Instructions

This tool is laid out in a logical order that answers the following questions you might get from customers:
1. Does FSMA affect me? - FDA Registration tab
2. Are you registered with FDA as a food processor? - FDA Registration tab
3. Do I qualify for exemption?- FSMA, Produce, FSVP (for importers) Exemptions tabs
4. What regulation and audit type applies to me? - Audit Types tab
5. What is my compliance deadline? - Compliance Dates tab

If you work the tabs in this order you should be able to walk the customer through a logical path that will determine
their compliance status, what their compliance deadline is and the appropriate audit tool. Bear in mind that a facility
may be subject to more than one rule and therefore may require more than one readiness assessment.

FDA Registration Screener

Are you already registered with the FDA under the Homeland Security
Act of 2003? Yes Click here to go to the FSMA Exemptions Logic Tree

No

Does one of the following describe your facility?

A domestic or foreign manufacturers or processor You do not need to register with the FDA and do not come under the
No
A domestic or foreign packer FSMA rules
A domestic or foreign storage operation

Yes

Is your facility one of the following?

A Private residence
A Farm*
A Restaurant
A Retail food establishment You do not need to register with the FDA
A Nonprofit food facility in which food is prepared for, or served Yes * Note: A farm may come under the Produce Rule
directly to, the consumer Click here to go to the Produce Exemptions Screener
A Fishing vessel that does not process fish
A Facility regulated exclusively and throughout the entire facility by
the U.S. Department of Agriculture, that is, facilities handling only
meat, poultry, or egg products.

No

You Must Register With the FDA

Click here to go to the FSMA Exemptions Logic Tree
 FSMA Exemptions and Modified Requirements
21 CFR 117 - Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls For Human Food

Are you a small supplier? You are Subject to the Preventive Controls Rule
Fewer than 500 employees Yes but with a later compliance date (2 years after the final rule)
Click here to go to the Audit Types page

No

Are you a very small business?

Less than $1 million in total annual sales of human food plus the
value of food held without sale OR Exempt from hazard analysis and risk-based preventive controls
Food sales averaging less than $500,000 per year during the last Yes when certain documentation is provided
three years AND GMPs Apply
Sales to qualified end-users* must exceed sales to others

No

Do you produce any of the following foods?

Foods subject to HACCP regulations (seafood Part 123 and If you are solely engaged in processing or manufacturing these
juice Part 120) foods, you are exempt
Foods subject to low-acid canned food regulations (only Yes If not, the food you produce that is not covered by these rules will be
microbiological hazards regulated under Part 113) covered by the PCHF Rule
Dietary supplements (Part 111) Click here to go to the Audit Types page
Alcoholic beverages

No

Are you solely engaged in the storage of unexposed packaged food?

GMPs apply
Note: If a warehouse stores exposed food, e.g., apples, iced broccoli Yes
Modified Requirements for refrigerated operations
etc, it comes under PGHF requirements

No

You are Subject to the Preventive Controls Rule

Click here to go to the Audit Types page

Foreign Supplier Verification Program

Coverage and Exemptions/Exclusions for 21 PART 112

Are you an importer as defined under Part 1 subpart L? That is, are See 21 CFR 1.500
you the U.S. owner or consignee of an article of food that is being
offered for import into the United States? Or, if there is no U.S. owner or
consignee of an article of food at the time of U.S. entry, are you the U.S. No FSVP does not apply
agent or representative of the foreign owner or consignee at the time of
entry?

Yes

Do you only import these foods? see 21 CFR 1.501

Fish and Fishery Products (in compliance with part 123), or
certain ingredients for use in fish and fishery products in
compliance with part 123
Juice (in compliance with part 120), or certain ingredients for use
in juice products in compliance with part 123
Food for research or evaluation
Certain alcoholic beverages, or certain ingredients for use in Yes FSVP does NOT apply to these foods.
alcoholic beverages
Certain meat, poultry, and egg products regulated by USDA
Food imported for personal consumption
Food that is transshipped
Food that is imported for processing and export
U.S. food that is exported and returned without further
manufacturing/processing in a foreign country

No

You do not need an FSVP with respect to microbiological hazards for see 21 CFR 1.502(b)
Do you import low acid canned food in compliance with 21 CFR part
Yes that food. Instead, you must verify and document that the food was
113?
produced in accordance with 21 CFR part 113.

No

Are you a receiving facility in compliance with requirements in the see 21 CFR 1.502(c)
Preventive Controls for Human Food or Preventive Controls for Animal
You are deemed in compliance with most aspects of FSVP, but must
food rules related to implementation of preventive controls for the
Yes satisfy the requirement for importer identification at entry.
hazards in the food or supply-chain programs, or are they not required
Click here to go to the Audit Types page
to implement a preventive control under those rules in certain specified
circumstances?

No

You are subject to modified FSVP requirements for those dietary see21 CFR 1.511
Do you import dietary supplements subject to certain dietary
supplements subject to separate, pre-existing Current Good
supplement current good manufacturing practice requirements in 21 Yes
Manufacturing Practices (CGMPs) requirements for dietary
CFR part 111?
supplements.

No

You are subject to modified FSVP requirements. An example of see 21 CFR 1.500 and
Are you a very small importer? For human food, an importer averaging modified requirements for certain importers is that they would not 1.512)
less than $1 million per year during the 3-year period preceding the Yes have to conduct hazard analyses and would be able to verify their
applicable calendar year, in sales of human food combined with the foreign suppliers by obtaining written assurances of compliance.
U.S. market Click here to go to the Audit Types page

No
Do you import food from certain small suppliers (i.e., qualified facilities You are subject to modified FSVP requirements for food from those See 21 CFR 1.512
under PCHF or PCAF, certain farms that are not covered farms under Yes suppliers.
the produce safety regulation, and certain small egg producers)? Click here to go to the Audit Types page

No

You are subject to modified FSVP requirements for food from those see 21 CFR 1.513
Do you import certain food from a country with an officially recognized countries. Includes determining that the supplier is in compliance with
Yes
or equivalent food safety system? U.S. safety regulations or relevant laws in country deemed equivalent.
Click here to go to the Audit Types page

No

You Are Subject to FSVP Requirements

Click here to go to the Audit Types page
 Audit Tools by Facility Type
Processor Processor Warehouse
Applicable Regulation Audit Tool Produce Human Food Animal Food DC Carrier Importer
21 CFR 112 - Standards for the Growing,
Harvesting, Packing, and Holding of Produce FSMA Readiness Assessment - Produce X X3
for Human Consumption
21 CFR 117 - Current Good Integrated Supplier Assurance/HARPC
Compliance Audit
X X
Manufacturing Practice,
Hazard Analysis, and Risk FSMA Readiness Audit for Human Food X X1 X3
Based Preventive Controls for Human Food FSMA Readiness Bolt-On for Human Food X X1

21 CFR 507 - Current Good

Animal Feed and Feed Ingredients CGMP and
Manufacturing Practice,
HARPC Audit Checklist
X4 X
Hazard Analysis, and Risk
Based Preventive Controls for Food for Animals
21 CFR 1.900 - Sanitary Transportation of
Nothing Yet X2 X2 X2 X2 X
Human and Animal Food
21 CFR 1.500 - Foreign Supplier Verification
FSMA Readiness Audit for Importers FSVP X 5
X 5
X 5
X 5
X
Programs for Food Importers
21 CFR 121 - Focused Mitigation Strategies to
Protect Food Against Intentional Adulteration Incorporated into SA Audit
Also a stand-alone audit (?) X X X X X X
(Food Defense)
1 - Modified Requirements
2 - Applies to owned fleet
3 - Used for supplier assessment criteria
4 - Applies if animal feed is produced on-site
5 - Applies if facility is the direct importer of foreign-made products

FSMA Compliance Dates

Final Rule Published

Rule Compliance: General Compliance: Small Compliance: Very Small
Date
1 year after final rule cGMP & PC 18 2 years after final rule 3 years after final rule
PC Human Food Sep 17 2015
months after final rule Supply-Chain* - Fewer than 500 FTE Employees - Less than $1,000,000 annual sales

1 year after final rule cGMP 2 years after final rule cGMP 3 years from final rule cGMP
PC Animal Food Sep 17 2015 3 years after final rule PC 4 years from final rule PC
2 years after final rule PC
- Fewer than 500 FTE Employees - Less than $2,500,000 annual sales
2 years + 60 days from final rule* 3 years + 60 days from final rule*
1 year + 60 days from final rule**
(compliance date applicable to (compliance date applicable to
(compliance date applicable to
Produce Safety Sep 17 2015 sprouts) sprouts)
sprouts)
2 years + 60 days from final rule** 3 years + 60 days from final rule* 4 years + 60 days from final rule*
- Less than $500,000 annual sales - Less than $250,000 annual sales
FSVP Nov 27 2015 18 months from final rule N/A N/A
Sanitary Transport April 6 2016 1 year from final rule 2 years from final rule N/A
- Fewer than 500 FTE Employees
4 years from final rule 5 years from final rule
Food Defense May 27 2016 3 years from final rule
- Fewer than 500 FTE Employees - Less than $10,000,000 annual sales
* Facilities must comply with the PCHF Supply-Chain Program the latter of 3/17/17 for general compliance (9/18/17 for small businesses) or 6 months after a
supplier is required to comply with the applicable rule.
** All farms have an additional 2 years to comply with certain agricultural water requirements.
6 months after the foreign supplier of the food is required to comply with the preventive controls regulations
There is no provision for very small shippers