If you read our blog (and we know you do), you’re up to speed on the fundamentals of Food Safety Modernization Act (FSMA) Section 204, including the Food Traceability List (FTL) and the food traceability “Final Rule.” Today, we’re looking at an important part of the regulations — the FSMA traceability lot code — and who must comply.
What is the FSMA traceability lot code?
The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”
Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)
A traceability lot code must be assigned when any of the following occur:
- Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
- Performing the first land-based receiving of a food obtained from a fishing vessel
- Transformation of a food
Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”
The FSMA traceability lot code in action: CTEs and KDEs
To fully understand the FSMA traceability lot code, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.
In broad terms:
- CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
- KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
- Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).
A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.
Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).
Do you have to comply? Are you exempt?
The Final Rule does have exceptions to the requirements we’ve discussed above.
Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”
Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.
However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.
Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.
Final thoughts
This is a lot to digest. Online tools are fine, but the better option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.
As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.
Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.
