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New FDA Guidance on FSMA Qualified Exempt Requirements During the COVID-19 Pandemic

by Guest Blogger |

The Food and Drug Administration (FDA) recently released a temporary guidance on the requirements that farms must meet to be considered qualified exempt under the Federal Food Safety Modernization Act (FSMA). This is important for small farms to be aware of if you have less than $561,494 in gross food sales annually (adjusted for inflation and averaged over the last three years), as your farm may be eligible for a partial exemption from the FSMA, if your farm meets one other criteria. 

The other criteria is what the law refers to as sales to a “qualified end user.” Farms that sell at least 50.1% of their sales (in dollars) to qualified end users AND have less than $561,494 gross food sales annually (adjusted for inflation) are considered qualified exempt farms under FSMA. Qualified end users are people who directly buy food from your farm (at a farmers’ market, through a community supported agriculture program, farm stand, etc.) or food sales you make directly to one restaurant or grocery store. Sales to qualified end users must be within the same state or Indian reservation as the farm or within 275 miles of the farm.

FDA recognizes that during this public health crisis farm supply chains are disrupted and farmers are selling product through new avenues that they may not have been previously. Some of those markets may not be qualified end users. To that end, “FDA does not intend to enforce the criteria regarding the portion of sales that are made to qualified end-users in 2020 (and any subsequent years that are affected by the COVID-19 public health emergency). This means that farms that are currently eligible for the qualified exemption and associated modified requirements will still be considered eligible even if they shift food sales away from qualified end-users, provided that they continue to meet the requirement that the average annual monetary value of all food they sell is less than $500,000, adjusted for inflation.”

This is important news for small farmers who may be concerned about losing their qualified exempt FSMA status due to changing sales outlets.

You can learn more about this new FDA temporary policy on the Federal Register.


This blog post was submitted by Kali Feiereisel and was originally published on the Community Alliance with Family Farmers (CAFF) and the Farmers Guild’s website on May 27, 2020.

Kali Feiereisel serves as CAFF and the Farmers Guild’s senior manager for farmer services. She provides food safety technical assistance to farmers as they further develop their practices to meet new requirements through CAFF’s food safety program.