Judge Nixes FDA Effort to Stay Intentional Adulteration Rule Deadline; FDA Files Another Request, Cites Shutdown
The Northern California U.S. District Court rejected on Oct. 21 the Food and Drug Administration’s attempt to delay the court’s Nov. 30 deadline for the agency’s intentional adulteration proposed rule. FDA had asked for a stay of the deadline for the Food Safety Modernization Act-required rulemaking while the U.S. Court of Appeals for the 9th Circuit hears the case. FDA has also filed a request for an “emergency stay” of the Nov. 30 intentional adulteration deadline with the appellate court.
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The deadline is one of several set by the District Judge Phyllis Hamilton in June (see 13062412). After finding FDA had long since missed deadlines for regulations imposed by Congress through the enactment of FSMA, Judge Hamilton ordered FDA to issue the final versions of seven FSMA rules by June 30, 2015, and set a Nov. 30 deadline for proposed rules to implement FSMA’s intentional adulteration and sanitary transport provisions. The court in August granted FDA an extension of the sanitary transport deadline until Jan. 31, but declined to move the intentional adulteration deadline (see 13081418). FDA subsequently appealed the district court decision to the 9th Circuit U.S. Court of Appeals.
Judge Hamilton denied on Oct. 21 FDA’s request for a postponement during the appeal of the deadline for the intentional adulteration proposal. Issuing the proposed rule by Nov. 30 won’t cause “irreparable injury” to FDA, as the agency argued, said Judge Hamilton. Even if it makes mistakes in its proposed rule, the agency would be able to correct it before the final regulations are issued, she said.
Meanwhile, FDA filed on Oct. 18 a request that the U.S. Court of Appeals issue an “emergency stay” of the lower court’s ruling. While issuing the intentional adulteration rule by Nov. 30 was unsound before the federal government shutdown, the loss of over two weeks of work has now made meeting that deadline “impossible,” FDA said in its motion. Trying to do so would be a waste of agency resources, FDA said. And in any case, the District Court overstepped its bounds when it set the deadlines, FDA argued.
Email ITTNews@warren-news.com for a copy of the filings.