, we disagree with comments do not explain how the long-
provisions to reduce redundancy, such some of the comments on whether some standing regulatory text has created a
as by combining provisions that address provisions are redundant. For example, problem, we have declined many of
similar topics or deleting some we disagree that § 117.80(b)(1) is these requests.
provisions that the comments view as redundant with § 117.80(b)(7) because
Likewise, in this document, we
unnecessary in light of other provisions. § 117.80(b)(7) is narrowly directed to
For example, one comment suggests we describe several editorial revisions that
raw materials and other ingredients
move § 117.80(b)(5) (storage of raw we made to improve the clarity of the
received in bulk and § 117.80(b)(1) is
materials, other ingredients, and CGMP requirements. However, we do
more generally directed to all raw
rework) to § 117.80(a)(1) (general not discuss comments that suggest
materials and other ingredients.
requirements) and another comment Rather than reorganize and combine editorial changes that simply suggest
suggests we delete requirements in requirements, or delete requirements using different words in the regulatory
§ 117.80(b)(1) for storing raw materials that some comments view as redundant text, but without explaining why the
and ingredients because they are with other requirements, we have editorial revisions would improve the
redundant with the storage focused on comments requesting clarity of the provisions. These long-
requirements in § 117.80(b)(7). specific changes to the current standing CGMPs have been in place and
(Response 69) We decline these requirements to reflect current practices interpreted for decades, and we see no
requests. We acknowledge that there is in the manufacturing, processing, reason to revise them without a reason
some redundancy in subpart B and that packing, and holding of human food to do so.
we could improve the logical structure and to make these current requirements (Comment 70) Some comments ask us
of subpart B by moving some of the clearer (see sections XIII through XXII). to specify that several of the CGMP
requirements as recommended by some Doing so is consistent with the goals of requirements in subpart B only apply
comments. However, these provisions modernizing the umbrella CGMP ‘‘where the potential for contamination
have been in effect for decades, either requirements. However, we have exists.’’ (See table 8.) Other comments
since 1969 (when the umbrella CGMPs declined many of these requests to make ask us to change some requirements to
were first established (34 FR 6977, April specific changes to particular CGMP recommendations or to specify that they
26, 1969) or since 1986 (when we last provisions. In general, in evaluating the only apply ‘‘as appropriate.’’ (See table
revised the umbrella CGMPs (51 FR requested specific changes, we 8.)
TABLE 8—CGMP REQUIREMENTS THAT COMMENTS ASK US TO APPLY ‘‘WHERE THE POTENTIAL FOR CONTAMINATION
EXISTS’’ OR ASK US TO CHANGE TO RECOMMENDATIONS
Examples of CGMP requirements that comments ask us to apply Examples of CGMP requirements that comments ask us to change to
‘‘where the potential for contamination exists’’ recommendations
§ 117.20(a)—Management responsibility for maintaining grounds .......... § 117.35(a)—General maintenance.

§ 117.20(b)—Suitability of plant construction and design ........................ § 117.35(b)(1)—Cleaning Compounds and Sanitizing Agents.
§ 117.35(a)—General maintenance .......................................................... § 117.35(b)(2)—Identification and Storage of Toxic Materials.
§ 117.35(c)—Pest control ......................................................................... § 117.35(c)—Pest control.
§ 117.37—Sanitary facilities and controls ................................................ § 117.35(d)—Sanitation of food-contact surfaces.
§ 117.40(a)(1)—Design of plant equipment and utensils ......................... § 117.40(a)(6)—Maintenance of food-contact surfaces.
§ 117.40(a)(3)—Installation and maintenance of equipment ................... § 117.40(b)—Seams on food-contact surfaces.
§ 117.40(b)—Seams on food-contact surfaces ........................................ § 117.40(c)—Construction of equipment.
§ 117.40(c)—Construction of equipment .................................................. § 117.40(e)—Freezer and cold storage compartments.
§ 117.40(d)—Holding, conveying, and manufacturing systems.
§ 117.80(a)(1)—Adequate sanitation principles.
§ 117.80(a)(3)—Supervision of overall sanitation.
(Response 70) We decline these step for pest control in the plant is to § 117.40, a plant requires clean and
requests. These long-standing avoid attracting pests. As required by sanitary equipment regardless of the
provisions apply generally to the plant, § 117.20(b), a plant requires suitable specific potential for contamination
equipment and utensils in the plant, construction and design regardless of associated with a particular piece of
sanitary operations and sanitary the specific potential for contamination equipment or the type of food being
facilities in a plant, and operations at any particular location in the plant. produced, because dirty equipment at
conducted in a plant. To suggest Each of the seven more specific one location in a plant can attract pests
otherwise is inconsistent with the provisions governed by § 117.20(b) adds or become a harborage for
precepts of good manufacturing the context that the requirements are environmental pathogens that can
practices. directed to what is ‘‘adequate’’ (e.g., eventually lead to contamination in
For example, as required by adequate space, adequate precautions, multiple locations in the plant. As
§ 117.20(a), an establishment must have and adequate cleaning), and the defined required by § 117.80(a)(10), a food plant
control of its grounds regardless of the term ‘‘adequate’’ provides context that requires adequate sanitation regardless
specific food being produced, because the purpose of the requirements for of the specific potential for
litter, waste, weeds, and grass can all plant construction and design are contamination, and the term ‘‘adequate’’
attract and harbor pests, and the first related to public health. As required by provides flexibility for how an
establishment designs and implements for a prohibited act under section the referenced criteria in section
its sanitation program when the 301(uu) of the FD&C Act (21 U.S.C. 402(a)(3) of the FD&C Act, in that
potential for contamination is low. As 331(uu)). Some comments support the proposed § 117.1(a)(1) describes
required by § 117.80(a)(3), a plant proposed provisions without change. manufacturing conditions whereas
requires adequate sanitation regardless For example, one comment expresses section 402(a)(3) of the FD&C Act
of the specific potential for the view that one strength of the long- describes actual adulterated product.
contamination, and someone must be in standing CGMPs is their applicability to (Response 73) We disagree with these
charge of sanitation to determine what the broad spectrum of food comments. We interpret ‘‘otherwise
needs to be done, where it needs to be manufacturing, from the manufacture of unfit for food’’ in this long-standing
done, and how often it needs to be done. processed products and packaging of statement of applicability to be broader
The individual(s) who supervises the fresh produce to production of food than physical properties of the food and
sanitation of the plant has flexibility in additives and GRAS substances. (We to apply to the manufacturing
the design and implementation of a note that some packaging of fresh conditions of the food.
sanitation program when the potential produce (e.g., packaging of RACs on a (Comment 74) Some comments note
for contamination is low. farm) is not subject to the CGMPs.) that FSMA granted FDA mandatory
In addition, the CGMP requirements Some comments that support the recall authority for adulterated food.
are flexible requirements that each proposed provisions ask us to clarify These comments express concern that
establishment can adapt to its own how we will interpret the provisions theoretically we could use a violation of
operations, equipment, and food (see, e.g., Comment 72). the requirements for hazard analysis
products. For example, § 117.35(a) In the following paragraphs, we and risk-based preventive controls to
requires that buildings, fixtures, and discuss comments that ask us to clarify determine that food is adulterated,
other physical facilities of the plant the proposed requirements or that thereby providing the basis for a
must be maintained in a clean and disagree with, or suggest one or more mandatory recall of that food. These
sanitary condition and must be kept in changes to, the proposed requirements. comments raise three issues regarding
repair adequate to prevent food from After considering these comments, we how we will apply § 117.1(a), with
becoming adulterated. Cleaning and are finalizing the provisions as consequences for a potential mandatory
sanitizing of utensils and equipment proposed, with editorial and conforming recall of food.
must be conducted in a manner that changes as shown in table 52. First, these comments note that the
protects against allergen cross-contact regulatory text stating that the ‘‘criteria
A. Comments on Proposed § 117.1(a)— and definitions’’ apply in making a
and against contamination of food, food-
Applicability determination of adulteration appears to
contact surfaces, or food-packaging
materials. The standards established by We proposed that the criteria and encompass the entirety of the rule. As
the requirement are to protect against definitions in part 117 apply in a result, farms or facilities that violate
contamination and allergen cross- determining whether a food is any of the requirements in the proposed
contact, and the defined term adulterated: (1) Within the meaning of rule, including components not directly
‘‘adequate’’ provides the context that the section 402(a)(3) of the FD&C Act in that related to the safety of the food (such as
specific measures adopted by an the food has been manufactured under recordkeeping requirements), could face
establishment are related to public such conditions that it is unfit for food; a risk that we would deem their food
health. or (2) within the meaning of section adulterated.
(Comment 71) Some comments ask us 402(a)(4) of the FD&C Act in that the Second, these comments assert that
to change the phrase ‘‘work-in-process’’ food has been prepared, packed, or held the regulatory text suggests that we
to ‘‘in-process materials’’ in several under insanitary conditions whereby it would not automatically consider a food
provisions throughout proposed subpart may have become contaminated with adulterated as a result of a violation of
B because they believe ‘‘in-process filth, or whereby it may have been the proposed rule, because it states that
materials’’ to be more familiar, rendered injurious to health. We also the criteria and definitions ‘‘apply in
straightforward, and commonly proposed that the criteria and determining’’ whether a food will be
understood than ‘‘work-in-process.’’ definitions in part 117 also apply in considered adulterated, rather than that
(Response 71) ‘‘Work-in-process’’ is determining whether a food is in the food ‘‘is’’ adulterated.
the common industry term used in violation of section 361 of the Public Third, these comments state that it is
widely disseminated industry Health Service Act (42 U.S.C. 264). not clear how the exemption applicable
publications (Ref. 23) (Ref. 24) and has (Comment 72) Some comments ask us to qualified facilities is included in the
been in use for more than 30 years in to clarify that part 117 does not apply ‘‘criteria and definitions’’ used in
the umbrella CGMPs. In addition, we to activities that are subject to the making a determination of adulteration.
did not receive any comments objecting requirements for CGMPs, hazard These comments ask us to clarify that
to the use of this term when we analysis and risk-based preventive we will not just automatically assume
proposed to include it in previous controls for animal food and feed by that qualified facilities are selling
revisions to the umbrella CGMPs inserting ‘‘intended for consumption by adulterated food because they are by
(proposed rule 44 FR 33238 at 33247, humans’’ after ‘‘food’’ in § 117.1(a). definition exempt from the
June 8, 1979; final rule, 51 FR 22458, (Response 72) We decline this requirements for hazard analysis and
June 19, 1986). Therefore, we have request. As discussed in Response 6, the risk-based preventive controls.
retained the phrase ‘‘work-in-process’’ applicability of these regulations to (Response 74) The comments are
in the final rule. human food is specified in the correct that the criteria and definitions
regulatory text by the title of the rule ‘‘apply in determining’’ whether a food
VIII. Subpart A: Comments on and by its placement in Subchapter B, will be considered adulterated, rather
Proposed § 117.1—Applicability and rather than Subchapter E, of 21 CFR. than that the food ‘‘is’’ adulterated. In
Status (Comment 73) Some comments assert determining whether a food that is
We proposed to redesignate § 110.5 as that there is a clear difference between manufactured, processed, packed, or
proposed § 117.1, and to add a provision the criteria in proposed § 117.1(a)(1) held in violation of part 117 (including
relevant to FSMA’s statutory provisions used to describe adulterated food and a violation of the recordkeeping
requirement) is adulterated, we would or agent in charge of such facility is definition of ‘‘hazard,’’ noting that doing
consider the totality of the available required to comply with, and is not in so is consistent with FSMA, current
data and information about the violation compliance with, section 418 of the industry practice, and Codex and global
and the food before reaching a FD&C Act or subparts C, D, E, or F of HACCP standards. Some comments that
conclusion that the food is adulterated. part 117 (proposed § 117.1(b)). support a proposed definition suggest
Although this rule does not address (Comment 75) Some comments from alternative or additional regulatory text,
the mandatory recall provisions of State regulatory agencies note that this such as adding examples to make the
FSMA, the statutory provisions new provision is not covered under the definition clearer (see, e.g., Comment 81
establish two basic criteria. (See section applicable State statute and that making and Comment 87). Some comments that
423(a) of the FD&C Act (21 U.S.C. 350l).) any changes to the State statute can be support a proposed definition ask us to
First, we must determine that there is a a lengthy process that takes up to 3 clarify how we will interpret the
‘‘reasonable probability’’ that the food is years to complete. definition (see, e.g., Comment 77 and
adulterated under section 402 of the (Response 75) See Response 5 for a Comment 87).
FD&C Act or misbranded under section discussion of our approach to working
with our food safety partners in the In the following sections, we discuss
403(w) of the FD&C Act. A violation of comments that ask us to clarify the
part 117 would be relevant to States.
proposed definitions or that disagree
determining whether a food is C. Comments on Proposed § 117.1(c)— with, or suggest one or more changes to,
adulterated under section 402. Second, Specific CGMP Requirements the proposed definitions. After
we must determine that there is a We proposed to redesignate § 110.5(b) considering these comments, we have
reasonable possibility that the use of, or as proposed § 117.1(c) with no changes. revised the proposed requirements as
exposure to, that food will cause serious We received no comments that shown in table 9, with editorial and
adverse health consequences or death to disagreed with our proposal, and are conforming changes as shown in table
humans or animals. Not all food that is finalizing the proposed provision 52. We also have deleted the definition
adulterated has a reasonable probability without change. of ‘‘should,’’ because the final rule does
of causing serious adverse health
IX. Subpart A: Comments on Proposed not use that term.
consequences or death to humans or
animals. For examples of food § 117.3—Definitions We also discuss definitions for
contamination with a reasonable We proposed to revise some additional terms (i.e., ‘‘audit,’’
probability of causing serious adverse definitions that had been established in ‘‘correction,’’ ‘‘defect action level,’’
health consequences or death to humans part 110, redesignate and re-establish ‘‘full-time equivalent employee,’’
or animals, see the annual reports of the the remaining definitions in part 117 ‘‘qualified facility exemption,’’ ‘‘raw
Reportable Food Registry (RFR) (Ref. 25) (except for the definition of ‘‘shall,’’ agricultural commodity,’’ ‘‘supply-
(Ref. 26) (Ref. 27) (Ref. 28). which we proposed to delete), and chain-applied control,’’ ‘‘written
A facility that is exempt from any establish several new definitions in part procedures for receiving raw materials
requirement of part 117, including the 117. Some comments support one or and other ingredients,’’ and ‘‘unexposed
requirements for hazard analysis and more of these proposed definitions packaged food’’) that we are establishing
risk-based preventive controls, would without change. For example, some in the final rule to simplify the
not be in violation of part 117 if it did comments state that they support the regulatory text throughout the
not comply with provisions that it is not proposed definitions for the following regulations and improve clarity. We also
subject to. terms with no suggested revisions: discuss a new name (i.e., ‘‘preventive
critical control point, facility, food controls qualified individual’’) for the
B. Comments on Proposed § 117.1(b)— definition of a term that we had
allergen, food-contact surfaces,
Prohibited Act proposed to name ‘‘qualified
microorganism, mixed-type facility,
We proposed that the operation of a monitor, plant, safe-moisture level, individual’’ and are establishing a new
facility that manufactures, processes, subsidiary, and validation. Some definition for the term ‘‘qualified
packs, or holds food for sale in the comments support our proposal, in the individual.’’ Finally, we discuss
United States is a prohibited act under 2014 supplemental preventive controls definitions that comments ask us to add,
section 301(uu) of the FD&C Act (21 notice, to use the phrase ‘‘chemical but that we did not add, to the final
U.S.C. 331(uu)) if the owner, operator, (including radiological)’’ in the rule.
TABLE 9—DEFINITIONS THAT WE PROPOSED TO ESTABLISH IN § 117.3

Did we make any
Did we receive any changes to the pro-
Current definition If current, did we comments that disposed definition other
Definition (§ 110.3) or new propose any agreed with the defi- than the editorial and
definition? revisions? nition we proposed to conforming changes
include in part 117? listed in Table 52?
Acid foods or acidified foods ........................ Current ......................... No ............................. No ............................. No.
Adequate ...................................................... Current ......................... No ............................. Yes ............................ No.
Affiliate .......................................................... New .............................. N/A ............................ Yes ............................ No.
Allergen cross-contact .................................. New .............................. N/A ............................ Yes ............................ No.
Audit .............................................................. New in the final rule .... N/A ............................ N/A ............................ N/A.
Batter ............................................................ Current ......................... No ............................. No ............................. No.

Blanching ...................................................... Current ......................... No ............................. No ............................. No.
Calendar day ................................................ New .............................. N/A ............................ No ............................. No.
Correction ..................................................... New in the final rule .... N/A ............................ N/A ............................ N/A.
Critical control point ...................................... Current ......................... Yes ............................ Yes ............................ No.
Defect action level ........................................ New in the final rule .... N/A ............................ N/A ............................ N/A.
Environmental pathogen ............................... New .............................. N/A ............................ Yes ............................ Yes.
TABLE 9—DEFINITIONS THAT WE PROPOSED TO ESTABLISH IN § 117.3—Continued

Did we make any
Facility ........................................................... New .............................. N/A ............................ Yes ............................ No.

Farm ............................................................. New .............................. N/A ............................ See discussion of No.1
§ 1.227 in section
IV.B.
FDA ............................................................... New .............................. N/A ............................ No ............................. No.
Food .............................................................. Current ......................... No ............................. Yes ............................ No.
Food allergen ................................................ New .............................. N/A ............................ Yes ............................ No.
Food-contact surfaces .................................. Current ......................... Yes ............................ No ............................. No.
Full-time equivalent employee ...................... New in the final rule .... N/A ............................ N/A ............................ N/A.
Harvesting ..................................................... New .............................. N/A ............................ See discussion of Yes.
§ 1.227 in section
IV.C.
Hazard .......................................................... New .............................. N/A ............................ Yes ............................ Yes.
Holding .......................................................... New .............................. N/A ............................ See discussion of Yes.
§ 1.227 in section
IV.D.
Known or reasonably foreseeable hazard ... New .............................. N/A ............................ Yes ............................ Yes.
Lot ................................................................. Current ......................... No ............................. Yes ............................ Yes.
Manufacturing/processing ............................. New .............................. N/A ............................ See discussion of Yes.
§ 1.227 in section
IV.E.
Microorganisms ............................................ Current ......................... Yes ............................ Yes ............................ No.
Mixed-type facility ......................................... New .............................. N/A ............................ See discussion of No.
§ 1.227 in section
IV.F.
Monitor .......................................................... New .............................. N/A ............................ Yes ............................ Yes.
Packaging (when used as a verb) ............... New .............................. N/A ............................ Yes ............................ The final rule does not
include a definition of
packaging (when
used as a verb).
Packing ......................................................... New .............................. N/A ............................ See discussion of No.
§ 1.227 in section
IV.G.
Pathogen ...................................................... New .............................. N/A ............................ Yes ............................ No.
Pest ............................................................... Current ......................... No ............................. Yes ............................ No.
Plant .............................................................. Current ......................... Yes ............................ Yes ............................ Replace the term ‘‘es-
tablishment’’ with
‘‘structure’’.
Preventive controls ....................................... New .............................. N/A ............................ Yes ............................ No.
Preventive controls qualified individual ........ New .............................. N/A ............................ Yes ............................ No, except to change
the name of the term
from ‘‘qualified indi-
vidual’’ to ‘‘preven-
tive controls qualified
individual’’.
Qualified auditor ........................................... New .............................. N/A ............................ Yes ............................ Yes.
Qualified end-user ........................................ New .............................. N/A ............................ Yes ............................ Yes.
Qualified facility ............................................ New .............................. N/A ............................ Yes ............................ No.
Qualified facility exemption ........................... New in the final rule .... N/A ............................ N/A ............................ N/A.
Qualified individual ....................................... New in the final rule .... N/A ............................ N/A ............................ N/A.
Quality control operation .............................. Current ......................... No ............................. No ............................. No.
Raw agricultural commodity ......................... New in the final rule .... N/A ............................ N/A ............................ N/A.
Ready-to-eat (RTE) food .............................. New .............................. N/A ............................ Yes ............................ No.
Receiving facility ........................................... New .............................. N/A ............................ Yes ............................ No.
Rework .......................................................... Current ......................... No ............................. No ............................. No.
Safe-moisture level ....................................... Current ......................... Yes ............................ No ............................. No.
Sanitize ......................................................... Current ......................... Yes ............................ Yes ............................ Yes.
Should ........................................................... Current ......................... No ............................. No ............................. Deleted the definition.
Significant hazard ......................................... New .............................. N/A ............................ Yes ............................ Yes, including chang-
ing the term to ‘‘haz-
ard requiring a pre-
ventive control’’.
Significantly minimize ................................... New .............................. N/A ............................ Yes ............................ No.
Small business ............................................. New .............................. N/A ............................ Yes ............................ Yes.
Subsidiary ..................................................... New .............................. N/A ............................ Yes ............................ No.
Supplier ......................................................... New .............................. N/A ............................ Yes ............................ Yes.
Supply-chain -applied control ....................... New in the final rule .... N/A ............................ N/A ............................ N/A.
Unexposed packaged food ........................... New in the final rule .... N/A ............................ N/A ............................ N/A.
TABLE 9—DEFINITIONS THAT WE PROPOSED TO ESTABLISH IN § 117.3—Continued

Did we make any
Validation ...................................................... New .............................. N/A ............................ Yes ............................ Yes.

Verification .................................................... New .............................. N/A ............................ Yes ............................ Yes.
Very small business ..................................... New .............................. N/A ............................ Yes ............................ Yes.
Water activity ................................................ Current ......................... No ............................. No ............................. No.
Written procedures for receiving raw mate- New in the final rule .... N/A ............................ N/A ............................ N/A.
rials and other ingredients.
You ............................................................... New .............................. N/A ............................ No ............................. No.
1 The ‘‘farm’’ definition in § 117.3 is a cross-reference to the ‘‘farm’’ definition in the section 415 registration regulations. Although we did revise
the ‘‘farm’’ definition in the section 415 registration regulations (see section IV.B), the cross-reference we are establishing in § 117.3 is
unchanged.
A. Redesignation problems when applying CGMP (Comment 78) Some comments assert
We proposed to redesignate all requirements, including requirements that the definitions of ‘‘affiliate’’ and
definitions in § 110.3(a) through (r) as directed to the management of waste or ‘‘subsidiary’’ fail to account for the legal
proposed § 117.3, eliminate paragraph the provisions for disease control and differences between a piece of property
designations (such as (a), (b), and (c)), hygiene. Our intent in using the term (i.e., a facility) and a business entity or
and add new definitions in alphabetical ‘‘adequate’’ is to provide flexibility for person. These comments ask us to
order. We received no comments that a food establishment to comply with the consider amending the proposed
disagreed with our proposal, and are requirement in a way that is most definition of ‘‘qualified facility’’ to
finalizing the proposed redesignations. suitable for its establishment. We clarify what sales to include in
decline the request to develop guidance determining whether a facility so
B. Definitions in Current Part 110 That to explicitly address ‘‘thresholds’’ or to qualifies.
We Proposed To Delete describe processes that qualify as (Response 78) See Response 118.
We proposed to delete the definition adequate. The CGMPs established in 3. Allergen Cross-Contact
of ‘‘shall’’ and use ‘‘must’’ instead. We this are broadly applicable procedures
and practices rather than very specific We proposed to define the term
received no comments that disagreed
procedures and practices where ‘‘allergen cross-contact’’ to mean the
with our proposal, and are deleting the
additional interpretation from FDA unintentional incorporation of a food
definition of ‘‘shall’’ as proposed.
might be appropriate. allergen into a food.
C. Definitions That We Proposed To (Comment 79) Some comments assert
Establish in Part 117 2. Affiliate and Subsidiary that the term ‘‘incorporation’’ used in
We proposed to define the term the definition is a vague term that has
1. Adequate entirely different meanings when used
‘‘affiliate’’ to mean any facility that
We proposed to define the term controls, is controlled by, or is under by different segments of the food
‘‘adequate’’ to mean that which is common control with another facility. industry (e.g., the term would mean
needed to accomplish the intended We proposed to define the term something different to a produce
purpose in keeping with good public ‘‘subsidiary’’ to mean any company wholesaler than to a cereal
health practice. which is owned or controlled directly or manufacturer). These comments ask us
(Comment 76) Some comments assert indirectly by another company. These to provide either a clarification or a
that the definition is vague and ask us proposed definitions would incorporate definition for the term ‘‘incorporation.’’
to clarify what constitutes ‘‘adequate’’ the definition in sections 418(l)(4)(A) (Response 79) By ‘‘unintentional
for systems such as operating systems and (D) of the FD&C Act and would incorporation of a food allergen into
for waste treatment and disposal. Other make the meanings of these terms clear food’’ we mean that the food allergen
comments ask us to develop guidance when used in the proposed definition of would be in a food when the producer
on thresholds and processes that qualify ‘‘qualified facility.’’ of the food did not intend it to be in the
as ‘‘adequate.’’ Other comments assert (Comment 77) Some comments ask us food—e.g., if a milk-based beverage
that the word ‘‘adequate’’ must be used to clarify that a facility that has no contains soybeans in addition to milk.
in combination with the word material connection with another food Several provisions of the rule require
‘‘reasonable’’ to properly describe the processing operation would not be that a facility take steps to prevent such
intended measures and precautions. As considered as an ‘‘affiliate’’ of that unintentional incorporation of a food
an example, these comments assert that operation. allergen into food. See our previous
the definition of ‘‘adequate’’ could lead (Response 77) It is not clear what the discussion of the importance of
to excessive requirements when applied comments mean by ‘‘no material preventing allergen cross-contact (78 FR
to the provisions for disease control and connection with another food 3646 at 3693).
hygiene (§ 117.10). processing operation.’’ To the extent
(Response 76) We disagree that this that a facility does not control, is not 4. Critical Control Point
long-standing definition of the term controlled by, or is not under common We proposed to revise the definition
‘‘adequate’’ is vague. The comments do control with another facility, we agree for ‘‘critical control point’’ to mean a
not provide any examples of how we that the facility would not be considered point, step, or procedure in a food
have interpreted this definition in the an affiliate of that food processing process at which control can be applied
past in a way that creates practical operation. and is essential to prevent or eliminate
a food safety hazard or reduce such food combined with a safety factor to pathogens (e.g., Cronobacter spp.) can
hazard to an acceptable level. account for uncertainty in that estimate. also be environmental pathogens (78 FR
(Comment 80) Some comments ask us For example, if it is estimated that there 3646 at 3816).
to specify that a critical control point is would be no more than 1000 (i.e., 3 logs) We have not included the indicator
essential to reduce the presence of Salmonella organisms in the food, and organism Listeria spp. as an example of
hazards such as microorganisms to a safety factor of 100 (i.e., 2 logs) is an environmental pathogen, whether in
‘‘minimize the risk of foodborne illness’’ employed, a process adequate to reduce the regulatory text, in the preamble of
rather than to ‘‘reduce such hazard to an Salmonella spp. would be a process this document, or in guidance. Although
acceptable level.’’ These comments capable of reducing Salmonella spp. by we agree that Listeria spp. is an
assert that this revision would be 5 logs. appropriate indicator organism when
consistent with the approach in the conducting verification testing for
proposed produce safety rule. Other 5. Environmental Pathogen sanitation controls, the definition in
comments disagree with the proposed We proposed to define the term question is for a pathogen, not for
definition because it does not define a ‘‘environmental pathogen’’ to mean a indicators of a pathogen. Other
term (i.e., acceptable level) used in the pathogen capable of surviving and provisions of the rule are more
definition. persisting within the manufacturing, appropriate to provide the context that
(Response 80) We decline to modify processing, packing, or holding a facility has flexibility for how to
the definition as requested by these environment such that food may be conduct verification testing for an
comments. The proposed definition contaminated and may result in environmental pathogen, including an
matches the statutory definition in foodborne illness if that food is option to test for an indicator organism.
section 418(o)(1) of the FD&C Act and consumed without treatment to (See, e.g., § 117.165(a)(2) and (3).)
is consistent with definitions in the significantly minimize or prevent the L. monocytogenes, Salmonella spp.,
NACMCF HACCP guidelines, the Codex environmental pathogen. We also and some of the other pathogens
HACCP Annex, and Federal HACCP proposed to specify that environmental mentioned in the comments have been
regulations for seafood, juice, and meat pathogen does not include the spores of associated with RACs. To the extent that
and poultry (78 FR 3646 at 3695). The pathogenic sporeformers. the comments are asking us to identify
proposed produce safety rule, which did (Comment 81) Some comments ask us some environmental pathogens that
not propose to define ‘‘critical control to include Salmonella spp. and L. have been associated with RACs, by
point,’’ focused on biological hazards. monocytogenes in the regulatory text as identifying these pathogens in the
However, critical control points may be examples of environmental pathogens regulatory text or in this preamble we
established to control chemical or because of the likelihood that these have done so. However, it is important
physical hazards in addition to environmental pathogens could to note that the term ‘‘environmental
biological hazards. The standard contaminate ready-to-eat (RTE) food. pathogen’’ as defined in this rule is
suggested by the comments is not Other comments ask us to provide a directed to pathogens in the food
inconsistent with the definition we broader list (including Escherichia coli, processing environment (such as the
proposed for ‘‘critical control point’’ in Campylobacter, pathogenic Vibrio, insanitary conditions in a facility that
the human preventive controls rule, Staphylococcus aureus, Clostridium packed cantaloupes linked to an
because preventing or eliminating a botulinum, Shigella, Yersinia outbreak of listeriosis (78 FR 3646 at
food safety hazard or reducing such enterocolitica, and viruses such as 3814)), not to pathogens present in the
hazard to an acceptable level would rotoviruses and noroviruses) in the growing environment for a RAC.
minimize the risk of foodborne illness. preamble to the final rule or in (Comment 82) Some comments ask us
However, the standard suggested by the guidance, and to make clear that the list to define ‘‘environmental pathogen’’ as
comments was narrowly directed to is not all-inclusive. Some comments a microorganism that is of public health
biological hazards, because chemical emphasize the need for flexible significance and is capable of surviving
and physical hazards generally cause language because any list of and persisting within the
injury rather than illness. microorganisms might change over time, manufacturing, processing, packing, and
We do not need to define every term particularly as new environmental holding environment of the food being
used in the definition. By specifying pathogens emerge. prepared.
that a point, step, or procedure in a food Some comments ask us to include the (Response 82) We decline this
safety process would reduce a hazard to indicator organism Listeria spp. in the request. The definition of
an ‘‘acceptable level,’’ the definition regulatory text, because analysis of ‘‘environmental pathogen’’ should not
provides flexibility for a facility to Listeria spp. is faster than analysis of L. change depending on the food being
determine an appropriate level in a monocytogenes. Other comments ask us prepared in a particular facility. As a
particular circumstance. Consistent with to include pathogens that have been practical matter, the facility will
the approach recommended in the associated with RACs, as reported by consider the manufacturing, processing,
proposed produce safety rule (78 FR CDC. packing, and holding environment of
3504 at 3545), a facility could use (Response 81) We agree that the food being prepared when it
current FDA guidance on Salmonella spp. and L. monocytogenes conducts its hazard analysis (§ 117.130).
microbiological hazards (e.g., Ref. 29 are useful examples of environmental (Comment 83) Some comments ask us
and Ref. 30) to inform its decision on pathogens and have added these two to focus attention on the areas where
what constitutes an acceptable level. In examples to the proposed definition, environmental monitoring is
those documents, we use the phrase which had not included examples. As particularly important by modifying the
‘‘adequately reduce’’ to mean capable of the comments point out, adding these definition to address the risk of
reducing the presence of Salmonella to two examples to the definition does not contamination to RTE food and to foods
an extent sufficient to prevent illness. mean that these two pathogens are the exposed to the environment after a
The extent of reduction sufficient to only environmental pathogens that a lethality step. Other comments ask us to
prevent illness usually is determined by facility must consider in its hazard consider the number and types of
the estimated extent to which analysis. New environmental pathogens different products produced, the
Salmonella spp. may be present in the can emerge at any time, and other complexity of processing procedures,
the amount of product produced, and ‘‘environmental pathogen’’ is directed to 6. Facility

whether an environmental sampling those pathogens that are capable of We proposed to define the term
program is in place. surviving and persisting within the ‘‘facility’’ to mean a domestic facility or
(Response 83) We decline these manufacturing, processing, packing, or a foreign facility that is required to
requests, which are asking us to specify holding environment of a food register under section 415 of the FD&C
in a definition factors associated with establishment, not the water that is used Act in accordance with the
developing an environmental in a food processing establishment. See requirements of 21 CFR part 1, subpart
monitoring program. The purpose of a the discussion of environmental H. Comments directed to the meaning of
definition is to simply explain what a pathogens in the food processing the term ‘‘facility’’ address its meaning
term means, not to establish environment in section I.D of the
requirements, or provide guidance about as established in the section 415
Appendix to the 2013 proposed human registration regulations, rather than this
requirements, that use the term. preventive controls rule (78 FR 3646 at
(Comment 84) Some comments ask us definition established in part 117. See
3813–3815, with corrected reference Comment 4 and Response 4.
to clarify the meaning of the term numbers at 78 FR 17142 at 17144–
‘‘persisting’’ as used in the definition, 17146). As discussed in that Appendix, 7. Farm
such as whether it means that a the available data and information
sanitation process will not remove the We proposed to define the term
associate insanitary conditions in food ‘‘farm’’ by reference to the definition of
microorganism. facilities with contamination of a
(Response 84) We use the term that term in proposed § 1.227 rather
number of foods with Salmonella spp. than by repeating the full text of the
‘‘persisting’’ to mean that a pathogen and L. monocytogenes. Such
can become established if cleaning is ‘‘farm’’ definition in part 117. See
contamination has led to recalls and to section IV.B for a discussion of the
not adequate. Once a pathogen becomes outbreaks of foodborne illness. As a
established, appropriate sanitation ‘‘farm’’ definition that we are
result, the rule includes several establishing in § 1.227.
measures can remove the pathogen. provisions directed to those pathogens,
However, sanitation procedures such as Salmonella spp. and L. 8. Food
necessary to eliminate an environmental
monocytogenes, that are capable of We proposed to define the term
pathogen that has become established
surviving and persisting within a food ‘‘food’’ to mean food as defined in
generally are more aggressive than
establishment (thereby serving as a section 201(f) of the FD&C Act and to
routine sanitation procedures.
(Comment 85) Some comments ask us source of contamination of the food include raw materials and ingredients.
to revise the definition to specify that establishment environment) and uses Under section 201(f), the term ‘‘food’’
the microorganisms are ‘‘potentially’’ of the defined term ‘‘environmental means: (1) Articles used for food or
public health significance. pathogens’’ to describe those pathogens. drink for man or other animals, (2)
(Response 85) We decline this These specific provisions do not apply chewing gum, and (3) articles used for
request. The definition is only directed to waterborne pathogens that do not components of any such article.
at those microorganisms that are of survive and persist within a food (Comment 87) Some comments ask us
public health significance. establishment. to include examples in the definition,
(Comment 86) One comment asserts By ‘‘pathogenic sporeformers,’’ we particularly dietary supplements and
that the proposed definition of mean ‘‘pathogenic sporeforming dietary ingredients. These comments
‘‘environmental pathogen’’ excludes the bacteria,’’ and we are substituting the also ask us to clarify whether the
waterborne pathogens Cyclospora and term ‘‘pathogenic sporeforming definition applies to food for human
Cryptosporidium and asks us to revise bacteria’’ for ‘‘pathogenic sporeformers’’ consumption, animal consumption, or
the definition so that these pathogens in the definition of ‘‘environmental both.
will be considered ‘‘environmental pathogen’’ to make that clearer. Both of (Response 87) We decline the request
pathogens’’ for the purposes of the the waterborne pathogens discussed by to include examples in the definition.
human preventive controls rule. The this comment are protozoan parasites, Dietary supplements and dietary
comment asserts that excluding these not bacteria (Ref. 31). ingredients are articles used for food or
waterborne pathogens does not take into The fact that waterborne organisms drink for man, as are many other
account the considerable food safety such as Cyclospora and articles. There are many examples of
hazard of ‘‘spores’’ of ‘‘pathogenic Cryptosporidium are not food and adding a limited list of
sporeformers’’ that can be present in ‘‘environmental pathogens’’ as that term examples could be confusing rather than
and delivered to a food processing is used in this rule does not mean that helpful. Although the definition of food
facility by processing and ingredient a facility has no responsibility to includes food for both human
water, both well water and surface water evaluate whether Cyclospora or consumption and animal consumption,
from either private or municipal supply, Cryptosporidium are known or the provisions of the rule are clearly
in both domestic and foreign facilities. reasonably foreseeable hazards that directed to food for human consumption
The comment asks us to delete the require a preventive control. For (see Response 6 and Response 72).
statement that an environmental example, when a fresh-cut produce (Comment 88) Some comments ask us
pathogen does not include the spores of processing facility receives produce to consider fundamental and important
pathogenic sporeformers so that, from a geographic region where differences between food additives and
according to the comment, Cyclospora Cyclospora or Cryptosporidium have GRAS substances and finished food.
and Cryptosporidium would fall within been associated with food safety These comments explain that food
the definition of ‘‘environmental problems, the facility likely would additives and GRAS substances may be
pathogen.’’ address the potential for contamination synthesized using various chemical and
(Response 86) We disagree that the of incoming produce with Cyclospora or biochemical processes, or may be
pathogens Cyclospora and Cryptosporidium in its supply-chain extracted, hydrolyzed or otherwise
Cryptosporidium should be considered program (see subpart G for the modified from their natural sources, and
‘‘environmental pathogens’’ as we use requirements of the supply-chain result in food safety hazards that are
that term in this rule. Our definition of program). quite different from finished food
preparations. These comments also their hazard evaluation; a facility that To the extent that the comment is
explain that food additives and GRAS appropriately determines through its asking us to revise either the statutory
substances are often produced using hazard analysis that there are no definition of ‘‘major food allergen’’ in
processes that minimize microbial hazards requiring preventive controls section 201(qq) of the FD&C Act, or to
contamination hazards and are almost would document that determination in revise the criteria for when a food shall
always used in food products that its written hazard analysis but would be deemed misbranded under section
undergo further downstream processing. not need to establish preventive controls 403(w) of the FD&C Act, we do not have
These comments assert that food and associated management authority to do so.
additives and GRAS substances components. (See Response 222.) (Comment 92) Some comments ask us
generally present a significantly lower to include an example of an ingredient
9. Food Allergen derived from an allergen in the
public health hazard compared to
finished food and should be regulated We proposed to define the term ‘‘food definition.
accordingly. allergen’’ to mean a major food allergen (Response 92) We decline this
(Response 88) Substances such as as defined in section 201(qq) of the request. The definition of ‘‘major food
food additives and GRAS substances are FD&C Act. allergen’’ in section 201(qq) of the FD&C
food and are subject to the requirements (Comment 90) Some comments ask us Act is sufficient to define the term.
of this rule. Both the CGMP to narrow the definition of food allergen Casein and whey protein, each of which
requirements in subpart B and the by specifying that a substance is only a are derived from milk, are examples of
requirements for hazard analysis and food allergen when it is not disclosed on ingredients that would satisfy the
risk-based preventive controls in the product label. definition of ‘‘major food allergen’’ in
subparts C and G provide flexibility to (Response 90) We decline this section 201(qq).
address all types of food. (As discussed request, which appears to confuse the
distinction between what a food 10. Harvesting
in section XLII, the final rule establishes
the requirements for a supply-chain allergen is and when a product would We proposed to establish in § 117.3
program in subpart G, rather than be misbranded under section 403(w) of the same definition of ‘‘harvesting’’ as
within subpart C as proposed. As a the FD&C Act. The substances listed in we proposed to establish in §§ 1.227 and
result, this document refers to subparts section 201(qq) of the FD&C Act are 1.328. See section IV.C for a discussion
C and G when broadly referring to the food allergens; if any of those of comments we received to the
requirements for preventive controls.) substances are not disclosed on the proposed definition of ‘‘harvesting’’ in
Some comments point out that one product label, then the product would §§ 1.227 and 1.328, and our responses to
strength of the long-standing CGMPs is be misbranded under section 403(w) of those comments.
their applicability to the broad spectrum the FD&C Act.
(Comment 91) Some comments ask us 11. Hazard
of food manufacturing, from the
manufacture of processed products to to expand the existing exemption for We proposed to define the term
production of food additives and GRAS RACs from the definition of major food ‘‘hazard’’ to mean any biological,
substances (see section VIII). A allergen in section 403(w)(1) of the chemical (including radiological), or
manufacturer of a food additive or FD&C Act to include raw fish. physical agent that is reasonably likely
GRAS substance has flexibility to (Response 91) This comment is to cause illness or injury in the absence
comply with the requirements of the unclear and appears to be confusing the of its control.
rule based on the nature of the definition of ‘‘major food allergen’’ in (Comment 93) Some comments
production processes and the outcome section 201(qq) of the FD&C Act with express concern that the rule would
of the hazard analysis for that food criteria for when a food shall be deemed refer to four levels of ‘‘hazard’’—i.e.,
substance. (See also Response 221.) to be misbranded under section 403(w) ‘‘hazard,’’ ‘‘known or reasonably
(Comment 89) Some comments ask us of the FD&C Act. Under section 403(w), foreseeable hazard,’’ ‘‘significant
to limit the definition of ‘‘food’’ as it a food shall be deemed misbranded if it hazard,’’ and ‘‘serious adverse health
would apply to the new requirements is not a raw agricultural commodity and consequences or death to humans or
for hazard analysis and risk-based it is, or it contains an ingredient that animals’’ hazard. These comments ask
preventive controls to only cover bears or contains, a major food allergen, us to provide sufficient clarity to be able
produce and processed foods covered by unless certain labeling requirements are to distinguish between these types of
the rules, rather than all food (human met. Under section 201(r) of the FD&C hazards and to provide examples in
and animal, produce and non-produce, Act, the term ‘‘raw agricultural guidance as to how these terms will be
low-risk and high-risk). commodity’’ means any food in its raw applied in determining compliance with
(Response 89) We decline this or natural state, including all fruits that the rule. Other comments express
request. It is not necessary to modify the are washed, colored, or otherwise concern that the definitions do not
definition of ‘‘food’’ to limit treated in their unpeeled natural form establish a meaningful distinction
applicability of the rule to human food. prior to marketing. Fish are food and, between ‘‘hazard’’ and ‘‘significant
(See Response 6.) The umbrella CGMPs thus, raw, unprocessed fish are RACs hazards’’ and do not sufficiently
that we are establishing in subpart B are within the meaning of section 403(w). distinguish between the hazards
long-standing provisions that establish Thus, the misbranding provisions of identified in the first and second steps
basic requirements for the section 403(w) would not apply to raw, of the hazard analysis (first narrowing
manufacturing, processing, packing, and unprocessed fish, because those hazards to ‘‘known or reasonably
holding of food to prevent adulteration misbranding provisions do not apply to foreseeable hazards’’ and then
and are not ‘‘one-size-fits-all.’’ (See RACs. However, the exemption in narrowing the ‘‘known or reasonably
Response 221.) The new requirements section 403(w) from the conditions foreseeable hazards’’ to ‘‘significant
for hazard analysis and risk-based under which a food shall be deemed to hazards’’).
preventive controls likewise are not be misbranded do not establish an (Response 93) The rule uses three of
‘‘one-size-fits-all,’’ and facilities that are exemption for RACs in the definition of these terms (i.e., ‘‘hazard,’’ ‘‘known or
subject to the rule would consider the ‘‘major food allergen’’ in section reasonably foreseeable hazard,’’ and the
risk presented by the products as part of 201(qq). proposed term ‘‘significant hazard’’) to
establish a tiered approach to the cause illness or injury. Likewise, other hazard’’ to mean a biological, chemical
requirements for hazard analysis and comments assert that any hazard that is (including radiological), or physical
risk-based preventive controls. The term ‘‘reasonably likely to cause illness or hazard that has the potential to be
‘‘hazard’ is the broadest of these three injury in the absence of its control’’ will, associated with the facility or the food.
terms—any biological, chemical if known or reasonably foreseeable, (Comment 96) Some comments
(including radiological), or physical likely be controlled by any support the definition as proposed,
agent that is reasonably likely to cause knowledgeable person. noting that it implies that the
illness or injury. To conduct its hazard (Response 94) We have deleted the implementation of a preventive control
analysis, a facility starts by first phrase ‘‘in the absence of its control’’ is based both on the severity and
narrowing down the universe of all from the definition of ‘‘hazard.’’ As likelihood of the hazard, can help to
potential hazards to those that are previously discussed, the phrase ‘‘in the distinguish between the requirements of
‘‘known or reasonably foreseeable’’ for absence of its control’’ is not included this rule and HACCP requirements, and
each type of food manufactured, in the definition of ‘‘hazard’’ in the provides for the proper consideration of
processed, packed, or held at its facility. Codex HACCP Annex, our HACCP both the food and the facility when
The outcome of the facility’s hazard regulation for seafood, or the HACCP determining whether a hazard is
analysis is a determination of regulation for meat and poultry, ‘‘known or reasonably foreseeable.’’
‘‘significant hazards’’—i.e., the subset of although it is included in the NACMCF Other comments ask us to modify the
those known or reasonably foreseeable HACCP Guidelines and our HACCP definition to specify that the term means
hazards that require a preventive regulation for juice (78 FR 3646 at a hazard ‘‘that is known to be, or has the
control. 3697). We agree that deleting this phrase potential to be,’’ associated with the
To make this clearer, we have: (1) from the definition of ‘‘hazard’’ will facility or the food’’ to better align with
Revised the proposed definition of more clearly distinguish between the the term as FDA proposed to define it
‘‘hazard’’; (2) changed the term terms ‘‘hazard’’ and ‘‘hazard requiring a in the proposed FSVP rule. (See 79 FR
‘‘significant hazard’’ to ‘‘hazard preventive control’’ that we are 58574 at 58595.)
requiring a preventive control’’; and establishing in this rule. We see no (Response 96) We have revised the
revised the definition of ‘‘hazard reason to propose an analogous change definition as requested by the comments
requiring a preventive control’’ to the definition of ‘‘hazard’’ in our to better align with the proposed FSVP
(formerly ‘‘significant hazard’’). See HACCP regulation for juice because that rule.
Response 94, Response 126, Response regulation only defines the single term (Comment 97) Some comments ask us
127, Response 128, and Response 129. ‘‘hazard’’ and, thus, the issue discussed
The rule does not define the term to revise the definition so that it
in these comments does not apply. addresses a hazard that is known to be,
‘‘serious adverse health consequences or We also replaced the phrase ‘‘that is
death to humans or animals’’ hazard. or has the potential to be, associated
reasonably likely to cause illness or with a food, the facility in which it is
However, the requirements for a supply- injury’’ with ‘‘that has the potential to
chain program refer to a hazard for manufactured/processed, or the location
cause illness or injury’’ to more clearly or type of farm on which it is grown or
which there is a reasonable probability distinguish ‘‘hazard’’ from ‘‘known or
that exposure to the hazard will result raised. These comments assert that the
reasonably foreseeable hazard.’’ This type of farm may affect those hazards
in serious adverse health consequences increases the alignment of the definition
or death to humans (see § 117.430(b)). that are known or reasonably
of ‘‘hazard’’ in this rule with the Codex foreseeable.
For additional information on how we definition of ‘‘hazard.’’
interpret ‘‘serious adverse health (Response 97) We decline this
consequences or death to humans or request, which appears related to
to add that the term hazard also means
animals,’’ see our guidance regarding another difference between the
any agent that would cause a food to
the Reportable Food Registry (Ref. 32) definition proposed in this rule and the
become adulterated under section 402 of
(Ref. 33), which addresses statutory definition of this term in the proposed
the FD&C Act.
requirements regarding ‘‘reportable (Response 95) The suggested addition FSVP rule. The proposed FSVP rule
foods.’’ As explained in that guidance, is inconsistent with current national would define ‘‘known or reasonably
a ‘‘reportable food’’ is an article of food and international understanding of what foreseeable hazard’’ as a hazard that is
(other than dietary supplements or constitutes a hazard (Ref. 34) (Ref. 35) known to be, or has the potential to be,
infant formula) for which there is a because it would include agents such as associated with a food or the facility ‘‘in
reasonable probability that the use of, or filth, which would adulterate food which it is manufactured/processed.’’
exposure to, such article of food will within the meaning of section 402(a)(4) (See 79 FR 58574 at 58595.) In this rule,
cause serious adverse health of the FD&C Act but would be unlikely we do not need to specify that the
consequences or death to humans or to cause illness or injury (Ref. 36). applicable facility is the one ‘‘in which
animals. The guidance includes the food is manufactured/processed’’
examples of circumstances under which 12. Holding because this rule applies to the owner,
food might be reportable. We proposed to establish in § 117.3 operator, or agent in charge of the
(Comment 94) Some comments assert the same definition of ‘‘holding’’ as we facility in which the food is
that the distinction between the proposed to establish in §§ 1.227 and manufactured, processed, packed, or
definitions of ‘‘hazard’’ and ‘‘significant 1.328. See section IV.D for a discussion held, and that applicability does not
hazard’’ is not discernable because the of comments we received to the need to be repeated in each provision.
proposed definition of ‘‘hazard’’ proposed definition of ‘‘holding’’ in To the extent that this comment is
currently takes into account whether or expressing concern about raw materials
§§ 1.227 and 1.328, and our responses to

not a ‘‘hazard’’ is or is not controlled. those comments. or other ingredients that a facility would
These comments ask us to delete the receive from a farm, those concerns
phrase ‘‘in the absence of its control’’ 13. Known or Reasonably Foreseeable would be considered in the facility’s
from the definition of ‘‘hazard’’ to Hazard hazard analysis, which would include a
clarify that hazards are simply the We proposed to define the term hazard evaluation that considers factors
agents that are reasonably likely to ‘‘known or reasonably foreseeable such as those related to the source of
raw materials and other ingredients (see (Comment 100) Some comments ask (Response 101) The purpose of the
§ 117.130(c)(2)(iii)). us to modify the proposed definition to specific code associated with a lot is to
(Comment 98) Some comments ask us make it more flexible and robust. These identify the food and associated
to include ‘‘food allergens’’ in the comments assert that the proposed production records—e.g., when
parenthetical where we list radiological definition appears to ignore other investigating a food safety problem or
hazards as a type of chemical hazard. potential definitions, such as products conducting a recall. We decline the
(Response 98) We decline this with common characteristics (such as request to define a term such as ‘‘lot
request. As previously discussed, the origin, variety, type of packing, packer, code’’ or ‘‘production code.’’ The
definitions of ‘‘hazard’’ or ‘‘food consignor, markings) and that multiple definition of ‘‘lot’’ is intended to
hazard’’ in the NACMCF HACCP ‘‘lots’’ can be produced during the same provide flexibility for an establishment
guidelines, the Codex HACCP Annex, time but with different lot designations. to determine the mechanism of
and Federal HACCP regulations for Other comments ask us to modify the assigning a code that is best suited to
seafood, juice, and meat and poultry all proposed definition so that it is not the food it produces.
define hazard with respect to biological, limited by a period of time and suggest (Comment 102) Some comments ask
chemical, and physical agents, and we using an approach that would allow for us to clarify the factors that can affect
proposed to include radiological agents a lot to be defined by either time or by the size of a ‘‘lot.’’ These comments
to implement section 418(b)(1)(A) of the a specific identifier. Other comments assert that minimizing the size of a lot
FD&C Act (78 FR 3646 at 3697). We express the view that the individual could be beneficial to an establishment
subsequently proposed to include operators should be able to define their if a recall is needed and express concern
radiological hazards as a subset of lot designations and make these that our proposed definition may differ
chemical hazards because comments definitions available to FDA upon from that used by a specific
recommended that we do so, and we request. Other comments assert that the establishment.
believe that facilities in the past have proposed definition is too prescriptive (Response 102) The definition
considered radiological hazards as and inflexible in that timeframe is not provides a company with flexibility to
chemical hazards when conducting a necessarily the most logical way to determine an appropriate size of a lot.
hazard analysis for the development of identify a lot (e.g., for batch production). 15. Manufacturing/Processing
HACCP plans (79 FR 58524 at 58557). Some comments suggest specific
changes to the text of the proposed We proposed to establish in § 117.3
In this document, we affirm our the same definition of ‘‘manufacturing/
proposal to implement section definition, such as ‘‘Lot means a body
of food designated by the facility with processing’’ as we proposed to establish
418(b)(1)(A) of the FD&C Act by in §§ 1.227 and 1.328. See section IV.E
specifically including radiological common characteristics, e.g., origin,
variety, type of packing, packer, for a discussion of comments we
hazards in the definition of hazard. We received to the proposed definition of
acknowledge that food allergen hazards consignor, markings or time of harvest,
packing or processing, which is ‘‘manufacturing/processing’’ in §§ 1.227
(together with pesticide and drug and 1.328, and our responses to those
residues, natural toxins, decomposition, separable by such characteristics from
other bodies of food.’’ comments.
and unapproved food or color additives)
also are a subset of chemical hazards but (Response 100) As judged by these 16. Microorganisms
do not find it necessary to list all comments, the long-standing definition We proposed to define the term
examples of chemical hazards in the of ‘‘lot’’ has the potential to be ‘‘microorganisms’’ to mean yeasts,
definition of hazard, just as we do not misinterpreted to mean that the molds, bacteria, viruses, protozoa, and
find it necessary to list multiple ‘‘specific code’’ must be based on time, microscopic parasites and include
examples of biological and physical such as a date. This is not the case. species having public health
hazards in the definition of hazard. The Although the term ‘‘lot’’ is associated significance. We also proposed that the
requirement to consider food allergen with a period of time, an establishment term ‘‘undesirable microorganisms’’
hazards in the hazard analysis is already has flexibility to determine the code, includes those microorganisms that are
explicit in the requirements for hazard with or without any indication of time of public health significance, that
identification (see § 117.130(b)(1)(ii)). in the code. For example, a code could subject food to decomposition, that
(Comment 99) Some comments be based on a date, time of day, indicate that food is contaminated with
suggest using the phrase ‘‘reasonably production characteristic (such as those filth, or that otherwise may cause food
anticipated contaminants’’ as a useful mentioned in the comments), to be adulterated.
phrase that clearly defines all hazards, combination of date/time/production (Comment 103) Some comments
whether deliberate or accidental, that characteristic, or any other method that express concern that the term
can cause adulteration in the food works best for the establishment. To ‘‘undesirable microorganisms’’ includes
supply. clarify that the rule does not require that microorganisms that subject food to
(Response 99) We decline this time be ‘‘indicated’’ by the code, and decomposition. These comments assert
request. We see no meaningful emphasize the establishment’s that the definition would expand
difference between ‘‘reasonably flexibility to determine the code, we regulation beyond food safety and ask
expected’’ and ‘‘reasonably have revised ‘‘period of time indicated us to clarify that decomposition means
anticipated.’’ We also see no benefit in by a specific code’’ to ‘‘period of time a degradation of product that is only
specifying that a hazard is a and identified by an establishment’s relevant when it affects the safety of the
‘‘contaminant’’ rather than an ‘‘agent’’ specific code.’’ product, rather than simple spoilage,
(which is the term used in the definition (Comment 101) Some comments ask because the presence of microorganisms
of ‘‘hazard’’). us to clarify the purpose of the ‘‘specific that can cause spoilage is an
code’’ associated with the lot (i.e., that unavoidable condition of fresh produce.
14. Lot it should give insight into production (Response 103) We have not modified
We proposed to define ‘‘lot’’ to mean history of the associated food) and to the regulatory text of this long-standing
the food produced during a period of define a term such as ‘‘lot code’’ or definition of the term ‘‘undesirable
time indicated by a specific code. ‘‘production code.’’ microorganisms’’ regarding
microorganisms that subject food to 17. Mixed-Type Facility not at CCPs, such as for controls that are
decomposition. As we noted during the We proposed to establish in § 117.3 not process controls and do not involve
rulemaking to first establish this the same definition of ‘‘mixed-type parameters and maximum or minimum
definition, the regulations are designed facility’’ as we proposed to establish in values, or combinations of values, to
to prevent the growth of undesirable §§ 1.227 and 1.328. See section IV.F for which a parameter must be controlled to
microorganisms, and the scope of the a discussion of comments we received significantly minimize or prevent a
definition is not limited to pathogens to the proposed definition of ‘‘mixed- hazard requiring a preventive control.
because these regulations are also typed facility’’ in §§ 1.227 and 1.328, For example, it is possible to monitor
concerned with sanitation, that a specific sanitation control activity
and our responses to those comments.
decomposition, and filth (51 FR 22458 has taken place, such as the cleaning of
at 22460). The comments do not provide 18. Monitor a piece of equipment to prevent allergen
any examples of how we have We proposed to define the term cross-contact.
interpreted this provision in the past in ‘‘monitor’’ to mean to conduct a The requirement for documenting
a way that creates practical problems to planned sequence of observations or monitoring in records is established by
the fresh produce industry when the requirements for monitoring, not by
measurements to assess whether a
applying CGMP requirements directed the definition of monitor. As discussed
process, point, or procedure is under
to preventing the growth of undesirable in Response 468, we have made several
control and to produce an accurate
microorganisms. revisions to the regulatory text, with
record for use in verification.
(Comment 104) Some comments ask associated editorial changes, to clarify
(Comment 106) Some comments
us to specify that the term ‘‘undesirable that monitoring records may not always
assert that our proposed definition of
microorganisms’’ includes be necessary.
monitoring is directed to the narrow
microorganisms that are resistant to
circumstance of monitoring that would 19. Packaging (When Used as a Verb)
drugs or antibiotics.
(Response 104) We decline this be applied to a CCP under the NACMCF We proposed to establish in § 117.3
request. The requirements of this rule HACCP guidelines and the Codex the same definition of ‘‘packaging (when
directed to preventing contamination HACCP Annex. These comments also used as a verb)’’ as we proposed to
with microorganisms are intended to assert that, using such definitions, establish in §§ 1.227 and 1.328.
keep microorganisms out of food monitoring would not apply to control (Comment 107) Some comments
regardless of whether a particular strain measures for which parameters cannot express concern about establishing the
of a specific microorganism (including a be established and that are not amenable definition of ‘‘packaging (when used as
pathogen, a microorganism that subjects to documentation. These comments a verb)’’ in part 117. These comments
food to decomposition, and a suggest that we use a definition of ask us to clarify how this proposed
microorganism that indicates that food monitoring consistent with that definition relates to other uses of the
is contaminated with filth) has the provided in ISO 22000:2005 word ‘‘packaging’’ in part 117, including
particular characteristic of being (conducting a planned sequence of use as an adjective in the common
resistant to drugs or antibiotics. observations or measurements to assess phrase ‘‘food-packaging materials,’’ and
(Comment 105) Some comments ask whether control measures are operating including some provisions directed to
us to provide lists of microorganisms as intended) to clarify that monitoring controlling allergen cross-contact and
that we consider indicative of may be conducted where appropriate for contamination in ‘‘food-packaging
‘‘contamination with filth’’ and our preventive controls that are not CCPs. materials.’’ Some comments ask us to
rationale for such consideration. (ISO is an abbreviation for establish definitions for terms such as
(Response 105) We decline this ‘‘International Organization for ‘‘food-packaging materials’’ or ‘‘primary
request, which is better suited for Standardization.’’ ISO develops and packaging’’ to clarify the meaning of the
guidance. In other circumstances, we publishes international standards.) term ‘‘packaging’’ as it has previously
have discussed coliforms and fecal According to these comments, an been used in part 110. Other comments
coliforms as indicators that food has advantage of this definition is that it ask us to clarify that provisions directed
been contaminated by manufacturing also would clarify the difference to preventing allergen cross-contact and
practices conducted under insanitary between monitoring activities contamination in ‘‘food-packaging
conditions (see, e.g., the discussion in (observations conducted during the materials’’ apply only to ‘‘food-contact
the proposed rule to establish Current operation of a control measure to ensure packaging,’’ not ‘‘secondary packaging.’’
Good Manufacturing Practice, Quality that it is under control) and verification Some comments focus on the
Control Procedures, Quality Factors, activities (to evaluate performance of a differences between the definition of the
Notification Requirements, and Records control measure). term ‘‘packing’’ and ‘‘packaging’’ with
and Reports, for the Production of Infant (Response 106) We have revised the respect to activities conducted on RACs.
Formula, 61 FR 36154 at 36171, July 9, definition of monitor to mean to Some comments ask us to clarify how
1996). As another example, conduct a planned sequence of the term ‘‘packaging (when used as a
‘‘Compliance Policy Guide Sec. 527.300 observations or measurements to assess noun)’’ would apply when used in part
Dairy Products—Microbial whether control measures are operating 117, even though we did not propose to
Contaminants and Alkaline Phosphatase as intended. We agree that the revised establish a definition for ‘‘packaging
Activity’’ provides that dairy products definition, which reflects an (when used as a noun)’’ in part 117.
may be considered adulterated within international standard, more effectively (Response 107) We have decided not
the meaning of section 402(a)(4) of the communicates that monitoring also to establish the definition ‘‘packaging
FD&C Act (21 U.S.C. 342(a)(4)), in that applies to controls that are not at CCPs (when used as a verb)’’ in part 117. That
they have been prepared, packed, or and may apply to control measures for definition was established in the section
held under insanitary conditions which parameters cannot be established. 415 registration regulations, in part, to
whereby they may have become However, we disagree that this identify those food establishments that
contaminated with filth, when definition signals that it is not possible would be subject to those regulations
(nontoxigenic) E. coli is found at certain to obtain documentation when based, in part, on the activity of placing
levels (Ref. 37). monitoring preventive controls that are food into a container that directly
contacts the food and that the consumer not involve additional manufacturing/ an animal does not belong in a food
receives. In addition, because the term processing (such as cutting). processing environment and suggest
‘‘packaging’’ (when used as a noun) can that we follow this meaning of
20. Packing
be used in a very general way to refer ‘‘objectionable.’’ These comments also
to both the container that directly We proposed to establish in § 117.3 note that there may be circumstances
contacts the food and to the outer the same definition of ‘‘packing’’ as we where the presence of an animal is
packaging of food that does not contact proposed to establish in §§ 1.227 and acceptable, such as the use of guide
the food, the section 414 recordkeeping 1.328. See section IV.G for a discussion dogs.
regulations established a definition of of comments we received to the (Response 110) We decline this
‘‘packaging’’ (when used as a noun) to proposed definition of ‘‘packing’’ in request. The meaning of the term
narrowly refer to ‘‘the outer packaging §§ 1.227 and 1.328, and our responses to ‘‘objectionable’’ as described in these
of food that bears the label and does not those comments. comments is consistent with our
contact the food,’’ because this narrow 21. Pathogen interpretation of this long-standing
definition was also necessary for the definition of ‘‘pest,’’ but we do not
purposes of those recordkeeping We proposed to define the term believe it is necessary to provide a
regulations. ‘‘pathogen’’ to mean a microorganism of definition. See the provisions for pest
However, the term ‘‘packaging’’ has public health significance. control (§ 117.35(c)), which allow the
long been used as a noun in the CGMPs (Comment 108) Some comments ask use of guard, guide, and pest-detecting
to generally refer to the container that us to revise the definition to mean a dogs.
directly contacts the food, rather than to ‘‘microorganism of such severity and
the outer packaging of food that does exposure that it would be deemed of 23. Plant
not contact the food (as it means in the public health significance’’ because the We proposed to define the term
section 414 recordkeeping regulations). significance of pathogens to public ‘‘plant’’ to mean the building or
Thus, the very specific connotation for health depends on the organism’s establishment or parts thereof, used for
the term ‘‘packaging’’ (when used as a severity and the nature of exposure. or in connection with the
noun) that was established in the (Response 108) We decline this manufacturing, processing, packing, or
section 414 recordkeeping regulations request. Our purpose in defining the holding of human food. See Comment
does not apply, and is causing term pathogen was to simplify the 63 for the comments on the definition
confusion. As the comments point out, regulations, including our long-standing of ‘‘plant’’ and Response 63 for our
our proposed definition of ‘‘packaging CGMP regulations, by substituting a response to those comments.
(when used as a verb)’’ is already single term (i.e., ‘‘pathogen’’) for a more
causing confusion in the context of part complex term (i.e., ‘‘microorganism of 24. Preventive Controls
117. Therefore, for clarity and simplicity public health significance’’) throughout We proposed to define the term
in part 117 we are not including in the the regulations. These comments appear ‘‘preventive controls’’ to mean those
final rule a definition of ‘‘packaging to be objecting to the use of the long- risk-based, reasonably appropriate
(when used as a verb).’’ A definition for standing phrase ‘‘microorganism of procedures, practices, and processes
‘‘packaging (when used as a verb)’’ public health significance,’’ which has that a person knowledgeable about the
remains in the section 415 registration been in our CGMP regulations for safe manufacturing, processing, packing,
regulations, where a business can decades, rather than to our proposal to or holding of food would employ to
continue to use the definition for define and use a simpler term in its significantly minimize or prevent the
purposes of determining whether either place. These comments fail to explain hazards identified under the hazard
or both of those regulations applies to how we have interpreted the current analysis that are consistent with the
its business. term ‘‘microorganism of public health current scientific understanding of safe
Part 117 establishes requirements for significance’’ in a way that does not take food manufacturing, processing,
manufacturing, processing, packing, and into account factors such as the severity packing, or holding at the time of the
holding human food. The definition of of illness and the route of exposure. analysis.
‘‘manufacturing/processing’’ we are (Comment 111) Some comments ask
establishing in this rule makes clear that 22. Pest us to clarify the meaning of ‘‘current
‘‘packaging’’ (when used as a verb) is a We proposed to define the term scientific understanding’’ because
manufacturing/processing activity and, ‘‘pest’’ to refer to any objectionable scientific understanding can vary
thus, that requirements that apply to animals or insects including birds, depending on the risk profile of a
manufacturing or processing activities rodents, flies, and larvae. commodity.
apply to packaging activities. Because (Comment 109) Some comments ask (Response 111) By ‘‘current scientific
part 117 is not the regulation that us to include reptiles in the definition understanding,’’ we mean to emphasize
describes whether a food establishment due to a past instance of Salmonella that scientific information changes over
is subject to the section 415 registration linked to lizard feces in an RTE nut- time and a facility needs to keep current
regulations or the section 414 manufacturing facility. regarding safe handling and production
recordkeeping regulations, it is not (Response 109) We decline this practices such that the facility has the
necessary for part 117 to do more. request. This long-standing definition information necessary to apply
The comments that express concern does not limit pests to those already appropriate handling and production
about the distinction between ‘‘packing’’ included as examples. Reptiles are practices.
and ‘‘packaging (when used as a verb)’’ objectionable animals that are known to
with respect to activities conducted on carry human pathogens and are 25. Preventive Controls Qualified
RACs no longer apply in light of the considered pests. Individual

revised ‘‘farm’’ definition that we are (Comment 110) Some comments ask We proposed to define the term
establishing in the section 415 us to clarify the meaning of the term ‘‘qualified individual’’ to mean a person
registration regulations. The revised ‘‘objectionable.’’ These comments state who has successfully completed
‘‘farm’’ definition provides for that, under the Canadian Pest Control training in the development and
packaging RACs when packaging does Products Act, objectionable means that application of risk-based preventive
controls at least equivalent to that provides flexibility for how an combination of training, experience, or
received under a standardized individual can become qualified, but education appropriate to perform audits.
curriculum recognized as adequate by this flexibility does not make the Some comments ask us to recognize that
the FDA or is otherwise qualified definition ambiguous. training and/or experience can make a
through job experience to develop and (Comment 113) Some comments ask person a qualified auditor; the
apply a food safety system. We have us to expand the definition so that it comments state that people with
changed the proposed term ‘‘qualified includes a team of preventive controls experience performing audits likely
individual’’ to ‘‘preventive controls qualified individuals, not just a single have applicable training but might not
qualified individual’’ because we are person. have completed a specific regimen of
establishing a new definition for (Response 113) We decline this courses. Some comments maintain that
‘‘qualified individual,’’ with a meaning request. The definition applies to each we should recognize the role of the
distinct from ‘‘preventive controls preventive controls qualified individual education of a potential qualified
qualified individual.’’ To minimize the that a facility relies on to satisfy the auditor, as well as training and
potential for confusion for when the requirements of the rule without experience to meet the criteria.
term ‘‘qualified individual’’ refers to the limiting the number of such preventive (Response 115) We agree that a
proposed meaning of the term and when controls qualified individuals. The qualified auditor might obtain the
the term ‘‘qualified individual’’ refers to requirements of the rule make clear that necessary auditing expertise in part
the meaning of that term as finalized in a facility may rely on more than through education, as well as through
this rule, in the remainder of this preventive controls qualified individual training and experience, and we have
document we use the new term (see, e.g., § 117.180(a)). revised the definition of qualified
‘‘preventive controls qualified (Comment 114) One comment asks us
auditor accordingly. However, we
individual’’ whenever we mean ‘‘a to include ‘‘trusted trader’’ (i.e., a
conclude that a person must have at
person who has successfully completed company or entity in the supply chain
least some actual experience in auditing
training in the development and proven to be low risk) in the definition
to meet the definition of a qualified
application of risk-based preventive of preventive controls qualified
auditor, i.e., the necessary technical
controls at least equivalent to that individual.
(Response 114) We decline this expertise cannot be obtained solely
received under a standardized through education and/or training.
curriculum recognized as adequate by request. The concept of ‘‘trusted trader’’
applies to a facility’s suppliers, not to Therefore, the revised definition retains
the FDA or is otherwise qualified the proposed criterion that a qualified
through job experience to develop and individuals qualified to develop and
apply a food safety system. auditor has technical expertise obtained
apply a food safety system,’’ even by experience, as well as by education
though the proposed rule used the term 26. Qualified Auditor and training.
‘‘qualified individual.’’ Likewise, we
We proposed to define the term (Comment 116) Some comments that
use the new term ‘‘preventive controls
‘‘qualified auditor’’ to mean a person support the proposed definition ask us
qualified individual’’ for the proposed
who is a preventive controls qualified to revise the definition to specify certain
term ‘‘qualified individual’’ when
individual as defined in this part and individuals who would be considered
describing the comments to the
has technical expertise obtained by a qualified auditors, such as FDA
proposed rule, even though those
combination of training and experience inspectors, properly trained Federal
comments use the term ‘‘qualified
appropriate to perform the auditing auditors, and State and private auditors
individual.’’
In the following paragraphs, we function as required by § 117.180(c)(2). operating under a contract with the
discuss comments on this proposed As discussed in Response 569, we have Federal Government.
definition. (See also our discussion (in revised the definition to specify that (Response 116) We have revised the
section XXXVI) of the requirements ‘‘qualified auditor’’ means a person who regulatory text to specify that examples
applicable to the preventive controls is a ‘‘qualified individual’’ as that term of a qualified auditor include: (1) A
qualified individual (§ 117.180(c)).) is defined in this final rule, rather than government employee, including a
(Comment 112) Some comments a ‘‘preventive controls qualified foreign government employee and (2) an
assert that the proposed definition of individual,’’ because some auditors may audit agent of a certification body that
preventive controls qualified individual be auditing businesses (such as produce is accredited in accordance with
is ambiguous. farms) that are not subject to the regulations in part 1, subpart M (i.e.,
(Response 112) The comments requirements for hazard analysis and regulations in our forthcoming third-
provide no basis for asserting that this risk-based preventive controls, and it party certification rule implementing
definition is ambiguous, such as would not be necessary for such an section 808 of the FD&C Act (21 U.S.C.
difficulties in how we have interpreted auditor to be a ‘‘preventive controls 348d)). Although we agree that it is
similar regulatory text in enforcing our qualified individual.’’ We also have useful to include examples of
HACCP regulations for seafood and clarified that the technical expertise is individuals who would have the
juice (§§ 123.10 and 120.13(b), obtained through education, training, or appropriate qualifications, the example
respectively). The proposed definition experience (or a combination thereof) of an audit agent of a certification body
includes a performance standard necessary to perform the auditing that has been accredited in accordance
(qualified to develop and apply a food function to align the description of with regulations in our forthcoming
safety system), two criteria for how a applicable education, training, and third-party certification rule adds
person can become qualified experience with the description of context about the standard for such
(specialized training or job experience), applicable education, training, and individuals. Because paragraph (2) of
and a description of the type of experience in the definition of the new provision refers to provisions in
applicable training (development and ‘‘qualified individual’’ (see § 117.3). a future third-party certification rule, we
application of risk-based preventive (Comment 115) Some comments ask will publish a document in the Federal
controls at least equivalent to that us to revise the definition of qualified Register announcing the effective date
received under a standardized auditor to include persons who have of paragraph (2) once we finalize the
curriculum). The proposed definition technical expertise obtained by a third-party certification rule.
27. Qualified End-user ‘‘retail food establishment’’ in the (Response 119) Any facility that
We proposed to define the term section 415 registration regulations. We determines that it satisfies the criteria
‘‘qualified end-user’’ to mean, with intend to issue a final rule to amend the for a ‘‘qualified facility’’ must notify
respect to a food, the consumer of the definition of ‘‘retail food establishment’’ FDA of that determination (see
food (where the term consumer does not in the section 415 registration § 117.201) and, thus, the first
include a business); or a restaurant or regulations in the near future. (See also determination will be made by the
retail food establishment (as those terms Response 4.) facility itself. During inspection, the
are defined in § 1.227) that: (1) Is investigator could ask to see the records
28. Qualified Facility
located (a) in the same State as the that support the facility’s determination
qualified facility that sold the food to We proposed to define ‘‘qualified to verify the facility’s determination.
such restaurant or establishment; or (b) facility’’ by incorporating the (Comment 120) Some comments
not more than 275 miles from such description of ‘‘qualified facility’’ in address that part of the definition that
facility; and (2) is purchasing the food section 418(l)(1) of the FD&C Act with discusses ‘‘average annual monetary
for sale directly to consumers at such editorial changes to improve clarity. value of the food manufactured,
restaurant or retail food establishment. That definition includes two types of processed, packed, or held at such
We have revised the definition of facilities: (1) A facility that is a very facility, that is sold.’’ These comments
‘‘qualified end-user’’ to add ‘‘or the small business as defined in this rule; ask us to clarify whether the operative
same Indian reservation’’ to clarify for and (2) A facility to which certain word in the clause is ‘‘held’’ or ‘‘sold.’’
purposes of this rule so that ‘‘in the statutory criteria apply regarding the (Response 120) The operative word,
same State’’ under section average monetary value of food sold by for the purpose of calculating the
418(l)(4)(B)(ii)(I) of the FD&C Act the facility and the entities to whom the average monetary value of that food, is
includes both within a State and within food was sold. ‘‘sold.’’ (See also Response 154
the reservation of a Federally- Some comments discuss issues regarding the applicability of the
Recognized Tribe. related to the definition of very small monetary threshold of sales of human
(Comment 117) Some comments business. See Comment 154, Comment food plus the market value of human
object to the description of a qualified 156, Comment 157, and Comment 158 food manufactured, processed, packed,
end-user as being not more than 275 and our associated responses. or held without sale (e.g., held for a
miles from a facility that sold the food (Comment 118) Some comments fee).)
and assert that there is no scientific or assert that the definitions of ‘‘affiliate’’
29. Ready-to-Eat Food (RTE Food)
risk-based reason to support the and ‘‘subsidiary’’ in the definition of
distance of 275 miles. Other comments ‘‘qualified facility’’ fail to account for We proposed to define the term
ask us to clarify whether the criterion of the legal differences between a piece of ‘‘ready-to-eat food’’ to mean any food
not more than 275 miles from a facility property (i.e., a facility) and a business that is normally eaten in its raw state or
that sold the food would provide for entity or person. These comments ask us any other food, including processed
qualified end-users to be located across to consider revising the proposed food, for which it is reasonably
State lines and/or international borders definition of ‘‘qualified facility’’ to foreseeable that the food would be eaten
relative to the facility that sold the food. clarify what sales to include in without further processing that will
Other comments ask us to revise the determining whether a facility so significantly minimize biological
definition of ‘‘restaurant or retail food qualifies. hazards.
establishment’’ to include businesses (Response 118) We have not revised (Comment 121) Some comments ask
such as supermarkets, supermarket the proposed definition of ‘‘qualified us to substitute ‘‘reasonably expected’’
distribution centers, food hubs, farm facility’’ as requested by these for ‘‘reasonably foreseeable.’’
stands, farmers markets, and CSA. comments. The sales to be included (Response 121) We decline this
(Response 117) We have not revised when a facility determines whether it request. We see no substantive
the definition of ‘‘qualified end-user,’’ meets the definition of a qualified difference between ‘‘reasonably
which reflects section 418(l)(4) of the facility are the sales of human food by expected’’ and ‘‘reasonably foreseeable.’’
FD&C Act, in response to these a business entity, which includes the The term ‘‘reasonably foreseeable’’ is
comments. As discussed in Response parent company and all its subsidiaries used in other provisions of the rule,
581, we intend to focus on records and affiliates. The total sales are including the defined term ‘‘known or
demonstrating that a facility is a very applicable to each entity, whether it is reasonably foreseeable hazard.’’
small business (i.e., financial records the parent, the subsidiary, or the (Comment 122) Some comments ask
demonstrating that a business averages affiliate. We intend to address issues us to clarify the distinction between a
less than a specified dollar threshold) such as these in guidance as directed by food that satisfies the definition of
rather than records demonstrating sales section 418(l)(2)(B)(ii) of the FD&C Act. ‘‘ready-to-eat’’ and a food that satisfies
directly to qualified end-users. (See also Comment 77 regarding the the definition of a RAC. Some of these
Likewise, we have not revised the definitions of ‘‘affiliate’’ and comments express concern that if tree
definition of ‘‘restaurant or retail food ‘‘subsidiary’’ and our associated fruits are classified as ‘‘RTE food’’ rather
establishment’’ to clarify whether responses. See also Response 154 than as a RAC, we could force packers
particular businesses such as those regarding the applicability of the to do mandatory product testing.
mentioned in the comments would be monetary threshold of sales of human (Response 122) The terms RTE food
considered as ‘‘qualified end-users.’’ food plus the market value of human and RAC are not mutually exclusive.
Focusing on whether a facility is a very food manufactured, processed, packed, Some RACs (such as lettuce, tomatoes,
small business makes it unnecessary to or held without sale (e.g., held for a berries, and apples) are ready-to-eat,
determine whether an enterprise that fee).) whereas other RACs (such as artichokes
receives the food is a retail food (Comment 119) Some comments ask and potatoes) are not. The requirements
establishment. However, as discussed in us to clarify who will determine for product testing as a verification
section I.E, we have issued a separate whether a particular facility is a activity are flexible requirements that
proposed rule to amend the definition of qualified facility. depend on the facility, the food, and the
nature of the preventive control (see 31. Sanitize meaning of the term ‘‘sanitize’’ without
§ 117.165). See also Response 525. We proposed to define ‘‘sanitize’’ to establishing any requirement for when
mean to adequately treat cleaned food- equipment must be sanitized.
30. Receiving Facility We have revised the definition so that
contact surfaces by a process that is
We proposed to define the term it means adequately treating ‘‘surfaces’’
effective in destroying vegetative cells of
‘‘receiving facility’’ to mean a facility rather than ‘‘food-contact surfaces.’’
microorganisms of public health
that is subject to subpart C of this part Doing so is consistent with the
significance, and in substantially
and that manufactures/processes a raw definition of ‘‘sanitize’’ in the PMO. As
reducing numbers of other undesirable
material or ingredient that it receives a technical matter, adequately treating
microorganisms, but without adversely
from a supplier. any surface—regardless of whether it is
affecting the product or its safety for the
a food-contact surface—by a process
(Comment 123) Some comments ask consumer. We proposed to revise this
that is effective in destroying vegetative
us to modify the definition to specify otherwise long-standing definition by
cells of pathogens, and in substantially
that the receiving facility could receive inserting the term ‘‘cleaned’’ before reducing numbers of other undesirable
the raw material or ingredient directly ‘‘food-contact surfaces’’ because microorganisms, but without adversely
from a supplier or by means of an chemical sanitizers can be inactivated affecting the product or its safety for the
intermediary entity. These comments by organic material and, thus, are not consumer, is ‘‘sanitizing’’ the surface.
assert that without this added regulatory effective unless used on clean surfaces Clarifying this technical meaning of the
text the proposed definition implies that (78 FR 3646 at 3697). term ‘‘sanitize’’ imposes no
the material or ingredient must be (Comment 125) Some comments ask requirements to sanitize surfaces other
received directly from the supplier. us to adopt a definition of ‘‘sanitize’’ than food-contact surfaces; the
(Response 123) We decline this similar to that found in the Pasteurized requirements for sanitizing surfaces are
request. As discussed in Response 658, Milk Ordinance (PMO), which established by provisions such as
the two parties that are critical to the recognizes that cleaning and sanitizing § 117.37(d), not by the definition of the
supplier verification program are the do not always have to be separate, term ‘‘sanitize.’’
receiving facility and the supplier, even sequential steps. These comments report
that the definition in the PMO is ‘‘the 32. Significant Hazard (Hazard
if there are entities in the supply chain
application of any effective method or Requiring a Preventive Control)
between the two. The definition of
receiving facility does not preclude the substance to properly cleaned surfaces We proposed to define the term
participation of intermediary entities in for the destruction of pathogens, and ‘‘significant hazard’’ to mean a known
the supply chain, and the rule does other microorganisms, as far as is or reasonably foreseeable hazard for
provide for such participation (see practicable.’’ Other comments agree which a person knowledgeable about
Response 657). However, the definition with the proposed definition as it the safe manufacturing, processing,
of receiving facility does highlight the applies to chemical sanitizers, but packing, or holding of food would,
fact that a receiving facility must have disagree that clean surfaces are required based on the outcome of a hazard
a link to a supplier. for effective sanitizing for those systems analysis, establish controls to
that use steam and dry heat, such as significantly minimize or prevent the
(Comment 124) Some comments that those authorized by Appendix F of the hazard in a food. The rule would use the
support the definition of receiving PMO. These comments ask us to clarify term ‘‘significant hazard’’ rather than
facility ask us to clarify that a cold that the ‘‘cleaning’’ should be ‘‘hazard reasonably likely to occur’’ to
storage facility is not by definition a appropriate to the specific food system reduce the potential for a
receiving facility because it is not and method used for sanitizing, and that misinterpretation that all necessary
engaged in manufacturing/processing, cleaning should only be required when preventive controls must be established
but could be a supplier if temperature the sanitizing process alone would not at CCPs (79 FR 58524 at 58526).
controls are needed to control a be effective without a prior cleaning (Comment 126) Comments support
significant hazard. step. using a term other than ‘‘hazard
(Response 124) We agree that a cold Some comments express concern reasonably likely to occur’’ and agree
storage facility is not likely to be a about whether the proposed definition that using a term other than ‘‘hazard
receiving facility if it is not engaged in of ‘‘sanitize’’ would preclude the reasonably likely to occur’’ throughout
manufacturing/processing. However, it continued, routine use of dry cleaning the rule will reduce the potential for a
is the nature of the activity as methods with no sanitizing step. These misinterpretation that all necessary
manufacturing/processing, rather than comments note that adding routine preventive controls must be established
the use of a preventive control for aqueous-based cleaning and sanitizing at CCPs.
purposes other than manufacturing/ procedures could create a public health Some comments support the
processing, that is relevant here. By risk in certain operations such as low- regulatory text of the proposed
definition, the supplier must also be moisture food production. These definition of the term ‘‘significant
engaged in manufacturing/processing, comments also note that dry cleaning hazard.’’ These comments state that the
raising animals, or growing food (see the procedures can result in equipment that, proposed regulatory text more closely
definition of ‘‘supplier’’ in § 117.3). A while sanitary, is neither visibly clean aligns with the principles in FSMA
cold storage facility has a responsibility nor suitable for aqueous chemical (‘‘reasonably foreseeable’’ and
to maintain foods that require sanitizers. ‘‘significantly minimize or prevent’’)
temperature control for safety at an (Response 125) We consider that and provides operators the flexibility to
appropriate temperature, but generally systems such as steam systems clean the implement a range of preventive
does not engage in manufacturing/ surfaces, as well as sanitize them and, controls that are commensurate with the
processing. However, a cold storage thus, satisfy the definition of ‘‘sanitize.’’ risk and probability posed by a specific
facility in the supply chain between the The definition of ‘‘sanitize’’ does not hazard. Some comments agree that the
supplier and the receiving facility could preclude the continued use of dry proposed regulatory text can clarify the
participate in supplier verification cleaning methods with no sanitizing difference between HACCP rules and
activities (see Response 657). step because the definition describes the the human preventive controls rule.
Some comments state that the proposed definition nonetheless express concern or ‘‘known or reasonably foreseeable
regulatory text plainly reflects the about the term ‘‘significant hazard.’’ hazard’’ where ‘‘significant hazard’’
concept that significant hazards are Some of these comments express should instead be used. As discussed in
those hazards to be addressed through concern that a facility may not recognize Comment 93, some comments express
the very broad category of preventive hazards that need to be controlled concern that the rule would refer to
controls, and the rule is explicit that because they do not rise to the multiple levels of hazard and ask us to
preventive controls may be controls commonly understood meaning of provide sufficient clarity to be able to
other than at CCPs. Some comments ‘‘significant.’’ Other comments express distinguish between these types of
state that the definition reflects the risk- concern that the adjective ‘‘significant’’ hazards.
based nature (i.e., both the severity of a is subject to many interpretations and (Response 126) We have changed the
potential hazard and the probability that suggest that the term ‘‘hazard requiring term ‘‘significant hazard’’ to ‘‘hazard
the hazard will occur) of the control’’ would be more straightforward, requiring a preventive control.’’ The
requirements and provides additional accurate, and suitable. new term uses the explicit language of
flexibility so that facilities can take into Other comments express concern that FSMA (i.e., ‘‘preventive control’’), is
account the nature of the preventive the term ‘‘significant hazard’’ could consistent with the specific suggestion
control in determining when and how to cause confusion because it has of one comment (i.e., hazard requiring a
establish and implement appropriate implications in HACCP systems. For
control’’), and is not commonly
preventive control management example, ‘‘significant hazard’’ is often
associated with HACCP systems. We
components. Some comments support used in the context of CCPs, and
decline the request to use the term
including the phrase ‘‘based on the preventive controls are not necessarily
‘‘food safety hazard’’ because that term
outcome of a hazard analysis’’ in the established at CCPs. Some of these
already is established in Federal HACCP
definition because it ensures that comments suggest that we eliminate the
regulations for seafood and meat/
identification of significant hazards will term and instead use the full regulatory
poultry, and the comments are
be risk based. Some comments ask us to text of the proposed definition in place
particularly concerned about using a
of ‘‘significant hazard’’ throughout the
preserve in the final definition two key term that has implications for HACCP
regulations. Other comments suggest
aspects that grant the food industry the systems. We also decline the request to
using a term such as ‘‘food safety
flexibility that it needs: (1) The logical use the term ‘‘actionable hazard,’’
hazard’’ or ‘‘actionable hazard’’ instead
conclusion that not all hazards will because the term ‘‘actionable’’ is
of ‘‘significant hazard’’ to avoid a term
have the same impact or will even associated with violations at a food
that has HACCP implications. Other
constitute ‘‘significant hazards’’ at all, processing plant.
comments state that the term
depending on the facility’s products and We reviewed the full regulatory text
‘‘significant hazard’’ has implications
position in the supply chain; and (2) the of proposed subpart C and replaced
for facilities that follow the Codex
fact that a ‘‘person knowledgeable about ‘‘significant hazard’’ with ‘‘hazard
HACCP Annex and express concern that
the safe manufacturing, processing, requiring a preventive control’’ in most
foreign facilities would be especially
packing, or holding of food’’ must be likely to be confused by the term cases. See table 10 for the provisions
knowledgeable about the specific food ‘‘significant hazard.’’ where we made that change and for an
produced at that facility and in that Some comments ask us to ensure that explanation of those provisions where
specific sector of the food industry. the term ‘‘significant hazard’’ is used we replaced ‘‘significant hazard’’ with
Some of the comments that support consistently and express the view that ‘‘hazard’’ or ‘‘hazard requiring a process
the regulatory text of the proposed some regulatory text refers to a ‘‘hazard’’ control.’’
TABLE 10—SUBSTITUTIONS FOR THE TERM ‘‘SIGNIFICANT HAZARD’’

Reason for substituting a term
Term substituted for ‘‘significant
Section Description other than ‘‘hazard requiring a
hazard’’
preventive control’’
117.130(a)(1) ................................. Requirement to conduct a hazard Hazard requiring a preventive N/A.1

analysis. control.
117.135(a)(1) ................................. Requirement to identify and im- Hazard requiring a preventive N/A.1
plement preventive controls. control.
117.135(c)(2)(ii) .............................. Maximum and minimum values Hazard requiring a process con- The provision is narrowly directed
associated with process control. to a specific category of pre-
trols. ventive controls—i.e., process
controls.
117.139 .......................................... Recall plan .................................... Hazard requiring a preventive N/A.1
control.
117.160 .......................................... Validation ...................................... Hazard .......................................... Specifying that a facility must vali-
date that the preventive con-
trols are adequate to control
‘‘the hazard’’ adequately com-
municates the requirement. In
contrast, specifying that a facil-
ity must validate that the pre-

ventive controls are adequate
to control the ‘‘hazard requiring
a preventive control’’ would be
unnecessarily bulky and awk-
ward.
TABLE 10—SUBSTITUTIONS FOR THE TERM ‘‘SIGNIFICANT HAZARD’’—Continued

Reason for substituting a term
Term substituted for ‘‘significant
Section Description other than ‘‘hazard requiring a
hazard’’ preventive control’’
117.165(a) ...................................... Activities for verification of imple- Hazard .......................................... Specifying that a facility must
mentation and effectiveness of verify that the preventive con-
preventive controls. trols are consistently imple-
mented and are effectively and
significantly minimizing or pre-
venting ‘‘the hazards’’ ade-
quately communicates the re-
quirement. In contrast, speci-
fying that a facility must verify
that the preventive controls are
consistently implemented and
are effectively and significantly
minimizing or preventing ‘‘the
hazards requiring a preventive
control’’ would be unnecessarily
bulky and awkward.
117.165(a)(3) ................................. Requirement for environmental Hazard requiring a preventive N/A.1
monitoring to verify implementa- control.
tion and effectiveness of pre-
ventive controls.
1 N/A = Not applicable.
We also reviewed the full regulatory the requirement establishes the a hazard addressed by the existing
text of proposed subpart C to evaluate applicability to ‘‘hazards requiring a controls does not rise to the level of
whether there were any circumstances preventive control.’’ Although we ‘‘significant hazard.’’
where the regulatory text should more acknowledge that using ‘‘hazard Other comments express concern that
appropriately refer to ‘‘hazard requiring requiring a preventive control’’ in place the term ‘‘significant hazard’’ may create
a preventive control’’ rather than of ‘‘hazard’’ throughout applicable a disincentive for facilities to
‘‘hazard’’ or ‘‘known or reasonably provisions of proposed subpart C would voluntarily implement preventive
foreseeable hazard.’’ The term ‘‘known emphasize the tiered approach to the controls for hazards that only pose a
or reasonably foreseeable hazard’’ requirements for hazard analysis and remote risk or are very rarely
appears only once, in the requirement risk-based preventive controls, doing so encountered, because implementing
for a facility to conduct a hazard would make the regulatory text preventive controls for hazards of very
analysis (§ 117.130(a)). We are retaining unnecessarily bulky and awkward and low probability and severity may be
‘‘known or reasonably foreseeable would be inconsistent with comments misinterpreted as requiring preventive
hazard’’ in that requirement because it that ask us to make the regulatory text controls applicable to a ‘‘significant
is necessary to implement the tiered understandable (see Comment 13). hazard’’ even if the hazard does not
approach to the requirements for hazard (Comment 127) Some comments meet the definition of ‘‘significant
analysis and risk-based preventive express concern that the proposed hazard’’ established in the rule. Some
controls (see Response 93). To reinforce definition of ‘‘significant hazard,’’ comments ask us to revise the definition
this tiered approach, and emphasize which contains the phrase ‘‘for which a to provide facilities with the flexibility
that the facility only conducts a hazard person . . . would establish controls’’ is and discretion to establish appropriate
analysis for known or reasonably problematic in that facilities are likely preventive controls for hazards that do
foreseeable hazards, we revised to have already established preventive not rise to the criteria of a ‘‘significant
‘‘hazard’’ to ‘‘known or reasonably controls for a variety of hazards that hazard,’’ as well as ensuring that
foreseeable hazard’’ in two additional may not rise to the level of control preventive controls that address remote
provisions in the requirements for management required for a ‘‘significant or very unlikely hazards not be subject
hazard identification (see the hazard’’ and would instead routinely be to the preventive control management
introductory regulatory text for addressed in ‘‘prerequisite programs.’’ requirements for a ‘‘significant hazard.’’
§ 117.130(b)(1) and (2)). These comments express particular (Response 127) We have revised the
In our review of the full regulatory concern that identification of these definition to specify that the term
text of proposed subpart C, we did not hazards in and of themselves should not ‘‘hazard requiring a preventive control’’
identify any circumstances where we elevate control of these hazards to the applies when a knowledgeable person
believe it is appropriate and necessary category of being a ‘‘significant hazard.’’ would, based on the outcome of a
to specify ‘‘hazard requiring a Some comments ask us to allow hazard analysis, ‘‘establish one or more
preventive control’’ in place of facilities to continue to implement preventive controls’’ rather than
‘‘hazard.’’ It is not necessary for the existing controls outside the framework ‘‘establish controls.’’ By narrowing
regulatory text of requirements for of this rule (i.e., outside the framework ‘‘controls’’ to ‘‘one or more preventive
preventive controls, the supply-chain that requires preventive control controls,’’ we mean to signify that the
program, the recall plan, corrective management components as appropriate proposed term ‘‘significant hazard’’
actions, and verification to specify to ensure the effectiveness of the (which we now refer to as ‘‘hazard
‘‘hazard requiring a preventive control’’ preventive controls, taking into account requiring a preventive control’’) only
every time that the requirements use the the nature of the preventive control and applies to those controls that the facility
term ‘‘hazard’’ because the context of its role in the food safety system) when establishes to comply with the
requirements of subparts C and G for integral for making a proper ‘‘hazard requiring a preventive control’’
hazard analysis and risk-based determination of whether a hazard is needs to be modified to state that
preventive controls. A facility that significant. Other comments ask us to preventive controls are implemented to
establishes other controls (such as those revise the definition to better reflect the control hazards that have a higher
that the comments describe as risk-based approach that preventive probability of resulting in public health
‘‘prerequisite programs,’’ or controls controls be implemented to control consequence in the absence of control.
directed to hazards of very low hazards that have a higher probability of The definition already communicates
probability and severity) for hazards resulting in public health consequence the role of risk (i.e., severity and
that are not, based on the outcome of the in the absence of control. probability) in conducting the hazard
facility’s hazard analysis, ‘‘hazards (Response 128) We have revised the analysis that identifies those hazards
requiring a preventive control’’ would definition of ‘‘significant hazard’’ requiring a preventive control.
not need to establish preventive control (which we now refer to as ‘‘hazard We also decline the request to repeat
management components for such requiring a preventive control’’) to in the definition of ‘‘hazard requiring a
controls. However, some controls specify that the hazard analysis includes preventive control’’ the requirement for
previously established in ‘‘prerequisite an assessment of the severity of the the types of information that a facility
programs’’ would be considered illness or injury if the hazard were to would consider in conducting its hazard
‘‘preventive controls.’’ We provide some occur and the probability that the analysis. The requirements for hazard
flexibility for facilities with respect to hazard will occur in the absence of analysis clearly specify that a facility
how they manage preventive controls, preventive controls. By specifying that must conduct its hazard analysis based
and the preventive control management the determination of a ‘‘significant on experience, illness data, scientific
components may be different for hazard’’ is based on the outcome of a reports, and other information (see
hazards that have been managed as hazard analysis, the proposed definition § 117.130(a)).
‘‘prerequisite programs’’ compared to did, as requested by the comments, (Comment 129) Some comments that
those managed with CCPs. A facility include the risk-based nature of the broadly address the overall framework
that is concerned about the potential for determination. However, explicitly for the new requirements for hazard
an investigator to disagree during adding that the hazard analysis is based analysis and risk-based preventive
inspection that certain controls are not on probability and severity (i.e., risk) controls ask us to consistently refer to
directed to ‘‘hazards requiring a makes the risk-based nature of the ‘‘the nature of the preventive control’’
preventive control’’ could, for example, determination clearer. (rather than simply to ‘‘the preventive
include information relevant to its We disagree that the proposed control’’) when communicating the
classification of those other controls in definition was tautological and would flexibility that a facility has in
collapse the second step of hazard identifying preventive controls and
its hazard analysis, whether by merely
analysis into the first. As discussed in associated preventive control
listing the ‘‘other controls’’ or by
Response 93, a facility begins its hazard management components. (See
providing a brief explanation why such
analysis by narrowing down the Comment 455). Other comments that
controls are not ‘‘preventive controls’’ as
universe of all hazards to those that are broadly address the overall framework
that term is defined in this rule.
‘‘known or reasonably foreseeable’’ for for the new requirements for hazard
(Comment 128) Some comments each type of food manufactured, analysis and risk-based preventive
assert that the proposed definition of processed, packed, or held at its facility. controls ask us to emphasize that the
‘‘significant hazard’’ is tautological The outcome of the facility’s hazard requirements for preventive control
because it essentially establishes a analysis is a determination of a subset management components convey not
‘‘significant hazard’’ to be a known or of those known or reasonably only that the application of a particular
reasonably foreseeable hazard (i.e., the foreseeable hazards—i.e., those hazards element is appropriate (i.e., capable of
type of hazards identified in the first requiring a preventive control. To the being applied), but also necessary for
step of the analysis) for which extent that these comments are asserting food safety. Some comments
preventive controls should be that the tautology was created by the recommend that we do so by specifying
implemented. These comments assert phrase ‘‘in the absence of its control’’ in that preventive control management
that the proposed definition of the proposed definition of ‘‘hazard,’’ we components take into account the role
‘‘significant hazard’’ would collapse the have deleted that phrase from the final of the preventive control in the food
second step of hazard analysis into the definition of ‘‘hazard’’ (see Response safety system. (See Comment 455.)
first, which in turn would lead to the 94). (Response 129) We agree with these
unintended consequence of facilities We decline the request to modify the comments and have revised the
identifying the same hazards in the definition to specify that a hazard definition of ‘‘hazard requiring a
second step as in the first. Other requiring a preventive control is one for preventive control’’ to specify that
comments ask us to revise the definition which there is a reasonable probability, preventive control management
to clarify and distinguish the two steps based on experience, illness data, components are established as
of the hazard analysis by specifying scientific reports, or other information appropriate to ‘‘the nature of the
within the definition that a significant relevant to the food or the facility, that preventive control and its role in the
hazard is a known or reasonably adverse health consequence or death facility’s food safety system.’’ (See also
foreseeable hazard for which there is a will occur in the absence of its control. Response 455, where we describe
reasonable probability, based on The standard for harm in the definition additional provisions that we have
experience, illness data, scientific of ‘‘hazard’’ is illness or injury. We revised to clarify that preventive control
reports, or other information relevant to disagree that the standard for harm in management components are
the food or the facility, that adverse the definition of ‘‘hazard requiring a established as appropriate to the nature
health consequence or death will occur preventive control’’ should be different of the preventive control and its role in
in the absence of its control. Some from (i.e., adverse health consequences), the facility’s food safety system.)
comments ask us to revise the definition or greater than (i.e., death), the standard (Comment 130) Some comments ask
to include evaluation of severity and for harm in the definition of ‘‘hazard.’’ us to modify the definition of
probability, because these concepts are We also disagree that the definition of ‘‘significant hazard’’ to specify that the
preventive control management and recall plan) to reflect food allergens regulations for juice, but is not subject
components be established as as a significant hazard. to the requirements of this rule.
appropriate to both the food and the (Response 132) We decline this (Comment 135) Some comments
intended use of the food. request. Food allergens are included as express concern about the potential for
(Response 130) We decline this an example of a chemical hazard that a divergent interpretations of the
request. It is not necessary to repeat in facility must consider when definition by industry and regulators.
the definition of ‘‘hazard requiring a determining whether there are any Some comments state that a baseline
preventive control’’ the requirement for known or reasonably foreseeable understanding between industry and
the hazard evaluation to consider the hazards requiring a preventive control regulatory officials will need to be
intended use of the food. The (§ 117.130(b)(1)(ii)), and the rule established as to what constitutes a
requirements for hazard evaluation specifically provides for food allergen ‘‘significant hazard’’ and what
clearly specify that a facility must controls where relevant. It is not preventive controls will be deemed to
consider the intended or reasonably necessary to include examples of food be adequate to control such a hazard.
foreseeable use of the food (see allergens as hazards requiring a Some comments ask us to provide
§ 117.130(c)(2)(viii)). preventive control throughout the guidance or allow ‘‘inter-state
(Comment 131) Some comments regulatory text. compacts’’ to provide guidelines on
assert that the problem is how to (Comment 133) Some comments what constitutes significant hazards in
separate the hazards addressed by express concern that too much major food industries. Other comments
‘‘HACCP’’ from those addressed by flexibility may make it harder for us to assert that the FSPCA provides the best
CGMPs. These comments suggest that inspect conditions in a facility over forum to identify what constitutes
control measures that are implemented time. These comments emphasize that ‘‘significant hazards’’ in food, and to
for hazards from ingredients and food- we must not permit facilities to interpret develop timely and appropriate
contact packaging material, and from the term ‘‘significant hazard’’ as guidance and training for addressing
production and process, be called CCPs allowing them to substitute inadequate such hazards. Other comments ask to
and that control measures that are sanitation programs—which may not engage with us early and often on the
implemented for hazards from require documentation of monitoring or development of applicable guidance
personnel, equipment, and the plant be verification measures—for necessary documents regarding what constitutes a
called preventive controls. critical control points. ‘‘significant hazard’’ for produce
(Response 131) The facility must (Response 133) We acknowledge that industry operations and provide an
control hazards through the application there can be a tension between the need opportunity to explain and discuss
of CGMPs and preventive controls as for flexible requirements that must current industry best practices and
appropriate to the hazard. Although apply to diverse food processing preventive controls to address identified
some preventive controls will be facilities and the regulatory need to significant hazards. Some comments ask
established at CCPs, and ‘‘CCP’’ is a evaluate compliance with requirements. us to develop an administrative
term commonly used in HACCP See Response 5 regarding our approach procedure to adjudicate differences in
systems, this rule establishes to enforcing the rule. Although professional opinion between a
requirements for hazard analysis and preventive controls, such as sanitation regulated firm and a Federal or State
risk-based preventive controls, not controls, are not always directed to regulatory agency regarding hazard
‘‘HACCP,’’ and this rule provides that critical control points (see ‘‘significance.’’
preventive controls include controls at § 117.135(a)(2)(ii)), we agree that there (Response 135) We agree that
CCPs, if there are any CCPs, as well as could be circumstances where we guidance will help create an
controls, other than those at CCPs, that would disagree with a facility about the understanding between industry and
are also appropriate for food safety (see measures it has in place regarding regulatory officials as to FDA
§ 117.135(a)(2)). sanitation. We will address such recommendations for hazards that
Under the rule, some hazards may be circumstances on a case-by-case basis. require preventive controls and
addressed by CGMPs and others by (Comment 134) Some comments appropriate preventive controls for
preventive controls. For example, if a express concern that the term those hazards. See Response 2 and
facility manufactures egg biscuit ‘‘significant hazard’’ may lead to Response 5. We decline the request to
sandwiches, it could establish a misunderstanding by medium and develop an administrative procedure to
preventive control, as a CCP, for cooking smaller processors and ask how adjudicate differences in professional
the eggs and establish CGMP controls to businesses with limited food safety opinion between a regulated firm and a
address the potential for personnel to experience will understand the Federal or State regulatory agency
contaminate the cooked egg and the egg difference between a food safety hazard regarding hazard ‘‘significance.’’ We
biscuit sandwiches. As another that is ‘‘reasonably likely to occur’’ (and, note that existing procedures provide
example, a facility could control a thus, must be controlled by a full for an outside party to obtain internal
physical hazard such as metal using HACCP Plan) and a ‘‘Significant agency review of a decision by an
screens and magnets under CGMPs and Hazard’’ that can be controlled by a employee other than the Commissioner
then use a metal detector as a preventive preventive control plan. (see § 10.75). The comments do not
control. See also Response 437, in (Response 134) In most cases, it will explain what they mean by ‘‘inter-state
which we give examples regarding not be necessary for a food processor to compacts’’ or provide any examples of
when a facility might control food understand the difference between a ‘‘inter-state compacts’’ and, thus, it is
allergen hazards through a combination hazard that is ‘‘reasonably likely to not clear what, if any, role an ‘‘inter-
of CGMP controls and ‘‘food allergen occur’’ in the concept of HACCP state compact’’ could play in
controls,’’ which are a particular type of requirements and a ‘‘hazard requiring a determining what constitutes a
preventive control (see § 117.135(c)(2)). preventive control’’ in the context of significant hazard in major food
(Comment 132) Some comments ask this rule. Instead, a food processor must industries.
us to add examples throughout the identify those regulations that apply to (Comment 136) Some comments ask
regulatory text (e.g., in the requirements it. For example, a processor of juice us to concur that ‘‘temporal hazards’’ in
for hazard analysis, preventive controls, products is subject to our HACCP milk and dairy products (specifically,
aflatoxin, pesticides, and radiological position, the commenter makes plan, and they do not need to monitor
contamination) do not represent assertions about the purpose of water the safety of their water.
‘‘significant hazards’’ that require standards established by the U.S. (Response 137) We decline the
monitoring and verification activities on Environmental Protection Agency request to change the regulatory text to
an ongoing basis. These comments also (EPA), the risk presented by water explicitly require that the hazard
ask us to acknowledge that in many quality to the production of safe food, analysis address any water used by the
cases the testing done by FDA and and the impact to food safety of EPA’s facility, whatever its source. Many of
others is sufficient for protecting public 2013 changes to the National Primary the commenter’s assertions address
health and that it is not necessary to Drinking Water regulations (EPA’s issues under the jurisdiction of EPA,
require ongoing monitoring by NPDW regulations; 41 CFR parts 141 such as ‘‘allowing’’ ‘‘5 percent off-spec
individual dairy facilities to comply and 142) regarding total coliforms water’’; whether current standards are
with the rule. (EPA’s total coliform rule) (78 FR 10270, universally achieved by all public water
(Response 136) We decline these February 13, 2013). systems; and whether it is appropriate
requests because such a determination The commenter asserts that EPA’s to allow some water systems to not
should be facility specific. However, we NPDW regulations hold public water disinfect the water they supply. Such
have revised the considerations for the suppliers to a standard that is protective issues that are under the jurisdiction of
hazard evaluation to clarify that in of drinking water, not food EPA are outside the scope of this
making the determination as to what manufacturing water. For example, the rulemaking. We consider that water
hazards require preventive controls, the commenter describes EPA’s NPDW standards directed to drinking water for
facility can consider factors such as the regulations as requiring water suppliers household use would also be adequate
temporal nature of the hazard (see to treat at least 95 percent of the water for the production of food products and,
§ 117.130(c)(2)(x) and Response 407). In they distribute to the public to the thus, have no reason to question
determining the appropriate preventive treatment technique standard of the whether a facility can rely on the
control management components, the treatment they use and then argues that standards in EPA’s NPDW regulations to
facility can take into account the nature a user of the water would not satisfy the long-standing CGMP
of the preventive control and its role in necessarily know if it was getting some requirement that any water that contacts
the facility’s food safety system (see of the ‘‘allowable 5 percent off-spec food, food-contact surfaces, or food-
§ 117.140(a)). water.’’ The commenter also asserts that packaging materials must be safe and of
(Comment 137) One commenter current standards in EPA’s NPDW adequate sanitary quality (§ 117.37(a)).
asserts that municipal drinking water regulations are not universally achieved For example, we consider that water
supplies can be variable such that they by all public water systems. The standards that EPA concludes are
could be a hazard that is reasonably commenter also asserts that EPA’s total appropriate for drinking water are also
likely to occur and that relying on coliforms rule further reduces the appropriate for the production of water-
municipal water will compromise food applicability of municipal water based beverages, which are mostly
safety. The commenter asks us to ‘‘close standards to food manufacturing (e.g., water. We also see no reason to
the gap’’ in Federal risk assessment because it reduced the frequencies of specifically require that a facility that
policies by adding regulatory text to the water monitoring and public notices satisfies the CGMP requirement for
proposed definition of ‘‘significant about water quality and instead shifted water also address water quality in its
hazard’’ to specify that the hazards are the regulatory scheme towards hazard analysis. Further, if a facility
based on the outcome of a hazard corrective action). chooses to address the safety of water in
analysis that includes any water used by According to the commenter 95,000 its hazard analysis (e.g., water used in
the facility, whatever its source. The public water systems do not disinfect washing fresh-cut produce), we consider
commenter further asserts that FDA the water they provide to the public, it more likely that the facility would
must require full scientific water risk and some studies have found infective treat the water onsite, obtain the water
analysis and written water safety plans viruses in drinking water samples in supplier’s records documenting the
and water treatment where necessary communities that did not disinfect their results of its water testing, or simply test
and that the written water safety plans water. According to the commenter, the water on a periodic basis, rather
must comply with FSMA standards for water supplies close to aquifers that than conduct a risk assessment for the
accurate and precise measurement were not disinfected before distribution water source.
instruments, monitoring, verification, have recently had boil water advisories, Under § 117.37(a), we expect any food
and documentation. The commenter demonstrating that problems with the establishment—regardless of whether it
asserts that in lieu of a full assessment water supply are reasonably likely to is a facility subject to FSMA’s
and testing, the plant could disinfect all occur. The commenter questions requirements for hazard analysis and
incoming water to a preventive control whether the food manufacturing plants risk-based preventive controls—to be
standard, and track and document using that water had water safety back- vigilant regarding public health
compliance. The commenter further up plans, stopped production, had advisories such as a ‘‘boil water
asserts that its commercially available monitoring measures in place to advisory’’ and to take appropriate action
technology provides the most cost determine the impact of the unsafe in light of such advisories. It is not
effective disinfection for a wide range of water, or recalled product manufactured necessary for the regulatory text to
sporeformers, bacteria, viruses, algae during the period when the municipal specify each potential problem or to
and molds. water systems had coliform positive specify the actions a food establishment
In addition, the commenter asserts tests but had not yet confirmed these must take to address each potential
that food manufacturers who are not tests and therefore had not yet issued
problem.
required to make a special effort to the advisory. The commenter also asks
understand the status of their water whether the facilities relied on the 33. Significantly Minimize
supply through a required risk traditional assumption that if they use We proposed to define the term
assessment process will not be aware of municipal water their food safety risk ‘‘significantly minimize’’ to mean to
the need to institute preventive controls analysis does not have to cover water, reduce to an acceptable level, including
for their water supply. To support its they do not need a written water safety to eliminate.
(Comment 138) Some comments and the American Farm Bureau to help approach, the number of full-time
assert that the definition of ‘‘acceptable oversee the revised study. The revised equivalent employees is determined by
level’’ for fresh produce is unclear Food Processing Sector Study is dividing the total number of hours of
because of the presence of spoilage available in the docket of this rule (Ref. salary or wages paid directly to
microorganisms, which subject food to 21). employees of the business entity
decomposition and reduce quality, but Our original analysis was based on claiming the exemption and of all of its
are not a public health concern. These the merger of Dun & Bradstreet data and affiliates and subsidiaries by the number
comments ask us to revisit and change FDA’s Food Facility Registration data to of hours of work in 1 year, 2,080 hours
regulatory text that either does not help us estimate the number of (i.e., 40 hours × 52 weeks).
clarify, or over-steps the intention of, manufacturing facilities that are also We received similar comments during
the rule. classified as farms. We have updated the rulemaking to establish the section
(Response 138) We proposed to define that data source and added data sources. 414 recordkeeping regulations, and in
‘‘significantly minimize’’ to give context To better account for farms that perform response to those comments we
to the term used in FSMA to define processing activities, we included established the definition of ‘‘full-time
‘‘preventive control.’’ Thus, in this rule Census of Agriculture (Ag Census) data equivalent employee’’ in the definitions
the term ‘‘significantly minimize’’ both to provide a count of total U.S. for that rule. As with the section 414
relates to hazards that will be addressed farms and to estimate the number of recordkeeping regulations and the
by preventive controls. The term farms conducting food processing nutrition labeling regulations, the
‘‘significantly minimize’’ would not be activities, to the extent that the data calculation for the number of employees
relevant to spoilage microorganisms identifies processing activities. We also affects exemptions (i.e., the exemptions
unless the facility determines, through included the Agricultural Resource for on-farm, low-risk activity/food
its hazard analysis, that the spoilage Management Survey (ARMS) data combinations in § 117.5(g) and (h),
microorganisms are a hazard requiring a because it included questions about which apply only to small and very
preventive control. The standard of some processing activities for select small businesses), not just compliance
‘‘acceptable level’’ is a flexible standard. commodities. dates. Therefore, we are establishing the
By ‘‘acceptable level,’’ we mean a level Both the Ag Census and ARMS are definition of ‘‘full-time equivalent
that will not cause illness or injury or silent about many processing activities. employee’’ in the definitions for this
result in adulterated food. Therefore, we also obtained estimates rule (§ 117.3) and modifying the
from commodity specialists at trade definition of ‘‘small business’’ to use the
34. Small Business associations, USDA, and universities term ‘‘500 full-time equivalent
We proposed to define the term with in-depth knowledge of the employees’’ rather than ‘‘500 persons.’’
‘‘small business’’ to mean, for the processing activities for specific (Comment 141) Some comments ask
purposes of part 117, a business agricultural commodities. We also us to base the definition of ‘‘small
employing fewer than 500 persons. As reached out to directors of promotion business’’ on the amount of sales, rather
previously discussed, we conducted a and marketing boards, and considered than on the number of employees, for
Food Processing Sector Study as marketing agreements and marketing consistency with the definition of ‘‘very
required by section 418(l)(5) of the orders for various vegetables, fruits, and small business.’’
FD&C Act (Ref. 19) and used the results tree nuts to obtain information about the (Response 141) We decline this
of the study in defining the term ‘‘small portion of farms that conduct food request. As previously discussed, we
business’’ (78 FR 3646 at 3700 to 3701). processing activities for use in this based the definition of ‘‘very small
We made the results of the Food study. business’’ on sales because the criterion
Processing Sector Study available in (Comment 140) Some comments ask of being a ‘‘very small business’’ plays
Docket No. FDA–2011–N–0920 and us to explain how to calculate the a significant role in determining
requested public comment on that number of full-time equivalent whether a facility is a ‘‘qualified
study. employees—e.g., with respect to facility,’’ and because the other
(Comment 139) Some comments temporary workers, seasonal workers, principal criterion for being a ‘‘qualified
express concern that the Food and part-time workers. facility’’ is based on sales (section
Processing Sector Study is not (Response 140) As previously 418(l)(1)(C) of the FD&C Act; see 79 FR
comprehensive. Some comments assert discussed, we proposed to establish the 58524 at 58556). In contrast, section
that FDA did not sufficiently collaborate same definition for small business as 418(l) of the FD&C Act does not specify
with USDA, and that FDA significantly that which has been established by the any particular criterion (whether sales
underestimated the number of mixed- U.S. Small Business Administration or number of employees) for the
use facilities, particularly by neglecting (SBA) under 13 CFR part 121 for most definition of ‘‘small business,’’ other
to count farms that perform the food manufacturers, and the limit of 500 than direct us to consider the results of
processing steps on RACs to become a employees would include all employees the Food Processing Sector Study.
processed food. Other comments assert of the business rather than be limited to Basing the definition of ‘‘small
that the Food Processing Sector Study is the employees at a particular facility (78 business’’ on the number of employees
woefully inadequate and must be FR 3646 at 3701). We will base the is consistent with our approach to
undertaken again to comply with the calculation on ‘‘full-time equivalent defining ‘‘small business’’ for our
law. employees’’ and use the same approach HACCP regulation for juice
(Response 139) We previously to calculating full-time equivalent (§ 120.1(b)(1)), the section 414
acknowledged the limitations of the employees for the purpose of this rule recordkeeping regulations (69 FR 71562,
Food Processing Sector Study (78 FR as we used to calculate full-time December 9, 2004), and our CGMP
3646 at 3700–3701). We have revised equivalent employees in the section 414 regulation for manufacturing, packaging,
and extended the results of our earlier recordkeeping regulations (see § 1.328). labeling, or holding operations for
study by expanding our data sources This approach is similar to the approach dietary supplements (72 FR 34752, June
and by including representatives from we used to calculate the small business 25, 2007).
USDA’s Economic Research Service, exemption for nutrition labeling of food (Comment 142) Some comments
USDA’s Agricultural Marketing Service, (21 CFR 101.9(j)(18)(iv)(D)). Under this assert that the specified number of
employees (i.e., 500) has no relevance to makes the very small business establishment that ‘‘harvests’’ food.
food safety. exemption irrelevant. These comments Doing so focuses the requirements for
(Response 142) The definition of ask us to create a simple and broad the supply-chain program (see subpart
‘‘small business’’ is relevant to two small business exemption for any small G) on the entity that produces the food,
aspects of this rule. First, it is relevant business conducting ‘‘low-risk rather than on the entity that removes
to the compliance date for the activities.’’ the food from the growing area, when
establishment, and provides an (Response 145) We disagree that the the grower and the harvester are not
additional year for establishments definition of a small business makes the under the same management. Doing so
satisfying the definition to comply with very small business exemption also simplifies the determination of who
the rule. As discussed in the Final irrelevant and decline the request to the supplier is in complex business
Regulatory Impact Analysis (FRIA) (Ref. create a ‘‘simple and broad small models, such as when a ‘‘handler’’
38), we estimate that the number of business exemption’’ for any small arranges for harvest by another business
small businesses that will be eligible is business conducting ‘‘low-risk entity.
45,936, accounting for 5.4 percent of the activities.’’ Although both small and As discussed in Response 22, we
food supply. Although the purpose of very small businesses are eligible for the consider a farm to be a type of
the rule is to improve food safety, exemption for such businesses that only ‘‘establishment’’ even though we revised
delaying the effective date for conduct specified low-risk activity/food the ‘‘farm’’ definition to refer to an
approximately 6 percent of the food combinations, other provisions apply ‘‘operation’’ rather than an
supply will not significantly affect food solely to very small businesses. For ‘‘establishment’’ within that definition.
safety in the long term. example, the compliance date for a very (Comment 146) Some comments
Second, the definition of ‘‘small small business is different from the assert that the definition of supplier is
business’’ is relevant to the statutory compliance date for a small business, not workable because the status of
exemptions for on-farm, low-risk and a very small business (but not a warehouses and brokers is unclear in
activity/food combinations for small business) is eligible for modified the definition. Other comments ask us
manufacturing/processing, packing, and requirements. to modify the definition to specify, in
holding food by farm mixed-type addition to the proposed definition, that
facilities. These statutory exemptions, 35. Supplier the supplier could be an intermediary
although expressly authorized only for We proposed to define the term entity that takes responsibility on behalf
small and very small businesses, ‘‘supplier’’ to mean the establishment of the receiving facility to ensure that
encompass risk and are limited, because that manufactures/processes the food, the food meets the requirements of this
a small or very small farm mixed-type raises the animal, or harvests the food part.
facility is only eligible for the that is provided to a receiving facility (Response 146) As discussed in
exemption if the only activities that the without further manufacturing/ Response 657, we agree that the role of
facility conducts are the specified on- processing by another establishment, intermediaries in the supply chain is
farm low-risk activity/food except for further manufacturing/ critical, and we have added options for
combinations. processing that consists solely of the entities other than the receiving facility
(Comment 143) Some comments addition of labeling or similar activity of to perform certain supplier verification
assert that the specified number of a de minimis nature. activities, provided that the receiving
employees (i.e., 500) may or may not be As discussed in Response 32, we have facility reviews and assesses the
indicative of business size. As an revised the ‘‘farm’’ definition to documentation produced by the other
example, the comment notes that explicitly include business models in entity and documents that review and
harvest employees may operate under which one operation grows crops but assessment. However, this does not
contract rather than be the grower’s does not harvest them, and another mean that these entities take on the role
employees. operation, not under the same of the supplier. As discussed in
(Response 143) If a farm mixed-type management, harvests crops but does Response 658 and Response 123, we
facility that is subject to this rule not grow them. As also discussed in believe it is important to supplier
employs harvest employees under Response 32, this revision represents a verification to retain the identities of
contract, the facility would include change from the existing and proposed two parties involved—the receiving
these employees in its calculation of ‘‘farm’’ definitions, which describe a facility and the supplier. Therefore, we
full-time equivalent employees and ‘‘farm’’ as an entity ‘‘devoted to the are retaining our definition of supplier.
would adjust for the temporary, growing and harvesting of crops’’ (Comment 147) Some comments
seasonal nature of the increased number (emphasis added). We proposed the regarding RACs ask us to modify the
of employees when it calculates the 12 ‘‘supplier’’ definition in the context of a definition of supplier in the case of
month average number of full-time single business entity ‘‘devoted to the commingled RACs, such that the
equivalent employees. (See Response growing and harvesting of crops’’ supplier would be the person
140 for the calculation of full-time (emphasis added). We used the term immediately back from the receiving
equivalents.) ‘‘harvesting,’’ rather than ‘‘growing,’’ to facility in the supply chain provided
(Comment 144) Some comments reflect the last stage of production on a that this entity (presumably a
assert that the human preventive farm, except for packing. warehouse or aggregator) voluntarily
controls rule and the produce safety rule Because the proposed ‘‘supplier’’ complies with the requirements of
should use the same definition of ‘‘small definition contemplated that the same subpart C of this part.
business.’’ business entity that grows crops also (Response 147) We decline this
(Response 144) We tailored the harvests them, we have revised the request. As discussed in Response 657,
definitions of ‘‘small business’’ to the ‘‘supplier’’ definition so that the grower we recognize that doing supplier
characteristics of the sectors of industry remains the supplier when the harvester verification with commingled products
subject to the two rules. is under separate management. will be a challenge. However, we
(Comment 145) Some comments Specifically, ‘‘supplier’’ is now defined believe it is important that there be a
assert that the definition of a small to include an establishment that link between the receiving facility
business as less than 500 employees ‘‘grows’’ food rather than an (which is manufacturing/processing the
food) and the supplier (who controlled validation from requirements for establishing in this rule specifies that
the hazard(s) in the food). We are verification—e.g., by moving the verification means the application of
allowing an entity such as an aggregator proposed requirements for verification methods, procedures, tests and other
or distributor to perform some to a distinct section in the regulatory evaluations, in addition to monitoring,
verification activities, so the outcome text. to determine whether a control measure
requested by these comments will be (Response 150) We have explained or combination of control measures is or
achieved while maintaining the how our proposed definitions for has been operating as intended and to
identities of the two primary parties in ‘‘validation’’ and ‘‘verification’’ align establish the validity of the food safety
the supplier verification relationship with a variety of widely recognized plan as a whole (emphasis added).
(see Response 657). definitions, including definitions Consistent with the request of the
(Comment 148) One comment asks us established by Codex, the NACMCF comments, the definition of
to clarify who would be the supplier in HACCP guidelines, and Federal HACCP ‘‘verification’’ uses the Codex
a situation in which dairy farms are regulations for seafood, juice, and meat description of verification as the
providing milk to a cooperative and poultry (78 FR 3646 at 3700). We application of methods, procedures,
collecting milk. disagree that validation is not an tests and other evaluations, in addition
(Response 148) In this example, the element of verification, but to monitoring.
dairy farms would be the suppliers acknowledge it is not necessary to say
because they are raising the animals. so within the definition of ‘‘validation.’’ 37. Very Small Business
(Comment 149) One comment asks us Although we have moved the details of We proposed to define the term ‘‘very
to clarify that the proposed definition of the requirements for validation from its small business’’ to mean, for the
supplier does not include sources of proposed location within the purposes of proposed part 117, a
processing aids or chemicals required requirements for verification (i.e., business that has less than $1,000,000 in
for post-harvest treatments and packing proposed § 117.155(a)) to a separate total annual sales of human food,
processes (including waxes, fungicides, section (§ 117.160), we did so as an adjusted for inflation. As discussed in
detergents and sanitizers). editorial change to improve clarity and the proposed rule, we conducted a Food
(Response 149) As defined, the readability rather than as a substantive Processing Sector Study as required by
supplier is the establishment growing change to signal that validation is not an section 418(l)(5) of the FD&C Act (Ref.
the food, not those establishments element of verification (see table 8 in 19) and used the results of the study in
providing inputs (such as waxes, the 2014 supplemental human defining the term ‘‘very small business’’
fungicides, detergents and sanitizers) to preventive controls notice, 79 FR 58524 (78 FR 3646 at 3700 to 3702). We made
that entity. at 58557). the results of the Food Processing Sector
We agree that validation can apply to Study available in Docket No. FDA–
36. Validation and Verification
a specific control measure as specified 2011–N–0920 and requested public
We proposed to define the term in the Codex definition. We also agree comment on that study. As discussed in
‘‘validation’’ to mean that element of that validation can apply to a Response 139, we have updated that
verification focused on collecting and combination of control measures as study (Ref. 21).
evaluating scientific and technical specified in the Codex definition. The (Comment 151) Some comments
information to determine whether the food safety plan is one example of a support the proposed dollar threshold of
food safety plan, when properly combination of control measures. $1,000,000, noting that it would provide
implemented, will effectively control Although we likewise agree that sufficient flexibility to companies that
the identified hazards. We proposed to verification can apply to a specific receive the exemption to allow them to
define the term ‘‘verification’’ to mean control measure as specified in the continue to operate. Some comments
those activities, other than monitoring, Codex definition, we disagree that to be that support the proposed dollar
that establish the validity of the food consistent with the Codex definition we threshold of $1,000,000 state that this
safety plan and that the system is should adopt a definition that excludes threshold is consistent with Congress’s
operating according to the plan. the application of verification to the mandate that the FSMA rules provide
(Comment 150) Some comments ask food safety plan. It is well established flexibility for all sizes and types of
us to revise the definitions of that some verification measures, such as businesses and facilities, including
‘‘validation’’ and ‘‘verification’’ to be testing for a pathogen, verify that small processing facilities co-located on
consistent with the Codex definitions. multiple control measures operated as farms, and provide special
(Codex defines ‘‘validation’’ to mean intended. (See, e.g., Codex’s discussion considerations for small and very small
obtaining evidence that a control of verification for uncooked fermented businesses. These comments also state
measure or combination of control sausages (Ref. 39)). that our proposal to adopt the
measures, if properly implemented, is To more clearly distinguish between $1,000,000 threshold is appropriate in
capable of controlling the hazard to a ‘‘validation’’ and ‘‘verification,’’ the light of the two options Congress
specified outcome. Codex defines definition of ‘‘validation’’ we are provided for facilities to qualify for
‘‘verification’’ to mean the application establishing in this rule specifies that modified requirements, and that
of methods, procedures, tests and other validation means obtaining and although Congress directed us to
evaluations, in addition to monitoring, evaluating scientific evidence that a consider the Food Processing Sector
to determine whether a control measure control measure, combination of control Study in establishing the very small
is or has been operating as intended measures, or the food safety plan as a business definition, it did not otherwise
(Ref. 39).) whole, when properly implemented, is establish parameters for us to use in
Some comments ask us to more capable of effectively controlling the setting this definition, leaving it largely
clearly distinguish between identified hazards (emphasis added). to our discretion. These comments argue
‘‘validation’’ and ‘‘verification.’’ Some We also made conforming changes that although Congress set out two
comments assert that validation is not associated with the revised definition of options whereby facilities could qualify
an element of verification as stated in ‘‘validation’’ in the requirements for for modified requirements, Congress did
our proposed definition and suggest that validation (see § 117.160(b)(2)). The not bind us to using both options. These
we clearly separate requirements for definition of ‘‘verification’’ we are comments express the view that when
Congress is silent on an issue, the under section 418(l)(4)(B) out of the law food sold by the facility to all other
agency may reasonably interpret its and state that an agency has no purchasers.)
authority. These comments state that authority to repeal a well-considered act We reaffirm our view, expressed in
proposing the $1,000,000 threshold for of Congress by fiat in a rulemaking. the 2014 supplemental human
a very small business is entirely (Response 151) We are establishing a preventive controls notice, that section
reasonable given that businesses this $1,000,000 threshold for the definition 418 of the FD&C Act does not limit how
size account for such a small percentage of ‘‘very small business.’’ We disagree we may define ‘‘very small business’’
of the food supply, and given Congress’s that a $1,000,000 threshold would other than by requiring us to consider
mandate that FDA establish flexible create a new category of exemption not the Food Processing Sector Study, and
standards considering the effects of the contemplated by FSMA. Under section we have done so. (See also Response
rules on small and very small 418(l)(1)(A) and (B) of the FD&C Act, a 152.) Therefore, we disagree that
businesses. very small business is a qualified adopting a $1,000,000 threshold would
Other comments disagree with the facility; under the exemption authorized conflict with the statutory structure of
proposed dollar threshold of $1,000,000. in section 418(l)(2) of the FD&C Act, a the qualified facility program in a way
Some of these comments assert that the qualified facility is subject to modified that effectively nullifies an entire
proposed dollar threshold of $1,000,000 requirements rather than the section of the law. We also disagree that
would create a new category of requirements for hazard analysis and our explanation in the 2014
exemption not contemplated by FSMA risk-based preventive controls. We have supplemental human preventive
and will create confusion for both those acknowledged that a $1,000,000 controls notice demonstrates that we
who may be subject to the rule and threshold exempts a greater portion of have made a deliberate decision to write
those trying to enforce it. These the food supply than thresholds of qualified facilities under section
comments ask us to instead adopt the either $250,000 or $500,000 (79 FR 418(l)(1)(C) of the FD&C Act, and the
$500,000 threshold we considered as 58524 at 58555), but reaffirm that under limitations on sales under section
‘‘Option 2’’ in the 2013 proposed the $1,000,000 threshold the businesses 418(l)(4)(B) of the FD&C Act, out of the
preventive controls rule (78 FR 3646 at that would be exempt from the law. Likewise, we disagree that we are
3702). Some comments assert that the requirements for hazard analysis and in any way ‘‘repealing’’ a
proposed $1,000,000 threshold would risk-based preventive controls would well-considered act of Congress by fiat
expose a larger number of consumers to represent a small portion of the in a rulemaking.
a heightened risk of contracting a (Comment 152) Some comments that
potential risk of foodborne illness;
foodborne illness. support a dollar threshold of $250,000
businesses that fall within this
Other comments reiterate their rather than $1,000,000 assert that the
definition of ‘‘very small business,’’ rationale we presented in the 2014
previous assertions that any dollar
threshold that exceeds $250,000 would collectively, produce less than 0.6 supplemental human preventive
be contrary to Congressional intent and percent of the food supply (Ref. 38). In controls notice for a $1,000,000
conflict with section 418(l) of the FD&C addition, most of these facilities will be threshold is inconsistent with the
Act. Some of these comments assert that subject to the CGMP requirements in rationale we presented in our ‘‘original
adopting a $1,000,000 threshold would subpart B; the only exemption from draft’’ of the 2013 proposed human
conflict with the statutory structure of those CGMP requirements is the preventive controls rule. These
the qualified facility program in a way exemption in § 117.5(k) (which applies comments quote that ‘‘original draft’’ of
that effectively nullifies a section of the to: (1) Farms; (2) certain fishing vessels; the 2013 proposed human preventive
law. Some of these comments assert that (3) establishments solely engaged in the controls rule as follows: ‘‘FDA is
the discussion in the 2014 supplemental holding and/or transportation of one or proposing to define the term ‘‘very small
human preventive controls notice did more RACs; (4) activities of ‘‘farm business’’ to mean, for the purposes of
not adequately address their comments mixed-type facilities’’ that fall within part 110, a business that has less than
submitted to the 2013 proposed human the definition of ‘‘farm’’; and (5) $250,000 in total annual sales of foods,
preventive controls rule because that establishments solely engaged in adjusted for inflation. We are proposing
discussion does not explain why we hulling, shelling, drying, packing, and/ to define very small business using a
believe the proposed $1,000,000 or holding nuts (without additional dollar amount that is, for practical
threshold is consistent with the statute’s manufacturing/processing)). purposes, the same as the dollar amount
definitions of a qualified facility in We disagree that a $1,000,000 of sales by a qualified facility to end
section 418(l)(1) of the FD&C Act. These threshold for the definition of ‘‘very users other than those that would satisfy
comments assert that the discussion in small business’’ will create confusion the definition of ‘‘qualified end users.’’
the 2014 supplemental human for both those who may be subject to the The proposed definition is consistent
preventive controls notice clearly rule and those trying to enforce it; in with the findings of a study that we
indicates that the definition is intended contrast, it is our view that a $1,000,000 conducted as required by section
to abrogate the definition of a qualified threshold will be less burdensome for 418(l)(5) of the FD&C Act.’’ These
facility under section 418(l)(1)(C) of the both the qualified facilities and FDA. comments note that we acknowledged,
FD&C Act because the ‘‘definition (See Response 581, where we explain in the 2014 supplemental preventive
would . . . simplify a facility’s that for compliance purposes we intend controls notice, that section 418(n)(1)(B)
determination of whether it is a to focus on financial records of the FD&C Act requires us to consider
qualified facility because the facility demonstrating that a business averages the Food Processing Sector Study for the
would only need to calculate its total less than the specified dollar threshold purpose of defining ‘‘very small
sales of human food rather than rather than records demonstrating that business’’ (79 FR 58524 at 58555) and
determine how much food was sold to the average annual monetary value of argue that it is difficult to see how the
qualified end-users.’’ The comments the food manufactured, processed, same study that supported defining a
assert that this discussion shows that we packed, or held at such facility that is very small business as one that has less
have made a deliberate decision to write sold directly to qualified end-users than $250,000 in total annual sales of
qualified facilities under section during a three-year period exceeded the food now supports a definition that puts
418(l)(1)(C) and the limitations on sales average annual monetary value of the that threshold at less than $1,000,000.
(Response 152) These comments are be completely exempt from the used to determine whether a facility is
citing a rationale in a draft version of requirements of the sanitary a very small business. The most recent
the 2013 proposed human preventive transportation rule. In contrast, the applicable calendar year is the current
controls rule, which we submitted to the $1,000,000 threshold we are year. For example, on June 3, 2024, 2024
Office of Management and Budget in establishing in this rule applies to very is the most recent applicable calendar
2011 (Ref. 40, p. 259). In that draft, we small businesses that will be subject to year and is the applicable calendar year
proposed a single option for the modified requirements rather than be when the 3 calendar years used to
definition of ‘‘very small business’’ (i.e., completely exempt. A very small determine whether a facility is a very
less than $250,000) and explained the business will have two options to small business are 2021–2023. The
reasons for proposing that single option, comply with the modified requirements exception is when 3 calendar years of
including an explanation that the option in the human preventive controls rule records are not available, such as when
was consistent with the findings of the (the food safety practices option and the a facility begins business after the
Food Processing Sector Study. In option to demonstrate compliance with compliance date for very small
contrast, in the published 2013 other applicable non-Federal food safety businesses. In such situations the
proposed human preventive controls law; see § 117.201(a)(2) and the applicable calendar year refers to the
rule that we issued for public comment discussion in sections XXXVIII.C.2 and year during which the calculation is
we identified three options as part of a XXXVIII.C.3). Regardless of which made but is not preceded by 3 calendar
co-proposal for the definition of very option a very small business chooses to years used to determine whether a
small business, and provided a basis to comply with the modified requirements, facility is a very small business.
support each option. For each option of we will inspect the business for As a companion change, we are
the co-proposal, we made the same compliance with the CGMPs and the explicitly requiring that a facility
statement regarding the Food Processing modified requirements. In contrast, if determine and document its status as a
Sector Study when we discussed the the final sanitary transportation rule qualified facility on an annual basis by
impact of the option on mixed-type excludes a ‘‘non-covered business’’ as no later than July 1 of each calendar
facilities—i.e., that it is apparent that would be defined in that rule, that year (see § 117.201(c)(1)). Although this
the number of co-located facilities is business would be completely exempt requirement was implicit in the
concentrated at the smaller end of the rather than subject to modified proposed requirement that a facility
size spectrum. We see no conflict requirements and, thus, would be not be must resubmit a notification to FDA if
between a statement (made in the inspected for compliance with any its status changes as a qualified facility
context of a single proposed option for aspect of the sanitary transportation (proposed § 117.201(c)(2), which we are
the definition of ‘‘very small business’’) rule. finalizing as § 117.201(c)(3)), we are
that a specific proposed definition was (Comment 154) Some comments ask making this requirement explicit to
consistent with the findings of the Food us to clarify how to classify the size of clarify the responsibility of the facility
Processing Sector Study and a statement a business that does not take ownership to affirmatively determine its status
(made in the context of three proposed of or directly sell food (e.g., warehouses when the calendar years that apply to
options for the definition of ‘‘very small and re-packing facilities) to determine the 3-year average change. The July 1
business’’) that it is apparent that the status as a qualified facility. deadline for a facility to determine its
number of co-located facilities is (Response 154) We have revised the status provides facilities with 6 months
concentrated at the smaller end of the definition to specify that the $1,000,000 to make the determination after the end
size spectrum. (See also Response 139 threshold applies to sales of human food of the previous 3 calendar years.
regarding the Food Processing Sector plus the market value of human food We also are establishing an earlier
Study.) manufactured, processed, packed, or compliance date for the financial
(Comment 153) Some comments held without sale (e.g., held for a fee). records that a facility maintains to
assert that the proposed $1,000,000 When there are no sales of human food, support its status as a very small
threshold would be inconsistent with market value of the human food business that is eligible for the qualified
our explanation, in the 2014 proposed manufactured, processed, packed, or facility exemption in § 117.5(a).
sanitary transportation rule, of the held without sale is a reasonable Specifically, the compliance date for a
definition of a ‘‘non-covered business’’ approach to calculating the dollar facility to retain records to support its
as one having less than $500,000 in total threshold for very small business. status as a qualified facility is January
annual sales. These comments note that (Comment 155) Some comments ask 1, 2016. Even with this earlier
we considered whether a less than $1 us to specify that the monetary compliance date for these records, we
million threshold should be applied but threshold for the definition be based on realize that although the calculation for
concluded: ‘‘[W]e believe such an average sales during a three-year period ‘‘very small business’’ in the regulatory
expansion would result in a greater risk on a rolling basis because otherwise text is based on 3 calendar years, a
of food becoming adulterated during firms may be subject to significant facility will only be required to have 2
transport due to insanitary food changes in status from year to year. calendar years of records as of the
transportation practices.’’ (Ref. 41) These comments also ask us to clarify general compliance date for very small
These comments assert that if we were that the sales are to be evaluated businesses. Specifically, by September
to apply the same analysis we used in retrospectively, not prospectively. 17, 2018 a facility that begins retaining
the 2014 proposed sanitary (Response 155) We have revised the applicable financial records on January
transportation rule to the human definition of very small business to 1, 2016, would only have such records
preventive controls rule, the threshold specify that it is based on an average for 2 previous calendar years. Therefore,
for a very small business would be during the 3-year period preceding the it would be reasonable for a facility to
below $500,000. applicable calendar year in sales of make the calculation based on the 2
(Response 153) The $500,000 human food plus the market value of previous calendar years. If a facility has
threshold we proposed in the 2014 human food manufactured, processed, records for 3 previous calendar years,
proposed sanitary transportation rule packed, or held without sale (e.g., held the facility could make the calculation
would apply to ‘‘non-covered for a fee). The applicable calendar year based on the longer time period. During
businesses’’—i.e., businesses that would is the year after the 3 calendar years inspection in 2018, when a facility has
records for the preceding 2 calendar dollar amount reflects sales within the covered by the preventive controls rule,
years, but not for the preceding 3 United States. would be inconsistent with the
previous calendar years, we will accept As discussed in Response 154, to threshold we proposed for the animal
records for the preceding 2 calendar address facilities such as those preventive controls rule. The threshold
years as adequate to support status as a warehouses and re-packing facilities we proposed for the animal preventive
qualified facility. We note that in some that do not take ownership or directly controls rule was based on ‘‘total annual
situations, a shorter time period is sell food we have revised the definition sales of food for animals, adjusted for
sufficient to determine that a facility is of ‘‘very small business’’ to specify that inflation,’’ which is exactly parallel to
not a very small business. For example, the $1,000,000 threshold applies to sales our proposal to base the threshold on
a facility with sales exceeding of human food plus the market value of ‘‘total annual sales of human food,
$3,000,000 for the preceding calendar human food manufactured, processed, adjusted for inflation.’’ We proposed
year cannot qualify as a very small packed, or held without sale (e.g., held several exemptions to the animal
business because no amount of sales for a fee). As with ‘‘sales,’’ facilities preventive controls rule (see proposed
from other years will reduce average such as those warehouses and re- § 507.5 (proposed 21 CFR 507.5)) and,
sales below the threshold of $1,000,000. packing facilities that pack or hold more thus, not all food for animals will be
The available financial records for a than the $1,000,000 threshold would subject to the animal preventive
facility that begins operations between have more resources than the facilities controls rule.
January 1, 2017 and September 17, 2018 being excluded. (Comment 158) Some comments ask
would not cover even 2 calendar years (Comment 157) Some comments ask us to base the threshold on the total
by September 17, 2018. During the first us to apply the rule to dairy farms with ‘‘volume of product’’ or ‘‘amount of
3 years of such a facility’s operation, it sales greater than $1 million annually of product’’ handled or sold. These
would be reasonable for a facility to processed or packaged dairy products, comments assert that an approach using
make the calculation based on records it rather than bulk sales of fluid milk. product volume or amount would be
has (i.e., for one or two preceding Other comments ask us to only include more risk-based because it would
calendar years), and we will accept the annual monetary value of food correlate more closely to consumer
records for the preceding one or two covered by the preventive controls rule, exposures than dollar amounts, which
years as adequate to support status as a rather than all human food. In can be skewed by product values.
qualified facility in these circumstances. particular, these comments argue that (Response 158) We use sales as a
When a facility does not begin food covered by the produce safety rule proxy for volume. We acknowledge that
operations until after January 1, 2018, it should not be counted in the calculation dollar amounts can be skewed by
would be reasonable for the facility to of the sales of food for the purpose of product values and, thus, sales are an
rely on a projected estimate of revenue defining very small business for the imperfect proxy for volume. However,
(or market value) when it begins preventive controls rule. Some of these we are not aware of a more practical
operations. We would evaluate the comments assert that basing the way to identify a threshold based on
credibility of the projection considering threshold on the monetary value of food volume or amount of product that could
factors such as the facility’s number of covered by the preventive controls rule, be applied across all product sectors,
FTEs. After the facility has records for rather than all human food, would be and the comments provide no
one or two preceding years, it would be necessary to be consistent with the suggestions for how their
reasonable for the facility to make the approach used in the proposed animal recommendation could be carried out.
calculation based on records it has (i.e., preventive controls rule, in which the (Comment 159) Some comments
for one or two preceding calendar years) sales threshold was based on sales of assert that our conclusion that our
and we will accept records for the animal food (i.e., the product regulated proposed definition of very small
preceding one or two calendar years as by the rule). business is controlled by the two
adequate to support status as a qualified (Response 157) We decline these references in sections 418(l)(5) and
facility in these circumstances. requests. As discussed in Response 156, 418(n)(1)(B) of the FD&C Act does not
(Comment 156) Some comments ask the purpose of the definition of ‘‘very provide a reasonable justification for our
us to only include the total annual sales small business’’ is principally to enable decision. These comments assert that it
of food in the United States, adjusted for such businesses to comply with is equally true that those two provisions
inflation, for foreign facilities that modified requirements, because they would not prevent us from adopting one
export food to the United States. have fewer resources to direct to full threshold (less than $250,000) for
(Response 156) We decline this compliance with the rule. Because of purposes of defining a qualified facility
request. The purpose of the definition of the exemptions in the human preventive (and for a very small business
‘‘very small business’’ is principally to controls rule (e.g., for processors of conducting on-farm low-risk activity/
enable such businesses to comply with seafood, juice, low-acid canned foods food combinations) and another (less
modified requirements, because they (LACF), and dietary supplements), than $1 million) for setting compliance
have fewer resources to direct to full basing the threshold on the monetary dates. These comments also assert that
compliance with the rule. A foreign value of food covered by the preventive this is exactly the determination we
business that sells more than the controls rule, rather than all human made for our proposed animal
threshold dollar amount of food has food, could lead to a situation where a preventive controls rule, where we
more resources than the businesses very large food processor (such as a proposed to define very small business,
being excluded, even if less than that juice processor with more than under the constraints of these same two
threshold dollar amount reflects sales to $20,000,000 in annual sales) would not references, as one with less than
the United States. Likewise, a domestic need to comply with the human $2,500,000 in sales. To give full effect to
business that sells more than the preventive controls rule for milk- and the design of the qualified facility
threshold dollar amount of food has soy-based beverages that it produces, if program while providing an adequate
more resources than the businesses the annual sales of milk- and soy-based compliance deadline, these comments
being excluded, even if that domestic beverages is less than $1,000,000. ask us to revise the definition of very
business exports some of its food and, We disagree that a threshold based on small business to mean ‘‘a business that
as a result, less than that threshold sales of human food, rather than food has less than $250,000 in total annual
sales of human food, adjusted for effectiveness of the preventive controls, definition of ‘‘very small business’’
inflation, except that for purposes of the taking into account the nature of the should reflect the probability and
effective dates in section 103(i) of the preventive control and its role in the severity of potential hazards in order to
FDA Food Safety Modernization Act (21 facility’s food safety system. A facility align with the rest of the regulation and
U.S.C. 350g note) the term means less that appropriately determines through promote public health interests.
than $1,000,000 in total annual sales of its hazard analysis that there are no (Response 162) We acknowledge that
human food.’’ hazards requiring preventive controls ingredients such as spices, which have
(Response 159) These comments are would document that determination in been associated with outbreaks of
unclear. We agree that we proposed to its written hazard analysis but would foodborne illness and large recalls, can
define very small business, for the not need to establish preventive controls contaminate a large volume of food (78
purposes of the animal preventive and associated management FR 3646 at 3665 and 3737). However,
controls rule, as one with less than components. (See Response 222). the suggestion that we define ‘‘very
$2,500,000 in sales (79 FR 58476 at (Comment 161) Some comments small business’’ in a way that reflects
58510), but disagree that we proposed to express concern that establishing a the probability and severity of potential
adopt one threshold for purposes of threshold based on U.S. dollars would hazards is neither practical nor aligned
defining a qualified facility and another place domestic firms at a disadvantage with a size-based nature of the term.
threshold for setting compliance dates. relative to foreign firms whose sales are The comments asserting that it is very
Regardless, we decline the request to often denominated in currencies valued likely that more facilities in exporting
adopt a threshold lower than $1,000,000 lower than the dollar and often reflect countries will be exempt under the
for purposes of defining a qualified much lower costs for factors such as definition, thus putting those located in
facility, which appears to be the land, labor, and environmental the United States at a disadvantage,
principal request of these comments compliance. These comments ask us to provided no basis for the assertion. As
(see Response 151). base the threshold on an alternate discussed in Response 156, we have
(Comment 160) Some comments measure, such as number of employees, declined the request to only include the
support the proposed dollar threshold of or to calculate the sales of foreign very total annual sales of food in the United
$1,000,000, provided that we also make small businesses using an appropriate States, adjusted for inflation, for foreign
changes to the ‘‘farm’’ definition to measure of purchasing power parity, if facilities that export food to the United
encompass activities of food hubs there is a straightforward way to do so. States.
performing low-risk packing and (Response 161) We decline these (Comment 163) Some comments
holding activities on RACs for requests. As previously discussed, we express concern that the Food
distribution in local food markets. If we use dollar estimates to evaluate the Processing Sector Study is not
do not revise the ‘‘farm’’ definition to percentage of all food produced in the comprehensive.
encompass such activities, these United States that would not be covered (Response 163) See Response 139
comments assert that a threshold dollar by the rule (79 FR 58524 at 58555). We regarding the Food Processing Sector
amount of $2,000,000 would be acknowledge that the definition of Study.
necessary to allay concerns that making ‘‘small business’’ is based on number of
food hubs subject to the requirements employees, and that two exemptions 38. You
for hazard analysis and risk-based (i.e., the exemptions in § 117.5(g) and We proposed to define the term ‘‘you’’
preventive controls would cause many (h) for on-farm, low-risk activity/food for purposes of part 117, to mean the
food hubs to fail, and would prevent the combinations) apply to small owner, operator, or agent in charge of a
start of new food hubs. businesses. However, the exemptions facility. We received no comments that
(Response 160) See Response 23 and for on-farm, low-risk activity/food disagreed with this proposed definition
Response 25. Food hubs that pack and combinations are limited to a narrow and are finalizing it as proposed.
hold RACs are covered by the ‘‘farm’’ sector of the food industry, whereas the
definition if the farm(s) that grow or exemption applicable to a very small D. Comments Asking FDA To Establish
raise the majority of the RACs packed business will apply to all sectors of the Additional Definitions or Otherwise
and held by the food hub own, or jointly food industry. Clarify Terms Not Defined in the Rule
own, a majority interest in the food hub. We do not know of a straightforward
1. Corrections
Thus some food hubs will not be way to calculate the sales of foreign very
required to register as a food facility small businesses using an appropriate (Comment 164) Some comments
and, thus, will not be subject to the measure of purchasing power parity and assert that clearly distinguishing
requirements for hazard analysis and are basing the threshold only on U.S. between the terms ‘‘corrective actions’’
risk-based preventive controls. Those dollars. and ‘‘corrections’’ will be imperative for
food hubs that exceed the specified (Comment 162) Some comments industry to comply with the rule and for
dollar threshold for a very small assert that the reach of potential harm regulators to enforce the rule. Some
business and are not within the ‘‘farm’’ from foods imported from very small comments ask us to use the ISO
definition would be subject to the businesses that would meet the definitions of ‘‘corrective actions’’ and
requirements for hazard analysis and proposed threshold of $1,000,000 may ‘‘corrections.’’ (According to ISO
risk-based preventive controls. be greater because they are more likely 22000:2005 definition 3.13, a
However, the preventive controls that to be ingredients, such as spices, and ‘‘correction’’ is action to eliminate a
the food hub would establish and argue that small amounts of spice can detected nonconformity; according to
implement would depend on the food contaminate a large volume of food and, ISO 22000:2005 definition 3.14,
hub, the food, and the outcome of the thus, cause widespread illnesses. Other corrective action is action to eliminate
facility’s hazard analysis, and the comments assert that it is very likely the cause of a detected nonconformity
preventive control management that more facilities in exporting or other undesirable situation.) Other
components that the food hub would countries will be exempt under the comments ask us to eliminate the term
establish and implement for its definition, thus putting those located in ‘‘correction’’ and instead revise the rule
preventive controls would be the United States at a disadvantage. to clarify the type of situation in which
established as appropriate to ensure the These comments assert that the ‘‘corrective actions’’ are neither
necessary nor appropriate. As an recurrence.) We believe that this include shipping containers such as
example, these comments suggest that definition will be adequate to cartons and crates that pose no risk of
the proposed provisions for corrections distinguish ‘‘corrective actions’’ from introducing contaminants or food
could refer to ‘‘prompt actions taken in ‘‘corrections.’’ allergens into food.
response to minor and isolated As an example, if a facility applies (Response 166) For the purposes of
deviations that do not directly impact sanitation controls for an environmental the provisions that require protection
product safety.’’ pathogen such as L. monocytogenes and against allergen cross-contact and
Other comments agree with the food residue is observed on ‘‘clean’’ against contamination of food, food-
concept of simple ‘‘corrections’’ but equipment prior to production, contact surfaces, and food-packaging
assert that the term ‘‘corrections’’ is corrections would involve re-cleaning materials, the term ‘‘food-packaging
unnecessary and could be confusing and sanitizing the equipment before it is materials’’ does not include shipping
because different facilities may use the used. Because the observation of food containers such as cartons and crates
term differently. These comments residue was made prior to production of that pose no risk of introducing
explain that sometimes ‘‘correction’’ is food, no food is affected, and no actions contaminants or food allergens into
used to refer to the action taken to fix are needed with respect to food. food. We are not adding a definition of
a deviation, and may or may not be part Although there are actions that can be ‘‘food-packaging materials’’ to the
of an overall corrective action taken to taken to prevent reoccurrence, such as definitions in § 117.3 because the
identify the root cause of the deviation re-training sanitation personnel, these provisions requiring protection against
and to prevent a similar occurrence. types of actions are not always needed. contamination are long-standing
These comments suggest that the provisions that have been applied in the
2. Defect Action Level
provisions explain that prompt actions manner requested by the comment and,
taken to address minor and isolated (Comment 165) Some comments that thus, adding a definition is not
deviations are not subject to the same address the proposed provisions necessary to address the comment’s
requirements as corrective actions to regarding ‘‘defect action levels’’ request.
address potentially systemic concerns, (proposed § 117.110) ask us to define
without defining the term ‘‘corrections.’’ that term so that its meaning will be 4. Must
(Response 164) We are defining the clear. (Comment 167) Some comments ask
term ‘‘correction’’ to mean an action to (Response 165) We have added a us to define the term ‘‘must.’’
identify and correct a problem that definition of the term ‘‘defect action (Response 167) We decline this
occurred during the production of food, level’’ to mean a level of a non- request. The term ‘‘must’’ has a common
without other actions associated with a hazardous, naturally occurring, meaning, and it is not necessary to
corrective action procedure (such as unavoidable defect at which FDA may establish a specific meaning for this
actions to reduce the likelihood that the regard a food product ‘‘adulterated’’ and term specifically for this rule.
problem will recur, evaluate all affected subject to enforcement action under
food for safety, and prevent affected section 402(a)(3) of the FD&C Act. This 5. Parameter and Value as Used in the
food from entering commerce). We agree definition derives from the definition in Requirements for Process Controls
that clearly distinguishing between the our long-standing ‘‘Defect Levels (Comment 168) Some comments ask
terms ‘‘corrective actions’’ and Handbook’’ (Ref. 36), which we us to define the terms ‘‘parameter’’ and
‘‘corrections’’ will be important for both continue to reference in the provisions ‘‘value’’ used in the requirements for
industry and regulators. We established in this rule regarding defect preventive controls (§ 117.135). These
acknowledge that one way to action levels. This definition also comments ask us to define ‘‘parameter’’
distinguish between ‘‘corrective derives from the long-standing as a measurable attribute and ‘‘value’’ as
actions’’ and actions that we would provisions in § 110.110, which referred a specific measurement.
consider ‘‘corrections’’ could be to avoid to natural or unavoidable defects in food (Response 168) We decline this
the term ‘‘corrections’’ and instead say for human use that present no health request. Both of these terms are used in
what we mean each time the rule uses hazard and noted that some foods the context of process controls and both
the term ‘‘corrections.’’ However, after contain natural or unavoidable defects have common meanings when
reviewing the full regulatory text of that at low levels are not hazardous to associated with process controls.
proposed subpart C we concluded that health. These long-standing provisions Therefore, it is not necessary for the rule
it was not practical to do so, because the also noted that we establish maximum to define them.
term ‘‘corrections’’ was used more often levels for these defects in foods
in a title or a cross-reference than in a produced under current good 6. Raw Materials
provision where the full text of what we manufacturing practice and use these Some comments ask us to define ‘‘raw
mean by the term ‘‘corrections’’ is levels in deciding whether to materials’’ (see Comment 65). As
necessary to communicate a recommend regulatory action. discussed in Response 65, we have
requirement. Our definition of declined to do so.
‘‘corrections’’ focuses on the first step in 3. Food-Packaging Material
a ‘‘corrective action procedure’’ (i.e., (Comment 166) Some comments point 7. Qualified Facility Exemption
identify and correct the problem) and out that the proposed human preventive (Comment 169) Some comments note
also specifies those aspects of a controls rule would amend certain that some of the terminology associated
corrective action procedure that do not provisions requiring prevention of with the exemption for qualified
apply to a correction (i.e., actions to contamination and allergen cross- facilities in the human preventive
reduce the likelihood that the problem contact of food and food-contact controls rule is different from
will recur, evaluate all affected food for surfaces to add ‘‘food-packaging terminology associated with an
safety, and prevent affected food from materials,’’ a term which is not defined. exemption in the proposed produce
entering commerce). (A note to the ISO These comments ask us to clarify that safety rule. These comments point out
22000:2005 definition of corrective ‘‘food-packaging materials’’ is limited to that the exemption in the proposed
action indicates that it includes cause packaging materials that are capable of produce safety rule refers to ‘‘qualified
analysis and is taken to prevent contaminating food and does not exemptions’’ (§ 112.5), whereas the
exemption in the proposed human a food-safety standpoint and that the storage of such foods, not the
preventive controls rule refers to produce shipped in vented crates manufacturing, processing, or packing
‘‘exemptions’’ and ‘‘qualified facilities’’ presents virtually no food-safety risk of such foods. For practical purposes,
(§ 117.5(a)). These comments ask us to because its environmental exposure is food that is not exposed to the
harmonize the terminology associated minimal. Some comments state that environment will be protected from
with the exemption for qualified they do not believe Congress intended outside bacteria by the packaging. See
facilities in the human preventive the term ‘‘not exposed to the also the discussions in Response 170
controls rule with the terminology environment’’ to mean only airtight, and Response 232 regarding produce
associated with ‘‘qualified exemptions’’ sealed containers. packed in ‘‘vented crates,’’ which is not
in the proposed produce safety rule. (Response 170) We acknowledge that ‘‘unexposed packaged food.’’
(Response 169) We have revised the certain fruits and vegetables may need
human preventive controls rule in two to be distributed in vented crates but E. Additional Definitions To Clarify
ways to better harmonize the disagree that such produce is ‘‘packaged Terms Not Defined in the Proposed Rule
terminology associated with the food not exposed to the environment.’’ 1. Audit
exemption for qualified facilities in the We consider ‘‘packaged food not As already noted, some comments ask
human preventive controls rule with an exposed to the environment’’ and us to make the various rules we are
analogous exemption in the proposed ‘‘unexposed packaged food’’ to mean establishing to implement FSMA
produce safety rule. First, we have that the food is in a form that prevents consistent with each other, and we have
added a definition for the term any direct human contact with the food worked to align the provisions of this
‘‘qualified facility exemption,’’ to mean (78 FR 3646 at 3712). Although rule with the provisions of the FSVP
an exemption applicable to a qualified environmental exposure to produce rule to the extent practicable. (See
facility under § 117.5(a) (see the packed in vented crates would be less Comment 9 and Response 9.) To align
regulatory text in § 117.3). Second, we than environmental exposure to these provisions, we are establishing in
also have made conforming changes produce packed in open crates, a vented this final rule a definition of ‘‘audit’’
throughout the rule to use the term crate can subject produce to analogous to the definition of ‘‘audit’’
‘‘qualified facility exemption’’ when it contamination from condensate in we proposed for the FSVP rule. For the
applies. (See table 52.) It is not practical aerosols carried by the air handling purposes of this rule, ‘‘audit’’ means the
to fully harmonize the relevant system, moisture dripping onto systematic, independent, and
terminology in these two rules due to containers, particulates blown through documented examination (through
differences in the framework applicable the facility by the air handling system, observation, investigation, records
to food businesses subject to section 418 fingers of handlers during handling of review, discussions with employees of
of the FD&C Act compared to the crates, objects that may be inadvertently the audited entity, and, as appropriate,
framework applicable to farms subject to inserted through the vents, pests that sampling and laboratory analysis) to
section 419 of the FD&C Act. For can access the produce through the assess a supplier’s food safety processes
example, a farm is not a ‘‘facility’’ and, vents, etc. We believe it is appropriate and procedures.
thus, it would be confusing to refer to for facilities storing produce in vented
the applicable exemption established in crates to conduct a hazard analysis and 2. Full-Time Equivalent Employee
the final produce safety rule as a evaluate whether there are hazards that As discussed in Response 140, we
‘‘qualified facility exemption’’ or to refer would require a preventive control. have established a definition for ‘‘full-
to the business entities that would be (Comment 171) Some comments ask time equivalent employee’’ as a term
exempt from the final produce safety us to interpret ‘‘not exposed to the used to represent the number of
rule as ‘‘qualified facilities.’’ environment’’ to mean packaged with employees of a business entity for the
food grade material that is impermeable purpose of determining whether the
8. Unexposed Packaged Food to outside bacteria or other business qualifies for the small business
As discussed in section XII, some contamination. These comments state exemption. The number of full-time
comments ask us to clarify that that materials that prevent human equivalent employees is determined by
modified requirements for packaged contact with the food can nonetheless dividing the total number of hours of
food that is not exposed to the permit passage of contaminants and salary or wages paid directly to
environment only apply to such food express concern about migration of employees of the business entity and of
that requires time/temperature control chemicals, not approved as food-contact all of its affiliates and subsidiaries by
for safety (TCS food). To do so, we are substances, from outer wrappers. the number of hours of work in 1 year,
defining the term ‘‘unexposed packaged (Response 171) We decline this 2,080 hours (i.e., 40 hours × 52 weeks).
food’’ to mean packaged food that is not request. A facility that packages If the result is not a whole number,
exposed to the environment and using ‘‘unexposed packaged food’’ is round down to the next lowest whole
this term throughout the rule. Doing so responsible for complying with all number.
simplifies the regulatory text and makes applicable requirements for the
it clearer. production of the food, including 3. Raw Agricultural Commodity
(Comment 170) Some comments note requirements established under section We have added a definition of the
that certain fruits and vegetables must 409 of the FD&C Act (21 U.S.C. 348) term ‘‘raw agricultural commodity’’ to
be stored and distributed in vented regarding indirect food additives and have the meaning given in section 201(r)
packaging to allow for proper air food contact substances when packaging of the FD&C Act. We decided to define
circulation and the escape of gases food. Likewise, a facility that packs this term in the rule to simplify the
produced in the ripening process. These ‘‘unexposed packaged food’’ in outer
provisions in part 117 that refer to raw

comments ask us to interpret ‘‘not wrappers is responsible to ensure the agricultural commodities.
exposed to the environment’’ in a way safety of the food it packed, including
that would include produce packed in ensuring that food is not contaminated 4. Supply-Chain-Applied Control
such vented crates. Some comments from chemicals in the outer wrappers. We have added a definition of the
assert that ‘‘exposed to the The exemption applicable to term ‘‘supply-chain-applied control’’ to
environment’’ must be meaningful from ‘‘unexposed packaged food’’ applies to mean a preventive control for a hazard
in a raw material or other ingredient X. Subpart A: Comments on should specify that each person engaged
when the hazard in the raw material or Qualifications of Individuals Who in food manufacturing, processing,
other ingredient is controlled before its Manufacture, Process, Pack, or Hold packing, or holding (including
receipt. We decided to define this term Food temporary and seasonal personnel and
in the rule to simplify the provisions in In 2002, FDA convened a CGMP supervisors) must receive training as
part 117, and in the discussions in this Modernization Working Group (CGMP appropriate to the person’s duties;
document, that refer to preventive Working Group) to determine whether specify the frequency of training (e.g.,
controls applied by a supplier before part 110 is in need of further revision. upon hiring and periodically thereafter);
receipt by a receiving facility. In 2005, the CGMP Working Group specify that training include the
5. Written Procedures for Receiving Raw issued a report (CGMP Working Group principles of food hygiene and food
Materials and Other Ingredients Report) summarizing the comments we safety, including the importance of
received, as well as our key findings (78 employee health and personal hygiene,
We have added a definition of the FR 3646 at 3651). One of the specific as applied at the facility; and specify
term ‘‘written procedures for receiving areas identified in the CGMP Working that records document required training
raw materials and other ingredients’’ to Group Report that presented an of personnel and, if so, specify
mean written procedures to ensure that opportunity to modernize the regulation minimum requirements for the
raw materials and other ingredients are was to ‘‘require appropriate training for documentation (e.g., the date of the
received only from suppliers approved supervisors and workers to ensure that training, the type of training, and the
by the receiving facility (or, when they have the necessary knowledge and person(s) trained). We also requested
necessary and appropriate, on a expertise in food hygiene, food comment on whether to establish some
temporary basis from unapproved protection, employee health and or all of the potential requirements for
suppliers whose raw materials or other personal hygiene to produce safe food education and training in subpart B,
ingredients are subjected to adequate products.’’ (78 FR 3646 at 3729) subpart C, or both.
verification activities before acceptance As previously discussed, FSMA
for use). We decided to define this term recognizes the importance of both In the following paragraphs, we
in the rule to simplify the provisions in training and CGMPs in preventing discuss comments that respond to our
part 117, and in this document, that hazards from occurring in foods in its requests for comment on potential
refer to these procedures. definition of preventive controls, which requirements for education and training
identifies supervisor, manager, and and for whether to establish any
6. Qualified Individual requirements in subpart B, subpart C, or
employee hygiene training, and CGMPs
As discussed in section X.A., we are under part 110, as some of the both. After considering these comments,
clarifying in new § 117.4(b)(1) that each procedures, practices, and processes we are establishing requirements for the
individual engaged in manufacturing, that may be included as preventive qualifications of individuals engaged in
processing, packing, or holding food controls (see sections 418(o)(3)(B) and manufacturing, processing, packing, or
(including temporary and seasonal 418(o)(3)(F) of the FD&C Act, holding food in new § 117.4 in subpart
personnel) or in the supervision thereof respectively) (78 FR 3646 at 3729). A, with associated recordkeeping
must have the education, training, or We proposed to re-establish part 110’s requirements established in § 117.9 in
experience (or a combination thereof) recommendations for training as subpart A. The regulatory text makes
necessary to manufacture, process, pack, proposed § 117.10(c) (FR 3646 at 3720). clear that these requirements,
or hold clean and safe food as In addition, we requested comment on established in subpart A, apply to
appropriate to the individual’s assigned how best to revise part 110’s current individuals engaged in manufacturing,
duties. To better align with the FSVP recommendations to implement section processing, packing, or holding food
rule, we using the term ‘‘qualified 418(o)(3) of the FD&C Act and the regardless of whether the individuals
individual’’ in new § 117.4(b)(1) and are recommendations of the CGMP Working conduct these activities under the
defining the term ‘‘qualified individual’’ Group with respect to training (FR 3646 framework of the CGMPs established in
to mean a person who has the at 3729). Specifically, we requested subpart B or the framework for hazard
education, training, or experience (or a comment on whether we should merely analysis and risk-based preventive
combination thereof) necessary to replace the current recommendations controls established in subparts C, D, E,
manufacture, process, pack, or hold for personnel education and experience and G. The regulatory text also makes
clean and safe food as appropriate to the with requirements or whether more clear that the qualification requirements
individual’s assigned duties. A qualified detail would be appropriate. As apply to the recordkeeping requirements
individual may be, but is not required examples of additional specificity, we of subpart F. See table 11 for a
to be, an employee of the establishment. requested comment on whether the rule description of these provisions.
TABLE 11—PROVISIONS FOR QUALIFICATIONS OF INDIVIDUALS WHO MANUFACTURE, PROCESS, PACK, OR HOLD FOOD
Final Proposed section
section Description
designation
designation
117.4(a)(1) .......... N/A ..................... Applicability to individuals who manufacture, process, pack, or hold food subject to subparts B and F.
117.4(a)(2) .......... N/A ..................... Applicability to individuals who manufacture, process, pack, or hold food subject to subparts C, D, E, F,
or G.
117.4(b)(1) .......... N/A ..................... Each individual engaged in manufacturing, processing, packing, or holding food must have the edu-
cation, training, or experience (or combination thereof) necessary to manufacture, process, pack, or
hold clean and safe food as appropriate to the individual’s assigned duties.
117.4(b)(2) .......... 117.10(c) ........... Required training in the principles of food hygiene and food safety, including the importance of em-
ployee health and personal hygiene.
117.4(c) ............... 117.10(d) ........... Additional qualifications of supervisory personnel.
117.4(d) ............... N/A ..................... Records of required training.
TABLE 11—PROVISIONS FOR QUALIFICATIONS OF INDIVIDUALS WHO MANUFACTURE, PROCESS, PACK, OR HOLD FOOD—
Continued
Final Proposed section
section Description
designation
designation
117.9 ................... N/A ..................... The required records are subject to the recordkeeping requirements of subpart F.
A. Applicability and Qualifications of food product (close to the farm or close assigned duties (§ 117.4(a)(1)). To clarify
All Individuals Engaged in to the fork) will need to be considered. how these qualification requirements
Manufacturing, Processing, Packing, or Other comments ask us to establish the apply to facilities, we are requiring that
Holding Food (Final § 117.4(a), (b), and recommendations of the CGMP Working the owner, operator, or agent in charge
(d)) Group in guidance rather than in the of a facility ensure that all individuals
rule. who manufacture, process, pack, or hold
(Comment 172) Some comments Some comments recommend that food subject to subparts C, D, E, F, or G
support changing the current employees be trained ‘‘initially’’ and are qualified to perform their assigned
recommendations for training to ‘‘periodically thereafter’’ but ask that we duties (§ 117.4(a)(2)).
requirements, e.g., by replacing recognize the seasonal nature of a We are not requiring training specific
‘‘should’’ with ‘‘must.’’ However, some facility’s workforce. Some comments to the person’s assigned duties. Each
of these comments also ask that the ask that the training include the establishment engaged in the
requirement allow sufficient flexibility principles of food hygiene and food manufacturing, processing, packing, and
for establishments to determine the safety, including the importance of holding of food for human consumption
scope and frequency of the training employee health and personal hygiene would already have procedures in place
based on the establishment, types of as applied at the facility. to ensure that all individuals who
products, and job responsibilities of the Some comments ask that training manufacture, process, pack, or hold
employee. Some of these comments requirements be established in subpart food know how to do their jobs.
assert that this position is consistent B so that the requirements apply to all However, to emphasize that we expect
with the concept in the food safety plan establishments that manufacture, all individuals who conduct such
of tailoring controls to the specific process, pack, or hold food, including activities to know how to do their jobs,
facility and operations, and also aligns establishments that are not subject to we are specifying that each individual
with the Global Food Safety Initiative FSMA’s requirements for hazard engaged in manufacturing, processing,
guidance document, which was based analysis and risk-based preventive packing, or holding food (including
on the recommendations of the Codex controls. These comments assert that temporary and seasonal personnel) or in
Alimentarius Commission (Codex). this broad training requirement would the supervision thereof must have the
Some of these comments ask that we improve food safety overall. Some education, training, or experience (or a
specify ‘‘as applicable to the plant comments that recommend establishing combination thereof) necessary to
operation’’ and ‘‘applicable to their the training requirement in subpart B manufacture, process, pack, or hold
assigned duties’’ to allow assert that training is more clean and safe food as appropriate to the
establishments flexibility in establishing appropriately considered a prerequisite individual’s assigned duties
risk-based training requirements program than a preventive control that (§ 117.4(b)(1)). To better align with the
specific to their operations. would belong in subpart C. forthcoming FSVP rule, we are using the
Other comments prefer more detail Other comments ask that the training term ‘‘qualified individual’’ in new
and ask that we establish requirements and related recordkeeping requirements § 117.4(b)(1) and are defining the term
addressing all of the recommendations for the facility’s preventive controls ‘‘qualified individual’’ to mean a person
of the CGMP Working Group. Some of qualified individuals be established who has the education, training, or
these comments note that doing so under subpart C because this is directly experience (or a combination thereof)
would be consistent with the proposed related to the facility’s food safety plan. necessary to manufacture, process, pack,
training requirements for the produce Other comments ask that training or hold clean and safe food as
safety rule. requirements be established in both appropriate to the individual’s assigned
Other comments prefer that we subpart B and subpart C. Other duties. A qualified individual may be,
continue to only provide comments assert that including but is not required to be, an employee
recommendations for education and requirements for education and training of the establishment. See the discussion
training and allow the food industry to in both subparts B and C would be of the term ‘‘preventive controls
determine the appropriate level of confusing. qualified individual’’ in section IX.C.25,
specific employee training that may be (Response 172) We are establishing a including a discussion of how we have
needed. These comments assert that series of requirements for the changed the proposed term ‘‘qualified
overly prescriptive and binding qualifications of individuals engaged in individual’’ to ‘‘preventive controls
requirements may not consider variables manufacturing, processing, packing, or qualified individual’’ because we are
such as training course content, training holding food in new § 117.4. First, to establishing a new definition for
provider, effectiveness of the course, clarify how these qualification ‘‘qualified individual,’’ with a meaning
and instructor and frequency of training requirements apply to establishments distinct from ‘‘preventive controls
per topic. In addition, comments assert subject to subparts B and F, we are qualified individual.’’
that factors such as an employee’s type requiring that the management of an We also are requiring that each
and length of experience, nature of establishment ensure that all individual engaged in manufacturing,
formal education, and the food product individuals who manufacture, process, processing, packing, or holding food
type and point in the food supply chain pack, or hold food subject to subparts B (including temporary and seasonal
at which the employee works with the and F are qualified to perform their personnel) or in the supervision thereof,
receive training in the principles of food employee health and personal hygiene, (Response 175) The requirements do
hygiene and food safety, including the to be fundamental to the concept of not address issuance of certificates or
importance of employee health and CGMPs. We agree that establishing a any other provisions that could create
personal hygiene, as appropriate to the training requirement in both subpart B road blocks for third-party providers.
food, the facility and the person’s and subpart C could be confusing. An establishment has flexibility to
assigned duties (see § 117.4(b)(2)). (Comment 173) Some comments ask develop or otherwise provide training in
Records that document this required that training not be limited to a narrow cooperation with public and private
training must be established and class of processors. Other comments organizations in a manner that suits its
maintained and are subject to the assert that anyone who works in the needs.
recordkeeping requirements of subpart F food industry should have mandatory (Comment 176) Some comments agree
(§§ 117.4(d) and 117.9). The rule does training and re-training. that any requirements should include
not specify the frequency of the required (Response 173) The training applies to training appropriate to the person’s
training. We expect that production all individuals engaged in duties but emphasize that the decision
employees will receive training before manufacturing, processing, packing, or as to what is appropriate to the person’s
working in production operations. holding food, consistent with the assigned duties should be determined
Based on a 2010 survey of the domestic requests of these comments. by the establishment.
food manufacturing industry, we expect (Comment 174) Some comments agree (Response 176) The requirement for
that most facilities will also provide that training should be documented and employees to receive training in the
some form of refresher training (Ref. 54). assert that those records should show principles of food hygiene and food
We disagree that we should continue safety, including the importance of
the date of training, a description of the
to only provide recommendations for employee health and personal hygiene,
training, and the name of the person
education and training. Although the as appropriate to the person’s assigned
trained. However, comments ask that we
comments express concern about overly duties, provides flexibility for the
allow flexibility in the way these
prescriptive requirements that may not establishment to provide training that is
records are kept. Other comments assert
consider variables that would affect an appropriate for its employees in light of
that requiring that records document
establishment’s training program (such each person’s assigned duties. However,
required training of personnel is
as training course content, training the rule does not require training
burdensome, arbitrary, and capricious.
provider, effectiveness of the course and specific to the person’s assigned duties.
(Response 174) The rule requires that (Comment 177) Some comments
instructor and frequency of training per
records that document training required assert that the training requirement
topic, an employee’s type and length of
by § 117.4(b)(2) be established and would be an unreasonable burden for
experience, nature of formal education,
maintained without prescribing any small businesses and that companies
and the food product type and point in
content of those records. Although one may incur substantial cost for the time
the food supply chain at which the
employee works with the food product), approach to documenting training that workers would be in training rather
the training requirement we are would be to provide the date of training, than in production. Some comments ask
establishing in the rule provides a description of the training, and the us to provide non-specific training
flexibility for each establishment to name of the person trained, the rule recommendations for smaller food
provide training, and determine the provides flexibility for each processors that need flexibility to
scope and frequency of the training, in establishment to document its training control the cost of training. Some
a way that works best for the in a way that works best for that comments assert that the training and
establishment. establishment. We disagree that education requirements must be
We agree that it is appropriate to requiring records to document required accessible and flexible enough to allow
establish training requirements so that training is burdensome, arbitrary, and employers to bring in temporary help
the requirements apply to all capricious in light of the strong support when demand is high without causing
establishments that manufacture, in the comments regarding CGMP a delay in hiring.
process, pack, or hold food, including modernization for records documenting Some comments assert that we must
establishments that are not subject to training and the flexibility provided by provide ongoing education, training,
FSMA’s requirements for hazard the rule for the content of training and outreach for previously regulated
analysis and risk-based preventive records. firms, newly regulated firms, regulators
controls, and we are establishing the (Comment 175) Some comments that that will be responsible for
qualification and training requirements support mandatory training nonetheless implementing the rules, and educators
in subpart A to clarify the applicability caution us to be flexible towards the who will help farmers and facilities
of these requirements to all development and deployment of understand and manage the new
establishments and facilities subject to mandatory training, including issuance requirements. Some comments assert
part 117. Although we agree that of certificates, so as not to create road that training is needed to educate
employees in facilities that are subject blocks for third-party service providers. farmers, the food industry, and State
to the requirements for hazard analysis These comments state that education and local authorities as well.
and risk-based preventive controls need and training and/or capacity building is (Response 177) All employees will
to understand their responsibilities a growing, rapidly evolving, and well- need enough training to do their jobs
under the facility’s food safety plan, we developed third-party service industry and understand the importance of
are setting forth a training requirement today, and that food companies often hygiene for food safety. The training
focused on the principles of food deliver their training to other raw offered does not need to be expensive
hygiene and food safety, including the material suppliers and contract (e.g., off-site training or off-the-shelf
importance of employee health and manufacturers. Some comments assert purchased training) and we expect that
personal hygiene, as recommended in that the training and education much of the training will be provided
the report of the CGMP Working Group programs should be developed and in-house by knowledgeable employees.
(Ref. 3). We consider training in the implemented in close cooperation with As discussed in Response 2, the FSPCA
principles of food hygiene and food State agencies, public institutions, and is developing a preventive controls
safety, including the importance of stakeholder organizations. training curriculum. These training
materials will be available online, and answer basic questions concerning Some comments support one or more
we expect these training materials to be hazards and controls in the facility. of the proposed exemptions without
useful to small businesses to use for in- (Response 180) We decline this change. For example, some comments
house training. request. We address each compliance note that the exemptions are specified
(Comment 178) Some comments ask situation on a case-by-case basis. in FSMA and, thus, reflect the intent of
us to continue to work with foreign B. Additional Requirements Applicable Congress. Some comments state that
governments on access to training and to Supervisory Personnel (Final some exemptions (i.e., those for
education to ensure that the industry as § 117.4(c)) products already subject to our HACCP
a whole is moving towards better regulations for seafood and juice, or to
advancements in food safety practices, We received no comments that
regulations for the control of
no matter the size, channels of disagreed with our proposal to retain
microbiological hazards for LACF) make
distribution, or geographic location. the requirement in part 110 that
responsibility for ensuring compliance sense because they are risk-based. Other
(Response 178) As discussed in comments that support one or more of
Response 717, we intend to work with by all personnel with all requirements
of this subpart must be clearly assigned the proposed exemptions ask us to
the food industry, education clarify particulars associated with these
to competent supervisory personnel. We
organizations, USDA, the U.S. Agency exemptions (see, e.g., Comment 209,
are correcting ‘‘all requirements of this
for International Development, and Comment 210, Comment 211, and
subpart’’ to ‘‘all requirements of this
foreign governments to develop tools Comment 212) or expand the scope of
part.’’ As a conforming change for
and training programs to facilitate some of these exemptions (see, e.g.,
consistency with the provisions of
implementation of this rule. Comment 185, Comment 196, Comment
§ 117.4(b), we are replacing the phrase
(Comment 179) Some comments ‘‘competent supervisory personnel’’ 197, Comment 208, and Comment 221).
assert that the preventive controls with the phrase ‘‘supervisory personnel Other comments ask us to include
qualified individual should perform the who have the education, training, or additional exemptions in the rule (see
trainings. Some comments assert that experience (or a combination thereof) section XI.K).
the preventive controls qualified necessary to supervise the production of
individual should be responsible for In the remainder of this section, we
clean and safe food.’’ discuss comments that ask us to clarify
determining the appropriate frequency
and scope of training for each facility XI. Subpart A: Comments on Proposed the proposed exemptions or that
and employee, and the records § 117.5—Exemptions disagree with, or suggest one or more
necessary to document that appropriate We proposed to establish a series of changes to, the proposed exemptions.
training has been conducted. exemptions from the requirements for We also discuss comments that ask us
(Response 179) We decline these hazard analysis and risk-based to include additional exemptions in the
requests. Although we agree that the preventive controls that would be rule. After considering these comments,
person delivering such training should established in subpart C, with modified we have revised the proposed
be knowledgeable, we are providing requirements in some cases. We also exemptions as shown in table 12 with
flexibility for facilities to provide proposed to redesignate § 110.19(a) (a editorial and conforming changes as
training as appropriate to the facility, pre-existing exemption from CGMP shown in table 52. A key conforming
including through on-line CGMP or requirements applicable to change that affects all proposed
other food safety courses. establishments engaged solely in the exemptions from the requirements of
(Comment 180) Some comments ask harvesting, storage, or distribution of subpart C is that the final exemptions
that this rule provide FDA (and those one or more RACs) as § 117.5(k) and to are from the requirements of subpart G,
States under contract) the ability to revise this exemption to adjust and as well as subpart C. As discussed in
require certification of industry clarify what activities fall within this section XLII, the final rule establishes
managers and training of employees if exemption based on experience and the requirements for a supply-chain
serious operational hazards are found changes in related areas of the law since program in subpart G, rather than
and management and staff are unable to issuance of the CGMP regulation. within subpart C as proposed.
TABLE 12—REVISIONS TO THE PROPOSED EXEMPTIONS

Section Exemption Modification
117.5(g) .................... From the requirements of subpart C for on-farm packing or • Made changes consequential to the revised ‘‘farm’’ defi-
holding of food by a small or very small business if the nition—i.e., no longer identifying any packing or holding
only packing and holding activities subject to section 418 activities for any RACs.
of the FD&C Act that the business conducts are the • Clarified that the modified requirements do not apply to
specified low-risk packing or holding activity/food com- on-farm packing or holding of food by a very small busi-
binations. ness if the only packing and holding activities subject to
section 418 of the FD&C Act that the business conducts
are the listed low-risk packing or holding activity/food
combinations.
• Updated food categories consistent with the food cat-
egories included in table 1 in the section 103(c)(1)(C)
RA.
• Added low-risk packing or holding activity/food combina-

tions as a result of an updated risk assessment.
• Added a description of the food categories included in
§ 117.5(g) and (h).
TABLE 12—REVISIONS TO THE PROPOSED EXEMPTIONS—Continued

Section Exemption Modification
117.5(h) .................... From the requirements of subpart C for on-farm manufac- • Made changes consequential to the revised ‘‘farm’’ defi-
turing/processing activities conducted by a small or very nition—i.e.:
small business for distribution into commerce if the only —No longer distinguish between manufacturing/processing
manufacturing/processing activities subject to section activities conducted on a farm mixed-type facility’s own
418 of the FD&C Act that the business conducts are the RACs and manufacturing/processing activities conducted
specified low-risk manufacturing/processing activity/food on food other than the farm mixed-type facility’s own
combinations. RACs; and
—Eliminated activities, conducted on others’ RACs, that
would no longer be classified as manufacturing/proc-
essing and instead would be classified as harvesting,
packing, or holding.
• Clarified that the modified requirements do not apply to
on-farm manufacturing/processing activities conducted
by a very small business for distribution into commerce,
if the only manufacturing/processing activities subject to
section 418 of the FD&C Act that the business conducts
are the listed low-risk manufacturing/processing activity/
food combinations.
• Updated food categories consistent with the food cat-
egories included in table 1 in the section 103(c)(1)(C)
RA.
•Added low-risk manufacturing/processing activity/food
combinations as a result of an updated risk assessment.
117.5(k)(1)(iii) ........... From the requirements of subpart B for the holding and Changed from an exemption for specific activities (i.e.,
transportation of RACs. holding and transportation of RACs) to establishments
solely engaged in one or both of those activities.
117.5(k)(1)(v) ............ From the requirements of subpart B for certain activities Changed from an exemption for specific activities to estab-
conducted on nuts (without additional manufacturing/ lishments solely engaged in those activities.
processing).
A. General Comments on the Proposed remains subject to the CGMP sick. Other comments oppose this
Exemptions requirements in subpart B. proposed exemption, asserting that it is
(Comment 181) Some comments ask (Response 183) An establishment that not risk based and expressing concern
us to provide the same flexibility for is exempt from the requirements for that qualified facilities would cause
foreign small businesses as for domestic hazard analysis and risk-based significant food safety problems. Some
small businesses. preventive controls in subparts C and G comments ask us to strictly construct
(Response 181) The exemptions apply remains subject to the CGMP and narrowly apply the exemptions to
to both foreign small businesses and requirements in subpart B, unless that as few businesses as possible.
domestic small businesses. establishment is exempt from subpart B Some comments do not agree that
(Comment 182) Some comments note under § 117.5(k) (which applies to: (1) qualified facilities should be subject to
that proposed § 117.10(c) recommends, Farms; (2) certain fishing vessels; (3) modified requirements because even the
but would not require, that the establishments solely engaged in the modified requirements are burdensome.
responsible individual at a food holding and/or transportation of one or Some comments assert that qualified
establishment have a background of more RACs; (4) activities of ‘‘farm facilities having an average annual value
education, experience or a combination mixed-type facilities’’ that fall within of food sold during the previous three-
of both to provide a level of competence the definition of ‘‘farm’’; and (5) year period of $25,000 or less should be
necessary to produce clean and safe establishments solely engaged in exempt from all requirements related to
food. These comments ask us to make hulling, shelling, drying, packing, and/ hazard analysis and risk-based
this a requirement, rather than a or holding nuts (without additional preventive controls, including modified
recommendation, for the responsible manufacturing/processing)). requirements.
individual at any facility that is exempt (Response 184) The exemption for
B. Proposed § 117.5(a)—Exemption qualified facilities, including the criteria
from the requirements for hazard Applicable to a Qualified Facility
analysis and risk-based preventive for being a qualified facility and the
controls. These comments also ask us to We proposed that subpart C would applicability of modified requirements,
require presentation of the training not apply to a qualified facility, except is expressly directed by section 418(l) of
information to us before an exemption as provided by subpart E (Withdrawal of the FD&C Act. In defining ‘‘very small
is granted. an Exemption Applicable to a Qualified business’’ to mean a business (including
(Response 182) We decline these Facility), and that qualified facilities any subsidiaries and affiliates) averaging
requests. The statute does not require would be subject to the modified less than $1,000,000, adjusted for
that we pre-qualify a facility for an requirements in § 117.201. inflation, per year, during the 3-year
exemption. (Comment 184) Some comments period preceding the applicable

(Comment 183) Some comments ask support the proposed exemption for a calendar year in sales of human food
us to clarify whether an establishment qualified facility and assert that all plus the market value of human food
that is exempt from the requirements for farms should be eligible for this manufactured, processed, packed, or
hazard analysis and risk-based exemption until it is shown that food held without sale (e.g., held for a fee),
preventive controls in subpart C obtained from these farms makes people we constructed this exemption to apply
to businesses that, collectively, produce without a specific provision authorizing Facilities that are exempt from the
less than 0.6 percent of the food supply it to do so. requirements of subparts C and G with
(Ref. 38). In addition, as discussed in (Comment 188) Some comments ask respect to activities that are subject to
Response 151, most of these facilities us to specify in guidance that a qualified part 120 or part 123 are not required to
will be subject to the CGMP facility is not required to prepare and prepare and implement a food safety
requirements in subpart B. implement a food safety plan. plan in addition to their HACCP plans.
(Comment 185) Some comments (Response 188) We intend to (Comment 190) Some comments note
assert that a qualified facility should be recommend in guidance how a qualified that our HACCP regulations for juice
exempt from the CGMP requirements of facility could comply with the modified and seafood do not require facilities
subpart B, as well as the requirements requirements in § 117.201 without subject to those regulations to address
for hazard analysis and risk-based satisfying all of the requirements in radiological hazards and ask how
preventive controls in subpart C. subparts C and G. radiological hazards should be
(Response 185) The exemption for C. Proposed § 117.5(b) and (c)— addressed for activities that are subject
qualified facilities is expressly directed Exemptions Applicable to Food Subject to part 120 or part 123.
by section 418(l) of the FD&C Act and (Response 190) A facility that
to HACCP Requirements for Fish and
is limited to an exemption from the conducts activities that are subject to
Fishery Products (21 CFR Part 123) or
requirements for hazard analysis and part 120 or part 123 is not required to
for Juice (21 CFR Part 120)
risk-based preventive controls in address radiological hazards in its
We proposed that subpart C would HACCP plan if the facility is required to
subparts C and G. The comments not apply with respect to activities that
provide no basis for why new statutory comply with, and is in compliance with,
are subject to part 123 (21 CFR part 123) part 120 or part 123 with respect to such
requirements for hazard analysis and at a facility if the owner, operator, or
risk-based preventive controls should in activities. However, under some
agent in charge of the facility is required circumstances radiological hazards
any way impact the long-standing to comply with, and is in compliance might need to be considered. Moreover,
CGMPs requirements that apply to the with, part 123 with respect to such the facility would be subject to the
manufacturing, packing, and holding of activities. We also proposed that subpart CGMP requirement that storage and
human food. CGMPs provide the basic C would not apply with respect to transportation of food must be under
requirements for ensuring production of activities that are subject to part 120 (21 conditions that will, among other
safe and sanitary food. Following the CFR part 120) at a facility if the owner, things, protect against chemical
CGMPs is essential to properly address operator, or agent in charge of the (including radiological) contamination
public health risks from very small facility is required to comply with, and of food (§ 117.93).
facilities that are provided an exemption is in compliance with, part 120 with (Comment 191) Some comments state
from subparts C and G in order to respect to such activities. We requested that what is needed to assess
minimize the burden on such facilities. comment on the criteria that should be compliance with the applicable HACCP
(See also Response 221.) used to determine whether a facility is regulation is evidence of compliance
(Comment 186) Some comments ask in compliance with part 123 or part 120 with each specific requirement of the
us to clarify how the exemption applies (78 FR 3646 at 3704). regulation, such as compliance with
to diversified farms that produce both (Comment 189) Some comments ask requirements for a written hazard
exempt and non-exempt products. us to clarify whether a seafood allergen analysis and Sanitation Standard
(Response 186) We assume that this that is identified as a hazard should be Operating Procedures (SSOPs). Other
comment is referring to a farm mixed- included in a seafood HACCP plan or in comments ask us to provide guidance to
type facility that produces some a facility’s food safety plan. These industry and the regulatory community
products (such as juice or dietary comments also ask whether a food regarding the criteria that will be used
supplements) that are exempt from the allergen that is identified as a hazard in to determine when a facility is ‘‘in
requirements for hazard analysis and juice subject to part 120 should be compliance with’’ part 120 or part 123.
risk-based preventive controls, as well included in a juice HACCP plan or in a Some comments note that any
as some products that are not exempt facility’s food safety plan determination of compliance with one
from these requirements. The exemption (Response 189) There is no specific of our HACCP regulations would be
only applies to products that are not requirement in the seafood HACCP product specific, and that we would
otherwise exempt from the requirements regulation in part 123 that food allergen only be able to assess compliance on the
for hazard analysis and risk-based hazards be addressed in the seafood inspected product, not all of the
preventive controls. However, see the HACCP plan. However, Chapter 19 in products being produced at the facility.
discussion in Response 157 with our our guidance entitled ‘‘Fish and Fishery Some comments ask us to establish a
response to comments requesting that Products Hazards and Controls transparent process to follow when
we base the dollar threshold for the Guidance (Fourth Edition)’’ includes determining when to nullify an
definition of very small business only recommendations for the control of exemption applicable to food subject to
on the annual monetary value of food undeclared food allergens (Ref. 42). The HACCP in part 120 or part 123. These
covered by the preventive controls rule, juice HACCP regulation in part 120 comments made specific suggestions for
rather than all human food; we declined requires that a juice processor consider such a process, including through a
that request. the presence of undeclared ingredients HACCP inspection of a domestic facility
(Comment 187) Some comments ask that may be food allergens as part of its or a review of a facility’s HACCP plan
us to provide that a qualified facility hazard analysis, and several sections in and corresponding HACCP records for a
may voluntarily choose to comply with our guidance entitled ‘‘Juice HACCP foreign facility. These comments assert
the requirements for hazard analysis Hazards and Controls Guidance (First that FDA actions such as issuing
and risk-based preventive controls. Edition)’’ include recommendations for inspectional observations, issuing a
(Response 187) A qualified facility the control of food allergens (Ref. 43). Warning Letter, or making an imported
may voluntarily choose to comply with Both seafood processors and juice product subject to detention without
the requirements for hazard analysis processors would also address allergen physical examination, should not be the
and risk-based preventive controls hazards through application of CGMPs. basis for determining non-compliance
because in such situations a facility processes to ensure that the facility is subject to our HACCP regulation for
would have an opportunity to respond maintained in a sanitary condition juice.
to FDA with its approach to correcting adequate to significantly minimize or
D. Proposed § 117.5(d)—Exemption
problems. prevent hazards such as environmental
Some comments assert that the key Applicable to Food Subject to Part
pathogens, biological hazards due to
question for us to answer is when a 113—Thermally Processed Low-Acid
employee handling, and food allergen
situation will be so severe that it Foods Packaged in Hermetically Sealed
hazards (§ 117.135(c)(3)). A seafood
warrants requiring compliance with the Containers
processing facility that has ongoing
human preventive controls rule rather sanitation problems and contamination We proposed that subpart C would
than the applicable HACCP regulation. with, for example, an environmental not apply with respect to activities that
These comments raise questions about pathogen, but does not have a written are subject to part 113 at a facility if the
the practicality of requiring compliance SSOP, may be better able to address its owner, operator, or agent in charge of
with the human preventive controls rule sanitation problems by a combination of the facility is required to comply with,
for some products manufactured at a written sanitation controls and and is in compliance with, part 113
facility while continuing to require verification of those sanitation controls with respect to such activities. We also
compliance with the applicable HACCP through environmental monitoring proposed that this exemption would
regulation for other products (§ 117.165(a)(3)). Likewise, a juice apply only with respect to the
manufactured at that facility. These processor that has ongoing problems microbiological hazards that are
comments ask us to specify the added with microbial contamination of fruit it regulated under part 113. We requested
food safety protections that the human receives for processing may be better comment on the criteria that should be
preventive controls rule can provide able to address its supply of fruit by used to determine whether a facility is
that cannot be obtained by compliance complying with the specific in compliance with part 113 (78 FR
with the applicable HACCP regulation. requirements of the human preventive 3646 at 3704).
These comments also ask us to consider controls rule for a supply-chain program (Comment 194) Some comments
the likelihood that a facility that cannot (subpart G). express concern that the partial
comply with the applicable HACCP We expect that situations in which exemption for products subject to part
regulation would be able to comply with enforcement actions to ensure 113 could generate confusion for both
the human preventive controls rule. compliance with an applicable HACCP regulators and regulated facilities. These
Other comments ask whether we will regulation are insufficient to correct comments also assert that the partial
modify existing guidance on compliance problems, and lead to a facility losing its exemption for products subject to part
with applicable HACCP regulations to exemption from the requirements of 113 would generate duplicative
help facilities and inspectors subparts C and G, will be rare and will recordkeeping requirements under the
understand what is needed for a facility depend on very specific circumstances. two rules.
to maintain its exemption. Therefore, at this time we do not (Response 194) We acknowledge the
Some comments assert that the anticipate issuing guidance on when potential for confusion and expect any
statutory intent for compliance would violations of one of our HACCP confusion to decrease over time as both
be satisfied by enforcement actions regulations would cause us to require regulators and facilities gain experience
(such as administrative detention, compliance with subparts C and G. with the new requirements. We also
registration suspension, or mandatory (Comment 192) Some comments ask expect that in most instances a facility
recall) that will either ensure us to revise our HACCP regulations for that is subject to part 113, and that
compliance with the applicable HACCP seafood and juice to be consistent with evaluates potential microbiological
regulation, or prohibit that facility from subpart C to avoid the burden of having hazards as part of its hazard analysis,
distributing food. two systems within facilities that would conclude that the potential
(Response 191) We acknowledge the produce seafood or juice products, as hazards are controlled by the targeted
issues raised by these comments and well as other foods. requirements of part 113 and conclude
agree that in many situations the (Response 192) We decline this there are no microbiological hazards
appropriate action for us to take when request. Our HACCP regulations are that require preventive controls to
a facility is out of compliance with an already consistent with—though not significantly minimize or prevent the
applicable HACCP regulation will be to identical to—subpart C. Further, it is not hazards.
employ existing enforcement tools to clear that such facilities would need two We disagree that the partial
bring the facility into compliance with separate systems, given the similarities exemption for products subject to part
the applicable regulation. However, we in requirements and flexibility we have 113 would generate duplicative
also believe that there may be provided for implementing preventive recordkeeping requirements. The
circumstances where an added food controls. The food safety plan for the requirements of part 113 to control
safety benefit could be achieved by products not subject to the HACCP biological hazards are different from the
requiring compliance with the human regulations is likely to be very similar to requirements of subparts C and G to
preventive controls rule when a facility that for the foods subject to the HACCP conduct a hazard evaluation for
does not comply with an applicable regulations (which includes monitoring chemical and physical hazards, and
HACCP regulation. For example, the of SSOPs). To the extent that subparts implement preventive controls and
seafood HACCP regulation C and G contain additional associated preventive control
recommends—but does not require— requirements, a facility is free to management components to address
that a seafood processor have and perform similar actions for its products significant chemical and physical
implement a written SSOP. In contrast, hazards. Likewise, the records
produced under a HACCP regulation.

the human preventive controls rule (Comment 193) Some comments ask associated with the control of biological
requires that all preventive controls be us to exempt the production of fresh hazards under part 113 are not the same
written, and that preventive controls cider from the rule. as the records associated with a hazard
include, as appropriate to the facility (Response 193) Fresh cider is juice. A analysis, preventive controls, and
and the food, sanitation controls, which facility that produces fresh cider is associated preventive control
include procedures, practices, and eligible for the exemption for products management components for control of
chemical and physical hazards. even if the facility also makes food regulations in part 111, unless the
However, to the extent that a facility products that are not dietary regulations conflict. To the extent that
appropriately determines that existing supplements. Some comments assert the regulations conflict, the dietary
records required by part 113 can be used that the exemption applicable to the supplement manufacturer would
to demonstrate compliance with the manufacturing, processing, packing, or comply with the regulation in part 111.
requirements of subparts C and G, a holding of a dietary supplement should (Comment 198) Some comments ask
facility may rely on those records (see also apply to the manufacturing, us to clarify how the exemption applies
§ 117.330). processing, packing, or holding of a to foods, other than dietary
(Comment 195) Some comments ask dietary ingredient if the facility chooses supplements, that may be held in a
us to provide guidance to industry and to follow the dietary supplement CGMP facility that conducts activities in
the regulatory community regarding the regulation. compliance with the dietary supplement
criteria that will be used to determine (Response 196) The proposed CGMP regulation.
when a facility is ‘‘in compliance with’’ exemption is directed by section 103(g) (Response 198) The exemption does
part 113. of FSMA. None of these comments not apply to foods, other than dietary
(Response 195) We discuss similar explain how the desired expansion of supplements, that may be held in a
comments regarding the exemptions for the exemption is consistent with section facility that conducts activities in
products subject to one of our HACCP 103(g), which limits the provision to compliance with the dietary supplement
regulations in Response 191. As an ‘‘the manufacturing, processing, CGMP regulation. The owner, operator,
example, an LACF manufacturing packing, or holding of a dietary or agent in charge of a facility that
facility that has ongoing problems supplement’’ (78 FR 3646 at 3705). produces both dietary supplements and
controlling biological hazards may be (Comment 197) Some comments ask foods that are not dietary supplements
better able to address biological hazards us to revise the exemption applicable to must comply with the requirements of
by preparing and implementing a dietary supplements to add that this rule for hazard analysis and risk-
written food safety plan. As with subparts B and F do not apply to any based preventive controls, unless
facilities subject to our HACCP facility with regard to the another exemption applies as specified
regulations, we expect that situations in manufacturing, processing, packing, or in § 117.5.
which enforcement actions to ensure holding of a dietary supplement that is (Comment 199) Some comments ask
compliance with part 113 are in compliance with the requirements of us to use information collected in the
insufficient to correct problems, and part 111. These comments assert that it biennial food facility registration to help
lead to a facility losing its exemption would be illogical to subject the dietary determine whether a facility is in
from the requirements of subparts C and supplement industry to industry- compliance with part 111.
G, will be rare and will depend on very specific CGMPs (part 111), as well as a (Response 199) We decline this
specific circumstances. Therefore, at more general (and inherently less request. It would be the observations
this time we do not anticipate issuing applicable) CGMP standard in part 117. and findings from an inspection, rather
guidance on when violations of part 113 These comments also assert that the than information in a facility’s
could lead to this outcome. intent of the CGMPs in part 117 is to registration, that could help us
regulate industries and industry determine whether a facility is in
E. Proposed § 117.5(e)—Exemption
segments that have not previously been compliance with part 111. Information
Applicable to a Facility That
regulated and that failing to collected during registration provides
Manufactures, Processes, Packages, or
acknowledge the regulations already information on how we should inspect
Holds a Dietary Supplement
applicable to dietary supplements a facility, but has no bearing on whether
We proposed that subpart C would would be duplicative, redundant, and the facility is complying with applicable
not apply to any facility with regard to provide no additional safety or public regulations.
the manufacturing, processing, packing, health protection.
or holding of a dietary supplement that (Response 197) As discussed in the F. Proposed § 117.5(f)—Exemption
is in compliance with the requirements final rule establishing the dietary Applicable to Activities Subject to
of part 111 (Current Good supplement CGMP regulation, we Standards for Produce Safety in Section
Manufacturing Practice in included in part 111 the existing 419 of the FD&C Act
Manufacturing, Packing, Labeling, or requirements in part 110 that we believe We proposed that subpart C would
Holding Operations for Dietary are common to dietary supplement not apply to activities of a facility that
Supplements) and section 761 (Serious manufacturing (72 FR 34752 at 34764, are subject to section 419 (Standards for
Adverse Event Reporting for Dietary June 25, 2007). We recognized that there Produce Safety) of the FD&C Act (21
Supplements) of the FD&C Act. We may be operations related to the U.S.C. 350h). We received no comments
requested comment on the criteria that manufacturing of dietary supplements that disagreed with this proposal and
should be used to determine whether a for which certain provisions in part 110 are finalizing it as proposed.
facility is in compliance with part 111 (now largely subpart B of part 117)
and section 761 of the FD&C Act (78 FR apply, but that we did not determine to G. Proposed §§ 117.5(g) and (h)—
3646 at 3705). As noted in table 52, we be common to most dietary supplement Exemptions Applicable to On-Farm
corrected the exemption to match the manufacturing operations (e.g., for Low-Risk Activity/Food Combinations
title of part 111—i.e., ‘‘Current Good dietary supplements that are dehydrated Conducted by a Small or Very Small
Manufacturing Practice in and rely on the control of moisture Business
Manufacturing, Packaging, Labeling, or consistent with current § 110.80(b)(14) As discussed in section VI.A,
Holding Operations for Dietary (proposed § 117.80(c)(14)). As was the consistent with the statutory direction
Supplements.’’ case when we issued the final rule to in section 103(c) of FSMA, including
(Comment 196) Some comments establish dietary supplement CGMPs conducting a qualitative risk
assert that the entire facility should be and continues to be the case now, a assessment, we proposed three
exempt from the requirements of manufacturer would be required to exemptions for on-farm activity/food
subpart C if the facility implements the comply with the CGMP regulations in combinations conducted by farm-mixed-
dietary supplement CGMP regulation subpart B of part 117 in addition to the type facilities that are small or very
small businesses (proposed §§ 117.5(g), Specifically, a farm mixed-type facility are not low-risk activity/food
(h)(1), and (h)(2)). that only conducts low-risk activity/ combinations, or that should have
food combinations (such as making modified requirement rather than be
1. General Comments on the Proposed
certain jams or syrups) would be exempt exempt (e.g., if the foods have been the
Exemptions Applicable to On-Farm
from the requirements of subpart C, subject of Class I recalls or outbreaks of
Low-Risk Activity/Food Combinations
whereas an off-farm qualified facility foodborne illness).
Conducted by a Small or Very Small
making those same jams and syrups,
Business (Response 203) We decline this
while exempt from the requirements of
(Comment 200) Some comments subpart C, would nonetheless be subject request. With few exceptions, the
assert that conducting a low-risk to modified requirements in § 117.201. exemptions are established by
activity/food combination should be These comments ask whether it would specifying the activities that are not
sufficient to qualify any facility for be better for a farm or farm mixed-type subject to the requirements for hazard
exemption from subpart C, regardless of facility that satisfies criteria for a small analysis and risk-based preventive
whether the activity is conducted on- or very small business, and also satisfies controls, rather than the activities that
farm or off-farm, or meets the economic criteria for a qualified facility, to classify are subject to these requirements. When
threshold for a small or very small itself as a small or very small business an exemption does specify activities
business. or to classify itself as a qualified facility. that are subject to certain requirements
(Response 200) The statute provides (Response 202) In light of the final of the rule, the specified activities are a
specific direction for those facilities that ‘‘farm’’ definition, these comments no narrow exception (see § 117.5(k)). In the
can qualify for this exemption. (See longer apply with respect to activities case of the exemptions for the low-risk
sections 418(l) and 418(o)(2) of the within the farm definition. activity/food combinations listed in
FD&C Act.) See also Response 184 and For activities conducted by a farm § 117.5(g) and (h), the activity/food
Response 222. mixed-type facility, we acknowledge
(Comment 201) Some comments ask combinations that are subject to the
that the exemptions provided by
why the activity/food combinations requirements of subparts C and G are
§ 117.5(g) and (h) for on-farm low-risk
listed in proposed § 117.5(g) are not activity/food combinations are different extensive and it is not feasible to
consistent with the activity/food from the exemption provided by identify and list all of them.
combinations listed in proposed § 117.5(a) for a qualified facility. A farm In developing the low-risk activity/
§ 117.5(h). Some comments state that mixed-type facility that only conducts food combinations that are exempt from
the exemptions for farming activities are low-risk activity/food combinations the requirements, we conducted a
confusing. listed in § 117.5(g) and (h) is fully qualitative risk assessment (Ref. 4) that
(Response 201) The items listed in exempt from the requirements of considered whether manufacturing,
§ 117.5(g) only specify the food or food subparts C and G, and is not subject to processing, packing, or holding
category (rather than an activity/food the modified requirements in § 117.201, activities conducted on a farm mixed-
combination) because the activities even if that farm mixed-type facility is type facility had been implicated in
addressed in § 117.5(g) are, in all cases, also a very small business (and, thus, food that has been the subject of a Class
the same—i.e., packing and holding also is a qualified facility). To make this
activities. In contrast, the items listed in I recall or outbreak of foodborne illness.
clear, we have revised proposed
§ 117.5(h) specify a particular activity However, whether specific types of food
§ 117.5(g) to specify that § 117.201 does
(e.g., coating, mixing) in addition to a had been the subject of a Class I recall
not apply to on-farm packing or holding
food or food category (e.g., peanuts and of food by a very small business if the or outbreak of foodborne illness was
tree nuts) because there are multiple only packing and holding activities only one factor we considered. For
manufacturing/processing activities, subject to section 418 of the FD&C Act example, we also considered factors that
each associated with a particular food or that the business conducts are the listed impact the frequency and levels of
food category, listed in the provisions. low-risk packing or holding activity/ contamination of the food (Ref. 4). For
Although these exemptions are more food combinations. Likewise, we have additional discussion, see the section
complex than other exemptions (e.g., revised proposed § 117.5(h) to specify 103(c)(1)(C) RA (Ref. 4).
because they are directed to specific that § 117.201 does not apply to on-farm (Comment 204) Some comments ask
activities conducted on specific foods or manufacturing/processing activities for a process to keep the list of low-risk
food categories), the final ‘‘farm’’ conducted by a very small business for activity/food combinations up to date,
definition has simplified them to the distribution into commerce, if the only such as through guidance.
extent practicable. For example, under manufacturing/processing activities
the ‘‘farm’’ definition in the 2013 subject to section 418 of the FD&C Act (Response 204) We decline this
proposed preventive controls rule, that the business conducts are the listed request. The exemptions established in
whether an activity was packing or low-risk manufacturing/processing this rule are binding, whereas any list of
manufacturing/processing depended, in activity/food combinations. additional activity/food combinations
part, on whether the RACs being packed With these changes, a farm mixed- established in a guidance document
were the farm’s own RACs or others’ type facility that is a very small business would not be binding. We established
RACs. In contrast, under the ‘‘farm’’ and that only conducts the low-risk the list of activity/food combinations
definition established in this rule, activity/food combinations listed in included in these exemptions through
packing RACs is a ‘‘packing’’ activity, § 117.5(g) and/or (h) may find it an extensive public process, including a
regardless of ownership of the RACs advantageous to classify itself as a very request for comments on the section
being packed. small business eligible for the
103(c)(1)(C) draft RA. From this time

(Comment 202) Some comments note exemption in § 117.5(g) and/or (h) rather forward, the process available to a
a distinction between the exemptions than as a qualified facility, which would person who wishes us to consider an
for on-farm low-risk activity/food be subject to the modified requirements additional activity/food combination is
combinations conducted by small and in § 117.201. to submit a citizen petition in
very small businesses and the (Comment 203) Some comments ask accordance with 21 CFR 10.30.
exemption for qualified facilities. us to list activity/food combinations that
2. Proposed § 117.5(g)—Exemption 103(c)(1)(C) RA lists more types of food dehydrating fresh herbs to produce
Applicable to On-Farm Low-Risk categories. The purpose of listing more dried herbs), and packaging and labeling
Packing or Holding Activity/Food types of food categories was to make it such commodities, without additional
Combinations Conducted by a Small or clearer when a particular food is manufacturing/processing (such as
Very Small Business encompassed within a particular chopping and slicing), the packing and
activity/food combination. As one holding of which are within the ‘‘farm’’
We proposed that subpart C would
example, table 1 in the final section definition in § 1.227. Activities that are
not apply to on-farm packing or holding
103(c)(1)(C) RA lists food categories within the ‘‘farm’’ definition, when
of food by a small or very small business
such as baked goods, milled grain conducted on a farm mixed-type
if the only packing and holding
products, and other grain products (e.g. facility, are not subject to the
activities subject to section 418 of the
dried pasta), in place of the original requirements of subparts C and G of this
FD&C Act that the business conducts are
category ‘‘grain products.’’ As another part and therefore do not need to be
low-risk packing or holding activity/
example, table 1 in the section specified in the exemption.
food combinations on food not grown, 103(c)(1)(C) RA lists the broad term
raised, or consumed on that farm mixed- Second, we have added a provision
‘‘sap’’ and provides examples of (§ 117.5(g)((2)) describing the food
type facility or another farm or farm different types of sap to make clear that
mixed-type facility under the same categories listed in the exemption. For
activity/food combinations regarding example, this provision explains that
ownership. As a consequential change sap are broader than ‘‘maple sap.’’
in light of the final ‘‘farm’’ definition, ‘‘milled grain products’’ include
We have revised the final exemption
the final exemption no longer identifies processed food products such as flour,
to list food categories consistent with
any packing or holding activities for any bran, and cornmeal.
the food categories included in table 1
RACs (whether the farm’s own RACs or in the section 103(c)(1)(C) RA and The first column in table 13 lists the
others’ RACs), because an on-farm include those packing and holding food or food category that comments ask
establishment would no longer be activity/food combinations that the us to include in the exemption for on-
subject to the requirements for hazard section 103(c)(1)(C) RA determines to be farm, low-risk packing and holding
analysis and risk-based preventive low-risk. For additional details about activities. The second column lists the
controls when it packs or holds RACs, the outcome of the section 103(c)(1)(C) regulatory citation for the relevant
regardless of whether it is packing and RA on the specific activity/food exemption for on-farm packing and
holding its own RACs or others’ RACs. combinations described in the holding. Importantly, the full regulatory
(Comment 205) Some comments ask comments, see the section 103(c)(1)(C) text of the exemption includes some
us to expand the list of on-farm low-risk RA (Ref. 4). limitations that were not specified in
packing and holding activities to We also revised the proposed the comments, and table 13 should not
include packing and holding of food exemption to add two sets of be viewed as equating the requests of
products not expressly covered by the information that we believe will be the comments with the final regulatory
proposed exemption. See the food useful to a farm mixed-type facility text of the exemption. For example,
products listed in table 13 and table 14. when evaluating whether the farm’s § 117.5(g)(2)(ix) specifies that the food
(Response 205) We considered these packing activities satisfy the criteria for category ‘‘baked goods’’ includes
comments within the context of the the exemption. processed food products such as breads,
section 103(c)(1)(C) RA. Table 1 in the First, we have added a new provision brownies, cakes, cookies, and crackers,
section 103(c)(1)(C) draft RA listed (§ 117.5(g)((1)) explaining that the but does not include products that
activity/food combinations that we exemption in § 117.5(g) applies to require time/temperature control for
identified as likely to be conducted by packing or holding of processed foods safety (such as cream-filled pastries).
farm mixed-type facilities using broad on a farm mixed-type facility, except for See § 117.5(g)(2) for a description of
food categories such as ‘‘grain’’ and processed foods produced by drying/ those food categories listed in the
‘‘grain products.’’ In light of comments dehydrating RACs to create a distinct exemption for on-farm, low-risk packing
such as those described in Comment commodity (such as drying/dehydrating and holding activity/food combinations
205, table 1 in the final section grapes to produce raisins, and drying/ in table 13.
TABLE 13—REQUESTED FOOD OR FOOD CATEGORY AND RELEVANT EXEMPTION FOR ON-FARM LOW-RISK PACKING AND
HOLDING ACTIVITIES
Food or food category requested in the comments Relevant regulatory section
• Barley malt syrup ........................................................ § 117.5(g)(3)(xix)—Sugar.

• Barley malt extract ...................................................... § 117.5(g)(3)(xx)—Syrups.
• Other concentrated grain malt products in liquid or § 117.5(g)(3)(xxii)—Vinegar.
powder form. § 117.5(g)(3)(xxiii)—Any other processed food that does not require time/temperature
control for safety.
• Birch sap and syrup .................................................... § 117.5(g)(3)(xix)—Sugar.
• Cane syrup ................................................................. § 117.5(g)(3)(xx)—Syrups.
• Coconut sap and sugar.
• Date sugar.
• Palm sap and sugar.
• Sorghum juice and syrup.
• Other concentrated natural sweetener having a

water activity lower than 0.85 and made with an
adequate microbial reduction step.
Chips .............................................................................. § 117.5(g)(3)(xiii)—Other fruit and vegetable products.
• Crackers ...................................................................... § 117.5(g)(3)(i)—Baked goods.
• Bread crumbs.
• Dry bread.
TABLE 13—REQUESTED FOOD OR FOOD CATEGORY AND RELEVANT EXEMPTION FOR ON-FARM LOW-RISK PACKING AND
HOLDING ACTIVITIES—Continued
Food or food category requested in the comments Relevant regulatory section
Crude ‘‘dietary ingredient botanicals’’ in cut, chopped, § 117.5(g)(3)(xiii)—Other fruit and vegetable products.
or powdered form. § 117.5(g)(3)(xv) Other herb and spice products.
• Dried cereal ................................................................ § 117.5(g)(3)(xiv)—Other grain products.
• Dried pasta.
Dried herbs and spices, chopped or ground ................. § 117.5(g)(3)(xv)—Other herb and spice products.
Dry legume products (e.g., chickpea flour) .................... § 117.5(g)(3)(xiii)—Other fruit and vegetable products.
Dry, unsulfited, fruits and vegetables in cut, chopped, § 117.5(g)(3)(xiii)—Other fruit and vegetable products.
sliced, shredded, or other form.
Gums and resins ............................................................ § 117.5(g)(3)(vii)—Gums, latexes, and resins that are processed foods.
Herbal extracts (e.g., in solvents such as glycerin, al- § 117.5(g)(3)(xv)—Other herb and spice products.
cohol and oil).
• Honey infused with dried herbs or spices .................. § 117.5(g)(3)(xv)—Other herb and spice products.
• Oil and/or vinegar infused with dried herbs or spices.
Jerky ............................................................................... § 117.5(g)(3)(vi)—Game meat jerky.
Molasses and treacle ..................................................... § 117.5(g)(3)(xi)—Molasses and treacle.
Potato starch .................................................................. § 117.5(g)(3)(xiii)—Other fruit and vegetable products.
Popcorn .......................................................................... § 117.5(g)(3)(xiv)—Other grain products.
Salt, baking powder ........................................................ § 117.5(g)(3)(xxiii)—Any other processed food that does not require time/temperature
control for safety.
Vitamins, minerals, and processed dietary ingredients § 117.5(g)(3)(xxiii)—Any other processed food that does not require time/temperature
(e.g., bone meal) in powdered, granular, or other control for safety.
solid form.
In table 14, we list those foods or food on-farm, low-risk packing and holding
categories, requested by comments, that activities, and explain why.
are not included in the exemption for
TABLE 14—WHY CERTAIN REQUESTED FOOD CATEGORIES ARE NOT INCLUDED IN THE EXEMPTION FOR ON-FARM LOW-
RISK PACKING AND HOLDING ACTIVITIES
Food or food group requested in the comments Why the food or food group is not listed in the exemption
Barley malt and other grain malts .................................. Malting increases the potential for a hazard, e.g., growth of microbial pathogens such
as Salmonella, during the germination process. (However, the risk is mitigated when
malting is done in conjunction with making sugar, syrups or vinegar.)
Crude ‘‘dietary ingredient botanicals’’ in whole, form .... These are RACs, so packing and holding them is within the farm definition.
Dates (RACs) ................................................................. These are RACs, so packing and holding them is within the farm definition
Dried intact herbs and spices ........................................ Although these are processed foods, packing and holding them is specifically included
within the farm definition.
Dried legumes ................................................................ Although these are processed foods, packing and holding them is specifically included
within the farm definition.
Gums, resins, and exudates in solid, powdered, granu- Gums, resins and exudates (including latexes such as chicle) are RACs, so packing
lar, or paste form. and holding them is within the ‘‘farm’’ definition. These products are made into proc-
essed foods in some cases, such as by boiling or cutting. The powdered, granular
and paste forms from further processing are considered in the risk assessment as
‘‘any other processed food that does not require time/temperature control for safety.’’
3. Proposed § 117.5(h)—Exemption facility’s own RACs and those activity/ which no longer are classified as
Applicable to On-Farm Low-Risk food combinations that would be manufacturing/processing and instead
Manufacturing/Processing Activity/ exempt when conducted on food other are classified as harvesting, packing, or
Food Combinations Conducted by a than the farm mixed-type facility’s own holding. In addition, as discussed in
Small or Very Small Business RACs for distribution into commerce. Response 205 we have revised the final
As a consequential change in light of exemption to list food categories
We proposed that subpart C would
not apply to on-farm low-risk the final ‘‘farm’’ definition, the final consistent with the food categories
manufacturing/processing activities exemption no longer distinguishes included in table 1 in the section
conducted by a small or very small between manufacturing/processing 103(c)(1)(C) RA.
business if the only manufacturing/ activities conducted on a farm mixed- We also revised the proposed
processing activities subject to section type facility’s own RACs and exemption to add two sets of
418 of the FD&C Act that the business manufacturing/processing activities information that we believe will be
conducts are those listed in the conducted on food other than the farm useful to a farm mixed-type facility
proposed exemption. The proposed mixed-type facility’s own RACs. As when evaluating whether the farm’s
exemption specified those activity/food another consequential change, the manufacturing/processing activities
combinations that would be exempt exemption has been revised to eliminate satisfy the criteria for the exemption.
when conducted on a farm mixed-type activities, conducted on others’ RACs,
First, we have added a new provision (Comment 206) Some comments ask satisfies the criteria in that risk
(§ 117.5(h)((1)) explaining that the us to include in the exemption a single assessment for a low-risk activity/food
exemption in § 117.5(h) applies to list of low-risk manufacturing/ combination. When we determined
manufacturing/processing of foods on a processing activity/food combinations through the section 103(c)(1)(C) RA that
farm mixed-type facility, except for applicable to farm mixed-type facilities the requested activity/food combination
manufacturing/processing that is within conducting activities on their own RACs did not satisfy the criteria for a low-risk
the ‘‘farm’’ definition in § 1.227. Drying/ and farm mixed-type facilities activity/food combination, table 16
dehydrating RACs to create a distinct conducting activities on other’s RACs. explains why. See § 117.5(g)(2) for a
commodity (such as drying/dehydrating (Response 206) These comments no
description of the food categories listed
grapes to produce raisins, and drying/ longer apply. As a consequence of the
in the exemption for on-farm, low-risk
dehydrating fresh herbs to produce ‘‘farm’’ definition established by this
rule, the exemption no longer manufacturing/processing activity/food
dried herbs), and packaging and labeling
such commodities, without additional distinguishes between manufacturing/ combinations in table 15 and table 16.
manufacturing/processing (such as processing activities conducted on a The first column in table 15 lists the
chopping and slicing), are within the farm mixed-type facility’s own RACs activity/food combination that
‘‘farm’’ definition in § 1.227. In and manufacturing/processing activities comments ask us to include in the
addition, treatment to manipulate the conducted on food other than the farm exemption for on-farm, low-risk
ripening of RACs (such as by treating mixed-type facility’s own RACs. manufacturing/processing activity/food
produce with ethylene gas), and (Comment 207) Some comments ask combinations. The second column lists
packaging and labeling the treated us to include additional activity/food the regulatory citation for the relevant
RACs, without additional combinations in the exemption. See exemption for an on-farm
manufacturing/processing, is within the table 15 and table 16 for a list of the manufacturing/processing activity/food
‘‘farm’’ definition. In addition, coating requested additional activity/food combination. Importantly, the full
intact fruits and vegetables with wax, combinations. regulatory text of the exemption
oil, or resin used for the purpose of (Response 207) We evaluated each of
includes some limitations that were not
storage or transportation is within the the requested activity/food
combinations within the qualitative risk specified in the comments, and table 15
‘‘farm’’ definition. Activities that are
assessment (Ref. 4), unless the activity/ should not be viewed as equating the
within the ‘‘farm’’ definition, when
conducted on a farm mixed-type food combination was out of scope of requests of the comments with the final
facility, are not subject to the this rule (for example, if the requested regulatory text of the exemption. For
requirements of subparts C and G of this activity/food combination was directed example, § 117.5(g)(2)(ix) specifies that
part and therefore do not need to be to animal food rather than human food). the food category ‘‘baked goods’’
specified in the exemption. See table 15 and table 16 for the includes processed food products such
Second, we have added a provision outcome of our evaluation of these as breads, brownies, cakes, cookies, and
(§ 117.5(h)((2)) specifying that requests, based on the findings of the crackers, but does not include products
§ 117.5(g)(2) describes the food section 103(c)(1)(C) RA as to whether that require time/temperature control
categories listed in the exemption. the requested activity/food combination for safety (such as cream-filled pastries).
TABLE 15—REQUESTED ACTIVITY/FOOD COMBINATIONS AND RELEVANT EXEMPTION FOR ON-FARM LOW-RISK
MANUFACTURING/PROCESSING ACTIVITIES
Activity/food combination requested in the comments Regulatory section listing the exemption
Baking activities involving grain products ................................................ § 117.5(h)(3)(ix)—Making baked goods from milled grain products (e.g.,
breads and cookies).
Chopping, coring, cutting, peeling, pitting, shredding, and slicing. .......... § 117.5(h)(3)(ii)—Chopping, coring, cutting, peeling, pitting, shredding,
• Crackers, dry bread, bread crumbs ...................................................... and slicing:
• Dry cereal, popcorn .............................................................................. • Baked goods
• Gums, resins and exudates .................................................................. • Other grain products
• Jerky ...................................................................................................... • Gums/latexes/resins
• Game meat jerky.
Cooking low-moisture foods with dry heat ............................................... § 117.5(h)(3)(xxv)—Roasting and toasting baked goods.
Drying/dehydrating cut fruits and vegetables that are immediately § 117.5(h)(3)(iv)—Drying/dehydrating (that includes additional manufac-
moved into a drying process. turing or is performed on processed foods) other fruit and vegetable
products with pH less than 4.2, and other herb and spice products
(e.g., chopped fresh herbs, including tea).
• Distilling mint ......................................................................................... § 117.5(h)(3)(v)—Extracting (including by pressing, by distilling, and by
• Extracting virgin olive oil ....................................................................... solvent extraction) from:
• Extracting oils from seeds (e.g., sunflower seeds, flax seeds) ............ • Dried/dehydrated herb and spice products
• Making liquid botanical extracts from dry botanical raw material with • Fresh herbs
solvents such as glycerin, ethanol, vinegar, honey. • Fruits and vegetables
• Grains
• Other herb and spice products.
Grinding/milling/cracking/crushing: ........................................................... § 117.5(h)(3)(vii)—Grinding/milling/cracking/crushing:
• Crackers, dry bread, bread crumbs ...................................................... • Baked goods

• Dry cereal, dry pasta, popcorn ............................................................. • Other grain products
• Dry legumes .......................................................................................... • Dried/dehydrated fruit and vegetable products.
Mixing ....................................................................................................... § 117.5(h)(3)(xxii)—Mixing other herb and spice products.
• Honey infused with dried herbs or spices ............................................
• Oil and/or vinegar infused with dried herbs or spices ..........................
Making maple cream, maple sugar, and molded maple candy ............... § 117.5(h)(3)(x)—Making candy.
TABLE 15—REQUESTED ACTIVITY/FOOD COMBINATIONS AND RELEVANT EXEMPTION FOR ON-FARM LOW-RISK
MANUFACTURING/PROCESSING ACTIVITIES—Continued
Activity/food combination requested in the comments Regulatory section listing the exemption
Making molasses and treacle from sugarcane and sugar beets ............. § 117.5(h)(3)(xiv)—Making molasses and treacle.
• Making apple syrup ............................................................................... § 117.5(h)(3)(xix)—Making sugar and syrup from:
• Making syrups from sorghum, rice ....................................................... • Fruits and vegetables
• Making syrups from malted barley ....................................................... • Grains
• Making syrups such as birch and walnut syrup ................................... • Other grain products
• Saps.
Making vinegar, including infused and flavored vinegars ........................ § 117.5(h)(3)(xxi)—Making vinegar from fruits and vegetables, other
fruit and vegetable products, and other grain products.
§ 117.5(h)(3)(xxii)—Mixing other herb and spice products.
Processing tea .......................................................................................... § 117.5(h)(3)(iv)—Drying/dehydrating (that includes additional manufac-
turing or is performed on processed foods) other fruit and vegetable
products with pH less than 4.2, and other herb and spice products
(e.g., chopped fresh herbs, including tea).
TABLE 16—WHY CERTAIN REQUESTED ACTIVITY/FOOD COMBINATIONS ARE NOT INCLUDED IN THE EXEMPTION FOR ON-
FARM LOW-RISK MANUFACTURING/PROCESSING ACTIVITIES
Food or food group requested in the comments Why the food or food group is not listed in the exemption
Acidifying, pickling, and fermenting low-acid fruits and vegetables made Acidifying, pickling, and fermenting activities control microbial hazards
in compliance with CGMPs. and, thus, are not low-risk activities.
Cucumbers, garlic scapes, peppers, and other low-acid foods that are The production of low-acid processed foods must control the microbial
preserved. hazard C. botulinum and, thus, is not a low-risk activity.
Drying/dehydrating tea leaves (e.g., by withering) ................................... Drying/dehydrating tea leaves is within the ‘‘farm’’ definition.
Fermentation of vegetables ...................................................................... Fermenting activities control microbial hazards and, thus, are not low-
risk activities.
Food processing conducted in compliance with relevant State regula- It is the risk associated with the activity/food combination, not the regu-
tion. latory oversight by a State, that is relevant of this exemption.
Freezing fruit juices .................................................................................. Fruit juices are outside the scope of the RA based on the statutory
framework of FSMA.
Low-acid fruits and vegetables manufactured in compliance with The production of low-acid processed foods must control the microbial
CGMPs under the FD&C Act. hazard C. botulinum and, thus, is not a low-risk activity.
Making pickles and salsa ......................................................................... The processes for making pickles and salsa must control microbial
hazards and, thus, are not low-risk activities.
Roasting grains for animal feed ............................................................... This activity involves the production of animal food, which is subject to
the animal preventive controls rule rather than the human preventive
controls rule.
H. Proposed § 117.5(i)—Exemptions (Comment 208) Some comments ask supplemental animal preventive
Related to Alcoholic Beverages us to include the production of spent controls notice (79 FR 58476 at 58487–
grains, distillers’ grains, grape pomace, 58489). (See also the discussion in
Section 116 of FSMA (21 U.S.C. 2206) and other by-products of the section L regarding the specific CGMP
(Alcohol-Related Facilities) provides a manufacturing process within the provisions that will apply to these
rule of construction for certain facilities alcohol exemption. These comments foods.)
engaged in the manufacturing, argue that the mere act of separating and I. Proposed § 117.5(j)—Exemption
processing, packing, or holding of disposing of those by-products by sale Applicable to Facilities Solely Engaged
alcoholic beverages and other food. In or otherwise should not trigger an in Storage of Raw Agricultural
the proposed human preventive controls obligation to meet the requirements of Commodities Other Than Fruits and
rule, we discussed our interpretation of subpart C. Vegetables Intended for Further
section 116 of FSMA and requested (Response 208) The exemption Distribution or Processing
comment on our interpretation. Based established under the rule of
on our interpretation, we proposed that We proposed that subpart C would
construction in section 116 of FSMA not apply to facilities that are solely
subpart C would not apply with respect applies to alcoholic beverages, not to engaged in the storage of RACs (other
to alcoholic beverages at facilities any other food (see section 116(c) of than fruits and vegetables) intended for
meeting two specified conditions (78 FR FSMA (21 U.S.C. 2206(c)), and we have further distribution or processing. In the
3646 at 3707 to 3709). We also proposed revised the exemption to make the following paragraphs, we discuss
that subpart C would not apply with statutory applicability clearer (see table comments that ask us to clarify how the
respect to food other than alcoholic 52 and the regulatory text of § 117.5(i)). proposed exemption would apply to
beverages at facilities described in the As previously discussed (79 FR 58524 at specific circumstances.
exemption, provided such food is in 58558), the by-products described in (Comment 209) Some comments ask
prepackaged form that prevents direct these comments appear to be products whether this proposed exemption
human contact with the food and that would be used in food for animals (proposed § 117.5(j)) would apply to
constitutes not more than 5 percent of rather than in human food, and we facilities such as peanut buying points
the overall sales of the facility. addressed these by-products in the 2014 or bean elevators and assert that such
commodities are analogous to grains area or to the operations that take place requirements for compliance under
and the activities conducted at such there and that storage areas, whether section 418 of the FD&C Act with
facilities are analogous to those standing alone as a separate facility or respect to facilities that are solely
performed by grain elevators. incorporated into a larger processing engaged in the storage of RACs (other
(Response 209) We classify peanuts facility, store RACs safely. These than fruits and vegetables) intended for
and beans (such as kidney beans, lima comments ask us to recognize that further distribution or processing (78 FR
beans, and pinto beans) within the storage activities may include grain 3646 at 3709). The plain meaning of
category of ‘‘fruits and vegetables’’; we drying to standardize moisture levels ‘‘solely’’ is only, completely, entirely;
classify soybeans as grain (see the and preserve product quality. These without another or others; singly; alone
discussion of fruits and vegetables, 78 comments also ask us to expand the (Ref. 44). Facilities that conduct
FR 3646 at 3690 and proposed §§ 112.1 exemption in § 117.5(j) to also apply to manufacturing/processing activities in
and 112.2 in the proposed produce distinct and physically separate storage addition to holding activities are not
safety rule). The exemption for facilities areas that are used solely for storage of ‘‘solely’’ engaged in the storage of RACs
solely engaged in storage of RACs RACs (other than fruits and vegetables) (other than fruits and vegetables)
intended for further distribution or intended for further distribution or intended for further distribution or
processing does not apply to facilities processing. processing. See also Response 233
that store fruit and vegetable RACs and, (Response 210) The activities regarding a similar request regarding the
thus, does not apply to facilities such as included within the definition of applicability of the requirements for
peanut buying points and bean holding include activities that are hazard analysis and risk-based
elevators. As discussed in Response 25, performed as a practical necessity for preventive controls to a facility solely
we have revised the ‘‘farm’’ definition to the distribution of RACs. In the 2014 engaged in the storage of unexposed
provide that an operation devoted to supplemental human preventive packaged food.
harvesting (such as hulling or shelling), controls notice, we explained that
packing, and/or holding of RACs is facilities that conduct operations similar J. Proposed § 117.5(k)—Exemption
within the ‘‘farm’’ definition as a to those conducted at grain elevators Applicable to Farms, Fishing Vessels,
secondary activities farm, provided that and silos, such as some facilities that Activities of ‘‘Farm Mixed-Type
the primary production farm(s) that hold oilseeds, may satisfy the criteria for Facilities’’ Within the Definition of
grows, harvests, and/or raises the exemption if activities other than ‘‘Farm,’’ the Holding or Transportation
majority of the RACs harvested, packed, storage are performed as a practical of One or More Raw Agricultural
and/or held by the secondary activities necessity for the distribution of RACs Commodities, and Specified Activities
farm owns, or jointly owns, a majority (see 79 FR 58524 at 58537 and the Conducted on Specified Raw
interest in the secondary activities farm. definition of ‘‘holding’’ in § 117.3). Agricultural Commodities
With this revision, some operations Examples of holding activities include We proposed to redesignate
dedicated to holding RACs, including drying/dehydrating RACs when the § 110.19(a) as proposed § 117.5(k) and
fruit and vegetable RACs, will be within drying/dehydrating does not create a revise the exemption that had been in
the ‘‘farm’’ definition. distinct commodity (see § 117.3). Thus, § 110.19(a) to provide that subpart B
Peanut buying points and bean the specific example of drying grains to would not apply to: (1) Farms; (2)
elevators that do not meet the revised standardize moisture levels and fishing vessels that are not required to
farm definition are storing RACs that are preserve product quality would fall register as a food facility; (3) the holding
‘‘fruits and vegetables’’ and do not meet within the definition of holding as a or transportation of one or more RACs;
the criteria for exemption under practical necessity for the distribution of (4) activities of ‘‘farm mixed-type
§ 117.5(j). However, we would not RACs. A facility that stores oilseeds, and facilities’’ that fall within the definition
expect such facilities to need an dries them as a practical necessity for of ‘‘farm’’; and (5) hulling, shelling, and
extensive food safety plan. A facility the distribution of RACs, would be drying nuts (without manufacturing/
that appropriately determines through covered by the exemption in § 117.5(j). processing, such as roasting nuts).
its hazard analysis that there are no However, we decline the request to (Comment 211) Some comments ask
hazards requiring preventive controls modify the exemption in § 117.5(j) to us to clarify whether the proposed
would document that determination in also apply to distinct and physically exemption for the holding or
its written hazard analysis but would separate storage areas that are used transportation of one or more RACs
not need to establish preventive controls solely for storage of RACs (other than (proposed § 117.5(k)) would apply to
and associated management fruits and vegetables) intended for any food establishment, or only apply to
components. further distribution or processing. To farms and farm mixed-type facilities.
(Comment 210) Some comments refer the extent that the comments are asking (Response 211) The exemption
to our statement that there would not be us to do so to provide for facilities that applies to any food establishment.
significant public health benefit to be conduct activities as a practical (Comment 212) Some comments ask
gained by subjecting facilities that solely necessity for the distribution of RACs to us to clarify that CGMP requirements
store non-fruit and vegetable RACs be eligible for the exemption, doing so (such as requirements for the plant
intended for further distribution or is not necessary in light of the definition design to permit the taking of adequate
processing to the requirements of of holding. To the extent that the precautions to protect food in outdoor
subpart C (78 FR 3646 at 3709) and comments are asking us to do so to bulk vessels (§ 117.20(b)(3)) and
assert that the same conclusion applies provide for facilities that conduct requirements for warehousing and
to those portions of oilseed processing manufacturing/processing activities in distribution (§ 117.93) do not apply to
facilities that are devoted solely to RAC addition to holding activities, we the bulk outdoor storage of RACs for
storage. According to these comments, disagree that doing so would be further processing.
in the overwhelming majority of cases consistent with the statutory direction (Response 212) We are returning to
the inclusion of a separate RAC storage in FSMA. As previously discussed, the long-standing approach that the
area in the same building as the oilseed section 418(m) of the FD&C Act exemption applies to establishments
processing area will not introduce provides in relevant part that we may by ‘‘solely engaged’’ in specific activities.
additional risk either to the processing regulation exempt or modify the Under the exemption we are
establishing in § 117.5(k)(1)(iii), those hazard analysis and risk-based to revise the RAC exemption in § 110.19
activities are holding and/or preventive controls for facilities that are so that it would exempt the specifically
transportation of RACs. Under the ‘‘solely engaged’’ in the storage of identified activities when performed on
exemption we are establishing in unexposed packaged food to storage RACs, regardless of whether the
§ 117.5(k)(1)(v), those activities are areas of facilities that also engage in establishment that conducts those
hulling, shelling, drying, packing, and/ food processing activities—e.g., for activities also conducts other activities
or holding nuts. We explain why in the distributors that are engaged in limited that do not qualify for the exemption, in
following paragraphs. food processing, such as cutting part because the exemptions in section
These comments appear to interpret vegetables or packing ready-to-eat foods. 418(j)(1) applied to ‘‘activities’’ (i.e.,
the proposed exemption in a way that In our response, we noted that such covered by parts 120, 123, and 113) (see
goes beyond the long-standing ‘‘RAC distributors are not ‘‘solely’’ engaged in 78 FR 3646 at 3710). However, section
exemption’’ in § 110.19 and is the storage of unexposed packaged food 418(j)(1) is premised on the existence of
inconsistent with our intent in updating (see Response 233). similar mandatory requirements for
§ 110.19 to adjust and clarify what The questions raised by these those specific foods. In contrast, there
activities fall within this exemption comments led us to reexamine the are no requirements similar to subpart B
based on experience and changes in reasons we gave, in the 2013 proposed in some situations that would be exempt
related areas of the law since issuance human preventive controls rule and the under an exemption broadly directed to
of this exemption from the CGMPs (78 2014 supplemental human preventive the activities of holding and
FR 3646 at 3710). The suggestion of controls notice, for describing these transportation. For example, there
these comments—i.e., that CGMPs exemption in terms of the activities would be no other requirements similar
should not apply to the holding of conducted without specifying that the to subpart B (e.g., for pest control)
RACS in a facility that manufactures, establishment is ‘‘solely engaged’’ in applicable to an off-farm establishment
processes, or packs RACs–would not conducting these activities. For that stores apples in a controlled
make sense in some circumstances and example, in the 2013 proposed human atmosphere storage facility or to an
would create difficulties for preventive controls rule we explained establishment that stores harvested dry
establishments (in determining how to our assumption that if activities subject beans. We now believe that a better
comply with the CGMP requirements) to the CGMPs take place in the same comparison is to other exemptions in
and for regulators (in determining how establishment, compliance with the FSMA, such as the exemption in section
to enforce the CGMP requirements). For CGMPs with respect to those activities 103(c)(1)(D)(i) of FSMA for facilities
example, it does not make sense for the should provide necessary protection. engaged only in specific types of on-
part of a facility that holds RACs prior The comments led us to question that farm manufacturing, processing,
to processing to be exempt and the parts assumption. For example, with respect packing or holding activities, and the
of the facility that are processing the to the question posed by the comments exemption in section 418(m) of the
RACs and storing them after processing about the outdoor bulk storage of RACs FD&C Act for facilities solely engaged in
to be covered. Likewise, it does not for further processing, it is not clear storage of RACs (other than fruits and
make sense for part of a transportation how conducting subsequent activities vegetables) intended for further
vehicle to be covered and part to be on the RACs in accordance with the distribution or processing. It is
exempt. CGMP requirements would protect the reasonable to infer that one reason for
By revising these two proposed RACs during outdoor bulk storage. As the use of ‘‘solely’’ in the statutory
exemptions that derive from the ‘‘RAC discussed more fully in Response 660, provisions in section 103(c)(1)(D)(i) of
exemption’’ so that they apply only to processing fresh produce into fresh-cut FSMA and in section 418(m) of the
establishments ‘‘solely engaged’’ in the products increases the risk of bacterial FD&C Act is to avoid some of the
storage and/or transportation of RACs, growth and contamination. RACs stored problems we have discussed in this
and to establishments ‘‘solely engaged’’ in bulk outdoors before being processed response.
in the hulling, shelling, drying, packing, into fresh-cut produce must be stored in In the 2013 proposed human
and/or holding of nuts, we are providing clean containers or vessels such that preventive controls rule, we stated our
for a predictable framework for these do not contribute to belief that activities should be regulated
interpreting exemptions for facilities contamination of the produce before it the same way regardless of whether
‘‘solely engaged’’ in other activities. For is processed. In addition, as already activities subject to the CGMP
example, as discussed in Comment 209, noted in this response, in interpreting requirements take place in same
comments ask us to expand the the exemptions from subparts C and G establishment. However, as with the
exemption (in § 117.5(j)) from the for facilities that are solely engaged in exemptions in section 103(c)(1)(D)(i) of
requirements for hazard analysis and the storage of RACs (other than fruits FSMA and section 418(m) of the FD&C
risk-based preventive controls for and vegetables) intended for further Act, this is a situation where context
facilities that are ‘‘solely engaged’’ in distribution or processing (§ 117.5(j)) matters. RACs that are the sole food in
the storage of RACs (other than fruits and for facilities solely engaged in the a warehouse are different from RACs
and vegetables) intended for further storage of unexposed packaged food being held in a manufacturing
distribution or processing to also apply (§ 117.7), we do not consider that the operation. As already noted in this
to distinct and physically separate exemption for these ‘‘holding’’ activities response and as discussed more fully in
storage areas that are used solely for applies when holding is part of other Response 660, processing fresh produce
storage of such RACs. In our response, operations conducted by the facility. For into fresh-cut products increases the
we noted that facilities that conduct example, the exemption in § 117.7 risk of bacterial growth and
manufacturing/processing activities in would not apply to a packaged food contamination, and produce being
addition to holding activities are not warehouse of a processing facility, even stored before processing into fresh-cut
‘‘solely engaged’’ in the storage of such if the warehouse only stores unexposed produce must be protected against
RACs (see Response 209). In addition, as packaged food. contamination while being stored.
discussed in Comment 233, comments In the 2013 proposed human The exemptions we are establishing in
ask us to apply the exemption (in preventive controls rule we tentatively this rule for establishments solely
§ 117.7) from the requirements for concluded that it would be reasonable engaged in the storage and/or
transportation of RACs, and for propose any exemptions or exceptions manufacturing, processing, packing, and
establishments solely engaged in from the requirements of subpart C holding of food to prevent adulteration
hulling, shelling, drying, packing, and/ other than those contained in section should no longer apply to a particular
or holding nuts (without additional 103 of FSMA (78 FR 3646 at 3657). type of food establishment and, thus, we
manufacturing/processing, such as Likewise, we did not propose any have declined these requests.
roasting nuts), remain consistent with additional exemptions from the CGMP
2. Facilities That Comply With the
our announced intent to adjust and requirements other than to adjust and
Pasteurized Milk Ordinance
clarify what activities fall within this clarify what activities fall within a long-
exemption based, in part, on changes in standing exemption related to RACs (Comment 214) Some comments
related areas of the law since this based on experience and changes in discuss facilities that comply with the
exemption from the CGMP requirements related areas of the law since issuance Grade ‘‘A’’ PMO and are regulated
was first issued. As discussed in section of the CGMP regulation (78 FR 3646 at under the National Conference on
IV, we have made a number of changes 3709–3711). Interstate Milk Shipments (NCIMS)
to the ‘‘farm’’ definition, including In the remainder of section XI.K, we system (PMO facilities). NCIMS has
changes that provide for an operation respond to the specific requests for been part of a cooperative program
devoted to harvesting, packing, and/or additional exemptions from the among the U.S. Public Health Service/
holding of RACs to be a ‘‘farm’’ (i.e., a requirements of subparts C and G for FDA, the States and the dairy industry
‘‘secondary activities farm’’) (and, thus, hazard analysis and risk-based since 1950. Procedures for Governing
be exempt from the CGMP requirements preventive controls. None of these the Cooperative Program of the NCIMS
under § 117.5(k)(1)(i)) even though the specific requests describe (or otherwise include procedures establishing milk
operation does not grow RACs (see provide) evidence demonstrating that sanitation standards, rating procedures,
§ 117.3). With this revised ‘‘farm’’ the regulatory framework associated sampling procedures, laboratory
definition, some establishments that had with the request would address all of procedures, laboratory evaluation and
relied on the ‘‘RAC exemption’’ in the requirements of subparts C and G. sample collector procedures. As
§ 110.19 to be exempt from CGMP Therefore, we have declined all of these previously discussed (78 FR 3646 at
requirements as establishments solely requests. In some cases, a facility that is 3662), the PMO is a model regulation
engaged in the ‘‘storage’’ of RACs, or subject to other Federal, State, or local published and recommended by the
because they were solely engaged in the regulations that have some of the same U.S. Public Health Service/FDA for
requirements as subparts C and G will voluntary adoption by State dairy
harvesting (such as hulling and shelling)
not have to repeat the same activity and regulatory agencies to regulate the
and storage (which includes drying) of
will be able to use any existing records production, processing, storage and
nuts, will be exempt from the CGMP
to demonstrate compliance and distribution of Grade ‘‘A’’ milk and milk
requirements because they are a ‘‘farm.’’
supplement those actions and records as products to help prevent milkborne
As a result, there are fewer operations
necessary to demonstrate compliance disease. Appendix K—HACCP Program
that need to rely on exemptions that are
with the remaining requirements of of the PMO—describes a voluntary,
an outgrowth of the long-standing RAC
subparts C and G (see, e.g., 79 FR 58524 NCIMS HACCP Program alternative to
exemption in § 110.19.
at 58542, Response 215, Response 216, the traditional inspection system. A
K. Comments Requesting Additional Response 219, and the discussion of milk plant, receiving station or transfer
Exemptions § 117.330 in section XLI.G). In one case station may not participate in the
(for facilities subject to the PMO; see voluntary NCIMS HACCP Program
1. Introduction
Response 214), we have extended the unless the regulatory agency responsible
(Comment 213) We received date for compliance with the for the oversight of the facility agrees to
comments requesting several additional requirements of subparts C and G in participate with the dairy plant(s),
exemptions from the requirements for light of comments expressing an intent receiving station(s) and transfer
hazard analysis and risk-based to revise the current requirements of a station(s) in the NCIMS HACCP
preventive controls in subpart C, the Federal/State cooperative program to Program. Currently all 50 States, the
CGMP requirements of subpart B, or incorporate the requirements of this District of Columbia, and Puerto Rico
both. See the remainder of section XI.K rule. In other cases, a facility may have adopted the PMO by reference or
for a description of the specific requests. determine and document through its have codified the PMO or similar
(Response 213) Each year, about 48 hazard analysis that no preventive provisions in State regulations. At its
million Americans (1 in 6) get sick, controls are necessary to prevent its biennial conferences, the NCIMS
128,000 are hospitalized, and 3,000 die food products from being adulterated considers changes and modifications to
from foodborne diseases, according to under section 402 of the FD&C Act or the Grade ‘‘A’’ PMO to further enhance
recent estimates from the Centers for misbranded under section 403(w) of the the safety of Grade ‘‘A’’ milk and milk
Disease Control and Prevention (CDC) FD&C Act (see, e.g., Response 222, products, including the administrative
(Ref. 45). This is a significant public Response 226, Response 229, and the and technical details on how to obtain
health burden that is largely discussion of § 117.130 in section XXV). satisfactory compliance. Changes
preventable. We believe that Such facilities, although not exempt, ultimately accepted by NCIMS voting
improvements to our CGMP regulations, will have a reduced burden to comply delegates (representatives from States
coupled with implementation of with the rule, if the outcome of their and territories) are forwarded to FDA for
FSMA’s directives to focus more on hazard analysis is that there are no concurrence before they become
preventing food safety problems than on hazards requiring preventive controls. effective.
reacting to problems after they occur, Likewise, in the remainder of section Some comments recommend that we
can play an important role in reducing XI.K we respond to the specific requests make full use of the existing milk safety
foodborne illness (other than foodborne for additional exemptions from the system of State regulatory oversight for
illnesses that are the result of improper CGMP requirements of subpart B. None Grade ‘‘A’’ milk and milk products
food handling practices in the home and of these requests provide a basis for why provided through the NCIMS and the
food service settings, which would not the long-standing CGMP provisions that food safety requirements of the PMO.
be addressed by this rule). We did not establish basic requirements for the Some comments assert that we are
exceeding our authority by requiring continuance of an effective milk safety date for PMO-regulated facilities to
PMO-regulated facilities to comply with system with State regulatory oversight. comply with the requirements of
both the PMO and the requirements of However, the PMO does not address all subparts C and G to September 17, 2018.
FSMA for hazard analysis and risk- of the requirements of subparts C and G, Doing so is consistent with the request
based preventive controls. such as requirements relevant to the of comments asking us to ‘‘stay’’ the
Some comments ask us to exempt potential presence of environmental application of the requirements for
PMO-regulated facilities (or the PMO- pathogens in the food processing hazard analysis and risk-based
regulated part of a PMO facility that also environment (see, e.g., preventive controls to PMO-regulated
produces food products not covered by §§ 117.130(c)(1)(ii) and facilities and work with the NCIMS
the PMO) from the requirements of the 117.150(a)(1)(ii)(B)). Such provisions cooperative program to effect the
rule for hazard analysis and risk-based could help to prevent food safety necessary modifications to the PMO so
preventive controls, or to otherwise problems from the consumption of food that it will include all of the
determine that facilities operating in produced by PMO facilities and play an requirements in the human preventive
compliance with the PMO are also in important role in reducing foodborne controls rule. The extended compliance
compliance with those requirements. illness. For example, in 2007, date is not equivalent to an exemption.
These comments suggest we could, as contamination of a PMO-regulated Regardless of whether the PMO is
an interim step if we find it necessary, facility with the environmental modified to include the requirements of
stay the application of these pathogen L. monocytogenes was the a final human preventive controls rule
requirements to PMO-regulated facilities cause of three deaths via listeriosis (Ref. by the extended compliance date, PMO
and work with the NCIMS cooperative 46). As another example, there have facilities must comply with the human
program to enact any modifications to been large-scale recalls as a result of preventive controls rule on September
the PMO as may be needed to warrant contamination of dried milk with the 17, 2018.
an exemption or comparability environmental pathogen Salmonella The extended compliance date also is
determination. The comments (Ref. 47). responsive to comments that identified
characterize these changes as ‘‘minor.’’ In addition, the NCIMS HACCP complex implementation issues
Some comments ask for clarification Program is a voluntary program and, as concerning the interstate movement of
as to whether the human preventive of March 17, 2015, had been utilized by milk and milk products and imported
controls rule would preempt the PMO if only 11 of approximately 625 PMO milk. If the requirements of this rule for
there are any conflicts or duplications facilities (Ref. 48). Further, the current hazard analysis and risk-based
between the human preventive controls NCIMS HACCP Program does not preventive controls are incorporated
rule and the PMO. Some comments ask address all of the requirements of into the PMO by the compliance date,
us to explain our position concerning subparts C and G, such as such implementation issues will be
the interstate movement of milk and environmental monitoring as a
moot, because a facility that complies
milk products and imported milk if the verification of sanitation controls for
with the revised PMO would also
final rule does not recognize that PMO- environmental pathogens and a supply-
regulated facilities are also in comply with this rule. As the
chain program for non-dairy ingredients
compliance with the requirements of the compliance date approaches, it will be
(Ref. 49). The PMO also does not
human preventive controls rule for clearer as to whether any or all of the
address food allergen controls, which
hazard analysis and risk-based necessary revisions to the PMO will be
are appropriate for those Grade ‘‘A’’
preventive controls. These comments in place by the compliance date for
facilities that also handle food
ask: (1) Whether the final rule will PMO facilities. If it appears that these
containing allergens other than milk.
become the de facto standard or the revisions will not be in place by the
The comments do not provide a basis
standard enforced by the FDA for the for why we should exempt PMO compliance date for PMO facilities, we
movement of milk in interstate facilities from the rule in light of the will take steps to address
commerce and for imported milk; (2) differences between the requirements of implementation issues specific to this
how the final rule will affect States that this rule and the requirements of the Federal/State cooperative program.
have adopted the PMO as their law/ PMO. In establishing a compliance date of
regulation for the production and NCIMS has initiated work to modify September 17, 2018 for PMO facilities,
processing of products such as fluid the PMO and that work is expected to we considered: (1) The extent of
milk products and cottage cheese; and include all of the requirements in a final revisions that must be made to
(3) how a final rule that does not human preventive controls rule. FDA incorporate the requirements of this rule
recognize the PMO and the products has committed resources to work with for hazard analysis and risk-based
made under the PMO will affect other the appropriate NCIMS Committees to preventive controls into the PMO; (2)
Federal rules, policy, procedures, or make the necessary changes. However, the process to revise the PMO; and (3)
practices that require compliance with the NCIMS process will not be complete the date at which the necessary
the PMO. in time for PMO facilities to meet the revisions to the PMO could begin to be
(Response 214) We agree that we first two compliance dates for this rule made. We discuss each of these
should make use of the existing system (i.e., September 19, 2016 for businesses considerations in the following
of State regulatory oversight for Grade other than small and very small paragraphs.
‘‘A’’ milk and milk products provided businesses, and September 18, 2017 for We disagree that the necessary
through the NCIMS and the food safety small businesses), because the next revisions to incorporate the
requirements of the PMO. The NCIMS scheduled Conference following the requirements of this rule for hazard
program has been effective from a publication of this final rule would be analysis and risk-based preventive
regulatory standpoint, and has likely April 2017. Therefore, to make use of controls into the PMO are ‘‘minor.’’
had a significant public health impact in the existing system of State regulatory There are gaps between the
reducing the incidence of foodborne oversight for Grade ‘‘A’’ milk and milk requirements of this rule and the current
illness attributable to milk and milk products provided through the NCIMS required and voluntary provisions of the
products. FDA is committed to the and the food safety requirements of the PMO (Ref. 49), and gaps such as
mission of the NCIMS and ensuring the PMO, we are extending the compliance provisions directed to environmental
monitoring, supply-chain controls, and implemented by a trained individual as supplement existing records associated
food allergen controls are not ‘‘minor.’’ meeting the requirements of the human with its HACCP plans and prerequisite
With respect to process, NCIMS preventive controls rule. Some of these programs with other required
considers changes and modifications to comments note that the NCIMS HACCP components of a food safety plan (such
the Grade ‘‘A’’ PMO at its biennial Program describes a voluntary, NCIMS as recall plan and, when applicable, a
conferences, and proposals with the HACCP Program alternative to the supply-chain program and written
necessary changes must be voted on at traditional inspection system. Other verification procedures for
such a biennial meeting. The next comments discuss the EU Dairy HACCP environmental monitoring) (see
scheduled biennial conference is in the Program and assert that the preventive § 117.330(b)). Moreover, the rule
spring of 2017. Although it may be controls system mandated by FSMA is provides additional flexibility for a
possible for NCIMS to convene a special a HACCP-like system but is not as facility that relies on both existing
conference in 2016 for the purpose of robust as the EU Dairy HACCP Program. records and newly established records
voting on proposals to revise the PMO Other comments ask us to support and to keep the records either separately or
to make it comply with the recognize industry-driven, mandatory combined (see § 117.330(b)).
requirements of this rule, practicalities programs that afford the same level of The flexibility provided by the
such as the availability of funds for a public health protection as the human provisions for use of existing records
special conference could interfere with preventive controls rule. also enables a facility to comply with
any plans for a special conference. In Other comments note that facilities the requirement (in § 117.310) for the
addition, given that we do not view the such as pizza manufacturing facilities owner, operator, or agent in charge of a
necessary changes as ‘‘minor,’’ it could are ‘‘dual jurisdiction’’ facilities, facility to sign and date the facility’s
take more than one round of proposals regulated and inspected by both FDA food safety plan, even when
for revising the PMO before a proposal and USDA’s Food Safety and Inspection components of the food safety plan are
receives the votes necessary to be Service (FSIS). These comments assert kept separately. For example, when the
adopted. Because the provisions of this that such facilities already are operating food safety plan consists of one or more
rule will not be established until the under FSIS-approved HACCP plans, and existing HACCP plans, one or more
date of publication of this final rule, any their HACCP plans cover FDA-regulated prerequisite programs that include food
preliminary drafts of proposals to products, as well as FSIS-regulated safety controls, a recall plan, a written
modify the PMO (e.g., to incorporate the products. These comments acknowledge supply-chain program, written
provisions that we proposed in the 2014 that there are differences between FSIS’ verification procedures such as
supplemental preventive controls HACCP regulation and FDA’s proposed environmental monitoring, and any
notice) before today’s date may need requirements for hazard analysis and other components required by the rule,
revision to reflect the final provisions of risk-based preventive controls but one approach for signing and dating the
the rule. nonetheless assert that requiring dual food safety plan could be to collect all
In light of all these considerations, we jurisdiction facilities to operate under these documents in a single location
are establishing September 17, 2018 as two different food safety plans would (e.g., a binder or folder) with a cover
the date for PMO facilities to comply result in unnecessary duplication of page containing the signature of the
with the requirements for hazard effort and confusion. owner, operator, or agent in charge of
analysis and risk-based preventive (Response 215) Whether a particular the facility and the date on which the
controls in part 117, subparts C and G. HACCP program implemented by a cover page was signed. However,
The compliance date for PMO facilities trained individual would satisfy the because the food safety plan also could
to comply with the CGMP requirements requirements of the human preventive be a set of documents kept in different
of subpart B is also September 17, 2018, controls rule will depend on whether locations within the facility, a facility
and PMO facilities will continue to the particular HACCP program satisfies could sign and date a list of the relevant
comply with part 110 until that date. all of the requirements of the rule. (See documents (e.g., as in a Table of
Under NCIMS procedures, changes Response 213.) For operations that have Contents). (See also the discussion in
agreed to by the voting delegates at the implemented HACCP programs that are Response 369 that a food safety plan
2017 NCIMS conference (and to which generally similar to the provisions of may be prepared as a set of documents
FDA concurs) would be effective within part 117, the burden of complying kept in different locations within the
one year of the electronic publication of should be minimal in light of the facility (e.g., based on where they will
the NCIMS documents; or by official provisions of § 117.330, which provides be used)).
notification by FDA to the States and for use of existing records. As an
example, if a facility has an existing 4. Facilities That Are Subject to
the dairy industry of ‘‘Actions from the
HACCP plan (or multiple HACCP plans Requirements for Acidified Foods
2017 NCIMS Conference;’’ or by a
previously determined effective date for different types of foods), supported (Comment 216) Some comments ask
(e.g., September 17, 2018). We believe by certain prerequisite programs that us to exempt (or partially exempt)
that the date of September 17, 2018 include food safety controls, the facility facilities that produce acidified foods
appropriately balances the need to would not need to duplicate or re-write from the requirements of subpart C,
realize the benefits of FSMA’s its existing HACCP plans or prerequisite because acidified foods are subject to
requirements for hazard analysis and programs, as long as the existing HACCP the specific food safety regulation in
risk-based preventive controls with the plans and prerequisite programs contain part 114 (21 CFR part 114) in addition
practicalities associated with revising all of the required information and to the CGMP requirements in subpart B.
the PMO to incorporate the satisfy the requirements of subpart F, or If we do not do so, these comments ask
are supplemented as necessary to us to clarify whether a scheduled
requirements of this rule.

include all of the required information process established for an acidified food
3. Facilities That Have an Established and satisfy the requirements of subpart would be accepted as a process that had
HACCP Program F (see § 117.330(a)). Because the rule been validated as a preventive control
(Comment 215) Some comments ask also provides that the required for a microbiological hazard. Some of
us to recognize operations that have an information does not need to be kept in these comments mention specific
established HACCP Program one set of records, a facility may acidified food products, such as salsa.
Other comments ask us to withdraw complying with the requirements of part Establishments that are solely engaged
part 114 and regulate acidified foods 114, including frequent pH testing and in the holding or transportation of shell
under part 117 to avoid confusion, and recording of results, to exercise eggs are exempt from the CGMP
then consider acidification as a sufficient control so that the finished requirements in subpart B (see the
preventive control. equilibrium pH values for acidified exemption for establishments solely
(Response 216) We agree that the foods are not higher than 4.6 engaged in the holding or transportation
specific CGMP requirements already (§ 114.80(a)(2)), and to address of one or more RACs in
established in part 114 play a key role deviations from scheduled processes § 117.5(k)(1)(iii)). Facilities that are
in the safe production of acidified foods, (§ 114.89). A facility that produces required to register, but are solely
but disagree that it would be acidified foods could demonstrate engaged in the storage of shell eggs
appropriate to exempt facilities that are compliance with the requirements of intended for further distribution or
subject to part 114 from the subparts C and G of this rule by relying processing, are exempt from the
requirements of subparts C and G. As on the records it is currently required to requirements for hazard analysis and
the comments suggest, the long-standing establish and maintain (§ 114.100), as risk-based preventive controls in
requirements of part 114 could function applicable, supplemented as necessary subparts C and G (see the exemption in
as a type of preventive control. (see § 117.330). § 117.5(j)).
However, part 114 does not address all (Comment 217) Some comments ask Shell egg processing facilities that are
of the requirements of subparts C and G, whether a qualified facility with regulated exclusively, throughout the
such as the requirement to address activities that are subject to part 114 entire facility, by USDA under the Egg
chemical and physical hazards. (Acidified Foods) would be exempt Products Inspection Act (21 U.S.C. 1031
We also disagree that we should from the requirements of Subpart C. et seq.) are exempt from the section 415
withdraw part 114 and simply consider (Response 217) A qualified facility is registration regulations and, thus, are
acidification as a preventive control exempt from the requirements of not subject to the requirements of this
under subparts C and G. The long- subparts C and G, and instead subject to rule for hazard analysis and risk-based
standing requirements of part 114 the modified requirements in § 117.201,
preventive controls (subparts C and G).
provide many details that do not fit for all foods that it produces, including
within the framework of this rule, and acidified foods. 6. Facilities That Produce Infant
we do not believe that it is in the best Formula
5. Egg Facilities
interest of public health to simply
(Comment 218) Some comments ask (Comment 219) Some comments ask
eliminate those details.
A processor of acidified foods can us to exempt shell egg facilities that are us to exempt the production of infant
consider its current scheduled also regulated by USDA and by State formula from the requirements of
processes, established in accordance shell egg grading programs from the subpart C after we issue a final rule
with part 114, when conducting the requirements of both subpart B and establishing requirements for CGMPs
hazard analysis required by this rule subpart C or at least recognize these and quality control procedures for
(§ 117.130). A processor of acidified establishments as meeting the infant formula.
foods could, through its hazard analysis, requirements for subpart B and Subpart (Response 219) We issued an interim
determine and document that the C without further routine FDA final rule entitled ‘‘Current Good
microbiological hazards associated with inspection. Some comments ask us to Manufacturing Practices, Quality
its products are addressed by preventive exempt shell egg establishments subject Control Procedures, Quality Factors,
controls in its scheduled processes to part 118 (21 CFR part 118) Notification Requirements, and Records
established under part 114. To the (Production, Storage, And and Reports, for Infant Formula’’ on
extent that the processor considers an Transportation Of Shell Eggs) from the February 10, 2014 (79 FR 7934) and a
existing scheduled process to be a requirements of subpart C because part final rule (the infant formula rule)
preventive control as that term is 118 already requires shell egg adopting, with some modifications, that
defined in this rule, the processor establishments to take specific, interim final rule on June 10, 2014 (79
would establish and implement concrete, steps to prevent the hazard FR 33057).
preventive control management Salmonella from contaminating eggs on We agree that the requirements of the
components (i.e., monitoring, corrective the farm and from further growth during infant formula rule play a key role in the
actions and corrections, and verification storage and transportation. safe production of infant formula, but
(including validation)) as appropriate to (Response 218) Shell eggs are RACs. disagree that it would be appropriate to
ensure the effectiveness of that The on-farm production of shell eggs is exempt facilities that are subject to the
preventive control, taking into account exempt from both the CGMP infant formula rule from the
the nature of the preventive control. requirements in subpart B (see the requirements of subparts C and G. The
Again, a processor of acidified foods can exemption for farms in § 117.5(k)(1)(i)) infant formula rule does not address all
consider its current procedures, and from the requirements for hazard of the requirements of subparts C and G,
established in accordance with part 114, analysis and risk-based preventive such as requirements relevant to the
when determining what preventive controls in subparts C and G (because a potential presence of environmental
control management components to ‘‘farm’’ is exempt from the requirement pathogens in the food processing
establish and implement. For example, to register as a food facility). Likewise, environment (see, e.g.,
a facility that previously validated a the packing of shell eggs by egg §§ 117.130(c)(1)(ii) and
scheduled process can rely on its packinghouses that are within the 117.150(a)(1)(ii)(B)). As with products
existing validation records and would ‘‘farm’’ definition established during such as acidified foods (see Response
not need to repeat the validation or this rulemaking are exempt from both 216), a manufacturer of infant formula
make a new record. Processes issued by the CGMP requirements in subpart B could demonstrate compliance with the
a process authority for acidified foods and the requirements for hazard requirements of subparts C and G of this
are generally accepted as validated analysis and risk-based preventive rule by relying on the records it is
processes. As another example, a facility controls in subparts C and G, (see currently required to establish and
can consider its current procedures for Response 25). maintain (§ 106.100), as applicable,
supplemented as necessary (see defined as that which is needed to required to register is required by the
§ 117.330). accomplish the intended purpose in statute (see the definition of facility in
keeping with good public health section 418(o)(2) of the FD&C Act).
7. Small Businesses
practice. As another example, Section 418(h) of the FD&C Act requires
(Comment 220) Some comments ask provisions directed to raw materials that a facility prepare and implement a
us to provide more exemptions for small require that they be washed or cleaned food safety plan, unless an exemption
farms and small facilities. ‘‘as necessary’’ to remove soil or other applies. Neither FSMA nor this rule
(Response 220) We decline this contamination (see § 117.80(b)(1)). establishes a broad exemption for ‘‘low-
request. As discussed in Response 213, Moreover, some comments point out risk’’ facilities, including ‘‘low-risk’’
the exemptions we are establishing are that one strength of the long-standing facilities that are regularly inspected by
those provided by section 103 of FSMA. CGMPs is their applicability to the State, local, or tribal government
Small farm that only conduct activities broad spectrum of food manufacturing, agencies. As discussed in Response 213,
within the ‘‘farm’’ definition are not from the manufacture of processed the exemptions we are establishing are
subject to the human preventive products and packaging of fresh those specifically authorized by the
controls rule. Small farms that also produce to production of food additives statute.
conduct activities outside the ‘‘farm’’ and GRAS substances (see section VIII).
definition (such as manufacturing jams The new requirements for hazard
(As already noted, some packaging of analysis and risk-based preventive
or jellies) (and, thus, are farm mixed- fresh produce (e.g., packaging of RACs
type facilities) are eligible for an controls are not ‘‘one-size-fits-all,’’ and
on a farm) is not subject to the CGMPs.) facilities that are subject to the rule
exemption if the only such activities (Comment 222) Some comments
they conduct are the low-risk activity/ would consider the risk presented by
assert that we should not base the
food combinations specified in the the products as part of their hazard
requirements for hazard analysis and
exemptions in § 117.5(g) and (h). Small evaluation. (See § 117.130(c)(1)(i),
risk-based preventive controls on the
farms that are subject to this rule as farm which requires that the hazard analysis
status of a business as a facility that is
mixed-type facilities, and other small include an evaluation of identified
required to register under the section
businesses, will have an extra year to known or reasonably foreseeable
415 registration regulations if there is no
comply with the rule. As discussed in hazards to assess the severity of the
risk from consumption of food produced
Response 222, the new requirements for illness or injury if the hazard were to
by that business. Some comments assert
hazard analysis and risk-based occur and the probability that the
that a food safety plan should only be
preventive controls are flexible, and the required for high-risk processing hazard will occur in the absence of
preventive controls (if any) that a facilities because adhering to CGMPs is preventive controls.) Although each
facility would establish and implement sufficient for low-risk facilities. Some facility subject to the rule must prepare
would depend on the outcome of the comments assert a food safety plan and implement a food safety plan, the
facility’s hazard analysis and therefore should be required for large businesses, preventive controls that the facility
would be tailored to the operation. but not for small and medium-size would establish and implement would
These aspects of this rulemaking businesses, including small businesses depend on the facility, the food, and the
provide ample flexibility to small that manufacture low-risk foods that are outcome of the facility’s hazard analysis
businesses. sterilized before being eaten and already (§§ 117.130 and 117.135(c)). In addition,
undergo a 48-point inspection twice a the preventive control management
8. Exemptions Based on Risk components (i.e., monitoring, corrective
year.
(Comment 221) Some comments ask Some comments ask us to adopt a actions and corrections, and
us to exempt facilities identified as commodity-specific approach to the verification) that a facility would
conducting low-risk activities from the exemptions and to only apply the establish and implement for its
CGMP requirements. requirements for hazard analysis and preventive controls would be
(Response 221) We decline this risk-based preventive controls to RACs established as appropriate to ensure the
request. The umbrella CGMPs that we that fall within the five highest-risk effectiveness of the preventive controls,
are establishing in subpart B are long- commodity groups and to any other taking into account the nature of the
standing provisions that establish basic specific commodities that we determine preventive control and its role in the
requirements for the manufacturing, pose a comparable risk based on facility’s food safety system
processing, packing, and holding of food outbreak history and the commodity’s (§ 117.140(a)). A facility that
to prevent adulteration. For example, characteristics. appropriately determines through its
food that is exposed must be protected Other comments note that some States hazard analysis that no preventive
against contamination from the plant’s provide ‘‘exemptions’’ for ‘‘non- controls are necessary to prevent its
grounds, the design and construction of potentially-hazardous foods.’’ These food products from being adulterated
the plant, and sanitary operations comments assert that there should be under section 402 of the FD&C Act or
regardless of whether the national agreement on what such foods misbranded under section 403(w) of the
uncontaminated food could be ‘‘high- are and, if such foods are truly low risk, FD&C Act would document that
risk’’ or ‘‘low-risk’’; contamination there should not be onerous determination in its written hazard
introduced during the production of requirements regardless of the size of analysis but would not need to establish
food can adulterate any food. In the business. preventive controls and associated
addition, these umbrella CGMPs are not (Response 222) We decline these preventive control management
‘‘one-size-fits-all’’ in that many requests to establish additional components for its products. A facility
provisions provide flexibility to tailor exemptions based on risk, other than the that is a very small business as that term
specific practices to the nature of the exemptions for on-farm low-risk is defined in this rule is exempt from
food and the activities being conducted. activity/food combinations provided by the requirements of subparts C and G,
For example, many provisions establish section 103(c)(1)(D) of FSMA (§ 117.5(g) including the requirement to prepare
a performance standard in which the and (h)). The applicability of the and implement a food safety plan, and
measures taken must be ‘‘adequate’’ to requirements of the human preventive is instead subject to the modified
comply with the rule, where adequate is controls rule to facilities that are requirements in § 117.201.
We expect that there will be many and/or raises the majority of the nuts RACs is not otherwise exempt from
circumstances in which a facility owns, or jointly owns, a majority either the CGMP requirements or the
appropriately determines that certain interest in the hulling/shelling requirements for hazard analysis and
biological, chemical, or physical operation). Because hulling/shelling is a risk-based preventive controls. As
hazards are not hazards requiring a harvesting activity, not a holding discussed in Response 221, the umbrella
preventive control that must be activity, those hulling/shelling CGMPs that we are establishing in
addressed in the food safety plan. There operations that are not within the subpart B are long-standing provisions
are several types of food products for ‘‘farm’’ definition are not eligible for the that establish basic requirements for the
which a facility may determine that exemption for facilities solely engaged manufacturing, processing, packing, and
there are no hazards requiring a in the storage of RACs (other than fruits holding of food to prevent adulteration.
preventive control. Such products could and vegetables) intended for further Packing operations that are within the
include, but are not limited to: many distribution or processing (§ 117.5(j)). ‘‘farm’’ definition are exempt from the
crackers, most bread, dried pasta, many As discussed in Response 222, there is requirements for hazard analysis and
cookies, many types of candy (hard no exemption for ‘‘low-risk operations.’’ risk-based preventive controls (because
candy, fudge, maple candy, taffy and However, a facility that appropriately ‘‘farms’’ are exempt from the section 415
toffee), honey, molasses, sugar, syrup, determines through its hazard analysis registration requirements for
soft drinks, and jams, jellies, and that there are no hazards requiring ‘‘facilities’’). As discussed more fully in
preserves from acid fruits. preventive controls would document Response 222, the new requirements for
that determination in its written hazard hazard analysis and risk-based
9. Hullers/Shellers
analysis but would not need to establish preventive controls are not ‘‘one-size-
(Comment 223) Some comments ask preventive controls and associated fits-all.’’ Although each facility subject
us to clarify whether an operation solely management components. to the rule must prepare and implement
engaged in hulling/shelling would
10. Fruit and Vegetable RACs a food safety plan, the preventive
qualify for the exemption from the
controls that the facility would establish
requirements for hazard analysis and (Comment 224) Some comments ask
and implement would depend on the
risk-based preventive controls for us to clarify the two exemptions
facility, the food, and the outcome of the
facilities that solely are engaged in the applicable to RACs—i.e., the exemption
facility’s hazard analysis. In addition,
storage of RACs (other than fruits and from CGMP requirements for the
the preventive control management
vegetables) intended for further holding or transportation of one or more
distribution or processing (§ 117.5(j)). RACs (§ 117.5(k)) and the exemption components that a facility would
Other comments ask us to clarify from the requirements for hazard establish and implement for its
whether an operation that is solely analysis and risk-based preventive preventive controls would be
engaged in hulling/shelling and, thus, is controls for facilities solely engaged in established as appropriate to ensure the
exempt from the CGMP requirements of the storage of RACs (other than fruits effectiveness of the preventive controls,
subpart B would also be exempt from and vegetables) intended for further taking into account the nature of the
the requirements for hazard analysis distribution or processing (§ 117.5(j)). preventive control and its role in the
and risk-based preventive controls in These comments ask whether an off- facility’s food safety system.
subpart C. Some of these comments farm holding facility that strictly deals 11. Enclosed Outdoor Vessels
assert that it seems contrary to the with fruit and vegetable RACs would be
principles of HACCP that a facility that exempt from subpart B, but not subpart (Comment 225) Some comments ask
is not required to implement CGMPs C. us to exempt enclosed outdoor vessels
(which is a foundation of HACCP) Some comments assert that operations from the specific CGMP provisions
would still need to develop a food safety that pack RACs other than fruits and (such as requirements for the plant
plan. Some comments assert that vegetables intended for further design to permit the taking of adequate
requiring these operations to apply distribution or processing should be precautions to protect food in outdoor
HACCP standards to what is an exempt from both CGMP requirements bulk vessels (§ 117.20(b)(3)) and
extension of harvesting is overkill, and requirements for hazard analysis requirements for warehousing and
because the consumer is ultimately and risk-based preventive controls. distribution (§ 117.93)) if they are
protected by processes at the handler These comments ask us to expand the properly ‘‘risk assessed’’ and covered by
(processor) level. Other comments assert exemption from CGMP requirements for appropriate procedures for preventing
that our clarification that operations that the holding or transportation of one or contamination, and system verification
hull/shell/dry nuts are exempt from the more RACs to include the packing of is implemented.
CGMP requirements recognizes that RACs (other than fruits and vegetables). (Response 225) We decline this
hulling/shelling activities are low risk These comments also ask us to include request. The long-standing CGMP
and do not alter the status of a RAC. packing RACs in the exemption from requirements are comprehensive,
Because the requirements for hazard subpart C for facilities solely engaged in interrelated provisions intended to
analysis and risk-based preventive the storage of RACs (other than fruits prevent the adulteration of food.
controls will be applied by those and vegetables) intended for further Specifying particular provisions that
receiving product from the huller/ distribution or processing. would not apply if a food establishment
sheller, it does not seem appropriate for (Response 224) Under the revised appropriately implements other
an operation that is explicitly exempt ‘‘farm’’ definition, some operations that provisions would be contrary to this
from CGMP requirements to be required pack RACs will be within the ‘‘farm’’ comprehensive approach to food safety,
to conduct a hazard analysis, implement definition (i.e., if the farms that grow or in addition to being both impractical
controls, conduct monitoring, etc. raise the majority of the RACs own, or and difficult to administer. If a food
(Response 223) Under the revised jointly own, a majority interest in the establishment has appropriately
‘‘farm’’ definition, some hulling/shelling packing operation). Packing operations determined that its procedures for
operations will be within the ‘‘farm’’ that are within the ‘‘farm’’ definition are preventing contamination adequately
definition (i.e., if the primary exempt from the CGMP requirements address the requirements for the safe
production farm(s) that grows, harvests, (§ 117.5(k)(1)). However, the packing of storage of food in enclosed outdoor
vessels, it should have no difficulty being considered under the 2013 not expect them to register; therefore
demonstrating that during inspection. proposed produce safety rule) or to these operations would not be subject to
establish a higher sales limit (i.e., the requirements of subparts C and G for
12. Supermarket Distribution Centers
$100,000) applicable to both the human hazard analysis and risk-based
(Comment 226) Some comments ask preventive controls rule and the preventive controls.
us to exempt supermarket distribution produce safety rule. We also decline the request not to
centers from the requirements of subpart (Response 227) We decline the cover facilities with less than $25,000 or
C and instead require them to have requests to exempt (or partially exempt) $100,000 in annual sales. (See the
written CGMPs. If this request is not the business models described in these discussion in Response 220, in which
accepted, then these comments ask us to we declined the request to provide more
comments. (See Response 213.) None of
either exempt supermarket distribution exemptions for small farm mixed-type
these requests describe or provide
centers from the requirements of subpart facilities and other small facilities).
evidence that the regulatory framework
C for those packaged foods not exposed However, if a local or regional facility
associated with the business model
to the environment (with modified such as those described in the
would address all of the requirements of
requirements for unexposed, comments is a very small business, the
subparts C and G. Many of the types of
refrigerated, packaged TCS foods), or facility would be subject to modified
facilities listed have multiple business
specify that there are no significant requirements (§ 117.201) rather than to
models that conduct different types of
hazards for such a facility to address in the full requirements for hazard analysis
activities. For example, USDA defines a
a food safety plan. and risk-based preventive controls.
(Response 226) A supermarket regional food hub as ‘‘a business or
When such an operation is not a farm,
distribution center must register as a organization that actively manages the
a retail food establishment, or a very
food facility because it holds food for aggregation, distribution, and marketing
small business, the preventive controls
human consumption and does not of source-identified food products
that a facility would establish and
satisfy any of the criteria for entities that primarily from local and regional
implement would depend on the
are not required to register (see § 1.226). producers to strengthen their ability to
facility, the food, and the outcome of the
As discussed in Response 222, the satisfy wholesale, retail, and
facility’s hazard analysis, and any
preventive controls that a facility would institutional demand.’’ (Ref. 50). Some
preventive control management
establish and implement would depend food hubs have facilities at which they
components associated with a facility’s
on the facility, the food, and the conduct activities, including dry and preventive controls would be
outcome of the facility’s hazard cold storage, grading, packing, labeling, established as appropriate to ensure the
analysis, and any preventive control and light processing (trimming, cutting, effectiveness of the preventive controls,
management components associated and freezing), whereas other food hubs taking into account the nature of the
with a facility’s preventive controls never physically handle the product preventive control and its role in the
would be established as appropriate to sold but instead rely on farmers and facility’s food safety system. (See
ensure the effectiveness of the contract trucking firms to provide Response 222.)
preventive controls, taking into account aggregation and transportation services
the nature of the preventive control and (Ref. 50). Some food hubs have a farm- 14. Production of Raw Sugar
its role in the facility’s food safety to-business model (e.g., selling to food (Comment 228) Some comments ask
system. In the case of a facility that is cooperatives, grocery stores, us to exempt the production of raw
a supermarket distribution center, the institutional foodservice companies, sugar that is destined for refining from
facility would, as part of its evaluation, and restaurants), while others have a the requirements in subpart C for hazard
determine whether any preventive farm-to-consumer model (i.e., selling analysis and risk-based preventive
controls are necessary for unexposed, directly to the consumer, e.g., through a controls.
non-refrigerated packaged foods. The CSA), and some are hybrids that do both (Response 228) Making sugar from
facility might determine that the (Ref. 50). Some food hubs combine sugarcane or sugar beets is a low-risk
modified requirements in § 117.206 for produce distribution with food activity/food combination (see
unexposed, refrigerated, packaged TCS processing operations (shared § 117.5(h)), and the statutory exemption
foods are appropriate to apply to such commercial processing space, or in § 117.5(h) would apply to a small or
foods that it holds. If so, the facility ‘‘incubator kitchens’’). Thus, some of very small business that makes sugar
could establish its food safety plan by these operations could be exempt. For on-farm if the only other activities it
building on the provisions established example, some of these operations may conducts outside the farm definition are
in § 117.206. fall within the revised ‘‘farm’’ definition the low-risk activity/food combinations
(e.g., if the farms that grow or raise the in § 117.5(g) and (h).
13. Local and Regional Facilities Such majority of the RACs own, or jointly We decline the request to extend this
as Kitchen Incubators, Food Hubs, and own, a majority interest in a food hub exemption to a small or very small
Grower Marketing Cooperatives or a grower marketing cooperative and business that makes sugar off-farm or to
(Comment 227) Some comments ask the food hub or grower marketing a business that is not a small or very
us to provide flexibility to local and cooperative does not conduct any small business (see Response 213). As
regional facilities that do not qualify for activities outside of the ‘‘farm’’ discussed in Response 222, the
an exemption from subpart C (e.g., definition). Other operations could be preventive controls that such businesses
‘‘kitchen incubators’’ and farm mixed- exempt if they fall within the definition would establish and implement would
type facilities that are subject to State or of ‘‘retail food establishment’’ (see depend on the facility, the food, and the
local laws). Some comments ask us to Response 4). With respect to produce outcome of the facility’s hazard
exempt (or partially exempt) food hubs, auction houses, to the extent that these analysis, and any preventive control
grower marketing cooperatives, operations are simply a location for management components associated
‘‘produce auctions,’’ and similar buyers and sellers to meet and to sell with a facility’s preventive controls
entities. Some comments ask us not to and transfer produce and the food is not would be established as appropriate to
cover facilities with less than $25,000 in stored, we do not consider such ensure the effectiveness of the
annual sales (similar to a provision facilities to be holding food and would preventive controls, taking into account
the nature of the preventive control and biological, chemical, or physical established in § 117.206 of subpart D
its role in the facility’s food safety hazards are not hazards requiring a (proposed § 117.7(b)).
system. An off-farm facility that makes preventive control that must be Some comments support these
sugar from sugarcane or sugar beets can addressed in the food safety plan. The proposed provisions without change.
consider the findings of the section provisions of the rule that allow a For example, one comment expresses
103(c)(1)(C) RA (i.e., that this is a low- facility to appropriately determine that the view that the safety of these
risk activity/food combination) in a particular hazard is not a hazard products would be ensured during the
determining whether there are any requiring a preventive control in certain manufacturing process by companies
hazards requiring a preventive control. food products are not equivalent to an that comply with the stringent
A facility that appropriately determines exemption from the rule. For example, requirements of the proposed rule, and
through its hazard analysis that there a facility that appropriately determines no new hazards will be introduced to
are no hazards requiring preventive that there are no hazards requiring a the food at these facilities. Other
controls would document that preventive control associated with its comments that support the proposed
determination in its written hazard food products must document that provisions ask us to clarify some aspects
analysis but would not need to establish determination in its written hazard of the provisions (see, e.g., Comment
preventive controls and associated analysis (§ 117.130(a)(2)); however, no 230) or to clarify how the provisions
management components. preventive controls, including supplier will apply in particular circumstances
verification activities, and associated (see, e.g., Comment 231 and Comment
15. Biological Hazards in Olive Oil
management components would be 232). Other comments that support the
(Comment 229) Some comments ask required in such a situation. As proposed provisions ask us to broaden
us to establish an exemption for the discussed in Response 222, there are them (see, e.g., Comment 233, Comment
consideration of biological hazards such several types of food products for which 234, and Comment 235).
as Salmonella and pathogenic E. coli in a facility may determine that there are In the following paragraphs, we
olive oil. no hazards requiring a preventive discuss comments that ask us to clarify
(Response 229) We decline this control. the proposed requirements or that
request. The rule requires the facility to disagree with, or suggest one or more
XII. Subpart A: Comments on Proposed
conduct a hazard analysis to determine changes to, the proposed requirements.
§ 117.7—Applicability of Part 117 to a
hazards requiring a preventive control. After considering these comments, we
Facility Solely Engaged in the Storage
If the facility appropriately determines have revised the proposed requirements
of Unexposed Packaged Food
through its hazard analysis that as shown in table 17, with editorial and
biological hazards such as Salmonella We proposed that subpart C would conforming changes as shown in table
and pathogenic E. coli are not hazards not apply to a facility solely engaged in 52. A key conforming change that affects
requiring a preventive control in its the storage of packaged food that is not § 117.7 is that the final exemption is
product, then these hazards would not exposed to the environment (proposed from the requirements of subpart G, as
be addressed in the facility’s food safety § 117.7(a)). We also proposed that a well as subpart C. As discussed in
plan. facility solely engaged in the storage of section XLII, the final rule establishes
We expect that there will be many packaged food that is not exposed to the the requirements for a supply-chain
circumstances in which a facility environment would be subject to the program in subpart G, rather than
appropriately determines that certain modified requirements that would be within subpart C as proposed.
TABLE 17— REVISIONS TO THE PROPOSED APPLICABILITY OF SUBPARTS C AND D TO A FACILITY SOLELY ENGAGED IN
THE STORAGE OF UNEXPOSED PACKAGED FOOD
Section Description Revision
117.7(b) ........................ Applicability of subpart Clarification that subpart D only applies to those unexposed packaged foods that require
D. time/temperature control to significantly minimize or prevent the growth of, or toxin produc-
tion by, pathogens.
(Comment 230) Some comments ask packaged food, including unexposed (Response 231) We decline this
us to clarify the interplay between the packaged food that requires time/ request. In the 2013 proposed human
proposed exemption (proposed § 117.7) temperature control to significantly preventive controls rule, we tentatively
and the proposed modified minimize or prevent the growth of, or concluded that it would be rare for a
requirements (proposed § 117.206) to toxin production by, pathogens is frozen food to be a TCS food (78 FR
better reflect that the modified subject to the modified requirements in 3646 at 3774), and we affirm that
requirements would apply only to TCS § 117.206 of subpart D for any conclusion in this document. However,
foods. Some comments ask us to clarify unexposed packaged food that requires specifying in the regulatory text that a
that if a facility stores both TCS food time/temperature control to frozen food is not a TCS food would
and non-TCS food (i.e., unexposed significantly minimize or prevent the require us to conclude that a frozen food
packaged food that does not require growth of, or toxin production by, would ‘‘never’’ (rather than ‘‘rarely’’) be
time/temperature control for safety), pathogens. a TCS food, and we lack information to
then the modified requirements only support ‘‘never.’’

apply for the portion of the facility that (Comment 232) Some comments
holds the TCS foods. us to revise the regulatory text to be
explicit that frozen unexposed packaged assert that a hazard analysis of the risks
(Response 230) We have revised food is not a TCS food subject to associated with storage of produce in
§ 117.7(b) to clarify that a facility solely modified requirements. vented crates would reveal no
engaged in the storage of unexposed significant hazards and, thus, that even
if we do not agree that produce (Response 233) We disagree with the requirements of section 418 with respect
packaged in vented crates satisfies the comment’s interpretation of the term to the activities subject to those
criterion ‘‘not exposed to the ‘‘solely.’’ The plain meaning of ‘‘solely’’ regulations but not with respect to other
environment,’’ we should exercise is only, completely, entirely; without activities (78 FR 3646 at 3704).
enforcement discretion for produce another or others; singly; alone (Ref. 44). (Response 234) We disagree that a
packaged in vented crates. The facility described in the comment is designated storage area in an
(Response 232) As discussed in not ‘‘solely’’ engaged in the storage of establishment that conducts
Response 170, produce stored in vented unexposed packaged food. manufacturing, processing, or packing
crates is not ‘‘unexposed packaged Such a facility must conduct a hazard in addition to storage can fall within the
food.’’ Although environmental analysis that addresses all activities exemption for facilities ‘‘solely engaged
exposure to produce packed in vented conducted by the facility. As discussed in . . . storage.’’ The statute provides
crates would be less than environmental in Response 222, the preventive controls authority for us to exempt or modify the
exposure to produce packed in open that the facility would establish and requirements for compliance with
crates, a vented crate can subject implement would depend on the respect to ‘‘facilities’’ that are solely
produce to contamination. Thus, we facility, the food, and the outcome of the engaged in the storage of packaged foods
disagree that we should not enforce the facility’s hazard analysis, and any that are not exposed to the environment
provisions of the rule for such produce. preventive control management (section 418(m) of the FD&C Act). The
A facility that stores produce packed in components associated with a facility’s statute defines ‘‘facility’’ as a domestic
vented crates must conduct a hazard preventive controls would be facility or a foreign facility that is
analysis and evaluate whether there are established as appropriate to ensure the required to register under section 415 of
any hazards requiring a preventive effectiveness of the preventive controls, the FD&C Act (section 418(o)(2) of the
control. However, as discussed in taking into account the nature of the FD&C Act). The section 415 registration
Response 222, the preventive controls preventive control and its role in the regulations define facility as ‘‘any
that the facility would establish and facility’s food safety system. A facility establishment, structure, or structures
implement would depend on the that stores unexposed packaged food under one ownership at one general
facility, the food, and the outcome of the that is not a TCS food could, for physical location . . .’’ The comment’s
facility’s hazard analysis, and any example, determine that no preventive interpretation that we could view
preventive control management controls and associated management ‘‘areas’’ of registered facilities to be
components associated with a facility’s components would be necessary for ‘‘facilities that are solely engaged in . . .
preventive controls would be those foods. A facility that stores the storage of packaged foods that are
established as appropriate to ensure the unexposed refrigerated packaged TCS not exposed to the environment’’ is
effectiveness of the preventive controls, food could, for example, determine that inconsistent with the statutory and
taking into account the nature of the preventive controls and management regulatory framework under sections
preventive control and its role in the components patterned after the 415 and 418 of the FD&C Act.
facility’s food safety system. A facility modified requirements in § 117.206 are See also the discussion in Response
that appropriately determines through adequate to address hazards requiring a 233 regarding how a facility that both
its hazard analysis that there are no preventive control associated with that stores unexposed packaged food and
hazards requiring a preventive control food. conducts activities such as food
associated with its food products would (Comment 234) Some comments ask processing or packing could address the
document that determination in its us to allow a facility to designate a requirements for hazard analysis and
written hazard analysis (§ 117.130(a)(2)) storage area as a separate facility for risk-based preventive controls for the
but would not need to establish purposes of compliance with the storage activities conducted by the
preventive controls and associated requirements for hazard analysis and facility.
preventive control management risk-based preventive controls. In the (Comment 235) Some comments ask
components for its products. comments’ view, an area solely engaged us to consider an alternative to the
(Comment 233) Some comments ask in the storage of unexposed packaged exemption for unexposed packaged
us to apply the exemption to storage food could fall within the exemption in foods when a facility conducts
areas of facilities that also engage in § 117.7 even though other areas would manufacturing, processing, packing, or
food processing activities—e.g., for be subject to the requirements for holding activities in addition to storing
distributors that are engaged in limited hazard analysis and risk-based unexposed packaged food. Specifically,
food processing, such as cutting preventive controls. these comments ask us to recognize that
vegetables or packing RTE foods. These Some comments contrast our the minimal risks of storing unexposed
comments assert that the intent of the proposed approach to applying the packaged foods can be addressed
term ‘‘solely’’ is to make clear that a statutory provision for facilities ‘‘solely through a combination of compliance
facility that conducts an activity subject engaged in . . . storage’’ with our with the modified requirements for TCS
to the exemption does not escape proposed approach to applying section foods (if applicable) and the CGMPs in
responsibility for complying with the 418 of the FD&C Act to farm mixed-type subpart B and state that doing so would
requirements for hazard analysis and facilities and facilities that conduct be consistent with our discussion in the
risk-based preventive controls when activities subject to one of our HACCP 2013 proposed human preventive
conducting activities that are not regulations. These comments point out controls rule.
exempt. In the comment’s example, a that, for farm mixed-type facilities, we (Response 235) These comments
facility that cuts vegetables or packs determined that section 418 applies appear to suggest the outcome of a
RTE foods would prepare and only with respect to the activities that facility’s hazard analysis for storing
implement a food safety plan for cutting trigger registration (78 FR 3646 at 3705). unexposed packaged food—i.e., that the
vegetables and packing RTE foods, but Likewise, these comments point out that only hazards requiring a preventive
would not conduct a hazard analysis to for facilities that conduct activities control are the potential for growth of
determine whether there are significant subject to our HACCP regulations for pathogens in refrigerated unexposed
hazards for storing unexposed packaged seafood or juice, we determined that the packaged foods and that the preventive
food. facilities can be exempt from the controls and preventive control
management components specified in Food Technologists (Ref. 52). A facility with some revisions to modernize them.
the modified requirements for TCS food solely engaged in storage of unexposed Some comments agree with one or more
are adequate to address such hazards. It packaged food can consult the Food of these proposed provisions without
is the responsibility of the facility’s Code or work with the manufacturer of change. For example, some comments
preventive controls qualified individual the food to identify TCS food. state that the proposed provisions for
to identify the hazards requiring a Alternatively, such a facility could disease control are already widely
preventive control associated with the simply treat any refrigerated food as a practiced across the produce industry
facility and the food it stores, as well as TCS food. and are part of most food safety
the appropriate preventive controls and Although we agree with comments
guidance and standards. Some
preventive control management that in general yogurt would not be a
comments that support the proposed
components. However, we agree that in TCS food, whether a particular yogurt is
a TCS food would depend on what is revisions suggest alternative or
some cases the approach suggested in
these comments would be appropriate. added to the yogurt. For example, in additional regulatory text (see, e.g.,
(Comment 236) Some comments 1989 an outbreak of foodborne botulism Comment 243 and Comment 244) or ask
assert that it is difficult to identify TCS in the United Kingdom from the us to clarify how we will interpret the
foods and that the benefits of consumption of yogurt containing revised provision (see, e.g., Comment
undertaking that work are unclear when added hazelnut conserve (puree) caused 239). Other comments that support
existing CGMP requirements protect 27 illnesses and one death (Ref. 53). The provisions that we proposed to re-
public health. These comments ask us to hazelnut puree had not been adequately establish in part 117 without change ask
work with industry and professional processed to prevent toxin production us to revise or clarify those provisions
organizations to develop guidance on by C. botulinum. Even though this (see, e.g., Comment 237, Comment 238,
when the modified requirements apply. particular outbreak was not related to Comment 240, and Comment 241).
Other comments ask us to specify that the question of whether yogurt is a TCS In the following sections, we discuss
specific foods such as yogurt are not food, it demonstrates the importance of comments that ask us to clarify the
TCS foods and provide scientific having a preventive controls qualified proposed provisions or that disagree
information to support their request. individual consider all hazards
(Response 236) This document does with, or suggest one or more changes to,
associated with a product to determine
not include guidance on whether the proposed provisions, including
whether there are hazards requiring a
specific foods, such as yogurt, are TCS preventive control, including comments on provisions that we
foods. Information on whether specific temperature control. proposed to re-establish in § 117.10 with
foods are TCS foods is already widely no changes. After considering these
available—e.g., in Annex 3, Chapter 1 XIII. Subpart B: Comments on Proposed comments, we have revised the
(Purpose and Definitions) of the Food § 117.10—Personnel proposed provisions as shown in table
Code (Ref. 51) and in a report prepared We proposed to re-establish the 18, with editorial and conforming
for us under contract by the Institute of provisions of § 110.10 in new § 117.10 changes as shown in table 52.
TABLE 18—PERSONNEL PROVISIONS

Did we Did we get
propose comments
revisions that dis- Did we modify the proposed
Provision or request agreed with regulatory text?
comment on the proposed
potential provision?
revisions?
§ 117.10—Management Responsibility ......................................................... No ................ Yes .............. Yes.

§ 117.10(a)—Disease Control ....................................................................... No ............... Yes .............. Yes.
§ 117.10(b)—Cleanliness .............................................................................. Yes .............. No ................ No.
§ 117.10(b)(1)—Outer Garments .................................................................. Yes .............. Yes .............. No.
§ 117.10(b)(2)—Personal Cleanliness .......................................................... No ................ No ................ No.
§ 117.10(b)(3)—Washing Hands ................................................................... No ................ No ............... No.
§ 117.10(b)(4)—Unsecured Jewelry and Other Objects ............................... Yes .............. Yes .............. No.
§ 117.10(b)(5)—Gloves ................................................................................. Yes .............. Yes .............. No.
§ 117.10(b)(6)—Hair Restraints .................................................................... No ................ No ................ No.
§ 117.10(b)(7)—Clothing and Other Personal Belongings ........................... Yes .............. Yes .............. No.
§ 117.10(b)(8)—Eating Food, Drinking Beverages, and Using Tobacco ..... Yes .............. Yes .............. Yes.
§ 117.10(b)(9)—Any Other Necessary Precautions ..................................... Yes .............. Yes .............. No.
§ 117.10(c)—Education and Training ........................................................... Yes .............. Yes .............. Shifted to § 117.4 as a requirement
rather than a recommendation.
§ 117.10(d)—Supervision .............................................................................. Yes .............. No ................ Shifted to § 117.4.
A. Management Responsibility for (Comment 237) Some comments ask disagree that the term ‘‘all’’ in this long-
Requirements Applicable to Personnel us to remove ‘‘all’’ because it is too standing provision is too extreme and
We proposed no revisions to the extreme and prescriptive. These prescriptive, but find that the term ‘‘all’’
requirement that plant management comments ask us to instead specify that is not necessary to communicate the
must take all reasonable measures and the intended measures and precautions intent of the requirement. We decline
precautions to ensure compliance with must be ‘‘adequate.’’ the request to add ‘‘adequate.’’ The
the provisions for disease control, (Response 237) We have revised the intent of the requirement is to
cleanliness, and training. regulatory text to delete ‘‘all.’’ We communicate our expectation that these
measures and precautions are protect against allergen cross-contact preventive controls would be distinct
reasonable. Other, more specific and, thus, the establishment has from the more general CGMP
provisions that management must flexibility to take appropriate steps to requirements in this provision.
address specify that particular measures satisfy the requirements in the context
3. Proposed § 117.10(b)(5)—Gloves
and precautions must be ‘‘adequate’’ of the establishment and the food it
(see § 117.10(b)(2), (3), and (4)). produces. Requiring a line worker to We proposed that the methods for
change outer garments when switching maintaining cleanliness include
B. Proposed § 117.10(a)—Disease between individual food-production maintaining gloves, if they are used in
Control lines could be an appropriate precaution food handling, in an intact, clean, and
We proposed no revisions to the for some establishments. When a facility sanitary condition. We also proposed to
requirement that any person who, by that is subject to the requirements for delete a recommendation that gloves
medical examination or supervisory hazard analysis and risk-based should be of an impermeable material.
observation, is shown to have, or preventive controls determines that it is Although some comments ask us to
appears to have, an illness, open lesion, necessary to require a line worker to retain this nonbinding recommendation,
including boils, sores, or infected change outer garments to prevent as discussed in Response 67 we are
wounds, or any other abnormal source allergen cross-contact between food- deleting those non-binding
of microbial contamination by which production lines, the facility could recommendations of part 110 that we
there is a reasonable possibility of food, decide to establish such a procedure as are not establishing as requirements.
food-contact surfaces, or food-packaging a food allergen control under
4. Proposed § 117.10(b)(7)—Clothing
materials becoming contaminated, must § 117.135(c)(2).
and Other Personal Belongings
be excluded from any operations which 2. Proposed § 117.10(b)(4)—Unsecured
may be expected to result in such We proposed to require that the
Jewelry and Other Objects methods for maintaining cleanliness
contamination until the condition is
corrected. Personnel must be instructed We proposed to require that the include storing clothing or other
to report such health conditions to their methods for maintaining cleanliness personal belongings in areas other than
supervisors. include removing all unsecured jewelry where food is exposed or where
(Comment 238) Some comments ask and other objects that might fall into equipment or utensils are washed.
us to provide flexibility to not exclude food, equipment, or containers, and (Comment 241) Some comments ask
from operations personnel who have an removing hand jewelry that cannot be us to specify that the requirements only
open lesion (such as boils, sores or any adequately sanitized during periods in apply to ‘‘extra’’ clothing. These
other infected wounds) that is covered which food is manipulated by hand. If comments express concern that the
completely using appropriate first aid such hand jewelry cannot be removed, requirement otherwise might be
materials. it may be covered by material which can interpreted to mean that no personal
(Response 238) We have revised the be maintained in an intact, clean, and clothing is allowed in these areas (e.g.,
regulatory text to reflect flexibility such sanitary condition and which effectively that employees are permitted to wear
as that provided in FDA’s Food Code protects against the contamination by only company-issued uniforms).
(Ref. 51). Under the Food Code, workers these objects of the food, food-contact (Response 241) We decline this
need not be excluded if an open lesion surfaces, or food-packaging materials. request. This long-standing provision of
(Comment 240) Some comments ask the umbrella GMPs has been in place for
on hands and wrists, or on exposed
us to modify the requirements to decades. The comments do not provide
portions of arms, is protected by an
provide that they only apply as any examples of how we have
impermeable cover, and workers need
appropriate to each operation and interpreted this provision in the past to
not be excluded if an open lesion on
recommend that jewelry be removed mean that employees must wear
other parts of the body is covered by a
when the company’s hazard analysis company-issued uniforms.
dry, durable, tight-fitting bandage.
determines that it is a hazard. These
C. Proposed § 117.10(b)—Cleanliness comments acknowledge that jewelry is a 5. Proposed § 117.10(b)(8)—Eating Food,
physical hazard in some instances, but Drinking Beverages, and Using Tobacco
1. Proposed § 117.10(b)(1)—Outer assert that objects such as jewelry are We proposed to require that the
Garments not a physical hazard for operations methods for maintaining cleanliness
We proposed that the methods for conducted on many medium- to large- include confining the following to areas
maintaining cleanliness include wearing sized RACs (e.g., melons, apples, other than where food may be exposed
outer garments suitable to the operation oranges, potatoes). or where equipment or utensils are
in a manner that protects against the (Response 240) We decline this washed: eating food, drinking beverages,
contamination of food, food-contact request. We included this long-standing or using tobacco.
surfaces, or food-packaging materials provision of the umbrella CGMPs during (Comment 242) Some comments note
and to protect against the cross-contact our last revision of the food CGMPs that the provision would no longer
of food. based on public comments during that require that chewing gum be confined to
(Comment 239) Some comments ask rulemaking (51 FR 22458 at 22463). The areas other than where food may be
us to clarify whether the newly provision provides flexibility for an exposed or where equipment or utensils
proposed requirement to prevent establishment to do what is appropriate are washed. These comments ask us
allergen cross-contact would require a in the context of its own operations— whether this omission was intentional,
line worker to change outer garments e.g., by limiting some requirements to or whether we are simply considering
when switching between individual ‘‘unsecured’’ jewelry and by providing that requirements applicable to
food-production lines if separate major options to cover hand jewelry during ‘‘chewing gum’’ are covered by those for
allergens are present on the food periods in which food is manipulated ‘‘eating food.’’ Some comments state
production lines. by hand. Although a facility could that it would not be immediately
(Response 239) The provision does decide to also establish preventive obvious to many laypersons as to
not prescribe the specific methods by controls for jewelry as a physical hazard whether the chewing of gum is included
which wearing outer garments must following a hazard analysis, such in ‘‘eating food.’’
(Response 242) We agree that covered by this rule, workers must move sunscreen generally are classified as
removing the phrase ‘‘chewing gum’’ away from the packing operations to get over-the-counter medicines.
from this provision could make it a drink. The establishment can make
XIV. Subpart B: Comments on Proposed
unclear that this long-standing drinking water available in a designated
§ 117.20—Plant and Grounds
requirement regarding chewing gum area that is nearby, and provide
still applies and we have revised the multiple designated areas when We proposed to re-establish the
proposed regulatory text to retain the appropriate to make drinking water provisions of § 110.20 in new § 117.20
express requirement regarding chewing readily available to all workers. with some revisions to modernize them.
gum. As the comments point out, the Some comments agree with one or more
statute includes chewing gum in its 6. Proposed § 117.10(b)(9)—Any Other of these proposed revisions without
definition of ‘‘food’’ (see section 201(f) Necessary Precautions change. Some comments that support
of the FD&C Act). However, in this long- We proposed that the methods for the proposed revisions suggest
standing provision, the term ‘‘chewing maintaining cleanliness include taking alternative or additional regulatory text
gum’’ is used to mean ‘‘the act of any other necessary precautions to (see, e.g., Comment 251 and Comment
chewing’’ rather than to refer to the gum protect against contamination of food, 256) or ask us to clarify how we will
itself. food-contact surfaces, or food-packaging interpret the revised provision (see, e.g.,
(Comment 243) Some comments materials with microorganisms or Comment 253). Other comments that
regarding processes conducted on RACs foreign substances (including support provisions that we proposed to
ask us to modify the regulatory text to perspiration, hair, cosmetics, tobacco, re-establish in part 117 without change
distinguish ‘‘drinking beverages’’ from chemicals, and medicines applied to the ask us to revise or clarify those
‘‘drinking water.’’ These comments note skin) and to protect against cross- provisions (see, e.g., Comment 246,
that this provision is of concern to their contact of food. Comment 247, Comment 248, Comment
industry because drinking water needs 250, and Comment 254).
to be readily available to workers. (Comment 244) Some comments ask In the following sections, we discuss
(Response 243) We decline this us to specify that the provision applies comments that ask us to clarify the
request. We acknowledge that workers to ‘‘medicines or other products’’ proposed provisions or that disagree
may need ready access to drinking water applied to the skin. with, or suggest one or more changes to,
when conducting activities on RACs, (Response 244) We decline this the proposed provisions, including
particularly in an environment that is request. The comment does not explain comments on provisions that we
largely outdoors (such as in an off-farm what ‘‘other products’’ applied to the proposed to re-establish in § 117.20 with
packinghouse that has a roof but is skin are not already covered by no changes. After considering these
otherwise largely unenclosed). ‘‘cosmetics’’ and ‘‘medicines.’’ For comments, we have revised the
However, this provision does not apply example, powders and lotions applied proposed provisions as shown in table
to on-farm activities such as harvesting as ‘‘make-up’’ generally would be 19, with editorial and conforming
of RACs. During packing activities cosmetics and products such as changes as shown in table 52.
TABLE 19—PROVISIONS FOR PLANT AND GROUNDS

Did we Did we get
propose Did we
comments
revisions modify the
that dis-
Provision or request proposed
agreed with
comment on regulatory
the proposed
potential text?
provision?
revisions?
§ 117.20(a)—Grounds ......................................................................................................................... No ................ Yes .............. No.

§ 117.20(a)(1)—Equipment, Litter, Waste, Weeds, and Grass .......................................................... No ............... Yes .............. No.
§ 117.20(a)(2)—Roads, Yards, and Parking Lots ............................................................................... No ................ No ............... No.
§ 117.20(a)(3)—Draining Areas .......................................................................................................... No ................ No ............... No.
§ 117.20(a)(4)—Operating Systems for Waste Treatment and Disposal ........................................... No ................ Yes .............. Yes.
§ 117.20(a)(5)—Grounds Not Under the Operator’s Control .............................................................. Yes .............. Yes .............. Yes.
§ 117.20(b)—Plant Construction and Design ..................................................................................... Yes .............. Yes .............. No.
§ 117.20(b)(1)—Space for Equipment and Materials ......................................................................... No ................ Yes .............. Yes.
§ 117.20(b)(2)—Food Safety Controls, Operating Practices, or Design ............................................ Yes .............. Yes .............. Yes.
§ 117.20(b)(3)—Outdoor Bulk Vessels ............................................................................................... Yes .............. Yes .............. Yes.
§ 117.20(b)(4)—Plant Construction ..................................................................................................... Yes .............. No ................ No.
§ 117.20(b)(5)—Lighting ...................................................................................................................... No ................ Yes .............. Yes.
§ 117.20(b)(6)—Ventilation ................................................................................................................. Yes .............. Yes .............. Yes.
§ 117.20(b)(7)—Screening or Other Protection .................................................................................. No ................ Yes .............. No.
A. Proposed § 117.20(a)—Grounds that will protect against the of food being produced, because litter,
contamination of food. waste, weeds, and grass can all attract
1. Proposed § 117.20(a)—Management
(Comment 245) Some comments ask and harbor pests, and the first step for
Responsibility for Maintaining Grounds us to specify that the requirements do pest control in the plant is to avoid
We proposed no revisions to the not apply to test/pilot kitchens. attracting pests.
requirement that the grounds about a (Response 245) We decline this
food plant under the control of the request. An establishment must have
operator must be kept in a condition control of the grounds under its control
regardless of the specific food or amount
2. Proposed § 117.20(a)(1)—Equipment, ‘‘adequate’’ for the purpose of this (Comment 249) Some comments ask
Litter, Waste, Weeds, and Grass provision, such as whether it requires us to specify that the requirements for
We proposed no revisions to the compliance with local plumbing codes. suitability of plant construction and
requirement that the methods for (Response 247) The term ‘‘adequate’’ design apply only where the potential
adequate maintenance of grounds has been in § 110.20(a) and (a)(4) since for contamination exists.
1986 (51 FR 22477). This long-standing (Response 249) We decline this
include properly storing equipment,
provision addresses matters under request. A plant requires suitable
removing litter and waste, and cutting
FDA’s jurisdiction rather than local construction and design regardless of
weeds or grass within the immediate
plumbing codes. An example of waste the specific potential for contamination
vicinity of the plant buildings or at any particular location in the plant.
structures that may constitute an disposal under FDA’s jurisdiction is an
operating system for water disposal. Each of the seven more specific
attractant, breeding place, or harborage provisions governed by § 117.20(b) adds
for pests. Such an operating system would be
inadequate if it allowed water to the context that the requirements are
(Comment 246) Some comments ask directed to what is ‘‘adequate’’ (e.g.,
us to specify ‘‘immediately adjacent to’’ accumulate on the facility grounds and
become an attractant for pests. adequate space, adequate precautions,
rather than ‘‘the immediate vicinity.’’ and adequate cleaning). The defined
These comments also ask us to provide (Comment 248) Some comments ask term ‘‘adequate’’ provides context that
guidance on the importance of us to clarify how the requirements in the purpose of the requirements for
pollinator habitat so that inspectors will § 117.20(a) would apply to potential plant construction and design are
view such areas within the greater problems associated with neighboring related to public health.
context of the farm and not immediately grounds. Other comments note that we
see that the farm is out of compliance. proposed to address potential problems 2. Proposed § 117.20(b)(1)—Placement
(Response 246) We decline the with neighboring grounds within the of Equipment and Storage of Materials
request to modify the regulatory text of final sentence of this provision We proposed no revisions to the
this long-standing provision. We note (proposed § 117.20(a)(4)) and suggest requirement that the plant must provide
that a ‘‘farm’’ is not subject to the CGMP editorial changes to more clearly sufficient space for such placement of
requirements of subpart B (see identify the requirements regarding equipment and storage of materials as is
§ 117.5(k)). We do not see that the grounds under the control of a necessary for the maintenance of
suggested modification would provide neighboring entity. sanitary operations and the production
any specific information to investigators (Response 248) These provisions do of safe food.
who are inspecting a food establishment not require an establishment to take (Comment 250) Some comments
(such as a farm mixed-type facility or action on its neighbor’s property to assert that the phrase ‘‘maintenance of
packing shed) that has pollinator habitat protect against contamination, but do sanitary operations’’ is unclear because
near plant buildings or structures. We require an establishment to be aware of it does not clearly communicate that
expect that investigators will adapt their any problems that may affect its own maintenance of equipment and the
inspection programs to account for such grounds. For example, if a neighbor’s facility is necessary for the production
circumstances and food establishments grass is long, the establishment is not of safe food. These comments ask us to
will take steps to prevent weeds or grass required to mow the neighbor’s grass, revise the provision to specify that the
in a pollinator habitat from leading to but if the long grass in the neighbor’s plant must provide sufficient space for
problems with pests in the plant. property provides a breeding ground for such placement of equipment and
3. Proposed § 117.20(a)(4)—Operating pests, the establishment needs to be storage of materials as is necessary for
Systems for Waste Treatment and aware of this potential for maintenance, sanitary operations, and
Disposal contamination and may need to take the production of safe food.
mitigating actions (e.g., enhanced pest (Response 250) We agree that the
We proposed no revisions to the control in the bordering areas). suggested revision adds clarity and have
requirement that the methods for We have clarified the proposed modified the provision as requested.
adequate maintenance of grounds must requirements by redesignating the final The revised requirement is consistent
include operating systems for waste sentence of proposed § 117.20(a)(4) as with the governing paragraph in
treatment and disposal in an adequate § 117.20(a)(5) and specifying that the § 117.20(b), which clearly addresses
manner so that they do not constitute a requirements of newly designated both maintenance and sanitary
source of contamination in areas where § 117.20(a)(5) apply if the plant grounds operations.
food is exposed. If the plant grounds are are bordered by grounds not under the
bordered by grounds not under the 3. Proposed § 117.20(b)(2)—Reduce
operator’s control and not maintained in Potential for Contamination and
operator’s control and not maintained in the manner described in § 117.20(a)(1)
the manner described in § 117.20(a)(1) Allergen Cross-Contact Through
through (a)(4) (rather than in Adequate Food Safety Controls and
through (a)(3), care must be exercised in § 117.20(a)(1) through (a)(3)).
the plant by inspection, extermination, Operating Practices or Effective Design
or other means to exclude pests, dirt, B. Proposed § 117.20(b)—Plant We proposed that the plant must
and filth that may be a source of food Construction and Design permit the taking of proper precautions
contamination. 1. Proposed § 117.20(b)—Suitability of to reduce the potential for
(Comment 247) Some comments Plant Construction and Design contamination of food, food-contact
assert that the term ‘‘adequate’’ has been surfaces, or food-packaging materials
added to this provision and is We proposed that the plant buildings with microorganisms, chemicals, filth,
ambiguous when used to describe the and structure must be suitable in size, and other extraneous material, and to
way in which ‘‘operating systems for construction, and design to facilitate reduce the potential for cross-contact.
waste treatment and disposal’’ must be maintenance and sanitary operations for The potential for cross-contact and
managed, even though that term is food-production purposes (i.e., contamination may be reduced by
defined in the rule. These comments ask manufacturing, processing, packing, and adequate food safety controls and
us to clarify what constitutes holding). operating practices or effective design,
including the separation of operations the provision does not preclude the use (Comment 255) Some comments ask
in which cross-contact and of such containers. Although the us to specify ‘‘where necessary’’ to
contamination are likely to occur, by provision specifies the use of protective modify ‘‘adequate.’’
one or more of the following means: coverings, it does so only as an example (Response 255) We decline this
Location, time, partition, air flow, of an effective means of precautions to request because ‘‘where necessary’’ is
enclosed systems, or other effective protect food held in outdoor vessels. captured by ‘‘is needed’’ in the long-
means. Other specified examples of precautions standing definition of ‘‘adequate.’’
(Comment 251) Some comments ask to protect food held in outdoor bulk (Comment 256) Some comments ask
us to specify both air flow systems and vessels include controlling areas over us to specify that the provision requires
dust control systems as examples of and around the vessels to eliminate minimizing dust and that the applicable
separation of operations in which harborages for pests, and checking on a areas include areas where dust could
allergen cross-contact and regular basis for pests and pest cause allergen cross-contact.
contamination are likely to occur. infestation. Such measures to protect (Response 256) We agree that it is
(Response 251) We agree that both air against pests are appropriate when food important to minimize dust (e.g., dust
flow systems and dust control systems such as fruit is held in outdoor from milk powder that could be a source
are appropriate examples of separation containers. (See also Response 327.) of allergen cross-contact) and have
of operations and have added these We agree that the measures taken by modified the provision as requested.
examples as requested. the establishment are those applicable
7. Proposed § 117.20(b)(7)—Screening
4. Proposed § 117.20(b)(3)—Food in to public health protection. To make
this clearer, we have revised the We proposed no revisions to the
Outdoor Bulk Vessels requirement that the plant must
provision to refer to ‘‘adequate
We proposed that the plant must precautions’’ rather than ‘‘proper provide, where necessary, adequate
permit the taking of proper precautions precautions,’’ because the defined term screening or other protection against
to protect food in outdoor bulk vessels ‘‘adequate’’ focuses on public health. pests.
by any effective means, including using (Comment 257) Some comments ask
protective coverings, controlling areas 5. Proposed § 117.20(b)(5)—Lighting us to add examples of adequate
over and around the vessels to eliminate We proposed no revisions to the screening, such as by window screens,
harborages for pests, checking on a requirement that the plant must provide door sweeps, gap sealant, or other
regular basis for pests and pest adequate lighting in hand-washing appropriate measures.
infestation, and skimming fermentation areas, dressing and locker rooms, and (Response 257) We decline this
vessels. toilet rooms and in all areas where food request. Although the examples
(Comment 252) Some comments is examined, processed, or stored and suggested by the comment appear to be
express concern about applying these where equipment or utensils are acceptable, examples of screening are
provisions to the transport of large RACs cleaned; and provide safety-type light not necessary in this long-standing
such as watermelons and assert that bulbs, fixtures, skylights, or other glass requirement.
there would be no food safety advantage suspended over exposed food in any XV. Subpart B: Comments on Proposed
to doing so after the RACs had spent the step of preparation or otherwise protect § 117.35—Sanitary Operations
growing season in an uncovered against food contamination in case of
environment. glass breakage. We proposed to re-establish the
(Response 252) The comments are (Comment 254) Some comments ask provisions of § 110.35 in new § 117.35
mistaken about these requirements, us to add that the plant must provide with some revisions to modernize them.
which relate to installed bulk vessels adequate lighting in areas where food is Some comments agree with one or more
such as outdoor tanks, silos, etc. packed and to substitute the term of these proposed provisions without
Moreover, this section addresses the ‘‘shatter-resistant’’ for the term ‘‘safety- change. Some comments that support
construction and design of the plant, not type.’’ the proposed revisions suggest
transportation. To make this clearer, we (Response 254) We have revised the alternative or additional regulatory text
have revised the provision to specify provision to specify that it applies to (see, e.g., Comment 258, Comment 261,
that it applies to ‘‘installed outdoor bulk areas in the plant where food is Comment 263, Comment 269, Comment
vessels.’’ examined, manufactured, processed, 272, and Comment 273) or ask us to
(Comment 253) Some comments ask packed, or held. Doing so makes the clarify how we will interpret the revised
us to clarify that the requirements do terms in this provision consistent with provision (see, e.g., Comment 260,
not apply to open containers of RACs terms used throughout the CGMPs (78 Comment 267, Comment 268, and
that are subject to further processing. FR 3646 at 3692). We also have Comment 270). We also proposed to
Other comments assert that lugs, totes, substituted the term ‘‘shatter-resistant’’ delete current § 110.35(d)(5)
corrugated bins, and harvest containers for the term ‘‘safety-type.’’ ‘‘Shatter- (requirements for sanitizing agents)
used to hold fruit are not bulk vessels resistant’’ is a more modern term because it would be redundant with
that are subject to the provision. The describing the safety features that are another proposed provision (proposed
comments explain that these containers specified in the provision. § 117.35(b)(1)). We received no
are designed and built to be open at the comments that disagreed with this
top, with air holes on the sides and 6. Proposed § 117.20(b)(6)—Ventilation proposed deletion and are not re-
bottom that provide an adequate air We proposed that a plant must establishing current § 110.35(d)(5) in
flow to the fruit. provide adequate ventilation or control part 117.
(Response 253) The requirement equipment to minimize odors and In the following sections, we discuss
applies to installed bulk vessels, not vapors in areas where they may comments that ask us to clarify the
containers (including lugs, totes, contaminate food; and locate and proposed provisions or that disagree
corrugated bins, and harvest containers operate fans and other air-blowing with, or suggest one or more changes to,
generally) that are delivered to a food equipment in a manner that minimizes the proposed provisions. After
establishment for packing or processing. the potential for contaminating food- considering these comments, we have
(See discussion in Response 252.) Thus, contact surfaces and for cross-contact. revised the proposed provisions as
shown in table 20, with editorial and conforming changes as shown in table
52.
TABLE 20—PROVISIONS FOR SANITARY OPERATIONS

Did we Did we get
propose Did we
comments
revisions modify the
that dis-
Provision or request proposed
agreed with
comment on regulatory
the proposed
potential text?
provision?
revisions?
§ 117.35(a)—General Maintenance .................................................................................................... Yes .............. Yes .............. Yes.

§ 117.35(b)(1)—Substances Used in Cleaning and Sanitizing .......................................................... Yes .............. Yes .............. Yes.
§ 117.35(b)(2)—Storage of Toxic Materials ........................................................................................ Yes .............. Yes .............. No.
§ 117.35(c)—Pest Control ................................................................................................................... Yes .............. Yes .............. Yes.
§ 117.35(d)—Sanitation of Food-Contact Surfaces ............................................................................ Yes .............. Yes .............. No.
§ 117.35(d)(1)—Food-Contact Surfaces Used for Manufacturing/Processing or Holding .................. Yes .............. Yes .............. Yes.
§ 117.35(d)(2)—Wet Cleaning ............................................................................................................ Yes .............. Yes .............. Yes.
§ 117.35(d)(3)—Single-Service Articles .............................................................................................. Yes .............. Yes .............. Yes.
§ 117.35(e)—Sanitation of Non-Food-Contact Surfaces .................................................................... Yes .............. Yes .............. Yes.
§ 117.35(f)—Storage and Handling of Cleaned Portable Equipment and Utensils ............................ Yes .............. Yes .............. No.
A. Proposed § 117.35(a)—General acknowledge the appropriate degree of B. Proposed § 117.35(b)—Substances

Maintenance sanitation required in different areas of Used in Cleaning and Sanitizing;
We proposed that buildings, fixtures, a plant. Importantly, however, the fact Storage of Toxic Materials
and other physical facilities of the plant that the degree of sanitation may be 1. Proposed § 117.35(b)(1)—Cleaning
must be maintained in a sanitary different does not mean that it could be Compounds and Sanitizing Agents
condition and must be kept in repair appropriate, for example, for pests to be
We proposed that cleaning
sufficient to prevent food from present in areas, like utility rooms, that
compounds and sanitizing agents used
becoming adulterated. Cleaning and may not need the same degree of
in cleaning and sanitizing procedures
sanitizing of utensils and equipment sanitation as a processing room. must be free from undesirable
must be conducted in a manner that (Comment 260) Some comments microorganisms and must be safe and
protects against cross-contact and assert that by its nature, the operations adequate under the conditions of use.
contamination of food, food-contact of some facilities generate dust and We also proposed that mechanisms to
surfaces, or food packaging materials. debris. For example, although comply with provisions related to
(Comment 258) Some comments ask equipment such as conveyors and cleaning compounds and sanitizing
us to specify that buildings, fixtures, screens used for hulling and shelling agents must be safe and effective and
and other physical facilities of the plant almonds can be cleaned before use, as provided examples of ways to achieve
must be maintained in a ‘‘clean’’ soon as operations begin dust will such compliance (78 FR 3646 at 3721).
condition in addition to a ‘‘sanitary’’ Only the toxic materials listed in this
accumulate on the surfaces of the
condition. provision may be used or stored in a
equipment. Some comments ask us to
(Response 258) We have revised the plant where food is processed or
clarify that the intent of the CGMP
requirement as requested. Doing so is exposed.
consistent with other provisions of requirements for sanitary operations is
subpart B that specify clean and sanitary to ensure that equipment is clean prior
us to specify that ‘‘Cleaning and
conditions (e.g., the personnel to use, with the understanding that once
sanitizing agents used on food-contact
cleanliness provisions in § 117.10(b)(4) operations commence, dust will
surfaces must contain only ingredients
and (5)), including the requirements for accumulate and that the presence of this which are generally recognized as safe
sanitary operations (see the type of dust and debris does not or are approved in § 178.1010 for use in
requirements for substances used in necessarily mean that sanitation is not cleaning and sanitizing food-contact
cleaning and sanitizing in § 117.35(b)(1) being regularly conducted. surfaces’’ because this information will
and the requirements for sanitation of (Response 260) We agree that the be useful to processors who may be
food-contact surfaces in § 117.35(d)). intent of the CGMP requirements for unaware of the specific kinds of
(Comment 259) Some comments ask sanitary operations is to ensure that substances approved for food-contact
us to qualify the level of sanitation equipment is clean prior to use. surfaces. Other comments ask us to
required for different areas of the plant However, the fact that dust and debris specify that residual levels of cleaning
because the degree of sanitation can accumulate during some production and sanitizing agents which are
required for a warehouse or utility room operations does not excuse the generally recognized as safe or are
is different from the degree of sanitation establishment from taking appropriate approved for use on food-contact
required for a processing room. surfaces are permissible.
steps to prevent food from becoming
(Response 259) We decline this (Response 261) We decline these
contaminated. The timing and extent of

request. The requirement is a long- requests. Requirements such as those
such steps would depend on the nature
standing provision that has been used in applicable to substances added to food
this context for decades. The comments of the food and the production
or substances used in cleaning and
do not provide any examples of how we operation. sanitizing food-contact surfaces are
have interpreted this provision in the available elsewhere in our regulations
past in a manner that does not and it is neither practical nor necessary
to use the CGMP requirements of part the food, food-contact surfaces or food- that it is always possible to prevent all
117 as a means to communicate some or packaging materials. types of pests. Some comments assert
all of these other requirements. For Other comments ask us to specify that that it is not always possible to prevent
example, the manufacturer of a food pests must not be allowed in any area all types of pests, especially on farms
product must also comply with food of a food plant ‘‘where appropriate’’ or and in areas where pests are prevalent
labeling regulations ranging from ‘‘where the potential for contamination because of the presence of conditions
declaration of ingredients (§ 101.4) to exists.’’ Other comments assert that over which the food manufacturer has
health claims (part 101, subpart E). animals should be excluded from all no control. Some comments assert that
areas that are used by production or a food establishment should be required
2. Proposed § 117.35(b)(2)— packaging employees or that to take all reasonable measures to
Identification and Storage of Toxic communicate with food processing, exclude pests, but an outright ‘‘exclude’’
Materials packing, or storage areas. Some is unrealistic.
We proposed that toxic cleaning comments ask us to clarify whether this (Response 265) The requirements
compounds, sanitizing agents, and provision includes administrative apply to activities conducted in a plant
pesticide chemicals must be identified, offices, cafeterias, and other rooms that and do not apply to activities that are
held, and stored in a manner that are not directly involved in the within the ‘‘farm’’ definition, such as
protects against contamination of food, processing, packing, or holding of food harvesting RACs and on-farm packing of
food-contact surfaces, or food-packaging because the provision applies to ‘‘any RACs. We disagree that effective
materials. We also proposed to remove area of a food plant.’’ measures cannot be taken to exclude
a recommendation for following all (Response 263) We have revised the pests from a plant that is fully enclosed.
relevant regulations promulgated by regulatory text to account for ‘‘pest- When a plant is only partially enclosed
other Federal, State, and local detection dogs.’’ However, we have not (e.g., a partially enclosed area that
government agencies for the application, otherwise modified the regulatory text processes seafood taken off a fishing
use, or holding of toxic cleaning of this long-standing provision as a vessel, or a partially enclosed building
compounds, sanitizing agents, and result of these comments. Areas of the on an off-farm establishment that packs
pesticides. food plant (such as a cafeteria) that are RACs), we would interpret the provision
not directly involved with production in a manner consistent with the
may nonetheless be a source of provisions of previous guidance, such as
us to specify that we require that the
contamination (e.g., if there are pests in our 2005 ‘‘Guide to Produce Farm
compounds, agents, and pesticides be
that area). We have long provided that Investigations’’ and the final provisions
used according to the manufacturer’s
specified types of dogs may be allowed of the produce safety rule. We are not
instructions.
in some areas of a plant provided that modifying the requirement to
(Response 262) We decline this the presence of the dogs is unlikely to incorporate this interpretation because
request. Such a recommendation is result in contamination, and the pest control in buildings that are only
more properly addressed by the comments provide no basis for why this partially enclosed will be a concern for
applicable Federal, State, and local qualified exception is no longer only a small percentage of
government agencies. See the discussion appropriate. establishments subject to subpart B.
at 78 FR 3646 at 3721. (Comment 264) Some comments ask
us to specify that insecticides and D. Proposed § 117.35(d)—Sanitation of
C. Proposed § 117.35(c)—Pest Control Food-Contact Surfaces
rodenticides are types of pesticides and
We proposed that pests must not be that the use of these substances is We proposed that all food-contact
allowed in any area of a food plant. permitted in accordance with the surfaces, including utensils and food-
Guard or guide dogs may be allowed in Federal Insecticide, Fungicide, and contact surfaces of equipment, must be
some areas of a plant if the presence of Rodenticide Act (FIFRA) label cleaned as frequently as necessary to
the dogs is unlikely to result in precautions and restrictions. protect against cross-contact and
contamination of food, food-contact (Response 264) We have revised the contamination of food.
surfaces, or food-packaging materials. regulatory text to specify the ‘‘use of (Comment 266) Some comments ask
Effective measures must be taken to pesticides’’ rather than the ‘‘use of us to specify that all food-contact
exclude pests from the manufacturing, insecticides and rodenticides ‘‘to use surfaces must also be sanitized.
processing, packing, and holding areas the broader term ‘‘pesticides.’’ We also (Response 266) We decline this
and to protect against the contamination modified the regulatory text to clarify request. These long-standing
of food on the premises by pests. The that the restrictions on use of pesticides requirements identify specific
use of insecticides or rodenticides is is when the pesticides are used ‘‘to circumstances when food-contact
permitted only under precautions and control pests.’’ We made this surfaces must be sanitized (see
restrictions that will protect against the modification because we are aware that § 117.35(d)(2), which specifies
contamination of food, food-contact some food processing processes (such as circumstances when food-contact
surfaces, and food-packaging materials. fumigating almonds) involve treating surfaces must be sanitized when used in
(Comment 263) Some comments ask food with substances that are classified wet processing operations). The
us to specify ‘‘pest-detection’’ dogs in as ‘‘pesticides.’’ Without this comment provided no basis for why
addition to guard and guide dogs modification, the provision could food-contact surfaces must be sanitized
because the use of animals to detect mistakenly appear to prevent when they will be used in
pests is widespread in the professional establishments from conducting such manufacturing/processing or holding
pest management industry for concealed low-moisture food or why food-contact
processes.
and difficult to find pests. Comments We decline to modify the text to surfaces must be sanitized when used in
assert that like guard and guide dogs, account for FIFRA label precautions and wet processing operations other than the
detection dogs are well trained and restrictions. See (Response 262). circumstances specified in
should be permissible in areas of the (Comment 265) Some comments § 117.35(d)(2). There are some situations
plant where the presence of the dog is express concern that the phrases ‘‘must in which food-contact surfaces do not
unlikely to result in contamination of not be allowed’’ and ‘‘exclude’’ suggest need to be sanitized. For example, raw
materials and other ingredients for (Response 269) We have revised the both processing of low-moisture foods
processing may be held in clean provision to specify that it applies to and wet processing. It is not practical to
containers prior to processing with steps food-contact surfaces used for describe all variations of complex
lethal to microorganisms; sanitizing manufacturing, processing, packing, or manufacturing scenarios that may
such containers is not necessary for the holding low-moisture food. Doing so involve both wet processing and low-
production of safe food. makes the terms in this provision moisture foods. Instead, we expect both
(Comment 267) Some comments ask consistent with terms used throughout industry and regulators to appropriately
us to clarify that we are not requiring an the CGMPs (78 FR 3646 at 3692). apply the specific requirements
absolutely allergen-free environment, (Comment 270) Some comments ask associated with the sanitary condition of
but rather that the expectation is that us to clarify that the proposed food-contact surfaces during such
the manufacturer will take steps to requirement to maintain food-contact complex manufacturing scenarios. The
identify potential sources of allergen surfaces in a sanitary condition is not a comments do not provide any examples
cross-contact and implement preventive requirement to sanitize all product of how we have interpreted this
measures. Some comments ask us to contact surfaces. These comments also provision in the past in a way that does
also clarify that dedicated lines or ask us to specifically allow the not accommodate manufacturing
equipment are not required for effective continued use of cleaning methods processes such as those it describes.
preventive control of food allergens. based on a risk assessment, including (Comment 272) Some comments ask
Some comments discuss practical dry cleaning with no sanitizing step. us to specify that food-contact surfaces
difficulties that arise when balancing Some comments ask us to clarify that used for manufacturing/processing or
the need to control microorganisms ‘‘sanitary condition’’ is not synonymous holding low-moisture food be in a clean,
such as Salmonella in chocolate and with ‘‘sanitized’’ from an antimicrobial dry, sanitary condition ‘‘prior to use or
low-moisture confectionary products standpoint. the start of production’’ instead of ‘‘at
(through procedures such as dry (Response 270) See Response 266. time of use’’ to more accurately reflect
cleaning) with the control of allergens This provision does not require that all the reality of food processing. Some
(which may be controlled better when product contact surfaces be sanitized comments express concern that properly
wet cleaning procedures are used). and, thus, it is not necessary to specify cleaned and sanitized food-contact
that dry cleaning methods with no
(Response 267) See also the surfaces begin to accumulate small dust
sanitizing step are acceptable in certain
discussion of food allergen controls in particles on the surface of conveyors,
circumstances. We do not consider
Response 429. This rule does not sizing screens, and other equipment
‘‘sanitary condition’’ to be synonymous
establish a particular standard for surfaces as soon as operations
with ‘‘sanitized.’’ We consider ‘‘sanitary
preventing allergen cross-contact. In commence. These comments assert that
condition’’ to be a state of cleanliness.
general, when we do establish a it is unrealistic to keep the equipment
Terms such as ‘‘sanitize’’ and
standard we avoid ‘‘absolute’’ standards in a clean, dry, sanitary condition
‘‘sanitizing’’ are associated with the
such as the ‘‘absolutely allergen-free’’ during the entire operation.
reduction of microorganisms.
standard mentioned by the comment. (Comment 271) Some comments ask (Response 272) We have revised the
Likewise, the rule does not require the us to specify different requirements for regulatory text to specify that the
use of dedicated lines or equipment for food-contact surfaces used during requirement applies ‘‘before use.’’ We
effective prevention of allergen cross- different stages of manufacturing/ agree that ‘‘before use’’ more accurately
contact. As the comments suggest, the processing or holding. These comments describes the intent of the requirement.
intent of the requirement is for the explain that the provision does not F. Proposed § 117.35(d)(2)—Wet
manufacturer to take steps to identify accommodate initial processing steps Cleaning
potential sources of allergen cross- prior to moisture removal where food-
contact and implement preventive contact surfaces will be exposed to We proposed that in wet processing,
measures. moist (non-dry) conditions. These when cleaning is necessary to protect
(Comment 268) Some comments ask comments also explain that the against cross-contact and the
us to clarify that the use of advisory provision also does not recognize that introduction of microorganisms into
label statements is appropriate when food-contact surfaces may not appear to food, all food-contact surfaces must be
allergen cross-contact has been reduced be ‘‘sanitary’’ when raw materials cleaned and sanitized before use and
to the greatest extent possible, but handled at initial processing steps have after any interruption during which the
cannot be eliminated with certainty. not yet undergone subsequent processes food-contact surfaces may have become
(Response 268) See Response 434 for designed to eliminate microorganisms of contaminated. Where equipment and
a discussion about the use of advisory public health concern. Some comments utensils are used in a continuous
label statements. ask us to specify that food-contact production operation, the utensils and
surfaces only need to be clean and food-contact surfaces of the equipment
E. Proposed § 117.35(d)(1)—Food- must be cleaned and sanitized as
Contact Surfaces Used for sanitary ‘‘before use and after any
interruption during which the food- necessary.
Manufacturing/Processing or Holding (Comment 273) Some comments ask
contact surfaces may have become
We proposed that food-contact contaminated.’’ Comments also ask us to us to specify that this requirement
surfaces used for manufacturing/ specify that ‘‘finished product low- applies when cleaning is necessary to
processing or holding low-moisture food moisture food-contact surfaces must be protect against allergen cross-contact or
must be in a clean, dry, sanitary maintained in a clean, dry, and sanitary the introduction of microorganisms into
condition at the time of use. When the condition.’’ food, not only when both conditions are
surfaces are wet-cleaned, they must, (Response 271) We decline these satisfied.
when necessary, be sanitized and requests. This long-standing provision (Response 273) We have revised the
thoroughly dried before subsequent use. has been used in this context for regulatory text to specify ‘‘necessary to
(Comment 269) Some comments ask decades. The full requirements for protect against allergen cross-contact or
us to specify ‘‘packing’’ for clarity and sanitation of food-contact surfaces the introduction of microorganisms into
completeness. (§ 117.35(d), (d)(1), and (d)(2)) address food.’’
G. Proposed § 117.35(d)(3)—Single- have not previously considered that the facility will help prevent transmission
Service Articles term ‘‘handling’’ includes ‘‘storage’’ in of public health pathogens into food
We proposed that single-service this context. See the regulatory text for processing areas. Some comments assert
articles (such as utensils intended for the final provision containing all of that sanitizing non-food-contact surfaces
one-time use, paper cups, and paper these modifications. could also assist with minimizing risks
towels) should be stored in appropriate from possible pathogen transfer to food-
H. Proposed § 117.35(e)—Sanitation of
containers and must be handled, contact surfaces.
Non-Food-Contact Surfaces (Response 278) We decline these
dispensed, used, and disposed of in a We proposed that non-food-contact requests. We acknowledge that there
manner that protects against cross- surfaces of equipment used in the could be some benefit to sanitizing non-
contact and contamination of food, operation of a food plant should be food-contact surfaces with substances
food-contact surfaces, or food-packaging cleaned in a manner and as frequently that would reduce pathogens but
materials. We also requested comment as necessary to protect against cross- disagree that treating non-food-contact
on whether to require, rather than contact and contamination of food, surfaces with substances that would
recommend, that single-service articles food-contact surfaces, and food- reduce pathogens is necessary if the
be stored in appropriate containers (78 packaging materials. We also requested surfaces are kept clean. The provision
FR 3646 at 3721). comment on whether to establish these does not preclude an establishment
(Comment 274) Comments are mixed recommendations as requirements (78 from sanitizing non-food-contact
regarding whether to require, rather FR 3646 at 3722). surfaces in addition to cleaning them, if
than recommend, that single-service (Comment 275) Some comments ask the establishment determines that doing
articles be stored in appropriate us to change this recommendation to a so is necessary or prudent for its
containers. Some comments ask us to requirement to prevent the creation of operations. See also Response 125.
keep this provision as a insanitary conditions and the (Comment 279) Some comments ask
recommendation, whereas other adulteration of product. us not to designate the frequency for
comments ask us to change this (Response 275) We have revised the cleaning of non-food-contact surfaces
recommendation to a requirement. One regulatory text to establish this because doing so would create an
comment asking us to retain the recommendation as a requirement. unnecessary burden for smaller
provision as a recommendation asserts (Comment 276) Some comments facilities.
that these practices have never resulted assert that it is impractical to sanitize all (Response 279) The provision does
in a food safety risk. non-food-contact surfaces in a farm not specify the frequency for cleaning of
Other comments ask us to specify that mixed-type facility and that this non-food-contact surfaces. Instead, it
‘‘single-service articles must be handled provision should only apply to those specifies that the surfaces be cleaned
in a manner that protects against areas where a RAC is being transformed ‘‘as frequently as necessary.’’
allergen cross-contact and into a processed food.
contamination of food.’’ These (Response 276) These comments I. Proposed § 117.35(f)—Storage and
comments assert that the proposed use appear to misinterpret the proposed Handling of Cleaned Portable
of ‘‘must’’ and ‘‘appropriate’’ in the provision, which does not require Equipment and Utensils
same sentence will lead to sanitizing any non-food-contact We proposed that cleaned and
inconsistency in determining what is surfaces, but rather requires cleaning the sanitized portable equipment with food-
‘‘appropriate’’ for each individual non-food-contact surfaces of equipment. contact surfaces and utensils should be
situation. In addition, the comments (See also Response 278.) stored in a location and manner that
assert that the common definition of (Comment 277) Some comments ask protects food-contact surfaces from
‘‘handling’’ encompasses ‘‘appropriate us to specify that this provision applies cross-contact and contamination. We
storage, dispensing, usage, and to non-food-contact surfaces of also requested comment on whether to
disposal.’’ equipment used ‘‘where food is exposed establish this provision as a requirement
(Response 274) We have decided to or in the food production sections.’’ rather than a recommendation (78 FR
establish this provision as a requirement (Response 277) We decline these 3646 at 3722).
rather than as a recommendation. requests. The provision clearly (Comment 280) Comments are mixed
Articles used in the manufacturing, addresses equipment used in the regarding whether to require, rather
processing, packing, or holding of food operation of a food plant, which than recommend, provisions for cleaned
must not cause allergen cross-contact or includes food storage in addition to food and sanitized portable equipment with
contamination of food, food-contact production. Non-food-contact surfaces food-contact surfaces and utensils.
surfaces, or food-packaging materials, can become harborages for Some comments ask us to keep this
regardless of whether the articles are environmental pathogens (Ref. 55). provision a recommendation, whereas
single-service or would be used Specifying that non-food-contact other comments ask us to change this
multiple times. surfaces be cleaned as frequently as recommendation to a requirement.
We have revised the regulatory text to necessary to protect against allergen Some comments agree that it is
accept some, but not all, of the cross-contact and against contamination important that these food-contact
suggestions in these comments. We provides flexibility for industry and surfaces are clean and sanitary when
deleted ‘‘in appropriate containers’’ so regulators to interpret this long-standing used, but because storage of equipment
as not to prescribe a specific mechanism provision as appropriate to the and utensils could be for an extended
for complying with the requirement. We establishment and the food being period of time, the comments ask us to
also deleted ‘‘dispensed’’ and ‘‘used’’ processed. specify that this requirement applies
because we agree that these terms are (Comment 278) Some comments ask before the subsequent use of the
captured by the term ‘‘handled.’’ We us to specify that non-food-contact equipment and utensils.
have not deleted ‘‘stored’’ because other surfaces be sanitized or ‘‘sanitized (Response 280) The intent of the
provisions of these long-standing where appropriate.’’ Other comments provision is to emphasize that
CGMPs refer to both storage and assert that sanitizing of high touch areas equipment that is cleaned and sanitized
handling (see § 117.35(f)) and, thus, we in the non-processing areas of a food at one location has the potential to
become contaminated or be subject to equipment’’ because some large, equipment used to transport food to a
allergen cross-contact before or during stationary pieces of equipment may location other than the establishment.
movement to a location in which the have wheels.
XVI. Subpart B: Comments on Proposed
equipment is used. Examples of such (Response 282) The provision is § 117.37—Sanitary Facilities and
equipment are portable mixing kettles, directed to the storage of equipment that Controls
tables, and slicers. We are establishing does not remain stationary in a given
the provision as a requirement because establishment, regardless of whether the We proposed to re-establish the
of the importance of ensuring that food- equipment is designed in such a way so provisions of § 110.37 in new § 117.37
contact surfaces are clean and sanitary that it could readily be moved in that with some revisions to modernize them.
at time of use. establishment or another establishment. Some comments agree with one or more
(Comment 281) Some comments These comments appear to misinterpret of these proposed provisions without
assert that the manner in which this the proposed provision, which does not change. Some comments that support
equipment is stored includes the specify that equipment be installed the proposed provisions suggest
location and therefore such wording is away from a wall. (See also Response alternative or additional regulatory text
redundant. These comments ask us to 296.) (see, e.g., Comment 285 and Comment
modify the language to remove 286). Other comments that support the
‘‘location.’’ proposed provisions ask us to revise or
(Response 281) We acknowledge that us to clarify this provision to adapt
industry practices for transport of clarify current provisions that we
‘‘manner’’ in which the equipment is
watermelons because it is unrealistic proposed to re-establish in part 117
stored could be interpreted to include
and impractical to clean the carpet or without change (see, e.g., Comment
‘‘location’’ but disagree that this
replace the cardboard lining the harvest 290).
interpretation would be universal. The
storage location can affect the potential buses that transport watermelons on a In the following sections, we discuss
for the equipment to become regular basis. Other comments ask that comments that ask us to clarify the
contaminated or subject to allergen the use of wooden totes to transport proposed provisions or that disagree
cross-contact, and we are retaining it in nuts from the field to the wash and with, or suggest one or more changes to,
the rule. dryer operators remains an option for the proposed provisions, including
(Comment 282) Some comments state this industry. comments on provisions that we
that they support the proposed revision (Response 283) These comments proposed to re-establish in § 117.37 with
for ‘‘all new equipment installations appear to have misinterpreted this no changes. After considering these
being away from the wall,’’ but request provision, which relates to the storage comments, we have revised the
a waiver for equipment installed before and handling of cleaned portable proposed provisions as shown in table
this rule is issued. These comments ask equipment and utensils used within an 21, with editorial and conforming
for a clear definition of ‘‘portable establishment rather than to vehicles or changes as shown in table 52.
TABLE 21—PROVISIONS FOR SANITARY FACILITIES AND CONTROLS

Did we propose Did we get
revisions or comments that Did we modify the
Provision request comment disagreed with proposed
on potential the proposed regulatory text?
revisions? provision?
§ 117.37(a)—Water Supply ...................................................................................... Yes ....................... Yes ....................... No.

§ 117.37(b)—Plumbing ............................................................................................. No ........................ No ........................ No.
§ 117.37 (b)(1), (2), and (3) ..................................................................................... No ........................ No ........................ No.
§ 117.37(b)(4)—Adequate floor drainage ................................................................ No ........................ Yes ....................... No.
§ 117.37(b)(5)—Backflow ......................................................................................... Yes ....................... No ........................ No.
§ 117.37(c)— Sewage Disposal ............................................................................... No ........................ Yes ....................... Yes.
§ 117.37(d)—Toilet Facilities .................................................................................... Yes ....................... Yes ....................... No.
§ 117.37(e)—Hand-Washing Facilities ..................................................................... Yes ....................... Yes ....................... No.
§ 117.37(f) —Rubbish and Offal Disposal ............................................................... Yes ....................... No ........................ No.
A. Proposed § 117.37(a)—Water Supply (Comment 284) Some comments with defined microbial standards. When
express concern that because the facilities that pack or process produce
We proposed that the water supply provision does not define specific subject to the produce safety rule use
must be sufficient for the operations microbial limits, it is possible that a untreated ground water or surface water
intended and must be derived from an packer or processor that is subject to the to wash produce, the measures
adequate source. Any water that CGMPs for human food could have described in the proposed produce
contacts food, food-contact surfaces, or more flexibility in interpreting and safety rule are appropriate measures to
food-packaging materials must be safe following water quality expectations demonstrate that water used in packing
and of adequate sanitary quality. than a farm that will be subject to the and processing of produce is safe and of
Running water at a suitable temperature, produce safety rule. adequate sanitary quality when the
and under pressure as needed, must be produce does not undergo any
(Response 284) We expect that most
provided in all areas where required for processing to reduce pathogens.
facilities subject to this rule will have
the processing of food, for the cleaning access to a public water supply that (Comment 285) Some comments ask
of equipment, utensils, and food- would not, under the provisions of the us to modify the requirement that water
packaging materials, or for employee proposed produce safety rule, require must be safe and of adequate sanitary
sanitary facilities. testing to demonstrate that it complies quality by specifying that the standard
for water quality is ‘‘as defined in 40 and do not allow for any standing water other means better suited to its
CFR part 141.’’ These comments also subsequent to washing and sanitizing operations.
ask us to specify that compliance with activities.
E. Proposed § 117.37(e)—Hand-Washing
this requirement may be verified by any (Response 287) This provision does Facilities
effective means, such as examination of not prohibit standing water—e.g.,
the supplier’s specifications or test during vegetable or other wet processing We proposed to replace the existing
reports; purchase of the water under a operations. However, floors should CGMP requirements for hand-washing
supplier’s guarantee or certification; or provide for drainage, e.g., be sloped facilities (i.e., that hand-washing
analyzing the water. towards drains, and standing water facilities must be adequate and
(Response 285) We decline these should be minimized to the extent convenient and be furnished with
requests. The CGMP provisions apply to possible to reduce the potential for running water at a suitable temperature,
diverse establishments, including some contamination of food and food-contact along with recommendations for how to
establishments that do not have access surfaces. This is a long-standing comply with these requirements) with a
to water that satisfies the drinking water provision and the comment does not requirement that each plant must
requirements of 40 CFR part 141. For provide any information as to how this provide hand-washing facilities
example, seafood processing vessels has been interpreted in the past to not designed to ensure that an employee’s
may need to use seawater to clean areas allow for standing water during hands are not a source of contamination
of the ship used for food processing. processing or subsequent to washing of food, food-contact surfaces, or food-
This long-standing provision has been and sanitizing activities. packaging materials, by providing
in place since the umbrella CGMPs were facilities that are adequate, convenient,
first established and the comments do C. Proposed § 117.37(c)—Sewage
Disposal and furnish running water at a suitable
not provide any examples of food safety temperature. We also proposed to delete
problems that would have been We proposed that sewage disposal the guidance on how to comply with the
addressed by the proposed change. must be made into an adequate requirements.
Moreover, the CGMP Working Group sewerage system or disposed of through
report (Ref. 3) did not identify the water (Comment 290) Some comments ask
other adequate means. us to clarify the meaning of ‘‘suitable
quality standard as something that (Comment 288) Some comments ask
needed to be changed. temperature’’ in this provision.
us to specify that sewage ‘‘must be
(Comment 286) Some comments ask (Response 290) By ‘‘suitable
disposed.’’
us to specify that running water be temperature,’’ we mean a temperature
provided only ‘‘at appropriate (Response 288) We have revised the that does not discourage employees
locations.’’ regulatory text to consistently use the from adequately washing hands, or from
(Response 286) We decline this verb ‘‘dispose’’ rather than to use a noun washing hands at all, because the water
request. We agree that running water (i.e., ‘‘disposal’’) in the first clause. is either too cold or too hot.
must be provided only ‘‘at appropriate D. Proposed § 117.37(d)—Toilet (Comment 291) Some comments ask
locations.’’ However, in the context of Facilities that we specify that hot water should be
this provision ‘‘appropriate locations’’ provided so that this provision is more
means ‘‘in all areas where required for We proposed to replace the existing
CGMP requirements for toilets (i.e., that consistent with similar rules for most
the processing of food, for the cleaning State and local jurisdictions that
of equipment, utensils, and food- each plant provide its employees with
adequate, readily accessible toilet interpret ‘‘suitable temperature’’ as
packaging materials, or for employee ‘‘hot.’’ Some comments ask whether we
sanitary facilities’’ as has been specified facilities, along with recommendations
for how to comply with these are deleting a current requirement for
for decades. hot water to be provided at a hand-wash
requirements) with a requirement that
B. Proposed § 117.37(b)—Plumbing each plant must provide its employees station.
We proposed that plumbing must be with adequate, readily accessible toilet (Response 291) We are not deleting a
of adequate size and design and facilities. We proposed that toilet current requirement for hot water to be
adequately installed and maintained to: facilities must be kept clean and must provided at a hand-wash station. The
(1) Carry sufficient quantities of water to not be a potential source of comments may be mistaking our CGMP
required locations throughout the plant; contamination of food, food-contact, or requirements with the provisions of our
(2) properly convey sewage and liquid food-packaging materials. We also Food Code, which specify that a hand-
disposable waste from the plant; (3) proposed to delete the guidance on how washing sink shall be equipped to
avoid constituting a source of to comply with the requirements. provide water at a temperature of at
contamination to food, water supplies, (Comment 289) Some comments ask least 38 degrees C (110 degrees F)
equipment, or utensils or creating an us to retain the guidance we proposed through a mixing valve or combination
unsanitary condition; (4) provide to delete. Some comments ask us to faucet (See section 5–202.12 of the Food
adequate floor drainage in all areas retain some of the guidance and make Code) (Ref. 51).
where floors are subject to flooding-type some of it optional to allow for We decline the request to modify the
cleaning or where normal operations flexibility based on the design of the regulatory text so that it requires that
release or discharge water or other facility. Some comments provide ‘‘hot water’’ be provided. This long-
liquid waste on the floor; and (5) specific editorial suggestions to include standing requirement for a ‘‘suitable
provide that there is not backflow from, the guidance in this provision. temperature,’’ without specifying a
or cross-connection between, piping (Response 289) We decline these requirement for ‘‘hot water,’’ means that
systems that discharge waste water or requests. As noted in the final rule the water should be neither too hot nor
sewage and piping systems that carry establishing CGMPs for dietary too cold to discourage personnel from
water for food or food manufacturing. supplements (72 FR 34752 at 34817), it washing their hands. We continue to
(Comment 287) Some comments is unnecessary to require specific believe that it is not necessary to specify
assert that requirements for adequate features because an establishment may a particular temperature or to use the
floor drainage are overly prescriptive be able to achieve compliance through subjective term ‘‘hot.’’
XVII. Subpart B: Comments on how we will interpret the provision redesignation and are finalizing it as
Proposed § 117.40—Equipment and (see, e.g., Comment 308). Other proposed.
Utensils comments that support the proposed In the following sections, we discuss
provisions ask us to revise or clarify comments that ask us to clarify the
We proposed to re-establish the current provisions that we proposed to proposed requirements or that disagree
provisions of § 110.40 in new § 117.40 re-establish in part 117 without change with, or suggest one or more changes to,
with some revisions to modernize them. (see, e.g., Comment 292, Comment 300, the proposed provisions, including
Some comments agree with one or more and Comment 310). comments on provisions that we
of these proposed provisions without We also proposed to reorganize proposed to re-establish in § 117.40 with
change. Some comments that support provisions found in current § 110.40(a) no changes. After considering these
the proposed provisions suggest by creating paragraph designations (a)(1) comments, we have revised the
alternative or additional regulatory text through (a)(6) with associated editorial proposed provisions as shown in table
(see, e.g., Comment 301, Comment 305, changes. We received no comments that 22, with editorial and conforming
and Comment 307) or ask us to clarify disagreed with this proposed changes as shown in table 52.
TABLE 22—PROVISIONS FOR EQUIPMENT AND UTENSILS

§ 117.40(a)(1)—Design of Plant Equipment and Utensils ....................................... No ........................ Yes ....................... No.
§ 117.40(a)(2)—Design Construction, and Use of Equipment and Utensils ........... No ........................ Yes ....................... Yes.
§ 117.40(a)(3)—Installation and Maintenance of Equipment ................................... Yes ....................... Yes ....................... Yes.
§ 117.40(a)(4)—Corrosion-Resistant Food-Contact Surfaces ................................. No ........................ Yes ....................... No.
§ 117.40(a)(5)—Food-Contact Surfaces and Nontoxic Materials ............................ No ........................ Yes ....................... Yes.
§ 117.40(a)(6)—Maintenance of Food-Contact Surfaces ........................................ Yes ....................... Yes ....................... No.
§ 117.40(b)—Seams on Food-Contact Surfaces ..................................................... Yes ....................... Yes ....................... No.
§ 117.40(c)—Construction of Equipment ................................................................. No ........................ Yes ....................... Yes.
§ 117.40(d)—Holding, Conveying, and Manufacturing Systems ............................. No ........................ Yes ....................... Yes.
§ 117.40(e)—Freezer and Cold Storage Compartments ......................................... Yes ....................... Yes ....................... No.
§ 117.40(f)—Accurate and Precise Instruments and Controls ................................ Yes ....................... Yes ....................... No.
§ 117.40(g)—Compressed Air or Other Gases ........................................................ No ........................ Yes ....................... No.
A. Proposed § 117.40(a)—Design, necessary to apply the requirement to the provision and have incorporated
Construction, Use, Installation, and equipment such as welding equipment them into the regulatory text.
Maintenance of Equipment and Utensils used in an establishment’s machine
3. Proposed § 117.40(a)(3)—Installation
shop. Accordingly, we have made the
1. Proposed § 117.40(a)(1)—Design of and Maintenance of Equipment
following modifications to the
Plant Equipment and Utensils We requested comment on whether to
provision: (1) Specify that the provision
We proposed no revisions to the applies to all plant equipment and establish the current recommendation
requirement that all plant equipment utensils ‘‘used in manufacturing, that all equipment be so installed and
and utensils must be so designed and of processing, packing, or holding food’’; maintained as to facilitate the cleaning
such material and workmanship as to be (2) specify that equipment and utensils of the equipment and of all adjacent
adequately cleanable, and must be must be ‘‘adequately’’ maintained, spaces as a requirement (78 FR 3646 at
properly maintained. rather than ‘‘properly’’ maintained, to 3723).
(Comment 292) Some comments ask emphasize the public health goal of the (Comment 294) Some comments
us to specify that this provision only requirement; and (3) specify that the assert that we should establish this
applies to equipment and utensils used purpose of the requirement is to protect recommendation as a requirement in
for, or in connection with, food against allergen cross-contact and light of recent findings of the pathogen
manufacturing, processing, packing, or contamination. L. monocytogenes in environmental
holding and appropriate to the stage of swab samples taken from food
production it is used in. These 2. Proposed § 117.40(a)(2)—Design, processing plants.
comments assert that ‘‘all plant Construction, and Use of Equipment (Response 294) We agree with these
equipment and utensils’’ is too broad and Utensils comments that an additional reason to
and that the requirements for establish this recommendation as a
We proposed no revisions to the requirement, in addition to the reasons
cleanliness of the equipment and
requirement that the design, we provided in the 2013 proposed
utensils differ at various stages of
construction, and use of equipment and preventive controls rule (78 FR 3646 at
production. Other comments ask us to
utensils must preclude the adulteration 3728), is that it could facilitate cleaning
specify ‘‘as needed to protect against
allergen cross-contact and of food with lubricants, fuel, metal for environmental pathogens. We have
contamination.’’ fragments, contaminated water, or any revised the regulatory text to change
(Response 292) We agree that it is not other contaminants. ‘‘should’’ to ‘‘must.’’

necessary to apply the provision to all (Comment 293) Some comments (Comment 295) Some comments
plant equipment and utensils, regardless suggest editorial changes to the suggest that we make editorial changes,
of what the equipment is and whether provision to improve clarity. for clarity and completeness, to read ‘‘so
it has any role in the production of food. (Response 293) We agree that the as to facilitate the cleaning and
For example, we agree that it is not suggested changes improve the clarity of maintenance’’ rather than ‘‘so installed
and maintained as to facilitate the food, and, if applicable, cleaning (Response 301) We decline these
cleaning.’’ compounds and sanitizing agents. requests. As proposed, the requirement
(Response 295) We agree that the (Comment 298) Some comments applies to all food-contact surfaces,
suggested changes improve the clarity of assert that food-contact surfaces or including those on equipment and
the provision and have incorporated utensils could be dedicated to allergens utensils; it is not necessary to separately
them into the regulatory text. only or non-allergens only. specify that the requirement applies to
(Comment 296) Some comments (Response 298) We agree that equipment and utensils. We are not
support the proposed revision for ‘‘all dedicating food-contact surfaces and specifying that single-use food-contact
new equipment installations being away utensils is one way to comply with surfaces do not need to be maintained.
from the wall,’’ but ask that we provide various requirements of this rule to Using equipment or utensils that have
a waiver for equipment that has been prevent allergen cross-contact, but single-use food-contact surfaces may be
installed prior to the issuance of this disagree that we should require this one way to satisfy the requirements of
rulemaking. particular mechanism to prevent the provision, although single use items
(Response 296) These comments allergen cross-contact. Other may still need to be protected from
appear to misinterpret the proposed mechanisms can prevent allergen cross- allergen cross-contact and from
provision, which does not specify that contact, such as adequately cleaning contamination, e.g., by protective
equipment be installed away from a equipment and surfaces between uses. packaging.
wall. The requirement is to install (Comment 299) Some comments ask (Comment 302) Some comments ask
equipment so as to facilitate both us to specify that food-contact surfaces us to require that the surfaces also be
cleaning and maintenance. This must be made of food-grade materials appropriately cleaned and sanitized.
provision has been a long-standing and suitably durable. (Response 302) We decline this
recommendation. Moreover, if the (Response 299) We decline these request. Cleaning and sanitizing of food-
existing equipment is installed in a way requests. Food-grade materials must be contact surfaces is covered by
that it cannot be cleaned, it would not non-toxic. The comment provides no § 117.35(d) and does not need to be
have been in compliance with existing examples of circumstances in which the repeated here.
CGMP requirements for the design and (Comment 303) Some comments ask
long-standing criterion of ‘‘nontoxic’’ is
construction of the plant (§ 110.20). For us to strike the phrase ‘‘including
inadequate. We agree that ‘‘suitably
example, the current CGMPs have long unlawful indirect food additives.’’
durable’’ could be interpreted to capture
required that the design and These comments assert that the wording
the general intent of the current text that
construction of the plant must provide would be equally effective without the
specifies ‘‘designed to withstand the
sufficient space for such placement of phrase and that striking it would result
environment of their intended use and
equipment and storage of materials as is in a stronger and more absolute
the action of food, and, if applicable,
necessary for the maintenance of requirement.
cleaning compounds and sanitizing (Response 303) We decline this
sanitary operations and the production agents,’’ but disagree that this
of safe food (§ 110.20(a)(1)). request. Although some persons might
interpretation would be universal and realize that the provision requires them
4. Proposed § 117.40(a)(4)—Corrosion- are retaining the long-standing to protect against unlawful indirect food
Resistant Food-Contact Surfaces regulatory text. additives, such an interpretation may
We proposed no revisions to the (Comment 300) Some comments ask not be universal.
requirement that food-contact surfaces us to specify that food-contact surfaces
must be designed to withstand cleaning B. Proposed § 117.40(b)—Seams on
must be corrosion-resistant when in
procedures. Food-Contact Surfaces
contact with food.
(Comment 297) Some comments ask (Response 300) We have revised the We proposed that seams on food-
us to specify that the requirement only regulatory text to include cleaning contact surfaces must be smoothly
applies where appropriate for food procedures. For example, food-contact bonded or maintained so as to minimize
safety. Other comments ask us to specify surfaces must be designed to withstand accumulation of food particles, dirt, and
that the food-contact surfaces be the actions of scrubbing utensils that organic matter, and thus minimize the
corrosion-resistant as appropriate to the could scratch or pit the equipment, opportunity for growth of
type of food and other substances with creating cracks and crevices that could microorganisms and cross-contact.
which they come in contact. be difficult to clean and lead to a niche (Comment 304) Some comments
(Response 297) We decline these where environmental pathogens could assert that this provision should not
requests. We disagree with the lodge and potentially contaminate food apply to all establishments—e.g., that it
implication that the condition of some produced using the equipment. seems directed towards bakeries but
food-contact surfaces would not be inapplicable to establishments that pack
6. Proposed § 117.40(a)(6))—
relevant to food safety. We also disagree produce.
Maintenance of Food-Contact Surfaces
that it would be acceptable for some (Response 304) The provision requires
food products to be in contact with We proposed that food-contact an establishment to minimize
surfaces susceptible to corrosion, surfaces must be maintained to protect accumulation of food particles, dirt, and
regardless of the nature of the food food from cross-contact and from being organic matter in seams on food-contact
product. contaminated by any source, including surfaces to minimize the opportunity for
unlawful indirect food additives. As an growth of microorganisms and allergen
5. Proposed § 117.40(a)(5)—Food- inadvertent error, we specified that this cross-contact and provides flexibility for
Contact Surfaces and Nontoxic requirement would be designated as how to comply with the requirement
Materials § 117.40(a)(5); we intended to specify (i.e., through smoothly bonded seams or

We proposed no revisions to the that it be designated § 117.40(a)(6). through maintenance). Minimizing the
requirement that food-contact surfaces (Comment 301) Some comments ask accumulation of food particles, dirt, and
must be made of nontoxic materials and us to specify that this requirement also organic matter in seams on food-contact
designed to withstand the environment applies to equipment and utensils but surfaces is appropriate for all
of their intended use and the action of does not apply to single-use items. establishments that produce food.
C. Proposed § 117.40(c)—Construction E. Proposed § 117.40(e)—Freezer and (Comment 309) Some comments ask
of Equipment Cold Storage Compartments us to specify ‘‘calibrated’’ for clarity,
We proposed that equipment that is in accuracy, and completeness. Some
We proposed that each freezer and comments assert that proper calibration
the manufacturing or food-handling area cold storage compartment used to store
and that does not come into contact of such equipment is essential to ensure
and hold food capable of supporting food safety, and does not entail so large
with food must be so constructed that it growth of microorganisms must be fitted
can be kept in a clean condition. a cost as to preclude even small
with an indicating thermometer, companies from compliance.
(Comment 305) Some comments ask temperature measuring device, or
us to specify ‘‘areas where food is (Response 309) We decline this
temperature-recording device so request. The request of this comment is
manufactured, processed, or packed’’
installed as to show the temperature already addressed by our proposal to
and clarify that the equipment must be
accurately within the compartment. We revise this long-standing provision to
constructed so that it can be kept
also proposed to delete the require that these types of instruments
‘‘appropriately clean and sanitary.’’
(Response 305) We have revised the recommendation that each freezer and be accurate, as well as precise. As
provision to specify that it applies to cold storage compartment used to store discussed in Comment 519 and
areas in the plant where food is and hold food capable of supporting Response 519, some types of
manufactured, processed, packed, or growth of microorganisms be fitted with instruments generally are subject to
held. Doing so makes the terms in this an automatic control for regulating accuracy checks rather than to
provision consistent with terms used temperature or with an automatic alarm calibration.
throughout the CGMPs (78 FR 3646 at system to indicate a significant
temperature change in a manual G. Proposed § 117.40(g)—Compressed
3692). Consistent with (Response 258, Air or Other Gases
we also have modified the provision to operation.
specify that the equipment must be (Comment 308) Some comments ask We proposed no revisions to the
constructed so that it can be kept ‘‘clean us to clarify that this requirement is requirement that compressed air or
and sanitary.’’ only for foods that require temperature other gases mechanically introduced
(Comment 306) Some comments ask control for food safety, and does not into food or used to clean food-contact
us to consider inserting technical apply to any intact fruits or vegetables surfaces or equipment must be treated
language to address systems used for that are only held at specific in such a way that food is not
sanitizing in food processing temperatures for quality and shelf-life contaminated with unlawful indirect
environments to ensure they meet purposes. Some comments ask us to food additives.
generally accepted design principles for change this requirement to a (Comment 310) Some comments ask
food grade equipment. Some comments recommendation for the same reason. us to specify that compressed air or
ask us to specify that the equipment Some comments assert that temperature other gases must be ‘‘filtered or
must be constructed of materials that control for intact fruits and vegetables is otherwise treated’’ for clarity.
will not get corroded by cleaning likely not always necessary or even (Response 310) We decline this
chemicals and that welded joints must desirable (e.g., to avoid chill damage). request. We agree that filtration is a
be of non-corrosive materials and common treatment to prevent
(Response 308) We decline this
‘‘dressed’’ to eliminate porous surfaces contamination, but disagree that it is
request. The requirement applies to
and occlusions. necessary to modify this long-standing
refrigerated storage when the
(Response 306) We decline these requirement to add this particular
establishment has placed food in a
requests. It is not necessary to specify example of a treatment to prevent
refrigerated storage compartment,
every type of equipment that could be contamination with unlawful indirect
whether for food safety or for food
used in a food processing environment food additives. As written, the provision
quality (e.g., to prevent the growth of
or every situation that must be provides flexibility for an establishment
spoilage microorganisms). The
addressed to satisfy the specific to determine the appropriate treatment
provision, which is an existing
requirements of this provision and the for compressed air or other gases in a
requirement in § 110.40, does not
more general requirements of manner that works best for its plant.
specify which foods must be refrigerated (Comment 311) Some comments ask
§ 117.40(a).
or what the refrigeration temperature us to strike the phrase ‘‘with unlawful
D. Proposed § 117.40(d)—Holding, must be. However, once the indirect food additives.’’ These
Conveying, and Manufacturing Systems establishment has determined that comments assert that the wording
We proposed no revisions to the refrigerated storage is appropriate, either would be equally effective without the
requirement that holding, conveying, for food safety or food quality, it is phrase and that striking it would result
and manufacturing systems, including appropriate to require that the in a stronger and more absolute
gravimetric, pneumatic, closed, and establishment have evidence that it is requirement.
automated systems, must be of a design refrigerating the food as it has decided (Response 311) We decline this
and construction that enables them to be to do. request. Although some persons might
maintained in an appropriate sanitary F. Proposed § 117.40(f)—Accurate and realize that the provision requires them
condition. Precise Instruments and Controls to protect against unlawful indirect food
(Comment 307) Some comments ask additives, such an interpretation may
us to specify that these systems also We proposed that instruments and not be universal.
need to be maintained in an controls used for measuring, regulating,
appropriately clean condition in or recording temperatures, pH, acidity, XVIII. Subpart B: Comments on
addition to a sanitary condition. water activity, or other conditions that Proposed § 117.80(a)—General
(Response 307) Consistent with control or prevent the growth of Processes and Controls
Response 258, we have revised the undesirable microorganisms in food We proposed to re-establish the
provision to specify that the equipment must be accurate and precise and provisions of § 110.80 in new
must be constructed so that it can be adequately maintained, and adequate in § 117.80(a) with some revisions to
kept ‘‘clean and sanitary.’’ number for their designated uses. modernize them and with some
redesignations. Some comments support Comment 317). Other comments that with, or suggest one or more changes to,
one or more of these proposed support the proposed provisions ask us the proposed provisions, including
provisions without change. Some to revise or clarify current provisions comments on provisions that we did not
comments that support the proposed that we proposed to re-establish in part propose to revise. After considering
provisions suggest alternative or 117 without change (see, e.g., Comment these comments, we have revised the
additional regulatory text (see, e.g., 312 and Comment 320). proposed provisions as shown in table
Comment 316) or ask us to clarify how In the following sections, we discuss 23, with editorial and conforming
we will interpret the provision (see, e.g., comments that ask us to clarify the changes as shown in table 52.
proposed provisions or that disagree
TABLE 23—PROVISIONS FOR GENERAL PROCESSES AND CONTROLS
§ 117.80(a)(1 )—Adequate sanitation principles ...................................................... No ........................ Yes ....................... No.

§ 117.80(a)(2)—Quality control operations .............................................................. No ........................ Yes ....................... No.
§ 117.80(a)(3)—Supervising overall sanitation ........................................................ No ........................ Yes ....................... No.
§ 117.80(a)(4)—Production procedures ................................................................... Yes ....................... Yes ....................... Yes.
§ 117.80(a)(5)—Chemical, microbial, or extraneous-material testing procedures .. Yes ....................... Yes ....................... No.
§ 117.80(a)(6)—Contaminated food ......................................................................... No ........................ Yes ....................... No.
A. Proposed § 117.80(a)(1)—Adequate of low-moisture almonds, sanitation evidence that industry commonly

Sanitation Principles intervals may be extended in order to understands the use of the term
We proposed no revisions to the minimize addition of water into the ‘‘suitable’’ in the context of CGMP
requirements of current § 110.80 facility. requirements in addition to
(proposed § 117.80(a)(1)) that all (Response 313) We decline this requirements applicable to ingredients
operations in the manufacturing, request. By specifying that sanitation used in standardized foods, we note that
processing, packing, and holding of food principles must be ‘‘adequate,’’ the we substituted the term ‘‘suitable’’ for
(including operations directed to provision already provides flexibility ‘‘fit’’ in another provision
receiving, inspecting, transporting, and such as that requested by these (§ 110.80(a)(1)) in response to comments
segregating) be conducted in accordance comments. In addition, the rule does not from industry stating that ‘‘suitable’’
with adequate sanitation principles. specify any time intervals for was a more familiar term than ‘‘fit’’ (51
(Comment 312) Some comments ask conducting sanitation operations and, FR 22458 at 22470).
us to clarity ‘‘adequate sanitation thus, the provision needs no
C. Proposed § 117.80(a)(3)—Supervision
principles.’’ Some of these comments qualification to provide flexibility for an
of Overall Sanitation
express concern that facilities receiving establishment to adopt a frequency of
raw produce that will be further cleaned sanitation procedures consistent with its We proposed no revisions to the
or processed will be unable to meet this operations. requirements of current § 110.80
requirement and assert that this (proposed § 117.80(a)(3)) that overall
B. Proposed § 117.80(a)(2)—Quality sanitation of the plant be under the
requirement will not provide additional Control Operations
public health benefits. supervision of one or more competent
(Response 312) These comments fail We proposed no revisions to the individuals assigned responsibility for
to explain how we have interpreted the requirements of current § 110.80 this function.
provision in a way that has been (proposed § 117.80(a)(2)) that (Comment 315) Some comments ask
problematic such that clarification is appropriate quality control operations us to revise this provision to specify that
necessary. The term ‘‘adequate’’ is a be employed to ensure that food is it applies to overall cleaning of the
long-standing term that we defined in suitable for human consumption and plant, as well as overall sanitation of the
its current form when we first that food-packaging materials are safe plant.
established the umbrella CGMPs in 1969 and suitable. (Response 315) We decline this
(34 FR 6977 at 6978). Furthermore, (Comment 314) Some comments request. Sanitation is a general term that
during a previous rulemaking to revise assert that specifying that food- already encompasses cleaning (and, as
the umbrella CGMPs and establish packaging materials must be ‘‘safe and appropriate, sanitizing).
current § 110.80 we explained that the suitable’’ is confusing because the
definition for ‘‘safe and suitable’’ at D. Proposed § 117.80(a)(4)—Production
phrase ‘‘adequate sanitation principles’’
§ 130.3(d) defines the phrase with Procedures
must be broad so that industry can
easily adapt sanitation principles to its respect to ingredients. We proposed that all reasonable
existing procedures (51 FR 22458 at (Response 314) The requirement is a precautions must be taken to ensure that
22461). long-standing provision that has been production procedures do not
(Comment 313) Some comments ask used in this context for decades. When contribute to cross-contact and
us to specify that operations be we first proposed this provision during contamination from any source.
conducted in accordance with adequate a previous rulemaking to revise the (Comment 316) Some comments
sanitation principles ‘‘specific to the umbrella CGMPs, we included this assert that the phrase ‘‘all reasonable
operation’’ to provide for extended time exact phrase and did not receive any precautions’’ is too extreme and
intervals between sanitation procedures. comments regarding its use (44 FR prescriptive and suggest that ‘‘adequate’’
These comments explain that in the case 33238 at 33246). Furthermore, as would be more appropriate than ‘‘all’’ to
describe the intended measures and for environmental pathogens rather than dried protein product, can sometimes be
precautions. for other substances that may rehydrated, and a food establishment
(Response 316) We agree that contaminate the food processing could repeat the processing to reduce
‘‘adequate’’ is more appropriate than environment. Likewise, the provision pathogens. Other products, such as
‘‘all’’ and have substituted the word does not establish requirements for many types of produce, are not normally
‘‘adequate’’ for ‘‘all reasonable’’ in the environmental monitoring for finished processed to reduce pathogens, and
final rule. product. As discussed in Response 317, product quality may be impacted by
E. Proposed § 117.80(a)(5)—Chemical, the provision provides flexibility for an such treatments. Even though
Microbial, or Extraneous-Material establishment to test when testing is processing techniques such as
Testing Procedures appropriate, such as when the facility irradiation have the potential to reduce
determines testing would be useful to pathogens, irradiation is a food additive
We proposed that chemical, verify adherence to CGMPs or when
microbial, or extraneous-material testing that requires approval. For example, as
there is a problem such as allergen
procedures must be used where of January 15, 2015, irradiation had
cross-contact.
necessary to identify sanitation failures been approved for control of foodborne
or possible cross-contact and food F. Proposed § 117.80(a)(6)— pathogens and extension of shelf-life in
contamination. Contaminated Food fresh iceberg lettuce and fresh spinach,
(Comment 317) Some comments ask We proposed no revisions to the but not in other fresh leafy greens. Using
whether the word ‘‘must’’ in the requirements of current § 110.80 irradiation for a purpose that has not
provision means that testing will always (proposed § 117.80(a)(6)) that all food been approved (such as for the
be required, including for food that has become contaminated to the irradiation of fresh leafy greens other
allergens. Other comments assert that extent that it is adulterated be rejected, than fresh iceberg lettuce and fresh
testing should only be used when there or if permissible, treated or processed to spinach) would render the food
is reason to suspect a specific problem eliminate the contamination. adulterated under section 402(a)(2)(C)(i)
has occurred and when methods are (Comment 320) Some comments of the FD&C Act and, thus, it would not
available. assert that the use of the phrase ‘‘if be appropriate to treat or process fresh
(Response 317) Testing is not always permissible’’ is vague and confusing and leafy greens other than fresh iceberg
required. The provision provides should be replaced by a statement of lettuce and fresh spinach using
flexibility for an establishment to test precisely what is impermissible. irradiation.
when appropriate, such as when a (Response 320) We acknowledge that
facility determines that it is necessary to the phrase ‘‘if permissible’’ does not XIX. Subpart B: Comments on Proposed
use rapid ATP (adenosine triphosphate) communicate the circumstances under § 117.80(b)—Processes and Controls for
swabs as an indicator of microbial or which it is permissible to treat or Raw Materials and Other Ingredients
food residue contamination to verify process a food to eliminate
cleaning of a line prior to running a contamination. Rather than add such We proposed to re-establish the
different product (Ref. 56). Facilities circumstances to the rule, we have provisions of § 110.80(a) in new
commonly conduct tests on food for replaced the phrase ‘‘if permissible’’ § 117.80(b) with some revisions to
microorganisms that indicate sanitation with ‘‘if appropriate.’’ In the following modernize them. Some comments
failures, such as testing for total plate paragraphs, we discuss examples of support one or more of these proposed
count, generic E. coli, total coliforms, when treatment or processing to provisions without change. For
etc. (Ref. 57). When the number of such eliminate contamination would or example, some comments support a new
organisms exceeds expectation, would not be appropriate. provision that would require raw
sanitation or other failures are suspected Some RACs, such as cocoa beans, can materials and ingredients that are food
and the facility can take actions to become adulterated with insects or filth allergens, and rework that contains food
determine the source of the problem. but may be fumigated or cleaned in allergens, to be identified and held in a
(Comment 318) Some comments accordance with an application for manner that prevents allergen cross-
oppose any implication that food reconditioning submitted to FDA to contact. Some comments that support
manufacturers are required to develop bring the product into compliance. Acid the proposed provisions suggest
test methods or analytical standards, or or acidified canned goods with alternative or additional regulatory text
search out methods that are not readily microbial contamination due to a (see, e.g., Comment 324, Comment 325,
available, for this or any other purpose. container defect may be reconditioned Comment 328, and Comment 329) or ask
(Response 318) The provision does by sorting out the defective containers us to clarify how we will interpret the
not require food manufacturers to to ensure that containers released into provision (see, e.g., Comment 323 and
develop test methods or analytical commerce are intact and the product is Comment 327).
standards, or search out methods that not contaminated. Tree nuts with signs
are not readily available. of mold growth can be reconditioned In the following sections, we discuss
(Comment 319) Some comments using methods that separate the moldy comments that ask us to clarify the
suggest that testing as part of an nuts from those that are not proposed provisions or that disagree
environmental monitoring program contaminated. Tree nuts found to be with, or suggest one or more changes to,
should be risk-based and include contaminated with Salmonella may be the proposed provisions, including
allergens, but should not be required for treated by processes such as steam or comments on provisions that we did not
finished product. propylene oxide when such treatments propose to revise. After considering
(Response 319) The provision does have been validated to provide an these comments, we have revised the
not use the term ‘‘environmental adequate reduction of Salmonella. A proposed provisions as shown in table
monitoring,’’ which is a term that has heat-treated food contaminated from the 24, with editorial and conforming
come to be associated with monitoring environment, such as a heat-treated, changes as shown in table 52.
TABLE 24—PROVISIONS FOR PROCESSES AND CONTROLS FOR RAW MATERIALS AND OTHER INGREDIENTS
§ 117.80(b)(1)—Inspection, storage, and handling of raw materials and other in- Yes ....................... Yes ....................... Yes.
gredients.
§ 117.80(b)(2)—Levels of microorganisms in raw materials and other ingredients Yes ....................... Yes ....................... No.
§ 117.80(b)(3)—Natural toxins in raw materials and other ingredients ................... Yes ....................... Yes ....................... No.
§ 117.80(b)(4)—Pests, undesirable microorganisms, and extraneous material in Yes ....................... Yes ....................... No.
raw materials and other ingredients.
§ 117.80(b)(5)—Holding raw materials, other ingredients, and rework in bulk ....... Yes ....................... Yes ....................... No.
§ 117.80(b)(6)—Frozen raw materials and other ingredients .................................. No ........................ No ........................ No.
§ 117.80(b)(7)—Liquid and dry raw materials and other ingredients ...................... Yes ....................... Yes ....................... No.
§ 117.80(b)(8)—Raw materials and other ingredients that are food allergens ....... Yes ....................... Yes ....................... No.
A. Proposed § 117.80(b)(1)—Inspection, require, that containers and carriers of (Comment 323) Some comments
Segregation and Handling of Raw raw materials be inspected on receipt to express concern about the requirement
Materials and Other Ingredients ensure that their condition has not for pasteurization, explaining that fresh
We proposed that raw materials and contributed to allergen cross-contact, produce cannot be pasteurized.
ingredients must be inspected and contamination, or deterioration. (Response 323) The proposed
segregated or otherwise handled as Therefore, we are not re-establishing provision would not require
necessary to ascertain that they are this nonbinding recommendation as a pasteurization of products such as
clean and suitable for processing into requirement. Instead, as discussed in produce. The proposed provision
food and must be stored under Response 67, we have deleted this non- clearly states that pasteurization or
conditions that will protect against binding provision from the rule. other treatment is only required when
cross-contact and contamination and raw materials and other ingredients
B. Proposed § 117.80(b)(2)—Levels of contain levels of microorganisms that
minimize deterioration. Raw materials Microorganisms in Raw Materials and
must be washed or cleaned as necessary may render the food injurious to health
Other Ingredients of humans. However, when products
to remove soil or other contamination.
Water used for washing, rinsing, or We proposed that raw materials and such as produce contain levels of
conveying food must be safe and of ingredients must either not contain microorganisms that may render the
adequate sanitary quality. Water may be levels of microorganisms that may food injurious to health of humans, and
reused for washing, rinsing, or render the food injurious to health of the products cannot be pasteurized or
conveying food if it does not increase humans, or they must be pasteurized or otherwise treated so that they no longer
the level of contamination of the food or otherwise treated during manufacturing contain levels that would cause the
cause cross-contact. operations so that they no longer product to be adulterated, other
We also proposed to continue to contain levels that would cause the provisions require that the product be
recommend that containers and carriers product to be adulterated. We also rejected and disposed of in a manner
of raw materials be inspected on receipt proposed to delete guidance regarding that protects against the contamination
to ensure that their condition has not how to comply with this requirement. of other food (see, e.g., §§ 117.80(a)(6)
contributed to cross-contact, and 117.80(c)(9)).
(Comment 322) Some comments ask (Comment 324) Some comments
contamination, or deterioration.
us to supply the list of microorganisms assert that this requirement is overly
However, we also requested comment
that may render the food injurious to the broad and should only apply to RTE
on whether to establish this
health of humans. Some comments food. These comments express the view
recommendation as a requirement (78
assert that we would have to establish that we should not focus on the issue of
FR 3646 at 3724).
(Comment 321) Some comments acceptable pathogen concentration microbiological contamination in foods
express concern about revising current limits in order for industry to comply that are early in the supply chain (other
§ 110.80(a)(1) to require, rather than with this provision. than produce that will be consumed
recommend, that containers and carriers (Response 322) We are not providing without adequate processing or
of raw materials be inspected on receipt. a list of microorganisms that may render cooking). Some comments suggest
Some comments focus on practical the food injurious to the health of adding a statement to be provided in
problems associated with inspecting humans. CGMPs establish procedural commercial documentation
bins containing RACs such as produce. requirements, not declarations of foods accompanying the sale of produce not
These comments explain that produce that are adulterated. It is not necessary covered by the proposed produce safety
bins received by a packing for us to establish acceptable pathogen rule to alert potential purchasers to the
establishment are too large to be concentration limits in order for hazard that may exist and allow them to
handled directly and instead are industry to comply with this provision. determine whether the food offered for
delivered by a fork lift followed by Moreover, several Compliance Policy sale is suitable for their particular needs
automated travel through the Guides (CPGs) provide guidance to our or whether the food requires
establishment. investigators about agency policies that commercial formulation, processing, or
(Response 321) We agree that apply when food is contaminated with both to adequately reduce
circumstances such as those described microorganisms, and these CPGs are microorganisms.
in these comments make it appropriate available to industry (Ref. 58) (Ref. 59) (Response 324) It is not necessary to
to continue to recommend, but not (Ref. 60) (Ref. 61) (Ref. 62). narrow this requirement to RTE food to
provide for use of raw materials and finished food. We also proposed to E. Proposed § 117.80(b)(5)—Holding
other ingredients that are early in the delete guidance regarding how to Raw Materials, Other Ingredients, and
supply chain. The requirement already comply with this requirement and to Rework in Bulk
clearly provides for pasteurization or delete a requirement for compliance We proposed that raw materials,
other treatment during manufacturing with action levels, which are not ingredients, and rework must be held in
operations so that the processed product binding. bulk, or in containers designed and
would no longer contain levels that constructed so as to protect against
would cause the product to be cross-contact and contamination and
adulterated. See also our previous us to delete ‘‘aflatoxin’’ from the
provision because it is redundant with must be held at such temperature and
discussion of the importance of this relative humidity and in such a manner
provision during a previous rulemaking ‘‘other natural toxin.’’
as to prevent the food from becoming
to revise the umbrella CGMPs (51 FR (Response 325) We decline this
adulterated. Material scheduled for
22458 at 22470). request. Aflatoxin is an important
We decline the request to require a rework must be identified as such.
natural toxin that is an example (Comment 327) Some comments
statement in commercial documentation illustrating what we mean when we
when produce is not covered by the express concern that this requirement
refer to ‘‘natural toxins.’’ An illustrative would make the use of wooden bins in
produce safety rule. As discussed in example does not create a redundancy.
section XXVII, we are providing for a the produce industry problematic and
narrow use of commercial D. Proposed § 117.80(b)(4)—Pests, ask us to clarify whether it is our intent
documentation, when a manufacturer/ Undesirable Microorganisms and to prohibit use of wooden bins. Some
processor that has identified a hazard Extraneous Materials in Raw Materials comments ask us to clarify whether the
requiring a preventive control does not and Other Ingredients provision would preclude using or
establish a preventive control because it: storing containers (such as trailers and
(1) Relies on its customer to ensure that We proposed that raw materials, gondolas used in the produce industry)
an identified hazard will be controlled ingredients, and rework susceptible to outdoors because such containers
and (2) discloses, in documents contamination with pests, undesirable cannot be covered.
accompanying the food, in accordance microorganisms, or extraneous material (Response 327) We do not intend to
with the practice of the trade, that the must comply with applicable FDA interpret this provision in such a way
food is ‘‘not processed to control regulations for natural or unavoidable that would prohibit the use of wooden
[identified hazard]’’ (See § 117.136(a)(2), defects if a manufacturer wishes to use bins in the produce industry or preclude
(3), and (4)). That use of commercial the materials in manufacturing food. We using and storing containers such as
documentation reflects the outcome of a also proposed to delete guidance trailers and gondolas outside.
hazard analysis—in particular, an regarding how to comply with this Importantly, these CGMP requirements
outcome in which the manufacturer/ requirement and to delete the are long-standing provisions that we
processor determines that a hazard requirement for compliance with action have not interpreted as prohibiting
requires a preventive control. The vast wooden containers in the produce
levels, which are not binding.
majority of the produce that we industry. See also our ‘‘Guide to
(Comment 326) Some comments ask Produce Farm Investigations’’ (Ref. 63),
proposed would not be subject to the
requirements of the forthcoming us to qualify that the requirement does which applies during investigations
produce safety rule would either be not apply if the manufacturing process when an outbreak and traceback
produce that is going to commercial includes steps that serve to investigation implicates a farm and
processing that adequately reduces the decontaminate the food. related operations, or as a follow-up to
presence of microorganisms of public (Response 326) We decline this a produce sample that tests positive for
health significance or produce that is request. We have defined ‘‘defect action contamination with a pathogen.
rarely consumed raw. Thus, there would level’’ to mean a level of a non- (Comment 328) Some comments ask
be no benefit to alert potential hazardous, naturally occurring, us to add ‘‘in-process’’ materials to the
purchasers to a hazard because such unavoidable defect at which FDA may provision.
produce has been determined to be low- regard a food product ‘‘adulterated’’ and (Response 328) We decline this
risk, based on the findings of a subject to enforcement action under request, which is already covered by
qualitative assessment of risk (e.g., for section 402(a)(3) of the FD&C Act (see § 117.80(c)(7). We note that the
produce rarely consumed raw) or requirements directed to raw materials
§ 117.3). It is not uncommon for an
because it will not go directly to the and other ingredients are established in
establishment to receive raw materials
consumer but to commercial processing § 117.80(b), whereas the requirements
(such as RACs) that contain extraneous
to adequately reduce pathogens. We see directed to in-process materials are
material that is removed before established in § 117.80(c).
no reason to also establish a broad
production. For example, some methods
CGMP requirement that would apply F. Proposed § 117.80(b)(7)—Liquid or
of harvesting vegetable RACs (e.g.,
regardless of the outcome of a hazard Dry Raw Materials and Other
pulling up most of the plant material in
analysis. Ingredients
the field) result in inclusion of
C. Proposed § 117.80(b)(3)—Natural extraneous material that is removed We proposed that liquid or dry raw
Toxins in Raw Materials and Other during initial cleaning steps at materials and ingredients received and
Ingredients processing facilities. It is not necessary stored in bulk form must be held in a
We proposed that raw materials and to revise this long-standing requirement manner that protects against cross-
ingredients susceptible to to provide for such common procedures. contact and contamination.
contamination with aflatoxin or other Moreover, in general we use the term (Comment 329) Some comments ask
natural toxins comply with current FDA ‘‘decontaminate’’ to refer to an action us to revise the proposed provision to
regulations for poisonous or deleterious taken when the substance is a hazardous clarify that liquid or dry raw materials
substances before these materials or substance (such as a pathogen) rather and ingredients received and stored in
ingredients are incorporated into than to a non-hazardous substance. bulk form must be held in a manner that
protects against deterioration, as well as product before labeling operations could that would be established in § 117.80(c)
in a manner that protects against have a sign such as ‘‘Contains peanuts.’’ except for the provisions that would be
allergen cross-contact and (Comment 331) Some comments ask established in § 117.80(c)(1) and (c)(16).
contamination. us to modify the proposed requirement
Some comments support one or more
(Response 329) We decline this to specify that it applies to raw
request. The rule already requires that materials and ingredients that ‘‘are or of these proposed provisions without
raw materials and ingredients be stored contain’’ food allergens and that it change. For example, some comments
under conditions that will minimize applies to in-process material, as well as support provisions directed to control
deterioration (see § 117.80(b)(1)). to raw materials and ingredients and to of, or preventing contamination with,
rework. These comments explain that undesirable microorganisms during
G. Proposed § 117.80(b)(8)—Raw manufacturing, storage, and handling.
such modifications would provide
Materials and Other Ingredients That Other comments that support the
clarity and completeness.
Are Food Allergens (Response 331) We decline these proposed provisions suggest alternative
We proposed to establish a new requests. The rule defines ‘‘food regulatory text (see, e.g., Comment 334)
requirement that raw materials and allergen’’ to mean a major food allergen or ask us to clarify how we will
ingredients that are food allergens, and as defined in section 201(qq) of the interpret the provision (see, e.g.,
rework that contains food allergens, be FD&C Act, and section 201(qq) of the Comment 345 and Comment 346). Other
identified and held in a manner that FD&C Act already specifies that a major comments that support the proposed
prevents cross-contact. food allergen is a food that is one of provisions ask us to revise or clarify
(Comment 330) Some comments ask several specified foods and food groups, provisions that we proposed to re-
us to exempt finished, packaged product or contains protein derived from one of
that is later reworked from the proposed establish in part 117 without change
these foods or food groups (78 FR 3646 (see, e.g., Comment 333).
requirement. at 3697). Thus, the request that the
(Response 330) We decline this provisions be directed to raw materials In the following sections, we discuss
request. A product that is in finished, and other ingredients that ‘‘are or comments that ask us to clarify the
packaged form, including label contain’’ food allergens is already proposed provisions or that disagree
information that identifies any food addressed in the definition of food with, or suggest one or more changes to,
allergen, would be in compliance with allergen. Requirements applicable to in- the proposed provisions, including
the requirement and need not be process material are addressed in comments on provisions that we did not
exempted. However, when a product is § 117.80(c)(5). propose to revise. After considering
packaged, but not yet labeled, it is these comments, we have revised the
necessary to identify the product in a XX. Subpart B: Comments on Proposed
§ 117.80(c)—Manufacturing Operations proposed provisions as shown in table
way (other than a product label) that 25, with editorial and conforming
would prevent allergen cross-contact We proposed that current § 110.80(b)
changes as shown in table 52.
while the packaged product is being would become proposed § 117.80(c). We
held. For example, shelves holding the also proposed revisions to all provisions
TABLE 25—PROVISIONS FOR PROCESSES AND CONTROLS FOR MANUFACTURING OPERATIONS

Did we propose revisions Did we get comments that Did we modify the
Provision or request comment on disagreed with the proposed regulatory text?
potential revisions? proposed provision?
§ 117.80(c)(1)—Condition of equipment, utensils, and No ...................................... Yes .................................... Yes.

finished food containers.
§ 117.80(c)(2)—Conditions and controls for food manu- Yes .................................... Yes .................................... Yes.
facturing, processing, packing, and holding.
§ 117.80(c)(3)—Food that can support the rapid growth Yes .................................... Yes .................................... No.
of undesirable microorganisms.
§ 117.80(c)(4)—Measures to destroy or prevent the Yes .................................... Yes .................................... No.
growth of undesirable microorganisms.
§ 117.80(c)(5)—Work-in-Process and Rework ................ Yes .................................... Yes .................................... No.
§ 117.80(c)(6)—Finished food ......................................... Yes .................................... Yes .................................... No.
§ 117.80(c)(7)—Equipment, containers, and utensils ..... Yes .................................... Yes .................................... No.
§ 117.80(c)(8)—Metal and other extraneous material ..... Yes .................................... Yes .................................... Yes.
§ 117.80(c)(9)—Disposal of adulterated food, raw mate- Yes .................................... Yes .................................... Yes.
rials, and other ingredients.
§ 117.80(c)(10)—Manufacturing operations .................... Yes .................................... No ...................................... Yes.
§ 117.80(c)(11)—Heat blanching, and growth and con- Yes .................................... Yes .................................... Yes.
tamination by thermophilic microorganisms, during
manufacturing operations.
§ 117.80(c)(12)—Batters, breading, sauces, gravies, Yes .................................... Yes .................................... Yes.
dressings, and other similar preparations.
§ 117.80(c)(13)—Filling, Assembling, Packaging and Yes .................................... Yes .................................... No.
Other Operations.
§ 117.80(c)(14)—Food that relies on the control of water Yes .................................... Yes .................................... Yes.
activity for preventing the growth of undesirable

microorganisms.
§ 117.80(c)(15)—Food that relies on the control of pH Yes .................................... Yes .................................... Yes.
for preventing the growth of undesirable microorga-
nisms.
§ 117.80(c)(16)—Requirements for ice used in contact No ...................................... Yes .................................... Yes.
with food.
TABLE 25—PROVISIONS FOR PROCESSES AND CONTROLS FOR MANUFACTURING OPERATIONS—Continued

§ 117.80(c)(17)—Food-manufacturing areas and equip- Yes (proposed to delete) ... Yes .................................... No (deleted as proposed).
ment.
A. Proposed § 117.80(c)(1)—Condition rulemaking to establish this provision in cold food because there is a direct
of Equipment, Utensils, and Finished part 110. (See the discussion at 51 FR correlation between temperature abuse
Food Containers 22458 at 22471, in which we responded and growth of pathogenic bacteria.
We proposed no revisions to the to comments asking us to change (Response 335) We agree that
requirements of current § 110.80(b)(1) ‘‘finished product container to ‘‘bulk temperature abuse can lead to growth of
(proposed § 117.80(c)(1)) that equipment product container’’ by explaining that pathogenic bacteria. Importantly, the
and utensils and finished food finished product containers includes temperatures that have been in current
containers be maintained in an bulk product containers.) Rather than § 110.80(b)(3) were recommendations
acceptable condition through perpetuate questions as to how we are rather than requirements. As discussed
appropriate cleaning and sanitizing, as interpreting ‘‘finished,’’ we have deleted in Response 67, we have deleted non-
necessary. Insofar as necessary, this adjective. binding provisions from the rule and
equipment must be taken apart for intend to issue guidance that will
B. Proposed § 117.80(c)(2)—Conditions include much of the guidance that we
thorough cleaning. and Controls for Food Manufacturing,
(Comment 332) Some comments have deleted from the umbrella CGMPs.
Processing, Packing, and Holding As noted in the 2013 proposed human
assert that this provision precludes the
use of wooden bins, because wooden We proposed that all food preventive controls rule (see table 8, 78
bins cannot be sanitized. manufacturing, processing, packing, and FR 3646 at 3715), the temperatures
(Response 332) This requirement is a holding must be conducted under such needed for safe holding may vary and
long-standing provision that provides conditions and controls as are necessary the diversity of food to which the
flexibility for an establishment to to minimize the potential for the growth provision applies makes it inappropriate
sanitize when appropriate by specifying of microorganisms or for the to specify these temperatures in
that equipment, utensils, and food contamination of food. We also regulation. There is information
containers be sanitized ‘‘as necessary.’’ proposed to delete guidance regarding available currently on appropriate
For example, equipment food-contact how to comply with this requirement. temperatures for a variety of foods (e.g.,
surfaces are usually sanitized after (Comment 334) Some comments ask in the Food Code (Ref. 51) and the PMO
cleaning to minimize the potential for us to add ‘‘in-process materials and (Ref. 64)). Moreover, a continued
contaminating food with undesirable rework,’’ ‘‘cross-contact,’’ and ‘‘or approach to specific temperatures for
microorganisms that accumulate during deterioration’’ for clarity and holding hot food and cold food through
processing and grow in food residues on completeness. non-binding guidance is particularly
the equipment. When containers such as (Response 334) We agree that adding appropriate because we can reasonably
wooden bins cannot be sanitized, the ‘‘allergen cross-contact’’ is necessary for expect ongoing scientific advances that
establishment is responsible for taking completeness and have revised the would alter our thinking on appropriate
appropriate steps to adequately clean proposed provision to include it. We temperatures to hold hot food and cold
and maintain the containers to also agree that the provision needs to food.
minimize the potential for address deterioration; doing so is (Comment 336) Some comments ask
contaminating food with undesirable consistent with the requirements us to require that food that can support
microorganisms. To clarify that the applicable to raw materials and other the rapid growth of undesirable
standard governing the condition of the ingredients (see § 117.80(b)(1)). We microorganisms be held at temperatures
equipment, utensils, and finished food decline the request to add ‘‘in-process or ‘‘in another manner’’ that will
containers is the same public health materials and rework’’ to this provision prevent the food from becoming
standard that applies to other provisions because in-process materials and rework adulterated. These comments assert that
in § 117.80, we have revised the are already covered by the phrase ‘‘all current or future technology may
provision to specify that containers be food.’’ provide other means of preventing
kept in ‘‘adequate’’ condition rather microbial growth besides temperature
C. Proposed § 117.80(c)(3)—Food That controls—e.g., through use of pressure
than ‘‘acceptable’’ condition.
(Comment 333) Some comments ask Can Support the Rapid Growth of or in another as-yet-unforeseen manner.
us to delete the term ‘‘finished’’ from Undesirable Microorganisms (Response 336) We agree that current
‘‘finished food containers’’ so that the We proposed that all food that can or future technology may provide other
requirements applicable to the support the rapid growth of undesirable means of preventing microbial growth
condition of equipment, utensils, and microorganisms must be held at besides temperature controls. However,
food containers will be more complete. temperatures that will prevent the food we disagree that it is necessary to
(Response 333) We agree that the from becoming adulterated during modify the requirement to provide for
requirements should apply to all food manufacturing, processing, packing, and preventing microbial growth by means
containers used during manufacturing holding. We also proposed to delete other than temperature control, because
operations, not just to ‘‘finished food recommendations for how to comply the provision does not identify specific
containers.’’ We note that we received with this requirement. temperatures that must be used to
comments about the most appropriate (Comment 335) Some comments ask prevent the food from becoming
adjective to describe the food containers us to keep requirements for specific adulterated. If, for example, a food that
subject to this requirement during the temperatures for holding hot food and currently requires refrigeration to
prevent adulteration becomes shelf- ingredients, or refuse that are (Response 342) We decline this
stable as a result of new technology, the unprotected not be handled request. The closed pressurized system
provision as written would allow the simultaneously in ‘‘the same area’’ described by the comment appears to
food to be held at room temperature rather than in ‘‘a receiving, loading, or satisfy the requirements of the
rather than under refrigeration. shipping area.’’ The comments assert provision, as would other systems
that this would be clearer. commonly used in the food industry.
D. Proposed § 117.80(c)(4))—Measures The purpose of the provision is to set
To Destroy or Prevent the Growth of the standard; it is not necessary to add
request. We narrowly directed the
Undesirable Microorganisms that no specific actions are necessary for
provision to address the potential for
We proposed that measures such as allergen cross-contact and for those systems that inherently comply
sterilizing, irradiating, pasteurizing, contamination by unprotected raw with the requirement.
cooking, freezing, refrigerating, materials, ingredients, and refuse when H. Proposed § 117.80(c)(8)—Metal or
controlling pH, or controlling water finished food is in a receiving, loading, Other Extraneous Material
activity that are taken to destroy or or shipping area. Broadening the
prevent the growth of undesirable provision to prohibit handling raw We proposed that effective measures
microorganisms must be adequate under materials, ingredients, or refuse in the must be taken to protect against the
the conditions of manufacture, same area as finished food would imply inclusion of metal or other extraneous
handling, and distribution to prevent that raw materials, ingredients, or refuse material in food and to delete guidance
food from being adulterated. will never be handled in the production regarding how to comply with this
(Comment 337) Some comments area where they may be needed or requirement.
express concern that the measures listed (Comment 343) Some comments
generated during production.
could be interpreted as an exhaustive assert that it could be more effective
(Comment 340) Some comments ask from the perspective of food safety to
list of processing methods and, thus, us to revise the provision to add ‘‘in-
hinder the development of new use a risk-based approach to
process’’ food and ‘‘cleaning and implementing protective measures
technologies. These comments suggest sanitizing agents, and other chemicals’’
adding ‘‘or other measures’’ at the end against the inclusion of metal or other
for clarity and completeness. extraneous material in food. These
of the list. (Response 340) We decline this
(Response 337) The phrase ‘‘such as’’ comments assert that the risk of
request. Work-in-process foods are inclusion of metal is higher in cut fruits
indicates that these are examples of covered separately in § 117.80(c)(5), and
processing methods and that the list is or vegetables than in fresh whole fruits
cleaning and sanitizing agents are or vegetables and, thus, the measures
not all inclusive. We believe that the list addressed in the requirements for
of examples and wording of the used to protect against the inclusion of
sanitary operations (see § 117.35(b)(2)). metal should be different in cut fruits or
provision adequately express the intent
behind this provision and allow the use G. Proposed § 117.80(c)(7)—Equipment, vegetables than in fresh whole fruits or
of other measures without the suggested Containers, and Utensils vegetables.
addition. (Response 343) We agree that the
We proposed that equipment, measures used to protect against the
E. Proposed § 117.80(c)(5)—Work-in- containers, and utensils used to convey, inclusion of metal likely will be
Process and Rework hold, or store raw materials, work-in- different for cut fruits or vegetables than
process, rework, or food must be for fresh whole fruits or vegetables and
We proposed that work-in-process
constructed, handled, and maintained that a risk-based approach can be
and rework must be handled in a
during manufacturing, processing, helpful in determining how to comply
manner that protects against cross-
packing, and holding in a manner that with the requirement. To emphasize the
contact, contamination, and growth of
protects against cross-contact and utility of a risk-based approach, we have
undesirable microorganisms.
(Comment 338) Comments that contamination. revised the provision to require
address this proposed requirement ask (Comment 341) Some comments ask ‘‘adequate’’ measures rather than
us to use the term ‘‘in-process us to specify that the equipment, ‘‘effective’’ measures; as defined in the
materials’’ rather than ‘‘work-in- containers, and utensils also must be rule (see § 117.3), the term ‘‘adequate’’
process.’’ cleaned and sanitized during means that which is needed to
(Response 338) As discussed in manufacturing, processing, packing, and accomplish the intended purpose in
Response 71, we decline this request. holding in a manner that protects keeping with good public health
against cross-contact and against practice.
F. Proposed § 117.80(c)(6)—Finished contamination.
Food (Response 341) We decline this I. Proposed § 117.80(c)(9)—Disposal of
We proposed that effective measures request. Cleaning and sanitizing are Adulterated Food, Raw Materials, and
must be taken to protect finished food addressed in the requirements for Other Ingredients
from cross-contact and contamination sanitary operations (see § 117.35(a)) and We proposed that food, raw materials,
by raw materials, ingredients, or refuse. do not need to be addressed again in the and ingredients that are adulterated
When raw materials, ingredients, or requirements for manufacturing must be disposed of in a manner that
refuse are unprotected, they must not be operations. protects against the contamination of
handled simultaneously in a receiving, (Comment 342) Some comments ask other food or, if the adulterated food is
loading, or shipping area if that us to add the phrase ‘‘where appropriate capable of being reconditioned, it must
handling could result in cross-contact or for food safety’’ at the beginning of the be reconditioned using a method that
contaminated food. Food transported by provision because food gases are has been proven to be effective. We also
conveyor must be protected against manufactured, held, and distributed in proposed an editorial change to make
cross-contact and contamination as a closed pressurized system and are clear that reconditioning, rather than
necessary. therefore not exposed to personnel or disposal, is an option and to delete a
(Comment 339) Some comments ask environmental conditions where there is provision that could be viewed as
us to specify that raw materials, an impact on food safety. providing an option to simply
reexamine adulterated food and J. Proposed § 117.80(c)(10)—Performing should be minimized by the use of
subsequently find it not to be Manufacturing Steps adequate operating temperature and by
adulterated. We proposed that steps such as periodic cleaning and requested
(Comment 344) Some comments ask washing, peeling, trimming, cutting, comment on whether to establish these
us to retain the provision to reexamine sorting and inspecting, mashing, two recommendations as requirements
adulterated food and subsequently find dewatering, cooling, shredding, (78 FR 3646 at 3726).
(Comment 348) Some comments
it not to be adulterated. These extruding, drying, whipping, defatting,
support establishing the
comments explain that there are and forming must be performed so as to
recommendations in this provision as
processes that can remove contaminants protect food against cross-contact and
requirements. Other comments oppose
such as pesticides and heavy metals contamination. We proposed that food
doing so and assert that these detailed
from foods such as botanical extracts. should be protected from contaminants
steps may not be important to protect
Although laboratory studies or that may drip, drain, or be drawn into
the public health.
small-scale pilot batches may give an food and requested comment on
(Response 348) We disagree that the
indication that the reconditioning is whether to establish the
use of adequate operating temperature
likely to be effective, they cannot always recommendation regarding physical
and periodic cleaning are not important
guarantee the treatment will be equally protection of food from contaminants
to protect public health. Improper
effective when scaled up to that may drip, drain, or be drawn into
cooling can lead to growth of pathogenic
commercial-scale production batches. the food as a requirement (78 FR 3646
sporeforming bacteria if product
Because these methods have not been at 3726). We also proposed to delete two
remains too long at temperatures that
‘‘proven to be effective,’’ the appropriate recommendations regarding adequate
support their multiplication. In
approach to determining whether the cleaning and sanitizing of food-contact
addition, growth of thermophiles, while
reconditioned food is no longer surfaces and regarding the use of time
not a public health issue, can lead to
adulterated is reexamination after the and temperature controls.
product spoilage, and, thus,
reconditioning is complete. (Comment 347) Some comments agree
adulteration. We are establishing these
that we should require, rather than
(Response 344) We agree with these two recommendations as requirements
recommend, that food be protected from
comments and have revised the in the regulatory text, along with
contaminants that may drip, drain, or be
provision to make clearer that associated editorial changes.
drawn into food. Other comments
reexamination can only be used to express concern that turning the current L. Proposed § 117.80(c)(12)—Batters,
subsequently find that the food is not recommendation into a requirement Breading, Sauces, Gravies, Dressings,
adulterated after the food has been could lead to a de facto requirement for and Other Similar Preparations
reconditioned. See the regulatory text of closed systems to be used in food
§ 117.80(c)(9). We proposed that batters, breading,
production. Some comments ask us to sauces, gravies, dressings, and other
(Comment 345) Some comments ask specify that the requirements only apply similar preparations must be treated or
us to clarify that the provision only where food is exposed. maintained in such a manner that they
applies if the food has actually been (Response 347) We agree that we are protected against cross-contact and
found to be adulterated. The comments should require, rather than recommend, contamination. We also proposed to
assert that the provision should not that food be protected from clarify that these steps require
apply where product has been placed contaminants that may drip, drain, or be protection against cross-contact and to
‘‘on hold’’ due to an equipment failure drawn into food. We have not revised delete the recommendations for how to
(e.g., if product is put on hold due to an the regulatory text to specify that the comply with this requirement.
inoperative metal detector until the requirements only apply where food is (Comment 349) Some comments agree
establishment can retest for potential exposed, because such protections that we should delete the provided
metal contaminants). would only be needed if foods are examples of mechanisms to achieve
(Response 345) The provision only exposed to such conditions. Such a compliance.
applies if the food is adulterated. In the requirement would not lead to a de facto (Response 349) We have deleted the
example described in these comments, requirement for a closed system, examples as proposed.
if the food is not adulterated, the because this is not the only way to (Comment 350) Some comments ask
establishment would not need to protect food from such contaminants. us to modify the provision to clarify that
dispose of, or recondition, the product. For example, covers can be used on it applies to preparations that are held
kettles and tanks, and shields can be and used repeatedly over time and to
(Comment 346) Some comments ask placed over conveyor lines. add ‘‘dipping solutions’’ as another
us to clarify that the provision does not
K. Proposed § 117.80(c)(11)—Heat example of such a preparation.
apply to grains subject to the review (Response 350) We agree that the
inspection provisions provided for by 7 Blanching and Growth and
provision applies to preparations that
CFR 800.125 and 800.135. Contamination by Thermophilic
are held and used repeatedly over time
(Response 346) In many cases, grains Microorganisms During Manufacturing
and that ‘‘dipping solutions’’ is a useful
subject to the review inspection Operations
example to add. We have revised the
provisions provided for by 7 CFR We proposed that heat blanching, regulatory text as requested by these
800.125 and 800.135 are RACs that are when required in the preparation of comments.
being held or transported by an food, should be effected by heating the (Comment 351) Some comments ask
establishment solely engaged in holding food to the required temperature, us to add that another purpose of the
or transporting RACs and subpart B holding it at this temperature for the requirement is to minimize the potential
(including § 117.80(c)(8)) would not required time, and then either rapidly for the growth of undesirable
apply to the grains (see § 117.5(k)). In cooling the food or passing it to microorganisms.
addition, as noted in Response 345, this subsequent manufacturing without (Response 351) This request would
provision only applies to food that is delay. We proposed that thermophilic promote consistency in the
adulterated. growth and contamination in blanchers requirements throughout § 117.80 and
we have revised the regulatory text prevent growth of undesirable O. Proposed § 117.80(c)(15)—Food That
accordingly. microorganisms. Relies on the Control of pH for
(Response 353) The rule defines safe Preventing the Growth of Undesirable
M. Proposed § 117.80(c)(13)—Filling,
moisture level as a level of moisture low Microorganisms
Assembling, Packaging and Other
Operations enough to prevent the growth of We proposed that food, including acid
undesirable microorganisms in the and acidified food, that relies
We proposed that filling, assembling, finished product and notes that the safe
packaging, and other operations must be principally on the control of pH for
moisture level is related to water preventing the growth of undesirable
performed in such a way that the food activity (§ 117.3). Although in most
is protected against cross-contact, microorganisms must be monitored and
cases water activity is the most suitable maintained at a pH of 4.6 or below. We
contamination, and growth of measurement to predict food safety,
undesirable microorganisms. We also also proposed to delete the
moisture content is frequently used to recommendations for how to comply
proposed to delete the
assess the stability of grains and nuts with this requirement.
recommendations for achieving
with respect to prevention of growth (Comment 357) Some comments ask
compliance with this requirement.
(Comment 352) Some comments ask and mycotoxin production by molds. us to use the term ‘‘equilibrated pH’’ or
us to specify that the requirement We are retaining the term ‘‘safe moisture ‘‘finished equilibrium pH’’ for
applies only to finished food to level’’ as a broader term that takes into consistency with part 114. Some
differentiate it from other provisions in account the fact that measuring comments ask us to add a definition for
§ 117.80 and assert that without the moisture level and measuring water ‘‘equilibrated pH’’ in § 117.3.
modification the provision would be activity are both common industry (Response 357) We decline these
redundant. practice and, depending on the food, requests. It is not necessary for this
(Response 352) The specific can be measures that are appropriate to long-standing provision in the umbrella
requirements of § 117.80(c)(13) are not assess safety. The comments provide no food CGMPs to use specialty terms used
redundant with other provisions in basis for the assertion that this long- in the more specific CGMPs that apply
§ 117.80. The long-standing provisions standing provision is not an adequate to acidified foods in order to make clear
of § 117.80 first address general food safety measure. that the operative pH for the safety of
requirements (§ 117.80(a)) and then (Comment 354) Some comments such foods is 4.6 or below.
address more specific requirements assert that water activity may not be the (Comment 358) Some comments ask
applicable to raw materials and other only factor responsible for preventing us to more closely adhere to the current
ingredients (§ 117.80(b)) and the growth of undesirable language (i.e., food such as acid and
manufacturing operations (§ 117.80(c)). microorganisms in dry products and ask acidified food . . .) rather than the
Although the comment does not define us to modify the regulatory text to take proposed language (i.e., food, including
‘‘finished food,’’ we consider that term into account other synergistic barriers acid food and acidified food . . .) to
to apply to a packaged and labeled food for microbial growth and toxin make it clear that the list is not intended
product; filling, assembling, and formation. to be complete.
packaging operations would be (Response 354) We agree with these (Response 358) The final rule retains
conducted on in-process food to create comments and have revised the the long-standing language ‘‘such as’’ as
a finished product. Regardless of regulatory text to clarify that such requested by the comments. (See also
whether the appropriate term would be products rely ‘‘principally’’ on the the discussion in Response 68.)
‘‘finished’’ or ‘‘in-process food,’’ the control of water activity. P. Proposed § 117.80(c)(16)—
comment provides no reason for why (Comment 355) Some comments Requirements for Ice Used in Contact
this long-standing provision is not clear assert that nuts should be ‘‘maintained’’ With Food
without specifying the production stage at an appropriate moisture level rather
of a food product that is subject to We proposed no revisions to the
than ‘‘processed to’’ an appropriate
filling, assembling, and packaging requirements of current § 110.80(b)(16)
moisture level.
operations. (proposed § 117.80(c)(16)) that when ice
(Response 355) We acknowledge that is used in contact with food, it must be
N. Proposed § 117.80(c)(14)—Food That some products need only be made from water that is safe and of
Relies on the Control of Water Activity ‘‘maintained’’ at a safe moisture level adequate sanitary quality, and must be
for Preventing the Growth of and may not need to be processed to used only if it has been manufactured in
Undesirable Microorganisms achieve that level. However, we disagree accordance with current good
We proposed that food, including dry that it is necessary to modify this long- manufacturing practice.
mixes, nuts, intermediate moisture food, standing requirement to specify this (Comment 359) Some comments ask
and dehydrated food, that relies on the distinction. The comments do not us to replace the requirement that water
control of water activity for preventing provide examples of how we have been must be safe and of adequate sanitary
the growth of undesirable interpreting this provision in a way that quality with a cross-reference to the
microorganisms must be processed to, does not accommodate the differences water quality requirements of
and maintained at, a safe moisture level. in products. § 117.37(a).
We also proposed to delete the (Comment 356) Some comments ask (Response 359) We acknowledge that
recommendations for achieving us to more closely adhere to the current cross-referencing the water quality
compliance with this requirement. regulatory text (i.e., food, such as dry requirements established in § 117.37(a),
(Comment 353) Some comments mixes . . .) rather than the proposed without describing those requirements,
assert that moisture level is not an regulatory text (i.e., food, including dry would accurately convey the
adequate food safety control measure. mixes . . .). requirements for ice used in contact
The comments ask us to revise the (Response 356) The final rule retains with food. However, we believe there is
requirement to reflect that it is the the long-standing language ‘‘such as’’ as value added by continuing to emphasize
proper maintenance of water activity, requested by the comments. (See also the water quality standard within the
rather than moisture level, that will the discussion in Response 68.) requirements for ice used in contact
with food. We have added a cross- 117.20(a), 117.35(a), 117.40(a)(1), revisions, we proposed that storage and
reference to § 117.37(a) but have not 117.80(a), and 117.93) already require transportation of food must be under
deleted ‘‘safe and of adequate sanitary that an establishment prevent conditions that will protect against
quality.’’ contamination from any source. (See cross-contact and biological, chemical,
also the discussion in Response 67 physical, and radiological
Q. Proposed Deletion of Current
about our decision to delete those non- contamination of food, as well as against
§ 110.80(b)(17)—Food-Manufacturing
binding provisions of part 110 that we deterioration of the food and the
Areas and Equipment
are not establishing as requirements.) container.
We proposed to delete the current Some comments support one or more
recommendation that food- XXI. Subpart B: Comments on Proposed
of these proposed revisions without
manufacturing areas and equipment § 117.93—Warehousing and
change. For example, some comments
used for manufacturing human food not Distribution
support adding radiological hazards as
be used to manufacture nonhuman food- Current § 110.93 requires that storage an additional category of contaminants
grade animal feed or inedible products, and transportation of finished food be to the list of contaminants which may
unless there is no reasonable possibility under conditions that will protect food be encountered in warehousing and
for the contamination of the human against physical, chemical, and distribution because food may be
food. We tentatively concluded that this microbial contamination, as well as subject to contamination with
recommendation would be more against deterioration of the food and the radiological hazards. Other comments
appropriate in guidance, which could container. We proposed a series of that support the proposed provisions
include examples of situations where revisions to these current suggest alternative regulatory text (see,
there is no reasonable possibility for the requirements—i.e., to apply the e.g., Comment 361) or ask us to clarify
contamination of the human food. requirements to ‘‘food’’ rather than to how we will interpret the provision
(Comment 360) Some comments ask ‘‘finished food’’; clarify that storage and (see, e.g., Comment 363).
us to retain this provision for clarity and transportation of food must be under In the following sections, we discuss
as a means to educate small, foreign, conditions that will protect against comments that ask us to clarify the
and new food processors. allergen cross-contact in addition to proposed provision or that disagree
(Response 360) We decline this protecting against contamination of with, or suggest one or more changes to,
request. The focus of the provision is to food; add radiological hazards as an the proposed provision. After
emphasize the importance of additional category of contaminants; considering these comments, we are
manufacturing food in a way that and require protection against finalizing the provision as proposed (see
prevents contamination. Other ‘‘biological,’’ rather than ‘‘microbial’’ table 26), with editorial and conforming
provisions (such as §§ 117.10(b), contamination. With all of these changes as shown in table 52.
TABLE 26—PROVISIONS FOR WAREHOUSING AND DISTRIBUTION

117.93—Warehousing and distribution ........................... Yes .................................... Yes .................................... No.
(Comment 361) Some comments issues associated with the short shelf address a radiological hazard when
express concern that produce will spoil life of produce in such facilities and, circumstances warrant. The comment
and deteriorate even under the best thus, that modifications such as those provides no basis for its assertion that
conditions. These comments ask us to suggested by the comments are regulations directed to radiological
modify the proposed requirements to necessary. hazards will act as a double regulation
address these concerns, such as by (Comment 362) Some comments to hinder amicable trade activities and
specifying that the conditions will assert that regulations directed to will increase economic burden to
‘‘reasonably protect’’ or by revising radiological hazards will act as a double manufacturers.
‘‘will protect’’ to ‘‘will minimize to regulation to hinder amicable trade (Comment 363) Some comments
acceptable levels.’’ activities and will increase economic support our proposal to specify that the
(Response 361) We decline this burden to manufacturers. As discussed requirements apply to ‘‘food’’ rather
request. In some cases, this provision in Comment 410, these same comments than to ‘‘finished food,’’ provided that
will not apply to produce (i.e., when the ask us to provide that a facility subject doing so does not affect common and
produce is a RAC subject to the to the requirements for hazard analysis safe practices for the transportation of
exemption for an establishment solely and risk-based preventive controls may RACs, such as transporting raw produce
engaged in the holding or transportation rely on existing systems in place to from the field, or from packinghouses,
of one or more RACs; see § 117.5(k)). manage radiological risks, such as steps in open top containers such as field
When the produce is not subject to the taken by government officials to inspect boxes, totes and gondola trucks.
RAC exemption (e.g., when the produce ingredients obtained from a geographic (Response 363) As discussed in the
is being handled in a fresh-cut region that has been the subject of a 2013 proposed human preventive
processing facility), requiring storage nuclear accident. controls rule, we proposed to apply the
and transportation of produce under the (Response 362) See Response 410 for CGMP requirements for storage and
conditions specified in the provision is a discussion of how a facility may transportation to ‘‘food’’ rather than
appropriate. The comments provide no consider existing systems in place to ‘‘finished food’’ to ensure food safety
basis that we have been enforcing this manage radiological risks, but still has throughout the food chain, regardless of
long-standing provision in a manner responsibilities to establish and whether a food product is a raw material
that does not acknowledge practical implement preventive controls to or ingredient or in its finished state (78
FR 3646 at 3727). We intend this documentation accompanying the sale [identified hazard]’’ (See § 117.136(a)(2),
revision to clarify that the CGMP contain any of the following notices (3), and (4)).
provisions for warehousing and may be sold or otherwise distributed to
distribution apply to raw materials and XXII. Subpart B: Comments on
any user except a commercial processor:
ingredients, including RACs. When a Proposed § 117.110 (Natural or
Not grown in compliance with part 112;
food establishment that stores and Unavoidable Defects in Food for
Not for fresh or raw consumption; May
transports RACs is subject to the CGMP Human Use That Present No Health
require commercial formulation,
provisions, common and safe storage Hazards)
processing, or both to adequately reduce
and transportation practices such as microorganisms. We proposed to revise the current
those described in our 1998 guidance provisions directed to natural or
entitled ‘‘Guide to Minimize Microbial (Response 364) We decline to add
such a provision to the CGMP unavoidable defects in food for human
Food Safety Hazards for Fresh Fruits use that present no health hazard. Some
and Vegetables (Ref. 13) would be requirements for distribution of food. As
noted in Response 324, we do not see comments support one or more of these
appropriate.
a benefit to labeling produce as proposed provisions without change.
(Comment 364) As noted in Response
324, under the proposed produce safety indicated because we believe that the Other comments that support the
rule a farm that produces covered vast majority of such produce is low proposed provisions suggest alternative
produce that is distributed for risk. However, as also noted in or additional regulatory text (see, e.g.,
commercial processing would be Response 324, we are providing for a Comment 365, Comment 367, and
required to maintain documentation of narrow use of commercial Comment 368).
the identity of the recipient of the documentation, which would include In the following sections, we discuss
commercial processor. Some comments produce, when a manufacturer/ comments that ask us to clarify the
appear to assume that a farm might processor that has identified a hazard proposed provisions or that disagree
distribute such products with requiring a preventive control does not with, or suggest one or more changes to,
information disclosing that such establish a preventive control because it: the proposed provisions, including
produce was not grown in compliance (1) Relies on its customer to ensure that comments on provisions that we did not
with part 112, should not be consumed an identified hazard will be controlled propose to revise. After considering
raw, and/or requires commercial and (2) discloses, in documents these comments, we have revised the
processing. These comments ask us to accompanying the food, in accordance proposed provisions as shown in table
add a provision that no food whose with the practice of the trade, that the 27, with editorial and conforming
labels, labeling, or commercial food is ‘‘not processed to control changes as shown in table 52.
TABLE 27—PROVISIONS FOR DEFECT ACTION LEVELS

117.110(a) and (b)—Description of defect action levels No ...................................... Yes .................................... Yes.
117.110(c)—Quality control operations that reduce nat- Yes .................................... Yes .................................... No.
ural or unavoidable defects to the lowest level cur-
rently feasible.
117.110(d)—Mixing adulterated food with food that is Yes .................................... Yes .................................... Yes.
not adulterated.
117.110(e)—How to obtain the booklet ‘‘Defect Action Yes (proposed to delete) ... Yes .................................... Yes (provided Internet ad-
Levels’’. dress).
We proposed that some foods, even section 402(a)(4) of the FD&C Act that We also proposed that the mixing of
when produced under current good food not be prepared, packed, or held a food containing defects at levels that
manufacturing practice, contain natural under unsanitary conditions whereby it render that food adulterated with
or unavoidable defects that at low levels may have become contaminated with another lot of food is not permitted and
are not hazardous to health. The filth, or whereby it may have been renders the final food adulterated,
proposed provisions specify that FDA rendered injurious to health, or the regardless of the defect level of the final
establishes maximum levels for these requirements in part 117 that food food. (Proposed § 117.110(d)).
defects in foods produced under current manufacturers, processers, packers, and We proposed to delete current
good manufacturing practice and uses holders must observe current good § 110.110(e), which specifies that a
these levels in deciding whether to manufacturing practice. Evidence Defect Levels Handbook (a compilation
recommend regulatory action. The indicating that such a violation exists of the current defect action levels for
proposed provisions also specify that natural or unavoidable defects in food
causes the food to be adulterated, even
defect action levels are established for for human use that present no health
though the amounts of natural or
foods when it is necessary and feasible hazard) may be obtained upon request
unavoidable defects are lower than the from the Center for Food Safety and
to do so, and that these levels are
subject to change upon the development currently established defect action Applied Nutrition.
of new technology or the availability of levels. The manufacturer, processor, (Comment 365) Some comments
new information (proposed § 117.110(a) packer and holder of food must at all assert that the word ‘‘defects’’ may
and (b)). times utilize quality control operations cause confusion in industry, because the
We also proposed that compliance that reduce natural or unavoidable term ‘‘defects’’ is commonly used to
with defect action levels does not defects to the lowest level currently describe quality or physical type
excuse violation of the requirement in feasible (proposed § 117.110(c)). attributes that do not pose a risk to
public health. These comments ask us to allocate resources to hazards also ask us to add an FDA Web site
consider using another term, such as commensurate with their potential where the handbook may be obtained.
‘‘contaminant,’’ in place of the term impact to the public health. (Response 368) We have added a
‘‘defect.’’ (Response 366) We agree that reference to the Defect Levels Handbook
(Response 365) We decline this reducing natural or unavoidable defects (Ref. 36) to the provisions as examples
request. The specific term requested by to ‘‘the lowest level currently feasible’’ of defect action levels that may render
the comments (i.e., contaminant) often does not require a facility to exceed food adulterated, including an address
carries the connotation of hazardous to CGMPs or go beyond preventive on the FDA Web site where this
health. However, we have added a controls identified through a hazard handbook may be obtained.
definition of the term ‘‘defect action analysis.
(Comment 367) Some comments XXIII. Subpart C: Comments on Overall
level’’ to the rule (see Response 165 and
assert that the word ‘‘reduce’’ in Framework for Hazard Analysis and
§ 117.3). The defined term makes clear
§ 117.110 (c) may not be appropriate for Risk-Based Preventive Controls
that the term does not refer to quality or
physical type attributes such as those all facilities. As an example, the In the 2014 supplemental human
described in the comments. We also comments explain that a brownskin preventive controls notice, we proposed
have deleted the first two full almond facility that solely sizes and
a series of changes to proposed subpart
sorts product before packaging may not
paragraphs of the proposed provision C and reopened the comment period
have processes to reduce microbial
(proposed § 117.110(a) and (b)), which specifically with respect to these
contaminants. Instead, that facility may
are no longer necessary to provide changes. The proposed changes
rely upon custom processors to reduce
context about the regulatory impact of included: (1) Eliminating the term
the level of microbial contamination. In
the term ‘‘defect action level,’’ because ‘‘hazard reasonably likely to occur’’
such a case, these comments note that
the new definition of ‘‘defect action throughout proposed subpart C (and,
it would be more accurate for the
level’’ explains that a defect action level thus, deleting the definition we had
provision to specify using quality
is a level of a non-hazardous, naturally proposed for this term); (2) adding a
control operations that ensure the
occurring, unavoidable defect at which new defined term, ‘‘significant hazard,’’
lowest level currently feasible for
FDA may regard a food product natural or unavoidable defects. and, in general, using this new term
‘‘adulterated’’ and subject to (Response 367) We have not revised instead of ‘‘hazard reasonably likely to
enforcement action under section the provision to account for occur’’ throughout the re-proposed
402(a)(3) of the FD&C Act. circumstances such as those described regulations; (3) defining ‘‘known or
(Comment 366) Some comments in these comments. We acknowledge reasonably foreseeable hazard’’ in place
assert that a facility subject to this that the production of some food of ‘‘reasonably foreseeable hazard’’ and
provision will implement both CGMPs products requires that food pass through clarifying that the new term means a
and a food safety plan as guiding multiple facilities before the finished hazard ‘‘that has the potential to be
‘‘quality control operations’’ appropriate food is distributed into commerce, and associated with the facility or the food’’
for this purpose. These comments also that a specific pathogen reduction step rather than ‘‘a potential . . . hazard that
assert that reducing natural or may occur at only one of the applicable may be associated with the facility or
unavoidable defects to ‘‘the lowest level facilities. The comments do not provide the food’’; and (4) providing additional
currently feasible’’ does not require a any examples of how we have flexibility to address concerns about re-
facility to exceed CGMPs or go beyond interpreted this long-standing provision writing existing plans or programs to
preventive controls identified through a in the past in a way that creates conform with the requirement of the
hazard analysis. In the view of these practical problems when applying the human preventive controls rule.
comments, doing so would run contrary provision to facilities such as those We received many comments on the
to the risk-based principles that described in the comments. overall framework for hazard analysis
underlie FSMA and leading food safety (Comment 368) Some comments ask and risk-based preventive controls. We
programs by requiring that all hazards us to retain the provision, in discuss each of these comments in the
be managed equally without considering § 110.110(e), specifying that the Defect discussion of the specific regulatory text
the outcomes of the hazard analysis. Levels Handbook may be obtained upon applicable to each comment. We show
These comments assert that successful, request from the Center for Food Safety highlights of the changes we made after
responsible food safety programs and Applied Nutrition. These comments considering these comments in table 28.
TABLE 28—REVISIONS TO THE OVERALL FRAMEWORK FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS
117.3 ....................... Definition of ‘‘significant hazard’’ ........................................... Revise the proposed term ‘‘significant hazard’’ to ‘‘hazard
requiring a preventive control’’ and revise the definition to
emphasize the role of risk in determining whether a haz-
ard requires a preventive control.
117.3 ....................... Definition of ‘‘corrections’’ ...................................................... Define the term ‘‘correction’’ to distinguish ‘‘corrections’’
from ‘‘corrective actions.’’
117.135(c)(1), Flexibility in preventive controls and preventive control Clarify that preventive control management components de-
117.140(a), management components for monitoring, corrective ac- pend on the role of a preventive control in the facility’s
117.145, tions and corrections, and verification. food safety system, as well as the nature of the preven-
117.155(a), tive control.

117.160(a),
117.165(a),
117.165(b).
117.130(b)(1), Hazard identification .............................................................. Emphasize that the hazard identification focuses on known
117.130(b)(2). or reasonably foreseeable hazards (rather than on all
hazards).
TABLE 28—REVISIONS TO THE OVERALL FRAMEWORK FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS—
Continued
117.145(c) ............... Monitoring records ................................................................. Provide for the use of ‘‘exception records’’ for monitoring
preventive controls.
117.150(a) ............... Corrective action procedures ................................................. Clarify that corrective action procedures depend on the na-
ture of the hazard.
117.150(c) ............... Corrections ............................................................................. Provide for additional circumstances when corrections, rath-
er than corrective actions, are warranted.
117.160(c) ............... Preventive controls that do not require validation ................. Clarify that a list of preventive controls that do not require
validation is not an exhaustive list.
117.165(a)(5) .......... Activities to verify implementation and effectiveness ............ Clarify that there could be alternative verification activities
of implementation and effectiveness other than those that
we specify in the rule.
117.165(b) ............... Written procedures for verification of implementation and Clarify that written procedures for verification of implemen-
effectiveness. tation and effectiveness are established and implemented
as appropriate to the role of the preventive control in the
facility’s food safety system, as well as appropriate to the
facility, the food, and the nature of the preventive control.
117.170(b) ............... Reanalysis ............................................................................. Provide for reanalysis of an applicable portion of the food
safety plan (rather than the complete food safety plan) in
specified circumstances.
XXIV. Subpart C: Comments on individual’’ for the proposed term set of records (see § 117.330 (b)), and a
Proposed § 117.126—Food Safety Plan ‘‘qualified individual’’ when describing food safety plan may be prepared as a
We proposed requirements for a food the comments to the proposed rule, set of documents kept in different
safety plan. Some comments support the even though those comments use the locations within the facility (e.g., based
proposed requirements without change. term ‘‘qualified individual.’’ on where they will be used), provided
Some comments that support the We proposed that several other that each set of documents is onsite. As
proposed provisions suggest alternative provisions of subpart C be under the provided in the recordkeeping
or additional regulatory text (see, e.g., oversight of a ‘‘qualified individual’’ provisions, electronic records are
Comment 377 and Comment 381) or ask (now ‘‘preventive controls qualified considered to be onsite if they are
us to clarify how we will interpret the individual’’), and also proposed accessible from an onsite location.
provision (see, e.g., Comment 370). requirements that would apply to the (Comment 370) Some comments agree
In the following sections, we discuss ‘‘qualified individual’’ (now ‘‘preventive with our previous statements that
comments that ask us to clarify the controls qualified individual’’). See, e.g., facilities should be able to group food
proposed requirements or that disagree §§ 117.160, 117.165, 117.170, 117.180, types or production method types if
with, or suggest one or more changes to, 117.190, and 117.206). As discussed in hazards, control measures, parameters,
the proposed requirements. After the preceding paragraph, in the and required procedures, such as
considering these comments, we are remainder of this document, we monitoring, are identical (78 FR 3646 at
finalizing the provisions as proposed, substitute the new term ‘‘preventive 3730). These comments note that
with editorial and conforming changes controls qualified individual’’ for the exceptions should be carefully
as shown in table 52. proposed term ‘‘qualified individual,’’ delineated and followed as appropriate.
We proposed that the food safety plan when describing these proposed Some comments ask us to clarify that
be under the oversight of one or more provisions and the comments to these we will allow food safety plans to share
‘‘qualified individuals.’’ As discussed in proposed provisions. common provisions where there are
section IX.C.25, we have changed the uniform systems in place. Some
A. Proposed § 117.126(a)(1)—
proposed term ‘‘qualified individual’’ to comments ask us to clarify whether one
Requirement for a Food Safety Plan
‘‘preventive controls qualified plan is required for the facility or for
individual’’ because we are establishing We proposed that you must prepare, each crop/food item individually.
a new definition for ‘‘qualified or have prepared, and implement a (Response 370) We are requiring that
individual,’’ with a meaning distinct written food safety plan. a facility have a written food safety plan
from ‘‘preventive controls qualified (Comment 369) Some comments ask that covers all the foods that it
individual.’’ To minimize the potential us to emphasize that ‘‘written’’ means manufactures, processes, packs, or
for confusion for when the term ‘‘any type of recordable and holds. We recognize that, to the extent
‘‘qualified individual’’ refers to the reproducible format’’ (e.g., as paper or that the controls are the same, there may
proposed meaning of the term and when electronic documents). Some comments be common controls that broadly apply
the term ‘‘qualified individual’’ refers to ask us to specify that the components of to some or all of a facility’s food
the meaning of that term as finalized in the food safety plan need not be in a products. However, any product- or
this rule, in the remainder of this single document or stored in one place. process-specific differences must be
document we substitute the new term (Response 369) A ‘‘written’’ food carefully delineated and observed in
‘‘preventive controls qualified safety plan can be either a paper practice.

individual’’ for the proposed term document or an electronic document, as In some facilities with limited types
‘‘qualified individual,’’ even though the provided by § 117.305(a). The final rule of products, the written food safety plan
proposed rule used the term ‘‘qualified specifies that required information may contain a single set of procedures
individual.’’ Likewise, we substitute the (which would include the food safety that addresses all of the products
new term ‘‘preventive controls qualified plan) does not need to be kept in one produced. For example, a facility
making fruit-flavored beverages may be limits’’ for process controls rather than engaged in the storage of packaged food
able to address all of its beverages in the require these foundational documents to that is not exposed to the environment
same set of procedures. For other be rewritten simply to change is exempt from the requirements of
facilities, there may not be a practical terminology. subparts C and G, including the
way to group the products and the (Response 372) A facility that has a requirement to prepare and implement
written food safety plan may need to HACCP plan (or other food safety plan) a food safety plan, and is instead subject
contain more than one set of procedures in place before this rule becomes to the modified requirements in
to address all of its products. For effective can build off its existing § 117.206.
example, a facility that makes both RTE program and can rely on existing (Comment 375) Some comments ask
entrees and entrees that are not RTE records, supplemented as necessary to us to clarify that a food safety plan is
may choose to group the RTE entrees in include all of the required information not required for facilities that store
one set of procedures, but have a and satisfy the requirements of this rule unexposed, refrigerated, packaged TCS
separate set of procedures for the (see § 117.330). The rule does not foods.
entrees that are not RTE. However, to preclude the use of terms like ‘‘critical (Response 375) We agree that a
the extent that some of the written limits’’ that are associated with HACCP facility ‘‘solely engaged’’ in the storage
procedures in the food safety plan are systems. of unexposed, refrigerated, packaged
the same for both RTE entrees and (Comment 373) Some comments ask TCS food is exempt from the
entrees that are not RTE, the facility us to provide templates that facilities requirements of subparts C and G,
need not duplicate those procedures in can use as models to develop their food including the requirement to prepare
its written food safety plan. For safety plans. Some comments ask us to and implement a food safety plan, and
example, a facility that uses an accept Good Agricultural Practices is instead is subject to the modified
electronic food safety plan could store (GAPs) food safety plan formats and/or requirements in § 117.206 (see § 117.7).
written procedures in multiple folders HACCP plans. Some comments provide However, if a facility engages in other
in the electronic system, and the food specific templates for us to consider. activities in addition to the storage of
safety plan for individual products (or (Response 373) We decline the unexposed, refrigerated, packaged TCS
groups of products) could simply request to provide templates for foods, the exemption does not apply. In
hyperlink to the written procedures facilities to use to develop their food such a case, the facility must prepare
applicable to each product. Likewise, a safety plans. The rule does not specify and implement a food safety plan.
facility that uses a paper-based food the format of a food safety plan, and a However, the modified requirements of
safety plan could store written facility has flexibility to format its food § 117.206 can be informative with
procedures in a binder or file cabinet, safety plan in a way that works best for respect to what the food safety plan
with written cross-references to the facility, provided that the plan could include regarding the storage of
procedures that apply to more than one includes all required information. In unexposed, refrigerated, packaged TCS
product. general, internationally recognized food food.
(Comment 371) Some comments ask safety plan formats would be acceptable, (Comment 376) Some comments ask
us to provide that the food safety plan although modification and us to explain why a written food safety
be handled at the corporate level rather supplementation may be necessary to plan is necessary, because adoption of a
than the facility level if a corporation comply with all requirements of the rule HACCP system is only voluntary under
owns many facilities. (see § 117.330 on the use and adaptation the Codex General Principles of Food
(Response 371) A corporation may of existing records). Training materials Hygiene.
designate an individual at the corporate being developed by the FSPCA may be (Response 376) The requirement to
level as the owner, operator, or agent in useful in developing food safety plans prepare and implement a written food
charge of a particular facility. In (see Response 2). safety plan is required by U.S. law (i.e.,
addition, an employee of the We note that activities of farm mixed- by section 418(h) of the FD&C Act). In
corporation, whether at headquarters or type facilities that are within the ‘‘farm’’ contrast, Codex standards are
at another facility owned by the definition (e.g., packing and holding recommendations for voluntary
corporation, may provide input into a RACs) are not subject to the human application by members and, thus,
particular facility’s food safety plan. As preventive controls rule. However, to Codex provisions are only mandatory if
previously discussed, the food safety the extent that some components of the standard is adopted by a country in
plan needs to be facility specific (see the GAPs-based food safety plans are its national legislation.
discussion of the facility-based nature of relevant to a facility (e.g., for an off-farm
the food safety plan in the 2013 packinghouse), the facility has B. Proposed § 117.126(a)(2)—
proposed human preventive controls flexibility to format its plan in a way Preparation of the Food Safety Plan by
rule, 78 FR 3646 at 3732). For example, that is consistent with GAPs-based food a Preventive Controls Qualified
even if a corporation makes similar safety plans. Individual
products at two separate facilities, it is (Comment 374) Some comments ask We proposed that the food safety plan
unlikely that the two facilities have us to clarify that a food safety plan is must be prepared, or its preparation
exactly the same equipment and layout. not required when a facility is exempt overseen, by one or more preventive
Procedural instructions must be tailored as a qualified facility (§ 117.5(a)) or as controls qualified individuals.
to the equipment being used, and the a facility solely engaged in the storage (Comment 377) Some comments ask
layout of a facility may affect its of packaged food that is not exposed to us to provide for a group of preventive
approach to preventive controls such as the environment (§ 117.7). controls qualified individuals to
food allergen controls. (Response 374) A qualified facility is prepare, or oversee the preparation of, a
(Comment 372) Some comments ask exempt from the requirements of food safety plan.
us to provide for facilities that have subparts C and G, including the (Response 377) The proposed
HACCP plans to build off their existing requirement to prepare and implement regulatory text included in the 2014
HACCP programs. As an example, these a food safety plan, and is instead subject supplemental human preventive
comments state that we could allow to the modified requirements in controls notice provides for the food
facilities to use terms like ‘‘critical § 117.201. Likewise, a facility solely safety plan to be prepared, or its
preparation overseen, by one or more to nearby farms, and farmers feel more by a preventive controls qualified
preventive controls qualified comfortable working with State individual.
individuals, and we are finalizing that employees.
(Response 380) A farm is not subject C. Proposed § 117.126(b)—Contents of a
provision as proposed.
(Comment 378) Some comments ask to this rule for activities within the Food Safety Plan
us to specify that oversight of the food ‘‘farm’’ definition. A farm mixed-type We proposed that the written food
safety plan is voluntary rather than facility that is a small or very small safety plan must include the written
required. business and only conducts the low-risk hazard analysis, preventive controls
(Response 378) We decline this activity/food combinations specified in (including the supplier program and the
request. The food safety plan is the § 117.5(g) and (h) is exempt from the recall plan), procedures for monitoring
foundation for a preventive approach to requirements of subparts C and G, the implementation of the preventive
producing safe food. As previously including the requirement for oversight controls, corrective action procedures,
discussed, the food safety plan must be of the food safety plan by a preventive and verification procedures. As
designed to identify, and to significantly controls qualified individual. discussed in more detail in section XLII,
minimize or prevent, hazards for the Furthermore, a farm mixed-type facility we have revised the phrase ‘‘supplier
purpose of preventing illness or injury that is a very small business, but does program’’ to ‘‘supply-chain program’’
(78 FR 3646 at 3731). The comments fail not satisfy the criteria for the throughout the regulatory text. In the
to explain how a facility could ensure exemptions specified in § 117.5(g) and remainder of this document, we use the
the proper design of an effective food (h), is a qualified facility that is exempt phrase ‘‘supply-chain program’’ in
safety plan without oversight by an from the requirements of subparts C and section headings and when referring to
individual who satisfies the minimum G, and is instead subject to modified the provisions of the final rule. We
requirements for a preventive controls requirements that do not require continue to use the term ‘‘supplier
qualified individual (see the discussion oversight of a food safety plan by a program’’ when describing the proposed
of the requirements for a preventive preventive controls qualified individual. provisions and the comments regarding
controls qualified individual in section Moreover, we expect that some training the proposed provisions.
XXXVI). materials and courses will be available (Comment 381) Some comments ask
(Comment 379) Some comments online, thereby helping to mitigate us to specify that sanitation controls
assert that oversight of the food safety costs, both associated with training of a must be in the food safety plan. Some
plan by a preventive controls qualified preventive controls qualified individual comments ask us to require equipment
individual should not be required for and loss of production manpower standards in the food safety plan, noting
products subject to the PMO because the during training. that it is not possible to clean and
production of such products is subject We disagree that it would be sanitize equipment that is not designed
to the NCIMS process. appropriate for an officer or employee of and constructed to be cleanable by
(Response 379) As discussed in a State agricultural agency to provide meeting specific standards.
Response 214, we agree we should make oversight of the food safety plan. The (Response 381) Sanitation controls are
use of the existing system of oversight food safety plan and its oversight are the one type of preventive control. As
provided for by NCIMS, which has been responsibility of the facility, not State appropriate to the facility and the food
part of a cooperative program among the government officials. The role of an (e.g., to control hazards such as
U.S. Public Health Service/FDA, the officer or employee of a State environmental pathogens), sanitation
States, and the dairy industry since agricultural agency would be in controls for cleanliness of food-contact
1950, and we have provided an determining whether the applicable surfaces and prevention of allergen
extended compliance date in order that facility is in compliance with the rule, cross-contact and cross contamination
the PMO be revised for consistency with such as during inspection. State would be required to be in the food
this rule. Under a revised PMO, Grade extension agents may be available to safety plan (§ 117.135(c)(3)).
‘‘A’’ facilities would need a preventive assist small businesses, even if those We are not adding a requirement to
controls qualified individual to make agents are not the designated preventive include equipment standards in the
decisions about hazards and verification controls qualified individual for the food safety plan. The CGMPs
procedures such as environmental facility, provided that such agents do established in subpart B already require
monitoring specific to a facility and to not also have any role in determining that all plant equipment and utensils be
review food safety records. whether the applicable facility is in so designed and of such material and
(Comment 380) Some comments compliance with the rule. workmanship so to be adequately
express concern about the cost We acknowledge that oversight of a cleanable (§ 117.40(a)(1)). It is not
associated with oversight of the food food safety plan by a preventive controls practical to specify equipment standards
safety plan by a preventive controls qualified individual is a cost associated in the CGMPs due to the wide range of
qualified individual, regardless of with the rule, and we have accounted equipment used by the food industry,
whether the preventive controls for that cost in the FRIA for this rule including equipment subject to ongoing
qualified individual is employed by the (Ref. 38). To minimize the burden on development and improvement.
facility or is a third party. These the smallest businesses, the definition of (Comment 382) Some comments ask
comments focus on the burden that this ‘‘very small business’’ establishes a us to recognize that existing HACCP
oversight would place on farms and $1,000,000 threshold, adjusted for plans, such as those developed in
small businesses, and note that the food inflation, during the 3-year period accordance with the EU 2004 Food
industry is a ‘‘low margin’’ industry. preceding the applicable calendar year. Hygiene law and GFSI-compliant food
Some comments ask us to provide for an As already noted, a facility that satisfies safety plans, can satisfy the
officer or employee of a State the definition of very small business is requirements for what must be in a food
agricultural agency to provide oversight exempt from the requirements of safety plan.
of the food safety plan, because such subparts C and G and instead is subject (Response 382) To the extent that an
persons have the most specialized to modified requirements (see existing HACCP plan or GFSI-compliant
knowledge concerning that State, it is § 117.201), which do not require a food food safety plan includes all required
more efficient for State officials to travel safety plan that is prepared or overseen information, a facility can use such
plans to meet the requirements of this with background information and rule does not specify how a facility
rule. We expect that many existing specific examples of differences, would identify any applicable CCPs or
plans will need only minor including how firms are directed to set critical limits. Importantly, this rule
supplementation to fully comply with their critical control points and critical explicitly provides that preventive
these requirements. Relying on existing limits. controls include controls other than
records, with supplementation as (Response 383) Table 29 compares the those at CCPs that are also appropriate
necessary to demonstrate compliance provisions of the food safety plan for food safety (§ 117.135(a)(2)(ii)). See
with the requirements of the human required by this rule to the provisions also Response 2, in which we discuss
preventive controls rule, is acceptable of HACCP plans in some current
both future guidance and a preventive
(see § 117.330). requirements or guidelines for HACCP
controls training curriculum being
(Comment 383) Some comments ask systems. See also the discussion in the
us to explain the differences between 2013 proposed human preventive developed by the FSPCA. We expect
the food safety plan being established to controls rule (78 FR 3646 at 3730–3732) that both of these resources will help
implement FSMA and HACCP plans and our memorandum comparing the facilities, including foreign facilities,
established under current requirements provisions of this rule to various understand the requirements for a food
or guidelines for HACCP systems. These existing domestic and international safety plan.
comments ask us to provide exporters HACCP-based standards (Ref. 65). This
TABLE 29—A COMPARING THE FOOD SAFETY PLAN TO HACCP PLANS

Federal HACCP
NACMCF HACCP Codex HACCP rules for juice,
Requirements PC Rule Guidelines Annex seafood, and meat
and poultry
Written plan .. Yes ......................................... Yes ......................................... Yes ......................................... Yes.

Who is re- The owner, operator or agent A HACCP team may need as- Individual businesses, with The processor.
sponsible in charge of a facility must sistance from outside ex- advice when necessary
for pre- prepare, or have prepared, perts knowledgeable in the from other sources.
paring the and implement a written hazards associated with the
plan? food safety plan. The food product and process.
safety plan must be pre-
pared, or its preparation
overseen, by one or more
preventive controls qualified
individuals.
What does • Written hazard analysis ...... • Written hazard analysis ...... • Written hazard analysis ...... • Written hazard analysis.
the plan • Written preventive controls • Must include the hazard, • Must include CCPs and crit- • Must list all food safety haz-
contain? • Written supply-chain pro- the CCPs, and critical limits. ical limits. ards that are reasonably
gram. • Must include monitoring • Must include monitoring likely to occur, CCPs, and
• Written recall plan ............... procedures. procedures. critical limits.
• Written procedures for mon- • Must include corrective ac- • Must include corrective ac- • Must list monitoring proce-
itoring the implementation tions. tions. dures.
of the preventive controls. • Must include verification • Must include verification • Must include corrective ac-
• Written corrective action procedures. procedures. tion procedures.
procedures. • Must include recordkeeping • Must include records .......... • Must include verification
• Written verification proce- procedures. procedures;
dures. • Must include recordkeeping
procedures.
Is oversight Yes ......................................... Yes ......................................... Yes ......................................... Yes.
required by
a person
qualified by
training and
experi-
ence?
D. Proposed § 117.126(c)—Records E. Comments on Potential Requirements simultaneously with the required

for Submission of a Facility Profile to biennial update of the food facility
We proposed that the food safety plan FDA registration. We described potential
is a record that is subject to the benefits to having a facility’s food safety
recordkeeping requirements of subpart We requested comment on whether to
require submission to FDA of a subset plan in advance of an inspection, such
F. We received no comments that as aiding in the efficient oversight of
of the information that would be in a
disagreed with this proposed preventive controls by allowing us to
food safety plan (78 FR 3646 at 3768).
requirement and are finalizing it as better target inspectional activities to

This information, which could be
proposed. referred to as a ‘‘facility profile,’’ could facilities that produce foods that have
be submitted through an electronic form an increased potential for contamination
using a menu selection approach at the (particularly contamination with
same time as facility registration, and biological hazards). We noted that
could be updated biennially facilities could benefit from our advance
preparation through interaction with not advance food safety goals or have a and hazard evaluation. Some comments
better-informed investigators and commensurate benefit to food safety. support the proposed requirements
potentially reduced inspection time. We Some comments express concern about without change. For example, some
requested comment on the utility and protection of confidential information. comments support our proposal for the
necessity of such an approach and on Other comments express concern that hazard analysis to address ‘‘known or
the specific types of information that we would misinterpret the submitted reasonably foreseeable hazards’’ because
would be useful in developing a facility information in the absence of discussion this is consistent with Codex. Other
profile. We also requested comment on with the facility. Some comments assert comments agree that the hazard analysis
any additional benefits that might be that receiving and evaluating the should address both the severity of the
obtained from using such an approach submitted information would be too
potential hazard and the probability that
and any potential concerns with this time-consuming for FDA, whereas other
the hazard will be present in a food
approach. comments assert that submitting the
information would be too time- product. Other comments state that
We noted that we had previously testing for environmental pathogens
announced an opportunity for public consuming for the facility. Some
comments state that a subset of the may be impractical in certain situations
comment on the proposed collection of for facilities in chemical plants that also
additional food facility profile information that would be submitted
could be found in the Establishment produce food additives and that the
information on a voluntary basis from proposed requirements for hazard
firms that complete the FDA food Inspection Reports. Some comments
assert that we could use information evaluation make it clear that in such
facility registration process (Federal
already available through the Reportable facilities environmental monitoring
Register of May 11, 2012, 77 FR 27779).
Food Registry to identify facilities that would not be required. Some comments
In contrast to the voluntary submission
of food facility profile information have needed to address a serious food that support the proposed provisions
safety violation and target our suggest alternative or additional
described in that notice, in the 2013
inspectional resources to those facilities. regulatory text (see, e.g., Comment 385,
proposed human preventive controls
Some comments state that a facility Comment 395, Comment 406, and
rule we requested comment on whether
profile is a not a static document and Comment 407) or ask us to clarify how
the submission of such information
would be very difficult to keep up-to- we will interpret the provision (see, e.g.,
should be required.
date. Comment 418).
(Comment 384) Some comments state (Response 384) We have decided that
that submission of a facility profile we will not establish a requirement for In the following sections, we discuss
would be useful and support requiring submission of a facility profile. We will comments that ask us to clarify the
such a submission. However, most of explore other mechanisms to achieve proposed requirements or that disagree
the comments that addressed our the goals we described in the 2013 with, or suggest one or more changes to,
request for comments on such a proposed human preventive controls the proposed requirements. After
submission express concern. Some rule. considering these comments, we have
comments assert that requiring revised the proposed requirements as
submission of a facility profile is XXV. Subpart C: Comments on
shown in table 30, with editorial and
outside of FDA’s statutory authority Proposed § 117.130—Hazard Analysis
conforming changes as shown in table
under FSMA. Other comments assert We proposed requirements for hazard 52.
that submitting a facility profile would analysis, including hazard identification
TABLE 30—REVISIONS TO THE PROPOSED REQUIREMENTS FOR HAZARD ANALYSIS

117.130(a)(1) ................................... Requirement for a hazard analysis Specify that a facility must ‘‘conduct a hazard analysis’’ to identify
and evaluate known or reasonably foreseeable hazards, rather
than merely specify that a facility must ‘‘identify and evaluate’’
known or reasonably foreseeable hazards.
117.130(a)(2) ................................... Requirement for the hazard anal- Clarify that the hazard analysis must be written, regardless of its out-
ysis to be written. come.
117.130(b)(1) and (b)(2) ................. Hazard identification ...................... Emphasize that the hazard identification focuses on known or rea-
sonably foreseeable hazards (rather than on all hazards).
117.130(b)(1)(iii) .............................. Hazard identification ...................... Add examples of physical hazards.
117.130(c)(1)(ii) ............................... Hazard evaluation .......................... Provide that hazard evaluation does not need to include an evalua-
tion of environmental pathogens whenever RTE food is exposed to
the environment prior to packaging if the packaged food includes a
control measure (such as a formulation lethal to the pathogen) that
would significantly minimize the pathogen.
117.130(c)(2)(x) ............................... Hazard evaluation .......................... Provide an example of ‘‘other relevant factor’’ that the hazard evalua-
tion must consider (the example is the temporal (e.g., weather-re-
lated) nature of some of some hazards (e.g., levels of some natural
toxins)).
A. Proposed § 117.130(a)—Requirement information, known or reasonably We also proposed that the hazard
for a Written Hazard Analysis foreseeable hazards for each type of food analysis must be written. As discussed
manufactured, processed, packed, or in Response 126, we have revised the
We proposed that you must identify held at your facility to determine term ‘‘significant hazard’’ to ‘‘hazard
and evaluate, based on experience, whether there are significant hazards. requiring a preventive control.’’
illness data, scientific reports, and other
(Comment 385) Some comments ask analysis and assert that such a information to evaluate, irrespective of
us to specify that the rule requires a requirement would be consistent with whether the information is available.
written hazard analysis even if the the requirements of the FSIS HACCP (Comment 390) Some comments point
hazard analysis concludes that no regulation for meat and poultry. out that the Codex HACCP Annex
hazards exist. (Response 387) We made no changes includes ‘‘mileposts’’ for the
(Response 385) As proposed, the to the regulatory text to specifically identification of hazards, recommending
regulatory text would require a written require that a facility ‘‘provide that the HACCP Annex apply to ‘‘all of
hazard analysis even if the hazard supporting documentation’’ in its the hazards that may be reasonably
analysis concludes that no hazards hazard analysis. A facility has flexibility expected to occur at each step from
exist. To make this clearer, we have to determine the appropriate content of primary production, processing,
made two revisions to the regulatory its written hazard analysis, provided manufacture, and distribution until the
text. First, we have revised the that the written hazard analysis point of consumption.’’ These
regulatory text to specify that a facility complies with the requirements for comments ask us to include such
must ‘‘conduct a hazard analysis’’ to hazard identification and hazard ‘‘mileposts’’ in the requirements to
identify and evaluate known or evaluation (see § 117.130(b) and (c)). A conduct a hazard analysis to put the
reasonably foreseeable hazards, rather facility must be able to justify its hazard regulations in better alignment with the
than merely specify that a facility must analysis decisions, even if the Codex HACCP Annex and underscore
‘‘identify and evaluate’’ known or supporting documentation is not the fact that food producers cannot
reasonably foreseeable hazards. Second, specifically included with the hazard anticipate or be responsible for
we have revised the regulatory text to analysis. For example, a facility that customer behavior that is contrary to
specify that the hazard analysis must be relies on one or more scientific general principles of food safety.
written regardless of its outcome. publications to support its hazard (Response 390) By ‘‘mileposts’’ for
(Comment 386) Some comments analysis might include a bibliography hazard identification, we assume that
assert that a facility should not be able listing the relevant publications, but not the comments are referring to the steps
to conclude that no hazard exists in its include a copy of the listed included in the Codex HACCP Annex
production process and that any such publications. Differences in the regarding the recommendation to list all
conclusion reached should be a ‘‘red regulatory text of this rule compared to potential hazards associated with each
flag’’ to FDA investigators. the FSIS HACCP regulation for meat and step, conduct a hazard analysis, and
(Response 386) The purpose of a poultry reflect the flexible framework consider any measures to control
hazard analysis is to identify and provided by FSMA but do not create a identified hazards. These steps include
evaluate known or reasonably conflict. consideration of: (1) The likely
foreseeable hazards to determine (Comment 388) Some comments ask occurrence of hazards and severity of
whether there are any hazards requiring us to modify the provision to specify their adverse health effects; (2) the
a preventive control. If a facility that the hazard analysis identify and qualitative and/or quantitative
appropriately determines, under the evaluate known or reasonably evaluation of the presence of hazards;
oversight of a preventive controls foreseeable hazards for each type of food (3) survival or multiplication of
qualified individual, that no such manufactured, processed, packed, or microorganisms of concern; (4)
hazards exist, then that is the outcome held at the facility, including hazards in production or persistence in foods of
of its hazard analysis, and the facility the raw materials and ingredients used toxins, chemicals or physical agents;
must document that outcome in its in the food (emphasis added). and (5) conditions leading to these
written hazard analysis. (See also (Response 388) We decline this factors (Ref. 34).
Response 222, Response 226, Response request. Other provisions in the We agree that a hazard analysis
229, Response 232, Response 397, requirements for hazard analysis specify should address known or reasonably
Response 721, and Response 726.) that the hazard evaluation must foreseeable hazards at each step from
However, we agree that our consider raw materials and ingredients primary production, processing,
investigators should take appropriate (see § 117.130(c)(2)(iii)). It is not manufacture, and distribution until the
steps to evaluate a facility’s hazard necessary to repeat the specific point of consumption. For example, a
analysis when the outcome is that there requirements associated with the hazard facility that produces cut or shredded
are no hazards requiring a preventive evaluation in the provision that directs RTE carrots might consider pathogens
control. We expect that our investigators each facility to conduct a hazard such as Salmonella that can occur at
would both review the facility’s written analysis. primary production; metal from the
hazard analysis and discuss the (Comment 389) Some comments ask slicers or shredders, and L.
outcome with the facility. During the us to modify the provision to use ‘‘or’’ monocytogenes as an environmental
initial stages of implementation, we also instead of ‘‘and’’ in the clause ‘‘based on pathogen, during manufacturing/
expect that our investigators will ask experience, illness data, scientific processing; and refrigeration until the
subject matter experts in our Center for reports, and other information’’ because end of the shelf life to prevent the
Food Safety and Applied Nutrition it is not necessary to evaluate all of the growth of pathogenic sporeforming
(CFSAN) to review such a hazard specified criteria in all cases. bacteria.
analysis. Over time, as our investigators (Response 389) We decline this However, to the extent that these
gain experience with appropriate request. We agree that in some cases comments are asserting that a facility
determinations that there are no hazards some of the specified types of can ignore consumer behavior that the
requiring a preventive control, we information may not be available. For facility considers contrary to principles
expect that there will be fewer example, if a food product has not been of food safety, we disagree. For example,
circumstances in which our associated with foodborne illness, there a facility could not conclude that it need
investigators would consult CFSAN would be no illness data. However, not identify and evaluate known or
about such an outcome. modifying the provision as suggested by reasonably foreseeable hazards because
(Comment 387) Some comments ask the comments would establish a the facility intends to provide cooking
us to require facilities to provide regulatory requirement in which a instructions on the label of a packaged
supporting documentation in the hazard facility could pick and choose which food. Consumer research indicates that
consumer cooking practices are not (Comment 394) As discussed in (Comment 398) Some comments ask
uniform and that many consumers do Comment 126, some comments express us to broaden the examples listed for
not follow some cooking instructions, concern that the rule would refer to chemical hazards to include ‘‘allergens
such as those on frozen foods or multiple levels of hazards (i.e., and ingredients associated with food
directions specifying that a product ‘‘hazards,’’ ‘‘known or reasonably sensitivities.’’
should be cooked until it reaches a foreseeable hazards,’’ and ‘‘significant (Response 398) We decline this
certain temperature (Ref. 66) (Ref. 67). hazards’’ (which we now refer to as request. Although the presence of an
(Comment 391) Some comments ask ‘‘hazards requiring a preventive undeclared ingredient associated with a
us to require that the hazard analysis be control’’) and ask us to provide food sensitivity (such as the color
re-evaluated every three years and sufficient clarity to be able to additive Yellow #5) can be considered
updated as needed. distinguish between these types of a chemical hazard for the sensitive
(Response 391) The written hazard hazards. population, it is neither practical nor
analysis is one component of the food (Response 394) As discussed in necessary for the list of examples of
safety plan, and the food safety plan is Response 126, we have revised the chemical hazards in the regulatory text
subject to reanalysis at least every three requirements for hazard identification to to be exhaustive.
years (see § 117.170). emphasize that the hazard identification (Comment 399) Some comments
(Comment 392) Some comments state focuses on known or reasonably assert that we should not require all
that the standard for hazard analysis in foreseeable hazards (rather than on all food safety plans to specifically address
the human preventive controls rule hazards). the likelihood of radiological hazards.
should both align with the re-proposed (Comment 395) Some comments ask (Response 399) The rule only requires
requirements for hazard analysis set us to include examples of physical that a facility consider whether
forth in the supplemental FSVP notice hazards in the regulatory text. radiological hazards are known or
and be consistent with the statutory (Response 395) We have added reasonably foreseeable, and we have
standard for hazard analysis in section stones, glass, and metal fragments as described situations where radiological
418(b)(1) of the FD&C Act. examples of physical hazards in the hazards could be considered to be
(Response 392) We have aligned the regulatory text. This is consistent with known or reasonably foreseeable (78 FR
requirements of the human preventive the regulatory text for biological and 3646 at 3667). A facility that
controls rule and the proposed FSVP chemical hazards, even though the appropriately determines that no
rule to the extent practicable, consistent hazards listed in section 418(b)(1) of the radiological hazards are known or
with the applicable statutory FD&C Act include examples of chemical reasonably foreseeable would document
requirements. and biological hazards but do not that determination in its written hazard
(Comment 393) Some comments ask include examples of physical hazards. analysis but would not need to establish
us to endorse a template, format, or style (Comment 396) Some comments ask preventive controls and associated
to be used for a hazard analysis to us to separately list some hazards (such preventive control management
ensure these analyses are conducted as parasites and drug residues) rather components to address radiological
consistently across the food industry than include them as examples of hazards.
and that auditors are consistent in their biological hazards and chemical (Comment 400) Some comments
evaluation. hazards. addressing radiological hazards ask us
(Response 393) We decline this (Response 396) We decline this to clarify that radiological hazards are
request. See Response 373. request. Although section 418(b)(1)(A) an example of chemical hazards; clarify
of the FD&C Act lists such items the requirements by identifying specific
B. Proposed § 117.130(b)—Hazard separately, we believe it is clearer to radiological hazards and including them
Identification acknowledge that some of the hazards in the regulatory text; develop a baseline
We proposed that the hazard listed in the statute are in fact a subset for acceptable levels and specific
identification must consider hazards of the broader categories of biological monitoring recommendations for each
that include biological, chemical, and and chemical hazards. product; defer compliance on the
physical hazards. We proposed to list (Comment 397) Some comments ask control of radiological hazards until
examples of biological hazards (i.e., us to rephrase the requirement for more comprehensive information is
microbiological hazards such as hazard identification to specify ‘‘The available to industry and regulators on
parasites, environmental pathogens, and hazard analysis must identify hazards’’ how best to control for and assess
other pathogens) and chemical hazards rather than ‘‘The hazard identification compliance in controlling the hazard;
(i.e., radiological hazards and must consider hazards.’’ clarify whether irradiation of produce
substances such as pesticide and drug (Response 397) We decline this for phytosanitary purposes must be
residues, natural toxins, decomposition, request. The provision is directed to the considered as a potential radiological
unapproved food or color additives, and first step of a hazard analysis—i.e., hazard; confirm that a facility is
food allergens). In the preamble (78 FR hazard identification—rather than to the required to assess only two types of
3646 at 3734)], we provided examples of overall hazard analysis (which is radiological hazards (production water
physical hazards (i.e., stones, glass, or addressed in § 117.130(a)). The purpose and accidental contamination from
metal fragments that could of the hazard identification is to accidental release from a nuclear
inadvertently be introduced into food) consider the types of hazards listed in facility); and clarify whether we will
but did not propose to include these the provision as a step in determining require consideration of radiological
examples in the regulatory text. whether there are any hazards requiring hazards by processors subject to our
We also proposed that the hazard a preventive control; the suggestion of HACCP regulations for seafood and
identification must consider hazards the comments implies that such hazards juice.
that may be present in the food if they will always be identified. As discussed (Response 400) The regulatory text
occur naturally, may be unintentionally in Response 386, the outcome of a specifies that radiological hazards are an
introduced, or may be intentionally hazard analysis for a food product could example of chemical hazards. We
introduced for purposes of economic be that there are no hazards requiring a decline the requests to identify specific
gain. preventive control. radiological hazards, include them in
the regulatory text, and develop a plan but unexpected intentional hazards rule. We continue to believe that there
baseline for acceptable levels, with should be part of a food defense plan. is benefit in taking this preventive
specific monitoring recommendations (Response 401) This rule only approach to economically motivated
for each product type. As discussed in requires a facility to consider adulteration, and not solely on
the 2013 proposed human preventive intentionally introduced hazards when enforcing the preexisting misbranding
controls rule (78 FR 3646 at 3667), such hazards are introduced for and adulteration provisions of the FD&C
radiological contamination of foods is a purposes of economic gain. Hazards that Act after a violation occurs.
rare event. The most relevant may be intentionally introduced by acts As discussed in sections XLII through
information that would lead a food of terrorism are the subject of the 2013 XLIX, we are finalizing supply-chain
facility to consider and evaluate a proposed intentional adulteration rule program provisions. It is consistent with
specific radiological hazard to (78 FR 78014, December 24, 2013). the framework of this rule for a facility
determine whether it is a hazard (Comment 402) Some comments to address hazards requiring a
requiring a preventive control would be disagree that the human preventive preventive control that may be
publicly disseminated information controls rule should address hazards intentionally introduced for purposes of
following a particular event, such as that are intentionally introduced for economic gain through the facility’s
contamination arising from accidental purposes of economic gain supply-chain program.
release from a nuclear facility or from (economically motivated adulteration). (Comment 403) Some comments
damage to a nuclear facility from a Some of these comments assert that express concern about identifying
natural disaster. We already have issued economically motivated adulteration is hazards that may be intentionally
guidance on levels of concern for not a good fit for the hazard analysis introduced for purposes of economic
radionuclides that could be a known or and preventive controls framework gain because there are potentially an
reasonably foreseeably hazard in certain because it is, in all but the rarest of unlimited number of unknown or yet-to-
circumstances, such as after an accident circumstances, an issue of product be-identified hazards that could be
at a nuclear facility (Ref. 68). In light of integrity and quality, whereas food intentionally introduced for purposes of
this current guidance, we see no reason safety systems are designed and built to economic gain by an unscrupulous
to provide additional guidance to prevent or mitigate food safety hazards. supplier. These comments disagree with
address hypothetical circumstances or Some comments state that traditional our attempt to narrow the field of
to defer compliance until more food safety hazards are primarily both potential scenarios for economically
information is available. identified and addressed at the facility motivated adulteration to circumstances
level, but economically motivated where there has been a pattern of such
A facility does not need to consider
adulteration is typically handled by the adulteration in the past.
sources of radiation used in accordance Some comments assert that our
corporate parent company, where
with a food additive regulation in its attempt to narrow the field of potential
supply chain management programs are
hazard analysis. Such sources are safe scenarios for economically motivated
typically located. These comments also
for their intended use. As with any assert that food safety-related adulteration is both too broad and too
other equipment and substances used in economically motivated adulteration is narrow at the same time. These
the manufacture of food, a facility must extremely rare and that predicting comments assert that our attempt is too
comply with all applicable safety economically motivated adulteration to broad, because we expect facilities to
requirements established either under prevent it is extremely difficult. Some consider patterns of adulteration from
the terms of a food additive regulation comments assert there will be no the past ‘‘even though the past
or by an authority such as the measurable benefit to food safety by occurrences may not be associated with
Occupational Safety and Health imposing requirements to consider the specific supplier or the specific food
Administration. Although production economically motivated adulteration as product’’ and a requirement to consider
water and accidental contamination part of a food safety plan and that doing every potential product and potential
from accidental release from a nuclear so will consume limited resources supplier makes the task open ended.
facility would be the two most likely without a corresponding increase in These comments further assert that our
sources of radiological hazards that a consumer protection. Other comments attempt is too narrow, because a focus
facility would need to address, we are assert that there is no need to require a on patterns of adulteration in the past is
not limiting the facility’s facility to identify hazards intentionally unlikely to reveal potential future
responsibilities to these two sources. We introduced for purposes of economic instances of economically motivated
cannot anticipate the future. gain because the misbranding and adulteration and because those
We have not taken action to revise adulteration provisions of the FD&C Act intending to defraud purchasers for
either our HACCP regulations for already sufficiently provide safeguards economic gain are trying to avoid
seafood and juice or our current against economic gain. detection. According to these
guidance on hazards and controls for (Response 402) We agree with the comments, once a food safety-related
seafood and juice (Ref. 42) (Ref. 43) to comments stating that the requirement instance of economically motivated
require or recommend that processors of to consider hazards intentionally adulteration is uncovered, perpetrators
those products address radiological introduced for purposes of economic quickly move to carry out their
hazards in their food safety plans. gain is narrow. Such hazards will be fraudulent activities in a different way.
However, in the event of a situation identified in rare circumstances, usually Some comments assert that there are
such as an accident at a nearby nuclear in cases where there has been a pattern alternative ways to control hazards that
facility, it would be prudent for such of economically motivated adulteration may be intentionally introduced for
processors to consider whether the in the past. In addition, we define purposes of economic gain without
potential for contamination with hazards to only include those agents specific regulatory requirements, such
radiological hazards would warrant that have the potential to cause illness as by having an effective supplier
modification of their food safety plans. or injury. Economically motivated approval program with appropriate
(Comment 401) Some comments adulteration that affects product qualification and verification activities;
assert that predictable intentional integrity or quality, for example, but not through business-to-business relations,
hazards should be in the food safety food safety, is out of the scope of this expectations, and contracts; and through
a vulnerability assessment and control adulteration that has the potential to the hazard will occur in the absence of
plan tailored specifically to cause illness or injury. Under the final preventive controls; and environmental
economically motivated adulteration. rule, a facility does not need to identify pathogens whenever an RTE food is
(Response 403) We disagree that the a hazard related to economically exposed to the environment prior to
requirement is too broad. A facility must motivated adulteration when there is no packaging and the packaged food does
conduct a hazard analysis for each type risk to public health or when the not receive a treatment that would
of food manufactured, processed, economically motivated adulteration is significantly minimize the pathogen
packed, or held at the facility. There is not known or reasonably foreseeable. (proposed § 117.130(c)(1)). We also
no requirement to consider every We agree that the three circumstances proposed that the hazard evaluation
potential product or potential supplier. suggested by the comments are an must consider the effect of the following
We also disagree that the requirement is appropriate focus for facilities who seek on the safety of the finished food for the
too narrow. Some individuals intending guidance on how to approach the intended consumer: (1) The formulation
to defraud purchasers for economic gain requirements, but decline the request to of the food; (2) the condition, function,
will develop entirely novel ways of specify these limitations of the scope in and design of the facility and
adulterating food to suit their purposes. the regulatory text. As already noted, equipment; (3) raw materials and
We agree that these circumstances may some comments assert that our attempt ingredients; (4) transportation practices;
not lend themselves to the preventive to narrow the field of potential scenarios (5) manufacturing/processing
approach required here. We encourage, for economically motivated adulteration procedures; (6) packaging activities and
but do not mandate, that facilities adopt is both too broad and too narrow at the labeling activities; (7) storage and
other measures they deem appropriate same time (see Comment 403). Although distribution; (8) intended or reasonably
to mitigate the risks of economically we continue to believe that the foreseeable use; (9) sanitation, including
motivated adulteration that this instances in which a facility will employee hygiene; and (10) any other
rulemaking does not address. Still, the identify a hazard intentionally relevant factors (proposed
repeated economically motivated introduced for economic gain will be § 117.130(c)(2)).
adulteration of spices with toxic rare, we also consider that limiting the (Comment 406) Some comments ask
colorants demonstrates that patterns of scope of the requirement in the us to revise the requirement to include
economically motivated adulteration regulatory text would be both pre- an evaluation of environmental
can emerge and should be considered as judging the future and inconsistent with pathogens to avoid the implication that
part of a food safety plan (see the the public health objectives of this rule. an intervention is needed when there
examples in the 2014 supplemental (Comment 405) Some comments ask
may be other controls (such as pH or
human preventive controls notice, 79 us to allow implementation of the major
formulation) that would significantly
FR 58524 at 58550–58551). provisions in FSMA before establishing
minimize or prevent the pathogen.
(Comment 404) Some comments ask requirements to address economically
These comments suggest that we revise
us to limit the requirement to identify motivated adulteration. These
the provision to require that a hazard
hazards that may be introduced for comments assert that economically
purposes of economic gain to only those motivated adulteration requires a evaluation include an evaluation of
hazards that pose a risk to public health completely different paradigm than environmental pathogens whenever an
for which there has been a pattern in the unintentional adulteration. In addition, RTE food is exposed to the environment
past. Some comments assert that in because economically motivated prior to packaging and the packaged
those few instances where a hazard was adulteration is typically addressed food does not receive a treatment ‘‘or
intentionally introduced the underlying through product specifications, supplier otherwise include a control measure’’
intention was to defraud rather than to relationships, and good business that would significantly minimize the
cause harm, and the food safety hazard practices, implementation of these other pathogen.
was an unintended consequence. Some provisions of the human preventive (Response 406) We have revised the
comments ask us to focus the hazard controls rule are likely to have a provision on the hazard evaluation for
identification solely on inbound positive effect on preventing environmental pathogens to specify that
products, because it is obvious that economically motivated adulteration. the packaged food does not receive a
hazards introduced by the facility itself (Response 405) We disagree that treatment or otherwise include a control
will not be prevented through a hazard economically motivated adulteration measure (such as a formulation lethal to
analysis. Some comments ask us to requires a completely different the pathogen) that would significantly
narrow the scope of the requirement by paradigm than unintentional minimize the pathogen. We agree that
specifying that facilities focus on three adulteration. Hazards intentionally controls such as formulation can
situations: (1) Situations in which there introduced for economic gain are function as a ‘‘kill step’’ and that the
has been a pattern of similar addressed here with the same provision should make clear that such
adulteration in the past; (2) foods or preventive framework as every other controls can be used in lieu of
ingredients for which quality assurance hazard. As such, we do not see a ‘‘treatment.’’
methods may not sufficiently compelling reason to delay (Comment 407) Some comments ask
characterize the food or ingredient to implementation of the requirements to us to clarify what we meant by ‘‘other
assure its identity, and; (3) foods or address economically motivated relevant factors’’ and note that natural
ingredients for which there are adulteration. disasters (which we previously
substitutes that are likely to be harmful discussed) (78 FR 3646 at 3738) are
that would be considered obvious to one C. Proposed § 117.130(c)—Evaluation of ‘‘usually exceptional events’’ that are
skilled in food science. Whether a Hazard Requires a Preventive best managed in a facility crisis
(Response 404) We decline to make Control management plan. Other comments ask
the changes suggested in these We proposed that the hazard analysis us to specify that the hazard evaluation
comments, because they are must include an evaluation of the must consider any relevant geographic,
unnecessary. Because of our definition identified hazards to assess the severity temporal, agricultural, or other factors
of hazard, the requirement is already of the illness or injury if the hazard that may affect the severity or
limited to economically motivated were to occur and the probability that probability of the hazard.
(Response 407) We included ‘‘other existing systems in place to manage (Response 412) We decline this
relevant factors’’ to emphasize that the radiological risks, such as steps taken by request. It is not necessary to define
list of factors in the provision is not an government officials to inspect every term and phrase included in the
exhaustive list and that a facility is ingredients obtained from a geographic rule. See the Appendix to the 2013
responsible to consider those factors region that has been the subject of a proposed preventive controls rule for
that play a role in its determination of nuclear accident. examples of food products that are, or
whether a potential hazard is a hazard (Response 410) A facility may are not, exposed to the environment (78
requiring a preventive control, consider all available resources in FR 3646 at 3819). In the context of doing
regardless of whether those factors are appropriately determining whether a a hazard analysis, the facility must
listed in the provision. A facility that known or reasonably foreseeable appropriately determine whether
already addresses circumstances such as radiological hazard is a hazard requiring contamination of RTE foods with
natural disasters in other plans may a preventive control and in pathogenic organisms from the
consider the applicable part of those appropriately determining what production environment can occur; to
plans to be part of its food safety plan preventive controls, and associated make such an appropriate determination
(see § 117.330). preventive control management does not require a definition of
We agree that geographic, temporal, components, to establish and implement ‘‘exposed to the environment.’’
and agricultural factors are examples of in light of a radiological hazard that is (Comment 413) Some comments
‘‘other relevant factors.’’ For example, a hazard requiring a preventive control. assert that the proposed requirement to
hazards such as aflatoxin are subject to However, existing systems in place to consider the effect of ‘‘intended or
a weather-dependent effect in that manage radiological risks, such as after reasonably foreseeable use’’ on the
aflatoxin levels in some RACs are more a nuclear accident, do not absolve a safety of the finished food for the
of a problem in some years than in facility of its responsibilities to establish intended consumer is too open-ended
others. We have added the temporal and implement preventive controls to and vague to provide clear direction to
nature of some hazards associated with address a radiological hazard when industry and regulators pertaining to
some RACs as an example of ‘‘other circumstances warrant. compliance obligations. These
relevant factors’’ to consider (see (Comment 411) Some comments comments ask us to substitute
§ 117.130(c)(2)(x)). assert that there would be no need to ‘‘expected use’’ for ‘‘intended or
(Comment 408) Some comments reasonably foreseeable use.’’
evaluate an environmental pathogen if
assert that it is unnecessary to establish (Response 413) We decline this
the finished food is inherently incapable
a specific provision that identifies request. We agree that the term
of supporting pathogen survival (e.g., in
environmental pathogens as a hazard ‘‘expected use’’ has potential to
acid or acidified foods). These communicate both intended use and
that is required to be evaluated.
(Response 408) We are retaining the comments ask us to modify the reasonably foreseeable use but disagree
provision, which we proposed to requirement to narrow the that this interpretation would be
highlight the importance of circumstances when it would apply to universal. We are retaining ‘‘intended or
environmental pathogens in some whenever an RTE food is ‘‘capable of reasonably foreseeable use’’ to be
facilities and to make clear that supporting pathogen growth to, or explicit that a facility must consider
sanitation controls, with appropriate survival at, infectious levels.’’ what is reasonably foreseeable in
verification, may be necessary in (Response 411) The suggestion of the addition to what is intended. (See also
addition to sanitation measures that the comments pre-judges the outcome of the Response 121.)
facility establishes as a matter of CGMP. hazard analysis for a wide variety of (Comment 414) Some comments
(Comment 409) Some comments food products. A facility can consider express concern about the potential for
assert that it can be difficult to factors such as whether the formulation a hazard evaluation to overlook food
determine ‘‘the severity of the illness or of a food would not support the growth allergens and assert that food allergens
injury if the hazard were to occur’’ for of the pathogen to increased numbers, must be designated as significant
a food that is not RTE food, especially or would cause pathogens to die off over hazards whenever they occur. Other
for raw materials and ingredients. time, in determining whether an comments assert that a determination of
(Response 409) We acknowledge that environmental pathogen is a hazard whether a food allergen is a significant
determining the severity of the illness or requiring a preventive control. hazard should consider protein levels in
injury if the hazard were to occur can Importantly, for many pathogens the ingredients. Other comments assert that
be more difficult for some foods than for mere presence of the pathogen presents food allergens are not a problem in
other foods. However, recent outbreaks a risk of illness, and the time necessary produce, except for tree nuts.
and large-scale recalls demonstrate the for pathogens in the food to die off due (Response 414) The hazard
potential for some raw materials and to the formulation of the food varies. identification must consider chemical
other ingredients to cause serious illness Thus, a facility that appropriately hazards, including food allergens
or injury (78 FR 3646 at 3656 and 3737). determines that an environmental (§ 117.130(b)(1)(ii)). Thus, food allergens
For reasons such as these, the rule pathogen is not a hazard requiring a cannot be overlooked. Whether the
requires that a facility identify and preventive control due to factors such as protein level of a food allergen in
evaluate multiple sources of information formulation of a food would need to ingredients is a factor that must be
(i.e., experience, illness data, scientific document the basis for its determination considered in the hazard evaluation
reports, and other information) and also in its written hazard analysis. would be determined by the preventive
requires that the food safety plan (which (Comment 412) Some comments ask controls qualified individual who must
includes the written hazard analysis) be us to include a definition for ‘‘exposed conduct or oversee the hazard analysis.
prepared, or its preparation overseen, by to the environment’’ to avoid confusion. We agree that most produce does not
one or more preventive controls These comments state their satisfy the definition of food allergen,
qualified individuals (see understanding that this phrase means but the evaluation of whether a food
§ 117.126(a)(2)). that the product is in a form that is allergen hazard exists in any particular
(Comment 410) Some comments ask exposed and/or subject to direct human food still must be considered by the
us to provide that a facility may rely on contact. preventive controls qualified individual
who must conduct or oversee the hazard makes processed fruit products using a regulation is new. The provision
analysis. processes to adequately control specifies that a facility must evaluate
(Comment 415) Some comments ask pathogens. whether an environmental pathogen is a
us to specify that the hazard evaluation (Comment 418) Some comments note hazard requiring a preventive control in
be more specific about issues relevant to our previous discussion about particular circumstances—i.e.,
raw materials and ingredients, including conducting a hazard evaluation for whenever an RTE food is exposed to the
how raw materials are selected and pathogens, including addressing environment prior to packaging and the
shipped, how suppliers are evaluated, whether a specific product has been packaged food does not receive a
and how shipments are inspected on documented to be contaminated with treatment or otherwise include a control
receipt. such pathogens (78 FR 3646 at 3737). measure (such as a formulation lethal to
(Response 415) We decline this These comments ask us to clarify what the pathogen) that would significantly
request. When a hazard requiring a we mean by ‘‘documented,’’ particularly minimize the pathogen. The written
preventive control in a raw material or in the context of a single incident. hazard analysis must be prepared (or its
other ingredient is controlled before (Response 418) We expect a facility to preparation overseen by) a preventive
receipt, the receiving facility would take appropriate steps to remain aware controls qualified individual (see
address such specifics in the supply- of current reports of food § 117.126(a)(2) and (b)(1)). The
chain program that would be required as contamination. For example, such preventive controls qualified individual
a preventive control (see subpart G). In reports are often disseminated through for a facility that determines that an
addition, the rule already specifies that press releases that we post on our Web environmental pathogen is not a hazard
the hazard evaluation must consider the site when firms send them to us, and a requiring a preventive control in such
effect of raw materials and other facility can subscribe to our service that circumstances must document that
ingredients on the finished food alerts interested persons to recalls, determination, and a regulator would
(§ 117.130(c)(2)(iii)). market withdrawals, and other safety consider the adequacy of the facility’s
(Comment 416) Some comments ask alerts (Ref. 69). In appropriately documented determination before
us to specify that a hazard evaluation determining whether a pathogen is a reaching a conclusion as to whether the
consider the history of the class of hazard requiring a preventive control, facility had failed to satisfy the
product causing outbreaks from a the facility would consider factors such requirements. However, the use of a
particular pathogen. as the severity of the hazard and the hand sink or boot dip prior to entering
(Response 416) We decline this probability that the hazard would occur the processing area to reduce the
request. The rule already specifies that in the absence of preventive controls. likelihood of environmental pathogens
the hazard analysis must be based on Whether a single incident warrants may also be considered to be part of the
experience, illness data, scientific consideration of a pathogen as a hazard sanitation controls for the
reports, and other information (see requiring a preventive control may environmental pathogen.
§ 117.130(a)). depend on the incident. (Comment 421) Some comments
(Comment 417) Some comments (Comment 419) Some comments ask assert that the hazard assessment must
assert that a facility that exports fresh us to specify that the hazard analysis document that the benefits of using a
fruit to the United States should not be consider the impact of a pathogen on particular chemical outweigh the
required to consider storage and high-risk populations. potential risks, such as the risks of the
distribution of the food because storage (Response 419) We decline this chemical causing antibiotic resistance.
and distribution are parts of the supply request. The rule requires that a hazard Other comments ask us to consider the
chain that are not known or controlled evaluation consider the severity of the factors listed in the provision for
by the supplier. These comments also illness or injury if the hazard were to potential benefits, as well as risks.
assert that records showing where the occur. This evaluation would consider (Response 421) A hazard is an agent
facility sent the food should suffice the expected population of consumers that is reasonably likely to cause illness
when a facility exports fresh fruit to the and the severity of consequences when or injury in the absence of its control
United States. Likewise, some the expected population is exposed to a (§ 117.3). As previously discussed, the
comments assert that a facility that pathogen that is a known or reasonably focus of the requirement on risk (i.e., the
exports fresh fruit to the United States foreseeable hazard in the food. severity of the hazard and the likelihood
should not be required to consider (Comment 420) Some comments that it will occur) is consistent with the
intended or foreseeable use because the assert that the proposed requirements NACMCF HACCP guidelines, the Codex
facility could not necessarily ascertain for hazard evaluation could be HACCP Annex, and Federal HACCP
the intended or foreseeable use. interpreted in many ways. For example, regulations for seafood, juice, and meat
(Response 417) Each facility is part of a facility could conclude that the and poultry (78 FR 3646 at 3735). None
a complex food supply chain and a presence of a hand sink or boot dip of these national or international
supplier must consider how its food prior to entering the processing area will guidelines or regulations suggest that a
products are likely to be stored, reduce the likelihood of environmental risk-benefit analysis is part of a hazard
distributed, and used. For example, pathogens and that environmental analysis.
entities that transport a food product pathogens are not a significant hazard, Moreover, these comments appear to
generally rely on the shipper (in this whereas a regulator could interpret this be directed to a determination by a
case, the facility exporting the fruit) to provision to mean that a facility must facility of which raw materials or other
provide information relevant to the safe always consider an environmental ingredients to intentionally add to a
handling of the food during transport. pathogen to be a significant hazard food product rather than to biological,
As another example, a facility exporting when the criteria in the provision are chemical, or physical hazards that, for
fruit could simply assume that its food met, unless the facility can provide example, occur naturally in the raw
product will be consumed without any evidence to the contrary. materials or other ingredients or may be
processing to reduce any pathogens that (Response 420) We agree that the unintentionally introduced. Any raw
may be on the fruit, unless it knows that requirements for hazard evaluation are material or other ingredient that a
its food product is destined for a subject to alternative interpretations. facility adds to a food product must be
commercial processing facility that This is often the case, particularly when lawful. This rule does not address the
criteria for determining whether a (Response 423) We address specifics hazards will be significantly minimized
particular raw material or other about the responsibilities of shipping or prevented and the food
ingredient is lawful under the facilities and receiving facilities in the manufactured, processed, packed, or
applicable statutory provisions (e.g., 2014 proposed sanitary transportation held by the facility will not be
under section 409 of the FD&C Act rule (79 FR 7006). We will address adulterated under section 402 of the
regarding food additives). comments regarding the responsibilities FD&C Act or misbranded under section
(Comment 422) Some comments of shippers and receivers in the final 403(w) of the FD&C Act. Some
object to the use of sucrose fatty acid sanitary transportation rule. For the comments support the proposed
esters as an example (in our previous purpose of the hazard analysis, whether requirements without change. For
discussion, 78 FR 3646 at 3737) for a particular facility would identify food
example, some comments agree that
distinguishing between raw materials transportation as a critical control point
and ingredients because sucrose fatty preventive controls must be written and
through its hazard analysis would
acid esters are an obscure product and depend on the circumstances, such as include process controls, food allergen
the example does not clearly distinguish whether the food is a TCS food. We controls, sanitation controls, a recall
between the two terms. expect a facility that identifies plan, and other controls as appropriate
(Response 422) As discussed in temperature control, including during and necessary. Some comments that
Response 65, we have decided to return transportation, as a preventive control support the proposed provisions suggest
to the phrase ‘‘raw materials and other (whether or not as a CCP), to alternative or additional regulatory text
ingredients’’ (rather than the proposed communicate the need for appropriate (see, e.g., Comment 428, Comment 431,
phrase ‘‘raw materials and ingredients’’) temperature control to the person Comment 432, and Comment 439) or ask
throughout the rule to make it clear that transporting the food. us to clarify how we will interpret the
raw materials are ingredients. As a (Comment 424) Some comments ask provision (see, e.g., Comment 425,
result, it is not necessary to provide a us to clarify our previous statements (78 Comment 437, and Comment 440).
more broadly applicable example to FR 3646 at 3737) regarding whether and In the following sections, we discuss
distinguish between the terms. how label information, such as cooking
(Comment 423) Some comments ask comments that ask us to clarify the
instructions, may be a factor to consider
us to clarify how the requirements of proposed requirements or that disagree
in a hazard evaluation.
this rule apply to transportation (Response 424) See Response 390 with, or suggest one or more changes to,
practices and assert that a facility regarding consumer research about the proposed requirements. After
receiving product should not be consumer cooking practices. considering these comments, we have
responsible for hazards in foods that are revised the proposed requirements as
not being transported under its custody. XXVI. Subpart C: Comments on shown in table 31, with editorial and
Other comments assert that we should Proposed § 117.135—Preventive conforming changes as shown in table
require all entities across the supply Controls 52.
chain to identify food transportation as We proposed requirements to identify
a critical control point under the and implement preventive controls to
facility’s hazard analysis. provide assurances that significant
TABLE 31—REVISIONS TO THE PROPOSED REQUIREMENTS FOR PREVENTIVE CONTROLS

117.135(c)(1) ........................ Process controls ................. Clarify that the requirements for process controls depend on the role of the process
control in the food safety system.
117.135(c)(2)(i) .................... Food allergen controls ....... Specify that food be protected from allergen cross-contact during handling, as well
as during storage.
A. Proposed § 117.135(a)—Requirement implement preventive controls that are (facilities) to subject almonds to a
To Identify and Implement Preventive appropriate to the facility and the food. process that delivers a minimum 4-log
Controls Other comments support the destruction of Salmonella. The process
We proposed that you must identify clarification, in the 2014 supplemental can be applied by the almond handler
and implement preventive controls, human preventive controls rule, that not (facility) or off-site at a ‘‘custom
including at critical control points, if all preventive controls are established at processor.’’ These comments agree that
any, to provide assurances that CCPs and that some food safety plans preventive controls should be written,
significant hazards will be significantly will have not CCPs. We are finalizing but ask us to clarify whether
minimized or prevented and the food the provision as proposed with the documentation of treatment by its
manufactured, processed, packed, or editorial and conforming changes in ‘‘custom processor’’ would be accepted
held by your facility will not be table 52. as a ‘‘written preventive control’’ when
adulterated under section 402 of the the ‘‘custom processor’’ controls the
B. Proposed § 117.135(b)—Requirement
FD&C Act or misbranded under section hazard.
for Written Preventive Controls
403(w) of the FD&C Act. We also (Response 425) The question posed by
proposed that these preventive controls We proposed that preventive controls these comments highlights the
include controls at CCPs, if there are must be written. difference between the records required
any CCPs, and controls, other than those (Comment 425) Some comments from in the food safety plan and the records
at CCPs, that are also appropriate for the almond industry explain that documenting the implementation of the
food safety. USDA’s regulations for a mandatory food safety plan. The ‘‘written
Some comments support the program for reduction of Salmonella on preventive controls’’ are part of the food
flexibility provided to facilities to almonds require almond handlers safety plan, whereas the records
documenting treatment are make a point that water activity may not (Comment 429) Some comments
implementation records. be necessary for food safety even when assert that food allergen controls should
Implementation records documenting maximum or minimum values are be based on hazard analysis and risk.
treatment, whether by a facility or its assigned. In this example, a parameter Other comments provide examples of
‘‘custom processor,’’ would not satisfy for water activity could be set at less existing industry guidance that
the requirements for written preventive than 0.85 based on the control of addresses food allergen controls. Some
controls. However, specifying that the Staphylococcus aureus, but such a comments note that food allergen
preventive control for a specific hazard parameter would not be necessary for controls are addressed in the PMO (e.g.,
is a particular treatment by a ‘‘custom food safety for a product such as a dry Appendix K, the voluntary HACCP
processor,’’ along with information that seasoning blend that has a water activity program).
describes the treatment, would satisfy of 0.2–0.3. This comment also notes that Other comments assert that
the requirement for written preventive when there are many different controls establishing food allergen controls at
controls. working together to minimize or prevent this time is premature or that food
one hazard simultaneously (such as a allergen controls need to be balanced
C. Proposed § 117.135(c)(1)—Process with pathogen controls. Some
formulation that uses a combination of
Controls comments ask us to clarify whether the
moisture, pH, titratable acidity, and salt
We proposed that preventive controls level), noncompliance with any one standard that would be established for
include process controls as appropriate parameter will not necessarily result in food allergen controls is ‘‘absolutely
to the facility and the food. Process an unsafe product. allergen free.’’
controls include procedures, practices, (Response 426) See Response 455. We (Response 429) We have
and processes to ensure the control of have revised the regulatory text to acknowledged that it is premature to
parameters during operations such as specify that process controls must require validation of food allergen
heat processing, acidifying, irradiating, include parameters and minimum or controls (see 78 FR 3646 at 3755 and
and refrigerating foods. Process controls maximum values as appropriate to both Response 515). However, we disagree
must include, as appropriate to the the nature of the applicable control and that requiring a facility to establish food
applicable control, parameters its role in the facility’s food safety allergen controls as a preventive control
associated with the control of the system. is premature at this time, as evidenced
hazard, and the maximum or minimum (Comment 427) Some comments ask by the existing industry guidance, and
value, or combination of values, to us to delete the phrase ‘‘to significantly requirements of programs such as
which any biological, chemical, or minimize or prevent a significant Appendix K of the PMO, submitted by
physical parameter must be controlled hazard.’’ comments. We agree that whether a
to significantly minimize or prevent a (Response 427) We decline this facility appropriately determines that
significant hazard. request. ‘‘Significantly minimize or food allergen controls are necessary will
(Comment 426) Some comments state prevent a significant hazard’’ (which we be based on the outcome of the hazard
that assigning a parameter and have revised to ‘‘significantly minimize analysis (see the requirements for
associated minimum and maximum or prevent a hazard requiring a hazard analysis in § 117.130(a) and (c)).
values for some process controls (such preventive control’’) is the standard for A facility that already has established
as refrigeration (including freezing), controlling the hazards. Although the food allergen controls based on
baking, or water activity) may be phrase could be viewed as redundant recommendations in industry guidelines
possible, but not be necessary for food with the standard in the requirement to or requirements of programs such as the
safety. These comments ask us to identify and implement preventive voluntary HACCP program of the PMO
require minimum and maximum values controls (§ 117.135(a)(1)), repeating that can incorporate those established food
to be assessed against the applicable standard in the requirements for allergen controls into its own, facility-
food safety need, or otherwise make parameters and the minimum or specific food safety plan, and rely on its
clear that the implications of not maximum values associated with existing records for those food allergen
controlling minimum and maximum control of the hazard emphasizes the controls to demonstrate compliance
values must be assessed in light of the standard, which is appropriate for with the requirements of this rule (see
circumstances. Other comments express process controls. § 117.330). Whether a facility needs to
concern that ‘‘as appropriate to the establish food allergen controls in
applicable control’’ could be interpreted D. Proposed § 117.135(c)(2)—Food addition to pathogen controls depends
as suggesting that if it is merely feasible Allergen Controls on the outcome of the facility’s hazard
to establish parameters for a process We proposed that preventive controls analysis; a facility that determines that
control, they must be established. Other include, as appropriate to the facility both allergens and pathogens are
comments express concern that the and the food, food allergen controls that hazards requiring a preventive control
proposed requirement suggests that if a include those procedures, practices, and in the manufacturing, processing,
parameter is not ‘‘controlled,’’ a processes employed for ensuring packing, or holding of a food product
regulator could conclude that the protection of food from allergen cross- must address both hazards.
facility is not in compliance with the contact, including during storage and The requirements for food allergen
rule because it necessarily has not use, and for labeling the finished food, controls do not establish a particular
significantly minimized or prevented a including ensuring that the finished standard. In general, when we do
significant hazard. food is not misbranded under section establish a standard we avoid
One comment provides two examples 403(w) of the FD&C Act. ‘‘absolute’’ standards such as the
of refrigeration controls to explain its (Comment 428) Some comments ask
‘‘absolutely allergen free’’ standard

view that the management components us to specify that food be protected from mentioned by the comment.
for refrigeration controls will vary allergen cross-contact during handling, We appreciate receiving examples of
depending on the role of refrigeration as well as during storage. food allergen control guides.
within the facility’s overall food safety (Response 428) We have revised the (Comment 430) Some comments ask
system. (See Comment 455.) This provision as requested by the us to revise the proposed requirement
comment also provides an example to comments. from ‘‘food allergen controls must
include’’ to ‘‘food allergen controls procedures, practices, and processes allergens inadvertently incorporated
include.’’ employed for labeling the finished food into manufactured foods, due to the
(Response 430) In the 2014 include those for ensuring that the number of reports concerning
supplemental human preventive finished food is not misbranded under consumers who have experienced
controls notice, we proposed a series of section 403(w) of the FD&C Act. adverse reactions following exposure to
revisions to the overall framework of the Requiring that labeling procedures, an allergenic substance in a food. We
requirements for hazard analysis and practices, and processes ensure that also described our previous actions
risk-based preventive controls, major food allergens are properly targeting food manufacturers, including:
including revisions to the requirements disclosed would be redundant with the (1) A notice to manufacturers entitled
for preventive controls to emphasize proposed requirement that they ensure ‘‘Label Declaration of Allergenic
that the preventive controls that a that the finished food is not misbranded Substances in Foods’’ in 1996 (Ref. 72);
facility must establish and implement under section 403(w). (2) an FDA/state partnership to increase
are those appropriate to the facility and (Comment 432) Some comments ask industry’s understanding of food
the food (79 FR 58524 at 58541–58543). us to revise the requirement that food allergens and to identify effective
With respect to food allergen controls, allergen controls must include labeling manufacturing controls (Ref. 73); and (3)
we proposed to first specify what food controls by adding the phrase ‘‘as a statement of policy, to our staff,
allergen controls ‘‘include’’ (i.e., appropriate’’ because section regarding food allergens (Ref. 74).
procedures, practices, and processes to 201(qq)(2)(A) of the FD&C Act excludes In 2012, we requested comments
control food allergens), as requested by highly refined oils from the definition of relevant to conducting a risk assessment
these comments. However, we also ‘‘major food allergen.’’ to establish regulatory thresholds for
proposed to continue to specify (Response 432) We decline this major food allergens as defined in
minimum requirements for what food request because qualifying that the FALCPA (77 FR 74485, December 14,
allergen controls must include when a requirement applies ‘‘as appropriate’’ is 2012). We noted that regulatory
facility determines that a food allergen not necessary to achieve the outcome thresholds would help industry to
is a hazard requiring a preventive requested by the rule comments. If a conduct allergen hazard analyses and
control—i.e., those procedures, food ingredient, such as a highly refined develop standards for evaluating the
practices, and processes employed for oil, is not a major food allergen, it is not effectiveness of allergen preventive
ensuring protection of food from subject to the requirements for food controls.
allergen cross-contact and for labeling allergen controls. However, establishing regulatory
the finished food. (Comment 433) Some comments policy or requirements, such as a long-
To the extent that these comments are assert that quantification or term strategy regarding use of allergen
asking us to clarify the distinction measurement of specific parameters is advisory labeling, or a specific threshold
between a description of what not appropriate for some food allergen for a food allergen or a ‘‘zero-tolerance’’
constitutes a food allergen control and controls. policy, is outside the scope of this rule.
the minimum requirements for what (Response 433) We agree with these The provisions of this rule, whether the
food allergen controls must include comments. In the 2014 supplemental CGMPs in subpart B or the requirements
when a facility determines that a food human preventive controls notice, we for hazard analysis and risk-based
allergen is a hazard requiring a clarified that the requirements for preventive controls in subparts C and G,
preventive control, the regulatory text parameters and maximum and are directed to procedures, practices,
we proposed in the 2014 supplemental minimum values apply to process and processes for the safe
human preventive controls notice controls. manufacturing, processing, packing, and
modified the regulatory text as (Comment 434) Some comments ask holding of food rather than to special
requested. However, to the extent that us to establish thresholds for food labeling policies or specific levels of
these comments are asking us to modify allergens. Other comments assert that substances (such as food allergens) that
the provision so that it no longer we should not have a ‘‘zero-tolerance’’ would render food adulterated or
establishes the minimum requirements approach to food allergens. Some misbranded.
for what food allergen controls must comments ask us to require advisory (Comment 435) Some comments
include when a facility determines that labeling (such as a label statement that assert that food allergen controls need
a food allergen is a hazard requiring a a food that does not contain an allergen not be required in specific situations,
preventive control, we disagree. The ingredient was processed in a facility such as during the storage and transport
listed minimum requirements are that also processes foods that do have of coffee and the storage of packaged
consistent with long-standing specific allergen ingredients) if we do foods not exposed to the environment.
approaches to the control of food not establish a ‘‘zero-tolerance’’ policy (Response 435) Whether food allergen
allergens and provide flexibility for a for food allergen controls. Other controls are necessary in any particular
facility to identify and implement those comments assert we should allow circumstance depends on the outcome
procedures, practices, and processes advisory labeling in light of difficulties of the facility’s hazard analysis.
most suited to the control of food in developing food allergen controls. Although coffee is not a food allergen,
allergen hazards in light of the facility (Response 434) In 2008, we whether coffee requires food allergen
and its food products (Ref. 70) (Ref. 71); announced a public hearing on the use controls during storage and transport
see also the discussion at 78 FR 3646 at of advisory labeling of allergens in foods depends on factors such as how the
3741. as part of a long-term strategy to help coffee is stored and transported and
(Comment 431) Some comments ask manufacturers use allergen advisory whether there is potential for allergen
us to revise the requirement that food labeling that is truthful and not cross-contact. Although we agree that
allergen controls must include labeling misleading, conveys a clear and uniform the potential for allergen cross-contact
controls by adding the phrase ‘‘to ensure message, and adequately informs food- during the storage of packaged foods not
that major food allergens are properly allergic consumers and their caregivers exposed to the environment is low, it is
disclosed.’’ (73 FR 46302, October 8, 2008). In that the responsibility of the preventive
(Response 431) We decline this document, we explained our concerns controls qualified individual who
request. The provision requires that the with food allergens, including food conducts or oversees the hazard analysis
to make an appropriate determination to hold corn intended for human E. Proposed § 117.135(c)(3)—Sanitation
for an individual facility. consumption. The corn used for Controls
(Comment 436) Some comments scouring would be handled We proposed that preventive controls
assert that implementation of food appropriately—e.g., by diverting to use include, as appropriate to the facility
allergen controls poses particular in animal food, because food allergens and the food, sanitation controls that
challenges in the context of milling are not hazards requiring a preventive include procedures, practices, and
operations. As an example, these control in food for animals. Doing so processes to ensure that the facility is
comments explain that most milling would reduce the potential for residual maintained in a sanitary condition
operations do not handle soy. However, soybeans to be present in the next lot of adequate to significantly minimize or
allergen cross-contact between grains corn, sold for human consumption. prevent hazards such as environmental
and soy can occur at various points in
(Comment 437) Some comments ask pathogens, biological hazards due to
the chain of production and transport,
us to clarify when a facility would be employee handling, and food allergen
such that grains arriving at a milling
facility might already contain low levels expected to establish food allergen hazards. We also proposed that
of soy. These comments also assert that controls rather than rely on the CGMP sanitation controls must include
the presence in a desired grain of low requirements (in subpart B) to prevent procedures, practices, and processes for
levels of soy or of other grains is allergen cross-contact, particularly for the cleanliness of food-contact surfaces,
consistent with U.S. Grain Standards. oilseed processors who only need to including food-contact surfaces of
For example, the Grain Inspection, address soy allergens. utensils and equipment, and procedures
Packers and Stockyards Administration for the prevention of allergen cross-
(Response 437) Food allergen controls contact and cross-contamination from
(GIPSA) definition of corn allows for the are applicable to facilities that handle
presence of between 2 percent and 7 insanitary objects and from personnel to
any of the foods that are food allergens. food, food packaging material, and other
percent foreign material, depending on Any facility that handles a single food
the grade of corn, and the presence of food-contact surfaces and from raw
allergen, such as a processor only product to processed product.
up to 10 percent of other grains for handling soybeans to make soybean oil,
which standards have been set. (Comment 439) Some comments ask
may simply need to ensure that the us to use the term ‘‘primary packaging
Although millers use equipment that products it ships into commerce are
helps to separate the desired grain from material’’ rather than ‘‘food packaging
labeled with the food allergen. (If the material.’’
soy or other grains, these comments
oils are highly refined and do not (Response 439) We decline this
assert that complete elimination of soy
contain soy proteins, the facility may request. See Response 166, in which we
and other grains is not practicable even
under CGMP. These comments ask us to need to prevent cross-contact with less discuss what we mean by ‘‘food
acknowledge that complete elimination highly refined oils that may contain soy packaging material’’ (e.g., we do not
of allergen cross-contact is not feasible proteins.) If the facility only produces intend the term ‘‘food-packaging
in certain operations even under CGMP foods that contain the single food materials’’ to include shipping
and that the intermittent presence of allergen, there would not be any foods containers such as cartons and crates
undeclared allergens is possible in for which cross-contact could occur. For that pose no risk of introducing
certain foods, notwithstanding the facilities that handle more than one contaminants or food allergens into
observance of CGMP. allergen-containing food or both foods food).
(Response 436) We acknowledge that that contain a specific food allergen (Comment 440) Some comments ask
GIPSA standards may allow for the along with foods that do not contain us to clarify whether the requirements
presence of foreign material, and that that food allergen (such as a facility that for sanitation controls apply to all food
foreign material could be a food allergen roasts almonds, macadamia nuts, and facilities or only to those that make RTE
such as soy. However, such standards cashews), the facility could establish products.
are not determinative as to whether preventive controls to ensure that (Response 440) The requirements for
hazards requiring a preventive control common equipment is cleaned between sanitation controls apply to all food
will be significantly minimized or each type of nut. The facility could use facilities, not just those that make RTE
prevented and the food manufactured, CGMPs to ensure that the different nuts products. The facility must determine
processed, packed, or held by a facility are stored separately before and after through its hazard analysis when
will not be adulterated under section roasting to prevent cross-contact. sanitation controls are necessary to
402 of the FD&C Act or misbranded address a hazard requiring a preventive
under section 403(w) of the FD&C Act. control. It is reasonable to assume that
us to confirm that FSMA does not
Thus, as the comments point out, grains sanitation controls will be more
change prior agency guidance on the
that arrive at a facility for milling may common in facilities that make RTE
reasonable steps that should be taken to
contain levels of a food allergen that a products than in facilities that make
prevent allergens from being
milling operation would not be able to non-RTE products.
unintentionally incorporated into the (Comment 441) Some comments
eliminate. In circumstances such as
food and the limited use of allergen assert that sanitation controls are not
these, supply-chain controls directed to
advisory statements where the risk of necessary to prevent any hazards in
the supplier’s cleaning procedures, in
allergen cross-contact cannot be distribution facilities where food-
addition to separation techniques
eliminated through CGMPs. contact surfaces are not present. Other
applied at milling, may be necessary to
enable the milling operation to satisfy (Response 438) Prior agency guidance comments assert that sanitation controls
its responsibilities under this rule. For on the reasonable steps that should be should be required in all cases (rather
example, a supplier that uses storage taken to prevent allergens from being than ‘‘as appropriate’’) given their
bins to hold soybeans at some times and unintentionally incorporated into the central importance.
corn at other times could agree to food and the limited use of allergen (Response 441) Under the framework
additional ‘‘cleaning’’ of bins previously advisory statements is still applicable. established by FSMA—and
used to store soybeans by ‘‘scouring’’ (See also the discussion in Response implemented in this rule—each facility
the bin with corn before using the bin 434.) determines through its hazard analysis
when sanitation controls are necessary would be required by proposed refrigeration for food quality rather than
to control a hazard requiring a § 117.137. See the discussion of for food safety.
preventive control. The rule neither comments on the recall plan (final (Response 443) Additional
establishes circumstances (such as in § 117.139) in section XXVIII. information about foods that do not
distribution centers) where sanitation require refrigeration for food safety is
H. Proposed § 117.135(c)(6)—Other
controls are not necessary nor pre- available in the Food Code (Ref. 51)
Controls
judges whether sanitation controls are (see, e.g., the definition of TCS food and
necessary in specific circumstances. We proposed that preventive controls the examples of foods that are not TCS
Although we do not expect that include any other procedures, practices, foods in section 1–2 of the Food Code).
facilities such as distribution centers and processes necessary to satisfy the
requirements of § 117.135(a). Examples XXVII. Subpart C: Circumstances in
would determine through their hazard
of other controls include hygiene Which the Owner, Operator, or Agent
analysis that sanitation controls are
training and other current good in Charge of a Manufacturing/
required, we do expect all food
manufacturing practices. Processing Facility Is Not Required To
establishments that are subject to the
(Comment 442) Some comments ask Implement a Preventive Control (Final
CGMP requirements established in
us to specify that preventive controls §§ 117.136 and 117.137)
subpart B to fully comply with
applicable requirements for sanitation. include controls on raw materials and In the 2014 supplemental human
other ingredients. preventive controls notice, we provided
F. Proposed § 117.135(c)(4)—Supply- (Response 442) The final rule an opportunity for public comment on
Chain Controls specifies that preventive controls potential requirements for a supplier
We proposed that supplier controls include supply-chain controls as program as a preventive control,
include the supplier program. See the appropriate to the facility and the food. including comments on when a supplier
discussion of comments on the supplier The request of these comments is program would not be required. As
program, now in subpart G, in sections addressed by the requirements for the discussed in more detail in section XLII,
XLII through XLIX. As discussed in supply-chain program (see we have revised the phrase ‘‘supplier
more detail in section XLII, we have § 117.135(c)(4) and subpart G). program’’ to ‘‘supply-chain program’’
revised the phrase ‘‘supplier program’’ (Comment 443) Some comments refer throughout the regulatory text. As
to ‘‘supply-chain program’’ throughout to our discussion that an example of an summarized in table 32 and discussed
the regulatory text. As a companion ‘‘other’’ preventive control could more fully in the following paragraphs,
change, we have revised § 117.135(c)(4) include temperature control for a TCS after considering comments on when a
to refer to ‘‘supply-chain controls’’ refrigerated food, and our discussion supplier program would not be
rather than ‘‘supplier controls.’’ that although many refrigerated foods required, we are establishing two new
only require refrigeration for food provisions. Although both provisions
G. Proposed § 117.135(c)(5)—Recall quality, some refrigerated foods do have an effect on the required supply-
Plan require refrigeration for food safety (78 chain program, they would be
We proposed that preventive controls FR 3646 at 3744). These comments ask implemented outside the framework of
include, as appropriate, a recall plan as us to be clearer about foods that require a supply-chain program.
TABLE 32—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF
A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL
Final section Proposed section Description Revision

designation designation
117.136(a)(1) .... N/A .................................. A manufacturer/processor is not required to implement a pre- N/A.
ventive control if it determines and documents that the type
of food (e.g., RACs such as cocoa beans, coffee beans, and
grains) could not be consumed without application of an ap-
propriate control.
117.136(a)(2) .... 117.136(a)(1)(ii)(C) ......... A manufacturer/processor is not required to implement a pre- Includes a requirement for doc-
ventive control if it relies on its customer who is subject to umentation that the food is
the requirements for hazard analysis and risk-based preven- ‘‘not processed to control
tive controls in subpart C to ensure that the identified hazard [identified hazard].’’
will be significantly minimized or prevented and both (1) dis-
closes in documents accompanying the food that the food is
‘‘not processed to control [identified hazard]’’ and (2) annu-
ally obtains from its customer written assurance that the cus-
tomer has established and is following procedures that will
significantly minimize or prevent the identified hazard.
ventive control if it relies on its customer who is not subject
to the requirements for hazard analysis and risk-based pre-
ventive controls in subpart C to provide assurance it is man-
ufacturing, processing, or preparing the food in accordance
with applicable food safety requirements and it: (1) Discloses

in documents accompanying the food, in accordance with the
practice of the trade, that the food is ‘‘not processed to con-
trol [identified hazard]’’; and (2) annually obtains from its cus-
tomer written assurance that it is manufacturing, processing,
or preparing the food in accordance with applicable food
safety requirements.
TABLE 32—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF
A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL—Continued

117.136(a)(4) .... 117.136(a)(1)(ii)(C) ......... A manufacturer/processor is not required to implement a pre- • Addresses the circumstance
ventive control if it relies on its customer to ensure that the where an entity (other than
food will be processed to control the identified hazard by an the facility’s customer) in the
entity in the distribution chain subsequent to the customer distribution chain controls the
and both: (1) Discloses in documents accompanying the food hazard.
that the food is ‘‘not processed to control [identified hazard]’’ • Includes a requirement for
and (2) annually obtains from its customer written assurance documentation that the food
that the customer will both disclose the information that the is ‘‘not processed to control
food is ‘‘not processed to control [identified hazard]’’ and will [identified hazard].’’
only sell to another entity that agrees, in writing, it will follow
procedures that will significantly minimize or prevent the
identified hazard (if the entity is subject to the requirements
for hazard analysis and risk-based preventive controls in
subpart C) or manufacture, process, or prepare the food in
accordance with applicable food safety requirements (if the
entity is not subject to the requirements for hazard analysis
and risk-based preventive controls in subpart C), or obtain a
similar written assurance from the entity’s customer.
ventive control if it has established, documented, and imple-
mented a system that ensures control, at a subsequent dis-
tribution step, of the hazards in the food product it distributes
and documents the implementation of that system.
117.136(b) ......... 117.136(g)(3) .................. Records documenting the applicable circumstances in Includes a requirement for doc-
§ 117.136(a). umentation of the additional
circumstances in which a
manufacturer/processor is
not required to implement a
preventive control.
117.137 ............. N/A .................................. A facility that provides a written assurance under N/A.
§ 117.136(a)(2), (3), or (4) must act consistently with the as-
surance and document its actions taken to satisfy the written
assurance.
The first provision allows a would not have been required to have customer that the food is ‘‘not processed
manufacturer/processor to not a supplier program if it relied on its to control [identified hazard]’’; (2)
implement a preventive control if the customer to control the hazard and written assurance from customers
manufacturer/processor determines and annually obtained from its customer regarding appropriate procedures to
documents that the type of food (e.g., written assurance that the customer has ensure that the food will receive further
RACs such as cocoa beans, coffee beans, established and is following procedures processing to control the identified
and grains) could not be consumed (identified in the written assurance) that hazards; and (3) provisions relating to
without application of the appropriate will significantly minimize or prevent accountability for written assurances.
control (see § 117.136(a)(1)). We the hazard. As discussed in Response (In these provisions, ‘‘customer’’ means
describe comments leading to this 445, we are replacing this provision a commercial customer, not a
provision, and our response to those with several provisions that apply when consumer.)
comments, in Comment 444 and a manufacturer/processor identifies a (Comment 444) Some comments
Response 444, respectively. Although hazard requiring a preventive control express concern about the ability for
we are establishing these provisions (‘‘identified hazard’’), does not control distributors/cooperatives to identify the
outside the framework of the supply- the identified hazard, but can individual farms that harvested the
chain program, these provisions demonstrate and document that the produce when such farms are more than
continue to play a role in the identified hazard will be controlled by one step back in the food chain from the
requirements for a supply-chain an entity in its distribution chain. A distributor/cooperative. Some
program, because they also provide an manufacturer/processor that satisfies the comments assert that receiving facilities
exception to the requirements for a criteria in these provisions will not be should not be required to verify
manufacturer/processor to establish and required to implement a preventive suppliers with which they do not have
implement a supply-chain program. control for the identified hazard. Under a direct commercial relationship. These
The second provision relates to these provisions, the combination of comments note that, in the case of the
comments we received on a proposed three requirements will provide cocoa bean supply chain, the processing
exception to the requirement for a adequate assurance that the food will be facility likely has no direct relationship
manufacturer/processor to establish and processed to control the identified with the thousands of farms involved in
implement a supplier program hazard before it reaches consumers. the growing and harvesting of the beans.
(proposed § 117.136(a)(1)(ii)(C)). (See These requirements are: (1) Some comments ask for an exemption
Comment 445.) Under proposed Documentation provided by the from supplier verification activities for
§ 117.136(a)(1)(ii)(C), a receiving facility manufacturer/processor to its direct foods such as cocoa beans because,
although cocoa processors do not recordkeeping requirements of subpart determine whether annual updates of
currently rely on farms to control F. written assurance are necessary. Other
hazards, and would therefore not need See also Comment 657, in which we comments ask us to specify that a
to verify farms, it is problematic to have discuss comments asking us to add receiving facility need not establish and
a requirement that potentially could flexibility to the requirements for a implement a supplier program for raw
necessitate traceback to farms. supply-chain program such that any materials and ingredients that are RACs
(Response 444) We are establishing a entity other than the receiving facility intended for further processing.
provision, applicable to both the supply can perform supplier verification Some comments assert that the
chain and the distribution chain of a activities. As discussed in Response presence of low levels of pathogens on
manufacturer/processor, for a 657, the rule provides additional a raw product that will be subject to a
circumstance when a manufacturer/ flexibility in the supply-chain program lethal process further downstream does
processor does not need to implement a with regard to who can perform certain not pose a risk to the consumer, and
preventive control. The specific food activities (see § 117.415). should not be considered a significant
product identified by some of the (Comment 445) Some comments ask hazard (i.e., a hazard requiring a
comments (i.e., cocoa beans) is part of us to delete the criterion for control of preventive control). These comments
a class of food products (principally the hazard by the receiving facility’s also assert that if we maintain that
RACs) that could simply not be eaten customer, with annual written Salmonella contamination is a
without processing that would control assurance that the customer had significant hazard for each member of
the hazards requiring a preventive established and was following the supply chain, then we should allow
control. Other RACs in this class of food procedures (identified in the written the preventive control to be applied in
products are coffee beans, grains, and assurance) that would significantly a subsequent step at another facility.
some RACs that are rarely consumed minimize or prevent the hazard. The Other comments ask us to clarify that a
raw. Therefore, we are providing that a stated reasons varied. For example, facility would not need to develop
manufacturer/processor does not need some comments state that a receiving preventive controls where it produces
facility may have so many customers raw materials or ingredients that are
to implement a preventive control if it
that it is not possible to obtain written subject to subsequent processing that
determines and documents that the type
assurance annually from all customers. will address known or reasonably
of food (e.g., RACs such as cocoa beans,
Other comments express concern that a foreseeable hazards.
coffee beans, and grains) could not be
customer may be unwilling to describe (Response 445) We are establishing
consumed without application of the
confidential trade secrets in order to several provisions, specifically
appropriate control (see § 117.136(a)(1)).
identify in writing the procedures the applicable to the distribution chain of a
The regulatory text does not specify
customer has established and is manufacturer/processor, for
RACs ‘‘rarely consumed raw’’ because
following to control the hazard. Other circumstances when a manufacturer/
‘‘rarely consumed raw’’ is not the same
comments express concern about ‘‘legal processor does not need to implement a
as ‘‘could not be consumed without issues’’ when a receiving facility needs preventive control (§§ 117.136(a)(2),
application of the appropriate control.’’ to assess the adequacy of the customers’ (a)(3), (a)(4) and (a)(5), (b)(2), (b)(3),
However, depending on the facility, the procedures for controlling a hazard (b)(4), and (b)(5), 117.137, and 117.335).
RAC, and the food produced by the because under current business See Response 444 for another new
manufacturer/processor, there may be practices a vendor can provide provision that applies to the supply
some circumstances where a assurance to a buyer (its customer), but chain in addition to the distribution
manufacturer/processor could buyers do not typically provide such chain (§ 117.136(a)(1)).
determine that a particular RAC that assurance to vendors. Some comments Under the first of these provisions
passes through its facility satisfies the express concern that written assurance (§ 117.136(a)(2)), a manufacturer/
criterion ‘‘could not be consumed does not guarantee that the customer is processor is not required to implement
without application of the appropriate actually doing anything to significantly a preventive control if it relies on its
control.’’ minimize or prevent the hazard. customer (who is subject to the
In other cases, a facility that conducts Some comments ask us to provide an requirements for hazard analysis and
a manufacturing/processing activity on alternative that would allow the risk-based preventive controls in
produce rarely consumed raw may receiving facility to provide subpart C) to ensure that the identified
satisfy the criteria in other new documentation to its customer about a hazard will be significantly minimized
provisions (§ 117.136(a)(2), (3), and (4)) hazard that needs a preventive control or prevented and: (1) Discloses in
in which it relies on its customer to at a processing facility later in the documents accompanying the food, in
provide assurance that the food will be distribution chain rather than obtain accordance with the practice of the
processed to control the identified written assurance that its customer will trade, that the food is ‘‘not processed to
hazard. In still other cases, such a control a hazard. If written assurance control [identified hazard]’’; and (2)
facility may have determined through must be required, these comments ask annually obtains from its customer
its hazard analysis that there are no us to allow the written assurance written assurance, subject to the
hazards requiring a preventive control, provided by the customer to state that requirements of § 117.137, that the
and will not consider whether one of the customer would evaluate the hazard customer has established and is
the circumstances in new § 117.136 and if necessary establish and follow following procedures (identified in the
apply. procedures to significantly minimize or written assurance) that will significantly
As a consequential addition, new prevent the hazard. minimize or prevent the hazard. The
§ 117.136(b) specifies the records that a Some comments state the receiving manufacturer/processor would include
manufacturer/processor would need to facility may not know the identity of all the specific hazard requiring a
satisfy the documentation requirements its ultimate customers, particularly if preventive control (e.g., Salmonella)
established in new § 117.136(a)(1), and the receiving facility sells its products to where the statement says ‘‘[identified
we have added new § 117.136(b) to the a distributor who then sells to other hazard].’’ A facility that provides the
list of implementation records entities. Some comments ask us to written assurance must act consistently
(§ 117.190) that are subject to the provide flexibility for facilities to with the assurance and document its
actions taken to satisfy the written Under the fourth of these provisions customer has established and is
assurance (see new § 117.137). The (§ 117.136(a)(5)), a manufacturer/ following to control the hazard. For
documents could be bills of lading or processor is not required to implement example, the customer could merely
other papers that accompany the food, a preventive control if it has established, state that its manufacturing processes
or labels on the containers of the food. documented, and implemented a system include a lethality step for microbial
Under the second of these provisions, that ensures control, at a subsequent pathogens of concern.
(§ 117.136(a)(3)), a manufacturer/ distribution step, of the hazards in the We agree that it is appropriate to
processor is not required to implement food product it distributes and require that the manufacturer/processor
a preventive control if it relies on its documents the implementation of that provide documentation to its customer
customer (who is not subject to the system. Comments did not provide indicating that the food must be
requirements for hazard analysis and examples of such a system, but we do processed to control an identified
risk-based preventive controls in not want to preclude the development hazard. Such documentation will be a
subpart C) to provide assurance it is of such systems. means of clear communication from the
manufacturing, processing, or preparing We have added several other manufacturer/processor to its customer.
the food in accordance with applicable requirements related to these new When the hazard will not be controlled
food safety requirements and it: (1) provisions that we are specifically by the customer, the customer will still
Discloses in documents accompanying establishing as circumstances in which have documentation that can be passed
the food, in accordance with the a manufacturer/processor need not on to the entity that is expected to
practice of the trade, that the food is implement a preventive control. As process the food to control the
‘‘not processed to control [identified already noted in this response, new identified hazard, so that it will be very
hazard]’’; and (2) annually obtains from § 117.137 requires that a facility that clear to that entity that the identified
its customer written assurance that it is provides a written assurance must act hazard still needs to be controlled.
consistently with the assurance and (Comment 446) Some comments ask
manufacturing, processing, or preparing
document its actions taken to satisfy the us to delete the proposed requirement to
the food in accordance with applicable
written assurance. In addition, new maintain the written assurance as a
food safety requirements. By ‘‘customer
§ 117.136(b)(2), (3), (4), and (5) specify record.
who is not required to implement (Response 446) We decline this
preventive controls under part 117’’ we the records that a manufacturer/
processor would need to satisfy the request. As already discussed in this
mean entities such as qualified facilities section, it is the combination of
documentation requirements
and retail food establishments. requirements (i.e., for documentation
established in new § 117.136(a)(2), (3),
Under the third of these provisions (4), and (5), and new § 117.335 that the food is ‘‘not processed to
(§ 117.136(a)(4)), a manufacturer/ establishes requirements applicable to control [identified hazard]’’; assurance
processor is not required to implement the written assurance between a from customers regarding appropriate
a preventive control if it relies on its manufacturer/processor and its procedures to ensure that the food will
customer to provide assurance that the customer. Taken together, the receive further processing to control the
food will be processed to control the provisions of §§ 117.137 and 117.335 identified hazards; and provisions
identified hazard by an entity in the establish legal responsibilities for a relating to accountability for written
distribution chain subsequent to the facility that provides a written assurances) that will provide adequate
customer and: (1) Discloses in assurance under § 117.136(a)(2), (3), or assurance that the food will be
documents accompanying the food, in (4), even if that facility is not a processed to control the identified
accordance with the practice of the manufacturer/processor. hazard before it reaches consumers.
trade, that the food is ‘‘not processed to The point of these provisions is to Records documenting the written
control [identified hazard]’’; and (2) ensure that hazards that a manufacturer/ assurances are a key component of the
annually obtains from its customer processor has determined, through its provisions.
written assurance, subject to the hazard analysis, require a preventive
requirements of § 117.137, that the XXVIII. Subpart C: Comments on
control, but are not controlled in the
customer will disclose in documents Proposed Requirements for a Recall
supply chain before the manufacturer/
accompanying the food, in accordance Plan (Final § 117.139)
processor or by the manufacturer/
with the practice of the trade, that the processor, are in fact controlled by a We proposed that you must establish
food is ‘‘not processed to control subsequent entity in the distribution a written recall plan for food with a
[identified hazard]’’. The manufacturer/ chain. With the assurance from the first significant hazard and that the recall
processor also must obtain written manufacturer/processor’s customer that plan must include certain procedures.
assurance that its customer will only the hazards will be controlled after the Some comments support the proposed
sell to another entity that agrees, in food product leaves the manufacturer/ requirements without change. For
writing, it will: (1) Follow procedures processor, it is not necessary for the first example, some comments express the
(identified in a written assurance) that manufacturer/processor to implement view that a written recall plan is critical
will significantly minimize or prevent the applicable preventive control. We in the event of a system breakdown
the hazard (if the entity is subject to the continue to believe that annual written where adulterated foods have been
requirements for hazard analysis and assurance from a manufacturer/ distributed. Some comments that
risk-based preventive controls in processor’s direct customer is an support the proposed requirements note
subpart C), or manufacture, process, or appropriate mechanism to ensure that that many model plans are available to
prepare the food in accordance with its customer is aware of the identified industry. Other comments state that the
applicable food safety requirements (if hazard and is taking steps to ensure that proposed requirements for a recall plan
the entity is not subject to the the food is processed to control the mirror guidelines in many fresh produce
requirements for hazard analysis and identified hazard. We do not believe commodity-specific food safety
risk-based preventive controls in that a manufacturers/processor will guidelines and seem appropriate for all
subpart C); or (2) obtain a similar need all of the details of its customer’s types of facilities handling fresh
written assurance from the entity’s process to satisfy the requirement to produce. Some comments that support
customer. state in writing the procedures the the proposed provisions suggest
alternative or additional regulatory text with the authority to mandate a food The rule specifies that the
(see, e.g., Comment 447, Comment 452, recall (section 423 of the FD&C Act). requirements for preventive control
Comment 453, and Comment 454). These comments assert that it would be management components (i.e.,
In the following paragraphs, we reasonable for us to conclude that in monitoring, corrective actions and
discuss comments that ask us to clarify order to efficiently carry out section 423 corrections, and verification) apply as
the proposed requirements or that of the FD&C Act we should issue appropriate to ensure the effectiveness
disagree with, or suggest one or more requirements governing the conduct of of the preventive control, taking into
changes to, the proposed requirements. recalls, because section 423 of the FD&C account the nature of the preventive
After considering these comments, we Act requires that we provide a firm with control (§ 117.140(a)). As previously
are finalizing the requirements as an opportunity to voluntarily recall a discussed, the preventive control
proposed with the conforming revision product before issuing an order to the management components are directed at
to use the term ‘‘hazard requiring a firm to cease distribution and recall a food that remains at the facility,
preventive control’’ rather than product. whereas the recall plan addresses food
‘‘significant hazard.’’ See Response 126 (Response 447) We decline the that has left the facility (78 FR 3646 at
and table 52. We also are redesignating request to establish requirements for a 3745). Our determination that the nature
the requirements as § 117.139. As written recall plan as a CGMP of the recall plan does not require these
discussed in section XXVII, we are requirement in subpart B and are preventive control management
establishing a provision applying to establishing the requirements as a components demonstrates the flexibility
certain assurances in § 117.137. preventive control in subpart C as provided by FSMA and this rule, not
proposed. We acknowledge that a recall that the recall plan must be considered
A. Proposed § 117.137(a)—Requirement
plan would be useful to all food a CGMP rather than a preventive
for a Written Recall Plan (Final
establishments, and we encourage all control.
§ 117.139(a))
food establishments to have a recall We have not yet made a
We proposed that you must establish plan. However, the report issued by the determination of whether we should
a written recall plan for food with a CGMP Modernization Working Group issue requirements governing the
significant hazard. did not identify the lack of a written conduct of recalls, rather than rely on
(Comment 447) Some comments ask recall plan as something that needed to the guidelines in part 7, in order to fully
us to require a written recall plan for all be changed (Ref. 3). (See 78 FR 3646 at implement section 423 of the FD&C Act.
food (rather than just for food with a 3651 for a discussion of the CGMP However, we have issued draft guidance
significant hazard) and to establish the Modernization Working Group and the entitled ‘‘Draft Guidance for Industry:
requirements for a written recall plan as process leading to its report.) However, Questions and Answers Regarding
CGMP requirements in subpart B rather going forward we intend to monitor Mandatory Food Recalls’’ which, when
than as part of the requirements for whether the lack of a broader finalized, would address topics such as
hazard analysis and risk-based requirement for a recall plan leads to the criteria for a mandatory recall and
preventive controls in subpart C. These problems when food establishments that the process that FDA must follow for a
comments assert that all products can be are not subject to the requirements of mandatory recall (Ref. 75).
subject to a recall. These comments subpart C are faced with recall (Comment 448) Some comments
contrast recall plans with other situations. As we gain experience with assert that the requirements for a recall
preventive controls in that recall plans the impact of the new requirement for plan should only apply to RTE food.
are often specific to a firm or facility, a recall plan on those facilities subject (Response 448) These comments are
but rarely are specific to particular to subpart C, we can reassess at a later suggesting that the rule predetermine
foods. In addition, these comments note date whether to conduct rulemaking to the outcome of the hazard analysis at all
that a recall may be administered and broaden the requirement to apply to all facilities. The framework provided by
managed at the corporate office rather food establishments subject to the FSMA and established in this rule
than at the specific manufacturing CGMP requirements in subpart B. For makes it the responsibility of each
facility that produced the food. now, food establishments that are not facility to appropriately determine the
Some comments note the subject to subpart C can continue to hazards requiring a preventive control,
requirements for a written recall plan follow our long-standing recall policy in and establish preventive controls as
are sufficiently different from other part 7. appropriate to the facility and the food.
provisions in subpart C that we Consistent with the overall framework (Comment 449) Some comments ask
proposed to specify that the recall plan of FSMA, a recall plan (like other us to cross-reference the provisions of
would not be subject to the preventive preventive controls) is only required part 7 (21 CFR part 7) rather than
control management requirements for when the facility has identified a hazard establish requirements that these
monitoring, corrective actions, and requiring a preventive control. A facility comments assert would be duplicative
verification (see § 117.140(c)). Some could establish a recall plan that applies with the provisions of part 7. These
comments note that facilities that are to other foods it manufactures. We comments ask us to address any more
exempt from the requirements of recognize that recalls may be managed substantive requirements than are
subpart C, but remain subject to the by the corporate office of a firm rather already in part 7 as part of a review of
CGMP requirements, would not be than at the specific manufacturing part 7. These comments assert that part
required to have a recall plan unless we facility that produced the food. Nothing 117 should require a written recall plan,
establish the requirements in subpart B. in the rule precludes this approach. In but not require a ‘‘written recall plan for
Some comments note that our such cases the corporate recall policy the food,’’ to be consistent with the
authority to require recall plans is not would be reflected in a facility’s recall approach of part 7.
limited to section 418 of the FD&C Act plan. (See also (Response 371.) In (Response 449) We decline these
and that we can use other legal addition, a facility that identifies one or requests. Part 7 addresses enforcement
authority to impose a requirement for more hazards requiring a preventive policy, and the provisions for recalls in
recall plans in subpart B. Some control in multiple food products could subpart C of part 7 are ‘‘Guidance on
comments note that FSMA specifically use the same recall plan for all Policy, Procedures, and Industry
amended the FD&C Act to provide us applicable food products. Responsibilities.’’ These recall
provisions do not establish a small business to simply specify that when conducting a recall. However, we
requirements and are not binding on it will telephone its customers. decline the request to specify what a
industry. They also are broadly directed Although we decline the request to facility must include in its procedures
to recalls for all FDA-regulated specify that the manufacturer, rather because facilities may use different
products, not just food. As already than the distributor, is the responsible approaches in how they carry out recalls
discussed (see Response 447), nothing party for notifying the public, the rule and the information they need to do so.
in this rule would prevent a facility that provides flexibility for a distributor to For example, not all facilities use that
establishes a recall plan for a particular establish, through its business same data for identifying the product
food from using that recall plan for any relationships with manufacturers, that that may be impacted by a recall.
food product that the facility decides to this would be the procedure established (Comment 453) Some comments ask
recall. in the distributor’s recall plan. us to specify that the procedures require
(Comment 451) Some comments ask facilities to notify us about a recall to
B. Proposed § 117.137(b)—Procedures us to delete the proposed requirement ensure that all suppliers, retailers, and
That Describe the Steps To Be Taken, that the recall plan include procedures consumers will have adequate
and Assign Responsibility for Taking for a facility to notify the public about notification of the recall action. Other
Those Steps (117.139(b)) any hazard presented by the food when comments agree that it is important for
We proposed that the recall plan must appropriate to protect public health. facilities to involve us in a recall
include procedures that describe the These comments assert that such a situation as soon as possible, but assert
steps to be taken, and assign requirement would be highly subjective that the best way to address such a
responsibility for taking those steps, to and create a nebulous regulatory burden notification is through the existing RFR
perform the following actions as that could subject facilities to system. These comments assert that
appropriate to the facility: (1) Directly unnecessary regulatory oversight and additional procedures or means to
notify the direct consignees of the food enforcement actions. notify us would involve unnecessary
being recalled, including how to return (Response 451) We decline this additional steps and be duplicative,
or dispose of the affected food; (2) notify request. Our guidance for a recall with no improvement to the public
the public about any hazard presented strategy has long recommended issuing health. Some comments ask us to
by the food when appropriate to protect a public warning to alert the public that specify that the appropriate State
the public health; (3) conduct a product being recalled presents a regulatory agency with inspection
effectiveness checks to verify that the serious hazard to health in urgent jurisdiction be notified in the event of
recall is carried out; and (4) situations where other means for a recall.
appropriately dispose of recalled food preventing use of the recalled product (Response 453) We agree with
(e.g., through reprocessing, reworking, appear inadequate (§ 7.42(b)(2)). comments that it is important to notify
diverting to a use that does not present Operationally, such notification to the us about a recall and that doing so can
a safety concern, or destroying the food). public is so common that our current help to ensure that suppliers, retailers,
We requested comment on whether: (1) home page on our Internet site (Ref. 76) and consumers will have adequate
The proposed procedures are gives prominence to recall information, notification of the recall action. We also
appropriate for all types of facilities; (2) and we have established a free email agree that the existing procedures to
we should require a recall plan to subscription service for updates on notify us through the RFR system can
include procedures and assignment of recalls (Ref. 77). Consistent with the accomplish this goal when a food
responsibility for notifying FDA of long-standing recall policy in part 7, presents a risk of serious adverse health
recalls subject to the plan; and (3) we subpart C, the proposed requirement consequences or death and that it
should include a requirement for a qualifies that the notification to the therefore is not necessary to duplicate
mock recall as a verification activity. public is ‘‘when appropriate to protect the notification procedures already
(Comment 450) Some comments ask public health.’’ established in the RFR system in part
us to modify the proposed requirements (Comment 452) Some comments ask 117. However, we encourage facilities to
for a recall plan to clearly differentiate us to specify that food recall plans include in their recall plan any
between manufacturers and distributors. include a minimum data requirement procedures they have to comply with
These comments note that distributors about the food product in question. the RFR or to include a cross-reference
are often not the initial recalling firm These comments assert that information to those procedures. Doing so may save
and ask us to clarify that the such as lot, batch, product size, and time, which is critical during a recall.
manufacturer, rather than the production date are critical in sorting When the recalled food does not present
distributor, is the responsible party for defective products from non-defective a risk of serious adverse health
notifying the public. Other comments ones. consequences or death (and, thus, there
ask us to modify and simplify the (Response 452) The procedures that is no report to the RFR), our guidance
details of the recall plan for smaller must be established in a recall plan are entitled ‘‘Guidance for Industry: Product
businesses based on product, those that describe the steps that will be Recalls, Including Removals and
distribution, and other factors. taken to notify entities that a product Corrections’’ recommends that recalling
(Response 450) In the 2014 must be removed from commerce, to firms notify the local FDA District
supplemental human preventive verify that product is removed, and to Recall Coordinator as soon as a decision
controls notice, we revised the proposed appropriately dispose of the product. is made that a recall is appropriate and
requirements for a recall plan by Information (such as lot, batch, product prior to the issuance of press or written
specifying that the procedures in the size, and production date) is necessary notification to customers (Ref. 78).
recall plan are ‘‘as appropriate to the to be able to carry out the steps that Including this guidance with the
facility.’’ As a result, the rule explicitly must be included in the procedures and facility’s recall procedures may also
provides flexibility for a recall plan to can be a useful component of the save time.
be different based on characteristics procedures that a facility includes in its Likewise, we agree with comments
such as size of the facility or the role of recall plan, because a facility would that it is important to notify appropriate
the facility in the food supply chain. For need to obtain such information about State regulatory agencies about a recall.
example, the rule provides flexibility for the specific product being recalled However, procedures are available for
State regulatory agencies to rapidly that the current recall procedures in part whether the rule should require a mock
receive information from us about food 7 do not recommend mock recalls. Some recall as a verification activity for the
recalls. For example, State regulatory comments assert that a requirement to recall plan, and we have decided to not
agencies can receive automatic include a mock recall as a verification require a facility to conduct a mock
notification about food recalls that we activity would be an excessive and recall as a verification activity for its
post on our Web site (Ref. 79). We note inappropriate burden. Some comments recall plan so that the focus of the
that whatever methods are used to note that retail facilities execute monitoring, corrective actions, and
dispose of adulterated food should multiple recalls each week and that verification in the rule remains focused
comply with State and local adding the requirement to perform a on food being produced rather than on
requirements. mock recall would be an unnecessary food that is distributed in commerce. A
(Comment 454) Some comments ask burden on the retail industry. Likewise, facility that voluntarily conducts a mock
us to add a requirement for mock recalls some comments note that foodservice recall would establish metrics
on a regular basis, such as annually. distributors are experts in conducting appropriate to its plan and take action
Some of these comments state that mock recall activities, because they are (such as modifications to its procedures,
recalls would familiarize the staff and routinely affected by manufacturer or additional training for its employees)
communications network(s) with the recalls. if it is not satisfied with the results of
recall process and would improve the Some comments ask us to clarify the the mock recall.
facility’s capacity to conduct effective ‘‘metrics’’ for a mock recall, particularly We note that retail companies are not
and efficient recalls in the event of a with respect to the consequences of subject to this rule and, thus, are not
contamination event. Other comments failing to meet an appropriate metric if subject to the requirement to have a
assert that mock recalls would be the a mock recall is conducted as a written recall plan.
only way to determine the effectiveness verification activity.
XXIX. Comments on Proposed
of a recall program. Some comments (Response 454) We agree that a mock
§ 117.140—Preventive Control
note that mock recalls would be recall would familiarize the facility with
Management Components
particularly critical for manufacturers the recall process, could improve the
that have limited experience in actual facility’s capacity to conduct effective We proposed preventive control
recalls. Other comments note that and efficient recalls during a management components as appropriate
information from mock recalls could contamination event, may be to ensure the effectiveness of the
support development of guidance on particularly helpful for manufacturers preventive controls, taking into account
best practices for recalls. Some that have limited experience in actual the nature of the preventive control.
comments recommend that any recalls, and could support the Most of the comments that support the
requirement for a mock recall as a development of guidance on best proposed provisions suggest alternative
verification measure include sufficient practices for recalls, and we encourage or additional regulatory text (see, e.g.,
flexibility to accommodate diverse facilities to conduct one or more mock Comment 455).
procedures and mechanisms. recalls to accomplish these goals. In the following sections, we discuss
Some comments acknowledge that a However, as previously discussed, a comments that disagree with, or suggest
mock recall could be an important recall plan would address food that had one or more changes to, the proposed
element of a recall plan but recommend left the facility, whereas the proposed requirements. After considering these
that mock recalls remain voluntary, requirements for monitoring, corrective comments, we have revised the
such as by including mock recalls as an actions, and verification would all be proposed requirements as shown in
example of how verification may be directed at food while it remains at the table 33, with editorial and conforming
accomplished. Other comments note facility. Comments are mixed regarding changes as shown in table 52.
TABLE 33—REVISIONS TO THE PROPOSED REQUIREMENTS FOR PREVENTIVE CONTROL MANAGEMENT COMPONENTS
117.140 ........................................... Flexible requirements for preven- Provide that preventive control management components take into
tive control management com- account both the nature of the preventive control and its role in the
ponents. facility’s food safety system.
A. Proposed § 117.140(a)—Flexible management of preventive controls, and provides for a framework whereby
Requirements for Monitoring, Corrective including the explicit provision that appropriate decisions may be reached
Actions and Corrections, and preventive control management regarding hazards that require
Verification components take into account the management controls that may include
We proposed that, with some nature of the preventive control. Some monitoring, corrections or corrective
exceptions, the preventive controls of these comments state that the actions, verification, and records. Other
would be subject to three preventive provisions for the preventive control comments state that the provisions will
control management components as management components will allow allow businesses to allocate resources to
appropriate to ensure the effectiveness facilities to tailor their food safety plans spend the most time and resources
of the preventive controls, taking into to their specific facility, product, and controlling and monitoring those
account the nature of the preventive process and ensure that the regulatory hazards that pose the greatest risk to
control: monitoring, corrective actions requirements are risk-based. Other public health.
and corrections, and verification. comments state that the proposed However, many of these comments
(Comment 455) Some comments approach acknowledges the safety also ask us to convey not only that the
support our proposal to provide benefits derived from the use of application of a particular management
flexibility in the oversight and prerequisite programs, such as CGMPs, component be appropriate (i.e., capable
of being applied), but also that it be temperature exceeds a specific value. that there will be fewer circumstances
necessary for food safety (i.e., to meet The facility also would find it in which our investigators would
the overall FSMA food safety goals or to unnecessary to verify its ongoing consult CFSAN about such an outcome.
ensure a particular control is effective) monitoring. See also Response 5.
by specifying that the preventive control (Response 455) We agree that (Comment 457) Some comments
management components take into preventive control management express concern with the number of
account both the nature of the components should take into account provisions that will impact certain types
preventive control and its role within both the nature of the preventive control of operations. As an example, these
the facility’s overall food safety system. and its role in the facility’s food safety comments assert that a fresh-cut
Some of these comments ask us to make system and have modified the produce facility potentially could be
companion changes reflecting that the regulatory text of § 117.140 to required to implement supplier
preventive control management incorporate this suggestion. We verification, environmental monitoring,
components take into account both the reviewed the full regulatory text of and product testing, whereas a peanut
nature of the preventive control and its proposed subpart C and made similar butter producer may not be required to
role within the facility’s overall food modifications to the regulatory text for implement any of those three
safety system throughout applicable the definition of ‘‘hazard requiring a provisions. According to these
provisions of the rule, such as the preventive control’’ (§ 117.3); process comments, supplier verification most
definition of ‘‘significant hazard’’ controls (§ 117.135(c)(1)); monitoring likely would not be required if the
(which we now refer to as ‘‘hazard (§ 117.145); verification (§ 117.155); manufacturing operation of the peanut
requiring a preventive control’’) and in validation (§ 117.160); and verification butter manufacturer includes a kill step
the requirements for preventive of implementation and effectiveness to significantly minimize Salmonella,
controls, monitoring, corrective actions (§ 117.165). because the ‘‘significant hazard’’ would
and corrections, and verification. Some (Comment 456) Some comments be addressed at the receiving facility.
comments ask us to consistently refer to assert that the flexibility explicitly These comments interpret our previous
‘‘the nature of the preventive control’’ provided in the regulatory text could discussions about product testing, in the
(rather than simply to ‘‘the preventive result in some facilities taking a broad 2013 proposed preventive controls rule,
control’’) when communicating the approach to significant hazards and as evidence that such a peanut butter
flexibility that a facility has in other facilities taking a more detailed manufacturer also would likely not
identifying preventive controls and approach. These comments express conduct product testing. If the peanut
associated preventive control concern that inspectors will view the butter product is hot-filled into jars,
management components. detailed approach (e.g., with more there would be no RTE food exposed to
preventive controls) as the standard to the environment and, thus, the facility’s
One comment provides two examples judge compliance with the rule. Other hazard analysis would not be required
of refrigeration controls to explain its comments express concern that to consider the potential for
view that the management components identifying a large number of preventive contamination with environmental
for refrigeration controls will vary controls could also undermine the value pathogens.
depending on the role of refrigeration of HACCP programs because treating too (Response 457) We acknowledge that
within the facility’s overall food safety many controls as CCPs will pull some facilities will need to do more
system. In the first example, a facility resources from those controls that are than others, because the rule is flexible
that manages the process of cooling a truly critical. and risk-based. Importantly, the rule
cream cheese as a CCP would validate (Response 456) We agree that facilities does not require every fresh-cut produce
its refrigeration control, establish time are likely to take different approaches to operation to conduct environmental
and temperature parameters that must complying with the rule. A facility- monitoring, even though it does require
be met, monitor those parameters and specific approach is consistent with each fresh-cut produce operation to
confirm their use through verification, FSMA, which places responsibility for consider whether it is necessary.
and, if the parameters were not met, hazard analysis and risk-based We disagree that the flexibility
then follow a specific corrective action preventive controls on the owner, provided in the regulatory text would
procedure to address the situation. In operator, or agent in charge of the lead a peanut butter manufacturer to
contrast, after the initial cooling process facility (section 418(a) of the FD&C Act). conclude that there would be no RTE
for the hot-filled product, the facility We agree that having too many CCPs food exposed to the environment when
would manage refrigerated storage could dilute their significance, but not peanut butter is hot-filled into jars. In
differently. The facility would not keep every hazard will require a CCP to be the production of peanut butter, the kill
validation data to support the specific controlled. See table 6 in the 2014 step (i.e., roasting) happens before the
temperature chosen because the supplemental preventive controls rule rest of the manufacturing process, and
temperatures needed to keep food safe for two examples of preventive controls the roasted peanuts are exposed to the
are widely known and accepted. that would not be CCPs (79 FR 58524 at environment before the filling step. At
Although the facility may choose to 58542). the filling step, the temperature is hot
establish temperature parameters, the During the initial stages of enough to fill the jars but is not hot
facility typically would not apply such implementation, we expect that our enough to act as a kill step to
values as hard and fast limits in the investigators will ask subject matter significantly minimize any pathogens
same way as it would for a CCP (e.g., experts in CFSAN to review the that contaminated the peanuts after they
because a 5 degree increase over the outcome of the facility’s hazard were roasted. As a result, in contrast to
upper end of the temperature range for analysis, the preventive controls the interpretation of the comments, the
a short time would not be meaningful to established by the facility, and the peanut butter production described by
food safety). The facility may choose not associated preventive control the comments does involve RTE food
to monitor temperature continuously management components that the exposed to the environment, and the
and, even if the facility does monitor facility has established and facility’s hazard analysis must consider
temperature continuously it would only implemented. Over time, as our the potential for contamination with
generate ‘‘exception records’’ when the investigators gain experience, we expect environmental pathogens. However,
when a peanut butter manufacturer tentative conclusion to require nature of any supplier non-
concludes that it requires sanitation monitoring of the performance of the conformance; (2) review of records; and
controls for environmental pathogens, it preventive controls (78 FR 3646 at (3) reanalysis. We address comments on
is more likely that the peanut butter 3747). We are affirming that conclusion the supply-chain program in sections
manufacturer would conduct in this rule (see Response 461). XLII through XLIX. We are finalizing the
environmental monitoring (rather than (Comment 459) Some comments applicability of preventive control
product testing) as a verification of its assert that regulations issued under the management components to the supply-
sanitation controls. (The peanut butter Health Insurance Portability and chain program as proposed.
manufacturer may also conclude that Accountability Act of 1996 (HIPAA)
would prevent a facility from C. Proposed § 117.140(c)—Recall Plan Is
product testing is a useful tool to verify
monitoring employee health if it Not Subject to Preventive Control
its overall food safety system.) Likewise,
establishes a Good Worker Hygiene Management Components
a facility that buys peanut butter for use
in an RTE food would need to consider Program as a preventive control. We proposed that the recall plan
whether it needs supply-chain controls (Response 459) The basis of these would not be subject to the preventive
for the manufacturer that performed the comments is unclear. We do not expect control management components.
kill step for Salmonella and whether it that activities associated with (Comment 460) As discussed in
needs sanitation controls for monitoring of employee health would Comment 447, some comments ask us to
environmental pathogens and include activities that would be contrary establish requirements for a written
environmental monitoring as to provisions of the Health Insurance recall plan as a CGMP requirement in
verification of its sanitation controls. Portability and Accountability Act of subpart B rather than as a preventive
(Comment 458) Some comments state 1996. Employee health could be control in subpart C. As a companion
that USDA’s regulations (in 7 CFR addressed through long-standing CGMP change, some of these comments ask us
205.201(a)(3)) for the NOP include provisions (see § 117.10(a) and (b)). to delete our proposed provision that
regulatory text to ‘‘ensure the Specifically, with respect to disease the recall plan would not be subject to
effectiveness’’ of measures in that control there could be supervisory the preventive control management
program and that this regulatory text is observation of illness or conditions such components.
similar to regulatory text in the as an open lesion, with appropriate (Response 460) As discussed in
requirements for preventive control action to exclude the worker from Response 447, we are establishing the
management components. These operations in which there is a requirements as a preventive control in
comments assert that this type of reasonable possibility of food, food- subpart C as proposed. Therefore, we
regulatory text has created compliance contact surfaces, or food-packaging are finalizing the provision that the
challenges and ask us to consult with materials becoming contaminated recall plan not be subject to the
USDA about its experience with (§ 117.10(a)). Generally, the regulations preventive control management
implementing effectiveness language described in this comment (commonly components.
associated with monitoring practices referred to as ‘‘the Privacy Rule’’) apply
XXX. Subpart C: Comments on
and procedures and ensure that the final to disclosures made by a health care
Proposed § 117.145—Monitoring
rule uses regulatory text that will be provider, not to the questions of an
clearly understood and readily employer (Ref. 80). See 45 CFR 160.103, We proposed to establish
implementable by those subject to its which defines a ‘‘covered entity’’ as a requirements for monitoring the
provisions. health plan; a health care clearinghouse; preventive controls. We also discussed
(Response 458) Under the USDA and a health care provider who our tentative conclusion that the
regulation cited by these comments, an transmits any health information in language of section 418 of the FD&C Act
organic production or handling system electronic form in connection with a regarding monitoring is ambiguous and
plan must include a description of the transaction covered by the Privacy Rule. that it would be appropriate to require
monitoring practices and procedures to The Privacy Rule does not prevent a monitoring of the ‘‘performance’’ of
be performed and maintained, including supervisor, human resources worker or preventive controls.
the frequency with which they will be others from asking an employee for a Some comments agree with our
performed, to ‘‘verify that the plan is doctor’s note or other information about tentative conclusion regarding the
effectively implemented.’’ We have not health if the employer needs the ambiguous nature of section 418. For
consulted with USDA regarding its information to administer sick leave, example, some comments state that our
experience in evaluating compliance workers’ compensation, wellness interpretation seems appropriate
with this requirement because we programs, or health insurance (45 CFR because requiring monitoring of the
addressed the issue likely to cause these 164.512(b)(1)(v)). ‘‘effectiveness’’ of the preventive
compliance challenges for monitoring controls would be redundant with
practices and procedures in an organic B. Proposed § 117.140(b)—Applicability required verification activities. In
production or handling system plan of Preventive Control Management addition, requiring monitoring of the
when we established our requirements Components to the Supply-Chain performance of preventive controls is
for monitoring preventive controls. Program consistent with applicable domestic and
Specifically, we require that a facility We proposed that the supplier internationally recognized standards.
monitor the preventive controls with program (which we now refer to as Some comments support the proposed
adequate frequency to ‘‘provide ‘‘supply-chain program’’) is subject to provisions without change. For
assurance that they are consistently the following preventive control example, some comments note that the
performed,’’ not to ‘‘verify that the plan management components as appropriate proposed requirement for written
is effectively implemented.’’ Our to ensure the effectiveness of the procedures for monitoring is similar to
requirements more clearly distinguish supplier program, taking into account globally recognized food safety
the purpose of monitoring and the nature of the hazard controlled standards and current industry practices
verification activities. See our previous before receipt of the raw material or and is a proactive measure to help
discussion of the relationship between ingredient: (1) Corrective actions and facilities prevent problems. Some
monitoring and verification, and our corrections, taking into account the comments that support the proposed
provisions suggest alternative or our tentative conclusion or with the Act regarding monitoring is ambiguous
additional regulatory text (see, e.g., proposed requirements, or ask us to and that it would be appropriate to
Comment 466 and Comment 467) or ask clarify the proposed requirements or require monitoring of the
us to clarify how we will interpret the suggest one or more changes to the ‘‘performance’’ of preventive controls.
provision (see, e.g., Comment 465 and proposed requirements. After We also have revised the proposed
Comment 468). considering these comments, we are requirements as shown in table 34, with
In the following paragraphs, we affirming our tentative conclusion that editorial and conforming changes as
discuss comments that disagree with the language of section 418 of the FD&C shown in table 52.
TABLE 34—REVISIONS TO THE PROPOSED REQUIREMENTS FOR MONITORING

117.145 ........................................... Flexibility in requirements for mon- Provide that monitoring take into account both the nature of the pre-
itoring. ventive control and its role in the facility’s food safety system.
117.145(c)(1) ................................... Records of monitoring ................... Provide that records of refrigeration temperature during storage of
food that requires time/temperature control to significantly minimize
or prevent the growth of, or toxin production by, pathogens may be
affirmative records demonstrating temperature is controlled or ex-
ception records demonstrating loss of temperature control.
117.145(c)(2) ................................... Records of monitoring ................... Provide for exception records for monitoring of preventive controls
other than refrigeration.
A. Our Tentative Conclusion To Require (Response 462) See Response 106, in establishing partnerships for achieving
Monitoring of the Performance of which we discuss comments on the compliance (see section 209(b) of
Preventive Controls definition of monitoring and describe FSMA).
(Comment 461) Some comments the changes we have made to that (Comment 464) Some comments
disagree with our tentative conclusion definition to address concerns about the express concern about monitoring for
that it would be appropriate to require potential to confuse ‘‘monitoring the radiological hazards. Some comments
monitoring of the ‘‘performance’’ of performance of preventive controls’’ claim hardships for fruit packinghouses
preventive controls and assert that the with verification activities that address required to analyze and monitor
concept of ‘‘performance evaluation’’ is ongoing implementation of control radiological hazards. Some comments
too complex to be included in the rule. measures. object to comprehensive monitoring for
(Response 461) These comments may (Comment 463) Some comments radiological hazards and note that the
have misinterpreted what we meant by assert that authority should be explicitly Codex Principles of Food Hygiene (Ref.
‘‘monitoring performance of preventive granted to the States to conduct food 81) do not address radiological hazards.
controls.’’ We used the term safety monitoring and that we should Some comments from foreign entities
‘‘performance’’ to mean ‘‘the execution maintain our responsibilities for request an exemption from the
or accomplishment of an action, product tracing. requirements to monitor radiological
operation, or process undertaken or (Response 463) These comments hazards because their government
ordered’’ (78 FR 3646 at 3747). We misinterpret the provisions of section already monitors the food supply for
acknowledge that the definition of 418 of the FD&C Act and this rule. radiological safety at a national level.
‘‘monitoring’’ that we are establishing in Section 418 places the responsibility for (Response 464) These comments
this rule includes that the purpose of establishing and implementing a food misinterpret the proposed requirements
observations or measurements safety system (including hazard for monitoring. In this rule,
conducted as part of monitoring is to analysis, risk-based preventive controls, ‘‘monitoring’’ means to conduct a
‘‘assess’’ whether control measures are preventive control management planned sequence of observations or
operating as intended. However, we components (including monitoring, measurements to assess whether control
provided examples showing that this corrective action procedures, and measures are operating as intended,
assessment is a straightforward verification), and recordkeeping) on the such as measuring temperature during a
determination of whether a process is owner, operator, or agent in charge of a process in which temperature is critical
operating as intended and is not a facility, not on FDA or any other to controlling a hazard. The comments
complex evaluation as asserted by the regulatory authority. This requirement seem to be referring to a situation in
comments. (See, e.g., the discussion of for monitoring within the framework of which a receiving facility would find it
monitoring the temperature of a process hazard analysis and risk-based appropriate to test incoming raw
for roasting nuts, 78 FR 3646 at 3746– preventive controls is distinct from materials or other ingredients to ensure
3747.) regulatory oversight of food safety, such that they are not contaminated with a
(Comment 462) Some comments that as during inspections and investigations radiological hazard. In such a
support monitoring the performance of of outbreaks of foodborne illness, which circumstance, testing the incoming
preventive controls assert that our generally involve product tracing. We materials would not be monitoring, but
proposed definition of ‘‘monitoring’’ agree that it is important to coordinate rather would be a preventive control
(proposed § 117.3), and our preamble regulatory oversight of food safety with (different from its usual role in
discussions of ‘‘monitoring,’’ have the the States and other food safety verification). Regardless, whether a
potential to confuse ‘‘monitoring the partners. As discussed in Response 5, facility would need to conduct such
performance of preventive controls’’ we are working through the PFP to testing (e.g., after an accident at a
with verification activities that address develop and implement a national nuclear facility near one of the facility’s
ongoing implementation of control Integrated Food Safety System suppliers) would be determined based
measures. consistent with FSMA’s emphasis on on the outcome of its hazard analysis.
As part of its hazard analysis, a facility (Response 466) We decline this Accordingly, the rule specifies that the
that identifies a radiological hazard as a request. The NACMCF HACCP facility establish written procedures and
hazard requiring a preventive control, guidelines characterize continuous conducts monitoring as appropriate to
and determines that testing raw monitoring as the ideal situation and the preventive control, rather than based
materials and other ingredients is an specifically note that continuous on risk associated with the hazard. (See,
appropriate preventive control, could monitoring is always preferred ‘‘when e.g., the discussion of monitoring the
consider the extent to which any testing feasible.’’ The NACMCF HACCP temperature of a process for roasting
conducted by its government on raw guidelines also note that continuous nuts, 78 FR 3646 at 3746–3747.)
materials and other ingredients reduces monitoring is possible with many types We decline the request to specify that
the need for, or extent of, its own of physical and chemical methods. the frequency of monitoring preventive
testing. However, as we previously discussed, controls must have a scientific basis.
both the NACMCF HACCP guidelines Monitoring should take place with
B. Proposed § 117.145(a)—Flexibility in sufficient frequency to detect a problem
and the Codex HACCP Annex
Requirements for Monitoring in the performance of a preventive
acknowledge that continuous
We proposed that, as appropriate to monitoring may not be possible, or even control. The importance of the
the preventive control, you must necessary, in all cases (78 FR 3646 at preventive control to the safety of the
establish and implement written 3748). food can be one factor in setting a
procedures, including the frequency (Comment 467) Some comments agree frequency. We acknowledge that
with which they are to be performed, for that frequency and areas to be tested scientific information may be
monitoring the preventive controls, and and monitored need to be determined appropriate in determining the
monitor the preventive controls with based on each product and facility and frequency of monitoring in some cases.
adequate frequency to provide ask us to allow each individual facility For example, the frequency may be
assurance that they are consistently to determine the frequency and areas to statistically based, such as with
performed. be monitored based on a completed risk statistical process control. However, in
(Comment 465) Some comments assessment. Some comments ask us to some cases factors other than scientific
assert that some food allergen controls specify that the frequency of monitoring information may be appropriate in
are not ‘‘monitored’’ in the sense that preventive controls must have a determining the frequency of
HACCP controls are monitored. Some scientific basis. monitoring. For example, historical
comments support a ‘‘visibly clean’’ (Response 467) It is unclear whether information on the consistency of the
standard for monitoring for food the comment agreeing that monitoring control measure can be a factor in
allergens. frequency and areas to be tested need to determining frequency. When
(Response 465) To the extent that be determined based on each product variability of the process is low, the
these comments are asserting that the and facility was directed to the frequency may be less than with a
types of monitoring activities that a monitoring provision or to process that has more variability. As
facility would establish likely would be environmental monitoring. Regardless, another example, a process that is
different for food allergen controls than by requiring written procedures for operated at a point close to a food safety
for a control at a CCP for a product monitoring, and specifying that the parameter limit may be monitored more
subject to a HACCP plan, we agree. procedures include the frequency with frequently than one where there is a
Under the rule, a facility has flexibility which the procedures are to be large safety margin built into the
to establish preventive control performed, the rule provides that each process.
management components, including facility must determine the frequency of
monitoring, as appropriate to the monitoring, as well as details such as C. Proposed § 117.145(b)—Records
preventive control, and the nature of the areas to be monitored. However, we We proposed that all monitoring of
any monitoring activity will depend on decline the request to specify that these preventive controls must be
the nature of the preventive control and procedures be based on a completed documented in records that are subject
its role in the facility’s food safety ‘‘risk assessment.’’ The rule requires the to verification and records review.
system. In addition, a facility could facility to conduct a hazard analysis, (Comment 468) Some comments point
determine, for example, that it will which determines whether there are any out that table 6 in the 2014
visually observe food allergen controls hazards requiring a preventive control, supplemental human preventive
as a verification activity and not and the facility would establish controls notice includes an example of
establish a separate ‘‘monitoring’’ preventive controls for such hazards as a monitoring activity that generally
activity within the meaning of appropriate to the facility and the food. would not require monitoring records
§ 117.145. For example, a facility that The facility must consider factors (i.e., monitoring for foreign material
uses several food allergens as associated with risk (i.e., the severity of with x-rays) (see 79 FR 58524 at 58542).
ingredients could store each of the food the illness or injury if the hazard were These comments assert that this
allergens in a separate area of the to occur and the probability that the example is in conflict with the proposed
facility, and then ‘‘visually observe’’ hazard will occur in the absence of regulatory text and ask us to modify the
that the various food allergens are in preventive controls) in evaluating regulatory text to provide the flexibility
their assigned storage areas. We agree whether any potential hazard is a we acknowledged in the 2014
that ‘‘visibly clean’’ can be a minimum hazard requiring a preventive control supplemental human preventive
standard that a facility could apply (§ 117.130(c)). Risk could be relevant to controls notice. Other comments ask us
during verification of food allergen a facility’s identification of appropriate to specify that monitoring must be
controls by visual observation. preventive controls for a particular documented as appropriate to the nature
(Comment 466) Some comments ask hazard requiring a preventive control. of the preventive control.
us to require continuous monitoring of However, it is the nature of the Some comments ask us to recognize
preventive controls because the preventive control, rather than the risk the acceptability of monitoring systems
NACMCF HACCP guidelines associated with the hazard, that is more that exclusively provide exception
recommend continuous monitoring of relevant to the frequency of monitoring reports. These comments describe
controls where possible. and the areas to be monitored. exception reporting as a structure where
automated systems are designed to alert circumstances provided in the result in a record only when the system
operators and management on an comments—i.e., for monitoring detects foreign material.
exception basis—i.e., only when a refrigeration temperature. Therefore, we
XXXI. Subpart C: Comments on
deviation from food safety parameter have revised the regulatory text to
Proposed § 117.150—Corrective Actions
limits are observed by the system. These provide that records of refrigeration
and Corrections
comments assert that, in many cases, temperature during storage of food that
monitoring of preventive controls can be requires time/temperature control to We proposed to establish
done by automated systems that provide significantly minimize or prevent the requirements for corrective actions and
exception reporting in a much more growth of, or toxin production by, corrections. Some comments support
efficient manner than if performed by pathogens may be affirmative records the proposed requirements without
operators and that automated demonstrating temperature is controlled change. For example, some comments
monitoring allows for increased or exception records demonstrating loss assert that there is virtually no reason to
sampling frequency (often continuous) of temperature control. Although the have a food safety plan unless there are
and reduction of human error. The comments specifically requested that we proper corrective actions in place so the
comments provide an example of a clarify our view on exception records in product can be properly disposed of.
refrigeration temperature control that the preamble, we believe that clarifying Some comments agree that there should
notifies on exception (e.g., high the regulatory text will be more useful, be written procedures for corrective
temperature alarm) and may only record both to facilities and to regulatory actions and note the importance of
temperatures that exceed the specified agencies that conduct inspections for identifying and evaluating the problem,
temperature (without recording compliance with the rule. If a facility correcting it, and documenting the
temperatures that meet control uses ‘‘exception records,’’ the facility corrective action. Some comments
requirements). These comments must have evidence that the system is express the view that the proposed
acknowledge that such systems must be working as intended, such as a record requirement for clear corrective action
validated and periodically verified to that the system has been challenged by in the event of an unanticipated
ensure they are working properly. These increasing the temperature to a point at problem, and documenting all
comments ask us to clarify in the which an ‘‘exception record’’ is corrective actions, contributes to a
preamble to the final rule that generated. (See also Response 602 and comprehensive safety plan. Some
monitoring systems can work Response 610.) comments that support the proposed
affirmatively or by exception and that We also have revised the regulatory provisions suggest alternative or
both types of systems and their related text to provide that exception records additional regulatory text (see, e.g.,
documentation are acceptable. may be adequate in circumstances other Comment 469, Comment 470, Comment
(Response 468) We have made several than monitoring of refrigeration 479, Comment 480, and Comment 485).
revisions to the regulatory text, with temperature. For example, in table 6 of In the following paragraphs, we
associated editorial changes, to clarify the 2014 supplemental human discuss comments that disagree with, or
that monitoring records may not always preventive controls notice the example suggest one or more changes to, the
be necessary. We agree that the we provided of a monitoring activity proposed requirements. After
exception reporting described in these that generally would not require considering these comments, we have
comments, including validation and monitoring records is monitoring for revised the proposed requirements as
periodic verification to ensure that the foreign material with x-rays. We believe shown in table 35, with editorial and
system is working properly, would be that an x-ray system that monitors for conforming changes as shown in table
an acceptable monitoring system in the foreign material with x-rays would 52.
TABLE 35—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CORRECTIVE ACTIONS AND CORRECTIONS
117.150(a) ........................ Corrective action procedures ............. Clarify that corrective action procedures depend on the nature of the haz-
ard, as well as the nature of the preventive control.
117.150(a)(1) .................... Corrective action procedures ............. Clarify that the specified list of corrective action procedures is not intended
to be exhaustive.
117.150(b) ........................ Corrective action in the event of an Specify that the requirement applies when ‘‘a corrective action procedure’’
unanticipated food safety problem. (rather than ‘‘a specific corrective action procedure’’) has not been estab-
lished.
117.150(b)(1)(ii) ................ Corrective action in the event of an Specify that the requirement applies when a preventive control, combination
unanticipated food safety problem. of preventive controls, or the food safety plan as a whole is found to be
ineffective (rather than just when a single preventive control has been
found to be ineffective).
117.150(c)(2) .................... Corrections ......................................... Provide for additional circumstances when corrections, rather than correc-
tive actions, are warranted.
A. Proposed § 117.150(a)(1)— preventive controls are not properly or appropriate indicator organism
Requirement To Establish and implemented. The corrective action detected through environmental
Implement Corrective Action Procedures procedures must include procedures to monitoring.

address, as appropriate, the presence of (Comment 469) Some comments note
We proposed that, with some
a pathogen or appropriate indicator that we proposed to list two
exceptions, as appropriate to the
organism in an RTE product detected as circumstances that require written
preventive control you must establish
and implement written corrective action a result of product testing, as well as the corrective active procedures (i.e.,
procedures that must be taken if presence of an environmental pathogen product testing and environmental
monitoring) and that it is not clear corrective actions should be the facility, that no food is affected),
whether this list is intended to be proportional to the nature of the testing then that is what its corrective action
exhaustive or not (i.e., whether written results. These comments ask us to procedures would say. The reason to
corrective action procedures are require that a facility establish and have corrective action procedures is to
required in only these two implement corrective action procedures consider the likely scenarios in advance,
circumstances, or whether there may be that must be taken if preventive controls with appropriate input from the
other circumstances that require written are not properly implemented as facility’s food safety team and
corrective action procedures). These appropriate to the nature of the hazard, preventive controls qualified individual,
comments ask us to insert ‘‘but are not the nature of the control measure, and rather than react to these scenarios on
limited to’’ after ‘‘must include’’ if we the extent of the deviation. an ad hoc basis.
intend that the list is not exhaustive. (Response 470) We have revised the (Comment 472) Some comments ask
Likewise, other comments state our regulatory text to specify that the us to require that corrective actions
proposal to specifically require corrective action procedures are include an analysis to determine the
corrective action procedures may result established and implemented based on root cause of a problem, not only
in a misunderstanding by some facilities the nature of the hazard in addition to identify it. These comments also ask us
about the need to take corrective actions the nature of the preventive control. We to require follow-up actions to ensure
in circumstances other than in response agree that the nature of the hazard plays the corrective action was effective and
to testing results, other non- a key role in the corrective actions that assert that although the requirements
conformances, or other types of a facility would take. Although a address the need to reanalyze the food
verification activities. These comments facility’s corrective action procedures safety plan they do not appear to
assert that it would be better for food likely would specify actions to take specifically address a review of the
safety if the regulatory requirements based on the extent of the deviation, we corrective action.
took a more principled approach and consider this a detail that does not need (Response 472) The requests of these
generally required corrective action to be specified in the rule. comments do not require any revisions
procedures, with the importance of (Comment 471) Some comments ask to the regulatory text. The rule does not
corrective action procedures for testing us to revise the provisions to clarify that use the term ‘‘root cause’’ but it does
programs addressed through guidance. corrective action procedures are not require the facility to take appropriate
If, however, we conclude that specific always necessary when testing detects action, when necessary, to reduce the
requirements for corrective action the presence of a pathogen or indicator likelihood that the problem will recur
procedures for testing programs are organism. These comments assert that (see § 117.150(a)(2)(ii)). Root cause
necessary, these comments ask us to the extent of the corrective actions analysis is simply part of a common
clarify that the nature and extent of any should be proportional to the nature of approach to complying with this
corrective actions should be the testing results themselves because requirement. (Knowing the root cause is
proportional to the nature of the test the level of contamination matters for key to reducing the likelihood that a
findings. those microorganisms with thresholds problem will happen again.) The rule
(Response 469) We have revised the that need to be taken into account and also requires a review of records of
regulatory text, with associated editorial because the location of contamination in corrective actions, but does so as a
revisions and redesignations, to clarify the food processing environment verification activity rather than as part
that the specified list of corrective matters (e.g., the zone in the facility of the corrective action procedures (see
action procedures is not intended to be where the contamination is detected). § 117.165(a)(4)).
exhaustive (i.e., not limited to the two (For information about zones associated (Comment 473) Some comments ask
corrective action procedures that we with environmental monitoring, see 78 us to revise the proposed rule to address
specified in the proposed human FR 3646 at 3816.) corrective actions in a more general way
preventive controls rule). The approach (Response 471) We decline this and then outline areas where specific
we used in the modified regulatory text request. These comments appear to be corrective action procedures would be
(i.e., ‘‘You must establish and confusing the requirement to establish helpful, such as for testing programs, in
implement written corrective action and implement corrective action guidance.
procedures . . ., including procedures procedures with the content of the (Response 473) The proposed
to address, as appropriate . . .’’ is corrective action procedures. These provisions do not prescribe the outcome
similar to the approach used in several comments also appear to assume that a of the corrective action procedures, but
other provisions of the rule. (See, e.g., requirement to have corrective action merely direct the facility to the types of
requirements for allergen controls procedures (which describe the steps to actions that the procedures must
(§ 117.135(c)(2)); sanitation controls be taken to ensure that appropriate address. In essence, the proposed
(§ 117.135(c)(3)(i)); and monitoring action is taken to identify and correct a provisions already do, as the comments
(§ 117.145(a).) We decline the problem and, when necessary, to reduce request, address corrective actions in a
suggestion to modify the regulatory text the likelihood that the problem will general way.
by adding ‘‘but is not limited to’’ after recur; that all affected food is evaluated (Comment 474) Some comments ask
‘‘includes.’’ The word ‘‘includes’’ does for safety; and that all affected food is us to specify that the requirements also
not need to be followed by ‘‘but is not prevented from entering into commerce apply when a preventive control is
limited to’’ to clearly communicate that when appropriate) pre-determines the found to be ineffective.
a following list is not complete. (See outcome of following the corrective (Response 474) We have not revised
Response 68.) We agree that the nature action procedures. This is not the case. the regulatory text as requested by these
and extent of any corrective actions in If, as the comments assert, a facility comments. The appropriate action when
response to the findings of testing concludes, for example, that the nature a preventive control is found to be
programs should be proportional to of some test results do not warrant steps ineffective is to reanalyze the food
nature of the test findings. (See to reduce the likelihood that the safety plan and to establish and
Response 470.) problem will recur and that affected implement a preventive control that is
(Comment 470) Some comments state food is safe and lawful (or, in the case effective, not follow a corrective action
that the nature and extent of the of finding a pathogen in some zones in procedure. A corrective action
procedure is intended to address a not adulterated under section 402 of the for Salmonella Species in Human Foods
problem that happens when following FD&C Act or misbranded under section and Direct-Human-Contact Animal
the procedures in a food safety plan that 403(w) of the FD&C Act, there would be Foods’’ (Ref. 82).
previously was verified to be valid, not no need to take steps to prevent that
C. Proposed § 117.150(b)—Corrective
to fix problems on an ongoing basis food from entering commerce.
(Comment 476) Some comments Action in the Event of an Unanticipated
when a preventive control is ineffective
assert that the proposed regulatory text Problem
(and, thus, the food safety plan is not
valid). We agree that some of the steps could be misunderstood as a With some exceptions, we proposed
that apply to corrective actions may requirement to establish a new that you must take corrective action to
need to be taken, such as evaluating preventive control after implementing a identify and correct a problem, reduce
affected food for safety and ensuring corrective action procedure. These the likelihood that the problem will
that adulterated food does not enter comments also assert that it would be recur, evaluate all affected food for
commerce. This is addressed by the inappropriate to assume that corrective safety, and, as necessary, prevent
provisions for corrective actions in the action procedures always correct a affected food from entering commerce as
event of an unanticipated problem problem with the implementation of a would be done following a corrective
(§ 117.150(b)(1)(ii)), which require new or additional preventive control. action procedure if any of the following
specific corrective actions to be taken (Response 476) We received these circumstances apply: (1) A preventive
(§ 117.150(b)(2)). comments before we issued the 2014 control is not properly implemented
supplemental human preventive and a specific corrective action has not
B. Proposed § 117.150(a)(2)—Content of controls notice. The proposed regulatory been established; (2) a preventive
Corrective Action Procedures text in the 2014 supplemental human control is found to be ineffective; or (3)
We proposed that corrective action preventive controls notice addresses the a review of records finds that the
procedures must describe the steps to be issues identified in these comments by records are not complete, the activities
taken to ensure that: (1) Appropriate clearly separating the requirement to conducted did not occur in accordance
action is taken to identify and correct a take appropriate action to identify and with the food safety plan, or appropriate
problem that has occurred with correct a problem that has occurred decisions were not made about
implementation of a preventive control; from the requirement to take corrective actions. We also proposed
(2) appropriate action is taken to reduce appropriate action, when necessary, to that if any of these circumstances apply,
the likelihood that the problem will reduce the likelihood that the problem when appropriate you must reanalyze
recur; (3) all affected food is evaluated will recur. the food safety plan to determine
for safety; and (4) all affected food is (Comment 477) Some comments ask whether modification of the food safety
prevented from entering into commerce, us to provide that requirements for plan is required.
if you cannot ensure that the affected corrective actions be principle-based (Comment 479) Some comments ask
food is not adulterated under section (e.g., containment of affected product, us to delete the proposed requirement
402 of the FD&C Act or misbranded control restored to operation before that a facility must reanalyze the food
under section 403(w) of the FD&C Act. commencing production) rather than safety plan in the event of an
(Comment 475) Some comments prescriptive. unanticipated problem. These
assert that the corrective action (Response 477) The requirements for comments argue that FSMA does not
procedures should not consider food to corrective actions established by this specify reanalysis in the event of an
be ‘‘affected’’ if it is immediately rule are principle-based in that they unanticipated problem. In addition,
subjected to an additional (or repeat) require the facility to describe the steps these comments assert that the proposed
preventive control after determining that it will take rather than prescribe the requirement for reanalysis in the event
that the initial preventive control was steps that it will take. of an unanticipated problem would be
not properly implemented. These (Comment 478) Some comments ask redundant with the proposed
comments discuss an example in which us to revise the provision to make re- requirements for reanalysis as a
there is a temperature deviation below sampling and/or re-testing one of the verification activity (proposed
accepted parameter limits for a given first steps in a corrective action § 117.170) and would not add value for
process, and the incorrectly processed procedure to take into account human food safety. These comments also assert
product is re-processed correctly, and error. These comments assert that that the term ‘‘problem’’ is ambiguous
assert that it would be illogical to mishandling during sampling, transport, and ask us to replace ‘‘problem’’ with
consider the food to be ‘‘affected’’ in and testing can contribute to a false ‘‘food safety issue’’ if we retain the
this circumstance. Other comments ask positive result and that if the results of provision in the final rule.
us to modify the requirements to specify a follow-up test are negative, then the (Response 479) We acknowledge that
that they apply to all affected food ‘‘if previous test could be considered an section 418 of the FD&C Act does not
any.’’ anomaly that could be ignored. explicitly specify that a facility must
(Response 475) We decline the (Response 478) We decline this reanalyze its food safety plan in the
request to modify the regulatory text to request. We disagree that an appropriate event of an unanticipated problem.
specify that the requirements apply to approach to positive findings of a test However, as previously discussed,
all affected food ‘‘if any.’’ Food is for contamination is to re-sample and requiring reanalysis of the food safety
‘‘affected’’ if a preventive control is not re-test and to consider positive findings plan after an unanticipated problem is
properly implemented during its to be an anomaly if subsequent test consistent with the NACMCF HACCP
production. However, the rule does not results are negative. Many food products guidelines, the Codex HACCP Annex,
pre-determine the consequences when are not homogeneous and and Federal HACCP regulations for
food is ‘‘affected.’’ Instead, the rule contamination is localized. Even for seafood, juice, and meat and poultry (78
requires the facility to evaluate the homogeneous food products (such as FR 3646 at 3752). In the 2014
affected food for safety. If, as in the fluids), the problem could be the supplemental human preventive
example described by the comments, sensitivity of the method if the level of controls notice, we clarified that
the facility re-applies the preventive contamination is low. See our guidance reanalysis would be conducted ‘‘when
control such that the food is safe and is entitled ‘‘Guidance for Industry: Testing appropriate.’’ For example, if a problem
occurs because personnel did not (Response 480) We have revised the prevent significant hazards is
understand the procedures or carry out regulatory text to delete the word inconsistent with an expectation to
the procedures correctly, additional ‘‘specific.’’ prevent recurrence.
training for applicable personnel may be (Comment 481) Some comments ask (Response 483) We disagree that our
warranted, but there likely would be no us to emphasize that reanalysis is acknowledgement that preventive
need to reanalyze the food safety plan. required only when a combination of controls may not always be able to
We disagree that the term ‘‘problem’’ two events occurs (i.e., a preventive prevent significant hazards is
is ambiguous. The term ‘‘problem’’ control is not properly implemented, inconsistent with an expectation to
signifies that something is wrong, and the facility has not established a prevent recurrence. Even when a
whereas the term suggested by the corrective action procedure). preventive control is not always able to
comments (i.e., ‘‘issue’’) may or may not (Response 481) In the 2014 prevent a hazard requiring a preventive
signify that something is wrong. The supplemental human preventive control, it can reduce the likelihood that
analogous provisions in the NACMCF controls notice, we proposed revisions the hazard will adulterate the food
HACCP guidelines (Ref. 34), the Codex to the regulatory text to clearly specify within the meaning of section 402 of the
HACCP Annex (Ref. 35), and Federal the circumstances requiring reanalysis. FD&C Act or misbrand the food within
HACCP regulations for seafood, juice, One such circumstance is when a the meaning of section 403(w) of the
and meat and poultry is ‘‘deviation.’’ preventive control is not properly FD&C Act. For example, a facility
We avoided the term ‘‘deviation’’ implemented and a corrective action processing fresh-cut produce can reduce
because ‘‘deviation’’ has the potential to procedure has not been established the likelihood of contamination of
signify that the requirements of this rule (§ 117.150(b)(1)(i)). The final provision incoming fresh produce with L.
for corrective actions only apply when includes the revisions included in the monocytogenes through enhanced
a preventive control is at a CCP, which 2014 supplemental human preventive supply-chain controls for incoming
is not the case. We agree that the controls notice and is consistent with fresh produce, along with appropriate
requirements are directed to problems the request of these comments. sanitation controls. As discussed in
related to food safety, and in the 2014 (Comment 482) Some comments ask
Response 470, we have revised the
supplemental human preventive us to add that corrective actions in the
regulatory text to specify that the
controls notice we modified the title of event of an unanticipated problem also
corrective action procedures are
the requirement to be ‘‘Corrective action apply when a preventive control is
established and implemented based on
in the event of an unanticipated food ‘‘missing.’’
(Response 482) We have revised the the nature of the hazard in addition to
safety problem.’’ However, we continue the nature of the preventive control,
to use the simpler term ‘‘problem’’ in regulatory text to require corrective
actions whenever a preventive control, because the nature of the hazard plays
the remainder of the regulatory text. a key role in the corrective actions that
Specifying that the nature of the combination of preventive controls, or
the food safety plan as a whole, is a facility would take. When a preventive
problem is ‘‘food safety’’ in the title is
ineffective. (See § 117.150(b)(1)(ii).) In control is not able to prevent a hazard,
sufficient to focus the requirement on
assessing what the comment might the facility must focus on minimizing
food safety.
We agree that there is a relationship mean by a preventive control that is the hazard.
between the requirements for corrective ‘‘missing,’’ we concluded that an (Comment 484) Some comments ask
actions in the event of an unanticipated unanticipated problem could, in some us to replace the term ‘‘reanalyze’’ with
food safety problem and the cases, mean that a combination of the term ‘‘reassess.’’
requirements for reanalysis. To reduce preventive controls, or the facility’s food (Response 484) We decline this
redundant regulatory text, in the 2014 safety plan as a whole (rather than a request. See Response 551.
supplemental human preventive single preventive control), simply was D. Proposed § 117.150(c)—Corrections
controls notice we proposed to modify not effective. If this is the case,
the regulatory text of the requirements reanalysis would be appropriate, and we We proposed that you do not need to
for reanalysis to specify that reanalysis also have modified the requirements for comply with the requirements for
is required when appropriate after an reanalysis to specify that a facility must corrective actions and corrections for
unanticipated food safety problem, and reanalyze its food safety plan whenever conditions and practices that are not
we are establishing that modified it finds that a preventive control, consistent with specified food allergen
provision in this final rule. Importantly, combination of preventive controls, or controls or sanitation controls if you
the provisions for reanalysis continue to the food safety plan as a whole is take action, in a timely manner, to
require reanalysis when a preventive ineffective. (See also Response 556.) correct such conditions and practices.
control is found to be ineffective. We are (Comment 483) Some comments (Comment 485) Some comments
not aware of any circumstances in assert that fresh and fresh-cut produce support our proposal to provide for
which it would not be appropriate to operations are unlikely to prevent corrections, rather than corrective
reanalyze the food safety plan if a recurrence of occasional detections of actions, for sanitation controls and some
preventive control is found to be human pathogens (particularly L. food allergen controls in some
ineffective. monocytogenes, which is a soil circumstances. Other comments assert
(Comment 480) Some comments microorganism whose normal habitat is that situations in which ‘‘corrections’’
assert that the word ‘‘specific’’ is not in the field) because there is no ‘‘kill can be applied are not limited to
appropriate as a modifier for ‘‘corrective step’’ for pathogens and because the sanitation and food allergen controls
action procedure’’ because many source of contamination may not be and could include actions to address
preventive controls will have corrective identified. These comments point out other preventive controls such as
action procedures that allow flexibility that we recognize that preventive preventive maintenance controls or
based on the nature of the hazard and controls may only be able to CGMPs. As discussed in Comment 164,
control. These comments also state that ‘‘significantly minimize’’ significant some comments emphasize the
the term ‘‘specific’’ in this context is hazards and assert that our importance of distinguishing between
more appropriate for a CCP control in a acknowledgement that preventive the terms ‘‘correction’’ and ‘‘corrective
HACCP system. controls may not always be able to action.’’
(Response 485) We have revised the include validation, verification of actions, and documentation of
regulatory text, with associated editorial monitoring, verification of corrective verification activities. See sections
revisions and redesignations, to provide actions, verification of implementation XXXIII through XXXV for comments on
for corrections, rather than corrective and effectiveness, written procedures, the proposed requirements for
actions and corrective action reanalysis, and documentation of all validation, verification of
procedures, for minor and isolated verification activities. We also requested implementation and effectiveness,
problems that do not directly impact comment on whether we should specify written procedures, and reanalysis. See
product safety. As discussed in the verification activities that must be table 37, table 38, and table 39 for a
Response 164, we also have defined the conducted for verification of monitoring summary of the revisions to those
term ‘‘correction’’ to mean an action to (78 FR 3646 at 3756) and for verification proposed requirements.
identify and correct a problem that of corrective actions (78 FR 3646 at Some comments support the proposed
occurred during the production of food, 3756), and if so, what verification requirements for verification of
without other actions associated with a activities should be required. monitoring, verification of corrective
corrective action procedure (such as To improve clarity and readability, in actions, and documentation of
actions to reduce the likelihood that the the 2014 supplemental human verification activities without change.
problem will recur, evaluate all affected preventive controls notice we proposed
food for safety, and prevent affected For example, comments support the
to move the more extensive verification documentation of verification activities
food from entering commerce). requirements for validation, (see section XXXII.C). In the following
E. Proposed § 117.150(d)—Records implementation and effectiveness, and paragraphs, we discuss comments on
We proposed that all corrective reanalysis from the single proposed the flexibility provided for a facility to
actions (and, when appropriate, section (proposed § 117.150) to separate conduct verification activities as
corrections) must be documented in sections (proposed §§ 117.160, 117,165, appropriate to the nature of the
records and that these records are and 117.170, respectively). In addition, preventive control. We also discuss
subject to the verification requirements to address comments that asked us to comments that address our request for
in §§ 117.155(a)(3) and 117.165(a)(4)(i). provide more flexibility to facilities, comment on whether we should revise
We received no comments that including flexibility in determining the regulatory text to specify the
disagreed with this proposed whether and how to conduct verification activities that must be
requirement and are finalizing it as verification activities, in the 2014 conducted for verification of monitoring
proposed. supplemental human preventive and for verification of corrective actions,
controls notice we proposed that the or express concern that the
XXXII. Subpart C: Comments on verification activities be performed ‘‘as requirements as proposed are too
Proposed § 117.155—Verification appropriate to the preventive control.’’ prescriptive. After considering these
In the 2013 proposed human In this section, we discuss the comments, we have revised the
preventive controls rule, we proposed proposed requirements for verification verification requirements described in
verification activities that would of monitoring, verification of corrective § 117.155 as shown in table 36.
TABLE 36—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VERIFICATION

117.155 ........................................... Flexibility to conduct verification Provide that verification activities take into account both the nature of
activities. the preventive control and its role in the facility’s food safety sys-
tem.
A. Flexibility in Requirements for would not need verification of corrections, and verification)
Verification monitoring. Other comments ask us to individually provide flexibility, either
(Comment 486) Some comments allow facilities flexibility to verify that by specifying that the provisions apply
support the flexibility provided by use preventive controls are effective in the as appropriate to the nature of the
of the phrase ‘‘as appropriate to the manner prescribed by FSMA—i.e., such preventive control and its role in the
preventive control’’ in the requirement controls should be deemed to be facility’s food safety system (i.e., for
that verification activities must include, effective by an appropriate means as monitoring and verification) or both the
as appropriate to the preventive control, determined and supported by the nature of the preventive control and the
specified verification activities (i.e., facility within its food safety plan. nature of the hazard (i.e., for corrective
validation, verification that monitoring (Response 486) The provisions for actions and corrections). The word
is being conducted, verification that preventive control management ‘‘must’’ specifies the type of activities
appropriate decisions about corrective components make clear that all that a facility can use to satisfy the
actions are being made, verification of preventive control management requirements for a particular preventive
implementation and effectiveness, and components, including verification, are control management component.
reanalysis). These comments emphasize required as appropriate to ensure the We are retaining the term ‘‘must.’’
that verification activities must be effectiveness of the preventive control, However, we agree that the rule should
tailored to the preventive control and taking into account the nature of the provide flexibility for additional
assert that the use of the word ‘‘must’’ preventive control and its role in the verification of implementation and
is potentially confusing in light of this facility’s food safety system (see effectiveness. To provide that additional
flexibility—e.g., because not all § 117.140). Likewise, the provisions for flexibility, we have revised the specific
preventive controls must be validated each of the preventive control requirements for verification of
for food safety, and those preventive management components (i.e., implementation and effectiveness to
controls that do not need monitoring monitoring, corrective actions and provide for other activities appropriate
for verification of implementation and ‘‘check’’ whether the metal detector is verification activities that must be
effectiveness (see § 117.165(a)(5)). As a rejecting test pieces of metal. conducted for corrective actions.
conforming revision, we have revised (Response 488) We are establishing 4. Proposed § 117.155(a)(4)—
the requirement for review of records to the requirements for verification of Verification of Implementation and
include a review of records of ‘‘other monitoring as part of a system for Effectiveness
verification activities’’ within a hazard analysis and risk-based
reasonable time after the records are preventive controls, not as a matter of We proposed that verification
created (see § 117.165(a)(4)(ii)). CGMP. As previously discussed (78 FR activities must include, as appropriate
3646 at 3756), verification of monitoring to the preventive control, verification of
B. Proposed § 117.155(a)—Verification implementation and effectiveness in
Activities is consistent with the FSIS HACCP
regulation for meat and poultry, which accordance with § 117.165. See section
1. Proposed § 117.155(a)(1)—Validation requires direct observations of XXXIV for comments on verification of
monitoring activities as an ongoing implementation and effectiveness.
We proposed that verification
activities must include, as appropriate verification activity (9 CFR 5. Proposed § 117.155(a)(5)—Reanalysis
to the preventive control, validation in 417.4(a)(2)(ii)). We disagree that our
example of how verification of We proposed that verification
accordance with § 117.160. See section activities must include, as appropriate
XXXIII for comments on validation as a monitoring could be conducted when a
metal detector is a preventive control is to the preventive control, reanalysis in
verification activity. accordance with § 117.170. See section
impractical; observation of the operator
2. Proposed § 117.155(a)(2)— conducting the check with test pieces by XXXV for comments on reanalysis as a
Verification of Monitoring a supervisor, or having a quality verification activity.
We proposed that verification assurance person run a test, is not C. Proposed § 117.155(b)—
activities must include, as appropriate uncommon. However, in the 2014 Documentation of Verification Activities
to the preventive control, verification supplemental human preventive We proposed that all verification
that monitoring is being conducted in controls notice, we clarified that activities must be documented in
accordance with § 117.145. We verification that monitoring is being records. We received no comments that
requested comment on whether we conducted is required as appropriate to disagreed with this proposed
should specify the verification activities the preventive control. With this added requirement and are finalizing it as
that must be conducted for monitoring, flexibility, a facility could, for example, proposed.
and, if so, what verification activities determine that it would satisfy the
should be required. requirement for verification of D. Comments on Potential Requirements
(Comment 487) Comments that monitoring by reviewing records under Regarding Complaints
address our request for comment on § 117.165(a)(4). Doing so would be We requested comment on whether
whether we should specify the consistent with the NACMCF HACCP and how a facility’s review of
verification activities that must be guidelines (Ref. 35), the Codex HACCP complaints, including complaints from
conducted for monitoring ask us to not guidelines (Ref. 34), and FDA’s HACCP consumers, customers, or other parties,
do so because this prescriptive approach regulations for seafood and juice, which should be required as a component of its
would be too limiting. These comments all address verification of monitoring activities to verify that its preventive
ask us to instead provide flexibility for through the review of records (78 FR controls are effectively minimizing the
the facility to determine the appropriate 3646 at 3756). occurrence of hazards (78 FR 3646 at
verification activities. 3. Proposed § 117.155(a)(3)— 3768).
(Response 487) We agree that we Verification of Corrective Actions (Comment 490) Some comments ask
should provide flexibility for the facility us to require review of consumer
to determine these verification We proposed that verification complaints as a verification activity and
activities, and are not specifying the activities must include, as appropriate note that our HACCP regulations for
verification activities that must be to the preventive control, verification seafood and juice require that
conducted for monitoring. that appropriate decisions about verification activities include a review
(Comment 488) Some comments corrective actions are being made in of consumer complaints to determine
express concern that the proposed accordance with § 117.150. We whether they relate to the performance
requirements for verification of requested comment on whether this of the HACCP plan or reveal the
monitoring would bring food CGMPs to section should specify the verification existence of unidentified CCPs. Some
the same level as pharmaceutical activities that must be conducted for comments note circumstances in which
CGMPs. These comments assert that our corrective actions, and if so, what consumer complaints have identified
example of how verification of verification activities should be food safety problems that resulted in a
monitoring could be conducted when a required. company report to the RFR.
metal detector is a preventive control is (Comment 489) Some comments ask Some comments state that the
impractical (FR 3646 at 3756). These us not to specify the verification frequency and type of complaints a
comments explain that a quality control activities that must be conducted for facility receives is a very good indicator
officer is not likely to go out onto the corrective actions because this approach of the underlying issues associated with
plant floor every shift to verify the would be too limiting. These comments food production, reviewing these
operator’s metal detector readings but ask us to instead provide flexibility for records would provide valuable insight
would instead document the metal the facility to determine the appropriate into the type of issues that should be
detector readings, which would be verification activities. investigated, and this type of
captured as part of the batch record (Response 489) We agree that we verification activity could be therefore
review. These comments suggest that a should provide flexibility for the facility be extremely effective with little to no
more appropriate description of what a to determine the appropriate cost because the facility would already
facility would do when a metal detector verification activities for corrective be performing this type of activity.
is a preventive control would be to actions, and are not specifying the Some comments state that many
foodborne outbreaks have been to food safety. Other comments assert XXXIII. Subpart C: Comments on
identified through complaints and a that complaints would be acted upon Proposed § 117.160—Validation
review of complaints is a critical immediately for business reasons, and
component of a food safety system. that waiting to react to complaints until We proposed to establish
Other comments state that a food conducting a review of records as a requirements for validation of
safety review of complaints is a prudent verification activity would be too late. preventive controls. Some comments
part of a food safety program but that Other comments assert that complaints support the proposed requirements
the value of such a review is in are sensitive business information. without change. For example, some
providing information and feedback for Other comments assert that some comments agree that validation must be
continuous improvement of the food consumer complaints are false or performed by (or overseen by) a
safety management system rather than emotional (rather than factual) and have preventive controls qualified individual
as a verification of preventive controls. no place in development of preventive and that some preventive controls (e.g.,
These comments caution against use of controls. Some comments assert that food allergen controls, sanitation
consumer complaints as a regulatory FSMA does not expressly direct us to controls, and recall plans) do not
requirement for verification of the food require review of complaints. Some require validation. Some comments that
safety plan because most complaints comments assert that review of support the proposed provisions suggest
relate to product quality. If such a complaints is not a precise scientific alternative or additional regulatory text
requirement is nonetheless established process, and that consumer comments (see, e.g., Comment 491, Comment 500,
in the final rule, these comments are often open to different Comment 501, Comment 503, and
recommend that the rule only require interpretations. Comment 513) or ask us to clarify how
follow-up and documentation for the (Response 490) We are not we will interpret the provision (see, e.g.,
rare occurrences where consumer establishing a requirement for a review Comment 499, Comment 502, and
complaints relate to food safety issues. of complaints as a verification activity. Comment 508).
Other comments ask us not to require We agree that review of complaints is In the following paragraphs, we
review of complaints as a verification more likely to be useful in providing discuss comments that ask us to clarify
activity. Some of these comments assert information and feedback for the proposed requirements or that
that complaints rarely relate to food continuous improvement of the food disagree with, or suggest one or more
safety or yield information that leads to safety system rather than as a changes to, the proposed requirements.
discovery of a food safety issue. Some verification of preventive controls. After considering these comments, we
comments assert that requiring review However, we encourage facilities to do have revised the proposed requirements
of consumer complaints could result in such a review, as they occasionally do as shown in table 37, with editorial and
unnecessary time and effort being spent uncover food safety issues such as an conforming changes as shown in table
on an activity with a limited correlation undeclared allergen. 52.
TABLE 37—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VALIDATION

117.160(a) ....................................... Flexibility for validating preventive Provide that validation be conducted as appropriate to both the na-
controls. ture of the preventive control and its role in the facility’s food safety
system.
117.160(b)(1) ................................... Circumstances requiring validation Provide that, when necessary to demonstrate the control measures
can be implemented as designed, validation may be performed: (1)
Within 90 days after production of the applicable food first begins;
or (2) within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation
of) a written justification.
117.160(b)(1) ................................... Circumstances requiring validation Add an additional circumstance requiring validation—i.e., whenever a
change to a control measure or combination of control measures
could impact whether the control measure or combination of control
measures, when properly implemented, will effectively control the
hazards requiring a preventive control.
117.160(c) ....................................... Preventive controls that do not re- Clarify that a list of preventive controls that do not require validation
quire validation. is not an exhaustive list.
A. Flexibility in the Requirements To the 2014 supplemental human text specifies that validation
Validate Preventive Controls preventive controls notice because the requirements apply ‘‘as appropriate to
With some exceptions (see discussion regulatory text (i.e., ‘‘[e]xcept as the nature of the preventive control,’’
of proposed § 117.160(b)(3) in section provided by . . .’’) narrowly provides that phrase could be interpreted to mean
XXXIII.D), we proposed that you must exceptions only for validation of food that only the validation act itself can be
validate that the preventive controls allergen controls, sanitation controls, tailored and that the facility does not
identified and implemented in supplier controls, and the recall plan, have the flexibility to conclude that
accordance with proposed § 117.135 to whereas the preamble discussion validation isn’t necessary.
control the significant hazards are provides other examples of preventive Some comments assert that the
adequate to do so (proposed controls that would not require proposed regulatory text would prevent
§ 117.160(a)). validation (i.e., zoning, training, us from requiring validation of specific
(Comment 491) Some comments preventive maintenance, and allergen or sanitation controls where it
assert that the regulatory text is in refrigerated storage). These comments may be prudent to do so, either now or
conflict with the preamble discussion in also assert that although the regulatory in the future as a result of a newly
identified hazard, establishment of (Comment 493) Some comments (Response 496) GFSI was established
regulatory allergen threshold(s), or the assert that validation is more to support improvements in food safety
development of a tool, such as a test appropriate for a HACCP regulation and management systems to ensure
method, that would enable validation of that requiring the validation of all confidence in the delivery of safe food
the control for the specific hazard. preventive controls does not reflect the to consumers worldwide (Ref. 83). GFSI
(Response 491) We have deleted flexibility mandated by section has developed a guidance document
‘‘except as provided by paragraph (b)(3) 418(n)(3)(A) of FSMA. Other comments that specifies a process by which food
of this section’’ from proposed assert that effective preventive measures safety schemes may gain recognition by
§ 117.160(a) to remove the limitation may be identified in the future that are GFSI, the requirements to be put in
seen by the comments on the exceptions not amenable to validation and it would place for a food safety scheme seeking
to the requirement for validation of be counterproductive for them not to be recognition by GFSI, and the key
preventive controls. We also have employed in food safety plans because elements for production of safe food or
revised the regulatory text of they cannot meet the validation feed, or for service provision (e.g.,
§ 117.160(c) to provide that a facility requirements. These comments explain contract sanitation services or food
does not need to validate other that certain control measures are not transportation), in relation to food safety
preventive controls, if the preventive suitable for validation activities due to (Ref. 83). We have no plans to endorse
controls qualified individual prepares the nature of the activity or previous certification under GFSI (or any other
(or oversees the preparation of) a written validation by another entity (e.g., a standard setting organization) as
justification that validation is not supplier). satisfying the requirements for
applicable based on factors such as the (Response 493) The 2013 proposed validation. However, to the extent that
nature of the hazard, and the nature of human preventive controls rule would scientific and technical information
the preventive control and its role in the not have required the validation of all available from GFSI or another standard
facility’s food safety system. We preventive controls. For example, we setting organization provides evidence
specified that the determination that specifically proposed that the validation that a control measure, combination of
validation is not required must be made of preventive controls need not address control measures, or the food safety plan
by the preventive controls qualified food allergen controls, sanitation as a whole is capable of effectively
individual to emphasize that specialized controls, and the recall plan. To controlling the identified hazards, a
experience is necessary to evaluate emphasize that a facility has flexibility facility may use such information to
whether validation is required. We in appropriately determining which satisfy the validation requirements of
made a conforming revision to the list other preventive controls require the rule.
of responsibilities of the preventive validation, in the 2014 supplemental (Comment 497) Some comments ask
controls qualified individual (see human preventive controls notice we us to provide guidance and clarification
§ 117.180(a)). revised the proposed regulatory text to on topics relevant to validation, such as
(Comment 492) Some comments ask commodity-specific guidance to help
require validation ‘‘as appropriate to the
us to separate requirements for facilities understand what preventive
nature of the preventive control.’’ See
validation from requirements for controls are capable of being validated
(Response 491 for additional revisions
verification because verification and and to design testing to ensure
we have made to the regulatory text to
validation are two different concepts validation conditions always exceed
and combining them is confusing. Some provide flexibility for a facility to
conditions during production. Some
comments point out that while section determine that validation is not
comments ask us to clarify our
418(f)(1) of the FD&C Act explicitly necessary.
expectations for a validated process and
requires verification, it does not require (Comment 494) Some comments ask on conducting studies for validation
validation. Some of these comments us to allow validation of the whole purposes, particularly for preventive
assert that our proposed requirements system instead of individual controls. controls applied to fresh and fresh-cut
for validation exceed the mandate of (Response 494) See the discussion of produce (such as reduction of pathogens
FSMA while others argue that the lack the definition of validation in Response in wash water for fresh-cut leafy greens
of explicit language in section 418 of the 150. Under the definition, validation with the use of sanitizers, which the
FD&C Act gives us legal flexibility in can be directed to a control measure, comments characterize as scientifically
determining whether and how to require combination of control measures, or the difficult and time consuming). Some
validation. food safety plan as a whole. comments ask us to provide resources
(Response 492) Our approach is (Comment 495) Some comments ask for validation, noting that some
consistent with section 418 of the FD&C us to align validation requirements with preventive controls will be difficult to
Act. Section 418(f)(1) of the FD&C Act the relative risk of operations. validate and that no scientific research
requires verification of the preventive (Response 495) Validation or data are available for certain controls.
controls, and validation is an element of requirements apply only to preventive Some comments ask us to delay
verification (see both the NACMCF controls that are established and enforcement for the validation
HACCP guidelines (Ref. 35) and our implemented based on the outcome of a requirements until a readily accessible
HACCP regulation for juice (§ 120.3(p)). hazard analysis, which requires repository of validated processes, and
We agree that the purpose of validation consideration of risk. We also require scientific and technical information, can
is different from the purpose of other validation as appropriate to the nature be created to assist stakeholders in
verification activities, and we have of the preventive control and its role in complying with the validation
revised the definitions of both terms to the facility’s food safety system. This requirements.
make this clearer. Although we are provides flexibility with respect to (Response 497) We intend that the
establishing a separate regulatory validation and allows consideration of guidance we are developing will
section for the validation requirements, risk. address topics such as those
we did so to improve clarity and (Comment 496) Some comments ask recommended in the comments. (See
readability rather than as a substantive whether we will endorse certification Response 2.) In addition, there is a
change relevant to the issues discussed under GFSI as satisfying the ‘‘wash water validation group’’ with
in these comments (See Response 150). requirements for validation. members from government (including
FDA, USDA and CDC) and industry reanalysis of the food safety plan reveals Guidelines (Ref. 84). Some comments
(including producers, chemical the need to do so. note that food additives may only be
suppliers, and equipment suppliers) (Comment 499) Some comments ask produced a few times per year at plants
developing information on how to us to clarify whether an individual that also produce industrial, cosmetic,
validate the efficacy of antimicrobial attending food safety training by an and excipient grade products, and that
chemicals in wash water for fresh-cut entity such as a cooperative extension or this production schedule may make it
produce processes to demonstrate that a State department of agriculture could impractical to meet the proposed 6-
the antimicrobials in the washing be a ‘‘preventive controls qualified week timeframe. Some comments note
process are effective for minimizing the individual’’ for the purpose of that the seasonal nature of production of
risk of cross-contamination. The FSPCA performing or overseeing the validation some food products may make it
and the Produce Safety Alliance (PSA) of preventive controls. impractical to perform all required
are developing information for training, (Response 499) See the discussion in validations within 6 weeks. Some
which may be useful to facilities, section XXXVI.B.1 for additional comments suggest that validation be
including facilities that process information about training applicable to performed within a specified number of
produce. We are not requiring facilities a preventive controls qualified production batches, such as 10
to comply with the rule, including the individual. We have not specified production batches. Some comments
validation requirements, for 1, 2, or 3 additional requirements for a preventive emphasize the need for flexibility and
years depending on the size of the controls qualified individual with ask us to both adopt a 90-day timeframe
facility. We expect that segments of the respect to validation. A person may be and provide for a longer timeframe with
food industry will work together and a preventive controls qualified a written justification, or provide for
with the FSPCA and the PSA to develop individual through job experience, as ongoing evidence of process validation.
scientific and technical information that well as training. Food safety training Some comments ask us to specify that
can be used as evidence to validate a provided by an entity such as a validation be performed within a
variety of preventive controls, and that cooperative extension specialist or a reasonable time as justified by the
this information will be helpful to State department of agriculture could be preventive controls qualified individual.
facilities. appropriate training for many of the Some comments ask for more time for
functions of the preventive controls small businesses to perform validation
qualified individual if the training is studies.
us to develop a mechanism for industry
consistent with the standardized
to make sure their approach and studies (Response 501) We note that the 90-
curriculum being developed by the
meet the requirements of the rule, such day timeframe for validation is
FSPCA.
as certification of process authorities or (Comment 500) Some comments that established in FSIS’ regulations at 9 CFR
the establishment of a liaison between discuss the distinction between 304.3(b) and (c) and 9 CFR 381.22(b)
FDA and industry to ensure validation validation and verification ask us to and (c) (Conditions for receiving
protocols are in compliance. align with the distinction made in FSIS’ inspection for meat and meat products
(Response 498) As discussed in Compliance Guidelines on HACCP and poultry and poultry products,
Response 2, we are developing several Systems Validation (FSIS Validation respectively). The FSIS Validation
guidance documents within FDA, Guidelines) (Ref. 84). As discussed in Guidelines are a companion to those
including guidance on validation. In those guidelines, there are two distinct regulations. We have revised the
addition, as part of a collaborative effort elements to validation: design and regulatory text, with associated editorial
with the FSPCA we are obtaining execution. The design element changes, to make two changes to the
technical information useful for addresses the scientific or technical proposed 6-week timeframe for
developing commodity/industry sector- support for the system design, and the validation of preventive controls. First,
specific guidelines for preventive execution element addresses the initial, we have adopted the 90-day timeframe
controls and outreach to industry, and practical, in-plant demonstration that already established in FSIS’ regulations
we intend that effort to include the system can perform as expected. by specifying that when necessary to
guidance on approaches to satisfy the (Response 500) As discussed in demonstrate the control measures can
validation requirements of the rule. We Response 150, the definition of be implemented as designed, validation
do not intend to develop a mechanism validation focuses on whether a control may be performed within 90 days after
for certification of process authorities or measure, combination of control production of the applicable food first
establish a liaison between FDA and measures, or the food safety plan as a begins. Although we had proposed a 6-
industry to ensure validation protocols whole is capable of controlling the week timeframe based on the 3 to 6-
are in compliance. The guidance we are identified hazards and, thus, captures week timeframe suggested in the Codex
developing on validation should help the design element of validation. We Guidelines for the Validation of Food
industry determine whether their have revised the validation Safety Control Measures (Ref. 39)
validation approaches are likely to be requirements to clarify that it may be (Codex Validation Guidelines), we agree
acceptable to us. necessary to perform validation during that practical limitations associated
production to demonstrate the control with the production of some food
B. Proposed § 117.160(b)(1)—When
measures can be implemented as products may make it difficult to
Validation Must Be Performed and Role
designed. perform validation within 6 weeks. The
of the Preventive Controls Qualified
(Comment 501) Some comments 90-day timeframe in FSIS’ regulations,
Individual in Validation
question whether 6 weeks is enough and incorporated into the FSIS
We proposed that validation of the time to perform all applicable validation Validation Guidelines, reflects more
preventive controls must be performed studies that would address the than 15 years of experience with
by (or overseen by) a preventive controls execution element of validation. Some validating HACCP systems for meat and
qualified individual prior to comments ask us to explain the basis for poultry. Although we have provided for
implementation of the food safety plan the proposed 6-week timeframe. Some validation to be performed within 90
(or, when necessary, during the first 6 comments ask us to align with the 90- days after production of the applicable
weeks of production) and whenever a day timeframe in the FSIS Validation food first begins, we do not believe it
would take a full 90 days of production (Response 503) We have revised the (Comment 506) As discussed in
to determine whether the facility can regulatory text to require validation Comment 150, some comments ask us to
provide assurances that a control whenever a change to a control measure revise the definition of ‘‘validation’’ to
measure is working as intended to or combination of control measures be consistent with the Codex
control the hazard. could impact whether the control definitions.
Second, we have provided for measure or combination of control (Response 506) The Codex definition
validation within a reasonable measures, when properly implemented, of validation is ‘‘Obtaining evidence
timeframe, provided that the preventive will effectively control the hazards that a control measure or combination of
controls qualified individual prepares requiring a preventive control. Under control measures, if properly
(or oversees the preparation of) a written this provision, a facility would re- implemented, is capable of controlling
justification for a timeframe that validate a preventive control if, for the hazard to a specified outcome.’’ The
exceeds 90 days after production of the example, a different type of equipment definition of ‘‘validation’’ we are
applicable food first begins. We is used to deliver a heat process, establishing in this rule specifies that
acknowledge that practical limitations because it would be necessary to validation means obtaining and
such as those described in the determine that the new equipment can evaluating scientific evidence that a
comments could prevent a facility from consistently achieve the required control measure, combination of control
performing the validation within 90 temperature and time of the process. measures, or the food safety plan as a
days after production of the applicable However, a facility would not need to whole, when properly implemented, is
food first begins. A timeframe that re-validate a preventive control if, for capable of effectively controlling the
exceeds 90 days after production of the example, a thermal process is changed identified hazards, which more closely
applicable food first begins will be the by increasing the time or temperature, aligns with the Codex definition. As a
exception rather than the norm and we because a less stringent thermal process conforming change for consistency with
are requiring that the preventive would already have been validated. the revisions we made to the definition,
controls qualified individual provide (or (Comment 504) Some comments ask we have revised the proposed
oversee the preparation of) a written us to require validation both before requirements for validation of
justification for such a timeframe. We production and 6 weeks after preventive controls to specify that
made a conforming revision to the list production begins. validation of preventive controls must
of responsibilities of the preventive include obtaining and evaluating
controls qualified individual (see scientific and technical evidence (or,
request. A facility has flexibility to
§ 117.180(a)). when such evidence is not available or
perform validation as appropriate to the
is inadequate, conducting studies) to
(Comment 502) Some comments ask nature of the preventive controls,
determine whether the preventive
us to clarify that the time period when whether before production (e.g., by
controls, when properly implemented,
validation is performed would be obtaining and evaluating generally
will effectively control the hazards. (See
considered as production time rather available scientific and technical
also Response 150.)
than ‘‘down time.’’ These comments information or by conducting studies), (Comment 507) Some comments
explain that many farms with on-farm after production begins (to demonstrate assert that our discussion of validation
processing activities conduct those the control measures can be refers to ‘‘scientific proof’’ for the
activities sporadically for a brief period. implemented as designed during full- validation of a processing step and ask
For a processing activity that may be scale production), or both. us to define what is and is not
conducted for only 2 or 3 days within (Comment 505) Some comments considered scientific proof for
a six week period, the facility may not assert that qualified third parties should validation.
have enough production run time to conduct all process validations. (Response 507) We used terms such as
validate controls. (Response 505) The critical factor is ‘‘scientific and technical information’’
(Response 502) As discussed in that the validation be performed (or and ‘‘scientific and technical basis’’
Response 501, we have provided for overseen) by an individual who has the rather than ‘‘scientific proof’’ when
validation within a reasonable appropriate training and experience to discussing validation. For information
timeframe, provided that the preventive validate the control measures. This about what we mean by ‘‘scientific and
controls qualified individual prepares preventive controls qualified individual technical information,’’ see 78 FR 3646
(or oversees the preparation of) a written could be a third party or an employee at 3753–3754.
justification for a timeframe that of the facility. Employees of the facility (Comment 508) Some comments ask
exceeds 90 days after production of the have a vested interest in ensuring that us to clarify expectations of validations
applicable food first begins. A facility the controls are effective, including by for basic sanitary processes.
would design a preventive control that appropriately validating the controls, (Response 508) The requirements for
is valid based on scientific and just as a ‘‘disinterested’’ third party validation only apply to preventive
technical information and then would have. controls. To the extent that the comment
determine that the control can be is referring to sanitary practices
applied in the facility. It is unlikely that C. Proposed § 117.160(b)(2)—What
governed by CGMPs (such as in
this will require a full 90 days of Validation Must Include
§§ 117.35 and 117.37), the validation
production, and we see no reason for a We proposed that the validation of requirements would not apply. To the
facility to significantly extend the preventive controls must include extent that the comment is referring to
validation time—e.g., to a year or collecting and evaluating scientific and sanitation controls established as a
more—because it only produces for 2– technical information (or, when such preventive control, those sanitation
3 days every 6 weeks. information is not available or is controls are excluded from the
(Comment 503) Some comments ask inadequate, conducting studies) to validation requirements (see
us to add another circumstance when determine whether the preventive § 117.160(a)(3)(ii)).
validation would be required—i.e., controls, when properly implemented, (Comment 509) Some comments ask
whenever a change is made to the will effectively control the significant that we not require further validation of
control being applied. hazards. well-accepted preventive controls, such
as refrigeration temperature and roasting modeling, and other technical other preventive controls, if the
coffee. information from equipment preventive controls qualified individual
(Response 509) A facility may rely on manufacturers and other sources. These prepares (or oversees the preparation of)
generally available scientific and comments assert that the development a written justification that validation is
technical information to demonstrate of validation data is not appropriate for not applicable based on factors such as
the adequacy of controls such as a number of preventive controls in the nature of the hazard, and the nature
refrigeration and roasting processes for fresh-cut operations (e.g., temperature of the preventive control and its role in
coffee, but must obtain that information control, employee hygiene practices, the facility’s food safety system. We see
and establish it as a record (see and product separation protocols). no reason to also eliminate the list of
§ 117.155(b)). Other comments assert that there are a those controls for which we have
(Comment 510) Some comments variety of circumstances in which the already determined that validation is
express concern that specific methods collection and evaluation of scientific not necessary, and require each facility
are not available to enable validation. and technical information is not to develop its own rationale for
Some comments express concern that necessary (e.g., the use of sieving or concluding that validation is not
the requirement to ‘‘conduct studies’’ metal detectors to control physical necessary based on the nature of these
might be intended, or could be hazards). preventive controls. The rule would not
interpreted, to mean that firms are (Response 512) See Response 491 and prevent a facility from validating one of
required to develop or validate Response 493. We agree that not all these preventive controls, such as a food
analytical methods (either in general or preventive controls require validation, allergen control, if it chooses to do so.
for specific food matrices). These and the facility has flexibility to take (See also Response 514.)
comments assert that any such into account the nature of the (Comment 514) Some comments
requirement would incur extreme costs preventive control when determining assert that the proposed regulatory text
and burdens without delivering whether to perform validation. The would prevent us from requiring
commensurate public health benefits. regulatory text, which provides for validation of specific allergen or
(Response 510) We do not intend the scientific and technical evidence that a sanitation controls where it may be
requirement to ‘‘conduct studies’’ to control measure is capable of effectively prudent to do so, either now or in the
mean that firms are required to develop controlling the identified hazards, future as a result of a newly identified
or validate analytical methods. provides for the use of ‘‘indirect hazard, establishment of regulatory
(Comment 511) Some comments ask methods’’ as recommended by the allergen threshold(s), or the
us to clarify that dry pasta facilities comments. However, even when sources development of a tool, such as a test
would not be required to validate that such as scientific publications are the method, that would enable validation of
their extrusion or drying process basis for validation, studies may be the control for the specific hazard. Other
provides a 5-log reduction for needed to demonstrate that the process comments assert that validation of food
Salmonella. These comments assert that used can be implemented in the facility allergen controls for some food allergens
a ‘‘kill step’’ is not necessary for foods to control the hazard. For example, is possible now and that we should not
such as dry pasta because consumers scientific publications may support use preclude future requirements as it
cook the product before consumption of a specific concentration of sanitizer becomes possible to validate food
and that validation would be costly, in produce wash water to prevent cross- allergen controls for other allergens in
time-consuming, and impractical. contamination. The facility would still the future. Other comments state that a
(Response 511) The rule does not need to demonstrate it can consistently preventive controls qualified individual
require any specific performance maintain that concentration under should determine appropriate validation
standards, such as the 5-log reduction operating conditions. for food allergen controls. Other
standard in our HACCP regulation for comments state that scientific studies
juice (see § 120.24). A dry pasta facility D. Proposed § 117.160(b)(3)—Preventive
are not needed to validate food allergen
that evaluates Salmonella as a known or Controls for Which Validation Is Not controls because monitoring is
reasonably foreseeable hazard may Required sufficient.
determine that the nature of the dry We proposed that validation need not (Response 514) This rule establishes
pasta product (and, thus, its reasonably address food allergen controls, requirements that will apply when the
foreseeable use) makes it unlikely that it sanitation controls, the recall plan and rule becomes effective. It does not
would be consumed without a ‘‘kill the supplier program (which we now address the potential for additional
step’’ (i.e., cooking sufficient to refer to as the ‘‘supply-chain program’’). requirements that we could establish,
adequately reduce Salmonella) by the (Comment 513) Some comments ask through additional rulemaking, in the
consumer and the facility could us to eliminate the specific list of future. The rule does not preclude a
conclude that its extrusion or drying controls that are excluded from the facility from validating any of its food
process is not a preventive control. In validation requirement and instead allergen controls, and we encourage
contrast, when the nature of the product revise the regulatory text to provide the facilities to validate food allergen
(such as refrigerated cookie dough) is facility with flexibility to determine controls as appropriate to the facility,
such that its reasonably foreseeable use when validation is appropriate. (See the food, and the specific food allergen
includes consumption without cooking also Comment 491.) control. However, if a facility decides to
(or without cooking sufficient to (Response 513) As discussed in validate any of its food allergen
adequately reduce Salmonella) by the Response 491, we have deleted ‘‘except controls, the rule does not require that
consumer, it would not be appropriate as provided by paragraph (b)(3) of this such validation be conducted or
to rely on cooking by the consumer to section’’ from proposed § 117.160(a) to overseen by a preventive controls
control a known or reasonably remove the limitation seen by the qualified individual.
foreseeable biological hazard. comments on the exceptions to the As previously discussed, we agree
(Comment 512) Some comments requirement for validation of preventive that food allergen controls generally are
recommend validation via indirect controls. We also have revised the not evaluated through scientific studies
methods such as scientific publications, regulatory text of § 117.160(c) to provide and that monitoring (e.g., by visual
government documents, predictive that a facility does not need to validate observation) that these activities do not
result in allergen cross-contact provides are generally directed to verifying that a preventive control. We also proposed
sufficient assurance that the controls are control measure is functioning as that you must establish and implement
functioning as intended to prevent the intended rather than whether the written procedures for the frequency of
hazard of undeclared food allergens in control measure is capable of effectively calibrating process monitoring
the food due to allergen cross-contact controlling the hazard. However, they instruments and verification
(78 FR 3646 at 3755). can also be part of a validation study to instruments, product testing, and
(Comment 515) Some comments determine whether a sanitation environmental monitoring.
assert that validation of food allergen procedure effectively removes a food
controls and sanitation controls is Some comments that support the
allergen from equipment surfaces if a
already possible through sample swabs proposed provisions suggest alternative
facility decides to validate such
and, thus, that reliance strictly on visual procedures. or additional regulatory text (see, e.g.,
observation for potential allergen cross- Comment 516, Comment 519, Comment
contact and sanitation controls does not XXXIV. Subpart C: Comments on 539, Comment 540, Comment 544, and
appear to be appropriate. Proposed § 117.165—Verification of Comment 545) or ask us to clarify how
(Response 515) As discussed in Implementation and Effectiveness we will interpret the provision (see, e.g.,
Response 150, validation is directed to We proposed that you must verify that Comment 522, Comment 523, Comment
determining whether a control measure, the preventive controls are consistently 528, and Comment 536). In the
when properly implemented, is capable implemented and are effectively and following paragraphs, we discuss
of effectively controlling a hazard. significantly minimizing or preventing comments that ask us to clarify the
Procedures such as sample swabs (e.g., the significant hazards. We proposed proposed requirements or that disagree
of equipment used for food containing that to do so you must conduct specified with, or suggest one or more changes to,
an allergen to determine if the allergen activities (i.e., calibration, product the proposed requirements. After
protein is present after cleaning, and of testing, environmental monitoring, and considering these comments, we have
equipment following a dry cleaning review of records) as appropriate to the revised the proposed requirements as
procedure to determine microbial load) facility, the food, and the nature of the shown in table 38.
TABLE 38—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VERIFICATION OF IMPLEMENTATION AND EFFECTIVENESS
117.165(a) ............................ Flexibility in the requirement to conduct activities to Provide that activities for verification of implementation
verify implementation and effectiveness. and effectiveness take into account both the nature
of the preventive control and its role in the facility’s
food safety system.
117.165(a)(1) ....................... Verification of implementation and effectiveness for Provide for accuracy checks in addition to calibration.
process monitoring instruments and verification in-
struments.
117.165(a)(4)(i) .................... Timeframe for review of records of monitoring and cor- Provide for records review within 7 working days after
rective action records. the records are created, or within or within a reason-
able timeframe, provided that the preventive controls
qualified individual prepares (or oversees the prepa-
ration of) a written justification.
117.165(a)(5) ....................... Other activities appropriate for verification of implemen- Clarify that there could be alternative verification activi-
tation and effectiveness. ties of implementation and effectiveness other than
those that we specify in the rule.
117.165(b) ............................ Written procedures for verification of implementation Clarify that written procedures for verification of imple-
and effectiveness. mentation and effectiveness are established and im-
plemented as appropriate to the role of the preven-
tive control in the facility’s food safety system, as well
as appropriate to the facility, the food, and the nature
of the preventive control.
117.165(b)(1) ....................... Written procedures for verification of implementation Require written procedures for accuracy checks in addi-
and effectiveness for process monitoring instruments tion to calibration.
and verification instruments.
A. Flexibility in the Requirement To testing; (3) environmental monitoring; environmental monitoring, and review
Conduct Activities To Verify and (4) review of records. of records more specifically.
Implementation and Effectiveness In the following paragraphs, we (Comment 516) Some comments
discuss comments generally directed to express support for the flexibility
We proposed that you must verify that the need for a facility to have flexibility provided by specifying that verification
the preventive controls are consistently to apply these requirements activities must be conducted ‘‘as
implemented and are effectively and (particularly the requirements for appropriate to the facility, the food, and
significantly minimizing or preventing product testing and environmental the nature of the preventive control.’’
the significant hazards by conducting monitoring) in a manner that works best Some comments state that the proposed
specified activities as appropriate to the for the facility in light of its food provision means that, based on risk, a
facility, the food, and the nature of the products and the nature of the fresh fruit packing operation could
preventive control. We proposed to preventive controls that would be decide whether or not to do product
specify the following verification verified. In sections XXXIV.B through testing and, when applicable, the type of
activities: (1) Calibration; (2) product XXXIV.F, we discuss the requirements test and the testing frequency. Some
for calibration, product testing, comments agree with the proposed
provisions because they address product (Response 516) The provisions for 17149–17151). As with environmental
testing through flexible written verification provide flexibility by monitoring, product testing must be
procedures that consider both testing specifying that they apply as conducted as appropriate to the facility,
and corrective action plans rather than appropriate to the nature of the the food, and the nature of the
through mandatory or prescribed preventive control and its role in the preventive control. For example, a raw
requirements. Other comments agree facility’s food safety system. As noted material or other ingredient added to an
with the proposed provisions because by some comments, the provisions RTE food after a pathogen ‘‘kill step’’
they require facilities to develop and address testing through flexible written must be tested before use when the raw
use testing programs that are tailored to procedures that allow facilities to material or other ingredient has been
their facility, equipment, processes, develop and use testing programs that associated with a pathogen and has not
products, and other specific are tailored to their facility, equipment, been treated to significantly minimize or
circumstances and do not prescribe processes, products, and other specific prevent that pathogen (e.g., spices
specific requirements for testing, such circumstances. We agree that an added to snack chips, a food that has
as finished product testing. Some appropriate outcome of the hazard been previously involved in an outbreak
comments state that product testing may analysis for some facilities will be that of foodborne illness). Product testing
not be effective in identifying the product testing and environmental would be required because it is
acceptability of a specific ingredient or monitoring are not required; it is not appropriate to the facility (one making
finished product lot on any given day, necessary to grant an ‘‘exemption’’ to an RTE food), the food (spiced snack
but it can help assess and verify the allow a facility to achieve this outcome. chips), and the nature of the preventive
effectiveness of a food safety plan as a For example, environmental monitoring control (there is no control applied to
whole and the facility’s capability to would be required to verify the spices added to the snack chips).
consistently deliver against it. effectiveness of sanitation controls When process control testing for an
Some comments assert that the when an RTE food is exposed to the indicator organism, or environmental
preamble discussion in the 2014 environment prior to packaging and the monitoring for an indicator organism,
supplemental human preventive packaged food does not receive a indicates an RTE food is reasonably
controls notice is in conflict with the treatment or otherwise include a control likely to be contaminated with a
proposed regulatory text and ask us to measure (such as a formulation lethal to pathogen, that food must be tested for
modify the regulatory text to provide the the pathogen) that would significantly the pathogen. For example, if
flexibility we signaled in that minimize the pathogen because such environmental monitoring reveals food-
supplemental notice. These comments environmental monitoring is contact surfaces that are used in the
express concern that the term ‘‘must’’ appropriate to the facility (one production of soft cheese are
(i.e., ‘‘you must conduct activities that manufacturing RTE foods), the food (an contaminated with Listeria spp. and
include the following’’) could be RTE food exposed to the environment), additional environmental monitoring
interpreted to mean that activities listed and the nature of the preventive control following corrective actions indicates
in the regulatory text (in particular, (sanitation controls). Foods such as food-contact surfaces are still
product testing and environmental peanut butter, soft cheeses, dried dairy contaminated with Listeria spp.,
monitoring) are always required in some products for use in RTE foods, and product testing would be required
form. Some comments ask us to clarify roasted nuts are among the products for because it is appropriate to the facility
whether product testing and (one making an RTE food), the food (soft
which manufacturing operations would
environmental monitoring are required cheese, which supports the growth of L.
need to have an environmental
or optional. Other comments assert that monocytogenes), test results from
monitoring program when such foods
facilities should have the flexibility to environmental monitoring (which show
are exposed to the environment. In an
determine whether to conduct product the presence of an indicator organism
FDA memorandum on environmental
testing and environmental monitoring for L. monocytogenes on food-contact
monitoring, we discuss several
based on a risk assessment. Some surfaces in the food processing
outbreaks of foodborne illness attributed
comments assert that there are environment), and the nature of the
to contamination from the environment
circumstances (such as in warehouses preventive control (sanitation controls
(Ref. 55). These examples illustrate the
and distribution centers; in the to prevent contamination by
severe consequences that can occur environmental pathogens, which appear
production of gases used in food; in
operations that hull and shell nuts; and when environmental pathogens to be inadequate).
in the production of refined vegetable contaminate a product as a result of The word ‘‘must’’ specifies the type of
oils) where these tests would not be inadequate preventive controls and how activities that a facility can use to satisfy
necessary. Some comments assert that a environmental monitoring can be used the requirements for a particular
determination to conduct environmental to verify the adequacy of the preventive preventive control management
monitoring should be on a case-by-case controls. component, and we are retaining the
basis and that other verification We discuss product testing for term ‘‘must.’’ However, we agree that
activities may be used (such as process microbial pathogens in another FDA the rule should provide flexibility for
verifications or testing of intermediates) memorandum, including the use of additional verification of
to verify implementation and pathogens and indicator organisms and implementation and effectiveness. To
effectiveness. Some comments assert microbial testing of foods for process provide that additional flexibility, we
that there would be no reason to control and for problem solving (Ref. have revised the specific requirements
conduct environmental monitoring in 85). The circumstances in which for verification of implementation and
the shell egg processing plant, given the product testing would be required are effectiveness to provide for other
testing in henhouses required by part dependent on a variety of factors, as activities appropriate for verification of
118. Other comments ask us to exempt described in that memorandum and in implementation and effectiveness (see
operations when their hazard analysis the Appendix to the 2013 proposed § 117.165(a)(5)). (See also Response
appropriately concludes that there is no human preventive controls rule (78 FR 486.)
foreseeable risk. 3646 at 3818–3820, with reference (Comment 517) Many comments ask
See also Comment 486. numbers corrected in 78 FR 17142 at us to issue guidance, rather than
requirements, for product testing and publish a list of possible topics for and to verify that such measures are
environmental monitoring based on future guidance each year; seek input in effective through environmental
concerns such as the following: The advance from the sustainable agriculture monitoring.
value of environmental monitoring will and local/regional food system We have acknowledged limitations of
be reduced if it becomes a minimum community before preparing draft product testing (78 FR 3646 at 3819–
regulatory requirement; in many cases guidance (including public meetings, 3820) and agree that a facility should
environmental pathogens can be workshops, and formation of an consider such limitations when
eliminated by proper preparation by the advisory committee); hold public determining whether to conduct
consumer; there are well-known meetings on draft guidance after product testing and keep such
limitations to product testing and publication; and present draft guidance limitations in mind when obtaining
negative results from product testing to an advisory committee including negative results from product testing.
can create a false sense of security; representatives from the sustainable We also agree that product testing is not
product testing is not preventive, would agriculture and local/regional food preventive. However, the mere facts that
put industry into a reactive mode, and system community. there are limitations, and that product
would pull valuable resources from (Response 517) We are retaining the testing is itself not a preventive
activities focused on preventing requirements for product testing and measure, do not eliminate all benefits of
contamination; there is limited environmental monitoring in the rule, product testing; we agree with
technology available to test fresh with the revisions, already discussed, to comments (described in Comment 516)
produce, and limited time available due provide that verification activities that although product testing may not be
to the perishable nature of the depend on the role of the preventive effective in identifying the acceptability
commodity; any regulatory requirement control in the facility’s food safety of a specific ingredient or finished
will soon be outdated as products system (see Response 455); corrective product lot on any given day, it can help
change and science improves; neither action procedures depend on the nature assess and verify the effectiveness of a
product testing nor environmental of the hazard (see Response 470); and food safety plan as a whole and the
monitoring are required by HACCP written procedures for product testing facility’s capability to consistently
systems; product testing would vastly and environmental monitoring are deliver against it. We agree that there is
increase the cost of the rule and will established and implemented as limited technology available to test fresh
drive many businesses out of business appropriate to the role of the preventive produce and expect testing of fresh
without necessarily improving food control in the facility’s food safety produce by a facility as a verification of
safety; and requirements for product system (see Response 455). These
its food safety plan as a whole would be
testing would require the States to direct revisions clarify in the regulatory text
the exception rather than the norm.
resources to respond to non-compliant the flexibility that we discussed in the
2014 supplemental human preventive We disagree that regulatory
product testing results, and such
controls notice (79 FR 58524 at 58543– requirements for product testing and
resources would be better directed to
58545). Some of the comments that ask environmental monitoring will soon be
environmental monitoring.
Some of these comments emphasize us to issue guidance rather than outdated as products change and
the need for flexibility so that product requirements appear to believe that only science improves; the rule requires
testing and environmental monitoring guidance can provide sufficient reanalysis of the food safety plan as a
are options that are available to the flexibility for product testing and whole at least every 3 years, and
facility rather than requirements for all environmental monitoring. This is not requires reanalysis of the food safety
facilities. Other comments assert that the case. See Response 516. plan as a whole, or the applicable
guidance provides greater opportunity We disagree that environmental preventive control, in light of new
for industry innovation and stakeholder monitoring will be become a minimum information (see § 117.170(a) and (b)(2)).
participation to determine the regulatory requirement in all cases; the We disagree that the lack of specific
appropriate use of verification decision to conduct environmental provisions for product testing and
measures, and avoids a ‘‘one-size-fits- monitoring is made by the facility and environmental monitoring in HACCP
all’’ approach to regulations. Some of some comments discuss specific systems should preclude us from
these comments state that we should examples of when environmental establishing requirements for product
encourage environmental monitoring to monitoring or product testing would not testing and environmental monitoring in
be conducted ‘‘through facility specific be warranted (see Comment 516). We this rule; as previously discussed, not
food safety plans,’’ which would acknowledge that in some cases every provision in section 418 of the
provide the flexibility necessary to environmental pathogens can be FD&C Act is identical to HACCP as
monitor risks associated with exposures eliminated by proper preparation by the described in current literature (78 FR
of RTE foods. Other comments state that consumer, but this rule will not change 3646 at 3660). Moreover, the HACCP
operators should be given the necessary consumer behavior (see, e.g., our systems have provisions for verification
flexibility to implement any discussion of a prepackaged, activities, as we consider these to be.
requirements in the most effective and refrigerated cookie dough that was We agree that there are some costs to
efficient manner using a risk-based implicated in an E. coli O157:H7 product testing, but the rule provides
approach and taking into account the outbreak that caused 76 confirmed cases flexibility for the facility to determine
specific conditions of their facilities and of illness, including 35 hospitalizations when product testing is appropriate. We
operations. Some comments express (78 FR 3646 at 3665)). Also, as noted in acknowledge that the States will be
concern that including a requirement Response 390, we note that many required, in many cases, to follow up on
makes it difficult for businesses to consumers do not follow some cooking positive findings obtained during
justify a conclusion that testing is not instructions. Moreover, the fact that product testing but disagree that this is
necessary. consumer preparation would be capable a reason to eliminate the proposed
Some comments ask us to solicit of eliminating an environmental requirements. The States would only be
drafts of proposed guidance documents pathogen is not a reason to not take directing resources when the findings
from the sustainable agriculture and reasonable measures to prevent indicate contamination of food, and
local/regional food system community; contamination from the environment doing so will protect public health.
We will follow the procedures in C. Comments Directed to Proposed (Comment 522) Some comments ask
§ 10.115 for issuing guidance Requirements for Both Product Testing us to clarify that tests can be performed
documents. Under § 10.115(f), members (Proposed § 117.165(a)(2) and (b)(2)) by third-party facilities or laboratories,
of the public can suggest areas for and Environmental Monitoring as well as by the facility itself. Some
guidance document development and (Proposed § 117.165(a)(3) and (b)(3)) comments ask us to clarify that we will
submit drafts of proposed guidance accept test results in the same format as
documents for FDA to consider. Under We proposed that to verify that the the format used for other purposes, such
§ 10.115(g), after we prepare a draft preventive controls are consistently as third-party certification services.
guidance we may hold public meetings implemented and are effectively and (Response 522) The rule places no
or workshops, or present the draft significantly minimizing or preventing restrictions on who conducts testing.
guidance document to an advisory the significant hazards you must However, facilities have a responsibility
committee for review; doing so is not conduct activities that include product to choose testing laboratories that will
common and is determined on a case- testing and environmental monitoring, produce reliable and accurate test
by-case basis. as appropriate to the facility, the food, results. (See Response 524.) The rule
and the nature of the preventive control does not specify the format of test
(§ 117.165(a)(2) and (a)(3)). We also results, provided that the record
us to consider the volume of product
proposed that you must establish and documenting testing satisfies the
produced in establishing the verification
implement written procedures for recordkeeping requirements of subpart
testing requirements because volume-
product testing and for environmental F.
based testing is a way to address the
monitoring. (Comment 523) Some comments
burden that testing requirements may
create for small facilities. (Comment 520) Some comments ask express concern about requirements for
us to revise the regulatory text to be product testing and environmental
explicit that there are circumstances monitoring in light of section 202 of
request. Although a facility would
when product testing and FSMA (section 422 of the FD&C Act).
establish the frequency of testing if it
environmental monitoring would not be (Section 422 of the FD&C Act addresses
determines, through its hazard analysis,
necessary. laboratory accreditation for the analyses
that product testing or environmental
(Response 520) We decline this of foods, including use of accredited
monitoring is warranted, volume does
request. We discussed examples laboratories in certain circumstances
not play a role in most statistical and including requirements for
sampling plans. See the discussion of relevant to this request in memoranda
that we placed in the docket for this rule accredited laboratories to report the
statistical sampling plans in the results of laboratory testing to FDA in
Appendix to the 2013 proposed human as references to the 2014 supplemental
human preventive controls notice (Ref. certain circumstances.) These comments
preventive controls rule (78 FR 3646 at express concern that requirements for
3819–3820). 55) (Ref. 85). However, the actual
decision as to whether product testing facilities to submit results of
B. Proposed § 117.165(a)(1)— and environmental monitoring are environmental monitoring to us will
Calibration warranted depend on the actual facility create an additional disincentive to
and its food product, as well as the looking for pathogens established in the
We proposed to require calibration of facility. These comments assert that the
process monitoring instruments and nature of the preventive control and its
role in the facility’s food safety system, results of environmental monitoring
verification instruments. tests should be available to us for
(Comment 519) Some comments and a slight variation on circumstances
that would lead one facility to conclude inspection but not submitted to us if
distinguish ‘‘calibration’’ from an product has not been distributed and
accuracy check, which the comments that such testing programs were not
required could lead a different facility to that submitting the results of routine
describe as a test to confirm that a tests would be burdensome without
particular equipment or measurement the opposite conclusion.
benefit. These comments ask us to
device is accurate. These comments (Comment 521) Some comments clarify whether facilities or laboratories
assert that calibration may not be discuss topics for us to include in would be required to submit the results
possible for certain equipment or guidance on procedures for product of environmental monitoring tests to us.
measurement devices, and the testing and environmental monitoring, Likewise, some comments ask us to
appropriate corrective action may be such as which pathogens to test for; the clarify whether product testing
replacement or application of corrective range of products that should be tested; (including testing of raw materials or
values. These comments ask us to circumstances that warrant testing; what other ingredients as part of supplier
specify that an accuracy check may be a facility would document and what controls) is subject to the requirements
used as a verification activity in lieu of factors the facility would consider of section 422 of the FD&C Act for using
calibration. before determining that product testing accredited laboratories and for reporting
(Response 519) We have revised the is not appropriate for its food product; test results to us. Other comments ask
proposed requirements to require frequency of sampling and number of us to establish standards and procedures
calibration of process monitoring samples to be collected; actions to take for certifying laboratories that would
instruments and verification after a positive result; available test perform the tests. These comments
instruments, or checking them for methods; reporting requirements for assert that these standards and
accuracy. However, if the outcome of an results; compliance strategies; and procedures are needed to ensure the
accuracy check is that a process criteria for laboratories conducting the credibility of the testing and to provide
monitoring instrument or verification testing. direction for facilities that establish in-
instrument is not accurate, the facility (Response 521) The memoranda that house testing facilities. Other comments
must follow up by calibrating the we placed in the docket for this rule as urge us to establish regulations
device, rather than by applying references to the 2014 supplemental implementing section 422 of the FD&C
corrective values, when it is practical to human preventive controls notice (Ref. Act because they would complement
do so and replace the device when it is 55) (Ref. 85) address many of these the requirements of the human
not practical to calibrate it. topics. preventive controls rule and because
model laboratory standards that address have a responsibility to choose testing because certain produce RACs are
quality controls, proficiency testing, labs that will produce reliable and classified as RTE foods. Other
training, and education of laboratory accurate test results even if the rule does comments reiterate requests that we not
personnel offer the protections not require the facility to specify interpret produce held in vented crates
necessary for ensuring reliable, accurate whether the laboratory is accredited. to be ‘‘exposed to the environment,’’ so
test results. Other comments assert that (Comment 525) Some comments that facilities that only hold food could
if laboratories are not accredited or express concern about how the qualify for the exemption for facilities
samples are not collected in a sanitary requirements for product testing will solely engaged in the storage of
manner, there is no guarantee the results apply to the produce industry. For unexposed packaged food. These
will be scientifically valid. example, some comments assert that comments assert that holding produce
(Response 523) Section 422 of the product testing on intact RACs is not an in vented crates presents a low risk of
FD&C Act would require, in relevant effective way to ensure food safety and contamination from environmental
part, that food testing be conducted by assume that product testing would pathogens and that environmental
an accredited laboratory (and the results apply only to foods we consider to pose pathogens do not qualify as a hazard
of such testing be sent directly to FDA) a greater risk, like fresh fruits and requiring preventive controls. Some
whenever such testing is conducted in vegetables consumed raw. Some comments assert that neither product
response to a specific testing comments assert that product testing testing nor environmental monitoring
requirement established under the would be an excessive and unnecessary would be warranted for facilities that
FD&C Act or its implementing cost on farms and in low-risk facilities hull and dry walnuts because at this
regulations, when applied to address an that pack and hold RACs. Other stage walnuts are not a finished
identified or suspected food safety comments strongly object to mandatory commercial commodity or an RTE food.
problem, or to support admission of a product testing for fresh and fresh-cut Some comments that express concern
food under an Import Alert that requires produce. These comments assert that about the requirements for
food testing. Although another the results of product testing are environmental monitoring focus on the
rulemaking will address the unlikely to provide useful information environmental pathogen L.
requirements of section 422 of the FD&C for RACs and support application of monocytogenes. Some of these
Act, our current thinking is that routine GAPs and CGMPs rather than product comments assert that fresh produce
product testing and environmental testing. Some comments express poses a unique challenge in that L.
monitoring conducted as a verification concern that the fresh-cut produce monocytogenes is routinely found in the
activity is not being applied to address industry will be dramatically changed if outdoor environment and its occasional
an identified or suspected food safety every lot of product needs to be tested transient detection on raw produce in
problem that requires food testing and and that such testing would certainly low numbers does not necessarily
would not be subject to requirements to add expense without making the food indicate poor practices, that a
use an accredited laboratory that would any safer. Other comments assert that contamination event has occurred due
submit the results to FDA. We will produce contamination occurs at so low to insanitary conditions, or that such
review the results of environmental a frequency that product testing for occasional transient detection presents
monitoring and product testing, if any, produce (including tree nuts) is not an elevated public health risk. These
during inspections. economically feasible through any comments assert that the occasional
The primary concern expressed in scientifically valid sampling protocol. detection of transient L. monocytogenes
these comments was with respect to These comments also assert that ‘‘test in low numbers on food-contact surfaces
laboratories reporting results to FDA and hold’’ would require building where produce is handled is to be
and not with use of accredited additional cooling operations in all expected and must be considered and
laboratories. The rule requires a facility facilities and that, because of short shelf addressed in the drafting of
to establish and implement written life, testing of produce would negatively environmental monitoring procedures
procedures for product testing and impact quality and marketing. Other for produce facilities. Other comments
environmental monitoring and that the comments assert that industry data have state that not all produce operations will
procedures for such testing be shown a sporadic and limited finding of be susceptible to harborage of L.
scientifically valid. One way to comply pathogens in product and statistical monocytogenes. Other comments state
with the requirement that testing sampling profiles do not provide that they will not support mandatory
procedures be scientifically valid is to sufficient evidence that product testing environmental monitoring for facilities
use an accredited laboratory. is an effective use of time and money. that handle RACs until we amend our
(Comment 524) Some comments ask Other comments assert that facilities policies regarding the regulatory
us to expand the proposed requirement handling produce RACs are a unique consequences of a single detection of
to identify the laboratory conducting the type of facility and repeat previous potentially transient and low levels of L.
testing to also specify whether that requests that we allow all produce monocytogenes on a food-contact
laboratory is accredited and uses the operations handling RACs to be covered surface.
appropriate standards (such as quality by the produce safety rule, rather than (Response 525) We acknowledge the
control, proficiency testing, and trained the human preventive controls rule, to limitations of product testing for
laboratory staff). These comments assert ensure that such facilities will not be produce RACs and fresh-cut produce.
that such information would be useful expending resources on testing that As discussed in Response 517, the
to facilities. could be better directed to product testing that this rule requires as
(Response 524) We decline this implementation of preventive controls. a verification activity is to help assess
request. These comments appear to be Likewise, some comments express and verify the effectiveness of a food
asking us to establish in the human concern about how the requirements for safety plan and the facility’s capability
preventive controls rule requirements environmental monitoring will apply to to consistently deliver against it, not as
related to section 422 of the FD&C Act. the produce industry. For example, a ‘‘hold and test’’ procedure to establish
Doing so in advance of regulations some comments express concern that the acceptability of every lot or batch.
implementing section 422 of the FD&C off-farm packinghouses would be We do not expect either product testing
Act is premature. However, facilities subject to environmental monitoring or environmental monitoring to be
common in facilities that process, pack, raised issues, similar to the issues A facility that identifies an
or hold produce RACs. We agree that described in these comments, regarding environmental pathogen as a hazard
there would be little or no benefit to the detection of L. monocytogenes on requiring a preventive control such as
product testing or environmental food-contact surfaces, and we intend to sanitation controls would conduct
monitoring in facilities that pack or hold re-issue that draft guidance for public environmental monitoring. Such a
produce RACs that are rarely consumed comment in the near future. facility would decide what, if any, role
raw, such as potatoes. We expect that The memoranda that we prepared on product testing would play as a
many facilities that process, pack, or product testing and environmental verification activity, or as part of a
hold produce RACs that are RTE foods monitoring for the 2014 supplemental corrective action as a result of positive
may conclude, as a result of their hazard human preventive controls notice (Ref. findings from environmental
analysis, that neither product testing nor 55) (Ref. 85) include some examples monitoring, based on the facility, the
environmental monitoring is warranted. relevant to facilities that process, pack, food, the nature of the preventive
We also expect that many facilities that or hold produce. In light of the control, and the role of the preventive
process, pack, or hold produce RACs questions we have received regarding control in the facility’s food safety
that are RTE foods will conclude that similarities and differences for off-farm system.
the limitations of product testing when packing and holding compared to on- (Comment 528) Some comments ask
applied to produce reduce the value of farm packing and holding, we are us to clarify (or specify) when product
product testing for their products and considering developing a separate testing would be directed at raw
would direct their resources to food guidance on this topic. materials and other ingredients and
safety practices and verification (Comment 526) Some comments when product testing would be directed
measures other than product testing. In express concern about the cost of testing at finished product. Some comments
addition, we expect that some facilities and suggest creation of a one-time grant favor testing raw materials and other
will see benefits in conducting program for very small businesses that ingredients as part of ‘‘product testing,’’
environmental monitoring as a would assist them in developing their whereas other comments state that
verification measure and would direct initial food safety plans and testing testing raw materials and other
resources to such activities. programs. ingredients should be considered part of
We disagree that produce held in a supplier program rather than
(Response 526) Very small businesses
vented crates is not exposed to the verification of implementation and
are qualified facilities that are subject to
environment (see Response 170), but effectiveness. Other comments state that
modified requirements, which do not
agree that holding produce in vented it is unclear what preventive control
require testing or development of a food step would be verified by product
crates presents a low risk of
contamination from environmental safety plan. We intend that the guidance testing and what types of facilities
pathogens. We do not expect that we are developing will be helpful to all would be required to perform product
facilities that store produce in vented sizes of businesses that are subject to the testing. One comment from a supplier of
crates would conclude, as a result of requirements for product testing and produce states that testing its product
their hazard analysis, that environmental monitoring. (See (i.e., produce testing) is not an adequate
environmental pathogens are a hazard Response 2.) measure of its cleaning and sanitation
requiring preventive controls during D. Proposed § 117.165(a)(2)—Product program and asks us to clarify that
storage activities. See Response 25 for a Testing product testing is not on final product
discussion of how this final rule and that final product testing is not
broadens the number of packinghouses (Comment 527) Some comments ask required.
that will be governed by the provisions us to require finished product testing for (Response 528) We use the term
of the produce safety rule. See the food products designated as high-risk, ‘‘product testing’’ to mean testing any
discussions, in the 2014 supplemental particularly when the product supports food product, whether raw materials or
human preventive controls notice (79 pathogen growth during its shelf life. other ingredients, in-process foods, or
FR at 58535–536) and in Response 25, Other comments suggest that finished finished products (Ref. 85) and, thus,
of the similarities and differences for product or ingredient testing should be product testing can be directed to any of
off-farm packing and holding compared implemented as appropriate in these food products. For example,
to on-farm packing and holding. We situations where a risk has been testing raw materials and other
note that some of the comments express identified and an effective preventive ingredients could be verification of a
concern related to operations that, as a control cannot be implemented. Other supplier; testing in-process material
result of changes in the farm definition, comments ask us to require product after a kill step could be verification of
may fall within that definition (e.g., testing if an environmental pathogen is process control; testing finished product
some walnut hullers and dryers) and identified as a significant hazard. could be verification of the food safety
would not be subject to the (Response 527) We decline these plan as a whole, and capture a problem
requirements of this rule. requests. A facility’s decision to conduct introduced during manufacture,
We agree that not all produce product testing, and to establish the including from contaminated raw
facilities are susceptible to harborage frequency of such testing, will reflect a materials and other ingredients. Product
with L. monocytogenes. For example, risk-based approach consistent with its testing generally is not the most
harborage with L. monocytogenes is hazard analysis. Consequently, we effective means of measuring the
more likely to be a potential hazard in expect that facilities that produce foods adequacy of cleaning and sanitation
certain wet packing operations (e.g., wet that have frequently been associated programs, but such testing is common to
packing operations for cantaloupes) with outbreaks of foodborne illness, or track a facility’s overall hygienic
(Ref. 86). Comments that we previously produce food for which an effective production measures.
received about our draft guidance preventive control cannot be (Comment 529) Some comments
entitled ‘‘Guidance for Industry: Control implemented, would establish product assert that a facility that implements
of Listeria monocytogenes in testing programs more often than supplier verification and environmental
Refrigerated or Frozen Ready-To-Eat facilities that do not produce such monitoring (or other measures) should
Foods; Draft Guidance’’ (Ref. 87) have foods. not be required to perform product
testing in addition to the other controls verification program, Competent for all food manufacturing, processing,
and verification measures. Authorities are obligated to demonstrate packing, and holding to be conducted
(Response 529) The facility that it will directly deliver demonstrable under such conditions and controls as
determines whether product testing is food safety benefits. According to these are necessary to minimize the potential
necessary as appropriate to the facility, comments, other than for specific for the growth of microorganisms or for
the food, and the nature of the pathogens, random, intermittent the contamination of food
preventive control and its role in the finished product testing should (§ 117.80(c)(2)).
facility’s food safety system. The factors primarily be used as a measure of (Response 533) Environmental
mentioned by the comment are process control, not for acceptance monitoring would be a verification
examples of factors that a facility would testing; product testing should normally activity to ensure that sanitation
consider in making its determination. be viewed as a monitoring and review controls are being implemented and are
(Comment 530) Some comments ask tool, not as a product conformance effective. The CGMP testing requirement
us to revise the requirement for product verification tool. Testing programs for cited by the comments neither explicitly
testing to clarify that product testing product conformance verification requires environmental monitoring, nor
applies to significant hazards. should be the exception rather than the describes the circumstances in which
(Response 530) We decline this rule. Other comments suggest seeking environmental monitoring would be
request. Product testing is a verification advice from either the National needed. The cited CGMP requirement
activity for a preventive control, and a Advisory Committee on Microbiological for raw materials and ingredients would
preventive control is established for a Criteria for Foods or the FDA Food not negate the need for environmental
‘‘significant hazard’’ (which we now Advisory Committee on establishing monitoring to verify that sanitation
refer to as ‘‘hazard requiring a statistically based product testing controls are preventing environmental
preventive control’’). It is not necessary programs for process control. pathogens from becoming established in
to repeat, for each type of verification (Response 532) These comments a ‘‘niche’’ or harborage site (78 FR 3646
activity, that the activity applies to appear to have misunderstood the at 3814). The cited CGMP requirement
hazards requiring a preventive control. proposed requirements for product to minimize the potential for the growth
(Comment 531) Some comments testing. Consistent with the views of microorganisms or for the
assert that the real point of product expressed by these comments, we contamination of food does not specify
testing is to test all lots or batches. proposed requirements for product that a food establishment verify that it
These comments explain that they testing as a verification measure of the is meeting this requirement through
would be required to retest every lot of food safety plan as a whole, not for environmental monitoring.
product in order to pass an analysis of product conformance or lot acceptance. (Comment 534) Some comments ask
the product on to its customers, even if We do not intend to initiate the us to specify that environmental
testing had already been performed by consultation process described by these monitoring of pathogens be executed
their vendors (i.e., suppliers), because comments; however, we may consider according to a risk analysis.
each of their customers receives a requesting the assistance of advisory (Response 534) We decline this
proprietary blend. These comments committees on process control testing in request. See the discussion in Response
further explain that it is not the future. 467, which explains how risk applies to
economically or physically possible to the facility’s hazard analysis and the
retest small lots of product already E. Proposed § 117.165(a)(3)— determination by the facility to establish
tested by their vendors, and that the risk Environmental Monitoring preventive controls for hazards
has already been mitigated by its We proposed to require requiring a preventive control as
vendors. environmental monitoring, for an appropriate to the facility and the food.
(Response 531) The situation environmental pathogen or for an In contrast, the requirements for
described by these comments appears to appropriate indicator organism, if environmental monitoring are a
be a supplier-customer relationship in contamination of a ready-to-eat food verification activity that a facility would
that the customer—not this rule—has with an environmental pathogen is a conduct to verify that one or more
established a requirement for a significant hazard, by collecting and preventive controls are consistently
certificate of analysis for every lot of testing environmental samples. implemented and are effectively and
received product. As discussed in (Comment 533) Some comments significantly minimizing or preventing
Response 517, the product testing that assert that requirements for the hazards requiring a preventive
this rule requires as a verification environmental monitoring as a control and would be established as
activity is to help assess and verify the verification activity would be appropriate to the facility, the food, and
effectiveness of a food safety plan and unnecessary in light of proposed the nature of the preventive control
the facility’s capability to consistently revisions to some CGMP requirements, rather than according to a risk analysis.
deliver against it, not to establish the such as: (1) A requirement to use (Comment 535) Some comments ask
acceptability of every lot or batch. chemical, microbial, or extraneous- us to expand the requirements for
(Comment 532) Some comments material testing procedures where environmental monitoring. For example,
assert that we should set out a necessary to identify sanitation failures comments ask us to broadly require
consultation process by which or possible allergen cross-contact and environmental monitoring in the
identification of hazards, situations, or food contamination (§ 117.80(a)(5)); (2) a following circumstances: as a
product types that may require finished requirement for raw materials and component of every food safety
product testing is undertaken (noting ingredients to either not contain levels program; in any facility in which there
that there may be significant of microorganisms that may render the is a risk of contamination by an
international differences) before food injurious to the health of humans, environmental pathogen, not just
establishing requirements for product or to be pasteurized or otherwise treated facilities that make RTE food; whenever
testing in the rule. These comments also during manufacturing operations so that there is a risk of environmental
assert that before product testing is they no longer contain levels that would contamination if a likelihood exists that
mandated as a potential control step, as cause the product to be adulterated a person may consume the food raw; for
opposed to as part of a general (§ 117.80(b)(2)); and (3) a requirement spores of pathogenic sporeforming
bacteria if there is a possibility the hazard analysis is that a food allergen environmental monitoring, and supplier
spores could germinate and multiply in hazard is a hazard requiring a verification activities within a
a packaged food or under storage or preventive control (§ 117.130(b)(1)(ii) reasonable time after the records are
preparation conditions in the home; and and (c)). A facility that determines that made.
for unintended food allergens. a food allergen hazard requires (Comment 538) Some comments
(Response 535) We decline these preventive controls could, for example, assert that it is not necessary for a
requests. We are requiring a facility to establish sanitation controls for food preventive controls qualified individual
evaluate environmental pathogens allergens and a swabbing program to to conduct or oversee review of records
whenever an RTE food is exposed to the verify those sanitation controls. Even as a verification activity, noting that
environment prior to packaging and the though the facility would take swabs review of records in another food safety
packaged food does not receive a from the food processing environment, regulation (i.e., the LACF requirements
treatment or otherwise include a control such swabs would not be considered in part 113) can be done by persons
measure (such as a formulation lethal to ‘‘environmental monitoring’’ as that adequately trained in recordkeeping and
the pathogen) that would significantly term is used in this rule. review of records.
minimize the pathogen (Comment 536) Some comments ask (Response 538) The rule does not
(§ 117.130(c)(1)(ii)). This risk-based us to clarify whether the requirement for preclude review of records by persons
requirement is a minimum requirement; environmental monitoring ‘‘if other than the preventive controls
a facility can do more if its preventive contamination of an RTE food with an qualified individual, provided that the
controls qualified individual determines environmental pathogen is a significant preventive controls qualified individual
that doing so would be appropriate. hazard’’ refers to all RTE foods. provides oversight for that review.
The definition of RTE food does (Response 536) The requirements for Oversight by a preventive controls
include food for which it is reasonably environmental monitoring are addressed qualified individual is necessary
foreseeable that the food will be eaten to RTE foods (including RACs, as well because the review of records is critical
without further processing that would as processed foods) that are exposed to to assessing the facility’s application of
significantly minimize biological the environment unless the packaged the preventive controls system and,
hazards (§ 117.3)). The definition of RTE food receives a treatment or thus, is fundamental to ensuring its
environmental pathogen (§ 117.3) otherwise includes a control measure successful operation (78 FR 3646 at
excludes the spores of pathogenic (such as a formulation lethal to the 3757–58). Oversight by a preventive
sporeforming bacteria, and we decline pathogen) that would significantly controls qualified individual is
the request to require environmental minimize the pathogen. See consistent with requirements of Federal
monitoring (by revising the definition of § 117.130(c)(1)(ii) and the discussion in HACCP regulations for seafood, juice,
environmental pathogen) for such Response 406. See also Comment 525 and meat and poultry, and with
spores if there is a possibility the spores and Response 525 for a discussion of NACMCF HACCP guidelines (Ref. 35)
could germinate and multiply in a environmental monitoring as it could (78 FR 3646 at 3757–58).
packaged food or under storage or apply to the produce industry. (Comment 539) Some comments ask
preparation conditions in the home. As (Comment 537) Some comments us to provide for a timeframe longer
previously discussed, pathogenic suggest that a mechanism to reduce than one week (such as 7 working days)
sporeforming bacteria are normally costs could be to clarify that for review of records of monitoring and
present in foods and unless the foods environmental testing should only be corrective actions. Some comments ask
are subjected to conditions that allow done on food-contact surfaces. us to provide the same flexibility for
multiplication, they present minimal (Response 537) We disagree that it review of records of monitoring and
risk of causing illness. Because would be appropriate to focus corrective actions as we proposed for
pathogenic sporeforming bacteria are so environmental monitoring only on food- review of records of calibration, product
commonly present in food, a more contact surfaces. It is well-established testing, environmental monitoring, and
appropriate approach to the risks that successful environmental supplier verification activities (‘‘within
presented by pathogenic sporeforming monitoring programs look to eliminate a reasonable time’’ after the records are
bacteria would be to focus on their environmental pathogens from non- made)—e.g., because some preventive
potential presence in raw materials and food-contact surfaces as a means to keep controls may be monitored less
other ingredients and implement the pathogens from contaminating food- frequently than is typical in a traditional
appropriate measures to prevent their contact surfaces and thereby HACCP plan dominated with CCPs.
growth (e.g., formulation, refrigeration) contaminating food. Some comments note that corrective
rather than to monitor for them in the actions may not be fully implemented
F. Proposed § 117.165(a)(4)—Review of within 7 days and ask us to provide for
food processing environment.
We decline the request to expand the Records review of these records within a week
requirement to all foods, not just RTE We proposed to require review of or other timeframe determined to be
foods. Although facilities are required to specified records by (or under the appropriate to ensure that potentially
apply CGMPs to prevent contamination oversight of) a preventive controls hazardous goods do not enter
of foods that are not RTE, these foods qualified individual, to ensure that the commerce. Some comments ask us to
will receive a treatment that will records are complete, the activities retain the one week timeframe for
significantly minimize or prevent reflected in the records occurred in review of records associated with
environmental pathogens at a later accordance with the food safety plan, perishable foods, but to extend the
stage. the preventive controls are effective, timeframe to one month for
Environmental monitoring is directed and appropriate decisions were made nonperishable foods.
at microbiological hazards, not chemical about corrective actions. We proposed Some comments state that some food
hazards such as food allergens. The rule to require review of records of processors that operate on a batch
requires a facility to evaluate known or monitoring and corrective action production basis (rather than a
reasonably foreseeable food allergen records within a week after the records continuous production basis) review all
hazards and to establish food allergen are made, and review of records of records related to a particular batch all
controls when the outcome of the calibration, product testing, at once just before release of the batch
for distribution. These comments assert relatively large number of affected lots verification instruments, may be faced
that it would be inefficient, of product. with recall decisions for a relatively
unnecessary, and needlessly (Comment 540) Some comments ask large number of affected lots of product.
complicated to require management to us to revise the provisions for review of (Comment 543) Some comments
review a few production records in records by more generally referring to emphasize the importance of calibrating
advance of the normal complete records records of ‘‘verification testing (e.g., those instruments and monitoring
review, particularly when laboratory product testing and/or environmental devices that are critical to the
testing conducted on the batch by an monitoring as applicable).’’ preventive control, and reviewing the
outside laboratory takes several weeks (Response 540) We have revised the associated records, before validation of
to complete. regulatory text to refer to records of a lethality step and as frequently as
(Response 539) We have revised the ‘‘testing (e.g., product testing, necessary thereafter. These comments
proposed requirement to require review environmental monitoring).’’ question whether requiring review of
of records of monitoring and corrective (Comment 541) Some comments refer
calibration records ‘‘within a reasonable
actions within 7 working days after the to our request for comment on whether
time’’ will be adequate.
the regulatory text should specify the
records are made or within a reasonable (Response 543) We agree that
verification activities that must be
timeframe, provided that the preventive instruments and monitoring devices that
conducted for corrective actions (see the
controls qualified individual prepares are critical to a preventive control
discussion in Comment 489 and
(or oversees the preparation of) a written should be calibrated, and calibration
Response 489). These comments assert
justification for a timeframe that records should be reviewed, before
that if we do not further specify
exceeds 7 working days. A timeframe conducting studies to validate a
verification activities for corrective
that exceeds 7 working days will be the lethality step. However, the provision is
actions then we should eliminate the
exception rather than the norm. For directed at verification of
proposed requirement to review records
example, reviewing records before implementation and effectiveness of
of corrective actions.
release of product may be considered (Response 541) Records are necessary preventive controls on an ongoing basis.
adequate by a facility, although this may to document all verification activities This rule does not prescribe specific
be later than one week after the records (see § 117.155(b)). The fact that the rule steps that a facility must take before
were created. A facility may determine provides flexibility for the facility to conducting validation studies.
that all records for a lot of product will appropriately determine the verification A facility has flexibility to
be reviewed after product testing or activities for corrective actions, rather appropriately determine the frequency
environmental monitoring records than prescribes these verification of reviewing calibration records based
relevant to that lot of product are activities, has no bearing on the on the facility, the food, and the nature
available, which may be more than a requirement to document the of the preventive control. We agree that
week after monitoring records were verification activities. it would be prudent to review
created. We made a conforming change (Comment 542) Some comments state calibration records of those instruments
to the list of responsibilities of the that records of calibration activities are and monitoring devices that are critical
preventive controls qualified individual reviewed at the time the calibration is to the preventive control more
to address the requirement for the performed. These comments assert that frequently than of those instruments
preventive controls qualified individual in most cases a formal scheduled review and monitoring devices that are not
to provide (or oversee the preparation of calibration records is not required to critical to the preventive control. As
of) a written justification for such a ensure the effectiveness of the control discussed in Response 542, depending
timeframe (see § 117.180(a)). and that records review of calibrations on the nature of the control for which
We are not requiring that a facility should be based upon the nature of the the instrument is being calibrated, a
review records of monitoring and control being calibrated. facility that reviews calibration records
corrective actions before release of (Response 542) The purpose of infrequently, and finds a problem with
product or that the timeframe for the reviewing records as a verification calibration of process monitoring
review depend on the shelf life of the activity is to ensure that the records are instruments and verification
food. The purpose of reviewing records complete, the activities reflected in the instruments, may be faced with recall
is not to determine whether to release records occurred in accordance with the decisions for a relatively large number
product. Instead, the purpose of food safety plan, the preventive controls of affected lots of product.
reviewing records is to ensure that the are effective, and appropriate decisions
records are complete, the activities were made about corrective actions. G. Proposed § 117.165(b)—Written
reflected in the records occurred in Although records may be reviewed at Procedures
accordance with the food safety plan, the time they are made, the review of 1. Proposed § 117.165(b)(1)—Frequency
the preventive controls are effective, records as a verification activity of Calibration
and appropriate decisions were made includes oversight by a preventive
about corrective actions. However, a controls qualified individual (see We proposed that you must establish
facility will have flexibility to review Response 538). Because the timeframe and implement written procedures for
records of monitoring and corrective for review of calibration records is the frequency of calibrating process
actions within a timeframe that exceeds ‘‘within a reasonable time after the monitoring instruments and verification
7 working days, such as before product records are created,’’ the facility has instruments.
release, provided that the facility flexibility over the frequency of (Comment 544) As discussed in
provides a written justification for doing conducting this review. However, Comment 519, some comments ask us to
so. As discussed in Response 542, depending on the nature of the control specify that an accuracy check may be
depending on the nature of the record, for which the instrument is being used as a verification activity in lieu of
a facility that reviews these types of calibrated, a facility that reviews calibration. These comments also ask us
records in a timeframe that exceeds 7 calibration records infrequently, and to specify that written procedures
working days, and finds a problem, may finds a problem with calibration of address the frequency of accuracy
be faced with recall decisions for a process monitoring instruments and checks, as well as calibration.
(Response 544) Consistent with rule (78 FR 3646 at 3812 to 3813), and describe how sampling was conducted
Response 519, we have revised the noted that this interpretation was (to establish that the sample obtained
proposed requirement to specify that consistent with our previous discussion adequately represents the lot of product
written procedures address the of the term ‘‘scientifically valid’’ (in the sample is intended to represent);
frequency of accuracy checks, as well as place of ‘‘validated’’) in the rulemaking and include the procedures for sample
calibration. to establish CGMP requirements for quality control from field to lab. Other
dietary supplements (68 FR 12158 at comments assert that the frequency of
2. Proposed § 117.165(b)(2) and (b)(3)—
12198, March 13, 2003). While validated environmental monitoring and product
Product Testing and Environmental
methods are considered ‘‘scientifically testing is unclear and express concern
Monitoring
valid,’’ methods that have not gone that frequent swabbing and frequent
We proposed that you must establish through formal validation processes but testing could cause cheeses to be held
and implement written procedures for have been published in scientific past their optimum ripeness if they are
product testing. We proposed that journals, for example, may also be fresh or soft ripened.
procedures for product testing must: (1) ‘‘scientifically valid.’’ We do expect (Response 546) We decline the
Be scientifically valid; (2) identify the methods used for testing to be adequate request to prescribe additional details,
test microorganism(s); (3) specify the for their intended use. such as those described in these
procedures for identifying samples, We have had several years comments, in the requirements for
including their relationship to specific interpreting the term ‘‘scientifically written procedures for product testing
lots of product; (4) include the valid’’ in the context of the requirement, and environmental monitoring. As with
procedures for sampling, including the in the dietary supplement CGMPs, that other procedures required by the rule,
number of samples and the sampling the manufacturer must ensure that the those relating to environmental
frequency; (5) identify the test(s) tests and examinations that it uses to monitoring and product testing must be
conducted, including the analytical determine whether the specifications adequate for their intended purpose.
method(s) used; (6) identify the are met are appropriate, scientifically Further, procedures will not be identical
laboratory conducting the testing; and valid methods (§ 111.75(h)(1)). Although in all circumstances. For example, a
(7) include the corrective action we agree that methods that are facility that produces products with a
procedures required by § 117.150(a)(1). ‘‘scientifically valid’’ would also be short shelf life may choose a different
Likewise, we proposed that you must ‘‘technically sound,’’ we disagree that frequency of swabbing and testing than
establish and implement written the hypothetical concern that we would a facility that produces products with a
procedures for environmental construe ‘‘scientifically valid’’ to mean long shelf life.
monitoring. Procedures for ‘‘validated’’ warrants changing (Comment 547) Some comments ask
environmental monitoring must: (1) Be ‘‘scientifically valid’’ to a new term us to provide more flexibility in product
scientifically valid; (2) identify the test (such as ‘‘technically sound’’) in light of testing by not requiring establishments
microorganism(s); (3) identify the our previous statements regarding this to provide written procedures for
locations from which the samples will term and experience in the context of product testing and corrective action
be collected and the number of sites to CGMP requirements. See the final rule procedures.
be tested during routine environmental establishing the dietary supplement (Response 547) These comments are
monitoring; (4) identify the timing and CGMPs for additional discussion on the unclear. By requiring that a facility
frequency for collecting and testing terms ‘‘validated’’ and ‘‘scientifically establish its own procedures, the rule
samples; (5) identify the test(s) valid’’ (72 FR 34752 at 34853). provides facilities with flexibility to
conducted, including the analytical (Comment 546) Some comments develop a product testing program that
method(s) used; (6) identify the support the proposed requirements for works best for its facility and its
laboratory conducting the testing; and written procedures for environmental products. We are retaining the
(7) include the corrective action monitoring, including providing requirements for written procedures for
procedures required by § 117.150(a)(1). flexibility to use indicator organisms product testing, as well as for corrective
(Comment 545) Some comments and to design the timing, location, and action procedures.
express concern that the word ‘‘valid’’ frequency of environmental monitoring (Comment 548) Some comments ask
in the phrase ‘‘scientifically valid’’ programs in a risk-based manner, and in us to add a provision requiring that all
could be construed to mean ‘‘validated’’ not prescribing specific locations (e.g., positive results must result in corrective
because not all testing protocols can be food-contact surfaces or ‘‘zone 1’’) or action being taken.
validated within the traditional meaning sample quantities for testing. Other (Response 548) We decline this
of the term. These comments state their comments ask us to add details to the request. The rule requires that a facility
belief that what we intend is for these written procedures for product testing must establish and implement written
testing programs to be ‘‘technically and environmental monitoring corrective action procedures that must
sound.’’ Other comments express regarding when and where sampling is be taken if preventive controls are not
concern that ‘‘scientifically valid’’ may required and the number of samples to properly implemented, including
be interpreted to mean that firms are take. Some comments ask us to make procedures to address, as appropriate,
required to develop or validate sure the most current ‘‘sampling the presence of a pathogen or
analytical methods (either in general or planning science’’ is used for appropriate indicator organism in an
for specific food matrices). environmental monitoring by specifying RTE product detected as a result of
(Response 545) We are retaining the that procedures for environmental product testing and the presence of an
term ‘‘scientifically valid’’ in these monitoring must employ ‘‘sample environmental pathogen or appropriate
provisions. We disagree that we would quality criteria objectives.’’ Other indicator organism detected through
interpret ‘‘scientifically valid’’ to mean comments assert that the product testing environmental monitoring (see
that facilities are required to develop or procedure requirements are inadequate § 117.150(a)(1)). However, the rule does
validate analytical methods. We and ask us to require that procedures for not pre-determine what corrective
discussed our interpretation of the term product testing specify the procedures actions a facility must take when
‘‘scientifically valid’’ in the Appendix to for identifying samples (including their presented with positive results from
the 2013 proposed preventive controls relationship to specific lots of product); product testing or environmental
monitoring. The corrective action XXXV. Subpart C: Comments on regulatory text (see, e.g., Comment 549,
procedures that a facility would Proposed § 117.170—Reanalysis Comment 550, Comment 552, Comment
develop, and the actual corrective We proposed to establish 553, Comment 557, and Comment 558).
actions that the facility would take, will requirements for reanalysis of the food In the following paragraphs, we
depend on the nature of the hazard and safety plan. Some comments support the discuss comments that disagree with, or
the nature of the preventive control, as proposed requirements without change. suggest one or more changes to, the
well as information relevant to the For example, comments agree that a proposed requirements. After
positive result (e.g., pathogen or preventive controls qualified individual considering these comments, we have
indicator organism, product or must perform (or oversee) the reanalysis revised the proposed requirements as
environment, food-contact surface or (see section XXXV.D). Some comments shown in table 39, with editorial and
non-food-contact surface). that support the proposed provisions conforming changes as shown in table
suggest alternative or additional 52.
TABLE 39—REVISIONS TO THE PROPOSED REQUIREMENTS FOR REANALYSIS
117.170(b) ........................ Circumstances that require reanalysis Provide for reanalysis of an applicable portion of the food safety plan (rath-
er than the complete food safety plan) in specified circumstances.
117.170(b)(4) .................... Circumstances that require reanalysis Require reanalysis of the food safety plan as a whole, or the applicable
portion of the food safety plan, whenever a preventive control, combina-
tion of preventive controls, or the food safety plan as a whole is found to
be ineffective.
117.170(c) ........................ Timeframe to complete the reanalysis Clarify that the requirement applies to completing the reanalysis and vali-
dating any additional preventive controls (as appropriate to the nature of
the preventive control and its role in the facility’s food safety system),
rather than to completing the reanalysis and implementing any additional
preventive controls (emphasis added).
A. Proposed § 117.170(a)— (Comment 550) Some comments ask (Comment 552) Some comments ask
Circumstances Requiring Reanalysis us to recognize other terminologies us to require reanalysis on an annual
We proposed that you must conduct already used by some facilities (e.g., basis, noting that annual reanalysis is
a reanalysis of the food safety plan: (1) ‘‘reassess’’). required by Federal HACCP regulations
At least once every 3 years; (2) (Response 550) We have for seafood, juice, and meat and poultry.
whenever a significant change in the acknowledged that the terminology used (Response 552) We decline this
activities conducted at your facility in relation to the concept of request. We proposed to require
creates a reasonable potential for a new ‘‘reanalysis’’ varies in current reanalysis at least once every 3 years as
hazard or creates a significant increase regulations and guidelines for systems a minimum requirement in the event
in a previously identified hazard; (3) such as HACCP (78 FR 3646 at 3759). that there is no other circumstance
whenever you become aware of new A facility may choose to use a term such warranting reanalysis (see proposed
information about potential hazards as ‘‘reassessment’’ in its records—e.g., if § 117.170(a)(1)). That 3-year minimum
associated with the food; (4) whenever it relies on existing records that use the is consistent with the statute (see
appropriate after an unanticipated food term ‘‘reassessment’’ to satisfy some or section 418(i) of the FD&C Act). As a
safety problem; and (5) whenever you all of the requirements of this rule for practical matter, we expect that
find that a preventive control is reanalysis. However, the human reanalysis will occur more frequently as
ineffective. preventive controls rule will use a a result of changes in the activities
(Comment 549) Some comments single term (i.e., reanalyze) to minimize conducted at a facility (see final
assert that the need to reanalyze the the potential for confusion about § 117.170(b)(1) through (4)).
food safety plan will depend on the whether different terms have a different (Comment 553) Some comments
nature of the preventive control and its meaning for the purposes of the rule. suggest editorial changes to improve the
role in the food safety system. These (Comment 551) Some comments ask readability of the requirement to
comments also assert that if a specific us to define ‘‘reanalysis’’ to mean ‘‘a conduct reanalysis when there is a
preventive control is found to be reassessment of the validity of a change in a preventive control.
ineffective, only the applicable portion preventive control or food safety plan to (Response 553) We are including
of the food safety plan would need to be control a hazard. Reanalysis may these editorial changes in the regulatory
reanalyzed. include a system review and, where text, which now reads whenever ‘‘a
(Response 549) We agree and have necessary, activities to revalidate a significant change in the activities
revised the regulatory text, with control measure or combination of conducted at your facility creates a
associated editorial changes and control measures.’’ reasonable potential . . .’’
redesignation, to separate the (Response 551) We decline this (Comment 554) Some comments
requirement to reanalyze the food safety request. Reanalysis goes beyond assert that the proposed requirement to
plan as a whole every 3 years from all assessing the validity of a preventive conduct reanalysis whenever you
other circumstances when reanalysis is control or food safety plan to control a become aware of new information about
required ‘‘for cause.’’ When reanalysis is hazard. Reanalysis can also include potential hazards associated with the
‘‘for cause,’’ the regulatory text provides assessing whether all hazards have been food does not align with FSMA
that reanalysis is of the food safety plan identified, whether established statutory language, is ambiguous, and
as a whole, or the applicable portion of procedures are practical and effective, would establish vague compliance
the food safety plan. and other factors. obligations.
(Response 554) We disagree. See our necessary, the facility would include new preventive control. We have made
previous discussion regarding the that preventive control in its food safety several revisions to the regulatory text,
emergence of the pathogen L. plan along with associated preventive with associated editorial changes, to
monocytogenes in the mid-1980’s and control management components, clarify the requirements for reanalysis.
the first outbreak of foodborne illness in including verification to establish the First, we have clarified that reanalysis
the United States, in 2006–2007, caused validity of the food safety plan. can be routine (at least every 3 years) or
by consumption of peanut butter ‘‘for cause’’ (i.e., a significant change
B. Proposed § 117.170(b)—Timeframe
contaminated with Salmonella (78 FR that creates the potential for a new
To Complete Reanalysis
3646 at 3759). Although we hazard or an increase in a previously
acknowledge that the proposed We proposed that you must complete identified hazard; when you become
requirement is not explicit in section the reanalysis and implement any aware of new information about
418(i) of the FD&C Act, we disagree it additional preventive controls needed to potential hazards associated with the
is not in alignment with FSMA as a address the hazard identified, if any, food; when there is an unanticipated
whole. FSMA directs the owner, before the change in activities at the food safety problem; or whenever a
operator, or agent in charge of a facility facility is operative or, when necessary, preventive control, combination of
to evaluate the hazards that could affect during the first 6 weeks of production. preventive controls or the food safety
food manufactured, processed, packed, We have clarified that the requirement plan as a whole is ineffective). Second,
or held by such facility and identify and is to complete the reanalysis and we have specified that the reanalysis
implement preventive controls to validate (rather than implement) any ‘‘for cause’’ may be for the entire food
significantly minimize or prevent the additional preventive controls as safety plan or only for an applicable
occurrence of those hazards (see section appropriate to the nature of the portion.
418(a) of the FD&C Act). In other words, preventive control and its role in the In addition, as discussed in Response
FSMA focuses on a system to prevent facility’s food safety system. 557, we have clarified that the
food safety problems rather than a (Comment 557) As discussed in reanalysis and the validation, as
system to react to problems after they Comment 501, some comments question appropriate to the nature of the
occur. Requiring that a facility reanalyze whether 6 weeks is enough time to preventive control and its role in the
its food safety plan, or the applicable perform all applicable validation studies facility’s food safety system, of any
portion of the food safety plan, in that would address the execution additional preventive controls needed to
response to information such as the element of validation. Likewise, some address an identified hazard would
emergence of a new foodborne comments question whether 6 weeks is need to be completed before any change
pathogen, or an outbreak of foodborne enough time to complete reanalysis. in activities (including any change in
illness from consumption of a food (Response 557) Consistent with preventive controls) is operative. When
product not previously associated with revisions we have made to the additional time is necessary, we have
foodborne illness from a well-known timeframe to complete validation (see provided for a timeframe within 90 days
pathogen, aligns very well with the Response 501), we have revised the after production of the applicable food
statutory direction in FSMA. timeframe to complete the reanalysis first begins or within a reasonable
(Comment 555) Some comments ask and validate, as appropriate to the timeframe, provided that the preventive
us to specify that reanalysis is required nature of the preventive control and its controls qualified individual provides
when a preventive control ‘‘fails to be’’ role in the facility’s food safety system, (or oversees the preparation of) a written
properly implemented rather than when any additional preventive controls to be justification for a timeframe that
a preventive control ‘‘is not’’ properly within 90 days after production of the exceeds 90 days after production of the
implemented. applicable food first begins or within a applicable food first begins. In other
(Response 555) We decline this reasonable timeframe, provided that the words, if you decide to make a change,
request. We see no meaningful preventive controls qualified individual you should conduct a reanalysis before
difference between ‘‘fails to be’’ and ‘‘is provides (or oversees the preparation of) you make that change if there is
not’’ in this context, except that ‘‘fails to a written justification for a timeframe potential for that change to create or
be’’ could lead to questions about the that exceeds 90 days after production of increase a hazard; a reanalysis that
meaning of the term ‘‘fails’’ in this the applicable food first begins. We results in changes to preventive controls
context. made a conforming change to the list of should be completed and the preventive
(Comment 556) Some comments ask responsibilities of the preventive controls validated, as appropriate to the
us to add a requirement to conduct controls qualified individual (see nature of the preventive control and its
reanalysis whenever a preventive § 117.180(a)). role in the facility’s food safety system,
control is found to be ‘‘missing’’ in (Comment 558) Some comments state before changes in activities to produce
addition to whenever a preventive that the phrase ‘‘before the change in food using a new preventive control are
control is found to be ‘‘ineffective.’’ activities at the facility is operative’’ is put into operation. However, we
(Response 556) We have revised the ambiguous in that it is unclear if the acknowledge that it may be necessary to
regulatory text to require reanalysis phrase is referencing the initial change produce product to demonstrate a
whenever a preventive control, a in activities that triggered the reanalysis revised preventive control can be
combination of preventive controls, or or a change in activities subsequent to implemented appropriately, and
the food safety plan as a whole, is the reanalysis. These comments ask us provide for an extended timeframe to
ineffective. (See § 117.170(b)(4).) A to clarify the requirement by make this assessment.
‘‘missing’’ preventive control could be substituting the phrase ‘‘before the
discovered during verification to relevant process is operative.’’ C. Proposed § 117.170(c)—Requirement
establish the validity of the food safety (Response 558) We agree that there To Revise the Written Food Safety Plan
plan as a whole or as a result of an was ambiguity in this phrase, because or Document Why Revisions Are Not
unanticipated problem. (See Response changes in activities could result in the Needed
482.) If circumstances lead a facility to need for reanalysis and reanalysis could We proposed that you must revise the
conclude that an additional (or result in the need for changes in written food safety plan if a significant
different) preventive control is activities, both of which can result in a change is made or document the basis
for the conclusion that no revisions are and a qualified auditor. Some comments the preventive controls qualified
needed. We received no comments that support the proposed requirements individual serve as the process
disagreed with this proposed without change. Some comments that authority, serve as the auditor, and offer
requirement and are finalizing it as support the proposed provisions suggest final sign off on a validation and
proposed. alternative or additional regulatory text corrective actions, and suggest that a
(see, e.g., Comment 563 and Comment third party may be necessary to ensure
D. Proposed § 117.170(d) —Requirement
568) or ask us to clarify how we will that uniform standards are applied.
for Oversight of Reanalysis by a
interpret the provisions (see, e.g., (Response 561) To the extent that the
Preventive Controls Qualified Individual
Comment 560, Comment 564, and comment suggests that the functions of
We proposed that a preventive Comment 571). the preventive controls qualified
controls qualified individual must In the following paragraphs, we individual create a conflict of interest,
perform (or oversee) the reanalysis. We discuss comments that ask us to clarify we disagree. The rule focuses on the
received no comments that disagreed the proposed requirements or that need for applicable training and
with this proposed requirement and are disagree with, or suggest one or more experience to perform certain functions.
finalizing it as proposed. See section changes to, the proposed requirements. The preventive controls qualified
XXXVI.B.1 for comments on the After considering these comments, we individual must develop (or oversee the
qualifications for a preventive controls are finalizing the provisions as proposed development of) the food safety plan
qualified individual who would perform with conforming changes as shown in that controls the identified hazards and
or oversee the reanalysis. table 52. then ensure through review of records
E. Proposed § 117.170(e)—Reanalysis on A. Proposed § 117.180(a) and (b)—What that the plan is being implemented as
the Initiative of FDA a Preventive Controls Qualified designed. The rule does not require that
Individual or Qualified Auditor Must Do a facility engage a third party to provide
We proposed that you must conduct oversight of any individual, including a
a reanalysis of the food safety plan or Oversee
preventive controls qualified individual,
when FDA determines it is necessary to We proposed to list the functions that but does not preclude a facility from
respond to new hazards and must be performed by one or more doing so if it chooses.
developments in scientific preventive controls qualified
understanding. individuals (i.e., preparation of the food B. Proposed § 117.180(c)—Qualification
(Comment 559) Some comments ask safety plan; validation of the preventive Requirements
us to issue formal, written controls; review of records for
1. Proposed § 180(c)(1)—Preventive
communications about new hazards and implementation and effectiveness of
Controls Qualified Individual
developments in scientific preventive controls and appropriateness
understanding. These comments express of corrective actions; and reanalysis of We proposed that to be a preventive
concern that communications of this the food safety plan) or by a qualified controls qualified individual, the
type could be inconsistent if they are auditor (i.e., conduct an onsite audit). individual must have successfully
communicated by individual We proposed to list these functions for completed training in the development
investigators. Other comments ask us to simplicity (i.e., to make it easy to see all and application of risk-based preventive
specify in the regulatory text that it is of the requirements in a single place). controls at least equivalent to that
the Commissioner of Food and Drugs We specified that this list of functions received under a standardized
who makes the determination that it is already proposed to be established in curriculum recognized as adequate by
necessary to conduct a reanalysis of the applicable sections of the rule did not FDA or be otherwise qualified through
food safety plan. in itself impose any additional job experience to develop and apply a
(Response 559) We agree that a requirements. food safety system. We also proposed
communication from FDA about the (Comment 560) Some comments ask that this individual may be, but is not
need to reanalyze the food safety plan us to clarify whether the preventive required to be, an employee of the
should be issued in a formal written controls qualified individual must be on facility.
manner but disagree that it is necessary the premises during operating hours. (Comment 562) Some comments ask
to specify that it is the Commissioner of Other comments ask us to clarify that us to work with industry to establish a
Food and Drugs who makes the the preventive controls qualified national training curriculum and
determination that it is necessary to individual is not responsible for standards for knowledge requirements
conduct a reanalysis of the food safety performing laboratory testing, because before the final rule is issued.
plan. The comment provides no basis the preventive controls qualified Comments recommend that curriculum
for precluding such a determination by individual may not be appropriately and training requirements be consistent
an organizational component (such as educated and trained for laboratory with already existing standards,
CFSAN or a component of FDA’s Office testing. including Better Process Control School,
of Regulatory Affairs) that has (Response 560) The rule does not International HACCP, GFSI, Seafood
operational responsibility for food safety require that the preventive controls HACCP, and those trainings offered by
and subject matter experts to advise the qualified individual be onsite during Cooperative Extension or State
managers in those organizational operating hours. The rule also does not Agriculture departments. Some
components. require that the preventive controls comments ask us to allow flexibility for
qualified individual be responsible for industry to continue current training
XXXVI. Subpart C: Comments on performing laboratory testing, although programs without receiving express
Proposed § 117.180—Requirements review of testing records (e.g., records of approval from the FSPCA. Other
Applicable to a Preventive Controls product testing or environmental comments ask that a standardized
Qualified Individual and a Qualified testing) must be conducted or overseen curriculum for training a preventive
Auditor by a preventive controls qualified controls qualified individual be
We proposed to establish individual. harmonized with the GFSI requirement.
requirements for the qualifications of a (Comment 561) Some comments ask (Response 562) As discussed in
preventive controls qualified individual us to consider the implication of having Response 2, the FSPCA is establishing a
standardized curriculum. The is the responsibility of the owner, businesses that are not small or very
curriculum will focus on the specific operator, or agent in charge of the small businesses will need to comply
requirements of the human preventive facility to determine whether any with the rule within one year, and very
controls rule. Training providers do not individual who prepares (or oversees small businesses are not required to
need approval from the FSPCA to use the preparation of) the food safety plan develop a food safety plan or conduct
the curriculum. has appropriate qualifications to do so, other activities that require oversight by
(Comment 563) Some comments ask whether by on-the-job experience or by a preventive controls qualified
who will assess the qualifications of a training. individual.
particular preventive controls qualified There are some differences in the (Comment 567) Some comments ask
individual or determine whether requirements of the human preventive us to develop training that emphasizes
particular individuals are in fact controls rule compared to the the need for appropriate equipment
‘‘qualified.’’ Some comments ask us to requirements of HACCP regulations for standards.
use an outcome-based demonstration of seafood, juice, and meat and poultry (Response 567) The training will
competency. Some comments ask us to such that training provided by the focus on the specific requirements of the
specify that all work experience must be International HACCP Alliance may not human preventive controls rule, which
comparable or that a preventive controls be equivalent. Such an individual may does not establish requirements for
qualified individual must pass a need to obtain supplemental training equipment standards.
proficiency test. Some comments ask us specific to the rule. Alternatively, a (Comment 568) Some comments ask
to establish minimum standards for person who has received the us to provide that the standardized
competency. Some comments ask us to International HACCP Alliance training curriculum can be recognized as
clarify what job experiences would be and has implemented a HACCP plan adequate by the competent authority for
sufficient. Some comments ask how we may be qualified through job food safety in each country rather than
will verify that reported training and experience. by FDA. One comment cited a
experience are true. (Comment 565) Some comments ask requirement in one country for training
(Response 563) We are not us to emphasize that a standardized that is consistent with Codex HACCP.
establishing minimum standards for curriculum in the development and (Response 568) We decline this
competency and do not intend routinely application of risk-based preventive request. The standardized curriculum
to directly assess the qualifications of controls may not provide a preventive will be available to training providers,
persons who function as the preventive controls qualified individual with and we expect market forces will result
controls qualified individual, whether sufficient expertise to design and in the development in foreign countries
by their training or by their job conduct robust, scientific validation of training consistent with the
experience. Instead, we intend to focus studies to support the adequacy of standardized training curriculum. As
our inspections on the adequacy of the control measures. noted previously (see Response 564),
food safety plan. As necessary and (Response 565) We acknowledge that HACCP-based training may not be
appropriate, we will consider whether a single training course may not provide equivalent to the standardized
deficiencies we identify in the food adequate training for every function of curriculum because of the specific
safety plan suggest that the preventive the preventive controls qualified requirements of this rule. However, we
controls qualified individual may not individual for the foods produced by a believe that the flexibility provided by
have adequate training or experience to facility. In some cases an individual the alternative that a preventive controls
carry out the assigned functions, may gain the full complement of qualified individual may be otherwise
including whether reported training and knowledge and experience through qualified through job experience to
experience is accurately represented. multiple, specific training courses; in develop and apply a food safety system
(Comment 564) Some comments ask other cases an individual may gain the provides an approach to address the
us to provide for competency full complement of knowledge and circumstances in a foreign country with
requirements to be met through on-the- experience through job experience or respect to preventive controls qualified
job experience in lieu of traditional through a combination of training and individuals until the training is
classroom training. Some comments ask job experience. available. In addition we will work with
us to clarify what we mean by training (Comment 566) Some comments ask partners around the world—including
that is ‘‘at least equivalent’’ to that us not to establish requirements that are the Alliances, regulatory counterparts,
received under a standardized overly strict because there is a finite and multinational organizations—to
curriculum recognized as adequate by supply of food safety experts in the promote training to the global
FDA. Some comments ask us to clarify country and many facilities will need community of food suppliers. We intend
whether individuals who have multiple preventive controls qualified to meet both the letter and the spirit of
successfully completed training in the individuals. our obligation to the World Trade
development and application of risk- (Response 566) We disagree that the Organization to facilitate training on the
based preventive controls through requirements applicable to the new regulations, particularly in
programs delivered and recognized preventive controls qualified individual developing nations.
under the International HACCP Alliance should be designed to match any
would be considered to have completed current limitations in the number of 2. Proposed § 117.180(c)(2)—Qualified
training ‘‘equivalent’’ to that recognized individuals who have the knowledge Auditor
by FDA for the development and and skill to prepare (or oversee the We proposed that to be a qualified
application of risk-based preventive preparation of) a food safety plan. We auditor, a preventive controls qualified
controls. expect that market forces will act to individual must have technical
(Response 564) The requirements do increase the number of preventive expertise obtained by a combination of
provide for qualification through controls qualified individuals to match training and experience appropriate to
appropriate job experience, such as the demand generated by this rule. In perform the auditing function.
experience with successfully addition, as discussed in section LVI.A, (Comment 569) Some comments
implementing HACCP systems or other we are staggering the compliance dates object to the proposed requirement that
preventive-based food safety systems. It for the rule, so that only those a qualified auditor must be a preventive
controls qualified individual with XXXVII. Subpart C: Comments on implementing preventive controls to
certain technical auditing expertise. One Proposed § 117.190—Implementation address the hazards, and is monitoring
comment asserts that a qualified auditor Records the preventive controls to ensure that
should not be required to have the We proposed to list all records such controls are effective, it must
broader skills of a preventive controls documenting implementation of the provide notification to consumers of
qualified individual. food safety plan in § 117.190(a). We certain facility information by one of
(Response 569) We have revised the two procedures, depending on whether
noted that proposed § 117.190(a) would
definition of ‘‘qualified auditor,’’ and a food packaging label is required on the
not establish any new requirements but
the requirements applicable to a food.
merely make it obvious at a glance what
‘‘qualified auditor,’’ such that a Consistent with the statutory
implementation records are required
‘‘qualified auditor’’ means a person who direction of section 418(l) of the FD&C
under proposed part 117, subpart C. We
is a ‘‘qualified individual’’ as that term Act, we proposed the following
is defined in this final rule, rather than received no comments that disagreed
with this proposed provision and are modified requirements for qualified
a ‘‘preventive controls qualified facilities: (1) Submission of certain
individual,’’ because some auditors may finalizing it as proposed.
We proposed that the records that you documentation (proposed § 117.201(a));
be auditing businesses (such as produce (2) procedures for submission of the
farms) that are not subject to the must establish and maintain are subject
to the requirements of proposed subpart documentation (proposed § 117.201(b));
requirements for hazard analysis and (3) the frequency of the submissions
risk-based preventive controls, and it F (Requirements Applying to Records
that Must be Established and (proposed § 117.201(c)); (4) notification
would not be necessary for such an to consumers in certain circumstances
auditor to be a ‘‘preventive controls Maintained). (Proposed subpart F would
establish requirements that would apply (proposed § 117.201(d)); and (5)
qualified individual.’’ applicable records that a qualified
(Comment 570) Some comments ask to all records that would be required by
the various proposed provisions of facility must maintain.
us to consider specifying training for In the 2013 proposed human
qualified auditors. These comments also proposed part 117.) We received no
comments that disagreed with this preventive controls rule, we tentatively
ask us to consider certain industry concluded that a certified statement
documents in any guidance we may proposed provision and are finalizing it
as proposed. would be acceptable for the purposes of
issue regarding qualified auditors. satisfying the submission requirements
(Response 570) At this time, we are XXXVIII. Subpart D: Comments on of proposed § 117.201(a). We also
not planning to specify a training Proposed § 117.201—Modified requested comment on the efficiency
curriculum for qualified auditors. If we Requirements That Apply to a and practicality of submitting the
develop guidance related to qualified Qualified Facility required documentation using the
auditors, we will consider industry
As previously discussed (78 FR 3646 existing mechanism for registration of
documents that are already available.
at 3769), sections 418(l)(2)(A) and (B) of food facilities, with added features to
C. Proposed § 117.180(d)—Records the FD&C Act provide that a qualified enable a facility to identify whether or
We proposed that all applicable facility must submit two types of not the facility is a qualified facility.
training must be documented in records, documentation to us. The first type of Some comments support one or more
including the date of the training, the required documentation relates to food of the proposed requirements without
type of training, and the person(s) safety practices at the facility, with two change. For example, some comments
trained. For clarity, we have revised the options for satisfying this state that our proposed interpretation of
requirement to specify the type of documentation requirement. Under the the statutory term ‘‘business address’’ is
training that must be documented—i.e., first option, the qualified facility may consistent with our use of the term
applicable training in the development choose to submit documentation that ‘‘business address’’ in our regulations
and application of risk-based preventive demonstrates that it has identified regarding information that must be
controls (see 78 FR 3646 at 3762). potential hazards associated with the included in a prior notice for imported
(Comment 571) Some comments ask food being produced, is implementing food (21 CFR 1.281). Some comments
us to explain how job experience should preventive controls to address the that support the proposed provisions
be documented in records to prove hazards, and is monitoring the suggest alternative or additional
qualifications. preventive controls to ensure that such regulatory text (see, e.g., Comment 587
(Response 571) The rule does not controls are effective. Alternatively, through Comment 589, Comment 591
require documentation of job under the second option, the qualified through Comment 593, and Comment
experience. A facility has flexibility to facility may choose to submit 596 through Comment 598) or ask us to
determine whether and how to documentation (which may include clarify how we will interpret the
document the job experience of a licenses, inspection reports, certificates, provision (see, e.g., Comment 572 and
preventive controls qualified individual. permits, credentials, certification by an Comment 579 through Comment 585).
For example, a facility could ask a appropriate agency (such as a State In this section, we discuss comments
preventive controls qualified individual department of agriculture), or other that ask us to clarify the proposed
to provide a resume documenting evidence of oversight), that the facility requirements or that disagree with, or
applicable experience. As discussed in is in compliance with State, local, suggest one or more changes to, the
Response 563, we intend to focus our county, or other applicable non-Federal proposed requirements. We also address
inspections on the adequacy of the food food safety law. The second type of comments discussing our tentative
safety plan. As necessary and required documentation relates to conclusion regarding the submission of
appropriate, we will consider whether whether the facility satisfies the certified statements to FDA, including
deficiencies we identify in the food definition of a qualified facility. submitting certified statements using
safety plan suggest that the preventive If a qualified facility does not prepare the existing mechanism for registration
controls qualified individual may not documentation demonstrating that it has of food facilities. After considering these
have adequate experience to carry out identified potential hazards associated comments, we have revised the
the assigned functions. with the food being produced, is proposed requirements as shown in
table 40, with editorial and conforming average (of sales plus market value of requiring that a facility determine and
changes as shown in table 52. human food held without sale) during document its status as a qualified
As discussed in Response 155, we the 3-year period preceding the facility on an annual basis (see
have revised the definition of very small applicable calendar year and, as a § 117.201(c)(1)).
business to specify that it is based on an companion change, we are explicitly
TABLE 40—REVISIONS TO THE PROPOSED MODIFIED REQUIREMENTS FOR QUALIFIED FACILITIES

117.201(a) ............................ Documentation to be sub- • Specify that the submitted documentation is an ‘‘attestation.’’
mitted. • Add ‘‘tribal’’ as an example of applicable non-Federal food safety law.
117.201(b) ............................ Procedure for submission .. Update details regarding the electronic and paper submission of a form specific to
the attestation requirement.
117.201(c) ............................ Frequency of determination • New requirement to determine and document status as a qualified facility on an
and submission. annual basis no later than July 1 of each calendar year.
• Specify that a facility that begins manufacturing, processing, packing or holding
food after September 17, 2018 must submit the attestation before beginning such
operations.
• Specify that a facility must notify FDA of a change in status from ‘‘not a qualified
facility’’ to ‘‘qualified facility’’ by July 31 of the applicable calendar year.
• Specify that when the status of a facility changes from ‘‘qualified facility’’ to ‘‘not
a qualified facility’’ based on the annual determination, the facility must notify
FDA of that change in status using Form 3942a by July 31 of the applicable cal-
endar year.
• Specify that the required biennial submissions of the attestations must be made
during a timeframe that will coincide with the required biennial updates to facility
registration.
117.201(d) ............................ Timeframe for compliance When the status of a facility changes from ‘‘qualified facility’’ to ‘‘not a qualified fa-
with the requirements of cility,’’ the facility must comply with subparts C and G no later than December 31
subparts C and G. of the applicable calendar year unless otherwise agreed to by FDA and the facil-
ity.
117.201(e) ............................ Notification to consumers ... Conforming changes associated with the term ‘‘attestation.’’
117.201(f) ............................. Records .............................. Conforming changes associated with the term ‘‘attestation.’’
A. Comments on Submission of a documentation would enable us to proposed § 117.201(b) to update details

Certification Statement easily review food safety plans or regarding the electronic and paper
inspection reports and to target our submission of a form specific to this
(Comment 572) Some comments ask compliance and enforcement activities attestation requirement. Third, we have
us to clarify the distinction between the to those qualified facilities that pose a revised proposed § 117.201(e) (final
documentation that would be submitted greater risk because of inadequate § 117.201(f)) to specify that you must
to FDA and the records that a qualified prevention measures or deficient maintain those records relied upon to
facility relies on to support the inspections. support the ‘‘attestations’’ that are
submitted documentation. (Response 572) We are affirming our required by § 117.201(a).
Some comments agree with our tentative decision that we will not We acknowledge that requiring
tentative conclusion to use certified require a qualified facility to submit to submission of the actual documentation
statements to satisfy the proposed FDA, as part of its attestation, the would enable us to easily review food
submission requirements, noting that it underlying documentation that safety plans or inspection reports and to
would save time and money and reduce establishes its compliance. We agree target our compliance activities based
the paperwork burden on qualified that the underlying records are needed on information that we see in those food
facilities. Some comments ask us to to determine compliance with the safety plans or inspection reports.
revise the proposed requirements to documentation requirements and that a However, as discussed in Response 384,
make this use of certified statements qualified facility must retain the we are not requiring that other facilities
explicit in the regulatory text. documents it is relying on to support its submit a ‘‘facility profile’’ that would
Other comments disagree with our attestation and make them available to allow us to more broadly review food
tentative conclusion to use certified us during inspection. We also agree that safety plans and target our compliance
statements to satisfy the submission the regulatory text needs to be explicit activities based on information that we
requirements. These comments focus on regarding the required documentation see in those food safety plans and will
the importance of actual copies of and that we need to clearly distinguish instead explore other mechanisms to
documents in determining compliance between the documentation that would achieve the goals we described in the
with the documentation requirements be submitted to FDA and the records 2013 proposed human preventive
and assert that proof of qualification that a qualified facility relies on to controls rule for a facility profile.
requires more than a checked box in an support the submitted documentation.
on-line registration database. Some Therefore, we have made the following B. General Comments on Modified
comments ask us to require that a three revisions to the proposed Requirements That Apply to a Qualified
qualified facility affirm that it has the regulatory text. Facility
original documents on file and available First, we have revised proposed (Comment 573) Some comments
for FDA inspection. Other comments § 117.201(a) to specify that the assert that the proposed modified
assert that requiring qualified facilities submitted documentation is an requirements would create a costly
to submit copies of the actual ‘‘attestation.’’ Second, we have revised burden for qualified facilities (e.g.,
registering and making submissions to facility back through the supply chain if combinations (specified in § 117.5(g)
FDA) that would not be imposed on there is a problem. and (h)).
other types of exempted facilities. Some (Response 575) The rule does include (Response 577) We describe these
of these comments question whether the a labeling requirement analogous to the comments in more detail in Comment
exemption for qualified facilities is applicable labeling requirement in the 202. As discussed in Response 202, a
meaningful in light of the significant proposed produce safety rule (see farm mixed-type facility that is a very
burden imposed by the proposed § 117.201(e)). However, that labeling small business and that only conducts
modified requirements. Some comments requirement only applies to one of the the low-risk activity/food combinations
contrast the proposed modified two options that a qualified facility has listed in § 117.5(g) and (h) may find it
requirement for qualified facilities to for satisfying the submission advantageous to classify itself as a very
submit documentation to FDA with requirements (see § 117.201(a)(2) and small business eligible for the
proposed requirements for all other (e)). Specifically, a labeling requirement exemption in § 117.5(g) and (h) (which
facilities to simply establish and applies if the qualified facility chooses is not subject to the modified
maintain applicable records. to attest that it is in compliance with requirements in § 117.201) rather than
(Response 573) The submission applicable non-Federal food safety laws as a qualified facility (which is subject
requirements that we are establishing in (§ 117.201(a)(2)(ii) and (e)). However, to the modified requirements in
this rule for qualified facilities reflect the labeling requirement does not apply § 117.201).
the statutory framework for qualified if the qualified facility chooses to attest (Comment 578) Some comments
facilities (section 418(l)(2)(B) of the that it has identified the potential express concern about State access to
FD&C Act). Although the submission hazards associated with the food being the records that a qualified facility
requirements only apply to qualified produced, is implementing preventive maintains to support its attestations,
facilities, the reporting burden controls to address the hazards, and is particularly when a State would
associated with submission of an monitoring the performance of the conduct an inspection for compliance
attestation is much lower than the preventive controls to ensure that such with part 117 under contract to FDA.
recordkeeping burden for facilities that controls are effective (§ 117.201(a)(2)(i)). These comments express concern about
are subject to the requirements for The difference between the the time and resources necessary to
hazard analysis and risk-based requirements of the human preventive verify the status of a facility as a
preventive controls (see section LXI). controls rule and the proposed produce qualified facility and note that previous
(Comment 574) Some comments ask safety rule reflect differences in the mechanisms whereby we provide
us to minimize setting different distinct statutory provisions governing information to States in advance of
standards even though the modified the two rules. inspection have been slow. These
requirements reflect express statutory (Comment 576) Some comments comments also express concern that if
provisions. emphasize that the modified the State must verify the ‘‘qualified
(Response 574) These comments requirements need to ensure adequate facility’’ status of all firms, including
appear to be referring to the statutory protection of public health and state those that are not FDA contracts, this
provisions of section 418(n)(3)(C) of the that we should maintain and exercise could delay their ability to conduct
FD&C Act, which specify that the oversight of qualified facilities. Some timely inspections and increase
regulations we establish to implement comments ask that we provide enough inspection time, reducing the number of
section 418 of the FD&C Act specificity so that qualified facilities inspections conducted.
acknowledge differences in risk and know and understand their food safety (Response 578) We are sensitive to the
minimize, as appropriate, the number of responsibilities towards consumers. time required for various inspection
separate standards that apply to separate (Response 576) A facility that satisfies activities and intend to communicate
foods. We disagree that the statutory criteria to be a qualified facility with States regarding our expectations
provisions of section 418(n)(3)(C) are continues to be responsible to produce for how to verify whether a facility is a
directly relevant to the submission food that will not be adulterated under qualified facility.
requirements of this rule for qualified section 402 of the FD&C Act or (Comment 579) Some comments point
facilities. The requirements for qualified misbranded under section 403 of the out that the proposed procedures for
facilities, but not other facilities, to FD&C Act. Such a facility is also subject submission are silent on the process and
submit documentation to FDA reflect to the requirements of section 421 of the timeframe for our review and approval
different regulatory requirements. The FD&C Act regarding frequency of of the submitted documentation and ask
different regulatory requirements are inspection of all facilities and to the us to clarify this process and timeframe.
directed at different facilities, and do new administrative tools provided by Other comments ask us to clarify the
not set separate standards for particular FSMA, such as for suspension of consequences to a facility if its
foods. Regardless, even if the statutory registration (section 415 of the FD&C submission is found to be insufficient.
provisions of section 418(n)(3)(C) were Act) and for mandatory recall (section (Response 579) We will not be
relevant to the submission requirements 423 of the FD&C Act). As discussed in approving the submitted attestations.
of qualified facilities, provisions of this Response 151, we expect that most Instead, we intend to use the
rule that reflect express statutory qualified facilities will be subject to the information to determine whether the
provisions would not conflict with the CGMP requirements of subpart B. As we facility should be inspected for
statutory direction in section do now, we will continue to inspect compliance with the requirements for
418(n)(3)(C). these facilities for compliance with hazard analysis and risk-based
(Comment 575) Some comments ask those CGMP requirements. preventive controls, or for compliance
us to implement the same labeling (Comment 577) Some comments ask with the modified requirements. During
requirements that we proposed to which exemption a farm mixed-type the inspection, we would ask to see the
establish for farms that would be facility should follow if it satisfies records that the facility maintains to
eligible for a ‘‘qualified exemption’’ in criteria for a qualified facility support any submitted attestations.
the proposed produce safety rule, noting (§ 117.5(a)), as well as criteria for a very (Comment 580) Some comments ask
that such labeling requirements would small business that only conducts on- us to clarify whether a foreign facility
allow us to trace food produced by the farm low-risk activity/food would need to submit documentation of
its status as qualified facility. These averages less than the $1,000,000 the applicable documentation should
comments note that a foreign facility threshold adjusted for inflation, during include and how exhaustive it should
also would be required to provide the 3-year period preceding the be. Some comments ask whether
information to an importer and assert applicable calendar year) rather than documentation (such as a food safety
that submitting information to both FDA records demonstrating that the average plan) must address all operations at the
and an importer would be a duplication annual monetary value of the food establishment or only those that trigger
of effort. These comments ask us to manufactured, processed, packed, or the registration of the establishment as
allow a foreign facility that is a qualified held at such facility that is sold directly a facility. Some comments ask us to
facility to submit information to either to qualified end-users during a three- clarify the difference between having
FDA or the importer, rather than to both year period exceeded the average annual documentation to support food safety
FDA and the importer. monetary value of the food sold by the practices and attesting that the facility
(Response 580) We decline this facility to all other purchasers. We has such documentation. Other
request. Documentation submitted to an expect that financial records comments ask whether a qualified
importer would not reach FDA and, demonstrating that a business is a very facility would need to have records
thus, could not satisfy the requirements small business will be less burdensome documenting a risk analysis and
of this rule. As discussed in Response for a qualified facility to maintain and monitoring.
572, we are requiring submission of an require fewer resources for FDA to (Response 584) If a qualified facility
attestation, on a form that can be review. submits an attestation regarding its food
submitted either electronically or on (Comment 582) Some comments ask safety practices, the documentation that
paper, rather than submission of the whether documentation demonstrating the facility maintains for review during
underlying information. that a facility is a qualified facility must inspection must specify that the facility
be prepared by a ‘‘preventive controls has identified the potential hazards
C. Proposed § 117.201(a)— qualified individual’’ as that term is associated with the food being
Documentation To Be Submitted defined in § 117.3. produced, is implementing preventive
1. Proposed § 117.201(a)(1)— (Response 582) The rule does not controls to address the hazards, and is
Documentation That the Facility Is a require that documentation monitoring the performance of the
Qualified Facility demonstrating that a facility is a preventive controls to ensure that such
qualified facility be prepared by a controls are effective (see
We proposed that a qualified facility ‘‘preventive controls qualified § 117.201(a)(2)(i)). For example, a
must submit documentation that the individual.’’ qualified facility that produces one or
facility is a qualified facility. We also (Comment 583) Some comments ask more nut butters might have
proposed that for the purpose of how the adjustment for inflation will be documentation specifying that it has
determining whether a facility satisfies calculated and how regulators such as determined that Salmonella is a hazard
the definition of a qualified facility, the the States will get this information. requiring a preventive control,
baseline year for calculating the (Response 583) We intend to use the describing the roasting process that will
adjustment for inflation is 2011. As Federal calculation for the Gross control Salmonella, describing
discussed in Response 572, we have Domestic Product price deflator, as sanitation controls to prevent
revised the provision to specify that the provided by the Bureau of Economic contamination of the nut butters with
documentation that must be submitted Analysis, to adjust for inflation. We will Salmonella, and describing an
is an attestation. make the inflation-adjusted dollar value environmental monitoring program to
(Comment 581) Some comments ask to the baseline very small business sales verify that its sanitation controls are
us to clarify the documentation required cut-offs (e.g., $1,000,000 in 2011) effective. Likewise, a qualified facility
to certify that an operation is a qualified available on our Internet site. We will that prepares cooked soups that require
facility. Some comments ask us to update the values for the very small refrigeration for safety might have
explicitly state that the documentation business exemptions and qualifications documentation specifying that it has
must include financial and sales records annually using this calculation. determined that Salmonella is a hazard
of the business and its subsidiaries or requiring a preventive control and
affiliates. Some comments ask us to 2. Proposed § 117.201(a)(2)(i)—First
supporting the temperature and time
clarify the types of records that would Option for Documentation: Food Safety
used in a thermal process to kill
be required to be submitted by foreign Practices
Salmonella, with temperature controls
establishments to support the We proposed two options for for safety and procedures for monitoring
classification of a foreign establishment satisfying the statutory documentation the temperature controls. A qualified
as a ‘‘qualified facility.’’ requirement in section 418(l)(2)(B)(i) of facility that makes pickles might have
(Response 581) The submission to the FD&C Act. Under the first option documentation specifying that the
FDA will be an attestation rather than (the food safety practices option), a hazard requiring a preventive control is
the records that the qualified facility qualified facility could submit C. botulinum, specifying the final
relies on to support the attestation; documentation demonstrating that it has equilibrium pH (of the pickled
however, you must maintain those identified the potential hazards cucumbers) that is controlling the
records relied upon to support the associated with the food being hazard, and demonstrating its
‘‘attestations’’ (see § 117.201(f)). As produced, is implementing preventive monitoring of the pH during the
previously discussed, consistent with controls to address the hazards, and is production process.
section 418(l)(2)(B)(ii) of the FD&C Act monitoring the performance of the As discussed in Response 572, a
we intend to issue guidance on the preventive controls to ensure that such qualified facility that chooses the food
records that a facility could retain to controls are effective. As discussed in safety practices option for complying
demonstrate that it is a qualified facility Response 572, we have revised the with the submission requirements of
(78 FR 3646 at 3770). We intend to focus provision to specify that the submission this rule will attest to that by checking
on records demonstrating that a facility is an attestation. a statement on a form. In contrast, a
is a very small business (i.e., financial (Comment 584) Some comments food safety plan (or other
records demonstrating that a business assert that the rule is vague about what documentation) that the qualified
facility relies on to support the (Comment 589) Some comments ask D. Proposed § 117.201(b)—Procedure for
attestation will be a record subject to the us to revise the proposed provision to Submission
recordkeeping requirements of subpart make clear that a facility could submit We proposed that the documentation
F. an applicable attestation if the facility is must be submitted to FDA either
(Comment 585) Some comments ask subject to a State or local ‘‘cottage food’’ electronically or by mail. As discussed
us to clarify whether the submission law (laws allowing sale of certain food in Response 572, we have revised the
requirement addresses compliance with from home kitchens). These comments regulatory text to update details
the CGMP requirements of subpart B. explain that some cottage food laws do regarding the electronic and paper
(Response 585) The submission not require State or local authorities to
submission of a specific form. We are
requirement does not address inspect a facility or otherwise document
developing paper and electronic
compliance with the CGMP that the facility is in compliance with
versions of Form FDA 3942a, which is
requirements of subpart B. the cottage food law. In addition, under
an information collection provision that
some of these cottage food laws a
3. Proposed § 117.201(a)(2)(ii)—Second is subject to review by OMB under the
facility would not have documentation
Option for Documentation: Compliance Paperwork Reduction Act of 1995 (44
such as a license to support its
With Other Applicable Non-Federal U.S.C. 3501–3520). We intend to make
compliance with food safety
Food Safety Law the paper Form FDA 3942a available in
requirements. Some of these comments
Under the second option for satisfying the near future and invite comments
ask us to revise the proposed provision
the statutory documentation to specify that a facility could rely on consistent with procedures for approval
requirement, a qualified facility could a copy of the relevant State law or of the form by OMB.
submit documentation that it is in regulation and a letter from the facility (Comment 591) Some comments
compliance with State, local, county, or stating that it complies with that law or recommend that any interface for
other applicable non-Federal food safety regulation, or certification by an electronic submission of certification
law, including relevant laws and appropriate agency (such as a State statements post adequate notice of
regulations of foreign countries. As department of agriculture). requirements the facility must meet and
discussed in Response 572, we have (Response 589) As discussed in warnings detailing potential penalties
revised the provision to specify that the Response 572, we have revised the (e.g., for fraudulent submission).
submission is an attestation. We also regulatory text.to provide for qualified (Response 591) We intend that the
have revised the provision to add facilities to submit an attestation that electronic submission system will
‘‘tribal’’ as an example of applicable the facility is in compliance with State, operate in a manner similar to the
non-Federal food safety law to clarify local, county, or other applicable non- existing electronic submission system
for purposes of this rule that a qualified Federal food safety law. During an for registration of food facilities,
facility could submit an attestation that inspection, we expect the facility to be including a certification statement
it is in compliance with tribal food able to show us how the facility is advising the person signing the form
safety law. complying with the applicable food that, under 18 U.S.C. 1001, anyone who
(Comment 586) Some comments safety regulation (including relevant makes a materially false, fictitious, or
object to the proposed provision. These licenses, inspection reports, certificates, fraudulent statement to the U.S.
comments point out that State and local permits, credentials, or certifications), Government is subject to criminal
requirements are inconsistent and assert and producing safe food. penalties. We intend to include a
that such requirements are not (Comment 590) Some comments ask similar certification statement on paper
sufficiently rigorous to substitute for the us to provide resources to the States to forms that will be available for qualified
FSMA requirement to conduct a hazard implement the proposed provision. facilities that choose to submit by paper
analysis and establish and execute a These comments also ask us to develop rather than through the electronic
documented food safety plan. and implement a strategic plan to system. The electronic and paper
(Response 586) The provision reflects provide resources (e.g., training, submission forms will focus on the
the express statutory direction of section guidance) to State and local inspection attestation statements rather than on
418(l)(2)(B)(i)(II) of the FD&C Act. See agencies in advance of the anticipated other requirements that the facility is
Response 576. increased burden on State and local subject to. The Small Entity Compliance
(Comment 587) Some comments ask inspection programs that will be created Guide that we will issue in accordance
us to specify that a qualified facility by the provision. with section 212 of the Small Business
must document its compliance with the (Response 590) We do not believe that Regulatory Enforcement Fairness Act
food safety laws of the State where its specific training for State or other (Public L. 104–121) will be better suited
products are sold. government counterparts is necessary to helping qualified facilities
(Response 587) We decline this for the purposes of inspecting a understand the requirements of the rule
request. We interpret section qualified facility that attested to having than information presented on a
418(l)(2)(B)(i)(II) of the FD&C Act to documentation from a non-Federal submission form.
apply to the State where a qualified regulatory authority. The State or other
government counterpart would merely E. Proposed § 117.201(c)—Frequency of
facility is located. This is consistent
examine applicable documentation Determination and Submission
with how States conduct inspections.
(Comment 588) Some comments ask (such as a license, inspection report, We proposed that the documentation
us to specify that a qualified facility certificate, permit, credentials, or must be: (1) Submitted to FDA initially
must document compliance with all certification by an appropriate agency within 90 days of the applicable
applicable non-Federal food safety laws. (such as a State department of compliance date; and (2) resubmitted at
(Response 588) We decline this agriculture), which is specified in the least every 2 years, or whenever there is
request. Section 418(l)(2)(B)(i)(II) of the provision. After inspecting such a material change to the information
FD&C Act refers to compliance with documentation, the State or other applicable to determining the status of
‘‘State, local, county or other applicable government counterpart would focus on a facility.
non-Federal food safety law’’ (emphasis inspection for compliance with CGMPs, (Comment 592) Some comments
added). as it has done in the past. assert that the proposed timeframe of 90
days to submit the required For qualified facilities that do not begin year. A facility that does not determine
documentation would not provide operations until after December 2018, that change in status until the required
sufficient time to gather and submit the the first biennial submission will be date of July 1 would still have 6 months
required documentation and ask us to required in a timeframe less than two to comply with the full requirements for
extend the timeframe—e.g., to 120 or years, but once the qualified facility has hazard analysis and risk-based
180 days. made its first submission the subsequent preventive controls. As we have done in
(Response 592) We are retaining the biennial submissions will all be at two- the case of a qualified exemption being
proposed timeframe for the initial year intervals. Coordinating the biennial withdrawn (see § 117.257(d)(1)), we are
submission (within 90 days of the submissions of the required attestations providing flexibility for a facility to
applicable compliance date). The only with the biennial registration will comply in an alternative timeframe if
documentation that the qualified facility reduce the cumulative economic impact agreed to by FDA and the facility.
will need to submit is an attestation, on the food industry of complying with (Comment 594) Some comments ask
which does not need to be gathered. two separate requirements because us to specify that the required
Importantly, however, documentation qualified facilities that choose to submit attestations be submitted annually
supporting the attestation must be electronically will be able to submit rather than every 2 years. These
available for inspection by September electronically while accessing the same comments assert that annual submission
17, 2018. As discussed in Response 155 electronic portal used for facility would be consistent with the statutory
the compliance date for a facility to registration. This approach is consistent provisions that determine eligibility for
retain records to support its status as a with our approach to food labeling status as a qualified facility based on
qualified facility is January 1, 2016. As requirements, where we establish a sales, which will vary each year. These
a companion change, we are explicitly Uniform Compliance Date (see, e.g., 79 comments also assert that using the
requiring that a facility determine and FR 73201, December 10, 2014). current mechanism for registration of
document its status as a qualified (Comment 593) Some comments ask food facilities would not be burdensome
facility on an annual basis by no later us to include an option within the and would provide us with assurances
than July 1 of each calendar year (see system to notify us when a facility’s that only facilities that satisfy criteria to
§ 117.201(c)(1)). status as a ‘‘qualified facility’’ changes— be a qualified facility will operate under
In addition, we have revised proposed e.g., because its business expands or the modified requirements, thereby
§ 117.201(c)(1) (which we are finalizing changes. minimizing risk to public health.
as § 117.201(c)(2)(i)(A), (B), and (C)) to (Response 593) Notifying us when Other comments ask us to specify that
specify the timeframe for the initial there is a change in the facility’s status the required attestations be submitted
submission for three distinct from ‘‘qualified facility’’ to ‘‘not a every 5 years rather than every 2 years.
circumstances: (1) By December 17, qualified facility’’ is a requirement These comments assert that doing so
2018, for a facility that begins rather than an option. We included this would be consistent with the statutory
manufacturing, processing, packing or requirement in the proposed rule, and direction of section 201 of FSMA
holding food before September 17, 2018; are establishing it in this final rule. We (Targeting of Inspection Resources) for
(2) Before beginning operations, for a made editorial changes to the provision non-high risk food facilities. These
facility that begins manufacturing, to make this clearer. comments also assert that we did not
processing, packing or holding food We also established a series of dates provide specific reasons for the
after September 17, 2018; or (3) By July associated with the facility’s change in proposed 2 year timeframe and that re-
31 of the applicable calendar year, when status from ‘‘qualified facility’’ to ‘‘not submitting the attestations every two
the status of a facility changes from ‘‘not a qualified facility.’’ First, we are years will increase cost in time and
a qualified facility’’ to ‘‘qualified specifying that when the status of a labor.
facility’’ based on the annual facility changes from ‘‘qualified facility’’ (Response 594) We decline both of
determination required by paragraph to ‘‘not a qualified facility’’ based on the these requests. The rule already requires
(c)(1) of this section. See the discussion required annual determination, the resubmission whenever there is a
in Response 155 regarding the approach facility must notify FDA of that change material change to the information that
we intend to take in a number of in status using Form 3942a by July 31 changes the status of a facility as a
circumstances that could lead to a of the applicable calendar year (see qualified facility. Therefore, if the
facility having records to support its § 117.201(c)(3)). We have provided the facility’s sales change its status, so that
status as a qualified facility for fewer facility with flexibility to wait until July it is no longer a qualified facility, the
than 3 preceding calendar years. 1 of a given calendar year to determine rule requires that facility to notify us
We have revised the provision to whether its status changes (see when its status changes. (Note that the
specify that the required biennial § 117.201(c)(1)); 30 days is an adequate definition of very small business
submissions of the attestations must be timeframe to submit the form notifying established in this rule is based on an
made during a timeframe that will us of the change in status. average (of sales plus market value of
coincide with the required biennial Second, we are specifying that when human food held without sale) during
updates to facility registration (See the status of a facility changes from the 3-year period preceding the
section 102 of FSMA)—i.e., during the ‘‘qualified facility’’ to ‘‘not a qualified applicable calendar year, rather than on
period beginning on October 1 and facility,’’ the facility must comply with annual sales plus market value. See
ending on December 31, beginning in subparts C and G no later than Response 155.) A biennial submission is
2020. In determining that 2020 would December 31 of the applicable calendar adequate to otherwise require a
be the first year for the required biennial year unless otherwise agreed to by FDA qualified facility to affirmatively attest
submissions of the attestations, we first and the facility (see § 117.201(d)). In that it continues to satisfy the criteria
considered that the first submission of essence, this provision can provide a for being a qualified facility. A biennial
an attestation would be approximately facility with up to a full year to comply submission is not overly burdensome,
December 2018 for qualified facilities with the full requirements for hazard because a facility can coordinate its
that are operating as of the date of this analysis and risk-based preventive biennial submission with its biennial
final rule (i.e., approximately 90 days controls when the facility determines its update to its facility registration. The
after the date of publication of this rule). change in status early in the calendar suggested 5-year submission based on
the targeted inspection frequency for to appear on labels or other required are subject to the requirements in
non-high risk food facilities implies that notifications when the facility has opted subpart F (see § 117.305(a)), which
all qualified facilities produce such to not submit documentation directed to specifies that these requirements apply
foods, which is not the case. food safety practices. In this document, to all records required by this rule,
we are affirming that tentative rather than by specifying these
F. Proposed § 117.201(d)—Notification
conclusion. As discussed in section requirements within the provisions
to Consumers (Final § 117.201(e))
LVI.A, we are establishing January 1, directed to modified requirements for
We proposed that a qualified facility 2020, as the date when a qualified qualified facilities.
that does not submit documentation of facility that is subject to the notification (Comment 598) Some comments ask
its food safety practices must provide requirements of § 117.201(e)(1) must us to include a new section in subpart
notification to consumers as to the name notify consumers of the complete F to cover additional requirements
and complete business address of the business address of the facility where applying to the records that a qualified
facility where the food was the food was manufactured or facility must keep and make available to
manufactured or processed (including processed. FDA upon request. These comments
the street address or P.O. box, city, state, assert that such a section is necessary to
and zip code for domestic facilities, and G. Proposed § 117.201(e)—Records ensure that qualified facilities
comparable full address information for (Final § 117.201(f)) understand their obligations. These
foreign facilities). We proposed that a qualified facility comments also assert that clarity is
(Comment 595) Some comments must maintain those records relied upon needed in light of the nature of the
assert that the proposed requirement to support the required documentation. financial records that would be required
exceeds what is already present for food We also proposed that the records that to support the facility’s status as a
in packaged form (21 CFR 101.5), and a qualified facility must maintain would qualified facility.
that these differences will create be subject to the requirements that (Response 598) We decline this
confusion for regulators and producers would be established in subpart F of request. As discussed in Response 581,
alike, with added costs but no food this rule. As discussed in Response 572, consistent with section 418(l)(2)(B)(ii) of
safety benefits. Some comments assert after considering comments we have the FD&C Act we intend to issue
that the proposed requirement will revised the rule to specify that a guidance on the records that a facility
likely cause consumer confusion at qualified facility must maintain those could retain to demonstrate that it is a
point of purchase and may discourage records relied upon to support the qualified facility rather than specify
retail and food service buyers from required attestations (rather than the these records in the human preventive
receiving products from qualified required documentation). controls rule. Section 117.201(f) already
facilities. Some comments ask us to (Comment 596) Some comments ask specifies that a qualified facility must
specify that when a food packaging label us to explicitly specify that we have maintain those records relied upon to
is required, the required information access to documents that establish a support the required attestations. There
must appear prominently and facility as a qualified facility. Some is no need to repeat this requirement in
conspicuously on the label in comments assert that a facility may subpart F, which establishes general
compliance with § 101.5. reasonably assume that records such as requirements for all records required by
(Response 595) We decline these financial records would not be available the rule but does not specify those
requests. The requirement for to us because such records are excluded records required to demonstrate
notification to consumers is mandated from the records that we have access to compliance with particular
by section 418(l)(7)(A) of the FD&C Act. under the Public Health Security and requirements of the rule.
The labeling requirements applicable to Bioterrorism Preparedness and
packaged foods (§ 101.5) are established XXXIX. Subpart D: Comments on
Response Act of 2002 (the Bioterrorism
under a different statutory provision Proposed § 117.206—Modified
Act), as provided by § 1.362.
than the labeling requirements (Response 596) The rule explicitly Requirements That Apply to a Facility
applicable to qualified facilities (i.e., specifies that we have access to records Solely Engaged in the Storage of
under section 403(e) of the FD&C Act that are required by the rule (see Unexposed Packaged Food
(21 U.S.C. 343(e)) rather than section § 117.320). If a facility relies on We proposed that if your facility is
418(l)(7) of the FD&C Act). The financial records to demonstrate its solely engaged in the storage of
comments provide no explanation of the status as a qualified facility, we will unexposed packaged food, you must
basis for their assertion that these have access to those financial records. conduct certain activities for any such
differences will create confusion for The exemption referred to by the refrigerated packaged food that requires
consumers at point of purchase or comments for financial records (§ 1.362) time/temperature control to
discourage retail and food service is narrowly targeted to records required significantly minimize or prevent the
buyers from receiving products from by the section 414 recordkeeping growth of, or toxin production by,
qualified facilities. As previously regulations and does not apply to microorganisms of public health
discussed (78 FR 3646 at 3771), the use records required by this human significance. We requested comment on
of the term ‘‘business address’’ in preventive controls rule. the proposed list of modified
section 418(l)(7) of the FD&C Act (Comment 597) Some comments ask requirements. Some comments that
contrasts with Congress’ use of a us to revise the rule to define support the proposed provisions suggest
different term, ‘‘place of business,’’ in documentation as the actual records or alternative or additional regulatory text
section 403(e) of the FD&C Act. These true copies of the actual records. (see, e.g., Comment 599, Comment 600,
comments do not address the reasons (Response 597) The rule explicitly Comment 604, Comment 606, Comment
we previously discussed for our specifies that the records a qualified 608, and Comment 610) or ask us to
tentative conclusion that the use of the facility relies on to support the required clarify how we will interpret the
term ‘‘business address’’ in section attestations must be actual records, true provision (see, e.g., Comment 601 and
418(l)(7) demonstrates Congress’ intent copies, or electronic records. However, Comment 602).
to require the facility’s full address, it does so by requiring that the records In this section, we discuss comments
including the street address or P.O. box, that a qualified facility must maintain that ask us to clarify the proposed
requirements or that disagree with, or proposed requirements. After revised the proposed requirements as
suggest one or more changes to, the considering these comments, we have shown in table 41.
TABLE 41—REVISIONS TO THE PROPOSED MODIFIED REQUIREMENTS FOR UNEXPOSED, REFRIGERATED, PACKAGED FOOD
117.206(a) ....................................... Circumstances that make a facility Clarify that the requirements apply to a temperature control area in a
subject to the modified require- facility that holds TCS food rather than to each product in the hold-
ments for unexposed, refrig- ing facility.
erated packaged food.
117.206(a)(3) ................................... Modified requirements for correc- Clarify that corrective actions need only be taken when a loss of tem-
tive actions. perature control may impact the safety of the TCS food.
117.206(a)(4)(i) ............................... Modified requirements for Provide additional flexibility for accuracy checks, in addition to cali-
verification of temperature con- bration, to verify that temperature controls are consistently imple-
trols. mented.
117.206(a)(4)(iii) .............................. Modified requirements for Provide additional flexibility for reviewing records of monitoring and
verification of temperature con- corrective actions either within a week after the records are made
trols. or within a reasonable timeframe.
117.206(a)(5)(i) ............................... Records documenting the moni- Provide additional flexibility for records documenting the monitoring of
toring of temperature controls. temperature controls to be kept either as affirmative records dem-
onstrating temperature is controlled or as exception records dem-
onstrating loss of temperature control.
117.206(a)(5)(ii) ............................... Records documenting corrective Conforming change associated with the modified requirements for
actions. corrective actions to clarify that records of corrective actions are re-
quired when there is a loss of temperature control that may impact
the safety of the TCS food.
A. Proposed § 117.206(a)—Modified conduct activities ‘‘for any such FD&C Act to determine the storage
Requirements for Unexposed refrigerated packaged food.’’ conditions necessary for food safety and
Refrigerated Packaged Food That (Comment 600) Some comments to take steps to ensure that the food is
Requires Time/Temperature Controls disagree with our tentative conclusion stored under conditions that will ensure
that it would be rare for a facility solely its safety.
1. Proposed § 117.206(a)(1)—Establish
and Implement Temperature Controls engaged in the storage of unexposed It is not necessary to specify this joint
packaged food to not have information responsibility for determining storage
We proposed that if your facility is regarding whether a refrigerated conditions in the rule, because the rule
subject to the modified requirements, packaged food is a TCS food and, if so, already clearly specifies that its
you must establish and implement what specific temperature controls are provisions apply to persons who
temperature controls adequate to necessary for safe storage of the food. manufacture/process food, as well as to
significantly minimize or prevent the These comments ask us to specify that persons who hold food. Both the
growth of, or toxin production by, the responsibility for determining warehouse and the manufacturer have
microorganisms of public health whether a food is a TCS food falls to the flexibility in determining how to
significance. manufacturer of the food rather than the comply with the rule, including the
We also tentatively concluded that it warehouse storing the food, because the specific mechanism whereby the
would be rare for a facility solely warehouse merely provides a service. warehouse would receive information
engaged in the storage of unexposed Other comments note that the food about storage of a food product from the
packaged food to not have information product owners determine the optimal manufacturer or owner of the product.
regarding whether a refrigerated conditions for storage of their products Moreover, a citizen petition submitted
packaged food is a TCS food and, if so, based on their own hazard analysis and to FDA [Docket No. FDA–2011–P–0561],
what specific temperature controls are preventive controls, and that the food in requesting an exemption or modified
necessary for safe storage of the food. product owners can simply requirements for facilities solely
We requested comment on this tentative communicate those requirements to the engaged in the storage of unexposed
conclusion. warehouses that will store the products. packaged foods, asserts that such
(Comment 599) Some comments ask (Response 600) In this type of facilities work closely with food
us to clarify that the requirement to circumstance, it is appropriate for the manufacturers to understand the
establish and implement temperature manufacturer of the food to share the conditions and controls needed to
controls applies to temperature control responsibility with the warehouse for ensure the quality of the foods they
areas in a facility rather than to each proper storage of the food. The various store and distribute and that
product in a facility. provisions of section 418 of the FD&C manufacturers appropriately instruct the
(Response 599) We agree that the act explicitly place the responsibility for warehouses to ensure packaged
requirement to establish and implement complying with the requirements for products are being properly stored (78
temperature controls applies to hazard analysis and risk-based FR 3646 at 3712).
temperature control areas in a facility preventive controls, including modified (Comment 601) Some comments ask
rather than to each product in a facility. requirements, on the owner, operator, or us to clarify which facility—the
To make this clearer, we have revised agent in charge of a facility and, thus, shipping facility or the receiving
the proposed requirement to clarify that a facility that is a warehouse is facility—will be responsible for
the facility must conduct activities as responsible for its own food safety plan. ensuring that temperature control is
appropriate to ensure the effectiveness Regardless, the manufacturer also has maintained during transportation of
of the temperature controls rather than responsibilities under section 418 of the TCS foods.
(Response 601) See Response 423, 3. Proposed § 117.206(a)(3)— to correct a problem with the control of
which notes our intention to address Requirement to Take Corrective Actions temperature within a week after the
comments regarding the responsibilities We proposed that if your facility is records are made.
of shippers and receivers in the final subject to the modified requirements, (Comment 606) Some comments
sanitary transportation rule. you must take appropriate corrective assert that the proposed requirement to
actions if there is a problem with the ‘‘calibrate’’ devices that monitor and
2. Proposed § 117.206(a)(2)—Monitor
temperature controls for a TCS food. record temperature is inconsistent with
the Temperature Controls
(Comment 604) Some comments ask the requirement to test such devices for
We proposed that if your facility is us to narrow the term ‘‘temperature accuracy in the LACF regulations in part
subject to the modified requirements, controls’’ to more specifically focus it 113. These comments assert that
you must monitor the temperature on temperature controls that are ‘‘accuracy check’’ is a more appropriate
controls with sufficient frequency to relevant to food safety because some term to use in the modified
provide assurance they are consistently problems with the controls may not requirements because many instruments
performed. We requested comment on impact the product temperature (and, that monitor or record temperature have
whether there would be a benefit to thus, would not impact food safety). very low drift values and may seldom
requiring a facility to develop written (Response 604) We have revised the require calibration.
procedures for monitoring temperature. proposed requirement (and the (Response 606) We have revised the
(Comment 602) Some comments ask applicable recordkeeping requirement) proposed requirements to require
us to explain in the preamble of the to specify that corrective actions are verification that temperature controls
final rule that we will accept monitoring necessary only when there is a loss of are consistently implemented by
systems that provide exception reports temperature control that may impact the calibrating temperature monitoring and
to satisfy the modified requirements. safety of a TCS food. recording devices or checking them for
The comments describe exception (Comment 605) Some comments accuracy. However, if the outcome of an
reporting as a structure where assert that the responsibility for accuracy check is that a temperature
automated systems are designed to alert determining any corrective actions for a monitoring or recording device is not
operators and management when the TCS food when there is a loss of accurate, the facility must follow up by
monitoring system observes a deviation temperature control falls to the calibrating or replacing the device. See
from an established limit. These manufacturer of the food rather than to also Comment 519 and Response 519.
comments assert that monitoring of the warehouse. These comments also (Comment 607) Some comments
preventive controls by automated assert that a warehouse is a third party assert that reviewing records of
systems can be more efficient than who is not legally empowered to make calibration or accuracy checks is only
monitoring by personnel, and can independent decisions about when and needed if a designated tolerance is
eliminate human error. where to ship the product, or not to ship exceeded.
(Response 602) See also Response 468 it at all. These comments ask us to (Response 607) Although we
and Response 610. We have revised the clarify that the responsibility of a recognize that in most instances an out-
recordkeeping provisions of these warehouse for ‘‘preventing’’ affected of-calibration device will be identified
modified requirements to provide that food entering commerce ends when the and corrected at the time a calibration
the temperature monitoring records for product is returned to the manufacturer or accuracy check is performed, this is
the modified requirements may be kept or processor. not always the case. The purpose of
either as affirmative records (Response 605) Returning affected reviewing records of calibration or
demonstrating temperature is controlled food to the manufacturer/processor or accuracy checks is to identify a problem
or as exception records demonstrating owner of the food is one way to satisfy that may have been missed or may not
loss of temperature control. Although the requirement to prevent food from have been corrected rather than to react
the comments explicitly ask us to entering commerce if the owner, to a problem after the problem is
provide a clarification in the preamble operator, or agent in charge of a identified. The records review is also a
of this rule, we decided the clarification warehouse cannot ensure the affected verification that the temperature
within the regulatory text would be food is not adulterated under section controls were consistently implemented
clearer to facilities that are subject to the 402 of the FD&C Act, either on its own and that corrective actions were taken if
requirements, as well as to investigators or after consultation with the needed.
who will be inspecting facilities for manufacturer or processor of the food. It (Comment 608) Some comments ask
compliance with the rule. is not necessary to specify this specific us to modify the frequency of checking
(Comment 603) Some comments state action on the part of a warehouse in the monitoring records to specify that it be
that written procedures for monitoring regulatory text. done with a frequency to demonstrate
temperature are not necessary. One control rather than within a week after
reason provided by the comments is that 4. Proposed § 117.206(a)(4)— the records are made.
the required records (specified in Requirement To Verify Consistent (Response 608) Consistent with
proposed § 117.206 (a)(5)) would Implementation of Temperature Response 539, we have revised the
provide sufficient information on the Controls proposed requirement to require review
type and frequency of monitoring. We proposed that if your facility is of records of monitoring (as well as
Another reason is that the specific subject to the modified requirements, records of corrective actions taken to
activities we proposed to ensure the you must verify that temperature correct a problem with the control of
effectiveness of the temperature controls controls are consistently implemented temperature) within 7 working days
already address activities that a facility by: (1) Calibrating temperature after the records are created or within a
would include in a written procedure. monitoring and recording devices; (2) reasonable timeframe, provided that the
(Response 603) We agree with the reviewing records of calibration within preventive controls qualified individual
comments that the rule does not need to a reasonable time after the records are prepares (or oversees the preparation of)
require that a facility develop written made; and (3) reviewing records of a written justification for a timeframe
procedures for monitoring temperature. monitoring and corrective actions taken that exceeds 7 working days.
(Comment 609) Some comments record review are not value-added. rule (such as the timeframe for
assert that the proposed verification and These comments ask us to revise the compliance with an order withdrawing
review activities are too prescriptive proposed provision to require a record an exemption), whereas others would be
because they require reviews that are only if a deviation in the environmental new provisions (such as a procedure to
not necessary. However, these temperature from the prescribed limits reinstate an exemption that had been
comments also assert that the proposed was noted. withdrawn). In this section of this
verification activities are too vague (Response 610) See also Response 468 document we discuss comments that we
because they do not specify the reasons and Response 602. We have revised the received on the withdrawal provisions
for reviewing the records. These regulatory text to provide that in the 2013 proposed human preventive
comments ask us to focus the regulatory temperature monitoring records may be controls rule, but did not address in the
text on achieving the overall objective of kept either as affirmative records 2014 supplemental human preventive
the review (i.e., ensuring the adequacy demonstrating temperature is controlled controls notice. We also discuss
of the control) and to provide examples or as exception records demonstrating comments that we received on the re-
of meaningful review activities in loss of temperature control. The revised proposed withdrawal provisions in the
guidance. provision is consistent with the more 2014 supplemental human preventive
(Response 609) We disagree that the general requirement for monitoring controls notice.
proposed verification activities would records of refrigeration temperature Most of the comments that support
require reviews that are not necessary. during storage of TCS food (see the proposed provisions suggest
As noted in Response 607, the purpose § 117.145(c)(2)). alternative or additional regulatory text
of the records review is both to identify B. Proposed § 117.206(b)—Records (see, e.g., Comment 612 through
a problem with a temperature Comment 614, Comment 620 through
We proposed that the records that a
monitoring device that may not have Comment 626, Comment 628, Comment
facility must establish and maintain for
been detected or corrected, and to verify 629, and Comment 631 through
the proposed modified requirements are
that the temperature controls were Comment 633) or ask us to clarify how
subject to the requirements that would
consistently implemented and that we will interpret the provision (see, e.g.,
be established in proposed subpart F.
corrective actions were taken if needed. We received no comments that Comment 617).
The requirement is consistent with disagreed with our proposal, and are For several provisions, we received no
requirement for records review in finalizing proposed § 117.206(b) without comments that disagreed with our
subpart C (§ 117.165(a)(4)), which change. proposal, and are finalizing the
specifies records review as a verification provisions without change. These
activity to ensure that the records are XL. Subpart E: Comments on Proposed provisions are § 117.274 (Presiding
complete, the activities reflected in the New Provisions for Withdrawal of a officer for an appeal and for an informal
records occurred in accordance with the Qualified Facility Exemption hearing); § 117.277 (Timeframe for
food safety plan, the preventive controls In the 2013 proposed human issuing a decision on an appeal);
are effective, and appropriate decisions preventive controls rule, we proposed to § 117.280 (Revocation of an order to
were made about corrective actions. establish procedural requirements that withdraw a qualified facility
would govern our withdrawal of an exemption); and § 117.284 (Final agency
5. Proposed § 117.206(a)(5)—Establish
exemption for a qualified facility action).
and Maintain Records
(proposed subpart E; the withdrawal In the following paragraphs, we
We proposed that if your facility is provisions). In the 2014 supplemental discuss comments that ask us to clarify
subject to the modified requirements, human preventive controls notice, we the proposed requirements or that
you must establish and maintain records discussed several comments we disagree with, or suggest one or more
that document monitoring, corrective received on these withdrawal changes to, the proposed requirements.
actions, and verification activities. provisions, and proposed modifications After considering these comments, we
(Comment 610) Some comments state and additions to them. Some of the re- have revised the proposed requirements
that temperature controls in refrigerated proposed provisions would modify the as shown in table 42, with editorial and
warehouses are extremely reliable and provisions that we included in the 2013 conforming changes as shown in table
therefore extensive recordkeeping and proposed human preventive controls 52.
TABLE 42—REVISIONS TO THE PROPOSED PROVISIONS FOR WITHDRAWAL OF A QUALIFIED FACILITY EXEMPTION
117.251(b)(2) ....................... Timeframe for a qualified facility to respond to a notifi- Allow 15 calendar days, rather than 10 calendar days,
cation from FDA about circumstances that may lead for the facility to respond.
FDA to withdraw the facility’s exemption.
117.257(c) ............................ Contents of an order to withdraw a qualified facility ex- Editorial changes to clarify that the order will specify
emption. which of two circumstances that may lead FDA to
withdraw a qualified facility exemption apply, or
whether both of these two circumstances apply.
117.257(d)(1) ....................... Contents of an order to withdraw a qualified facility ex- Specify that the timeframe for the qualified facility to
emption. comply with the order is 120 calendar days after the
date of receipt of the order, or within a reasonable
timeframe, agreed to by FDA, based on a written jus-

tification, submitted to FDA, for a timeframe that ex-
ceeds 120 calendar days from the date of receipt of
the order.
117.257(e) ............................ Contents of an order to withdraw a qualified facility ex- Include a statement informing the facility that it may ask
emption. us to reinstate an exemption that was withdrawn by
following the procedures in § 117.287.
TABLE 42—REVISIONS TO THE PROPOSED PROVISIONS FOR WITHDRAWAL OF A QUALIFIED FACILITY EXEMPTION—
Continued
117.257(d)(2) ....................... Timeframe for a qualified facility to appeal an order Allow 15 calendar days, rather than 10 calendar days,
withdrawing the facility’s exemption. for the facility to appeal the order.
117.260 ................................ Compliance with, or appeal of, an order to withdraw a Specifies that a qualified facility that loses its exemption
qualified facility exemption. would no longer need to comply with the modified re-
quirements that apply to qualified facilities that have
an active exemption.
117.260(a)(1) and (c)(1) ...... Compliance with, or appeal of, an order to withdraw a Specify that the timeframe for the qualified facility to
qualified facility exemption. comply with the order is 120 calendar days after the
date of receipt of the order, or within a reasonable
timeframe, agreed to by FDA, based on a written jus-
tification, submitted to FDA, for a timeframe that ex-
ceeds 120 calendar days from the date of receipt of
the order.
A. Proposed § 117.251—Circumstances process, but suggest that we could issue qualified facility exemption, other than
That May Lead FDA To Withdraw a guidance rather than include these to notify the facility in writing of
Qualified Facility Exemption provisions in the rule to allow us greater circumstances that may lead us to
We proposed that we may withdraw flexibility should we have to act quickly withdraw the exemption, provide an
the exemption that would apply to a to protect the public health. opportunity for the facility to respond in
qualified facility in the event of an Other comments disagree with these writing, and consider the actions taken
active investigation of a foodborne proposed provisions and ask us to by the facility to address the
illness outbreak that is directly linked to delete them from the final rule. These circumstances we describe. The rule
the qualified facility, or if we determine comments assert that FSMA does not clearly specifies that regulatory actions
that it is necessary to protect the public require us to describe the actions that such as a warning letter, recall,
health and prevent or mitigate a we may take prior to withdrawing a administrative detention, suspension of
foodborne illness outbreak based on qualified facility exemption and that it registration, refusal of food offered for
conditions or conduct associated with a is not necessary to do so because it is import, seizure, and injunction are
qualified facility that are material to the customary for us to work with a food actions that we ‘‘may’’ (not ‘‘must’’) take
safety of the food manufactured, facility to address problems before before issuing an order to withdraw a
processed, packed, or held at such taking enforcement actions. These qualified facility exemption. Providing
facility. We also proposed that before comments also express concern that the facility with an opportunity to
we issue an order to withdraw an listing possible regulatory actions before correct the problems before we take
exemption, we: (1) May consider one or we would issue an order to withdraw a steps to withdraw an exemption has the
more other actions to protect the public qualified facility exemption could create potential to save agency resources
health or mitigate a foodborne illness an expectation that we will always associated with preparing an order,
outbreak; (2) must notify you, in exercise such regulatory actions before responding to an appeal of the order and
writing, of circumstances that may lead issuing the order. These comments also request for a hearing, and administering
us to withdraw the exemption, and express concern that being bound by a hearing. Directing resources to help a
provide an opportunity for you to these provisions could prevent us from facility correct problems, rather than to
respond in writing, within 10 calendar acting quickly to protect public health. administer a withdrawal process that
days of the date of receipt of the (Response 611) We are retaining the could be resolved by the time of a
notification, to our notification; and (3) provisions regarding certain actions we hearing, is appropriate public health
must consider your actions to address may take, and other actions we must policy.
the circumstances that may lead us to take, before issuing an order to (Comment 612) Some comments ask
withdraw the exemption. withdraw a qualified facility exemption. us to specify that the notification of
(Comment 611) Some comments agree We agree that it is customary for us to circumstances that may lead FDA to
with the proposed provisions regarding work with a food facility to address withdraw the exemption must include
certain actions we may take, and other problems before taking enforcement facts specific to the situation and
actions we must take, before issuing an actions but disagree that specifying this information about how the facility can
order to withdraw a qualified facility customary practice in the rule would remedy the situation.
exemption. For example, some prevent us from acting quickly to (Response 612) By specifying that we
comments agree that other regulatory protect public health. As previously must notify the facility of circumstances
actions should be considered before discussed, we consider that issuing an that may lead us to withdraw an
withdrawing a qualified facility order to withdraw an exemption would exemption, we mean that we would
exemption, and some comments agree be a rare event, in part because include facts specific to the situation. It
that it is appropriate to assess corrective alternative actions such as those is the responsibility of the facility, not
actions taken by a qualified facility in described in these provisions may FDA, to remedy the situation.
response to a food safety problem when provide a more expeditious approach to (Comment 613) Some comments ask
considering whether to withdraw its correcting a problem than withdrawing us to state affirmatively that we must
exemption. Other comments agree that an exemption (79 FR 58524 at 58553). not withdraw the exemption if the
these provisions are reasonable and will We also disagree that the rule binds us facility has satisfactorily addressed the
provide qualified facilities due process to take alternative regulatory action problematic conditions or conduct at
and greater clarity on the withdrawal before issuing an order to withdraw a the facility. These comments assert that,
without this affirmative statement, the days’’ or ‘‘working days’’ throughout the the order is issued; (2) provide that any
requirement that we ‘‘consider the provisions directed to withdrawal of an officer or qualified employee of FDA
actions taken by the facility’’ remains exemption. Some comments ask us to may issue the order after it has been
unclear. use ‘‘business days’’ rather than approved; (3) specify that we would
(Response 613) We decline this ‘‘calendar days’’ or ‘‘working days.’’ issue the order to the owner, operator,
request. If the facility has satisfactorily (Response 616) We have expressed or agent in charge of the facility; and (4)
addressed the problematic conditions or the timeframes for all of the withdrawal require that the order be in writing and
conduct, there would be no problematic provisions in calendar days. be signed and dated by the officer or
circumstances for us to describe in the (Comment 617) Some comments ask qualified employee of FDA who is
order withdrawing the qualified facility us to clarify that the decision to issuing the order.
exemption. withdraw a qualified exemption is an (Comment 620) Some comments ask
(Comment 614) Some comments ask individualized determination and will us to include in the procedures
us to provide additional time for a not be applied to a class of farmers by timeframes for: (1) Submitting an order
qualified facility to respond, in writing, stating this clearly in the preamble. after an initial determination that
to a notification of circumstances that (Response 617) The decision to criteria for withdrawing an exemption
may lead us to withdraw its exemption. withdraw a qualified exemption is an are met; (2) approval or denial by the
Comments suggest timeframes of 60, 90, individualized determination and will FDA District Director; (3) issuing the
and 120 days as a reasonable or not be applied to a class of facilities or withdrawal (with automatic revocation
appropriate period of time for a farmers. of order if FDA does not issue the order
qualified facility to compile information (Comment 618) Some comments within the specified timeframe); and (4)
and documentation of facts and to assert that the timeframes for delivery of the order to the owner,
respond to a notification of responding to a notification that an operator, or agent in charge of the
circumstances that may cause us to exemption may be withdrawn should be facility. Other comments recommend
withdraw its exemption. Some of these the same regardless of whether the that the procedures for issuing an order
comments express concern that the notification is sent to a qualified facility specify that we send the order in a way
proposed deadline is too short, and that subject to the human preventive that ensures its receipt, such as through
the short timeframe violates the intent controls rule or a farm subject to the certified mail with confirmation of
of the exemption. Some comments ask produce safety rule. These comments delivery to ensure the facility operator
us to establish graduated response state that many small farms do value- receives the order.
times, with less response time allowed added processing and will be subject to (Response 620) We are not
for more serious food safety concerns. both rules. establishing timeframes for the steps we
(Response 614) We have revised the (Response 618) Although the produce take before a facility receives an order
provision to provide for 15 calendar safety rule is not yet final, we intend to for withdrawal of an exemption. The
days, rather than 10 calendar days, for make the administrative procedures timeframes surrounding our internal
a facility to respond in writing to our associated with withdrawal of an process for developing an order have no
notification. The 15-day timeframe is exemption consistent to the extent bearing on the time that a facility will
the same as the timeframe for practicable, including the timeframe for need to respond to the order or on the
responding to a warning letter. responding to a notification. information it will need to do so. We
Circumstances that could lead us to (Comment 619) Some comments ask agree that it is appropriate to specify
withdraw a qualified facility exemption us to expand the scope of the timeframes for the procedural steps that
require prompt action on the part of a withdrawal provisions to include follow a facility’s receipt of an order,
facility, just as circumstances that lead facilities that would satisfy criteria for and the withdrawal procedures include
us to issue a warning letter require an exemption from the requirements for such timeframes.
prompt action. hazard analysis and risk-based We are not specifying that we send an
(Comment 615) Some comments ask preventive controls for low-risk activity/ order in a way that ensures its receipt.
us to clarify how an exemption can be food combinations (i.e., the exemptions Although certified mail with
revoked (and restored) on diversified in proposed § 117.5(g) and (h)). confirmation of delivery is one way to
farms that produce both exempt and (Response 619) We decline this ensure receipt, other methods are
non-exempt products. request. Section 418 of the FD&C Act available, including delivery through
(Response 615) We assume that this does not provide for withdrawal of the private carriers that provide
comment is referring to a farm mixed- exemptions established in § 117.5(g) and mechanisms to document receipt. In
type facility that produces some (h). The withdrawal provision in section light of the provision (which we
products (such as juice or dietary 418(l)(3) of the FD&C Act is limited to included in the 2014 supplemental
supplements) that are exempt from the qualified facilities. human preventive controls notice)
requirements for hazard analysis and linking the timeframes for a facility to
risk-based preventive controls, as well B. Proposed § 117.254—Issuance of an
comply with, or appeal, an order to the
as some products that are not exempt Order To Withdraw a Qualified Facility
date of receipt of the order (rather than
from these requirements. Neither Exemption
to the date of the order), it will be up
withdrawing nor reinstating a qualified We proposed procedures for the steps to us to deliver the order in a way that
facility exemption would have any we would take to issue an order to provides us with evidence of receipt.
impact on products that are not subject withdraw an exemption applicable to a
to the requirements for hazard analysis qualified facility, including procedures C. Proposed § 117.257—Contents of an
and risk-based preventive controls. In that would: (1) Emphasize that a senior Order To Withdraw a Qualified Facility
contrast, administrative procedures FDA official (such as an FDA District Exemption

such as injunction and suspension of Director, the Director of the Office of We proposed specific information that
registration likely would apply to all Compliance in the Center for Food would be included in an order to
food production by the facility. Safety and Applied Nutrition, or a more withdraw an exemption, including: (1)
(Comment 616) Some comments ask senior FDA official) must approve an The date of the order and the name,
us to consistently use either ‘‘calendar order to withdraw the exemption before address, and location of the qualified
facility; (2) a brief, general statement of withdrawal provisions to incorporate would have preferred the proposed
the reasons for the order, including the suggestions of these comments. The timeframe of 10 calendar days could
information relevant to the comments appear to be more focused on request that the hearing be held more
circumstances that led us to issue the whether the circumstances that lead us quickly than 15 calendar days.
order; (3) a statement that the facility to issue an order meet an evidentiary The 15-day timeframe is the same as
must either comply with subpart C standard than on explaining the the timeframe for responding to a
within 120 calendar days of receipt, or problem so that a facility can both warning letter. As discussed in
appeal the order within 10 calendar understand the problem and respond Response 614, circumstances that could
days of receipt; (4) the text of section with particularity to the facts and issues lead us to withdraw a qualified facility
418(l) of the FD&C Act and of the contained in the order. The withdrawal exemption require prompt action on the
withdrawal provisions in part 117, provisions that we are establishing in part of a facility, just as circumstances
subpart E; (5) information about an this provision require the order to that lead us to issue a warning letter
informal hearing on an appeal of the include a brief, general statement of the require prompt action.
order; and (6) contact information for reasons for the order, including (Comment 624) Some comments
appropriate senior FDA officials, as well information relevant to: (1) An active support the proposed timeframe of 120
as the name and the title of the FDA investigation of a foodborne illness calendar days for a qualified facility
representative who approved the order. outbreak that is directly linked to the whose exemption has been withdrawn
(Comment 621) Some comments facility; or (2) conditions or conduct to comply with the human preventive
recommend that the order specify which associated with a qualified facility that controls rule, but ask us to make the
of the two circumstances that could lead are material to the safety of the food timeframe for complying with a FSMA
us to issue the order apply. manufactured, processed, packed, or rule the same regardless of whether the
(Response 621) We have made held at the facility. The requirements exemption is withdrawn from a
editorial changes to the regulatory text that we are establishing in this qualified facility subject to the human
to make it more clear that the provision provision would enable a qualified preventive controls rule or from a farm
requires us to specify which facility to both understand the problem subject to the produce safety rule. Other
circumstance applies (i.e., an active and respond to it. In addition, because comments ask us to extend the
investigation of foodborne illness, or other requirements in these withdrawal timeframe to come into compliance—
conduct or conditions associated with provisions specify that we must notify e.g., to 1 or 2 years. Some of these
the qualified facility), or whether both a qualified facility of circumstances that comments suggest that qualified
of these two circumstances apply. See may lead us to withdraw its exemption facilities should have 120 days to
the revised regulatory text for before we issue the actual order, the develop a plan of action, but 2 years to
§ 117.257(c). order withdrawing the exemption fully comply. Some of the comments
(Comment 622) Some comments ask would be the second time that the argue that large farms and
us to add more specific requirements for facility hears about the problems (see manufacturers are given a year to come
the content of an order to withdraw an § 117.251(b)(2)). We intend that the into compliance, and that requiring
exemption, including specific evidence process of responding to the notification small and very small businesses to
about the circumstances leading to the that we must send before issuing an comply in a shorter time period would
order. The comments maintain that order to withdraw an exemption, effectively drive them out of business.
doing so would help the facility respond including discussing the problems with Other comments ask us to consider
with particularity to the facts and issues FDA as warranted, would provide provisions that would require
contained in the order if the facility additional information to the facility to compliance with only those portions of
appeals the order. The comments also enable the facility to both understand the rule that formed the basis for the
recommend that the order include the the problem and respond to it. revocation.
evidence on which the order is based (Comment 623) Some comments ask (Response 624) We continue to
including, as applicable, evidence us to provide 15 ‘‘business days’’ from believe that the 120-day timeframe is
linking the active investigation of a date of receipt of the order, rather than adequate, but we have added flexibility
foodborne illness outbreak directly to the proposed 10 calendar days from date such that a facility may request, with a
the facility or measurable evidence of receipt of the order, for the facility to justification in writing to FDA, a
(collected using generally accepted appeal the order. reasonable timeframe for compliance
scientific standards) indicating the (Response 623) We have revised the that exceeds 120 calendar days from the
presence in the facility of pathogens that provision to provide for 15 calendar receipt of the order. FDA must grant the
pose an imminent threat to public days, rather than 15 business days, for request for the facility to receive the
health, or conduct or conditions that are a facility to appeal the order. We also extended timeframe. We are not
material to the safety of food. The have made conforming changes to generally extending the timeframe
comments also recommend that the establish the same 15 calendar because circumstances that could lead
order include, when applicable, a timeframe in all provisions that specify us to withdraw a qualified facility
statement explaining how altering the the timeframe to appeal the order (i.e., exemption require prompt action on the
conduct or conditions would prevent or §§ 117.260(a)(2), 117.264(a)(1), and part of a facility. A qualified facility that
mitigate a foodborne illness outbreak. 117.267(a)(2)). We also extended the receives an order to withdraw its
(Response 622) We agree that the timeframe for the hearing to be held to exemption would have received
order must provide sufficient be within 15 calendar days, rather than advance notification of the
information to enable a facility to the proposed 10 calendar days, after the circumstances leading to the order and
respond with particularity to specific date the appeal is filed to provide more would have had an opportunity to
evidence about the circumstances time for the facility to prepare for the correct the problems rather than have us
leading to the order. However, we hearing (see § 117.270(a)). The proceed to issue the order (see
disagree that the order must do so by timeframe for the hearing to be held § 117.251(b)). If the facility requests a
including the specific information continues to provide for an alternative hearing, more than 40 days could elapse
recommended by the comments, and we timeframe agreed upon in writing by between the date that the facility
have not revised the proposed both the facility and FDA; a facility that receives the order and the date that the
presiding officer for the hearing D. Proposed § 117.260—Compliance documents and records that they are not
confirms the order to withdraw the With, or Appeal of, an Order To required to keep.
exemption. Given that the Withdraw a Qualified Facility (Response 627) We decline this
circumstances that would lead us to Exemption request. In a withdrawal action, FDA is
issue the order involve either: (1) An providing a qualified facility multiple
We proposed that: (1) You must either
active investigation of a foodborne opportunities to persuade FDA that
comply with applicable requirements of
illness outbreak that is directly linked to withdrawal is not appropriate. If the
part 117 within 120 calendar days of
the qualified facility; or (2) a facility relies on documentation as part
receipt, or appeal the order within 10
determination that withdrawal of the of its response, it is reasonable to
calendar days of receipt; (2) submission
exemption is necessary to protect the require that this documentation be
of an appeal, including submission of a
public health and prevent or mitigate a provided to FDA.
request for an informal hearing, will not
foodborne illness outbreak based on operate to delay or stay any F. Proposed § 117.267—Procedure for
conditions or conduct associated with administrative action unless the Requesting an Informal Hearing
the qualified facility that are material to Commissioner of FDA, as a matter of
the safety of the food manufactured, We proposed that if you appeal the
discretion, determines that delay or a order: (1) You may request an informal
processed, packed, or held at the stay is in the public interest; and (3) if
facility, a delay of 1 to 2 years to comply hearing, and must do so together with
you appeal the order, and we confirm your written appeal (within 10 calendar
with the rule is not warranted. We also the order, you must comply with
do not believe that it would be days of the date of receipt of the order;
applicable requirements of part 117 and (2) a request for an informal hearing
appropriate to require a facility to come within 120 calendar days of
into compliance with only those may be denied, in whole or in part, if
confirmation of receipt of the order. the presiding officer determines that no
provisions that formed the basis of the (Comment 626) Some comments ask
revocation. The provisions of subparts C genuine and substantial issue of
us to specify that a qualified facility that material fact has been raised by the
and G are interrelated and operate as a loses its exemption from the
system and therefore are not optimized material submitted; you would receive
requirements for hazard analysis and written notice of the presiding officer’s
through piecemeal implementation. risk-based preventive controls would no
However, FDA may consider staggered determination, explaining the reason for
longer need to comply with the the denial.
implementation as an option in granting modified requirements that apply to (Comment 628) Some comments ask
a request for an extension of the qualified facilities that have an active us to guarantee a hearing so that a
timeframe to comply with an order to exemption. qualified facility can present its case in
withdraw the exemption for a qualified (Response 626) A qualified facility person before having its exemption
facility. that loses its exemption from the revoked.
As already discussed, the new requirements for hazard analysis and (Response 628) We decline this
requirements for hazard analysis and risk-based preventive controls would no request. We agree that a qualified
risk-based preventive controls are not longer need to comply with the facility has a right to appeal an order to
‘‘one-size-fits-all.’’ Although each modified requirements that apply to withdraw an exemption, and we have
facility subject to the rule must prepare qualified facilities that have an active provided for a right to appeal.
and implement a food safety plan, the exemption. To make this clearer, the
preventive controls that the facility final withdrawal procedures now G. Proposed § 117.270—Requirements
would establish and implement would include this information (see the Applicable to an Informal Hearing
depend on the facility, the food, and the regulatory text for § 117.260(c)). We proposed that if you request an
outcome of the facility’s hazard informal hearing, and we grant the
analysis. In addition, the preventive E. Proposed § 117.264—Procedure for request: (1) The hearing will be held
control management components that a Submitting an Appeal within 10 calendar days after the date
facility would establish and implement We proposed that: (1) To appeal an the appeal is filed or, if applicable,
for its preventive controls would be order, you must submit a written appeal within a timeframe agreed upon in
established as appropriate to ensure the to FDA within 10 calendar days of writing by you and by us; (2) the
effectiveness of the preventive controls, receipt and respond with particularity presiding officer may require that the
taking into account the nature of the to the facts and issues contained in the hearing be completed within 1 calendar
preventive control and its role in the order, including any supporting day; and (3) we must conduct the
facility’s food safety system. (See documentation upon which you rely; hearing in accordance with part 16 (21
Response 222.) and (2) in your written appeal, you may CFR part 16), with some specified
Although the produce safety rule is include a written request for an informal modifications, including that no party
not yet final, we intend to make the hearing. shall have the right, under § 16.119, to
administrative procedures associated (Comment 627) Some comments ask petition FDA for reconsideration or a
with withdrawal of an exemption us to rely on records kept in the normal stay of the presiding officer’s final
consistent to the extent practicable, course of business for documentation decision.
including the timeframe to comply with that will be sufficient to respond to an (Comment 629) Some comments
the applicable rule if an exemption is order to withdraw a qualified facility’s object to our proposal that no party shall
withdrawn. exemption, rather than requiring a have the right, under § 16.119, to
(Comment 625) Some comments ask facility to ‘‘respond with particularity to petition FDA for reconsideration or a
us include in the order a statement that the facts and issues contained in the stay of the presiding officer’s final
a facility may request that FDA reinstate order, including any supporting decision. These comments assert that
an exemption that was withdrawn by documentation upon which the owner, our justification (i.e., that the
following the procedures in § 117.287. operator or agent in charge of the facility circumstances that would lead to a
(Response 625) We have revised the relies.’’ These comments assert that we withdrawal merit prompt action and
requirements for the contents of an should not require a facility that that a facility has the opportunity for
order as requested by these comments. submits a written appeal to provide judicial review in accordance with 21
CFR 10.45) is not a sufficient argument outbreak is not directly linked to your controls in favor of reinstating its
for justifying the removal of the option facility, FDA will reinstate your exempt status. These comments ask us
to file a motion for reconsideration or qualified facility exemption and will to eliminate the proposed provisions
stay. These comments ask us to revise notify you in writing that your exempt allowing for reinstatement.
proposed § 117.270(c)(6) to specify that status has been reinstated. Some comments do not support the
the qualified facility shall have the right We proposed that if your exemption proposed reinstatement provisions
to file a motion for reconsideration or was withdrawn both in the event of an when a food facility has been directly
stay. active investigation of a foodborne linked to a foodborne illness outbreak.
(Response 629) We decline this illness outbreak that is directly linked to Some comments support the proposed
request. In the 2014 supplemental your facility and because FDA had reinstatement provisions only when we
human preventive controls notice, we determined that it is necessary to determine, after finishing an active
proposed an additional mechanism for a protect the public health and prevent or investigation of a foodborne illness
qualified facility to present its view that mitigate a foodborne illness outbreak outbreak, that the outbreak is not
its exemption should not be based on conditions or conduct directly linked to the facility that had its
withdrawn—i.e., by providing advance associated with your facility that are exemption withdrawn.
written notification to a qualified material to the safety of the food (Response 630) We disagree that the
facility if we are considering manufactured, processed, packed, or proposed reinstatement provisions
withdrawing an exemption and held at such facility, and FDA later would give the exemption an
providing an opportunity for the facility determines, after finishing the active impermissibly broad construction. The
to respond before we issue an order to investigation of a foodborne illness express statutory language of section
withdraw an exemption. We also outbreak, that the outbreak is not 418(l) of the FD&C Act does not support
proposed to provide an opportunity for directly linked to your facility, FDA will the comments’ assertion that the
reinstatement of an exemption that had inform you of this finding, and you may withdrawal provision is a ‘‘one strike,
been withdrawn. We believe the ask FDA to reinstate your qualified you’re out’’ provision. We also disagree
multiple opportunities now available to facility exemption. that reinstatement would undermine the
a facility provide adequate (Comment 630) Some comments agree intent of the withdrawal provision
opportunities for a facility’s views to be with our tentative conclusion that the because it would reduce the incentive
considered, and further mechanisms are absence of a specific provision in for small food processors to ensure that
not warranted. section 418 of the FD&C Act for the the products they sell are as safe as
reinstatement of an exemption that is possible. We expect that the withdrawal
H. Proposed § 117.287—Reinstatement withdrawn does not preclude us from provision itself provides a big incentive
of a Qualified Facility Exemption That providing for such a process (79 FR for small food processors to ensure that
Was Withdrawn 58524 at 58553). Other comments the products they sell are as safe as
We proposed four provisions for disagree with that tentative conclusion possible because of the business
reinstating a withdrawn qualified and assert that Congress crafted the disruption that would occur if they are
facility exemption. First, we proposed withdrawal provision as a ‘‘one strike, subject to withdrawal of the exemption.
that if the FDA District Director in you’re out’’ provision. These comments We proposed that a facility would need
whose district your facility is located also assert that including the to present data and information to
(or, in the case of a foreign facility, the withdrawal provision as a ‘‘one strike, demonstrate that it has adequately
Director of the Office of Compliance in you’re out’’ provision was an essential resolved the problems with the
the Center for Food Safety and Applied part of the legislative agreement that conditions or conduct that are material
Nutrition) determines that a facility has allowed for adoption of the qualified to the safety of the food manufactured,
adequately resolved problems with the facility exemption. These comments processed, packed, or held at the
conditions and conduct that are material also assert that reinstatement would facility, such that continued withdrawal
to the safety of the food manufactured, undermine the intent of the withdrawal of the exemption is not necessary to
processed, packed, or held at the facility provision because it would reduce the protect public health and prevent or
and that continued withdrawal of the incentive for small food processors to mitigate a foodborne illness outbreak.
exemption is not necessary to protect ensure that the products they sell are as We disagree that we should
public health and prevent or mitigate a safe as possible. These comments also categorically refuse to consider
foodborne illness outbreak, the FDA assert that a recognized principle of reinstating a qualified facility
District Director in whose district your statutory interpretation provides that exemption if we had withdrawn the
facility is located (or in the case of a exemptions to statutes should be strictly exemption because a food facility had
foreign facility, the Director of the Office construed, particularly when the statute been directly linked to a foodborne
of Compliance in the Center for Food addresses public health and safety, and illness outbreak. First, if information
Safety and Applied Nutrition) will, on that we are giving the exemption an later comes to light to raise considerable
his own initiative or on the request of impermissibly broad construction. doubt that a qualified facility had,
a facility, reinstate the exemption Some comments ask why we believe indeed, been directly linked to a
(proposed § 117.287(a)). that a business deserves a ‘‘second bite foodborne illness outbreak, and
Second, we proposed that you may of the apple’’ in light of the conditions and conduct at the facility do
ask FDA to reinstate an exemption that understanding (under proposed not otherwise warrant withdrawing the
has been withdrawn by following § 117.251(b) and (c)) that we will first facility’s exemption, it would be
specific steps (§ 117.287(b)(1) and (2)). seek to correct problems before appropriate for us to reinstate the
Third, we proposed that if your considering withdrawal. These facility’s exemption. Second, we would
exemption was withdrawn in the event comments also question at what point a only reinstate the exemption if we
of an active investigation of a foodborne facility would apply for reinstatement, determined that a facility has
illness outbreak that is directly linked to and ask why we would allow a facility adequately resolved any problems with
your facility and FDA later determines, that has already come into compliance the conditions and conduct that are
after finishing the active investigation of with FSMA’s requirement to implement material to the safety of the food
a foodborne illness outbreak, that the preventive controls to abandon those manufactured, processed, packed, or
held at the facility and that continued the data and information presented in inspection activities and intend to
withdrawal of the exemption is not the request, not after a pre-determined communicate with States regarding our
necessary to protect public health and timeframe. expectations for how to verify whether
prevent or mitigate a foodborne illness a facility is a qualified facility. The
I. Conforming Amendment to 21 CFR
outbreak. status of a facility as a qualified facility
Part 16
(Comment 631) Some comments that principally affects the requirements that
support the reinstatement of a We proposed to amend § 16.1(b)(2) to it is subject to, and will be most useful
withdrawn exemption ask us to include part 117, subpart E, relating to to FDA and our food safety partners
establish a timeframe within which FDA the withdrawal of an exemption when preparing for inspection. At this
will reinstate an exemption. Some applicable to a qualified facility, in the time we do not intend to establish a
comments ask us to specify in the list of regulatory provisions under system notifying the applicable State
regulatory text that the reinstatement which regulatory hearings are available. authorities at a point in time when the
would occur in a reasonable period of We received no comments that status of a facility as a qualified facility
time, both in circumstances where FDA disagreed with this proposed provision, changes, whether as a result of
has decided on its own initiative to and are finalizing it as proposed. withdrawal or reinstatement of a
reinstate the exemption and in J. Other Comments on the Withdrawal qualified facility exemption or because
circumstances where a facility submits Provisions the facility’s business has grown to the
a request for reinstatement. Some point where it exceeds the financial
(Comment 634) Several comments ask
comments suggest 10 days is a threshold for very small business. See
us to provide clarification through
reasonable period of time within which also Response 635.
guidance, issued for public comment,
FDA should reinstate an exemption.
on a variety of topics associated with XLI. Subpart F: Comments on Proposed
(Response 631) We decline the
the withdrawal provisions. New Recordkeeping Requirements
requests to establish a timeframe for (Response 634) We will consider the
reinstatement in the regulatory text. If need for guidance in the future. At this We proposed to establish in subpart F
we determine on our own initiative to time, we consider that withdrawing an requirements that would apply to all
reinstate an exemption (e.g., because we exemption would be both rare and records that would be required by the
later determine, after finishing the dependent upon the circumstances. We various provisions of proposed part 117,
active investigation of a foodborne need to direct our resources to including general requirements related
illness outbreak, that the outbreak is not developing guidance on issues that to the content and form of records;
directly linked to the facility), our would apply more broadly, and more additional requirements specific to the
determination would be effective generally, than the withdrawal food safety plan; requirements for
immediately. If we receive a request to provisions. record retention; requirements for
reinstate a withdrawn exemption, we (Comment 635) Some comments ask official review of records by FDA; and
intend to respond in a reasonable detailed questions about how we would public disclosure.
timeframe consistent with available coordinate the withdrawal process with
resources. In some cases, we may Some comments support the proposed
the States. requirements without change. For
respond that we need more information (Response 635) In general, we work
in order to evaluate your request. example, some comments state that the
with our State partners and other
(Comment 632) Some comments ask proposed 2-year retention period is
government counterparts in dealing
that the process for reinstatement consistent with the majority of food
with enforcement actions, including
include at least one level of safety guidelines currently being used in
coordinating actions or deferring to each
administrative appeal if we deny a the fresh produce industry. Some
other when one department has
facility’s request for reinstatement. comments that support the proposed
authority to swiftly act to protect the
(Response 632) We have not revised provisions suggest alternative or
consumer. In the specific case of this
the regulatory text to provide for an additional regulatory text (see, e.g.,
rule, we are working through the PFP to
administrative appeal if we deny a Comment 639, Comment 642, and
develop and implement a national
facility’s request for reinstatement. Comment 644 through Comment 646) or
Integrated Food Safety System
Existing procedures allow a facility to ask us to clarify how we will interpret
consistent with FSMA’s emphasis on
ask for a meeting with applicable FDA the provision (see, e.g., Comment 643
establishing partnerships for achieving
officials (see 21 CFR 10.65(c)) and and Comment 650).
compliance (see Response 5 and section
appeal our decision if we deny the 209(b) of FSMA). In the following paragraphs, we
request (see 21 CFR 10.75). (Comment 636) Some comments ask discuss comments that ask us to clarify
(Comment 633) Some comments ask us to add provisions regarding the proposed requirements or that
us to establish a 1-year probationary notification of the appropriate State disagree with, or suggest one or more
period before the withdrawn qualified regulatory agency when a qualified changes to, the proposed requirements.
facility exemption could be fully facility exemption is withdrawn and After considering these comments, we
reinstated. reinstated. have revised the proposed requirements
(Response 633) We decline this (Response 636) We decline this as shown in table 43, with editorial and
request. We intend to act on a request request. As previously noted, we are conforming changes as shown in table
for reinstatement based on the merits of sensitive to the time required for various 52.
TABLE 43—REVISIONS TO THE PROPOSED RECORDKEEPING REQUIREMENTS

117.305(c) ............................ General requirements applying to records ..................... Provide that the time of an activity being documented
only include the time of the activity when appropriate.
117.305(g) ............................ General requirements applying to records ..................... Specify that electronic records are exempt from the re-
quirements of 21 CFR part 11.
TABLE 43—REVISIONS TO THE PROPOSED RECORDKEEPING REQUIREMENTS—Continued

117.315(a)(2) ....................... Requirements for record retention .................................. Specify that records that a facility relies on during the
3-year period preceding the applicable calendar year
to support its status as a qualified facility must be re-
tained at the facility for as long as necessary to sup-
port the status of a facility as a qualified facility dur-
ing the applicable calendar year.
117.315(c) ............................ Requirements for record retention .................................. Provide for offsite storage of all records other than the
food safety plan, provided that the offsite records can
be retrieved and provided onsite within 24 hours of
request for official review.
117.315(d) ............................ Requirements for record retention .................................. Provide that the food safety plan may be transferred to
some other reasonably accessible location if the
plant or facility is closed for a prolonged period, pro-
vided that it is returned to the plant or facility within
24 hours of request for official review.
117.320 ................................ Requirements for official review ...................................... Clarify that FDA may copy records upon oral or written
request by a duly authorized representative of the
Secretary of Health and Human Services.
117.325 ................................ Requirements for public disclosure ................................. Specify that the requirement applies to records ‘‘ob-
tained by FDA’’.
117.335 ................................ Special requirements applicable to a written assurance • Establish requirements applicable to all written assur-
ances required by the rule.
• Establish additional requirements applicable to writ-
ten assurances that are required when a food prod-
uct distributed by manufacturer/processor requires
further processing for food safety by a subsequent
manufacturer.
A. Proposed § 117.301—Records Subject qualified facilities that operate under accordance with part 11 (21 CFR part
to the Requirements of Subpart F non-Federal food safety laws. 11)); (2) contain the actual values and
(Response 637) We decline this observations obtained during
We proposed that all records required request. We based the proposed monitoring and, as appropriate, during
by part 117 would be subject to all exemption on a statutory provision that verification activities; (3) be accurate,
requirements of subpart F, except that a qualified facility is not subject to indelible, and legible; (4) be created
certain specific requirements (proposed certain requirements, including the concurrently with performance of the
§ 117.310) would apply only to the statutory recordkeeping requirements activity documented; (5) be as detailed
written food safety plan. We also (see section 418(l)(2) of the FD&C Act). as necessary to provide history of work
proposed that certain proposed Although the modified requirements performed; and (6) include the name
requirements (e.g., for records to contain that apply to a qualified facility require and location of the plant or facility, the
the actual values and observations submission of certain attestations to date and time of the activity
obtained during monitoring and, as FDA (see § 117.201(a) and (b)), and documented, the signature or initials of
appropriate, during verification these attestations must be supported by the person performing the activity, and,
activities) would not apply to the documentation (see § 117.201(f)), the where appropriate, the identity of the
records that would be kept by qualified rule does not require that records kept product and the production code, if any.
facilities. by a qualified facility to support its We have revised the provision to
attestations be the same type of records require information adequate to identify
(Comment 637) Some comments the plant or facility (e.g., the name, and
that would be kept by a facility subject
disagree with the proposal to exempt when necessary, the location of the
to subparts C and G. For example, if the
the records that would be kept by plant or facility) rather than to always
facility attests that it has identified the
qualified facilities from requirements to require both the name and location of
potential hazards associated with the
keep accurate, detailed records. The the plant or facility (see § 117.305(f)(1)).
food being produced, implemented
comments note that the proposed preventive controls to address the In some cases, the name of the plant or
exemption would apply to qualified hazards, and is monitoring the facility will be adequate to identify it—
facilities regardless of whether they performance of the preventive controls, e.g., when a plant or facility is not part
operate under the first option for the qualified facility might support its of a larger corporation that has facilities
documentation (i.e., food safety attestation by having a standard at more than one location. In other
practices) or under the second option operating procedure for monitoring cases, the name of the plant or facility
for documentation (i.e., compliance preventive controls rather than detailed may not, by itself, be adequate to
with non-Federal food safety laws). records of actual monitoring. identify the plant or facility—e.g., when
These comments assert that the a plant or facility is part of a larger
proposed detailed recordkeeping B. Proposed § 117.305—General corporation with more than one location
requirements should apply to records Requirements Applying to Records and the ‘‘name’’ of each plant or facility
relating to monitoring food safety We proposed that the records must: is the same.
practices and ask us to revise the (1) Be kept as original records, true (Comment 638) Some comments
proposed requirements so that this copies, or electronic records (and that assert that compliance with part 11 for
exemption would apply only to those electronic records must be kept in the secure operation of many systems
currently in use is unnecessary and years ago in which we acknowledged sensitive and would not require
would create the need to redesign and that part 11 is unworkable in many documentation of the time the activity
recreate existing systems, thus leading respects and decided to exercise is performed. These comments ask us to
to considerable cost and complexity. enforcement discretion for part of the modify the proposed requirements so
These comments identify the regulations and announced plans to that the records would only require the
requirement for hardware and software reexamine part 11 as a whole. time of the activity documented where
to be validated as a key cost concern Some comments recommend that we appropriate for food safety.
and assert that validation activities develop guidance, with input from key (Response 639) We agree that certain
would be difficult to maintain and stakeholders, to describe the kinds of activities (e.g., record review and
would not deliver added value. As an systems and steps that can be used to verification activities) are not time-
example, these comments explain that assure records meet the required sensitive and, thus, would not need to
an expectation for validation of standard. This guidance should clearly include the time that the activity was
electronic recordkeeping software and establish that specific security needs performed. The final rule provides
hardware would be particularly will depend on the circumstances, flexibility for the facility to determine
problematic because software patches including the system at issue, its when to document the time by
and security updates are distributed on intended use, the criticality of the specifying that the time be documented
a nearly weekly basis, and express the preventive control or other food safety ‘‘when appropriate’’ (see
view that validation procedures are measure it is used to manage, and other § 117.305(f)(2)).
most appropriately applied before use of relevant factors. For example, these (Comment 640) Some comments
a new system and after major software comments explain that a quality system assert that concurrent record creation
changes or updates. These comments used to manage CCP documentation will prove difficult in many food-
also assert that it would be costly, would have greater security needs than processing environments. These
burdensome, and require specialized a review of a Certificate of Analysis for comments ask us to modify the
resources to modify or replace existing a non-sensitive ingredient. proposed requirement that records be
electronic systems to comply with part (Response 638) In light of the created concurrently with the
11. These comments provide an substantial burden that could be created performance of the activity documented
example in which a facility needed by the need to redesign large numbers to qualify that the requirement only
more than nine months to upgrade one of already existing electronic records applies where feasible, and that the
system alone to comply with part 11, and recordkeeping, we are providing in records could be created as soon as
and note that it would not be unusual new § 117.305(g) that records that are possible thereafter under circumstances
for companies to employ multiple established or maintained to satisfy the where concurrent record creation is not
systems, so the burden and cost would requirements of part 117 and that meet feasible.
exponentially increase. These comments the definition of electronic records in (Response 640) We decline this
ask us to instead require facilities that § 11.3(b)(6) are exempt from the request. The comments did not provide
use electronic records to use a secure requirements of part 11. As we did in any examples of activities where
system that ensures records are the section 414 recordkeeping concurrent record creation in food
trustworthy, reliable, and generally regulations, we also are specifying that manufacturing, processing, packing, or
equivalent to paper records and records that satisfy the requirements of holding environments would prove
handwritten signatures executed on part 117, but that also are required difficult, and we are not aware of any
paper. under other applicable statutory such example. For example, we are not
Other comments express concern provisions or regulations, remain aware of any difficulty complying with
about the financial burden for small subject to part 11. The rule provides that long-standing similar requirements
facilities such as farm mixed-type a facility may rely on existing records to associated with our HACCP regulations
facilities and ask us to either modify satisfy the requirements of this rule, and for seafood and juice (see §§ 123.9(a)(4)
requirements for farm mixed-type this rule does not change the status and 120.12(b)(4), respectively).
facilities, very small businesses, and under part 11 of any such records if (Comment 641) Some comments
small businesses or provide that such those records are currently subject to express concern about ‘‘apparent
facilities be fully exempt from part 11 part 11. As we did in the rulemaking to mandates’’ that we will require records
requirements for electronic records. establish the section 414 recordkeeping to be kept in the English language and
Other comments state that, as with the regulations, we are establishing a assert that the language of food factory
recordkeeping requirements under the conforming change in part 11 to specify documents should not be dictated as a
Bioterrorism Act, such requirements are in new § 11.1(i) that part 11 does not precondition for food exports. These
disproportionate to the regulatory need. apply to records required to be comments ask us to limit the documents
Other comments state that many established or maintained under part that must written in English to reduce
operators that use electronic data 117, and that records that satisfy the translation and records duplication.
records in the produce industry use requirements of part 117, but that also These comments also ask us to focus the
open software and would not meet part are required under other applicable requirements for English language on
11 requirements. statutory provisions or regulations, those documents that must be submitted
Some comments state that major remain subject to part 11. to FDA.
advances in software technology have Although we are not specifying that (Response 641) We did not propose to
been made since part 11 published in part 11 applies, facilities should take require that any ‘‘factory records’’ (such
1997, and such advances must be appropriate measures to ensure that as the written food safety plan
carefully considered in evaluating any records are trustworthy, reliable, and (§ 117.126) and the implementation
potential expansion or new applications generally equivalent to paper records records listed in § 117.190) be kept in
of part 11. These comments also state and handwritten signatures executed on the English language. Consistent with
that we already are in the process of paper. other regulations for submissions to
reevaluating part 11 for the regulations (Comment 639) Some comments FDA (such as for registration of a food
for which it currently applies, citing assert that certain production and facility), the form we will use for a
industry guidance issued more than 10 associated activities are not time- qualified facility to submit its required
attestations (§ 117.201(b) and (c)) will be except for the food safety plan, offsite (see § 117.315(c)). As a companion
in the English language. storage of records is permitted after 6 change, we have revised the proposed
months following the date that the provision directed to the special
C. Proposed § 117.310—Additional
records were made if such records can circumstance of storing records when a
Requirements Applying to the Food
be retrieved and provided onsite within facility is closed for prolonged periods
Safety Plan
24 hours of request for official review; of time so that it only relates to the
We proposed that the food safety plan and (4) if the plant or facility is closed offsite storage of the food safety plan in
must be signed and dated by the owner, for a prolonged period, the records may such circumstances (see § 117.315(d)).
operator, or agent in charge of the be transferred to some other reasonably (Comment 645) Some comments
facility upon initial completion and accessible location but must be returned assert that a two year retention period
upon any modification. to the plant or facility within 24 hours for records is much longer than needed
(Comment 642) Some comments state for official review upon request. for a product with a short shelf life
that the provision would exclude the (Comment 643) Some comments ask (such as milk) and may not be long
preventive controls qualified individual us to clarify that the 2-year record enough for products with very long
from signing and dating the food safety retention requirement only applies to shelf lives (such as oils). These
plan unless the preventive controls records created after the compliance comments ask us to establish a retention
qualified individual is the owner, date for the final rule. period that is risk-based and related to
operator, or agent in charge of the (Response 643) The retention the shelf life of the product rather than
facility. These comments ask us to requirements only apply to records ‘‘one-size-fits-all.’’ As an example, these
revise the rule to allow the preventive created after the applicable compliance comments suggest that we could set the
controls qualified individual to sign and date for the final rule. See Response 155 retention requirement as 2 years past the
date the food safety plan (e.g., because and section LVI.A, which explain that date of manufacture or 1 year past an
it is the preventive controls qualified the compliance date for a facility to ‘‘expiration’’ date, whichever is longer.
individual who prepares (or oversees retain records to support its status as a These comments also suggest that
the preparation of) the food safety plan). qualified facility is January 1, 2016. See documentation on raw materials could
Some comments ask us to require that also Response 646, which explains that be maintained for two years after final
any preventive controls qualified we have revised the record retention product lot is manufactured.
individuals who prepare (or oversee the provisions to specify that records that a (Response 645) We decline these
preparation of) specific sections of the facility relies on during the 3-year requests. The proposed 2-year retention
food safety plan sign and date the period preceding the applicable period is authorized by the statute (see
applicable sections. calendar year to support its status as a section 418(g) of the FD&C Act).
(Response 642) We decline these qualified facility must be retained at the Moreover, the reasons discussed by the
requests. The statute expressly directs facility as long as necessary to support comments for linking the retention
the owner, operator, or agent in charge the status of a facility as a qualified period to shelf life are more relevant to
of a facility to prepare the food safety facility during the applicable calendar the record retention requirements for
plan (see section 418(h) of the FD&C year. the purpose of tracking potentially
Act). As previously discussed, such a (Comment 644) Some comments ask contaminated food (21 CFR part 1,
signature would provide direct evidence us to delete the proposed requirement to subpart J; see § 1.360) than to the record
of the owner, operator or agent’s keep records on site for 6 months or 2 retention requirements for the purpose
acceptance of the plan and commitment years (depending on the record) and of evaluating compliance with this rule.
to implementation of the plan (78 FR assert that it should suffice to require (Comment 646) Some comments ask
3646 at 3782). A facility has flexibility that records be available within 24 us to require that qualified facilities
to require the signature of one or more hours of request or within a reasonable keep financial and sales records for 3 or
preventive controls qualified period of time. Some comments assert 4 years, because a qualified facility must
individuals who prepared, or oversaw that a facility should be able to keep document that the average value of food
the preparation of, its food safety plan records in the location where they are it sold during the prior 3 years did not
in addition to the minimum signature created, which may be at corporate exceed $500,000 annually.
requirement specified in the rule. headquarters. Comments also assert that (Response 646) We have revised the
Likewise, a facility also has flexibility to specifying the location for record record retention provisions to specify
require the signature of one or more storage will increase costs but will not that records that a facility relies on
members of its food safety team who contribute to improvements in public during the 3-year period preceding the
contributed to the preparation of the health. Some comments ask us to permit applicable calendar year to support its
food safety plan, even if those off-site storage for all records more than status as a qualified facility must be
individuals are not serving as the 6 months old, in contrast to the 2-year retained at the facility as long as
preventive controls qualified individual retention period we proposed for necessary to support the status of a
for the facility. (See also Response 377.) records relating to the general adequacy facility as a qualified facility during the
of equipment or processes being used by applicable calendar year. As discussed
D. Proposed § 117.315—Requirements a facility, including the results of in Response 155, the definition of very
for Record Retention scientific studies and evaluations. small business established in this rule is
We proposed that: (1) All required (Response 644) We have revised the based on an average (of sales plus
records must be retained at the plant or provisions to provide for offsite storage market value of human food held
facility for at least 2 years after the date of all records (except the food safety without sale) during the 3-year period
they were prepared; (2) records relating plan), provided that the records can be preceding the applicable calendar year.
to the general adequacy of equipment or retrieved and made available to us Thus, both of the criteria for the
processes being used by a facility, within 24 hours of request for official qualified facility exemption are based
including the results of scientific review. We expect that many records on financial records associated with the
studies and evaluations, must be will be electronic records that are preceding 3-year period. The actual
retained at the facility for at least 2 years accessible from an onsite location and, retention time necessary to support the
after their use is discontinued; (3) thus, would be classified as being onsite status of a qualified facility during the
applicable calendar year could be as regulations for seafood and juice. The authorized inspection so that we may
long as 4 years. For example, if we issues raised by these comments are understand the full context of what the
inspect a facility on May 1, 2024, the similar to some of the issues raised by records show. Some comments point
facility would have retained the records comments during the rulemaking to out that there would be challenges
from 2021–2023 for 3 years and 4 establish our HACCP regulations for associated with credential validation
months. If we inspect the facility on seafood (see the discussion at 60 FR when we asked for records to be sent
December 28, 2024, the facility would 65096 at 65137–65140, December 18, remotely, such as in an email request.
have retained the records from 2021– 1995) and our regulations in part 118 for Some comments ask that we modify the
2023 for nearly 4 years. the prevention of Salmonella Enteritidis proposed requirement to specify that
in shell eggs. We intend to copy records records would only be made available to
E. Proposed § 117.320—Requirements
on a case-by-case basis as necessary and us during a facility inspection.
for Official Review (Response 648) We have decided not
appropriate. We may consider it
We proposed that all records required necessary to copy records when, for to establish any requirements for a
by proposed part 117 be made promptly example, our investigators may need facility to send records to us. We will
available to a duly authorized assistance in reviewing a certain record review records when we are onsite in
representative of the Secretary of HHS from relevant experts in headquarters. If the course of an authorized inspection,
upon oral or written request. We asked we are unable to copy the records, we and copy records as necessary and
for comment on whether we should would have to rely solely on our appropriate. (See also Response 647.)
require a facility to send records to us investigators’ notes and reports when We are not modifying the proposed
rather than make the records available drawing conclusions. In addition, requirement to specify that records
for review at a facility’s place of copying records will facilitate follow-up would only be made available to us
business and, if so, whether we should regulatory actions. We primarily intend during a facility inspection because it is
require that the records be submitted to copy records such as the results of not necessary to do so. The regulatory
electronically. product testing or environmental text specifying that the records be made
(Comment 647) Some comments monitoring when we conduct an available to a duly authorized
assert that we should not copy inspection for cause—e.g., as a result of representative of the Secretary of Health
documents as part of routine an outbreak investigation, violative and Human Services provides the
investigations so as to prevent critical sample results, or follow up to a context that the records would be made
documents from release under the consumer complaint. See Response 650 available during inspection.
Freedom of Information Act (FOIA). for a discussion of how the FOIA would
These comments are particularly F. Proposed § 117.325—Public
apply to records, such as records of Disclosure
concerned that our ability to copy testing as a verification activity, that we
verification records (such as testing copy during an inspection and maintain We proposed that records required by
records) and potentially release these in our system. proposed part 117 are subject to the
records under the FOIA would See also Response 649 for a disclosure requirements under part 20
discourage facilities from testing as a discussion of how the public disclosure (21 CFR part 20).
verification activity. These comments requirements of this rule align with (Comment 649) Some comments
also express concern that some facilities those of our HACCP regulations for assert that the proposed requirements
would include in their food safety plans seafood and juice. governing public disclosure are not
elements, not required by the proposed (Comment 648) Some comments aligned with other risk-based preventive
rule, that address food defense as well strongly oppose any requirement for controls programs, such as HACCP
food safety, and that disclosure of such submission of records to FDA remotely programs. These comments argue that
a food safety plan without proper and assert that there is no basis in the proposed requirements should be
redaction could provide useful FSMA for such a requirement. Some realigned with other risk-based
information to persons seeking to defeat comments express concern about our preventive controls programs to
the facility’s food defense strategies. In ability to protect confidential preserve the privacy of information
addition, these comments express information (such as supplier and maintained in required records unless
concern that the task of reviewing all of customer records received by a facility that information has been otherwise
these records and redacting trade secrets under the protection of confidentially made publicly available. Some
and confidential information would agreements) that is transmitted comments suggest that we revise the
further set back FDA’s already electronically (e.g., the information proposed requirements to be analogous
overburdened FOIA offices and create might be released through computer to the public disclosure requirements in
even longer delays in responding to hacking or leaks). Some comments note our HACCP regulations for seafood and
FOIA requests. that inadvertent disclosure of juice (see §§ 123.9(d) and 120.12(f),
As discussed in Comment 649, some information related to specific products, respectively). One comment
comments suggest that we revise the hazards, and preventive controls acknowledged our statements that the
proposed public disclosure implemented at food facilities could proposed requirements governing public
requirements (proposed § 117.325) to be both prove harmful from a commercial disclosure are consistent with, but
analogous to the public disclosure or competitive standpoint and expose framed differently than, the disclosure
requirements in our HACCP regulations existing vulnerabilities in the U.S. food provisions of our HACCP regulations for
for seafood and juice (see §§ 123.9(d) supply, thus potentially rendering food seafood and juice (79 3646 at 3783), but
and 120.12(f), respectively). facilities susceptible to malicious attack. nonetheless asks us to provide a more
(Response 647) We have revised the Some comments oppose the concept detailed explanation of how our
proposed requirement to specify that all of a ‘‘desk audit’’ whereby our proposed approach is consistent with
required records must be made investigators conduct their inspections the disclosure provisions in our HACCP
promptly available ‘‘for official review from a remote office without actually regulations for seafood and juice.
and copying’’ to increase the alignment visiting the facility and assert that our (Response 649) We disagree that the
of the recordkeeping requirements of access to company records must be proposed provisions governing public
this rule with those of our HACCP conducted on-site in the course of an disclosure are not aligned with the
public disclosure provisions of our CGMP inspections in processing plants, confidentiality of data or information is
HACCP regulations for seafood and our experience with enforcing our uncertain. During any such consultation
juice. Our regulations in part 20 HACCP regulations for seafood and FDA would provide any necessary
regarding public information apply to juice, and our understanding from the information to the person who provided
all agency records, regardless of whether FRIA for this rule make it clear that food the data or information at issue.
a particular recordkeeping requirement safety plans will take each facility some (Comment 652) Some comments ask
says so. In the case of the recordkeeping time and money to develop. Thus, we us to modify the proposed requirement
requirements for our HACCP regulations conclude that food safety plans to clarify that it is ‘‘records required by
for seafood and juice, we framed the generally will meet the definition of this part and provided to the Agency,’’
provisions regarding public disclosure trade secret, including the court’s rather than ‘‘records obtained by the
by providing specific details about how definition in Public Citizen Health Agency’’ that are subject to public
particular provisions in part 20 (i.e., Research Group v. FDA, 704 F.2d 1280 disclosure.
§ 20.61 (Trade secrets and commercial (D.C. Cir. 1983). Plans that incorporate (Response 652) We agree that it is
or financial information which is unique regimens or parameters to appropriate to specify that the
privileged or confidential) and § 20.81 achieve product safety, which are the disclosure requirements of this rule
(Data and information previously result of considerable research and apply to information that we maintain
disclosed to the public)) would apply to effort, will surely meet this definition. as a record (see the description of
the applicable records, because we Moreover, there is value in a plan to ‘‘record’’ in § 20.20(e)). (See also the
recognized that such details were of a company that produces it for no other discussion (in the proposed rule to
particular interest to the regulated reason than that it took work to write. establish our seafood HACCP regulation,
industries. In the case of the The equity in such a product is not 59 FR 4142 at 4160, January 28, 1994)
recordkeeping requirements for this readily given away to competitors. We that there are significant legal and
rule, we framed the provisions regarding expect that plant configurations will be practical questions as to whether FDA
public disclosure by more broadly unique to individual processors, or at has the authority to require disclosure of
referring to all the requirements of part least have unique features, as was the industry records that are not in FDA’s
20, consistent with our more recent case in the seafood industry (Ref. 88). possession.) However, we see no
approach for framing the provisions While generic plans will have great meaningful distinction between records
regarding public disclosure in the rule utility in many circumstances, they ‘‘provided to FDA’’ and records
‘‘Prevention of Salmonella Enteritidis in serve primarily as starting points for ‘‘obtained by FDA,’’ and have revised
Shell Eggs During Production, Storage, processors to develop their own plans. the provision to specify that records
and Transportation’’ (part 118; see Facilities will still need to expend time obtained by FDA in accordance with
§ 118.10(f)). For example, provisions and money to tailor a generic plan to this part are subject to the disclosure
such as § 20.20 (Policy on disclosure of their individual circumstances. requirements under part 20. The revised
Food and Drug Administration records) We would establish the status of regulatory text makes clear that the
apply to all records that we have in our verification records, such as the results requirements of Part 20 attach to those
system, including HACCP records, even of product testing and environmental documents obtained by FDA. To the
though the HACCP regulations do not monitoring, as available for, or protected extent that these comments are
specify that this is the case. from, public disclosure on a case-by- addressing the difference between
As discussed in Response 647, to case basis. As discussed in Response records provided during inspection and
increase the alignment between this rule 647, we primarily intend to copy such records submitted to us, as already
and our HACCP regulations for seafood records when we conduct an inspection discussed we have decided not to
and juice, we have revised the proposed for cause. We also intend to copy such require submission of certain records to
requirement regarding our access to records if the preliminary assessment by us (see Response 648).
records to specify that all required our investigator during a routine
G. Proposed § 117.330—Use of Existing
records must be made promptly inspection is that regulatory follow-up
Records
available ‘‘for official review and may be appropriate (e.g., if these records
copying.’’ demonstrate that an environmental We proposed that existing records
(Comment 650) Some comments ask pathogen has become established in a (e.g., records that are kept to comply
us to clarify that the disclosure niche environment in a food processing with other Federal, State, or local
requirements of part 20 include plant). regulations, or for any other reason) do
protections for trade secrets and (Comment 651) Some comments not need to be duplicated if they contain
privileged or confidential commercial assert that our regulations in §§ 20.47 all of the required information and
information and financial information. and 20.48 require us to consult with the satisfy the requirements of subpart F.
Other comments ask us to clarify that entity providing information prior to Existing records may be supplemented
written food safety plans and associated disclosing such information. These as necessary to include all of the
records are not subject to public comments ask us to provide a small required information and satisfy the
disclosure because they represent trade business compliance guide that would requirements of subpart F. We also
secret or confidential commercial allow smaller entities to understand our proposed that the information required
information. Other comments ask us to procedures for publicly disclosing by part 117 does not need to be kept in
clarify how the disclosure requirements information, including information one set of records. If existing records
of part 20 would apply to verification maintained in records required by this contain some of the required
records (such as testing records). rule, to allow opportunity for redaction information, any new information
(Response 650) The questions raised of ‘‘confidential’’ information prior to required by part 117 may be kept either
in these comments are similar to some disclosure. separately or combined with the
of the questions raised during the (Response 651) We disagree with the existing records.
rulemaking to establish our HACCP comments’ interpretation of §§ 20.47 Comments that address this proposed
regulation for seafood (see the and 20.48. Section 20.47 requires requirement support it. For example,
discussion at 60 FR 65096 at 65137– consultation with the person providing some comments state that this provision
65140). Our experience in conducting data or information only when the would provide flexibility to facilities to
comply with the record requirements in monitoring records must be created signatures of authorized officials; and
an efficient manner. Other comments concurrently with the monitoring the applicable assurance.
state that this provision would prevent activity and contain the signature or The provisions of § 117.335(b),
companies from having to duplicate initials of the person conducting the together with another new provision
records or create new records solely to monitoring. If the facility has an existing (§ 117.137), establish legal
satisfy recordkeeping requirements. form that it uses to document the responsibilities under the rule for a
(Comment 653) Some comments state monitoring activity, and that form does facility that provides a written
that food safety plan records are a ‘‘web not provide (or have space to add) assurance regarding a food product that
of related documents’’ that may be used information adequate to identify the a manufacturer/processor distributes
in other programs and cannot be plant or facility (e.g., the name and, without application of a preventive
collected or ‘‘reduced to a binder.’’ when necessary, the location of the control that is needed to control a
(Response 653) We agree that food facility), and does have (or have space hazard. This responsibility exists even
safety plan records could be considered to add) a place for the signature of the for a facility that is not itself a
a ‘‘web of related documents’’—i.e., a person performing the activity, we manufacturer/processor, such as for a
set of records that could include expect the facility to modify the form facility that is a distributor. We are
documents used in other programs. We rather than use the existing form. The establishing legal responsibilities for the
also agree that the food safety plan provisions for ‘‘supplementing’’ existing facilities that provide these written
records need not be collected in a single records do not extend to providing assurances because following these
location or ‘‘reduced to a binder.’’ See information identifying the facility, or assurances is critical to ensuring that
the discussion in Response 215 about signatures, on separate pages. required preventive controls are applied
how a food safety plan could consist of (Comment 654) Some comments state to the food by an entity in the
one or more existing HACCP plans, one that our review of records should be distribution chain before the food
or more prerequisite programs that reaches consumers.
limited to issues under our jurisdiction,
include food safety controls, and other
regardless of the other information that I. Other Comments on the
components required by the rule, and be
may be contained in the record. Other Recordkeeping Requirements of Subpart
dated and signed even if its components
comments ask us to ensure that F
are not kept in a single location.
Likewise, the records documenting inspectors are adequately trained on (Comment 655) Some comments
implementation of the plan could be a how to review facility records for the assert that the extensive recordkeeping
‘‘web of related documents.’’ For requisite information across multiple requirements of every aspect of farm
example, a facility that collects samples sets of documents, as needed. and food production would be crushing
of product and sends them to a (Response 654) Section 418(h) of the to small and mid-sized businesses.
laboratory for testing would have FD&C Act requires that the written plan These comments ask us to replace the
records documenting its collection of that documents and describes the proposed recordkeeping requirements
samples, as well as records procedures used by the facility to with a brief farm plan that outlines
documenting the laboratory’s test comply with the requirements of section perceived risks and how the farmer
results. Consistent with the 418, together with the documentation of plans to address those risks.
requirements of the rule for written monitoring of preventive controls, (Response 655) We decline this
procedures for product testing instances of nonconformance material to request, which is largely moot in light
(§ 117.165(b)(2)) and the general food safety, the results of testing and of the changes we have made to the
recordkeeping requirements of subpart F other means of verification, instances ‘‘farm’’ definition and to the
(§ 117.305), the sampling records would when corrective actions were classification of activities on-farm and
contain information such as the name implemented, and the efficacy of off-farm (see the discussion in section
and location of the facility, the date preventive controls and corrective IV of this document and table 1 in the
when the samples were collected, the actions, be made available to FDA. Our Appendix to the 2014 supplemental
signature or initials of the person inspectors will be trained to focus on human preventive controls notice (79
collecting the samples, and the identity the written food safety plan and the FR 58524 at 58571–58572)). None of the
and lot code of the sampled product. records documenting implementation of activities within the ‘‘farm’’ definition
Likewise, the laboratory report would the plan during inspections. Our (i.e., packing and holding RACs, and
contain information identifying the inspectors have experience in the certain processing activities (such as
laboratory, the product tested (and review of records that a food business drying grapes to produce raisins, and
associated lot code), the test analyte, the establishes and maintains for more than packaging RACs such as strawberries,
test(s) conducted (including the one purpose—e.g., during the review of without additional manufacturing/
analytical method(s) used), the date of records kept under the section 414 processing), will be subject to this rule
the test(s), the test results, and the recordkeeping regulations during the if performed on a farm.
signature or initials of the person who investigation of an outbreak of
conducted the test. Alternatively, it foodborne illness. XLII. Subpart G: General Comments on
would be acceptable to have the Proposed Requirements for a Supply-
H. Final § 117.335—Special Chain Program
signature or initials of the person who Requirements Applicable to a Written
approved the release of the test results In the 2014 supplemental human
Assurance
from the laboratory. Together, these preventive controls notice, we provided
records contain all the required As discussed in section XXVII, new an opportunity for public comment on
information to associate them with a § 117.335 establishes requirements potential requirements for a supplier
facility, a specific lot of product, and the applicable to the written assurance a program as a preventive control. The
results of laboratory testing on that manufacturer/processor obtains from its supplier program for a receiving facility
product. customer. New § 117.335(a) applies to would be limited to those raw materials
Although the provisions for use of all written assurances required by the and other ingredients for which the
existing records provide flexibility, rule—i.e., the assurance must contain receiving facility has identified a
there are some limitations. For example, the effective date; printed names and significant hazard (which we now refer
to as ‘‘hazard requiring a preventive regarding whether (and, if so, how) the applicable documentation, and
control’’). Under the definitions final human preventive controls rule document the receiving facility’s review
established in this rule, ‘‘supplier’’ should address the potential for gaps in and assessment. Providing this
means the establishment that supplier controls when a hazard is additional flexibility required a series of
manufactures/processes the food, raises controlled at Point A in the supply changes to multiple proposed
the animal, or grows the food that is chain (e.g., by Supplier A, a farm), and provisions. To improve clarity and
provided to a receiving facility without Point B in the supply chain is a facility readability we redesignated proposed
further manufacturing/processing by (such as Warehouse B, Distributor B, or § 117.136 into eight distinct sections of
another establishment, except for Packing Shed B) that only packs or regulatory text in a newly established
further manufacturing/processing that holds food, but does not manufacture/ subpart G (Supply-Chain Program), with
consists solely of the addition of process food (and therefore would not editorial changes associated with the
labeling or similar activity of a de be required to have a supplier program) new structure of the redesignated
minimis nature; ‘‘receiving facility’’ before passing it on to Point C in the
regulations. See table 44 for the section
means a facility that is subject to supply chain, which also would not be
numbers and titles in subpart G. See
subparts C and G and that required to have a supplier program
manufactures/processes a raw material (e.g., Retail Food Establishment C or table 45 for an overview of the major
or other ingredient that it receives from Consumer C). We discussed an example revisions to the proposed requirements
a supplier (see § 117.3). in which Packing Shed B distributes for a supplier program. See sections
We previously explained our produce it packs after receiving the XLIII through XLIX for a discussion of
understanding that, particularly for produce from Farm A directly to retail the specific provisions of the final
RACs, there may be multiple facilities (which would not be subject to requirements for a supplier program,
establishments, including cooperatives, the requirements of the human and table 46, table 47, table 48, table 49,
packinghouses, and distributors, preventive controls rule); under the table 50, and table 51 for more detailed
between a receiving facility and the proposed suppler control program no summaries of revisions to these specific
establishment that would be considered supplier controls would be applied to provisions. Because table 45 is an
the supplier, which would make Farm A. We requested comment on overview, the changes identified in table
supplier verification very challenging whether verification activities should be 45 appear again in table 46, table 47,
under certain circumstances (79 FR required in circumstances in which a table 48, table 49, table 50, and table 51.
58524 at 58548). We requested comment RAC such as fresh produce will not be Because the editorial changes associated
on what verification activities would be sent to any facilities that would be with the redesignation are extensive, we
appropriate for receiving facilities to required to have preventive controls do not list them in table 52.
conduct when a raw material or before reaching consumers. The title of subpart G is ‘‘Supply-
ingredient passes through more than In the remainder of this section, we
Chain Program’’ rather than ‘‘Supplier
one facility that would not be required discuss comments that address our
Program.’’ As shown in table 45 and
to verify control of hazards if supplier request for comment on complex
discussed in more detail in section
programs are limited to manufacturers/ supply-chain scenarios such as those
processors. We discussed an example in described in the 2014 supplemental XLIII.D, we have added one requirement
which a receiving facility is a fresh-cut human preventive controls notice. We applicable to non-suppliers. ‘‘Supply-
processing facility that receives produce also describe our reasons for revising chain program’’ is a more appropriate
from a distributor, who receives the proposed requirements for a term to reflect a subpart that includes a
produce from a cooperative, and neither supplier program to provide additional requirement applicable to non-suppliers
the distributor nor the cooperative is flexibility for an entity other than the in addition to the requirements
required to establish supplier controls receiving facility to determine, conduct, applicable to suppliers. In the
for the farms where the hazards are and document the appropriate supplier remainder of this document, we use the
being controlled, and we asked what verification activities. When an entity phrase ‘‘supply-chain program’’ in
supplier controls should be applied for other than the receiving facility section headings and when referring to
the produce coming from the farms. We determines, conducts, or both the provisions of the final rule. We
requested comment on whether and determines and conducts the continue to use the term ‘‘supplier
how the requirements for supplier appropriate supplier verification program’’ when describing the proposed
verification should address such activities, the receiving facility must provisions and the comments regarding
situations. We also requested comment review and assess that entity’s the proposed provisions.
TABLE 44—REDESIGNATION OF THE REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM IN SUBPART G

[Supply-chain program]
Section Description
117.405 .................. Requirement to establish and implement a supply-chain program.

117.410 .................. General requirements applicable to a supply-chain program.
117.415 .................. Responsibilities of the receiving facility.
117.420 .................. Using approved suppliers.
117.425 .................. Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
117.430 .................. Conducting supplier verification activities for raw materials and other ingredients.
117.435 .................. Onsite audit.

117.475 .................. Records documenting the supply-chain program.
TABLE 45—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM

Throughout .............. Throughout ............ The type of preventive control Refer to ‘‘supply-chain-applied control’’ rather than ‘‘preventive
applicable to the supply-chain control’’ or variations such as ‘‘hazard requiring a preventive
program. control when the hazard is controlled before receipt of the raw
material or other ingredient.’’
117.136(a)(2) .......... 117.136(a)(1)(ii) ..... A supply-chain program is not Shifted to be in provisions outside the framework of the supply-
(in subpart C) .......... required when the hazard will chain program in subpart G.
be controlled by the receiving
facility’s customer in the dis-
tribution chain.
117.405(a)(2) .......... N/A ......................... Circumstances that do not re- The receiving facility does not need a supply-chain program
quire a supply-chain program. when the receiving facility is an importer, is in compliance with
the forthcoming FSVP requirements, and has documentation
of verification activities conducted under the forthcoming
FSVP program.
117.405(a)(3) .......... N/A ......................... Exemption from the require- Exemption for food supplied for research or evaluation.
ments for a supply-chain pro-
gram.
117.405(c) ............... N/A ......................... Requirements applicable to non- When a supply-chain-applied control is applied by an entity
suppliers. other than the receiving facility’s supplier (e.g., when a non-
supplier applies controls to certain produce (i.e., produce that
will be subject to the forthcoming produce safety rule), be-
cause growing, harvesting, and packing activities are under
different management), the receiving facility must (1) verify the
supply-chain-applied control; or (2) obtain documentation of
an appropriate verification activity from another entity, review
and assess the entity’s applicable documentation, and docu-
ment that review and assessment.
117.410(c) ............... 117.136(a)(3)(ii) ..... Purpose of the supply-chain Specify only that the supply-chain program must provide assur-
program. ance that a hazard requiring a supply-chain-applied control
has been significantly minimized or prevented.
117.410(d) ............... 117.136(b) ............. Factors that must be considered • Clarification that these factors must be considered in approv-
in determining appropriate ing suppliers, as well as in determining appropriate supplier
supplier verification activities. verification activities.
• Flexibility in the factors that must be considered if a supplier is
a qualified facility, a produce farm that will not be subject to
the forthcoming produce safety rule on the basis of size and/
or direct farm marketing, or a shell egg producer that is not
subject to the requirements of 21 CFR part 118 (production,
storage, and transportation of shell eggs) because it has less
than 3,000 laying hens.
117.415(a) ............... N/A ......................... Responsibilities of the receiving Provide flexibility for an entity other than the receiving facility to
facility. determine, conduct, and document supplier verification activi-
ties, provided that the receiving facility reviews and assesses
applicable documentation from that entity and documents the
receiving facility’s review and assessment.
117.415(b) ............... N/A ......................... Responsibilities of the receiving Specify documentation that a receiving facility may not accept
facility. from a supplier to satisfy the receiving facility’s responsibilities
for its supply-chain program.
117.420(a) ............... 117.136(a)(3)(i) ...... Approval of suppliers ................. Explicit requirement for a receiving facility to approve its sup-
pliers.
117.420(b) ............... 117.136(a)(3)(i) ...... Approval of suppliers ................. Explicit requirement for a receiving facility to establish and follow
written procedures for receiving raw materials and other ingre-
dients.
117.430(e) ............... N/A ......................... Alternative supplier verification Provide for an alternative supplier verification activity when the
activity. supplier is a shell egg producer with less than 3,000 laying
hens.
117.430(f) ................ N/A ......................... Independence of the supplier .... Specify that there must not be any financial conflicts of interests
that influence the results of the verification activities listed in
§ 117.410(b) and payment must not be related to the results
of the activity.
117.435(c)(1) ........... 117.136(e) ............. Substitution of an inspection for Provide additional flexibility for domestic inspection by represent-
an audit. atives of other Federal agencies (such as USDA), or by rep-
resentatives of State, local, tribal, or territorial agencies.
117.475 ................... 117.136(g) ............. Records documenting the sup- List additional records associated with the revised provisions.
ply-chain program.
(Comment 656) Several comments ask establish requirements for a supplier assert that the benefits of a supplier
us to issue guidance rather than program in the rule. Some comments verification program do not outweigh
the costs, that we did not consider the FSVP regulations that we proposed to responsibility of the receiving facility,
effects of such a requirement on farms establish in part 1, subpart L, so that the rule specifies that only a receiving
and small businesses, and that FSMA they do not have to duplicate facility can approve suppliers (see
does not actually contain a requirement verification activities (see §§ 117.415(a)(1) and 117.420(a) and
for a supplier verification program. § 117.405(a)(2)). Response 658).
Conversely, other comments support (Comment 657) Some comments that We disagree that complex supply
including a mandatory supplier program addressed questions we asked in the chains make a supply-chain program too
in the rule for hazards that are 2013 proposed human preventive difficult and that a receiving facility
controlled in raw materials and other controls rule and the 2014 supplemental cannot be expected to reach further back
ingredients before receipt by the human preventive controls notice in a supply chain than the entity
receiving facility, although many recommend that we add flexibility to immediately before it in the supply
comments assert that a supplier the requirements for a supplier program chain. Supply-chain programs are
verification program should be viewed such that any entity in the supply chain currently used by facilities as a standard
as a verification activity rather than a between the supplier and the receiving business practice and we understand
preventive control. Some comments facility can perform supplier that some of those supply chains are
assert that a mandatory domestic verification activities. Some comments complex, with entities between the
supplier program is necessary to ask us to allow a receiving facility to receiving facility and the supplier. We
provide parity with the requirements of have a supplier program established for acknowledge that complex supply
the FSVP rule authorized by FSMA, it by another entity. Other comments chains present a challenge because
while other comments assert that assert that it would be too burdensome information will need to flow through
FSMA’s authorization of foreign for a receiving facility to consider any several entities to allow the link
supplier verification should not be used information related to the supplier’s between the receiving facility and the
to justify a domestic supplier program. supplier or to go further back in the supplier. However, we believe a supply-
Some of these comments single out our supply chain beyond the entity that is chain program is a critical preventive
request for comment, in the proposed one back from the receiving facility. control for receiving facilities that will
FSVP rule, on whether to allow an Other comments assert that we should rely on suppliers to control hazards in
entity that would be both an importer eliminate any requirements for a raw materials and other ingredients.
(under the FSVP rule) and a receiving supplier program from the rule because Although distributors, brokers, and
facility (under the human preventive a supplier program involving more other entities in the supply chain
controls rule) to be deemed in entities than just the receiving facility between a receiving facility and its
compliance with the FSVP rule if it was and the supplier would become too supplier are not required to have a role
in compliance with the supplier complex. Some comments express in supplier verification, they have the
verification provisions of the human concern that we would be creating ‘‘an option to determine, conduct, and
preventive controls rule, and agree with environment where our supply chain is document supplier verification
such an approach (78 FR 47730 at required to be disclosed to our activities as a service to the receiving
45748). customers via product testing, audits facility if they so choose. If these
(Response 656) We agree that it is and supplier verification,’’ asserting that entities choose not to participate in
necessary to include a mandatory this would discourage customers from supplier verification, the receiving
supply-chain program in the rule to buying from entities such as re-packers facility will need to reach back in the
ensure the safety of food where hazards when they could go to the source. Some supply chain past them. In such
are controlled in raw materials and comments state that we have not taken situations, it may be necessary for the
other ingredients before receipt by a into account the low-risk nature of entities between the receiving facility
receiving facility, and we are finalizing specific industries such as those that re- and the supplier to provide the identity
such a requirement in this rule. The pack already processed foods. Other of the supplier to the receiving facility,
statute specifically identifies supplier comments ask us to confirm that if that identity is not available on the
verification activities as a preventive distributors and warehouses are not raw material or other ingredient or
control (see section 418(o)(3) of the included in the requirements for a otherwise apparent. In such cases, the
FD&C Act). Further, we believe a supplier program because they would role that distributors, brokers,
supply-chain program is a measure that not likely meet the definition of a aggregators, and similar entities would
a person knowledgeable about food receiving facility or a supplier. play in supplier verification would be
safety would establish and implement (Response 657) We agree with minimal. We cannot determine whether
in order to significantly minimize or comments recommending additional having to provide the identity of the
prevent hazards requiring a preventive flexibility in the supply-chain program supplier to the receiving facility would
control in an incoming raw material or with regard to who can perform certain change buying practices. However, we
other ingredient. activities and have added this flexibility believe that manufacturers consider a
Supplier verification is sufficiently to the final rule (see § 117.415). Because number of factors in determining who
important for the control of hazards in the receiving facility and the supplier they will purchase from, including the
both domestic and imported foods that may be separated by several entities in services provided, and that there will
FSMA contains provisions for both a supply chain, we are allowing such continue to be a role for aggregators, re-
domestic and foreign supplier entities (e.g., distributors, brokers, packers, brokers, and others. We have
verification (sections 418(o)(3) and 805 aggregators) to determine, conduct, and provided flexibility for these entities to
of the FD&C Act). Because we have document supplier verification play a role in supplier verification if the
aligned the provisions for supplier activities as a service to the receiving receiving facility and the business entity
verification in the FSVP rule with the facility, provided that the receiving determine there is a benefit to do so.
provisions for a supply-chain program facility reviews and assesses applicable See also the discussion in section
in this rule, we are allowing importers documentation provided by the other XLV regarding the specific provisions of
and receiving facilities to take advantage entity and documents that review and § 117.415. Although comments focus on
of that fact in considering compliance assessment. However, because the flexibility for an entity in the supply
with both part 117 and our forthcoming approval of suppliers is ultimately the chain between the supplier and the
receiving facility to perform supplier the same role as an establishment that consumer. Some comments assert that
verification activities, and such entities manufactures/processes the food, raises any firm that sells directly to retail food
are the most likely entities to be the the animal, or grows the food. establishments or consumers should
entities determining, conducting, and (Comment 659) Some comments ask have a supplier program in place, while
documenting supplier verification us to provide flexibility in the content other comments assert that this is not
activities, the flexibility provided by the of the supplier program. Some necessary, particularly in the case of
rule is not limited to such entities. comments assert that specifying the RACs.
(Comment 658) Some comments ask content of the supplier program would Some comments maintain that the
us to establish a general requirement for result in duplicative requirements on produce safety rule will provide
a supplier program without specifying suppliers, who must first comply with adequate assurances of safety for
roles and responsibilities for the various certain regulations and then covered produce and that covering such
entities involved. Other comments ask demonstrate that compliance in order to products with the supplier verification
us to define ‘‘supplier’’ as the entity comply with a different regulation. requirements of the human food
with which the receiving facility has a (Response 659) We disagree that a preventive controls rule would be
commercial relationship. requirement for a supply-chain program subjecting this produce to duplicative
(Response 658) We disagree that we in which compliance with an requirements. These comments
should establish a general requirement underlying regulation is demonstrated is recommend that, if some verification is
for a supply-chain program without duplicative with the need to comply required in these ‘‘gaps’’ on which we
specifying roles and responsibilities for with the underlying regulation. The asked for comment, entities in these
the various entities involved. Although requirement for a supply-chain program categories be allowed to voluntarily
we have added flexibility to provide is not mandating that the facility or farm apply certain supplier verification best
that an entity other than the receiving comply twice with the human practices rather than be subject to the
facility may determine, conduct, and preventive controls rule or the produce supplier program requirements of this
document supplier verification safety rule; it is merely requiring that rule.
activities (see § 117.415), we continue to the compliance by the facility or the (Response 660) As previously
believe it is important to clearly define farm with the applicable regulation be discussed (79 FR 58524 at 58548), fresh
two roles in the supply chain that share verified to ensure that hazards requiring produce often goes directly from the
the primary responsibility in the a preventive control are being farm to a distributor and then on to
supplier verification process—i.e., the controlled. retail food establishments and/or
receiving facility and the supplier. In all We are continuing to specify the basic consumers. We are not requiring any of
cases where we have added flexibility content of a supply-chain program—i.e., the entities in this supply chain to do
for participation by an entity other than using approved suppliers; determining supplier verification under part 117, so
the receiving facility, the responsibility appropriate supplier verification the farm’s compliance with the produce
for the supply-chain program is clearly activities; conducting supplier safety rule, if applicable, will not be
lodged with the receiving facility, and verification activities; and establishing verified unless done voluntarily. In
linked to the supplier (see § 117.415). records documenting these activities contrast, we are requiring that a
To emphasize the responsibility of the (see § 117.410(a)). However, the rule manufacturer/processor that uses
receiving facility and its link to the provides flexibility in the choice of covered produce to make a processed
supplier, the final rule clearly states that supplier verification activities and how product such as fresh-cut produce
the receiving facility must approve its often such activities must be performed. establish and implement a supply-chain
suppliers before receiving raw materials (See §§ 117.410(b)(4) and 117.430(b)(2), program. As we have previously
and other ingredients (see § 117.420(a)). (c), (d), and (e)). In addition, the rule discussed, processing fresh produce into
For the supply-chain program to be provides for an alternative supplier fresh-cut products increases the risk of
meaningful and robust, there must be an verification activity for certain entities bacterial growth and contamination
exchange of information between these (see § 117.430(c), (d), and (e)) regarding (Ref. 89). This has the potential to
two entities—the entity receiving the alternative supplier verification increase the exposure to pathogens,
food and the entity that controlled the activities for qualified facilities, certain because contamination of a few pieces
hazard—even when an entity other than produce farms, and certain shell egg of raw produce can be spread to many
the receiving facility participates by producers, respectively). servings of processed fresh-cut produce.
determining, conducting, and (Comment 660) As already noted in Disturbing the physical barriers of
documenting some supplier verification this section, in the 2014 supplemental produce (e.g., by cutting the produce)
activities. The ultimate responsibility human preventive controls notice we and inadequate temperature control of
for supplier verification rests with the asked for comment on whether fresh-cut produce can enhance bacterial
receiving facility through its verification activities should be required growth (including growth of pathogens,
determination in approving suppliers in circumstances in which a RAC such if present). The increased risk presented
and in reviewing and assessing as fresh produce will not be sent to any by processing of fresh produce makes it
applicable documentation provided by facilities that would be required to have appropriate to subject this processed
another entity. Therefore, we also preventive controls before reaching food to the full requirements of the
disagree that the definition of consumers. In response, we received human preventive controls rule in
‘‘supplier’’ should be revised to be the comments both in support of, and in addition to the requirements of the
next entity back in a supply chain (e.g., opposition to, a requirement that forthcoming produce safety rule for the
the entity with which a receiving verification activities be conducted in RACs that are used to make this
facility has a commercial relationship). circumstances in which produce would
processed food.
The entity with which a receiving go directly from an establishment that
facility has a commercial relationship would not be required to have supplier XLIII. Subpart G: Comments on
might be a distributor, broker, or controls (e.g., farm, warehouse, Requirement To Establish and
aggregator. A distributor, broker, or distributor) to another establishment not Implement a Supply-Chain Program
aggregator does not control an identified required to have supplier controls (e.g., We proposed that the receiving
hazard and, therefore, cannot assume retail food establishment) or to a facility must establish and implement a
risk-based supplier program for those § 117.136(a)). We also proposed implement a written supplier program
raw materials and ingredients for which circumstances when a receiving facility or that disagree with, or suggest one or
the receiving facility has identified a would not be required to have a more changes to, the proposed
significant hazard when the hazard is supplier program. requirements. After considering these
controlled before receipt of the raw In the following sections, we discuss comments, we have revised the
material or ingredient (proposed comments that ask us to clarify the regulatory text as shown in table 46.
proposed requirement to establish and
TABLE 46—REVISIONS TO THE PROPOSED REQUIREMENTS TO ESTABLISH AND IMPLEMENT A SUPPLY-CHAIN PROGRAM
N/A ............................... 117.136(a)(2)(i) .......... A supplier program is not required when Deleted as unnecessary.
there are no hazards requiring a preventive
control.
N/A ............................... 117.136(a)(2)(i) .......... A supplier program is not required when the Deleted as unnecessary.
preventive controls at the receiving facility
are adequate to significantly minimize or
prevent each of the hazards requiring a
preventive control.
117.136(a)(2) ............... 117.136(a)(2)(iii) ......... A supplier program is not required when the Shifted to be in provisions outside the frame-
hazard will be controlled by the receiving work of the supply-chain program in sub-
facility’s customer in the distribution chain. part G.
117.405(a)(2) ............... N/A ............................. Circumstances that do not require a supply- A receiving facility is an importer, is in com-
chain program even though the receiving pliance with the forthcoming FSVP require-
facility’s hazard analysis determines that a ments, and has documentation of
hazard requires a supply-chain-applied verification activities conducted under the
control. forthcoming FSVP program.
117.405(a)(3) ............... N/A ............................. Exemption from the requirements for a sup- Exemption for food supplied for research or
ply-chain program. evaluation.
117.405(c) ................... N/A ............................. Requirements applicable to non-suppliers ..... When a supply-chain-applied control is ap-
plied by an entity other than the receiving
facility’s supplier (e.g., when a non-supplier
applies controls to certain produce (i.e.,
produce that will be subject to the forth-
coming produce safety rule), because
growing, harvesting, and packing activities
are under different management), the re-
ceiving facility must (1) verify the supply-
chain-applied control; or (2) obtain docu-
mentation of an appropriate verification ac-
tivity from another entity, review and as-
sess the entity’s applicable documentation,
and document that review and assessment.
A. Requirement for a Written Supply- hazard in the raw material or other chain program applies when the
Chain Program (Final § 117.405(a)(1) ingredient is controlled before its outcome of a hazard analysis is that a
and (b)) receipt (see § 117.3) and use the more known or reasonably foreseeable hazard
specific term ‘‘supply-chain-applied requires a preventive control, and the
We proposed that the receiving control,’’ rather than the broader term hazard would be controlled by the
facility must establish and implement a ‘‘preventive control,’’ throughout the receiving facility’s supplier. The
risk-based supplier program for those provisions for a supply-chain program. requirement applies regardless of
raw materials and ingredients for which (Comment 661) As discussed in whether the hazard requiring a
the receiving facility has identified a Comment 656, several comments ask us preventive control is, or is not, a hazard
significant hazard when the hazard is to issue guidance rather than establish that would be introduced into a food for
controlled before receipt of the raw requirements for a supplier program in the purposes of economic gain.
material or ingredient. We also the rule. (Comment 663) Some comments ask
proposed that the supplier program (Response 661) See Response 656 for us to specify that a Certificate of
must be written. (See proposed a discussion of our reasons for declining Analysis or other documentation of the
§ 117.136(a)(1)(i) and (2).) To improve this request and establishing existence and/or level of a hazard could
clarity, we have revised the revision to requirements for a supply-chain be provided to the receiving facility to
substitute the phrase ‘‘hazard requiring program in the rule. indicate the potential for an actual
a supply-chain-applied control’’ for the (Comment 662) Some comments ask existence of a hazard so that the
phrase ‘‘significant hazard when the us to revise the regulatory text to receiving facility could evaluate
hazard is controlled before receipt of the remove the condition that all hazards be whether the hazard requires a
raw material or ingredient.’’ We have foreseeable so that the supplier program preventive control. One comment
added a definition for the term ‘‘supply- can address economically motivated explains that chemical contaminants
chain-applied control’’ to mean a adulteration. such as lead are not controlled through
preventive control for a hazard in a raw (Response 662) This comment is easily described ‘‘procedures’’ but are
material or other ingredient when the unclear. The requirement for a supply- instead controlled through factors such
as product formulation (e.g., controlling that there is a hazard requiring a the hazard from the requirements for a
the levels of contaminants in each preventive control, and that the supply-chain program to a series of
ingredient depending on the proportion appropriate control is applied by the provisions that apply when a
of the ingredient in the finished food) supplier. On the contrary, the Certificate manufacturer/processor identifies a
and serving size. These comments of Analysis simply demonstrates that hazard requiring a preventive control,
explain that chemical contaminants the supply-chain-applied control but can demonstrate and document that
such as lead may require control in one functioned as intended. the hazard will be controlled by an
context (e.g., if children are the target (Comment 664) One comment asks us entity in its distribution chain (see
consumers) but not in another context to specify in the regulatory text that the §§ 117.136 and 117.137). However, as
(e.g., if adults are the target consumers supplier program must be written ‘‘if discussed in Response 665 and section
and the product is unlikely to be required’’ because there are specified XLIII.C, we also are establishing two
consumed by children). This comment circumstances when a supplier program additional circumstances when a
expresses concern about whether is not required. supply-chain program is not required
customers would be willing to provide (Response 664) We decline this (see § 117.405(a)(2) and (3)).
the receiving facility with confidential request. Although the rule provides (Comment 665) As noted in Comment
information about the customer’s own circumstances when a supply-chain 656, some comments single out our
hazard analysis with respect to sensitive program is not required (see request for comment, in the proposed
topics (e.g., how much lead it has § 117.405(a)(2)), it is not necessary to FSVP rule, on whether to allow an
decided to allow in its finished specify, for all other provisions of the entity that would be both an importer
products, or how its product supply-chain program, that the (under the FSVP rule) and a receiving
formulation controls the level of lead in provision only applies ‘‘if required.’’ facility (under the human preventive
its finished food). Furthermore, in such B. Circumstances That Do Not Require controls rule) to be deemed in
cases the receiving facility will not even a Written Supply-Chain Program (Final compliance with the FSVP rule if it was
know whether the chemical § 117.405(a)(2)) in compliance with the supplier
contaminant constitutes an actual verification provisions of the human
‘‘hazard’’ for the purposes of the We proposed that the receiving preventive controls rule, and agree with
customer’s finished food. This comment facility is not required to establish and such an approach (78 FR 47730 at
also asserts that a Certificate of Analysis implement a supplier program for raw 45748).
provided to a receiving facility materials and ingredients for which (Response 665) As noted in Response
constitutes ‘‘control before receipt of the there are no significant hazards; the 656, we have aligned the provisions for
raw material or ingredient.’’ preventive controls at the receiving supplier verification in the FSVP rule
(Response 663) We do not understand facility are adequate to significantly with the provisions for a supply-chain
the concern of this comment. A minimize or prevent each of the program in this rule, and we are
receiving facility and a supplier do not significant hazards; or the receiving allowing importers that are receiving
need to share all of the details of facility relies on its customer to control facilities to take advantage of that fact in
product formulation for a receiving the hazard and annually obtains from its considering compliance with our
facility to communicate its requirements customer written assurance that the forthcoming FSVP regulations that we
to a supplier. In the example provided customer has established and is proposed to establish in part 1, subpart
by the comment, the receiving facility following procedures (identified in the L, so that they do not have to duplicate
could provide the supplier with a written assurance) that will significantly verification activities (see
written specification for a contaminant minimize or prevent the hazard. (See § 117.405(a)(2)).
such as lead, and the supplier could proposed § 117.136(a)(1)(ii)(A), (B), and (Comment 666) Some comments
demonstrate that it satisfied the (C).) support the specified criteria for when
receiving facility’s specification by We are deleting the proposed a receiving facility would not be
providing a Certificate of Analysis provision that a supplier program is not required to establish and implement a
showing the results of laboratory testing required for raw materials and supplier program. Other comments
for lead. Neither the written ingredients for which there are no express concern that these criteria
specification provided by the receiving ‘‘significant hazards’’ (which we now suggest no supplier verification is
facility, nor the Certificate of Analysis refer to as ‘‘hazards requiring a needed at all in some circumstances
provided by the supplier, would preventive control’’) because it is despite supplier verification activities
disclose confidential information about unnecessary. The supply-chain program being potentially informative about a
the formulations or procedures of either is required when a hazard identified in particular supplier. These comments ask
entity. the receiving facility’s hazard analysis us to establish some general
This comment also appears to identifies a hazard requiring a supply- requirement to perform verification
misunderstand the applicability of the chain-applied control; it is not activities for all suppliers.
supply-chain program. The rule requires necessary to also state the converse. (Response 666) We decline this
a supply-chain program when the Likewise, we are deleting the proposed request because it is neither risk-based
receiving facility has identified, through provision that a supplier program is not nor consistent with the nature and
its hazard analysis, that there is a hazard required if the preventive controls at the purpose of the supply-chain program,
requiring a supply-chain-applied receiving facility are adequate to which is to provide assurance that a
control. In the circumstances described significantly minimize or prevent each hazard requiring a supply-chain-applied
by the comment, a Certificate of of the significant hazards. In such a control has been significantly
Analysis or other documentation of test case, the outcome of the hazard analysis minimized or prevented (see the
results from the supplier to the would not be that the hazard requires a regulatory text of § 117.410(c)). We agree
receiving facility could demonstrate that supply-chain-applied control. that some degree of verification of all
the supplier has controlled the hazard to As discussed in section XXVII, after suppliers may prove useful to a
the receiving facility’s specifications, considering comments, we are shifting receiving facility for various purposes,
but would not overturn the outcome of the provision in which the receiving and the rule would not prevent a
the receiving facility’s hazard analysis facility relies on its customer to control receiving facility from establishing a
supply-chain program for all of its corporate headquarters, with applicable preventive controls rule and the 2014
suppliers regardless of risk and documentation available during supplemental human preventive
regardless of whether the applicable inspection. controls notice, which all describe a
hazard in a raw material or other ‘‘farm’’ as an entity ‘‘devoted to the
C. Exemption for Food Supplied for
ingredient is controlled before its growing and harvesting of crops’’
Research or Evaluation (Final
receipt. (emphasis added).
(Comment 667) Some comments ask § 117.405(a)(3)) We proposed the requirements for a
us to specify that a ‘‘kill step’’ would be We are establishing an exemption supplier program in the context of a
an adequate indicator to significantly from the requirement for a receiving single business entity ‘‘devoted to the
minimize or prevent significant hazards facility to establish and implement a growing and harvesting of crops’’
identified by the receiving facility when supply-chain program when it receives (emphasis added), in which packing
the receiving facility controls the food for the purposes of research or operations were often done by that same
hazard. evaluation, provided that certain business entity. The final ‘‘farm’’
(Response 667) These comments conditions are met (see § 117.405(a)(3)). definition accommodates business
appear to misunderstand the Those conditions are that the food: (1) models where growing, harvesting, and
applicability of the supply-chain Is not intended for retail sale and is not packing operations will be done by
program. The rule requires a supply- sold or distributed to the public; (2) is different business entities. Harvesting
chain program when the receiving labeled with the statement ‘‘Food for and packing operations include some
facility has identified, through its research or evaluation use’’; (3) is supply-chain-applied controls, such as
hazard analysis, that there is a hazard supplied in a small quantity that is controls on worker hygiene, quality of
requiring a preventive control and the consistent with a research, analysis, or water used during harvesting and
receiving facility’s manufacturing/ quality assurance purpose, the food is packing operations, and establishing
processing will not control the hazard. used only for this purpose, and any and following water-change schedules
In the circumstances described by the unused quantity is properly disposed of; for recirculated water, even though the
comment, the receiving facility is and (4) is accompanied with documents, harvesting and packing operations do
controlling the hazard and a supply- in accordance with the practice of the not fall within the definition of
chain program for the raw material or trade, stating that the food will be used ‘‘supplier.’’
other ingredient is not required. It is not for research or evaluation purposes and A receiving facility has an obligation
necessary to specify the types of cannot be sold or distributed to the to identify and implement preventive
controls that the receiving facility may public. The exemption is analogous to controls to provide assurances that any
use to control the hazard. an exemption we proposed for the FSVP hazards requiring a preventive control
(Comment 668) Some comments ask rule under section 805(f) of the FD&C will be significantly minimized or
us to specify that a receiving facility Act. (See proposed § 1.501(c), 78 FR prevented and the food manufactured,
need not establish and implement a 45730 at 45745). We believe it is not processed, packed, or held by the
supplier program for raw materials and necessary to conduct supplier facility will not be adulterated under
ingredients if those raw materials or verification activities when food is section 402 of the FD&C Act or
ingredients were received from an obtained in this limited circumstance. misbranded under section 403(w) of the
affiliated party within the same FD&C Act (see section 418(c) of the
D. Additional Requirements for Non-
corporate or controlling entity. FD&C Act and § 117.135(a)). That
(Response 668) We decline this Suppliers (Final § 117.405(c))
obligation includes responsibilities for
request. With the revisions we have As discussed in section IV.B, the final raw materials and other ingredients
made to the proposed requirements for rule includes several revisions to the when a supply-chain-applied control is
a supplier program, the supply-chain ‘‘farm’’ definition in response to applied by an entity other than the
program that we are establishing in this comments. For example, as discussed in receiving facility’s supplier. An example
rule provides ample opportunities for an Comment 23 comments emphasize that of such a situation is when produce that
affiliated party within the same farming operations can have complex will be covered by the forthcoming
corporate or controlling entity to business structures, and ask us to revise produce safety rule is grown, harvested,
establish and implement a supply-chain the ‘‘farm’’ definition to provide for and packed under different
program that is suited to its relationship these business models. In response to management. To clarify the receiving
to these entities. For example, as these comments, we have added a new facility’s responsibilities when a supply-
discussed in Response 687, a receiving definition for a ‘‘secondary activities chain-applied control is applied by a
facility might be able to determine and farm,’’ which provides for practices non-supplier, we are establishing a
document a justification for a supplier such as packing by cooperatives and requirement specifying that when a
verification activity other than an packinghouses under the ownership of supply-chain-applied control is applied
annual audit when a supplier is an multiple growers to remain within the by an entity other than the receiving
affiliated party based on the receiving ‘‘farm’’ definition (See Response 25). facility’s supplier (e.g., when a non-
facility’s knowledge of the corporate Another change to the ‘‘farm’’ definition supplier applies controls to certain
policies regarding food safety practices accommodates business models in produce (i.e., produce that will be
(see § 117.430(b)(2)). In addition, as which one operation grows crops but subject to the forthcoming produce
discussed in Response 690, we have does not harvest them, and another safety rule), because growing,
agreed that the corporate parent of a operation, not under the same harvesting, and packing activities are
facility can be active in developing and management, harvests crops but does under different management), the
implementing the facility’s food safety not grow them (see Response 32). As receiving facility must: (1) Verify the
plan (see section XXIV.A). If, for discussed in Response 32, this revision supply-chain-applied control; or (2)
example, a corporate headquarters is a change from the ‘‘farm’’ definition obtain documentation of an appropriate
establishes and implements a supply- established in the section 415 verification activity from another entity,
chain program for use company-wide, a registration regulations in 2003, and the review and assess the entity’s applicable
receiving facility could rely on supplier proposed revisions to the ‘‘farm’’ documentation, and document that
verification activities conducted by its definition in the 2013 proposed human review and assessment. See
§ 117.405(c). Because § 117.405(c) refers suppliers as a service to the receiving We will consider whether it will add
to provisions in a future produce safety facility, provided that the receiving value to discuss the principles in these
rule, we will publish a document in the facility reviews and assesses applicable proposed provisions in guidance that
Federal Register announcing the documentation provided by the other we intend to develop for the supply-
effective date of that provision once we entity and documents that review and chain program.
finalize the produce safety rule. assessment. Likewise, under
XLIV. Subpart G: Comments on General
We do not expect the receiving § 117.405(c)(2) a receiving facility could
Requirements Applicable to a Supply-
facility to follow all of the requirements obtain documentation of review of
Chain Program
of subpart G applicable to ‘‘suppliers’’ applicable records maintained by the
when verifying control by a ‘‘non- harvester or packer from another entity, We proposed several requirements
supplier,’’ as required by § 117.405(c). review and assess the entity’s applicable generally applicable to the supplier
Instead, we expect the receiving facility documentation, and document that program (such as factors to consider in
will take steps such as a review of the review and assessment. determining appropriate supplier
non-supplier’s applicable food safety verification activities (proposed
E. Proposed General Requirements for § 117.136(b)), as well as several
records. For example, if a receiving
the Supply-Chain Program That We Are requirements more narrowly targeted to
facility receives produce from a supply
Not Including in the Final Rule specific aspects of the supplier program
chain that includes a separate grower,
(Proposed § 117.136(a)(4) and (5)) (such as requirements applicable to
harvester, and packer, the grower is the
supplier and the requirements of We proposed that when supplier onsite audits). As part of the
subpart G applicable to ‘‘suppliers’’ verification activities are required for redesignation of proposed § 117.136 into
apply to the grower. To verify controls more than one type of hazard in a food, subpart G, with eight distinct sections,
applied by the harvester, the receiving the receiving facility must conduct the we are establishing the more general
facility could review the harvester’s verification activity or activities requirements in § 117.410 (see table 47).
records, such as records of training for appropriate for each of those hazards. Most comments that support the
harvest workers and records of We also proposed that for some hazards, proposed provisions suggest alternative
agricultural water quality used in in some situations it will be necessary or additional regulatory text (see, e.g.,
harvest operations. To verify controls to conduct more than one verification Comment 671, Comment 672, Comment
applied by the packer, the receiving activity and/or to increase the frequency 675, Comment 676, and Comment 678).
facility could review the packer’s of one or more verification activities to In the following sections, we discuss
records, such as records of agricultural provide adequate assurances that the comments that ask us to clarify the
water quality used in packing hazard is significantly minimized or proposed requirements or that disagree
operations. As discussed in Response prevented. We have concluded that with, or suggest one or more changes to,
657, we are allowing entities such as these provisions are largely self-evident the proposed requirements. After
distributors, brokers, and aggregators to and need not be included in the considering these comments, we have
determine, conduct, and document regulatory text. Therefore, we are not revised the regulatory text as shown in
verification activities that apply to finalizing these proposed provisions. table 47.
TABLE 47—REVISIONS TO THE PROPOSED GENERAL REQUIREMENTS APPLICABLE TO A SUPPLY-CHAIN PROGRAM

117.410(a) ............... 117.136(a)(3) ......... What the supply-chain program Add that the supply-chain program includes, when applicable,
must include. verifying a supply-chain-applied control applied by an entity
other than the receiving facility’s supplier and documenting
that verification, or obtaining documentation of an appropriate
verification activity from another entity, reviewing and assess-
ing that documentation, and documenting the review and as-
sessment.
117.410(b) ............... 117.136(c)(1) ......... Appropriate supplier verification N/A.
activities.
117.410(c) ............... 117.136(a)(3)(ii) ..... Purpose of supplier verification Specify only that the supply-chain program must provide assur-
activities for raw materials ance that a hazard requiring a supply-chain-applied control
and other ingredients. has been significantly minimized or prevented.
117.410(d) ............... 117.136(b) ............. Factors that must be considered Clarify that the factors apply in approving suppliers, as well as in
when approving suppliers and determining appropriate supplier verification activities.
determining appropriate sup-
plier verification activities for
raw materials and other ingre-
dients.
117.410(d) ............... 117.136(b) ............. Factors that must be considered • Specify that three of the factors relate to ‘‘supplier perform-
when approving suppliers and ance.’’
determining appropriate sup- • Specify ‘‘The entity or entities that will be applying controls for
plier verification activities for the hazards requiring a supply-chain-applied control’’ rather
raw materials and other ingre- than ‘‘Where the preventive controls for those hazards are ap-
dients; Supplier performance. plied for the raw material and ingredients—such as at the sup-
plier or the supplier’s supplier.’’
• Add ‘‘other FDA compliance actions related to food safety’’ as
an example of information relevant to the supplier’s compli-
ance with applicable FDA food safety regulations
TABLE 47—REVISIONS TO THE PROPOSED GENERAL REQUIREMENTS APPLICABLE TO A SUPPLY-CHAIN PROGRAM—

Continued
• Clarify that consideration of supplier performance includes,

when applicable, relevant laws and regulations of a country
whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the
United States and information relevant to the supplier’s com-
pliance with those laws and regulations
• Provide flexibility in the factors that must be considered if a
supplier is a qualified facility, a produce farm that will not be
subject to the forthcoming produce safety rule on the basis of
size and/or direct farm marketing, or a shell egg producer that
is not subject to the requirements of 21 CFR part 118 (pro-
duction, storage, and transportation of shell eggs) because it
has less than 3,000 laying hens
117.410(e) ............... 117.136(f) .............. Supplier non-conformance ........ N/A.
A. Description of What the Supply- 117.430, 117.435, and 117.475 in claim this is an unnecessary burden that
Chain Program Must Include (Final sections XLVI, XLVII, XLVIII, and XLIX, is not authorized by FSMA.
§ 117.410(a)) respectively. (Response 669) We are retaining
As discussed in section XLIII.D, the onsite audits as an appropriate supplier
We proposed to require that a final rule establishes a verification verification activity. As noted in our
supplier program include verification requirement when a supply-chain- memorandum on supplier programs,
activities, as appropriate to the hazard, applied control is applied by an entity onsite audits are commonly used by
and documentation of these activities, to other than the receiving facility’s industry in the verification of supplier
ensure raw materials and ingredients are supplier (see § 117.405(c)). For clarity, performance (Ref. 83). Onsite audits
received only from suppliers approved § 117.410(a) states this general provide the opportunity to review the
for control of the hazard(s) in that raw requirement for the supply-chain food safety plan and written procedures
material or ingredient (or, when program in § 117.405(a)(5), and and to observe the implementation of
necessary and appropriate, on a § 117.405(c) provides the specific food safety procedures, as well as to
temporary basis from unapproved requirements that apply when a supply- review the records related to the past
suppliers) (proposed § 117.136(a)(3)(i)). chain-applied control is applied by an application of control measures,
We also proposed to require that a entity other than the receiving facility’s including laboratory test results. Audits
supplier program include verification supplier. also provide the opportunity to
activities, as appropriate to the hazard, interview employees to assess their
and documentation of these activities. B. Appropriate Supplier Verification understanding of the food safety
We also proposed requirements Activities ((Final § 117.410(b)) measures for which they are
applicable to the determination and We proposed to require that responsible. Thus, an audit can provide
documentation of appropriate supplier appropriate supplier verification for a more comprehensive assessment of
verification activities (proposed activities include: (1) Onsite audits; (2) food safety implementation by a facility,
§ 117.136(b)). We also proposed specific sampling and testing of the raw material and often is used in approving food
documentation requirements for records or ingredient, which may be conducted suppliers. Comments that oppose
associated with the supplier program by either the supplier or receiving including onsite audits as a verification
(proposed § 117.136(g)). facility; (3) review by the receiving activity are concerned that farms will be
The final rule specifies that the facility of the supplier’s relevant food required to have audits to verify that
supply-chain program must include: (1) safety records; or (4) other appropriate they are in compliance with produce
Using approved suppliers; (2) supplier verification activities based on safety standards or facilities will be
determining appropriate supplier the risk associated with the ingredient required to have audits to verify
verification activities (including and the supplier (proposed preventive controls. These comments
determining the frequency of § 117.136(c)(1)). apparently refer to the provision in
conducting the activity); (3) conducting (Comment 669) Some comments section 419(c)(1)(E) of the FD&C Act that
supplier verification activities; and (4) support the inclusion of onsite audits as the regulation issuing standards for the
documenting supplier verification an appropriate supplier verification safety of produce ‘‘not require a
activities. For clarity, § 117.410(a) states activity. However, other comments business to hire a consultant or other
this general requirement for the supply- oppose it, and ask us to remove the third party to identify, implement,
chain program and §§ 117.420, 117.425, onsite audit requirement from the certify compliance with these
117.430, 117.435, and 117.475 provide supplier verification program, stating procedures, processes and practices,’’ or
the specific requirements for using that Congress prohibited FDA from the provision in section 418(n)(3)(D) of
approved suppliers, determining requiring third parties to verify or audit the FD&C Act that the preventive
appropriate supplier verification compliance with the rules. These controls regulation ‘‘not require a
activities, conducting verification comments express concern that the facility to hire a consultant or other
activities, specific requirements for supplier verification program effectively third party to identify, implement,
onsite audits, and records, respectively. imposes an ‘‘entire second layer of certify or audit [preventive] controls.’’
See the discussion of the specific regulation’’ on produce farms that are The regulations proposed under section
requirements of §§ 117.420, 117.425, supplying ingredients to processors, and 419 of the FD&C Act do not impose such
requirements. The requirements for testing is not useful for products with laboratory) to conduct sampling and
supplier verification in this rule (under short shelf life, such as fresh produce. testing.
section 418 of the FD&C Act) provide for (Response 670) We are retaining (Comment 672) Some comments
audits as one supplier verification sampling and testing as an appropriate suggest that, for a facility regularly
activity. Although the rule does specify supplier verification activity. As noted undergoing audits, reviewing a
an annual onsite audit as the in our memorandum on supplier ‘‘supplier’s relevant food safety records’’
appropriate supplier verification programs, sampling and testing are should allow for the receiving facility to
activity when a hazard in a raw material commonly used by industry in the review documentation related to pre-
or other ingredient will be controlled by verification of supplier performance existing audits. These comments ask us
the supplier and is one for which there (Ref. 83). We have previously discussed to revise the provision to add
is a reasonable probability that exposure factors that impact the utility and ‘‘including, but not limited to, records
to the hazard will result in serious frequency of raw material/ingredient related to audits previously performed
adverse health consequences or death to testing (see the Appendix published in on the supplier’s facility.’’
humans, the receiving facility is not the 2013 proposed human preventive (Response 672) We decline this
required to hire a third party to conduct controls rule (78 FR 3646 at 3818–3820); request. The comment misinterprets
the audit. Any qualified auditor, other republished in its entirety with what we mean by a ‘‘supplier’s relevant
than the supplier, may conduct the corrected reference numbers on March food safety records.’’ The rule provides
audit, including an employee of the 20, 2013, 78 FR 17142 at 17149–17151). for onsite audits as a verification
receiving facility or another entity, such We agree that there are benefits in activity, as well as reviewing a
as an entity in the supply chain between having sampling and testing conducted ‘‘supplier’s relevant food safety
the supplier and the receiving facility. by the supplier, because the supplier records.’’ When an annual audit is
The rule also provides that a receiving can then take appropriate action with determined to be an appropriate
facility may determine and document respect to the findings, including not verification activity (see
that other verification activities and/or shipping contaminated product. § 117.430(b)(1)), the audit would be
less frequent onsite auditing of the However, because contamination with reviewed by the receiving facility, but a
supplier provide adequate assurance microbial pathogens is likely to be non- review of this audit is not what we
that the hazards are controlled (see homogeneous and the numbers of meant by a ‘‘supplier’s relevant food
§ 117.430(b)(1) and (2)). Audits already pathogens are likely to be low, a safety records.’’ As described in our
conducted on a supplier’s facility or negative does not guarantee the absence memorandum on supplier programs,
operation for other business purposes of contamination. This should be taken food safety records are records
may meet the requirement for supplier into account when deciding which documenting that the food safety
verification activity (or activities) is procedures that have been established to
verification. In addition, the rule
appropriate. Because of the limitations control hazards are being followed and
provides alternative requirements for
of sampling and testing, the controls the are adequately controlling such hazards
verification of suppliers that are farms
supplier has in place to minimize (Ref. 83). Thus, a receiving facility may
that are not a covered farm under part
contamination, and the management of obtain documentation of a supplier’s
112 in accordance with § 112.4(a), or in
those controls, are key in determining control measures for a particular lot of
accordance with §§ 112.4(b) and 112.5
when sampling and testing is a raw material or ingredient provided to
(see § 117.430(d)). Finally, we have also
appropriate as a verification activity. the receiving facility, such as the
provided that inspections may
For short shelf life products, where records created when a process control
substitute for an audit under specified
holding product pending test results can measure was applied. The food safety
circumstances (see § 117.435(c)). records may also include supplier
negatively impact product shelf life, an
While we realize that some farms may onsite audit to verify control of hazards records that show that the supplier’s
receive audits under the supplier may be more appropriate than sampling supplier has controlled a hazard. Such
verification provisions of part 117, we and testing. records may include audits, for
note that farms that might receive an (Comment 671) Some comments ask example, when the supplier’s supplier
audit because they are suppliers to a us to specify in the regulatory text that controls the hazard and the supplier’s
receiving facility produce a limited sampling and testing can be conducted records include records of an audit
subset of the total produce production by or on behalf of the supplier or the conducted with respect to the hazard
that comes from farms. These are receiving facility. control activities of the supplier’s
products such as leafy greens for fresh- (Response 671) The provisions of supplier. To emphasize that the review
cut processing operations and fruits and § 117.415 specify the responsibilities of of a supplier’s relevant food safety
vegetables that are going into ready-to- the receiving facility, and allow a records can include records other than
eat products like deli salads. These are receiving facility to conduct all supplier records of audits, we have revised the
products for which there is a history of verification activities, including documentation requirements applicable
outbreaks and, therefore, good reason to sampling and testing. These provisions to review of a supplier’s food safety
do appropriate supplier verification also provide that a supplier, or an entity records to specify that the
activities. other than the receiving facility (such as documentation must include the general
(Comment 670) Some comments an entity in the supply chain between nature of the records reviewed (see
support the inclusion of sampling and the supplier and the receiving facility), § 117.475(c)(9)). By ‘‘general nature of
testing of the raw material or other can conduct sampling and testing, the records reviewed,’’ we mean
ingredient as an appropriate supplier provided that the receiving facility information such as ‘‘records of process
verification activity, and note that reviews and assesses the documentation controls.’’
verification testing is more effective provided by the supplier. The rule (Comment 673) Some comments
when conducted by the supplier than places no restrictions on when a support the inclusion of other
the receiving facility because the receiving facility, a supplier, or an appropriate supplier verification
supplier can control the lot of product entity other than the receiving facility activities based on the risks associated
tested. However, other comments could have a business relationship with with the ingredient and the supplier,
oppose it, stating that sampling and a third party (such as a contract because it provides flexibility for
facilities to design risk-based programs activities, as appropriate to the hazard, However, the supply-chain program
that are appropriate for their operations. and documentation of these activities, to applies to hazards requiring a supply-
Comments suggest other verification verify that: (1) The hazard is chain-applied control, and the supply-
activities may include receiving raw significantly minimized or prevented; chain program must provide assurance
materials and other ingredients from a (2) the incoming raw material or that a hazard requiring a supply-chain-
supplier without a full audit report if ingredient is not adulterated under applied control has been significantly
the supplier maintains certification to a section 402 of the FD&C Act or minimized or prevented. In the example
standard recognized by GFSI; providing misbranded under section 403(w) of the where the receiving facility is relying on
for documentary verification (such as FD&C Act; and (3) the incoming raw the supplier to control aflatoxin, the
fact-specific questionnaires and material or ingredient is produced in provision would require the receiving
representations exchanged between the compliance with the requirements of facility to verify that the hazard
supplier and the receiving facility); and applicable FDA food safety regulations (aflatoxin) has been significantly
confirming that a facility, especially a (proposed § 117.136(a)(3)(ii)). We have minimized or prevented by the supplier.
small manufacturing facility, is licensed revised the provision to specify that the
D. Factors That Must Be Considered
by the appropriate State or local supply-chain program must provide
When Approving Suppliers and
regulatory authority. assurance that a hazard requiring a
(Response 673) We are retaining this Determining Appropriate Supplier
supply-chain-applied control has been
provision to allow other appropriate Verification Activities for Raw Materials
significantly minimized or prevented. If
supplier verification activities based on and Other Ingredients (Final
the supply-chain program provides
supplier performance and the risk § 117.410(d))
assurance that a hazard requiring a
associated with the raw material or supply-chain-applied control has been We proposed that in determining and
other ingredient. We have revised the significantly minimized or prevented, it documenting the appropriate
regulatory text to refer to ‘‘supplier is not necessary to also specify that the verification activities, the receiving
performance and the risk associated incoming raw material or ingredient is facility must consider the following: (1)
with the raw material or other not adulterated under section 402 of the The hazard analysis, including the
ingredient’’ because ‘‘supplier FD&C Act or misbranded under section nature of the hazard, applicable to the
performance’’ is more appropriate than 403(w) of the FD&C Act. We also have raw material and ingredients; (2) where
‘‘risk associated with the supplier.’’ We deleted the requirement that the the preventive controls for those
use the term ‘‘risk’’ as defined by the verification activities must verify that hazards are applied for the raw material
Codex Alimentarius Commission to be the incoming raw material or ingredient and ingredients—such as at the supplier
‘‘a function of the probability of an is produced in compliance with the or the supplier’s supplier; (3) the
adverse health effect and the severity of requirements of applicable FDA food supplier’s procedures, processes, and
that effect, consequential to a hazard(s) safety regulations and instead focused practices related to the safety of the raw
in food’’ (Ref. 90). As discussed in that requirement as a factor that must be material and ingredients; (4) applicable
section XLIV.D, the considerations for considered in approving suppliers and FDA food safety regulations and
supplier performance, which can be determining the appropriate supplier information relevant to the supplier’s
related to the probability of a hazard in verification activities and the frequency compliance with those regulations,
the raw material or ingredient and the with which they are conducted rather including an FDA warning letter or
severity of adverse health effects that than as one of the stated purposes of the import alert relating to the safety of the
can result, are broader than this. supply-chain program. See the food; (5) the supplier’s food safety
We agree that a supplier’s certification regulatory text of § 117.410(d)(i)(iii)(B). performance history relevant to the raw
to a GFSI scheme that considers FDA (Comment 674) Some comments ask materials or ingredients that the
food safety regulations can be a us to revise this provision to state that receiving facility receives from the
consideration in the determination of the receiving facility’s use of the supplier, including available
the type and frequency of the incoming raw material or ingredient information about results from testing
verification activity conducted. will not cause the finished food to be raw materials or ingredients for hazards,
Similarly, fact-specific questionnaires adulterated under section 402 of the audit results relating to the safety of the
and representations exchanged between FD&C Act or misbranded under section food, and responsiveness of the supplier
the supplier and the receiving facility 403(w) of the FD&C Act. These in correcting problems; and (6) any
can be a consideration in the comments assert that FSMA does not other factors as appropriate and
determination of the type and frequency mandate, nor is it reasonable to expect, necessary, such as storage and
of the verification activity conducted. that incoming raw materials and transportation practices (proposed
Confirming that a facility is licensed by ingredients will not be adulterated § 117.136(b)).
the appropriate State or local regulatory under section 402, and that it is As discussed in Response 657,
authority should not serve as the only acceptable for a receiving facility to Response 658, and section XLVI.A, we
verification that a supplier is controlling control the ‘‘adulterating hazard,’’ even have revised the regulatory text
the hazard, because the requirements for if it relies on the supplier to control regarding use of approved suppliers to
a license and the degree of inspectional other hazards. more explicitly state that the receiving
oversight could vary greatly. We do (Response 674) We decline this facility must approve suppliers. The
provide for modified supplier request. We acknowledge that in some factors that must be considered in
verification activities for qualified circumstances a receiving facility may determining the appropriate supplier
facilities, which are very small rely on the supplier to control certain verification activities are equally
hazards, while controlling other hazards relevant to approving suppliers, and the
businesses (§ 117.430(c)).
itself. For example, a receiving facility final rule requires that these factors
C. Purpose of Supplier Verification that produces peanut-derived products must be considered in approving
Activities for Raw Materials and Other could rely on its supplier for the control suppliers, as well as in determining
Ingredients (Final § 117.410(c)) of the chemical hazard aflatoxin, but appropriate supplier verification
We proposed to require that a control the biological hazard Salmonella activities. For clarity and consistency
supplier program include verification through its own roasting process. with terms used throughout the final
provisions for a supply-chain program, (Comment 675) Some comments supplier verification activities are
the final rule specifies ‘‘the entity or support the flexibility for receiving appropriate, not to determine whether
entities that will be applying controls facilities to determine the appropriate supplier oversight is needed. Once a
for the hazards requiring a supply- supplier verification activities and receiving facility has already
chain-applied control’’ rather than frequency with which to conduct these determined that a hazard requiring a
‘‘Where the preventive controls for activities. Some comments state that not preventive control is controlled before
those hazards are applied for the raw all of the factors that we proposed a receipt of a raw material or other
material and ingredients—such as at the receiving facility consider are relevant ingredient, supplier oversight is needed.
supplier or the supplier’s supplier.’’ for the process of selecting the We recognize that there is need for
As discussed in Response 673, we are verification activity. These comments additional flexibility regarding
using the term ‘‘supplier performance,’’ suggest changing the regulatory text to conducting supplier verification
rather than ‘‘risk of supplier,’’ when require a receiving facility to consider activities. As discussed in Response
discussing factors associated with ‘‘both food and supplier related risks, 657, we are providing significant
suppliers. The final rule groups three of including the following, as appropriate’’ additional flexibility to address this
the proposed factors as ‘‘supplier and then listing the factors as proposed. situation in the final rule.
performance.’’ As a companion change Other comments suggested similar (Comment 678) Some comments
to emphasize that ‘‘supplier changes to the regulatory text. object to the proposed requirement to
performance’’ applies to all three of (Response 675) We disagree that some consider applicable FDA food safety
these factors, we refer to the supplier’s of the factors that we proposed a regulations and information relevant to
‘‘food safety history’’ rather than ‘‘food receiving facility must consider are not the supplier’s compliance with those
safety performance history.’’ relevant to determining the appropriate regulations, including an FDA warning
verification activity. Every factor might letter or import alert relating to the
We also have revised the regulatory
not be determinative in all cases, and safety of the food. These comments
text to clarify that consideration of
our requirement merely to consider each assert that it is difficult for a receiving
supplier performance includes, when
factor does not assume so. However, any facility to know a supplier’s compliance
applicable, relevant laws and
one of these factors could be crucial status, because it is not easy to obtain
regulations of a country whose food
depending on the food, the hazard, and this kind of information in a timely
safety system FDA has officially fashion. Some comments ask us to
the nature of the preventive control. We
recognized as comparable or has develop an online database to house this
continue to consider it appropriate to
determined to be equivalent to that of information to help make it easier to
require receiving facilities to consider
the United States and information find. Some comments ask us to replace
each of these factors in making their
relevant to the supplier’s compliance the broad requirement to consider
determinations about the appropriate
with those laws and regulations. We applicable FDA food safety regulations
verification activities.
made this change because the final rule (Comment 676) Some comments ask and information relevant to the
includes several provisions that us to clarify that the phrase ‘‘the nature supplier’s compliance with those
acknowledge that some food of the hazard’’ means the nature of the regulations with a narrower requirement
establishments, including food hazard requiring control. to only consider any FDA warning letter
establishments that are ‘‘suppliers’’ as (Response 676) We have revised the or import alert relating to the safety of
that term is defined in this rule, operate regulatory text to specify ‘‘the nature of the food.
in a foreign country. (See, e.g., the the hazard controlled before receipt of (Response 678) We are retaining the
definition of ‘‘qualified auditor’’ in the raw material or other ingredient.’’ broad requirement to consider
§ 117.3 and §§ 117.201(a)(2)(ii), The revised regulatory text is consistent applicable FDA food safety regulations
117.201(e), 117.405(a)(2), 117.430(c), with regulatory text in the provisions for and information relevant to the
117.435(c)(1)(ii), 117.435(c)(2), and the preventive control management supplier’s compliance with those
117.475(c)(15)). Some of these components (see § 117.140(b), which regulations. Such information is
provisions (e.g., §§ 117.405(a)(2), specifies ‘‘taking into account the nature relevant to supplier performance
117.430(c), 117.435(c)(1)(ii), of the hazard controlled before receipt regardless of whether there is an
117.435(c)(2), and 117.475(c)(15)) are in of the raw material or other applicable warning letter or import
the requirements for a supply-chain ingredient’’). alert. For example, if a receiving facility
program. When the supplier is in a (Comment 677) Some comments agree purchases canned green beans to use in
foreign country whose food safety that a receiving facility must consider making vegetable soup, it is appropriate
system FDA has officially recognized as where the preventive controls for for the receiving facility to verify that its
comparable or determined to be hazards are applied for the raw supplier is producing the canned green
equivalent to that of the United States, materials and ingredients, such as at the beans in accordance with part 113.
a receiving facility may substitute the supplier or the supplier’s supplier. We currently have a searchable online
written results of an inspection by the Other comments assert that this database for warning letters (Ref. 91)
applicable food safety authority for an consideration should not be used to and another searchable online database
audit, provided that certain conditions determine if supplier oversight is for import alerts (Ref. 92). Both of these
are met (see § 117.435(c)(1)(ii) and (2)). needed. Other comments state that it databases are available to the public
The final rule provides flexibility for may be hard to review the procedures from our homepage at http://
alternative verification requirements for used by a supplier’s supplier and www.fda.gov. We also publicize actions
certain entities (see § 117.430(c), (d), beyond and ask us to provide clear to suspend a facility’s registration, such
and (e)). We have revised the factors flexibility regarding requirements for as in our 2012 suspension of registration
that must be considered regarding the content and performance of a due to Salmonella contamination of nut
supplier performance to reflect the receiving facility’s supplier program. butter and nut products manufactured,
flexibility the rule provides for (Response 677) The purpose of the processed, packed, and held by the
conducting supplier verification requirement to consider where the facility (Ref. 93). Under the requirement
activities for these entities (see hazard is controlled is to assist a to consider supplier performance with
§ 117.410(d)(2)). receiving facility in determining what respect to applicable food safety
regulations, a receiving facility cannot Salmonella, and becomes aware that review and assessment. We are
ignore published information relating to cheeses from this supplier have been specifying that flexibility in § 117.415.
a supplier’s compliance with applicable associated with an undeclared allergen We have titled this section
FDA food safety regulations in due to improper labeling, the receiving ‘‘Responsibilities of the receiving
determining the appropriate verification facility would determine that it should facility’’ to emphasize the responsibility
activities, such as publicized implement verification activities related of the receiving facility for its supply-
information regarding suspension of to label control to prevent undeclared chain program. (See Response 657 and
registration. To emphasize this point, allergens. Response 658.) Although comments
we have revised the regulatory text to (Comment 680) Some comments ask focus on flexibility for an entity in the
specify that the applicable information us to replace the phrase ‘‘examples of supply chain between the supplier and
includes ‘‘other FDA compliance factors that a receiving facility may the receiving facility to perform supplier
actions related to food safety.’’ We also determine are appropriate and necessary verification activities, and such entities
have revised the regulatory text to are storage and transportation’’ with are the most likely entities to be the
specify that the compliance relates to an ‘‘such as storage and transportation.’’ entities determining, conducting, and
FDA warning letter or import alert (Response 680) We have made this documenting supplier verification
relating to the ‘‘safety of food,’’ rather editorial change. activities, the flexibility provided by the
than the ‘‘safety of the food,’’ to provide E. Supplier Non-Conformance (Final rule is not limited to such entities.
flexibility for a receiving facility to § 117.410(e)) The rule does, however, set some
identify information that may raise a bounds on the flexibility for
question about a supplier’s compliance We proposed that if the owner,
operator, or agent in charge of a determining, conducting, and
history in a more general way, rather documenting appropriate supplier
than only with respect to a particular receiving facility determines through
auditing, verification testing, relevant verification activities. For example, as
food. discussed in Response 657 and
consumer, customer or other
(Comment 679) Some comments state Response 658, only the receiving facility
complaints, or otherwise that the
we should only require consideration of can approve its suppliers. As another
supplier is not controlling hazards that
the supplier’s food safety performance example, although it would not be
the receiving facility has identified as
history relevant to the hazards requiring appropriate for a supplier to determine
significant, the receiving facility must
control in the raw materials or the appropriate supplier verification
take and document prompt action in
ingredients that the receiving facility activities for itself, we had proposed
accordance with § 117.150 to ensure
receives from the supplier. that it would be appropriate for a
that raw materials or ingredients from
(Response 679) Consideration of the the supplier do not cause food that is supplier to conduct sampling and
supplier’s food safety history relevant to manufactured or processed by the testing of raw materials and ingredients
the raw materials or other ingredients receiving facility to be adulterated as a supplier verification activity
that the receiving facility receives from under section 402 of the FD&C Act or (proposed § 117.136(c)(1)(ii)), and we
the supplier will be focused on the misbranded under section 403(w) of the are retaining that provision in the final
hazard that the supplier is controlling FD&C Act (proposed § 117.136(f)). rule (see § 117.415(a)(4)). Likewise, it is
because that is the food safety (Comment 681) Some comments common industry practice for a supplier
information the receiving facility will object to the use of the word to arrange for an audit by a third party
consider to be most relevant and for ‘‘significant’’ in this proposed provision, (Ref. 83), and the new flexibility
which the receiving facility would recommending that we replace it with provision does not prohibit a receiving
develop a history. The information ‘‘requiring control by the supplier.’’ facility from relying on an audit
could indicate that certain verification These comments reason that these provided by its supplier when the audit
activities may be more appropriate than activities are only necessary if the of the supplier was conducted by a
others for verifying the control of the receiving facility is relying on the third-party qualified auditor in
hazard at that particular supplier or supplier to control the specific hazards. accordance with the requirements of the
provide information useful in (Response 681) We have revised the rule applicable to audits (§ 117.435). See
determining a frequency for the regulatory text to state ‘‘a hazard § 117.415 for the full text of this new
verification activity. However, we requiring a supply-chain-applied flexibility provision.
decline to revise the provision to specify control’’ rather than ‘‘significant.’’ XLVI. Subpart G: Comments on Using
that consideration should be limited to Approved Suppliers and Determining
the hazards requiring control. Even XLV. Subpart G: New Requirement
Specifying the Responsibilities of the Appropriate Supplier Verification
though this is the most relevant Activities
information, a facility may become Receiving Facility (Final § 117.415)
aware of information with respect to a As discussed in Response 657, after We proposed requirements for the use
raw material or other ingredient considering comments we are providing of approved suppliers (proposed
provided to another customer of the flexibility for an entity other than the § 117.136(a)(3)(i)) and for determining
supplier that may suggest the need to receiving facility to determine, conduct, and documenting appropriate supplier
conduct a different verification activity. and document the appropriate supplier verification activities (proposed
For example, if the receiving facility is verification activities, provided that the § 117.136(b)). See table 48 for a
obtaining a cheese product from a receiving facility reviews and assesses description of the final provisions and
supplier that is controlling pathogens the entity’s applicable documentation, the changes we have made to clarify the
such as L. monocytogenes and and documents the receiving facility’s requirements.
TABLE 48—REVISIONS TO THE PROPOSED REQUIREMENTS FOR APPROVING SUPPLIERS AND FOR DETERMINING AND
DOCUMENTING APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES
Final section Proposed section des- Description Revision
designation ignation
117.420(a) ................... 117.136(a)(3)(i) .......... The receiving facility must approve suppliers Explicit statement of this requirement.
and document that approval.
117.420(b)(1) ............... 117.136(a)(3)(i) .......... Written procedures for receiving raw mate- Explicit requirement for written procedures.
rials and other ingredients must be estab-
lished and followed.
117.420(b)(2) ............... ..................................... The purpose of the written procedures is to N/A.
ensure that raw materials and other ingre-
dients are received only from approved
suppliers (or, when necessary and appro-
priate, on a temporary basis from unap-
proved suppliers whose raw materials or
other ingredients the receiving facility sub-
jects to adequate verification activities be-
fore acceptance for use).
117.420(b)(3) ............... 117.136(a)(3)(i) .......... Use of the written procedures for receiving Conforming change associated with the ex-
raw materials and other ingredients must plicit requirement to establish and follow
be documented. written procedures.
117.425 ........................ 117.136(b) .................. Requirement to determine and document ap- N/A.
propriate supplier verification activities.
A. Using Approved Suppliers (Final mean written procedures to ensure that develop supplier verification plans and
§ 117.420) raw materials and other ingredients are a process for unapproved sources.
We proposed to require that a received only from suppliers approved (Response 682) We will consider
supplier program include verification by the receiving facility (or, when including guidance for use of
activities, as appropriate to the hazard, necessary and appropriate, on a unapproved suppliers on a temporary
and documentation of these activities, to temporary basis from unapproved basis in guidance that we intend to issue
ensure raw materials and ingredients are suppliers whose raw materials or other regarding the supply-chain program. We
received only from suppliers approved ingredients are subjected to adequate do not believe that the final
for control of the hazard(s) in that raw verification activities before acceptance requirements regarding the use of
material or ingredient (or, when for use), and use that term throughout approved suppliers will require
necessary and appropriate, on a subpart G. For example, a facility could increased implementation time. The
temporary basis from unapproved design a checklist for employees to use principal change is to allow flexibility
suppliers whose raw materials or when raw materials and other for entities in the supply chain other
ingredients the receiving facility ingredients are delivered to the facility. than the receiving facility to establish
subjects to adequate verification We decided to specify use of written written procedures for receiving raw
activities before acceptance for use) procedures for receiving raw materials materials and other ingredients and
(proposed § 117.136(a)(i)). and other ingredients in light of the document that written procedures for
This proposed requirement included flexibility the final rule provides for an receiving raw materials and other
an implicit requirement that a facility entity other than the receiving facility ingredients are being followed.
must approve suppliers. For clarity, we (such as an entity in the supply chain B. Determining Appropriate Verification
make that requirement, and between the supplier) to conduct this Activities (Final § 117.425)
documentation of that approval, explicit activity (see § 117.415(a)(2)). Although
in the final rule. (See § 117.420(a)). we agree that such an entity can do this The rule requires that a supply-chain
The rule continues to require that a as a service to the receiving facility, a program include determining
receiving facility ensure raw materials written procedure is appropriate to appropriate supplier verification
and other ingredients are received only ensure a robust and meaningful activities (including determining the
from suppliers approved for control of verification. As a companion change, we frequency of conducting the activity)
the hazard(s) in that raw material or (see § 117.410(a)(2)). Comments that
revised the associated documentation
other ingredient (or, when necessary addressed the proposed provision for
requirement to specify documentation
and appropriate, on a temporary basis determining appropriate verification
of use of the written procedures.
from unapproved suppliers whose raw activities (which provides flexibility to
materials or other ingredients are (Comment 682) Some comments the facility to determine the appropriate
subject to adequate verification support the requirement to approve verification activities) did not disagree
activities before acceptance for use), but suppliers. Other comments ask us to with it. (See Comment 675.) The rule
we revised the provision to specify that provide guidance for use of unapproved also requires that certain factors must be
the receiving facility must do so by suppliers on a temporary basis, because considered in determining appropriate
establishing and following written the use of unapproved suppliers could verification activities (§ 117.410(d)). We
procedures, and require documentation be a high risk situation. Other comments discuss those factors, and comments
that these procedures were followed. To emphasize that if the final supplier that addressed those factors, in section
simplify the provisions, we also approval process is significantly XLIV.D. Both of these provisions (i.e.,
established a definition for the term changed compared to the proposed § 117.410(a)(2) and § 117.410(d)) derive
‘‘written procedures for receiving raw supplier approval process, industry from the proposed requirement
materials and other ingredients’’ to must have enough time to plan and regarding factors that must be
considered in determining appropriate must be determined in accordance with Comment 688, Comment 690, and
supplier verification activities the requirements of § 117.410(d). Comment 695) or ask us to clarify how
(proposed § 117.136(b)). To give XLVII. Subpart G: Comments on we will interpret the provision (see, e.g.,
prominence to both the responsibility Conducting Supplier Verification Comment 684 and Comment 685). In the
and the flexibility to determine Activities for Raw Materials and Other following sections, we discuss
appropriate supplier verification Ingredients comments that ask us to clarify the
activities, and emphasize the factors proposed requirements or that disagree
We proposed requirements applicable
that must be considered in addressing with, or suggest one or more changes to,
to conducting supplier verification
this responsibility, new § 117.425 activities (proposed § 117.136(c)). Most the proposed requirements. After
specifies that appropriate supplier comments that support the proposed considering these comments, we have
verification activities (including the provisions suggest alternative or revised the proposed requirements as
frequency of conducting the activity) additional regulatory text (see, e.g., shown in table 49.
TABLE 49—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR
RAW MATERIALS AND OTHER INGREDIENTS
117.430(a) ................... 117.136(c)(1) .............. Requirement to conduct one or more appro- Add reference to an additional provision that
priate supplier verification activities. provides for alternative supplier verification
activities for shell egg producers that have
less than 3,000 laying hens.
117.430(b)(1) ............... 117.136(c)(2)(i) ........... Requirement to conduct an onsite audit as N/A.
the supplier verification activity when the
hazard being controlled by the supplier is
one for which there is a reasonable prob-
ability that exposure to the hazard will re-
sult in serious adverse health con-
sequences or death to humans.
117.430(b)(2) ............... 117.136(c)(2)(ii) .......... Exception to the requirement to conduct an N/A.
annual onsite audit with a written deter-
mination.
117.430(c) ................... 117.136(c)(3) .............. Alternative supplier verification activity when • Modify the regulatory text to better align
the supplier is a qualified facility. with the responsibilities of a qualified facil-
ity to submit an attestation to FDA about its
food safety practices or its compliance with
State, local, county, tribal, or other applica-
ble non-Federal food safety law, including
relevant laws and regulations of foreign
countries.
• Clarify that the date for a receiving facility
to obtain written assurance that a supplier
is a qualified facility is before first approv-
ing the supplier for an applicable calendar
year, and on an annual basis thereafter, by
December 31 of each calendar year for the
following calendar year.
• Provide for written assurance that, when
applicable, the supplier is producing the
raw material or other ingredient in compli-
ance with relevant laws and regulations of
a country whose food safety system FDA
has officially recognized as comparable or
has determined to be equivalent to that of
the United States.
117.430(d) ................... 117.136(c)(3) .............. Alternative supplier verification activity when • Clarify that the applicable farms are ‘‘not
the supplier is a farm that is not a ‘‘covered covered farms’’ rather than ‘‘not subject to
farm’’ under part 112 in accordance with part 112’’ because some of these farms
§ 112.4(a) or in accordance with are subject to modified requirements in
§§ 112.4(b) and 112.5. § 112.6.
• Clarify that the date for a receiving facility
to obtain written assurance from the farm
about its status is before first approving the
supplier for an applicable calendar year,
and on an annual basis thereafter, by De-
cember 31 of each calendar year for the

following calendar year.
TABLE 49—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR
RAW MATERIALS AND OTHER INGREDIENTS—Continued
• Clarify that the written assurance from the

farm is an acknowledgement that its food is
subject to section 402 of the Federal Food,
Drug, and Cosmetic Act (or, when applica-
ble, that its food is subject to relevant laws
and regulations of a country whose food
safety system FDA has officially recognized
as comparable or has determined to be
equivalent to that of the United States).
117.430(e) ................... N/A ............................. Alternative supplier verification activity when Specify an additional situation where the re-
the supplier is a shell egg producer that ceiving facility can consider an alternative
has fewer than 3,000 laying hens. supplier verification activity.
A. Requirement To Conduct One or documents its determination that other involve third-party audits (78 FR 3646
More Supplier Verification Activities verification activities and/or less at 3818–3820); republished in its
(Final § 117.430(a)) frequent onsite auditing of the supplier entirety with corrected reference
provide adequate assurance that the numbers on March 20, 2013, 78 FR
With two exceptions, we proposed
hazards are controlled. (Proposed 17142 at 17149–17151). An online
that the receiving facility must conduct
§ 117.136(c)(2)). survey of retail suppliers noted that
and document one or more specified (Comment 683) Some comments
supplier verification activities for each such certification enhanced their ability
support the provision for audits when to produce safe food (Ref. 94). We agree
supplier before using the raw material there is a reasonable probability that
or ingredient and periodically thereafter that onsite audits can identify problems
exposure to the hazard will result in in ways that paperwork reviews cannot.
(proposed § 117.136(c)(1)). See section serious adverse health consequences or
XLIV.B for a discussion of comments Because an audit involves more than
death to humans. Some of these simply observing the facility producing
regarding the appropriate verification comments state that audits should be
activities (i.e., onsite audits, sampling a food product, we believe it is more
the default verification activity in order than just a ‘‘snapshot’’ of the supplier’s
and testing, records review, and other to eliminate facilities choosing the
appropriate supplier verification programs. As discussed in Response
lowest cost option regardless of whether 669, onsite audits can include
activities based on supplier performance it was best for food safety. Other
and the risk associated with the raw observations, records review and
comments state that audits would be the employee interviews.
material or other ingredient). See best option for facilities that cannot visit
sections XLVII.C and XLVII.D for a each supplier annually and that onsite The requirement to conduct an annual
discussion of the proposed exceptions inspection can identify problems in audit in specified circumstances is risk-
to this requirement to conduct and ways that paperwork reviews cannot. based because the specified
document verification activities. As However, other comments oppose this circumstances are limited to situations
discussed in section XLVII.E, the final requirement. Some of these comments where there is a reasonable probability
rule provides for an additional express concern that this requirement that exposure to the hazard in the raw
circumstance in which an alternative does not allow the necessary flexibility material or other ingredient will result
supplier verification activity may be for a facility to tailor an effective in serious adverse health consequences
conducted—i.e., when the supplier is a supplier program based upon risk. Other or death to humans. The food safety
shell egg producer that has fewer than comments state that annual audits are controls applied by suppliers of such
3,000 laying hens. neither the preferred nor the most raw materials or other ingredients are
effective verification measure and more important than for other types of
B. Requirement for an Onsite Audit as hazards because of the serious adverse
a Verification Activity When a Hazard express concern that the provision sets
a precedent that annual audits are the health consequences that can occur if
Has a Reasonable Probability of the hazards are not controlled. Annual
Resulting in Serious Adverse Health preferred or most effective verification
measure and that other verification audits are required of certification
Consequences or Death to Humans schemes that are benchmarked to the
(Final § 117.430(b)) activities often can help paint a more
accurate picture of a supplier over time. Global Food Safety Initiative Guidance
We proposed that when a hazard in a Other comments express concern that Document for GFSI recognition (Ref.
raw material or ingredient will be audits only give a ‘‘snapshot’’ of a 95). We disagree that this requirement
controlled by the supplier and is one for supplier’s performance at a given time does not provide flexibility in choosing
which there is a reasonable probability and ask that we not overemphasize verification activities; in recognition
that exposure to the hazard will result audits. that other verification activities can help
in serious adverse health consequences (Response 683) We are retaining this paint a more accurate picture of a
or death to humans, the receiving provision as proposed. As we indicated supplier over time, we have provided
facility must have documentation of an in the Appendix of our 2013 proposed for alternative verification activities or
onsite audit of the supplier before using preventive controls rule, an increasing audit frequencies if the receiving facility
the raw material or ingredient from the number of establishments are requiring, documents its determination that other
supplier and at least annually thereafter. as a condition of doing business, that verification activities and/or less
We also proposed that this requirement their suppliers become certified to food frequent onsite auditing of the supplier
does not apply if the receiving facility safety management schemes that provide adequate assurance that the
hazards are controlled (see requirement for an audit is ‘‘outside the identify, implement, certify or audit
§ 117.430(b)(2)). scope of FSMA.’’ Other comments state preventive controls.’’ As noted in that
(Comment 684) Some comments ask that manufacturing or processing response, a facility is not required to
us to define those products that may facilities should not require suppliers hire a third party to conduct an audit.
trigger the requirement for an audit, that are produce farms to conduct (Comment 687) Some comments
especially with respect to farms. These annual onsite audits in three specified support the flexibility to not conduct an
comments question how to assess circumstances: (1) If the farm is not annual onsite audit if the receiving
whether a hazard could result in serious subject to the produce safety standards facility documents its determination
adverse health consequences or death to (e.g., the produce is not eaten raw, or that other verification activities and/or
humans. the farm is not covered because total less frequent onsite auditing of the
(Response 684) We decline this annual sales exclude it, because these supplier provide adequate assurance
request. Any list of such products farms are so small as to pose minimal that the hazards are controlled. Other
would be extensive and it is unlikely we risk to the food supply and audits comments question how a facility
could capture all the circumstances in would be cost-prohibitive for them); (2) would prove that alternative measures
which this could apply. Hazards for if the farm is subject to the produce are equally effective as an annual audit,
which there is a reasonable probability safety standards (because these farms when it is not known how effective an
that exposure to the hazard will result are already regulated); and (3) if the annual audit is. Other comments assert
in serious adverse health consequences farm has been GAP certified (because that the provision is meaningless
or death to humans are those for which this would mean they were undergoing because a farm or facility would not take
a recall of a violative product posing duplicative requirements). the legal risk of verifying it has received
such a hazard is designated as ‘‘Class 1’’ (Response 686) When a supplier farm ‘‘adequate assurance,’’ because this
under 21 CFR 7.3(m)(1). Examples of is not subject to the produce safety would be subject to an FDA inspector’s
such hazards that, in some standards because of low sales revenue, interpretation.
circumstances, have resulted in serious we have provided for modified (Response 687) This provision
adverse health consequences or death to verification requirements (see requires a facility to use a verification
humans include pathogens or their § 117.430(d)). For produce not subject to activity that provides adequate
toxins in RTE foods and undeclared the produce safety standards because assurance that a hazard is controlled,
food allergens. Foods (other than dietary they are rarely consumed raw, we not to determine how effective an audit
supplements or infant formula) would not expect receiving facilities to is and assess whether alternative
containing a hazard for which there is identify hazards requiring a preventive measures are equally effective.
a reasonable probability that exposure to control that would be controlled before As an example of using an alternative
the hazard will result in serious adverse receipt of the raw material or ingredient; approach to an annual onsite audit,
health consequences or death to humans thus such produce would not be subject consider the situation in which a
or animals are considered reportable to the supply-chain program. receiving facility is part of a larger
foods; examples of foods FDA has We disagree that a farm should not be corporation, is making trail mix, and
considered to present a reasonable subject to the requirements of the obtains roasted peanuts from a supplier
probability of serious adverse health supply-chain program in this rule that is a subsidiary of the corporation
consequences or death can be found in simply because it is subject to the and is operating under the same food
our Guidance for Industry: Questions produce safety rule. The produce safety system as the receiving facility.
and Answers Regarding the Reportable subject to the produce safety rule may The receiving facility could determine
Food Registry as Established by the contain hazards that could result in that the food safety requirements
Food and Drug Administration serious adverse health consequences or established by the parent company and
Amendments Act of 2007 (Ref. 32) and death to humans; unless such produce applied at the subsidiary provide the
(Ref. 33). will receive a treatment that needed assurance that Salmonella in
(Comment 685) Some comments ask significantly minimizes these hazards, raw peanuts is adequately controlled.
us to clarify the role of third-party the controls for the hazards are those The facility could support its decision
audits and the GAP program and ask us applied by the farm. GAP certification by documenting this determination,
to allow GAPs to be a voluntary involves an audit of the farm; as noted including the procedures in effect at the
mechanism to satisfy buyer demands for in Response 685, GAPs audits that supplier and the activities used by the
food safety certification. comply with the requirements of this corporation to verify that the subsidiary
(Response 685) Although the rule rule may be viewed as an appropriate operates in accordance with corporate
would not require a receiving facility to verification activity, and the food safety policies and practices to
hire a third party to conduct an audit, certification audit could serve two ensure that hazards are adequately
onsite audits can include third-party purposes. controlled.
audits. There are likely to be benefits for We disagree that a requirement for an We disagree that the provision is
suppliers to have a third-party audit, audit is ‘‘outside the scope of FSMA.’’ meaningless because a farm or facility
because the same audit may be See the discussion in Response 669 would see a legal risk in using an
acceptable by multiple receiving regarding the provision in section alternative to annual onsite audits as a
facilities as an appropriate supplier 419(c)(1)(E) of the FD&C Act that the supplier verification activity. First, a
verification activity. For farms, GAPs regulation issuing standards for the farm would be a supplier and would not
audits may be viewed as an appropriate safety of produce ‘‘not require a be the entity that would determine
supplier verification activity. GAPs business to hire a consultant or other whether an onsite audit or some other
audits and other third-party audits third party to identify, implement, supplier verification activity is
would need to comply with the certify compliance with the procedures, appropriate. As established in § 117.415,
requirements of this rule applicable to processes and practices’’ and the determining the appropriate supplier
onsite audits (see § 117.435). provision in section 418(n)(3)(D) of the verification activity would be the
(Comment 686) Some comments FD&C Act that the preventive controls responsibility of a receiving facility, and
assert that we should delete this regulation ‘‘not require a facility to hire although appropriate supplier
provision entirely, stating that this a consultant or other third party to verification activities could be
determined by another entity in the but the approach and documentation in calendar year; and (2) by December 31
receiving facility’s supply chain as a that situation likely would be different of each calendar year (rather than ‘‘at
service, the supplier verification from an approach and documentation the end of the calendar year’’) and that
activities could not be determined by used when the supplier and the the written assurance is regarding the
the supplier itself. Second, although receiving facility are part of the same status of the qualified facility for the
there is always a potential for corporation. following calendar year. By specifying
differences in interpretation between an (Comment 690) Some comments ask ‘‘by December 31,’’ a receiving facility
FDA inspector and an inspected firm, that we not limit the determination for can work with each applicable supplier
we are establishing a new inspection a supplier verification activity other to determine the specific date within a
paradigm focused on whether firms are than an onsite audit to a determination calendar year for that supplier to
implementing systems that effectively by the receiving facility. These annually notify the receiving facility
prevent food contamination, requiring comments explain that the corporate about its status. See also Response 155,
fundamentally different approaches to parent of a facility can be the entity that Response 592, and Response 593, the
food safety inspection and compliance. makes this determination. These requirements in § 117.201(a) for an
For example, FDA intends to deploy comments suggest that we can account annual determination of the status of a
specialized investigators, backed up by for the role of the corporation by facility as a qualified facility, and the
technical experts, to assess the specifying that a facility documents ‘‘the requirements in § 117.201(d) that apply
soundness and performance of a determination’’ (rather than ‘‘its’’ when the status of a facility changes
facility’s food safety system (Ref. 12). In determination). from ‘‘qualified facility’’ to ‘‘not a
addition, a central element of FDA’s (Response 690) We have agreed that qualified facility.’’ A receiving facility
strategy to gain industry compliance is the corporate parent of a facility can be and its suppliers have flexibility to
to help make available to farmers, food active in developing and implementing approach the potential for the status of
processors, and importers—especially the facility’s food safety plan (see a facility to shift between ‘‘qualified
small businesses—the education and section XXIV.A). However, the specific facility’’ and ‘‘not a qualified facility’’
technical assistance they need to suggestion of these comments is not (or vice versa) in a way that works best
understand and implement FSMA’s new necessary to achieve the outcome for their specific business relationship.
prevention-oriented standards (Ref. 6). requested by the comments because of As discussed in section XLIV.D, we
The new inspection paradigm and the editorial changes we made to provide have revised the requirements for
assistance and training for industry for entities other than the receiving considering supplier performance to
should help minimize different facility to determine and conduct the provide that the receiving facility may,
interpretations between industry and appropriate supplier verification when applicable, consider relevant laws
regulators. activities. and regulations of a country whose food
(Comment 688) Some comments ask C. Alternative Verification Activity safety system FDA has officially
us to require facilities to notify us when When the Supplier Is a Qualified recognized as comparable or has
they determine that an alternative to an determined to be equivalent to that of
Facility (Final § 117.430(c))
audit is an appropriate supplier the United States, and information
verification activity and be able to We proposed that if a supplier is a relevant to the supplier’s compliance
justify and document how an alternative qualified facility the receiving facility with those laws and regulations, rather
verification activity provides the same need not comply with the specified than consider applicable FDA food
level of assurance as an onsite audit. verification requirements if the safety regulations and information
(Response 688) We decline this receiving facility: (1) Documents, at the relevant to the supplier’s compliance
request. We will assess a facility’s end of each calendar year, that the with applicable FDA food safety
supplier verification activities during a supplier is a qualified facility; and (2) regulations. We have made a
facility inspection, including the obtains written assurance, at least every conforming change to the alternative
documentation that an alternative 2 years, that the supplier is producing verification activities for a qualified
verification activity provides the same the raw material or ingredient in facility (see the regulatory text of
level of assurance as an onsite audit. compliance with applicable FDA food § 117.430(c)(2)).
(Comment 689) Some comments ask safety regulations and that the raw (Comment 691) Some comments
us to specify the type of documentation material or ingredient is not adulterated support this alternative supplier
required for our investigators to under section 402 of the FD&C Act or verification activity because it provides
determine when the activities are ‘‘in misbranded under section 403(w) of the flexibility. Other comments ask us to
compliance with the law and sufficient FD&C Act. The written assurance must revise the provision so that it only
to protect public health.’’ include a brief description of the requires that the supplier document its
(Response 689) We decline this processes and procedures that the status as a qualified facility. Still other
request. The facility’s approach to the supplier is following to ensure the comments ask us to remove all
determination, and the applicable safety of the food. provisions on qualified facilities
documentation required to support that This rule has several provisions that because they view these provisions as
determination, would depend on the require written assurances. We have effectively adding a second layer of
circumstances. For example, in established specific elements that each regulations on produce farms, and claim
Response 687 we discuss a possible of these written assurances must this is not authorized by FSMA. Other
approach in a situation in which a include—i.e., the effective date; printed comments ask us to delete the
receiving facility is part of a corporation names and signatures of authorized requirement that the written assurance
and obtains an ingredient from a officials; and the applicable assurance include a brief description of the
supplier that is a subsidiary of the (see § 117.335). processes and procedures that the
corporation and is operating under the We have revised the provision to supplier is following to ensure the
same food safety system as the receiving clarify that the receiving facility must safety of the food.
facility. Another situation could be have written assurance that a facility is (Response 691) We have revised the
when a receiving facility has many years a qualified facility: (1) Before first provisions for an alternative verification
of experience with the same supplier, approving the supplier for an applicable activity for a qualified facility to better
align with the responsibilities of a (Response 692) We decline these monetary value of the food sold to all
qualified facility to submit an attestation requests. A supplier verification activity other buyers). In the 2014 supplemental
to FDA about its food safety practices needs to consider supplier performance human preventive controls notice, we
(§ 117.201(b)(2)(i)) or its compliance on an ongoing basis. Procedures and erroneously referred to these farms as
with State, local, county, tribal, or other practices evolve over time, and it is farms ‘‘not subject to the requirements
applicable non-Federal food safety law, appropriate for a receiving facility that in part 112.’’ While produce farms that
including relevant laws and regulations is obtaining written assurance from a make less than $25,000 are not subject
of foreign countries (§ 117.201(b)(2)(ii)) supplier as an alternative verification to the requirements in part 112, produce
(see the regulatory text of § 117.430(c)). activity to be aware of both procedures farms that satisfy the requirements for a
Importantly, a qualified facility is still and practices that have changed, as well qualified exemption are not subject to
subject to CGMPs and the FD&C Act, as procedures and practices that have the full requirements of part 112, but
and if the qualified facility is a supplier stayed the same. The specified they do have certain modified
controlling a hazard it is reasonable for timeframe for updating the written requirements that they must meet, as
a receiving facility to expect the assurance—i.e., at least every two described in § 112.6. We have corrected
qualified facility to provide to the years—is reasonable. the description of these farms in
receiving facility an assurance that A supplier can only provide § 117.430(d).
reflects an attestation the facility has assurance about raw materials and other We have revised the provision to
made to FDA. As modified, one ingredients that it supplies to the clarify that the receiving facility must
possibility is for a qualified facility to receiving facility, not about the food have documentation that the raw
provide a receiving facility with a brief product that the receiving facility will material or other ingredient provided by
description of the preventive controls it produce using the supplier’s raw the supplier is not subject to part 112 in
is implementing to control the material or other ingredients. accordance with § 112.4(a), or in
applicable hazard, consistent with an accordance with §§ 112.4(b) and 112.5:
D. Alternative Verification Activity
attestation of its food safety practices in (1) Before first approving the supplier
When the Supplier Is a Produce Farm
accordance with § 117.201(a)(2)(i). For for an applicable calendar year; and (2)
That Is Not a ‘‘Covered Farm’’ for the
example, the qualified facility could by December 31 of each calendar year
Purposes of the Future Produce Safety
state that its manufacturing processes (rather than ‘‘at the end of the calendar
Rule (Final § 117.430(d))
include a lethality step for microbial year’’) and that the documentation is
pathogens of concern. As required by We proposed that if a supplier is a regarding the status of supplier for the
§ 117.201(f), a qualified facility that farm that is not subject to the following calendar year. By specifying
submits an attestation to FDA about its requirements that we have proposed to ‘‘by December 31,’’ a receiving facility
food safety practices would have be established in the produce safety rule can work with each applicable supplier
documentation of those practices to in accordance with proposed § 112.4 to determine the specific date within a
support its attestation to FDA and, thus, regarding the raw material or ingredient calendar year for that supplier to
would have documentation to support that the receiving facility receives from annually notify the receiving facility
its written assurance to the receiving the farm, the receiving facility does not about its status. See also the discussion
facility. Although a qualified facility need to comply with the verification in section XLVII.C regarding a similar
that submits an attestation to FDA about requirements if the receiving facility: (1) revision we made when the supplier is
its food safety practices also would have Documents, at the end of each calendar a qualified facility.
documentation of monitoring the year, that the raw material or ingredient (Comment 693) Some comments
performance of the preventive controls provided by the supplier is not subject support the proposed alternative
to ensure that such controls are effective to the produce safety rule; and (2) supplier verification activity. Other
as required by § 117.201(a)(2)(i), we are obtains written assurance, at least every comments support applying the
not requiring the qualified facility to 2 years, that the supplier is producing proposed alternative supplier
describe its monitoring of the the raw material or ingredient in verification activity more broadly—i.e.,
performance of preventive controls to compliance with applicable FDA food to any farm that will not be subject to
ensure that they are effective. safety regulations and that the raw part 112 (e.g., a farm that grows wheat),
Alternatively, a qualified facility could material or ingredient is not adulterated stating that both small and large non-
provide a receiving facility with a under section 402 of the FD&C Act. See produce farms should have the same
statement that the facility is in also § 117.335, which establishes option as farms that are exempted under
compliance with State, local, county, specific elements that this written § 112.4. Some comments ask us to revise
tribal, or other applicable non-Federal assurance must include—i.e., the the alternative verification requirements
food safety law, including relevant laws effective date; printed names and to apply to raw materials from farms
and regulations of foreign countries. signatures of authorized officials; and that do not grow and harvest ‘‘produce’’
We disagree that the alternative the applicable assurance. as we proposed to define it in § 112.3(c)
verification activity for produce farms Produce farms that are not ‘‘covered so that the alternative verification
would add a second layer of regulations farms’’ under § 112.4 of the forthcoming requirements would apply to grain.
on produce farms and are retaining this produce safety rule have less than Some comments assert that it is not
provision. See Response 693. $25,000 in annual sales averaged over possible to receive ‘‘written assurances’’
(Comment 692) Some comments ask the previous 3-year period, or satisfy the of compliance from growers of grain
us to remove the requirement that the requirements for a qualified exemption because there is no safety standard for
written assurance be obtained at least in § 112.5 and associated modified grain growers, and that any such
every 2 years. Other comments ask us to requirements in § 112.6 based on documents would be essentially
revise the purpose of the written average monetary value of all food sold meaningless.
assurance from ‘‘the raw material or (less than $500,000) and direct farm Some comments ask us to revise the
ingredient is not adulterated’’ to ‘‘the marketing (during the previous 3-year requirement to obtain written assurance
receiving facility’s use of the raw period, the average annual monetary so that it does not apply to ‘‘food not
material or ingredient will not cause the value of food sold directly to qualified subject to the requirements of part 112
finished food to be adulterated.’’ end users exceeded the average annual of this chapter pursuant to part 112.2.’’
Other comments assert that a (Comment 694) Some comments ask E. Alternative Verification Activity
documentation requirement for us to delete this alternative supplier When the Supplier Is a Shell Egg
commodities that will be exempt from verification activity because they see it Producer That Has Less Than 3,000
the produce safety rule would increase as a contradiction to the traceability Laying Hens (Final § 117.430(e))
recordkeeping burdens without added provisions of the Bioterrorism Act and We are establishing an additional
benefit because produce that will be FSMA, because ‘‘traceback’’ is only alternative supplier verification activity
exempt from the produce safety rule is required for ‘‘one step back’’ or for a when a supplier is a shell egg producer
low-risk. single supplier for a particular shipment that is not subject to the requirements of
Some comments assert that farms
of food. part 118 because it has less than 3,000
should not have to provide written
assurances because the requirement is (Response 694) The supply-chain laying hens. See the regulatory text of
ambiguous. These comments assert that program that is being established in this § 117.430(e). The provision is analogous
exempt farmers are small-scale rule is a preventive control for the to the alternative supplier verification
producers who are subject primarily to ongoing production of safe food, not a activity when a supplier is a farm that
state and local laws and this provision ‘‘traceback’’ provision, established meets the criteria in § 117.430(d) and
would require them to provide written would account for a very small amount
under the Bioterrorism Act, to help
assurances that they are complying with of eggs in the food supply. See also
address credible threats relating to food
unspecified Federal regulations. The § 117.335, which establishes specific
that is reasonably believed to be
comments claim that, without seeking elements that the required written
adulterated and to present a threat of assurance must include—i.e., the
legal counsel, many exempt farmers serious adverse health consequences or
would be unable to provide such effective date; printed names and
death to humans or animals. signatures of authorized officials; and
assurances, limiting the ability of these
farmers to market their products to non- (Comment 695) Some comments ask the applicable assurance.
exempt facilities (the overwhelming us to specify 3 options for verification
F. Independence of Persons Who
majority of the food market). if a supplier is a farm subject to the Conduct Supplier Verification Activities
(Response 693) We have revised the requirements of part 112: (1) (Final § 117.430(f))
provision to specify that the written Documentation at the end of each
assurance from the farm must state that calendar year that the raw material or In the 2014 supplemental preventive
the farm acknowledges that its food is ingredient provided by the supplier is controls notice, we requested comment
subject to section 402 of the FD&C Act subject to part 112; (2) written on whether we should include in the
(or, when applicable, that its food is assurance, at least every 2 years, that the final preventive controls rule
subject to relevant laws and regulations requirements to address conflicts of
supplier is producing the raw material
of a country whose food safety system interest for individuals conducting
or ingredient in compliance with
FDA has officially recognized as verification activities and, if so, the
applicable FDA food safety regulations scope of such requirements.
comparable or has determined to be and that the raw material or ingredient
equivalent to that of the United States). (Comment 696) Some comments ask
is not adulterated under the FD&C Act; that conflict of interest provisions not be
Any business that introduces food into or (3) evidence that the supplier is
interstate commerce is subject the written too broadly, and be limited to
certified to a recognized third-party circumstances where the individual
prohibited acts provisions in section
GAP/GHP/GMP/HACCP audit scheme. employee carrying out the verification
301 of the FD&C Act, and is accountable
if it produces food that is adulterated. (We note that we are assuming that activities has a direct personal financial
As discussed in Response 444, new ‘‘GHP’’ is an abbreviation for ‘‘Good interest in or financial ties to the
§ 117.136(a) allows a manufacturer/ Hygienic Practice.’’) supplier (e.g., owns a substantial
processor to not implement a preventive (Response 695) We decline this amount of stock in the supplier or is
control if it determines and documents request. Documenting that a raw personally paid directly by the
that the type of food (e.g., RACs such as material or other ingredient is subject to supplier). Comments state that it would
cocoa beans, coffee beans, and grains) the produce safety rule has no bearing not be uncommon for a receiving facility
could not be consumed without on whether the farm is complying with to have a shared financial interest in the
application of the appropriate control. that rule to control the hazards. With supplier (e.g., partial ownership of one
We believe most receiving facilities will by the other or both being owned by the
respect to all farms subject to the
take advantage of this provision, and not same parent company). Thus,
requirements of part 112 providing a
establish supply-chain controls under employees that have an indirect
written assurance, as discussed in
the supply-chain program in subpart G financial interest (e.g., owning stock in
Response 693, the amount of food a supplier because they own stock in
for a number of RACs.
This alternative supplier verification produced by the small farms that could their own company, which in turn owns
activity is intended to minimize the provide written assurance to a receiving an interest in the supplier) should not
burden on suppliers that are small facility is small, and the exposure to be disqualified from performing
farms. The amount of food produced by food from such farms therefore is low. verification activities. Comments also
such farms is small, and the exposure to We disagree that it is appropriate to indicate that a laboratory analyst
food from such farms therefore is low. extend this alternative supplier performing ingredient testing should not
We disagree that a written assurance verification activity to larger farms be precluded from testing ingredients
from such a farm would be meaningless. because such farms provide a larger from a supplier in which the analyst has
Any business that distributes food in volume of produce. a potential conflict of interest, as long as
interstate commerce is subject to the A farm that has been subject to an the analyst is not aware of the identity
FD&C Act, and must produce food that audit that complies with the of the supplier at the time the test is
is in compliance with the FD&C Act, requirements of this rule can provide performed.
regardless of whether FDA has the results of the audit. (Response 696) We are establishing a
established a specific regulation requirement that there must not be any
governing the production of the food. financial conflicts of interests that
influence the results of the verification food certifications, or sampling and XLVIII. Subpart G: Comments on
activities listed in § 117.410(b) and testing. Onsite Audit
payment must not be related to the (Response 697) We have specified that
results of the activity. This does not the requirements do not prohibit a We proposed requirements that would
prohibit employees of a supplier from receiving facility from relying on an apply to an onsite audit. Most
performing the functions specified in audit provided by its supplier when the comments that support the proposed
§ 117.415 in accordance with § 117.415. audit of the supplier was conducted by provisions suggest alternative or
For example, this provision would not a third-party qualified auditor (see additional regulatory text (see, e.g.,
prohibit an employee of a supplier from § 117.415(c)). We also have specified Comment 698, Comment 701, and
conducting sampling and testing so that that a supplier may conduct and Comment 702) or ask us to clarify how
the supplier could provide the results in document sampling and testing of raw we will interpret the provision (see, e.g.,
documentation provided to the materials and other ingredients, for the Comment 703 and Comment 704). In the
receiving facility. The provisions would hazard controlled by the supplier, as a following sections, we discuss
not prevent a person who is employed supplier verification activity for a comments that ask us to clarify the
by a receiving facility from having an particular lot of product and provide the proposed requirements or that disagree
indirect financial interest in a supplier documentation to the receiving facility
with, or suggest one or more changes to,
(e.g., if a company in which the (see § 117.415(a)(4)). This acknowledges
the proposed requirements. After
employee owns stock owns an interest that it is common for suppliers to
include Certificates of Analysis for tests considering these comments, we have
in the supplier).
(Comment 697) Comments ask that we conducted on specific lots of product revised the proposed requirements as
not preclude a supplier from hiring an along with the shipment to the receiving shown in table 50.
outside party to perform onsite audits, facility.
TABLE 50—REVISIONS TO THE PROPOSED REQUIREMENTS FOR ONSITE AUDITS

117.435(a) ............... 117.136(d)(1) ......... An onsite audit of a supplier N/A.

must be performed by a quali-
fied auditor.
117.435(b) ............... 117.136(d)(2) ......... An onsite audit must consider Clarify that, when applicable, an onsite audit may consider rel-
applicable FDA regulations. evant laws and regulations of a country whose food safety
system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States.
117.435(c)(1)(i) ....... 117.136(e)(1) ......... Substitution of inspection for do- Broaden the list of applicable inspections to include inspections
mestic suppliers. by representatives of other Federal agencies (such as the
United States Department of Agriculture), or by representa-
tives of State, local, tribal, or territorial agencies.
117.435(c)(1)(ii) and 117.136(e)(2) ......... Substitution of inspection for for- N/A.
117.435(c)(2). eign suppliers.
117.435(d) ............... N/A ......................... Use of a third-party auditor that If the onsite audit is solely conducted to meet the requirements
has been accredited in ac- of the human preventive controls rule by an audit agent of a
cordance with regulations that certification body that is accredited in accordance with regula-
will be established in the tions that will be established in part 1, subpart M, the audit is
forthcoming third-party certifi- not subject to the requirements in those regulations.
cation rule.
A. Requirements Applicable to an and § 117.190 lists implementation and regulations of a country whose food
Onsite Audit (Final § 117.435(a) and (b)) records). safety system FDA has officially
As discussed in section XLIV.D, we recognized as comparable or has
We proposed that an onsite audit of have revised the requirements for determined to be equivalent to that of
a supplier must be performed by a considering supplier performance to the United States.
qualified auditor. If the raw material or provide that the receiving facility may, (Comment 698) Comments support a
ingredient at the supplier is subject to when applicable, consider relevant laws requirement that an onsite audit be
one or more FDA food safety and regulations of a country whose food performed by a qualified auditor,
regulations, an onsite audit must safety system FDA has officially provided that we finalize provisions (in
consider such regulations and include a recognized as comparable or has proposed § 117.136(e)) whereby an
review of the supplier’s written plan determined to be equivalent to that of inspection by certain authorities could
(e.g., HACCP plan or other food safety the United States, and information substitute for an audit. Some comments
plan), if any, including its relevant to the supplier’s compliance ask us to specify that the rule permits
implementation, for the hazard being with those laws and regulations, rather the use of audits conducted by private
audited (proposed § 117.136(d)). We than consider applicable FDA food third-party food safety auditing firms.
have revised ‘‘including its safety regulations and information Other comments ask us to provide a list
implementation’’ to ‘‘and its relevant to the supplier’s compliance of recognized private third-party food
implementation’’ to emphasize that with applicable FDA food safety safety schemes and consider making
implementation of the plan is distinct regulations. We have made a third-party food safety certification to a
from the plan itself (e.g., § 117.126(c) conforming change to the requirements recognized audit scheme mandatory for
establishes the recordkeeping for an onsite audit to clarify that an all food operations that grow, pack,
requirement for the food safety ‘‘plan,’’ onsite audit may consider relevant laws hold, and manufacture/process food for
wholesale markets. Other comments ask qualified auditor is a qualified (Comment 701) Some comments ask
us to further specify that FDA will audit individual (as defined in § 117.3) and us to delete the proposed requirement
all food facilities no less than once has technical expertise obtained through for a review of the supplier’s written
every 5 years to verify that private third- education, training or experience (or a plan as part of an audit because review
party audits are consistent with FDA combination thereof) necessary to of the supplier’s food safety plan should
audits and findings. perform the auditing function. See be part of an overall supplier
(Response 698) See our discussion in Response 700, in which we discuss verification program when the supplier
section XLVIII.B of the final provisions auditor qualifications with respect to is controlling a hazard that could cause
governing substitution of inspection for the GFSI’s auditor competency model, serious adverse health consequences or
an audit. We agree that onsite audits noting that the provisions for auditor death, but should not be tied to an
may be conducted by third parties but competency for GFSI are consistent with audit. These comments state that
disagree that it is necessary to specify our definition of a qualified auditor. receiving facilities may choose to use an
this in the rule. Nothing in this rule GFSI schemes that consider FDA food unannounced audit program where the
prevents a facility from hiring a third safety regulations and include a review auditor spends time focusing on the
party to conduct audits. of the supplier’s written HACCP plan actual conditions on the production
We decline the requests to provide a (or other food safety plan), if any, and floor, with a review of the supplier’s
list of recognized private third-party its implementation, with respect to the food safety plan being done as a
food safety schemes or to make third- hazard being controlled are likely to separate verification activity.
party food safety certification to a satisfy the requirements for an onsite (Response 701) We decline this
recognized audit scheme mandatory for audit. We expect that audits being request. We agree that review of an
all food operations that grow, pack, conducted for other purposes will also applicable food safety plan should be
hold, and manufacture/process food for be used to satisfy supplier verification part of an overall supplier verification
wholesale markets. The rule provides audit requirements and such audits will program and that the review of the food
flexibility regarding use of third-party be adjusted as needed to conform to the safety plan may be conducted separately
auditors and the information is easily requirements of this rule. from the observation of actual
obtained from other sources. Likewise, (Comment 700) Some comments conditions on the production floor,
we decline the request to specify that assert that GFSI-benchmarked audits provided that both are conducted within
FDA will ‘‘audit’’ all food facilities no and other similarly accredited audits the annual timeframe. However, we
less than once every 5 years to verify should be considered equivalent to believe it important that the audit
that private third-party audits are onsite audits. address whether the food safety plan is
consistent with FDA audits and (Response 700) See our description of being implemented as designed, and
findings. We will inspect food facilities GFSI in Response 496. The GFSI other comments to this rule support that
for compliance with this rule, not to guidance document requires audit view. For example, as discussed in
verify the findings of a third-party audit, scheme owners to have a clearly defined Comment 648 regarding our inspection
with a frequency consistent with our and documented audit frequency of a food facility, some comments assert
responsibilities under the FD&C Act. program, which must ensure a that our access to company records must
(Comment 699) Some comments minimum audit frequency of one audit be conducted onsite in the course of an
express concern about the multiple per year of an organization’s facility authorized inspection so that we may
audits that facilities are subject to each (Ref. 83), and a GFSI-compliant food understand the full context of what the
year and ask us to encourage those safety scheme must include procedures records show. Thus, the onsite
subject to the rule to accept an audit for conducting internal audits (Ref. 95). observations and the food safety plan
performed by any of the ‘‘bona fide To be used to satisfy the requirements review cannot be entirely separated, as
authorities’’ where it is warranted. of this rule, a GFSI-benchmarked audit, the comment seems to suggest.
Other comments note that food as with any audit, must address all We note that the requirement to
manufacturers conduct their own audits requirements of this rule, including the include a review of the supplier’s food
and have developed extensive expertise requirement to consider applicable FDA safety plan only applies when the
in doing so, and oppose any supplier food safety regulations and include a supplier has a food safety plan. For
verification requirement that would review of the supplier’s written plan example, we did not propose a
affect those audits. Other comments ask (e.g., HACCP plan or other food safety requirement for a farm that would be
us to allow audits such as GFSI plan), if any. subject to the forthcoming produce
benchmark schemes to satisfy supplier As discussed in our memorandum on safety rule to have a food safety plan.
verification requirements to avoid supplier programs (Ref. 83), the GFSI
adding a new audit to audits currently guidance document also specifies that B. Substitution of Inspection by FDA or
being conducted. Some comments the person who performs the audit an Officially Recognized or Equivalent
express concern that requiring a new needs to be qualified to do so. As Food Safety Authority
audit in addition to audits already being described in ‘‘GFSI Food Safety Auditor We proposed that instead of an onsite
conducted could lead to auditor Competencies,’’ the GFSI’s auditor audit, a receiving facility may rely on
shortages and unnecessary additional competency model lists three main the results of an inspection of the
costs. components for auditor competencies: supplier by FDA or, for a foreign
(Response 699) We expect that a (1) Auditing skills and knowledge; (2) supplier, by FDA or the food safety
facility will adopt an approach to audits technical skills and knowledge; and (3) authority of a country whose food safety
that works best for the facility and behavior and systems thinking (Ref. 96). system FDA has officially recognized as
minimizes the number of audits Within each main component, GFSI comparable or has determined to be
conducted for the same facility. An provides details of specific tasks and the equivalent to that of the United States,
employee of a receiving facility may required auditor knowledge and skills to provided that the inspection was
perform an audit, provided that the perform the specific tasks (Ref. 96). The conducted within 1 year of the date that
employee satisfies the criteria provisions for auditor competency are the onsite audit would have been
established in the rule for qualified consistent with our definition of a required to be conducted. For
auditors. Under § 117.3 and § 117.180, a qualified auditor. inspections conducted by the food
safety authority of a country whose food requirements for an adequate written independence of third-party auditors/
safety system FDA has officially justification. certification bodies who conduct foreign
recognized as comparable or determined (Comment 703) Some comments ask food safety audits and to help ensure the
to be equivalent to that of the United us to clarify what we mean by ‘‘food reliability of food and facility
States, the food that is the subject of the safety authority of a country whose food certifications, issued by third-party
onsite audit must be within the scope of safety system FDA has officially auditors/certification bodies, that we
the official recognition or equivalence recognized as comparable or has will use in making certain decisions
determination, and the foreign supplier determined to be equivalent to that of relating to imported food, such as food
must be in, and under the regulatory the United States.’’ These comments certifications required by FDA as a
oversight of, such country (proposed also ask whether a specific country condition of granting admission to a
§ 117.136(e)). qualifies and whether HACCP food determined to pose a safety risk.
(Comment 702) Some comments ask certificates issued by a specific foreign (Comment 705) Comments support
us to allow State or local inspection government agency would replace an use of third-party auditors, but
reports, as well as FDA inspection onsite audit. emphasize that such auditors need not
reports, to substitute for an onsite audit (Response 703) A country whose food be accredited under the requirements to
for small and very small facilities. Other safety system FDA has officially be established under our forthcoming
comments ask us to create a ‘‘safe recognized as ‘‘comparable’’ to that of third-party certification rule.
harbor’’ provision in which a supplier the United States would be one for (Response 705) We agree that a third-
providing a copy of permits obtained which there is a signed systems party auditor who conducts an audit as
from the most recent inspection done by recognition arrangement or other a supplier verification activity to satisfy
Federal, State, or local health authorities agreement between FDA and the the requirements of this rule need not be
satisfies the supplier verification country establishing official recognition accredited under our forthcoming third-
requirement; if there are no permits, of the foreign food safety system. party certification rule. In addition, we
review of relevant records and/or Information on FDA systems recognition see no reason that any requirements of
can be found on the FDA Web site (Ref. our forthcoming third-party certification
sampling of raw material based on scale
97). As of March 2015, FDA only has a rule should apply to an audit merely
of production should be adequate.
signed systems recognition agreement because it was conducted by a person
(Response 702) We have revised the with New Zealand, but agreements with who had been accredited under that
regulatory text to provide for an other countries are under development. rule. To make this clear, we have added
appropriate inspection of the supplier We would not accept a HACCP a provision to specify that if an onsite
for compliance with applicable FDA certificate issued by a foreign audit is solely conducted to meet the
food safety regulations by FDA, by government as a substitute for an onsite requirements of this rule by an audit
representatives of other Federal agencies audit, but a receiving facility could agent of a certification body that is
(such as USDA), or by representatives of consider whether such a certificate accredited in accordance with
State, local, tribal, or territorial agencies. could be part of its justification for regulations in part 1, subpart M, the
We are specifying that the inspection conducting another supplier verification audit is not subject to the requirements
must be ‘‘appropriate’’ and be activity in lieu of an annual onsite in those regulations. See § 117.435(d).
conducted for compliance ‘‘with audit, or for conducting an audit on a Because § 117.435(d) refers to
applicable FDA regulations’’ to make less frequent basis than annually. provisions in a future third-party
clear that the inspection must be (Comment 704) Some comments ask certification rule, we will publish a
sufficiently relevant to an onsite audit to us to clarify that the applicable document in the Federal Register
credibly substitute for an onsite audit. standards will be those applied by the announcing the effective date of
For example, inspection by USDA to food safety authority of a country with § 117.435(d) once we finalize the third-
determine whether a farm satisfies the a food safety system recognized as party certification rule.
requirements of the produce safety rule comparable or equivalent rather than
could constitute an appropriate XLIX. Subpart G: Comments on
having to achieve compliance with the
inspection that could substitute for an Records Documenting the Supply-Chain
applicable U.S. FDA food safety
audit, but an inspection by USDA to Program
regulations.
determine whether a farm satisfies the (Response 704) The applicable We proposed to require
requirements of the National Organic standards will be those applied by the documentation of verification activities
Program could not. food safety authority of a country with in records, including minimum
We have not provided for substitution a food safety system recognized as requirements for records documenting
of a ‘‘permit obtained from the most comparable or equivalent to that of the an audit, records of sampling and
recent inspection’’ for an onsite audit. United States. testing, and records documenting a
We do not see how a ‘‘permit’’ could review by the receiving facility of the
shed light on whether a business is C. Onsite Audit by a Third-Party supplier’s relevant food safety records.
complying with specific applicable FDA Auditor Accredited for the Purposes of We also proposed that the receiving
regulations. We have provided for an Section 808 of the FD&C Act facility must review such records in
alternative verification activity to the We have proposed to establish accordance with the requirements
annual onsite audit (such as a review of regulations (in part 1, subpart M) to applicable to review of records as a
relevant records and/or sampling of raw provide for accreditation of third-party verification activity (i.e., in accordance
material) with a written justification auditors/certification bodies to conduct with § 117.165(a)(4)).
(see § 117.430(b)). The rule would not food safety audits of foreign food We did not receive comments on the
preclude an appropriate review of entities, including registered foreign documentation requirements associated
records, or sampling and testing of raw food facilities, and to issue food and with a written supplier program,
materials, by other Federal agencies, or facility certifications (78 FR 45782, July determination of appropriate supplier
by representatives of State, local, tribal, 29, 2013). The purpose of the proposed verification activities, review of records,
or territorial agencies, provided that the third-party certification rule is to help supplier verification activities other
receiving facility satisfies the us ensure the competence and than an annual onsite audit when the
hazard being controlled by the supplier and document that approval, before to the requirements established in part
is one for which there is a reasonable receiving raw materials and other 118 because it has less than 3,000 laying
probability that exposure to the hazard ingredients from those suppliers (see hens (§ 117.430(e)); (3) when applicable,
will result in serious adverse health § 117.420(a)). The second of these a receiving facility must verify a supply-
consequences or death to humans, requirements is that written procedures chain-applied control applied by an
alternative supplier verification activity for receiving raw materials and other entity other than the receiving facility’s
when the supplier is a qualified facility, ingredients must be established and supplier (§ 117.405(c); and (4) entities
substitution of inspection for an audit, followed (see § 117.420(b)(1)). We are other than the receiving facility may
or supplier nonconformance (proposed including in § 117.475 the determine, conduct, and document
§ 117.136(g)(1), (2), (7), (9), (10), (12), documentation associated with these certain specified supplier verification
and (13), respectively). We are finalizing requirements (see § 117.475(c)(3) and activities, provided that the receiving
these documentation requirements with (4)). facility reviews and assesses the other
editorial and conforming changes The supply-chain program includes entity’s applicable documentation, and
associated with the final requirements four provisions that were not in the
documents its review and assessment
of the supply-chain program. proposed human preventive controls
(§ 117.415). We are establishing the
The supply-chain program includes rule: (1) A receiving facility that is an
associated documentation requirements
two provisions that are explicit importer can comply with the foreign
requirements of the final human supplier verification requirements in the in § 117.475(c)(2), (14), (17), and (18),
preventive controls rule, but had been FSVP rule rather than conduct supplier respectively.
implicit requirements of the proposed verification activities for that raw In the following sections, we discuss
human preventive controls rule. The material or other ingredient under this comments on the proposed records for
first of these provisions is the explicit rule (§ 117.405(a)(2)); (2) a receiving the supplier program. After considering
requirement that the receiving facility facility may use an alternative these comments, we have revised the
must approve suppliers in accordance verification activity for a supplier that is proposed requirements as shown in
with the requirements of § 117.410(d), a shell egg producer that is not subject table 51.
TABLE 51—REVISIONS TO THE PROPOSED REQUIREMENTS FOR RECORDS FOR THE SUPPLY-CHAIN PROGRAM
Did we receive Did we revise the documentation re-
comments quirement other than editorial and
Final section Proposed section Description regarding the conforming changes associated with
designation designation proposed the final requirements for the supply-
requirement? chain program?
117.475(a) ............. N/A ......................... The records documenting the supply- N/A ..................... Consequential change associated with
chain program are subject to the re- establishing the requirements for a
quirements of subpart F. supplier in subpart G rather than
subpart C.
117.475(b) ............. 117.136(g) ............. The receiving facility must review the Yes ..................... No.
records in accordance with
§ 117.165(a)(4).
117.475(c)(1) ......... 117.136(g)(1) ......... The written supply-chain program ....... No ....................... N/A.
117.136(b)(2) ......... 117.136(g)(3) ......... Annual written assurance from a re- Yes ..................... Shifted to be in provisions outside the
ceiving facility’s customer. framework of the supply-chain pro-
gram in subpart G.
117.475(c)(2) ......... N/A ......................... Documentation obtained from an im- N/A ..................... N/A.
porter.
117.475(c)(3) ......... 117.136(g)(1) ......... Documentation of the approval of a No ....................... No.
supplier.
117.475(c)(4) ......... 117.136(g)(1) ......... Written procedures for receiving raw No ....................... No.
materials and other ingredients.
117.475(c)(5) ......... 117.136(g)(4) ......... Documentation demonstrating use of Yes ..................... Yes.
the written procedures for receiving
raw materials and other ingredients.
117.475(c)(6) ......... 117.136(g)(2) ......... Documentation of the determination of No ....................... No.
the appropriate supplier verification
activities for raw materials and other
ingredients.
117.475(c)(7) ......... 117.136(g)(5) ......... Documentation of the conduct of an Yes ..................... Added a requirement for the docu-
onsite audit. mentation to include the name of
the supplier subject to the onsite
audit.
117.475(c)(8) ......... 117.136(g)(6) ......... Documentation of sampling and test- Yes ..................... Specify that the documentation include
ing conducted as a supplier the date(s) on which the test(s)
verification activity. were conducted and the date of the
report.
117.475(c)(9) ......... 117.136(g)(7) ......... Documentation of the review of the No ....................... Specify that the documentation must
supplier’s relevant food safety include the general nature of the
records. records reviewed and conclusions of
the review.
TABLE 51—REVISIONS TO THE PROPOSED REQUIREMENTS FOR RECORDS FOR THE SUPPLY-CHAIN PROGRAM—Continued
Did we receive Did we revise the documentation re-
comments quirement other than editorial and
Final section Proposed section Description regarding the conforming changes associated with
designation designation proposed the final requirements for the supply-
requirement? chain program?
117.475(c)(10) ....... 117.136(g)(8) ......... Documentation of other appropriate Yes ..................... Specify that the other appropriate sup-
supplier verification activities. plier verification activities are based
on supplier performance and the
risk associated with the raw material
or other ingredient.
117.475(c)(11) ....... 117.136(g)(9) ......... Documentation of any determination No ....................... No.
that verification activities other than
an onsite audit, and/or less frequent
onsite auditing of a supplier, provide
adequate assurance that the haz-
ards are controlled when a hazard
in a raw material or other ingredient
will be controlled by the supplier
and is one for which there is a rea-
sonable probability that exposure to
the hazard will result in serious ad-
verse health consequences or death
to humans.
117.475(c)(12) ....... 117.136(g)(10) ....... Documentation of an alternative No ....................... Provide for documentation, when ap-
verification activity for a supplier that plicable, of a written assurance that
is a qualified facility. the supplier is producing the raw
material or other ingredient in com-
pliance with relevant laws and regu-
lations of a country whose food
safety system FDA has officially rec-
ognized as comparable or has de-
termined to be equivalent to that of
the United States.
117.475(c)(13) ....... 117.136(g)(11) ....... Documentation of an alternative Yes ..................... No.
verification activity for a supplier that
is a farm that supplies a raw mate-
rial or other ingredient that would
not be a covered farm subject to the
forthcoming produce safety rule.
117.475(c)(14) ....... N/A ......................... Documentation of an alternative N/A ..................... N/A.
verification activity for a supplier that
is a shell egg producer that is not
subject to the requirements estab-
lished in part 118 because it has
less than 3,000 laying hens.
117.475(c)(15) ....... 117.136(g)(12) ....... The written results of an appropriate No ....................... No.
inspection of the supplier for compli-
ance with applicable FDA food safe-
ty regulations by FDA, by represent-
atives of other Federal agencies
(such as USDA), or by representa-
tives from State, local, tribal, or terri-
torial agencies, or the food safety
authority of another country when
the results of such an inspection is
substituted for an onsite audit.
117.475(c)(16) ....... 117.136(g)(13) ....... Documentation of actions taken with No ....................... No.
respect to supplier non-conformance.
117.475(c)(17) ....... N/A ......................... Documentation of verification of a sup- N/A ..................... N/A.
ply-chain- applied control applied by
an entity other than the receiving fa-
cility’s supplier.
117.475(c)(18) ....... N/A ......................... When applicable, documentation of N/A ..................... N/A.
the receiving facility’s review and
assessment of documentation of a
supplier verification activity provided
by a supplier or by an entity other

than the receiving facility.
A. Applicability of the Recordkeeping supply-chain program’’ (see audit and documentation of corrective
Requirements of Subpart F § 117.475(c)). actions taken in response to significant
We have added new § 117.475(a) to deficiencies identified during the audit.
C. Documentation Demonstrating Use of
specify that the records documenting These comments explain that FDA’s
the Written Procedures for Receiving
the supply-chain program in subpart G access to such documentation during
Raw Materials and Other Ingredients
are subject to the requirements of inspection might discourage suppliers
(Final § 117.475(c)(5))
from allowing unannounced audits.
subpart F. Under the proposed human We proposed to require These comments ask us to delete these
preventive controls rule, the documentation demonstrating that proposed requirements. If the
documentation requirements would products are received only from requirement regarding documentation of
have been in subpart C, and the approved suppliers (proposed corrective actions remains in the final
applicability of subpart F was specified § 117.136(g)(4)). rule, these comments ask us to limit
in § 117.190 in subpart C. The new (Comment 708) Some comments such documentation to situations in
provision specifying the applicability of support the proposed requirement with which the identified deficiencies posed
subpart F to the records associated with no changes. Other comments ask us to a risk to public health.
the supply-chain program is a specify ‘‘raw materials and ingredients’’ (Response 710) We are retaining these
consequential change associated with rather than ‘‘products’’ in the regulatory documentation requirements as
establishing the requirements for a text. proposed. These comments appear to be
supply-chain program in subpart G, (Response 708) We have revised the suggesting that documentation
rather than in subpart C. regulatory text to specify ‘‘raw materials requirements be established based on
B. Requirement To Review Records of and other ingredients’’ with associated whether a business entity would want
the Supply-Chain Program (Final conforming changes. us to see information during inspection
§ 117.475(b)) D. Documentation of the Conduct of an rather than on the utility and value of
Onsite Audit (Final § 117.475(c)(7)) the documentation. We expect that
We proposed that a receiving facility receiving facilities, in general, maintain
must review records documenting the We proposed to require documentation of the conclusions of
supplier program in accordance with documentation of an onsite audit. This audits that they have conducted or
the requirements applicable to review of documentation must include: (1) arranged to have conducted. A receiving
records as a verification activity (i.e., in Documentation of audit procedures; (2) facility must approve all of its suppliers,
accordance with § 117.165(a)(4)). the dates the audit was conducted; (3) and documentation of corrective actions
(Proposed § 117.136(g)) the conclusions of the audit; (4) taken in response to significant
(Comment 706) Some comments ask corrective actions taken in response to deficiencies identified during an audit
us to provide consideration for records significant deficiencies identified has value to a receiving facility in
associated with the supplier program to during the audit; and (5) documentation determining whether to approve a
be administered and maintained at that the audit was conducted by a supplier before first receiving any raw
corporate headquarters rather than at qualified auditor. For clarity, we have materials or other ingredients and then
individual facilities, because this is revised the regulatory text to specify on an ongoing basis.
common industry practice. documentation of the ‘‘conduct’’ of an The rule does not require that onsite
(Response 706) We are aware that audit and added a requirement for the audits be unannounced, although we
certain programs are administered, and documentation to include the name of acknowledge that some receiving
records are maintained, at corporate the supplier subject to the onsite audit. facilities may see value in unannounced
headquarters rather than at individual (Comment 709) Some comments ask audits. We decline the request to require
facilities. The rule provides that offsite us to maintain the confidentiality of a receiving facility to maintain
storage of records is permitted if such audit reports and exempt such audit documentation of corrective actions
records can be retrieved and provided reports from disclosure under the FOIA. only if the identified deficiencies posed
onsite within 24 hours of request for (Response 709) These comments are a risk to public health. If, for example,
official review and electronic records similar to comments we received related a supplier’s facility has filthy conditions
are considered to be onsite if they are to disclosure of other records required or the raw materials and other
accessible from an onsite location (see by this part (See Comment 647 and ingredients it supplies are contaminated
§ 117.315(c)). We expect that the facility Comment 650). We would establish the with filth, a receiving facility may find
would be able to access information and status of supply-chain program records, it inappropriate to approve that
records relevant to the supply-chain such as audit reports, as available for, or supplier. Even though filth often does
program within 24 hours (e.g., protected from, public disclosure on a not pose a risk to public health, a food
electronically) when the records are case-by-case basis. As discussed in may be deemed to be adulterated under
maintained at corporate headquarters. Response 647, we primarily intend to section 402(a)(4) of the FD&C Act if it
As necessary and appropriate, we copy such records when we conduct an has been prepared, packed, or held
intend to work with facilities on a case- inspection for cause or if the under insanitary conditions whereby it
by-case basis to determine the best way preliminary assessment by our may have become contaminated with
to review records associated with the investigator during a routine inspection filth.
supply-chain program when the supply- is that regulatory follow-up may be
chain program is administered at the appropriate (e.g., if the report indicates E. Documentation of Sampling and
corporate level. that a significant food safety problem Testing (Final § 117.475(c)(8))
(Comment 707) Some comments ask was noted). See Response 650 for a We proposed to require records of
us to clarify in the regulatory text that discussion of situations in which sampling and testing. These records
the required records are ‘‘as appropriate records would, or would not, be must include: (1) Identification of the
to the supplier program.’’ protected from disclosure. raw material or ingredient tested
(Response 707) We have revised the (Comment 710) Some comments (including lot number, as appropriate)
regulatory text to specify that the express concern about maintaining and the number of samples tested; (2)
required records are ‘‘as applicable to its documentation of the conclusions of an identification of the test(s) conducted,
including the analytical method(s) used; F. Documentation of Other Appropriate part 112 in accordance with § 112.4(a),
(3) the date(s) on which the test(s) were Supplier Verification Activity (Final or in accordance with §§ 112.4(b) and
conducted; (4) the results of the testing; § 117.475(c)(10)) 112.5, before approving the supplier and
(5) corrective actions taken in response We proposed to require records of on an annual basis thereafter; and (2)
to detection of hazards; and (6) other appropriate verification activities the written assurance that the farm
information identifying the laboratory based on the risk associated with the acknowledges that its food is subject to
conducting the testing. ingredient. For clarity and consistency, section 402 of the FD&C Act (or, when
(Comment 711) Some comments ask we have revised the proposed applicable, that its food is subject to
us to not apply the requirement to relevant laws and regulations of a
requirement to specify ‘‘documentation’’
maintain records related to sampling country whose food safety system FDA
of the other appropriate supplier
and testing to the receipt of RACs has officially recognized as comparable
verification activity rather than
because sampling and testing of RACs is or has determined to be equivalent to
‘‘records’’ of the activity. As a
neither common nor effective for that of the United States).
conforming change associated with (Comment 715) Some comments ask
detecting biological or chemical using the term ‘‘supplier performance,’’
hazards, especially in raw, intact us to delete this documentation
rather than ‘‘risk of supplier,’’ when requirement because RACs except fruits
produce. discussing factors associated with
(Response 711) We decline this and vegetables should be exempt from
suppliers (see Response 673), the final supplier verification.
request. These comments appear to requirement specifies that the other
suggest that documentation (Response 715) See Response 693.
appropriate supplier verification This alternative supplier verification
requirements be established based on activities are based on the supplier
the frequency and utility of sampling activity is intended to minimize the
performance and the risk associated burden on suppliers that are small
and testing a particular commodity with the raw material or other farms.
rather than on a determination by a ingredient. (Comment 716) Some comments ask
receiving facility that sampling and (Comment 714) Some comments ask us to include a cross-reference to the
testing is an appropriate supplier us to also specify that an ‘‘other’’ applicable requirement.
verification activity for a particular appropriate supplier verification (Response 716) We have not added
supplier. We disagree with such a activity be based on the risk associated this cross-reference. We agree that
suggestion. A receiving facility that has with raw materials and suppliers. adding the cross-reference has the
determined that sampling and testing is (Response 714) We have revised the potential to be helpful, but it also has
an appropriate supplier verification regulatory text to specify the potential to clutter the regulatory
activity needs to maintain records of ‘‘Documentation of other appropriate text. We considered it would be more
those results as it would for any other supplier verification activities based on useful to specify what the
supplier verification activity. To the the supplier performance and the risk documentation needs to be rather than
extent that these comments are associated with the raw material or to specify the cross-reference to the
concerned that the supply-chain other ingredient.’’ The revised applicable alternative supplier
program requires sampling and testing regulatory text of the documentation verification activity.
of RACs, we emphasize that this is not tracks the regulatory text of this ‘‘other’’
the case. See also Response 525 for a appropriate supplier verification L. Holding Human Food By-Products
discussion of the usefulness of sampling activity (see § 117.410(b)(4)). As Intended for Use in Animal Food
and testing as a verification measure for discussed in Response 673, ‘‘supplier In the 2014 supplemental animal
RACs. performance’’ is more appropriate than preventive controls notice, we discussed
(Comment 712) Some comments ask ‘‘risk associated with the supplier.’’ proposed revisions to the human food
us to allow documentation of testing to CGMPs to address comments about the
include the date the test results were G. Documentation of an Alternative
practice of human food manufacturers
reported as an alternative to the date(s) Verification Activity for a Supplier That
sending by-products to local farmers or
on which the test(s) were conducted. Is a Farm That Is Not a ‘‘Covered Farm’’
animal food manufacturers for use as
(Response 712) We have revised the for the Purposes of the Future Produce
animal food (79 FR 58524 at 58558). We
provision to require ‘‘The date(s) on Safety Rule (Final § 117.475(c)(13))
explained that we were proposing these
which the test(s) were conducted and We proposed to require revisions as part of the rulemaking for
the date of the report.’’ We agree that the documentation of an alternative the animal preventive controls rule. (See
date on which the test results are verification activity for a supplier that is the discussion of these proposed
reported can be important, but it should a farm that is not a ‘‘covered farm’’ for revisions in the animal preventive
not be a replacement for the date of the the purposes of the future produce controls rule.) Because we proposed
test. safety rule, including: (1) The these revisions as part of the rulemaking
(Comment 713) Some comments ask documentation that the raw material or for the animal preventive controls rule,
us to add ‘‘if necessary’’ to the end of ingredient provided by the supplier is we also are finalizing these provisions
the proposed requirement for not subject to the produce safety rule; as part of that rulemaking. See the final
documentation of corrective actions and (2) the written assurance that the animal preventive controls rule,
taken in response to detection of supplier is producing the raw material published elsewhere in this issue of the
hazards. or ingredient in compliance with Federal Register, for our response to
(Response 713) We decline this applicable FDA food safety regulations comments on these proposed revisions
request. The documentation is always and that the raw material or ingredient to the human food CGMPs. The final
necessary if corrective actions are taken. is not adulterated under section 402 of provisions, being established in § 117.95
The provision is about maintaining the FD&C Act. We have revised the (Holding and distribution of human
documentation when corrective actions documentation to reflect the final food by-products for use as animal
are taken, not about the fact that requirements of § 117.430(d)—i.e., to food), require that:
corrective actions may not always be require: (1) Written assurance that the (1) Human food by-products held for
needed. supplier is not a covered farm under distribution as animal food without
additional manufacturing or processing in implementation for small businesses small businesses are less burdensome
by the human food processor, as in those countries. For technical and are described in § 117.201 of this
identified in § 507.12, must be held assistance, the comments request regulation.
under conditions that will protect training and other forms of assistance to In addition to the 1 to 3 year time
against contamination, including the help producers understand and periods for compliance for all firms, and
following: implement the regulation. modified requirements for very small
• Containers and equipment used to (Response 717) The concept of special businesses, we intend to work with the
convey or hold human food by-products and differential treatment is food industry, education organizations,
for use as animal food before incorporated in the WTO Agreements. USDA, the United States Agency for
distribution must be designed, Article 10.2 of the WTO SPS Agreement International Development, and foreign
constructed of appropriate material, states: ‘‘Where the appropriate level of governments to develop tools and
cleaned as necessary, and maintained to sanitary or phytosanitary protection training programs to facilitate
protect against the contamination of allows scope for the phased implementation of this rule.
human food by-products for use as introduction . . . longer time-frames for (Comment 718) Some comments
animal food; compliance should be accorded on assert that the food safety systems of the
• Human food by-products for use as products of interest to developing European Union and other countries
animal food held for distribution must country Members so as to maintain afford a similar level of food safety
be held in a way to protect against opportunities for their exports.’’ protection and must therefore be
contamination from sources such as In 2001, at the WTO Ministerial recognized by FDA as equivalent under
trash; and Conference in Doha, WTO Members the WTO SPS Agreement. These
• During holding, human food by- issued a Ministerial Decision that comments urge FDA to accept the
products for use as animal food must be interpreted the special and differential HACCP plans and other steps taken to
accurately identified. obligations of the SPS Agreement (Ref. comply with European food safety laws
(2) Labeling that identifies the by- 98). The Ministerial Decision defined as being sufficient to comply with this
product by the common or usual name ‘‘longer time-frame for compliance’’ to rule.
must be affixed to or accompany human normally mean a period of not less than (Response 718) The concept of
food by-products for use as animal food 6 months. ‘‘equivalence’’ for food safety regulatory
when distributed. We recognize that businesses of all measures is contained in Article 4 of the
(3) Shipping containers (e.g., totes, sizes may need more time to comply World Trade Organization Agreement
drums, and tubs) and bulk vehicles used with the new requirements established on the Application of Sanitary and
to distribute human food by-products under this rule. As discussed in section Phytosanitary Measures (the ‘‘SPS
for use as animal food must be LVI.A, the first compliance date for Agreement’’) (Ref. 99). That article
examined prior to use to protect against businesses other than small and very provides that WTO Member countries
contamination of the human food by- small businesses will be one year after ‘‘shall accept the sanitary or
products for use as animal food from the this final rule is published in the phytosanitary measures of other
container or vehicle when the facility is Federal Register. Recognizing that Members as equivalent, even if these
responsible for transporting the human smaller businesses may need more time measures differ from their own or from
food by-products for use as animal food to comply with the requirements, FDA those used by other Members trading in
itself or arranges with a third party to is allowing two years for small the same product, if the exporting
transport the human food by-products businesses and three years for very Member objectively demonstrates to the
for use as animal food. small businesses to comply. We importing Member that its measures
anticipate that these extended achieve the importing Member’s
LI. Comments by Foreign Governments implementation periods for small appropriate level of sanitary or
and Foreign Businesses businesses and very small businesses phytosanitary protection.’’ This
We received several comments from will apply to a number of businesses in provision of the SPS Agreement
foreign governments and foreign developing countries. Because all of envisions a process in which the
businesses covering a wide range of these time periods are longer than the 6 exporting country provides evidence to
issues. Many of those comments were month minimum defined in the WTO the food safety regulator in the
similar to comments made on certain Ministerial Decision, we believe these importing country in order to
topics by domestic stakeholders, so we implementation periods are sufficient to ‘‘objectively demonstrate’’ that the food
are addressing those comments in other address the needs of businesses in safety system in the exporting country
sections throughout this preamble. In developing countries, particularly for meets the level of food safety protection
this section, we are responding to small and very small businesses in such established by the importing country.
comments that are primarily focused on countries. To date, FDA has considered
international issues, such as the In addition to the extended time equivalence as most appropriately
obligations of the United States under periods for compliance for small and applied to the assessment of a foreign
the World Trade Organization very small businesses, we have also government’s specific programs for
Agreement (WTO). established modified requirements for specific types of foods, such as shellfish
(Comment 717) Some comments by very small businesses, which we define and dairy products. In that context, the
foreign government representatives ask as a business (including any equivalence assessment provides a very
us to provide ‘‘special and differential subsidiaries and affiliates) averaging detailed comparison of each measure
treatment’’ along with technical less than $1,000,000, adjusted for that a country applies in controlling
assistance to help exporters from inflation, per year, during the 3-year risks associated with the particular
developing countries meet the period preceding the applicable commodity under review. FDA
requirements of the rule. For special and calendar year in sales of human food continues to have latitude to engage in
differential treatment, the comments plus the market value of human food equivalence determinations for market
propose extended periods of time for the manufactured, processed, packed, or access and as required by our
implementation of the rule by producers held without sale (e.g., held for a fee). regulations for certain commodities. For
in developing countries, and flexibility These modified requirements for very example, FDA has active equivalence
deliberations underway on Grade ‘‘A’’ recognition’’ to explore ways to leverage determined to be equivalent to that of
dairy and will continue to engage in the work of food safety authorities in the United States (see
equivalence activities as needed. countries that have food safety systems §§ 117.410(d)(1)(iii)(B); 117.430(c)(2),
In contrast to the assessment of that are comparable to that of FDA. (d)(2), and (e)(2); and 117.435(b) and
equivalence for the regulation of Systems recognition assessment (c)(1)(ii).
specific foods based upon a detailed provides a tool for identifying countries We also note that we intend to
review of an individual food safety where FDA can establish closer publish a final FSVP rule in the near
measure or group of measures applied to regulatory partnerships, including future. There, we intend to establish
a specific food, FDA has established a leveraging the work conducted by FDA modified requirements for food
process of assessing foreign food safety and foreign food safety authorities. imported from a foreign supplier in, and
systems to identify systems that offer a under the regulatory oversight of, a
comparable level of public health We agree that the systems recognition
program can allow FDA to take into country whose food safety system FDA
protection as the U.S. food safety system has officially recognized as
for FDA regulated foods. We refer to that account the effectiveness of a foreign
food safety regulatory system as we ‘‘comparable’’ to that of the United
process as ‘‘systems recognition,’’ which States.
we discuss in Response 719. develop a compliance framework for
(Comment 719) Some comments urge imported foods from a country for Section 117.405(a)(2) of this rule
FDA to include a provision in this rule which we have made an affirmative provides the option for a receiving
that would reflect a determination made determination of comparability via the facility that is an importer to comply
by FDA in the ‘‘systems recognition’’ systems recognition program. While we with the supplier verification
process so that FDA’s compliance decline to add an exemption for food requirements in this rule or with the
framework, including audit and imported from a country with foreign supplier verification program
inspection activities, take into account affirmative systems recognition requirements that we will establish in
the effectiveness of the regulatory or determination by FDA, we note that the part 1, subpart L for a raw material or
administrative control of food safety systems recognition program is based other ingredient. We intend that the
systems. These comments ask us to upon the concept that foreign food final FSVP rule will contain a similar
include a provision in this rule producers can meet U.S. food safety provision (derived from proposed
establishing that an affirmative systems requirements by providing assurances § 1.502), so that only one supplier
recognition determination by FDA for that these foods are produced according verification procedure needs to be
an exporting country would be a to the food safety standards of a country undertaken in order to comply with
sufficient basis to exempt exporting that FDA has found to be comparable or both rules when the specified
producers from that country from their equivalent to that of the United States. conditions are met.
obligation to comply with the Therefore, foreign producers of foods LII. Editorial and Conforming Changes
requirements of this rule. Another that are subject to a systems recognition
comment urges FDA to utilize the agreement can show that their products The revised regulatory text includes
systems recognition process to recognize are meeting FDA’s requirements for several changes that we have made to
the effectiveness of the EU system in imported foods by virtue of the fact that make the requirements more clear and
order to avoid unnecessary or they are meeting their domestic food improve readability. The revised
duplicative requirements and controls safety standards. Several provisions of regulatory text also includes several
on food imports from the European the supply-chain program specifically conforming changes that we have made
Union. provide for consideration of relevant when a change to one provision affects
(Response 719) We agree, in part, with laws and regulations of a country whose other provisions. We summarize the
this comment. Since 2010, FDA has food safety system FDA has officially principal editorial and conforming
been developing a program of ‘‘systems recognized as comparable or has changes in table 52.
TABLE 52—PRINCIPAL EDITORIAL AND CONFORMING CHANGES

Designation in the revised Revision Explanation
regulatory text (§ )
• 1.227 ............................................ Alphabetize the examples of har- Make it easier to compare the examples of harvesting activities to the
• 1.328 vesting activities in the definition examples of manufacturing/processing activities in the definition of
• 117.3 of ‘‘harvesting’’. ‘‘manufacturing/processing.’’
• 1.227 ............................................ Alphabetize the examples of man- Make it easier to compare the examples of manufacturing/processing
• 1.328 ufacturing/processing activities activities to the examples of harvesting activities in the definition of
• 117.3 in the definition of ‘‘manufac- ‘‘harvesting.’’
turing/processing’’.
• 11.1(i) .......................................... Specify that part 11 does not Conforming change associated with the recordkeeping requirements
apply to records required to be in § 117.305, which provide that part 11 does not apply to records
established or maintained under required to be established or maintained under part 117.
part 117, and that records that
satisfy the requirements of part
117, but that also are required
under other applicable statutory
provisions or regulations, remain

subject to part 11.
Throughout part 117 ....................... • Substitute the term ‘‘adequate’’ Conforming change associated with our proposal, in the 2014 supple-
for the term ‘‘sufficient’’. mental human preventive controls notice, to make this substitution
• Substitute the term ‘‘inadequate’’ so that the rule consistently uses the term ‘‘adequate.’’
for the term ‘‘insufficient’’.
TABLE 52—PRINCIPAL EDITORIAL AND CONFORMING CHANGES—Continued

Throughout part 117 ....................... Substitute the term ‘‘pathogen’’ for Conforming change associated with the definition of ‘‘pathogen.’’
the term ‘‘microorganism of pub-
lic health significance’’.
Throughout part 117 ....................... Substitute the term ‘‘allergen Conforming change associated with the definition of ‘‘allergen cross-
cross-contact’’ for the term contact.’’
‘‘cross-contact’’.
Throughout part 117 ....................... Substitute the term ‘‘preventive Conforming change associated with adding the term ‘‘preventive con-
controls qualified individual’’ for trols qualified individual.’’
the term ‘‘qualified individual’’.
Throughout part 117 ....................... Substitute the term ‘‘unexposed Conforming change associated with the definition of ‘‘unexposed
packaged food’’ for the phrase packaged food.’’
‘‘packaged food that is not ex-
posed to the environment’’.
Throughout part 117 ....................... Substitute the phrase ‘‘chemical Conforming change associated with the definition of ‘‘hazard.’’
(including radiological) hazards’’
for phrases such as ‘‘chemical
and radiological hazards’’.
Throughout part 117 ....................... Substitute the term ‘‘hazard requir- Conforming change associated with the proposed definition of ‘‘sig-
ing a preventive control’’ for the nificant hazard’’ (which we now refer to as ‘‘hazard requiring a pre-
term ‘‘significant hazard’’. ventive control.’’)
Throughout part 117 ....................... Shorten ‘‘raw agricultural com- Conforming change associated with the new definition of ‘‘raw agri-
modity as defined in section cultural commodity.’’
201(r) of the Federal Food,
Drug, and Cosmetic Act’’ to
‘‘raw agricultural commodity’’.
117.1(a) ........................................... Redesignate subparagraphs to Improve clarity.
distinguish between applying the
provisions in determining wheth-
er food is adulterated and apply-
ing the provisions in determining
whether there is a violation of
the PHS Act.
117.3 ............................................... Substitute ‘‘apply’’ for ‘‘are applica- Improve clarity.
ble’’ in the introductory para-
graph.
117.3 ............................................... Editorial changes to verb tense in Improve clarity.
the definition of ‘‘ready-to-eat
food’’.
117.3 ............................................... Specify that the definition of ‘‘very Give prominence to this aspect of the definition of ‘‘very small busi-
small business’’ includes any ness.’’ The relevance of subsidiaries and affiliates to the definition
subsidiaries and affiliates of the of ‘‘very small business’’ is established in the definition of ‘‘qualified
business. facility,’’ but including it again in the definition of ‘‘very small busi-
ness’’ will help to ensure that it is considered when determining
whether the business is within the dollar threshold established in
the definition of ‘‘very small business.’’
117.3, 117.5, 117.7(a), Substitute ‘‘subparts C and G’’ for Conforming change associated with the redesignation of the require-
117.257(d)(1). ‘‘subpart C’’. ments for a supply-chain program in new subpart G.
117.5(e) ........................................... Substitute ‘‘packaging’’ for ‘‘pack- Correction to use the same term as is used in part 111 for CGMPs
ing’’. for dietary supplements.
117.5(i) ............................................ Substitute ‘‘Subparts C and G of Improve clarity.
this part do not apply with re-
spect to food that is not an alco-
holic beverage’’ for ‘‘Subparts C
and G of this part do not apply
with respect to food other than
an alcoholic beverage’’ (empha-
sis added).
117.5(k)(2) ....................................... Specify that the provision applies Clarification. The provision only applies to those produce RACs that
to those RACs that are produce will have applicable requirements in the produce safety rule.
as will be defined in the final
produce safety rule.
• 117.10(b), (b)(1), and (b)(9) ........ Editorial changes to clearly distin- Improve clarity.
• 117.20(b)(2) and (b)(6) ................ guish requirements directed to
• 117.35(a), (d), (d)(2), (d)(3), (e), allergen cross-contact from re-
and (f). quirements directed to contami-

nation.
• 117.40(a)(6) and (b)
• 117.80(a)(4) and (a)(6)
• 117.80(b)(1), (b)(5), and (b)(7)
• 117.80(c)(6), (c)(7), (c)(10), and
(c)(12)

• 117.93
• 117.10 .......................................... Conforming changes associated The definition of ‘‘plant’’ focuses on the building, structure, or parts
with the definition of ‘‘plant’’. thereof, used for or in connection with the manufacturing, proc-
essing, packing, or holding of human food. The term ‘‘establish-
ment’’ focuses on a business entity rather than on buildings or
other structures.
• 117.20(a)
• 117.37(d)
• 117.305(f)
117.35(b) ......................................... Refer to ‘‘letter of guarantee’’ rath- This long-standing CGMP provision is not limited to documents from
er than ‘‘supplier’s guarantee’’. a ‘‘supplier’’ as that term is defined in this rule.
117.37(d) ......................................... Refer to ‘‘employees’’ rather than Editorial change.
‘‘its employees’’.
• 117.80(b)(1) through (8) .............. Changes to consistently refer to Return to long-standing terminology in the CGMPs previously estab-
• 117.80(c)(7) and (c)(9) raw materials and ‘‘other ingre- lished in part 110.
dients’’.
117.80(c)(7) ..................................... Refer to ‘‘other food’’ rather than Raw materials and other ingredients, work-in-process, and rework are
‘‘food’’ in the phrase ‘‘raw mate- all types of food.
rials and other ingredients,
work-in-process, rework, or
food’’.
117.126(b)(3), 117.135(c)(4), Refer to ‘‘supply-chain program’’ Conforming change associated with the title of final subpart G (pro-
117.140(b), 117.160(c)(4), rather than ‘‘supplier program’’. posed § 117.136).
117.190(a)(5).
• 117.160(b)(2) ............................... Conforming changes associated Improve clarity; consistency with the requirements for validation.
• 117.170(b)(4) with the definition of ‘‘validation’’.
117.165(a)(4)(ii) ............................... Refer to ‘‘supply-chain verification Consequential change as a result of the requirement in § 117.405(c)
activities,’’ as well as ‘‘supplier for verification of an entity that is in the supply-chain but is not a
verification activities’’. supplier.
117.165(b)(1) ................................... Changes to require written proce- Conforming change associated with the requirements to calibrate
dures for method and frequency process monitoring instruments and verification instruments (or
of accuracy checks for process check them for accuracy).
monitoring instruments and
verification instruments.
117.170(c)(2) ................................... Conforming changes associated Consistency with the requirements for validating preventive controls.
with the timeframe for validating
preventive controls.
117.170(d) ....................................... Editorial changes to the require- Improve clarity.
ment to revise the written food
safety plan or document why re-
visions are not needed.
117.180(a)(3) ................................... Change to specify the role of the Conforming change associated with flexibility to determine the time-
preventive controls qualified in- frame for validation of a preventive control.
dividual in determining an alter-
native timeframe for validation.
117.180(a)(4) ................................... Change to specify the role of the Conforming change associated with flexibility to determine that vali-
preventive controls qualified in- dation of a preventive control is not required.
dividual in determining that vali-
dation is not required.
preventive controls qualified in- frame for review of records of monitoring and corrective actions.
native timeframe for review of
records of monitoring and cor-
rective actions.
preventive controls qualified in- frame for completing reanalysis.
native timeframe for completing
reanalysis.
117.80(b)(3) ..................................... Delete ‘‘current’’ from ‘‘current ‘‘Current’’ is unnecessary.
FDA regulations’’.

117.201(a)(2)(ii) ............................... Editorial change to place the Improve clarity.

clause ‘‘including through li-
censes, inspection reports, cer-
tificates, permits, credentials,
certification by an appropriate
agency (such as a State depart-
ment of agriculture), or other
evidence of oversight’’ at the
end of the provision, rather than
in a parenthetical at the begin-
ning of the provision.
117.206(a)(2) ................................... Editorial change to specify ‘‘pro- Improve clarity.
vide assurance that the tem-
perature controls are consist-
ently performed’’ rather than
‘‘provide assurance that they are
consistently performed’’.
• 117.206(a)(4)(ii) ........................... Substitute the phrase ‘‘records are Consistency with other recordkeeping requirements of the rule.
• 117.206(a)(4)(iii) created’’ for the phrase ‘‘records
are made’’.
117.206(a)(4)(iii) .............................. Change ‘‘within a week’’ to ‘‘within Conforming change associated with review of records of monitoring
7 working days’’. and corrective action records.
Subpart E (title) ............................... Substitute the term ‘‘qualified facil- Conforming change associated with the definition of ‘‘qualified facility
• 117.251 ity exemption’’ for the phrase exemption.’’
• 117.254 ‘‘exemption applicable to a
• 117.257 qualified facility’’ or the phrase
• 117.260 ‘‘exemption applicable to a
• 117.264 qualified facility under
• 117.280 § 117.5(a)’’.
• 117.251
117.251(b)(1) ................................... Change ‘‘import alert’’ to ‘‘refusal Align with statutory language regarding imports rather than with spe-
of food offered for import’’. cific procedures that FDA uses for refusing admission to foods of-
fered for import.
117.254(a) ....................................... Change ‘‘FDA official senior to The provision refers to two ‘‘Directors’’ and the clause applies to ei-
such Director’’ to ‘‘FDA official ther Director.
senior to either such Director’’.
117.257(c)(2) ................................... Refer to ‘‘conditions or conduct’’ Consistency with regulatory text in § 117.251(a)(2).
rather than ‘‘conduct or condi-
tions’’.
• 117.260(a)(2) ............................... Change ‘‘within 10 calendar days’’ Conforming change to reflect a timeframe of 15 calendar days, rather
• 117.264(a)(1) to ‘‘within 15 calendar days’’. than 10 calendar days, in the order withdrawing a qualified facility
• 117.267(a)(2) exemption.
• 117.270(a)
• 117.287(a) ................................... Specify ‘‘any problems with the Clarify that reinstatement of a qualified exemption that was withdrawn
• 117.287(b)(2) conditions and conduct’’ rather requires resolution of any problems, regardless of whether the
than ‘‘problems with the condi- problems related to conditions, conduct, or both conditions and
tions and conduct’’ or ‘‘problems conduct.
with the conditions or conduct’’.
117.305 ........................................... Refer to ‘‘lot code’’ rather than Consistency with the definition of ‘‘lot.’’
‘‘production code’’.
117.310 ........................................... Editorial changes to present the Improve clarity.
requirement in active voice.
LIII. Comments on FSMA’s Rulemaking consider to be an appropriate balance comments ask us to retain this
Provisions between acknowledging differences in flexibility in the final rule by describing
risk and minimizing the number of the required and expected results of the
A. Comments on Requirements in
separate standards applied to separate program, but not going as far as
Section 418(n)(3) of the FD&C Act
foods (78 FR 3646 at 3785). prescribing the process and
Regarding Content methodology taken to get there. Other
(Comment 720) Some comments agree
FSMA specifies that this rule that the proposed human preventive comments emphasize that the final rule
acknowledge differences in risk and controls rule reflects a risk-based must provide sufficient flexibility to
minimize, as appropriate, the number of approach and our recognition that a allow facilities to adopt practices that
separate standards that apply to separate ‘‘one -size-fits-all’’ approach is not are practical and effective for their
foods (section 418(n)(3)(C) of the FD&C appropriate in the application of hazard specific, individual operations.
Act). As previously discussed, we analysis and risk-based preventive (Response 720) The final rule directs
consider that the proposed human controls across the entire domestic and the owner, operator, or agent in charge
preventive controls rule strikes what we international food industry. These of a facility to establish and implement
a food safety plan that includes a apply as appropriate to the facility, the PMO and allow dairy products to
written hazard analysis, preventive food, the nature of the preventive continue to be regulated under one
controls that the facility identifies to control and its role in the facility’s food standard, the PMO. These comments
control hazards requiring a preventive safety system, the nature of the hazard, also assert that exempting PMO-
control, and establish and implement or a combination of these factors (see, regulated facilities from the rule would
appropriate preventive control e.g., § 117.135(c), (c)(1), and (c)(3); allow us to better tailor our
management components to ensure the § 117.140(a) and (b); § 117.150(a); requirements to those foods not
effectiveness of the preventive controls, § 117.160(a); § 117.165(a) and (b)); and currently manufactured under such
taking into account the nature of the § 117.410(d)(1)). The exemptions we are regulatory programs, which would also
preventive control and its role in the establishing are provided by section 103 minimize the need to develop separate
facility’s food safety system. As of FSMA. As discussed in Response guidance and standards for this segment
requested by the comments, the rule 222, facilities that are subject to the rule of the dairy industry.
does not prescribe the process and would consider the risk presented by (Response 723) See Response 214 for
methodology to ‘‘get there.’’ the products as part of their hazard a discussion of our approach to PMO-
(Comment 721) Some comments ask evaluation. A facility that appropriately regulated facilities.
us to adopt a commodity-specific determines that there are no hazards (Comment 724) Some comments
approach to RACs when activities requiring a preventive control assert that the rule addresses differences
conducted on RACs are subject to the associated with its food products would in risk based on the number of people
human preventive controls rule. The document that determination in its affected in the event of contaminated
requested commodity-specific approach written hazard analysis but would not product being sold rather than on the
would exempt (or, at a minimum, defer need to establish preventive controls types of hazards identified for a
regulation of) ‘‘low-risk commodities and associated preventive control particular food and the ability to
(such as table grapes)’’ from the human management components for its address those hazards via preventive
preventive controls rule. These products. (See also Response 16.) practices, because the rule bases
comments note that we have (Comment 722) Some comments modified requirements on company
acknowledged that just five commodity interpret the statutory direction in revenues, customer type (restaurant and
groups (leafy greens, tomatoes, herbs, section 418(n)(3)(C) of the FD&C Act to retail establishments), and customer
melons, and sprouts) accounted for 77 mean that Congress granted us authority location (275 mile radius). These
percent of all produce-related outbreaks, to provide flexibility for businesses of comments assert that the proposed
54 percent of produce-related illnesses, all sizes and types (i.e., not just small modified requirements do not properly
and 56 percent of produce-related businesses), as well as to acknowledge address food safety risk through
hospitalizations between 1996 and 2010 differences in risk. These comments prevention and ask us to establish risk-
(78 FR 3504 at 3525). These comments assert that section 418(n)(3)(C) grants us based standards that require preventive
assert that the principal benefits of the authority to exempt distribution centers practices to address identified hazards
FSMA rules will come from regulating from the requirements for hazard for a particular food and process for all
these crops and that we cannot claim to analysis and risk-based preventive companies manufacturing, processing,
have acknowledged differences in risk if controls because: (1) Distribution packing, and holding food.
we adopt a ‘‘one-size-fits-all’’ strategy. centers are very low-risk facilities and Other comments assert that the
These comments ask us to apply the (2) requiring distribution centers to statutory direction to require hazard
human preventive controls rule only to comply with those requirements would analysis and risk-based preventive
RACs that fall within the five highest- not be practicable. controls for all facilities that are
risk commodity groups and to any other (Response 722) We disagree with required to register as a food facility
specific commodities that we have these comments. See Response 221 for under the section 415 registration
determined pose a comparable risk our response to comments that ask us to regulations does not take into
based on outbreak history and the establish exemptions based on the risk consideration the significant differences
commodity’s characteristics. presented by a food product and in risk profiles of fresh produce
Other comments asserting that the Response 226 for our response to facilities and food processing and
rule is ‘‘one-size-fits-all’’ likewise ask us comments that request an exemption for manufacturing facilities. These
to apply the human preventive controls facilities such as supermarket comments further assert that the section
rule only to the highest risk distribution centers. The rule 415 registration regulations are not risk-
commodities but do not narrowly direct establishes an exemption for facilities based but simply served to keep a
their request to RACs. Some of these solely engaged in the storage of catalogue of facilities supplying the U.S.
comments state that regulations must be unexposed packaged food (see food supply and that it is not logical or
scale- and supply-chain appropriate to § 117.7(a)), except that there are appropriate that a fresh produce facility
be effective and assert that a ‘‘one-size- modified requirements for such that packs RACs should be subject to the
fits-all’’ approach will put small and establishments engaged in the storage of same regulatory controls as food
mid-sized farms and processors out of TCS foods (see § 117.7(b) and 117.206). manufacturing facilities such as those
business, undermining public health (Comment 723) Some comments state that produce canned foods or infant
goals, such as increased production of, that Grade ‘‘A’’ dairy products are formula.
availability of, and access to healthy already effectively regulated under the (Response 724) We disagree with
foods, as well as economic opportunity, PMO, and assert that subjecting these these comments. See Response 222, in
equity, and job-creation goals. products to the human preventive which we respond to comments
(Response 721) We decline these controls rule would apply two separate asserting that a food safety plan should
requests to apply the human preventive standards, doubling rather than only be required for high-risk processing
controls rule only to foods determined minimizing the number of separate facilities. The new requirements for
to be of the highest risk and disagree standards that apply to separate foods. hazard analysis and risk-based
that the rule is ‘‘one-size-fits-all.’’ For These comments ask us to instead preventive controls are not ‘‘one-size-
example, several provisions of the rule acknowledge the reduced risk profile of fits-all,’’ and facilities that are subject to
expressly qualify that the requirements foods produced in accordance with the the rule would consider the risk
presented by the products as part of examples of differences requested by unpasteurized milk, and that this aging
their hazard evaluation. these comments. period was presumed to act as a control
However, neither this rule nor our measure to reduce the risk that
B. Comments on Requirements in updated memorandum (Ref. 65) provide pathogens would be present when the
Section 418(n)(5) of the FD&C Act firms with direction on how to set their cheese was consumed. We recently
Regarding Review of Hazard Analysis CCPs and critical limits. A facility has issued a request for comments and for
and Preventive Controls Programs in flexibility to establish and implement scientific data and information that
Existence on the Date of Enactment of appropriate preventive controls, would assist us in identifying and
FSMA including controls at CCPs and evaluating intervention measures that
FSMA directs us to review regulatory including any critical limits that the might have an effect on the presence of
hazard analysis and preventive control facility determines are necessary to bacterial pathogens in cheeses
programs in existence on the date of its provide assurances that hazards manufactured from unpasteurized milk
enactment, including the PMO, to requiring a preventive control will be (80 FR 46023, August 3, 2015). It is
ensure that the regulations we establish significantly minimized or prevented premature to determine what role, if
are consistent, to the extent practicable, and the food manufactured, processed, any, an aging process could play in a
with applicable domestic and packed, or held by the facility will not food safety plan for the manufacture of
internationally-recognized standards in be adulterated under section 402 of the cheese from unpasteurized milk.
existence on that date. (See section FD&C Act or misbranded under section (Comment 727) Some comments
418(n)(5) of the FD&C Act.) Consistent 403(w) of the FD&C Act. assert that we did not make the required
with that statutory direction, we (Comment 726) Some comments ask comparison of the proposed human
previously compared the key features of whether we concluded, in light of the preventive controls rule to the PMO
our proposed requirements to statutory direction in section 418(n)(5) available for review.
implement section 418 of the FD&C Act of the FD&C Act, that the CGMP
requirements in combination with the (Response 727) The required
to certain domestic and international comparison of the proposed human
food safety standards (Ref. 100) (78 FR standards of identity for cheese in part
133 do not provide adequate public preventive controls rule to the PMO is
3646 at 3785 to 3788). available in the docket for this
health controls within the cheese
In the following paragraphs, we rulemaking (Docket FDA–2011–N–0920)
manufacturing industry. According to
discuss comments specifically directed (see Reference 193 to the proposed
these comments, under regulations in
to the statutory direction in section human preventive controls rule). We
part 133 many cheeses have an option
418(n)(5) of the FD&C Act. For examples stated that it was available during the
to use unpasteurized milk, provided the
of other comments related to the discussion of section 418(n)(5) of the
cheese manufactured from
consistency of the proposed human FD&C Act (36 FR 3646 at 3786). For this
unpasteurized milk is aged for at least
preventive controls rule with applicable final rule, we have both updated this
60 days at not less than 35 degrees F.
domestic and internationally-recognized comparison (Ref. 65) and prepared a
These comments ask whether the 60 day
standards, see Comment 8, Comment aging process will be recognized as a separate comparison of the final
215, Comment 372, Comment 718, and preventive control. provisions of this rule to the PMO (Ref.
Comment 719. (Response 726) Section 418(n)(5) of 49).
(Comment 725) Some comments the FD&C Act directs us to review
assert that a proper harmonization is LIV. Comments on Proposed Removal
‘‘regulatory hazard analysis and of 21 CFR Part 110—Current Good
needed with international standards and preventive control programs’’ in
ask us to harmonize the FSMA Manufacturing Practice in
existence on the date of its enactment. Manufacturing, Packing, or Holding
requirements for the food safety plan We have not considered provisions in
with international and domestic HACCP Human Food
the standards of identity (whether in
programs. These comments also ask us part 133 or in other standards of We proposed to remove current part
to explain any differences between the identity) in our analysis directed by 110 after the compliance date for all
FSMA food safety plan and the existing section 418(n)(5) of the FD&C Act, businesses to be in compliance with the
HACCP programs and ask us to provide because standards of identity are not requirements of new part 117. We
exporters with background information hazard analysis and preventive controls received no comments that disagreed
and specific examples of differences, programs. We establish food standards, with this proposal. As discussed in
including how firms are directed to set such as the standards in part 133 section LVI.A, businesses will be
their CCPs and critical limits. (Cheeses and Related Cheese Products) required to comply with new part 117
(Response 725) As previously under section 401 of the FD&C Act (21 1, 2, or 3 years after September 17, 2015,
discussed (Ref. 102 and 78 FR 3646 at U.S.C. 341) to promote honesty and fair depending on the size of the business.
3785 to 3788), we believe the human dealing in the interest of consumers. In Thus, part 110 will be removed on
preventive controls rule is consistent contrast to this role of food standards, September 17, 2018.
with existing food safety programs. We hazard analysis and preventive control LV. Comments on Proposed Conforming
have updated our 2012 memorandum programs (e.g., HACCP) involve a Amendments
entitled ‘‘Comparison of Proposed systematic approach to the
Subpart C (Hazard Analysis and Risk- identification and assessment of the risk We proposed a series of conforming
Based Preventive Controls) to Various (likelihood of occurrence and severity) amendments to current regulations (in
Existing Domestic and International of hazards from a particular food or food §§ 106.100(j) and (n), 114.5, 120.3,
HACCP-Based Standards’’ (Ref. 102) to production process or practice and the 120.5, 120.6(b), 123.3, 123.5(a),
reflect the provisions of the final human control of those hazards (78 FR 3646 at 123.11(b), 129.1, 179.25(a), and 211.1(c))
preventive controls rule (rather than the 3659). that refer to the requirements of part
proposed human preventive controls We acknowledge that part 133 110. With the proposed conforming
rule) (Ref. 65). The comparative format requires an aging period, such as at least changes, these current regulations
of the updated memorandum provides 60 days at not less than 35 degrees F, would refer to part 117, as well as part
the background information and specific for cheese manufactured from 110. We also proposed that when part
110 is removed, all references to part CGMPs would apply to all food comments, we are establishing the
110 be removed from our regulations. establishments, including those effective and compliance dates as
We received no comments that establishments that are subject to the proposed, except for the following three
disagreed with the proposed conforming CGMPs in subpart B, but exempt from changes. First, we are extending the
changes. Therefore, at this time we are the new requirements for hazard compliance date for PMO-regulated
amending each of these current analysis and risk-based preventive facilities to comply with the
regulations so that they refer to part 117, controls in subparts C and G. For the requirements of subparts C and G to
as well as part 110. When part 110 is purpose of determining its compliance September 17, 2018 (See Response 214).
removed, we will issue conforming date, the definitions of ‘‘small business’’ Second, we are establishing an earlier
amendments to remove all references to and ‘‘very small business’’ established compliance date for the financial
part 110 from our regulations. in this rule apply, regardless of whether records that a facility maintains to
a food establishment is subject to support its status as a very small
LVI. Effective and Compliance Dates requirements of another rule (such as business that is eligible for the qualified
A. Effective and Compliance Dates for our HACCP regulation for juice in part facility exemption in § 117.5(a).
Part 117 120) that may have a different definition Specifically, the compliance date for a
for ‘‘small business’’ and ‘‘very small facility to retain records to support its
We proposed that any final rule based business.’’
on proposed part 117 become effective status as a qualified facility is January
Most of the comments support
60 days after its date of publication in staggering the compliance dates. For 1, 2016. (See Response 155.) Third, we
the Federal Register, with staggered example, one comment states that the are establishing separate compliance
compliance dates (78 FR 3646 at 3673). rule would substantially prevent wide- dates for the supply-chain program
Businesses other than small and very ranging harm associated with provisions. As discussed in Response
small businesses would have 1 year contaminated processed foods, but at a 729, a receiving facility’s compliance
from the date of publication of the final reasonable cost to the food industry, date with the supply-chain program
rule to comply with the rule, whereas with ample exclusions and extended provisions of this rulemaking is the later
small businesses would have 2 years compliance dates for small facilities. of: (1) March 17, 2017; (2) for a receiving
and very small businesses would have However, some of the comments that facility that is a small business,
3 years to comply with the rule. We support staggering the compliance dates September 18, 2017; and (3) when the
proposed that these staggered suggest extending the compliance dates supplier of a raw material or other
compliance dates would apply to the for some sizes of business (see, e.g., ingredient will be subject to the human
modernized CGMPs that would be Comment 728, Comment 730, and preventive controls rule or the produce
established in subpart B of part 117, as Comment 731). safety rule, 6 months after the receiving
well as the new requirements for hazard In the following sections, we discuss facility’s supplier of that raw material or
analysis and risk-based preventive comments that suggest extensions to the other ingredient is required to comply
controls (78 FR 3646 at 3674). The proposed compliance dates or ask us to with the applicable rule. See table 53
staggered compliance dates for clarify how the compliance dates will and table 54 for a summary of these
compliance with the modernized apply. After considering these compliance dates.
TABLE 53—COMPLIANCE DATES FOR THE REQUIREMENTS OF PART 117 OTHER THAN THE REQUIREMENTS FOR A
SUPPLY-CHAIN PROGRAM
[Subpart G]
Size of business Compliance date
Qualified facility (including very small business) as defined in § 117.3 ... September 17, 2018, except that the compliance date for a facility to
retain records to support its status as a qualified facility is January 1,
2016.
Small business as defined in § 117.3 ....................................................... September 18, 2017.
Businesses subject to the Pasteurized Milk Ordinance ........................... September 17, 2018.
All other businesses ................................................................................. September 19, 2016.
TABLE 54—COMPLIANCE DATES FOR THE REQUIREMENTS OF THE SUPPLY-CHAIN PROGRAM

[Subpart G]
Situation Compliance date
A receiving facility is a small business and its supplier will not be sub- September 18, 2017.
ject to the human preventive controls rule or the produce safety rule.
A receiving facility is a small business and its supplier is subject to the The later of: September 18, 2017 or 6 months after the receiving facili-
human preventive controls rule or the produce safety rule. ty’s supplier of that raw material or other ingredient is required to
comply with the applicable rule.
A receiving facility is not a small business or a very small business and March 17, 2017.
its supplier will not be subject to the human preventive controls rule
or the produce safety rule.

A receiving facility is not a small business or a very small business and 6 months after the receiving facility’s supplier of that raw material or
its supplier will be subject to the human preventive controls rule or other ingredient is required to comply with the applicable rule.
the produce safety rule.
We also are establishing two provide a minimum of 1 year between seafood, and requirements such as
additional compliance dates applicable the date when a food labeling regulation conducting a hazard analysis and
to qualified facilities. First, we are is issued and the date when a food implementing appropriate preventive
establishing December 17, 2018 as the establishment must comply with that controls, with associated preventive
compliance date for (1) the initial regulation. Following this pattern, we control management components, are no
submission of the attestation by a intend that the next uniform compliance longer novel. We agree that the details
facility that it is a qualified facility (see date will be January 1, 2020 for food of the final requirements could not be
§ 117.201(a)(1)) and (2) the attestation labeling regulations that are issued known until publication of this final
by a qualified facility about its food between January 1, 2017 and December rule, and that the guidance we are
safety practices (see § 117.201(a)(2)(i)) or 31, 2018. A qualified facility that developing can help businesses develop
that it is in compliance with non- submits an attestation that it is in or modify their food safety plans and
Federal food safety law (see compliance with non-Federal food training programs. However, the
§ 117.201(a)(2)(ii)). safety law would become subject to the statutory direction in section 418 of the
Second, we are establishing January 1, notification requirement during this FD&C Act is extensive and, thus,
2020, as the compliance date for the timeframe—i.e., by December 31, 2018. signaled the general nature of the
notification requirement of The compliance date that we are requirements as early as January 4,
§ 117.201(e)(1). A qualified facility that establishing for the notification 2011, when FSMA was signed into law.
submits an attestation that it is in requirement of § 117.201(e) (i.e., January In addition, we conducted extensive
compliance with applicable non-Federal 1, 2020) is consistent with the approach stakeholder outreach during the 10-
food safety law must notify consumers of a uniform compliance date and will month comment period for the 2013
as to the name and complete business provide a qualified facility that chooses proposed human preventive controls
address of the facility where the food to submit an attestation about rule (79 FR 58524 at 58528). We also
was manufactured or processed (see compliance with non-Federal food provided public notice about proposed
§ 117.201(e)). If a food packaging label is safety law with more than 1 year from changes to the farm-related definitions
required, the required notification must the applicable general compliance date that affect the determination of whether
appear prominently and conspicuously to comply with the notification a business is subject to the rule, the
on the label of the food (see requirement. This compliance date also framework for hazard analysis and risk-
§ 117.201(e)(1)). This notification will provide such a qualified facility based preventive controls, and about
requirement may require some qualified with more than 4 years to comply with specific potential requirements for
facilities to update the labels of their the notification requirement relative to environmental monitoring, product
packaged food products. the date of publication of this rule. testing, and a supplier program, in the
For many labeling requirements, the (Comment 728) Some comments 2014 supplemental human preventive
timeframe for a food establishment to assert that one year is not a sufficient
controls notice, and conducted outreach
comply with new or revised labeling amount of time for any size firm to
activities to discuss the new or revised
requirements is governed by a uniform comply with the human preventive
proposed provisions in that
compliance date (see, e.g., 79 FR 73201, controls rule based on experiences with
supplemental notice (see section I.A and
December 10, 2014 and 77 FR 70885, the implementation of our HACCP
Ref. 1 and Ref. 2). In light of the broad
November 28, 2012). Use of a uniform regulation for seafood. These comments
awareness of preventive programs such
compliance date provides for an orderly assert that HACCP required a ‘‘cultural
as HACCP, the statutory direction in
and economical industry adjustment to change’’ for many seafood processors.
FSMA, and extensive outreach
new labeling requirements by allowing The comments acknowledge that the
associated with this rulemaking, we
sufficient lead time to plan for the use knowledge of HACCP and food safety
of existing label inventories and the systems has advanced throughout the disagree that the largest businesses will
development of new labeling materials. food industry in the nearly 20 years need more than one year to fully adapt
This policy serves consumers’ interests since we established our HACCP their programs to the specific
as well because the cost of multiple regulation for seafood but nonetheless requirements of the final rule. Although
short-term label revisions that would assert that firms will need to modify a business may find it useful to revise
otherwise occur would likely be passed previously developed food safety plans certain aspects of its food safety plan, or
on to consumers in the form of higher in order to comply with the rule. The enhance its training materials, after we
prices. We generally announce a comments also assert that training issue implementation guidance such as
uniform compliance date during cannot realistically begin until both the that discussed in Response 2, such
November or December of even- final rule and associated guidance are revisions would serve to enhance the
numbered calendar years, and establish published and that the experiences with company’s food safety plan rather than
the uniform compliance date to be implementing our HACCP regulation for be a necessary resource before a food
January 1 of an upcoming even- seafood should be magnified for the safety plan could be developed and
numbered calendar year. For example, human preventive controls rule because implemented or before employees could
in December, 2014, we issued a final the universe of food processors needing be trained in their specific duties
rule establishing January 1, 2018, as the to comply will be much larger, both in associated with implementing the plan.
uniform compliance date for food the United States and throughout the Moreover, for our HACCP regulation
labeling regulations that are issued world. These comments ask us to for seafood we established a single
between January 1, 2015, and December establish a 2-year compliance period for compliance date regardless of the size of
31, 2016 (79 FR 73201). Likewise, in the largest firms to allow time for the the business, and announced our
November, 2012, we issued a final rule training programs and guidance intention to monitor the progress of the
establishing January 1, 2016, as the documents to be developed. industry after publication of the final
uniform compliance date for food (Response 728) We decline this rule. If we determined that the
labeling regulations that are issued request. As the comments acknowledge, compliance date for that regulation was
between January 1, 2013, and December approximately 20 years have elapsed placing a significant and unreasonable
31, 2014 (77 FR 70885, November 28, since we issued the final rule burden on the industry, particularly on
2012). These uniform compliance dates establishing our HACCP regulation for small businesses, we were willing to
consider an extension for as much as particular supplier and then be required compliance time provided for small and
one additional year or some form of to revise this supply-chain program very small businesses sufficiently
additional technical assistance (Federal shortly thereafter once the supplier is minimizes the burden on those
Register of December 18, 1995, 60 FR subject to an applicable new food safety businesses. (See also Response 731.)
65096 at 65169). Approximately 5 years regulation—specifically, the human (Comment 731) Some comments
later, we issued the final rule for our preventive controls rule or the assert that differences between the
HACCP regulation for juice (January 19, forthcoming produce safety rule. proposed compliance dates for different
2001, 66 FR 6138), in which we Therefore, a receiving facility’s sizes of businesses subject to the human
staggered the compliance dates based on compliance date with the supply-chain preventive controls rule and the
business size and provided only one program provisions of this rulemaking is proposed compliance dates for different
year for the largest businesses to the later of: (1) March 17, 2017; (2) for sizes of businesses subject to the
comply. The staggered compliance dates a receiving facility that is a small produce safety rule will create
that we proposed for the human business, September 18, 2017; and (3) confusion within industry and State and
preventive controls rule based on when the supplier of a raw material or local regulators. These comments also
business size are consistent with the other ingredient will be subject to the express concern that certain farms will
approach we took for the HACCP human preventive controls rule or the be subject to both rules at the same time,
regulation for juice, given increased produce safety rule, six months after the and that compliance with each rule will
awareness of hazard analysis and the receiving facility’s supplier of that raw require significant investment of both
application of risk-based preventive material or other ingredient is required resources and time, both to understand
controls in the years after we issued the to comply with the applicable rule. and to implement the various
final rule for seafood HACCP. (Comment 730) One comment from a provisions. These comments ask us to
(Comment 729) Some comments point State department of agriculture asserts consider a process to permit very small
out that there are staggered compliance that the farm-related definitions in the and small farms (as defined under the
deadlines for small and very small 2013 proposed human preventive proposed produce safety rule) that are
businesses under both the human controls rule would cover a large sector also mixed-type facilities subject to the
preventive controls rule and the of agricultural operations that would not
human preventive controls rule to apply
produce safety rule. These comments be able to comply due to cost and would
for a one-time compliance period
express concern that to the extent a need a longer compliance schedule.
(Response 730) We believe that the extension of twelve months by notifying
receiving facility subject to the human FDA in writing. These comments assert
preventive controls rule is required to revised definitions that we proposed in
the 2014 supplemental human that only a small percentage of
comply with the rule sooner than a businesses will be eligible for such a
current or prospective supplier, that preventive controls notice for ‘‘farm,’’
and for on-farm manufacturing, one-time extension and that the
receiving facility is in effect creating
processing, packing, and holding extension will enable a farmer to plan
pressure for that supplier to come into
activities that trigger a requirement for accordingly, first implementing the
compliance on a timetable inconsistent
an establishment that is also a farm to produce safety rule and then
with that established in the rules. The
register as a food facility, largely address implementing the human preventive
‘‘adequacy’’ of the receiving facility’s
these comments. Many activities that controls rule.
verification activities becomes
potentially even more problematic to farms conduct on RACs, and that would (Response 731) We decline this
demonstrate to FDA inspectors. have triggered a requirement to register request. See Response 730 regarding the
(Response 729) We are establishing under the definitions established in the impact of the revised farm-related
separate compliance dates for the section 415 registration regulations in definitions on businesses that conduct
supply-chain program provisions. While 2003 (68 FR 58894), will not trigger a on-farm activities. A small or very small
this adds complexity, we are doing this requirement to register under the business that only conducts the on-farm
for two main reasons. First, we are definitions we are establishing in this low-risk activity/food combinations we
aligning, to the extent feasible, the final rule. have specified as exempt (see § 117.5(g)
compliance dates of the supply-chain We are aware of the impact that food and (h)) is exempt from all requirements
program provisions of this rule with the safety rulemakings may have on small for hazard analysis and risk-based
compliance dates of the forthcoming and very small businesses, and in the preventive controls. A very small
FSVP rule, which we intend to publish 2001 final rule to establish our HACCP business that conducts on-farm activity/
in the near future. This will provide regulation for juice we began the food combinations in addition to those
greater consistency across the programs, practice of reducing the burden on these low-risk activity/food combinations
particularly with respect to the businesses by staggering the compliance would be subject to an exemption as a
verification of domestic and imported dates and giving small and very small qualified facility and is subject only to
raw materials and ingredients. For the businesses additional time to comply the modified requirements we are
FSVP rule, we proposed a minimum with food safety regulations. Since that establishing in § 117.201.
compliance period of 18 months. time, we have continued this practice of A small business that would not be
Second, to address the concerns staggering compliance dates in exempt because it conducts other
expressed in these comments we want rulemakings such as establishing activities in addition to those low-risk
to minimize the likelihood that a CGMPs for dietary supplements (June activity/food combinations that would
receiving facility will be required to 25, 2007, 72 FR 34752) and preventing qualify the business for an exemption
comply with the supply-chain program Salmonella Enteritidis in Shell Eggs will have 2 years to comply with the
provisions of this rulemaking before its During Production, Storage, and human preventive controls rule. We
supplier is required to comply with Transportation (July 9, 2009, 74 FR acknowledge that complying with both
applicable new food safety regulations 33030 at 33034). We believe that the the human preventive controls rule and
implementing FSMA. Our goal is to staggered compliance dates in this final the produce safety rule involves
avoid a situation in which a receiving rule provide adequate time for significant new requirements, but we
facility would be required to develop a businesses of all sizes to comply with have provided extended compliance
supply-chain program for a food from a the rule, and that the additional periods and done substantial outreach.
(Comment 732) Some comments ask are now within the ‘‘farm’’ definition 129, 179, and 211 are technical
us to clarify when a very small business and, thus, exempt from those amendments that add a cross-reference
would need to comply with the rule if regulations. During the 60 day period to part 117 where the current regulation
the business starts up after the rule goes between the publication of this rule and refers to part 110. The conforming
into effect. For example, if a very small its effective date, FDA does not intend amendment to part 11 adds a reference
business starts up six months after the to prioritize enforcing the section 415 to the scope of part 11 that the records
date of the final rule, would that registration regulations and the section required under part 117 are not subject
business have 2.5 years to comply, or 414 recordkeeping regulations for to part 11. The conforming amendment
would it need to comply immediately? businesses that will no longer be subject to part 16 adds a reference to the scope
(Response 732) A very small business to either or both of those regulations of part 16 for new procedures in part
that is operating as of the date of once the revisions are effective. 117, subpart E that provide a person
publication of the final rule, or begins However, we cannot predetermine with an opportunity for a hearing under
operating any time before the whether some businesses that part 16. These conforming amendments
compliance date for very small previously were not subject to the are effective on November 16, 2015, the
businesses, must comply with the rule section 415 registration regulations, the same date as the effective date of part
by the compliance date for very small section 414 recordkeeping regulations, 117. We are not establishing compliance
businesses. That date is fixed in time or both will not become subject to one dates for these conforming amendments.
and is not a moving date based on or both of those regulations. The As a practical matter, compliance dates
market entry. A very small business that approach we are taking to the will be determined by the dates for
begins operation any time after the compliance date for the revisions to compliance with part 117.
compliance date for very small these regulations is the same as the
businesses must comply with the rule D. Delayed Effective Dates for Provisions
approach we took when we first That Refer to the Forthcoming Rules for
when it begins operation, and should established these regulations. First, for
plan accordingly. Produce Safety and Third-Party
the section 415 registration regulations, Certification
B. Effective and Compliance Dates for the compliance date is the same date as
the effective date. Such establishments The following provisions refer to
Revisions to Part 1 provisions we intend to establish in the
must register as a food facility by
This rule includes revisions to the November 16, 2015. (See 68 FR 58894, near future in part 112 (Standards for
‘‘farm definition,’’ and to activities which establishes an effective date for the Growing, Harvesting, Packing, and
related to the ‘‘farm definition,’’ in the section 415 registration regulations Holding of Produce for Human
§§ 1.227 and 1.328. This rule also Consumption): §§ 117.5(k)(2), 117.8,
but does not establish a different date
includes technical amendments to 117.405(c), 117.410(d)(2)(ii), 117.430(d),
for compliance with those regulations.)
§§ 1.241, 1.276, and 1.361. We did not and 117.475(c)(13). In addition,
An establishment that is required to
discuss effective and compliance dates paragraph (2) of the definition of
register as a food facility by November
for these revisions to part 1 in either the ‘‘qualified auditor’’ in § 117.3, and
16, 2015 will be required to comply
2013 proposed human preventive § 117.435(d) refers to provisions we
with the requirements in part 117 as
controls rule or the 2014 supplemental intend to establish in the near future in
described in section LVI.A.
human preventive controls notice. See For the section 414 recordkeeping part 1, subpart M (Accredited Third-
table 55 for the effective dates and Party Food Safety Audits and Food or
regulations, we are requiring that
compliance dates that we are Facility Certification). In addition,
establishments that become subject to
establishing in this final rule. As with §§ 117.405(a)(2) and 117.475(c)(2) refer
these requirements for the first time as
the requirements we are establishing in to provisions we intend to establish in
a result of the revisions that become
part 117, the revisions to part 1 become the near future in part 1, subpart L
effective November 16, 2015 comply
effective 60 days after the date of (Foreign Supplier Verification Programs
with the requirements using the same
publication of this rule (i.e., November for Food Importers). We will publish a
criteria as we applied when we first
16, 2015). The compliance dates for the document in the Federal Register
established this regulation as shown in
technical amendments to §§ 1.241, announcing the effective dates of
table 55. (See 69 FR 71562, December 9,
1.276, and 1.361 are the same as the paragraph (2) of the definition of
effective dates. Two of these technical 2004.)
‘‘qualified auditor’’ in § 117.3, and
amendments change the citation to the §§ 117.5(k)(2), 117.8, 117.405(c),
FD&C Act from ‘‘the act’’ to ‘‘the Federal
TABLE 55—COMPLIANCE DATES FOR
117.410(d)(2)(ii), 117.430(d),
Food, Drug, and Cosmetic Act’’; the THE SECTION 414 RECORDKEEPING
117.405(a)(2), 117.435(d), 117.475(c)(2)
third technical amendment updates a REGULATIONS and 117.475(c)(13).
cross-reference to the definition of
‘‘manufacturer’’ in regulations for the Size of business Compliance date LVII. Compliance and Enforcement
prior notice of imported food. 10 or fewer full-time September 18, 2017.
Gaining industry compliance with the
The principal impact of the equivalent employ- provisions of this rule is as important as
substantive revisions to the definitions ees establishing the provisions. A central
in the section 415 registration Businesses employ- March 17, 2017. element of our strategy to gain industry
regulations and the section 414 ing fewer than 500, compliance is to help make available to
recordkeeping regulations is whether but more than 10 facilities subject to this rule the
the revised definitions affect the full-time equivalent education and technical assistance they
classification of a business as an entity employees need to understand and implement the
All other businesses September 19, 2016.

that is subject to these regulations. We requirements (Ref. 6). Within the
believe that some businesses that were Agency we are establishing a Food
subject to one or both of these C. Effective Dates for Conforming Safety Technical Assistance Network
regulations will no longer be subject to Amendments and seeking funding to increase FDA
either of these regulations because the The conforming amendments to staffing to provide a central source of
activities that these businesses conduct regulations in parts 106, 114, 120, 123, information to support industry
understanding and implementation of inspectors, compliance officers, and and safety, and other advantages;
FSMA standards (Ref. 6). This will other staff involved in food safety distributive impacts; and equity). The
allow us to respond in a timely and activities (Ref. 12). Agency believes that this final rule is a
consistent way to industry questions on We also plan to leverage the resources significant regulatory action under
preventive controls technical and of State, local, tribal, and territorial Executive Order 12866.
compliance issues (Ref. 6). governments to conduct domestic The Regulatory Flexibility Act
We also are working in collaboration verification activities. We are working requires Agencies to analyze regulatory
with the FSPCA to develop training with officials from these governments options that would minimize any
materials and establish training and through the PFP to develop and significant impact of a rule on small
technical assistance programs (Ref. 5) implement a national Integrated Food entities. Because facilities with less than
and (Ref. 7). The FSPCA includes Safety System, which will focus on 20 employees (both qualified and non-
members from FDA, State food establishing partnerships for achieving qualified facilities) will bear a large
protection agencies, the food industry, compliance (see section 209(b) of portion of the costs, the Agency
and academia. It is funded by a grant to FSMA), and which will allow us to concludes that the final rule will have
the Illinois Institute of Technology’s utilize the thousands of State, local, and a significant economic impact on a
Institute for Food Safety and Health, a tribal inspectors available to help with substantial number of small entities.
nationally-recognized leader in food the domestic verification process. Section 202(a) of the Unfunded
safety. In addition to developing a Consistent with FSMA, we will use Mandates Reform Act of 1995 requires
standardized preventive controls our current resources, new resources that Agencies prepare a written
training curriculum, the FSPCA is that we obtain, and our partnerships to statement, which includes an
developing selected sections of model conduct regular inspections of covered assessment of anticipated costs and
food safety plans for several food types facilities, focusing on those facilities benefits, before proposing ‘‘any rule that
that will provide needed instructional that pose the highest risk to food safety. includes any Federal mandate that may
examples. Although we have provided Section 201 of FSMA mandates that result in the expenditure by State, local,
funding to the FSPCA to develop a FDA inspect domestic high-risk and tribal governments, in the aggregate,
standardized preventive controls facilities no less than once every 3 or by the private sector, of $100,000,000
training curriculum, we are unable to years. We are currently meeting this or more (adjusted annually for inflation)
fund training for individual groups who mandate, and even exceeding it with in any one year.’’ The current threshold
might need particular training materials. respect to certain domestic high-risk after adjustment for inflation is $144
We also are partnering with the NIFA facilities. Once the FSMA rulemakings million, using the most current (2014)
of USDA to administer the FSMA- come into effect, we intend to build on Implicit Price Deflator for the Gross
mandated National Food Safety this track record and to have an FDA or Domestic Product. FDA expects this
Training, Education, Extension, State inspection of domestic high-risk final rule to result in a 1-year
Outreach, and Technical Assistance human food facilities on an annual basis expenditure that will exceed this
Program, a grant program to provide to ensure hazards have been amount.
technical assistance for FSMA significantly minimized or prevented in
compliance to owners and operators of compliance with this rule. LX. Analysis of Environmental Impact
small and medium-size farms and small FDA has determined under 21 CFR
food processors (Ref. 8). Such efforts LVIII. Executive Order 13175
25.30(j) that this action is of a type that
will help ensure widespread voluntary In accordance with Executive Order does not individually or cumulatively
compliance by encouraging greater 13175, FDA has consulted with tribal have a significant effect on the human
understanding and adoption of government officials. A Tribal Summary environment (Ref. 102) (Ref. 103).
established food safety standards, Impact Statement has been prepared Therefore, neither an environmental
guidance, and protocols. that includes a summary of Tribal assessment nor an environmental
With regard to inspections, we will officials’ concerns and how FDA has impact statement is required.
conduct regular inspections of domestic addressed them (Ref. 101). Persons with
facilities to ensure that facilities subject access to the Internet may obtain the LXI. Paperwork Reduction Act of 1995
to this rule are adequately implementing Tribal Summary Impact Statement at This rule contains information
the required preventive controls and http://www.fda.gov/pchfrule or at collection provisions that are subject to
supply-chain program, pursuant to our http://www.regulations.gov. Copies of review by OMB under the Paperwork
inspection authority under section 704 the Tribal Summary Impact Statement Reduction Act (PRA) of 1995 (44 U.S.C.
of the FD&C Act. Our inspections will also may be obtained by contacting the 3501–3520). A description of these
verify that such facilities are person listed under FOR FURTHER provisions is given in the following
implementing systems that effectively INFORMATION CONTACT. paragraphs with an estimate of the
prevent food contamination, and in annual recordkeeping and reporting
particular, that they comply with the LIX. Economic Analysis of Impacts
burdens. Included in the estimate is the
rule by implementing preventive FDA has examined the impacts of the time for reviewing instructions,
controls, including supply-chain final rule under Executive Order 12866, searching existing data sources,
programs, to provide assurances that Executive Order 13563, the Regulatory gathering and maintaining the data
any hazard requiring a preventive Flexibility Act (5 U.S.C. 601–612), and needed, and completing and reviewing
control or supply-chain applied control the Unfunded Mandates Reform Act of each collection of information.
has been significantly minimized or 1995 (Pub. L. 104–4). Executive Orders Title: Current Good Manufacturing
prevented. 12866 and 13563 direct Agencies to Practice, Hazard Analysis and Risk-
In order to effectively carry out this assess all costs and benefits of available Based Preventive Controls for Human
new paradigm of food safety prevention, regulatory alternatives and, when Food.
we will need to reorient and retrain our regulation is necessary, to select Description: The Food and Drug
staff. To this end, we are seeking regulatory approaches that maximize Administration (FDA) is proposing to
additional funding, including for the net benefits (including potential amend its regulation for Current Good
training of more than 2,000 FDA economic, environmental, public health Manufacturing Practice in
Manufacturing, Packing, or Holding human preventive controls rule as good requirements or to learn about the
Human Food (CGMPs) to modernize it business practice. Comments believe requirements for their facility rather
and to add requirements for domestic that preventive food safety systems are than 15 hours.
and foreign facilities that are required to the norm for the food industry. (Comment 736) Comments suggest
register under section 415 of the Federal Comments believe this is demonstrated that the PRA review does not account
Food, Drug, and Cosmetic Act (the by what they cite as 57 percent of the for reduced training costs for small and
FD&C Act) to establish and implement industry already operating under very small facilities derived from the
hazard analysis and risk-based HACCP programs. Not accounting for availability for hire of trained
preventive controls for human food. the effects of widespread adoption of employees. The average turnover rate in
FDA is taking this action as part of its HACCP may result in an overestimate. manufacturing in 2010 was 15 percent,
announced initiative to revisit the The reason a majority of food facilities suggesting some small businesses will
CGMPs since they were last revised in have already implemented HACCP or a be able to hire qualified individuals
1986 and to implement new statutory HACCP-like systems is that preventive rather than training current employees.
provisions in section 418 of the FD&C systems are the best, most cost-effective (Response 736) We agree that some
Act. means of insuring against recall costs new employees will already be trained
Description of Respondents: Section and potential criminal liability for but we believe that we accounted for
418 of the FD&C Act is applicable to the releasing adulterated product into those that are already trained by only
owner, operator or agent in charge of a commerce. If the industry standard is including burden hours for employees
food facility required to register under prevention, then the baseline for at facilities that disclosed to our survey
section 415 of the FD&C Act. Generally, calculating PRA burdens should be that they did not conduct training. In
a facility is required to register if it adjusted to account for that. addition, we estimated a turnover rate of
manufactures, processes, packs, or holds (Response 734) We concur that we do 10 percent, which indicates that fewer
food for consumption in the United not account for those facilities that are new employees would require training
States. There are 83,819 such facilities; in the process of adopting our than proposed by the comments,
37,134 of these facilities are considered requirements independently. We do indicating that we did not overestimate
‘‘qualified’’ facilities and have reduced address the impact of a likely trend the burden hours.
requirements in regards to this rule- toward adopting our requirements in the (Comment 737) Comments assert that
making. uncertainty analysis of our FRIA (Ref. we underestimated the recordkeeping
In the following paragraphs, we 38). burden of the proposed information
describe and respond to the comments (Comment 735) Comments assert that collection, that our methodology and
that we received for the PRA for both knowledge transferred from facilities assumptions are wrong or that it is not
our 2013 proposed human preventive already applying HACCP will be possible to adequately assess the
controls rule and our 2014 available to small and very small accuracy of our recordkeeping burden
supplemental human preventive facilities during the delayed estimates. Comments further dispute
controls notice. We numbered each implementation period. Delayed our assessment that creation of a single
comment to help distinguish between implementation periods usually food safety plan will require 110 hours
different comments. The number contemplate that smaller businesses will and that one plan will be required per
assigned to each comment is purely for benefit from increased availability of facility. In the experience of the
organizational purposes and does not advanced technology and knowledge comments’ member organization, it
signify the comment’s value, that can lower the costs of compliance. takes considerably longer, with a
importance, or the order in which it was Related comments suggest that the PRA median of over 200 hours per facility.
received. does not appear to have considered that Additionally, many plants currently
(Comment 733) Comments stated that during the three-year implementation have more than one HACCP plan in
we overestimated the recordkeeping period standardized templates and place. Large plants have multiple
burden because we assume the burden software for hazard analyses and food products, raw materials, processes, and
is evenly distributed across all facilities safety plans may become available for equipment. Comments report that one
beginning in the first year. However, food facilities. The availability of large plant has 34 plans in place that
facilities that are not small or very small templates and software would reduce took approximately 860 hours to
have one year from the effective date of the time needed for small and very develop and another large plant has 25
the rule to come into compliance. For small facilities to prepare mandatory plans in place that took approximately
small facilities, compliance is delayed documents. 1385 hours to develop.
for 2 years and very small facilities will (Response 735) We concur that (Response 737) We concur that
have 3 years. The agency’s 7 year delayed implementation periods will establishments might have more than
horizon for discounting burdens would benefit smaller businesses from the one HACCP plan in place and we
need to be staggered to account for the increased availability of advanced acknowledge that large establishments
delayed compliance dates in order to technology and knowledge that can might require considerably more than
arrive at a consistent annualized burden lower the costs of compliance. We 110 hours to develop a food safety plan.
of the records collection. allowed the staggered compliance Our estimate is based on the average
(Response 733) We clarify that our period for this very reason. We revised time to create a food safety plan for
estimate for the recordkeeping burden our estimate of the costs to learn about establishments of all sizes, so our
for the first year is for the first full year the requirements of rule in the main estimate includes very small facilities
that all facilities are responsible for the analysis. In our revised analysis, we that are likely to require considerably
requirements for the rule. We note that estimate that facilities with fewer than less than 110 hours, too.
the FRIA (Ref. 38) now uses a 10 year 20 employees will devote 5 hours to (Comment 738) Comments assert that
horizon for discounting burdens. learning about their requirements, rather it is not clear if our assessment includes
(Comment 734) Comments support than 10 hours. For facilities with 20 to the considerable pre-work time that is
our estimate that many facilities already 99 employees, one individual at the required as an input to development of
keep the records required by section 418 level of an operations manager will take a HACCP plan. Pre-work includes
of the FD&C Act and the proposed about 10 hours to review and assess the activities such as employee training,
assembling the food safety plan team year, this one line would have 2700 unavoidable part of any manufacturing
(which may require outside experts, and records per year. Most plants have environment, it should be expected that
specific company experts like multiple lines and conduct monitoring all facilities subject to preventive
microbiologists, procurement, research beyond metal detectors and bar code controls regulations will have corrective
and development, etc.), creating the scanners. A large plant may have well actions to document annually.
processing and product profile, and over 730 monitoring events per day— Comments claim that our time estimate
creating a flow diagram. Some estimated not per year as FDA estimates. also appears to be low. Comments report
that approximately 150–300 hours of (Response 741) We concur that a large that their member’s facilities typically
pre-work are needed per facility before establishment might have significantly engage in between 10 and 60 corrective
the actual HACCP plan is prepared. more monitoring events. Our analysis is actions per year for critical control point
(Response 738) Our analysis for the based on the average of all deviations, which is considerably higher
PRA includes pre-work time to the establishments, including very small than our proposed estimate of two
extent that pre-work time includes establishments that are unlikely to so actions per year. Although it may take
preparing the documents that are many events. In the absence of only one hour to manage the record
required in accordance with the rule. substantiated evidence for the large involved with the corrective action,
The preparation of records for the average number of monitoring events, additional time would be required to
validation of process controls might be we decline to revise our estimate. investigate the underlying issue and
considered pre-work and would be (Comment 742) Comments let us implement the corrective action. We
considered in our estimate. We disagree know that it is unclear what activities expect it can take between two and four
that all of the pre-work mentioned by are included in our time estimate. hours to investigate a single corrective
the comments should be included in our Comments claim that the amount of action and come up with a solution.
estimate of the burden hours. time required to produce a record will (Response 743) We revised our
(Comment 739) Comments believe vary depending on whether the estimate estimate for the number of
that a robust food safety plan should be only includes documenting time to establishments that would be subject to
developed by a multidisciplinary group create the record or whether it also the requirements to 16,285 based on the
of professionals with a broad skill set. includes the underlying task of most recent number of facilities
These comments believe that it is monitoring and follow-up tasks like registered with FDA and that are subject
unclear what wage rate we used in our filing. Furthermore, the number of to subparts C and G. We address
estimate of the operating and monitoring events could be significantly elsewhere our reason for not requiring
maintenance costs associated with higher than the estimate if all preventive all facilities to be subject to subparts C
implementing and maintaining a food controls are subject to similar and G. We recognize that some facilities
safety plan or if those estimates consider monitoring requirements as critical will conduct more than our estimate of
the range of wages applicable to the control points. Thus, although some two corrective actions per year. Our
broad team involved in plan tasks may take only three minutes to estimate is based on actions that must
development. monitor, our members suggest that six be made to correct a problem that has
(Response 739) We concur that a minutes per monitoring event may be a occurred with the implementation of a
multidisciplinary group of professionals more accurate estimate of the preventive control; or that might affect
is likely to be involved in the plan information collection burden. the safety of the food. Many corrective
development. Our estimate is based on (Response 742) We concur with the actions might occur to address product
an average wage rate for the type of comments that time will vary by what’s quality problems, unrelated to food
professional that would be likely to included in the task. The PRA requires safety. Further, our estimate for the PRA
develop the specific document. We that we include in our burden estimate is necessarily only related to the
included our estimate for the average the time for reviewing instructions, recordkeeping burden, and should not
wage rate that we used for each type of searching existing data sources, include the additional time that would
document in our description. gathering and maintaining the data be required to investigate the underlying
(Comment 740) Comments suggest needed, and completing and reviewing issue and implement the corrective
that our estimate that facilities will keep each collection of information. We action.
records of 730 monitoring activities and believe our estimate of 3 minutes, as an (Comment 744) Comments noted that
that each record can be made in about average over time, accurately reflects the our estimate for keeping verification
three minutes (36.5 hours total per year entire requirement for recordkeeping, records assumes facilities will keep
per facility), severely underestimates including the initial time to create, records of 244 verification events and
both the number of activities and the maintain and file the records. Many, if that each record can be made in about
time required. not most, records can be created, three minutes (12.2 hours total per year
(Response 740) Comments did not maintained and filed in batch to reduce per facility). Comments claim that our
provide supporting evidence. In the time, especially when done assessment does not explain whether
absence of a better substantiated electronically, so we decline to revise this estimate considers the broad scope
estimate, we decline to revise our our estimate of 3 minutes, in the of activities included in the definition of
estimate. absence of more evidence. ‘‘verification’’ in the proposed rule
(Comment 741) Comments assert that (Comment 743) Comments claim that (proposed § 117.150), although it
we severely underestimated the number our estimated burden for corrective should. The proposed regulatory
of monitoring records. Comments claim action records assumes that 18,291 definition of verification not only
that several of their members reported facilities subject to preventive controls includes verification of monitoring,
over 50,000 monitoring events in their will have two corrective actions to corrective actions, and implementation
facilities annually. They provided as an document, which will take one hour and effectiveness (e.g., calibration), but
example that if one production line has each to record. Our assessment does not also includes validation and reanalysis.
two metal detectors and one barcode explain the basis for estimating that Validation and reanalysis of a food
scanner, there would be three records only 18,291 facilities will engage in safety plan are extensive activities that
per shift, with three shifts per day. corrective actions. Because occasional take tens, if not hundreds, of hours to
Assuming 300 days of operation per deviations from expected values are an conduct. The estimate does not appear
to account for these activities. The controls qualified individual. Comments (Response 746) We requested
comments note that even when provide as an example, that a thermal comment on whether to require
considering just the traditional activities process authority outside of the plant submission to FDA of a subset of the
considered as verification under may be a qualified individual in terms information that would be in a food
HACCP, their members’ experience of confirming the process has a safety plan. After considering
shows that our current verification validated kill step, while the same comments, we decided that we will not
estimate is too low. They received a facility will likely have a qualified establish a requirement for submission
wide range of estimates of the number individual responsible for approving the of a facility profile. To the extent that
of verification events conducted food safety plan. This situation would this comment is addressing the form
annually—from about 200 to over increase the time burden beyond used for registering a food facility with
14,000 events per year. Similarly, their estimate. FDA, such a comment is outside the
members report that it takes them (Response 745) Our estimate of 47,484 scope of this rule-making. Moreover, an
between 8 minutes and 2 hours per establishments that will need to establishment that meets the definition
verification event. It is unclear whether document the training of their of a retail food establishment is not a
our estimate includes only the time to preventive controls qualified individual facility required to register.
handle the record or also the time to was based on our estimate of the
(Comment 747) Comments believe
conduct the verification. The comments number of facilities that are subject to
that our ICR contains redundant
suggest this missing information in our subparts C and G of the rule. We
collections. Comments believe that our
estimate may explain the range of updated our estimate to 46,685 based on
existing Food Facility Registration
responses in our survey. Comments our most recent count of facilities
Module requests information on facility
claim that the time to conduct the registered with FDA. Our estimate is
type and products handled, while our
verification should be included. based on the requirement that only one
ICR seeks the same information.
(Response 744) We concur that our preventive controls qualified individual
estimates should assess the full scope of is necessary to perform the requirements Commenters believe that we should
activities associated with recordkeeping. of the provisions that require a minimize redundancies to the greatest
Our analysis did neglect to include the preventive controls qualified individual. extent possible and use the information
recordkeeping activities for the Moreover, some preventive controls that we already have. As such, we
validation of process controls, which are qualified individuals may be qualified should not be requesting information on
an essential part of verification. We by experience and there would not be a facility type, products handled and, if it
added our estimate for the burden of need for documentation of training. decides to as we recommend, types of
validation and we revised our (Comment 746) Comments note that storage, through this ICR. All of these
description about the recordkeeping our estimate for submitting a new data points are already collected by the
burden for the food safety plan to state domestic food facility profile will take existing Food Facility Registration
that our estimate does include the 15 minutes. Comments believe that we Module.
burden of reanalysis of the food safety grossly underestimate the amount of (Response 747) The ICR associated
plan. For the purposes of the PRA, our time retailers will need to respond to with this rule-making is not redundant.
estimate of the burden of recordkeeping the form. Comments believe that the The ICR associated with food facility
is only for the time of recordkeeping, typical distribution center carries 26 of registration with FDA is a separate rule-
not the full verification activity. We the 27 product categories listed in the making and a separate burden. This
decline to revise our estimate based on Draft Form. Providing detail on the PRA contains the ICR for completing all
the comment because insufficient potential hazards and preventive the requirements for a food facility to
evidence was presented about just the controls implemented for each product develop a hazard analysis and
time for recordkeeping. will take retailers a total of 20–30 or preventive controls; not register their
(Comment 745) Comments noted that more hours per facility. Most chain facility. See Response 746.
we estimate that 47,484 food retailers have multiple facilities. A (Comment 748) Comments suggest
manufacturers will need to document national retailer will easily have a dozen that our estimated time and costs to
the training of their preventive controls or more distribution centers. The largest comply with the requirement to label
qualified individual, which will take 15 food retailers will have several dozen. It products from certain qualified facilities
minutes per facility. (We note that the is conceivable that hundreds of hazard do not come under the PRA because the
proposed rule defined and used the and preventive control entries will be address requirement is a disclosure, and
term ‘‘qualified individual, but the term required to be made for each not an information collection.
in the final rule is ‘‘preventive controls distribution center to respond to the
qualified individual, and we use the Draft Form if such facilities are required (Response 748) We concur that the
term ‘‘preventive controls qualified to input information on hazards they do requirement to add a qualified facility
individual’’ in describing these not control. The typical distribution address to the product label is a third-
comments on this topic.) They are center carries more than 13,000 different party disclosure burden, and because it
unclear why we estimate that only SKUs of FDA-regulated foods. is a disclosure burden, is subject to the
47,484 food manufacturers and not all Completing the form itself will require PRA. We revised our estimate for the
registered facilities subject to preventive several hours due to all of the entries. hour burden for each of these
controls would be required to have a Compiling the information for each disclosures to be 15 minutes as shown
preventive controls qualified individual facility will take 20–30 hours. Under the in table 69 of the PRA, to reflect that
and to document that person’s training. PRA, comments believe that we are this will not be a coordinated label
Comments state that their members required to consider not only the time change for most qualified facilities so
found that we are accurate in our it takes to complete the form, but also most will not be updating their labels
assumption, although our estimate for the time it takes to compile the anyway.
the documentation may take 30 minutes information. Comments believe that we Information Collection Burden Estimate
in some situations. Comments also must revise our estimate of the burden
suggest that many facilities may need to imposed by the information collection FDA estimates the burden for this
document more than one preventive request (ICR). information collection as follows:
Recordkeeping Burden For the burden for corrective action review of their supplier’s relevant food
We estimate that about 46,685 records (§ 117.175(a)(3) we estimate that safety records § 117.475(c)(9), among up
facilities subject to subparts C and G twice per year 16,285 facilities subject to 18 possible supplier related records.
Hazard Analysis and Risk-Based to subparts C and G Hazard Analysis Our estimate follows the same pattern as
Preventive Controls will need to create and Risk-Based Preventive Controls will that for other records. We estimate that
a food safety plan (§ 117.175(a)(1)) have corrective actions to document. there are 16,285 facilities subject to
which is a compilation of many written The documentation of those corrective subparts C and G Hazard Analysis and
food safety procedures. We total the actions is expected to take one hour for Risk-Based Preventive Controls that will
hour burdens as presented throughout each record for a total hour burden of need to keep as many as 18 additional
the FRIA (Ref. 38) to then create an 32,570. records for an average of 10 records of
average hour burden for each facility to We estimate that there are 8,143 their approved suppliers and review
create or complete a food safety plan. facilities subject to subparts C and G records. Based on estimates throughout
We estimate that creation of the food Hazard Analysis and Risk-Based the FRIA, we estimate that each of the
safety plan will require 110 hours. The Preventive Controls that will need to 16,285 establishments will maintain
total hour burden on an annual basis is keep additional records of verification these records and that the total time for
46,685 facilities × 110 hours = 5,135,350 activities. Based on estimates of this recordkeeping will be about 4 hours
hours. There are no capital costs or verification records created, when for a total hour burden of 651,400.
operating and maintenance costs appropriate, throughout the FRIA, we We estimate that 46,685
associated with this collection of estimate that 8,143 facilities will keep establishments subject to subparts C and
information. records of 244 verification activities and G Hazard Analysis and Risk-Based
We estimate the burden for disclosing that each record can be made in about Preventive Controls will need to
to a customer, in documents to 3 minutes (0.05 hours) for a total hour document the training of their
accompany foods that require further burden of 101,675. preventive controls qualified
processing, that the food has not been The burden for keeping validation individuals (§ 117.180(d)). We estimate
processed to control a specified hazard records (§ 117.160) follows the same that this will require 15 minutes (0.25
(§ 117.136), is 15 minutes per record. pattern as that for verification records. hours) per facility total for a total hour
We estimate that 16,285 establishments We estimate that there are 3,677 burden of 11,671.
will each make one of these disclosures facilities subject to subparts C and G
for a total recordkeeping burden of Hazard Analysis and Risk-Based Under § 117.206(a)(5) facilities are
4,071 hours. Preventive Controls that will need to required to keep records documenting
The burden for keeping monitoring keep additional records of the validation (1) the monitoring of temperature
records (§ 117.175(a)(2)) follows the of their process control activities within controls for refrigerated packaged food,
same pattern as that for the food safety their food facilities. Based on estimates (2) the corrective actions taken when
plan. We estimate that there are 8,143 of the establishments that will require there is a problem with the control of
facilities subject to subparts C and G validation, when appropriate, temperature for refrigerated packaged
Hazard Analysis and Risk-Based throughout the FRIA, we estimate that food, and (3) the verification activities
Preventive Controls that will need to each of the 3,677 facilities will keep relating to the temperature control of
keep additional records of the records of six validation activities for a refrigerated packaged food. We believe
monitoring that they do of different total of 22,062 records. We estimate that that the keeping of such records is
activities within their food facilities. each record can be made in about 15 already common industry practice and
Based on estimates of monitoring minutes (0.25 hours) for a total hour will not constitute an additional
created, when appropriate, throughout burden of 5,515. paperwork burden.
the FRIA, we estimate that each of the The burden for keeping supplier Table 56 shows the estimated annual
8,143 facilities will keep records of 730 records is for the use of approved recordkeeping burden associated with
monitoring activities and that each suppliers and for establishments to this rule. There are no capital costs or
record can be made in about 3 minutes document their audits § 117.475(c)(7), operating and maintenance costs
(0.05 hours) for a total hour burden of the sampling and testing of their associated with this collection of
297,220. ingredients § 117.475(c)(8), and the information.
TABLE 56—ESTIMATED ANNUAL RECORDKEEPING BURDEN

Average
Number of
Number of Total annual burden per
21 CFR Part 1, Subpart 117 records per Total hours
recordkeepers records recordkeeping
recordkeeper (in hours)
117.126 (c) and 117.170(d) food safety plan and reanaly-

sis ................................................................................... 46,685 1 46,685 110 5,135,350
117.136 assurance records ............................................... 16,285 1 16,285 0.25 4,070
117.145 (c) monitoring records .......................................... 8,143 730 5,944,390 0.05 297,220
117.150 (d) corrective actions and corrections records .... 16,285 2 32,570 1 32,570
117.155(b) verification records .......................................... 8,143 244 1,986,892 0.05 101,675
117.160 validation records ................................................. 3,677 6 22,062 .25 5,515
117.475(c)(7), 117.475(c)(8), and 117.475(c)(9) among
up to 18 supplier records ............................................... 16,285 1 16,285 4 651,400

117.180(d) Records that document applicable training for
the preventive controls qualified individual. ................... 46,685 1 46,685 .25 11,671
Total annual burden hours ......................................... ........................ ........................ ........................ .......................... 6,239,471
1 There are no capital costs or operating and maintenance costs associated with this collection of information
Reporting Burden Qualified facilities must report their to spend 0.5 hour every 2 years
status as such a facility every 2 years; reporting to FDA their status as a
Table 57 shows the estimated annual status will likely be reported qualified facility for a total annual hour
reporting burden associated with this electronically through a web portal burden of about 9,283 hours (37,134
rule. maintained by FDA. This requirement facilities × 0.5 responses annually × 0.5
will cause the 37,134 qualified facilities hours per response).
TABLE 57—ESTIMATED ANNUAL REPORTING BURDEN

[Very small business <$1 m] 1
Average
Number of
Number of Total annual burden per
21 CFR Section (or FDA Form No.) responses per Total hours
respondents responses response
respondent (in hours)
117.201(e) Qualified facility ................................................. 37,134 0.5 18,567 0.5 9,283
Total burden hours ....................................................... ........................ ........................ ........................ ........................ 9,283

1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Third Party Disclosure Burden label. We estimate the hour burden of 0.25 hours adding their address to their
Under § 117.201(e) qualified facilities this disclosure is 15 minutes per new labels for a total hour burden of
must add the address of the facility disclosure. This requirement will cause about 9,283 hours (37,134 facilities ×
where the food is manufactured to their the 37,134 qualified facilities to spend 0.25 hours per response).
TABLE 58—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN

[Very small business <$1 m] 1
Average
Number of
20 CFR section Number of Total burden per
responses per Total hours
(or FDA Form No.) respondents responses response
respondent (in hours)
117.201(e) Qualified facility ................................................. 37,134 1 37,134 0.25 9,283
Total burden hours ....................................................... ........................ ........................ ........................ ........................ 9,283
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73. FDA, ‘‘Food Allergen Partnership,’’ 84. USDA Food Safety and Inspection
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74. FDA, ‘‘CPG, Sec. 555.250 Statement of on July10, 2015. Accessed and printed on April 2, 2015.
Policy for Labeling and Preventing Cross- 85. FDA Memorandum, ‘‘Product Testing,’’ 97. FDA, ‘‘Information for Foreign
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Manuals/CompliancePolicyGuidance notice. (http://www.fda.gov/Food/International
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September 12, 2014. Contamination of Produce,’’ 2014. Accessed and printed on March 26,
75. FDA, ‘‘Draft Guidance for Industry: 87. FDA, ‘‘Guidance for Industry: Control of 2015.
Questions and Answers Regarding Listeria Monocytogenes in Refrigerated 98. World Trade Organization, ‘‘WTO
Mandatory Food Recalls,’’ (http:// or Frozen Ready-to-Eat Foods (Draft Ministerial Conference: Implementation-
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GuidanceDocumentsRegulatory GuidanceRegulation/Guidance www.wto.org/english/thewto_e/minist_e/
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76. FDA, ‘‘FDA Homepage,’’ (http:// September 13, 2011. See Reference 126 99. World Trade Organization, ‘‘The WTO
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77. FDA, ‘‘Recalls, Market Withdrawals, & Configuration of HACCP Plans,’’ 1995. english/tratop_e/sps_e/spsagr_e.htm),
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accounts/USFDA/subscriber/new?topic_ of Fresh-cut Fruits and Vegetables,’’ 100. FDA, ‘‘Comparison of Proposed Subpart
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Recalls, Including Removals and February, 2008. Accessed and printed on Based Standards,’’ 2012. See Reference
Corrections,’’ (http://www.fda.gov/ June 1, 2015. 193 to the 2013 proposed human
Safety/Recalls/IndustryGuidance/ 90. Codex Alimentarius Commission, ‘‘Codex preventive controls rule.
ucm129259.htm), November 3, 2003. Alimentarius Commission Procedural 101. FDA, ‘‘Tribal Summary Impact
Accessed and printed on February 19, Manual, 23rd Edition,’’ (ftp://ftp.fao.org/ Statement,’’ 2015.
2015. codex/Publications/ProcManuals/ 102. FDA, ‘‘Memorandum on the
79. FoodSafety.gov, ‘‘Get Food Safety Manual_23e.pdf), 2015. Accessed and Modernization of Food Current Good
Widget,’’ (http://www.foodsafety.gov/ printed on March 26, 2015. Manufacturing Practices (CGMP) As
recalls/widget/index.html), March 27, 91. FDA, ‘‘Inspections, Compliance, Required by the Food Safety
2015. Accessed and printed on March Enforcement, and Criminal Modernization Act of 2011,’’ 2011. See
13, 2015. Investigations: Warning Letters,’’ (http:// Reference 36 to the 2014 supplemental
80. U.S. Department of Health and Human www.fda.gov/ICECI/Enforcement human preventive controls notice.
Services, ‘‘Employers and Health Actions/WarningLetters/default.htm), 103. FDA, ‘‘Memorandum on the Re-Proposal
Information in the Workplace HIPAA March 26, 2015. Accessed and printed of Select Provisions of the Proposed
Privacy Rule,’’ (http://www.hhs.gov/ocr/ on March 26, 2015.
Rule: Current Good Manufacturing
privacy/hipaa/understanding/ 92. FDA, ‘‘Import Alerts,’’ (http://
Practice and Hazard Analysis and Risk-
consumers/employers.html), 2015. www.fda.gov/ForIndustry/Import
Based Preventive Controls for Human
Accessed and printed on April 2, 2015. Program/ImportAlerts/default.htm),
Food,’’ 2014. See Reference 35 to the
81. Codex Alimentarius Commission, 2015. Accessed and printed on March
2014 supplemental human preventive
‘‘Recommended International Code of 26, 2015.
controls notice.
Practice: General Principles of Food 93. FDA, ‘‘Letter to Sunland Inc. Concerning
Hygiene CAC/RCP1–1969, Rev. 4–2003,’’ Suspension of Food Facility Registration; List of Subjects
(https://www.idfa.org/docs/default- Notice of Opportunity for Hearing,’’
source/resource-library/391_cxp_ (http://www.fda.gov/aboutfda/centers 21 CFR Part 1
001e.pdf?sfvrsn=0; http://www.codex offices/officeoffoods/cfsan/cfsanfoia
alimentarius.org/download/standards/ electronicreadingroom/ucm329370.htm), Cosmetics, Drugs, Exports, Food
23/CXP_001e.pdf), 2003. Accessed and November 26, 2012. Accessed and labeling, Imports, Labeling, Reporting
printed on October 27, 2009. See printed on March 26, 2015. and recordkeeping requirements.
21 CFR Part 11 § 1.227 What definitions apply to this or another farm under the same
subpart? management consists only of:
Administrative practice and
The definitions of terms in section (1) Drying/dehydrating raw
procedure, Computer technology,
201 of the Federal Food, Drug, and agricultural commodities to create a
Reporting and recordkeeping
Cosmetic Act apply to such terms when distinct commodity (such as drying/
requirements.
used in this subpart. In addition, for the dehydrating grapes to produce raisins),
21 CFR Part 16 purposes of this subpart: and packaging and labeling such
Administrative practice and Calendar day means every day shown commodities, without additional
procedure. on the calendar. manufacturing/processing (an example
Facility means any establishment, of additional manufacturing/processing
21 CFR Part 106 structure, or structures under one is slicing);
Food grades and standards, Infants ownership at one general physical (2) Treatment to manipulate the
and children, Nutrition, Reporting and location, or, in the case of a mobile ripening of raw agricultural
recordkeeping requirements. facility, traveling to multiple locations, commodities (such as by treating
that manufactures/processes, packs, or produce with ethylene gas), and
21 CFR Part 110 holds food for consumption in the packaging and labeling treated raw
Food packaging, Foods. United States. Transport vehicles are agricultural commodities, without
not facilities if they hold food only in additional manufacturing/processing;
21 CFR Part 114 the usual course of business as carriers. and
Food packaging, Foods, Reporting and A facility may consist of one or more (3) Packaging and labeling raw
recordkeeping requirements. contiguous structures, and a single agricultural commodities, when these
building may house more than one activities do not involve additional
21 CFR Part 117 distinct facility if the facilities are under manufacturing/processing (an example
Food packaging, Foods. separate ownership. The private of additional manufacturing/processing
residence of an individual is not a is irradiation); or
21 CFR Part 120 (2) Secondary activities farm. A
facility. Nonbottled water drinking
Foods, Fruit juices, Imports, water collection and distribution secondary activities farm is an
Reporting and recordkeeping establishments and their structures are operation, not located on a primary
requirements, Vegetable juices. not facilities. production farm, devoted to harvesting
(1) Domestic facility means any (such as hulling or shelling), packing,
21 CFR Part 123
facility located in any State or Territory and/or holding of raw agricultural
Fish, Fishery products, Imports, of the United States, the District of commodities, provided that the primary
Reporting and recordkeeping Columbia, or the Commonwealth of production farm(s) that grows, harvests,
requirements, Seafood. Puerto Rico that manufactures/ and/or raises the majority of the raw
21 CFR Part 129 processes, packs, or holds food for agricultural commodities harvested,
consumption in the United States. packed, and/or held by the secondary
Beverages, Bottled water, Food (2) Foreign facility means a facility activities farm owns, or jointly owns, a
packaging, Reporting and recordkeeping other than a domestic facility that majority interest in the secondary
requirements. manufactures/processes, packs, or holds activities farm. A secondary activities
21 CFR Part 179 food for consumption in the United farm may also conduct those additional
States. activities allowed on a primary
Food additives, Food labeling, Food Farm means: production farm as described in
packaging, Radiation protection, (1) Primary production farm. A paragraphs (1)(ii) and (iii) of this
Reporting and recordkeeping primary production farm is an operation definition.
requirements, Signs and symbols. under one management in one general Food has the meaning given in section
21 CFR Part 211 (but not necessarily contiguous) 201(f) of the Federal Food, Drug, and
physical location devoted to the Cosmetic Act:
Drugs, Labeling, Laboratories, growing of crops, the harvesting of (1) Except for purposes of this
Packaging and containers, Prescription crops, the raising of animals (including subpart, it does not include:
drugs, Reporting and recordkeeping seafood), or any combination of these (i) Food contact substances as defined
requirements, Warehouses. activities. The term ‘‘farm’’ includes in section 409(h)(6) of the Federal Food,
Therefore, under the Federal Food, operations that, in addition to these Drug, and Cosmetic Act; or
Drug, and Cosmetic Act and under activities: (ii) Pesticides as defined in 7 U.S.C.
authority delegated to the Commissioner (i) Pack or hold raw agricultural 136(u).
of Food and Drugs, 21 CFR chapter I is commodities; (2) Examples of food include: Fruits,
amended as follows: (ii) Pack or hold processed food, vegetables, fish, dairy products, eggs,
provided that all processed food used in raw agricultural commodities for use as
PART 1—GENERAL ENFORCEMENT such activities is either consumed on food or as components of food, animal
REGULATIONS that farm or another farm under the feed (including pet food), food and feed
same management, or is processed food ingredients, food and feed additives,
■ 1. The authority citation for 21 CFR identified in paragraph (1)(iii)(B)(1) of dietary supplements and dietary
part 1 continues to read as follows: this definition; and ingredients, infant formula, beverages
(including alcoholic beverages and
Authority: 15 U.S.C. 1333, 1453, 1454, (iii) Manufacture/process food,

1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. provided that: bottled water), live food animals, bakery
321, 331, 332, 333, 334, 335a, 343, 350c, (A) All food used in such activities is goods, snack foods, candy, and canned
350d, 352, 355, 360b, 360ccc, 360ccc–1, consumed on that farm or another farm foods.
360ccc–2, 362, 371, 374, 381, 382, 387, 387a, under the same management; or Harvesting applies to farms and farm
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264. (B) Any manufacturing/processing of mixed-type facilities and means
■ 2. Revise § 1.227 to read as follows: food that is not consumed on that farm activities that are traditionally
performed on farms for the purpose of milling, mixing, packaging (including and nursing home kitchens are
removing raw agricultural commodities modified atmosphere packaging), restaurants; and
from the place they were grown or pasteurizing, peeling, rendering, treating (2) Pet shelters, kennels, and
raised and preparing them for use as to manipulate ripening, trimming, veterinary facilities in which food is
food. Harvesting is limited to activities washing, or waxing. For farms and farm provided to animals are restaurants.
performed on raw agricultural mixed-type facilities, manufacturing/ Retail food establishment means an
commodities, or on processed foods processing does not include activities establishment that sells food products
created by drying/dehydrating a raw that are part of harvesting, packing, or directly to consumers as its primary
agricultural commodity without holding. function. A retail food establishment
additional manufacturing/processing, Mixed-type facility means an may manufacture/process, pack, or hold
on a farm. Harvesting does not include establishment that engages in both food if the establishment’s primary
activities that transform a raw activities that are exempt from function is to sell from that
agricultural commodity into a processed registration under section 415 of the establishment food, including food that
food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act it manufactures/processes, packs, or
Federal Food, Drug, and Cosmetic Act. and activities that require the holds, directly to consumers. A retail
Examples of harvesting include cutting establishment to be registered. An food establishment’s primary function is
(or otherwise separating) the edible example of such a facility is a ‘‘farm to sell food directly to consumers if the
portion of the raw agricultural mixed-type facility,’’ which is an annual monetary value of sales of food
commodity from the crop plant and establishment that is a farm, but also products directly to consumers exceeds
removing or trimming part of the raw conducts activities outside the farm the annual monetary value of sales of
agricultural commodity (e.g., foliage, definition that require the establishment food products to all other buyers. The
husks, roots or stems). Examples of to be registered. term ‘‘consumers’’ does not include
harvesting also include cooling, field Nonprofit food establishment means a businesses. A ‘‘retail food
coring, filtering, gathering, hulling, charitable entity that prepares or serves establishment’’ includes grocery stores,
removing stems and husks from, food directly to the consumer or convenience stores, and vending
shelling, sifting, threshing, trimming of otherwise provides food or meals for machine locations.
outer leaves of, and washing raw consumption by humans or animals in Trade name means the name or
agricultural commodities grown on a the United States. The term includes names under which the facility
farm. central food banks, soup kitchens, and conducts business, or additional names
Holding means storage of food and nonprofit food delivery services. To be by which the facility is known. A trade
also includes activities performed considered a nonprofit food name is associated with a facility, and
incidental to storage of a food (e.g., establishment, the establishment must a brand name is associated with a
activities performed for the safe or meet the terms of section 501(c)(3) of product.
effective storage of that food, such as the U.S. Internal Revenue Code (26 U.S. agent means a person (as defined
fumigating food during storage, and U.S.C. 501(c)(3)). in section 201(e) of the Federal Food,
drying/dehydrating raw agricultural Packaging (when used as a verb) Drug, and Cosmetic Act residing or
commodities when the drying/ means placing food into a container that maintaining a place of business in the
dehydrating does not create a distinct directly contacts the food and that the United States whom a foreign facility
commodity (such as drying/dehydrating consumer receives. designates as its agent for purposes of
hay or alfalfa)). Holding also includes Packing means placing food into a this subpart. A U.S. agent cannot be in
activities performed as a practical container other than packaging the food the form of a mailbox, answering
necessity for the distribution of that and also includes re-packing and machine or service, or other place where
food (such as blending of the same raw activities performed incidental to an individual acting as the foreign
agricultural commodity and breaking packing or re-packing a food (e.g., facility’s agent is not physically present.
down pallets), but does not include activities performed for the safe or (1) The U.S. agent acts as a
activities that transform a raw effective packing or re-packing of that communications link between the Food
agricultural commodity into a processed food (such as sorting, culling, grading, and Drug Administration (FDA) and the
food as defined in section 201(gg) of the and weighing or conveying incidental to foreign facility for both emergency and
Federal Food, Drug, and Cosmetic Act. packing or re-packing), but does not routine communications. The U.S. agent
Holding facilities could include include activities that transform a raw will be the person FDA contacts when
warehouses, cold storage facilities, agricultural commodity, as defined in an emergency occurs, unless the
storage silos, grain elevators, and liquid section 201(r) of the Federal Food, Drug, registration specifies under § 1.233(e)
storage tanks. and Cosmetic Act, into a processed food another emergency contact.
Manufacturing/processing means as defined in section 201(gg) of the (2) FDA will treat representations by
making food from one or more Federal Food, Drug, and Cosmetic Act. the U.S. agent as those of the foreign
ingredients, or synthesizing, preparing, Restaurant means a facility that facility, and will consider information
treating, modifying or manipulating prepares and sells food directly to or documents provided to the U.S. agent
food, including food crops or consumers for immediate consumption. the equivalent of providing the
ingredients. Examples of ‘‘Restaurant’’ does not include facilities information or documents to the foreign
manufacturing/processing activities that provide food to interstate facility.
include: Baking, boiling, bottling, conveyances, central kitchens, and other (3) Having a single U.S. agent for the
canning, cooking, cooling, cutting, similar facilities that do not prepare and purposes of this subpart does not
distilling, drying/dehydrating raw serve food directly to consumers. preclude facilities from having multiple
agricultural commodities to create a (1) Entities in which food is provided agents (such as foreign suppliers) for
distinct commodity (such as drying/ to humans, such as cafeterias, other business purposes. A firm’s
dehydrating grapes to produce raisins), lunchrooms, cafes, bistros, fast food commercial business in the United
evaporating, eviscerating, extracting establishments, food stands, saloons, States need not be conducted through
juice, formulating, freezing, grinding, taverns, bars, lounges, catering facilities, the U.S. agent designated for purposes
homogenizing, irradiating, labeling, hospital kitchens, day care kitchens, of this subpart.
You or registrant means the owner, ‘‘Packing’’; and revise the definitions for and/or raises the majority of the raw
operator, or agent in charge of a facility ‘‘Farm’’, ‘‘Food’’, ‘‘Holding’’, and agricultural commodities harvested,
that manufactures/processes, packs, or ‘‘Manufacturing/processing’’ to read as packed, and/or held by the secondary
holds food for consumption in the follows: activities farm owns, or jointly owns, a
United States. majority interest in the secondary
§ 1.328 What definitions apply to this activities farm. A secondary activities
■ 3. In § 1.241, revise paragraph (a) to subpart?
read as follows: farm may also conduct those additional
* * * * * activities allowed on a primary
§ 1.241 What are the consequences of Farm means: production farm as described in
failing to register, update, or cancel your (1) Primary production farm. A paragraphs (1)(ii) and (iii) of this
registration? primary production farm is an operation definition.
(a) Section 301 of the Federal Food, under one management in one general Food has the meaning given in section
Drug, and Cosmetic Act prohibits the (but not necessarily contiguous) 201(f) of the Federal Food, Drug, and
doing of certain acts or causing such physical location devoted to the Cosmetic Act. Examples of food include,
acts to be done. Under section 302 of the growing of crops, the harvesting of but are not limited to fruits; vegetables;
Federal Food, Drug, and Cosmetic Act, crops, the raising of animals (including fish; dairy products; eggs; raw
the United States can bring a civil action seafood), or any combination of these agricultural commodities for use as food
in Federal court to enjoin a person who activities. The term ‘‘farm’’ includes or as components of food; animal feed,
commits a prohibited act. Under section operations that, in addition to these including pet food; food and feed
303 of the Federal Food, Drug, and activities: ingredients and additives, including
Cosmetic Act, the United States can (i) Pack or hold raw agricultural substances that migrate into food from
bring a criminal action in Federal court commodities; the finished container and other articles
to prosecute a person who is responsible (ii) Pack or hold processed food,
that contact food; dietary supplements
for the commission of a prohibited act. provided that all processed food used in
and dietary ingredients; infant formula;
Under section 306 of the Federal Food, such activities is either consumed on
beverages, including alcoholic beverages
Drug, and Cosmetic Act, FDA can seek that farm or another farm under the
and bottled water; live food animals;
debarment of any person who has been same management, or is processed food
bakery goods; snack foods; candy; and
convicted of a felony relating to identified in paragraph (1)(iii)(B)(1) of
canned foods.
importation of food into the United this definition; and
(iii) Manufacture/process food, * * * * *
States. Failure of an owner, operator, or Harvesting applies to farms and farm
agent in charge of a domestic or foreign provided that:
(A) All food used in such activities is mixed-type facilities and means
facility to register its facility, to update activities that are traditionally
required elements of its facility’s consumed on that farm or another farm
under the same management; or performed on farms for the purpose of
registration, or to cancel its registration removing raw agricultural commodities
in accordance with the requirements of (B) Any manufacturing/processing of
food that is not consumed on that farm from the place they were grown or
this subpart is a prohibited act under raised and preparing them for use as
section 301(dd) of the Federal Food, or another farm under the same
management consists only of: food. Harvesting is limited to activities
Drug, and Cosmetic Act. performed on raw agricultural
(1) Drying/dehydrating raw
* * * * * agricultural commodities to create a commodities, or on processed foods
■ 4. In § 1.276, revise paragraph (b)(9) to distinct commodity (such as drying/ created by drying/dehydrating a raw
read as follows: dehydrating grapes to produce raisins), agricultural commodity without
and packaging and labeling such additional manufacturing/processing,
§ 1.276 What definitions apply to this
subpart? commodities, without additional on a farm. Harvesting does not include
manufacturing/processing (an example activities that transform a raw
* * * * * agricultural commodity into a processed
of additional manufacturing/processing
(b) * * * food as defined in section 201(gg) of the
is slicing);
(9) Manufacturer means the last Federal Food, Drug, and Cosmetic Act.
(2) Treatment to manipulate the
facility, as that word is defined in Examples of harvesting include cutting
ripening of raw agricultural
§ 1.227, that manufactured/processed (or otherwise separating) the edible
commodities (such as by treating
the food. A facility is considered the last portion of the raw agricultural
produce with ethylene gas), and
facility even if the food undergoes commodity from the crop plant and
packaging and labeling treated raw
further manufacturing/processing that removing or trimming part of the raw
agricultural commodities, without
consists of adding labeling or any agricultural commodity (e.g., foliage,
additional manufacturing/processing;
similar activity of a de minimis nature. husks, roots or stems). Examples of
and
If the food undergoes further (3) Packaging and labeling raw harvesting also include cooling, field
manufacturing/processing that exceeds agricultural commodities, when these coring, filtering, gathering, hulling,
an activity of a de minimis nature, then activities do not involve additional removing stems and husks from,
the subsequent facility that performed manufacturing/processing (an example shelling, sifting, threshing, trimming of
the additional manufacturing/ of additional manufacturing/processing outer leaves of, and washing raw
processing is considered the is irradiation); or agricultural commodities grown on a
manufacturer. (2) Secondary activities farm. A farm.
* * * * * secondary activities farm is an Holding means storage of food and
■ 5. In § 1.328, remove the definitions operation, not located on a primary also includes activities performed
for ‘‘Act’’ and ‘‘Packaging’’; add production farm, devoted to harvesting incidental to storage of a food (e.g.,
definitions in alphabetically order for (such as hulling or shelling), packing, activities performed for the safe or
‘‘Harvesting’’, ‘‘Mixed-type facility’’, and/or holding of raw agricultural effective storage of that food, such as
‘‘Packaging (when used as a noun)’’, commodities, provided that the primary fumigating food during storage, and
‘‘Packaging (when used as a verb)’’, and production farm(s) that grows, harvests, drying/dehydrating raw agricultural
commodities when the drying/ and also includes re-packing and provisions or regulations, remain
dehydrating does not create a distinct activities performed incidental to subject to this part.
commodity (such as drying/dehydrating packing or re-packing a food (e.g.,
hay or alfalfa)). Holding also includes activities performed for the safe or PART 16—REGULATORY HEARING
activities performed as a practical effective packing or re-packing of that BEFORE THE FOOD AND DRUG
necessity for the distribution of that food (such as sorting, culling, grading, ADMINISTRATION
food (such as blending of the same raw and weighing or conveying incidental to
agricultural commodity and breaking packing or re-packing)), but does not ■ 9. The authority citation for 21 CFR
down pallets), but does not include include activities that transform a raw part 16 continues to read as follows:
activities that transform a raw agricultural commodity, as defined in Authority: 15 U.S.C. 1451–1461; 21 U.S.C.
agricultural commodity into a processed section 201(r) of the Federal Food, Drug, 141–149, 321–394, 467f, 679, 821, 1034; 28
food as defined in section 201(gg) of the and Cosmetic Act, into a processed food U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.
Federal Food, Drug, and Cosmetic Act. as defined in section 201(gg) of the
Holding facilities could include ■ 10. In § 16.1(b)(2), add the following
Federal Food, Drug, and Cosmetic Act.
warehouses, cold storage facilities, entry in numerical order to read as
* * * * * follows:
storage silos, grain elevators, and liquid
storage tanks. ■ 6. Revise § 1.363 to read as follows:
§ 16.1 Scope.
Manufacturing/processing means § 1.363 What are the consequences of * * * * *
making food from one or more failing to establish or maintain records or
ingredients, or synthesizing, preparing, make them available to FDA as required by
(b) * * *
treating, modifying or manipulating this subpart? (2) * * *
food, including food crops or (a) The failure to establish or maintain §§ 117.251 through 117.287 (part 117,
ingredients. Examples of records as required by section 414(b) of subpart E of this chapter), relating to
manufacturing/processing activities the Federal Food, Drug, and Cosmetic withdrawal of a qualified facility
include: Baking, boiling, bottling, Act and this regulation or the refusal to exemption.
canning, cooking, cooling, cutting, permit access to or verification or * * * * *
distilling, drying/dehydrating raw copying of any such required record is
agricultural commodities to create a a prohibited act under section 301 of the PART 106—INFANT FORMULA
distinct commodity (such as drying/ Federal Food, Drug, and Cosmetic Act. REQUIREMENTS PERTAINING TO
dehydrating grapes to produce raisins), CURRENT GOOD MANUFACTURING
evaporating, eviscerating, extracting (b) The failure of a nontransporter
immediate previous source or a PRACTICE, QUALITY CONTROL
juice, formulating, freezing, grinding, PROCEDURES, QUALITY FACTORS,
homogenizing, irradiating, labeling, nontransporter immediate subsequent
recipient who enters an agreement RECORDS AND REPORTS, AND
milling, mixing, packaging (including NOTIFICATIONS
modified atmosphere packaging), under § 1.352(e) to establish, maintain,
pasteurizing, peeling, rendering, treating or establish and maintain, records
required under § 1.352(a), (b), (c), or (d), ■ 11. The authority citation for 21 CFR
to manipulate ripening, trimming, part 106 continues to read as follows:
washing, or waxing. For farms and farm or the refusal to permit access to or
verification or copying of any such Authority: 21 U.S.C. 321, 342, 350a, 371.
mixed-type facilities, manufacturing/
processing does not include activities required record, is a prohibited act
■ 12. In § 106.100, revise paragraph (n)
that are part of harvesting, packing, or under section 301 of the Federal Food,
to read as follows:
holding. Drug, and Cosmetic Act.
Mixed-type facility means an (c) The failure of any person to make § 106.100 Records.
establishment that engages in both records or other information available to * * * * *
activities that are exempt from FDA as required by section 414 or (n) Production control, product
registration under section 415 of the 704(a) of the Federal Food, Drug, and testing, testing results, complaints, and
Federal Food, Drug, and Cosmetic Act Cosmetic Act and this regulation is a distribution records necessary to verify
and activities that require the prohibited act under section 301 of the compliance with parts 106, 107, 109,
establishment to be registered. An Federal Food, Drug, and Cosmetic Act. 110, 113, and 117 of this chapter, or
example of such a facility is a ‘‘farm with other appropriate regulations, shall
mixed-type facility,’’ which is an PART 11—ELECTRONIC RECORDS;
ELECTRONIC SIGNATURES be retained for 1 year after the
establishment that is a farm, but also expiration of the shelf life of the infant
conducts activities outside the farm formula or 3 years from the date of
definition that require the establishment ■ 7. The authority citation for 21 CFR
part 11 continues to read as follows: manufacture, whichever is greater.
to be registered.
Authority: 21 U.S.C. 321–393; 42 U.S.C.
* * * * *
* * * * *
Packaging (when used as a noun) 262.
PART 110—[Removed and Reserved]
means the outer packaging of food that ■ 8. In § 11.1, add and reserve
bears the label and does not contact the paragraphs (g) and (h) and add ■ 13. Remove and reserve part 110,
food. Packaging does not include food paragraph (i) to read as follows: effective September 17, 2018.
contact substances as they are defined
§ 11.1 Scope.
in section 409(h)(6) of the Federal Food, PART 114—ACIDIFIED FOODS
* * * * *
Drug, and Cosmetic Act.

Packaging (when used as a verb) (i) This part does not apply to records ■ 14. The authority citation for 21 CFR
means placing food into a container that required to be established or maintained part 114 continues to read as follows:
directly contacts the food and that the by part 117 of this chapter. Records that
Authority: 21 U.S.C. 342, 371, 374; 42
consumer receives. satisfy the requirements of part 117 of U.S.C. 264.
Packing means placing food into a this chapter, but that also are required
container other than packaging the food under other applicable statutory ■ 15. Revise § 114.5 to read as follows:
§ 114.5 Current good manufacturing 117.155 Verification. 117.435 Onsite audit.

practice. 117.160 Validation. 117.475 Records documenting the supply-
The criteria in §§ 114.10, 114.80, 117.165 Verification of implementation chain program.
114.83, 114.89, and 114.100, as well as and effectiveness.
Authority: 21 U.S.C. 331, 342, 343, 350d
117.170 Reanalysis.
the criteria in parts 110 and 117 of this note, 350g, 350g note, 371, 374; 42 U.S.C.
117.180 Requirements applicable to a
chapter, apply in determining whether 243, 264, 271.
preventive controls qualified individual
an article of acidified food is and a qualified auditor.
adulterated: 117.190 Implementation records required
Subpart A—General Provisions
(a) Within the meaning of section for this subpart. § 117.1 Applicability and status.
402(a)(3) of the Federal Food, Drug, and Subpart D—Modified Requirements (a) The criteria and definitions in this
Cosmetic Act in that it has been
117.201 Modified requirements that apply part apply in determining whether a
manufactured under such conditions
to a qualified facility. food is:
that it is unfit for food; or 117.206 Modified requirements that apply (1) Adulterated within the meaning
(b) Within the meaning of section to a facility solely engaged in the storage of:
402(a)(4) of the Federal Food, Drug, and of unexposed packaged food. (i) Section 402(a)(3) of the Federal
Cosmetic Act in that it has been
Subpart E—Withdrawal of a Qualified Food, Drug, and Cosmetic Act in that
prepared, packed, or held under
Facility Exemption the food has been manufactured under
insanitary conditions whereby it may
117.251 Circumstances that may lead FDA such conditions that it is unfit for food;
have become contaminated with filth, or
to withdraw a qualified facility or
whereby it may have been rendered exemption. (ii) Section 402(a)(4) of the Federal
injurious to health. 117.254 Issuance of an order to withdraw Food, Drug, and Cosmetic Act in that
■ 16. Add part 117 to read as follows: a qualified facility exemption. the food has been prepared, packed, or
117.257 Contents of an order to withdraw
PART 117—CURRENT GOOD held under insanitary conditions
a qualified facility exemption.
MANUFACTURING PRACTICE, 117.260 Compliance with, or appeal of, an whereby it may have become
HAZARD ANALYSIS, AND RISK– order to withdraw a qualified facility contaminated with filth, or whereby it
BASED PREVENTIVE CONTROLS FOR exemption. may have been rendered injurious to
HUMAN FOOD 117.264 Procedure for submitting an health; and
appeal. (2) In violation of section 361 of the
Subpart A—General Provisions 117.267 Procedure for requesting an Public Health Service Act (42 U.S.C.
informal hearing. 264).
Sec. 117.270 Requirements applicable to an
117.1 Applicability and status. (b) The operation of a facility that
informal hearing.
117.3 Definitions. 117.274 Presiding officer for an appeal and manufactures, processes, packs, or holds
117.4 Qualifications of individuals who for an informal hearing. food for sale in the United States if the
manufacture, process, pack, or hold food. 117.277 Timeframe for issuing a decision owner, operator, or agent in charge of
117.5 Exemptions. on an appeal. such facility is required to comply with,
117.7 Applicability of subparts C, D, and 117.280 Revocation of an order to withdraw and is not in compliance with, section
G of this part to a facility solely engaged a qualified facility exemption.
in the storage of unexposed packaged
418 of the Federal Food, Drug, and
117.284 Final agency action. Cosmetic Act or subpart C, D, E, or F of
food. 117.287 Reinstatement of a qualified
117.8 Applicability of subpart B of this part this part is a prohibited act under
facility exemption that was withdrawn.
to the off-farm packing and holding of section 301(uu) of the Federal Food,
raw agricultural commodities Subpart F—Requirements Applying to Drug, and Cosmetic Act.
117.9 Records required for this subpart. Records That Must Be Established and (c) Food covered by specific current
Maintained good manufacturing practice regulations
Subpart B—Current Good Manufacturing
Practice 117.301 Records subject to the also is subject to the requirements of
requirements of this subpart. those regulations.
117.10 Personnel. 117.305 General requirements applying to
117.20 Plant and grounds. records. § 117.3 Definitions.
117.35 Sanitary operations. 117.310 Additional requirements applying
117.37 Sanitary facilities and controls. The definitions and interpretations of
to the food safety plan.
117.40 Equipment and utensils. 117.315 Requirements for record retention. terms in section 201 of the Federal
117.80 Processes and controls. 117.320 Requirements for official review. Food, Drug, and Cosmetic Act apply to
117.93 Warehousing and distribution. 117.325 Public disclosure. such terms when used in this part. The
117.110 Defect action levels. 117.330 Use of existing records. following definitions also apply:
Subpart C—Hazard Analysis and Risk- 117.335 Special requirements applicable to Acid foods or acidified foods means
Based Preventive Controls a written assurance. foods that have an equilibrium pH of 4.6
117.126 Food safety plan. Subpart G—Supply-Chain Program or below.
117.130 Hazard analysis. 117.405 Requirement to establish and
Adequate means that which is needed
117.135 Preventive controls. implement a supply-chain program. to accomplish the intended purpose in
117.136 Circumstances in which the 117.410 General requirements applicable to keeping with good public health
owner, operator, or agent in charge of a a supply-chain program. practice.
manufacturing/processing facility is not 117.415 Responsibilities of the receiving Affiliate means any facility that
required to implement a preventive facility. controls, is controlled by, or is under
control. 117.420 Using approved suppliers. common control with another facility.
117.137 Provision of assurances required 117.425 Determining appropriate supplier Allergen cross-contact means the
under § 117.136(a)(2), (3), and (4). verification activities (including
117.139 Recall plan. determining the frequency of conducting
unintentional incorporation of a food
117.140 Preventive control management the activity). allergen into a food.
components. 117.430 Conducting supplier verification Audit means the systematic,
117.145 Monitoring. activities for raw materials and other independent, and documented
117.150 Corrective actions and corrections. ingredients. examination (through observation,
investigation, records review, Food means food as defined in section Hazard requiring a preventive control
discussions with employees of the 201(f) of the Federal Food, Drug, and means a known or reasonably
audited entity, and, as appropriate, Cosmetic Act and includes raw foreseeable hazard for which a person
sampling and laboratory analysis) to materials and ingredients. knowledgeable about the safe
assess a supplier’s food safety processes Food allergen means a major food manufacturing, processing, packing, or
and procedures. allergen as defined in section 201(qq) of holding of food would, based on the
Batter means a semifluid substance, the Federal Food, Drug, and Cosmetic outcome of a hazard analysis (which
usually composed of flour and other Act. includes an assessment of the severity of
ingredients, into which principal Food-contact surfaces are those the illness or injury if the hazard were
components of food are dipped or with surfaces that contact human food and to occur and the probability that the
which they are coated, or which may be those surfaces from which drainage, or hazard will occur in the absence of
used directly to form bakery foods. other transfer, onto the food or onto preventive controls), establish one or
Blanching, except for tree nuts and surfaces that contact the food ordinarily more preventive controls to significantly
peanuts, means a prepackaging heat occurs during the normal course of minimize or prevent the hazard in a
treatment of foodstuffs for an adequate operations. ‘‘Food-contact surfaces’’ food and components to manage those
time and at an adequate temperature to includes utensils and food-contact controls (such as monitoring,
partially or completely inactivate the surfaces of equipment. corrections or corrective actions,
naturally occurring enzymes and to Full-time equivalent employee is a verification, and records) as appropriate
effect other physical or biochemical term used to represent the number of to the food, the facility, and the nature
changes in the food. employees of a business entity for the of the preventive control and its role in
Calendar day means every day shown purpose of determining whether the the facility’s food safety system.
on the calendar. business qualifies for the small business Holding means storage of food and
Correction means an action to identify exemption. The number of full-time also includes activities performed
and correct a problem that occurred equivalent employees is determined by incidental to storage of a food (e.g.,
during the production of food, without dividing the total number of hours of activities performed for the safe or
other actions associated with a salary or wages paid directly to effective storage of that food, such as
corrective action procedure (such as employees of the business entity and of fumigating food during storage, and
actions to reduce the likelihood that the all of its affiliates and subsidiaries by drying/dehydrating raw agricultural
problem will recur, evaluate all affected the number of hours of work in 1 year, commodities when the drying/
food for safety, and prevent affected 2,080 hours (i.e., 40 hours × 52 weeks). dehydrating does not create a distinct
food from entering commerce). If the result is not a whole number, commodity (such as drying/dehydrating
Critical control point means a point, round down to the next lowest whole hay or alfalfa)). Holding also includes
step, or procedure in a food process at number. activities performed as a practical
which control can be applied and is Harvesting applies to farms and farm necessity for the distribution of that
essential to prevent or eliminate a food mixed-type facilities and means food (such as blending of the same raw
safety hazard or reduce such hazard to activities that are traditionally agricultural commodity and breaking
an acceptable level. performed on farms for the purpose of down pallets), but does not include
Defect action level means a level of a removing raw agricultural commodities activities that transform a raw
non-hazardous, naturally occurring, from the place they were grown or agricultural commodity into a processed
unavoidable defect at which FDA may raised and preparing them for use as food as defined in section 201(gg) of the
regard a food product ‘‘adulterated’’ and food. Harvesting is limited to activities Federal Food, Drug, and Cosmetic Act.
subject to enforcement action under performed on raw agricultural Holding facilities could include
section 402(a)(3) of the Federal Food, commodities, or on processed foods warehouses, cold storage facilities,
Drug, and Cosmetic Act. created by drying/dehydrating a raw storage silos, grain elevators, and liquid
Environmental pathogen means a agricultural commodity without storage tanks.
pathogen capable of surviving and additional manufacturing/processing, Known or reasonably foreseeable
persisting within the manufacturing, on a farm. Harvesting does not include hazard means a biological, chemical
processing, packing, or holding activities that transform a raw (including radiological), or physical
environment such that food may be agricultural commodity into a processed hazard that is known to be, or has the
contaminated and may result in food as defined in section 201(gg) of the potential to be, associated with the
foodborne illness if that food is Federal Food, Drug, and Cosmetic Act. facility or the food.
consumed without treatment to Examples of harvesting include cutting Lot means the food produced during
significantly minimize the (or otherwise separating) the edible a period of time and identified by an
environmental pathogen. Examples of portion of the raw agricultural establishment’s specific code.
environmental pathogens for the commodity from the crop plant and Manufacturing/processing means
purposes of this part include Listeria removing or trimming part of the raw making food from one or more
monocytogenes and Salmonella spp. but agricultural commodity (e.g., foliage, ingredients, or synthesizing, preparing,
do not include the spores of pathogenic husks, roots or stems). Examples of treating, modifying or manipulating
sporeforming bacteria. harvesting also include cooling, field food, including food crops or
Facility means a domestic facility or coring, filtering, gathering, hulling, ingredients. Examples of
a foreign facility that is required to removing stems and husks from, manufacturing/processing activities
register under section 415 of the Federal shelling, sifting, threshing, trimming of include: Baking, boiling, bottling,
outer leaves of, and washing raw canning, cooking, cooling, cutting,
Food, Drug, and Cosmetic Act, in

accordance with the requirements of agricultural commodities grown on a distilling, drying/dehydrating raw
part 1, subpart H of this chapter. farm. agricultural commodities to create a
Farm means farm as defined in Hazard means any biological, distinct commodity (such as drying/
§ 1.227 of this chapter. chemical (including radiological), or dehydrating grapes to produce raisins),
FDA means the Food and Drug physical agent that has the potential to evaporating, eviscerating, extracting
Administration. cause illness or injury. juice, formulating, freezing, grinding,
homogenizing, irradiating, labeling, hazards identified under the hazard (2) The average annual monetary
milling, mixing, packaging (including analysis that are consistent with the value of all food sold during the 3-year
modified atmosphere packaging), current scientific understanding of safe period preceding the applicable
pasteurizing, peeling, rendering, treating food manufacturing, processing, calendar year was less than $500,000,
to manipulate ripening, trimming, packing, or holding at the time of the adjusted for inflation.
washing, or waxing. For farms and farm analysis. Qualified facility exemption means an
mixed-type facilities, manufacturing/ Preventive controls qualified exemption applicable to a qualified
processing does not include activities individual means a qualified individual facility under § 117.5(a).
that are part of harvesting, packing, or who has successfully completed Qualified individual means a person
holding. training in the development and who has the education, training, or
Microorganisms means yeasts, molds, application of risk-based preventive experience (or a combination thereof)
bacteria, viruses, protozoa, and controls at least equivalent to that necessary to manufacture, process, pack,
microscopic parasites and includes received under a standardized or hold clean and safe food as
species that are pathogens. The term curriculum recognized as adequate by appropriate to the individual’s assigned
‘‘undesirable microorganisms’’ includes FDA or is otherwise qualified through duties. A qualified individual may be,
those microorganisms that are job experience to develop and apply a but is not required to be, an employee
pathogens, that subject food to food safety system. of the establishment.
decomposition, that indicate that food is Qualified auditor means a person who Quality control operation means a
contaminated with filth, or that is a qualified individual as defined in planned and systematic procedure for
otherwise may cause food to be this part and has technical expertise taking all actions necessary to prevent
adulterated. obtained through education, training, or food from being adulterated.
Mixed-type facility means an experience (or a combination thereof) Raw agricultural commodity has the
establishment that engages in both necessary to perform the auditing meaning given in section 201(r) of the
activities that are exempt from function as required by § 117.180(c)(2). Federal Food, Drug, and Cosmetic Act.
registration under section 415 of the Examples of potential qualified auditors Ready-to-eat food (RTE food) means
Federal Food, Drug, and Cosmetic Act include: any food that is normally eaten in its
and activities that require the (1) A government employee, raw state or any other food, including a
establishment to be registered. An including a foreign government processed food, for which it is
example of such a facility is a ‘‘farm employee; and reasonably foreseeable that the food will
mixed-type facility,’’ which is an (2) An audit agent of a certification be eaten without further processing that
establishment that is a farm, but also body that is accredited in accordance would significantly minimize biological
conducts activities outside the farm with regulations in part 1, subpart M of hazards.
definition that require the establishment this chapter. Receiving facility means a facility that
to be registered. Qualified end-user, with respect to a is subject to subparts C and G of this
Monitor means to conduct a planned
food, means the consumer of the food part and that manufactures/processes a
sequence of observations or
(where the term consumer does not raw material or other ingredient that it
measurements to assess whether control
include a business); or a restaurant or receives from a supplier.
measures are operating as intended.
Packing means placing food into a retail food establishment (as those terms Rework means clean, unadulterated
container other than packaging the food are defined in § 1.227 of this chapter) food that has been removed from
and also includes re-packing and that: processing for reasons other than
activities performed incidental to (1) Is located; insanitary conditions or that has been
packing or re-packing a food (e.g., (i) In the same State or the same successfully reconditioned by
activities performed for the safe or Indian reservation as the qualified reprocessing and that is suitable for use
effective packing or re-packing of that facility that sold the food to such as food.
food (such as sorting, culling, grading, restaurant or establishment; or Safe-moisture level is a level of
and weighing or conveying incidental to (ii) Not more than 275 miles from moisture low enough to prevent the
packing or re-packing), but does not such facility; and growth of undesirable microorganisms
include activities that transform a raw (2) Is purchasing the food for sale in the finished product under the
agricultural commodity into a processed directly to consumers at such restaurant intended conditions of manufacturing,
food as defined in section 201(gg) of the or retail food establishment. processing, packing, and holding. The
Federal Food, Drug, and Cosmetic Act. Qualified facility means (when safe moisture level for a food is related
Pathogen means a microorganism of including the sales by any subsidiary; to its water activity (aw). An aw will be
public health significance. affiliate; or subsidiaries or affiliates, considered safe for a food if adequate
Pest refers to any objectionable collectively, of any entity of which the data are available that demonstrate that
animals or insects including birds, facility is a subsidiary or affiliate) a the food at or below the given aw will
rodents, flies, and larvae. facility that is a very small business as not support the growth of undesirable
Plant means the building or structure defined in this part, or a facility to microorganisms.
or parts thereof, used for or in which both of the following apply: Sanitize means to adequately treat
connection with the manufacturing, (1) During the 3-year period preceding cleaned surfaces by a process that is
processing, packing, or holding of the applicable calendar year, the average effective in destroying vegetative cells of
human food. annual monetary value of the food pathogens, and in substantially reducing
Preventive controls means those risk- manufactured, processed, packed or numbers of other undesirable
based, reasonably appropriate held at such facility that is sold directly microorganisms, but without adversely
procedures, practices, and processes to qualified end-users (as defined in this affecting the product or its safety for the
that a person knowledgeable about the part) during such period exceeded the consumer.
safe manufacturing, processing, packing, average annual monetary value of the Significantly minimize means to
or holding of food would employ to food sold by such facility to all other reduce to an acceptable level, including
significantly minimize or prevent the purchasers; and to eliminate.
Small business means, for purposes of verification activities before acceptance (c) Subparts C and G of this part do
this part, a business employing fewer for use). not apply with respect to activities that
than 500 full-time equivalent You means, for purposes of this part, are subject to part 120 of this chapter
employees. the owner, operator, or agent in charge (Hazard Analysis and Critical Control
Subsidiary means any company of a facility. Point (HACCP) Systems) at a facility if
which is owned or controlled directly or you are required to comply with, and
indirectly by another company. § 117.4 Qualifications of individuals who are in compliance with, part 120 of this
Supplier means the establishment that manufacture, process, pack, or hold food.
chapter with respect to such activities.
manufactures/processes the food, raises (a) Applicability. (1) The management (d)(1) Subparts C and G of this part do
the animal, or grows the food that is of an establishment must ensure that all not apply with respect to activities that
provided to a receiving facility without individuals who manufacture, process, are subject to part 113 of this chapter
further manufacturing/processing by pack, or hold food subject to subparts B (Thermally Processed Low-Acid Foods
another establishment, except for and F of this part are qualified to Packaged in Hermetically Sealed
further manufacturing/processing that perform their assigned duties. Containers) at a facility if you are
consists solely of the addition of (2) The owner, operator, or agent in required to comply with, and are in
labeling or similar activity of a de charge of a facility must ensure that all compliance with, part 113 of this
minimis nature. individuals who manufacture, process, chapter with respect to such activities.
Supply-chain-applied control means a pack, or hold food subject to subpart C, (2) The exemption in paragraph (d)(1)
preventive control for a hazard in a raw D, E, F, or G of this part are qualified of this section is applicable only with
material or other ingredient when the to perform their assigned duties. respect to the microbiological hazards
hazard in the raw material or other (b) Qualifications of all individuals that are regulated under part 113 of this
ingredient is controlled before its engaged in manufacturing, processing, chapter.
receipt. packing, or holding food. Each (e) Subparts C and G do not apply to
Unexposed packaged food means individual engaged in manufacturing, any facility with regard to the
packaged food that is not exposed to the processing, packing, or holding food manufacturing, processing, packaging,
environment. (including temporary and seasonal or holding of a dietary supplement that
Validation means obtaining and personnel) or in the supervision thereof is in compliance with the requirements
evaluating scientific and technical must: of part 111 of this chapter (Current Good
evidence that a control measure, (1) Be a qualified individual as that Manufacturing Practice in
combination of control measures, or the term is defined in § 117.3—i.e., have the Manufacturing, Packaging, Labeling, or
food safety plan as a whole, when education, training, or experience (or a Holding Operations for Dietary
properly implemented, is capable of combination thereof) necessary to Supplements) and section 761 of the
effectively controlling the identified manufacture, process, pack, or hold Federal Food, Drug, and Cosmetic Act
hazards. clean and safe food as appropriate to the (Serious Adverse Event Reporting for
Verification means the application of individual’s assigned duties; and Dietary Supplements).
methods, procedures, tests and other (2) Receive training in the principles (f) Subparts C and G of this part do
evaluations, in addition to monitoring, of food hygiene and food safety, not apply to activities of a facility that
to determine whether a control measure including the importance of employee are subject to section 419 of the Federal
or combination of control measures is or health and personal hygiene, as Food, Drug, and Cosmetic Act
has been operating as intended and to appropriate to the food, the facility and (Standards for Produce Safety).
establish the validity of the food safety the individual’s assigned duties. (g)(1) The exemption in paragraph
plan. (c) Additional qualifications of (g)(3) of this section applies to packing
Very small business means, for supervisory personnel. Responsibility or holding of processed foods on a farm
purposes of this part, a business for ensuring compliance by individuals mixed-type facility, except for processed
(including any subsidiaries and with the requirements of this part must foods produced by drying/dehydrating
affiliates) averaging less than be clearly assigned to supervisory raw agricultural commodities to create a
$1,000,000, adjusted for inflation, per personnel who have the education, distinct commodity (such as drying/
year, during the 3-year period preceding training, or experience (or a dehydrating grapes to produce raisins,
the applicable calendar year in sales of combination thereof) necessary to and drying/dehydrating fresh herbs to
human food plus the market value of supervise the production of clean and produce dried herbs), and packaging
human food manufactured, processed, safe food. and labeling such commodities, without
packed, or held without sale (e.g., held (d) Records. Records that document additional manufacturing/processing
for a fee). training required by paragraph (b)(2) of (such as chopping and slicing), the
Water activity (aw) is a measure of the this section must be established and packing and holding of which are
free moisture in a food and is the maintained. within the ‘‘farm’’ definition in § 1.227
quotient of the water vapor pressure of of this chapter. Activities that are within
the substance divided by the vapor § 117.5 Exemptions. the ‘‘farm’’ definition, when conducted
pressure of pure water at the same (a) Except as provided by subpart E of on a farm mixed-type facility, are not
temperature. this part, subparts C and G of this part subject to the requirements of subparts
Written procedures for receiving raw does not apply to a qualified facility. C and G of this part and therefore do not
materials and other ingredients means Qualified facilities are subject to the need to be specified in the exemption.
written procedures to ensure that raw modified requirements in § 117.201. (2) For the purposes of paragraphs
materials and other ingredients are (b) Subparts C and G of this part do (g)(3) and (h)(3) of this section, the
received only from suppliers approved not apply with respect to activities that following terms describe the foods
by the receiving facility (or, when are subject to part 123 of this chapter associated with the activity/food
necessary and appropriate, on a (Fish and Fishery Products) at a facility combinations. Several foods that are
temporary basis from unapproved if you are required to comply with, and fruits or vegetables are separately
suppliers whose raw materials or other are in compliance with, part 123 of this considered for the purposes of these
ingredients are subjected to adequate chapter with respect to such activities. activity/food combinations (i.e., coffee
beans, cocoa beans, fresh herbs, products made without additional legumes; pitted, dried fruits; sliced,
peanuts, sugarcane, sugar beets, tree manufacturing/processing beyond dried apples; snack chips);
nuts, seeds for direct consumption) to drying/dehydrating, packaging, and/or (xiv) Other grain products (e.g., dried
appropriately address specific hazards labeling as described in paragraph pasta, oat flakes, and popcorn);
associated with these foods and/or (g)(2)(v) of this section. This category (xv) Other herb and spice products
processing activities conducted on these also does not include products that (e.g., chopped or ground dried herbs,
foods. require time/temperature control for herbal extracts);
(i) Dried/dehydrated fruit and safety, such as fresh herb-infused oils. (xvi) Peanut and tree nut products
vegetable products includes only those (vii) Grains include barley, dent- or (e.g., roasted peanuts and tree nut
processed food products such as raisins flint-corn, sorghum, oats, rice, rye, flours);
and dried legumes made without wheat, amaranth, quinoa, buckwheat (xvii) Processed seeds for direct
additional manufacturing/processing and oilseeds for oil extraction (such as consumption (e.g., roasted pumpkin
beyond drying/dehydrating, packaging, cotton seed, flax seed, rapeseed, seeds);
and/or labeling. soybeans, and sunflower seed). (xviii) Soft drinks and carbonated
(ii) Other fruit and vegetable products (viii) Milled grain products include water;
includes those processed food products processed food products such as flour, (xix) Sugar;
that have undergone one or more of the bran, and corn meal. (xx) Syrups (e.g., maple syrup and
following processes: acidification, (ix) Baked goods include processed agave syrup);
boiling, canning, coating with things food products such as breads, brownies, (xxi) Trail mix and granola;
other than wax/oil/resin, cooking, cakes, cookies, and crackers. This (xxii) Vinegar; and
cutting, chopping, grinding, peeling, (xxiii) Any other processed food that
category does not include products that
shredding, slicing, or trimming. does not require time/temperature
require time/temperature control for
Examples include flours made from control for safety (e..g., vitamins,
safety, such as cream-filled pastries.
legumes (such as chickpea flour), (x) Other grain products include minerals, and dietary ingredients (e.g.,
pickles, and snack chips made from processed food products such as dried bone meal) in powdered, granular, or
potatoes or plantains. Examples also cereal, dried pasta, oat flakes, and other solid form).
include dried fruit and vegetable (h)(1) The exemption in paragraph
popcorn. This category does not include
products made with additional (h)(3) of this section applies to
milled grain products as described in
manufacturing/processing (such as manufacturing/processing of foods on a
paragraph (g)(2)(viii) of this section or
dried apple slices; pitted, dried plums, farm mixed-type facility, except for
baked goods as described in paragraph
cherries, and apricots; and sulfited manufacturing/processing that is within
(g)(2)(ix) of this section.
raisins). This category does not include (3) Subparts C and G of this part do the ‘‘farm’’ definition in § 1.227 of this
dried/dehydrated fruit and vegetable not apply to on-farm packing or holding chapter. Drying/dehydrating raw
products made without additional of food by a small or very small agricultural commodities to create a
manufacturing/processing as described business, and § 117.201 does not apply distinct commodity (such as drying/
in paragraph (g)(2)(i) of this section. to on-farm packing or holding of food by dehydrating grapes to produce raisins,
This category also does not include a very small business, if the only and drying/dehydrating fresh herbs to
products that require time/temperature packing and holding activities subject to produce dried herbs), and packaging
control for safety (such as fresh-cut section 418 of the Federal Food, Drug, and labeling such commodities, without
fruits and vegetables). and Cosmetic Act that the business additional manufacturing/processing
(iii) Peanut and tree nut products conducts are the following low-risk (such as chopping and slicing), are
includes processed food products such packing or holding activity/food within the ‘‘farm’’ definition in § 1.227
as roasted peanuts and tree nuts, combinations—i.e., packing (or re- of this chapter. In addition, treatment to
seasoned peanuts and tree nuts, and packing) (including weighing or manipulate ripening of raw agricultural
peanut and tree nut flours. conveying incidental to packing or re- commodities (such as by treating
(iv) Processed seeds for direct packing); sorting, culling, or grading produce with ethylene gas), and
consumption include processed food incidental to packing or storing; and packaging and labeling the treated raw
products such as roasted pumpkin storing (ambient, cold and controlled agricultural commodities, without
seeds, roasted sunflower seeds, and atmosphere) of: additional manufacturing/processing, is
roasted flax seeds. (i) Baked goods (e.g., bread and within the ‘‘farm’’ definition. In
(v) Dried/dehydrated herb and spice cookies); addition, coating intact fruits and
products includes only processed food (ii) Candy (e.g., hard candy, fudge, vegetables with wax, oil, or resin used
products such as dried intact herbs maple candy, maple cream, nut brittles, for the purpose of storage or
made without additional taffy, and toffee); transportation is within the ‘‘farm’’
manufacturing/processing beyond (iii) Cocoa beans (roasted); definition. Activities that are within the
drying/dehydrating, packaging, and/or (iv) Cocoa products; ‘‘farm’’ definition, when conducted on a
labeling. (v) Coffee beans (roasted); farm mixed-type facility, are not subject
(vi) Other herb and spice products (vi) Game meat jerky; to the requirements of subparts C and G
includes those processed food products (vii) Gums, latexes, and resins that are of this part and therefore do not need to
such as chopped fresh herbs, chopped processed foods; be specified in the exemption.
or ground dried herbs (including tea), (viii) Honey (pasteurized); (2) The terms in paragraph (g)(2) of
herbal extracts (e.g., essential oils, (ix) Jams, jellies, and preserves; this section describe certain foods
extracts containing more than 20 associated with the activity/food
(x) Milled grain products (e.g., flour,

percent ethanol, extracts containing bran, and corn meal); combinations in paragraph (h)(3) of this
more than 35 percent glycerin), dried (xi) Molasses and treacle; section.
herb- or spice-infused honey, and dried (xii) Oils (e.g., olive oil and sunflower (3) Subparts C and G of this part do
herb- or spice-infused oils and/or seed oil); not apply to on-farm manufacturing/
vinegars. This category does not include (xiii) Other fruit and vegetable processing activities conducted by a
dried/dehydrated herb and spice products (e.g., flours made from small or very small business for
distribution into commerce, and other fruit and vegetable products with (xii) Making dried pasta from grains;
§ 117.201 does not apply to on-farm pH less than 4.2 (e.g., cut fruits and (xiii) Making jams, jellies, and
manufacturing/processing activities vegetables); preserves from acid fruits and
conducted by a very small business for (vii) Grinding/cracking/crushing/ vegetables with a pH of 4.6 or below;
distribution into commerce, if the only milling baked goods (e.g., crackers), (xiv) Making molasses and treacle
manufacturing/processing activities cocoa beans (roasted), coffee beans from sugar beets and sugarcane;
subject to section 418 of the Federal (roasted), dried/dehydrated fruit and (xv) Making oat flakes from grains;
Food, Drug, and Cosmetic Act that the vegetable products (e.g., raisins and (xvi) Making popcorn from grains;
business conducts are the following dried legumes), dried/dehydrated herb (xvii) Making snack chips from fruits
low-risk manufacturing/processing and spice products (e.g., intact dried and vegetables (e.g., making plantain
activity/food combinations: basil), grains (e.g., oats, rice, rye, wheat), and potato chips);
(i) Boiling gums, latexes, and resins; other fruit and vegetable products (e.g., (xviii) Making soft drinks and
(ii) Chopping, coring, cutting, peeling, dried, pitted dates), other grain products carbonated water from sugar, syrups,
pitting, shredding, and slicing acid (e.g., dried cereal), other herb and spice and water;
fruits and vegetables that have a pH less products (e.g., chopped dried herbs), (xix) Making sugars and syrups from
than 4.2 (e.g., cutting lemons and limes), peanuts and tree nuts, and peanut and fruits and vegetables (e.g., dates), grains
baked goods (e.g., slicing bread), dried/ tree nut products (e.g., roasted peanuts); (e.g., rice, sorghum), other grain
dehydrated fruit and vegetable products (viii) Labeling baked goods that do not products (e.g., malted grains such as
(e.g., pitting dried plums), dried herbs contain food allergens, candy that does barley), saps (e.g., agave, birch, maple,
and other spices (e.g., chopping intact, not contain food allergens, cocoa beans palm), sugar beets, and sugarcane;
dried basil), game meat jerky, gums/ (roasted), cocoa products that do not (xx) Making trail mix and granola
latexes/resins, other grain products (e.g., contain food allergens), coffee beans from cocoa products (e.g., chocolate),
shredding dried cereal), peanuts and (roasted), game meat jerky, gums/ dried/dehydrated fruit and vegetable
tree nuts, and peanut and tree nut latexes/resins that are processed foods, products (e.g., raisins), other fruit and
products (e.g., chopping roasted honey (pasteurized), jams/jellies/ vegetable products (e.g., chopped dried
peanuts); preserves, milled grain products that do fruits), other grain products (e.g., oat
(iii) Coating dried/dehydrated fruit not contain food allergens (e.g., corn flakes), peanut and tree nut products,
and vegetable products (e.g., coating meal) or that are single-ingredient foods and processed seeds for direct
raisins with chocolate), other fruit and (e.g., wheat flour, wheat bran), molasses consumption, provided that peanuts,
vegetable products except for non-dried, and treacle, oils, other fruit and tree nuts, and processed seeds are
non-intact fruits and vegetables (e.g., vegetable products that do not contain treated to significantly minimize
coating dried plum pieces, dried pitted food allergens (e.g., snack chips made pathogens;
cherries, and dried pitted apricots with from potatoes or plantains), other grain (xxi) Making vinegar from fruits and
chocolate are low-risk activity/food products that do not contain food vegetables, other fruit and vegetable
combinations but coating apples on a allergens (e.g., popcorn), other herb and products (e.g., fruit wines, apple cider),
stick with caramel is not a low-risk spice products (e.g., chopped or ground and other grain products (e.g., malt);
activity/food combination), other grain dried herbs), peanut or tree nut (xxii) Mixing baked goods (e.g., types
products (e.g., adding caramel to products, (provided that they are single- of cookies), candy (e.g., varieties of
popcorn or adding seasonings to ingredient, or are in forms in which the taffy), cocoa beans (roasted), coffee
popcorn provided that the seasonings consumer can reasonably be expected to beans (roasted), dried/dehydrated fruit
have been treated to significantly recognize the food allergen(s) without and vegetable products (e.g., dried
minimize pathogens, peanuts and tree label declaration, or both (e.g., roasted blueberries, dried currants, and raisins),
nuts (e.g., adding seasonings provided or seasoned whole nuts, single- dried/dehydrated herb and spice
that the seasonings have been treated to ingredient peanut or tree nut flours)), products (e.g., dried, intact basil and
significantly minimize pathogens), and processed seeds for direct consumption, dried, intact oregano), honey
peanut and tree nut products (e.g., soft drinks and carbonated water, sugar, (pasteurized), milled grain products
adding seasonings provided that the syrups, trail mix and granola (other than (e.g., flour, bran, and corn meal), other
seasonings have been treated to those containing milk chocolate and fruit and vegetable products (e.g., dried,
significantly minimize pathogens)); provided that peanuts and/or tree nuts sliced apples and dried, sliced peaches),
(iv) Drying/dehydrating (that includes are in forms in which the consumer can other grain products (e.g., different
additional manufacturing or is reasonably be expected to recognize the types of dried pasta), other herb and
performed on processed foods) other food allergen(s) without label spice products (e.g., chopped or ground
fruit and vegetable products with pH declaration), vinegar, and any other dried herbs, dried herb- or spice-infused
less than 4.2 (e.g., drying cut fruit and processed food that does not require honey, and dried herb- or spice-infused
vegetables with pH less than 4.2), and time/temperature control for safety and oils and/or vinegars), peanut and tree
other herb and spice products (e.g., that does not contain food allergens nut products, sugar, syrups, vinegar,
drying chopped fresh herbs, including (e.g., vitamins, minerals, and dietary and any other processed food that does
tea); ingredients (e.g., bone meal) in not require time/temperature control for
(v) Extracting (including by pressing, powdered, granular, or other solid safety (e.g., vitamins, minerals, and
by distilling, and by solvent extraction) form); dietary ingredients (e.g., bone meal) in
from dried/dehydrated herb and spice (ix) Making baked goods from milled powdered, granular, or other solid
products (e.g., dried mint), fresh herbs grain products (e.g., breads and form);
(e.g., fresh mint), fruits and vegetables (xxiii) Packaging baked goods (e.g.,
cookies);
(e.g., olives, avocados), grains (e.g., (x) Making candy from peanuts and bread and cookies), candy, cocoa beans
oilseeds), and other herb and spice tree nuts (e.g., nut brittles), sugar/syrups (roasted), cocoa products, coffee beans
products (e.g., chopped fresh mint, (e.g., taffy, toffee), and saps (e.g., maple (roasted), game meat jerky, gums/
chopped dried mint); candy, maple cream); latexes/resins that are processed foods,
(vi) Freezing acid fruits and (xi) Making cocoa products from honey (pasteurized), jams/jellies/
vegetables with pH less than 4.2 and roasted cocoa beans; preserves, milled grain products (e.g.,
flour, bran, corn meal), molasses and agricultural commodities (other than requirement for raw agricultural
treacle, oils, other fruit and vegetable fruits and vegetables) intended for commodities that are produce as
products (e.g., pitted, dried fruits; further distribution or processing. defined in part 112 of this chapter may
sliced, dried apples; snack chips), other (k)(1) Except as provided by be achieved by complying with subpart
grain products (e.g., popcorn), other paragraph (k)(2) of this section, subpart B of this part or with the applicable
herb and spice products (e.g., chopped B of this part does not apply to any of requirements for packing and holding in
or ground dried herbs), peanut and tree the following: part 112 of this chapter.
nut products, processed seeds for direct (i) ‘‘Farms’’ (as defined in § 1.227 of
consumption, soft drinks and this chapter); § 117.9 Records required for this subpart.
carbonated water, sugar, syrups, trail (ii) Fishing vessels that are not subject (a) Records that document training
mix and granola, vinegar, and any other to the registration requirements of part required by § 117.4(b)(2) must be
processed food that does not require 1, subpart H of this chapter in established and maintained.
time/temperature control for safety (e.g., accordance with § 1.226(f) of this (b) The records that must be
vitamins, minerals, and dietary chapter; established and maintained are subject
ingredients (e.g., bone meal) in (iii) Establishments solely engaged in to the requirements of subpart F of this
powdered, granular, or other solid the holding and/or transportation of one part.
form); or more raw agricultural commodities;
(xxiv) Pasteurizing honey; (iv) Activities of ‘‘farm mixed-type Subpart B—Current Good
(xxv) Roasting and toasting baked facilities’’ (as defined in § 1.227 of this Manufacturing Practice
goods (e.g., toasting bread for croutons); chapter) that fall within the definition of § 117.10 Personnel.
(xxvi) Salting other grain products ‘‘farm’’; or
(e.g., soy nuts), peanut and tree nut The management of the establishment
(v) Establishments solely engaged in must take reasonable measures and
products, and processed seeds for direct hulling, shelling, drying, packing, and/
consumption; and precautions to ensure the following:
or holding nuts (without additional (a) Disease control. Any person who,
(xxvii) Sifting milled grain products manufacturing/processing, such as
(e.g., flour, bran, corn meal), other fruit by medical examination or supervisory
roasting nuts). observation, is shown to have, or
and vegetable products (e.g., chickpea (2) If a ‘‘farm’’ or ‘‘farm mixed-type
flour), and peanut and tree nut products appears to have, an illness, open lesion,
facility’’ dries/dehydrates raw including boils, sores, or infected
(e.g., peanut flour, almond flour). agricultural commodities that are
(i)(1) Subparts C and G of this part do wounds, or any other abnormal source
produce as defined in part 112 of this of microbial contamination by which
not apply with respect to alcoholic chapter to create a distinct commodity,
beverages at a facility that meets the there is a reasonable possibility of food,
subpart B of this part applies to the food-contact surfaces, or food-packaging
following two conditions: packaging, packing, and holding of the
(i) Under the Federal Alcohol materials becoming contaminated, must
dried commodities. Compliance with be excluded from any operations which
Administration Act (27 U.S.C. 201 et this requirement may be achieved by
seq.) or chapter 51 of subtitle E of the may be expected to result in such
complying with subpart B of this part or contamination until the condition is
Internal Revenue Code of 1986 (26 with the applicable requirements for
U.S.C. 5001 et seq.) the facility is corrected, unless conditions such as
packing and holding in part 112 of this open lesions, boils, and infected
required to obtain a permit from, chapter.
register with, or obtain approval of a wounds are adequately covered (e.g., by
notice or application from the Secretary § 117.7 Applicability of subparts C, D, and an impermeable cover). Personnel must
of the Treasury as a condition of doing G of this part to a facility solely engaged in be instructed to report such health
business in the United States, or is a the storage of unexposed packaged food. conditions to their supervisors.
foreign facility of a type that would (a) Applicability of subparts C and G. (b) Cleanliness. All persons working
require such a permit, registration, or Subparts C and G of this part do not in direct contact with food, food-contact
approval if it were a domestic facility; apply to a facility solely engaged in the surfaces, and food-packaging materials
and storage of unexposed packaged food. must conform to hygienic practices
(ii) Under section 415 of the Federal (b) Applicability of subpart D. A while on duty to the extent necessary to
Food, Drug, and Cosmetic Act the facility solely engaged in the storage of protect against allergen cross-contact
facility is required to register as a unexposed packaged food, including and against contamination of food. The
facility because it is engaged in unexposed packaged food that requires methods for maintaining cleanliness
manufacturing, processing, packing, or time/temperature control to include:
holding one or more alcoholic significantly minimize or prevent the (1) Wearing outer garments suitable to
beverages. growth of, or toxin production by, the operation in a manner that protects
(2) Subparts C and G of this part do pathogens is subject to the modified against allergen cross-contact and
not apply with respect to food that is requirements in § 117.206 for any against the contamination of food, food-
not an alcoholic beverage at a facility unexposed packaged food that requires contact surfaces, or food-packaging
described in paragraph (i)(1) of this time/temperature control to materials.
section, provided such food: significantly minimize or prevent the (2) Maintaining adequate personal
(i) Is in prepackaged form that growth of, or toxin production by, cleanliness.
prevents any direct human contact with pathogens. (3) Washing hands thoroughly (and
such food; and sanitizing if necessary to protect against
(ii) Constitutes not more than 5 § 117.8 Applicability of subpart B of this contamination with undesirable
percent of the overall sales of the part to the off-farm packing and holding of microorganisms) in an adequate hand-
facility, as determined by the Secretary raw agricultural commodities. washing facility before starting work,
of the Treasury. Subpart B of this part applies to the after each absence from the work
(j) Subparts C and G of this part do off-farm packaging, packing, and station, and at any other time when the
not apply to facilities that are solely holding of raw agricultural hands may have become soiled or
engaged in the storage of raw commodities. Compliance with this contaminated.
(4) Removing all unsecured jewelry through (4) of this section, care must be provide shatter-resistant light bulbs,
and other objects that might fall into exercised in the plant by inspection, fixtures, skylights, or other glass
food, equipment, or containers, and extermination, or other means to suspended over exposed food in any
removing hand jewelry that cannot be exclude pests, dirt, and filth that may be step of preparation or otherwise protect
adequately sanitized during periods in a source of food contamination. against food contamination in case of
which food is manipulated by hand. If (b) Plant construction and design. The glass breakage.
such hand jewelry cannot be removed, plant must be suitable in size, (6) Provide adequate ventilation or
it may be covered by material which can construction, and design to facilitate control equipment to minimize dust,
be maintained in an intact, clean, and maintenance and sanitary operations for odors and vapors (including steam and
sanitary condition and which effectively food-production purposes (i.e., noxious fumes) in areas where they may
protects against the contamination by manufacturing, processing, packing, and cause allergen cross-contact or
these objects of the food, food-contact holding). The plant must: contaminate food; and locate and
surfaces, or food-packaging materials. (1) Provide adequate space for such operate fans and other air-blowing
(5) Maintaining gloves, if they are placement of equipment and storage of equipment in a manner that minimizes
used in food handling, in an intact, materials as is necessary for the potential for allergen cross-contact
clean, and sanitary condition. maintenance, sanitary operations, and and for contaminating food, food-
(6) Wearing, where appropriate, in an the production of safe food. packaging materials, and food-contact
effective manner, hair nets, headbands, (2) Permit the taking of adequate surfaces.
caps, beard covers, or other effective precautions to reduce the potential for (7) Provide, where necessary,
hair restraints. allergen cross-contact and for adequate screening or other protection
(7) Storing clothing or other personal contamination of food, food-contact against pests.
belongings in areas other than where surfaces, or food-packaging materials
food is exposed or where equipment or with microorganisms, chemicals, filth, § 117.35 Sanitary operations.
utensils are washed. and other extraneous material. The (a) General maintenance. Buildings,
(8) Confining the following to areas potential for allergen cross-contact and fixtures, and other physical facilities of
other than where food may be exposed for contamination may be reduced by the plant must be maintained in a clean
or where equipment or utensils are adequate food safety controls and and sanitary condition and must be kept
washed: eating food, chewing gum, operating practices or effective design, in repair adequate to prevent food from
drinking beverages, or using tobacco. including the separation of operations becoming adulterated. Cleaning and
(9) Taking any other necessary in which allergen cross-contact and sanitizing of utensils and equipment
precautions to protect against allergen contamination are likely to occur, by must be conducted in a manner that
cross-contact and against contamination one or more of the following means: protects against allergen cross-contact
of food, food-contact surfaces, or food- location, time, partition, air flow and against contamination of food, food-
packaging materials with systems, dust control systems, enclosed contact surfaces, or food-packaging
microorganisms or foreign substances systems, or other effective means. materials.
(including perspiration, hair, cosmetics, (3) Permit the taking of adequate (b) Substances used in cleaning and
tobacco, chemicals, and medicines precautions to protect food in installed sanitizing; storage of toxic materials. (1)
applied to the skin). outdoor bulk vessels by any effective Cleaning compounds and sanitizing
means, including: agents used in cleaning and sanitizing
§ 117.20 Plant and grounds. (i) Using protective coverings. procedures must be free from
(a) Grounds. The grounds about a food (ii) Controlling areas over and around undesirable microorganisms and must
plant under the control of the operator the vessels to eliminate harborages for be safe and adequate under the
must be kept in a condition that will pests. conditions of use. Compliance with this
protect against the contamination of (iii) Checking on a regular basis for requirement must be verified by any
food. The methods for adequate pests and pest infestation. effective means, including purchase of
maintenance of grounds must include: (iv) Skimming fermentation vessels, these substances under a letter of
(1) Properly storing equipment, as necessary. guarantee or certification or
removing litter and waste, and cutting (4) Be constructed in such a manner examination of these substances for
weeds or grass within the immediate that floors, walls, and ceilings may be contamination. Only the following toxic
vicinity of the plant that may constitute adequately cleaned and kept clean and materials may be used or stored in a
an attractant, breeding place, or kept in good repair; that drip or plant where food is processed or
harborage for pests. condensate from fixtures, ducts and exposed:
(2) Maintaining roads, yards, and pipes does not contaminate food, food- (i) Those required to maintain clean
parking lots so that they do not contact surfaces, or food-packaging and sanitary conditions;
constitute a source of contamination in materials; and that aisles or working (ii) Those necessary for use in
areas where food is exposed. spaces are provided between equipment laboratory testing procedures;
(3) Adequately draining areas that and walls and are adequately (iii) Those necessary for plant and
may contribute contamination to food unobstructed and of adequate width to equipment maintenance and operation;
by seepage, foot-borne filth, or permit employees to perform their and
providing a breeding place for pests. duties and to protect against (iv) Those necessary for use in the
(4) Operating systems for waste contaminating food, food-contact plant’s operations.
treatment and disposal in an adequate surfaces, or food-packaging materials (2) Toxic cleaning compounds,
manner so that they do not constitute a with clothing or personal contact. sanitizing agents, and pesticide
source of contamination in areas where (5) Provide adequate lighting in hand- chemicals must be identified, held, and
food is exposed. washing areas, dressing and locker stored in a manner that protects against
(5) If the plant grounds are bordered rooms, and toilet rooms and in all areas contamination of food, food-contact
by grounds not under the operator’s where food is examined, manufactured, surfaces, or food-packaging materials.
control and not maintained in the processed, packed, or held and where (c) Pest control. Pests must not be
manner described in paragraphs (a)(1) equipment or utensils are cleaned; and allowed in any area of a food plant.
Guard, guide, or pest-detecting dogs surfaces from allergen cross-contact and becoming an attractant and harborage or
may be allowed in some areas of a plant from contamination. breeding place for pests, and protect
if the presence of the dogs is unlikely to against contamination of food, food-
result in contamination of food, food- § 117.37 Sanitary facilities and controls. contact surfaces, food-packaging
contact surfaces, or food-packaging Each plant must be equipped with materials, water supplies, and ground
materials. Effective measures must be adequate sanitary facilities and surfaces.
taken to exclude pests from the accommodations including:
manufacturing, processing, packing, and (a) Water supply. The water supply § 117.40 Equipment and utensils.
holding areas and to protect against the must be adequate for the operations (a)(1) All plant equipment and
contamination of food on the premises intended and must be derived from an utensils used in manufacturing,
by pests. The use of pesticides to control adequate source. Any water that processing, packing, or holding food
pests in the plant is permitted only contacts food, food-contact surfaces, or must be so designed and of such
under precautions and restrictions that food-packaging materials must be safe material and workmanship as to be
will protect against the contamination of and of adequate sanitary quality. adequately cleanable, and must be
food, food-contact surfaces, and food- Running water at a suitable temperature, adequately maintained to protect against
packaging materials. and under pressure as needed, must be allergen cross-contact and
(d) Sanitation of food-contact provided in all areas where required for contamination.
surfaces. All food-contact surfaces, the processing of food, for the cleaning (2) Equipment and utensils must be
including utensils and food-contact of equipment, utensils, and food- designed, constructed, and used
surfaces of equipment, must be cleaned packaging materials, or for employee appropriately to avoid the adulteration
as frequently as necessary to protect sanitary facilities. of food with lubricants, fuel, metal
against allergen cross-contact and (b) Plumbing. Plumbing must be of fragments, contaminated water, or any
against contamination of food. adequate size and design and other contaminants.
adequately installed and maintained to: (3) Equipment must be installed so as
(1) Food-contact surfaces used for
(1) Carry adequate quantities of water to facilitate the cleaning and
manufacturing/processing, packing, or
to required locations throughout the maintenance of the equipment and of
holding low-moisture food must be in a
plant. adjacent spaces.
clean, dry, sanitary condition before
(2) Properly convey sewage and liquid (4) Food-contact surfaces must be
use. When the surfaces are wet-cleaned,
disposable waste from the plant. corrosion-resistant when in contact with
they must, when necessary, be sanitized (3) Avoid constituting a source of food.
and thoroughly dried before subsequent contamination to food, water supplies, (5) Food-contact surfaces must be
use. equipment, or utensils or creating an made of nontoxic materials and
(2) In wet processing, when cleaning unsanitary condition. designed to withstand the environment
is necessary to protect against allergen (4) Provide adequate floor drainage in of their intended use and the action of
cross-contact or the introduction of all areas where floors are subject to food, and, if applicable, cleaning
microorganisms into food, all food- flooding-type cleaning or where normal compounds, sanitizing agents, and
contact surfaces must be cleaned and operations release or discharge water or cleaning procedures.
sanitized before use and after any other liquid waste on the floor. (6) Food-contact surfaces must be
interruption during which the food- (5) Provide that there is not backflow maintained to protect food from allergen
contact surfaces may have become from, or cross-connection between, cross-contact and from being
contaminated. Where equipment and piping systems that discharge waste contaminated by any source, including
utensils are used in a continuous water or sewage and piping systems that unlawful indirect food additives.
production operation, the utensils and carry water for food or food (b) Seams on food-contact surfaces
food-contact surfaces of the equipment manufacturing. must be smoothly bonded or maintained
must be cleaned and sanitized as (c) Sewage disposal. Sewage must be so as to minimize accumulation of food
necessary. disposed of into an adequate sewerage particles, dirt, and organic matter and
(3) Single-service articles (such as system or disposed of through other thus minimize the opportunity for
utensils intended for one-time use, adequate means. growth of microorganisms and allergen
paper cups, and paper towels) must be (d) Toilet facilities. Each plant must cross-contact.
stored, handled, and disposed of in a provide employees with adequate, (c) Equipment that is in areas where
manner that protects against allergen readily accessible toilet facilities. Toilet food is manufactured, processed,
cross-contact and against contamination facilities must be kept clean and must packed, or held and that does not come
of food, food-contact surfaces, or food- not be a potential source of into contact with food must be so
packaging materials. contamination of food, food-contact constructed that it can be kept in a clean
(e) Sanitation of non-food-contact surfaces, or food-packaging materials. and sanitary condition.
surfaces. Non-food-contact surfaces of (e) Hand-washing facilities. Each (d) Holding, conveying, and
equipment used in the operation of a plant must provide hand-washing manufacturing systems, including
food plant must be cleaned in a manner facilities designed to ensure that an gravimetric, pneumatic, closed, and
and as frequently as necessary to protect employee’s hands are not a source of automated systems, must be of a design
against allergen cross-contact and contamination of food, food-contact and construction that enables them to be
against contamination of food, food- surfaces, or food-packaging materials, by maintained in an appropriate clean and
contact surfaces, and food-packaging providing facilities that are adequate, sanitary condition.
materials. convenient, and furnish running water (e) Each freezer and cold storage
(f) Storage and handling of cleaned at a suitable temperature. compartment used to store and hold
portable equipment and utensils. (f) Rubbish and offal disposal. food capable of supporting growth of
Cleaned and sanitized portable Rubbish and any offal must be so microorganisms must be fitted with an
equipment with food-contact surfaces conveyed, stored, and disposed of as to indicating thermometer, temperature-
and utensils must be stored in a location minimize the development of odor, measuring device, or temperature-
and manner that protects food-contact minimize the potential for the waste recording device so installed as to show
the temperature accurately within the allergen cross-contact or increase the (3) Food that can support the rapid
compartment. level of contamination of the food. growth of undesirable microorganisms
(f) Instruments and controls used for (2) Raw materials and other must be held at temperatures that will
measuring, regulating, or recording ingredients must either not contain prevent the food from becoming
temperatures, pH, acidity, water levels of microorganisms that may adulterated during manufacturing,
activity, or other conditions that control render the food injurious to the health processing, packing, and holding.
or prevent the growth of undesirable of humans, or they must be pasteurized (4) Measures such as sterilizing,
microorganisms in food must be or otherwise treated during irradiating, pasteurizing, cooking,
accurate and precise and adequately manufacturing operations so that they freezing, refrigerating, controlling pH, or
maintained, and adequate in number for no longer contain levels that would controlling aw that are taken to destroy
their designated uses. cause the product to be adulterated. or prevent the growth of undesirable
(g) Compressed air or other gases (3) Raw materials and other microorganisms must be adequate under
mechanically introduced into food or ingredients susceptible to the conditions of manufacture,
used to clean food-contact surfaces or contamination with aflatoxin or other handling, and distribution to prevent
equipment must be treated in such a natural toxins must comply with FDA food from being adulterated.
way that food is not contaminated with regulations for poisonous or deleterious (5) Work-in-process and rework must
unlawful indirect food additives. substances before these raw materials or be handled in a manner that protects
other ingredients are incorporated into against allergen cross-contact,
§ 117.80 Processes and controls. contamination, and growth of
finished food.
(a) General. (1) All operations in the undesirable microorganisms.
(4) Raw materials, other ingredients,
manufacturing, processing, packing, and (6) Effective measures must be taken
and rework susceptible to
holding of food (including operations to protect finished food from allergen
contamination with pests, undesirable
directed to receiving, inspecting, cross-contact and from contamination
microorganisms, or extraneous material
transporting, and segregating) must be by raw materials, other ingredients, or
must comply with applicable FDA
conducted in accordance with adequate refuse. When raw materials, other
regulations for natural or unavoidable
sanitation principles. ingredients, or refuse are unprotected,
(2) Appropriate quality control defects if a manufacturer wishes to use
the materials in manufacturing food. they must not be handled
operations must be employed to ensure simultaneously in a receiving, loading,
that food is suitable for human (5) Raw materials, other ingredients,
and rework must be held in bulk, or in or shipping area if that handling could
consumption and that food-packaging result in allergen cross-contact or
materials are safe and suitable. containers designed and constructed so
as to protect against allergen cross- contaminated food. Food transported by
(3) Overall sanitation of the plant conveyor must be protected against
must be under the supervision of one or contact and against contamination and
must be held at such temperature and allergen cross-contact and against
more competent individuals assigned contamination as necessary.
responsibility for this function. relative humidity and in such a manner
as to prevent the food from becoming (7) Equipment, containers, and
(4) Adequate precautions must be utensils used to convey, hold, or store
taken to ensure that production adulterated. Material scheduled for
rework must be identified as such. raw materials and other ingredients,
procedures do not contribute to allergen work-in-process, rework, or other food
cross-contact and to contamination from (6) Frozen raw materials and other
ingredients must be kept frozen. If must be constructed, handled, and
any source. maintained during manufacturing,
(5) Chemical, microbial, or thawing is required prior to use, it must
be done in a manner that prevents the processing, packing, and holding in a
extraneous-material testing procedures manner that protects against allergen
must be used where necessary to raw materials and other ingredients
from becoming adulterated. cross-contact and against
identify sanitation failures or possible contamination.
allergen cross-contact and food (7) Liquid or dry raw materials and
(8) Adequate measures must be taken
contamination. other ingredients received and stored in
to protect against the inclusion of metal
(6) All food that has become bulk form must be held in a manner that
or other extraneous material in food.
contaminated to the extent that it is protects against allergen cross-contact (9) Food, raw materials, and other
adulterated must be rejected, or if and against contamination. ingredients that are adulterated:
appropriate, treated or processed to (8) Raw materials and other (i) Must be disposed of in a manner
eliminate the contamination. ingredients that are food allergens, and that protects against the contamination
(b) Raw materials and other rework that contains food allergens, of other food; or
ingredients. (1) Raw materials and other must be identified and held in a manner (ii) If the adulterated food is capable
ingredients must be inspected and that prevents allergen cross-contact. of being reconditioned, it must be:
segregated or otherwise handled as (c) Manufacturing operations. (1) (A) Reconditioned (if appropriate)
necessary to ascertain that they are Equipment and utensils and food using a method that has been proven to
clean and suitable for processing into containers must be maintained in an be effective; or
food and must be stored under adequate condition through appropriate (B) Reconditioned (if appropriate) and
conditions that will protect against cleaning and sanitizing, as necessary. reexamined and subsequently found not
allergen cross-contact and against Insofar as necessary, equipment must be to be adulterated within the meaning of
contamination and minimize taken apart for thorough cleaning. the Federal Food, Drug, and Cosmetic
deterioration. Raw materials must be (2) All food manufacturing, Act before being incorporated into other
washed or cleaned as necessary to processing, packing, and holding must food.
remove soil or other contamination. be conducted under such conditions (10) Steps such as washing, peeling,
Water used for washing, rinsing, or and controls as are necessary to trimming, cutting, sorting and
conveying food must be safe and of minimize the potential for the growth of inspecting, mashing, dewatering,
adequate sanitary quality. Water may be microorganisms, allergen cross-contact, cooling, shredding, extruding, drying,
reused for washing, rinsing, or contamination of food, and deterioration whipping, defatting, and forming must
conveying food if it does not cause of food. be performed so as to protect food
against allergen cross-contact and times utilize quality control operations (i) Biological hazards, including
against contamination. Food must be that reduce natural or unavoidable microbiological hazards such as
protected from contaminants that may defects to the lowest level currently parasites, environmental pathogens, and
drip, drain, or be drawn into the food. feasible. other pathogens;
(11) Heat blanching, when required in (b) The mixing of a food containing (ii) Chemical hazards, including
the preparation of food capable of defects at levels that render that food radiological hazards, substances such as
supporting microbial growth, must be adulterated with another lot of food is pesticide and drug residues, natural
effected by heating the food to the not permitted and renders the final food toxins, decomposition, unapproved food
required temperature, holding it at this adulterated, regardless of the defect or color additives, and food allergens;
temperature for the required time, and level of the final food. For examples of and
then either rapidly cooling the food or defect action levels that may render (iii) Physical hazards (such as stones,
passing it to subsequent manufacturing food adulterated, see the Defect Levels glass, and metal fragments); and
without delay. Growth and Handbook, which is accessible at (2) Known or reasonably foreseeable
contamination by thermophilic http://www.fda.gov/pchfrule and at hazards that may be present in the food
microorganisms in blanchers must be http://www.fda.gov. for any of the following reasons:
minimized by the use of adequate (i) The hazard occurs naturally;
operating temperatures and by periodic Subpart C—Hazard Analysis and Risk- (ii) The hazard may be
cleaning and sanitizing as necessary. Based Preventive Controls unintentionally introduced; or
(12) Batters, breading, sauces, gravies, (iii) The hazard may be intentionally
§ 117.126 Food safety plan.
dressings, dipping solutions, and other introduced for purposes of economic
(a) Requirement for a food safety plan. gain.
similar preparations that are held and
(1) You must prepare, or have prepared, (c) Hazard evaluation. (1)(i) The
used repeatedly over time must be
and implement a written food safety hazard analysis must include an
treated or maintained in such a manner
plan. evaluation of the hazards identified in
that they are protected against allergen
(2) The food safety plan must be paragraph (b) of this section to assess
cross-contact and against
prepared, or its preparation overseen, by the severity of the illness or injury if the
contamination, and minimizing the
one or more preventive controls hazard were to occur and the probability
potential for the growth of undesirable
qualified individuals. that the hazard will occur in the absence
microorganisms. (b) Contents of a food safety plan. The
(13) Filling, assembling, packaging, of preventive controls.
written food safety plan must include:
and other operations must be performed (1) The written hazard analysis as (ii) The hazard evaluation required by
in such a way that the food is protected required by § 117.130(a)(2); paragraph (c)(1)(i) of this section must
against allergen cross-contact, (2) The written preventive controls as include an evaluation of environmental
contamination and growth of required by § 117.135(b); pathogens whenever a ready-to-eat food
undesirable microorganisms. (3) The written supply-chain program is exposed to the environment prior to
(14) Food, such as dry mixes, nuts, as required by subpart G of this part; packaging and the packaged food does
intermediate moisture food, and (4) The written recall plan as required not receive a treatment or otherwise
dehydrated food, that relies principally by § 117.139(a); and include a control measure (such as a
on the control of aw for preventing the (5) The written procedures for formulation lethal to the pathogen) that
growth of undesirable microorganisms monitoring the implementation of the would significantly minimize the
must be processed to and maintained at preventive controls as required by pathogen.
a safe moisture level. § 117.145(a)(1); (2) The hazard evaluation must
(15) Food, such as acid and acidified (6) The written corrective action consider the effect of the following on
food, that relies principally on the procedures as required by the safety of the finished food for the
control of pH for preventing the growth § 117.150(a)(1); and intended consumer:
of undesirable microorganisms must be (7) The written verification (i) The formulation of the food;
monitored and maintained at a pH of 4.6 procedures as required by § 117.165(b). (ii) The condition, function, and
or below. (c) Records. The food safety plan design of the facility and equipment;
(16) When ice is used in contact with required by this section is a record that (iii) Raw materials and other
food, it must be made from water that is subject to the requirements of subpart ingredients;
is safe and of adequate sanitary quality F of this part. (iv) Transportation practices;
in accordance with § 117.37(a), and (v) Manufacturing/processing
§ 117.130 Hazard analysis. procedures;
must be used only if it has been
manufactured in accordance with (a) Requirement for a hazard analysis. (vi) Packaging activities and labeling
current good manufacturing practice as (1) You must conduct a hazard analysis activities;
outlined in this part. to identify and evaluate, based on (vii) Storage and distribution;
experience, illness data, scientific (viii) Intended or reasonably
§ 117.93 Warehousing and distribution. reports, and other information, known foreseeable use;
Storage and transportation of food or reasonably foreseeable hazards for (ix) Sanitation, including employee
must be under conditions that will each type of food manufactured, hygiene; and
protect against allergen cross-contact processed, packed, or held at your (x) Any other relevant factors, such as
and against biological, chemical facility to determine whether there are the temporal (e.g., weather-related)
(including radiological), and physical any hazards requiring a preventive nature of some hazards (e.g., levels of
contamination of food, as well as against control. some natural toxins).

deterioration of the food and the (2) The hazard analysis must be
written regardless of its outcome. § 117.135 Preventive controls.
container.
(b) Hazard identification. The hazard (a)(1) You must identify and
§ 117.110 Defect action levels. identification must consider: implement preventive controls to
(a) The manufacturer, processor, (1) Known or reasonably foreseeable provide assurances that any hazards
packer, and holder of food must at all hazards that include: requiring a preventive control will be
significantly minimized or prevented food-contact surfaces and from raw the food in accordance with applicable
and the food manufactured, processed, product to processed product. food safety requirements.
packed, or held by your facility will not (4) Supply-chain controls. Supply- (4) You rely on your customer to
be adulterated under section 402 of the chain controls include the supply-chain provide assurance that the food will be
Federal Food, Drug, and Cosmetic Act program as required by subpart G of this processed to control the identified
or misbranded under section 403(w) of part. hazard by an entity in the distribution
the Federal Food, Drug, and Cosmetic (5) Recall plan. Recall plan as chain subsequent to the customer and
Act. required by § 117.139. you:
(2) Preventive controls required by (6) Other controls. Preventive controls (i) Disclose in documents
paragraph (a)(1) of this section include: include any other procedures, practices, accompanying the food, in accordance
(i) Controls at critical control points and processes necessary to satisfy the with the practice of the trade, that the
(CCPs), if there are any CCPs; and requirements of paragraph (a) of this food is ‘‘not processed to control
(ii) Controls, other than those at CCPs, section. Examples of other controls [identified hazard]’’; and
that are also appropriate for food safety. include hygiene training and other (ii) Annually obtain from your
(b) Preventive controls must be current good manufacturing practices. customer written assurance, subject to
written. the requirements of § 117.137, that your
§ 117.136 Circumstances in which the customer:
(c) Preventive controls include, as owner, operator, or agent in charge of a
appropriate to the facility and the food: (A) Will disclose in documents
manufacturing/processing facility is not
(1) Process controls. Process controls accompanying the food, in accordance
required to implement a preventive control.
include procedures, practices, and with the practice of the trade, that the
(a) Circumstances. If you are a food is ‘‘not processed to control
processes to ensure the control of manufacturer/processor, you are not
parameters during operations such as [identified hazard]’’; and
required to implement a preventive (B) Will only sell to another entity
heat processing, acidifying, irradiating, control when you identify a hazard
and refrigerating foods. Process controls that agrees, in writing, it will:
requiring a preventive control (1) Follow procedures (identified in a
must include, as appropriate to the (identified hazard) and any of the written assurance) that will significantly
nature of the applicable control and its following circumstances apply: minimize or prevent the identified
role in the facility’s food safety system: (1) You determine and document that hazard (if the entity is subject to the
(i) Parameters associated with the the type of food (e.g., raw agricultural requirements for hazard analysis and
control of the hazard; and commodities such as cocoa beans, coffee risk-based preventive controls in this
(ii) The maximum or minimum value, beans, and grains) could not be subpart) or manufacture, process, or
or combination of values, to which any consumed without application of an prepare the food in accordance with
biological, chemical, or physical appropriate control. applicable food safety requirements (if
parameter must be controlled to (2) You rely on your customer who is the entity is not subject to the
significantly minimize or prevent a subject to the requirements for hazard requirements for hazard analysis and
hazard requiring a process control. analysis and risk-based preventive risk-based preventive controls in this
(2) Food allergen controls. Food controls in this subpart C to ensure that subpart); or
allergen controls include procedures, the identified hazard will be (2) Obtain a similar written assurance
practices, and processes to control food significantly minimized or prevented from the entity’s customer, subject to
allergens. Food allergen controls must and you: the requirements of § 117.137, as in
include those procedures, practices, and (i) Disclose in documents paragraphs (a)(4)(ii)(A) and (B) of this
processes employed for: accompanying the food, in accordance section, as appropriate; or
(i) Ensuring protection of food from with the practice of the trade, that the (5) You have established,
allergen cross-contact, including during food is ‘‘not processed to control documented, and implemented a system
storage, handling, and use; and [identified hazard]’’; and that ensures control, at a subsequent
(ii) Labeling the finished food, (ii) Annually obtain from your distribution step, of the hazards in the
including ensuring that the finished customer written assurance, subject to food product you distribute and you
food is not misbranded under section the requirements of § 117.137, that the document the implementation of that
403(w) of the Federal Food, Drug, and customer has established and is system.
Cosmetic Act. following procedures (identified in the (b) Records. You must document any
(3) Sanitation controls. Sanitation written assurance) that will significantly circumstance, specified in paragraph (a)
controls include procedures, practices, minimize or prevent the identified of this section, that applies to you,
and processes to ensure that the facility hazard. including:
is maintained in a sanitary condition (3) You rely on your customer who is (1) A determination, in accordance
adequate to significantly minimize or not subject to the requirements for with paragraph (a) of this section, that
prevent hazards such as environmental hazard analysis and risk-based the type of food could not be consumed
pathogens, biological hazards due to preventive controls in this subpart to without application of an appropriate
employee handling, and food allergen provide assurance it is manufacturing, control;
hazards. Sanitation controls must processing, or preparing the food in (2) The annual written assurance from
include, as appropriate to the facility accordance with applicable food safety your customer in accordance with
and the food, procedures, practices, and requirements and you: paragraph (a)(2) of this section;
processes for the: (i) Disclose in documents (3) The annual written assurance from
(i) Cleanliness of food-contact accompanying the food, in accordance your customer in accordance with
surfaces, including food-contact with the practice of the trade, that the paragraph (a)(3) of this section;
surfaces of utensils and equipment; food is ‘‘not processed to control (4) The annual written assurance from
(ii) Prevention of allergen cross- [identified hazard]’’; and your customer in accordance with
contact and cross-contamination from (ii) Annually obtain from your paragraph (a)(4) of this section; and
insanitary objects and from personnel to customer written assurance that it is (5) Your system, in accordance with
food, food packaging material, and other manufacturing, processing, or preparing paragraph (a)(5) of this section, that
ensures control, at a subsequent (2) Review of records in accordance (i) Appropriate action is taken to
distribution step, of the hazards in the with § 117.165(a)(4); and identify and correct a problem that has
food product you distribute. (3) Reanalysis in accordance with occurred with implementation of a
§ 117.170. preventive control;
§ 117.137 Provision of assurances (c) The recall plan established in (ii) Appropriate action is taken, when
required under § 117.136(a)(2), (3), and (4). § 117.139 is not subject to the necessary, to reduce the likelihood that
A facility that provides a written requirements of paragraph (a) of this the problem will recur;
assurance under § 117.136(a)(2), (3), or section. (iii) All affected food is evaluated for
(4) must act consistently with the safety; and
assurance and document its actions § 117.145 Monitoring.
As appropriate to the nature of the (iv) All affected food is prevented
taken to satisfy the written assurance. from entering into commerce, if you
preventive control and its role in the
§ 117.139 Recall plan. facility’s food safety system: cannot ensure that the affected food is
For food with a hazard requiring a (a) Written procedures. You must not adulterated under section 402 of the
preventive control: establish and implement written Federal Food, Drug, and Cosmetic Act
(a) You must establish a written recall procedures, including the frequency or misbranded under section 403(w) of
plan for the food. with which they are to be performed, for the Federal Food, Drug, and Cosmetic
(b) The written recall plan must monitoring the preventive control; and. Act.
include procedures that describe the (b) Monitoring. You must monitor the (b) Corrective action in the event of an
steps to be taken, and assign preventive controls with adequate unanticipated food safety problem. (1)
responsibility for taking those steps, to frequency to provide assurance that they Except as provided by paragraph (c) of
perform the following actions as are consistently performed. this section, you are subject to the
appropriate to the facility: (c) Records. (1) Requirement to requirements of paragraphs (b)(2) of this
(1) Directly notify the direct document monitoring. You must section if any of the following
consignees of the food being recalled, document the monitoring of preventive circumstances apply:
including how to return or dispose of controls in accordance with this section (i) A preventive control is not
the affected food; in records that are subject to verification properly implemented and a corrective
(2) Notify the public about any hazard in accordance with § 117.155(a)(2) and action procedure has not been
presented by the food when appropriate records review in accordance with established;
to protect public health; § 117.165(a)(4)(i). (ii) A preventive control, combination
(2) Exception records. (i) Records of of preventive controls, or the food safety
(3) Conduct effectiveness checks to
refrigeration temperature during storage plan as a whole is found to be
verify that the recall is carried out; and
of food that requires time/temperature ineffective; or
(4) Appropriately dispose of recalled
control to significantly minimize or (iii) A review of records in accordance
food—e.g., through reprocessing,
prevent the growth of, or toxin with § 117.165(a)(4) finds that the
reworking, diverting to a use that does
production by, pathogens may be records are not complete, the activities
not present a safety concern, or
affirmative records demonstrating conducted did not occur in accordance
destroying the food.
temperature is controlled or exception with the food safety plan, or appropriate
§ 117.140 Preventive control management records demonstrating loss of decisions were not made about
components. temperature control. corrective actions.
(a) Except as provided by paragraphs (ii) Exception records may be (2) If any of the circumstances listed
(b) and (c) of this section, the preventive adequate in circumstances other than in paragraph (b)(1) of this section apply,
controls required under § 117.135 are monitoring of refrigeration temperature. you must:
subject to the following preventive § 117.150 Corrective actions and (i) Take corrective action to identify
control management components as corrections. and correct the problem, reduce the
appropriate to ensure the effectiveness (a) Corrective action procedures. As likelihood that the problem will recur,
of the preventive controls, taking into appropriate to the nature of the hazard evaluate all affected food for safety, and,
account the nature of the preventive and the nature of the preventive control, as necessary, prevent affected food from
control and its role in the facility’s food except as provided by paragraph (c) of entering commerce as would be done
safety system: this section: following a corrective action procedure
(1) Monitoring in accordance with (1) You must establish and implement under paragraphs (a)(2)(i) through (iv) of
§ 117.145; written corrective action procedures this section; and
(2) Corrective actions and corrections that must be taken if preventive controls (ii) When appropriate, reanalyze the
in accordance with § 117.150; and are not properly implemented, food safety plan in accordance with
(3) Verification in accordance with including procedures to address, as § 117.170 to determine whether
§ 117.155. appropriate: modification of the food safety plan is
(b) The supply-chain program (i) The presence of a pathogen or required.
established in subpart G of this part is appropriate indicator organism in a (c) Corrections. You do not need to
subject to the following preventive ready-to-eat product detected as a result comply with the requirements of
control management components as of product testing conducted in paragraphs (a) and (b) of this section if:
appropriate to ensure the effectiveness accordance with § 117.165(a)(2); and (1) You take action, in a timely
of the supply-chain program, taking into (ii) The presence of an environmental manner, to identify and correct
account the nature of the hazard pathogen or appropriate indicator conditions and practices that are not
controlled before receipt of the raw organism detected through the consistent with the food allergen
material or other ingredient: environmental monitoring conducted in controls in § 117.135(c)(2)(i) or the
(1) Corrective actions and corrections accordance with § 117.165(a)(3). sanitation controls in § 117.135(c)(3)(i)
in accordance with § 117.150, taking (2) The corrective action procedures or (ii); or
into account the nature of any supplier must describe the steps to be taken to (2) You take action, in a timely
non-conformance; ensure that: manner, to identify and correct a minor
and isolated problem that does not control measure or combination of working days after the records are
directly impact product safety. control measures, when properly created or within a reasonable
(d) Records. All corrective actions implemented, will effectively control timeframe, provided that the preventive
(and, when appropriate, corrections) the hazards; and controls qualified individual prepares
taken in accordance with this section (iii) Whenever a reanalysis of the food (or oversees the preparation of) a written
must be documented in records. These safety plan reveals the need to do so; justification for a timeframe that
records are subject to verification in (2) Must include obtaining and exceeds 7 working days; and
accordance with § 117.155(a)(3) and evaluating scientific and technical (ii) Records of calibration, testing
records review in accordance with evidence (or, when such evidence is not (e.g., product testing, environmental
§ 117.165(a)(4)(i). available or is inadequate, conducting monitoring), supplier and supply-chain
studies) to determine whether the verification activities, and other
§ 117.155 Verification. preventive controls, when properly verification activities within a
(a) Verification activities. Verification implemented, will effectively control reasonable time after the records are
activities must include, as appropriate the hazards; and created; and
to the nature of the preventive control (c) You do not need to validate: (5) Other activities appropriate for
and its role in the facility’s food safety (1) The food allergen controls in verification of implementation and
system: § 117.135(c)(2); effectiveness.
(1) Validation in accordance with (2) The sanitation controls in (b) Written procedures. As
§ 117.160. § 117.135(c)(3); appropriate to the facility, the food, the
(2) Verification that monitoring is (3) The recall plan in § 117.139;
nature of the preventive control, and the
being conducted as required by (4) The supply-chain program in
role of the preventive control in the
§ 117.140 (and in accordance with subpart G of this part; and
(5) Other preventive controls, if the facility’s food safety system, you must
§ 117.145). establish and implement written
(3) Verification that appropriate preventive controls qualified individual
prepares (or oversees the preparation of) procedures for the following activities:
decisions about corrective actions are (1) The method and frequency of
a written justification that validation is
being made as required by § 117.140 calibrating process monitoring
not applicable based on factors such as
(and in accordance with § 117.150). instruments and verification
the nature of the hazard, and the nature
(4) Verification of implementation instruments (or checking them for
of the preventive control and its role in
and effectiveness in accordance with accuracy) as required by paragraph
the facility’s food safety system.
§ 117.165; and (a)(1) of this section.
(5) Reanalysis in accordance with § 117.165 Verification of implementation (2) Product testing as required by
§ 117.170. and effectiveness. paragraph (a)(2) of this section.
(b) Documentation. All verification (a) Verification activities. You must Procedures for product testing must:
activities conducted in accordance with verify that the preventive controls are (i) Be scientifically valid;
this section must be documented in consistently implemented and are (ii) Identify the test microorganism(s)
records. effectively and significantly minimizing or other analyte(s);
or preventing the hazards. To do so you (iii) Specify the procedures for
§ 117.160 Validation.
must conduct activities that include the identifying samples, including their
(a) You must validate that the following, as appropriate to the facility, relationship to specific lots of product;
preventive controls identified and the food, and the nature of the (iv) Include the procedures for
implemented in accordance with preventive control and its role in the sampling, including the number of
§ 117.135 are adequate to control the facility’s food safety system: samples and the sampling frequency;
hazard as appropriate to the nature of (1) Calibration of process monitoring (v) Identify the test(s) conducted,
the preventive control and its role in the instruments and verification including the analytical method(s) used;
facility’s food safety system. instruments (or checking them for (vi) Identify the laboratory conducting
(b) The validation of the preventive accuracy); the testing; and
controls: (2) Product testing, for a pathogen (or (vii) Include the corrective action
(1) Must be performed (or overseen) appropriate indicator organism) or other procedures required by § 117.150(a)(1).
by a preventive controls qualified hazard; (3) Environmental monitoring as
individual: (3) Environmental monitoring, for an required by paragraph (a)(3) of this
(i)(A) Prior to implementation of the environmental pathogen or for an section. Procedures for environmental
food safety plan; or appropriate indicator organism, if monitoring must:
(B) When necessary to demonstrate contamination of a ready-to-eat food (i) Be scientifically valid;
the control measures can be with an environmental pathogen is a (ii) Identify the test microorganism(s);
implemented as designed: hazard requiring a preventive control, (iii) Identify the locations from which
(1) Within 90 calendar days after by collecting and testing environmental samples will be collected and the
production of the applicable food first samples; and number of sites to be tested during
begins; or (4) Review of the following records routine environmental monitoring. The
(2) Within a reasonable timeframe, within the specified timeframes, by (or number and location of sampling sites
provided that the preventive controls under the oversight of) a preventive must be adequate to determine whether
qualified individual prepares (or controls qualified individual, to ensure preventive controls are effective;
oversees the preparation of) a written that the records are complete, the (iv) Identify the timing and frequency
justification for a timeframe that activities reflected in the records for collecting and testing samples. The
exceeds 90 calendar days after occurred in accordance with the food timing and frequency for collecting and
production of the applicable food first safety plan, the preventive controls are testing samples must be adequate to
begins; effective, and appropriate decisions determine whether preventive controls
(ii) Whenever a change to a control were made about corrective actions: are effective;
measure or combination of control (i) Records of monitoring and (v) Identify the test(s) conducted,
measures could impact whether the corrective action records within 7 including the analytical method(s) used;
(vi) Identify the laboratory conducting § 117.180 Requirements applicable to a (1) Documentation, as required by
the testing; and preventive controls qualified individual and § 117.136(b), of the basis for not
(vii) Include the corrective action a qualified auditor. establishing a preventive control in
procedures required by § 117.150(a)(1). (a) One or more preventive controls accordance with § 117.136(a);
qualified individuals must do or oversee (2) Records that document the
§ 117.170 Reanalysis. the following: monitoring of preventive controls;
(a) You must conduct a reanalysis of (1) Preparation of the food safety plan (3) Records that document corrective
the food safety plan as a whole at least (§ 117.126(a)(2)); actions;
once every 3 years; (2) Validation of the preventive (4) Records that document
(b) You must conduct a reanalysis of controls (§ 117.160(b)(1)); verification, including, as applicable,
the food safety plan as a whole, or the (3) Written justification for validation those related to:
applicable portion of the food safety to be performed in a timeframe that (i) Validation;
plan: exceeds the first 90 calendar days of (ii) Verification of monitoring;
(1) Whenever a significant change in production of the applicable food; (iii) Verification of corrective actions;
the activities conducted at your facility (4) Determination that validation is
(iv) Calibration of process monitoring
creates a reasonable potential for a new not required (§ 117.160(c)(5));
and verification instruments;
hazard or creates a significant increase (5) Review of records (§ 117.165(a)(4));
(6) Written justification for review of (v) Product testing;
in a previously identified hazard; (vi) Environmental monitoring;
(2) Whenever you become aware of records of monitoring and corrective
actions within a timeframe that exceeds (vii) Records review; and
new information about potential (viii) Reanalysis;
hazards associated with the food; 7 working days;
(7) Reanalysis of the food safety plan (5) Records that document the supply-
(3) Whenever appropriate after an chain program; and
unanticipated food safety problem in (§ 117.170(d)); and
(8) Determination that reanalysis can (6) Records that document applicable
accordance with § 117.150(b); and training for the preventive controls
be completed, and additional preventive
(4) Whenever you find that a qualified individual and the qualified
controls validated, as appropriate to the
preventive control, combination of auditor.
nature of the preventive control and its
preventive controls, or the food safety (b) The records that you must
role in the facility’s food safety system,
plan as a whole is ineffective. establish and maintain are subject to the
in a timeframe that exceeds the first 90
(c) You must complete the reanalysis requirements of subpart F of this part.
calendar days of production of the
required by paragraphs (a) and (b) of
applicable food.
this section and validate, as appropriate (b) A qualified auditor must conduct Subpart D—Modified Requirements
to the nature of the preventive control an onsite audit (§ 117.435(a)).
and its role in the facility’s food safety § 117.201 Modified requirements that
(c)(1) To be a preventive controls apply to a qualified facility.
system, any additional preventive qualified individual, the individual
controls needed to address the hazard (a) Attestations to be submitted. A
must have successfully completed
identified: qualified facility must submit the
training in the development and
(1) Before any change in activities following attestations to FDA:
application of risk-based preventive
(including any change in preventive (1) An attestation that the facility is a
controls at least equivalent to that
control) at the facility is operative; or qualified facility as defined in § 117.3.
received under a standardized
(2) When necessary to demonstrate For the purpose of determining whether
curriculum recognized as adequate by
the control measures can be a facility satisfies the definition of
FDA or be otherwise qualified through
implemented as designed: qualified facility, the baseline year for
job experience to develop and apply a
(i) Within 90 calendar days after calculating the adjustment for inflation
food safety system. Job experience may
production of the applicable food first is 2011; and
qualify an individual to perform these
begins; or (2)(i) An attestation that you have
functions if such experience has
(ii) Within a reasonable timeframe, identified the potential hazards
provided an individual with knowledge
provided that the preventive controls associated with the food being
at least equivalent to that provided
qualified individual prepares (or produced, are implementing preventive
through the standardized curriculum.
oversees the preparation of) a written controls to address the hazards, and are
This individual may be, but is not
justification for a timeframe that monitoring the performance of the
required to be, an employee of the
exceeds 90-calendar days after preventive controls to ensure that such
facility.
production of the applicable food first (2) To be a qualified auditor, a controls are effective; or
begins. (ii) An attestation that the facility is
qualified individual must have
(d) You must revise the written food in compliance with State, local, county,
technical expertise obtained through
safety plan if a significant change in the tribal, or other applicable non-Federal
education, training, or experience (or a
activities conducted at your facility food safety law, including relevant laws
combination thereof) necessary to
creates a reasonable potential for a new and regulations of foreign countries,
perform the auditing function.
hazard or a significant increase in a (d) All applicable training in the including an attestation based on
previously identified hazard or development and application of risk- licenses, inspection reports, certificates,
document the basis for the conclusion based preventive controls must be permits, credentials, certification by an
that no revisions are needed. documented in records, including the appropriate agency (such as a State
(e) A preventive controls qualified date of the training, the type of training, department of agriculture), or other
individual must perform (or oversee) the evidence of oversight.
and the person(s) trained.

reanalysis. (b) Procedure for submission. The
(f) You must conduct a reanalysis of § 117.190 Implementation records required attestations required by paragraph (a) of
the food safety plan when FDA for this subpart. this section must be submitted to FDA
determines it is necessary to respond to (a) You must establish and maintain by one of the following means:
new hazards and developments in the following records documenting (1) Electronic submission. To submit
scientific understanding. implementation of the food safety plan: electronically, go to http://www.fda.gov/
furls and follow the instructions. This the applicable calendar year unless (iii) Prevent the food from entering
Web site is available from wherever the otherwise agreed to by FDA and the commerce, if you cannot ensure the
Internet is accessible, including facility. affected food is not adulterated under
libraries, copy centers, schools, and (e) Notification to consumers. A section 402 of the Federal Food, Drug,
Internet cafes. FDA encourages qualified facility that does not submit and Cosmetic Act;
electronic submission. attestations under paragraph (a)(2)(i) of (4) Verify that temperature controls
(2) Submission by mail. (i) You must this section must provide notification to are consistently implemented by:
use Form FDA 3942a. You may obtain consumers as to the name and complete (i) Calibrating temperature monitoring
a copy of this form by any of the business address of the facility where and recording devices (or checking them
following mechanisms: the food was manufactured or processed for accuracy);
(A) Download it from http:// (including the street address or P.O. (ii) Reviewing records of calibration
www.fda.gov/pchfrule; box, city, state, and zip code for within a reasonable time after the
(B) Write to the U.S. Food and Drug domestic facilities, and comparable full records are created; and
Administration (HFS–681), 5100 Paint address information for foreign (iii) Reviewing records of monitoring
Branch Parkway, College Park, MD facilities), as follows: and corrective actions taken to correct a
20550; or (1) If a food packaging label is problem with the control of temperature
(C) Request a copy of this form by required, the notification required by within 7 working days after the records
phone at 1–800–216–7331 or 301–575– paragraph (e) of this section must are created or within a reasonable
0156. appear prominently and conspicuously timeframe, provided that the preventive
(ii) Send a paper Form FDA 3942a to on the label of the food. controls qualified individual prepares
the U.S. Food and Drug Administration (2) If a food packaging label is not (or oversees the preparation of) a written
(HFS–681), 5100 Paint Branch Parkway, required, the notification required by justification for a timeframe that
College Park, MD 20550. We paragraph (e) of this section must exceeds 7 working days;
recommend that you submit a paper appear prominently and conspicuously, (5) Establish and maintain the
copy only if your facility does not have at the point of purchase, on a label, following records:
reasonable access to the Internet. poster, sign, placard, or documents (i) Records (whether affirmative
(c) Frequency of determination of delivered contemporaneously with the records demonstrating temperature is
status and submission. (1) A facility food in the normal course of business, controlled or exception records
must determine and document its status or in an electronic notice, in the case of demonstrating loss of temperature
as a qualified facility on an annual basis Internet sales. control) documenting the monitoring of
no later than July 1 of each calendar (f) Records. (1) A qualified facility temperature controls for any such
year. must maintain those records relied upon refrigerated packaged food;
(2) The attestations required by to support the attestations that are (ii) Records of corrective actions taken
paragraph (a) of this section must be: required by paragraph (a) of this section. when there is a loss of temperature
(i) Submitted to FDA initially: (2) The records that a qualified facility control that may impact the safety of
(A) By December 17, 2018, for a must maintain are subject to the any such refrigerated packaged food;
facility that begins manufacturing, requirements of subpart F of this part. and
processing, packing, or holding food (iii) Records documenting verification
before September 17, 2018; § 117.206 Modified requirements that
activities.
(B) Before beginning operations, for a apply to a facility solely engaged in the
storage of unexposed packaged food. (b) The records that a facility must
facility that begins manufacturing,
establish and maintain under paragraph
processing, packing, or holding food (a) If a facility that is solely engaged
(a)(5) of this section are subject to the
after September 17, 2018; or in the storage of unexposed packaged
requirements of subpart F of this part.
(C) By July 31 of the applicable food stores any such refrigerated
calendar year, when the status of a packaged food that requires time/ Subpart E—Withdrawal of a Qualified
facility changes from ‘‘not a qualified temperature control to significantly Facility Exemption
facility’’ to ‘‘qualified facility’’ based on minimize or prevent the growth of, or
the annual determination required by toxin production by pathogens, the § 117.251 Circumstances that may lead
paragraph (c)(1) of this section; and facility must conduct the following FDA to withdraw a qualified facility
(ii) Beginning in 2020, submitted to activities as appropriate to ensure the exemption.
FDA every 2 years during the period effectiveness of the temperature (a) FDA may withdraw a qualified
beginning on October 1 and ending on controls: facility exemption under § 117.5(a):
December 31. (1) Establish and implement (1) In the event of an active
(3) When the status of a facility temperature controls adequate to investigation of a foodborne illness
changes from ‘‘qualified facility’’ to ‘‘not significantly minimize or prevent the outbreak that is directly linked to the
a qualified facility’’ based on the annual growth of, or toxin production by, qualified facility; or
determination required by paragraph pathogens; (2) If FDA determines that it is
(c)(1) of this section, the facility must (2) Monitor the temperature controls necessary to protect the public health
notify FDA of that change in status with adequate frequency to provide and prevent or mitigate a foodborne
using Form 3942a by July 31 of the assurance that the temperature controls illness outbreak based on conditions or
applicable calendar year. are consistently performed; conduct associated with the qualified
(d) Timeframe for compliance with (3) If there is a loss of temperature facility that are material to the safety of
subparts C and G of this part when the control that may impact the safety of the food manufactured, processed,
facility status changes to ‘‘not a such refrigerated packaged food, take packed, or held at such facility.
qualified facility.’’ When the status of a appropriate corrective actions to: (b) Before FDA issues an order to
facility changes from ‘‘qualified facility’’ (i) Correct the problem and reduce the withdraw a qualified facility exemption,
to ‘‘not a qualified facility,’’ the facility likelihood that the problem will recur; FDA:
must comply with subparts C and G of (ii) Evaluate all affected food for (1) May consider one or more other
this part no later than December 31 of safety; and actions to protect the public health or
mitigate a foodborne illness outbreak, (1) Comply with subparts C and G of calendar days of the date of receipt of
including a warning letter, recall, this part on the date that is 120 calendar the order, or within a reasonable
administrative detention, suspension of days after the date of receipt of the timeframe, agreed to by FDA, based on
registration, refusal of food offered for order, or within a reasonable timeframe, a written justification, submitted to
import, seizure, and injunction; agreed to by FDA, based on a written FDA, for a timeframe that exceeds 120
(2) Must notify the owner, operator, or justification, submitted to FDA, for a calendar days from the date of receipt of
agent in charge of the facility, in timeframe that exceeds 120 calendar the order; and
writing, of circumstances that may lead days from the date of receipt of the (2) You are no longer subject to the
FDA to withdraw the exemption, and order; or modified requirements in § 117.201.
provide an opportunity for the owner, (2) Appeal the order within 15
operator, or agent in charge of the calendar days of the date of receipt of § 117.264 Procedure for submitting an
facility to respond in writing, within 15 the order in accordance with the appeal.
calendar days of the date of receipt of requirements of § 117.264. (a) To appeal an order to withdraw a
the notification, to FDA’s notification; (e) A statement that a facility may qualified facility exemption, you must:
and request that FDA reinstate an exemption (1) Submit the appeal in writing to the
(3) Must consider the actions taken by that was withdrawn by following the FDA District Director in whose district
the facility to address the circumstances procedures in § 117.287. the facility is located (or, in the case of
that may lead FDA to withdraw the (f) The text of section 418(l) of the a foreign facility, the Director of the
exemption. Federal Food, Drug, and Cosmetic Act Office of Compliance in the Center for
and of this subpart; Food Safety and Applied Nutrition), at
§ 117.254 Issuance of an order to withdraw (g) A statement that any informal
the mailing address, email address, or
a qualified facility exemption. hearing on an appeal of the order must
facsimile number identified in the order
(a) An FDA District Director in whose be conducted as a regulatory hearing
within 15 calendar days of the date of
district the qualified facility is located under part 16 of this chapter, with
receipt of confirmation of the order;
(or, in the case of a foreign facility, the certain exceptions described in
§ 117.270; (2) Respond with particularity to the
Director of the Office of Compliance in facts and issues contained in the order,
the Center for Food Safety and Applied (h) The mailing address, telephone
number, email address, and facsimile including any supporting
Nutrition), or an FDA official senior to documentation upon which you rely.
either such Director, must approve an number of the FDA district office and
the name of the FDA District Director in (b) In a written appeal of the order
order to withdraw the exemption before
whose district the facility is located (or, withdrawing an exemption provided
the order is issued.
in the case of a foreign facility, the same under § 117.5(a), you may include a
(b) Any officer or qualified employee
information for the Director of the Office written request for an informal hearing
of FDA may issue an order to withdraw
of Compliance in the Center for Food as provided in § 117.267.
the exemption after it has been
approved in accordance with paragraph Safety and Applied Nutrition); and
§ 117.267 Procedure for requesting an
(a) of this section. (i) The name and the title of the FDA informal hearing.
(c) FDA must issue an order to representative who approved the order.
(a) If you appeal the order, you:
withdraw the exemption to the owner, § 117.260 Compliance with, or appeal of, (1) May request an informal hearing;
operator, or agent in charge of the an order to withdraw a qualified facility and
facility. exemption.
(d) FDA must issue an order to (2) Must submit any request for an
(a) If you receive an order under informal hearing together with your
withdraw the exemption in writing, § 117.254 to withdraw a qualified
signed and dated by the officer or written appeal submitted in accordance
facility exemption, you must either:
qualified employee of FDA who is with § 117.264 within 15 calendar days
(1) Comply with applicable
issuing the order. of the date of receipt of the order.
requirements of this part within 120
calendar days of the date of receipt of (b) A request for an informal hearing
§ 117.257 Contents of an order to withdraw the order, or within a reasonable may be denied, in whole or in part, if
a qualified facility exemption. the presiding officer determines that no
timeframe, agreed to by FDA, based on
An order to withdraw a qualified a written justification, submitted to genuine and substantial issue of
facility exemption under § 117.5(a) must FDA, for a timeframe that exceeds 120 material fact has been raised by the
include the following information: calendar days from the date of receipt of material submitted. If the presiding
(a) The date of the order; the order; or officer determines that a hearing is not
(b) The name, address, and location of (2) Appeal the order within 15 justified, written notice of the
the qualified facility; calendar days of the date of receipt of determination will be given to you
(c) A brief, general statement of the the order in accordance with the explaining the reason for the denial.
reasons for the order, including requirements of § 117.264.
information relevant to one or both of § 117.270 Requirements applicable to an
(b) Submission of an appeal, informal hearing.
the following circumstances that leads including submission of a request for an
FDA to issue the order: informal hearing, will not operate to If you request an informal hearing,
(1) An active investigation of a delay or stay any administrative action, and FDA grants the request:
foodborne illness outbreak that is including enforcement action by FDA, (a) The hearing will be held within 15
directly linked to the facility; or unless the Commissioner of Food and calendar days after the date the appeal
(2) Conditions or conduct associated is filed or, if applicable, within a
Drugs, as a matter of discretion,

with a qualified facility that are material determines that delay or a stay is in the timeframe agreed upon in writing by
to the safety of the food manufactured, public interest. you and FDA.
processed, packed, or held at such (c) If you appeal the order, and FDA (b) The presiding officer may require
facility. confirms the order: that a hearing conducted under this
(d) A statement that the facility must (1) You must comply with applicable subpart be completed within 1-calendar
either: requirements of this part within 120 day, as appropriate.
(c) FDA must conduct the hearing in review under § 10.45 of this chapter, the § 117.287 Reinstatement of a qualified
accordance with part 16 of this chapter, record of the administrative proceeding facility exemption that was withdrawn.
except that: consists of the record of the hearing and (a) If the FDA District Director in
(1) The order withdrawing an the presiding officer’s final decision. whose district your facility is located
exemption under §§ 117.254 and
§ 117.274 Presiding officer for an appeal (or, in the case of a foreign facility, the
117.257, rather than the notice under
§ 16.22(a) of this chapter, provides and for an informal hearing. Director of the Office of Compliance in
notice of opportunity for a hearing The presiding officer for an appeal, the Center for Food Safety and Applied
under this section and is part of the and for an informal hearing, must be an Nutrition) determines that a facility has
administrative record of the regulatory FDA Regional Food and Drug Director adequately resolved any problems with
hearing under § 16.80(a) of this chapter. or another FDA official senior to an FDA the conditions and conduct that are
(2) A request for a hearing under this District Director. material to the safety of the food
subpart must be addressed to the FDA manufactured, processed, packed, or
District Director (or, in the case of a § 117.277 Timeframe for issuing a decision held at the facility and that continued
on an appeal.
foreign facility, the Director of the Office withdrawal of the exemption is not
of Compliance in the Center for Food (a) If you appeal the order without necessary to protect public health and
Safety and Applied Nutrition) as requesting a hearing, the presiding prevent or mitigate a foodborne illness
provided in the order withdrawing an officer must issue a written report that outbreak, the FDA District Director in
exemption. includes a final decision confirming or whose district your facility is located
(3) Section 117.274, rather than revoking the withdrawal by the 10th (or, in the case of a foreign facility, the
§ 16.42(a) of this chapter, describes the calendar day after the appeal is filed. Director of the Office of Compliance in
FDA employees who preside at hearings (b) If you appeal the order and request the Center for Food Safety and Applied
under this subpart. an informal hearing: Nutrition) will, on his own initiative or
(4) Section 16.60(e) and (f) of this (1) If FDA grants the request for a on the request of a facility, reinstate the
chapter does not apply to a hearing hearing and the hearing is held, the exemption.
under this subpart. The presiding officer presiding officer must provide a 2-
must prepare a written report of the calendar day opportunity for the hearing (b) You may ask FDA to reinstate an
hearing. All written material presented participants to review and submit exemption that has been withdrawn
at the hearing will be attached to the comments on the report of the hearing under the procedures of this subpart as
report. The presiding officer must under § 117.270(c)(4), and must issue a follows:
include as part of the report of the final decision within 10-calendar days (1) Submit a request, in writing, to the
hearing a finding on the credibility of after the hearing is held; or FDA District Director in whose district
witnesses (other than expert witnesses) (2) If FDA denies the request for a your facility is located (or, in the case
whenever credibility is a material issue, hearing, the presiding officer must issue of a foreign facility, the Director of the
and must include a proposed decision, a final decision on the appeal Office of Compliance in the Center for
with a statement of reasons. The hearing confirming or revoking the withdrawal Food Safety and Applied Nutrition); and
participant may review and comment on within 10 calendar days after the date
the presiding officer’s report within 2- (2) Present data and information to
the appeal is filed.
calendar days of issuance of the report. demonstrate that you have adequately
The presiding officer will then issue the § 117.280 Revocation of an order to resolved any problems with the
final decision. withdraw a qualified facility exemption. conditions and conduct that are material
(5) Section 16.80(a)(4) of this chapter An order to withdraw a qualified to the safety of the food manufactured,
does not apply to a regulatory hearing facility exemption is revoked if: processed, packed, or held at your
under this subpart. The presiding (a) You appeal the order and request facility, such that continued withdrawal
officer’s report of the hearing and any an informal hearing, FDA grants the of the exemption is not necessary to
comments on the report by the hearing request for an informal hearing, and the protect public health and prevent or
participant under § 117.270(c)(4) are presiding officer does not confirm the mitigate a foodborne illness outbreak.
part of the administrative record. order within the 10-calendar days after (c) If your exemption was withdrawn
(6) No party shall have the right, the hearing, or issues a decision under § 117.251(a)(1) and FDA later
under § 16.119 of this chapter to revoking the order within that time; or determines, after finishing the active
petition the Commissioner of Food and (b) You appeal the order and request investigation of a foodborne illness
Drugs for reconsideration or a stay of the an informal hearing, FDA denies the outbreak, that the outbreak is not
presiding officer’s final decision. request for an informal hearing, and directly linked to your facility, FDA will
(7) If FDA grants a request for an FDA does not confirm the order within reinstate your exemption under
informal hearing on an appeal of an the 10-calendar days after the appeal is § 117.5(a), and FDA will notify you in
order withdrawing an exemption, the filed, or issues a decision revoking the writing that your exempt status has been
hearing must be conducted as a order within that time; or reinstated.
regulatory hearing under a regulation in (c) You appeal the order without
accordance with part 16 of this chapter, requesting an informal hearing, and (d) If your exemption was withdrawn
except that § 16.95(b) of this chapter FDA does not confirm the order within under both § 117.251(a)(1) and (2) and
does not apply to a hearing under this the 10-calendar days after the appeal is FDA later determines, after finishing the
subpart. With respect to a regulatory filed, or issues a decision revoking the active investigation of a foodborne
hearing under this subpart, the illness outbreak, that the outbreak is not
order within that time.

administrative record of the hearing directly linked to your facility, FDA will
specified in §§ 16.80(a)(1) through (3) § 117.284 Final agency action. inform you of this finding, and you may
and (a)(5) of this chapter and Confirmation of a withdrawal order ask FDA to reinstate your exemption
117.270(c)(5) constitutes the exclusive by the presiding officer is considered a under § 117.5(a) in accordance with the
record for the presiding officer’s final final agency action for purposes of 5 requirements of paragraph (b) of this
decision. For purposes of judicial U.S.C. 702. section.
Subpart F—Requirements Applying to (2) Records that a facility relies on § 117.335 Special requirements applicable
Records That Must Be Established and during the 3-year period preceding the to a written assurance.
Maintained applicable calendar year to support its (a) Any written assurance required by
status as a qualified facility must be this part must contain the following
§ 117.301 Records subject to the retained at the facility as long as elements:
requirements of this subpart.
necessary to support the status of a (1) Effective date;
(a) Except as provided by paragraphs facility as a qualified facility during the (2) Printed names and signatures of
(b) and (c) of this section, all records applicable calendar year. authorized officials;
required by this part are subject to all (b) Records that relate to the general (3) The applicable assurance under:
requirements of this subpart. adequacy of the equipment or processes (i) Section 117.136(a)(2);
(b) The requirements of § 117.310 being used by a facility, including the (ii) Section 117.136(a)(3);
apply only to the written food safety results of scientific studies and (iii) Section 117.136(a)(4);
plan. evaluations, must be retained by the (iv) Section 117.430(c)(2);
(c) The requirements of § 117.305(b), (v) Section 117.430(d)(2); or
facility for at least 2 years after their use
(d), (e), and (f) do not apply to the (vi) Section 117.430(e)(2);
is discontinued (e.g., because the facility
records required by § 117.201. (b) A written assurance required
has updated the written food safety plan
§ 117.305 General requirements applying (§ 117.126) or records that document under § 117.136(a)(2), (3), or (4) must
to records. validation of the written food safety include:
Records must: plan (§ 117.155(b))); (1) Acknowledgement that the facility
(a) Be kept as original records, true (c) Except for the food safety plan, that provides the written assurance
copies (such as photocopies, pictures, offsite storage of records is permitted if assumes legal responsibility to act
scanned copies, microfilm, microfiche, such records can be retrieved and consistently with the assurance and
or other accurate reproductions of the provided onsite within 24 hours of document its actions taken to satisfy the
original records), or electronic records; request for official review. The food written assurance; and
(b) Contain the actual values and safety plan must remain onsite. (2) Provision that if the assurance is
observations obtained during Electronic records are considered to be terminated in writing by either entity,
monitoring and, as appropriate, during onsite if they are accessible from an responsibility for compliance with the
verification activities; onsite location. applicable provisions of this part reverts
(c) Be accurate, indelible, and legible; (d) If the plant or facility is closed for to the manufacturer/processor as of the
(d) Be created concurrently with a prolonged period, the food safety plan date of termination.
performance of the activity documented; may be transferred to some other
(e) Be as detailed as necessary to reasonably accessible location but must Subpart G—Supply-Chain Program
provide history of work performed; and be returned to the plant or facility
(f) Include: § 117.405 Requirement to establish and
within 24 hours for official review upon implement a supply-chain program.
(1) Information adequate to identify request.
the plant or facility (e.g., the name, and (a)(1) Except as provided by
when necessary, the location of the § 117.320 Requirements for official review. paragraphs (a)(2) and (3) of this section,
plant or facility); All records required by this part must the receiving facility must establish and
(2) The date and, when appropriate, be made promptly available to a duly implement a risk-based supply-chain
the time of the activity documented; authorized representative of the program for those raw materials and
(3) The signature or initials of the Secretary of Health and Human Services other ingredients for which the
person performing the activity; and for official review and copying upon receiving facility has identified a hazard
(4) Where appropriate, the identity of oral or written request. requiring a supply-chain-applied
the product and the lot code, if any. control.
(g) Records that are established or § 117.325 Public disclosure. (2) A receiving facility that is an
maintained to satisfy the requirements Records obtained by FDA in importer, is in compliance with the
of this part and that meet the definition accordance with this part are subject to foreign supplier verification program
of electronic records in § 11.3(b)(6) of the disclosure requirements under part requirements under part 1, subpart L of
this chapter are exempt from the 20 of this chapter. this chapter, and has documentation of
requirements of part 11 of this chapter. verification activities conducted under
Records that satisfy the requirements of § 117.330 Use of existing records. § 1.506(e) of this chapter (which
this part, but that also are required (a) Existing records (e.g., records that provides assurance that the hazards
under other applicable statutory are kept to comply with other Federal, requiring a supply-chain-applied
provisions or regulations, remain State, or local regulations, or for any control for the raw material or other
subject to part 11 of this chapter. other reason) do not need to be ingredient have been significantly
duplicated if they contain all of the minimized or prevented) need not
§ 117.310 Additional requirements
applying to the food safety plan.
required information and satisfy the conduct supplier verification activities
requirements of this subpart. Existing for that raw material or other ingredient.
The owner, operator, or agent in
records may be supplemented as (3) The requirements in this subpart
charge of the facility must sign and date
necessary to include all of the required do not apply to food that is supplied for
the food safety plan:
information and satisfy the research or evaluation use, provided
(a) Upon initial completion; and
(b) Upon any modification. requirements of this subpart. that such food:
(b) The information required by this (i) Is not intended for retail sale and
§ 117.315 Requirements for record part does not need to be kept in one set is not sold or distributed to the public;
retention. of records. If existing records contain (ii) Is labeled with the statement
(a)(1) All records required by this part some of the required information, any ‘‘Food for research or evaluation use’’;
must be retained at the plant or facility new information required by this part (iii) Is supplied in a small quantity
for at least 2 years after the date they may be kept either separately or that is consistent with a research,
were prepared. combined with the existing records. analysis, or quality assurance purpose,
the food is used only for this purpose, (c) The supply-chain program must of this chapter because it has less than
and any unused quantity is properly provide assurance that a hazard 3,000 laying hens.
disposed of; and requiring a supply-chain-applied (e) If the owner, operator, or agent in
(iv) Is accompanied with documents, control has been significantly charge of a receiving facility determines
in accordance with the practice of the minimized or prevented. through auditing, verification testing,
trade, stating that the food will be used (d)(1) Except as provided by document review, relevant consumer,
for research or evaluation purposes and paragraph (d)(2) of this section, in customer or other complaints, or
cannot be sold or distributed to the approving suppliers and determining otherwise that the supplier is not
public. the appropriate supplier verification controlling hazards that the receiving
(b) The supply-chain program must be activities and the frequency with which facility has identified as requiring a
written. they are conducted, the following must supply-chain-applied control, the
(c) When a supply-chain-applied be considered: receiving facility must take and
control is applied by an entity other (i) The hazard analysis of the food, document prompt action in accordance
than the receiving facility’s supplier including the nature of the hazard with § 117.150 to ensure that raw
(e.g., when a non-supplier applies controlled before receipt of the raw materials or other ingredients from the
controls to certain produce (i.e., material or other ingredient, applicable supplier do not cause food that is
produce covered by part 112 of this to the raw material and other manufactured or processed by the
chapter)), because growing, harvesting, ingredients; receiving facility to be adulterated
and packing activities are under (ii) The entity or entities that will be under section 402 of the Federal Food,
different management), the receiving applying controls for the hazards Drug, and Cosmetic Act or misbranded
facility must: requiring a supply-chain-applied under section 403(w) of the Federal
(1) Verify the supply-chain-applied control; Food, Drug, and Cosmetic Act.
control; or (iii) Supplier performance, including:
(2) Obtain documentation of an (A) The supplier’s procedures, § 117.415 Responsibilities of the receiving
appropriate verification activity from processes, and practices related to the facility.
another entity, review and assess the safety of the raw material and other (a)(1) The receiving facility must
entity’s applicable documentation, and ingredients; approve suppliers.
document that review and assessment. (B) Applicable FDA food safety (2) Except as provided by paragraphs
regulations and information relevant to (a)(3) and (4) of this section, the
§ 117.410 General requirements applicable the supplier’s compliance with those receiving facility must determine and
to a supply-chain program. regulations, including an FDA warning conduct appropriate supplier
(a) The supply-chain program must letter or import alert relating to the verification activities, and satisfy all
include: safety of food and other FDA documentation requirements of this
(1) Using approved suppliers as compliance actions related to food subpart.
required by § 117.420; safety (or, when applicable, relevant (3) An entity other than the receiving
(2) Determining appropriate supplier laws and regulations of a country whose facility may do any of the following,
verification activities (including food safety system FDA has officially provided that the receiving facility
determining the frequency of recognized as comparable or has reviews and assesses the entity’s
conducting the activity) as required by determined to be equivalent to that of applicable documentation, and
§ 117.425; the United States, and information documents that review and assessment:
(3) Conducting supplier verification relevant to the supplier’s compliance (i) Establish written procedures for
activities as required by §§ 117.430 and with those laws and regulations); and receiving raw materials and other
117.435; (C) The supplier’s food safety history ingredients by the entity;
(4) Documenting supplier verification relevant to the raw materials or other (ii) Document that written procedures
activities as required by § 117.475; and ingredients that the receiving facility for receiving raw materials and other
(5) When applicable, verifying a receives from the supplier, including ingredients are being followed by the
supply-chain-applied control applied by available information about results from entity; and
an entity other than the receiving testing raw materials or other (iii) Determine, conduct, or both
facility’s supplier and documenting that ingredients for hazards, audit results determine and conduct the appropriate
verification as required by § 117.475, or relating to the safety of the food, and supplier verification activities, with
obtaining documentation of an responsiveness of the supplier in appropriate documentation.
appropriate verification activity from correcting problems; and (4) The supplier may conduct and
another entity, reviewing and assessing (iv) Any other factors as appropriate document sampling and testing of raw
that documentation, and documenting and necessary, such as storage and materials and other ingredients, for the
the review and assessment as required transportation practices. hazard controlled by the supplier, as a
by § 117.475. (2) Considering supplier performance supplier verification activity for a
(b) The following are appropriate can be limited to the supplier’s particular lot of product and provide
supplier verification activities for raw compliance history as required by such documentation to the receiving
materials and other ingredients: paragraph (d)(1)(iii)(B) of this section, if facility, provided that the receiving
(1) Onsite audits; the supplier is: facility reviews and assesses that
(2) Sampling and testing of the raw (i) A qualified facility as defined by documentation, and documents that
material or other ingredient; § 117.3; review and assessment.
(3) Review of the supplier’s relevant (ii) A farm that grows produce and is (b) For the purposes of this subpart,
food safety records; and not a covered farm under part 112 of a receiving facility may not accept any
(4) Other appropriate supplier this chapter in accordance with of the following as a supplier
verification activities based on supplier § 112.4(a), or in accordance with verification activity:
performance and the risk associated §§ 112.4(b) and 112.5; or (1) A determination by its supplier of
with the raw material or other (iii) A shell egg producer that is not the appropriate supplier verification
ingredient. subject to the requirements of part 118 activities for that supplier;
(2) An audit conducted by its hazard in a raw material or other to part 112 of this chapter in accordance
supplier; ingredient will be controlled by the with § 112.4(a), or in accordance with
(3) A review by its supplier of that supplier and is one for which there is §§ 112.4(b) and 112.5:
supplier’s own relevant food safety a reasonable probability that exposure to (i) Before first approving the supplier
records; or the hazard will result in serious adverse for an applicable calendar year; and
(4) The conduct by its supplier of health consequences or death to (ii) On an annual basis thereafter, by
other appropriate supplier verification humans: December 31 of each calendar year, for
activities for that supplier within the (i) The appropriate supplier the following calendar year; and
meaning of § 117.410(b)(4). verification activity is an onsite audit of (2) Obtains written assurance, at least
(c) The requirements of this section the supplier; and every 2 years, that the farm
do not prohibit a receiving facility from (ii) The audit must be conducted acknowledges that its food is subject to
relying on an audit provided by its before using the raw material or other section 402 of the Federal Food, Drug,
supplier when the audit of the supplier ingredient from the supplier and at least and Cosmetic Act (or, when applicable,
was conducted by a third-party annually thereafter. that its food is subject to relevant laws
qualified auditor in accordance with (2) The requirements of paragraph and regulations of a country whose food
§§ 117.430(f) and 117.435. (b)(1) of this section do not apply if safety system FDA has officially
there is a written determination that recognized as comparable or has
§ 117.420 Using approved suppliers. other verification activities and/or less determined to be equivalent to that of
(a) Approval of suppliers. The frequent onsite auditing of the supplier the United States).
receiving facility must approve provide adequate assurance that the (e) If a supplier is a shell egg producer
suppliers in accordance with the hazards are controlled. that is not subject to the requirements of
requirements of § 117.410(d), and (c) If a supplier is a qualified facility part 118 of this chapter because it has
document that approval, before as defined by § 117.3, the receiving less than 3,000 laying hens, the
receiving raw materials and other facility does not need to comply with receiving facility does not need to
ingredients received from those paragraphs (a) and (b) of this section if comply with paragraphs (a) and (b) of
suppliers; the receiving facility: this section if the receiving facility:
(b) Written procedures for receiving (1) Obtains written assurance that the (1) Obtains written assurance that the
raw materials and other ingredients. (1) supplier is a qualified facility as defined shell eggs produced by the supplier are
Written procedures for receiving raw by § 117.3: not subject to part 118 because the shell
materials and other ingredients must be (i) Before first approving the supplier egg producer has less than 3,000 laying
established and followed; for an applicable calendar year; and hens:
(2) The written procedures for (ii) On an annual basis thereafter, by (i) Before first approving the supplier
receiving raw materials and other December 31 of each calendar year, for for an applicable calendar year; and
ingredients must ensure that raw the following calendar year; and (ii) On an annual basis thereafter, by
materials and other ingredients are (2) Obtains written assurance, at least December 31 of each calendar year, for
received only from approved suppliers every 2 years, that the supplier is the following calendar year; and
(or, when necessary and appropriate, on producing the raw material or other (2) Obtains written assurance, at least
a temporary basis from unapproved ingredient in compliance with every 2 years, that the shell egg
suppliers whose raw materials or other applicable FDA food safety regulations producer acknowledges that its food is
ingredients are subjected to adequate (or, when applicable, relevant laws and subject to section 402 of the Federal
verification activities before acceptance regulations of a country whose food Food, Drug, and Cosmetic Act (or, when
for use); and safety system FDA has officially applicable, that its food is subject to
(3) Use of the written procedures for recognized as comparable or has relevant laws and regulations of a
receiving raw materials and other determined to be equivalent to that of country whose food safety system FDA
ingredients must be documented. the United States). The written has officially recognized as comparable
assurance must include either: or has determined to be equivalent to
§ 117.425 Determining appropriate
supplier verification activities (including
(i) A brief description of the that of the United States).
determining the frequency of conducting preventive controls that the supplier is (f) There must not be any financial
the activity). implementing to control the applicable conflicts of interests that influence the
Appropriate supplier verification hazard in the food; or results of the verification activities
activities (including the frequency of (ii) A statement that the facility is in listed in § 117.410(b) and payment must
conducting the activity) must be compliance with State, local, county, not be related to the results of the
determined in accordance with the tribal, or other applicable non-Federal activity.
requirements of § 117.410(d). food safety law, including relevant laws
and regulations of foreign countries. § 117.435 Onsite audit.
§ 117.430 Conducting supplier verification (d) If a supplier is a farm that grows (a) An onsite audit of a supplier must
activities for raw materials and other produce and is not a covered farm under be performed by a qualified auditor.
ingredients. part 112 of this chapter in accordance (b) If the raw material or other
(a) Except as provided by paragraph with § 112.4(a), or in accordance with ingredient at the supplier is subject to
(c), (d), or (e) of this section, one or §§ 112.4(b) and 112.5, the receiving one or more FDA food safety
more of the supplier verification facility does not need to comply with regulations, an onsite audit must
activities specified in § 117.410(b), as paragraphs (a) and (b) of this section for consider such regulations and include a
determined under § 117.410(d), must be produce that the receiving facility review of the supplier’s written plan
conducted for each supplier before receives from the farm as a raw material (e.g., Hazard Analysis and Critical
using the raw material or other or other ingredient if the receiving Control Point (HACCP) plan or other
ingredient from that supplier and facility: food safety plan), if any, and its
periodically thereafter. (1) Obtains written assurance that the implementation, for the hazard being
(b)(1) Except as provided by raw material or other ingredient controlled (or, when applicable, an
paragraph (b)(2) of this section, when a provided by the supplier is not subject onsite audit may consider relevant laws
and regulations of a country whose food (3) Documentation of the approval of provide adequate assurance that the
safety system FDA has officially a supplier; hazards are controlled when a hazard in
recognized as comparable or has (4) Written procedures for receiving a raw material or other ingredient will
determined to be equivalent to that of raw materials and other ingredients; be controlled by the supplier and is one
the United States). (5) Documentation demonstrating use for which there is a reasonable
(c)(1) The following may be of the written procedures for receiving probability that exposure to the hazard
substituted for an onsite audit, provided raw materials and other ingredients; will result in serious adverse health
that the inspection was conducted (6) Documentation of the consequences or death to humans;
within 1 year of the date that the onsite determination of the appropriate (12) The following documentation of
audit would have been required to be supplier verification activities for raw an alternative verification activity for a
conducted: materials and other ingredients; supplier that is a qualified facility:
(i) The written results of an (7) Documentation of the conduct of (i) The written assurance that the
appropriate inspection of the supplier an onsite audit. This documentation supplier is a qualified facility as defined
for compliance with applicable FDA must include: by § 117.3, before approving the
food safety regulations by FDA, by (i) The name of the supplier subject to supplier and on an annual basis
representatives of other Federal the onsite audit; thereafter; and
Agencies (such as the United States (ii) Documentation of audit (ii) The written assurance that the
Department of Agriculture), or by procedures; supplier is producing the raw material
representatives of State, local, tribal, or (iii) The dates the audit was or other ingredient in compliance with
territorial agencies; or conducted; applicable FDA food safety regulations
(iv) The conclusions of the audit; (or, when applicable, relevant laws and
(ii) For a foreign supplier, the written
(v) Corrective actions taken in regulations of a country whose food
results of an inspection by FDA or the
response to significant deficiencies safety system FDA has officially
food safety authority of a country whose
identified during the audit; and recognized as comparable or has
food safety system FDA has officially
(vi) Documentation that the audit was determined to be equivalent to that of
recognized as comparable or has
conducted by a qualified auditor; the United States);
determined to be equivalent to that of (13) The following documentation of
(8) Documentation of sampling and
the United States. an alternative verification activity for a
testing conducted as a supplier
(2) For inspections conducted by the verification activity. This supplier that is a farm that supplies a
food safety authority of a country whose documentation must include: raw material or other ingredient and is
food safety system FDA has officially (i) Identification of the raw material or not a covered farm under part 112 of
recognized as comparable or determined other ingredient tested (including lot this chapter:
to be equivalent, the food that is the number, as appropriate) and the number (i) The written assurance that supplier
subject of the onsite audit must be of samples tested; is not a covered farm under part 112 of
within the scope of the official (ii) Identification of the test(s) this chapter in accordance with
recognition or equivalence conducted, including the analytical § 112.4(a), or in accordance with
determination, and the foreign supplier method(s) used; §§ 112.4(b) and 112.5, before approving
must be in, and under the regulatory (iii) The date(s) on which the test(s) the supplier and on an annual basis
oversight of, such country. were conducted and the date of the thereafter; and
(d) If the onsite audit is solely report; (ii) The written assurance that the
conducted to meet the requirements of (iv) The results of the testing; farm acknowledges that its food is
this subpart by an audit agent of a (v) Corrective actions taken in subject to section 402 of the Federal
certification body that is accredited in response to detection of hazards; and Food, Drug, and Cosmetic Act (or, when
accordance with regulations in part 1, (vi) Information identifying the applicable, that its food is subject to
subpart M of this chapter, the audit is laboratory conducting the testing; relevant laws and regulations of a
not subject to the requirements in those (9) Documentation of the review of country whose food safety system FDA
regulations. the supplier’s relevant food safety has officially recognized as comparable
§ 117.475 Records documenting the
records. This documentation must or has determined to be equivalent to
supply-chain program. include: that of the United States);
(i) The name of the supplier whose (14) The following documentation of
(a) The records documenting the records were reviewed; an alternative verification activity for a
supply-chain program are subject to the (ii) The date(s) of review; supplier that is a shell egg producer that
requirements of subpart F of this part. (iii) The general nature of the records is not subject to the requirements
(b) The receiving facility must review reviewed; established in part 118 of this chapter
the records listed in paragraph (c) of this (iv) The conclusions of the review; because it has less than 3,000 laying
section in accordance with and hens:
§ 117.165(a)(4). (v) Corrective actions taken in (i) The written assurance that the
(c) The receiving facility must response to significant deficiencies shell eggs provided by the supplier are
document the following in records as identified during the review; not subject to part 118 of this chapter
applicable to its supply-chain program: (10) Documentation of other because the supplier has less than 3,000
(1) The written supply-chain program; appropriate supplier verification laying hens, before approving the
(2) Documentation that a receiving activities based on the supplier supplier and on an annual basis
facility that is an importer is in performance and the risk associated thereafter; and
compliance with the foreign supplier with the raw material or other (ii) The written assurance that the
verification program requirements ingredient; shell egg producer acknowledges that its
under part 1, subpart L of this chapter, (11) Documentation of any food is subject to section 402 of the
including documentation of verification determination that verification activities Federal Food, Drug, and Cosmetic Act
activities conducted under § 1.506(e) of other than an onsite audit, and/or less (or, when applicable, that its food is
this chapter; frequent onsite auditing of a supplier, subject to relevant laws and regulations
of a country whose safety system FDA § 120.3 Definitions. and 117 do not govern such terms where
has officially recognized as comparable The definitions of terms in section used in this part. * * *
or has determined to be equivalent to 201 of the Federal Food, Drug, and * * * * *
that of the United States); Cosmetic Act, § 101.9(j)(18)(vi) of this ■ 23. In § 123.5, revise paragraph (a) to
(15) The written results of an chapter, and parts 110 and 117 of this read as follows:
appropriate inspection of the supplier chapter are applicable to such terms
for compliance with applicable FDA when used in this part, except that the § 123.5 Current good manufacturing
food safety regulations by FDA, by definitions and terms in parts 110 and practice.
representatives of other Federal 117 do not govern such terms where (a) Except as provided by § 117.5(b),
Agencies (such as the United States such terms are redefined in this part and parts 110 and 117 of this chapter apply
Department of Agriculture), or by except that the terms facility, hazard, in determining whether the facilities,
representatives from State, local, tribal, and manufacturing/processing in parts methods, practices, and controls used to
or territorial agencies, or the food safety 110 and 117 do not govern such terms process fish and fishery products are
authority of another country when the where used in this part. * * * safe, and whether these products have
results of such an inspection is * * * * * been processed under sanitary
substituted for an onsite audit; conditions.
■ 19. Revise § 120.5 to read as follows:
(16) Documentation of actions taken
* * * * *
with respect to supplier non- § 120.5 Current good manufacturing
conformance; ■ 24. In § 123.11, revise the introductory
practice.
(17) Documentation of verification of text of paragraph (b) to read as follows:
Except as provided by § 117.5(c), parts
a supply-chain-applied control applied 110 and 117 of this chapter apply in § 123.11 Sanitation control procedures.
by an entity other than the receiving determining whether the facilities, * * * * *
facility’s supplier; and methods, practices, and controls used to
(18) When applicable, documentation (b) Sanitation monitoring. Each
process juice are safe, and whether the processor shall monitor the conditions
of the receiving facility’s review and food has been processed under sanitary
assessment of: and practices during processing with
conditions. sufficient frequency to ensure, at a
(i) Applicable documentation from an
entity other than the receiving facility ■ 20. In § 120.6, revise the first sentence minimum, conformance with those
that written procedures for receiving of paragraph (b) to read as follows: conditions and practices specified in
raw materials and other ingredients are part 110 of this chapter and in subpart
§ 120.6 Sanitation standard operating
being followed; B of part 117 of this chapter that are
procedures.
(ii) Applicable documentation, from both appropriate to the plant and the
* * * * * food being processed and relate to the
an entity other than the receiving (b) Monitoring. The processor shall
facility, of the determination of the following:
monitor the conditions and practices
appropriate supplier verification * * * * *
during processing with sufficient
activities for raw materials and other frequency to ensure, at a minimum,
ingredients; PART 129—PROCESSING AND
conformance with those conditions and BOTTLING OF BOTTLED DRINKING
(iii) Applicable documentation, from
practices specified in part 110 of this WATER
an entity other than the receiving
chapter and in subpart B of part 117 of
facility, of conducting the appropriate
this chapter that are appropriate both to ■ 25. The authority citation for 21 CFR
supplier verification activities for raw
the plant and to the food being part 129 continues to read as follows:
materials and other ingredients;
(iv) Applicable documentation, from processed. * * * Authority: 21 U.S.C. 342, 348, 371, 374;
its supplier, of: * * * * * 42 U.S.C. 264.
(A) The results of sampling and
testing conducted by the supplier; or PART 123—FISH AND FISHERY ■ 26. Revise § 129.1 to read as follows:
(B) The results of an audit conducted PRODUCTS
§ 129.1 Current good manufacturing
by a third-party qualified auditor in practice.
■ 21. The authority citation for 21 CFR
accordance with §§ 117.430(f) and The applicable criteria in parts 110
part 123 continues to read as follows:
117.435; and and 117 of this chapter, as well as the
(v) Applicable documentation, from Authority: 21 U.S.C. 321, 342, 343, 346,
348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, criteria in §§ 129.20, 129.35, 129.37,
an entity other than the receiving
2411, 264. 129.40, and 129.80 shall apply in
facility, of verification activities when a
determining whether the facilities,
supply-chain-applied control is applied ■ 22. In § 123.3, revise the first sentence methods, practices, and controls used in
by an entity other than the receiving of the introductory text to read as the processing, bottling, holding, and
facility’s supplier. follows: shipping of bottled drinking water are in
PART 120—HAZARD ANALYSIS AND § 123.3 Definitions.
conformance with or are operated or
CRITICAL CONTROL POINT (HACCP) administered in conformity with good
The definitions and interpretations of manufacturing practice to assure that
SYSTEMS terms in section 201 of the Federal bottled drinking water is safe and that
■ 17. The authority citation for 21 CFR Food, Drug, and Cosmetic Act (the act) it has been processed, bottled, held, and
part 120 continues to read as follows: and in parts 110 and 117 of this chapter transported under sanitary conditions.
are applicable to such terms when used
Authority: 21 U.S.C. 321, 342, 343, 346, in this part, except that the definitions
348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, PART 179—IRRADIATION IN THE
and terms in parts 110 and 117 do not PRODUCTION, PROCESSING AND
242l, 264.
govern such terms where such terms are HANDLING OF FOOD
■ 18. In § 120.3, revise the first sentence redefined in this part and except that
of the introductory text to read as the terms facility, hazard, and ■ 27. The authority citation for 21 CFR
follows: manufacturing/processing in parts 110 part 179 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 343, 348, PART 211—CURRENT GOOD (c) * * * Therefore, until further
373, 374. MANUFACTURING PRACTICE FOR notice, regulations under parts 110 and
FINISHED PHARMACEUTICALS 117 of this chapter, and where
■ 28. In § 179.25, revise paragraph (a) to applicable, parts 113 through 129 of this
read as follows: chapter, shall be applied in determining
■ 29. The authority citation for 21 CFR
§ 179.25 General provisions for food part 211 continues to read as follows: whether these OTC drug products that
irradiation. are also foods are manufactured,
Authority: 21 U.S.C. 321, 351, 352, 355, processed, packed, or held under
* * * * * 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. current good manufacturing practice.
(a) Any firm that treats foods with
ionizing radiation shall comply with the ■ 30. In § 211.1, revise the last sentence Dated: August 31, 2015.
requirements of parts 110 and 117 of in paragraph (c) to read as follows: Leslie Kux,
this chapter and other applicable Associate Commissioner for Policy.
regulations. § 211.1 Scope. [FR Doc. 2015–21920 Filed 9–10–15; 8:45 am]
* * * * * * * * * * BILLING CODE 4164–01–P

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Department of Health and Human Services

DEPARTMENT OF HEALTH AND 117.435(d), 117.475(c)(2), and A. Title of Part 117

C. Comments Regarding an Exemption for Business

Conveying, and Manufacturing Systems Operations § 117.139)

XXIX. Comments on Proposed § 117.140— G. Proposed § 117.165(b)—Written F. Proposed § 117.267—Procedure for

LIII. Comments on FSMA’s Rulemaking

COSTS AND HEALTH BENEFITS

One-time cost One-time cost

Learn about Rule $6 $96 $21 $0 $16 $14

Total Costs ........... 100 1,342 344 1,115 1,202 1,198

Total Health Bene-

TABLE OF ABBREVIATIONS AND ACRONYMS

Abbreviation/acronym What it means

TABLE OF ABBREVIATIONS AND ACRONYMS—Continued

TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

Produce for Human Consumption.

TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA—Continued

Farm ............................................ • A farm is an ‘‘operation’’ rather than an ‘‘establishment.’’

TABLE 6—OUTCOME OF THE PROPOSED GENERAL REVISIONS TO PART 110—Continued

§ 117.20(a)—Management responsibility for maintaining grounds .......... § 117.35(a)—General maintenance.

TABLE 9—DEFINITIONS THAT WE PROPOSED TO ESTABLISH IN § 117.3

Batter ............................................................ Current ......................... No ............................. No ............................. No.

TABLE 9—DEFINITIONS THAT WE PROPOSED TO ESTABLISH IN § 117.3—Continued

Facility ........................................................... New .............................. N/A ............................ Yes ............................ No.

TABLE 9—DEFINITIONS THAT WE PROPOSED TO ESTABLISH IN § 117.3—Continued

Validation ...................................................... New .............................. N/A ............................ Yes ............................ Yes.

the amount of product produced, and ‘‘environmental pathogen’’ is directed to 6. Facility

§§ 1.227 and 1.328, and our responses to

RACs no longer apply in light of the considered pests. Individual

TABLE 10—SUBSTITUTIONS FOR THE TERM ‘‘SIGNIFICANT HAZARD’’

117.130(a)(1) ................................. Requirement to conduct a hazard Hazard requiring a preventive N/A.1

ity must validate that the pre-

TABLE 10—SUBSTITUTIONS FOR THE TERM ‘‘SIGNIFICANT HAZARD’’—Continued

provisions in part 117 that refer to raw

TABLE 12—REVISIONS TO THE PROPOSED EXEMPTIONS

• Added low-risk packing or holding activity/food combina-

TABLE 12—REVISIONS TO THE PROPOSED EXEMPTIONS—Continued

exemption. (Comment 184) Some comments period preceding the applicable

produced under a HACCP regulation.

103(c)(1)(C) draft RA. From this time

• Barley malt syrup ........................................................ § 117.5(g)(3)(xix)—Sugar.

• Other concentrated natural sweetener having a

• Crackers, dry bread, bread crumbs ...................................................... • Baked goods

requirements of this rule.

Section Description Revision

then the modified requirements only support ‘‘never.’’

TABLE 18—PERSONNEL PROVISIONS

§ 117.10—Management Responsibility ......................................................... No ................ Yes .............. Yes.

TABLE 19—PROVISIONS FOR PLANT AND GROUNDS

§ 117.20(a)—Grounds ......................................................................................................................... No ................ Yes .............. No.

TABLE 20—PROVISIONS FOR SANITARY OPERATIONS

§ 117.35(a)—General Maintenance .................................................................................................... Yes .............. Yes .............. Yes.

A. Proposed § 117.35(a)—General acknowledge the appropriate degree of B. Proposed § 117.35(b)—Substances

contaminated. The timing and extent of

TABLE 21—PROVISIONS FOR SANITARY FACILITIES AND CONTROLS

§ 117.37(a)—Water Supply ...................................................................................... Yes ....................... Yes ....................... No.

TABLE 22—PROVISIONS FOR EQUIPMENT AND UTENSILS

(Response 292) We agree that it is not other contaminants. ‘‘should’’ to ‘‘must.’’

Materials § 117.40(a)(5); we intended to specify (i.e., through smoothly bonded seams or

§ 117.80(a)(1 )—Adequate sanitation principles ...................................................... No ........................ Yes ....................... No.

A. Proposed § 117.80(a)(1)—Adequate of low-moisture almonds, sanitation evidence that industry commonly

TABLE 25—PROVISIONS FOR PROCESSES AND CONTROLS FOR MANUFACTURING OPERATIONS