In February 2020, the FDA released a supplemental draft guidance for the Intentional Adulteration Rule. This was the last in three sections of the guidance to be released, and completes the document. The following is a brief summary of this portion of the draft guidance:
The supplemental draft guidance issued in February 2020 completes the IA guidance. Clerically, it fills in chapters missing from the previously published guidance, for chapters 5, 6, 7 and 9 along with some related Appendix.
The guidance will be pretty familiar to those familiar with food safety plans, covering the remaining management components for Mitigation Strategies; the corrective actions, and verification. Also new to this issue are the reanalysis components required for the Food Defense Plan. The management component for monitoring was already covered in the previously published guidance.
Taken together with the previously published guidance, you may notice that there is no validation requirement, such as validating that a kill step will actually result in a pathogen reduction. The Mitigation Strategies intended in the IA rule focus more on design and behaviors that will mitigate significant vulnerabilities, such as limiting access, so no scientific proof like validation is required. The verification requirements are more flexible and less resource intensive.
Similar to a food defense plan, these management components will have two aspects. There is planning for the management components that appear in the food defense plan (monitoring, corrective action and verification). There is also the documentation when you perform those same management components, such as each time you execute a corrective action.
The reanalysis requirements are quite similar to what you would find in a HACCP or Preventive Controls Plan. However the minimum reanalysis is less frequent, at 3 years. You also have to perform at least a partial reanalysis when there are significant changes in activities or new information about potential vulnerabilities or when there is improper implementation, as well as when it is requested (required) by FDA. These would all be similar to a Preventive Controls plan.