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.
The following examples show the Key Data Elements required for the Critical Tracking Events in three example supply chains – fresh cucumbers, tuna steaks, and soft cheese.
Takeaway: The Food Traceability Rule requires persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain and provide to their supply chain partners specific information – called Key Data Elements (KDEs) – for certain Critical Tracking Events (CTEs) in the food’s supply chain. This framework forms the foundation for effective and efficient tracing of food.
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.
