Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). The consent order, which was approved by the district court judge on June 11, 2019, establishes a timeline for FDA to publish a list of high-risk foods and engage in rulemaking setting forth additional traceability recordkeeping requirements for facilities that manufacture, process, pack, or hold those foods. 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). This memorandum provides background on the FSMA traceability provisions and then summarizes the consent order. As explained in more detail below, FDA is committing to designate the list of high-risk foods and issue a proposed rule that would establish recordkeeping requirements for these foods by September 8, 2020, and then issue the final rule by November 7, 2022.

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