FDA plans significant revision to FSMA rules

FDA plans to publish revised language for proposed rule on produce and human food regulations by early summer.

AFTER an extensive amount of comments were received, the Food and Drug Administration said "significant changes" will be needed in key provisions of the Food Safety Modernization Act (FSMA) rules on produce safety and preventive controls for human food.

As such, the agency plans to propose revised rule language and seek comments on the changes before implementing the new regulations.

FDA said it plans to publish revised language by early next summer.

In a statement on key provisions, Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, explained, "Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved. Everyone shares the goal of ensuring produce safety, but as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement."

FDA noted that in order to achieve this goal, it believes that significant changes will be needed in key provisions of the two proposed rules affecting small and large farm operators.

These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities and procedures for withdrawing the qualified exemption for certain farms.

A statement from Ferd Hoefner, National Sustainable Agriculture Coalition policy director, said the coalition is in "full agreement with FDA that these sections of the proposed rules need a new approach and major changes."

However, Hoefner said he appreciates that FDA may also include additional issues 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," he said.

The coalition also said careful economic and environmental analyses of the likely outcomes of implementation need to be updated. Hoefner explained that the original economic cost/benefit analysis that accompanied the proposed rules was "deeply flawed and needs to be redone."


Industry insight

"We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers," Taylor said.

Because the changes to the key provisions would be significant, FDA plans to provide a public comment period on the revised rule language. There may be other revisions to the proposed rules; the scope of the revised proposals will be determined after the agency completes the initial review of written comments.

"We believe that this additional step to seek further input on revised sections of the proposed rules that need significant adjustment is critical to fulfilling our continuing commitment to getting these rules right," Taylor noted.

The actions were welcomed by the industry as showing FDA's recognition of the rule's complexity and its willingness to take the extra step to ensure that the final rules will be as practical as possible for industry implementation, said Joel Newman, president and chief executive officer of the American Feed Industry Assn. (AFIA).

"No rule is perfect, but AFIA acknowledges FDA's intent to make these rules well suited for everyone involved in various industry segments," Newman said. "This is a positive sign for the future of FSMA."

AFIA has joined with others in the animal and feed industries seeking additional comment periods on FMSA rules if changes are made from the initial proposal, most notably the latest animal feed rule.

FDA remains under a court order regarding the timelines for finalizing these rules.

"FDA recognizes that completing these rules is essential to protecting the public health and is committed to completing them as quickly as possible," Taylor concluded.

Volume:85 Issue:52

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