Federal Register publications available for final rules to implement FSMA HARPC provisions for human and animal food.

  • On September 10, 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA).
  • On September 17, 2015, the final rules were published in the Federal Register.
    • Click here for the Federal Register publication of the final human HARPC rule (80 Fed. Reg. 55908).
    • Click here for the Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170).
  • Companies generally must comply with the requirements of the human HARPC rule by September 19, 2016.  For the animal HARPC rule, companies generally must comply with the Current Good Manufacturing Practice (CGMP) requirements by September 19, 2016, and with the HARPC requirements by September 18, 2017.  Both rules provide later compliance dates for small and very small businesses, for certain types of facilities (e.g., qualified facilities, facilities subject to the Pasteurized Milk Ordinance (for human HARPC rule)), and for certain provisions (e.g., the supply-chain program).  Additional detail regarding compliance dates is available on page 56128 of the preamble to the human HARPC rule and on page 56329 of the preamble to the animal HARPC rule.

Keller and Heckman LLP is preparing full analyses of both final rules and will host a complimentary webinar in the near future to summarize the implications of these rules for the food industry, focusing on both food processors and ingredient suppliers.