FDA Lawyer Concedes Difficulty in Meeting FSMA Deadlines

OAKLAND, Calif.A government lawyer on Wednesday acknowledged the difficulty the U.S. Food and Drug Administration (FDA) faces in meeting deadlines that Congress imposed under the 2-year-old Food Safety Modernization Act.

Thanks to a lawsuit filed last year by the Center for Food Safety and Center for Environmental Health, FDA finds itself in court after missing numerous deadlines under the sweeping law.

"Congress set tremendous tasks for the agency, and in no detail," Gerald Kell of the Justice Department stated, according to a news report from Law360 covering a hearing in California before U.S. District Court Judge Phyllis Hamilton. "We didn't get any new staff, or a new center, as we did with tobacco regulation. We got, 'You're the experts; you know how to deal with food safety; we want you to tighten the system.'"

The lawsuit claims FDA missed hundreds of deadlines, including the making of seven major food-safety regulations, and the plaintiffs want the judge to set new deadlines. That could prove tricky.

"I'm not sure what tools I have at my disposal to fashion an additional deadline," Hamilton said, according to Law360. "Why wouldn't any deadlines set by the court be as arbitrary as the congressional deadlines?"

In January, FDA proposed produce-safety and preventative control rules in support of FSMA's goal to prevent foodborne illness. Around the same time, the Center for Food Safety and Center for Environmental Health filed a motion for summary judgment in the lawsuit, seeking a finding that FDA violated FSMA and the Administrative Procedure Act because it missed the deadlines. In the motion, plaintiffs asked the judge to impose a court-ordered deadline for promulgating the food-safety rules.

The comprehensive food-safety law, plaintiffs allege, has not reduced the risk of foodborne illness to consumers, as illustrated by a number of outbreaks that have occurred in recent years.

"The continued occurrence of deadly outbreaks more than two years after Congress gave the FDA the authority to proactively prevent, rather than simply react to or respond to, threats to food safety demonstrates that FDA continues to thwart the intent of Congress and put the American public at serious risk of illness or death by its failure to promulgate the regulations Congress mandated," lawyers for the Center for Food Safety wrote.

The Justice Department contends plaintiffs "fail to appreciate the complexity of the tasks at hand and the real, concrete, and substantial progress the agency has made to date."

"Under the circumstances, the pace of the agency's implementation is eminently reasonable and judicial intervention is not warranted," government lawyers wrote in a court document last month.

The government said it has made substantial progress implementing FSMA since the lawsuit was filed. In a declaration filed with the court, Michael Taylor, FDA's Deputy Commissioner for Foods and Veterinary Medicine, pointed out the agency published a 178-page proposed rule that establishes preventative controls in human food facilities. FDA also has published a 143-page proposed rule establishing science-based minimum standards for the safe production and harvesting of certain fruits and vegetables.

But plaintiffs still aren't satisfied with FDA's progress, noting that the agency is giving the public 120 days to comment under the proposed rules that were published in January. This comment period, they griped, indicates "further delay and continued failure to promulgate any final rules required under FSMA."