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

Covered facilities that operate under the Mitigation Strategies to Protect Food Against Intentional Adulteration should be aware of the following changes outlined in the Final Rule.

This final rule is “aimed at preventing international adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.”

Who is covered?

Domestic and foreign companies are required to register as facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.


Exemptions From This rule:

  • Farms
  • Smaller companies
  • Holding of food (save for in liquid storage tanks)
  • Packaging, re-packaging, labeling, or re-labeling of food where the container that directly contacts the food remains intact
  • Manufacturing, processing, packaging, or holding of food for animals
  • Some alcoholic beverages

Similar to the Hazard Analysis Critical Control Point (HACCP) system, the FDA has advanced the safeguards for identification, evaluation, and control of food safety hazards.

Covered facilities are required to implement a food defense plan covering the following:

  • Vulnerability assessment
  • Mitigation strategies
  • Mitigation strategy management components
    1. Monitoring
    2. Corrective actions
    3. Verification
  • Training and recordkeeping

Compliance Dates:

  • Very Small Businesses – a business averaging less than $10,000,000 per year: five years after publication of the final rule.
  • Small Businesses – a business with fewer than 500 persons: four years after publication of the final rule.

Source: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm