Two public interest groups on Wednesday sued the FDA in California federal court in an attempt to force the agency to finally implement long-delayed provisions of the Food Safety Modernization Act. FSMA was passed 18 months ago with three rule set to be released for comment and implemented on the first anniversary of FSMA’s passage this past January.
In the lawsuit, filed in the Northern District of California, the Center for Food Safety and the Center for Environmental Health claim the FDA has missed seven critical deadlines for implementing the FSMA food safety rules. Among those cited in the complaint include the late preventive control rules, the on-farm packing regulations, the long awaited produce safety and foreign supplier verification rule, guidance on intentional adulteration, safe shipping rules for motor and rail vehicles, and the third-party auditor regulations.
The complaint acknowledges that many of these rules are with the Office of Budget and Management, but notes that the FDA has authority to bypass the OMB and implement the regulations as FSMA requires. This lawsuit is likely to gain attention, but will likely do little to move the ball on these rules. Speak to any regional director with the FDA and they will tell you they are keenly aware of the pressure to produce these rules. It’s a big process and one that is planned to be finished this fall. I expect this lawsuit to linger through the fall and be tossed out as moot once the rules are released. In the meantime it places a harsh spotlight on an agency scrambling to implement the most sweeping legislative change America’s food industry in the face of several large recalls.
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