FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
The FDA held a public meeting on June 15, 2026, to give the public an opportunity to share information on continued implementation of the Food Traceability Rule and areas of remaining concern, specifically as they relate to lot-level tracking and flexibilities for compliance. View the meeting recording.
To promote deeper understanding and more productive engagements with stakeholders on potential flexibilities the FDA has also released the following materials:
- Discussion Paper: Identifying Additional Flexibilities for Satisfying the Food Traceability Rule’s Lot-Level Tracking Requirement
- Report on FDA Traceability Readiness Tabletop Exercises
- Additional Frequently Asked Questions on the Rule
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The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.
The final rule aligns with current industry best practices and covers domestic, as well as foreign firms producing food for U.S. consumption, along the entire food supply chain in the farm-to-table continuum.
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Compliance Date
Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date. The original compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule was Tuesday, January 20, 2026. The FDA proposed to extend the compliance date for the rule by 30 months to July 20, 2028. Subsequently, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 directed FDA not to enforce the Food Traceability Rule prior to that same date. FDA intends to comply with this Congressional directive.
Source: www.fda.gov
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