New FDA traceability requirements are effective January 20, 2023. The FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods includes a requirement for those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The FDA notes that while the proposed requirements only apply to those foods on the FTL, “they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industrywide.”
What Are Critical Tracking Events (CTE)?
The Institute of Food Technologists (IFT), defined Critical Tracking Events (CTEs) as “those events that must be recorded in order to allow for effective traceability of products in the supply chain;” these are “those instances where products are moved between premises, is transformed, or is otherwise determined to be a point where data capture is necessary to trace a product.”
What Are Key Data Elements?
IFT also identified and recommended Key Data Elements (KDEs), which can be linked to CTEs and used to support product tracing. These include:
- Physical location that last handled the product, whether the manufacturer or not, and, if applicable, contact information for the broker who handled the transaction
- Incoming lot numbers of products received
- Amount of product manufactured or shipped
- Each physical location where cases were shipped (including individual retail and foodservice locations)
- Lot number(s) shipped to each location
- When (date/time) product was received and/or shipped
- Ingredients with corresponding lot numbers
How Are Key Data Elements (KDE) Linked to Critical Tracking Events?
GS1, a global, not-for-profit association, maintains standards for supply chain traceability. The GS1 System provides globally accepted identification numbers to support a common language for the communication of product information from company to company. GS1 identification numbers provide the link between a product and the information pertaining to it.
When a company assigns a GS1 identification number to a product, they define a set of standardized information about the product (e.g., size, weight, product type, etc.). Standardized information about products includes core data like selling units and product dimensions. Standardized information about commercial entities includes core data like location information about a warehouse or restaurant. Once defined by the company, the standardized product information can be stored and shared with trading partners.
GS1 offers a guide walking through a simple example of applying its standards to trace products and events across the supply chain.
What is the Compliance Date for the FSMA Traceability Rule?
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.
What Traceability Solutions Are FSMA Compliant?
CAT Square offers two solutions that support compliance with the FDA FSMA Food Traceability Final Rule:
IBM Food Trust Integration: In 2019, CAT Squared became an onboarding partner with IBM Food Trust. Our manufacturing platform collects processing data from the plant floor including critical tracking events, quality incidents, product attributes, compliance documentation, and supplier data. Our customers can choose to contribute any of this data to Food Trust via API (Application Programming Interface) to achieve end-to-end traceability of their supply chains.
CAT Squared FoodTrace: Our FoodTrace solution is a GS1- and EPCIS-based event repository that enables the asynchronous capture of critical supply chain tracking events occurring on the farm, to processors and distributors, and all the way to retail consumers. Our FoodTrace MESH application takes this further and allows for the sharing of data across supply chain players, enhancing demand, supply, and capacity planning and synchronization.
Please reach out to our team to learn how our solutions enforce FSMA compliance: