COVID-19, the Produce Safety Rule, and Records for Qualified Exempt Growers

Updated: Nov 23, 2021


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Photo Credit Edwin Remsberg

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On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced flexibility in the eligibility criteria for the qualified exemption from the Food Safety Modernization Act (FSMA) 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. This post will explain the temporary policy and how it impacts produce growers who fall within the qualified exempt category.


What is the qualified exemption to the Produce Safety Rule?


Produce farms are eligible for a Produce Safety Rule qualified exemption and associated modified requirements if they meet specific 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.

How did COVID-19 impact the qualified exemption to the Produce Safety Rule?


According to FDA, in the spring of 2020, with the onset of the COVID-19 pandemic, state and local governments across the United States instituted public health orders resulting in the temporary closure or limited operational status of many qualified end-users (restaurants, retail food establishments, and institutional food service establishments). The reduced demand of the qualified end-users impacted the ability of some farms to sell food to typical buyers and, consequently, may have affected some farms’ eligibility for qualified exemption under the Produce Safety Rule.


What is the temporary qualified exempt policy?


According to the temporary policy, 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).


The FDA issued the temporary policy to recognize that farmers have had to sell to available buyers during the COVID-19 public health emergency, wherever they are, to help reduce food shortages and food waste and to help support both farms and the U.S. economy. The FDA, therefore, 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.


How will growers determine eligibility for the qualified exemption in 2021 if they met the criteria for the qualified exemption in 2020?


For farms that were eligible for the qualified exemption in 2020, eligibility for qualified exemption status for 2021, and until the end of the public health emergency, may be determined based on:

  1. Documentation that the farm met all of the criteria for the qualified exemption in 2020, based on records from 2017, 2018, and 2019; and

  2. Documentation that the average annual monetary value of all food the farm sold during the preceding three-year period (e.g., 2018, 2019, and 2020 for determining status in 2021) was less than $500,000 (adjusted for inflation)

When are upcoming PSR trainings in Maryland?


The PSR requires all farms subject to the PSR to have at least one supervisor or responsible party attend a grower training. Between December 2021 and March 2022, the Maryland Food Safety Network plans to host two in-person grower training sessions and two virtual training sessions. The grower trainings that have been scheduled to date are as follows:

Funding for the training is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U2FFD007444 totaling $523,497 with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.


Anyone with questions about the PSR and/or PSR grower trainings can contact ALEI legal specialist, Sarah Everhart, 410-706-7377, severhart@law.umaryland.edu.

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