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Focus on Regulation

FDA and OMB Sued For Failing to Meet FSMA Deadlines

FDA and the White House Office of Management and Budget (OMB) were recently sued by two consumer advocacy groups for failing to meet several statutory rulemaking deadlines in the FDA Food Safety Modernization Act (FSMA).  In late 2011, FDA submitted four proposed rules implementing FSMA to OMB for review.  The proposed rules cover Preventive Controls (with separate proposed rules for human food and animal feed), Produce Safety Standards, and the Foreign Supplier Verification Program (FSVP).  The lawsuit alleges that the 8-9 month delay in OMB’s review of those rules—which are still pending—is unreasonable.

The lawsuit also challenges the letters sent to the food industry in June 2012 by the FDA Deputy Commissioner for Foods, Michael Taylor, which state that the agency will not enforce key provisions of FSMA until after final regulations are issued.  The plaintiffs are asking the court to order FDA both to issue the regulations according to a court-ordered timeline and to enforce all self-executing provisions in FSMA immediately.  The lawsuit was filed by the Center for Food and Safety and the Center for Environmental Health in the U.S. District Court for the Northern District of California.

In general, courts are reluctant to find unreasonable agency delay because they are hesitant to question agency priority setting and allocation of scarce resources.  Where successful, lawsuits alleging unreasonable delay by FDA generally have involved delays much longer than the present alleged delay in FSMA implementation.  Even when successful, these lawsuits did not result in a court ordering immediate action; rather courts have traditionally ordered a schedule for the agency to follow.  With respect to challenges to an agency’s exercise of enforcement discretion, courts traditionally give agencies wide latitude to shape enforcement priorities and plaintiffs have to meet a very high legal bar in order to prevail.