Judge denies more wiggle room for FDA rulemaking - The Packer

Judge denies more wiggle room for FDA rulemaking

08/14/2013 01:40:00 PM
Tom Karst

Keeping the Food and Drug Administration on a strict timeline for completion of food safety rules, a California district court judgeturned down an FDA motion asking for more time to issue regulations.

The regulations are about intentional adulteration and sanitary transport of food.

Final regulations related to the food safety legislation are due by June 30, 2015. That ruling, from U.S. District Court for the Northern District of California Judge Phyllis Hamilton, was prompted by a lawsuit by the Center for Food Safety, an advocacy group that says FDA has illegally missed Congressional deadlines for food safety regulations mandated by the Food Safety Modernization Act. In that law, Congress had set July 2012 as the date food safety rules should be final.

The agency has published proposed regulations in four of the seven areas required by the food safety law so far, including the produce safety rule, preventive controls for food facilities, foreign supplier verification and third party auditor accreditation. All of those proposed regulations have comment periods that end in November.

There is an expectation that the FDA will issue its proposed rule on sanitary transport of food fairly soon, said David Gombas, senior vice president for food safety and technology for the United Fresh Produce Association. On the other hand, Gombas said he had heard FDA may choose to issue an advance notice of rulemaking for the regulation on intentional adulteration. That may signal a longer timeline to complete that regulation, he said.

In its appeal to the court, FDA officials said the agency projects releasing the final rule for the intentional adulteration regulation during the second half of 2017. But in the Aug. 13 ruling,  the court said the FDA hadn’t done enough to argue its case.

“This court is unwilling to grant extension after extension, to permit the FDA to continually delay publication of this rule, in the face of the clear Congressional directive that this be a closed-end process,” Hamilton said in her ruling.

Gombas speculated the agency may be again forced to file an appeal.

“It would be unfortunate if a court-ordered deadline forced (FDA) to move too quickly,” he said.

However, a spokesman for the Center for Food Safety said the agency has had long enough to complete the food safety rules.

“This ruling is clear; FDA must step up and protect public health as it has been directed by Congress. Postponing these rules unnecessarily only endangers more lives. Center for Food Safety is pleased by today’s ruling and will continue to work to ensure consumers have a safe and healthy food supply,” George Kimbrell, senior attorney for Center for Food Safety, said in a news release from the group.

FDA spokesman Sebastian Cianci said the agency would not comment on the litigation.

Corrected: The article originally cited the wrong identification for the Center for Food Safety spokesman.



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