Here We Go Again: FDA Sued for Failure to Meet Yet Another FSMA Deadline

On August 19, the Center for Food Safety (CFS) and Center for Environmental Health (CEH) filed suit against the FDA. According to the two consumer groups, FDA has failed to promulgate final regulations and complete actions by mandatory deadlines set by the Food Safety Modernization Act (FSMA).

FSMA required that by Jan. 4, 2013, FDA 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.  Now, more than six years later, FDA has not accomplished this task.

Plaintiffs allege that “FDA’s failure to implement FSMA’s laboratory accreditation provisions by their statutory deadlines is an abdication of the agency’s fundamental responsibilities . . . and is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’ commands.”

This is certainly not the first time that FDA has been sued for failing to meet FSMA mandatory deadlines, as FSMA included an ambitious plan without consideration of the resources.  Plaintiffs have sued FDA two times for failing to meet deadlines for what they claim are critical regulations.  Just recently, in a consent decree filed on June 7, 2019, FDA agreed to a schedule for FDA action regarding the designation of high risk foods, including development of a list of “high risk” foods.

According to the Spring 2019 Unified Agenda, FDA planned (but failed) to issue the proposed rule for laboratory accreditations in May 2019.  It will be interesting to see if and how much this lawsuit will speed up FDA’s rulemaking.