crs_reports: R48925

Congressional Research Service reports with summaries, authors, and topic classifications.

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R48925 The Food and Drug Administration’s Food Traceability Rule: Overview and Issues for Congress 2026-04-29T04:00:00Z 2026-05-01T15:23:02Z Active Reports Laura Pineda-Bermudez Food Safety Foodborne illness outbreaks and subsequent recalls have garnered broad public attention to the safety of the U.S. food supply. The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA; P.L. 111-353), enacted in 2011, aimed to improve food safety, among other objectives. In Section 204 of FSMA, Congress directed FDA to improve the tracking and tracing of food through the supply chain by establishing additional recordkeeping requirements for facilities handling certain foods frequently associated with foodborne illness outbreaks. The additional recordkeeping requirements were intended to enable more efficient removal of products from the market in the case of an outbreak leading to a recall. FDA has established these recordkeeping requirements in the Food Traceability Rule, as described below. Prior to FSMA, some entities that handled, manufactured, packed, transported, or distributed food were required to keep records to trace food one step forward and one step back in the supply chain. Notably, farms and restaurants were not required to keep such records. Through FSMA, §204, Congress directed FDA to conduct pilot projects, collect and assess data, establish a list of high-risk foods, and issue regulation establishing additional recordkeeping requirements for foods on the high-risk list. Congress directed the agency to require certain records from entities that “manufacture, process, pack, or hold” foods on the list, including some previously exempt food establishments. FDA was to ensure the requirements were science-based and proportionate to risks associated with the food; that the public health benefits would outweigh the compliance costs; and that the burden on subject entities would be minimized whenever possible. FDA has implemented many of the Section 204 requirements. Some implementation has occurred after the deadlines set by Congress. On September 23, 2020, FDA published the proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (the “Food Traceability Rule”), and requested comments on the rule and its accompanying list of high-risk foods (the “Food Traceability List”). FDA published the final Food Traceability Rule, as well as the Food Traceability List, on November 21, 2022. The Food Traceability List includes some fresh-cut produce, some soft cheeses, shell eggs, nut butters, and some seafood. The Food Traceability Rule requires facilities that perform certain activities with these products to keep specific records to facilitate faster identification of the source of a foodborne illness outbreak. Enforcement of the rule spans across the supply chain: from harvest to transformation or processing, through distributors of the food product, to the final product sold at a restaurant or grocery store. Subject entities handling a food on the Food Traceability List are to maintain specific records for certain points in the item’s supply chain. In addition, subject entities are to provide FDA with specific information within 24 hours of a request—or within a reasonable time to which FDA has agreed—to help FDA during an outbreak or other public health threat. FDA estimated that the final rule would cover more than 323,000 domestic businesses operating more than 484,100 establishments and set the initial compliance date for January 20, 2026. In January 2024, the Government Accountability Office recommended that FDA finalize and document an implementation plan for the Food Traceability Rule to meet the 2026 compliance date. In September 2024, a stakeholder roundtable report published by the Reagan-Udall Foundation for the FDA indicated that industry stakeholders may not be aware of or prepared to be in compliance with the rule by January 2026. In March 2025, FDA announced its intention to extend the compliance date by 30 months and, in August 2025, published a notice of proposed rulemaking to provide additional time to covered entities to coordinate across the supply chain to fully implement the rule. In the FY2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (P.L. 119-37, Division B), Congress further directed that “no funds appropriated by this act may be used to administer or enforce the [Food Traceability Rule] ... prior to July 20, 2028.” Congress directed FDA to provide guidance and engage with stakeholders and to report on its implementation plan and the status of its product tracing system. Congress has provided direction to FDA on its implementation of FSMA and may use oversight mechanisms to continue to evaluate whether FDA activities to implement Section 204 are accomplishing the law’s intended goals. Congress may also consider whether or not additional legislation may be necessary to direct FDA’s actions and rule enforcement. Such legislation may include directing FDA to conduct additional pilot projects or tabletop exercises, to finalize an implementation plan, and to exempt certain entities from being subject to the rule. Congress may also consider whether further action is needed to achieve the goal of improving food safety through increased food traceability. https://www.congress.gov/crs_external_products/R/PDF/R48925/R48925.2.pdf https://www.congress.gov/crs_external_products/R/HTML/R48925.html

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