FDA Issues Proposed Rule for Food Traceability

The agency seeks extra record-keeping for those who handle food on the FDA’s Food Traceability List.

November 08, 2022

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) has proposed a new rule on food traceability to establish additional traceability record-keeping requirements (beyond what is already required) for entities that manufacture, process, pack or hold any foods included on the FDA’s Food Traceability List

The proposed rule, “Requirements for Additional Traceability Records for Certain Foods,” is part of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

“The proposed requirements would help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death,” wrote the FDA in a statement.

According to the FDA, those who manufacture, process, pack or hold foods on the Food Traceability List must establish and maintain records containing “Key Data Elements” associated with different “Critical Tracking Events.” While the proposed requirements would only apply to those foods on the list, they were designed to be suitable for all FDA-regulated food products. The agency says it would encourage the voluntary adoption of these practices industry-wide.

The comment periods for the proposed rule and information collection provisions have been extended and will now be available for public comment until February 22, 2023.

In December, the FDA released its Foodborne Outbreak Response Improvement Plan to enhance the speed, effectiveness, coordination and communication of investigations into outbreaks of foodborne illness.

In February 2021, NACS submitted comments to the FDA on its then proposed rule to establish additional traceability record-keeping requirements for certain foods, based on Section 204 of the Food Safety Modernization Act (FSMA), as part of the New Era of Smarter Food Safety initiative.

NACS signaled support for efforts to boost food traceability and safety in the food system. However, expressed concern that small retailers, which represent 63.5% of all convenience stores in the United States, would not be able to meet the proposed additional recordkeeping requirements.

NACS staff is currently reviewing this latest proposal to determine its impact on convenience industry retailers.

NACS has several food-safety resources for foodservice providers. Find them on the Food Safety topics page. NACS also offers free webinar on how to build a strong and effective food safety and cleanliness culture. The webinar, “The Case for Cleanliness,” is available to view on demand.