FDA will re-propose FSMA produce and human food rules

Published on: Dec 19, 2013

After extensive 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 comment on the changes before implementing the new regulations.

FDA said it plans to publish a revised proposed rule language by early summer 2014

In a statement on key provisions, FDA explained that it has made every effort to solicit input on the proposed rules in participating in more than 150 meetings and by traveling to numerous farms of varying types and sizes countrywide.

"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," the statement said. "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 went on to say 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 farmers.

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.

"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," the agency said.

Because the changes to the key provisions would be significant, FDA plans to propose revised rule language and seek comment on it, allowing the public the opportunity to provide input on our new thinking. There may be other revisions to the proposed rules; the scope of the revised proposals, on which EPA will seek further comment, will be determined after it 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," FDA added.

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," the statement added.