FDA’s third wave of food traceability tips

The U.S. Food and Drug Administration on Nov. 30 rolled out new tools and FAQs that will continue to inform stakeholders about the Food Traceability Rule and help covered entities come into compliance. The compliance date for all companies and people subject to the Food Traceability Rule isn’t until Jan. 20, 2026.

The Food Traceability Rule facilitates faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule’s requirements appear on the Food Traceability List (FTL).

Featured in the latest update are the following:

• New webpage about traceability lot codes, including examples of how Key Data Elements (KDEs) could appear on invoices and bills of lading
• Video highlighting some technological components of product tracing systems
• Examples of a traceability plan
• New Frequently Asked Questions (FAQs)
• New supply chain examples for deli salads
• Information on how to apply for a waiver or exemption if eligible

These featured tools are accessible from the FDA’s traceability webpage, along with:

• Supply chain examples for different commodities
• Fact sheets
• Guide to Getting Started with the Food Traceability Rule
• Translations of the codified portion of the rule, as well as many of the supporting materials and tools
• An interactive tool that explains Critical Tracking Events and Key Data Elements
• An interactive tool that identifies partial and full exemptions to the rule
• FAQs

FDA announced that routine inspections under the Food Traceability Rule will not begin until 2027 to give covered entities additional time to work together and ensure that traceability information is being maintained and shared within supply chains per the rule’s requirements. 

The 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), which was signed into law in January 2011. 

The FDA’s final rule on “Requirements for Additional Traceability Records for Certain Food(Food Traceability Final Rule) was issued in November 2022. It establishes traceability recordkeeping requirements beyond existing regulations for people who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).

The new requirements 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 deaths. 

People at the core of the new traceability rule are those 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. It covers domestic and foreign firms producing food for U.S. consumption along the entire food supply chain in the farm-to-table continuum.

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