With the introduction of the Food Safety Modernization Act (FSMA) of 2011 came the requirement for FDA to write a new regulation to protect the food supply from acts of terrorism. Congress felt that this was necessary after the tragedy of 9/11. FDA published the new rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121) in its final version on May 27, 2016. The regulation, referred to as the “IA Rule”, is designed to protect food from intentional acts of adulteration that are targeted to cause wide-spread public health harm. It requires implementing a HACCP-like system of controls designed to protect vulnerabilities on food processing lines and some storage facilities.
Any facility that is required to register with the FDA must implement the IA rule. Exemptions exist for animal food/feed facilities, alcoholic beverages, farms, very small facilities, activities that fall under the Produce Safety rules, and retail operations.
Companies with 500 or more FTE employees have a compliance date of July 26, 2019; just around the corner! Facilities with less than 500 FTE employees (“Small” size), but more than $10 M in annual sales must comply by July 27, 2020. Very small companies, with less than $10M in annual sales, are exempt from the regulation but must authenticate their sales in writing by July 26, 2021. The FDA recently announced that it will not begin compliance inspections until March, 2020!
The IA rule requires facilities to conduct vulnerability assessments for process lines, establish mitigation strategies for identified significant vulnerabilities, and implement these strategies with monitoring, corrective actions, and verification. A written food defense plan is also requirement, and it must be reanalyzed every 3 years.
Much like the FSMA Preventive Controls for Human Food regulation, the IA rule requires several types of employee training, including Food Safety Awareness Training, and Qualified Individual Training. A Food Defense Qualified Individual is required, who will conduct the vulnerability assessments, identify and explain mitigation strategies, prepare the food defense plan, and reanalysis the food defense plan. This “FD QI” must complete training which uses materials that are recognized by FDA or be qualified by job experience. To date, the FDA has only recognized two online training programs for vulnerability assessments and for mitigation strategies as a standardized curriculums. FSNW has recently developed an in-person course using training materials equivalent to these two recognized curriculums (see below).
To view the IA rule, see: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-mitigation-strategies-protect-food-against-intentional-adulteration . At this same web page, it is possible to also view two guidance documents further defining and explaining the regulation. The most recent guidance has example templates to create a food defense plan (Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry. Revised Draft Guidance, March 2019). FDA also has an online Food Defense Plan builder, but it has become outdated and it actually does not comply with the IA rule requirements!