The U.S. Food and Drug Administration (FDA) announced the finalization of a rule to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad.
Following FDA’s announcement, two of the food industry’s largest organizations, the FMI-Food Industry Association and the National Grocers Association, warned that the new rule exceeds FDA’s statutory authority and will disproportionately affect small grocers.
The final rule establishes additional traceability recordkeeping requirements for persons who manufacture, process, pack or hold foods the FDA has designated for inclusion on the Food Traceability List (FTL), including fresh leafy greens, nut butters, fresh-cut fruits and vegetables, and ready-to-eat deli salads. Specifically, the rule requires these entities to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).
The compliance date for all persons subject to the recordkeeping requirements is Tuesday, Jan. 20, 2026.
The FDA says it will be able to more rapidly and effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly general advisories or recalls that implicate unaffected food products.
“This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” said Frank Yiannas, the FDA’s deputy commissioner for food policy and response.”This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for the industry to adopt and leverage more digital, interoperable, and tech-enabled traceability systems both in the near term and the future.”
While the National Grocers Association and the FMI-Food Industry Association acknowledged USDA’s efforts to improve food traceability, they expressed concern about the rule’s impact on small grocery stores and that it significantly exceeds the statutory authority, both written and intended, by Congress.
“Having the safest food supply chain in the world is a common goal shared among stakeholders. However, while we appreciate FDA’s efforts, this final rule, unfortunately, does not take an approach that provides flexibility for smaller operators as intended by Congress,” said Stephanie Johnson, NGA’s vice president of government relations. “This final rule will disproportionately impact smaller retailers as it will be expensive to implement and require additional labor that many stores cannot spare.”
For her part, FMI – The Food IndustryAssociation’ss Director of Public Policy Jennifer Hatcher stated, “It is already clear that implementation of the rule’s requirements will require enormous investments of time and resources across the food industry, and it appears that this rule significantly exceeds the statutory authority, both written and intended, by Congress. FMI and our members are working daily to strengthen our food supply’s safety and the rapid elimination of any affected products. This work must be done most efficiently and consistently across all elements of the food supply chain with the least impact on food prices, the greatest impact on the bottom line, and consistency with the intent of the law passed in 2011. Based on our quick review of this incredibly complex rule, it fails to achieve this.”
To determine which foods should be included in the FTL, the FDA developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act (FSMA).
These foods include fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, tropical tree fruits, shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads, cheeses (other than hard cheese), finfish and crustaceans.
The FDA released a proposed rule in 2020 and held a public comment period where comments were received from food producers and other stakeholders through early 2021.
In response, the agency said that it has made several changes to the final rule to better align with current industry approaches to food traceability and harmonizes points in the supply chain where records must be maintained.
Key features of the final rule include:
- Critical Tracking Events: at specific points in the supply chain – such as harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods – records containing Key Data Elements are required.
- Traceability Plan: information essential to help regulators understand an entity’s traceability program. These include a description of the procedures used to maintain required records, reports of methods used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan, and a farm map for those that grow or raise food on the FTL.
- Additional Requirements: maintenance of records as original paper or electronic records, or true copies; providing requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed); and providing records in an electronic sortable spreadsheet when necessary to assist the FDA during an outbreak, recall or other threat to public health.
Enhanced recordkeeping requirements for FTL foods will allow for faster identification and rapid removal of potentially contaminated food from the market, ultimately resulting in fewer foodborne illnesses and deaths.