The objective of this document is to help farms determine their status within the Produce Safety Rule. The questions outlined follow a specific order so that the reader can have the pertinent information required to determine if the farm is not covered, eligible for a qualified exemption and modified requirements or a covered farm. If you need assistance, contact information for NC State University Produce Safety Area Specialized Agents is listed at the end of this document.

If you would like to use this template as a record, print the PDF document:

Template for farms to determine their status with the PSR in 2024

Definition of Produce

Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro).

1. Do you only grow produce for personal or on-farm consumption?

Yes______ No______

If your answer is Yes, then you are not covered by the Produce Safety Rule.

If your answer is No, go to question 2.

2. Use sales receipts or records to determine produce sales for the farm over the previous 3 years. Count all produce sold by the farm regardless of the fact the produce may be covered, rarely consumed raw or exempt (further processed) by the PSR or exempt.

Year 1 (Sales year: 2021)                                         $____________________

Year 2 (Sales year: 2022)                                         $____________________

Year 3 (Sales year: 2023)                                         $____________________

Add produce sales for Years 1-3                              $____________________   divide this number by 3

Average total produce sales for years 1-3          $____________________

Based on published FDA inflation rates for 2024*, if the average produce sales for the past three years are under $31,925* the farm is not covered by the PSR. For additional information go to the last section of this document.

If the average produce sales for the past three years are greater than $31,925* go to question 3.

*Source: FSMA Inflation Adjusted Cut-offs

Farms that are not covered by the PSR are not required to have a written record but this record is helpful in reassuring the status under the law.

3. Do you only grow rarely consumed raw produce?

Yes_____No______

Rarely consumed raw produce are fruits and vegetables that are almost always cooked before being consumed. “Rarely consumed raw” produce by FDA is included in this exhaustive list: Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts. Note that rarely consumed raw produce is also referred to as not covered produce in the Produce Safety Rule. For more information on this subject, see FDA’s Fact Sheet on Rarely Consumed Raw Produce.

If you answered Yes, the farm only grows rarely consumed raw produce then the farm is exempt from the Produce Safety Rule but is still subject to the provisions of the Federal Food, Drug and Cosmetic (FD&C) Act. In other words, the farm is responsible for making sure the produce is safe for human consumption.

If you answered No, go to question 4. Note that if you grow, pack or hold any  rarely consumed raw commodities these will not be inspected if you operate a covered farm during routine inspections. The farm can voluntarily follow practices outlined in the PSR for rarely consumed raw commodities but if the farm chooses not to follow practices, these have to be separated from all other crops that are subject to inspection while being packed or held at a packing house.

4. Do you grow produce that is intended for commercial processing that adequately reduces pathogens (for example, commercial processing with a “kill step”)?

Yes_____No______

If you answered Yes, then the farm must annually obtain a written assurance from either the customer performing the commercial processing or from your customer that an entity in the distribution chain subsequent to customer will perform commercial processing. Produce for which the grower has a written assurance that it will be commercially processed with a “kill” step is exempt from the PSR. Enforcement discretion for this guideline is still in place at the time this document is updated (May 2024). Learn more about enforcement discretion.

Examples of processing/manufacturing include: baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity, evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing.

Produce sold to restaurants that will be later cooked should not be included in this category.

If you answered No, go to question 5.

5. Determine if a farm is eligible for a Qualified Exemption and Modified Requirements.

To be eligible for this category, a farm must meet both requirements:

Requirement 1: Average food sales must be under $638,491* for years 2021-2023.

Requirement 2: The majority of food sales must be made to Qualified End Users (QEU) for years 2021-2023.

The dollar amounts listed here are based on the adjusted inflation rates published by FDA for 2024.

*Source: FSMA Inflation Adjusted Cut-offs

Requirement 1. Determine food sales for the farm.

Food is defined as articles used for food or drink for man or animals, or articles used to make components of it. It includes seeds and beans used to grow sprouts. Examples of food include: fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. Livestock and meat are both food within this definition. Consider that cotton, tobacco, and timber are not considered food.

If you operate a poultry or hog farm for an integrator typically the grower does not own the animals. Growers’ payments are for day to day care of the animals and therefore are not considered food. Verify this information before proceeding.

Use sales receipts or records to determine total food sales over the previous 3 years. Count all produce sold by the farm regardless of the fact the produce may be covered, rarely consumed raw or exempt (further processed) by the PSR.

Year 1 (Sales year: 2021)                                         $____________________

Year 2 (Sales year: 2022)                                         $____________________

Year 3 (Sales year: 2023)                                         $____________________

Add food sales for Years 1-3                                   $____________________   divide this number by 3

 Average total food sales for years 1-3               $____________________

Are the average food sales over $638,491 for the last three years?

Yes____ No____

If the answer is Yes, then the farm cannot claim a qualified exemption and is likely to be a covered farm. A covered farm is subject to inspections and must follow the practices outlined in the Produce Safety Rule. For more information, see summary of responsibilities of covered farms in the last section of this document.

If your answer is No, then go to requirement 2.

Requirement 2: The majority of food sales must be made to Qualified End Users (QEU) during the last three years.

Determine food sales to qualified end users (QEU) over the last three years. Qualified end users are people who will consume/eat the food they are buying from the farm. Such consumers include those that buy from you at a farm stand, farmers market, through Community Supported Agriculture, through the internet or any other direct marketing channel. This also includes sales the farm made to retail food establishments (grocery stores that you deliver to directly) and restaurants within 275 miles of your farm.

(A4) Average sales to QEU                                        _________________

(B4) Average sales to businesses (non QEU)            _________________

Are the average food sales to QEU (A4) greater than sales to businesses (B4) that are not considered Qualified end users? Yes________     No________

If the answer is Yes, then the farm has met the second requirement to be eligible for a qualified exemption.

If the answer is No, then the farm cannot claim the exemption and is likely to be a covered farm. A covered farm is subject to inspections and must follow the practices outlined in the Produce Safety Rule. For more information, see summary of responsibilities of covered farms in the last section of this document.

Further verification

If you follow this template and the sales to qualified end users are 51% or more, then the farm has met both requirements listed to be eligible for a qualified exemption and modified requirements.

*Sales receipts must also be retained to support this record.

Summary of responsibilities for farms under the Produce Safety Rule

1. Farms not covered: It is recommended to have a financial record to reassure produce sales are under the threshold established by FDA. A written record is not required by the Produce Safety Rule.

2. Farms that are eligible for a Qualified Exemption and Modified Requirements.

• The farm must establish and keep adequate records necessary to demonstrate that the farm satisfies the criteria for a qualified exemption, including a written record reflecting that an annual review has been performed and verification of the farm’s continued eligibility for the qualified exemption. If you complete this template using the PDF version, pages 3-5 can serve as the financial record. Receipts must accompany the record. All farms that fall under this category will need written financial records annually. The records do not need to be sent to NCDA Produce Safety Office or FDA, they are for the farm to have in the event they are contacted about the status under the PSR.
• Modified labeling: The labeling requirement consists of including the name and complete business address of the farm where the produce was grown either on the label of the produce or to display the same information at the point-of-purchase. The labeling requirement applies to all farms that claim a qualified exemption. This is not a requirement for covered farms. For more information on labeling, see link below.
• Grow produce under sanitary conditions and not place in commerce adulterated food. FDA can withdraw a qualified exemption if produce is adulterated. Produce is adulterated when it has been grown, harvested, packed, or held in a farm under such conditions that it is unfit for food or if it has been prepared, packed, or held under unsanitary conditions where it can be contaminated with filth or have been rendered injurious to health.
• A qualified exemption can be withdrawn in the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm; or if FDA determines that is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with the farm that are material to the safety of the food.

More information about qualified exemptions and modified requirements.

3. Covered farms. Covered farms are farms whose average food sales over the past 3 years are greater than $638,491 or that even when the sales are below that threshold they sell most of the food they grow, harvest, pack and/or hold to non-qualified end users (through brokers, distribution centers, etc.).

• A covered farm must have a responsible party attend the Produce Safety Alliance training.
• The farm must implement the practices outlined in the Produce Safety Rule.
• The farm must be ready for inspections. In North Carolina, inspections will generally be conducted by personnel from the NCDA C&S Produce Safety Program even though FDA inspectors can also do inspections. These are announced inspections where a farmer will be contacted and notified that they will be undergoing an inspection in the near future.

If after filling out this template, you need help understanding how the Produce Safety Rule impacts your farm contact your local County Extension Agent or Area Specialized Agents- Food Safety – Fresh Produce with N.C. Cooperative Extension. More information can also be found at NC Fresh Produce Safety.

Western NC
Elena Rogers – Area Specialized Agent- Food Safety/Fresh Produce elena_rogers@ncsu.edu or via phone at (828)352-2519

Eastern NC
Dr. Chip Simmons – Area Specialized Agent- Food Safety/Fresh Produce odsimmon@ncsu.edu or via phone at (919)414-5632