District Court Refuses to Stay FSMA Rulemaking Deadlines

Three days after the U.S. Food and Drug Administration (FDA) filed a motion for emergency stay pending appeal before the Ninth Circuit, the federal district court that had established November 30, 2013, as the deadline for the agency to publish notices of proposed rulemaking (NPRM) for specific food safety rules under the Food Safety Modernization Act denied the motion for stay pending appeal that FDA filed before it in September. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered October 21, 2013). Details about the emergency stay request based on delays attributable to the federal government shutdown appear in Issue 501 of this Update.

According to the district court, FDA failed to show that it would be irreparably injured absent a stay. The court recognized that the agency was unprepared to issue a final rule on the intentional adulteration of food by the November 2013 deadline, “But that is not what the injunction requires,” the court stated. “Rather, the FDA must merely promulgate an NPRM by November 30 that meets minimum APA [Administrative Procedure Act] requirements, or that provides notice to interested parties, or that discloses information bearing on the NPRM that the FDA currently possesses.” The court further noted, “The FDA alleges it currently lacks sufficient information on which to base its rule. But the FDA can remedy this deficiency after the NPRM is issued by using public comment to collect more information before the agency promulgates a final rule.”