FDA Proposes to Finalize Food Safety Rules Within Two Years
The Food and Drug Administration and the Center for Food Safety were unable to meet a June 10 deadline for agreeing on a timeframe for promulgating a number of regulatory changes required by the Food Safety Modernization Act. Instead the two sides offered up differing visions for when the rules would be completed, leaving it up to a federal judge to render a final decision.
Earlier this year the FDA issued its first two proposed rules to implement FSMA provisions, one on procedures to ensure safe produce and the other requiring domestic and foreign food facilities to establish plans to identify and respond to food safety hazards. Other proposed regulatory changes have yet to be published, including rules on the Foreign Supplier Verification Program, sanitary transportation of food products, accreditation of third-party auditors and protection against intentional adulteration.
According to press sources, the FDA says it could issue final rules on produce standards and facility safety plans by summer 2015, but the CFS wants them done by May 1, 2014. Proposed rules on the FSVP and accrediting third-party auditors would be issued this summer and finalized two years later under the FDA plan, but the CFS is urging them to be completed by the end of this year.
The FDA defended its proposal by noting that the complex nature of the subject matter and the extent of the changes made by FSMA make it difficult to commit to specific deadlines. The agency called its timeline “aggressive but achievable” provided that “no new obstacles arise.” A Reuters article cited a CFS attorney as expressing hope that the judge hearing the group’s case against the FDA will order a quicker turnaround given the “life or death” nature of the changes mandated by FSMA but also noted the comments of a former FDA official that “this is an enormously complicated undertaking” and that “the FDA has to have the time to be able to get it right.”