FDA Issues Final Food Defense Regulation

The FDA has finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply.

While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to 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.

Who is covered?

With some exceptions listed below, this rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act. This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. There are 3,400 covered firms that operate 9,800 food facilities. However, it does not cover farms.

Key Provisions

While this is the first time that companies are required to create a food defense plan, the FDA has taken an approach similar to Hazard Analysis Critical Control Point (HACCP) system, an approach adopted by industry for the identification, evaluation and control of food safety hazards. The FSMA rules advance and strengthen those safeguards.

1. Vulnerability assessment
2. Migration Strategies
3. Training and record keeping

Compliance Dates

This rule is a first of its kind, so education and outreach is critical. Additionally, FDA recognizes that many of the food facilities covered by this rule will also be meeting the requirements of other FSMA rules. Therefore, FDA is providing a longer timeline in the final rule for facilities to comply with the intentional adulteration rule.

1. Very Small Businesses
2. Small Businesses
3. Other Businesses