FDA Proposes Additional Food Traceability Requirements

Ingredients like cheese, shell eggs, nut butter, various produce, fin fish, and ready-to-eat deli salads are listed on a proposed regulation that was released on September 21 by the U.S. Food and Drug Administration (FDA) with the goal of establishing additional traceability recordkeeping requirements for operations that manufacture, process, pack, or hold these and other ingredients.

The proposal is part of FDA’s New Era of Smarter Food Safety Blueprint initiative. The main intent of this proposed regulation is to “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.” The new regulation would require operations to develop a description of the reference records they use to document and maintain identifiers for traceability, and how these codes are established.

Additionally, operations would need to provide any other information that will assist in explaining their processes for traceability. The new rule then requires establishing and assigning a traceability lot code when operations transform or create new foods that are listed on the Food Traceability List. The proposed change also provides growers, producers and even retailers with some explanation of what would be the requirements for their various facilities.

Stakeholders are encouraged to review and submit comments, scientific information, and questions within 120 days to assist the FDA in finalizing this regulation.