The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.
The final rule aligns with current industry best practices and covers domestic, as well as foreign firms producing food for U.S. consumption, along the entire food supply chain in the farm-to-table continuum.
Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date. The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026.
1. Critical Tracking Events (CTE) (§ 1.1325 through 1.1350)
The final rule identifies Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) will be required. The KDEs required will vary depending on the CTE that is being performed.
The Critical Tracking Events in the final rule are harvesting; cooling (before initial packing); initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel; first land-based receiving of a food obtained from a fishing vessel; shipping; receiving; and transformation of the food.
Below is a brief description of each CTE. For a detailed description of the KDEs that would be required for each CTE, see Critical Tracking Events and Key Data Elements. You can also see how the final rule applies in three different supply chain examples below, including the KDEs and CTEs that would be associated with each commodity.
Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities (RACs) from the place they are grown or raised and preparing them for use as food.
Cooling means active temperature reduction of a raw agricultural commodity (RAC) using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.
Initial Packing means packing a raw agricultural commodity (RAC), other than a food obtained from a fishing vessel, for the first time.
First Land-based Receiver is the person taking possession of a food for the first time on land directly from a fishing vessel.
Shipping is an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.
Receiving is an event in a food’s supply chain in which a food is received by someone other than a consumer after being transported (e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.
Transformation is an event in a food’s supply chain that involves manufacturing/processing or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List (FTL). Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling).
Traceability lot code (TLC) means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.
You must assign a traceability lot code to a food on the Food Traceability List (FTL) when you do any of the following: initially pack a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food. If you receive an FTL food from an entity that is exempt from the final rule, you must assign a TLC if one has not already been assigned (unless you are a retail food establishment or restaurant). Otherwise, you must not establish a new TLC when you conduct other activities (e.g., shipping) for a food on the Food Traceability List.
Once a food has been assigned a TLC, the records required at each Critical Tracking Event (CTE) must include that TLC. All of the Key Data Elements (KDEs), including the TLC, must be linked to the relevant traceability lot.
If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan containing the following information:
4. Additional Requirements (§ 1.1455)
The final rule also requires that:
To more information: