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FDA Must Complete FSMA Rules by Mid-2015, Judge Says

The U.S. Food and Drug Administration must publish all of the regulations required under the 2011 Food Safety Modernization Act by June 30, 2015, a federal judge ruled Friday.

Judge Phyllis Hamilton of the U.S. District Court of Northern California rejected FDA’s proposed timeline for completion of the regulations, which outlined “target timelines” of 2015 through 2016 for the publishing of all final rules.

“The court finds defendant’s ‘target timeframes’ to be an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction,” wrote Hamilton in her decision.

The ruling marked the latest, and possibly last, phase in the suit brought by the Center for Food Safety against FDA for the agency’s failure to meet several deadlines for the writing of FSMA-mandated rules. In a petition filed August 29, 2012, CFS asked the court to order the completion of the delayed rules.

Since that time, FDA has released three of the seven key rules that CFS sited as overdue in its filing, including the proposed rule for produce safety, the proposed rule for preventive controls across the food supply and new requirements for food facility registration.  Three other rules have been submitted to the White House Office of Management and Budget, which must approve the proposed rules before they are released. These include new standards for foreign food suppliers, preventive controls for animal feed and standards ensuring the neutrality of third-party audits.

A regulation ensuring the safe transport of food, also mandated by FSMA, has yet to be submitted to OMB.

On April 13 of this year, Judge Hamilton issued a motion for summary judgment, requesting the parties to submit remedy proposals for new deadlines.

While the Court found the deadlines submitted by FDA to be too fluid, it also acknowledged the complexity of FDA’s task and did not require the agency to publish all of its final rules by May 1, 2014, the amended deadline that CFS had proposed. The Court said this date was “overly restrictive” and could also lead to the curtailing of the public comment periods for the rules, a situation the Court wished to avoid.

“This is a critical victory for consumers, farmers, and the public health,” said George Kimbrell, CFS senior attorney in a statement. “The Court’s decision will ensure FDA cannot unduly delay these life-saving measures any longer, while also ensuring all interested parties have a meaningful say in their outcome.”

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