According to a June 10 court filing, the Food and Drug Administration expects to issue proposed rules on the foreign supplier verification program and accreditation of third party auditors by this summer, with final rules expected on both by the summer of 2015. The agency also estimates that final versions for the produce safety and the preventive controls rules will be issued by the summer of 2015.
That time line wasn’t as precise and quick as the Center for Food Safety proposed, however, as both the FDA and the Washington, D.C.-based advocacy group failed to agree on a time line ordered by the U.S. Court in the Northern District of California. The Center for Food Safety said it would like to see the FDA publish proposed rule of the foreign supplier verification program issued by Aug. 31 and a final rule by May of 2014. The Center would also like the proposed rule on accreditation of third-party auditors to be issued by Aug. 31 and a final version by the end of 2013.
The Center for Food Safety believes that the produce safety and the preventive control rules should be finalized by May 2014.
The two parties have been unable to come to terms with the time line for food safety regulations.
In a lawsuit brought by the Center for Food Safety against the FDA last fall, the consumer group said the agency failed to enact food safety regulations within the 18 months mandated after passage of the 2011 Food Safety Modernization Act. U.S. District Judge Phyllis Hamilton on April 22 ordered the FDA to work with the plaintiffs to establish a new timetable for food safety regulations by May 20. Hamilton of the Oakland U.S. District Court issued a ruling May 21 that gave the parties until June 10 after the two parties were unable to come to terms on a date by May 20.
George Kimbrell, senior attorney for the Center for Food Safety, Portland, Ore., said the FDA didn’t meet the court’s requirement.
“Last Monday (June 10) the parties submitted competing remedy proposals,” he said June 19. “We submitted one with actual deadlines, per the court’s order and FDA submitted one that was basically guesstimates that they refused to be held to, which we believe was contrary to the court’s order,” Kimbrell said. “They utterly failed to comply with the court’s order.”
He said it will be up to U.S. District Judge Phyllis Hamilton to issue a final remedy decision. Kimbrell said he is hopeful the Judge Hamilton will issue a final remedy without any delay, but said timing of her next move is unknown.
Sebastian Cianci, spokesman for the FDA, said in a June 19 statement that the FDA’s new timeline for food safety regulations are reasonable, given the complexity of the provisions mandated under the Food Safety Modernization Act.
David Acheson, former FDA official and partner at Leavitt Partners, said he doubts that FDA will be forced by the court to comply with arbitrary deadlines.
“I think the FDA is saying that 'This is the best we can do guys,’ ” he said. “The court can scream and holler all it wants but that is reality.” Acheson said the consequences that the court could bring seem to be negligible. “Nobody is going to support a piece of garbage coming out just for some silly time line,” he said.
The good news, he said, for industry observers is that the FDA’s communication with the courts gives a better sense of how fast FDA is moving. “I will say that I think if they slip past those deadlines there is going to be a lot of hollering from a lot of people.”