A federal court in California has determined that the Food and Drug Administration (FDA) has violated the Food Safety Modernization Act (FSMA) and Administrative Procedure Act (APA) by failing to promulgate, within FSMA deadlines, food-safety rules that implement the law. Ctr. for Food Safety v. Hamburg, No. 12-4529 (U.S. Dist. Ct., N.D. Cal., decided April 22, 2013). According to the court, Congress “intended that the implementing regulations be promulgated and finalized by a date certain. The dates set for completion of the regulations in the seven areas identified in the complaint have passed. However, that does not mean that the FSMA now should be interpreted as granting the FDA total discretion in deciding when to finalize the regulations. . . . Thus, the court finds that the imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of the FSMA.”
Still, agreeing with FDA “that the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress,” and in the hope that the parties could “arrive at a mutually acceptable schedule,” the court ordered them to meet and confer and, by May 20, 2013, prepare a “joint written statement setting forth proposed deadlines, in detail sufficient to form the basis of an injunction.”
In the April 26 Federal Register, FDA published notices extending the deadlines for public comment on its proposed FSMA implementation rules relating to “Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food” and “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” Comments on these proposals and the agency’s “Draft Qualitative Risk Assessment of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” are now requested by September 16, 2013.