FDA Publishes First of Three Installments of IA Rule Draft Guidance

On June 19, FDA recently issued a draft guidance document designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act. As discussed in a statement from FDA Commissioner Scott Gottlieb, the likelihood of an incident at a particular facility is low, but the intentional adulteration of the U.S. food supply represents a very serious threat – one that could have devastating public health consequences. 

To comply with the rule, food facilities covered by the IA rule will be required to develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies for those vulnerabilities. They must also ensure that the mitigation strategies are working. Thus, FDA is releasing draft guidance on the IA rule in a three-part series.

1. This first installment focuses on the components of the food defense plan; how to conduct vulnerability assessments using the key activity type method and how to identify and implement mitigation strategies and food defense monitoring requirements.
2. The second and third installments are intended to follow later this year. In the second draft guidance, FDA will focus on a vulnerability assessment approach that can be more tailored to a facility; it also will provide guidance on training requirements for a food facility’s employees.
3. The third guidance will provide greater detail on how to take corrective action; how to verify that a facility’s system is working; food defense plan reanalysis requirements and record-keeping requirements.

For more information, see Gottlieb’s statement and the draft guidance.