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FDA Issues Guidance on Small Business Definition for Food Preventive Controls Rules

The Food and Drug Administration finalized a guidance document on the definition of “small business” under Food Safety Modernization Act regulations on preventive controls for human food and animal food. Under those regulations, small businesses are defined as any businesses,…

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including subsidiaries and affiliates, that employ fewer than 500 full-time-equivalent employees at all facilities. Small businesses have later compliance dates for the preventive controls regulations, and in some cases may be exempt if they meet the definition of “farm mixed-type facilities.” The guidance details how to determine a company’s number of full-time-equivalent employees, including at affiliates and other facilities, and how small businesses are affected by the preventive controls regulations.