As we mentioned before, by January 2026, persons who manufacture, process, pack, commercialize, or hold foods included on the Food Traceability List (FTL) will need to record and save information, called Key Data Elements (KDEs), and share it with their clients or value-chain partners through each step of the chain, called Critical Tracking Events (CTEs).But, what are these Critical Tracking Events and Key Data Elements? We will continue to expand what these references are about and why they are important for the FDA.
The Critical Tracking events are all the steps in the value chain. Every time that the product suffers a modification or changes the entity that holds it, it is considered a CTE. In the case of agriculture and aquaculture, the first CTE is the harvesting. In the case of the fishing industry, the first CTE is the first port receiver. The end point for every case is the Retail or Food Service company that exposes and sells it to consumers. There are seven CTEs: Harvesting, Cooling, Initial Packing, First-Land Receiver, Shipping, Receiving, Transformation.
Considering that the main purpose for the agency is to identify quickly where the products come from and who intervened in the production and distribution process, the KDEs are the data about companies (such as name and contact info), location where it suffered a modification or transaction, dates, amounts, type of food, product, transformation description, traceability lot code, and destination.
In order to be more specific, we will try to explain the CTEs using the example of cucumbers that the FDA exposes (link to video). Growers do not have to keep any data unless they also harvest the cucumber, so the first recordkeeping happens when it is harvested. Later, the cucumber needs to be cooled and it is sent to another entity that cools it, hence, a new CTE. Both the harvesting and cooling entities must send their KDEs directly to the initial packer. This new participant transforms the harvest into a packed product, so it is a new CTE and it is where the product receives the first Traceability Lot Code. This initial packer will need to keep record of the information received from the cooling and the harvesting steps, and add the KDEs of the first packing process.
Continuing with the process, the first packaging entity will ship the products to another entity, so it will need to keep record of the shipping information and the receiver will need to record the receiving information. In this example, we will assume that this new organization will pack the food in smaller containers. This is considered a product transformation, hence, this institution will have to keep record of the transformation KDEs. Then, the transformation company will sell the products to a distribution center, so the first one will have to record shipping information and the second one will have to record receiving information. Finally, the distribution center will ship it to a retail or a food service enterprise, having to record shipping information and receiving information correspondingly.
Summarizing the process, we can conclude that the information of the first process adds up to the second. These two, will also be added to the information of the next one, and so on. “Central to the proposed requirements is the assignment, recording, and sharing of traceability lot codes (TLCs) for FTL foods, as well as linking these TLCs to other information identifying the foods as they move through the supply chain.” (FSMA Final Rule) When it comes to the retail or the food service, they will add their information and the whole value chain will be completed.