WASHINGTONThe U.S. Food and Drug Administration (FDA) has settled a lawsuit, agreeing to publish regulations by firm deadlines under the 3-year-old Food Safety Modernization Act (FSMA), a food-safety group that sued the agency announced Thursday.
The Center for Food Safety, which prevailed in a district court lawsuit that was filed against FDA in 2012 because the agency missed deadlines under FSMA, announced the settlement.
FDA has agreed to drop an appeal before the U.S. Court of Appeals for the 9th Circuit and follow the schedule below to submit the final rules to the Federal Register for publication:
· Aug. 30, 2015: preventative controls for human and animal food;
· Oct. 31, 2015: foreign supplier verification program;
· Oct. 31, 2015: produce safety standards;
· Oct. 31, 2015: accreditation of third party auditors;
· March 31, 2016: sanitary transportation of food and feed; and
· May 31, 2016: intentional contamination of food.
The Center for Food Safety said a federal court will supervise FDA's compliance with the settlement agreement.
FDA noted the settlement has not yet been approved by the court.
During the litigation, the agency cited the challenges of meeting aggressive timelines that Congress imposed under the food-safety law. FSMA was enacted in response to a series of outbreaks of foodborne illness and represents the most sweeping reform of food-safety law in more than 70 years.
In June 2013, U.S. District Judge Phyllis Hamilton ordered FDA to publish final rules no later than 2015. But FDA filed an appeal before the West Coast-based 9th Circuit.
"The FDA is committed to fully implementing the FSMA and to putting in place the modern, preventive framework envisioned by the law that will help to prevent foodborne illnesses and protect public health," a spokesperson for the agency said in a statement. "The agency is working as quickly and expeditiously as possible to meet our deadlines for the final rules, while also ensuring that we get these rules right."
The Center for Environmental Health joined the Center for Food Safety in the original lawsuit against FDA.