The final rule of the FDA’s Food Safety Modernization Act (FSMA) is intended to prevent the intentional tampering with acts intended to cause large-scale public health harm, including acts of terrorism directed at the food supply. Such acts, while unlikely to occur, could cause illness, death, or economic disruption of the food supply in the absence of mitigation strategies.

In developing the rule, FDA interacted with the intelligence department and considered vulnerability assessments conducted in collaboration with the food industry. While acts of intentional adulteration can take many other forms, including acts by disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause large-scale harm. Economic adulteration is addressed in the final rules of preventive controls for food and feed.

All facilities must ensure that personnel assigned to vulnerable areas receive appropriate training; facilities must maintain records of food defense monitoring, corrective actions, and verification activities. Each covered facility is required to prepare and implement a food defense plan. This plan must be in writing and identify vulnerabilities and process steps, mitigation strategies and procedures for food safety monitoring, corrective actions and verification. Compliance requirements for large facilities began in July 2019, and inspections will begin in March 2020.