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FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food

  • The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by FDA under 21 C.F.R. Part 117 and Part 507, respectively.  Meeting the “small business” definition has two main implications: (1) Certain small businesses (i.e., “farm mixed-type facilities”) are exempt from the human and animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations, and (2) Small businesses have later compliance dates for parts 117 and 507.

  • As previously reported on this blog, FDA released draft guidance on March 19, 2018 for determining the number of employees for purposes of meeting the “small business” definition under parts 117 and 507.  Notably, some compliance dates applicable to small businesses have not yet passed, such as the September 18, 2019 and September 17, 2020 extended compliance dates for written assurances in the customer provisions in 21 C.F.R. §§ 117.136(a)(2)(ii), (3)(ii), and 4(ii) and 507.36(a)(2)(ii), (3)(ii), and 4(ii), respectively.

  • With a June 21, 2019 notice, FDA released its final guidance on determining the number of employees under the “small business” definition.  Having received no substantive comments on the March 2018 draft guidance, FDA made only editorial changes to improve clarity and revised one example to make it more useful.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 175


About this Author

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...