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FDA Issues Guidance on Produce Safety Rule Exemption During COVID-19

The Food and Drug Administration (FDA) has published guidance announcing flexibility in the eligibility criteria for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule), due to disruptions to the supply chain for the duration of the COVID-19 public health emergency. As set forth in 21 CFR 112.5(a), a farm is eligible for a qualified exemption and associated modified requirements in a calendar year if during the previous three-year period, the average annual monetary value of food the farm sold directly to qualified end-users exceeded the average annual monetary value of the food the farm sold to all other buyers during that period, and the average annual monetary value of all food the farm sold during the three-year period was less than $500,000, adjusted for inflation. In order to support affected farms in selling food to all available buyers during the COVID-19 public health emergency, under specific circumstances FDA does not intend to enforce the criteria for sales to qualified end-users when determining eligibility for the qualified exemption under the Produce Safety Rule, for the duration of the public health emergency.