By Hilary Thesmar, Chief Science Officer and SVP Food Safety Programs, FMI, and Stephanie Harris, Chief Regulatory Officer and General Counsel, FMI
The FDA Food Traceability Final Rule is one of the most complex regulations under the FDA Food Safety Modernization Act. Published in November 2022, the final rule covers the entire food supply chain (domestic and foreign) and it requires persons who manufacture, process, pack, or hold foods on the Food Traceability List or foods that contain an ingredient on the Food Traceability List to maintain additional traceability records and provide information to the FDA within 24 hours. FDA hopes that the recordkeeping requirements in the final rule will result in faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
The industry is faced with many challenges - the final rule is complex, the scope of the Food Traceability List is vast and broad, and the regulatory requirements conflict with operational practices. Regardless, the food industry must navigate the challenging landscape and meet the requirements of the rule by the January 20, 2026, compliance date. The goal of the food industry is to comply with the regulation.
Over the last year, FMI members worked tirelessly to understand the rule in order to develop and implement solutions to meet the requirements. As part of these efforts, the industry aligned around the importance of leveraging data standards to help meet the requirements of the traceability rule. With a focus on awareness, education and advocacy, FMI has developed a number of tools and resources to support the industry as they diligently work toward achieving the goal of compliance.
With less than two years to the compliance date, the industry continues to put food safety first as they seek to implement feasible solutions to meet the requirements of the rule.
FMI Key Traceability Resources
For a more comprehensive list of resources developed, visit FMI’s Food Safety and Modernization Act Resource Center.
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