Thursday, June 20, 2013

Court Issues Proposed Order Setting Schedule of Deadlines for FDA Implementation of FSMA Rules

** Updated 8/15/2013: See Final Order

Enacted on January 4, 2011, the Food Safety Modernization Act (FSMA) imposed many obligations on the Food and Drug Administration (FDA). Attached to these obligations were deadlines for implementation of rules. Due to the failure of the FDA to implement rules according to these deadlines, on August 29, 2012, the Center for Food Safety (CFS) filed a complaint in the Northern District of California alleging that the FDA was in violation of FSMA and the APA, and asked the court to compel the agency to implement rules. On April 22, 2013, the court ordered the FDA and the CFS to jointly submit a schedule of deadlines for the implementation of FSMA rules.
On June 10, 2013, both the FDA and the CFS submitted implementation schedules. These schedules were submitted separately, however, as neither party could agree to a compromised schedule of deadlines. The plaintiffs (CFS) did not agree that the schedule submitted by the FDA was an actual schedule of deadlines and therefore submitted its own schedule. CFS stated that the FDA’s submission contained “target dates” for implementation, rather than the “firm dates” demanded by the court order. The FDA’s submission contained target time frames for implementation. It also contained factors that could potentially affect the time frames, such as the potential need for additional information or the need for re-proposal of a rule.

The court issued a proposed order on June 10, 2013, that requires the FDA to comply with the CFS schedule of deadlines. The order also stated that the FDA is enjoined from seeking additional time for rulemaking related to review by the Office of Management and Budget.  In addition, the FDA must submit quarterly progress reports detailing the rulemaking process to the court with the first report due September 1, 2013.
This case is docketed at 12-cv-04529.

Written By Sarah Doyle – Research Assistant
The Agricultural Law Resource and Reference Center
June 20, 2013

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