FDA Announcement - FSMA Final Food Traceability Rule
The Food and Drug Administration (FDA) has been working on the implementation of the Food Safety Modernization Act (FSMA), signed into law in January 2011. As part of that law, regulators have been working to define what the Food industry must do to comply. The FDA announced the final rule on those requirements earlier this week.
Many of our Gray Solutions customers are governed by the Food Safety Modernization Act (FSMA) and we are uniquely positioned to ensure they are up to speed. Our teams can provide expertise operationally and technically to assist in meeting these new requirements.
Our Production Solutions team helps customers better understand the requirements under the law, the accompanying regulations, and best practices for compliance. The Digital Solutions team knows what data to collect, when to collect it, how to retain it, and the preparation needed for reporting in the event there are any incidents.
The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability record-keeping 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 the 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.
The Food Traceability Final Rule requires entities to share information with other entities in their supply chain. Therefore, 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 compliance date for all persons subject to the record-keeping requirements is Tuesday, January 20, 2026.
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