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FDA Sued for Failure to Establish FSMA Accredited Labs Program by Statutory Deadline

On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the Food Drug Administration (FDA) in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the lawsuit is Section 422 of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by FSMA.  Section 422 (21 U.S.C. 350k) required that by January 4, 2013, FDA establish a program to detect and address foodborne illness outbreaks with more accredited laboratories and provide a database of accredited labs.  Among other requirements, FDA was to establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation; and develop model standards that a laboratory must meet in order to be accredited by a recognized accreditation body. 21 U.S.C. §350k(a).

In the complaint, CFS and CEH allege that missing the 2013 deadline and failing to propose final regulations by six years violated FSMA and the Administrative Procedures Act (APA), and “is putting millions of lives at continued risk from contracting foodborne illness, contrary to Congress’s commands.” According to CFS staff attorney, Ryan Talbott, “[a]ccurate laboratory testing is essential to reduce the foodborne illness threat. […] FDA was required to establish a comprehensive food testing program years ago, but has yet to do so. We will hold FDA accountable and protect the public health, as we always have.”

The lawsuit comes after 2018 saw several foodborne illness outbreaks, most notably the multistate outbreak of E. coli linked to romaine lettuce. In 2018, the Centers for Disease Control and Prevention (CDC) investigated 24 foodborne illness outbreaks as compared to 7 outbreaks in 2017.  This year, the CDC has already investigated 12 outbreaks.

CFS and CEH have sued FDA over missed FSMA deadlines twice before. Our readers may recall the 2012 suit against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013). The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. In October of 2018, CFS and CEH sued the agency for failure to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods by the statutory deadlines. On June 7, 2019, via Consent Decree, FDA agreed to a schedule of deadlines to establish reporting requirements for “high-risk” foods.

FDA has yet to respond to the current CFS and CEH complaint. 

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 233


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...