This past year was a big one for the Food Safety Modernization Act (FSMA), with the U.S. Food and Drug Administration (FDA) proposing six of its seven major rules. Now, there are a number of deadlines facing the agency in 2014.
Looking forward to this year, one key date to remember is Jan. 31 – the court-ordered deadline for FDA to release its sanitary transportation rule. This seventh rule is meant to ensure that human and animal food is not transported under unsafe conditions. It will include requirements for shippers, carriers by motor vehicle or rail, receivers, and others engaged in food transportation to use sanitary practices.
The comment periods for the produce safety and human food preventive controls concluded in November, but the environmental impact statement for produce safety and four other rules are still open for comments. The extended comment period for foreign supplier verification programs and accreditation of third-party auditors for foreign facilities ends Jan. 27. Comments are due for preventive controls for animal food by Feb. 26, for the environmental impact statement by March 14, and for mitigation for intentional adulteration by March 31.
While these four must conclude their comment periods by March 31, the transportation rule can stay open for comments until May 31.
And, to confuse the timeline a bit, FDA recently announced that, after closing comments for these five rules, it plans to seek more comments on revised language for certain portions of the produce safety and preventive controls rules. That language is expected “early summer 2014.”
Various groups at FDA are still working on dozens of guidance documents and reports that are required under FSMA, but the agency has not yet released a timeline for them.
After comment periods on all the proposed rules have ended, FDA will make any adjustments to their language and send them off for departmental and Office of Management and Budget review. The final rules must eventually be published in the Federal Register by June 30, 2015, in order to comply with a judge’s ruling from the U.S. District Court of Northern California.
