By Angel Suarez, EAS Consulting Group Independent Consultant
Under the Food Safety Modernization Act (FSMA) the FDA has finalized several major rules to ensure the safety of the food supply is a shared responsibility across the global supply chain. The last of these major rules is the FDA Food Traceability Rule, also known FSMA 204, short for Section 204(d) of the U.S. FDA Food Safety Modernization Act. The FSMA 204 aim is to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026. As we approach the deadline, it is imperative that all those subject to the rule implement traceability of food products prior to the deadline. This rule will be binding and have the full force and effect of law after the effective date.
Are Importers subject to the traceability rule? Importers may not be subject to the rule depending on whether they manufacture, process, pack, or hold any Food Traceability List (FTL) foods. If an importer is subject to the rule, they are only responsible for complying with the portions of the rule that apply to them, based on the Critical Tracking Event (CTE) performed.
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FDA’s laser focus on food traceability as part of a Smarter Era of Food Safety under the Food Safety Modernization Act (FSMA) has translated into great strides in the protection of the U.S. food supply. In January 2023, FDA strengthened these efforts with a final rule that established Additional Traceability Records for Certain Foods, produced domestically and imported, included in the Food Traceability List.
From farm to table, firms producing foods on the Food Traceability List must track specific Key Data Elements (KDE) for Critical Tracking Events (CTE), both forward and backward in the supply chain. This framework forms the foundation for effective and efficient tracing of food.
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Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role he had responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. He is the co-author of numerous publications including portions of the National Shellfish Sanitation Program’s Shellfish Equipment Construction Guide and the National Shellfish Sanitation Program’s Guide for the Control of Molluscan Shellfish Annotated Manual. In addition, he has developed training courses including FDA Certified Better Process Control School, Inspection and Sampling of Abnormal Food Metal Containers and the FDA Shellfish Officer Standardization Course. Angel has a B.S. with a major in Biology and minor in Chemistry and Physics from the Inter American University.
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