A federal court in California has determined that the U.S. Food and Drug Administration (FDA) has not met the standard for the court to issue an order amending the deadlines set forth in its June 2013 order for promulgating and finalizing implementing regulations under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (U.S. Dist. Ct., N.D. Cal., order entered August 13, 2013). Information about the court’s earlier order appears in Issue 489 of this Update.
Because the plaintiff agreed that the proposed sanitary transport rule deadline could be extended, however, the court granted FDA’s motion only to this extent. The proposed rule must be published by January 31, 2014, and the court will allow comment on it until May 31. The final rule must be published as originally specified—no later than June 30, 2015. The court rejected FDA’s request to extend the deadline for promulgation of the intentional adulteration rule and refused to grant it a stay, given that no notice of appeal had been filed.