FDA issues HARPC Draft Guidance and delays compliance dates for several key FSMA provisions.

  • FDA issued a final rule today that extends and clarifies the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  These changes are intended to address concerns about the practicality of compliance with certain provisions, better align compliance dates across the rules, and address technical issues.
  • The implicated rules are: (1) Preventive Controls for Human Food Rule, (2) Preventive Controls for Food for Animals Rule, (3) Produce Safety Rule, and (4) Foreign Supplier Verification Programs (FSVP) Rule.
  • Highlights of the final rule include:
    • extending the compliance dates with respect to “customer provisions” that apply when a manufacturer/processor identifies a hazard requiring a preventive control, does not control the identified hazard, and relies on an entity in its distribution chain to address the hazard; the earliest compliance date is September 19, 2018.
    • additional time for importers of food contact substances to comply with the FSVP rule; the earliest compliance date is May 28, 2019.
    • additional time for facilities that are covered by the two Preventive Controls rules for human and animal food (including CGMPs), and are solely engaged in packing and/or holding produce raw agricultural commodities; compliance dates for these entities are extended to align with the Produce Safety Rule.
  • For a detailed summary of the final rule extending compliance dates, please feel free to contact us at: fooddrug@khlaw.com.
  • Finally, FDA has also published a Draft Guidance concerning Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food.  The Draft Guidance, which is available for public comment starting today, August 24, 2016, explains FDA’s current thinking on how to comply with certain of the requirements for hazard analysis and risk-based preventive controls and specifically addresses how food producers should go about developing an appropriate food safety plan.  The deadline for comments is February 21, 2017.
  • Keller and Heckman is currently working on a detailed summary of the Draft Guidance.  In the meantime, interested parties may contact us for a copy of the summary and may email us at fooddrug@khlaw.com with any questions regarding the implications of FDA’s Draft Guidance.