FDA Says Court Schedule for FSMA Would Result in 'Ill-Conceived' Regulations
In arguing that the Food and Drug Administration’s implementation of the Food Safety Modernization Act has been too slow, “plaintiffs fail to appreciate the complexity of the tasks at hand and the real, concrete, and substantial progress the agency has made to date,” said the FDA in its reply to the Center for Food Safety’s Jan. 11 motion to compel issuance of several long-overdue FSMA regulations. The non-profit wants the Northern California District Court to mandate a timetable for FDA to issue FSMA regulations, including third-party auditing and the Foreign Supplier Verification Program.
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Despite the passing of several statutory deadlines, FDA is making progress, it said. FDA issued its produce safety and hazard analysis proposed rules Jan. 16. “These proposals are concrete steps that FDA has taken to implement the requirements” of FSMA, and “are three of the seven statutory requirements identified in plaintiffs’ complaint.”
In its motion, the Center for Food Safety pointed to several cases that it said show that the court has no choice but to find FDA’s delay unreasonable, because the delay violates strict deadlines violated by Congress. But according to FDA, that reading of the case law is incorrect. The Ninth Circuit case relied upon by the center to show the court lacks discretion only contains a footnote to that effect, FDA said, and the motion to compel agency action in that case was moot. And the “well settled case law” showing that the court shouldn’t have discretion on the delay’s reasonableness does not apply to the facts of this case, said FDA.
“Where, as here, Congress directed the agency to undertake such unusually comprehensive rulemakings, taking into account a myriad of scientific and regulatory issues and diverse interests, and consulting with a vast number of regulators and stakeholders, it would not be possible for the agency to execute these tasks on an immediate timeline,” the agency said. A court-mandate would be counter-productive because FSMA is “such a complex matter with such broad impact on the economy,” and the result would be “ill-conceived or incomplete regulations.”
The Center for Food Safety’s reply brief is due March 8, after which the court will hold a hearing March 27.
Email documents@ITTNews.com for a copy of FDA’s brief or Deputy Commissioner’s Michael Taylor’s attached statements detailing the agency’s progress in January 2012.