On July 15, 2020, the FDA announced that routine inspections of small businesses (those with fewer than 500 employees) to verify compliance with the Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) Rule will begin in March 2021. The compliance date is July 27, 2020.

The IA Rule is intended to prevent the adulteration of the food supply by intentional acts designed to cause wide-spread harm to the food supply and the public health (i.e. acts of terrorism). The rule generally applies to domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic Act (the rule does not cover farms) and, in an approach similar to the Hazard Analysis Critical Control Point (HACCP) system, requires that covered facilities develop a food defense plan. In particular, the rule requires:

• Vulnerability identification: At every step in their food production process, covered facilities must evaluate 1) the severity and scale of the potential impact on public health, 2) the degree of physical access to the product, and 3) the ability to successfully contaminate the product;
• Identification and implementation of mitigation strategies: At each step, vulnerabilities must be addressed with mitigation strategies tailored to the facility and its procedures. The implementation of these strategies must be monitored, with corrective actions taken where appropriate. Further monitoring and corrective actions should be subject to review by verification activities.
• Training and record keeping: Personnel in vulnerable areas must receive proper training and facilities must maintain records of food defense monitoring, corrective actions, and verification activities.

While inspection for large businesses under the IA rule was scheduled to begin in March 2020, COVID-19 has thus far delayed the start of routine inspections under the IA Rule (for recent news regarding resumption of certain domestic food facility inspections, see Keller and Heckman’s coverage here). When inspections under the IA rule begin, they will occur during regularly scheduled food safety inspections and will consist of “quick checks” that will ensure that the basic requirements of the rule have been met and will also give FDA an opportunity to educate covered facilities regarding implementation of a food defense plan.  Keller and Heckman will continue to monitor updates on the IA Rule and the resumption of food facility inspections.