SOURCE: FDA, 5/22/20 Today, the
U.S. Food and Drug Administration announced 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. For More
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