Court Requires FDA to Final FSMA Regulations by June 2015

Judge Phyllis Hamilton of the U.S. District Court of Northern California ruled that the FDA must publish all of the final regulations required under the Food Safety Modernization Act by June 30, 2015. This ruling expressly rejected the FDA’s proposed target timeline for 2015-2016 for the publication of the final rules.

As stated in the order:

April 22, 2013, the court issued an order granting plaintiffs’ motion for summary judgment and denying defendant’s motion for summary judgment. The court granted plaintiffs’ request for a judicial declaration that the FDA had violated the FMSA by failing to promulgate the required regulations in accordance with the deadlines mandated by Congress…. As the court found in the April 22, 2013 order, by setting deadlines for the promulgation of the implementing regulations, Congress indicated that the rule-making process should be closed-ended, rather than open-ended….In completing the FDA’s required rule making under the FSMA, with regard to proposed regulations that have not yet been published in the Federal Register, defendant is ORDERED to publish all proposed regulations by November 30, 2013. In each instance, the close of the comment period shall be no later than March 31, 2014. All final regulations shall be published in the Federal Register no later than June 30, 2015. Apartfrom these deadlines, defendant shall have the discretion to prioritize other matters relating to the rule making process.

Thus the process for the regulations that are out for review now, Preventive Controls and the Produce Safety Rules are on a faster track than had been contemplated; perhaps leaving no time for the circulation of a revised set of rules as had been contemplated by some parties.