United States District Judge Phyllis Hamilton has denied a request from the FDA for additional time to promulgate standards for preventing intentional adulteration of food, stating that although she is sympathetic to the FDA’s position, “the dispute here is between the FDA and Congress.”
The order is the latest development stemming from an August 2012 lawsuit filed in the Northern District of California by the Center for Food Safety (CFS) alleging that the FDA’s failure to meet statutory deadlines in implementing the Food Safety Modernization Act (FSMA) constituted unlawfully withheld and unreasonably delayed agency action under the Administrative Procedure Act (APA) and FSMA. CFS sought injunctive relief requiring the FDA to immediately promulgate all FSMA regulations.
The court held that the FDA’s failure to meet the statutory deadlines violated the APA and ordered CFS and the FDA to come up with a new timetable. The parties were unable to reach an agreement so they each submitted different schedules. The court established its own schedule, ordering that all proposed rules be published by November 30, 2013, all comment periods closed by March 31, 2014, and all final rules published by June 30, 2015. This most recent order grants the FDA an additional 60 days for the proposed regulations implementing the Sanitary Food Transportation Act (STA).