Some food hubs are not qualified end users under the FSMA Produce Safety Rule

Many growers think they are eligible for a qualified exemption under the Food Safety Modernization Act Produce Safety Rule because they sell to a food hub. A recent response from the FDA says this may not be the case.

Many small growers who sell produce that is covered under the Food Safety Modernization Act (FSMA) Produce Safety Rule may be counting on a special type of exemption based on them selling more than half their gross sales to a qualified end user. The rule defines qualified end users as the consumer of the food or restaurants and retail establishments within a certain distance (local sales). These can be buyers at a farmers’ market, Community Supported Agriculture (CSA) shareholders, a restaurant, grocery store or school cafeteria. What was unclear until recently was conditions where a food hub would be considered a qualified end user.

We now definitely know some food hubs do not count as qualified end users under the FSMA Produce Safety Rule. In response to Case 00202034, the Food and Drug Administration’s (FDA) Technical Assistance Network indicated food hubs with a farm-to-business model are unlikely to meet the definition of qualified end user, while those with a farm-to-consumer business model may meet the definition.

This excerpt from the response helps describe the situation, “Sales to the food hub would only be sales to a ‘qualified end-user’ if the food hub fits the definition of a retail food establishment or a restaurant, and meets the location requirements.”

As a reminder, farmers who grow more than $25,000 in total produce sales and particular kinds of produce covered under the FSMA Produce Safety Rule need to comply with the Produce Safety Rule. If a grower sells less than $500,000 in total food sales and the majority of sales are to a qualified end user, they can be eligible for a qualified exemption. So long as they maintain the qualified exemption, these farms are required to follow just a few key pieces of the Produce Safety Rule.

  1. All qualified-exempt produce farms need to perform and document an annual review of their exemption eligibility that includes records (three years of sales records with the dates of sales on them). The individual receipts don’t need to be signed or initialed by the farmer, but the annual review document does need to be signed. If a farmer is claiming eligibility for a qualified exemption based on local sales, the records need to include information supporting qualified end user status of the buyer.
  2. All exempt produce farms need to have their farm name and business address displayed at the point of sale. This can take the form of a sign at a farmers’ market or can be on a label as part of a CSA box or a bundle sold at a local grocery store.

If you grow fresh fruits and vegetables for commercial sale and don’t know whether you need to follow the requirements of the FSMA Produce Safety Rule, consider taking a free class by Michigan State University Extension. As part of Produce Safety Rule provision 112.22(c), “One supervisor or responsible party for each farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA.” This is a full-day training that takes a comprehensive look at how the FSMA Produce Safety Rule affects how you grow and harvest fresh fruits and vegetables.

MSU Extension will be offering a number of grower trainings in Michigan during fall 2017. For more information or to register, click on the following links:

These trainings will be followed by many more beginning in January 2018.

The FSMA Produce Safety Rule Grower Training will cover a broad swath of produce safety requirements. Topic areas include worker health and hygiene, water quality in pre-harvest and post-harvest environments, crop inputs and wildlife. Much of this training will help reinforce what growers already know and put into practice on their farms. Training doesn’t, and shouldn’t, end with the grower on a farm. A robust food safety culture on-farm depends on regular training of farm workers as well as continuing education at conferences and field days.

If you have difficulty tailoring good agricultural practices (GAPs) to your farm or would like to enroll in a grower training, contact the Agrifood Safety Work Group at or 517-788-4292.

Funding for this article was made possible in part by the Food and Drug Administration through grant PAR-16-137. The views expressed in the written materials do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices or organization imply endorsement by the United States Government.

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