New FDA Guidance on FSMA Qualified Exempt Requirements During Covid

The Food and Drug Administration (FDA) recently released 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 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. This 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 that directly buy food from your farm (e.g. at a farmer’s market, through a community supported agriculture program, farm stand, etc) or food sales you have directly to one restaurant or grocery store. Sales to qualified end users must be within the same state or Indian reservation of 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 that may be concerned about losing their qualified exempt FSMA status due to changing sales outlets. 

If you are a farmer and have questions about what this means for your farm please contact our food safety team at:

Grace –

Kali –