Food Safety Modernization Act proposed revisions to produce rule made public

Fresh market produce growers can see and comment on proposed produce safety rule revisions. This article reviews one aspect of the revisions, the process by which an exempt farm can have its exemption revoked, and provides information on how to comment.

With the release of the draft produce safety rule under the Food Safety Modernization Act (FSMA) and subsequent comment period extensions, growers and other industry professionals spoke loud and clear about their concerns over the rule in over 15,000 comments. These comments and interactions with industry gave the FDA insight that ultimately led to the Agency revising a number of portions and reopening only these portions for comment. One section of the revision dealt with the procedure used to handle revoking a farm’s exemption.

As was codified in the original rule, those farms who are qualified exempt under FSMA may have their qualified exemption revoked under circumstances where there is risk to public health. There were, however, many unanswered questions with regards to how the process will work. Now the FDA has provided an outline of how these revocations will be handled.

Once FDA knows of a farm whose produce may injure public health, the FDA may pursue any or all of the following options, including a warning letter, recall, administrative detention, refusal of food when it is imported, seizure and injunction. The FDA must notify the farmer when they find unsafe circumstances and allow the farm an opportunity to respond to the FDA’s claims and correct the problems. Finally, the FDA must consider the farm’s response when deciding whether to withdraw the exemption.

Public comment on only the revised sections of the rule is currently being collected until Dec. 15. This article does not cover all proposed modifications in the revision. Michigan State University Extension encourages individuals to look into all proposed revisions and comment before the deadline. Three options to comment are by submitting a comment online, faxing them to the FDA at 301-827-6870, or mailing them to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

As of Oct. 2, 2014, these rules are proposed and not final. The final rule regarding fresh produce may vary, so it is important to stay aware of what is finally decided. It is also important that the FDA hears from you about possible costs associated with compliance or potential impacts to production. Read more about the FSMA rule and how to constructively comment on the proposed rule.

If you have specific questions about the produce rule or have difficulty tailoring GAPs to your farm, contact the Agrifood Safety Work Group at or 517-788-4292.

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