Food Safety Advocates Sue FDA for Delaying FSMA Implementation

The Center for Food Safety and Center for Environmental Health have filed
a complaint for declaratory and injunctive relief against the Food and Drug
Administration (FDA) alleging that the agency has unlawfully delayed
adopting implementing regulations under the Food Safety Modernization
Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D.
Cal., filed August 29, 2012). According to the complaint, FDA has missed
seven statutory deadlines thus “failing to implement FSMA’s major food
safety regulations.” Characterizing the failure as “an abdication of the agency’s
fundamental responsibilities,” the plaintiffs claim that this delay “is putting
millions of lives at risk from contracting foodborne illnesses.” They also sued
the Office of Management and Budget, claiming that it has also missed statutory deadlines in failing to approve the implementing regulations that FDA
has submitted for its review.

The complaint recites Centers for Disease Control and Prevention estimates that one in six Americans contract foodborne illnesses each year, 128,000 are hospitalized and 3,000 die. Among the regulations the plaintiffs claim that FDA has failed to adopt are those that (i) establish “science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventive controls and documenting the implementation of preventive controls”; (ii) address “activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership . . . and on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership”; (iii) “establish science-based minimum standards for the safe production and harvesting of fruits and vegetables”; (iv) protect against the intentional adulteration of food; and (v) impose sanitary transportation practices on shippers and carriers.

The complaint also challenges FDA’s policy to “not enforce provisions that
are self-executing . . . even if FDA has not promulgated final regulations.” The
complaint refers to “devastating outbreaks” that have occurred since Congress
passed the FSMA, including Listeria-contaminated cantaloupes and apples,
and Salmonella-contaminated cilantro and tomatoes. Alleging violations of
the FSMA and Administrative Procedure Act, the plaintiffs seek a declaration
that the agencies have violated the law by failing to promulgate regulations
by statutory deadlines and an order requiring the agencies to promulgate and
approve all FSMA regulations “as soon as reasonably practicable, according to
a Court-ordered timeline.”