FDA Proposes Additional Food Traceability Requirements

Does your operation produce or use ingredients like cheese, shell eggs, nut butter, various produce, fin fish, and ready-to-eat deli salads?

If so, these and other ingredients are listed on proposed regulation that was released on Sept. 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. Stakeholders are encouraged to review and submit comments, scientific information, and questions within 120 days to assist the FDA in finalizing this regulation.

Originating from Section 204(d) of the Food Safety Modernization Act (FSMA), the proposed regulation is a byproduct of FDA’s New Era of Smarter Food Safety Blueprint. 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.”

They do so by decreasing the response time for identifying recipients of foods that may be adulterated to prevent or mitigate a foodborne illness outbreak. As proposed, only foods included in the Food Traceability List and any finished product that contains one or more of these ingredients would be required to comply.

The proposed regulation would require operations to develop a description of the reference records your facility will use to document and maintain required information, including a list of foods on the Food Traceability List that your facility ships, identifiers for traceability, and how you identify and establish traceability codes.

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.”

Additionally, operations would need to provide any other information that will assist in explaining your facility’s processes for traceability. The proposed 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 regulation also provides growers, producers and even retailers with some explanation of what would be the requirements for their various facilities.

Should you need any additional information about this proposed regulation or have additional questions, please contact us at info@aibinternational.com.