May 27, 2020
Flexibility set regarding criteria for exemption under Produce Safety Rule

The U.S. Food and Drug Administration announced May 22 that it will provide flexibility regarding eligibility criteria for the qualified exemption under the Produce Safety Rule during the COVID-19 public health emergency.

Under the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule, farms are eligible for a qualified exemption and associated modified requirements if they meet certain criteria:

  • The farm’s food sales averaged less than $500,000 (adjusted for inflation) per year during the previous three years; and
  • The average value of the farm’s sales to qualified end-users exceeded the average value of the farm’s sales to all others during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.

Because of COVID-19, state and local governments across the United States have instituted public health orders that have resulted in many restaurants and retail food establishments either closing or significantly limiting their operations, leaving many farmers without their usual buyers. The guidance issued today is intended to allow affected farmers to shift their sales away from qualified end-users while still being considered eligible for the qualified exemption. Specifically, under the temporary policy announced in the guidance, farms that are currently eligible for the qualified exemption and associated modified requirements will still be considered eligible, even if they shift sales away from qualified end-users, so long as they continue to meet the requirement that their average food sales during the previous three years total less than $500,000 (adjusted for inflation).

FDA recognizes that providing flexibility to farms to allow them to shift food sales to available buyers during the COVID-19 public health emergency can help reduce food waste and food shortages. This temporary policy is intended to remain in effect only for the duration of the public health emergency, after which the FDA intends to issue additional guidance.

Qualified exempt farms must comply with modified requirements under the Produce Safety Rule, which include establishing and keeping certain records and prominently displaying their name and business address on food packaging or at the point of sale. Farms are responsible for ensuring that the food they produce is not adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and they should use good agricultural practices to ensure the safety of their produce.

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