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District Court Requires All FSMA Final Rules By June 2015

Overdue regulations implementing the Food Safety Modernization Act must be published in final form by June 30, 2015, according to a June 21 order from the Northern California U.S. District Court. The order from Judge Phyllis Hamilton set deadlines for seven rulemakings, despite FDA’s insistence that hard deadlines would result in ill-conceived regulations. But the judge gave FDA some leeway. She set dates over a year after the deadlines proposed by the Center for Food Safety, given “FDA’s showing of the complexity of the task.”

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“This is a critical victory for consumers, farmers, and the public health,” said George Kimbrell, attorney for the Center for Food Safety, in a prepared statement (here). “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.” FDA declined comment on the decision.

Court Requires Deadlines, Not Goals

The Center for Food Safety filed its motion to compel FDA to issue its long overdue FSMA regulations on Jan. 11 (see 13011501). According to the D.C.-based non-profit, FSMA mandated seven specific deadlines for FDA rules implementing FSMA’s components, yet the agency failed to meet a single one. Past due regulations include final rules on produce safety, preventative controls, the Foreign Supplier Verification Program, third-party accreditation, intentional adulteration, and sanitary transport. FDA’s tardiness violated both FSMA and the Administrative Procedure Act, the non-profit said. The Center for Food Safety requested a declaration that the delays are illegal, a court order mandating a timetable for implementation, and court oversight of implementation.

In April, the district court ruled that FDA had violated FSMA and the APA by missing the deadlines set forth in the law (see 13042402). Rather than set new deadlines herself, Judge Hamilton urged FDA and the Center for Food Safety to come to an agreement. But the gap between the parties became apparent June 10, when FDA and the Center for Food Safety submitted fundamentally different proposals to the court (see 13061119). While the Center for Food Safety wanted hard deadlines of the type it said were originally envisioned by FSMA, the agency proposed “target timeframes,” or goals that it would try to meet. Given the complicated subject and the vagaries of the rulemaking process, “it is not feasible to predict with anything approaching certainty when the final FSMA regulations will be ready to be published,” FDA said.

On June 21, the court ruled in favor of the Center for Food Safety. “By setting deadlines for the promulgation of the implementing regulations, Congress indicated that the rule-making process should be closed-ended, rather than open-ended,” said Judge Hamilton in the decision. “Thus, 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.”

But the Center for Food Safety’s proposed deadlines would have been “overly restrictive in light of the FDA’s showing of the complexity of the task,” the court said. Given the complexity and wide range of groups that would be impacted by the regulations, the court refused to cut short the public comment period, and declined to prevent Office of Management and Budget Review. The court said it wouldn’t require quarterly progress reports from FDA, because it would just be another burden on the agency’s limited resources.

The Northern California District Court ordered FDA to publish all proposed regulations in the Federal Register by Nov. 31, 2013. For each proposed rule, the comment period must end by March 31, 2014. The FDA will have to publish all final rules by June 30, 2015.

Email ITTNews@warren-news.com for a copy of the court order.