• On May 16, 2016 (81 FR 30219), FDA issued a draft guidance document intended to assist “qualified facilities” comply with modified requirements under the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA). 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. (See previous blog coverage here.)
  • On September 14, 2018, FDA announced the availability of the finalized guidance document titled Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food And Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. (See also 83 Fed. Reg. 46878, September 17, 2018.) FDA concurrently announced the release of the required attestation forms, Form FDA 3942a for facilities subject to the PC Human Food rule, and Form FDA 3942b for facilities subject to the PC Animal Food Rule, along with instructions on how to fill them out and how they should be submitted.
  • Changes to the guidance were minor and include: (1) clarification regarding recordkeeping and FDA review of records, (2) clarification regarding how a facility can meet the definition of a “very small business,” (3) addition of new examples of calculations, and (4) explanation of a simpler method for determining whether a facility’s 3-year average of food sales and food market value is below the inflation adjusted threshold for a “very small business.”
  • The dates for submitting an attestation to FDA have not changed. Facilities subject to the PC Human Food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018. Facilities subject to the PC Animal Food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019. Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.