Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish a program for the recognition of accreditation bodies and accreditation of laboratories equipped to perform food safety testing, including developing model standards for laboratory accreditation. The lawsuit was brought in the U.S. District Court for the Northern District of California by the Center for Food Safety (CFS) and Center for Environmental Health (CEH).

CFS and CEH previously sued FDA for failing to meet the statutory deadlines for other FSMA requirements. In 2012, the groups sued FDA after the agency did not meet the statutory deadlines for promulgating the seven major FSMA regulations. FDA settled the lawsuit by establishing a schedule of deadlines for completion of the rulemakings, and FDA subsequently issued the regulations by the court-ordered deadlines. In October 2018, the groups sued FDA for failing to meet the statutory deadlines for FSMA’s traceability provisions. FDA entered into a consent agreement in June 2019 and agreed to implement the traceability provisions on a specified timeline. Neither of those lawsuits addressed the statutory deadlines related to laboratory accreditation that is at issue in this most recent lawsuit.

This blog post first provides background on the accredited laboratory provisions under FSMA and then summarizes the complaint. Click here to read more.


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