Food Safety Regulatory Update: Court Imposes Deadlines on FDA to Promulgate and Implement FSMA Rules by 2015
On June 21, 2013, the United States District Court for the Northern District of California issued an order requiring the U.S. Food and Drug Administration (“FDA”) to publish regulations under the Food Safety Modernization Act (“FSMA”) by June 30, 2015. (To read the full text of the June 21, 2013 order, please click here. For additional news coverage by Food Safety News, please read their article here.) As we previously reported here and here, the FSMA contains various sweeping provisions that significantly expanded the FDA’s authority to regulate the conditions under which food products are produced, manufactured, transported, imported, and marketed in the United States. In enacting the FSMA in January 2011, Congress set specific deadlines by which the FDA was expected to promulgate all of its food safety rules, with some deadlines as early as 180 days after FSMA’s enactment and others as late as two years thereafter. Although the FDA has made some progress in promulgating and implementing the FSMA, it has also missed several mandatory deadlines.
In August 2012, the Center for Food Safety and Center for Environmental Health (“Plaintiffs”) filed a complaint against FDA Commissioner Margaret Hamburg seeking declaratory and injunctive relief regarding the FDA’s failure to promulgate final regulations by the mandatory deadlines contained in the FSMA. (For additional news coverage, please read Food Safety News’s article here.) On April 22, 2013, the Court issued an order granting Plaintiffs’ motion for summary judgment and request for a judicial declaration that the FDA had violated the FSMA by failing to promulgate the required regulations in accordance with the deadlines mandated by Congress. (For more information, please read Bloomberg’s coverage here.) Moreover, the Court found that the Plaintiffs were entitled to injunctive relief, but requested the parties to submit a joint statement setting forth agreed proposed deadlines. The parties were unable to reach an agreement and submitted competing proposals for the court’s review.
The Plaintiffs submitted a schedule of proposed deadlines, which would have required the FDA to publish all final rules in the Federal Register by May 1, 2014. The Court rejected the Plaintiffs’ proposed schedule as “overly restrictive in light of the FDA’s showing of the complexity of the task” and the FDA’s “showing of diligence in attempting to discharge its statutory duty to promulgate regulations.” The FDA countered with proposed target timelines of 2015 through 2016 for the publishing of all final rules, which the Court also rejected as “an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction.” Instead, the Court imposed its own deadlines on the FDA, emphasizing the need for adequate time for public comment and review by the Office of Management and Budget (“OMB”). The Court’s order requires the FDA to publish all proposed regulations by November 30, 2013 and to close all comment periods no later than March 31, 2014. Additionally, the order requires the FDA to publish all final regulations in the Federal Register no later than June 30, 2015.
Even though the Court imposed firm deadlines on the FDA, it acknowledged that the FDA “has limited resources” to carry out the complex and difficult task of promulgating the FSMA. Moreover, while the Court’s decision seems intended to prevent the FDA from any further delay in implementing the FSMA, the timing of the Court’s deadlines, which provide a compromise between the proposals submitted by both parties, suggests that the Court was also reluctant to force the FDA to rush the procedural processes required to promulgate and implement the FSMA.
Fuerst Ittleman David & Joseph will continue to monitor the FSMA as it is implemented by the FDA. For more information, please feel free to contact us via email at email@example.com or by phone at (305) 350-5690.