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Draft Guidance Clarifies Number of Employees that Constitute a Small Business

Monday, March 26, 2018

(North American Meat Institute)

The Food and Drug Administration (FDA) issued draft guidance for industry describing how to determine the number of employees for purposes of the “small business” definition in the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for human and animal food rules. Certain small businesses are exempt from the human food preventive controls requirements and the animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Small businesses also have more time than larger businesses to comply with the final rules. Comments on the draft guidance will be accepted through May 21, 2018.

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