FDA Seeks Stay in FSMA Rulemaking Litigation
The U.S. Food and Drug Administration (FDA), currently under a district court
timeline for completing the implementing regulations required under the
Food Safety Modernization Act (FSMA), has filed an emergency stay pending
appeal before the Ninth Circuit Court of Appeals, arguing that the 16-day
government shutdown in October makes compliance “not only unsound
but impossible.” Ctr. for Food Safety v. Hamburg, No. 13-16841 (9th Cir., filed
October 18, 2013). Details about the district court’s refusal to amend the
deadlines appear in Issue 494 of this Update.
FDA specifically requests relief from the November 30 deadline for the publication of a proposed rule “addressing novel requirements for preventing the intentional adulteration of food.” The agency claims that compliance would “threaten to waste scarce agency resources and risk results inconsistent with the public interest by requiring FDA to spend the next several weeks completing and publishing a proposal that does not take account of pertinent information.” Further claiming that the district court “failed to apply governing legal principles and overstepped its authority,” FDA also seeks an expedited oral argument date for its appeal of the lower court order. A motion for stay is pending before the district court.