FDA Issues FSMA Preventive Controls Guidance for Small Businesses

FDA Issues FSMA Preventive Controls Guidance for Small Businesses

October 31, 2016

The U.S. Food and Drug Administration (FDA) today issued small entity compliance guidances 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).

The guidances are two of dozens of guidance documents the FDA intends to release as it continues with the implementation of FSMA. The agency released guidance for both the human and animal food rules in August 2016.