Fda 2011 N 0920 1553

Vol.
79 Monday,
No. 188 September 29, 2014
Part IV
Department of Health and Human Services

Food and Drug Administration
21 CFR Parts 16, 117, and 507
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals; Proposed Rule
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58524 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules
DEPARTMENT OF HEALTH AND Electronic Submissions V. The Farm Definition

HUMAN SERVICES A. 2013 Proposed Definitions of Farm,
Submit electronic comments in the Harvesting, Holding, and Packing
following way: B. Conducting Packing and Holding
Food and Drug Administration Federal eRulemaking Portal: http:// Activities on Others RACs
www.regulations.gov. Follow the C. Field Coring as a Harvesting Activity
21 CFR Parts 1, 16, and 117 instructions for submitting comments. D. Drying/Dehydrating Raw Agricultural
Commodities To Create a Distinct
[Docket No. FDA2011N0920] Written Submissions Commodity
Submit written submissions in the E. One General Physical Location
RIN 0910AG36 F. Proposed Revisions to the Exemption
following ways:
Mail/Hand delivery/Courier (for paper From CGMP Requirements for Farms
Current Good Manufacturing Practice and Activities of Farm Mixed-Type
and Hazard Analysis and Risk-Based submissions): Division of Dockets
Facilities That Fall Within the Farm
Preventive Controls for Human Food Management (HFA305), Food and Drug Definition
Administration, 5630 Fishers Lane, Rm. G. Comparing Proposed Requirements for
AGENCY: Food and Drug Administration, 1061, Rockville, MD 20852. Packing Produce Under the 2013
HHS. Instructions: All submissions received Proposed Preventive Controls Rule to
ACTION: Proposed rule; supplemental must include the Docket No. FDA Proposed Requirements for Packing
notice of proposed rulemaking. 2011N0920 for this rulemaking. All Produce Under the 2013 Proposed
comments received may be posted Produce Safety Rule
SUMMARY: The Food and Drug without change to http:// VI. Definitions of Holding and Packing
Administration (FDA or we) is A. 2013 Proposed Definition of Holding
www.regulations.gov, including any
B. 2013 Proposed Exemptions Relevant to
proposing to amend our 2013 proposed personal information provided. For the Definition of Holding
rule for Current Good Manufacturing additional information on submitting C. Comments on the 2013 Proposed
Practice (CGMP) and Hazard Analysis comments, see the Comments heading Exemption for a Facility Solely Engaged
and Risk-Based Preventive Controls for of the SUPPLEMENTARY INFORMATION in the Storage of RACs (Other Than
Human Food. In that 2013 proposed section of this document. Fruits and Vegetables) Intended for
rule, we proposed to amend the CGMP Docket: For access to the docket to Further Distribution or Processing
requirements to modernize them and to read background documents or D. Comments on the 2013 Proposed
add requirements for certain domestic comments received, go to http:// Exemption for a Facility Solely Engaged
and foreign facilities to establish and www.regulations.gov and insert the in the Storage of Packaged Food That Is
Not Exposed to the Environment
implement hazard analysis and risk- docket number, found in brackets in the
E. Proposed Revisions to the Definition of
based preventive controls for human heading of this document, into the Holding
food. We also proposed to revise certain Search box and follow the prompts F. Proposed Revisions to the Definition of
definitions in our current regulation for and/or go to the Division of Dockets Packing
Registration of Food Facilities to clarify Management, 5630 Fishers Lane, Rm. VII. Impact of the Proposed Revisions to the
the scope of an exemption from 1061, Rockville, MD 20852. Farm-Related Definitions on the
registration requirements for farms FOR FURTHER INFORMATION CONTACT: Classification of On-Farm Activities
and, in so doing, to clarify which Jenny Scott, Center for Food Safety and A. Comments on the 2013 Organizing
domestic and foreign facilities would be Principles for Classifying Activities
Applied Nutrition (HFS300), Food and Conducted on Farms and on Farm
subject to the proposed requirements for Drug Administration, 5100 Paint Branch Mixed-Type Facilities
hazard analysis and risk-based Pkwy., College Park, MD 20740, 240 B. Updated Organizing Principles That
preventive controls for human food. We 4022166. Would Apply to the Farm Definition
are taking this action because the SUPPLEMENTARY INFORMATION: C. Changes to Classification of On-Farm
extensive input we have received from Activities
public comments has led to significant Table of Contents VIII. Proposed Exemptions for On-Farm Low-
changes in our current thinking on Executive Summary Risk Activity/Food Combinations
certain key provisions of these proposed Purpose and Coverage of the Supplemental A. The 2013 Proposed Exemptions
rules. We are reopening the comment Notice of Proposed Rulemaking B. Comments on the 2013 Proposed
Summary of the Major Provisions of the Exemptions for On-Farm Low-Risk
period only with respect to specific
Supplemental Notice of Proposed Activity/Food Combinations
issues identified in this proposed rule. Rulemaking C. Impact of the Proposed Revisions to the
DATES: Submit either electronic or Costs and Benefits Definitions for Farm, Harvesting,
written comments on the proposed rule I. Background Holding, and Packing on the 2013
by December 15, 2014 Submit A. Introduction Proposed Exemptions for On-Farm Low-
comments on information collection B. 2013 Proposed Preventive Controls Rule Risk Activity/Food Combinations
issues under the Paperwork Reduction C. Definition of Retail Food IX. Overall Framework for Hazard Analysis
Establishment and Risk-Based Preventive Controls
Act of 1995 by December 15, 2014 (see
II. Public Comments A. 2013 Proposed Overall Framework for
the Paperwork Reduction Act of 1995 A. Opportunities for Public Comment Hazard Analysis and Risk-Based
section of this document). B. Overview of Public Comments on the Preventive Controls
ADDRESSES: You may submit comments 2013 Proposed Preventive Controls Rule B. Comments on the Reasonably Likely to
by any of the following methods, except C. Our Decision To Issue a Supplemental Occur Construct Within the 2013
that comments on information Notice of Proposed Rulemaking for Overall Framework for Hazard Analysis
collection issues under the Paperwork Public Comment and Risk-Based Preventive Controls
III. Scope of the Supplemental Notice of C. Proposed Revisions to the Overall
Reduction Act of 1995 must be
Proposed Rulemaking and Our Request Framework for Hazard Analysis and
submitted to the Office of Information for Public Comment Risk-Based Preventive Controls
and Regulatory Affairs, Office of IV. Legal and Regulatory Framework Under X. Potential Requirements for Product
Management and Budget (OMB) (see the Sections 415 and 418 of the FD&C Act Testing and Environmental Monitoring
Paperwork Reduction Act of 1995 and Regulations Implementing Section A. Our Request for Comment on Including
section of this document). 415 of the FD&C Act Requirements for Product Testing and
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules 58525
Environmental Monitoring in a Final Executive Summary requirements for product testing

Rule programs, environmental monitoring
B. Product Testing Purpose and Coverage of the
programs, supplier programs, and
C. Environmental Monitoring Supplemental Notice of Proposed
hazards that may be intentionally
XI. Potential Requirements for a Supplier Rulemaking
introduced for purposes of economic
Program We previously proposed to add gain, taking into account the comments
A. Our Request for Comment on When and requirements for certain domestic and we have reviewed so far. We are seeking
How Supplier Verification Activities Are foreign facilities to establish and comment on whether such requirements
an Appropriate Means of Implementing implement hazard analysis and risk- should be included in a final rule and,
the Statutory Framework of Section 418 based preventive controls for human if so, what (if any) modifications to the
of the FD&C Act food, as required by the FDA Food
B. Comments on When and How Supplier
proposed regulatory text would be
Safety Modernization Act (FSMA). The appropriate.
Verification Activities Are an
proposed requirements would apply to In the previous proposal, we
Appropriate Means of Implementing the
establishments that are required to requested comment on three options for
Statutory Framework of Section 418 of
register with us as a food facility. In classifying a facility as a very small
the FD&C Act
C. Potential Requirements for a Supplier
this document we are proposing to business, with consequences for
Program revise several previously proposed facilities in terms of eligibility for
D. Request for Additional Comment on requirements, taking into account the exemptions and the timeframe to
Requirements To Address Conflicts of comments we have reviewed so far, comply with this rule. In this document
Interest for Persons Conducting because the extensive input we have we are proposing a definition for very
Verification Activities received from public comments has led small business (i.e., a business that has
XII. Potential Requirements for the Hazard to significant changes in our current less than $1,000,000 in total annual
Analysis To Address Economically thinking on certain key provisions. sales of human food adjusted for
Motivated Adulteration Farms are exempt from the inflation).
A. Our Request for Comment on Whether registration requirements and, thus,
the Final Rule Should Address would be exempt from the proposed Summary of the Major Provisions of the
Economically Motivated Adulteration requirements for hazard analysis and Supplemental Notice of Proposed
B. Comments on Economically Motivated risk-based preventive controls for Rulemaking
Adulteration human food. We are proposing to revise The revised farm definition would
C. Potential Requirements To Address the definition of farm, as well as continue to describe a farm as an
Economically Motivated Adulteration definitions for three activities establishment devoted to the growing of
XIII. Provisions for Withdrawal of an (harvesting, holding, and crops, the raising of animals, or both.
Exemption for a Qualified Facility packing) that play a key role in However, the revised farm definition
A. 2013 Proposed Provisions for determining whether an establishment would no longer limit packing and
Withdrawal of an Exemption for a is within the farm definition. The holding of RACs to the farms own
Qualified Facility effect of the revised definitions would RACs; instead, a farm could now pack
B. Proposed Clarification of What FDA be that a farm would no longer be and hold RACs grown on another farm
Will Do Before Issuing an Order and
required to register as a food facility not under the same ownership. In
Proposed Mechanism for Re-Instating an
merely because it packs or holds raw addition, a farm could manufacture/
Exemption
agricultural commodities (RACs) grown process RACs by drying/dehydrating to
C. Proposed Revisions to the Content of an
Order To Withdraw an Exemption
on another farm not under the same create a distinct commodity (e.g., drying
D. Proposed Revisions to the Timeframes ownership. The revised definitions grapes to create raisins), and package
for a Facility To Comply With, or would not create any new and label the dried commodity, as long
Appeal, an Order circumstances where a farm that would as there was no additional processing.
XIV. Definition of Very Small Business not have been required to register under An example of additional processing
A. The 2013 Proposed Options for the previous proposal would now be might include slicing fruit and then
Definition of Very Small Business required to register. drying it, which would require
B. Comments on the 2013 Proposed In the previous proposal, we asked for additional manufacturing/processing
Options for Definition of Very Small comment on when and how three prior to drying. Because drying/
Business provisions (i.e., product testing dehydrating RACs to create a distinct
C. Proposed Revisions to the Definition of programs, environmental monitoring commodity creates a processed food, the
Very Small Business programs, and supplier programs) are an packing and holding of raisins would be
XV. Other New and Revised Proposed appropriate means of implementing the subject to the CGMP requirements for
Provisions statutory directives of FSMA. We also human food rather than to standards
A. Proposed New Definitions requested comment on whether a that we have separately proposed to
B. Proposed Revisions to Definitions facility should be required to address apply to produce RACs. Given the
C. Proposed Editorial Changes potential hazards that may be nature of this processed food (i.e., dried
XVI. Holding Human Food By-Products intentionally introduced for economic RACs), we tentatively conclude that the
Intended for Use in Animal Food reasons. Some comments to the requirements we separately proposed
XVII. Preliminary Regulatory Impact
previous proposal assert that additional for packing and holding produce RACs
Analysis
public comment is warranted before would be sufficiently similar to the
A. Overview
B. Regulatory Flexibility Act consideration is given to whether a final CGMP requirements to make it
C. Small Business Regulatory Enforcement rule includes or does not include appropriate to specify in the regulatory
Fairness Act of 1996 provisions that were discussed in the text that compliance with the CGMP
D. Unfunded Mandates Reform Act of 1995 previous proposal but for which we had requirements may be achieved by
XVIII. Paperwork Reduction Act of 1995 not included regulatory text in the complying with subpart B or with the
XIX. Analysis of Environmental Impact previous proposal. In this document we applicable requirements for packing and
XX. Comments are providing an opportunity for such holding produce RACs in the separate
XXI. References public comment on potential produce safety rule.
The previously proposed the nature of the preventive control if We seek comment on whether these
requirements for hazard analysis and contamination of a ready-to-eat food potential requirements discussed above
risk-based preventive controls applied a with an environmental pathogen is a should be included in a final rule.
construct we previously used in our significant hazard. The facility would be The previously proposed
Hazard Analysis and Critical Control required to have written procedures for requirements provided for an exemption
Point (HACCP) regulations for seafood environmental monitoring, corrective for certain facilities defined by FSMA as
and juicei.e., whether a known or action procedures to address the qualified facilities. As required by
reasonably foreseeable hazard was presence of an environmental pathogen FSMA, the previously proposed
reasonably likely to occur. In general, or appropriate indicator organism requirements also included an
our HACCP regulations for seafood and detected through the environmental administrative procedure whereby we
juice focus on critical control points to monitoring, and records of could withdraw that exemption under
control hazards that are reasonably environmental monitoring. certain circumstances. In this document,
likely to occur. We are proposing to The proposed requirements for a we are proposing a series of
eliminate the term hazard reasonably potential supplier program would, if modifications to the proposed
likely to occur throughout the included in a final rule, require supplier withdrawal provisions. These
proposed requirements to reduce the controls when the facilitys hazard modifications include describing the
potential for a misinterpretation that all analysis identifies a significant hazard steps we would take before withdrawing
necessary preventive controls must be for a raw material or ingredient, and that an exemption, including advance
established at critical control points hazard is controlled before the facility notification to the facility; a procedure
(CCPs). The revised regulations would receives the raw material or ingredient for re-instatement of a withdrawn
use a new term (significant hazard) in (e.g., if a supplier roasts the nuts that a exemption; and an additional 60 days
its place. facility would use to manufacture an for a facility whose exemption is
The defined term significant hazard energy bar). A facility would not need withdrawn to comply with the full
would be linked to the facilitys hazard to establish supplier controls if it requirements for hazard analysis and
analysis, which addresses risk (i.e., both controls that hazard, or if its customer risk-based preventive controls.
the severity of a potential hazard and controls that hazard. The supplier
Costs and Benefits
the probability that the hazard will program would be written. With one
occur). Thus, this term would reflect the exception, the receiving facility would We summarize the domestic
risk-based nature of the requirements. In have flexibility to determine the annualized costs of the proposed
addition, the revised regulations would appropriate verification activity (e.g., regulation with the revised provisions,
provide additional flexibility relative to onsite audit; sampling and testing of the including the potential requirements for
the previous proposal by providing that raw material or ingredient; review of the product testing, environmental
a facility can take into account the suppliers food safety records; or other monitoring, a supplier program, and
nature of a preventive control in appropriate verification activity). The potential requirements regarding
determining when and how to establish exception would be when there is a hazards that may be intentionally
and implement appropriate preventive reasonable probability that exposure to introduced for economic reasons, using
control management components, the hazard will result in serious adverse both a discount rate of 3 percent and 7
including monitoring, corrections or health consequences or death to percent, discounted over a 7 year period
corrective actions, verification, and humans. In this circumstance, the in the following table. The revised
records. Table 6 in the document receiving facility would be required to proposed regulation uses a very small
provides examples of flexibility have documentation of an onsite audit business definition of $1,000,000 and
provided by the rule, including of the supplier before using the raw includes potential additional
flexibility provided for a facility to take material or ingredient from the supplier requirements for facilities subject to
into account the nature of the and at least annually thereafter, unless subpart C to institute risk-based
preventive control when determining the receiving facility determines and environmental monitoring, product
the appropriate preventive control documents that that other verification testing and a supplier program as
management components. activities and/or less frequent onsite appropriate to the food, the facility and
The proposed requirements for auditing of the supplier provide the nature of the preventive controls,
product testing would, if included in a adequate assurance that the hazards are and controls to help prevent hazards
final rule, require that a facility conduct controlled. Instead of an onsite audit, a associated with economically motivated
product testing as an activity for receiving facility may rely on the results adulteration. As described in the
verification of implementation and of an inspection of the supplier by FDA updated Preliminary Regulatory Impact
effectiveness as appropriate to the or, for a foreign supplier, by FDA or the Analysis, for the final rule we anticipate
facility, the food, and the nature of the food safety authority of a country whose making several modifications to our
preventive control. The facility would food safety system FDA has officially estimate of the cost of our proposed rule
be required to have written procedures recognized as comparable or has (see section XVII).
for product testing, corrective action determined to be equivalent to that of As in our original proposal, we lack
procedures to address the presence of a the United States, provided that the sufficient information to fully estimate
pathogen or appropriate indicator inspection was conducted within 1 year the proposed rules likely benefits.
organism in a ready-to-eat product of the date that the onsite audit would Instead we attempt to estimate the total
detected as a result of product testing, have been required to be conducted. economic burden of the domestic
and records of product testing. The proposed requirements regarding illnesses that could potentially be
The proposed requirements for potential hazards that may be prevented by this rule. We do not expect
environmental monitoring would, if intentionally introduced for economic that all of these illnesses will be
included in a final rule, require that a reasons would, if included in a final prevented; rather, we expect that the
facility conduct environmental rule, require that a facility consider in rule would prevent some portion from
monitoring as an activity for verification its hazard analysis hazards that may be occurring. We estimate that there are
of implementation and effectiveness as intentionally introduced for purposes of close to 1,000,000 illnesses each year
appropriate to the facility, the food, and economic gain. that are attributable to FDA-regulated
food products that would fall under the to reduce the health burden to illnesses by approximately $471
scope of this proposed rule. The consumers by approximately the same million. We estimate that the average
monetized cost of these illnesses is amount as the compliance costs to cost per illness is $2,063, so reducing
estimated to be nearly $2 billion. This industry, and if we include the costs to the cost of illness by $471 million
ignores the costs to foreign firms and foreign firms but ignore the benefits to requires reducing the number of
benefits to foreign consumers. foreign consumers, the rule would have illnesses by at least 228,000 each year.
For the proposed rule to break even, to reduce the annual social cost of the
by which we mean for the proposed rule
ORIGINAL AND REVISED ESTIMATED TOTAL COSTS BASED ON ADDITIONAL PROVISIONS AND REVISED FACILITY COUNT
20 or fewer 20 to 99 100 to 499 500 or more
employees employees employees employees Total
Original Total Annualized Costs without

additional provisions discounted at
7% ...................................................... $208 million $67 million $43 million $1 million $319 million*
Original Total Annualized Costs without
additional provisions discounted at
3% ...................................................... $200 million $65 million $42 million $1 million $307 million*
Additional costs because of new provi-
sions discounted at 7% ...................... $19 million $20 million $10 million $2 million $52 million*
Additional costs because of new provi-
sions discounted at 3% ...................... $19 million $20 million $10 million $2 million $52 million*
Revised Total Annualized Costs dis-
counted at 7% .................................... $227 million $87 million $53 million $3 million $371 million*
Revised Total Annualized Costs dis-
counted at 3% .................................... $219 million $85 million $52 million $3 million $359 million*
Total Costs to Foreign Facilities (most
likely cost) annualized at 7% ............. .............................. .............................. .............................. .............................. $100 million
Total Costs to Foreign Facilities (most
likely cost) annualized at 3% ............. .............................. .............................. .............................. .............................. $100 million
Benefits .................................................. .............................. .............................. .............................. .............................. Unquantified
I. Background FSMA enables us to focus more on problems when they do occur. In

preventing food safety problems rather addition, the law gives us important
A. Introduction
than relying primarily on reacting to new tools to better ensure the safety of
The FDA Food Safety Modernization problems after they occur. The law also imported foods and encourages us to
Act (FSMA) (Pub. L. 111353), signed provides us with new enforcement form partnerships with State, local,
into law by President Obama on January authorities to help achieve higher rates tribal, and territorial authorities. Table 1
4, 2011, enables us to better protect of compliance with risk-based, identifies five proposed rules, issued to
public health by helping to ensure the prevention-oriented safety standards implement FSMA, that we discuss in
safety and security of the food supply. and to better respond to and contain this document.
TABLE 1PUBLISHED PROPOSED RULES FOR IMPLEMENTATION OF FSMA

Title Abbreviation Publication
Current Good Manufacturing Practice and Hazard Anal- 2013 proposed preventive controls rule ... 78 FR 3646, January 16, 2013.
ysis and Risk-Based Preventive Controls for Human
Food.
Standards for the Growing, Harvesting, Packing, and 2013 proposed produce safety rule .......... 78 FR 3504, January 16, 2013.
Holding of Produce for Human Consumption.
Foreign Supplier Verification Programs (FSVP) for Im- 2013 proposed FSVP rule ........................ 78 FR 45730, July 29, 2013.
porters of Food for Humans and Animals.
Focused Mitigation Strategies To Protect Food Against 2013 proposed intentional adulteration 78 FR 78014, December 24, 2013.
Intentional Adulteration. rule.
Current Good Manufacturing Practice and Hazard Anal- 2013 proposed animal food rule ............... 78 FR 64736, October 29, 2013.
ysis and Risk-Based Preventive Controls for Food for
Animals.
B. 2013 Proposed Preventive Controls established in part 110 (21 CFR part and changes in related areas of the law
Rule 110)) to modernize it; since issuance of the CGMP regulation;

Proposed to adjust and clarify what Proposed to re-establish the
In the 2013 proposed preventive provisions of current part 110 in new
controls rule, we: activities fall within the current
exemption from the CGMP requirements part 117 (21 CFR part 117);
Proposed to amend our regulation for Proposed to delete some non-binding
for establishments engaged solely in the
Current Good Manufacturing Practice in provisions of current part 110 and
harvesting, storage, or distribution of
Manufacturing, Packing, or Holding requested comment on whether to revise
Human Food (CGMPs; currently one or more RACs based on experience other non-binding provisions to
establish new requirements in proposed TABLE 2PROPOSED SUBPARTS IN (78 FR 17142 at 17143 through 17155;
part 117, or to simply retain them as NEW PART 117Continued the corrected Appendix) because all the
useful provisions of a comprehensive references to the Appendix as published
CGMP; Subpart Title in the 2013 proposed preventive
Requested comment on additional controls rule (78 FR 3646 at 3812
proposed revisions or clarifications to D .................... Modified Requirements. through 3824) had been numbered
our CGMP regulations, including E ..................... Withdrawal of an Exemption
Applicable to a Qualified
incorrectly.
whether to further implement
opportunities for CGMP modernization, Facility. C. Definition of Retail Food
F ..................... Requirements Applying to
such as on how best to revise the Establishment
Records That Must Be Es-
current provisions for training; tablished and Maintained.
Proposed to add, in newly established An establishment that meets the
G .................... Reserved.
part 117, requirements for domestic and definition of retail food establishment
foreign facilities that are required to In the 2013 proposed preventive is exempt from the requirements of the
register under section 415 of the Federal controls rule, we provided an extensive section 415 registration regulations and,
Food, Drug, and Cosmetic Act (the background discussing: thus, from FSMAs requirements for
FD&C Act) to establish and implement The provisions of FSMA most directly hazard analysis and risk-based
hazard analysis and risk-based applicable to the proposed preventive controls. Section 102(c) of
preventive controls for human food; requirements, particularly the statutory FSMA requires that we revise the
Proposed to add a definition for the provisions of section 103 of FSMA definition of retail food establishment
term mixed-type facilities, to add or (established in section 418 of the FD&C in 1.227 to clarify its intent. Some
modify definitions for certain activities Act); comments express concern that we did
(i.e., for harvesting, holding, Hazard Analysis and Critical Control not address the requirements of section
manufacturing/processing, and Points (HACCP) Systems; 102(c) of FSMA in the 2013 proposed
packing activities), and to revise the Food Safety Problems Associated preventive controls rule.
definition of farm as a conforming With Manufacturing, Processing,
revision in light of the proposed new Packing, and Holding Food for Human We are addressing the requirements of
definition of harvesting in our current Consumption; section 102(c) of FSMA in a separate
regulation for Registration of Food The Role of Testing as a Verification rulemaking and plan to issue a proposed
Facilities (21 CFR part 1, subpart H; the Measure in a Food Safety System rule to amend the definition of retail
section 415 registration regulations) to (including discussions about food establishment in the section 415
clarify the scope of the exemption from environmental monitoring as well as registration regulations and the section
the section 415 registration testing raw materials, ingredients, and 414 recordkeeping regulations in a
requirements for farms; finished product), largely in an future issue of the Federal Register.
Proposed to revise the definitions, in Appendix to the 2013 proposed
our current regulation (implementing preventive controls rule (the II. Public Comments
section 414 of the FD&C Act) for Appendix)); and A. Opportunities for Public Comment
Establishment and Maintenance of The Role of Supplier Approval and
Records for Foods (21 CFR part 1, Verification Programs in a Food Safety We requested comments on the 2013
subpart J; the section 414 recordkeeping System (largely in the Appendix). proposed preventive controls rule by
requirements); We also issued for public comment a May 16, 2013. We extended the
Requested comment on when and Draft Qualitative Risk Assessment of comment periods for the 2013 proposed
how product testing programs, Risk of Activity/Food Combinations for preventive controls rule, its information
environmental monitoring programs, Activities (Outside the Farm Definition) collection provisions, and the draft risk
and supplier approval and verification Conducted in a Facility Co-Located on assessment in response to several
are an appropriate means of a Farm (the draft risk assessment) (78 requests that we do so (see Table 3).
implementing the statutory framework FR 3824, January 16, 2013). The purpose
of FSMA; and Since issuing the 2013 proposed
of the draft risk assessment was to
Requested comment on whether a provide a science-based risk analysis of preventive controls rule, we conducted
final rule should address potential those activity/food combinations that numerous outreach activities. For
hazards that may be intentionally would be considered low risk, when example, we held three public meetings
introduced for economic reasons. conducted in a facility co-located on a to solicit oral stakeholder and public
We proposed to establish the farm. We used the tentative conclusions comments on the 2013 proposed
requirements for CGMPs, for hazard of the draft risk assessment to propose preventive controls rule, inform the
analysis and risk-based preventive to exempt food facilities that are small public about the rulemaking process
controls, and related requirements in or very small businesses that are (including how to submit comments,
new part 117 as shown in Table 2: engaged only in specific types of on- data, and other information to the
farm manufacturing, processing, rulemaking dockets), and respond to
TABLE 2PROPOSED SUBPARTS IN packing, or holding activities from the questions about the 2013 proposed
NEW PART 117 requirements for hazard analysis and preventive controls rule (see Table 3)
risk-based preventive controls. (Ref. 1) (Ref. 2) (Ref. 3) (Ref. 4) (Ref. 5)
Subpart Title We also issued a document correcting (Ref. 6). We also traveled across the
several typographical and stylistic errors country and around the world to discuss
A ..................... General Provisions. the 2013 proposed preventive controls
B ..................... Current Good Manufacturing
in the 2013 proposed preventive
Practice. controls rule and a mistake in the date rule, as well as the other foundational
C .................... Hazard Analysis and Risk- of a reference (78 FR 17142, March 20, FSMA proposed rules listed in section
Based Preventive Con- 2013). In that correction document, we I.A, with persons who would be affected
trols. republished the Appendix in its entirety by them (Ref. 7) (Ref. 8) (Ref. 9).
TABLE 3LIST OF Federal Register PUBLICATIONS REGARDING THE 2013 PROPOSED PREVENTIVE CONTROLS RULE
Description Publication
2013 proposed preventive controls rule, requesting comments by May 16, 2013 .............. 78 FR 3646, January 16, 2013.
Notice of availability of the draft risk assessment, requesting comments by February 15, 78 FR 3824, January 16, 2013.
2013.
Notice of public meeting (held in Washington D.C. on February 28, 2013) on the 2013 78 FR 6762, January 31, 2013.
proposed preventive controls rule and the 2013 proposed produce safety rule.
Notice of public meetings (held in Chicago, IL on March 11, 2013 and in Portland, OR on 78 FR 10107, February 13, 2013.
March 27, 2013) on the 2013 proposed preventive controls rule and the 2013 pro-
posed produce safety rule.
Notice extending comment period, until May 16, 2013, for the information collection provi- 78 FR 11611, February 19, 2013.
sions of the 2013 proposed preventive controls rule.
Reopening of the comment period, until May 16, 2013, for the draft risk assessment ....... 78 FR 15894, March 13, 2013.
Notice of correction for the 2013 proposed preventive controls rule ................................... 78 FR 17142, March 20, 2013.
Notice extending the comment period, until September 16, 2013, for the 2013 proposed 78 FR 24691, April 26, 2013.
preventive controls rule and its information collection provisions.
Notice extending the comment period, until September 16, 2013, for the draft risk as- 78 FR 24693, April 26, 2013.
sessment.
Notice extending the comment period, until November 15, 2013, for the 2013 proposed 78 FR 48636, August 9, 2013.
Notice extending the comment period, until November 22, 2013, for the 2013 proposed 78 FR 69604, November 20, 2013.
B. Overview of Public Comments on the warranted before any consideration of Modifications to our proposed
2013 Proposed Preventive Controls Rule whether a final rule should or should revisions to the definitions, in the
We received more than 8000 not include provisions discussed in the section 415 registration regulations, for
submissions on the proposed rule by the proposed rule, but for which we had not farm, harvesting, holding, and
close of the comment period, each included proposed regulatory text, such packing, with conforming changes in
containing one or more comments. We as potential requirements for product the section 414 recordkeeping
received submissions from diverse testing, environmental monitoring, a regulations and the proposed preventive
members of the public, including food supplier approval and verification controls rule;
facilities (including facilities co-located program, and potential hazards that may Modifications to our proposed
on a farm); farms; cooperatives; be intentionally introduced for revisions to the current exemption, in
coalitions; trade organizations; economic reasons. the CGMP regulations, for
consulting firms; law firms; academia; establishments engaged solely in the
public health organizations; public C. Our Decision To Issue a harvesting, storage, or distribution of
advocacy groups; consumers; consumer Supplemental Notice of Proposed one or more RACs;
Rulemaking for Public Comment Revisions to several definitions we
groups; Congress, Federal, State, local,
proposed to apply to the requirements
and tribal Government Agencies; and In December 2013, we issued a for hazard analysis and risk-based
other organizations. Some submissions statement noting the extensive input we preventive controls, including
included signatures and statements from have received from produce farmers and definitions for environmental
multiple individuals. others in the agricultural sector on the
Comments address virtually every pathogen, hazard, reasonably
2013 proposed produce safety rule and foreseeable hazard, and very small
provision of the 2013 proposed
the 2013 proposed preventive controls business;
preventive controls rule, including our
rule (Ref. 8). We stated that we believe New definitions for significant
requests for comment on including
that significant changes will be needed hazard, pathogen, and you;
additional provisions that we did not Revisions to the proposed procedures
in key provisions of the two proposed
include in the proposed regulatory text. that would govern withdrawal of an
rules affecting small and large farmers,
Although some comments focus on exemption from a qualified facility,
specific details of the proposed such as certain provisions affecting
mixed-use facilities (i.e., facilities co- including clarifications about the steps
requirements (such as whether the rule we would take before issuing an order
should define the term allergen cross- located on a farm). We also announced
our intent to propose revised regulatory to withdraw the exemption, an
contact rather than the term cross- expanded timeframe for a facility to
contact), other comments are broad in requirements and request comment on
them, allowing the public the comply with an order withdrawing an
nature (such as comments addressing exemption, and a mechanism for a
the overall framework of the proposed opportunity to provide input on our
new thinking. We noted that there may withdrawn exemption to be re-instated;
requirements for hazard analysis and and
risk-based preventive controls in be other revisions to the proposed rules
that we would issue for public A series of revisions to the proposed
proposed subpart C). Some comments requirements for hazard analysis and
comment, and that we would determine
question whether the proposed risk-based preventive controls

requirements reflected a risk-based the scope of the revised proposals after
(proposed subpart C) to:
approach (such as comments about how we complete our initial review of Emphasize the risk-based nature of
the requirements for hazard analysis written comments. the preventive controls and
and risk-based preventive controls III. Scope of the Supplemental Notice requirements for monitoring, corrective
would apply to facilities co-located on and Our Request for Public Comment actions, and verification activities;
farms). Some comments assert that Reduce the potential for
additional public comment would be In this document, we are proposing: misinterpretation that the rule requires
that all necessary preventive controls be this supplemental notice of proposed farm manufacturing, processing,
established at CCPs for all hazards that rulemaking in developing the final rule. packing and holding activities that
a facility addresses in its food safety would trigger a requirement for an
IV. Legal and Regulatory Framework
plan; establishment that is also a farm to
Increase flexibility for a facility to Under Sections 415 and 418 of the
register as a food facility and, thus, be
determine, based on the nature of a FD&C Act and Regulations
Implementing Section 415 of the FD&C subject to the requirements for hazard
preventive control, when requirements analysis and risk-based preventive
for preventive control management Act
controls with regard to its non-farm
components (i.e., monitoring, In the 2013 proposed preventive activities (78 FR 3646 at 3674). In the
corrective actions, and verification) are controls rule, we described the current 2013 proposed preventive controls rule,
appropriate; legal and regulatory framework that we explained how the status of a food
Substitute the pronoun you for the governs the determination of when an as a raw agricultural commodity (RAC)
owner, operator, or agent in charge of establishment is required to register as or a processed food affects the
the facility throughout these proposed a food facility in accordance with the requirements applicable to a farm under
requirements; section 415 registration regulations. We sections 415 and 418 of the FD&C Act.
Substitute the term adequate focused on the framework that governs
(which is a term we proposed to define) In the 2013 proposed preventive
whether an establishment that grows
in place of the term sufficient (which controls rule, we also articulated a
and harvests crops or raises animals
we did not propose to define); comprehensive set of organizing
satisfies the definition of farm
Improve readability, through because the facility registration principles that formed the basis for
rearrangement of some of the proposed requirements of section 415 of the FD&C proposed revisions to definitions that
regulatory text and editorial revisions Act do not apply to farms. When we classify activities on-farm and off-farm
(such as increased use of active voice). implemented the statutory requirements in the section 415 registration
In this document, we also are for registration of food facilities, we regulations (the 2013 organizing
providing an opportunity for public established a definition for farm that principles; see Table 3 in the 2013
comment on potential requirements for first describes a farm as a facility proposed preventive controls rule).
product testing, environmental devoted to the growing and harvesting Because these definitions also are
monitoring, a supplier program, and of crops, the raising of animals established in the section 414
hazards that may be intentionally (including seafood), or both ( 1.227; 68 recordkeeping regulations, these
introduced for purposes of economic FR 58894, October 10, 2003). Although organizing principles also would form
gain, including definitions of terms (i.e., that definition of farm then provides the basis for proposed revisions to
qualified auditor, receiving facility, that farms also pack or hold food, it definitions that classify activities on-
and supplier) that would be used in limits facilities that fall within the farm and off-farm in the section 414
some of those potential requirements. definition of farm to those that pack recordkeeping regulations.
We are seeking comment on whether or hold food grown, raised, or consumed In the 2013 proposed preventive
such requirements should be included on that farm or another farm under the controls rule, we proposed to add a
in a final rule and, if so, what (if any) same ownership. Thus, under the definition for the term mixed-type
modifications to the proposed current framework, an establishment facilities, to add or modify definitions
regulatory text would be appropriate. that is devoted to the growing and for certain activities (i.e., for
In this document, we also are harvesting of crops, but also packs and harvesting, holding,
informing stakeholders of a holds food not grown or raised on that manufacturing/processing, and
supplemental notice of proposed farm or on another farm under the same packing activities), and to revise the
rulemaking, published elsewhere in this ownership, would fall outside the definition of farm as a conforming
issue of the Federal Register, to amend definition of farm and be required to revision in light of the proposed new
the 2013 proposed animal food rule. register as a food facility. Because an definition of harvesting.
That supplemental notice includes establishment that is required to register In sections V and VI, we discuss
proposed revisions that would address as a food facility is subject to the comments on these and other provisions
comments about the practice of human requirements of section 418 of the FD&C of the 2013 proposed preventive
food manufacturers sending by-products Act, under the current framework a controls rule that are leading us to
to local farmers or animal food determination of whether an propose revised definitions for farm,
manufacturers for use as animal food. establishment devoted to the growing harvesting, packing, and holding;
We discuss these proposed and harvesting of crops is subject to and re-classify some activities as
requirements in sections V through XV. FSMAs requirements for hazard harvesting, packing, or holding. Briefly,
Because several of the proposed analysis and risk-based preventive the proposed changes would:
revisions relate to the overall framework controls depends, in part, on where the
Provide for on-farm packing and
in subpart C for hazard analysis and food that the establishment packs or
holding of RACs to remain within the
risk-based preventive controls, we are holds is grown or raised.
Under the current framework, a key farm definition regardless of ownership
including the complete regulatory text
factor in whether an establishment falls of the RACS;
for proposed subpart C. However, in this
document, we are reopening the within the definition of farm, even Include, within the farm definition,
comment period only with respect to with respect to crops it grows and a description of packing activities that
the issues specified in this section III. harvests itself, is whether the activities include packaging RACs grown or raised
Importantly, the proposed revisions to conducted by the farm fall within on a farm without additional
the provisions we have included in the definitions of harvesting, packing manufacturing/processing;
regulatory text are based on a or holding (which are within the Provide for field coring as an
preliminary review of the comments. farm definition). As discussed in the example of a harvesting activity to make
We will complete our review of 2013 proposed preventive controls rule, clear that on farm field coring of a
comments previously submitted and section 103 of FSMA directs us to RAC is an activity that is within the
consider the comments responsive to conduct rulemaking to clarify the on- farm definition;
Provide that activities performed Proposing modifications to our grown or raised on a farm or another
incidental to packing a food would be proposed revisions to the farm farm under the same ownership for
packing activities; definition; storage and transport, but would not
Provide that activities performed Proposing modifications to our include activities that transform a RAC
incidental to holding a food would be proposed revisions to the definitions of into a processed food.
holding activities; harvesting, holding, and packing
as conforming amendments to the B. Conducting Packing and Holding
Provide for drying/dehydrating RACs Activities on Others RACs
revised farm definition; and
to create a distinct commodity (such as Proposing modifications to our 1. Comments
the on-farm drying of grapes to produce proposed revisions to the current
raisins), and packaging and labeling Some stakeholders expressed concern,
exemption, in the CGMP regulations, for
such commodities, without additional in public sessions and in written
establishments engaged solely in the
manufacturing/processing, to remain comments, about how the proposed
harvesting, storage, or distribution of
within the farm definition; requirements for packing and holding
one or more RACs.
Seek comment on whether we should RACs would apply to a farm that would
We are reopening the comment period
retain, remove, or modify the phrase in with respect to these revised definitions be subject to the requirements for
one general physical location in the (proposed 117.3) and this revised hazard analysis and risk-based
farm definition; exemption (proposed 117.3(k)). See preventive controls because the farm
section VI for additional revisions that packs or holds produce grown on
Subject the packaging, packing, and others farms. Comments assert that
holding of dried RACs by farms and we are proposing to the definitions of
holding and packing. classifying establishments as being
farm mixed-type facilities to the CGMP within the farm definition, or outside
requirements in subpart B of proposed A. 2013 Proposed Definitions of Farm, the farm definition, based on who
part 117 as well as provide that Harvesting, Holding, and owns the RACs being packed is not a
compliance with these CGMP Packing risk-based classification. These
requirements may be achieved by comments also compare the
complying with the applicable Consistent with the organizing
principles regarding classification of requirements that would apply to a farm
requirements for packing and holding when packing produce in accordance
produce RACs in the separate produce activities on-farm and off-farm, we
proposed to define harvesting, as a with the 2013 proposed preventive
safety rule; and
new definition in 1.227 and 1.328, to controls rule to the requirements that
Reconsidered the classification of apply to farms and farm mixed-type would apply to a farm when packing
specific activities as harvesting, facilities and to mean activities that are produce in accordance with the 2013
packing, holding, or manufacturing/ traditionally performed by farms for the proposed produce safety rule. In
processing, when conducted on farms or purpose of removing RACs from the general, these comments express
on farm mixed-type facilities. These place they were grown or raised and concern about the lack of clarity and
changes in activity classification would preparing them for use as food. We consistency in the requirements for
result in a single circumstance (drying/ proposed that harvesting be limited to packing and holding RACs under the
dehydrating RACs to create a distinct activities performed on the farm on 2013 proposed preventive controls rule
commodity without additional which they were grown or raised, or and the 2013 proposed produce safety
manufacturing/processing) where a farm another farm under the same ownership, rule. Some of these comments assert
conducting manufacturing/processing and that harvesting does not include that treating on-farm packing and
would no longer be required to register activities that transform a RAC into a holding of RACs differently depending
as a food facility, but would not result processed food. The proposed definition on whether the RACs are grown on that
in any new circumstance where a farm included examples of activities that farm (or another farm under the same
would now be required to register as a would be harvesting. As a conforming ownership) or grown on a different farm
food facility. change to the proposed definition of under different ownership, fails to
Elsewhere in this issue of the Federal harvesting, we proposed to revise the reflect modern, cooperative farming
Register, we are issuing a supplemental definition of farm in current practices and to be risk-based.
notice of proposed rulemaking to amend 1.227(b)(3) and 1.328 to delete Comments also assert that it
the 2013 proposed animal food rule. examples of harvesting that currently unreasonable to force many farms to
That supplemental notice includes a appear in the farm definition. comply with two different sets of
discussion of farming models for raising We proposed to revise the definition requirements depending on whether
animals, including contract farming, of holding in 1.227 and 1.328 so they are packing and holding their own
fully vertically integrated farming, and that it would be a two-part definition produce or packing and holding
cooperative farming. That supplemental that would include, for farms and farm produce from another farm. In essence,
notice asks for comment on whether mixed-type facilities, activities comments assert it would be more
feed mills associated with fully traditionally performed by farms for the appropriate for farm activities such as
vertically integrated farming operations, safe or effective storage of RACs grown packing and holding produce to be
including cooperatives that fit this or raised on the same farm or another treated consistently under the two rules.
model, that meet the farm definition farm under the same ownership, but Comments also generally assert that the
(current or proposed revision) should be would not include activities that requirements in the 2013 proposed
required to register as a food facility transform a RAC into a processed food. produce safety rule for packing and
under section 415 of the FD&C Act and, We proposed to revise the definition holding activities (which would not
if so, what revisions to the farm of packing in 1.227 and 1.328 so require hazard analysis and risk-based
definition would be necessary. that it would be a two-part definition preventive controls) are more
V. The Farm Definition that would include, for farms and farm appropriate for farms than the
mixed-type facilities, activities (which requirements in the 2013 proposed
In this section of this document, we may include packaging) traditionally preventive controls rule for packing and
are: performed by farms to prepare RACs holding activities (which would require
hazard analysis and risk-based depend, in relevant part, on whether an ownership, to retain that aspect of the
preventive controls). establishment is a facility subject to the current farm definition in the revised
Some comments find it confusing for section 415 registration regulations. For definition. For additional discussion
the definition of farm to start by example, this would be the case for about manufacturing/processing
describing a farm as a facility in light requirements for the Reportable Food activities that would make an
of the definition of facility in section Registry (under section 417 of the FD&C establishment subject to the section 415
415(o)(2) of the FD&C Act as a facility Act), mandatory recall (under section registration regulations, see sections V.D
required to register under section 415 of 423 of the FD&C Act), and regulations and VII.
the FD&C Act. that we have proposed to establish We also are proposing that the
2. Proposed Revisions to the Definitions regarding intentional contamination packing activities (which may include
of Farm, Harvesting, Holding, related to terrorism (under sections 418 packaging) that we had proposed to
and Packing and 420 of the FD&C Act; see the include in the expanded definition of
proposed intentional adulteration rule, packing for farms and farm mixed-
In the rulemakings to establish the 78 FR 78014). We tentatively conclude type facilities be included in the farm
section 415 registration regulations and that impacts such as these, while not definition rather than in an expanded
the section 414 recordkeeping always optimal, are necessary to definition of packing. Under the
regulations, we defined farm with the establish a sensible framework of risk- revised farm definition, it will be
goal of doing so in a manner recognizing based regulations that both implement clear that an establishment devoted to
the traditional activities of FSMA and reflect common farm the growing of crops, the raising of
establishments commonly recognized to activities. Elsewhere in this issue of the animals, or both, can remain within the
be farms (see the discussions at 78 FR Federal Register, a supplemental notice farm definition if it packages RACs
3646 at 36763677 and 3679). As of proposed rulemaking regarding the grown or raised on a farm to prepare
already noted (see section V.A), we
produce safety rule (the produce safety them for storage and transport, without
proposed to expand the definition of
supplemental notice) discusses impacts additional manufacturing/processing.
packing to include activities
such as these, including a request for Packaging activities would continue to
traditionally performed by a farm to
comment on whether to include in the be considered manufacturing/processing
prepare its own RACs for storage and
final produce safety rule a requirement (78 FR 3646 at 36813682); however,
transport and to expand the definition
that a farm supplying produce to packaging a RAC would not transform
of holding to include activities
another farm that will pack or hold that the RAC into a processed food (see the
traditionally performed by a farm for the
produce should provide to the farm that discussion in the 2013 proposed
safe or effective storage of its own RACs.
receives the produce its name, complete preventive controls rule about whether
Comments assert that the packing and
holding of others RACs is a traditional business address, and description of the an activity transforms a RAC into a
and common activity by farms and that produce in any individual shipment. processed food (78 FR 3646 at 3678
the definition should not distinguish The produce safety supplemental notice 3679)). Importantly, we are proposing
between activities performed by a farm also requests comment on whether it limitations on what would be included
on its own RACs and activities would be appropriate to also require the within this addition to the farm
performed on RACs from other farms. farm that receives the shipment definition. This proposed provision
We tentatively conclude that it is maintain such record of information would not provide that packaging RACs
appropriate for packing and holding of and, if so, for what specified period of would remain within the farm
RACs, including produce, conducted on time. definition if the packaging includes
farms to remain within the farm Therefore, taking into account the additional manufacturing/processing
definition. This would result in packing comments we have reviewed so far we (e.g., the application of modified
and holding of covered produce being are proposing to revise the farm atmosphere packaging). Such
subject to the proposed produce safety definition so that it would no longer additional processing activities are not
rule, regardless of whether the activity limit establishments that fall within the akin to packing (see the discussion in
is conducted on the farms own produce farm definition to those that pack or the 2013 proposed preventive controls
or whether the activity is conducted on hold food grown, raised, or consumed rule (78 FR 3646 at 3686) that certain
others produce. This also would have on that farm or another farm under the packaging activities conducted on a
consequences beyond the preventive same ownership. Under the revised farm are akin to packing).
controls rule and the produce safety farm definition, an establishment We are not proposing any changes to
rule. For example, the revised farm devoted to the growing of crops, the the farm definition that we would
definition would be established in both raising of animals, or both, would establish in part 117, because the
the section 415 registration regulations remain within the farm definition proposed farm definition for the
and in the section 414 recordkeeping (and, thus, not be subject to the section purpose of part 117 simply referred to
regulations (see the revised regulatory 415 registration regulations and the the farm definition in the section 415
text for proposed 1.227 and 1.328, proposed requirements for hazard registration regulations.
respectively). Under the revised farm analysis and risk-based preventive The revised farm definition would
definition in the section 414 controls) even if it packs and holds require conforming changes to the
recordkeeping regulations, an RACs grown on another farm. To limit proposed definitions of harvesting,
establishment that packs and holds the potential for confusion related to the holding, and packing (in the
others RACs would no longer be term facility, we are proposing to section 415 registration regulations, the
required to establish and maintain substitute the term establishment for section 414 recordkeeping regulations,
records identifying the immediate the term facility in the revised and the proposed preventive controls
previous sources of those RACs and definition of farm. As a conforming rule) to remove limitations that the food
immediate subsequent recipients of change relevant to this substitution, we be grown on the same farm or a farm
those RACs. In addition, the scope of are adding to the farm definition the under the same ownership. (See the
covered establishments would change criterion, in the definition of facility, revised regulatory text for proposed
for other statutory requirements that that the establishment is under one 1.227, 1.328, and 117.3). In addition:
The revised regulatory text for the crops, the raising of animals, or both, sorting, cleaning or seeding) at an off-
definition of harvesting includes would remain within the farm farm facility. The comments maintain
field coring as an additional example definition (and, thus, not be subject to that the traditional activities of raisin
of a harvesting activity. See section V.C the section 415 registration regulations grape farmers associated with growing
for a discussion of this proposed and the proposed requirements for and harvesting natural condition
additional example. hazard analysis and risk-based raisins on farm are completely separate
The revised regulatory text for the preventive controls) even if it conducts and distinct from the processing and
definition of holding includes field coring of produce. The revised packing of processed raisins at a
revisions that we are proposing in definition of harvesting would be raisin processing facility. They note that
response to comments about how the included in the section 415 registration raisin grape farmers generally dry their
definition of holding would apply to regulations, the section 414 grapes either by cutting the grape
facilities such as grain elevators and recordkeeping regulations, and the clusters and placing them on trays to be
warehouses. See section VI.A through preventive controls rule. In this section naturally sun dried, or by allowing the
VI.E for a discussion of those proposed of this document, we are reopening the grapes to dry naturally on the vine. In
revisions. comment period with respect to both instances, there is no intervention
The revised regulatory text for the including field coring as an example by the farmer in the drying process;
definition of packing includes of a harvesting activity in this revised rather, the drying process occurs
changes that we are proposing to definition of harvesting (proposed naturally through the action of the sun.
provide for activities performed 117.3). These comments ask us to recognize this
incidental to packing a food. See section distinction and provide in the final rule
D. Drying/Dehydrating Raw Agricultural that on-farm activities such as drying
VI.F for discussions of those proposed
Commodities To Create a Distinct natural condition raisins in the field
revisions.
Commodity are exclusively subject to the produce
The revised definitions of farm,
harvesting, holding, and packing 1. Comments safety rule and that processing facility
would, if finalized, require changes to operations are subject to the preventive
Some comments refer to our
guidance documents we issued controls rule. They also specifically
discussion, in the 2013 proposed
regarding the section 415 registration mention the 1996 EPA policy statement
preventive controls rule, about guidance and ask us to determine that it does not
regulations and the section 414 jointly developed by FDA and the U.S.
recordkeeping regulations, including apply for the purposes of implementing
Environmental Protection Agency (EPA) FSMA.
specific examples of circumstances that regarding whether or not various
would make an establishment subject to activities transform RACs into processed 2. Proposed Revisions to the Farm
those requirements (e.g., Ref. 10, Ref. 11, foods, including a joint conclusion that Definition Regarding Drying/
Ref. 12, and Ref. 13). We intend to drying a RAC causes it to become a Dehydrating RACs To Create a Distinct
update affected guidance documents to processed food, unless the drying is for Commodity When the Drying/
reflect the final definitions. the purpose of facilitating storage or Dehydrating Is Akin to Harvesting and
C. Field Coring as a Harvesting Activity transportation of the commodity (78 FR There Is No Additional Processing
3646 at 36783679). In our discussion, The processes described in the
1. Comments we described a series of policy comments for drying grapes to natural
Some comments ask us to specify that statements and guidance documents, condition raisins are akin to other
activities such as core in field and issued by FDA and EPA regarding harvesting activities traditionally
clean and core are considered whether or not various activities conducted by farms on RACs grown and
harvesting, because these activities are transform RACs into processed foods harvested on farms, because they are
no different from an example (i.e., (78 FR 3646 at 36783679). We noted traditionally performed by farms for the
trimming of outer leaves of) included that FDA and EPA have jointly purpose of removing RACs from the
in the regulatory text of the definition of concluded that drying a RAC causes it place they were grown or raised and
harvesting. to become a processed food, unless the preparing them for use as food (see 78
drying is for the purpose of facilitating FR 3646 at 3681 and the proposed
2. Proposed Revision to the Definition of
storage or transportation of the definition of harvesting in proposed
Harvesting
commodity (see, e.g., (Ref. 14). We 117.3).
We are proposing revisions to the referenced a policy statement issued by We continue to consider that drying a
definition of harvesting in addition to EPA on the status of dried commodities RAC to create a distinct commodity
the revisions, discussed in section as RACs (the 1996 EPA policy causes it to become a processed food
V.B.2, that would be conforming statement; 61 FR 2386, January 25, and, thus, is a manufacturing/processing
amendments in light of the revised 1996). We also gave two examples of activity for the purpose of the section
farm definition. We are proposing to when we would consider that drying a 415 registration regulations. However, to
include field coring as an example of RAC created a processed food: (1) the extent that the comments are asking
a harvesting activity to make clear that Drying grapes to create raisins; and (2) us to determine that drying a RAC to
on farm field coring of a RAC (e.g., drying fresh herbs (such as peppermint) create a distinct commodity can, under
removing the core of lettuce in the field to create dried herbs, because in both circumstances such as those described
at the same time the stem is cut and these instances drying creates a distinct in the comments, remain within the
wrapper leaves removed) is a harvesting commodity and therefore a processed farm definition, we tentatively
activity, even though coring outside food. conclude that it is appropriate to do so,
of field coring (e.g., during the The comments contrast the growing provided that the drying/dehydrating
production of fresh-cut lettuce) is a and harvesting (including drying) of process is akin to harvesting. However,
manufacturing/processing activity. natural condition raisins (produced we would continue to classify drying
Under the revised harvesting with sun-drying or artificial RACs to create a distinct commodity as
definition, it would be clear that an dehydration) with raisins subject to manufacturing/processing rather than
establishment devoted to the growing of additional processing and packing (e.g., re-classify this activity as harvesting.
We do not consider it necessary or regulations and FSMAs requirements However, this definition specifically
prudent to classify this activity in two for hazard analysis and risk-based adds an explanatory statement that a
different ways for the purposes of the preventive controls for such activities. facility may consist of one or more
farm definition and determining our contiguous structures ( 1.227). During
E. One General Physical Location
responsibilities for antimicrobial the rulemaking to establish this
substances. 1. Comments on Whether the Farm definition of facility, we explained
To provide for drying/dehydrating Definition Should Specify That a Farm that we proposed to include this
that is akin to harvesting to remain Is in One General Physical Location explanatory sentence in the regulatory
within the farm definition, taking into text as a result of comments that we
Some comments emphasize that farms
account the comments we have received during our early outreach
throughout the country are now made
reviewed so far we are proposing that efforts (68 FR 5378 at 5381, February 3,
up of multiple, often non-contiguous
farms include establishments that, in 2003).
fields due to geographic and
addition to growing and harvesting
topographic conditions, local We are seeking comment on whether
crops, raising animals, or both,
development patterns, and the fact that we should retain, remove, or modify the
manufacture/process RACs by drying/
a single farm today often derives from phrase in one general physical
dehydrating the RACs to create a
multiple previous farms due to the need location in the farm definition. In
distinct commodity, and/or packaging
and/or labeling such commodities, to achieve economic efficiencies. Some responding to our request for comment
without additional manufacturing/ comments explain that as farm land on this issue, we ask commenters to
processing (see the revised regulatory increasingly is partitioned into smaller carefully consider what, if any, impacts
text for the farm definition in and smaller parcels through estate removing or modifying this phrase
proposed 1.227 and 1.328). This divisions or for other reasons, farmers could have on other rules that already
revised farm definition would purchasing land find that they are rarely include (or have proposed to include)
specifically address this circumstance able to purchase adjacent parcels. These the same definition of farm as would
because otherwise it would not be comments ask us to modify or remove be established in the section 415
within the farm definition. Drying/ the phrase in one general physical registration regulations, as well as how
dehydrating that is akin to harvesting location in the farm definition. One such impacts would best be addressed.
would not trigger the requirement to suggested modification is to replace the For example, elsewhere in this issue of
register as a facility and would not phrase in one general physical the Federal Register the produce safety
trigger the requirements for hazard location with an explanatory sentence, supplemental notice seeks comment on
analysis and risk-based preventive such as one clarifying that a farm may how we should interpret in one general
controls. Likewise, packaging and/or consist of one or more parcels of land physical location for the purposes of
labeling the dried commodities (which (or water) and may include one or more enforcing that rule. The produce safety
are processed food), would not trigger structures (e.g., outbuildings, barns, supplemental notice explains that
the requirement to register as a facility greenhouses, etc.). specifying that a farm is in one general
and would not trigger the requirements physical location could impact
2. Request for Additional Comment on
for hazard analysis and risk-based classification of farms subject to the
Whether the Farm Definition Should
preventive controls. As a companion produce safety rule as a small
Specify That a Farm Is in One General
change, we are proposing that the business or very small business and,
Physical Location
farm definition explicitly provide that thus affect the compliance date for that
packing and holding the dried During the rulemaking to establish the farm.
commodities (which are processed food) farm definition in the section 415
registration regulations, we explained F. Proposed Revisions to the Exemption
is within the farm definition. Whether From CGMP Requirements for Farms
a farm would be subject to the produce that a farm may consist of contiguous
parcels of land, ponds located on and Activities of Farm Mixed-Type
safety rule would depend on factors Facilities That Fall Within the Farm
included in the produce safety rule, contiguous parcels of land, or, in the
case of netted or penned areas located Definition
such as whether the RACs satisfy
criteria for covered produce. in large bodies of water, contiguous nets 1. 2013 Proposed Revisions to the
Importantly, we are proposing or pens (68 FR 5378 at 5381, February Exemption From the CGMP
limitations on when this special 3, 2003). However, we did not propose Requirements for Establishments
circumstance would apply. This to include this explanatory sentence in Engaged Solely in the Harvesting,
proposed provision would not provide the regulatory text. Comments Storage, or Distribution of One or More
that drying/dehydrating fruit would addressing one general physical RACs
remain within the farm definition if location focused on how specifying in
the dried/dehydrated fruit is subject to one general physical location would In the 2013 proposed preventive
additional manufacturing/processing, affect whether the farm would be controls rule, we proposed to adjust and
such as cutting the fruit or applying subject to the section 415 registration clarify what activities fall within the
sulfites (e.g., when manufacturing/ regulations. Our response to those current exemption from the CGMP
processing dried apples). Such comments focused on the nature of the requirements for establishments
additional processing activities are not activities being conducted rather than engaged solely in the harvesting,
akin to harvesting. They also are not on the contiguous or non-contiguous storage, or distribution of one or more
necessary for safe storage of the crop nature of parcels of land or nets (68 FR RACs (RAC exemption) based on
(which would be holding; see sections 58894 at 58906, October 10, 2003). experience and changes in related areas
VI.C., VI.E, and VII.C and Table 1 in the The definition of facility in the of the law since issuance of the CGMP
Appendix to this document). A farm section 415 registration regulations regulation. We proposed to provide that
that also manufactures/processes likewise specifies that a facility means the CGMP requirements of subpart B
products such as dried, cut apples any establishment, structure, or would not apply to farms, activities of
would be a farm mixed-type facility, structures under one ownership at one farm mixed-type facilities that fall
subject to the section 415 registration general physical location . . . within the farm definition, or the
holding or transportation of one or more requirements we separately proposed We also are proposing to clarify how
RACs (proposed 117.5(k)). for packing and holding produce RACs this exemption applies to activities
In the 2013 proposed produce safety would be sufficiently similar to the commonly conducted on nuts at a
rule, we proposed to implement section CGMP requirements to make it facility that is not a farm or farm-mixed
419 of the FD&C Act (standards for appropriate to specify in the regulatory type facility by specifying that subpart
produce safety) by establishing, in part text that compliance with the CGMP B does not apply to hulling, shelling,
112, standards for the growing, requirements may be achieved by and drying nuts (without
harvesting, packing, and holding of complying with subpart B or with the manufacturing/processing, such as
produce for human consumption. The applicable requirements for packing and roasting nuts). Hulling, shelling, and
proposed standards for produce safety holding produce RACs in the separate drying nuts (without additional
would apply only to RACs (see produce safety rule. However, we do not manufacturing/processing), are
proposed 112.1(a) and section intend to issue a final rule on this activities conducted by establishments
419(a)(1)(A) of the FD&C Act). specific option for achieving engaged solely in the harvesting,
2. Consequential Revision to the RAC compliance with the CGMP storage, or distribution of one or more
Exemption in Light of Proposed requirements that would apply to RACs and, thus, fall within the current
Changes to the Farm Definition processed food produced through RAC exemption in 110.19.
drying/dehydrating RACs until we issue
As discussed in section V.D of this the final produce safety rule. G. Comparing Proposed Requirements
document, we are proposing that an for Packing Produce Under the 2013
establishment that is devoted to the 3. Comments on the Proposed RAC Proposed Preventive Controls Rule to
growing and harvesting of crops, the Exemption Proposed Requirements for Packing
raising of animals, or both can remain Some comments ask us to exempt the Produce Under the 2013 Proposed
within the farm definition if it dries/ harvest and immediate transport of raw Produce Safety Rule
dehydrates RACs to create a distinct fishery commodities from the CGMP 1. Comments
commodity, and/or packages and/or requirements. Other comments ask us to
labels such commodities, without exempt facilities that conduct hulling Some stakeholders expressed concern,
additional manufacturing/processing. A and drying operations on shell nuts in public sessions and in written
farm that does so would transform a from the CGMP requirements. comments, about the proposed
RAC into a processed food. The growing requirements that would apply to an off-
and harvesting of produce RACs that 4. Proposed Additional Revisions to the farm facility that packs and holds
would be covered by the proposed RAC Exemption To Clarify Applicability produce. These comments focus on how
produce safety rule would be subject to to Certain RACs the proposed requirements for an off-
the standards for produce safety, but the We are proposing to clarify how the farm facility that packs and holds
dried commodities that are processed RAC exemption applies to seafood RACs produce under the requirements of the
food would not. Like any other by specifying that subpart B does not 2013 proposed preventive controls rule
processed food, such dried commodities apply to fishing vessels that are not would be different from the
would be subject to the CGMP subject to the registration requirements requirements, under the 2013 proposed
requirements (proposed subpart B) and of part 1, subpart H of this part in produce safety rule, that would apply to
would not be eligible for a RAC accordance with 1.226(f). Section on-farm packing and holding of
exemption, whether the current RAC 1.226(f) describes fishing vessels that produce. These comments assert that
exemption in 110.19 or the proposed are exempt from the registration the status of an establishment as a
RAC exemption in proposed requirements as those that not only facility subject to the section 415
117.5(k). harvest and transport fish but also registration requirements should not be
Therefore, as a consequence of our engage in practices such as heading, used as justification to subject packing
proposal to provide for drying/ eviscerating, or freezing intended solely and holding activities to different
dehydrating that is akin to harvesting to to prepare fish for holding on board a standards if there is no risk-based
remain within the farm definition, we harvest vessel. Section 1.226(f) also reason to do so. Some comments assert
also are proposing to revise the specifies that fishing vessels otherwise that the standards described in the 2013
exemption from CGMP requirements for engaged in processing fish are subject to proposed produce safety rule are more
farms and activities of farm mixed- the registration requirements, and than adequate for the safe handling
type facilities that fall within the describes processing for the purpose and packing of raw, intact fresh
farm definition to provide that if a of determining the exemption to mean produce, regardless of commodity, size
farm or farm mixed-type facility handling, storing, preparing, shucking, of operation, or source of produce.
dries/dehydrates RACs to create a changing into different market forms, These comments also assert that there is
distinct commodity, the CGMP manufacturing, preserving, packing, no evidence to suggest that different
requirements apply to the packaging, labeling, dockside unloading, holding, requirements for off-farm establishments
packing, and holding of the dried or heading, eviscerating, or freezing that pack and hold produce are needed
commodities. As discussed in section other than solely to prepare fish for to prevent contamination.
V.G of this document, we tentatively holding on board a harvest vessel. The
conclude that the specific steps that are practices identified in 117.226(f) 2. Summary of the Similarities and
necessary to ensure the safety of (heading, eviscerating, or freezing Differences for Off-Farm Packing and
Holding Compared to On-Farm Packing
produce that an establishment packs intended solely to prepare fish for

and holds would be the same regardless holding on board a harvest vessel) that and Holding
of the specific regulatory framework warrant an exemption from registration The specific steps that are necessary
applicable to the establishment. Given are activities conducted by to ensure the safety of produce that an
the nature of the processed food that establishments engaged solely in the establishment packs and holds generally
would be subject to the CGMP harvesting, storage, or distribution of would be the same regardless of
requirements (i.e., dried RACs), we one or more RACs and, thus, fall within whether the establishment is on-farm or
tentatively conclude that the the current RAC exemption in 110.19. off-farm. For example, several of the
CGMP requirements that would apply to facility would be able to start from such at 3709). We intended this provision to
an off-farm packing facility (e.g., a generic food safety plan, or to start exempt, for example, facilities that only
provisions for employee health and from the provisions of the final produce store whole grains (such as corn, wheat,
hygiene, the plant and its grounds, safety rule, in generating its own food barley, rye, grain sorghum, oats, rice,
sanitary operations and facilities, and safety plan, and to tailor its own food wild rice, and soybeans), unpasteurized
equipment and utensils) have an safety plan to its particular shell eggs, and unpasteurized milk from
analogous counterpart in the 2013 circumstances, such as the commodities the requirements for hazard analysis
proposed produce safety rule. In it packs and holds. and risk-based preventive controls,
addition, although an off-farm packing The FD&C Act makes the status of an provided that such facilities do not
facility would be required to establish establishment as a facility subject to the conduct other activities subject to
and implement a food safety plan, we section 415 registration requirements, FSMAs requirements for hazard
expect that its food safety plan would rather than a farm, relevant to which analysis and risk-based preventive
focus on a few key preventive controls, requirements apply to packing and controls (78 FR 3646 at 3709).
including some that would have holding activities. Section 418(a) of the Second, we proposed to exempt a
counterparts in the proposed produce FD&C Act, which applies to facilities facility solely engaged in the storage of
safety rule. For example, we expect that required to register, requires the owner, packaged food that is not exposed to the
the food safety plan for an off-farm operator, or agent in charge of a facility environment from the requirements for
packing facility would include to evaluate the hazards that could affect hazard analysis and risk-based
preventive controls such as maintaining food manufactured, processed, packed, preventive controls that would be
and monitoring the temperature of water or held by such facility, identify and established in subpart C (proposed
used during packing. These preventive implement preventive controls, monitor 117.7(a); see discussion at 78 FR 3646
controls would have counterparts under the performance of those controls, and at 3713). We intended this provision to
the 2013 proposed produce safety rule maintain records of this monitoring as a exempt, for example, facilities that store
(see, e.g., proposed 112.46(c)). We also matter of routine practice. Section packaged food in containers in a
expect that an off-farm packing facility 418(h) of the FD&C Act requires the warehouse. However, a facility solely
would establish sanitation controls to owner, operator, or agent in charge of a engaged in the storage of packaged food
address the cleanliness of food-contact facility to prepare a written plan that that is not exposed to the environment
surfaces (including food-contact documents and describes the and that requires time/temperature
surfaces of utensils and equipment) and procedures used by the facility to control to significantly minimize or
the prevention of cross-contamination comply with the requirements of section prevent the growth of, or toxin
from insanitary objects and from 418 of the FD&C Act (see section 418(h) production by, pathogens would be
personnel to food, food packaging of the FD&C Act). In contrast, section subject to modified requirements (see
material, and other food-contact 419 of the FD&C Act directs FDA (rather proposed 117.7(b) and 117.206).
surfaces. See the discussion in the 2013 than the owner, operator, or agent in In this section of this document, we
proposed preventive controls rule about charge of a farm) to establish science- are proposing revisions to the definition
an outbreak of listeriosis from based minimum standards for the safe of holding in addition to the
cantaloupes, which was attributed to production and harvesting of those revisions, discussed in section V.B.2,
insanitary conditions at a facility that types of fruits and vegetables, including that would be conforming amendments
washed, packed, cooled, and stored specific mixes or categories of fruits and in light of the revised farm definition.
intact cantaloupes (78 FR 3646 at 3814). vegetables, that are RACs for which FDA In this section of this document, we are
On-farm packing facilities would be has determined that such standards reopening the comment period with
subject to similar, but not identical, minimize the risk of serious adverse respect to the revised definition of
requirements (see e.g., proposed health consequences or death. holding (proposed 117.3).
112.111(b) for cleanliness of food
VI. Definitions of Holding and C. Comments on the 2013 Proposed
contact surfaces and proposed 112.113
Packing Exemption for a Facility Solely Engaged
for protection against contamination).
A. 2013 Proposed Definition of in the Storage of RACs (Other Than
An off-farm packing facility also
Holding Fruits and Vegetables) Intended for
would be required to establish and
Further Distribution or Processing
implement appropriate preventive We proposed to revise the definition
control management components, of holding in 1.227 and 1.328 (see Some comments support the proposed
including monitoring, corrections or section V.A). exemption for a facility solely engaged
corrective actions, and verification as in the storage of RACs (other than fruits
appropriate to the nature of the B. 2013 Proposed Exemptions Relevant and vegetables) intended for further
preventive control, and would establish to the Definition of Holding distribution or processing. However,
and maintain records relative to these We proposed two exemptions some stakeholders expressed concern,
preventive controls. Some of these directed to facilities solely engaged in during outreach activities such as the
management components also would the storage (i.e., holding) of certain public meetings and in written
have counterparts under the 2013 types of food, and explained our reasons comments, that the proposed definition
proposed produce safety rule (see, e.g., for doing so. of holding would preclude facilities
proposed 112.46(a) and (b)). Moreover, First, we proposed to exempt facilities such as grain elevators from being
we consider it likely that industry that are solely engaged in the storage of eligible for the exemption in proposed
associations and coalitions would RACs (other than fruits and vegetables) 117.5(j) because most such facilities
develop a generic food safety plan intended for further distribution or conduct a variety of activities in
applicable to off-farm packing and processing from the requirements for addition to storage. For example,
holding of produce covered by the hazard analysis and risk-based comments note that grain elevators
produce rule, based in large part on the preventive controls, and explained our typically conduct the following
final provisions of the produce safety reasons for proposing to do so (proposed activities that could be characterized as
rule. An off-farm packing and holding 117.5(j); see discussion at 78 FR 3646 being practical necessities, either for the
purposes of safe or effective storage or activities performed incidental to As discussed in section V.B.2, the
for meeting customer specifications: storage of food (e.g., activities performed revised definition of holding also
Fumigate grain to control pest infestation for the safe or effective storage of that would remove limitations on where the
during storage; food and activities performed as a food is grown or raised (as a conforming
Clean grain using various mechanisms practical necessity for the distribution of change to the revised definition of
(sifting, sieving, and screening); that food). In addition to the activities farm). The revised definition of
Convey grain throughout the facility; specifically identified in the comments, holding would now be a one-part
Dry grain received with high moisture we are aware of other activities (Ref. 15) definition that applies to all facilities
content; and that can be considered incidental to that hold food, rather than a two-part
Blend lots of grain. storage of RACs, either for the purposes definition that first specifies activities
Some comments recommend that we of safe or effective storage or for meeting that are within the definition regardless
modify the proposed definition for customer specifications, including: of the type of establishment and then
holding to (1) encompass activities Treating stored grain with protectant specifies additional activities that
performed for the safe or effective chemicals and pesticide alternatives would apply only to establishments that
storage of RACs (such as drying, (other than by fumigation) to control are farms or farm mixed-type facilities.
screening, conditioning, and fumigating) infestation; See the proposed regulatory text for the
off-farm and (2) encompass activities Using modified atmosphere definition of holding in proposed
performed on RACs as a practical treatments to control pests; 1.227, 1.328, and 117.3.
necessity for product distribution (such Using biological controls for pests; With this revised definition of
as blending different lots of the same Applying chemical preservatives to holding, facilities such as grain
commodity to meet a customers quality grain to prevent growth of mycotoxin- elevators and silos would, in most cases,
specifications). producing molds; satisfy the criteria for the proposed
Weighing grain; exemption for facilities solely engaged
D. Comments on the 2013 Proposed in the storage of RACs (other than fruits
Exemption for a Facility Solely Engaged Sampling and grading grain; and
and vegetables) intended for further
in the Storage of Packaged Food That Is Aerating grain to control temperature.
distribution or processing (proposed
Not Exposed to the Environment The revised definition of holding
117.5(j)), because the definition would
would be included in the section 415
Some comments support the proposed encompass activities performed as a
registration regulations, the section 414
exemption for a facility solely engaged practical necessity for the distribution of
recordkeeping regulations, and the
in the storage of packaged food that is RACs. Other facilities that conduct
preventive controls rule. Our previously
not exposed to the environment. These operations similar to those conducted at
proposed revisions already included
comments note that warehouses grain elevators and silos, such as some
activities traditionally performed by
typically conduct the following facilities that hold oilseeds, also may
farms and farm mixed-type facilities for satisfy these criteria for exemption.
activities that could be characterized as the safe or effective storage of RACs (78
being practical necessities, either for the With this revised definition of
FR 3646 at 3681). In this document, we holding, facilities such as warehouses
purposes of storage or for product are proposing to revise the definition of
distribution, including: would, in many cases, satisfy the
holding in all three regulations to: criteria for the proposed exemption for
Affix tracking labels; Clarify that holding also includes facilities solely engaged in the storage of
Transport to a storage location in the activities performed incidental to
warehouse;
packaged food that is not exposed to the
storage of a food (e.g., activities environment (proposed 117.7(a)),
Hold non-food products, including toys and performed for the safe or effective
beauty aids; because the definition would
Break down pallets of packaged food for
storage of that food and activities encompass activities that are a practical
distribution to the retail level in less-than- performed as a practical necessity for necessity for product distribution (such
pallet quantities; the distribution of that food (such as as breaking down pallets and affixing
Assemble sales kits for use in fundraising blending of the same commodity)); tracking labels). We are adding
drives; Broaden activities . . . performed for breaking down pallets to the
Assemble variety packs by packing; and the safe or effective storage of raw examples in the revised definition of
Use packaged food to build store displays. agricultural commodities to apply to holding so that the examples reflect
Some of these comments recommend all food, not just RACs; activities conducted on packaged food
that we modify the proposed definition Broaden activities . . . performed for as well as activities conducted on RACs.
for holding to encompass activities the safe or effective storage to apply to Although we are not adding more
that are performed on packaged food all establishments that hold food, not examples to reflect activities conducted
that is not exposed to the environment just farms and farm mixed-type on packaged food, the revised definition
(1) incidental to storage of the food activities; of holding also would include
(such as transport and storage of non- Add breaking down pallets to the activities such as assembling sales kits
food products); and (2) as a practical examples in the revised definition of and variety packs, because such
necessity for product distribution (such holding so that the examples reflect activities are similar to breaking down
as affixing tracking labels, breaking activities conducted on packaged food pallets except that the order of activities
down pallets, assembling sales kits and as well as activities conducted on RACs; is reversed.
variety packs, and building store and
F. Proposed Revisions to the Definition
displays). Specify that holding facilities could

include the listed types of facilities to of Packing
E. Proposed Revisions to the Definition clarify that some of these facilities might Just as there are some activities that
of Holding not meet the definition of a holding are performed incidental to storing a
Taking into account the comments we facility if they perform other activities food, there are some activities that are
have reviewed so far, we tentatively not included in the definition of holding performed incidental to packing a food.
conclude that we should revise the (e.g., if a grain elevator mixes different For example, sorting, culling, and
definition of holding to encompass commodities to prepare animal feed). grading RACs could be an activity
incidental to packing on a farm or farm See the revised regulatory text for the revise the organizing principles to
mixed-type facility, whereas off-farm definition of packing in proposed reflect the realities and range of
some sorting or similar activities such as 1.227, 1.328, and 117.3. activities that farms do to their crops to
culling or grading may be required to prepare those crops and get them to
VII. Impact of the Proposed Revisions
ensure that like items are packed markets.
to the Farm-Related Definitions on the
together, or to remove damaged items.
As another example, food may need to Classification of On-Farm Activities B. Updated Organizing Principles That
be conveyed (moved) about an A. Comments on the 2013 Organizing Would Apply to the Farm Definition
establishment for the purpose of Principles for Classifying Activities We articulated the 2013 organizing
packing it, and may need to be weighed Conducted on Farms and on Farm principles for classifying on-farm
to ensure that appropriate amounts are Mixed-Type Facilities activities to operate within the
packed. We tentatively conclude that we Some comments object to one or more framework, already established in the
should revise the definition of of the 2013 organizing principles. As section 415 registration regulations, in
packing so that it includes activities
previously discussed, some comments which an establishment that packs and
performed incidental to packing a food.
focused on the distinction (in the holds others RACs would be outside
The revised definition of packing
farm definition, and reflected in the farm definition and, thus, be
would be included in the section 415
Organizing Principle No. 4) that required to register as a food facility.
registration regulations, the section 414
conducting packing and holding Our proposed revisions to the farm
recordkeeping regulations, and the
activities on a farms own RACs would definition would change that framework
preventive controls rule. Our previously
be within the farm definition, but and, as a consequence, require that we
proposed revisions already included
conducting packing and holding reconsider those organizing principles.
activities traditionally performed by
activities on others RACs would be
farms and farm mixed-type facilities for Organizing Principles Nos. 1, 3 and 5
the safe or effective packing of RACs (78 outside the farm definition (see
remain fully consistent with the
FR 3646 at 36813682). In this section V.B.1). Other comments focused
proposed revisions to the farm
document, we are proposing to revise on Organizing Principle No. 3i.e., that
definition. However, there would be no
the definition of packing in all three activities should be classified based in
need to specify, in Organizing Principle
regulations to: part on whether the food operated on is
No. 2, that activities that farms
Clarify that packing also includes a RAC or a processed food, and on
traditionally do relate only to their own
activities performed incidental to whether the activity transforms a RAC
RACs. In addition, Organizing Principle
packing a food (e.g., activities performed into a processed food (see section
No. 4 would no longer apply, because
for the safe or effective packing of that V.C.1). One comment asserts that the
the revised farm definition would no
food (such as sorting, culling and 2013 organizing principles rest on a
flawed understanding of how farming longer classify an activity as within (or
grading)); outside of) the farm definition based,
Provide that activities performed works because they assume that farms
exist simply to grow crops and that in part, on whether an activity is
incidental to packing a food would conducted on a farms own RACs or on
apply to all establishments that pack getting those crops to market is
something that farms dont do. This others RACs. Therefore, we tentatively
food, not just to farms and farm mixed- conclude it is appropriate to delete
type facilities; and comment also asserts that the reality is
that a farm cannot stay in business Organizing Principle No. 4 in light of
Delete the provision, in the 2013
proposed preventive controls rule, that without marketing its crops and the proposed revisions to the farm
packing would include activities (which preparing those crops for market, and definition.
may include packaging) traditionally that the imperative to maximize the Taking into account the comments we
performed on a farm on RACs grown on value a farm receives for its crops have reviewed so far, Table 4 shows our
a farm for storage or transport, because creates the need for value-added current thinking regarding the
this issue would be addressed in the marketing and cooperative distribution. organizing principles applicable to the
revised farm definition. This comment recommends that we revised farm definition.
TABLE 4UPDATED ORGANIZING PRINCIPLES THAT WOULD APPLY TO THE REVISED FARM DEFINITION
No. Organizing principle
1 ........ The basic purpose of farms is to produce RACs, and RACs are the essential products of farms.
2 ........ 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, should all be within the definition of
farm.
3 ........ Activities should be classified based in part on whether the food operated on is a RAC or a processed food, and on whether the activity
transforms a RAC into a processed food.
4 ........ Manufacturing/processing, packing, or holding foodwhether RACs or processed foods, from any sourcefor consumption on the
farm should remain within the farm definition.
C. Changes to Classification of On-Farm Appendix to this document for a these on-farm activities. As can be seen
Activities comprehensive table comparing the in the Appendix, several on-farm
classification of on-farm activities as activities can be classified in more than
We reconsidered the classification of harvesting, packing, holding, or one way, and most of the changes in
specific activities as harvesting, manufacturing/processing in the 2013 activity classification merely reflect
packing, holding, or manufacturing/ proposed preventive controls rule to our additional activities (relative to the 2013
processing, when conducted on farms or current thinking on the classification of proposed preventive controls rule) that
on farm mixed-type facilities. See the
could be classified in more than one result of the proposed revisions to the being either a packing activity or a
way. For example, in the 2013 proposed farm definition would result in a holding activity, depending on when
preventive controls rule, we classified single circumstance (drying/dehydrating the drying/dehydrating took place. After
washing as a harvesting activity (e.g., RACs to create a distinct commodity reconsidering all of the activity
if RACs are washed while they are being without additional manufacturing/ classifications, we tentatively conclude
removed from the field) as well as a processing) where a farm conducting that such drying/dehydrating should
manufacturing/processing activity (e.g., manufacturing/processing would no continue to be classified as holding,
during the production of fresh-cut longer be required to register as a food but does not constitute packing. We
produce). In this supplemental notice of facility. Importantly, the revised farm request comment on this narrowed
proposed rulemaking, we also consider definition would not result in any new classification of drying/dehydrating
washing to be a packing activity (e.g., circumstance where a farm would now when the drying/dehydrating does not
if RACs are washed in a flume or dump be required to register as a food facility. create a distinct commodity.
tank located at the farms packing shed). Table 5 includes one activity (i.e.,
field coring) that we did not address in Table 5 includes one activity (i.e.,
(Because the definition of fermenting cocoa beans and coffee
manufacturing/processing specifies that the 2013 proposed preventive controls
rule. As discussed in section V.C, we are beans) that we would now classify
for farms and farm mixed-type facilities, differently than we did in the draft risk
manufacturing/processing does not including this activity to make clear that
on farm field coring of produce (e.g., assessment (issued in conjunction with
include activities that are part of the 2013 proposed preventive controls
harvesting, packing, or holding, removing the core of lettuce in the field
at the same time the stem is cut and rule). In the draft risk assessment (Ref.
including washing as an example of 16), we classified fermenting cocoa
wrapper leaves removed) is a harvesting
a manufacturing/processing activity beans and coffee beans as harvesting
activity, even though coring outside
would not mean that a farm is activities (see Footnote 2 in Table 23 of
of field coring (e.g., during the
conducting a manufacturing/processing the draft risk assessment). After
production of fresh-cut lettuce) is a
activity when it washes RACs in its reconsidering all of the activity
manufacturing/processing activity.
packing shed on its farm, because Table 5 includes one activity (i.e., classifications, we tentatively conclude
washing RACs on a farm would be a drying/dehydrating (incidental to that fermenting cocoa beans and coffee
packing activity.) holding) that we now would classify in beans should be classified as holding
See Table 5 in this document for a list fewer ways than we did in the 2013 rather than as harvesting, because
of the activity classifications that would proposed preventive controls rule. In fermentation generally happens after
change in light of the proposed the 2013 proposed preventive controls cocoa beans and coffee beans are
revisions to the farm definition and rule, we classified drying/dehydrating removed from the plants. We request
our reconsideration of activity (for purposes of storage or transport, comment on this reclassification of
classification. As shown in Table 5, rather than to create a distinct fermenting cocoa beans and coffee
changes in activity classification as a commodity) (e.g., drying alfalfa) as beans.
TABLE 5CHANGES IN CLASSIFICATION OF ACTIVITIES CONDUCTED ON FARMS OR ON FARM MIXED-TYPE FACILITIES

BASED ON THE PROPOSED REVISIONS TO THE FARM DEFINITION
Classified in 2013 Classified in supplemental notice of proposed Why would the re-classification represent a
Activity proposed preventive rulemaking change from the 2013 proposed preventive
controls rule controls rule? 2
Cooling ........................ Harvesting; ( 117.3); Harvesting (e.g., hydro-cooling leafy vege- Acknowledge that cooling can occur during
Mfg 1/Processing tables in the field). many farm operations.
( 117.3). Packing (e.g., hydro-cooling in a packing
shed)
Holding (e.g., cold storage)
Mfg/processing (e.g., refrigeration of proc-
essed food)
Drying/dehydrating (in- Packing or Holding Holding (e.g., drying hay or alfalfa) ............. Because we would no longer consider drying/
cidental to holding). (Tables 4 and 5). dehydrating to be a packing activity.
Drying/dehydrating to Mfg/Processing (Ta- Mfg/processing (e.g., drying grapes to cre- Because we are including this specific mfg/
create a distinct com- bles 4 and 5). ate raisins, and drying herbs to create a processing activity within the farm defini-
modity (transforms a distinct commodity) (because it transforms tion, provided that there is no additional
RAC into a proc- a RAC into a processed food) (but allowed manufacturing/processing.
essed food). within the farm definition).
Fermenting cocoa Harvesting (Footnote 2 Holding ........................................................ Because fermentation generally happens
beans and coffee in Table 23 of the after cocoa beans and coffee beans are re-
beans. draft Risk Assess- moved from the plants.
ment (Ref. 16)).
Field coring .................. N/A 3 ........................... Harvesting (e.g., coring lettuce in the field) Because FDA is addressing the activity for
the first time.
Filtering ........................ Harvesting ( 117.3) ... Harvesting (e.g., filtering honey) ................. Acknowledge that filtering can occur during
Packing (e.g., before packing honey) more than harvesting operations.
Removing stems and Harvesting ( 117.3) ... Harvesting (e.g., in the field) ....................... Acknowledge that removing stems/husks can
husks. Packing (e.g., in a packing shed) occur during more than harvesting oper-
ations.
Sifting ........................... Harvesting ( 117.3) ... Harvesting (e.g., in the field) ....................... Acknowledge that sifting can occur during
Packing (e.g., in a packing shed) more than harvesting operations.
TABLE 5CHANGES IN CLASSIFICATION OF ACTIVITIES CONDUCTED ON FARMS OR ON FARM MIXED-TYPE FACILITIES

BASED ON THE PROPOSED REVISIONS TO THE FARM DEFINITIONContinued
Classified in 2013 Classified in supplemental notice of proposed Why would the re-classification represent a
Activity proposed preventive rulemaking change from the 2013 proposed preventive
controls rule controls rule? 2
Using pesticides in Harvesting (Table 5) .. Harvesting (e.g., in the field) ....................... Acknowledge that using pesticides in wash
wash water. Packing (e.g., in a packing shed) water can occur during more than har-
vesting operations.
Washing ....................... Harvesting ( 117.3), Harvesting (e.g., in the field) ....................... Acknowledge that washing can occur during
and Mfg/Processing Packing (e.g., in a dump tank or flume in packing operations.
( 117.3). the farms packing shed)
Mfg/processing (e.g., during production of
fresh-cut produce)
1 Mfg = Manufacturing
2 This table focuses on any change in classification in this document compared to the classification, in the 2013 proposed preventive controls
rule, for activities conducted on a farms own RACs. The proposed revisions to the farm definition would make the distinction between whether
a farm conducted an activity on its own RACs or on others RACs irrelevant.
3 N/A = Not applicable.
VIII. Proposed Exemptions for On-Farm manufacturing/processing activity/food would have three principal effects on
Low-Risk Activity/Food Combinations combinations, as low-risk activity/food the proposed exemptions.
combinations eligible for inclusion in First, the proposed exemption for on-
A. The 2013 Proposed Exemptions
the proposed exemptions. farm packing or holding of food by a
In the 2013 proposed preventive We are confirming that an small or very small business would no
controls rule, we described provisions establishment that conducts more than longer identify any packing or holding
of FSMA that direct us to (1) conduct a one activity/food combination listed in activities for any RACs, because an on-
science-based risk analysis to cover the proposed exemptions for on-farm farm establishment would no longer be
specific types of on-farm packing, low-risk activity/food combinations subject to the requirements for hazard
holding, and manufacturing/processing would be eligible for the exemption. analysis and risk-based preventive
activities that would be outside the The regulatory text is written in the controls when it packs or holds RACs,
farm definition and, thus, subject to plural (e.g., if the only packing and regardless of whether it is packing and
the requirements for hazard analysis holding activities . . . that the business holding its own RACs or others RACs.
and risk-based preventive controls (78 conducts are the following low-risk The proposed exemption would
FR 3646 at 3674 and 36893691); and packing or holding activity/food continue to apply to on-farm packing
(2) consider the results of that science- combinations; and if the only and holding of processed foods (e.g.,
based risk analysis and exempt facilities manufacturing/processing activities . . . packing and holding of hard candy,
that are small or very small businesses that the business conducts are the fudge, taffy and toffee when conducted
from these requirements (or modify following). by a farm mixed-type facility).
these requirements, as we determine We have not yet completed either our Second, the proposed exemption for
appropriate), if such facilities are review of comments asking us to on-farm low-risk manufacturing/
engaged only in specific types of on- include additional activity/food processing activities conducted by a
activities that we determine to be low combinations in the proposed small or very small business would no
risk involving specific foods that we exemptions or our analysis of whether longer distinguish between
determine to be low risk. Consistent each of the recommended additions manufacturing/processing activities
with this statutory direction, we would satisfy the criteria, described in conducted on a farm mixed-type
developed the draft risk assessment and the draft risk assessment, for a low-risk facilitys own RACs and manufacturing/
made it available for public comment activity/food combination. However, processing activities conducted on food
(Ref. 16 and 78 FR 3824) and proposed based on our experience with the draft other than the farm mixed-type facilitys
three exemptions for on-farm activity/ risk assessment, and the similarity of own RACs.
food combinations conducted by farm- some of the recommended activity/food Third, the proposed exemption for on-
mixed-type facilities that are small or combinations to activity/food farm low-risk manufacturing/processing
very small businesses (proposed combinations we evaluated in the draft activities conducted by a small or very
117.5(g), (h)(1), and (h)(2)). risk assessment, we consider it likely small business would be revised to
that we will, after fully considering eliminate activities, conducted on
B. Comments on the 2013 Proposed
comments, include additional activity/ others RACs, which would no longer be
Exemptions for On-Farm Low-Risk
food combinations in these exemptions classified as manufacturing/processing
Activity/Food Combinations
when we issue the final rule. and instead would be classified as
Some comments request clarification harvesting, packing, or holding. For
C. Impact of the Proposed Revisions to example, mixing different lots of the
on whether an establishment that
the Definitions for Farm,
conducts more than one activity/food same RACs (e.g., cocoa beans, coffee
Harvesting, Holding, and Packing beans, intact fruits and vegetables, grain,
combination listed in the proposed
on the 2013 Proposed Exemptions for honey, maple sap, and peanuts and tree
exemptions for on-farm low-risk
On-Farm Low-Risk Activity/Food nuts) would remain within the farm
activity/food combinations would be
Combinations definition, and not be considered
eligible for the exemption. Other
comments recommend including The proposed revisions to the manufacturing/processing, regardless of
additional on-farm packing and holding definitions of farm, harvesting, whether the RACs being mixed are the
activity/food combinations, or on-farm holding, and packing, if finalized, farms own RACs or others RACs.
However, mixing grain products and Point (HACCP) regulations for seafood concern that the regulatory text, as
maple syrup (which are processed foods (21 CFR part 123) and juice (21 CFR part proposed, would limit a facilitys
rather than RACs) would be considered 120)i.e., whether a known or flexibility to develop and implement a
manufacturing/processing and, thus, reasonably foreseeable hazard was food safety system that was indeed risk-
would continue to be considered a low- reasonably likely to occur. In general, based. For example, some comments
risk manufacturing/processing activity our HACCP regulations for seafood and assert that regulatory text such as
listed within the exemption for on-farm juice focus on CCPs to control hazards [p]reventive controls must include, as
low-risk manufacturing/processing that are reasonably likely to occur. appropriate to the facility and the food
activities conducted by a small or very appears to provide flexibility, but the
B. Comments on the Reasonably Likely
small business. practical effect of the term must
To Occur Construct Within the 2013
We will update these proposed preceding the phrase include, as
Overall Framework for Hazard Analysis
exemptions when we issue the final appropriate to the facility and the food
and Risk-Based Preventive Controls
rule, after considering comments, and is to remove any flexibility as to what
reaching a decision in light of those Some stakeholders expressed concern, preventive controls must be established
comments, on the proposed revisions to during outreach activities such as the and implemented. As another example,
the definitions that impact the proposed public meetings and in written these comments emphasize that the
exemptions for low-risk activity/food comments, about including the proposed requirements did not
combinations. reasonably likely to occur approach sufficiently emphasize the risk-based
in the 2013 proposed preventive nature of each component of the overall
IX. Overall Framework for Hazard controls rule. Some comments express framework for hazard analysis and
Analysis and Risk-Based Preventive concern that using the phrase preventive controls, including
Controls reasonably likely to occur in two monitoring, corrective action
A. 2013 Overall Framework for Hazard different contexts (i.e., within our procedures, and verification activities,
Analysis and Risk-Based Preventive HACCP regulations as well as in our in addition to the hazard analysis and
Controls proposed preventive controls preventive controls. In general, these
regulations) would be confusing. Some comments recommend that we provide
In general, in the 2013 proposed comments assert that the reasonably greater flexibility to manage the control
preventive controls rule we proposed likely to occur approach was already of hazards based on an assessment of
that the owner, operator, or agent in so closely linked to our HACCP both the severity of the hazard and the
charge of a facility: regulations that the 2013 proposed probability that the hazard will occur in
Prepare and implement a food safety preventive controls rule would be the absence of preventive controls and
plan, which would include interpreted as requiring that all that we recognize the role of
documentation such as a written hazard necessary preventive controls be prerequisite programs in the
analysis and various written procedures; established at CCPs. These comments management of hazards. (One definition
Conduct a hazard analysis to identify note that such an interpretation would of prerequisite program is the
and evaluate known or reasonably be inconsistent with FSMA. For procedures, including good
foreseeable hazards to determine example, FSMA requires that the owner, manufacturing practices, that address
whether there are hazards that are operator, or agent in charge of a facility operational conditions providing the
reasonably likely to occur; identify and implement preventive foundation for the HACCP system (Ref.
Identify and implement preventive controls, including at critical control 17).)
controls, including at CCPs, if any, to points, if any (emphasis added) (section
provide assurances that hazards 418(c) of the FD&C Act). In addition, the C. Proposed Revisions to the Overall
identified as reasonably likely to definition of preventive controls in Framework for Hazard Analysis and
occur will be significantly minimized FSMA is broader than CCPs (section Risk-Based Preventive Controls
or prevented; 418(o)(3) of the FD&C Act). The The 2013 proposed preventive
Establish a written recall plan for food comments ask that we more explicitly controls rule would not have required
with a hazard identified as reasonably provide for implementation of a range of that all preventive controls be
likely to occur; preventive controls (not just at CCPs.) established at CCPs. However, we
Monitor the preventive controls with These comments also express concern acknowledge that it could be confusing
adequate frequency to provide that a facility that already had to use the same phrase reasonably
assurance that they are consistently established controls to address likely to occur in both our HACCP
performed; hazardsbut not at CCPswould need regulations and in the regulations we
Establish and implement written to revise its food safety plan and re- are proposing to establish to implement
corrective action procedures that must create any applicable records (e.g., FSMAs requirements for hazard
be taken if preventive controls are not various written procedures) to satisfy analysis and risk-based preventive
properly implemented; the recordkeeping requirements of the controls, because the phrase
Take appropriate corrective action in rule, which would add costs but no food reasonably likely to occur has been
the event of an unanticipated problem if safety benefits. Some comments suggest used as the basis for determining
a preventive control is not properly that the framework be clearer that the hazards that need to be addressed in a
implemented and a specific corrective requirements for preventive controls HACCP plan at CCPs.
action procedure has not been apply to hazards that are of such a Likewise, the 2013 proposed
established; nature that control measures to preventive controls rule would not have
Conduct certain verification activities; significantly minimize or prevent them limited a facilitys flexibility to develop
and are necessary for the production of a and implement a food safety system that
Establish and maintain certain safe food and therefore must be was indeed risk-based. However, we
records. addressed in the food safety plan. acknowledge that some specific changes
These proposed provisions applied a Other comments on the overall to the proposed regulatory text could
construct we previously used in our framework for hazard analysis and risk- help to clarify the risk-based nature of
Hazard Analysis and Critical Control based preventive controls express all provisions of subpart C.
We have not used the term reasonably likely to occur throughout two-part analysis on the part of a
prerequisite program in the proposed the proposed regulations. Significant facility. First, the facility would narrow
regulatory text because, like hazard hazard would mean a known or hazards to those hazards that are
reasonably likely to occur, it has a reasonably foreseeable hazard for which known or reasonably foreseeablei.e.,
connotation with respect to our seafood a person knowledgeable about the safe those biological, chemical (including
and juice HACCP programs, that is, it manufacturing, processing, packing, or radiological), or physical hazards that
connotes activities that a facility may do holding of food would, based on the have the potential to be associated with
that have an impact on product safety outcome of a hazard analysis, establish the facility or the food. Second, the
but which are outside the scope of the controls to significantly minimize or facility would narrow the known or
regulatory program. However, prevent the hazard in a food and reasonably foreseeable hazards to those
comments are not suggesting that components to manage those controls that a person knowledgeable about the
prerequisite programs that are essential (such as monitoring, corrections or safe manufacturing, processing, packing,
to ensuring food safety should be corrective actions, verification, and or holding of food would, based on the
outside the scope of this proposed records) as appropriate to the food, the outcome of a hazard analysis, establish
regulatory scheme. In fact, comments facility, and the nature of the control. controls to significantly minimize or
asking that we recognize the role of Defining known or reasonably prevent the hazard in a food as well as
prerequisite programs in the foreseeable hazard in place of components to manage those controls
management of hazards point out that reasonably foreseeable hazard and (such as monitoring, corrections or
preventive controls include control clarifying that the new term means a corrective actions, verification, and
measures that do not include CCPs and hazard that has the potential to be records) as appropriate to the food, the
that companies would consider many of associated with the facility or the food facility, and the nature of the control.
these to be prerequisite programs. We rather than a potential . . . hazard that The framework established by
acknowledge that oftentimes preventive may be associated with the facility or significant hazard also would
controls, other than those at critical the food; incorporate the concept of risk by
control points, are important parts of a Providing additional flexibility to
specifying that significant hazards are
food safety system, and must therefore address concerns about re-writing
based on the outcome of a hazard
be included in the food safety plan that existing plans or programs to conform
analysis. The hazard analysis would
would be required by this proposed with the requirement of the preventive
require an evaluation of known or
rule. We attempted to make that clear in controls rule by explicitly providing
reasonably foreseeable hazards to assess
the proposed requirement for preventive that:
two key aspects of riski.e., the severity
controls in 117.135(a) by incorporating Preventive controls include controls,
of the illness or injury if the hazard
reference to controls, other than those other than those at critical control
were to occur and the probability that
at critical control points, that are points, that knowledgeable persons
the hazard will occur in the absence of
necessary for food safety. commonly recognize as appropriate for
preventive controls.
We did not intend to require that a food safety;
facility re-create or duplicate existing The preventive control management See the revised regulatory text for the
records associated with controls; we components (i.e., monitoring, corrective proposed new definition of significant
simply laid out in the 2013 proposed actions, and verification) depend on the hazard (proposed 117.3). The term
preventive controls rule the activities nature of the control; and significant hazard has sometimes
for which we expect there to be records The recordkeeping requirements do been used in the context of HACCP to
and the information we expect to find not require duplication of existing refer to the hazards to be addressed in
in those records. records if those records contain all of a HACCP plan through CCPs. However,
Taking into account the comments we the required information and satisfy the this term is not used in the seafood,
have reviewed so far, we are proposing recordkeeping requirements of the juice or meat and poultry HACCP
a series of revisions to proposed subpart regulation. Existing records may be regulations, which focus on hazards
C and are reopening the comment supplemented as necessary to include reasonably likely to occur. We request
period specifically with respect to these all of the required information. In comment on both the proposed name of
proposed revisions. These proposed addition, the required information does the term and the proposed meaning of
revisions include: not need to be kept in one set of records. the term. See also the proposed new
Eliminating the term hazard If existing records contain some of the provision for the use of existing records
reasonably likely to occur throughout required information, any new (proposed 117.330, which would be
proposed subpart C (and, thus, deleting information required by the preventive established in subpart F). Table 6
the definition we had proposed for this controls rule may be kept either provides some examples of the
term). separately or combined with the flexibility that a facility would have in
Adding a new defined term, existing records. complying with the revised
significant hazard, and, in general, The framework provided by requirements that would be established
using this new term instead of hazard significant hazard would reflect a in subpart C.
TABLE 6EXAMPLES OF FLEXIBILITY FOR COMPLYING WITH THE REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS IN THE REVISED REQUIREMENTS IN PROPOSED SUBPART C
Flexibility related to . . . Example
Controls other than those at CCPs .......................................................... Dividing a facility into zones based on the risk with respect to contami-
nation of product can be a preventive control, but would not be re-
quired to have a CCP.
Controls other than those at CCPs .......................................................... Preventive maintenance that inspects and changes chopper blades on
a regular intervals may be considered a preventive control in some
instances but would not be required to have a CCP.
TABLE 6EXAMPLES OF FLEXIBILITY FOR COMPLYING WITH THE REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS IN THE REVISED REQUIREMENTS IN PROPOSED SUBPART CContinued
Flexibility related to . . . Example
Circumstances that do not require process controls ............................... Preventive controls for allergen cross-contact.
Circumstances that do not require process controls ............................... Supplier controls.
Monitoring activity that generally would not require monitoring records Monitoring for foreign material with x-rays.
Corrections that generally would not require records .............................. Re-cleaning and sanitizing inadequately cleaned food contact surfaces
before start up.
Preventive controls that would not require validation .............................. Zoning controls.
Preventive controls that would not require validation .............................. Segregation of allergens during storage.
Preventive controls that would not require validation .............................. Training.
Preventive controls that would not require validation .............................. Preventive maintenance.
Preventive controls that would not require validation .............................. Refrigerated storage.
Corrective action that generally would not require verification ................ Replacement of equipment.
X. Potential Requirements for Product broader than finished product testing, risk in the finished food). Other
Testing and Environmental Monitoring the use of product testing is tied to risk, comments note that product testing
and the regulations provide flexibility in would not be appropriate for certain
A. Our Request for Comment on
how product testing is used in a food types of facilities, such as distributors.
Including Requirements for Product
safety plan. Some comments assert that Some comments question whether
Testing and Environmental Monitoring
product testing is required by section product testing would be appropriate for
in a Final Rule
418 of the FD&C Act and that it is an products with a short shelf life (such as
In the 2013 proposed preventive appropriate means of verifying overall produce).
controls rule, we described the statutory control, especially for products that Some comments identify
framework of FSMA for product testing support pathogen growth. In the circumstances where product testing
and environmental monitoring as following paragraphs, we describe some wouldor would notbe appropriate
verification measures. We also of the key recommendations in the to include as a verification activity in a
requested comment on when and how comments regarding what should be food safety plan. For example,
product testing programs and tested, how testing could be tied to risk, comments state that product testing
environmental monitoring are an and how product testing could be used would be an appropriate verification
appropriate means of implementing in a food safety plan. activity to include in a food safety plan
section 418 of the FD&C Act (78 FR Some comments recommend that in plants that produce high-risk
3646 at 37623765). We specifically product testing include testing raw products; when there is a risk of
requested comment on including materials and ingredients, as well as in- contamination of the product or product
requirements for product testing line testing of product during contact surfaces; when the outcome of a
programs and environmental monitoring production. Some comments hazard analysis demonstrates that a
in a final rule. Although we did not recommend that requirements hazard can remain or be placed on
propose specific regulatory text, we encompassing more than finished ready-to-eat (RTE) products; when an
asked a series of questions about what product testing would provide environmental pathogen is considered a
such requirements should include. Our facilities with the flexibility to establish hazard reasonably likely to occur; when
discussions and questions about a risk-based testing program. For a positive result is obtained as a result
product testing focused on finished example, a facility that adds seasoning of environmental monitoring; after a
product testing. The Appendix to chips after the chips have been corrective action has been implemented
contained extensive background on the cooked using a process that would (such as after a product has been
role of testing as a verification measure significantly minimize pathogens may reworked because it tested positive for
in a modern food safety system (78 FR conclude that testing the seasoning used a pathogen); and in circumstances
3646 at 38123820; see also the as an ingredient would be a more where testing is the only practical way
corrected Appendix, 78 FR 17142 at appropriate verification activity than to verify the absence of a contaminant
17143 to 17151). testing finished product (i.e., the chips (such as aflatoxin). Some comments
B. Product Testing with the added seasoning). These state that product testing would not be
comments also assert that requirements an appropriate verification activity to
1. Comments on Product Testing for product testing would be more include in a food safety plan if a
Some comments support product consistent with the statutory direction positive result from environmental
testing as a verification activity and in section 418 of the FD&C Act than monitoring is found on a non-product-
make recommendations for what should requirements for finished product contact surface.
be tested, how testing could be tied to testing. Some comments recommend written
risk, and how product testing could be Some comments that emphasize the procedures for product testing. Some of
used in a food safety plan. Some of risk-based nature of any requirements these comments emphasize that any
these comments emphasize that product for product testing assert that product requirements for such written
testing would not be appropriate as a testing may be of limited value for a procedures should not be prescriptive.
control measure. Other comments do product that will undergo a kill step Some comments question whether it
not support including requirements for (a treatment to significantly minimize would be appropriate to require product
finished product testing as a pathogens) later in processing or that testing in light of known limitations
verification measure, but support does not support the survival or growth such as those discussed in section I.F of
including requirements for product of environmental pathogens (because the Appendix. For example, it is
testing in the final rule if the focus is such organisms are unlikely to pose a generally recognized that testing cannot
ensure the absence of a hazard, flexibility for a facility to make risk- contamination occurring in storage and
particularly when the hazard is present based decisions on when product distribution centers. Some of these
at very low levels and is not uniformly testing would be appropriate by comments express concern about broad
distributed. Moreover, these comments providing that the facility can take into requirements that would require
point out that the number of samples account the facility, the food, and the environmental monitoring in a manner
used for routine testing often is nature of the preventive control (e.g., that was not risk-based, such as when
statistically inadequate to provide whether the control is a kill step) rather an environmental pathogen is not
confidence in the safety of an individual than prescribe product testing in reasonably likely to occur. Some
lot in the absence of additional specific circumstance, or require that all commenters with varying views on the
information about adherence to types of facilities (including issue nonetheless asked FDA to issue
validated control measures (78 FR 3646 warehouses) conduct product testing. proposed regulatory text for
at 3819). Some commenters with For supplementary information relevant environmental monitoring for
varying views on the issue nonetheless to product testing, see the 2013 consideration.
asked FDA to issue proposed regulatory proposed preventive controls rule (78 2. Potential Requirements for
text for product testing for FR 3646 at 37633764), the corrected Environmental Monitoring
consideration. Appendix (78 FR 17142 at 17143 to
17151), and Ref. 18. Although the HACCP Annex of the
2. Potential Requirements for Product Codex General Principles of Food
Testing C. Environmental Monitoring Hygiene (Ref. 19) does not specifically
We acknowledge that there are 1. Comments on Environmental recommend environmental monitoring
limitations to product testing. Monitoring as a verification activity in HACCP
Nonetheless, product testing programs, systems, the Codex General Principles
when implemented appropriately based Some comments support of Food Hygiene (Ref. 20) does indicate
on the facility, the food, and the nature environmental monitoring as a that sanitation systems should be
of the preventive control, could be used verification activity. In general, these monitored for effectiveness and
to verify that the preventive controls are comments recommend that the final periodically verified, where appropriate,
effectively and significantly minimizing rule specifically require environmental by microbiological sampling of
or preventing the occurrence of monitoring when RTE product is environment and food contact surfaces,
identified hazards. Taking into account exposed to the environment prior to and regularly reviewed and adapted to
the comments we have reviewed so far, packaging and the packaged food does reflect changed circumstances.
we are providing an opportunity for not receive a treatment that would Environmental monitoring is
public comment on potential significantly minimize an recommended in Codex Guidelines on
requirements for product testing. Such environmental pathogen that could the Application of General Principles of
requirements would be tied to risk and contaminate the food when it is Food Hygiene to the Control of Listeria
addressed through flexible written exposed. Comments emphasize the need monocytogenes in Foods (see Annex I)
procedures that would address both test for flexible requirements that would (Ref. 21) and the Code of Hygienic
procedures and corrective action plans. allow facilities to tailor their programs Practice for Powdered Formulae for
In this section of this document, we based on risk. Infants and Young Children (see Annex
are reopening the comment period with Some comments that generally III) (Ref. 22). Moreover, currently
respect to our previous request for support environmental monitoring as a available data and information support
comment on when and how product verification activity nonetheless express the role of environmental monitoring in
testing programs are an appropriate concern about the potential for such a food safety system that incorporates
means of implementing FSMA. We are requirements to be overly prescriptive. hazard analysis and risk-based
seeking comment on whether Comments particularly express concern preventive controls. (See, e.g., the 2013
requirements for product testing should about potentially prescriptive proposed preventive controls rule (78
be included in a final rule and, if so, requirements for corrective actions if an FR 3646 at 37643765), the corrected
what (if any) modifications to the environmental pathogen or appropriate Appendix (78 FR 17142 at 17143 to
proposed regulatory text would be indicator organism is detected. Some 17151), and (Ref. 23). Environmental
appropriate. The proposed regulatory comments express concern about how monitoring programs, when
text would, if included in a final rule, potentially prescriptive requirements implemented appropriately based on the
establish requirements for: would impact products (such as facility, the food, and the nature of the
Product testing as an activity for produce) with a short shelf life. preventive control, could be used to
verification of implementation and Some comments do not support verify that the preventive controls are
effectiveness as appropriate to the including requirements for effectively and significantly minimizing
facility, the food, and the nature of the environmental monitoring as a or preventing the occurrence of
preventive control (proposed verification measure. Some of these identified hazards.
117.165(a)(2)); comments assert that requirements for Taking into account the comments we
Written procedures for product testing environmental monitoring would not be have reviewed so far, we are providing
(proposed 117.165(b)(2)); in accord with guidelines issued by the an opportunity for public comment on
Corrective action procedures for Codex Alimentarius Commission potential requirements for
product testing (proposed (Codex). Some comments note that environmental monitoring. The
117.150(a)(1)(ii)(A)); and environmental monitoring would not be potential requirements would provide
Records of product testing (proposed relevant to all products, such as flexibility for facilities to tailor their
117.155(b)); products that will be heat-treated or environmental monitoring programs
See the proposed regulatory text for otherwise subject to a kill-step. Other based on risk. Environmental
proposed subpart C for the full text of comments note that environmental monitoring would be required in the
such potential requirements. Consistent monitoring would not be relevant to specific circumstances where RTE
with the requests of the comments, the facilities such as food distributors, due product is exposed to the environment
proposed regulatory text would provide to the low likelihood of product prior to packaging and the packaged
food does not receive a treatment that environmental pathogens whenever an framework of FSMA for supplier
would significantly minimize an RTE food is exposed to the environment controlsi.e., the supplier verification
environmental pathogen that could prior to packaging and the packaged activities that section 418 of the FD&C
contaminate the food when it is food does not receive a treatment that Act includes as an example of
exposed. However, the potential would significantly minimize the preventive controls. We also requested
requirements would not otherwise pathogen (proposed 117.130(c)(1)(ii)); comment on when and how supplier
specify circumstances where Environmental monitoring, for an verification activities are an appropriate
environmental monitoring would be environmental pathogen (e.g., L. means of implementing section 418 (78
required and would instead require that monocytogenes) or for an appropriate FR 3646 at 37633767). We specifically
the facility conduct environmental indicator organism (e.g., Listeria spp.), requested comment on including
monitoring as appropriate to the facility, as an activity for verification of requirements for supplier approval and
the food, and the nature of the implementation and effectiveness as other verification activities in a final
preventive control. The potential appropriate to the facility, the food, and rule. Although we did not propose
requirements would also not be the nature of the preventive control, if specific regulatory text, we asked a
prescriptive in the types of corrective contamination of an RTE food with an series of questions about what such
actions needed in response to detecting environmental pathogen is a significant requirements should include. The
an environmental pathogen or hazard (proposed 117.165(a)(3)); Appendix contained extensive
appropriate indicator organism in the Records of environmental monitoring background on the role of supplier
environment; they would provide (proposed 117.155(b)); programs in a modern food safety
flexibility for facilities to establish and Written procedures for environmental system (78 FR 3646 at 38203821; see
implement written corrective action monitoring (proposed 117.165(b)(3)); also the corrected Appendix, 78 FR
procedures to identify and correct the and 17142 at 17151 to 17152).
problem, reduce the likelihood that the Corrective action procedures for
environmental monitoring (proposed B. Comments on When and How
problem will recur, evaluate all affected
117.150(a)(1)(ii)(B)). Supplier Verification Activities Are an
food for safety, and, as necessary,
See the proposed regulatory text for Appropriate Means of Implementing the
prevent affected food from entering
proposed subpart C for the full text of Statutory Framework of Section 418 of
commerce.
such potential requirements. For the FD&C Act
In this section of this document, we
are reopening the comment period with supplementary information relevant to Some comments support including
respect to our previous request for environmental monitoring programs, see requirements for a supplier program in
comment on when and how the 2013 proposed preventive controls a final rule. These comments emphasize
environmental monitoring is an rule (78 FR 3646 at 37643765), the the need for flexible requirements that
appropriate means of implementing corrected Appendix (78 FR 17142 at would allow facilities to tailor their
FSMA. We are seeking comment on 17143 to 17151), and Ref. 23. programs based on risk, including risk
whether requirements for environmental XI. Potential Requirements for a inherent to raw materials and
monitoring should be included in a final Supplier Program ingredients and risk that may be
rule and, if so, what (if any) associated with a particular supplier
modifications to the proposed A. Our Request for Comment on When (e.g., as reflected by the suppliers
regulatory text would be appropriate. and How Supplier Verification performance history). These comments
The proposed regulatory text would, if Activities Are an Appropriate Means of provide many specific
included in a final rule, establish Implementing the Statutory Framework recommendations for what such
requirements for: of Section 418 of the FD&C Act requirements shouldand should not
Performing, as part of the hazard In the 2013 proposed preventive include. We summarize these
evaluation, an evaluation of controls rule, we described the statutory recommendations in Table 7.
TABLE 7SUMMARY OF SPECIFIC RECOMMENDATIONS IN COMMENTS THAT SUPPORT REQUIREMENTS FOR A SUPPLIER
PROGRAM
Most comments support a requirement: Most comments do not support a requirement:
For receiving raw material and ingredients from approved suppliers ...... For a written list of approved suppliers (because the list would be sub-
ject to frequent (perhaps daily) change).
For verification of a facilitys immediate supplier ..................................... For verification of the suppliers supplier (because the facility has the
greatest knowledge, leverage and ability to conduct meaningful over-
sight of its immediate supplier and because it is the supplier who is
accountable to verify back one more step).
For records documenting that the basic requirements are being carried For documents such as an underlying audit report (because of con-
out. cerns about confidential information).
For audits as a verification activity, provided that the requirements are Prescribing the frequency of audits (particularly an annual frequency)
flexible and audits are not over-emphasized at the expense of other (because an audit is only one tool and audits should be based on
verification activities. risk and on the performance of the supplier).
Limiting a supplier program to facilities that manufacture or process Specifying that some hazards require more than one verification activ-
food. ity (because doing so would be too prescriptive and would not allow
the facility the flexibility to determine the appropriate risk-based ap-
proach).
For oversight of a supplier program by a qualified individual .................. For a receiving facility to identify the regulations to which the supplier
is subject (because the distinction would not be material to food
safety).
That would be consistent with the Foreign Supplier Verification Pro-
gram being established in a separate rulemaking
TABLE 7SUMMARY OF SPECIFIC RECOMMENDATIONS IN COMMENTS THAT SUPPORT REQUIREMENTS FOR A SUPPLIER
PROGRAMContinued
Most comments support a requirement: Most comments do not support a requirement:
Specifying that a supplier program may be managed at a corporate

level (rather than by specific facilities), because supplier programs
are often managed at the corporate level. Some comments specifi-
cally recommend that inspection of a supplier program take place at
the location where the program is managed, including at a corporate
location rather than at an individual facility.
Comments also address several other the supplier verification requirements provisions, on the manner and extent to
issues, such as whether the final rule should not prevent facilities from which the FSVP and preventive controls
should: sourcing ingredients from suppliers that supplier verification provisionsas
Be limited to circumstances where a are qualified facilities. well as other aspects of the FSVP and
hazard is controlled by the supplier, or In general, comments that simply preventive controls regulationsshould
be required even if the hazard would be oppose including a supplier program in be aligned in the final rules.
controlled by the receiving facility or by the final rule express concern about See the proposed regulatory text
the receiving facilitys customer. cost, ingredient diversity, and (proposed 117.136 and the applicable
Include requirements for specific duplication of efforts. Some of these definitions in proposed 117.3) for the
types of verification activities based comments recommend that we issue full text of such potential requirements.
only on the seriousness of hazards. guidance on supplier verification Briefly, the proposed regulatory text
Although some comments support such activities rather than establish would, if included in a final rule:
requirements, other comments do not requirements in the final rule. Some Establish definitions for terms used in
because the basis should be risk (which commenters, including those with the potential requirements for a supplier
includes probability as well as severity). varying views about the issue, program (i.e., receiving facility;
Allow substitution of an inspection nonetheless requested that FDA propose supplier; and qualified auditor)
(e.g., by FDA) for an audit. Although regulatory language for consideration. (proposed 117.3)
some comments support such a Establish a risk-based requirement for
C. Potential Requirements for a Supplier
substitution, others do not because they a written supplier program that:
Program
assert that an inspection and an audit Would require, with some exceptions,
are different in nature. Section 418 of the FD&C Act a supplier program for raw materials
Require a receiving facility to specifically identifies supplier and ingredients for which the receiving
consider relevant regulatory information verification activities as a preventive facility has identified a significant
about the supplier. Although some control (see section 418(o)(3) of the hazard when the hazard is controlled
comments support such requirements, FD&C Act), Supplier controls, when before receipt of raw material or
others do not (e.g., because the implemented appropriately, are an ingredient (proposed 117.136(a)(1) and
information (which can be part of an important preventive control that can (2); and
overall supplier assessment) may not be ensure that significant hazards will be Would not apply to raw materials and
available in a timely manner, is narrow significantly minimized or prevented for ingredients for which there are no
in scope, and would diminish the those raw materials and ingredients for significant hazards, the preventive
importance of the suppliers food safety which the receiving facility has controls at the receiving facility are
plan and the effectiveness of its identified a significant hazard when the adequate, or the receiving facility relies
implementation). hazard is controlled before receipt of the on the customer and obtains written
Include requirements related to raw material or ingredient. Taking into assurance (proposed 117.136(a)(1)(ii));
supplier non-conformance. Although account the comments we have Require verification activities, as
some comments support such reviewed so far, we are providing an appropriate to the hazard, and
requirements, others maintain that opportunity for public comment on documentation of such activities, to
supplier non-conformance would be potential requirements for a supplier ensure raw materials and ingredients are
better suited to guidance. Some program as a preventive control. In this received only from suppliers approved
comments specifically oppose a section of this document, we are for control of the hazard(s) in that raw
requirement for discontinuing use of reopening the comment period with material or ingredient (or, when
the supplier and recommend flexibility respect to our previous request for necessary and appropriate, on a
for how a receiving facility would comment on when and how supplier temporary basis from unapproved
address supplier non-conformance. programs are an appropriate means of suppliers whose raw materials or
Provide for alternative verification implementing FSMA. We are seeking ingredients the receiving facility
requirements when a supplier is a comment on whether requirements for a subjects to adequate verification
qualified facility (which is subject to supplier program should be included in activities before acceptance for use)
modified requirements; see proposed a final rule and, if so, what (if any) (proposed 117.136(a)(3)(i));
117.201 in the 2013 proposed modifications to the proposed Require verification activities to verify
preventive controls rule). Although regulatory text would be appropriate. that the hazard is significantly
some comments support alternative Elsewhere in this issue of the Federal minimized or prevented, the incoming
requirements for suppliers that are Register, we are issuing a supplemental raw material or ingredient is not
qualified facilities, others express notice of proposed rulemaking to amend adulterated under section 402 of the
concern about whether alternative the 2013 proposed FSVP rule. In that FD&C Act or misbranded under section
requirements can be practically supplemental notice we request 403(w) of the FD&C Act, and the
implemented. Some comments state that comment, in light of the statutory incoming raw material or ingredient is
produced in compliance with the implementation records for subpart C establishment rather than a facility
requirements of applicable FDA food (see proposed 117.126(b)(3), because a supplier may be an entity that
safety regulations (proposed 117.135(c)(4), 117.140(b), 117.160(b)(3), is not required to register under section
117.136(a)(3)(ii)); 117.165(a)(4), and 117.190(a)(4), 415 of the act and, thus, would not be
Provide flexibility for a receiving respectively). For supplementary a facility as that term would be
facility to determine and document the information relevant to a supplier defined for the purpose of this rule.
appropriate verification activities for program, see the 2013 proposed Under this definition, a facility that
raw materials and ingredients from preventive controls rule (78 FR 3646 at packs or holds the food without any
particular suppliers, based on a series of 37653767), the corrected Appendix (78 type of manufacturing/processing would
factors, except when there is a FR 17142 at 17151- 17152), and Ref. 24. not be a supplier. Under this approach,
reasonable probability that exposure to In the following paragraphs, we provide a facility would not be required to
a significant hazard will result in additional information about the establish a supplier program for food
serious adverse health consequences or potential proposed requirements for a products that it only packs or
death to humans (proposed supplier program. distributes. For example, a receiving
117.136(b) and 117.136(c)(1)) (see Reflecting the risk-based (including facility might receive a raw material or
next bullet); severity as well as probability) nature of ingredient from a distribution center
Require an annual audit as a a supplier program, a receiving facilitys that receives the raw material or
verification activity when there is a program would be limited to those raw ingredient from a manufacturing facility
reasonable probability that exposure to materials and ingredients for which the or a farm. The distribution center,
the hazard will result in serious adverse receiving facility has identified a which is the immediate previous source
health consequences or death to significant hazard. As discussed in of the raw material or ingredient, would
humans, unless the receiving facility section IX.C, significant hazard would not be required to establish a supplier
documents its determination that other be defined in the rule. Under the program and would not be considered
verification activities and/or less definition, hazards are determined to be the supplier; rather the supplier would
frequent onsite auditing of the supplier significant based on the outcome of a be the manufacturer or the farm (which
provide adequate assurance that the hazard analysis and, thus the manufactured/processed the food or
hazards are controlled (proposed determination would incorporate the harvested the food that was provided to
117.136(c)(2)); concept of risk. In addition, a receiving the distribution center and subsequently
Provide for an alternative verification facility would establish and implement to the receiving facility). In such
activity when the supplier is a qualified a supplier program only when a instance, if the receiving facility has
facility (proposed 117.136(c)(3)); significant hazard is controlled before identified a significant hazard for the
Provide for alternative verification receipt; a receiving facility would not be raw material or ingredient, and that
activities when the supplier is a farm required to establish and implement a hazard is controlled by the supplier (the
that would not be subject to the supplier program if the receiving manufacturer or the farm), the receiving
requirements in the final produce safety facility, or the receiving facilitys facility would establish verification
rule under proposed 112.4 (proposed customer, controls the hazard (and the activities related to the manufacturer or
117.136(c)(4)); customer provides assurances as to the the farm that provided the raw material
Require that an audit be conducted by control). Under this risk-based or ingredient to the distribution center.
a qualified individual who has technical approach, a processor of fresh-cut If a facility receives an ingredient
expertise obtained by a combination of produce generally would be required to from a supplier, but the control of the
training and experience appropriate to establish a supplier program for hazards hazard is by the suppliers supplier, the
perform the auditing function (proposed associated with the fresh produce it receiving facility would conduct
117.136(d)(1)) and proposed processes (which would be controlled supplier verification activities that
117.180); by the supplier during growing and would include verifying that the
Provide that inspection by FDA or an harvesting), but a manufacturer of an supplier has conducted appropriate
officially recognized or equivalent food acidified food would not be required to verification that its supplier has
safety authority may substitute for an establish a supplier program for peppers controlled the hazard, i.e., the receiving
audit (proposed 117.136(e)); that it uses to produce salsa if it will facility would review the suppliers
Require action to address supplier control any significant hazard for the food safety records for its suppliers
non-conformance (proposed peppers during manufacture of the control of the hazard. For example, if a
117.136(f)); and salsa. salad manufacturer is receiving cut
Require documentation of verification The potential supplier program would produce such as celery from a fresh-cut
activities in records (listed in proposed include requirements applicable to a produce supplier that receives celery
117.136(g)), including minimum receiving facility and the proposed from a farm, the salad manufacturer
requirements for records documenting definition of receiving facility would could conduct verification activities
an audit, records of sampling and describe a receiving facility as a facility related to the on-farm controls by
testing, and records documenting a that manufactures/processes a raw reviewing the supplier program of, and
review by the receiving facility of the material or ingredient that it receives verification activities conducted by, the
suppliers relevant food safety records from a supplier. A supplier would be fresh-cut produce supplier for its
(proposed 117.136(g)(5), (6), and (7), defined as the establishment that supplier, the farm (in addition to
respectively). manufactures/processes the food, raises verifying the fresh-cut produce
In addition, the potential addition of the animal, or harvests the food that is suppliers control of pathogens).
requirements for a supplier program provided to a receiving facility without We understand that, particularly for
would require conforming amendments further manufacturing/processing by RACs, there may be multiple
to other provisions of the rule, including another establishment, except for establishments, including cooperatives,
the requirements for a food safety plan, further manufacturing/processing that packing houses, and distributers,
preventive controls, validation, consist solely of the addition of labeling between a receiving facility and the
verification of implementation and or similar activity of a de minimis establishment that would be considered
effectiveness, and the list of nature. The supplier could be an the supplier, which would make
supplier verification very challenging onsite if they are accessible from an supplier); (3) the suppliers procedures,
under certain circumstances. However, onsite location, and we expect that processes, and practices related to the
we believe that supplier verification is many records for the supplier program safety of the raw materials and
very important for RACs, in particular would be in electronic form (and thus ingredients; (4) applicable FDA food
produce that will be further processed easily retrievable by a facility during an safety regulations and information
or consumed without a treatment that inspection). relevant to the suppliers compliance
will significantly minimize or prevent Rather than specifically require a with those regulations, including an
pathogens. We request comment on written list of approved suppliers, the FDA warning letter or import alert
what verification activities would be potential requirements would specify relating to the safety of the food; (5) the
appropriate for receiving facilities to that the supplier program be written and suppliers food safety performance
conduct when a raw material or include verification activities, as history relevant to the raw materials or
ingredient passes through more than appropriate to the hazard, and ingredients that the receiving facility
one facility that would not be required documentation of such activities, to receives from the supplier, including
to verify control of hazards if supplier ensure products are received only from available information about results from
programs are limited to manufacturers/ suppliers approved for control of the testing raw materials or ingredients for
processors. For example if a receiving hazard(s) in that raw material or hazards, audit results relating to the
facility is a fresh-cut processing facility ingredient (or, when necessary and safety of the food, and responsiveness of
that receives produce from a distributor, appropriate, on a temporary basis from the supplier in correcting problems; and
who receives produce from a unapproved suppliers whose raw (6) any other factors as appropriate and
cooperative, and neither the distributor materials or ingredients the receiving necessary, such as storage and
nor the cooperative is required to facility subjects to adequate verification transportation. Thus, a receiving facility
establish supplier controls for the farms activities before acceptance for use). would have flexibility to select a
where the hazards are being controlled, Such a program could include, for verification activity based on the
what supplier controls should be example, written procedures for circumstances.
applied for the produce coming from the approving suppliers, for approving (or The exception would be when there is
farms? We request comment on whether rejecting) specific raw materials and a reasonable probability that exposure to
and how the requirements for supplier ingredients, and for documenting that the hazard will result in serious adverse
verification should address such raw materials or ingredients are only health consequences or death to
situations. received from approved suppliers. The humans. In this circumstance, under the
In addition, we seek comment potential requirements would recognize potential supplier program, the
regarding whether (and, if so, how) the that there can be circumstances that receiving facility would be required to
final preventive controls rule should would require a facility to receive raw have documentation of an onsite audit
address the potential for gaps in materials or ingredients on a temporary of the supplier before using the raw
supplier controls when a hazard is basis from an unapproved supplier (e.g., material or ingredient from the supplier
controlled at Point A in the supply if there is a disruption in delivery of raw and at least annually thereafter. The
chain (e.g., by Supplier A, a farm), and materials and ingredients from potential requirement for an annual
Point B in the supply chain is a facility approved suppliers due to audit is limited to when there is a
(such as Warehouse B, Distributor B, or circumstances such as localized reasonable probability that exposure to
Packing Shed B) that only packs or flooding or malfunctioning equipment). the hazard will result in serious adverse
holds food, but does not manufacture/ We request comment on examples of health consequences or death to
process food (and therefore would not circumstances when it would be humans. Further, the receiving facility
be required to have a supplier program) necessary and appropriate to receive could select less frequent audits or a
before passing it on to Point C in the raw materials and ingredients on a different verification activity, if it
supply chain, which also would not be temporary basis from an unapproved documented its determination that the
required to have a supplier program supplier and on the types of verification less frequent onsite auditing or other
(e.g., Retail Food Establishment C or activities that a facility should conduct verification activity provides adequate
Consumer C). For example, if Packing on food from an unapproved supplier. assurance that the hazards are
Shed B distributes produce it packs after The potential requirements would controlled. The potential recordkeeping
receiving the produce from Farm A provide flexibility for the verification requirements that would apply to audits
directly to retail facilities (which would activities that the receiving facility would identify specific information that
not be subject to the requirements of would conduct for raw materials and the records must provide about the
this preventive controls rule), no ingredients. With one exception, the audit, including the conclusions of the
supplier controls would be applied to receiving facility would have flexibility audit, but would not specify that the
Farm A. Should verification activities be to select one or more of four possible underlying audit report is part of the
required in circumstances in which a activities: (1) onsite audit; (2) sampling required documentation of an audit.
RAC such as fresh produce will not be and testing of the raw material or A person who conducts an audit
sent to any facilities that would be ingredient, which could be conducted would need to be qualified to do so. To
required to have preventive controls by either the supplier or the receiving be qualified, a person who conducts an
before reaching consumers? facility; (3) review by the receiving audit (qualified auditor) would be
The potential supplier program would facility of the suppliers relevant food required to satisfy the criteria for a
be included in the food safety plan and, safety records; and (4) other appropriate qualified individual (a person who
thus, would be prepared (or overseen) supplier verification activities based on has successfully completed training in
by a qualified individual (see proposed the risk associated with the ingredient the development and application of
117.126(b)(7)). A supplier program and the supplier. To determine which risk-based preventive controls
could be established and maintained by option is appropriate, the receiving equivalent to that of an FDA-recognized
a facilitys corporate headquarters or facility could consider (1) the severity of standardized curriculum or is otherwise
parent entity. The recordkeeping the hazards; (2) where the preventive qualified through job experience to
requirements would specify that controls for those hazards are applied develop and apply a food safety system)
electronic records are considered to be (such as at the supplier or the suppliers and have technical expertise obtained
by a combination of training and authority of a country whose food safety a final rule on such alternative
experience appropriate to perform the system FDA has officially recognized as verification requirements until we issue
auditing function. comparable or determined to be the final produce safety rule.
The potential supplier program would equivalent to that of the United States)
require the receiving facility to know D. Request for Additional Comment on
for an audit, see the discussion in the
the FDA food safety regulations that Requirements To Address Conflicts of
proposed FSVP rule (78 FR 45730 at
apply to the supplier, and relevant 45758). In addition, we are asking for Interest for Persons Conducting
information about the suppliers comment on whether it would be Verification Activities
compliance with those regulations. The appropriate to substitute an inspection In the 2013 proposed FSVP rule, we
focus of section 418 of the FD&C Act is in another country (Country A) for an tentatively concluded that it would be
on preventing food safety problems audit when, for example, it is the food appropriate to address the
rather than on reacting to them. Section safety authority of Country B (whose independence of individuals conducting
418 of the FD&C Act requires the owner, food safety system FDA has officially verification activities (78 FR 45730 at
operator, or agent in charge of a facility recognized as comparable or determined 45759). We proposed that an individual
to establish and implement preventive to be equivalent to that of the United who conducts any verification activity
controls to significantly minimize or States) that conducted the inspection in must not have a financial interest in the
prevent known or reasonably Country A. foreign supplier and payment must not
foreseeable hazards. By specifying that The potential requirements would be related to the results of the activity,
supplier verification activities are a provide for alternative verification and provided that this would not
preventive control, section 418 requires requirements when a supplier subject to prohibit an importer, or the importers
the receiving facility to take necessary the requirements of section 418 of the employee, from conducting the
actions to ensure that raw materials and FD&C Act is a qualified facility subject verification activity (proposed
ingredients are not adulterated. To to modified requirements. Section 418 1.506(g)). As discussed in the 2013
determine whether incoming raw provides different requirements for proposed FSVP rule, we considered
materials and ingredients are qualified facilities, which are reflected such requirements necessary to prevent
adulterated, a receiving facility would in the different potential verification bias, or the appearance of bias, on the
need to know the regulatory framework requirements for such facilities. part of a person conducting a
that applies to the raw materials and Although the potential requirements verification activity (78 FR 45730 at
ingredients, and to have confidence that would allow a receiving facility to 45759).
its supplier is complying with that conduct an alternative verification We request comment on whether we
regulatory framework. activity when the supplier is a qualified should include in the final preventive
The potential supplier program would facility, they would not require this. controls rule requirements to address
include provisions to address non- Likewise, the potential requirements conflicts of interest for individuals
conformance by a supplier. This would provide for alternative conducting verification activities and, if
potential requirement would not verification requirements when a so, the scope of such requirements. For
prescribe when a particular corrective supplier is a farm that would not be example, should such requirements be
action (such as discontinuing a subject to the requirements of proposed directed to a subset of persons who
supplier) is necessary. A facility could 112.4 regarding the raw material or conduct verification activities (such as
substitute an inspection (whether by ingredient that the receiving facility auditors) or should they be directed
FDA or by the food safety authority of receives from the farm. Some of these more broadly? Would a requirement
a country whose food safety system FDA farms would be not be subject to the such as in the 2013 proposed FSVP rule
has officially recognized as comparable requirements of proposed 112.4 be appropriate, or would some other
or determined to be equivalent to that of because they satisfy the criteria, in requirement be more appropriate (such
the United States) for an audit. Even section 419(f) of the FD&C Act, for an as a requirement that persons be free of
though inspection procedures and audit exemption for direct farm marketing. conflicts of interest that are relevant to
procedures are not identical, we Other farms would not be subject to the the outcome of the activity)? What
tentatively conclude that a facility requirements of proposed 112.4 would constitute a financial interest in
should have flexibility to determine because the crops they grow would not a company sufficient to constitute a
whether an inspection could substitute be covered by the proposed produce conflict of interest for a person
for an audit based on characteristics safety rule, either based on the findings
conducting a supplier verification
such as the severity of the hazard, how of a qualitative assessment of risk
activity (e.g., conducting an audit of that
the supplier controls the hazard, and the associated with growing, harvesting,
company or conducting laboratory tests
suppliers performance history. For packing, and holding of produce (see
of that companys food)?
example, a facility that receives pickles the discussion of this qualitative
from a facility subject to the acidified assessment of risk in the 2013 proposed XII. Potential Requirements for the
foods regulations in 21 CFR 114 may produce safety rule, 78 FR 3504 at 3508 Hazard Analysis To Address
conclude that an FDA inspection for and 35223529) or because they account Economically Motivated Adulteration
compliance with acidified foods for a very small percentage of covered
A. Our Request for Comment on
regulations (concluding that no action is produce (see proposed 112.4 and the
indicated) provides adequate assurance discussion at 78 FR 3504 at 3549). Whether the Final Rule Should Address
that the facility is producing pickles in Although the potential requirements Economically Motivated Adulteration
compliance with the requirements of would allow a receiving facility to In the 2013 proposed preventive
applicable FDA food safety regulations conduct an alternative verification controls rule, we announced our intent
and that the pickles are not adulterated activity for such farms, they would not to implement the statutory requirements
under section 402 of the FD&C Act. For require this. Although the potential for hazards that may be intentionally
additional discussion of our reasons for requirements would provide for introduced, including by acts of
tentatively concluding that it would be alternative verification requirements for terrorism, in a separate rulemaking
appropriate to substitute an inspection farms that would not be subject to the rather than include them in the
(whether by FDA or by the food safety produce safety rule, we would not issue requirements for hazard analysis and
risk-based preventive controls (78 FR Another comment expresses the view We believe that it is practicable to
3646 at 3659). We tentatively concluded that food fraud is fundamentally determine whether economically
that intentional hazards, which are not different from both food safety and food motivated adulteration is reasonably
addressed in traditional HACCP or other defense. However, some comments do foreseeable. Importantly, we would not
food safety systems, likely will require support including expected intentional expect facilities to consider hypothetical
different kinds of controls and would be adulterants in the preventive controls economically motivated adulteration
best addressed in a separate rulemaking. rule and note that the U.S. scenarios for their food products. As
However, we also acknowledged that Pharmacopeial Convention (USP) has a discussed in the 2013 proposed
some kinds of intentional adulterants free on-line food fraud database (Ref. intentional adulteration rule, we would
could be viewed as reasonably likely to 25). (USP is a scientific nonprofit expect facilities to focus on
occur, e.g., in foods concerning which organization that sets standards for the circumstances where there has been a
there is a widely recognized risk of identity, strength, quality, and purity of pattern of such adulteration in the past,
economically motivated adulteration in medicines, food ingredients, and dietary suggesting a potential for intentional
certain circumstances. We provided an supplements manufactured, distributed adulteration even though the past
example of this kind of hazardi.e., the and consumed worldwide.) occurrences may not be associated with
addition of the chemical melamine to the specific supplier or the specific food
certain food products, apparently to C. Potential Requirements To Address
product (78 FR 78014 at 78027). For
enhance the measured protein content Economically Motivated Adulteration
example, in both the 2013 proposed
and/or perceived quality. We requested Taking into account the comments we preventive controls rule and the 2013
comment on whether to include have reviewed so far, we are providing proposed intentional contamination rule
potential hazards that may be an opportunity for public comment on we discussed a widespread incident of
intentionally introduced for economic a potential requirement for the hazard economically motivated adulteration in
reasons. We also requested comment on identification to consider hazards that which some milk firms in one country
when an economically motivated may be intentionally introduced for added melamine, a nitrogen-rich
adulterant can be considered reasonably purposes of economic gain (see industrial by-product, to diluted dairy
likely to occur. proposed 117.130(b)(2)(iii) in products to increase the apparent
When we developed the 2013 proposed subpart C). In this section of protein content (78 FR 3646 at 3659 and
proposed intentional contamination this document, we are reopening the 78 FR 78014 at 78021, respectively).
rule, we tentatively concluded that comment period with respect to our This adulteration resulted in significant
economically motivated adulteration previous request for comment on public health consequences, with more
would be best addressed through the whether to include potential hazards than 290,000 ill infants and 6 deaths in
approach in the preventive controls that may be intentionally introduced for that country. In light of this incident, a
rules for human food and for animal economic reasons. We are seeking prudent person would include in its
food (including hazard analysis, comment on whether this preventive hazard analysis the potential for
preventive controls, monitoring, melamine to be an economically
controls rule would be the most
corrective action, verification, and motivated adulterant in a facilitys food
appropriate rule to address FSMAs
recordkeeping) rather than through the products when using milk products
requirements to address hazards that
vulnerability assessment-type approach from a country where melamine
may be intentionally introduced (for
for intentional adulteration, where the adulteration had occurred and, based on
purposes of economic gain) and, if so,
intent is to cause wide-spread public the outcome of that hazard analysis,
what (if any) modifications to the
health harm, such as acts of terrorism
proposed regulatory text would be determine whether melamine is a
(see the 2013 proposed intentional
appropriate. We note that the hazard that must be addressed in the
adulteration rule, 78 FR 78014 at 7802).
preliminary regulatory impact analysis food safety plan. As none of this
We also explained our view that the
(PRIA) that presents the benefits and adulterated milk was exported to the
primary purpose of economically
costs of this proposed rule (Ref. 26) United States and no US suppliers have
motivated adulteration is to obtain
describes certain assumptions we are been a source of food safety problems
economic gain rather than to impact
making about the preventive controls, due to milk products adulterated for
public health, although public health
and their implementation, that would be economic gain, FDA does not expect a
harm may occur (78 FR 78014 at 78020).
established and implemented by a facility to consider the potential for
B. Comments on Economically facility that identifies a potential hazard melamine to be a significant hazard
Motivated Adulteration that may be intentionally introduced for when using domestic milk products, or
Some comments oppose including economic reasons as a significant milk products from other countries
requirements directed to economically hazard. We are seeking comment on when there is no history of melamine
motivated adulteration in the preventive alternative ways to control such adulteration associated with those
controls rule. These comments assert hazards. countries.
that the vast majority of economically Under the definitions that would be There are other well-known
motivated adulterants affect quality and established in the rule, a hazard would substances that have been used in
value rather than safety. These be an agent that is reasonably likely to economically motivated adulteration
comments also point out that the cause illness or injury in the absence of schemes, have potential to cause public
majority of food products could, in its control. Thus, the focus of the health harm, and would be prudent to
theory, be subject to economically potential requirement would be on consider in the types of food products
motivated adulteration but that it would those economically motivated that have been the subject of these
be difficult to determine if such adulterants that are reasonably likely to schemes. For example, dyes containing
adulteration is reasonably foreseeable. cause illness or injury in the absence of the heavy metal lead have been added
One comment recommends that we their control, not on economically to ingredients such as spices to enhance
draw a clear distinction between motivated adulterants that solely affect color. Lead can accumulate in the body
hazards that are intentionally quality and value with little or no over time and can cause health
introduced and those that are not. potential for public health harm. problems, including such as impaired
cognitive development in children (Ref. The 2013 proposed withdrawal contrasts FSMAs provisions for
27). Lead chromate is a chemical with provisions would: withdrawal with those for suspension,
a vibrant yellow color that has been Specify the circumstances under noting that FSMAs provisions for
used as an adulterant in turmeric to which we would withdraw an suspension specify a method to lift that
change the color of the spice to suggest exemption for a qualified facility suspension (i.e., submission of a
that it is of a higher quality (Ref. 28). (proposed 117.251); corrective action plan) but FSMAs
Lead oxide is a red chemical that has Establish procedures for us to issue an provisions for withdrawal of an
been used as an adulterant in paprika to order to withdraw the exemption, exemption provide no remedy for an
change the color of the spice to suggest including information that would be in exemption that is withdrawn.
that it is of a higher quality; in 1995, an the order (proposed 117.254 and In contrast, other comments express
incident was reported in Hungary in 117.257); concern that the 2013 proposed
which dozens of people were made ill Establish procedures whereby a withdrawal provisions fail to establish a
and several people died as a result of qualified facility may submit a written fair and clear process for withdrawing a
consuming contaminated paprika (Ref. appeal of our order to withdraw an qualified facilitys exempt status and
29). Sudan I is an orange-red powder exemption (proposed 117.260 and recommend that we revise the 2013
that had been added to chili powder as 117.264); proposed withdrawal provisions to
a coloring agent, but is now banned in Establish procedures for appeals, provide a more flexible framework that
many countries because the hearings, and decisions on appeals and would be both fair and clear. Some of
International Agency for Research on hearings (proposed 117.267, 117.270, these comments express concern that
Cancer has classified it as a category 3 117.274, and 117.277); and withdrawal of an exemption would
carcinogen (not classifiable as to its Specify the circumstances in which subject very small and small facilities to
carcinogenicity to humans) (Ref. 30); in an order to withdraw an exemption is unexpectedly high compliance costs
2005, contamination of an ingredient revoked (proposed 117.280). that could put them out of business.
prepared using chili powder containing Some comments recommend that we
B. Proposed Clarification of What FDA add a provision allowing a facility to
Sudan I led to a massive recall of food Will Do Before Issuing an Order and
products in the United Kingdom (Ref. voluntarily withdraw its exemption.
Proposed Mechanism for Re-Instating an Some comments recommend more
31). Exemption
In addition to the food-fraud database safeguards to ensure that the process to
mentioned in the comments, a recent 1. Comments withdraw an exemption is not abused.
report from the Congressional Research In general, these comments recommend
Some comments generally support the the following three principal revisions
Service provides additional information overall framework of the 2013 proposed to the 2013 proposed withdrawal
on economically motivated adulteration withdrawal provisions and express the
of food and food ingredients (Ref. 32). provisions:
view that withdrawal of exemption Establish a high threshold for
A recent report identified 137 unique should be both prompt and permanent
incidents in 11 food categories (Ref. 33). withdrawing an exemption, including
to protect public health. Some an evidentiary standard that would
XIII. Provisions for Withdrawal of an comments ask us to explain the apply to the criteria for withdrawing an
Exemption for a Qualified Facility difference between withdrawal of an exemption;
exemption and suspension of Provide for due process before we
A. 2013 Proposed Provisions for registration. One comment asks us to take steps to withdraw an exemption,
Withdrawal of an Exemption for a clarify the effect a suspension has on a including an opportunity for a qualified
Qualified Facility qualified facility and recommends that facility to maintain its exempt status
In the 2013 proposed preventive suspension automatically result in loss (e.g., by addressing the specified issues
controls rule, we explained the of the exemption. One comment of concern); and
provisions of FSMA that establish recommends that we withdraw an Provide an opportunity for
criteria for a facility to be a qualified exemption at the earliest signs of reinstatement of a withdrawn
facility, establish an exemption for problems, because doing so would be exemption.
qualified facilities, establish modified most protective of public health and In the following paragraphs, we
requirements for qualified facilities, and would be consistent with the principle provide more detail about comments
provide that we may withdraw the that a broad interpretation of statutory recommending these three principal
exemption otherwise granted to exemptions is disfavored when they revisions.
qualified facilities in specified affect public health and safety. This Threshold for withdrawing an
circumstances (section 418(l) of the comment also asserts that section 418 of exemption. Some comments assert that
FD&C Act; see 78 FR 3646 at 3657). We the FD&C Act provides a very low the 2013 proposed withdrawal
proposed to establish: threshold for initiating a withdrawal provisions are extremely vague and
Definitions relevant to these action, makes that withdrawal appear to give us broad authority to
provisions (proposed 117.3); permanent, and was designed to operate withdraw an exemption from a qualified
An exemption from the requirements on a one strike, youre out principle. facility without adequate evidence of an
for hazard analysis and risk-based This comment asserts that the actual harm or likely severe problem
preventive controls for qualified exemption section 418 provides to related to the facilitys practices. Some
facilities (proposed 117.5(a)); qualified facilities has no basis in food comments assert that we should
Modified requirements for qualified safety science or sound policy and narrowly interpret the statutory criteria
facilities (proposed 117.201); and endangers consumers and that for withdrawing an exemption to avoid
Procedural requirements that would withdrawal of an exemption would not action that is arbitrary and capricious,
govern our withdrawal of an exemption result in overly harsh consequences and that to do so we must show
for a qualified facility (proposed subpart because it would not close the facility. necessity and direct linkage between an
E; the 2013 proposed withdrawal One comment discusses our authority to active investigation of a foodborne
provisions) (see 78 FR 37023703, suspend the registration of a facility illness outbreak and the qualified
37683771, and 37753780). (section 102 of FSMA). This comment facility. Some of these comments
recommend that we define and clarify within a suitable timeframe. These protect the public health and prevent or
key terms (including directly linked, comments state that if the facility does mitigate a foodborne illness outbreak
necessary, associated, and not adequately address the problem in based on conduct or conditions
material to the safety of food). Some its response to the warning letter and associated with the qualified facility
of these comments also recommend that subsequent actions to correct the that are material to the safety of the food
we introduce a standard (such as problem, we would issue a temporary manufactured, processed, packed, or
credible evidence or credible and (e.g., six months) conditional held at such facility (proposed
substantial evidence that shows direct withdrawal, targeted to a particular 117.251(a) and (b), respectively). We
linkage to a problem at a specific issue, outlining how the facility can do not consider it necessary to define
facility) that would require us to meet remedy the problem. These comments terms such as directly linked,
an explicit evidentiary threshold when further state that if the facility still fails necessary, associated, or material
we find that conduct or conditions exist to correct the problem after receiving to the safety of food, or to introduce a
in a qualified facility sufficient to the temporary conditional withdrawal, standard (such as credible evidence
warrant withdrawal of an exemption. we would proceed with steps for full or credible and substantial evidence
Some comments recommend that the withdrawal of an exemption. that shows direct linkage to a problem
final withdrawal provisions explicitly Reinstatement of an exemption that on a specific farm or facility) to provide
provide that the credible and substantial was withdrawn. Some comments for a fair process that is neither arbitrary
evidence would only apply to an recommend that we provide a process nor capricious.
individual facility, and would not apply for each of three situations in which a We may suspend the registration of a
to a group or class of facilities. qualified facility might regain its facility if we determine that food
Due process before withdrawing an exemption status: manufactured, processed, packed,
exemption. Some comments note that Before reaching the deadline for received, or held by the facility has a
we have many enforcement tools that compliance specified in the withdrawal reasonable probability of causing
we can use in lieu of withdrawing an order, if the facility demonstrates that serious adverse health consequences or
exemption, particularly if there is an the conduct or conditions that triggered death to humans or animals. If we
immediate risk to public health. These the withdrawal order have been suspend a facilitys registration, no
include seeking an injunction (21 U.S.C. sufficiently resolved; person can import or export food into
332; section 302 of the FD&C Act); After the compliance deadline passes the U.S. from such facility, offer to
seizing the food at issue (21 U.S.C. if, during an informal hearing, the import or export food into the U.S. from
334(a)(f); section 304(a)(f) of the facility can show that the conduct or such facility, or otherwise introduce
FD&C Act); and administrative conditions that triggered the withdrawal food from such facility into intrastate or
detention of the food (21 U.S.C. 334(h); have been sufficiently resolved; or interstate commerce in the U.S. (See
section 304(h) of the FD&C Act). Other Automatically if we determine, after section 415(b) of the FD&C Act (21
comments note that we have a history finishing an active investigation of a U.S.C. 350d(b)). In contrast, we may
of providing a facility with foodborne illness outbreak, that the withdraw an exemption from a qualified
opportunities to fix a problem before outbreak is not directly linked to the facility in two circumstances: (1) In the
starting such an enforcement action facility. event of an active investigation of a
(e.g., by issuing a warning letter). These 2. Specific Proposed Additions and foodborne illness outbreak that is
comments recommend that we provide Modifications to the 2013 Proposed directly linked to the qualified facility;
such opportunities to qualified facilities Withdrawal Provisions or (2) if we determine that it is
before we take steps to withdraw an As discussed more fully in the necessary to protect the public health
exemption. following paragraphs, taking into and prevent or mitigate a foodborne
Some comments recommend that the account the comments we have illness outbreak based on conditions or
final withdrawal provisions allow for reviewed so far we are proposing to conduct associated with the qualified
partial withdrawal of an exemption in modify the 2013 proposed withdrawal facility that are material to the safety of
which FDA would indicate specific provisions to: the food manufactured, processed,
sections of the rule that the facility must Include specific regulatory actions packed, or held at such facility. (See
comply with. These comments assert that we must take, and other regulatory section 418(l)(3) of the FD&C Act). A
that small businesses should be able to actions that we may consider, before we facility that loses its exemption may
seek targeted solutions as needed issue an order to withdraw an distribute food if it is in compliance
without falling under all the exemption (proposed 117.251(b)); with applicable requirements.
substantive, costly provisions of the Clarify that an order to withdraw an The statutory criteria for suspension
rule. Some comments recommend that exemption must be approved by an FDA of registration are separate and distinct
the final withdrawal provisions District Director before it can be issued from the statutory criteria for
establish a three-tiered processTier 1: (proposed 117.254(a) and (b)); and withdrawal of an exemption and must
Warning letter; Tier 2: Temporary Provide a process for reinstating an be considered separately. Suspension of
conditional withdrawal of an exemption that has been withdrawn a facilitys registration does not change
exemption; and Tier 3: Full withdrawal (proposed 117.287). a facilitys status as a qualified facility.
of an exemption. For example, a See the revised regulatory text for If we take steps to suspend a qualified
warning letter would identify the proposed 117.251(b), 117.254(a) and facilitys registration, we may also
material conduct or conditions in (b), and 117.287. In this section of this separately consider whether the
question or how the facility is directly document, we are reopening the circumstances that may lead us to
linked to an active investigation of a comment period with respect to these withdraw the facilitys exemption exist
foodborne illness outbreak; include specific proposed provisions. and, if so, may follow the process that
information about how the facility could Both of the proposed circumstances would be established in the final
remedy the situation; and notify the for withdrawal of an exemption specify withdrawal provisions for doing so.
facility that it has 15 calendar days from significant public health reasons for As the comments point out, in many
receipt of the warning letter to respond doing so, related to an outbreak of circumstances we have provided
with a plan for remedying the problem foodborne illness, or being necessary to facilities with opportunities to fix a
problem before starting an enforcement the conditions or conduct that are We tentatively conclude that it would
action. Indeed, we consider that issuing material to the safety of the food be useful for the order to itself specify
an order to withdraw an exemption manufactured, processed, packed, or the two options that a facility has upon
would be a rare event, in part because held at the facility, such that continued receipt of the order, even though the
alternative actions may provide a more withdrawal of the exemption is not order would otherwise include this
expeditious approach to correcting a necessary to protect public health and information (because the order will
problem than withdrawing an prevent or mitigate a foodborne illness contain the full text of the withdrawal
exemption. However, taking into outbreak; provisions). Therefore, we are proposing
account the concerns expressed in the Provide that if we had withdrawn the to revise the requirements for the
comments we have reviewed so far, we exemption due, in whole or in part, to contents of an order to explicitly
are proposing to include specific actions an active investigation of a foodborne mention these two options. See the
that we must take, and other actions that illness outbreak that had been directly revised regulatory text of proposed
we may consider, before we issue an linked to the qualified facility and later 117.257(d).
order to withdraw an exemption. (See determine, after finishing the active D. Proposed Revisions to the
the revised regulatory text for proposed investigation, that the outbreak was not Timeframes for a Facility To Comply
117.251(b)). Briefly, the proposed directly linked to the facility, we would With, or Appeal, an Order
regulatory text would provide that we: either;
Notify a qualified facility in writing of Reinstate the exemption (if the only In this section of this document, we
circumstances that may lead us to are reopening the comment period with
reason for the withdrawal had been the
withdraw its exemption, and provide an respect to the timeframes in proposed
outbreak investigation); or
opportunity for the facility to respond, 117.257(d) and 117.260(a) and (c).
Inform the facility of our finding that
before we issue an order to withdraw the outbreak investigation was not 1. Comments
the exemption; directly linked to the facility, and
May consider alternative regulatory Some comments ask us to specify that
provide an opportunity for the facility to a facilitys timeframe for taking action
actions before issuing an order to
request reinstatement (if the exemption begins when the facility receives the
withdraw an exemption; and
Consider actions taken by the facility was withdrawn, in part, due to order, not when we issue the order.
to address the circumstances that may conditions and conduct that are material Other comments address the timeframes
lead us to withdraw its exemption to the safety of the food manufactured, for a facility to compile information
before issuing an order to withdraw the processed, packed, or held at the needed to appeal an order for
exemption. facility). withdrawal. These comments assert that
We are not proposing that we always We are not proposing to provide for the proposed timeframe of 10 days is
must take steps to withdraw an partial withdrawal of an exemption or insufficient, and recommend timeframes
exemption at the earliest signs of establish the three-tiered process such as 30 days or 90 days.
problems. Not all problems would recommended in the comments (i.e., Some comments contrast the
satisfy the statutory threshold for Warning letter; Temporary conditional proposed 60-day timeframe to comply
withdrawal of the exemption. Further, withdrawal of an exemption; and Full with the requirements for hazard
we believe it is appropriate to consider withdrawal of an exemption). Such a analysis and risk-based preventive
each situation on its individual merits, process is not required by section 418 controls when a facility loses its
such as whether there are illnesses, and would deprive FDA of needed exemption as a qualified facility with
whether there are significant violations flexibility to address the varying the timeframe that a facility would have
that could have contributed to the circumstances that might give rise to a to comply with these requirements
problem, whether the facility has taken possible withdrawal of the exemption. when the final rule first becomes
corrective actions to address the Further, the revised regulatory text effective. As discussed in the 2013
problem, and whether the actions taken provides for a qualified facility to proposed preventive controls rule, we
are likely to prevent a reoccurrence of receive written notification that proposed compliance dates that would
the situation. Moreover, FDA has other circumstances may lead us to withdraw be 2 years and 3 years after the date of
tools that may be available to more an exemption, and provides an the final rule for small and very small
quickly protect public health, including opportunity for the facility to respond. businesses, respectively. These
recall and administrative detention. FDA will consider this response and comments assert that these two
Regarding reinstatement, we actions taken by the facility in situations are parallel, because a
tentatively conclude that the absence of determining whether to withdraw the qualified facility that has had its
a specific provision in section 418 of the exemption. In addition the newly exemption withdrawn would be coming
FD&C Act for the re-instatement of an proposed provision for reinstatement of into compliance with the full
exemption that is withdrawn does not an exemption provides an opportunity requirements for hazard analysis and
preclude us from providing for such a for a facility to return to its status as a risk-based preventive controls for the
process, by which a facility may regain qualified facility. first time. These comments recommend
its status as a qualified farm. The that we change the timeframes in the
C. Proposed Revisions to the Content of
proposed regulatory text (see proposed 2013 proposed withdrawal provisions to
an Order To Withdraw an Exemption
117.287) would: better align with the compliance dates
Provide that we could reinstate an In this section of this document, we contemplated by the proposed rule and
exemption on our own initiative or in are reopening the comment period with by FSMA for small and very small
response to a written request from the respect to proposed 117.257(d). businesses. Some of these comments
facility; Some comments recommend that the recommend that a small business have
Require that a written request from a order explicitly state that the facility has 6 months, and that a very small business
facility include such data and the option to either comply with the have 18 months, to comply with the
information as are necessary to order or appeal the order (with a request order. Other comments recommend that
demonstrate that the facility has for an informal hearing) within 10 any business (whether small or very
adequately resolved the problems with calendar days. small) have two years to comply with
the order. Some of these comments requested comment on whether a dollar the coverage of the 2013 proposed
recommend that the timeframe be tied amount of sales that is more than, or preventive controls rule precisely those
to the date of the final determination less than, the $250,000, $500,000, or companies whose practices would be
rather than to the date of the order. $1,000,000 amounts would be most improved by it. Some of these
appropriate. comments evaluate the $250,000 limit
2. Proposed Revisions to Timeframes in the context of section 418(l) of the
We tentatively conclude that the B. Comments on the 2013 Proposed
FD&C Act, which defines a qualified
nature of what a facility would need to Options for Definition of Very Small
facility as either a very small business
Business
do to comply with an orderi.e., or a business with annual sales of less
comply with the full requirements for Comments support a variety of dollar than $500,000, provided a majority of its
hazard analysis and risk-based limits of total annual sales of food for sales are made directly to qualified end-
preventive controlsmakes the defining a very small business, users. These comments note that the
timeframes in the 2013 proposed including each of the three proposed options with a limit higher than
withdrawal provisions insufficient. options ($250,000, $500,000, and $250,000 would equal or exceed the
However, it is relevant that in contrast $1,000,000) as well as other dollar limits amount allowed for sales by qualified
to the general compliance dates, the that we did not include as proposed facilities to nonqualified end users
proposed withdrawal provisions would options (i.e., $2,000,000, $5,000,000 and under section 418(l)(1)(C) of the FD&C
only apply when a significant public $10,000,000). Comments assert that very Act and assert that statutory structure
health concern has been identified for a small facilities will incur a large portion and intent of section 418(l) of the FD&C
particular facility. of the costs associated with Act make the proposed $250,000 limit
We also tentatively conclude that it is implementing the 2013 proposed the only available option from among
appropriate to link the timeframe for preventive controls rule because very the three options we proposed. The
compliance to the date of receipt of the small facilities lack experience with comments also assert that the close
order, rather than to the date the order HACCP-based models. producer-customer relationship was a
was issued. Doing so would be Some comments support defining a control for safety when a business is
consistent with our other administrative very small business as one with total smaller than $500,000 in sales and
procedures, such as appeal of an order annual food sales up to $1,000,000. primarily sells directly to consumers or
for administrative detention ( 1.402). Some of these comments express locally to food retailers and restaurants.
Taking into account the comments we concern that using lower dollar sales Some comments support defining a
have reviewed so far, we are proposing amounts to define a very small business very small business as one with total
to require that a facility comply with an would discourage growth of very small annual food sales up to $2,000,000,
order to withdraw an exemption within processing facilities (especially those $5,000,000 or $10,000,000. In general,
120 days of the date of receipt of the co-located on a farm), would unfairly these comments express concern about
order. See the revised regulatory text for burden very small facilities, and could the costs associated with implementing
proposed 117.257(d) and 117.260(a) cause them to fail due to the estimated the requirements for hazard analysis
and (c). high cost of compliance; whereas setting and risk-based preventive controls. For
a higher dollar sales amount would example, the comments assert that these
XIV. Definition of Very Small Business encourage growth, innovation and costs would deter small farms with
A. The 2013 Proposed Options for diversification. Some of these comments gross annual sales between $250,000
note that adopting the threshold of and $5 million from expanding their
Definition of Very Small Business
$1,000,000 would establish that the full businesses (e.g., to develop value-added
We proposed three options for the preventive controls requirements would products), particularly when annual
definition of a very small business based apply to the businesses that produce the food sales include foods that would not
on total annual sales of food, adjusted vast majority of food products and that be not covered by the requirements for
for inflation: Option 1, $250,000; Option modified requirements would apply to hazard analysis and risk-based
2, $500,000; and Option 3, $1,000,000. smaller businesses that represent the preventive controls (such as for animal
The 2013 proposed preventive controls majority of producers but the minority food, whole produce, and low-risk
rule contained several provisions of the food supply. activity/food combinations conducted
relevant to very small businesses, Other comments support defining a by a small or very small business co-
including exemptions from subpart C in very small business as one with total located on a farm), and the sales would
117.5(g) and 117.5(h) for very small annual food sales up to $500,000. These largely be to qualified end-users. A
(and small) facilities engaged only in comments maintain that the $500,000 comment recommending a $10,000,000
specific types of on-farm activities limit would simplify the definition of a limit expresses concern that the costs
involving low-risk activity/food qualified facility, and make it easier for associated with implementing the
combinations, the exemption us to enforce than a lower dollar requirements for hazard analysis and
in 117.5(a) and modified requirements amount, because facilities would not risk-based preventive controls would be
in 117.201 for a very small business as need to calculate how much of their passed on to consumers.
a qualified facility, and extended time to sales were to qualified end-users (as Some comments do not support
comply with the rule. In defining a very they would under section 418(l)(1)(C) of defining a very small business based on
small business, we took into the FD&C Act). total annual food sales and recommend
consideration the study of the food Other comments support defining a an alternative definition based on the
processing sector required by section very small business as one with total number of employees (e.g., fewer than
418(l)(5) of the FD&C Act (Food annual food sales up to $250,000. These 20 employees). These comments assert
Processing Sector Study (Ref. 34); see comments maintain that the $250,000 that defining very small business based
78 FR 3646 at 37003701). In the 2013 limit would exempt the fewest facilities on number of employees would be
proposed preventive controls rule we among the three proposed options and consistent with the proposed definition
requested comment regarding the three that this would be in the interest of of small business (which is based on
proposed options for the definition of public health. Comments assert that number of employees) and with the
very small business. We also higher dollar limits would remove from smallest establishment size in the Food
Processing Sector Study. Other food rather than all food. We do not the numbers and their market share of
comments support using a combination expect that this proposed change would qualified and non-qualified facilities
of criteria for defining a very small have a significant effect on the number under different definitions for a very
business, including gross sales, number of facilities that satisfy the definition of small business using (1) the method in
of employees and risk level of the food very small business, because most our original PRIA (the number of
being prepared. facilities subject to the statutory facilities with less than $1 million in
Some comments support using the requirements for hazard analysis and annual sales) and (2) the number of
volume of food rather than total annual risk-based preventive controls do not firms with less than $1 million in
food sales. Some comments express make both human and animal food. annual sales (in which multiple
concern that the dollar sales would be However, some facilities co-located on a facilities may be under the ownership of
applied to all food sold, including food farm that would not satisfy the one firm). As noted in the updated PRIA
for animals, and recommend that we definition of very small business if (Ref. 26), in the final rule we will
base the value on food subject to the the limit on the sales of food includes calculate the number of qualified
preventive controls for human food rule, animal food as well as human food may facilities based on sales on a per firm
on produce and processed food, on fall within the revised definition that basis. Calculating sales at the per firm
human food (excluding animal feed) or would include a limit only on the sales level, we estimate that, as a group, those
on high-risk processed foods. of human food. businesses that have less than
We tentatively conclude that it is not $1,000,000 in total annual sales of foods
C. Proposed Revisions to the Definition
necessary for the dollar limit in the produce less than one percent of the
of Very Small Business
definition of very small business to be dollar value of food produced in the
In this supplemental notice of $250,000 or less to protect public United States that would be covered by
proposed rulemaking, we are proposing health. In the 2013 proposed preventive the rule without any special provisions
the definition of very small business as controls rule, we estimated the number for such businesses (Ref. 26), roughly
a business that has less than $1,000,000 of facilities that would be affected by equivalent to the percentage of food
in total annual sales of human food the size specified in the definition of produced by very small businesses
adjusted for inflation. This definition very small business. The size when the level for such entities is set at
would, as recommended by some specified in the definition of very $250,000 if the per facility method of
comments, simplify a facilitys small business would affect the calculation is used. In contrast, higher
determination of whether it is a compliance dates, the exemptions for dollar limits for very small business
qualified facility because the facility qualified facilities, and the exemptions (such as the $2,000,000 or $5,000,000
would only need to calculate its total for on-farm low-risk packing and limits recommended in some of the
sales of human food rather than holding activity food/combinations and
determine how much food was sold to comments) using the per firm method
on-farm low-risk manufacturing/ would affect more of the food produced
qualified end-users. The statutory processing activity food/combinations
construct does not prevent us from in the United States (approximately one
(proposed 117.5(a), (g), and (h), percent and two percent, respectively,
establishing a definition for very small respectively) (see 78 FR 3646 at 3702).
business that would include more roughly equivalent to the levels of food
We noted that as a group, businesses affected when the level is set at
facilities than those that would be with less than $1,000,000 in total
included under the statutory provision $500,000 and $1,000,000, respectively,
annual sales of foods produce less than using the per facility method) (Ref.
that considers sales to qualified end- two percent of all food produced in the
users (section 418(l)(1)(C) of the FD&C 26). We tentatively conclude that the
United States when measured by dollar
Act). Section 418(n)(1)(B) of the FD&C definition of very small business should
value. We acknowledge that this
Act directs FDA to define the term very exempt from the rule only a small
estimate of all food produced in the
small business for the purposes of percent of food to minimize the risk of
United States is higher than the
determining whether a facility is a foodborne illness and, thus, are
estimates for lower dollar limits (one-
qualified facility eligible for modified proposing a very small business
half of one percent of all food produced
requirements. Further, section definition of $1,000,000, which would
in the United States, or less than one-
418(n)(1)(B) requires us to consider the exempt less than one percent of the
half of one percent of all food produced
Food Processing Sector Study for the dollar value of food produced in the
in the United States, for limits of
purpose of defining very small $500,000 or $250,000, respectively). United States. We request comment on
business. FDA notes that section 418 of Regardless, under the revised definition this tentative conclusion and whether
the FD&C Act does not otherwise limit the businesses that would be exempt we should consider other dollar limits
how FDA may define very small from the requirements for hazard for very small business.
business. analysis and risk-based preventive A dollar limit in the definition of
We tentatively conclude that it is controls would represent a small very small business greater than
reasonable for the sales limit in the portion of the potential risk of $250,000 would not necessarily exempt
definition of very small business to be foodborne illness. those companies whose practices would
directed to human food rather than all In the proposed rule, we calculated be most improved by complying with
food, including animal food. The the costs of the rule, and estimated the the requirements for hazard analysis
proposed definition of very small percent of food produced in the United and risk-based preventive controls. The
business in this document is consistent States that would be subject to modified Food Processing Sector Study (Ref. 34)
with the proposed definition of very requirements (i.e., produced by concluded that there was no consistent
small business in the 2013 proposed qualified facilities), by determining pattern across food categories in terms
rule Current Good Manufacturing which facilities would be qualified of which sizes of establishments
Practice and Hazard Analysis and Risk- based on per facility sales. We believe contribute most to foodborne illness risk
Based Preventive Controls for Food for our current calculation based on firm (78 FR 3646 at 3701). Moreover, the
Animals (78 FR 64736, October 29, sales rather than facility sales is more facilities that would be classified as
2013), which would define such a consistent with section 418(l)(1)(B). In qualified facilities would be subject to
business with respect to sales of animal the updated PRIA (Ref. 26), we compare modified requirements (see proposed
117.201). Furthermore, all facilities the term pathogen to mean a using pronouns, without creating
that would be exempt from the microorganism that is of public health confusion, if we (1) define the term
requirements for hazard analysis and significance and to replace variations of you to mean, for purposes of part 117,
risk-based preventive controls would the phrase microorganism of public the owner, operator, or agent in charge
continue to be subject to the health significance with pathogen of a facility and (2) limit use of the term
prohibitions in the Federal Food, Drug, throughout the regulations. you to provisions in proposed
and Cosmetic Act against causing food subparts C, D, and E. See the revised
2. Proposed Definition of You
to be adulterated or misbranded and regulatory text for the definition of you
against distributing such food and to In the 2013 proposed preventive (in proposed 117.3) and its use
inspection by FDA. controls rule, we requested comment on throughout revised subpart C.
We are not proposing that the whether there is any meaningful
definition of very small business difference between the persons 3. Proposed Definition of Significant
consider number of employees as well identified in current part 110 (i.e., Hazard
as dollar limits, be based on number of plant management and operator) As discussed in section IX.C, we are
employees for consistency with the and the owner, operator, or agent in proposing to delete the proposed
definition of small business, or be charge identified in section 418 of the definition hazard reasonably likely to
based on volume of food sold rather FD&C Act. We also requested comment occur and instead establish a definition
than on dollar limits associated with on whether it would be appropriate to for significant hazard. See the revised
sales of food. There are two alternative refer to the owner, operator, or agent in regulatory text in proposed 117.3.
sets of criteria to be a qualified facility. charge of a plant, establishment, or
The criteria in section 418(l)(1)(C) of the facility throughout proposed part 117 4. Proposed Definition of Known or
FD&C Act are set out with regard to and, if so, whether the requirements Reasonably Foreseeable Hazard
sales. We believe it is appropriate for would be clear if we revised the As discussed in section IX.C, we are
the other criteria (related to being a proposed rule to use pronouns (such as proposing to delete the proposed
very small business) similarly to be you and your) within proposed part definition reasonably foreseeable
related to sales. As discussed in the 117. hazard and instead establish a
2013 proposed preventive controls rule, Comments that responded to this definition for known or reasonably
we proposed number of employees for request for comment focused on an foreseeable hazard. See the revised
the definition of small business in approach that would make the regulatory text in proposed 117.3.
part because it would be the same regulations clear. However, the
definition for small business as that comments were divided in terms of how 5. Potential Definitions of Qualified
which has been established by the U.S. to best provide clarity, particularly with Auditor, Receiving Facility, and
Small Business Administration under respect to use of pronouns such as Supplier
13 CFR 121 for most food you and your. Some of these As discussed in section XI.C, we are
manufacturers. We continue to believe comments express concern that it would providing an opportunity for public
that the proposed definition of small be confusing if the phrase owner, comment on potential requirements for
business, based on number of operator, or agent in charge applied a supplier program. If such
employees, is appropriate. both to plant management and operators requirements are included in a final
We are not proposing that the in the CGMP requirements (proposed rule, we would establish definitions for
definition of very small business subpart B, derived from current part three terms used in the potential
consider the risk associated with the 110) and to the owner, operator, or requirements for a supplier program
food manufactured, processed, packed agent in charge of a facility in the i.e., qualified auditor, receiving
or held by the facility. The description requirements for hazard analysis and facility, and supplier. See the
very small addresses size of a risk-based preventive controls proposed regulatory text in proposed
business, not risk associated with food (proposed subpart C). Other comments 117.3.
the facility manufactures, processes, do not express this concern and note
packs, or holds. that the use of pronouns would, as we B. Proposed Revisions to Definitions
suggested, make the regulations more In the 2013 proposed preventive
XV. Other New and Revised Proposed clear.
Provisions controls rule, we proposed to:
We acknowledge the potential for Delete the definition of the term
A. Proposed New Definitions confusion if the phrase owner, shall from the existing CGMP
operator, or agent in charge applies to regulations;
1. Proposed Definition of Pathogen both plant management and operators in Revise the definitions of several other
In the 2013 proposed rule, we proposed subpart B and to the owner, terms in the existing CGMP regulations;
proposed to define environmental operator, or agent in charge of a facility Retain the definitions of several other
pathogen to mean a microorganism in proposed subpart C. Most of the terms in the existing CGMP regulations,
that is of public health significance and provisions of proposed subpart B do not with no changes; and
is capable of surviving and persisting specify the role of plant management Establish several new definitions.
within the manufacturing, processing, or the operator of a plant or We received comment on many of
packing, or holding environment. establishment. To prevent confusion, we these proposed definitions. Taking into
Variations of the phrase microorganism tentatively conclude it is prudent to account the comments we have
of public health significance appear in retain terms such as plant reviewed so far, we are proposing to
several places in the existing CGMP management and operator in revise the definitions for three of these
regulations and in the 2013 proposed proposed subpart B. terms.
preventive controls rule. To both However, we tentatively conclude
simplify the regulations and use the that we can simplify the regulations 1. Revised Definition of Cross-contact
same term (i.e., pathogen) when we directed to the owner, operator, or We proposed to define the term
mean a microorganism of public agent in charge of a facility in cross-contact to mean the
significance, we are proposing to define provisions in subparts C, D, and E by unintentional incorporation of a food
allergen into a food. Some comments reasonably foreseeable hazard to consumed without treatment to
recommend that we define the term to mean a potential biological, chemical significantly minimize the
be allergen cross-contact rather than (including radiological), or physical environmental pathogen. The revised
cross-contact to reduce the potential hazard that may be associated with the definition of environmental pathogen
for confusion with the term cross- facility or the food. would specify that an environmental
contamination. We tentatively 3. Revised Definition of Environmental pathogen does not include the spores of
conclude that the term allergen cross- Pathogen pathogenic sporeformers and, thus,
contact may reduce the potential for recognizes that consumption of food
confusion with the term cross- We proposed to define the term contaminated by the spores of a
contamination and are proposing to environmental pathogen to mean a pathogenic sporeformer that is in the
establish a definition for the term microorganism that is of public health environment may not result in
allergen cross-contact rather than the significance and is capable of surviving foodborne illness. For example, if food
term cross-contact. and persisting within the is contaminated with spores of
manufacturing, processing, packing, or Clostridium botulinum, the
2. Revised Definition of Hazard and holding environment. We identified microorganism would not produce the
Reasonably Foreseeable Hazard Salmonella spp. and Listeria
botulinum toxin that causes illness
monocytogenes as examples of
Some comments recommend that we unless these spores are subject to
environmental pathogens. Some
include radiological hazards as a subset conditions that allow them to germinate
comments express concern that our
of chemical hazards in the definition into vegetative cells that produce the
proposed definition of environmental
hazard. Although radiological hazards toxin. Pathogenic sporeformers are
pathogen would capture organisms
would not be common, we believe that normally present in foods, and unless
such as pathogenic sporeformers whose
facilities in the past have considered the foods are subjected to conditions
presence in and of itself would not
them as chemical hazards when constitute a risk to public health. that allow multiplication, they present
conducting a hazard analysis for the We are proposing to revise the minimal risk of causing illness.
development of HACCP plans. The definition of an environmental pathogen C. Proposed Editorial Changes
revised regulatory text uses the phrase to mean a pathogen capable of surviving
chemical (including radiological) in and persisting within the The revised regulatory text includes
the definition of hazard and as manufacturing, processing, packing, or several changes that we are making to
applicable throughout the regulations. holding environment such that food make the requirements more clear and
As a conforming change, we are may be contaminated and may result in improve readability. We summarize the
proposing to revise the definition of foodborne illness if that food is principal editorial changes in Table 8.
TABLE 8PROPOSED EDITORIAL CHANGES

Designation in the revised regulatory
text Proposed revision Explanation
(Proposed )
Throughout part 117 ......................... Substitute the term adequate for the term suffi- For the purposes of part 117, there is no meaning-
cient. ful difference between adequate and suffi-
cient. We proposed to retain the definition of
adequate that is in the existing CGMP require-
ments in current part 110, but did not propose to
define sufficient. We tentatively conclude that
the regulations will be clearer if we use the single
term adequate throughout the regulations.
Throughout subparts C, D, and E .... Substitute the defined term you for owner, oper- Improve clarity and readability.
ator, or agent in charge of a facility.
117.126(c), 117.170(a)(4), Re-phrase the proposed requirements in active Improve clarity and readability.
117.170(a)(5), 117.170(d). voice.
117.126(d) ........................................ Specify that the food safety plan is a record that is Distinguish the requirements for the contents of the
subject to the requirements of subpart F within food safety plan from implementation records,
the requirements for the food safety plan which continue to be listed in 117.190.
( 117.126) rather than together with the require-
ments for other records required by the rule
( 117.190).
117.130(b)(1) and (b)(2) ................... Switch the order of paragraphs (b)(1) and (b)(2) We tentatively conclude that it is more logical to
compared to the order in the 2013 proposed pre- specify what hazards must be considered (i.e.,
ventive controls rule. biological, chemical (including radiological), and
physical) before specifying the reasons for how
the hazards could get into the food products (i.e.,
naturally occurring, unintentionally introduced, or
intentionally introduced for purposes of economic
gain).
117.135 ............................................. Shorten the title from Preventive controls for haz- Simplify the presentation of the requirements and
ards that are reasonably likely to occur to Pre- conform with the proposed deletion of the term
ventive Controls. hazards that are reasonably likely to occur.
TABLE 8PROPOSED EDITORIAL CHANGESContinued

Designation in the revised regulatory
text Proposed revision Explanation
(Proposed )
117.135(c)(1) .................................... Rearrange the requirements for (1) parameters as- It is more logical to place these requirements with
sociated with the control of the hazard and (2) process controls since their parameters and their
the maximum or minimum value, or combination values are associated with process controls.
of values, to which any biological, chemical, or
physical parameter must be controlled to be as-
sociated with process controls rather than be a
standalone requirement.
117.135(c)(3) and 117.150(c) ........... Move requirements for corrections for sanitation Improve clarity and readability.
controls from the requirements for preventive
controls (proposed 117.135) to the require-
ments for corrective actions (proposed 117.150).
117.137 ............................................. Shorten the title from Recall plan for hazards that Simplify the presentation of the requirements and
are reasonably likely to occur to Recall plan. conform with the proposed deletion of the term
hazards that are reasonably likely to occur.
117.145, 117.150, 117.155 .............. Redesignate the section numbers from the original Accommodate insertions of new 117.136 (supplier
section numbers in the 2013 proposed preventive program) and new 117.140 (preventive control
controls rule (proposed 117.140, 117.145, and management components).
117.150, respectively).
117.155, 117.160, 117.165, and Move the more extensive verification requirements Improve clarity and readability.
117.170. for validation, implementation and effectiveness,
and reanalysis from the single proposed section
(proposed 117.150) to separate sections (pro-
posed 117.160, 117,165, and 117.170, re-
spectively).
117.170(a)(4) .................................... Revise the requirements for reanalysis of the food Simplify the presentation of requirements and re-
safety plan after an unanticipated event in which duce redundancy in regulatory text for inter-re-
a preventive control is not properly implemented lated requirements.
to refer to the requirements for corrective actions
in light of such an event rather than repeat the
full text of those requirements for corrective ac-
tions.
117.170(c) ........................................ Specify the written food safety plan rather than Use the term food safety plan for consistency
the written plan.. throughout subpart C.
117.170(c) ........................................ Specify document the basis for the conclusion that Improve clarity and readability.
no revisions are needed rather than document
the basis for the conclusion that no additional or
revised preventive controls are needed.
117.170(e) ........................................ Specify You must conduct a reanalysis of the food Improve clarity by specifying what the owner, oper-
safety plan when FDA determines it is necessary ator, or agent in charge of the facility must do in
to respond to new hazards and developments in certain circumstances rather than what FDA may
scientific understanding rather than FDA may require.
require a reanalysis of the food safety plan to re-
spond to new hazards and developments in sci-
entific understanding.
117.190 ............................................. Change the title from Records required for subpart Accurately reflect the nature of the listed records
C to Implementation records. after moving recordkeeping requirements for the
food safety plan to 117.126.
117.190(a)(3)(ii) and (iii) ................... Add verification of in front of monitoring and Distinguish these requirements for records applying
corrective actions. to verification of monitoring and verification of
corrective actions from other requirements for
records of monitoring and records of correc-
tive actions.
XVI. Holding Human Food By-Products 117.5(i); 78 FR 3646 at 3707 to 3709). as animal feed once the spent grain is
Intended for Use in Animal Food We also proposed that subpart C would physically separated from the beer.
not apply with respect to food other Some comments ask us to include the
Section 116 of FSMA (21 U.S.C. 2206) than alcoholic beverages at facilities
(Alcohol-Related Facilities) provides a production of by-products of the
described in the exemption, provided alcoholic beverage manufacturing
rule of construction for certain facilities
such food is in prepackaged form that
engaged in the manufacturing, process (such as spent grains, distillers

processing, packing, or holding of prevents direct human contact with the grains, and grape pomace) within the
alcoholic beverages and other food. food and constitutes not more than 5 exemption applicable to alcoholic
Based on our interpretation of section percent of the overall sales of the beverages. These comments argue that
116, we proposed that subpart C would facility. However, we did note that in the mere act of separating and disposing
not apply with respect to alcoholic the case of a brewery manufacturing of those by-products by sale or
beverages at facilities meeting two animal feed, section 418 of the FD&C otherwise should not trigger an
specified conditions (proposed Act would apply to the spent grain sold
obligation to meet onerous and impacts; and equity). FDA has in any one year. The current threshold
expensive food safety regulations. developed a PRIA that presents the after adjustment for inflation is $144
The byproducts described in these benefits and costs of this proposed rule million, using the most current (2013)
comments appear to be products that (Ref. 26). FDA believes that the Implicit Price Deflator for the Gross
would be used in food for animals proposed rule will be a significant Domestic Product. FDA expects that the
rather than in human food. In response regulatory action as defined by proposed rule will result in a 1-year
to the 2013 proposed animal food rule, Executive Order 12866. FDA requests expenditure that would exceed this
we received many comments expressing comments on the PRIA. amount.
concerns from brewers and distillers The summary analysis of benefits and
costs included in this document is XVIII. Paperwork Reduction Act of
about whether that rule would allow
drawn from the detailed PRIA (Ref. 26) 1995
them to continue providing spent grains
for animal food. These spent grains are which is available at http:// This proposed rule contains
very commonly used as animal food, www.regulations.gov (enter Docket No. information collection provisions that
and are a subset of the much broader FDA2011N0920), and is also are subject to review by OMB under the
practice of human food manufacturers available on FDAs Web site at http:// Paperwork Reduction Act of 1995 (44
sending their peels, trimmings, and www.fda.gov/AboutFDA/ U.S.C. 35013520). The collections of
other by-products to local farmers or ReportsManualsForms/Reports/ information in the proposed rule have
animal food manufacturers rather than EconomicAnalyses/default.htm. been submitted to OMB for review
to landfills. under Section 3507(d) of the Paperwork
B. Regulatory Flexibility Act Reduction Act of 1995. FDA invites
Elsewhere in this issue of the Federal
Register, we are issuing a supplemental The Regulatory Flexibility Act comments on: (1) Whether the proposed
notice of proposed rulemaking to amend requires agencies to analyze regulatory collection of information is necessary
the 2013 proposed animal food rule. options that would minimize any for the proper performance of FDAs
Human food processors already significant impact of a rule on small functions, including whether the
complying with human food safety entities. Because many small businesses information will have practical utility;
requirements would not need to will need to implement a number of (2) the accuracy of FDAs estimate of the
implement additional preventive new preventive controls, FDA burden of the proposed collection of
controls or Current Good Manufacturing acknowledges that the final rules information, including the validity of
Practice regulations when supplying a resulting from this proposed rule will the methodology and assumptions used;
by-product (e.g., wet spent grains, fruit have a significant economic impact on (3) ways to enhance the quality, utility,
or vegetable peels, liquid whey) for a substantial number of small entities. and clarity of the information to be
animal food, except for proposed collected; and (4) ways to minimize the
C. Small Business Regulatory burden of the collection of information
CGMPs to prevent physical and Enforcement Fairness Act of 1996
chemical contamination when holding on respondents, including through the
The Small Business Regulatory use of automated collection techniques,
and distributing the by-product (e.g.,
Enforcement Fairness Act of 1996 when appropriate, and other forms of
ensuring the by-product it is not
(Public Law 104121) defines a major information technology.
comingled with garbage when being
rule for the purpose of congressional Title: Current Good Manufacturing
held or distributed). However, further
review as having caused or being likely Practice and Hazard Analysis and Risk-
processing a by-product for use as
to cause one or more of the following: Based Preventive Controls for Human
animal food (e.g., drying, pelleting, heat-
An annual effect on the economy of Food Proposed Rule and Amendments
treatment) would require compliance
$100 million or more; a major increase to Proposed Rule
with the Preventive Controls for Animal Description: FDA is proposing to
in costs or prices; significant adverse
Food rule. If any requirement regarding amend its proposed regulation for
effects on competition, employment,
preventing physical and chemical Current Good Manufacturing Practice In
productivity, or innovation; or
contamination in human food by- Manufacturing, Packing, Or Holding
significant adverse effects on the ability
products for use as animal food is Human Food (CGMPs) to add
of United States-based enterprises to
finalized, it will be finalized as part of requirements for domestic and foreign
compete with foreign-based enterprises
a final preventive controls rule for facilities that are required to register
in domestic or export markets. In
human food. under section 415 of the FD&C Act. The
accordance with the Small Business
XVII. Preliminary Regulatory Impact Regulatory Enforcement Fairness Act, amendments include potential
Analysis the Office of Management and Budget provisions that would require facilities
(OMB) has determined that this to establish and implement, as
A. Overview necessary, the following verification
proposed rule is a major rule for the
FDA has examined the impacts of this purpose of congressional review. activities: product testing,
proposed rule under Executive Order environmental monitoring, and a
12866, Executive Order 13563, the D. Unfunded Mandates Reform Act of supplier program. In addition, FDA is
Regulatory Flexibility Act (5 U.S.C. 1995 amending its proposed rule to require
601612), and the Unfunded Mandates Section 202(a) of the Unfunded that the hazard analysis and risk-based
Reform Act of 1995 (Pub. L. 1044). Mandates Reform Act of 1995 requires preventive controls for human food take
Executive Orders 12866 and 13563 that agencies prepare a written into account the possibility of
direct agencies to assess all costs and statement, which includes an economically motivated adulteration of
benefits of available regulatory assessment of anticipated costs and food.
alternatives and, when regulation is benefits, before proposing any rule that Description of Respondents: Section
necessary, to select regulatory includes any Federal mandate that may 418 of the FD&C Act is applicable to the
approaches that maximize net benefits result in the expenditure by State, local, owner, operator or agent in charge of a
(including potential economic, and tribal governments, in the aggregate, food facility required to register under
environmental, public health and safety, or by the private sector, of $100,000,000 section 415 of the FD&C Act. Generally,
and other advantages; distributive or more (adjusted annually for inflation) a facility is required to register if it
manufactures, processes, packs, or holds would choose to make use of product required hazard analysis to be
food for consumption in the United testing as a verification activity under performed by each facility. Facilities
States. There are 97,646 such facilities; 117.165(a)(2). These facilities would must now also consider hazards that
74,900 of which are considered create written procedures for such may be intentionally introduced for
qualified facilities under a very small testing. This is a one-time potential purposes of economic gain. We estimate
business definition with a $1 million burden of 16 hours (5.33 hours that this added requirement will
threshold and thus have reduced annualized). These potential burdens increase the one-time needed to write
requirements in regards to this rule- are shown in Table 9 rows 1 and 2. up the hazard analysis by 1 to 5 hours
making. Should the potential supplier program (average 3 hours; 1 hour annualized
The information collection estimate discussed above be finalized a receiving burden over 3 years) depending on
for the preventive controls for human facility would establish and implement facility size and number of processes for
food proposed rule may increase if the a risk-based supplier program for those 16,000 facilities. The operating and
potential requirements (the addition of raw materials and ingredients for which maintenance costs associated with
provisions for product testing, the receiving facility has identified a conducting the initial hazard analysis to
environmental monitoring, a supplier hazard that needs to be addressed in the assess the possibility of EMA are
program, and identifying any potential food safety plan; this includes whenever $5,100,000. These estimates are shown
hazards caused because of economically the receiving facility determines that a in Table 9 row 5.
motivated adulteration) are finalized. hazard that needs to be addressed in the
The information collection burden was We estimate on an annual basis that
food safety plan is controlled before
previously estimated to be 3,686,897 all 16,000 facilities will spend 0.1 hours
receipt of the raw material or ingredient.
hours; the revised estimate includes an per year updating the EMA section of
We estimate that should this potential
additional 74,692 hours should the their hazard analyses and that this
provision be included, about 2,417
newly proposed provisions be finalized. recurring burden has an associated
receiving facilities would incur a one-
To see the calculations for these operating and maintenance cost of
time burden of 16 hours (5.33 hours
additional burden hours, see Table 9. $1,300,000. This burden is shown in
annualized) to write up such a program.
For more information on the original Table 9 row 6.
This potential burden is shown in Table
calculation of the information burden 9 row 3. Some receiving facilities will have
estimate please refer to the proposed Should product testing, supplying facilities that meet the
rule PRA (See Ref. 194 in Docket FDA environmental monitoring, and supplier definition of qualified facilities; these
2011N0920). programs be finalized, records would facilities are not required to comply
need to be reviewed and maintained. with subpart C of the proposed rule. In
Information Collection Burden Estimate
We estimate that there are 689 facilities addition, in some cases the supplier
Supplemental Notice of Proposed that would review and keep such may be a farm not subject to the
Rulemaking Burden records as a result. These records would requirements in part 112 regarding the
FDA estimates the burden for this require on average about 30 minutes a raw material or ingredient that the
information collection as follows: month to review and file. There are receiving facility receives from the farm.
operating and maintenance costs Under proposed 117.136(c)(3) and
Recordkeeping Burden associated with the creation of these 117.136(c)(4) these qualified facilities
Should the potential provisions in records in the form of product testing and exempt farms will need to create
this proposed rule be included in any costs ($6,400,000 annually) and written assurances (to be given to their
final rule, we estimate 1,867 facilities environmental monitoring sampling receiving facility customers) to describe
subject to subpart CHazard Analysis costs ($7,200,000 annually) and audits the processes and procedures that the
and Risk-Based Preventive Controls will and ingredient testing costs of/for supplier is following to ensure the
choose to include environmental suppliers ($7,000,000 audits annually + safety of the food. We estimate that
monitoring procedures as a verification $1,000,000 testing annually). This there are 14,212 facility suppliers and
activity under 117.165(a)(3). These potential burden is shown in Table 9 farms that would need to create these
facilities would need to write-up such row 4. documents. We estimate that it will take
procedures; a one-time burden of 16 Under 117.130(b)(2)(iii) the 2 hours annually to prepare such
hours (5.33 hours annualized). We also supplemental notice of proposed documentation. This burden is shown
estimate that 319 food manufacturers rulemaking adds a new element to the in Table 9, row 7.
TABLE 9ESTIMATED POTENTIAL ANNUAL RECORDKEEPING BURDEN

Average burden
21 CFR Part 117, subpart Number of Number of Total annual per record- Total operating
C recordkeepers records per records keeping Total hours and maintenance
recordkeeper costs
(in hours)
Potential product testing

written procedures (po-
tential 117.165(a)(2)) 319 1 319 5.33 1,700 ............................
Potential environmental
monitoring written pro-

cedures (potential
117.165(a)(3)) ............ 1,867 1 1,867 5.33 9,951 ............................
Potential supplier program
written (potential
117.136(a)(2)) ............ 2,417 1 2,417 5.33 12,883 ............................
TABLE 9ESTIMATED POTENTIAL ANNUAL RECORDKEEPING BURDENContinued
Number of Average burden Total operating

21 CFR Part 117, subpart Number of records per Total annual per record- Total hours and maintenance
C recordkeepers records keeping
recordkeeper (in hours) costs
117.136(a)(3);
117.165(a)(4)
verification records ....... 689 12 8,268 0.5 4,134 $21,600,000
117.130(b)(2)(iii) written
HA for EMA .................. 16,000 1 16,000 1 16,000 $5,100,000
117.130(b)(2)(iii) updat-
ing written HA for EMA 16,000 1 16,000 0.1 1,600 $1,300,000
117.136(c)(3);
117.136(c)(4) qualified
or exempt suppliers as-
surances ....................... 14,212 1 14,212 2 28,424 ............................
Total annual burden

hours and costs ..... ............................ ............................ ............................ ............................ 74,692 $28,000,000
Reporting Burden document to http://www.regulations.gov 4. FDA, Transcript: FSMA Proposed Rules

or written comments to the Division of On Produce Safety And Preventive
There is no additional reporting Controls For Human Food Facilities. Public
burden under this supplemental notice Dockets Management (see ADDRESSES). It
Meeting, Day Two. March 12, 2013.
of proposed rulemaking. is only necessary to send one set of Available at http://www.fda.gov/Food/
comments. Identify comments with the GuidanceRegulation/FSMA/
Third Party Disclosure Burden docket number found in brackets in the ucm339097.htm and in Docket No. FDA
There is no additional third party heading of this document. Received 2011N0920.
disclosure burden under this comments may be seen in the Division 5. FDA, Transcript: FSMA Proposed Rules
supplemental notice of proposed of Dockets Management between 9 a.m. On Produce Safety And Preventive
and 4 p.m., Monday through Friday, and Controls For Human Food Facilities. Public
rulemaking. Meeting, Day One. March 27, 2013.
To ensure that comments on will be posted to the docket at http://
www.regulations.gov. Available at http://www.fda.gov/Food/
information collection are received, GuidanceRegulation/FSMA/
OMB recommends that written XXI. References ucm339096.htm and in Docket No. FDA
comments be faxed to the Office of 2011N0920.
The following references have been 6. FDA, Transcript: FSMA Proposed Rules
Information and Regulatory Affairs, placed on display in the Division of
OMB, Attn: FDA Desk Officer, FAX: On Produce Safety And Preventive
Dockets Management (see ADDRESSES) Controls For Human Food Facilities. Public
2023957285, or emailed to and may be seen by interested persons Meeting, Day Two. March 28, 2013.
oira_submission@omb.eop.gov. All between 9 a.m. and 4 p.m., Monday Available at http://www.fda.gov/Food/
comments should be identified with the through Friday. These references are GuidanceRegulation/FSMA/
title Current Good Manufacturing also available electronically at http:// ucm339096.htm and in Docket No. FDA
Practice And Hazard Analysis And Risk- www.regulatons.gov. We have verified 2011N0920.
Based Preventive Controls For Human 7. FDA, Record of Outreach Sessions on
the Web site addresses, but we are not
Food. FDA Proposed Rules, 2013. Available in
responsible for any subsequent changes Docket No. FDA2011N0920.
In compliance with the Paperwork to Web sites after this document 8. Taylor, M., Statement From FDA Deputy
Reduction Act of 1995 (44 U.S.C. publishes in the Federal Register. Commissioner for Foods and Veterinary
3407(d)), the Agency has submitted the Medicine, Michael Taylor, on Key
1. FDA, Transcript: FSMA Proposed Rules
information collection provisions of this On Produce Safety And Preventive Provisions of the Proposed FSMA Rules
proposed rule to OMB for review. These Controls For Human Food Facilities. Public Affecting Farmers, December 19, 2013.
requirements will not be effective until Meeting, Day One. February 28, 2013. Available at http://www.fda.gov/Food/
FDA obtains OMB approval. FDA will Available at http://www.fda.gov/Food/ GuidanceRegulation/FSMA/
publish a notice concerning OMB GuidanceRegulation/FSMA/ ucm379397.htm. Accessed and printed on
approval of these requirements in the ucm336329.htm and in Docket No. FDA January 29, 2014.
2011N0920. 9. Taylor, M., Your Input Is Bringing Change
Federal Register. to Food Safety Rules, December 19, 2013.
2. FDA, Transcript: FSMA Proposed Rules
XIX. Analysis of Environmental Impact On Produce Safety And Preventive Available at http://blogs.fda.gov/fdavoice/
Controls For Human Food Facilities. Public index.php/2013/12/your-input-is-bringing-
FDA has determined under 21 CFR Meeting, Day Two. March 1, 2013. change-to-food-safety-rules. Accessed and
25.30(j) that this action is of a type that Available at http://www.fda.gov/Food/ printed on January 29, 2014.
does not individually or cumulatively GuidanceRegulation/FSMA/ 10. FDA, Guidance for Industry: Questions
have a significant effect on the human ucm336329.htm and in Docket No. FDA and Answers Regarding Food Facility
environment (Ref. 35) (Ref. 36). 2011N0920. Registration (Fifth Edition), 2012.
Therefore, neither an environmental 3. FDA, Transcript: FSMA Proposed Rules 11. FDA, Guidance for Industry: What You
On Produce Safety And Preventive Need to Know About Registration of Food
assessment nor an environmental Facilities; Small Entity Compliance
Controls For Human Food Facilities. Public
impact statement is required. Meeting, Day One. March 11, 2013. Guide, 2012.
XX. Comments Available at http://www.fda.gov/Food/ 12. FDA, Guidance for Industry: Questions
GuidanceRegulation/FSMA/ and Answers Regarding Establishment and
Interested persons may submit either ucm339097.htm and in Docket No. FDA Maintenance of Records By Persons Who
electronic comments regarding this 2011N0920. Manufacture, Process, Pack, Transport,
Distribute, Receive, Hold, or Import Food http://www.lead.org.au/lanv3n3/lanv3n3- 321, 331, 332, 333, 334, 335a, 343, 350c,
(Edition 5), 2012. 6.html. Accessed and printed on February 350d, 352, 355, 360b, 360ccc, 360ccc1,
13. FDA, What You Need to Know About 20, 2014. 360ccc2, 362, 371, 374, 381, 382, 387, 387a,
Establishment and Maintenance of 30. International Agency for Research on 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.
Records, 2014. Cancer, Agents Classified by the IARC
14. FDA, Guidance for Industry: 2. Section 1.227 is amended by
Monographs, Volumes 1109, January 14,
Antimicrobial Food Additives, 1999. 2014. Available at http:// revising the definitions for Farm,
15. Cooperative Extension Service, Division monographs.iarc.fr/ENG/Classification/ Harvesting, Holding, and
of Agricultural Sciences and Natural ClassificationsAlphaOrder.pdf. Accessed Packing to read as follows:
Resources, Oklahoma State University; and printed on August 13, 2014.
USDA, Federal Grain Inspection Service; 31. U.K. Food Standards Agency, Sudan I 1.227 What definitions apply to this
USDA, Extension Service; USDA, Animal Timeline, February 24, 2005. http:// subpart?
and Plant Health Inspection Service, webarchive.nationalarchives.gov.uk/ * * * * *
Stored Product Management, Circular 20111206002505/http://www.food.gov.uk/ Farm means an establishment under
No. E912, January 1995. Available at safereating/chemsafe/sudani/ one ownership in one general physical
http://entomology.k-state.edu/doc/ sudanitimeline. Accessed and printed on
extensioncrop-pests/
location devoted to the growing and
February 25, 2014. harvesting of crops, the raising of
E912_All_Stored_Product_May3.pdf. 32. Congressional Research Service, Food
Accessed and printed on August 14, 2014. animals (including seafood), or both.
Fraud and Economically Motivated
16. FDA, Draft Qualitative Risk Assessment. Adulteration of Food and Food
The term farm includes
Risk of Activity/Food Combinations for Ingredients, January 10, 2014. Available at establishments that, in addition to these
Activities (Outside the Farm Definition) activities:
http://www.fas.org/sgp/crs/misc/
Conducted in a Facility Co-Located on a (1) Pack or hold raw agricultural
R43358.pdf. Accessed and printed on
Farm, 2012. commodities;
March 6, 2014.
17. National Advisory Committee on (2) Pack or hold processed food,
33. Everstine, K., J. Spink, and S. Kennedy,
Microbiological Criteria for Foods, Hazard
Analysis and Critical Control Point Economically Motivated Adulteration provided that all processed food used
Principles and Application Guidelines, (EMA) of Food: Common Characteristics of in such activities is either consumed
Journal of Food Protection, 61:12461259, EMA Incidents, Journal of Food on that farm or another farm under
1998. Protection, 76:723735, 2013. the same ownership, or is processed
18. FDA Memorandum, Product Testing, 34. Muth, M.K., C. Zhen, M. Coglaiti, S.
food identified in paragraph (3)(ii)(A)
2014. Karns, and C. Viator, Food Processing
Sector Study, Contract HHSF of this definition; and
19. Codex Alimentarius Commission, (3) Manufacture/process food,
Hazard Analysis And Critical Control 22320101745G, Task Order 13, Final
Report, 2011. provided that:
Point (HACCP) System And Guidelines For
Its Application. Annex to CAC/RCP 11969 35. FDA Memorandum, Re-proposal of (i) All food used in such activities is
(Rev. 42003), 2003. select provisions of the Proposed Rule: consumed on that farm or another farm
20. Codex Alimentarius Commission, Current Good Manufacturing Practice and under the same ownership; or
General Principles of Food Hygiene, Hazard Analysis and Risk-Based (ii) Any manufacturing/processing of
CAC/RCP 11969 (Rev. 42003), 2003. Preventive Controls for Human Food, food that is not consumed on that farm
21. Codex Alimentarius Commission, 2014. or another farm under the same
Guidelines on the Application of General 36. FDA Memorandum, Modernization of ownership consists only of:
Principles of Food Hygiene to the Control food current Good Manufacturing Practices (A) Drying/dehydrating raw
of Listeria monocytogenes in Ready-to-Eat (cGMP) as required by the Food Safety
Modernization Act of 2011, 2011.
agricultural commodities to create a
Foods, CAC/GL 612007, 2007.
distinct commodity, and packaging and
22. Codex Alimentarius Commission, Code
of Hygienic Practice for Powdered List of Subjects labeling such commodities, without
Formulae for Infants and Young Children, additional manufacturing/processing;
CAC/RCP 662008, 2008. 21 CFR Part 1 and
23. FDA Memorandum, Environmental Cosmetics, Drugs, Exports, Food (B) Packaging and labeling raw
Monitoring, 2014. labeling, Imports, Labeling, Reporting agricultural commodities, when these
24. FDA Memorandum, Supplier Program, activities do not involve additional
2014.
and recordkeeping requirements.
manufacturing/processing.
25. U.S. Pharmacopeial Convention, U.S. 21 CFR Part 16
Pharmacopeial Convention (USP) Food * * * * *
Fraud Database, March 6, 2014. Available Administrative practice and Harvesting applies to farms and farm
at http://www.usp.org/food-ingredients/ procedure. mixed-type facilities and means
food-fraud-database. Accessed and printed activities that are traditionally
on February 20, 2014. 21 CFR Part 117 performed on farms for the purpose of
26. FDA, FSMA Supplemental Notice of Food packaging, Foods. removing raw agricultural commodities
Proposed Rulemaking for Current Good from the place they were grown or
Manufacturing Practice and Hazard
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under raised and preparing them for use as
Analysis and Risk-Based Preventive
Controls for Human Food. Preliminary authority delegated to the Commissioner food. Harvesting is limited to activities
Regulatory Impact Analysis, 2014. of Food and Drugs, it is proposed that performed on raw agricultural
27. FDA, Supporting Document for 21 CFR chapter I, as proposed to be commodities on a farm. Harvesting does
Recommended Maximum Level for Lead in amended on January 16, 2013 (78 FR not include activities that transform a
Candy Likely to Be Consumed Frequently 3646), be further amended as follows: raw agricultural commodity, as defined
by Small Children, November, 2006. in section 201(r) of the Federal Food,

28. FDA, Best Value, Inc., Recalls PRAN PART 1GENERAL ENFORCEMENT Drug, and Cosmetic Act, into a
Bran[d] Turmeric Powder Due to Elevated REGULATIONS processed food as defined in section
Levels of Lead, October 16, 2013.
Available at http://www.fda.gov/safety/
201(gg) of the Federal Food, Drug, and
1. The authority citation for 21 CFR Cosmetic Act. Gathering, field coring,
recalls/ucm371042.htm. Accessed and
printed on February 25, 2014.
part 1 continues to read as follows: washing, trimming of outer leaves of,
29. LEAD Action News, Adulteration of Authority: 15 U.S.C. 1333, 1453, 1454, removing stems and husks from, sifting,
Paprika in Hungary, 1995. Available at 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. filtering, threshing, shelling, and
cooling raw agricultural commodities (ii) Any manufacturing/processing of in section 201(r) of the Federal Food,
grown on a farm are examples of food that is not consumed on that farm Drug, and Cosmetic Act, into a
harvesting. or another farm under the same processed food as defined in section
Holding means storage of food and ownership consists only of: 201(gg) of the Federal Food, Drug, and
also includes activities performed (A) Drying/dehydrating raw Cosmetic Act.
incidental to storage of a food (e.g., agricultural commodities to create a * * * * *
activities performed for the safe or distinct commodity, and packaging and
effective storage of that food and labeling such commodities, without PART 16REGULATORY HEARING
activities performed as a practical additional manufacturing/processing; BEFORE THE FOOD AND DRUG
necessity for the distribution of that and ADMINISTRATION
food (such as blending of the same raw (B) Packaging and labeling raw
agricultural commodity and breaking agricultural commodities, when these 4. The authority citation for 21 CFR
down pallets)), but does not include activities do not involve additional part 16 continues to read as follows:
activities that transform a raw manufacturing/processing. Authority: 15 U.S.C. 14511461; 21 U.S.C.
agricultural commodity, as defined in * * * * * 141149, 321394, 467f, 679, 821, 1034; 28
section 201(r) of the Federal Food, Drug, Harvesting applies to farms and farm U.S.C. 2112; 42 U.S.C. 201262, 263b, 364.
and Cosmetic Act, into a processed food mixed-type facilities and means 5. Section 16.1 is amended by revising
as defined in section 201(gg) of the activities that are traditionally the entry for 117.251 through
Federal Food, Drug, and Cosmetic Act. performed on farms for the purpose of 117.284 in paragraph (b)(2) to read as
Holding facilities could include removing raw agricultural commodities follows:
warehouses, cold storage facilities, from the place they were grown or
storage silos, grain elevators, and liquid raised and preparing them for use as 16.1 Scope.
storage tanks. food. Harvesting is limited to activities * * * * *
* * * * * performed on raw agricultural (b) * * *
Packing means placing food into a commodities on a farm. Harvesting does (2) * * *
container other than packaging the food not include activities that transform a 117.251 through 117.287 (part 117,
and also includes activities performed raw agricultural commodity, as defined subpart E), relating to withdrawal of an
incidental to packing a food (e.g., in section 201(r) of the Federal Food, exemption applicable to a qualified
activities performed for the safe or Drug, and Cosmetic Act, into a facility.
effective packing of that food (such as processed food as defined in section * * * * *
sorting, culling and grading)), but does 201(gg) of the Federal Food, Drug, and
not include activities that transform a Cosmetic Act. Gathering, field coring, PART 117CURRENT GOOD
raw agricultural commodity, as defined washing, trimming of outer leaves of, MANUFACTURING PRACTICE AND
in section 201(r) of the Federal Food, removing stems and husks from, sifting, HAZARD ANALYSIS AND RISK-BASED
Drug, and Cosmetic Act, into a filtering, threshing, shelling, and PREVENTIVE CONTROLS FOR HUMAN
processed food as defined in section cooling raw agricultural commodities FOOD
201(gg) of the Federal Food, Drug, and grown on a farm are examples of
Cosmetic Act. 6. The authority citation for part 117,
harvesting.
* * * * * Holding means storage of food and as proposed to be added on January 16,
3. Section 1.328 is amended by also includes activities performed 2013 (78 FR 3646), continues to read as
revising the definitions for Farm, incidental to storage of a food (e.g., follows:
Harvesting, Holding, and activities performed for the safe or Authority: 21 U.S.C. 331, 342, 343, 350d
Packing to read as follows: effective storage of that food and note, 350g note, 371, 374; 42 U.S.C. 243, 264,
activities performed as a practical 271.
1.328 What definitions apply to this
subpart? necessity for the distribution of that
Subpart AGeneral Provisions
food (such as blending of the same raw
* * * * * agricultural commodity and breaking
Farm means an establishment under 117.3 [Amended]
down pallets)), but does not include 7. Section 117.3 is amended as
one ownership in one general physical
activities that transform a raw follows:
location devoted to the growing and
agricultural commodity, as defined in a. By removing the definitions for
harvesting of crops, the raising of
section 201(r) of the Federal Food, Drug, cross-contact, hazard reasonably
animals (including seafood), or both.
and Cosmetic Act, into a processed food likely to occur, and reasonably
The term farm includes
as defined in section 201(gg) of the foreseeable hazard;
establishments that, in addition to these
Federal Food, Drug, and Cosmetic Act. b. By adding definitions for allergen-
activities:
(1) Pack or hold raw agricultural Holding facilities could include cross contact, known or reasonably
commodities; warehouses, cold storage facilities, foreseeable hazard, pathogen,
(2) Pack or hold processed food, storage silos, grain elevators, and liquid qualified auditor, receiving facility,
provided that all processed food used in storage tanks. significant hazard, supplier, and
such activities is either consumed on * * * * * you ; and
that farm or another farm under the Packing means placing food into a c. By revising the definitions for
same ownership, or is processed food container other than packaging the food environmental pathogen,
identified in paragraph (3)(ii)(A) of this and also includes activities performed harvesting, hazard, holding,
definition; and incidental to packing a food (e.g., packing, and very small business.
(3) Manufacture/process food, activities performed for the safe or The additions and revisions read as
provided that: effective packing of that food (such as follows:
(i) All food used in such activities is sorting, culling and grading)), but does
consumed on that farm or another farm not include activities that transform a 117.3 Definitions.
under the same ownership; or raw agricultural commodity, as defined * * * * *
Allergen cross-contact means the hazard that has the potential to be 8. Amend 117.5 by revising
unintentional incorporation of a food associated with the facility or the food. paragraph (k) to read as follows:
allergen into a food. * * * * * 117.5 Exemptions.
* * * * * Packing means placing food into a
Environmental pathogen means a container other than packaging the food * * * * *
and also includes activities performed (k)(1) Except as provided by
pathogen capable of surviving and
incidental to packing a food (e.g., paragraph (k)(2) of this section, subpart
persisting within the manufacturing,
activities performed for the safe or B of this part does not apply to any of
processing, packing, or holding
effective packing of that food (such as the following:
environment such that food may be
sorting, culling and grading)), but does (i) Farms (as defined in 1.227 of
contaminated and may result in
not include activities that transform a this chapter);
foodborne illness if that food is (ii) Fishing vessels that are not subject
consumed without treatment to raw agricultural commodity, as defined
to the registration requirements of part
significantly minimize the in section 201(r) of the Federal Food,
Drug, and Cosmetic Act, into a 1, subpart H of this part in accordance
environmental pathogen. Environmental with 1.226(f);
pathogen does not include the spores of processed food as defined in section
(iii) The holding or transportation of
pathogenic sporeformers. 201(gg) of the Federal Food, Drug, and
one or more raw agricultural
* * * * * Cosmetic Act.
Pathogen means a microorganism of commodities, as defined in section
Harvesting applies to farms and farm 201(r) of the Federal Food, Drug, and
public health significance.
mixed-type facilities and means Cosmetic Act;
activities that are traditionally * * * * * (iv) Activities of farm mixed-type
performed on farms for the purpose of Qualified auditor means a person who facilities (as defined in 1.227) that
removing raw agricultural commodities is a qualified individual as defined in fall within the definition of farm; or
from the place they were grown or this part and has technical expertise (v) Hulling, shelling, and drying nuts
raised and preparing them for use as obtained by a combination of training (without manufacturing/processing,
food. Harvesting is limited to activities and experience appropriate to perform such as roasting nuts).
performed on raw agricultural the auditing function as required by (2) If a farm or farm mixed-type
commodities on a farm. Harvesting does 117.180(c)(2). facility dries/dehydrates raw
not include activities that transform a * * * * * agricultural commodities to create a
raw agricultural commodity, as defined Receiving facility means a facility that distinct commodity, subpart B of this
in section 201(r) of the Federal Food, is subject to subpart C of this part and part applies to the packaging, packing,
Drug, and Cosmetic Act, into a that manufactures/processes a raw and holding of the dried commodities.
processed food as defined in section material or ingredient that it receives Compliance with this requirement may
201(gg) of the Federal Food, Drug, and from a supplier. be achieved by complying with subpart
Cosmetic Act. Gathering, field coring, * * * * * B or with the applicable requirements
washing, trimming of outer leaves of, Significant hazard means a known or for packing and holding in part 112 of
removing stems and husks from, sifting, reasonably foreseeable hazard for which this chapter.
filtering, threshing, shelling, and a person knowledgeable about the safe 9. Revise subpart C to read as follows:
cooling raw agricultural commodities manufacturing, processing, packing, or
grown on a farm are examples of holding of food would, based on the Subpart CHazard Analysis and Risk-
harvesting. outcome of a hazard analysis, establish Based Preventive Controls
Hazard means any biological, controls to significantly minimize or
Sec.
chemical (including radiological), or prevent the hazard in a food and 117.126 Food safety plan.
physical agent that is reasonably likely components to manage those controls 117.130 Hazard analysis.
to cause illness or injury in the absence (such as monitoring, corrections or 117.135 Preventive controls.
of its control. corrective actions, verification, and 117.136 Supplier program.
Holding means storage of food and records) as appropriate to the food, the 117.137 Recall plan.
also includes activities performed facility, and the control. 117.140 Preventive control management
* * * * * components.
incidental to storage of a food (e.g., 117.145 Monitoring.
activities performed for the safe or Supplier means the establishment that
117.150 Corrective actions and corrections.
effective storage of that food and manufactures/processes the food, raises 117.155 Verification.
activities performed as a practical the animal, or harvests the food that is 117.160 Validation.
necessity for the distribution of that provided to a receiving facility without 117.165 Verification of implementation and
food (such as blending of the same raw further manufacturing/processing by effectiveness.
agricultural commodity and breaking another establishment, except for 117.170 Reanalysis.
down pallets)), but does not include further manufacturing/processing that 117.180 Requirements applicable to a
activities that transform a raw consists solely of the addition of qualified individual and a qualified
labeling or similar activity of a de auditor.
agricultural commodity, as defined in 117.190 Implementation records.
section 201(r) of the Federal Food, Drug, minimis nature.
and Cosmetic Act, into a processed food * * * * * 117.126 Food safety plan.
as defined in section 201(gg) of the Very small business means, for (a) Requirement for a food safety plan.
Federal Food, Drug, and Cosmetic Act. purposes of this part, a business that has (1) You must prepare, or have prepared,
Holding facilities could include less than $1,000,000 in total annual and implement a written food safety
warehouses, cold storage facilities, sales of human food, adjusted for plan.
storage silos, grain elevators, and liquid inflation. (2) The food safety plan must be
storage tanks. * * * * * prepared, or its preparation overseen, by
Known or reasonably foreseeable You means, for purposes of this part, one or more qualified individuals.
hazard means a biological, chemical the owner, operator, or agent in charge (b) Contents of a food safety plan. The
(including radiological), or physical of a facility. written food safety plan must include:
(1) The written hazard analysis as packaging and the packaged food does (i) Ensuring protection of food from
required by 117.130(a)(2); not receive a treatment that would allergen cross-contact, including during
(2) The written preventive controls as significantly minimize the pathogen. storage and use; and
required by 117.135(b); (2) The hazard evaluation must (ii) Labeling the finished food,
(3) The written supplier program as consider the effect of the following on including ensuring that the finished
required by 117.136(a)(2); the safety of the finished food for the food is not misbranded under section
(4) The written recall plan as required intended consumer: 403(w) of the Federal Food, Drug, and
by 117.137(a); and (i) The formulation of the food; Cosmetic Act.
(5) The written procedures for (ii) The condition, function, and (3) Sanitation controls. Sanitation
monitoring the implementation of the design of the facility and equipment; controls include procedures, practices,
preventive controls as required by (iii) Raw materials and ingredients; and processes to ensure that the facility
117.145(a)(1); (iv) Transportation practices;
(v) Manufacturing/processing is maintained in a sanitary condition
(6) The written corrective action adequate to significantly minimize or
procedures as required by procedures;
(vi) Packaging activities and labeling prevent hazards such as environmental
117.150(a)(1); and pathogens, biological hazards due to
(7) The written verification activities;
(vii) Storage and distribution; employee handling, and food allergen
procedures as required by 117.165(b). hazards. Sanitation controls must
(viii) Intended or reasonably
(c) Records. The food safety plan include, as appropriate to the facility
foreseeable use;
required by this section is a record that (ix) Sanitation, including employee and the food, procedures, practices, and
is subject to the requirements of subpart hygiene; and processes for the:
F of this part. (x) Any other relevant factors. (i) Cleanliness of food-contact
117.130 Hazard analysis. surfaces, including food-contact
117.135 Preventive controls. surfaces of utensils and equipment;
(a) Requirement for a hazard analysis. (a)(1) You must identify and
(1) You must identify and evaluate, (ii) Prevention of allergen cross-
implement preventive controls to contact and cross-contamination from
based on experience, illness data, provide assurances that significant
scientific reports, and other information, insanitary objects and from personnel to
hazards will be significantly minimized food, food packaging material, and other
known or reasonably foreseeable or prevented and the food
hazards for each type of food food-contact surfaces and from raw
manufactured, processed, packed, or product to processed product.
manufactured, processed, packed, or held by your facility will not be
held at your facility to determine (4) Supplier controls. Supplier
adulterated under section 402 of the controls include the supplier program as
whether there are significant hazards. Federal Food, Drug, and Cosmetic Act
(2) The hazard analysis must be required by 117.136.
or misbranded under section 403(w) of (5) Recall plan. Recall plan as
written. the Federal Food, Drug, and Cosmetic
(b) Hazard identification. The hazard required by 117.137.
Act. (6) Other controls. Preventive controls
identification must consider: (2) Preventive controls required by
(1) Hazards that include: include any other procedures, practices,
paragraph (a)(1) of this section include,
(i) Biological hazards, including and processes necessary to satisfy the
as appropriate to the facility and the
microbiological hazards such as requirements of paragraph (a) of this
food:
parasites, environmental pathogens, and (i) Controls at critical control points section. Examples of other controls
other pathogens; (CCPs), if there are any CCPs; and include hygiene training and other
(ii) Chemical hazards, including (ii) Controls, other than those at CCPs, current good manufacturing practices.
radiological hazards, substances such as that are also appropriate for food safety. 117.136 Supplier program.
pesticide and drug residues, natural (b) Preventive controls must be
toxins, decomposition, unapproved food (a) Supplier program. (1)(i) Except as
written.
or color additives, and food allergens; (c) Preventive controls include, as provided in paragraph (a)(1)(ii) of this
and appropriate to the facility and the food: section, the receiving facility must
(iii) Physical hazards; and (1) Process controls. Process controls establish and implement a risk-based
(2) Hazards that may be present in the include procedures, practices, and supplier program for those raw
food for any of the following reasons: processes to ensure the control of materials and ingredients for which the
(i) The hazard occurs naturally; parameters during operations such as receiving facility has identified a
(ii) The hazard may be heat processing, acidifying, irradiating, significant hazard when the hazard is
unintentionally introduced; or and refrigerating foods. Process controls controlled before receipt of the raw
(iii) The hazard may be intentionally must include, as appropriate to the material or ingredient.
introduced for purposes of economic applicable control: (ii) The receiving facility is not
gain. (i) Parameters associated with the required to establish and implement a
(c) Hazard evaluation. (1)(i) The control of the hazard; and supplier program for raw materials and
hazard analysis must include an (ii) The maximum or minimum value, ingredients for which:
evaluation of the hazards identified in or combination of values, to which any (A) There are no significant hazards;
paragraph (b) of this section to assess biological, chemical, or physical (B) The preventive controls at the
the severity of the illness or injury if the parameter must be controlled to receiving facility are adequate to
hazard were to occur and the probability significantly minimize or prevent a significantly minimize or prevent each
that the hazard will occur in the absence significant hazard. of the significant hazards; or
of preventive controls. (2) Food allergen controls. Food (C) The receiving facility relies on its
(ii) The hazard evaluation required by allergen controls include procedures, customer to control the hazard and
paragraph (c)(1)(i) of this section must practices, and processes to control food annually obtains from its customer
include an evaluation of environmental allergens. Food allergen controls must written assurance that the customer has
pathogens whenever a ready-to-eat food include those procedures, practices, and established and is following procedures
is exposed to the environment prior to processes employed for: (identified in the written assurance) that
will significantly minimize or prevent the suppliers compliance with those qualified facility as defined by 117.3;
the hazard. regulations, including an FDA warning and
(2) The supplier program must be letter or import alert relating to the (ii) Obtains written assurance, at least
written. safety of the food; every 2 years, that the supplier is
(3) The supplier program must (5) The suppliers food safety producing the raw material or
include: performance history relevant to the raw ingredient in compliance with
(i) Verification activities, as materials or ingredients that the applicable FDA food safety regulations
appropriate to the hazard, and receiving facility receives from the and that the raw material or ingredient
documentation of these activities, to supplier, including available is not adulterated under section 402 of
ensure raw materials and ingredients are information about results from testing the Federal Food, Drug, and Cosmetic
received only from suppliers approved raw materials or ingredients for hazards, Act or misbranded under section 403(w)
for control of the hazard(s) in that raw audit results relating to the safety of the of the Federal Food, Drug, and Cosmetic
material or ingredient (or, when food, and responsiveness of the supplier Act. The written assurance must include
necessary and appropriate, on a in correcting problems; and a brief description of the processes and
temporary basis from unapproved (6) Any other factors as appropriate procedures that the supplier is
suppliers whose raw materials or and necessary. Examples of factors that following to ensure the safety of the
ingredients the receiving facility a receiving facility may determine are food.
subjects to adequate verification appropriate and necessary are storage (4) If a supplier is a farm that is not
activities before acceptance for use); and and transportation practices. subject to the requirements established
(ii) Verification activities and (c) Supplier verification activities for in part 112 of this chapter in accordance
documentation of these activities, as raw materials and ingredients. (1) with 112.4 regarding the raw material
required by paragraph (b) of this section, Except as provided in paragraph (c)(2) or ingredient that the receiving facility
to verify that: or (3) of this section, the receiving receives from the farm, the receiving
(A) The hazard is significantly facility must conduct and document one facility does not need to comply with
minimized or prevented; or more of the following supplier paragraphs (c)(1) and (2) of this section
(B) The incoming raw material or verification activities as determined by if the receiving facility:
ingredient is not adulterated under the receiving facility under paragraph (i) Documents, at the end of each
section 402 of the Federal Food, Drug, (b) of this section, for each supplier calendar year, that the raw material or
and Cosmetic Act or misbranded under before using the raw material or ingredient provided by the supplier is
section 403(w) of the Federal Food, ingredient and periodically thereafter: not subject to part 112 of this chapter;
Drug, and Cosmetic Act: and (i) Onsite audits; and
(C) The incoming raw material or (ii) Sampling and testing of the raw (ii) Obtains written assurance, at least
ingredient is produced in compliance material or ingredient, which may be every 2 years, that the supplier is
with the requirements of applicable conducted by either the supplier or producing the raw material or
FDA food safety regulations. receiving facility. ingredient in compliance with
(4) When supplier verification (iii) Review by the receiving facility of applicable FDA food safety regulations
activities are required under paragraph the suppliers relevant food safety and that the raw material or ingredient
(c) of this section for more than one type records; or is not adulterated under section 402 of
of hazard in a food, the receiving facility (iv) Other appropriate supplier the Federal Food, Drug, and Cosmetic
must conduct the verification activity or verification activities based on the risk Act.
activities appropriate for each of those associated with the ingredient and the (d) Onsite audit. (1) An onsite audit
hazards. supplier. of a supplier must be performed by a
(5) For some hazards, in some (2)(i) Except as provided by paragraph qualified auditor.
situations under paragraph (b) it will be (c)(2)(ii) of this section, when a hazard (2) If the raw material or ingredient at
necessary to conduct more than one in a raw material or ingredient will be the supplier is subject to one or more
verification activity and/or to increase controlled by the supplier and is one for FDA food safety regulations, an onsite
the frequency of one or more which there is a reasonable probability audit must consider such regulations
verification activities to provide that exposure to the hazard will result and include a review of the suppliers
adequate assurances that the hazard is in serious adverse health consequences written plan (e.g., HACCP plan or other
significantly minimized or prevented. or death to humans, the receiving food safety plan), if any, including its
(b) Determination and documentation facility must have documentation of an implementation, for the hazard being
of the appropriate verification activities. onsite audit of the supplier before using audited.
In determining and documenting the the raw material or ingredient from the (e) Substitution of inspection by FDA
appropriate verification activities, the supplier and at least annually thereafter. or an officially recognized or equivalent
receiving facility must consider the (ii) The requirements of paragraph food safety authority. (1) Instead of an
following: (c)(2)(i) of this section do not apply if onsite audit, a receiving facility may
(1) The hazard analysis, including the the receiving facility documents its rely on the results of an inspection of
nature of the hazard, applicable to the determination that other verification the supplier by FDA or, for a foreign
raw material and ingredients; activities and/or less frequent onsite supplier, by FDA or the food safety
(2) Where the preventive controls for auditing of the supplier provide authority of a country whose food safety
those hazards are applied for the raw adequate assurance that the hazards are system FDA has officially recognized as
material and ingredientssuch as at the controlled. comparable or has determined to be

supplier or the suppliers supplier; (3) If a supplier is a qualified facility equivalent to that of the United States,
(3) The suppliers procedures, as defined by 117.3, the receiving provided that the inspection was
processes, and practices related to the facility need not comply with conducted within 1 year of the date that
safety of the raw material and paragraphs (c)(1) and (2) of this section the onsite audit would have been
ingredients; if the receiving facility: required to be conducted.
(4) Applicable FDA food safety (i) Documents, at the end of each (2) For inspections conducted by the
regulations and information relevant to calendar year, that the supplier is a food safety authority of a country whose
food safety system FDA has officially (v) Corrective actions taken in steps to be taken, and assign
recognized as comparable or determined response to detection of hazards; and responsibility for taking those steps, to
to be equivalent, the food that is the (vi) Information identifying the perform the following actions as
subject of the onsite audit must be laboratory conducting the testing. appropriate to the facility:
within the scope of the official (7) Records of the review by the (1) Directly notify the direct
recognition or equivalence receiving facility of the suppliers consignees of the food being recalled,
determination, and the foreign supplier relevant food safety records. These including how to return or dispose of
must be in, and under the regulatory records must include: the affected food;
oversight of, such country. (i) The date(s) of review; (2) Notify the public about any hazard
(f) Supplier non-conformance. If the (ii) Corrective actions taken in presented by the food when appropriate
owner, operator, or agent in charge of a response to significant deficiencies to protect public health;
receiving facility determines through identified during the review; and (3) Conduct effectiveness checks to
auditing, verification testing, relevant (iii) Documentation that the review verify that the recall is carried out; and
consumer, customer or other was conducted by a qualified (4) Appropriately dispose of recalled
complaints, or otherwise that the individual. food (e.g., through reprocessing,
(8) Records of other appropriate reworking, diverting to a use that does
supplier is not controlling hazards that
supplier verification activities based on not present a safety concern, or
the receiving facility has identified as
the risk associated with the ingredient. destroying the food).
significant, the receiving facility must (9) Documentation of any
take and document prompt action in determination that verification activities 117.140 Preventive control management
accordance with 117.150 to ensure other than an onsite audit, and/or less components.
that raw materials or ingredients from frequent onsite auditing of a supplier, (a) Except as provided by paragraphs
the supplier do not cause food that is provide adequate assurance that the (b) and (c) of this section, the preventive
manufactured or processed by the hazards are controlled; controls required under 117.135 are
receiving facility to be adulterated (10) Documentation of an alternative subject to the following preventive
under section 402 of the Federal Food, verification activity for a supplier that is control management components as
Drug, and Cosmetic Act or misbranded a qualified facility, including: appropriate to ensure the effectiveness
under section 403(w) of the Federal (i) The documentation that the of the preventive controls, taking into
Food, Drug, and Cosmetic Act. supplier is a qualified facility as defined account the nature of the preventive
(g) Records. The receiving facility by 117.3; and control:
must document the following in records (ii) The written assurance that the (1) Monitoring in accordance with
and review such records in accordance supplier is producing the raw material 117.145;
with 117.165(a)(4). or ingredient in compliance with (2) Corrective actions and corrections
(1) The written supplier program; applicable FDA food safety regulations in accordance with 117.150; and
(2) Documentation of the appropriate and that the raw material or ingredient (3) Verification in accordance with
verification activities; is not adulterated under section 402 of 117.155.
(3) The annual written assurance that the Federal Food, Drug, and Cosmetic (b) The supplier program established
a receiving facilitys customer who is Act or misbranded under section 403(w) in 117.136 is subject to the following
controlling a significant hazard has of the Federal Food, Drug, and Cosmetic preventive control management
established and is following procedures Act. components as appropriate to ensure the
(identified in the written assurance) that (11) Documentation of an alternative effectiveness of the supplier program
will significantly minimize or prevent verification activity for a supplier that is taking into account the nature of the
the hazard; a farm that supplies a raw material or hazard controlled before receipt of the
(4) Documentation demonstrating that ingredient that is not subject to part 112 raw material or ingredient:
products are received only from of this chapter, including: (1) Corrective actions and corrections
approved suppliers; (i) The documentation that the raw in accordance with 117.150, taking
(5) Documentation of an onsite audit. material or ingredient provided by the into account the nature of any supplier
This documentation must include: supplier is not subject to part 112 of this non-conformance;
(i) Documentation of audit chapter; and (2) Review of records in accordance
procedures; (ii) The written assurance that the with 117.165(a)(4); and
(ii) The dates the audit was supplier is producing the raw material (3) Reanalysis in accordance with
conducted; or ingredient in compliance with 117.170.
(iii) The conclusions of the audit; applicable FDA food safety regulations (c) The recall plan established in
(iv) Corrective actions taken in and that the raw material or ingredient 117.137 is not subject to the
response to significant deficiencies is not adulterated under section 402 of requirements of paragraph (a) of this
identified during the audit; and the Federal Food, Drug, and Cosmetic section.
(v) Documentation that the audit was Act.
conducted by a qualified auditor. 117.145 Monitoring.
(12) Evidence of an inspection of the
(6) Records of sampling and testing. supplier by FDA or the food safety (a) As appropriate to the preventive
These records must include: authority of another country. control, you must:
(i) Identification of the raw material or (13) Documentation of actions taken (1) Establish and implement written
ingredient tested (including lot number, with respect to supplier non- procedures, including the frequency
as appropriate) and the number of conformance. with which they are to be performed, for
samples tested; monitoring the preventive controls; and
(ii) Identification of the test(s) 117.137 Recall plan. (2) Monitor the preventive controls
conducted, including the analytical For food with a significant hazard: with adequate frequency to provide
method(s) used; (a) You must establish a written recall assurance that they are consistently
(iii) The date(s) on which the test(s) plan for the food. performed.
were conducted; (b) The written recall plan must (b) All monitoring of preventive
(iv) The results of the testing; include procedures that describe the controls in accordance with this section
must be documented in records that are (2) If any of the circumstances listed (b) The validation of the preventive
subject to verification in accordance in paragraph (b)(1) of this section apply, controls:
with 117.155(a)(2) and records review you must: (1) Must be performed (or overseen)
in accordance with 117.165(a)(4)(i). (i) Take corrective action to identify by a qualified individual:
and correct the problem, reduce the (i) Prior to implementation of the food
117.150 Corrective actions and likelihood that the problem will recur, safety plan or, when necessary, during
corrections. the first 6 weeks of production; and
evaluate all affected food for safety, and,
(a) Corrective action procedures. As as necessary, prevent affected food from (ii) Whenever a reanalysis of the food
appropriate to the preventive control, entering commerce as would be done safety plan reveals the need to do so;
except as provided by paragraph (c) of following a corrective action procedure (2) Must include collecting and
this section: under paragraphs (a)(2)(i) through (iv) of evaluating scientific and technical
(1)(i) You must establish and this section; and information (or, when such information
implement written corrective action (ii) When appropriate, reanalyze the is not available or is inadequate,
procedures that must be taken if food safety plan in accordance with conducting studies) to determine
preventive controls are not properly 117.170 to determine whether whether the preventive controls, when
implemented. modification of the food safety plan is properly implemented, will effectively
(ii) The corrective action procedures required. control the significant hazards; and
required by paragraph (a)(1)(i) of this (c) Corrections applicable to food (3) Need not address:
section must include procedures to allergen controls and sanitation (i) The food allergen controls in
address, as appropriate: controls. You do not need to comply 117.135(c)(2);
(A) The presence of a pathogen or with the requirements of paragraphs (a) (ii) The sanitation controls in
appropriate indicator organism in a and (b) of this section for conditions and 117.135(c)(3);
ready-to-eat product detected as a result practices that are not consistent with the (iii) The supplier program in
of product testing conducted in food allergen controls in 117.136; and
accordance with 117.165(a)(2); and 117.135(c)(2)(i) or the sanitation (iv) The recall plan in 117.137.
(B) The presence of an environmental controls in 117.135(c)(3)(i) or (ii) if
pathogen or appropriate indicator 117.165 Verification of implementation
you take action, in a timely manner, to and effectiveness.
organism detected through the correct such conditions and practices.
environmental monitoring conducted in (a) Verification activities. You must
(d) Documentation. All corrective verify that the preventive controls are
accordance with 117.165(a)(3). actions (and, when appropriate,
(2) The corrective action procedures consistently implemented and are
corrections) taken in accordance with effectively and significantly minimizing
must describe the steps to be taken to this section must be documented in
ensure that: or preventing the significant hazards. To
records. These records are subject to do so you must conduct activities that
(i) Appropriate action is taken to
verification in accordance with include the following, as appropriate to
identify and correct a problem that has
117.155(a)(3) and records review in the facility, the food, and the nature of
occurred with implementation of a
accordance with 117.165(a)(4)(i). the preventive control:
preventive control;
(ii) Appropriate action is taken, when 117.155 Verification. (1) Calibration of process monitoring
necessary, to reduce the likelihood that (a) Verification activities. Verification instruments and verification
the problem will recur; activities must include, as appropriate instruments;
(iii) All affected food is evaluated for (2) Product testing, for a pathogen (or
to the preventive control:
safety; and (1) Validation in accordance with appropriate indicator organism) or other
(iv) All affected food is prevented 117.160. hazard;
from entering into commerce, if you (2) Verification that monitoring is (3) Environmental monitoring, for an
cannot ensure that the affected food is being conducted as required by environmental pathogen or for an
not adulterated under section 402 of the 117.140 (and in accordance with appropriate indicator organism, if
Federal Food, Drug, and Cosmetic Act 117.145). contamination of a ready-to-eat food
or misbranded under section 403(w) of (3) Verification that appropriate with an environmental pathogen is a
the Federal Food, Drug, and Cosmetic decisions about corrective actions are significant hazard, by collecting and
Act. being made as required by 117.140 testing environmental samples; and
(b) Corrective action in the event of an (and in accordance with 117.150). (4) Review of the following records
unanticipated food safety problem. (1) (4) Verification of implementation within the specified timeframes, by (or
Except as provided by paragraph (c) of and effectiveness in accordance with under the oversight of) a qualified
this section, you are subject to the 117.165; and individual, to ensure that the records
requirements of paragraph (b)(2) of this (5) Reanalysis in accordance with are complete, the activities reflected in
section if any of the following 117.170. the records occurred in accordance with
circumstances apply: (b) Documentation. All verification the food safety plan, the preventive
(i) A preventive control is not activities conducted in accordance with controls are effective, and appropriate
properly implemented and a specific this section must be documented in decisions were made about corrective
corrective action procedure has not been records. actions:
established; (i) Records of monitoring and
(ii) A preventive control is found to be 117.160 Validation. corrective action records within a week
ineffective; or (a) Except as provided by paragraph after the records are created.
(iii) A review of records in accordance (b)(3) of this section, you must validate (ii) Records of calibration, product
with 117.165(a)(4) finds that the that the preventive controls identified testing, environmental monitoring, and
records are not complete, the activities and implemented in accordance with supplier verification activities within a
conducted did not occur in accordance 117.135 to control the significant reasonable time after the records are
with the food safety plan, or appropriate hazards are adequate to do so as created.
decisions were not made about appropriate to the nature of the (b) Written procedures. As
corrective actions. preventive control. appropriate to the facility, the food, and
the nature of the preventive control, you (b) You must complete the reanalysis (2) Records that document corrective
must establish and implement written required by paragraph (a) of this section actions;
procedures for the following activities: and implement any additional (3) Records that document
(1) The method and frequency of preventive controls needed to address verification, including, as applicable,
calibrating process monitoring the hazard identified, if any, before the those related to:
instruments and verification change in activities at the facility is (i) Validation;
instruments as required by paragraph operative or, when necessary, during the (ii) Verification of monitoring;
(a)(1) of this section. first 6 weeks of production. (iii) Verification of corrective actions;
(2) Product testing as required by (c) You must revise the written food (iv) Calibration of process monitoring
paragraph (a)(2) of this section. safety plan if a significant change is and verification instruments;
Procedures for product testing must: made or document the basis for the (v) Product testing;
(i) Be scientifically valid; conclusion that no revisions are needed. (vi) Environmental monitoring;
(ii) Identify the test microorganism(s) (d) A qualified individual must (vii) Records review; and
or other analyte(s); perform (or oversee) the reanalysis. (viii) Reanalysis;
(iii) Specify the procedures for (e) You must conduct a reanalysis of (4) Records that document the
identifying samples, including their the food safety plan when FDA supplier program; and
relationship to specific lots of product; determines it is necessary to respond to (5) Records that document applicable
(iv) Include the procedures for new hazards and developments in training for the qualified individual and
sampling, including the number of scientific understanding. the qualified auditor.
samples and the sampling frequency; (b) The records that you must
(v) Identify the test(s) conducted, 117.180 Requirements applicable to a establish and maintain are subject to the
including the analytical method(s) used; qualified individual and a qualified auditor. requirements of subpart F of this part.
(vi) Identify the laboratory conducting (a) One or more qualified individuals 10. Revise 117.251 to read as
the testing; and must do or oversee the following: follows:
(vii) Include the corrective action (1) Preparation of the food safety plan
procedures required by 117.150(a)(1). ( 117.126(a)(2)); 117.251 Circumstances that may lead
(3) Environmental monitoring as (2) Validation of the preventive FDA to withdraw an exemption applicable to
required by paragraph (a)(3) of this a qualified facility.
controls ( 117.160(b)(1));
section. Procedures for environmental (3) Review of records ( 117.165(a)(4)); (a) FDA may withdraw the exemption
monitoring must: and applicable to a qualified facility under
(i) Be scientifically valid; (4) Reanalysis of the food safety plan 117.5(a):
(ii) Identify the test microorganism(s); ( 117.170(d)). (1) In the event of an active
(iii) Identify the locations from which (b) A qualified auditor must conduct investigation of a foodborne illness
samples will be collected and the an onsite audit ( 117.136(d)). outbreak that is directly linked to the
number of sites to be tested during (c)(1) To be a qualified individual, the qualified facility; or
routine environmental monitoring. The individual must have successfully (2) If FDA determines that it is
number and location of sampling sites completed training in the development necessary to protect the public health
must be adequate to determine whether and application of risk-based preventive and prevent or mitigate a foodborne
preventive controls are effective; controls at least equivalent to that illness outbreak based on conditions or
(iv) Identify the timing and frequency conduct associated with the qualified
received under a standardized
for collecting and testing samples. The facility that are material to the safety of
curriculum recognized as adequate by
timing and frequency for collecting and the food manufactured, processed,
FDA or be otherwise qualified through
testing samples must be adequate to packed, or held at such facility.
job experience to develop and apply a
determine whether preventive controls (b) Before FDA issues an order to
food safety system. Job experience may
are effective; withdraw an exemption applicable to a
qualify an individual to perform these
(v) Identify the test(s) conducted, qualified facility, FDA:
functions if such experience has
including the analytical method(s) used; (1) May consider one or more other
(vi) Identify the laboratory conducting provided an individual with knowledge
at least equivalent to that provided actions to protect the public health or
the testing; and mitigate a foodborne illness outbreak,
(vii) Include the corrective action through the standardized curriculum.
This individual may be, but is not including, a warning letter, recall,
procedures required by 117.150(a)(1). administrative detention, suspension of
required to be, an employee of the
117.170 Reanalysis. facility. registration, import alert, seizure, and
(a) You must conduct a reanalysis of (2) To be a qualified auditor, a injunction;
the food safety plan: qualified individual must have (2) Must notify the owner, operator, or
(1) At least once every 3 years; technical expertise obtained by a agent in charge of the facility, in
(2) Whenever a significant change is combination of training and experience writing, of circumstances that may lead
made in the activities conducted at your appropriate to perform the auditing FDA to withdraw the exemption, and
facility if the change creates a function. provide an opportunity for the owner,
reasonable potential for a new hazard or (d) All applicable training must be operator, or agent in charge of the
creates a significant increase in a documented in records, including the facility to respond in writing, within 10
previously identified hazard; date of the training, the type of training, calendar days of the date of receipt of
(3) Whenever you become aware of and the person(s) trained. the notification, to FDAs notification;
new information about potential and
hazards associated with the food; 117.190 Implementation records. (3) Must consider the actions taken by
(4) Whenever appropriate after an (a) You must establish and maintain the facility to address the circumstances
unanticipated food safety problem in the following records documenting that may lead FDA to withdraw the
accordance with 117.150(b); and implementation of the food safety plan: exemption.
(5) Whenever you find that a (1) Records that document the 11. Revise 117.254 to read as
preventive control is ineffective. monitoring of preventive controls; follows:
117.254 Issuance of an order to withdraw 14. Amend 117.264 by revising (2) Present data and information to
an exemption applicable to a qualified paragraphs (a) introductory text and demonstrate that you have adequately
facility. (a)(1) to read as follows: resolved the problems with the
(a) An FDA District Director in whose conditions or conduct that are material
district the qualified facility is located 117.264 Procedure for submitting an
appeal. to the safety of the food manufactured,
(or, in the case of a foreign facility, the processed, packed, or held at your
Director of the Office of Compliance in (a) To appeal an order to withdraw an
exemption applicable to a qualified facility, such that continued withdrawal
the Center for Food Safety and Applied of the exemption is not necessary to
Nutrition), or an FDA official senior to facility under 117.5(a), you must:
(1) Submit the appeal in writing to the protect public health and prevent or
such Director, must approve an order to mitigate a foodborne illness outbreak.
FDA District Director in whose district
withdraw the exemption before the
the facility is located (or, in the case of (c) If your exemption was withdrawn
order is issued.
a foreign facility, the Director of the under 117.251(a)(1) and FDA later
(b) Any officer or qualified employee Office of Compliance in the Center for
of FDA may issue an order to withdraw determines, after finishing the active
Food Safety and Applied Nutrition), at investigation of a foodborne illness
the exemption after it has been the mailing address, email address, or
approved in accordance with paragraph outbreak, that the outbreak is not
facsimile number identified in the order
(a) of this section. directly linked to your facility, FDA will
within 10 calendar days of the date of
(c) FDA must issue an order to reinstate your exemption under
receipt of the order;
withdraw the exemption to the owner, 117.5(a), and FDA will notify you in
* * * * * writing that your exempt status has been
operator, or agent in charge of the 15. Amend 117.267 by revising
facility. paragraph (a) to read as follows: reinstated.
(d) FDA must issue an order to (d) If your exemption was withdrawn
withdraw the exemption in writing, 117.267 Procedure for requesting an under both 117.251(a)(1) and (2) and
signed and dated by the officer or informal hearing.
FDA later determines, after finishing the
qualified employee of FDA who is (a) If you appeal the order, you: active investigation of a foodborne
issuing the order. (1) May request an informal hearing;
and illness outbreak, that the outbreak is not
12. Amend 117.257 by revising
(2) Must submit any request for an directly linked to your facility, FDA will
paragraph (d) to read as follows: inform you of this finding, and you may
informal hearing together with your
117.257 Contents of an order to withdraw written appeal submitted in accordance ask FDA to reinstate your exemption
an exemption applicable to a qualified with 117.264 within 10 calendar days under 117.5(a) in accordance with the
facility. of the date of receipt of the order. requirements of paragraph (b) of this
* * * * * * * * * * section.
(d) A statement that the facility must 16. Add 117.287 to subpart E to read 17. Amend 117.305 by revising
either: as follows: paragraph (b) to read as follows:
(1) Comply with subpart C of this part
on the date that is 120 calendar days 117.287 Reinstatement of an exemption 117.305 General requirements applying
that was withdrawn. to records.
after the date of receipt of the order; or
(2) Appeal the order within 10 (a) If the FDA District Director in
* * * * *
calendar days of the date of receipt of whose district your facility is located
(or, in the case of a foreign facility, the (b) Contain the actual values and
the order in accordance with the observations obtained during
Director of the Office of Compliance in
requirements of 117.264.
the Center for Food Safety and Applied monitoring and, as appropriate, during
* * * * * Nutrition) determines that a facility has verification activities;
13. Amend 117.260 by revising adequately resolved problems with the * * * * *
paragraphs (a) and (c) to read as follows: conditions and conduct that are material
18. Add 117.330 to subpart F to read
117.260 Compliance with, or appeal of, to the safety of the food manufactured,
processed, packed, or held at the facility as follows:
an order to withdraw an exemption
applicable to a qualified facility. and that continued withdrawal of the 117.330 Use of existing records.
(a) If you receive an order under exemption is not necessary to protect
public health and prevent or mitigate a (a) Existing records (e.g., records that
117.254 to withdraw an exemption
foodborne illness outbreak, the FDA are kept to comply with other Federal,
applicable to that facility under
District Director in whose district your State, or local regulations, or for any
117.5(a), you must either:
facility is located (or, in the case of a other reason) do not need to be
(1) Comply with applicable
foreign facility, the Director of the Office duplicated if they contain all of the
requirements of this part within 120
of Compliance in the Center for Food required information and satisfy the
calendar days of the date of receipt of
Safety and Applied Nutrition) will, on requirements of this subpart F. Existing
the order; or
his own initiative or on the request of records may be supplemented as
(2) Appeal the order within 10 a facility, reinstate the exemption.
calendar days of the date of receipt of necessary to include all of the required
(b) You may ask FDA to reinstate an information and satisfy the
the order in accordance with the exemption that has been withdrawn requirements of this subpart F.
requirements of 117.264. under the procedures of this subpart as

* * * * * follows: (b) The information required by this
(c) If you appeal the order, and FDA (1) Submit a request, in writing, to the part does not need to be kept in one set
confirms the order, you must comply FDA District Director in whose district of records. If existing records contain
with applicable requirements of this your facility is located (or, in the case some of the required information, any
part within 120 calendar days of the of a foreign facility, the Director of the new information required by this part
date of receipt of confirmation of the Office of Compliance in the Center for may be kept either separately or
order. Food Safety and Applied Nutrition); and combined with the existing records.
Dated: September 16, 2014. reconsideration of the classification of proposed preventive controls rule to our
Peter Lurie, specific activities as harvesting, packing, current thinking on the classification of these
holding, or manufacturing/processing, when on-farm activities as a result of the proposed
Associate Commissioner for Policy and
conducted on farms or on farm mixed-type revisions to the farm definition. As can be
Planning.
facilities (see the discussion of the proposed seen in Table 1, several on-farm activities can
Note: The following appendix will not additional example of a harvesting activity in
be classified in more than one way, and most
appear in the Code of Federal Regulations. the definition of harvesting in section V.C
and the discussion and Table 5 in section of the changes in activity classification
VII.C). Table 1 in this Appendix compares merely reflect additional activities (relative to
Appendix the 2013 proposed preventive controls rule)
the classification of on-farm activities as
The proposed rule that is the subject of this harvesting, packing, holding, or that could be classified in more than one
document includes a discussion of our manufacturing/processing in the 2013 way.
TABLE 1CLASSIFICATION OF ACTIVITIES CONDUCTED ON-FARMS AND FARM MIXED-TYPE FACILITIES
Classification Examples using the 2013 proposed farm Examples using the proposed revisions to the
definition * farm definition
Harvesting: Activities traditionally performed by Cooling RACs. Cooling RACs.

farms for the purpose of removing RACs Fermenting cocoa beans and coffee Field coring RACs ** (new example, not pre-
from growing areas and preparing them for beans ** (would change to holding). viously classified).
use as food. Harvesting does not include ac- Filtering RACs. Filtering RACs.
tivities that change a RAC into processed Gathering RACs. Gathering RACs.
food. Removing stems and husks from RACs. Removing stems and husks from RACs.
Shelling RACs. Shelling RACs.
Sifting RACs. Sifting RACs.
Threshing RACs. Threshing RACs.
Trimming of outer leaves from RACs. Trimming outer leaves from RACs.
Using pesticides in wash water on RACs. Using pesticides in wash water on RACs.
Washing RACs. Washing RACs.
Packing: Placing food in a container other than Coating RACs with wax/oil/resin for the pur- Coating RACs with wax/oil/resin for the pur-
packaging the food and activities performed pose of storage or transport. pose of storage or transport.
incidental to packing a food (e.g., activities Drying RACs for the purpose of storage or Cooling RACs ** (addl classification) ***.
performed for the safe or effective packing of transport ** (would change to only be classi- Filtering RACs ** (addl classification).
that food (such as sorting, culling and grad- fied as holding). Labeling RACs.
ing)), but does not include activities that Labeling RACs. Mixing RACs.
transform a RAC into a processed food. Mixing RACs. Packaging RACs regardless of ownership **
Packaging a farms or farm mixed-type fa- (expanded to include others RACs).
cilitys own RACs ** (would no longer be Putting RACs or individual unit cartons into
limited to own RACs). non-consumer containers.
Putting RACs or individual unit cartons into Removing stems and husks from RACs **
non-consumer containers. (addl classification).
Sorting/grading/culling RACs. Sifting RACS ** (addl classification).
Stickering RACs. Sorting/culling/grading RACs.
Stickering RACs.
Using pesticides in wash water on RACs **
(addl classification).
Washing RACs ** (addl classification).
Holding: Storage of food and activities per- Drying/dehydrating RACs during storage Cooling RACs ** (addl classification).
formed incidental to storage of a food (e.g., (incidental to packing or storing when the Drying/dehydrating RACs (incidental to stor-
activities performed for the safe or effective drying/dehydrating does not create a dis- ing when the drying/dehydrating does not
storage of that food, and activities performed tinct commodity) ** (would no longer be inci- create a distinct commodity).
as a practical necessity for the distribution of dental to packing, would only be incidental Fermenting cocoa beans and coffee beans
that food (such as blending of the same to holding). (change from previous classification as har-
commodity and breaking down pallets)). Fumigating RACs during storage. vesting).
Holding does not include activities that Sorting/culling/grading RACs. Fumigating RACs during storage to control
change a RAC into a processed food. Storing food. pests.
Sorting/culling/grading RACs.
Storing food.
TABLE 1CLASSIFICATION OF ACTIVITIES CONDUCTED ON-FARMS AND FARM MIXED-TYPE FACILITIESContinued
Classification Examples using the 2013 proposed farm Examples using the proposed revisions to the
definition * farm definition
Manufacturing/Processing: Making food from Artificial ripening. Artificial ripening.

one or more ingredients, or synthesizing, Baking. Baking.
preparing, treating, modifying, or manipu- Boiling/Evaporating. Boiling/Evaporating.
lating food, including food crops or ingredi- Bottling. Bottling.
ents. Examples of manufacturing/processing Canning. Canning.
activities are cutting, peeling, trimming, Chopping. Chopping.
washing, waxing, eviscerating, rendering, Coating RACs for purposes other than stor- Coating RACs for purposes other than stor-
cooking, baking, freezing, cooling, pasteur- age/transport. age/transport.
izing, homogenizing, mixing, formulating, bot- Cooking. Cooking.
tling, milling, grinding, extracting juice, dis- Cooling. Cooling.
tilling, labeling, or packaging. For farms and Coring. Coring (except field coring) ** (because field
farm mixed-type facilities, manufacturing/ Cracking. coring would be newly classified as har-
processing does not include activities that Crushing. vesting).
are part of harvesting, packing, or holding. Cutting. Cracking.
Distilling. Crushing.
Drying/dehydrating RACS to create a dis- Cutting.
tinct commodity. Distilling.
Eviscerating. Drying/dehydrating RACs to create a dis-
Extracting. tinct commodity.
Formulating. Eviscerating.
Freezing. Extracting.
Grinding. Formulating.
Homogenizing. Freezing.
Infusing. Grinding.
Irradiating. Homogenizing.
Labeling (other than RACs). Infusing.
Milling. Irradiating.
Mixing. Labeling (other than RACs).
Packaging (other than RACs). Milling.
Pasteurizing. Mixing.
Peeling. Packaging (other than RACs).
Rendering. Pasteurizing.
Roasting. Peeling.
Salting. Rendering.
Slaughtering and post-slaughter operations. Roasting.
Slicing. Salting.
Smoking. Slaughtering and post-slaughter operations.
Sorting, culling, grading (not incidental to Slicing.
packing or holding). Smoking.
Trimming. Sorting, culling, grading (not incidental to
Washing. packing or holding).
Waxing. Trimming.
Washing.
Waxing.
* Examples were included in Table 4, Table 5, and/or Proposed 117.3 and 117.5(g) and (h) in the 2013 Proposed Preventive Controls Rule
and/or in the Draft Risk Assessment (Ref. 1).
** Activities listed in italics represent a change between the 2013 farm definition and our current thinking in light of the proposed revisions to
the farm definition.
*** Addl = additional.
The following reference has been placed on reference is also available electronically at Farm Definition) Conducted in a Facility Co-
display in the Division of Dockets http://www.regulatons.gov. Located on a Farm, 2012.
Management (see ADDRESSES) and may be 1. FDA, Draft Qualitative Risk
[FR Doc. 201422446 Filed 91914; 8:45 am]
seen by interested persons between 9 a.m. Assessment. Risk of Activity/Food
and 4 p.m., Monday through Friday. This Combinations for Activities (Outside the BILLING CODE 416401P

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Department of Health and Human Services

DEPARTMENT OF HEALTH AND Electronic Submissions V. The Farm Definition

Environmental Monitoring in a Final Executive Summary requirements for product testing

Original Total Annualized Costs without

I. Background FSMA enables us to focus more on problems when they do occur. In

TABLE 1PUBLISHED PROPOSED RULES FOR IMPLEMENTATION OF FSMA

Rule 110)) to modernize it; since issuance of the CGMP regulation;

question whether the proposed risk-based preventive controls

produce that an establishment packs intended solely to prepare fish for

displays). Specify that holding facilities could

TABLE 5CHANGES IN CLASSIFICATION OF ACTIVITIES CONDUCTED ON FARMS OR ON FARM MIXED-TYPE FACILITIES

TABLE 5CHANGES IN CLASSIFICATION OF ACTIVITIES CONDUCTED ON FARMS OR ON FARM MIXED-TYPE FACILITIES

Flexibility related to . . . Example

Specifying that a supplier program may be managed at a corporate

TABLE 8PROPOSED EDITORIAL CHANGES

TABLE 8PROPOSED EDITORIAL CHANGESContinued

engaged in the manufacturing, process (such as spent grains, distillers

TABLE 9ESTIMATED POTENTIAL ANNUAL RECORDKEEPING BURDEN

Potential product testing

monitoring written pro-

TABLE 9ESTIMATED POTENTIAL ANNUAL RECORDKEEPING BURDENContinued

Number of Average burden Total operating

Total annual burden

Reporting Burden document to http://www.regulations.gov 4. FDA, Transcript: FSMA Proposed Rules

by Small Children, November, 2006. in section 201(r) of the Federal Food,

material and ingredientssuch as at the controlled. comparable or has determined to be

requirements of 117.264. under the procedures of this subpart as

TABLE 1CLASSIFICATION OF ACTIVITIES CONDUCTED ON-FARMS AND FARM MIXED-TYPE FACILITIES

Harvesting: Activities traditionally performed by Cooling RACs. Cooling RACs.

TABLE 1CLASSIFICATION OF ACTIVITIES CONDUCTED ON-FARMS AND FARM MIXED-TYPE FACILITIESContinued

Manufacturing/Processing: Making food from Artificial ripening. Artificial ripening.

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