Process exemptions within the Food Safety and Modernization Act

Process exemptions are one of many ways fruit and vegetable growers may need to only partially comply with the Food Safety and Modernization Act (FSMA) Produce Safety Rule.

There are a number of situations where fresh fruit and vegetable growers may not need to fully comply with the Food Safety and Modernization Act (FSMA). One such situation is when the fruit or vegetables grown are going to be processed. The U.S. Food and Drug Administration (FDA) calls this a process exemption.

To seek a process exemption, you need to disclose somewhere on a bill of lading, unit of sale, box or other sale document that the food is not processed to adequately reduce the presence of microorganisms of public health significance, according to the FDA’s Code of Federal Regulations Title 21.

You also need written assurance, at least annually, from the buyer saying the food has been commercially processed in a manner that adequately reduces the presence of microorganisms of public health concern prior to entering commerce, according to the FDA’s Code of Federal Regulations Title 21.

Recently, the FDA announced something they called enforcement discretion. With this enforcement discretion, growers seeking the processing exemption will not be required to have written assurances from their customers for two years while the FDA reconsiders that policy.

These rules are law and all growers who sell fruit and vegetables, irrespective of size, will need to make at least some changes as a result of them. Taking the time now to become familiar with what was published is imperative. One way to learn more is by attending a free, all-day FSMA Produce Safety Alliance grower training. The 2018 Winter Grower Produce Safety Certification Course, hosted by Michigan State University Extension, will cover a broad swath of produce safety. 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.

For more information or to register, visit 2018 Winter Grower Produce Safety Certification Course.

If you have difficulty tailoring GAPs (Good Agricultural Practices) to your farm or need help figuring out if you need to comply with the FSMA Produce Safety Rule, contact the Agrifood Safety Work Group at .(JavaScript must be enabled to view this email address) 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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