FDA Releases Final Installment of FSMA Intentional Adulteration Guidance; Inspections Start (Gulp) Next Month

February 19, 2020By Karin F.R. Moore

On February 13, the FDA released the final installment of guidance to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The FSMA final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May 2016. The rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. This latest draft guidance adds to the draft guidance previously published in March 2019. The latest chapters cover the following topics:

  • Chapter 5: Food Defense Corrective Actions
  • Chapter 6: Food Defense Verification
  • Chapter 7: Reanalysis, and
  • Chapter 9: Recordkeeping

It also includes appendices on FDA’s mitigation strategies database and how businesses can determine their status as a small or very small business under the rule.

The initial draft guidance included chapters on:

  • the components of the food defense plan;
  • how to conduct vulnerability assessments using the key activity type method;
  • how to identify and implement mitigation strategies; and
  • food defense monitoring requirements.

As a reminder, compliance requirements for large facilities under the IA Rule began in July 2019, but the FDA delayed enforcement of the Rule until March 2020. The IA Rule generally applies to food facilities that are required to register with the FDA, absent an exception. Both domestic and foreign companies who sell product in the U.S are affected.