FSMA's Produce Safety Rule Is Still Up For Discussion
By Laurel Maloy, contributing writer, Food Online
No single proposed FSMA Rule has received more buzz than the Proposed Rule for Produce Safety
The Food and Drug Administration (FDA) probably never thought that produce would be the thorn in its paw when it comes to FSMA. However, maybe it shouldn’t have come as a surprise, considering the number of small and very-small produce growers that will be affected by its legislation.
FSMA’s Proposed Rule for Produce Safety collides directly, in many instances, with the Farm Bill. As an example, Rep. Dan Benishek (R-MI) introduced an amendment to the Farm Bill in an effort to limit the FDA’s rulemaking ability under FSMA. In an unprecedented move, Congress moved uncharacteristically quickly, approving the amendment, albeit in a slightly less aggressive form. This was done even before the final produce rule language has gone to print.
The amendment requires the FDA to publish, in conjunction with the Final Produce Rule, an economic analysis, as well as an in-depth analytical discussion of the science utilized to develop the final rule. Additionally, the amendment requires the FDA to draft and publish a plan to methodically assess how the final rule will impact farming and ranching operations. The Comptroller will be required to report on these additional measures annually to the House and Senate Agricultural Committees. Though the intent of the amendment may be justifiable, the execution may prove to be a problematic challenge for the FDA. The agency has regularly questioned its ability to implement FSMA with its current funding levels.
Speaking of finalizing the produce rule — that too is awaiting another round of public comments. The reason is the recent release of the Environmental Impact Statement (EIS). Though an EIS was not initially called for or planned for, concerns were raised during the initial comment period on the Proposed Produce Safety Rule. Specifically, questions were raised about the impact on the groundwater supply in the Pacific Northwest due to the farming practices there. The National Environmental Policy Act (NEPA) requires any federal agency to conduct an EIS if it is thought a proposed action can substantially affect the environment. The proposed rule was found to potentially have a much-larger impact than initially thought. The FDA’s goal is to mitigate the environmental impacts while protecting the public’s health.
The Draft EIS is has been published in the Federal Register and is available for public comment. The comment period opened on January 12, 2015 and will close on March 13, with a public meeting to be held on February 10 in College Park, MD. Annette McCarthy, Ph.D., with the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is the author of the draft. The FDA has posted a Q&A with McCarthy, answering some of the most pressing questions. The information on the public meeting, as well as a link for registration, and contact information is available here.