Safe Wisconsin Produce (SWP) is responsible for education and compliance with Title 21 CFR Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, otherwise known as the Produce Safety Rule (PSR). The PSR is the one of seven rules created as part of the Food Safety Modernization Act (FSMA) and establishes a common set of standards for produce farming practices. The PSR categorizes all farms as covered or
exempt (see below).
Defining the Various Statuses
Covered farms must comply with all applicable PSR requirements when conducting covered activities on covered produce. Farms are subject to PSR requirements if the average annual dollar value of the produce they sold during the previous 3-year period was more than $25,000
adjusted for inflation, and are considered “covered farms" (21 CFR 112.4(a)).
Covered farms are subject to PSR inspection; SWP staff will contact covered farms to schedule PSR inspections. This FDA fact sheet explains what to expect during a PSR inspection.
A farm is not covered if exempt and has not had its exemption withdrawn. Read more about withdrawal of exemptions in
21 CFR 112.201-213.
Farms are exempt and not subject to PSR requirements if the average annual dollar value of the produce they sold during the previous 3-year period was less than $25,000
adjusted for inflation.
Although regulatory services are not available to exempt farms, non-regulatory services such as On-Farm Readiness Reviews, SWP Audits, Produce Safety Alliance (PSA) grower trainings, and other outreach and technical assistance are available to all exempt farms. All farms should keep records verifying their exemption status and re-evaluate their eligibility each year as the threshold will increase with inflation.
produce sales greater than $25,000 but
food sales less than $500,000 adjusted for inflation and which sell the majority dollar value of their food sales directly to qualified end-users, such as the consumer of the food or a restaurant or retail food establishment in the state or not more than 275 miles from the farm.
Qualified exempt farms must follow these modified requirements:
- Keep dated sales receipts and adequate records that demonstrate that you have performed an annual review of your farm's eligibility for a qualified exemption.
- Prominently label produce with the farm name and complete business address on the food packaging. If there is no packaging label (e.g., selling loose produce at the farmers market), the farm must prominently and conspicuously display the farm name and complete business address at the point of purchase, either on a label, poster, sign, placard, or receipt.
Withdrawal or Reinstatement of Status
Qualified exempt farms are exempt from regulatory services. However, farms must be diligent in their recordkeeping as their eligibility for the qualified exemption can change annually. Note that the food sales threshold changes with inflation. You can check the
FSMA inflation adjusted cut offs.
SWP may conduct a record review to verify a farm's qualified exemption status. A qualified exemption may be withdrawn if necessary to protect public health and prevent or mitigate a foodborne illness outbreak.
Although regulatory services are not available to exempt farms, non-regulatory services such as On-Farm Readiness Reviews, SWP Audits, PSA grower trainings, and other outreach and technical assistance are available to all exempt farms. All farms should keep records verifying their exemption status and re-evaluate their eligibility each year as the sales thresholds will change annually with inflation.
In addition to full-farm exemptions, specific commodities may be exempt if they fall within one of the following categories, noting that they are still produce for purposes of sales calculations and the farm cannot be commodity exempt if farming other covered produce commodities under the same management::
Rarely Consumed Raw. Produce that is listed in the comprehensive FDA Rarely Consumed Raw list is not covered by the PSR: 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.
Read more about FDA's rarely consumed raw facts.
Processing Exempt (on farm). Covered produce that is processed on-site under the farm definition or WI Act 101 (Pickle Bill):
- Drying/dehydrating raw agricultural commodities to create a distinct commodity (e.g., drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (e.g., slicing).
- Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing.
- Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (e.g., irradiation).
- WI Act 101 (Pickle Bill)
3. Processing Exempt (on farm licensed). Covered produce that is processed on-farm under a processing license.
The Small Entity Compliance Guide: Registration of Food Facilities provides guidance of which entities must register as a Food Facility, as per 21 CFR Part 1 Subpart H.
4. Processing Exempt (commercial). Covered produce destined for a commercial processing “kill step" that adequately reduces human pathogens and the grower has disclosed in accompanying documentation provided to the processor/buyer that states that the produce is “not processed to adequately reduce the presence of microorganisms of public health significance."
Examples of such “kill-step" processing include canning, refining, and distilling. More examples are provided in
21 CFR 112.2(b)(1).
(FDA intends to exercise enforcement discretion regarding the 112.2(b)(3) written assurance requirements until the rulemaking is complete. Read more in the Current Good Manufacturing Practice and Preventative Controls, Foreign Supplier Verification Programs, Intentional Adulteration and
Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions (March 2022))
5. Enforcement Discretion. Produce under FDA enforcement discretion:
In 2019 the FDA published a Guidance to Industry bulletin announcing an Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds.
Read more about PSR: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds.
6. Excluded. Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same management is not covered by the PSR.
Although regulatory services are not available to exempt farms, non-regulatory services such as On-Farm Readiness Reviews, SWP Audits, PSA grower trainings, and other outreach and technical assistance are available to all exempt farms. All farms should re-evaluate their eligibility each year based on the commodities they are growing, harvesting, packing and/or holding.
What category is your farm?
SWP publishes an annual survey and produce farm registry and encourages all produce farms to participate every year. The
SWP farm registry displays participating farms' statuses.
Don't see your farm? Take the
2022 produce questionnaire and registry survey and check the box to
participate in the produce safety registry, or reach out to a member of the SWP team for additional assistance.
View our SWP flow chart below to walk through the steps to learn how to determine if a farm is covered by the PSR. A printable version of this flowchart is also available in the "Is my farm covered by the new federal produce safety rules?" brochure (English |