Today, the FDA released the first of three installments of a draft guidance document designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The remaining two installments are expected to come out later this year.

The FSMA final rule on intentional adulteration 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. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date for the largest facilities arrives in July 2019.

This first part of the draft guidance includes chapters on: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.

The second installment will focus more specifically on vulnerability assessments and training requirements, with the third including greater detail on corrective action, verification, reanalysis, and recordkeeping requirements.

This draft guidance, in its entirety, is intended to be a resource that will help the food industry implement the IA provisions in a flexible and cost-effective manner. To further assist and engage stakeholders, FDA will announce plans to hold a public meeting on the draft guidance when the second installment is released later this year. All three parts will be available for public comment upon release.

For More Information

• Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply
• Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry (Draft)
• FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration