This baseline cut-off value was determined in 2011 and should be adjusted for inflation. Please visit FDA’s FSMA Inflation Adjusted Cut Offs page for updated monetary information. You must keep records for your annual produce sales to show your farm is below the coverage threshold for the applicable calendar year.

Produce that is defined by FDA as rarely consumed raw, such as potatoes, is not covered by this rule. Please see the Covered vs. Not Covered Produce factsheet for more information.

Produce used only for personal or on-farm consumption is exempt.

The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a "kill step") as long as certain disclosures are made and written assurances are received, with appropriate documentation.

You may be eligible for a qualified exemption if your farm meets two requirements:

• The farm must have less than $500,000 of total food (not only produce) sales using a previous 3-year rolling average, AND
• The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years. Qualified end-users are end consumers, restaurants, or retail food establishments located in the same state or Indian reservation as your farm or within 275 miles of your farm.

A farm with the qualified exemption must still meet certain modified requirements:

• Disclosing the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase;
• Record-keeping requirements:
  • (a) You must establish and keep records required including sales receipts kept in the normal course of business. Such receipts must be dated.
  • (b) You must establish and keep adequate records necessary to demonstrate that your farm satisfies the criteria for a qualified exemption, including a written record reflecting that you have performed an annual review and verification of your farm's continued eligibility for the qualified exemption.

Proving eligibility for qualified exemption requires three years of sales records to support the exemption. If you plan to apply for qualified exemption with the produce safety team, you may need to begin compiling sales records from previous years, depending on your business size and respective compliance date.

For more detailed information, view our Qualified Exemption Factsheet and Exemption/Exclusion Flowchart.