FDA to Designate High-Risk Foods Under Consent Decree

A California federal court has entered a consent decree compelling the U.S. Food and Drug Administration (FDA) to designate a list of high-risk foods as required by the Food Safety Modernization Act. Ctr. for Food Safety v. Azar, No. 18-6299 (N.D. Cal., entered June 7, 2019). The decree is the result of a lawsuit brought by the Center for Food Safety and Center for Environmental Health seeking to compel the agency to promulgate a list of “high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health” as well as host the list on the FDA website. The decree lists deadlines for FDA to meet—including September 8, 2020, for the designation—but allows the agency to seek extensions if it needs one “despite FDA’s best efforts (meaning commitment of agency time, money, energy, and resources that FDA reasonably anticipates will result in meeting the schedule in this Consent Decree).”