FDA to redraft, solicit more comments on FSMA

FDA to redraft, solicit more comments on FSMA

FDA will delay final rules for produce safety and preventive controls in order to draft and receive input on revisions to proposed regulations published in January 2013.

The Food and Drug Administration (FDA) announced it would delay issuing final rules to implement the produce safety and preventive controls for human food provisions of the 2011 FDA Food Safety Modernization Act (FSMA) in order to draft and receive input from interested parties on revisions to certain proposed regulations it published in January 2013.

"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," wrote FDA's Deputy Commissioner for Foods Michael Taylor in a blog post.

The American Herbal Products Association (AHPA) recently submitted nearly 200 pages of comments to FDA and urged the administration to publish a second set of proposed rules to collect additional comments.

"The broad and deep impact of the new, proposed regulations necessitates regulatory restraint," said AHPA President Michael McGuffin. "AHPA and its members appreciate FDA's decision to significantly rewrite portions of the proposed rules. AHPA urges FDA to streamline and focus the proposed rules to significantly minimize the burdens and costs while also preserving the new protections for food safety." 

Taylor wrote that, due to an evolution of FDA's thinking about the issues, the agency must make significant changes in key provisions of the two proposed rules that affect small and large farmers. Specifically, FDA is looking to redraft proposed regulatory language for 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.

FDA plans to seek comments on the revised proposed rules to allow the public to provide input. FDA says it will determine if additional revisions to the proposed rules and opportunities for further comments are needed after it completes the initial review of written comments.

"Our plan is to publish revised proposed rule language by early summer 2014," Taylor wrote. "We will accept additional comments only on those sections of the proposed rules that have been revised."

Since the proposed rules were originally issued in January 2013, FDA has held more than 150 meetings, visited numerous farms and received thousands of 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 wrote.

If implemented in the form initially proposed in January 2013, the FSMA regulations for produce could impact growers, processors, and distributors of botanicals and botanical raw materials based on the definitions included in the proposal. The proposed hazard analysis and risk-based preventive controls regulations for human food would not apply to cGMP-compliant dietary supplement manufacturers but would apply to suppliers of dietary ingredients and other component ingredients that are used by dietary supplement manufacturers.

AHPA will remain engaged in the FSMA rule-making process to ensure these rules do not unnecessarily burden AHPA members or their suppliers.

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