FDA Issues FSMA Preventive Controls Guidance for Small Businesses

Nov 17, 2016 | Amy Chang

The Food and Drug Administration (FDA) issued small entity compliance guidance under the FDA Food Safety Modernization Act (FSMA) to assist small and very small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules.

  • Small businesses, those with fewer than 500 full-time employees, must comply with the human and animal food rules by September 18, 2017.
  • Very small businesses, generally those averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales, are required to maintain records supporting Qualified Facility status as of January 1, 2016.
  • Qualified facilities need to come into compliance with the human and animal food rules by September 17, 2018.

The guidance outlines who must comply with the rule, who is exempt from parts of the rules or subject to modified requirements, and outlines key information for qualified facilities (i.e., small businesses).

For more information, go to:


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