Federal Court Grants Order Compelling FDA Rulemaking on FSMA
The Northern California U.S. District Court on April 22 granted the Center for Food Safety’s motion for an order mandating a timetable for implementation of the Food Safety Modernization Act, although it declined to set out specific deadlines in its ruling. Concerned that its own dates would be arbitrary, the court instead ordered the Center for Food Safety and the Food and Drug Administration to agree to a timeline by May 20.
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The Center for Food Safety filed its motion to compel FDA to issue its long overdue FSMA regulations on Jan. 11 (see 13011501). According to the D.C.-based non-profit, the Food Safety Modernization Act mandated seven specific deadlines for FDA rules implementing FSMA’s components, yet the agency failed to meet a single one. Past due regulations include final rules on produce safety, preventative controls, the Foreign Supplier Verification Program, third-party accreditation, intentional adulteration, and sanitary transport. FDA’s tardiness violated both FSMA and the Administrative Procedure Act, the non-profit said. The Center for Food Safety requested a declaration that the delays are illegal, a court order mandating a timetable for implementation, and court oversight of implementation.
FDA argued that its delayed implementation of FSMA isn’t unreasonable, and is the result of Congress’ unachievable deadlines (see 13022003). The rules are important for food safety, it said, but it is also important that the regulations be carefully developed, it said.
Congress did set deadlines, however, and just because those dates have been passed “does not mean that the FSMA now should be interpreted as granting the FDA total discretion in deciding when to finalize the regulations,” the court said. The concrete deadlines contained in the law render irrelevant the question of whether the delays are reasonable, it said. The agency’s delays constituted a failure to act under the APA, said the court. Given that Congress signaled its intent that the process be “closed-ended, rather than open-ended” by imposing the deadlines, the court decided to impose a timeline on the agency for FSMA implementation.
But the court agreed with the agency that the purpose of the food safety law would not be served by thoughtlessly conceived regulations, based on a timetable “unconnected to the magnitude of the task set by Congress. Rather than come up with the dates itself, the court ordered the Center for Food Safety and FDA to collaborate on the task. “It will behoove the parties to attempt to cooperate on this endeavor, as any decision by the court will necessarily be arbitrary,” the court said.
(Center for Food Safety v. Hamburg, Court No. C 12-4529 PJH, dated 04/22/13)
Email ITTNews@warren-news.com for a copy of the court’s judgment.