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FDA Amends FSMA Rules for FSVP and HARPC for Human and Animal Food

The U.S. Food and Drug Administration (FDA) issued supplements to its 2013 proposed rules to implement the "Hazard Analysis and Risk-Based Preventive Controls" (HARPC) and the "Foreign Supplier Verification Program" (FSVP) provisions of the Food Safety Modernization Act (FSMA). The proposed supplements do not make significant changes to the originally proposed rules and have little direct impact on food-contact substances, though several provisions are mentioned.

The proposed HARPC rules for human and animal foods were announced on January 16, 2013 (78 Fed. Reg. 3646) and October 29, 2013 (78 Fed. Reg. 64425), respectively. The supplements were published on September 29, 2014 (See 79 Fed. Reg. 58524 and 79 Fed. Reg. 58476).

Changes in both HARPC for Human Food and HARPC for Food for Animals include changes to the definition of "farm" to include packaging and holding facilities. The proposed supplements also change the term "hazard reasonably likely to occur" to "significant hazard" for which a personal knowledgeable about safe manufacturing, processing, and packing would establish risk mitigation standards.

Specific provisions in the Animal HARPC for frequent cleaning of food-contact surfaces were removed in the supplement, but general safety requirements for food-contact articles still are required. The supplement also includes direct provisions for dry-food processing. Additionally, the supplement proposes that human food by-products held for distribution without further manufacturing as animal food, must be stored to prevent contamination. Shipping containers that hold animal food must be inspected to ensure the food will not be contaminated.

A detailed summary of the proposed rule was published on on February 14, 2013. Comments on the proposed supplement are due December 15, 2014. FDA intends to comply with its court-imposed deadline to issue the final HARPC rule by August 30, 2015.

The proposed "Foreign Supplier Verification Program" (FSVP) rule was published on July 29, 2013 (78 Fed. Reg. 45730) and the proposed supplement was published on September 29, 2014 (79 Fed. Reg. 58574). As with HARPC, the proposed supplement does not contain significant changes to the original proposed rule, though FDA did propose harmonization of HARPC and FSVP. In the supplement, FDA says importers that are in compliance with HARPC will be deemed to be compliant with most of the FSVP program requirements. The revised rule does not explicitly exclude food-contact materials from the FSVP, a continuing point of concern for industry. Further information on the FSVP is available at

Comments on the proposed supplement for the FSVP rule are due December 15, 2014. FDA intends to comply with its court-imposed deadline to issue the final FSVP rule by October 31, 2015.