Advocacy Groups Sue FDA for Inaction on Foodborne Illness Programs

The Center for Food Safety and Center for Environmental Health have filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to promulgate rules for a program to improve foodborne-illness detection as required under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Azar, No. 19-5168 (N.D. Cal., filed August 19, 2019). The organizations allege that FDA failed to create a laboratory accreditation program “whereby an increased number of accredited laboratories following model standards developed by the agency would be in place ‘to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards.'”

“FDA’s failure to implement FSMA’s laboratory accreditation provisions by their statutory deadlines is an abdication of the agency’s fundamental responsibilities,” the complaint asserts. “Moreover, the agency’s unlawful withholding and unreasonable delay is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’s commands. This lawsuit therefore seeks to require FDA to complete the laboratory accreditation actions FSMA requires by Court-established deadlines.”