FDA Held In Violation of APA for Delay in Issuing FSMA Regulations

April 24, 2013

By Ricardo Carvajal

The U.S. District Court for the Northern District of California granted summary judgment to the Center for Food Safety and Center for Environmental Health in their lawsuit (see our previous post here) alleging that FDA’s delay in issuing regulations to implement the Food Safety Modernization Act ("FSMA") constitutes action unlawfully delayed or unreasonably withheld, in violation of the Administrative Procedure Act ("APA").  Because FSMA provides specific deadlines for the issuance of implementing regulations, the court concluded that “the failure to comply with those deadlines constitutes a ‘failure to act’ under the APA,” and therefore the court need not analyze whether FDA’s delay is unreasonable.  (Briefs in the case are available here, here, here, and here.)

In deciding what relief to grant, the court recognized that Congress did not intend for FDA to have “total discretion in deciding when to finalize the regulations,” but also noted 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.”  The court therefore ordered the parties to confer “in the hope that [they] will themselves arrive at a mutually acceptable schedule.”  Curiously, the court admonished that it would “behoove the parties to attempt to cooperate in this endeavor, as any decision by the court will necessarily be arbitrary.”  The parties are to submit a “joint written statement setting forth proposed deadlines” by May 20, 2013.

It may prove challenging for the parties to reach agreement on proposed deadlines for issuing the regulations that isn’t arbitrary, given the intricate relationship between several of the major regulations, the likelihood of extended review by OMB/OIRA, and the near certainty of industry insistence on comment periods commensurate with the complexity of the task at hand.