By Ashley Eisenbeiser, MS, CFS, Senior Director, Food and Product Safety Programs, FMI
Food traceability is all the buzz these days, especially since the release of FDA’s much anticipated Final Food Traceability Rule last month. Food traceability relates to the ability to track a food (and/or its ingredients) at any point in the food supply chain. It plays a critical role in foodborne illness investigations when regulators and industry need to identify where a contaminated food came from or where it was sold. It is also key to determining where contamination may have occurred and enabling the quick removal of affected product from the marketplace, reducing the risk of consumers becoming ill. Retailers and product suppliers have various systems in place to achieve this and to help track products at different points in the supply chain.
The final rule, “Requirements for Additional Traceability Records for Certain Foods,” establishes traceability recordkeeping requirements for persons who manufacture, process, pack or hold foods included on the Food Traceability List or foods that contain listed foods as ingredients. The final rule is intended to implement one of the final segments of the Food Safety Modernization Act (FSMA) – Section 204 - to provide a means for additional traceability of high-risk foods.
At the core of this rule is a requirement that persons subject to the rule maintain records containing Key Data Elements (KDE) associated with specific Critical Tracking Events (CTE) and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed. The rule applies to the entire supply chain, including retail food establishments and restaurants, and requires businesses to share information with entities in their supply chain. The compliance date for all persons subject to the rule is January 20, 2026.
Are you asking yourself, with a final rule published, how do I comply?
Whether you need to create a traceability system or improve your organization’s traceability system, here are a few steps to help you work toward compliance with the Food Traceability Final Rule.
- Review the Final Rule and the FMI Resources below.
- Assess Current Operations – Does your operation manufacture, process, pack or hold a food on the Food Traceability List or any food that contains a listed food as an ingredient? If yes, what role do you play?
- Complete a Gap Analysis – Review and evaluate your current traceability system.
- Questions to help evaluate your traceability system (Note this is not an exhaustive list)
- What KDEs do you currently capture?
- How are the KDEs captured and in what format?
- Where are the KDEs captured (i.e., source records, record storage location)?
- How are records maintained?
- How accessible are the KDEs/records containing KDEs (i.e., ease of access, time to access)?
- Who has permission to access the KDEs/records containing KDEs?
- How do you share information with supply chain partners?
- How do supply chain partners share information with you?
- What data/information do you share with supply chain partners?
- What data/information do supply chain partners share with you?
- Explore and Evaluate Traceability Solution Providers
- Create a Traceability Plan - If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan.
- Implement Traceability Plan.
Over the last few years, FMI has been working with FDA, food and beverage trade associations and member companies to identify issues and to advocate to make the rule more practical for the industry to implement and comply. Despite this, the final rule remains complex and will significantly impact how standard supply chain information is shared. FMI will continue to share information and resources and work with members to facilitate implementation and compliance with the rule. Information and resources related to the final rule are being compiled on the FMI FSMA Resource Center. Additionally, FMI has created a Question Portal to answer member traceability questions about the rule.
Food Traceability Resources and Information
- FMI FSMA Question Portal – Submit traceability questions and FMI will provide answers and additional resources to your questions and post the responses on our site.
- FMI News: FMI Expresses Concerns about Expanded Scope of Final Food Traceability Rule Well Beyond FDA’s Statutory Authority
- Traceability Resources on the FMI FSMA Resource Center
- FMI On-demand Digital Seminar: Food Traceability Final Rule - What is in the rule and how do we implement?
- FDA Food Traceability Resources
- IFT’s Global Food Traceability Center (GFTC) – GFTC and its partners work together to share knowledge, expertise, applied research, data, and resources to help addresses global food traceability challenges and opportunities across the supply chain.