FDA Announces Temporary Policy During the COVID-19 Public Health Emergency – Vegetable Crops Hotline

FDA Announces Temporary Policy During the COVID-19 Public Health Emergency

Recently, the Food and Drug Administration (FDA) announced a temporary policy regarding eligibility for the qualified exemption under the Food Safety Modernization Act (FSMA) Produce Safety Rule. The policy is designed to provide flexibility to growers during the COVID-19 public health emergency. The policy and guidance may be found on FDA’s website at https://www.fda.gov/media/138316/download.

Under the FSMA Produce Safety Rule, growers may receive a qualified exemption if total food sales (defined as anything that may be used as food and drink for humans and animals) are less than $500,000 annually and more than half of all sales are to a qualified end user. A qualified end user may be (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indiana reservation as the farm or not more than 275 miles away.

The COVID-19 public health emergency has made it very difficult for growers to interact directly with consumers and has resulted in the closure of many retail food establishments, such as restaurants. As a result, growers may need to find new or additional marketing venues. The purpose FDA’s temporary policy is to give flexibility and allow growers to seek out new or additional marketing venues while still being considered eligible for the qualified exemption. Under the temporary policy, “Growers who are eligible for a 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 temporary policy will be in effect only for the duration of the public health emergency. After that time, FDA intends to issue additional guidance.

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