FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

FDA has released a helpful and user friendly Food Safety Modernization Act (FSMA) compliance date webpage to assist farmers, manufacturers of food and food products, and other stakeholders.[1]  The webpage includes deadlines for the following rules:

  • Produce Safety (21 C.F.R. Part 112),
  • Preventive Controls for Human Food (21 C.F.R. Part 117),
  • Preventive Controls for Animal Food (21 C.F.R. Part 507),
  • Foreign Supplier Verification Program (21 C.F.R. Part 1, Subpart L),
  • Intentional Adulteration (21 C.F.R. Part 121), and
  • Sanitary Transportation of Human Food (21 C.F.R. Part 1, Subpart O).

As part of the compliance date guidance, FDA also provides a one-page user friendly “FSMA Final Rules: Key Dates” graphic.  As a courtesy, here is a link a copy of the graphic.

Overall, the guide is very useful, particularly for those entities that require compliance with one or more of the FSMA Rules. The webpage provides easy to access information regarding compliance date exceptions, which largely depend on the size and/or business type of the entity.  For example, the website allows easy comparison of the definition of a “very small business,” all of which include revenue thresholds that differ substantially depending on the applicable rule:

  • Preventive Controls for Human Food – less than $1 million per year,
  • Preventive Controls for Animal Food – less than $2.5 million per year,
  • Produce Safety – at least $25,000, but not more than $250,000 per year, and
  • Intentional Adulteration – less than $10 million per year.

In addition, the webpage includes up-to-date compliance dates.  Many of the FSMA Rules’ compliance dates have been extended-and, therefore the compliance dates in each Final Rule, as published in the Federal Register, are no longer accurate. 

Although there are no upcoming compliance dates remaining in 2017, there are a total of 14 separate compliance dates under all rules, except for Intentional Adulteration. Some significant compliance dates include:

  • January 26, 2018 – Large Farms must comply with Produce Safety (except certain water requirements).
  • March 19, 2018 – Foreign Supplier Verification requires an importer of human food or animal food to verify its suppliers’ compliance with any applicable Preventive Controls Rule.

September 17, 2018 – Qualified facilities (including very small businesses) are required to comply with Preventive Controls for Human Food.

[1] FDA, CDRH, “Food Safety Modernization Act: Compliance Dates” (last updated Oct. 23, 2017), available at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm540944.htm

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