On May 13, FDA announced the publication of a draft guidance to assist “qualified facilities” (i.e., very small or low-grossing businesses) in complying with the Preventive Controls for Human or Animal Food Rules (PC Final Rules) under the FDA Food Safety Modernization Act (FSMA) (Draft Guidance). 1,2
The Draft Guidance explains how to determine whether a business meets the definition of “qualified facility” and how to comply with the requirement to submit documentation to FDA that attests to its status as a qualified facility.3 Importantly, a business that meets the definition of a “qualified facility” is subject to modified (i.e., less stringent) requirements under 21 C.F.R. § 117.201 (Human Food) or 21 C.F.R. § 507.7 (Animal Food). The modified requirements require a company to annually submit a form to FDA that attests to the company’s status as a qualified facility, as well as maintain the records relied upon to support such attestations.
Among numerous other requirements, the PC Final Rules establish requirements for qualified facilities that produce food for humans and animals to conduct hazard analysis and risk-based preventive controls. Section II of the Draft Guidance provides definitions, calculations, other questions, and examples of calculations to determine whether a facility meets the definition of “qualified facility” under the PC Final Rule for Human Food, and how to submit Form FDA 3942a to attest to its status as a qualified facility. Similarly, section III of the Draft Guidance explains the definitions, calculations, other questions, and examples of how to determine whether a company meets the definition of “qualified facility” under the PC Final Rule for Animal Food, and how to submit Form FDA 3942b to attest to its status as a qualified facility.
Comment Period
Comments on the Draft Guidance should be submitted to Docket No. FDA-2016-D-1164 and are due 180 days after its publication in the Federal Register (May 16, 2016). For assistance with submitting comments to the Docket, please contact the author of this post.
1See CFSAN Constituent Update: FDA Issues Draft Guidance for Qualified Facilities under the FSMA Preventive Controls Rules (May 13, 2016) http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm499545.htm.
2FDA Draft Guidance for Industry, Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) (May 2016) http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM499509.pdf; see also 21 C.F.R. §§ 117.201; 507.7.
3The attestation should include either (i) identification of potential hazards associated with the food being produced, implemented preventive controls to address the hazards, and monitoring of the performance of the preventive controls to ensure that such controls are effective; or (ii) that the facility is in compliance with state, local, county, tribal, or other applicable non-federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a state department of agriculture), or other evidence of oversight. 21 C.F.R. §§ 117.201(2).