FSMA Update: FDA Will Revise and Re-release Portions of the Proposed Food Safety Rules

      Posted On: December 23, 2013

At the end of last week, the Food and Drug Administration (FDA) announced that they would be rewriting four major portions of the proposed Food Safety Modernization Act (FSMA) rules, and re-releasing them for additional public comment. Mike Taylor, the FDA’s Deputy Commissioner for Foods and Veterinary Medicine, stated that the decision to make significant changes to the rules was in response to the “extensive input we have received from produce farmers and others in the agricultural sector.” The Farmers Market Coalition (FMC) commends the FDA for considering and acting upon the concerns of America’s community farmers.

FMC also commends the farmers market community for stepping up and making your voices heard during this important rule-making process. Many FMC members dedicated significant time to crafting detailed, thoughtful comments on the proposed food safety regulations, and we are pleased to report that the FDA is responding to your efforts.

The four issues that will be rewritten are: definitions of mixed-use facilities and rules pertaining to value-added products; water quality standards; standards for using raw manure and compost; and due process considerations for farms

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who are eligible for qualified exemptions from FSMA requirements. These four issues will have a dramatic impact on direct-marketing farmers, and FMC is eager to continue working with the FDA to create reasonable, effective regulations. The FDA estimates that the revised rules will be released in the early summer of 2014.

While revising and re-releasing rules on four issues is a big step in the right direction for the FDA, there are plenty of other areas within the 800-pages of FSMA rules that also require significant changes. In a statement released by the National Sustainable Agriculture Coalition (NSAC), Ferd Hoefnner, NSAC Policy Director, responded to the FDA’s announcement:

We are cautiously optimistic that the approach they announced today – major changes on targeted issues that will be open for a second round of public comment – will be adequate for the task at hand, namely to lead toward a substantially reworked, clearer, and more practical proposal. The modernization of food safety rules is a major undertaking and it is more important to get it right than to meet any arbitrary deadlines for completion of the task.

These are not, however, the only issues needing major revision. We therefore very much appreciate that FDA says additional issues may be included in the second comment period revision process. For example, the on-farm co-management of conservation and food safety practices, including wildlife habitat protections, is a critical issue. So too is defining farms to include usual and customary farming activities, as well as counting only regulated food and not all farm products in determining eligibility for modified requirements. Moreover, rules must be written and included in this second public comment period to clarify that direct marketing operations are not subject to food facility registration, a clarification Congress told FDA to make.

There is still much work to be done, but for now, congratulations and thank you to FMC members for contributing to positive changes in our nation’s food system! FMC will keep you updated as the FSMA rule-making process progresses in 2014. For more information on FSMA, see FMC’s advocacy page, and recent webinar on the proposed rules.