Are You as an Importer Ready for FSMA Traceability Rule?

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.

The FDA encourages U.S. importers to work with their foreign suppliers to ensure there is an understanding of the traceability requirements for foods exported to the U.S.

During an outbreak investigation involving an FTL food, the FDA might seek to obtain information directly from foreign entities in the food’s supply chain, through the U.S. importer of the food, or through other means. All entities in the supply chain who manufacture, process, pack, or hold the FTL food, whether foreign or domestic, will need to determine how they will maintain required records and make them available to us upon request (unless the entity is subject to an exemption).

The rule does not require importers of FTL foods to verify the entities in their supply chain are in compliance with the rule requirements as a condition of importation. However, importers need to be aware of whether their suppliers are subject to, and in compliance with, the rule requirements because under section 801(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), an article of food is subject to refusal of admission if it appears that the requirements under the rule have not been met for that food (21 CFR 1.1460(b)).