Food Defense Training and the New “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” Rule
On May 27, 2016, the U.S. Food and Drug Administration (FDA) finalized a new food safety rule entitled “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” under the landmark FDA Food Safety Modernization Act. As such, food defense under FDA has now moved from a voluntary program to a mandated requirement for many food establishments. However, most of the larger food wholesalers have already established active food defense programs to protect their brand as well as to meet third-party audit requirements. The regulated industry may also look beyond the rule requirements for additional measures that may afford another layer of protection. A strong cost-benefit analysis before initiating any elective measures is essential. Within this article, the importance of food defense and awareness training, those training requirements found in the new FDA rule, and information that should be helpful in a cost-benefits analysis when considering training beyond the Rule requirements will be discussed.
While the scope of this article does not permit going through each of the new rule requirements in detail, a discussion of FDA’s overall approach to the rules and an assessment of the approach with regard to protecting against intentional adulteration will provide context as well as a starting point for rethinking training and enhancing your company’s food defense program.
Rule Summary
Overall, this rule will help to prevent wide-scale public health harm by requiring certain food companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply.
FDA decided to regulate food defense similar to a Hazard Analysis and Critical Control Points (HACCP) system, which has widespread usage by food processors. While the rule has similarities to HACCP, the rule also takes some different approaches by virtue of its focus on intentional contamination/adulteration of food product verses our historical focus of unintentional contamination/adulteration. For example, instead of identifying hazards as in HACCP, firms will identify vulnerabilities. Within this new rule, as with HACCP and the Preventive Controls for Human Food rule, monitoring, corrective action, verification and periodic reanalysis of the plan is required.
Under the new rule, for the first time, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate adulteration where the intent is to cause wide-scale public health harm. Regulated facilities now must identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records. Generally, a reanalysis is required every 3 years unless other certain criteria are met.