On Nov. 4, the U.S. Ninth Circuit Court of Appeals denied an FDA motion to delay issuing a draft rule on intentional adulteration of food required by the Food Safety Modernization Act. FDA sought to suspend that while the agency pursues an appeal, but the court denied that request.
However, the court said FDA will have extra time to propose its rule to protect against food has been intentionally adulterated. That proposed rule is now due by Dec. 20 instead of Nov. 30, as the court added time because of the government shutdown in October.
George Kimbrell, lead attorney with Center for Food Safety, the advocacy group that took FDA to court over their failure to meet Congressional deadlines for food safety regulations, said the group was pleased with the court’s ruling.
“FDA has put out all the draft regulations except the (intentional adulterated) regulation and they asked the court to be excused from that deadline and were denied it,” Kimbrell said.
The agency has already published proposed regulations on the produce safety rule, preventive controls for food facilities, foreign supplier verification and third party auditor accreditation.
Now, Kimbrell said the FDA must issue the proposed regulation on foods that have been intentionally adulterated by Dec. 20.
“Anything less would be sanctionalble; they will get it out,” Kimbrell said.
In the Ninth Circuit Court ruling, the judge OK’d an expedited hearing on the FDA’s appeal of the court-ordered deadlines. The court said opening brief and excerpts of record are due Dec. 23 The case is expected to be set for hearing by the week of March 10, 2014.
Kimbrell acknowledged that some industry groups want another round of proposed regulations for the produce safety rule and the preventive controls rule.
According to the court ruling, final regulations for all food safety rules are due by June 2015.
“That’s plenty of time for public comment to take place,” he said.
FDA has wanted an open-ended process that could extend to 2018, he said.
“That’s not acceptable and that’s not what Congress ordered when it set the deadlines into law and the court agreed with us several times,” Kimbrell said.
Sebastian Cianci, spokesman for the FDA, said in an e-mail Nov. 7 lthat the agency is “putting forth its best efforts to comply with the court-ordered deadlines.”