Yesterday, the U.S. District Court for the Northern District of California issued an order requiring FDA to propose new deadlines for issuance of regulations implementing the Food Safety Modernization Act (FSMA). Center for Food Safety v. Hamburg, 4:12-cv-04529 (N.D. Cal. Apr. 22, 2013).
In a lawsuit brought by two consumer groups, the court held that FDA’s failure to meet the statutory deadlines in FSMA constitutes a violation of the Administrative Procedures Act and FSMA’s statutory mandate. While acknowledging the complexity of FDA’s task and agreeing that “FDA is correct that the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered,” the court nevertheless ordered the parties to the lawsuit to mutually agree on a new timetable for FSMA implementation:
The parties are hereby ORDERED to meet and confer, and prepare a joint written statement setting forth proposed deadlines, in detail sufficient to form the basis of an injunction. The joint statement shall be submitted no later than May 20, 2013. After reviewing the statement, the court will determine whether any further written submissions would be helpful or necessary.
FDA must now either appeal the trial court’s decision or submit to court-ordered deadlines for its regulations implementing FSMA.
The court’s decision presents immediate challenges for the agency. Just last week, FDA Commissioner Margaret Hamburg, testifying before the Senate Agriculture Appropriations Subcommittee, signaled FDA’s intent to extend the comment periods of the two already published proposed rules, Preventive Controls for Human Food and Produce Standards, into September 2013. See Commissioner Hamburg’s testimony here.
The agency has not publicly commented on the ruling or whether it will appeal. We will update this post as new information emerges.
