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Court May Not Have Power to Hasten FSMA Implementation, Judge Says

The parties suing the U.S. Food and Drug Administration for its failure to meet several deadlines laid out in the Food Safety Modernization Act got discouraging news at a hearing last week when a federal judge said she might not be able to make FDA quicken its pace.

The case was filed last August in the U.S. District Court of Northern California by the Center for Food Safety and the Center for Environmental Health after FDA missed seven major deadlines laid out by Congress in the FSMA, which was signed into law by President Obama in 2011.

During a hearing Wednesday, Judge Phyllis Hamilton asked attorneys for the Center for Food Safety if it would be possible for the Court to implement a new timeline, reported Law360.

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

The plaintiffs’ lawyer George Kimbrell of the Center for Food Safety did not directly address the question, according to Law360, but he did re-emphasize the Center’s goals.

“We’re not asking the court to be a super-FDA, just to set a timetable,” said Kimbrell. “We’re asking that this should be a closed-ended process, with no further delay than is necessary, with oversight.”

Kimbrell stressed the importance of rapid implementation of the FSMA-mandated rules:

“These are literally life-or-death interests at play here. It’s hard to imagine a higher priority for the FDA.”

An attorney for FDA said the agency was not equipped to implement FSMA in the time frame laid out by Congress.

“Congress set tremendous tasks for the agency, and in no detail,” said Gerald Kell of the U.S. Department of Justice, according to Law360. “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.’”

Among the rules that FDA failed to publish on time are preventive controls for food facilities, preventive controls for animal feed facilities, a foreign supplier verification program and produce safety regulations – all cited by the Center for Food Safety in its complaint.

Since the case was filed, FDA has published proposed rules preventive controls for human food and for produce safety.

FDA’s rules are first submitted to the White House Office of Management and Budget, which must approve them before they are made available for public comment. OMB is also named as a defendant in the case.

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