Thursday, February 09, 2012 by Lee Mannering
FSMA rules update: several proposals, including produce safety, still at OMB
On December 9, the proposed “produce rule” as mandated by the Food Safety Modernization Act (FSMA) moved to review at the White House’s Office of Management and Budget (OMB). In late November, the proposed rules for foreign supplier verification and preventive controls also arrived at OMB. As of today, all three proposals remain under review.
Per the proposed produce rule’s abstract, FDA would create regulations setting enforceable standards for fresh produce safety at the farm and packinghouse, to reduce the risk of illness. Key themes include: prevention-oriented public health principles, learnings since FDA issued its good agricultural practice guidelines, modern preventive controls, the importance of environmental hazard assessments, and examples of risk reduction practices. The requirements will be scale-appropriate and commensurate with the relative risks and complexity of individual operations.
On preventive controls, FDA will develop rules for science-based minimum standards for hazard analysis and preventive controls. The agency will also create regulations for on-farm packing or holding of food and is proposing to amend its current good manufacturing practice regulations to require food facilities to develop and implement a written food safety plan.
For foreign supplier verification, the proposal will require that each importer have a program that assures that each foreign supplier produces food in compliance with processes and procedures that provide the same level of public health protection as those required under section 418 (hazard analysis and risk-based preventive controls) or section 419 (produce safety standards) of the Food, Drug & Cosmetic Act; and sections 402 (adulteration) and 403(w) (major food allergens) of the FD&C Act. FDA will, as appropriate, take into account differences among importers and types of imported foods, including differences in food risk.
It remains unclear when these proposed rules will move from OMB review to publication. However, it’s important to keep in mind that when the produce safety proposal is released, FDA is required by FSMA to conduct not less than three public meetings around the U.S. for comment. This is in addition to the normal comment protocols. FDA has made it clear it wants to hear from industry; check out this post from FDA on the importance of stakeholder engagement.
As always, PMA will continue to monitor these proposals’ progress closely and let you know of any updates as we learn them. In the meantime, visit our FSMA resource page for a summary of our activities to date on these important regulations. If you’ve got thoughts about the FSMA, share them with other members in the Food Safety Community on PMA Xchange.