Qualified Exemptions and Exclusions

Farms that are not covered by the Produce Safety Rule

The rule covers produces, but some types of produce and several categories of farms are exempt:

You make less than $25,000 in produce sales on a previous three year rolling average.

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.

You grow produce that is not covered by this rule.

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.

Your produce is for personal/on-farm consumption.

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

Your produce undergoes commercial processing.

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.

If you do not meet any of the above listed categories, you may be eligible for a Qualified Exemption from the Produce Safety Rule.

Qualified Exemption eligibility requirements

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 RI DEM Produce Safety Exemption/Exclusion Factsheet, Qualified Exemption Annual Review Guide, and Qualified Exemption Annual Review Form.

The RI DEM Produce Safety Exemption/Exclusion Factsheet was created to help you determine your regulatory status under the Produce Safety Rule. This factsheet provides a visual guide to help growers understand if your produce is covered under the Rule and if your farm may be eligible for a Qualified, or Processing Exemption.

If you think that you are eligible for a Qualified Exemption after reviewing the Exemption/Exclusion factsheet, please use the Qualified Exemption Annual Review Guide and Qualified Exemption Annual Review Form to help you determine your eligibility. Once completed, this form may be used to support your annual application for Qualified Exemption which can be found on our Produce Safety Portal.