FSMA's Final Rule On Food Defense: What You Need To Know

By Jennifer McEntire and Warren Stone, the Grocery Manufacturers Association

The FDA has released a pre-publication version of the last of the major FSMA rules: Mitigation Strategies to Protect Food Against Intentional Adulteration. The objective of the rule is to thwart an intentional attack on the food supply that results in widespread public health harm, whether conducted by an outsider, or someone within your facility such as a disgruntled employee.

The final rule, which was released ahead of schedule on May 26, provides an appropriate level of flexibility to firms required to develop and implement food defense plans, compared to the rule as initially proposed.

The types of facilities required to comply are limited compared to the other FSMA related rules; the Intentional Adulteration rule only applies to facilities manufacturing human food. Manufacturers of food for animals other than humans are exempt — as are farms, warehouses, and holding facilities. Further, the cutoff for a “very-small business” is $10 million, and these businesses are generally exempt, other than a requirement for documentation indicating they are indeed very-small businesses.