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Food Safety Modernization Act (FSMA) & Product Safety Rule (PSR) Overview
Click on the button below to complete the Farm Status Determination form.
Completing this form will help you determine what your Produce Safety Rule status is and will allow you to apply for an exemption, if eligible. Farms must verify their Produce Safety Rule status annually to qualify for an exemption or qualified exemption.
Here are some additional resources to help you determine your Produce Safety Rule status:
FDA Coverage and Exemptions/Exclusions flow chart: https://www.fda.gov/media/94332/download
Produce Safety Rule (PSR) Status Determination Guide
Produce farms are either exempt from the requirements of the PSR, qualified exempt, or subject to the PSR (covered).
Exempt
Your farm may apply for an exemption if it meets at least ONE of the following criteria:
- Average gross produce sales are less than $31,925 (based on 2021-2023 average)
- All produce is only grown for personal, family, or on-farm consumption
- All produce is commercially processed (e.g., canned, dehydrated, distilled, fermented)
- All of the produce grown is listed as “rarely consumed raw” in the Produce Safety Rule.
Rarely consumed raw list: Asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops); sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
Qualified Exempt
Your farm may apply for a qualified exemption if it meets BOTH of the following criteria:
- Average gross food sales are less than $638,491 (based on 2021-2023 average)
- AND
- More than 50% of food sales are to qualified end-users
Food – This includes both human food and animal feed (e.g., produce, grain, hay, meat, dairy, eggs, value-added products, processed foods, and baked goods).
Qualified end-users - either (a) the consumer of the food or (b) a restaurant or retail food establishment located in the same state or within 275 miles of the farm.
Subject to the PSR (Covered)
Your farm is likely subject to the requirements of the Produce Safety Rule - (covered by the PSR) if it does not meet the criteria for an exemption or qualified exemption.
Your farm is subject to the requirements of the PSR if it meets EITHER of the following criteria:
- Average annual produce sales OR food sales are greater than $638,491 (if the total food sales include more than $31,925 in produce sales)
- AND/OR
- Average gross produce sales are more than $31,925 (based on 2021-2023 average) AND more than 50% of food sales are NOT to qualified end-users
Note: All dollar figures listed on this guide are based on 2023 inflation adjusted values. The FDA updates these values in April of each year.
Contacts
Montana Rules and Code: Produce