The Food and Drug Administration Gets Sued for Delaying FSMA Implementation
It isn’t every day that a federal agency gets sued for failing to act. But that is exactly what happened to the United States Food and Drug Administration (FDA) last month. The public interest groups, The Center for Food Safety and The Center for Environmental Health, filed a complaint in California federal court against the FDA for allegedly failing to adopt implementing regulations under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (U.S. Dist. Ct., N.D. Cal., filed August 29, 2012).
According to the complaint, FDA has missed seven of FSMA’s statutory deadlines, thereby “failing to implement FSMA’s major food safety regulations.” As a consequence of this delay, the complaint asserts that FDA is putting millions of lives at risk from contracting food-borne illnesses. The Office of Management and Budget (OMB) is also named as a defendant. The complaint claims that OMB has also missed statutory deadlines in failing to approve the implementing regulations that FDA has submitted for its evaluation.
The narrative in the complaint is highly critical of the FDA. It recites estimates from the Centers for Disease Control and Prevention that 1 in 6 Americans contract food-borne illnesses each year, 128,000 are hospitalized and 3,000 die. It refers to “devastating outbreaks” that have occurred since Congress passed the FSMA, including Listeria-contaminated cantaloupes and apples, and Salmonella-contaminated cilantro and tomatoes. By alleging violations of the FSMA and Administrative Procedure Act, the plaintiffs seek a declaration that the agencies have violated the law and an order requiring that they promulgate and approve all FSMA regulations “as soon as reasonably practicable.”
Because of the breadth and scope of the FSMA, it is no secret that the FDA has struggled mightily in its efforts to implement its provisions. The plaintiffs’ complaint focuses on those that establish “science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventive controls and documenting the implementation of preventive controls.” In addition, the provisions regarding “science-based minimum standards for the safe production and harvesting of fruits and vegetables” are specifically discussed.
While it is doubtful that this lawsuit will result in any material change in the speed in which the FSMA’s provisions are ultimately implemented, it will be interesting to see how the FDA and OMB respond to its allegations.