Summary: Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule)

FDA is requiring domestic and foreign human food facilities to address hazards that may be introduced with the intention to cause wide scale public health harm. This rule requires human food facilities that are required to register and that are part of businesses with more than $10 million in annual sales, to create a food defense plan, identify actionable process steps, implement mitigation strategies and related food defense monitoring, corrective actions, and verification activities to protect these steps, train designated employees, and document these actions.

Regulatory Impact Analysis

Mitigation Strategies to Protect Food Against Intentional Adulteration (PDF - 308KB)

Federal Register: 81 FR 34165, May 27, 2016

Docket: FDA-2013-N-1425