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Judge places FDA on court-ordered schedule for FSMA rules

WASHINGTON — The Food & Drug Administration must issue final produce safety and preventive controls regulations no later than June 2015, and propose other key food-safety regulations by Nov. 20, 2013, according to a court order handed down by a federal judge after two consumer groups sued FDA over its delay in releasing FDA Food Safety Modernization Act rules.

The Center for Food Safety and Center for Environmental Health sued FDA last August for not meeting the deadlines Congress established in FSMA. Only two major regulations were proposed by FDA in January, while other proposals have been undergoing final White House review for months.

The FDA argued in the case that the law's requirement for multiple public meetings, resource constraints and the complexity of the issue made it nearly impossible to adhere to the Congressional mandate.

But U.S. District Judge Phyllis Hamilton sided with the groups in April, and after the FDA and the consumer groups could not reach a mutually agreed-upon timetable for the FSMA rules, she set her own timetable in a three-page court order issued June 21.

Under the new schedule, FDA must finalize the produce safety and preventive controls proposals by June 30, 2015, and propose all remaining regulations, including the Foreign Supplier Verification Program, third-party accreditation, preventive controls for animal foods and intentional contamination, by Nov. 30, 2013.

The public comment period cannot go later than March 31, 2014, and all final rules must be released by June 30, 2015, said the court.