Exemptions and the Produce Safety Rule

The Produce Safety Rule – the part of the Food Safety Modernization Act that applies to produce growers – blocks out some exemptions from the rule, based on sales volumes and customer-types. These exemptions have been the source of a lot of confusion, and plenty of misinformation. I have attempted to distill some clarity out of the rule itself, and have created some resources to help document eligibility for one of these exemptions.

​Does the Produce Safety Rule Apply to You?

In brief, the Produce Safety Rule creates two significant exemptions for fresh-market produce growers:

• The $25,000 produce-sales bottom threshold; and
• The qualified exemption.

There are also some issues about produce that is covered by the rule, and produce that is not covered by the rule, as well as compliance dates to consider.

With the support of Growing for Market magazine, I put together an article to address exemptions to the rule, compliance timelines, and training requirements for farmers.

A slightly revised version of that article, including links to citations in the Produce Safety Rule, is available here: 

• Does the Produce Safety Rule Apply to You? | (PDF) 

Qualified Exemption Resources

If your farm is eligible for a qualified exemption, FDA requires that you provide a written record reflecting that you have performed an annual review and verification of your farm’s continued eligibility for the qualified exemption.
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The accompanying records are designed to help you:

• Determine and document whether your customers meet the definition of a “qualified end-user”;
• Determine whether your sales numbers meet the criteria for the qualified exemption; and
• Provide documentation of your review and verification of your farm’s continued eligibility for the qualified exemption.

Please note that these record-keeping forms do not help you determine if your farm is a “not-covered farm” due to produce sales of less than $25,000 (adjusted for inflation), because FDA has not established a record-keeping requirement  for farms that meet this produce-sales bottom threshold.
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Although the following documents can stand on their own, I suggest that you read Does the Produce Safety Rule Apply to You? to get a more thorough understanding of the qualified exemption and association requirements.

These worksheets were in collaboration with University of Wisconsin Extension. I would like to thank UW Extension for their support. You can access versions of these documents at the UW On-Farm Produce Food Safety website.

Paper-Based Documentation

​The paper-based system has three components:

• Instructions for completing the paperwork;
• The Annual Summary of Farm Sales, to be completed each year;
• The Annual Review and Verification, which draws on the three most recent Annual Summaries of Farm Sales to help you determine and document your eligibility for the qualified exemption.

The Annual Summary of Farm Sales and the Annual Review and Verification are provided as separate documents because the first year you complete the review, you will need three farm-sales summaries.

Excel Spreadsheet Documentation

For the slightly more computer-savvy, this spreadsheet does exactly what the paper-based documentation does, with the added bonus that it does the math for you.

• Qualified Exemption Determination Spreadsheet (Excel)