COLLEGE PARK and ROCKVILLE, Md. — The US Food and Drug Administration (FDA) issued draft guidance to clarify the number of employees that determine a “small business” for the agency’s implementation of the Food Safety Modernization Act (FSMA).

Such implementations are stated in Title 21 of the Code of Federal Regulations, parts 117 and 507. Part 117 is directed to human food manufacturers and part 507 for animal food producers.

Part 507 of 21 CFR “created new animal food CGMP and preventive controls requirements for domestic and foreign facilities that are required to register under section 415 of the Food, Drug and Cosmetic Act,” according to the FDA, and provided requirements for establishing and maintaining hazard analysis and risk-based preventive controls.

The FDA defines a “small business” as one employing less than 500 full-time equivalent employees across the entire company, including all locations, subsidiaries and affiliates. The agency provides a detailed explanation on how to correctly calculate the number of full-time equivalent employees.

Farm mixed-type animal food manufacturers deemed as “small businesses” are exempt from animal food preventive controls requirements, which are listed in 21 CFR, part 507, subparts C and E, but only if the facility conducts only low-risk activity or food combinations [21 CFR 507.5(e) and (f)].

Compliance dates for “small businesses” are staggered, according to the FDA. They are Sept. 18, 2017 for CGMP requirements and Sept. 17, 2018 for animal food preventive controls requirements.

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