Thursday, August 15, 2013

Court Denies FDA Motion for Reconsideration of Deadlines for FSMA Rule Implementation

On August 13, 2013, the U.S. District Court for the Northern District of California denied the Food and Drug Administration’s motion for reconsideration of the court’s previous order that set a schedule of deadlines for Food Safety Modernization Act rule implementation. Specifically, the FDA asked the court to reconsider the deadlines for intentional adulteration and sanitary transport rulemaking (two of seven areas the court previously ruled on). The FDA argues that the complexity of the rulemaking for these two areas of FSMA will prevent the FDA from meeting the deadline set by the court.

The court did grant the FDA part of its motion by extending the deadline for publishing the proposed sanitary transport rule and the comment period, although, the date for the final rule implementation remains unchanged. The court denied the request to extend the deadline for promulgation of the intentional adulteration rule, noting that this dispute is between the FDA and Congress. The court states that it is unwilling to permit the FDA to continually delay implementation of this rule because of the clear Congressional directive that FSMA rule implementation be a closed-ended process.

For more information, please see the order filed by the court.
Written by Sarah L. Doyle - Research Assistant
The Agricultural Law Resource and Reference Center
August 15, 2013

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