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FSMA Final Food Safety Rule: Mitigation Strategies to Protect Food against Intentional Adulteration

FDA has finalized a new food safety rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent wide-scale public health harm by requiring companies in the U.S. and abroad to take steps to prevent intentional adulteration of the food supply, including acts of terrorism targeting the food supply.  While such insidious acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

The proposed rule was issued in December 2013 (see our posting about the proposed rule here).  Changes in the final rule, based on consideration of submitted public comments, are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

Under the new rule, for the first time, both domestic and foreign food facilities that are required to register with the FDA under the Federal Food, Drug, and Cosmetic (FD&C) Act must 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.  The rule is designed primarily to cover large companies whose products reach many people. There are some 3,400 covered firms that operate about 9,800 food facilities.

Exempted from the final rule are the following:

  • A very small business. While exempt, the business would be required to provide to FDA, upon request, documentation to demonstrate that the business is very small.
  • The holding of food, except the holding of food in liquid storage tanks.
  • The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact.
  • Activities that fall within the definition of “farm.”
  • Manufacturing, processing, packing, or holding of food for animals.
  • Alcoholic beverages, under certain conditions.
  • On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule.  These foods include certain types of eggs, and certain types of game meats.

Covered facilities now have to identify and implement mitigation strategies to address 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.  The final rule adopts an adaptable approach, akin to HACCP, that permits covered facilities necessary flexibility.  Key components of a facility’s written food defense plan must include:

  • Vulnerability assessment: This is the identification of vulnerabilities and actionable process steps for each type of food manufactured, processed, packed or held at the food facility.
  • Mitigation strategies: These should be identified and implemented at each actionable process step to provide assurances that vulnerabilities will be minimized or prevented.
  • Mitigation strategy management components: Steps must be taken to ensure the proper implementation of each mitigation strategy, including:
    • Monitoring;
    • Corrective actions; and
    • Verification.
  • Training and recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.

Food manufacturers at covered facilities are required to comply with the new regulations within three to five years of May 26, 2016, depending on the size of the business.

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