The U.S. District Court for the Northern District of California ruled late last month that FDA violated the Food Safety and Modernization Act of 2010 by failing to promulgate final regulations for FSMA by the deadlines imposed by Congress and contained in the legislation, reports The Food Institute.
The U.S. District Court for the Northern District of California ruled late last month that FDA violated the Food Safety and Modernization Act of 2010 by failing to promulgate final regulations for FSMA by the deadlines imposed by Congress and contained in the legislation, reports The Food Institute. FDA was directed to promulgate the regulations in seven areas and within 18 months of the effective date of Jan. 4, 2011. However, according to plaintiffs, Center for Food Safety and the Center for Environmental Health, FDA and Commissioner Margaret Hamburg, M.D. did not meet those mandatory deadlines pursuant to the Administrative Procedures Act (APA). The plaintiffs filed a legal complaint Aug. 29, 2012 seeking a judicial declaration that the FDA violated FMSA and the APA by failing to issue the regulations by the statutory deadlines, and continues to be in violation of those statutes for failing to promulgate the regulations. The legal complaint also sought injunctive relief from the court to order the FDA to issue the regulations as soon as reasonably possible, according to a court-ordered timeline, and requested that the court retain jurisdiction over the case to ensure compliance with the order.
Both the plaintiffs and the defendant sought summary judgment in the case, appropriate when there exists no dispute as to material fact, and as a general matter district courts are empowered by the APA to review agency action and have federal question jurisdiction over such claims. For a court to review agency action pursuant to the APA, there must be “final agency action for which there is no other adequate remedy in a court,” which can include a “failure to act.” In such a case, the a court can “compel agency action unlawfully withheld or unreasonably delayed.” The seven major food safety regulation areas include:
Of those, only two regulations were promulgated by FDA: the mandatory hazard analysis and safe production and harvesting of fruits and vegetables rules, both published in January 2013.
The FDA, which regulates more than $400 billion worth of domestic and imported food and hundreds of thousands of registered food facilities, claimed the regulations it was directed to promulgate under the FMSA are “novel and complex,” and during the period that it has been working on the new regulations it continued to monitor the food industry and exercised its preexisting authority. FDA also asserted that despite an organizational structure of implementation teams and working groups specifically directed at the expedited implementation of the FSMA, the agency found “the aggressive timelines set forth in the statute have proven to be unachievable.”
FDA conceded that FMSA provides specific deadlines for the promulgation of the regulations, but argued that because the issue under the APA is whether it “unreasonably delayed” in issuing the regulations, the matter in need of resolution was the reasonableness of FDA’s administrative timeline. The plaintiffs submitted in their motion that FSMA resulted from Congress’ recognition of the prevalence and severity of the food-borne illness problem, and argue that it was because of the need to remedy this problem that Congress instructed the FDA to act quickly to promulgate the needed regulations. The motion suggested that the court could either order the parties to stipulate to deadlines or order the FDA to provide the court with “expedited dates,” and then afford plaintiffs an opportunity to oppose the FDA’s proposed deadlines.
District Judge Phyllis J. Hamilton ruled that declaratory relief was proper, as FDA admittedly failed to comply with the mandatory rulemaking schedule. Additionally, the court found that imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of the FMSA, but the imposition of a timetable “unconnected to the magnitude of the task set by Congress” would not ultimately serve the purposes of ensuring food safety. To that end, District Judge Hamilton ordered the parties in the trial to meet and confer in order to prepare a joint written statement setting forth proposed deadlines, in detail sufficient to form the basis of an injunction. The joint statement also shall be submitted to the court no later than May 20. After reviewing the statement, the court will then determine whether any further written submissions would be helpful or necessary.