Despite the giant piles of rules, summaries, fact sheets, and guidance for the various FSMA rules. FDA didn’t publish a simple list of effective compliance dates for all of the rules until two full rules after the rules took effect. This list is now already out of date.

Further, only a couple months after the fancy PDF was posted several rules have been extended and modified. Ultimately it feels like it takes hours of sleuthing through FDA.gov to find the actual dates at any given moment.

Don’t worry, I’ve got your back; below is a complete list of FSMA compliance dates for all rules all in one place. I’ll keep this updated as FDA continues to extend compliance dates or certain provisions of the rule as I’m made aware of them through FDA/CFSAN updates and communications.

This list is current as of 2/5/2018.

 

 

 

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption – FSMA Final Rule on Produce Safety

 

Rule became effective: 01/26/2016

 

Record Retention Rules

 

• 01/26/2016 All firms

 

General Rule Dates

 

• 01/26/2018: All other businesses Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
• 01/28/2019: Small Businesses Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
• 01/27/2020: Very Small Businesses Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but no more than $250,000 (very small businesses).

 

Activities involving sprouts covered under subpart M

 

• 01/26/2017: All other businesses
• 01/26/2018: Small businesses
• 01/28/2019: Very Small Businesses

 

Specified Agricultural Water Requirements under subpart E

 

Note: FDA has proposed extending these dates  . If the rule passes, the years will reset to 2022, 2023, 2024.

 

• 01/27/2020: All other businesses
• 01/26/2021: Small businesses
• 01/26/2022: Very Small Businesses

 

Written Assurance Requirement

 

• Compliance dates have been extended for all rules. No produce safety rules relying on written assurance that a customer is controlling a hazard is required until 2019 for all other businesses subject to the sprout rule. All other dates are 2020 and beyond.
• Note: FDA is currently using enforcement discretion for this requirement depending on individual supplier flexibility.

 

 

 

 

Current good manufacturing practices and hazard analysis and risk-based preventive controls for human food – HARPC Rule

 

Rule became effective: 11/16/2015

 

General Rule Dates

 

• 09/19/2016: All other businesses
• 09/18/2017: Small businesses (businesses with fewer than 500 full-time equivalent employees)
• 09/17/2018: Very small businesses (businesses averaging less than $1 million per year (adjusted for inflation) in annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale)
• 09/17/2018: Dairy Facilities subject to the Pasteurized Milk Ordinance
• Facilities that only pack or hold raw agricultural commodities that are produce and/or nut hulls and shells have had their HARPC compliance date pushed out to match the compliance date with the produce rules above. FDA has extended this policy to secondary activites farms and coloring farms that may be subject to the rule.

 

Written Assurance Requirement

 

• Compliance dates have been extended for all rules. HARPC for human food had 2 years added to all compliance dates. Earliest being large facilities on 09/19/2018.
• Note: FDA is currently using enforcement discretion for this requirement depending on individual supplier flexibility.

 

Enforcement Discretion

 

• Note that FDA is currently using enforcement discretion on these dates for activities that are “Farm Related”.

FARM-RELATED ACTIVITIES: These are activities within the definition of “farm”
if performed on farms. These activities include growing and harvesting crops and
some manufacturing/processing activities: drying/dehydrating raw agricultural
commodities (RACs) to create a distinct commodity, treating RACs to manipulate
ripening, and packaging and labeling RACs.

• Note that FDA is currently using enforcement discretion on these requirements for human food byproducts that have been marked for use as animal food and undergo further processing at the same manufacturer.

Since issuing that guidance, the FDA has become aware of concerns about how the
preventive controls requirements apply to certain activities performed on human food
by-products for use as animal food before they are stored or transported and which
do not affect their safety profile.
The agency intends to exercise enforcement discretion for the following activities:
• Drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce
weight, bulk, or volume and/or
• Mixing, centrifuging, and similar activities to combine ingredients or separate components
(e.g., water and solids).
This enforcement discretion does not apply when these activities are performed to prevent
or significantly minimize animal food hazards, or when these activities introduce animal
food hazards.

 

 

 

Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – Animal food HARPC Rule

 

Rule became effective: 11/16/2015

 

Compliance with the CGMP portion of the rule

 

• 09/19/2016: All other businesses
• 09/18/2017: Small businesses (businesses with fewer than 500 full-time equivalent employees)
• 09/17/2018: Very small business (a business averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale)

 

Compliance with the Preventive Controls portion of the rule

 

• 09/18/2017: All other businesses
• 09/17/2018: Small businesses (businesses with fewer than 500 full-time equivalent employees)
• 09/17/2019: Very small business (a business averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale)

 

Cotton ginning facilities providing products for use as animal food

 

• An additional 16 month extension may be applied to the deadlines above, the earliest being 01/28/2019 for the PC portion of the rule in large facilities

 

Written Assurance Requirement

 

• Compliance dates have been extended for all rules. HARPC for animal food had 2 years added to all compliance dates. Earliest being large facilities on 09/18/2019
• Note: FDA is currently using enforcement discretion for this requirement depending on individual supplier flexibility.

 

 

 

Food Supplier Verification Programs (FSVP) for importers of food for humans and animals

 

Rule became effective: 01/26/2016

 

General Rule Dates

 

• 05/30/2017 For importers of food that isn’t subject to the HARPC or produce safety rules
• 07/26/2017 If the rules below aren’t applicable

 

Importer of food that is subject to the HARPC rule for human food:

 

• 05/30/2017 for all other foreign suppliers.
• 03/19/2018 for foreign suppliers that are small businesses
• 03/18/2018 for foreign suppliers that are very small businesses or that are qualified facilities as defined in 21 CFR 117.3
• 03/18/2019 for foreign suppliers that are subject to the Pasteurized Milk Ordinance

 

Importer of  food that is subject to the CGMP requirements of the HARPC Requirements for animal foods

 

• 05/30/2017 for all other foreign suppliers
• 03/19/2018 for foreign suppliers that are small businesses
• 03/18/2019 for foreign suppliers that are very small businesses or that are qualified facilities as defined in 21 CFR 507.3

 

Importer of food that is subject to the PC requirements of the HARPC Requirements for animal foods

 

• 03/19/2018 for all other foreign suppliers
• 03/18/2019 for foreign suppliers that are small businesses
• 03/17/2020 for foreign suppliers that are very small businesses or that are qualified facilities as defined in 21 CFR 507.3

 

Importer of food that is subject to the produce safety rule

 

• 07/26/2018 for all other foreign suppliers
• 07/29/2019 for foreign suppliers that are small businesses as defined in 21 CFR 112.3
• 07/27/2020 for foreign suppliers that are very small businesses as defined in 21 CFR 112.3

 

Importer of food that is subject to the produce safety rule provisions for sprouts

 

• 07/26/2017 for all other foreign suppliers
• 07/26/2018 for foreign suppliers that are small businesses as defined in 21 CFR 112.3
• 07/29/2019 for foreign suppliers that are very small businesses as defined in 21 CFR 112.3

 

Written Assurance Requirement

 

• Compliance dates have been extended for all rules. FSVP had 2 years added to all compliance dates. Earliest being large facilities selling human food on 05/30/2019
• Note: FDA is currently using enforcement discretion for this requirement depending on individual supplier flexibility.

 

Enforcement Discretion

 

Note that FDA is currently using enforcement discretion on these dates for products that are food contact substances.

After considering the issue, including comments and information provided by stakeholders,
the FDA has determined that because of certain characteristics related to the nature of food
contact substances, FDA’s premarket review and oversight of food contact substances, and
the regulatory framework for these substances, it is appropriate to exercise enforcement
discretion with regards to the FSVP regulation. In other words, FDA does not intend to
require importers of food contact substances to comply with the requirements of FSVP.

 

 

 

Mitigation strategies to protect food against intentional adulteration

 

Rule became effective: 07/26/2016

 

General Rule Dates

 

• 07/26/2019 All other businesses
• 07/26/2021 Very Small Businesses—a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee)
• 07/26/2020 Small Businesses—a business employing fewer than 500 persons

 

 

 

Sanitary Transportation of Human and Animal Food

 

Rule became effective: 04/06/2016

 

General Rule Dates

 

• 04/06/2018 Small businesses – businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after the publication of the final rule
• 04/06/2017 Other Businesses – a business that is not small and is not otherwise excluded from coverage

 

FF&F note: It seems that FDA is tacking on inspection of this rule to normal inspection activities.