Earlier this month, FDA announced finalization of its food traceability rule, which the agency says is designed to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad.
The final rule establishes additional food traceability recordkeeping requirements for those that manufacture, process, pack, or hold certain foods, including fresh leafy greens, nut butters, fresh-cut fruits and vegetables, and ready-to-eat deli salads. In collaboration with industry, 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 broad 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, FDA’s deputy commissioner for food policy and response, in a November 15 statement. “This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable and tech-enabled traceability systems both in the near term and the future.”
Foods subject to the final rule requirements appear on the Food Traceability List (FTL). To determine which foods should be included on the FTL, 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, and tropical tree fruits, as well as shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads, cheeses (other than hard cheese), finfish, and crustaceans.
Key features of the final rule include:
- Critical tracking events: At specific points in the supply chain—such as at harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods—records containing key data elements are required.
- Traceability plan: This information is essential to help regulators understand an entity’s traceability program and includes a description of the procedures used to maintain required records, descriptions of procedures 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 a food on the FTL.
- Additional requirements: Maintaining records as original paper or electronic records, or true copies; providing requested records to FDA within 24 hours of a request (or within a reasonable time to which the agency has agreed); and providing records in an electronic sortable spreadsheet when necessary to assist FDA during an outbreak, recall, or other threat to public health.
FDA says that these enhanced recordkeeping requirements for FTL foods outlined in the final food traceability rule will allow for faster identification and rapid removal of potentially contaminated food from the market, ultimately resulting in fewer foodborne illnesses and deaths.
The compliance date for the recordkeeping requirements is January 20, 2026.