FDA to revise and ask for comments on parts of FSMA
Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said Dec. 19 that the agency was reacting to comments from the produce industry made during meetings across the country and as part of the official comment period for two of the FSMA rules first published in January, 2013, covering fresh produce safety and preventive controls for eliminating pathogens.
“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,” Taylor said.
FDA will go back to the drawing board and make what it calls “significant changes” in these areas:
- Water quality standards and testing
- Standards for using raw manure and compost
- Provisions affecting mixed-use facilities
- 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,” Taylor said.
FDA said it plans to publish the revised proposed rule changes in “early summer” 2014. The agency will seek additional comments only on the portions of the proposed rules that have been revised, citing the court order that requires FSMA to be finalized by 2015. However, more changes may be in store.
“There may be other revisions to the proposed rules; the scope of the revised proposals, on which we will seek further comment, will be determined after we complete our 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 said.
Produce organizations hailed FDA’s decision to redraft some of the FSMA provisions.
“PMA is commending FDA for listening to and acknowledging significant concerns raised by produce stakeholders about the proposals issued in January 2013,” said Meg Miller, director of public relations for the Produce Marketing Association. “ FDA is taking steps to provide stakeholders with a new opportunity to review and provide comment on revised proposed produce and preventive control rule provisions that raised significant concern in the produce community.”
David Gombas, senior vice president of food safety and technology for the United Fresh Produce Association, also praised the FDA action.
“We are encouraged that FDA took seriously the extensive input they received from produce farmers and others in the agricultural sector with respect to the proposed Produce Safety and Preventive Controls rules,” said Gombas. “We appreciate FDA’s willingness to rethink these provisions and propose requirements that are more science and risk based. It is critical that FDA gets these FSMA rules right, and we believe this is a step in the right direction.”