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FSMA Guidance: Qualified Facility Q&A

FDA issues draft guidance regarding “qualified facilities” under FSMA HARPC framework.

  • In September 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA).  Under both the human food rule and the animal food rule, “qualified facilities” are subject to modified requirements.  A qualified facility is defined as:  (1) a very small business (defined with respect to annual market value of food sold or held); or (2) a facility with average annual sales of <$500,000 over the prior 3-year period and with at least 50% of sales directly to consumers or to local retailers or restaurants (within the same state or within 275 miles of facility).  21 CFR 117.3 (human food); 21 CFR 507.3 (animal food).  Under the modified requirements, a business must submit a form to FDA, attesting to its status as a qualified facility.

  • FDA has now released a draft guidance document intended to assist qualified facilities with HARPC compliance.  The draft guidance takes the form of an FAQ document and addresses how to determine whether a business meets the definition of a “qualified facility.”  The guidance also addresses when to submit the requisite attestation form to FDA, and a companion instructional document details how to obtain, complete, and submit the form (human food or animal food) to FDA.  Qualified facilities generally must submit their first attestation to FDA by December 17, 2018 (for human food) or by December 16, 2019 (for animal food).  Beginning in 2020, facilities must re-submit their attestation to FDA every two years during the food facility biennial registration renewal period (Oct 31-Dec 1).

  • The draft guidance document contains practical and detailed advice with respect to specific questions and issues that facilities may confront as they plan for HARPC compliance, e.g., how to perform the requisite accounting calculations, how to adjust for inflation, how to handle situations in which 3 years of financial records are not yet available, and how to convert foreign financial data into U.S. dollars, among others.  FDA will be accepting comments on the draft guidance until November 14, 2016.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...