The FSMA 204 Food Traceability Rule introduces new recordkeeping requirements for companies that manufacture, process, pack, or hold certain foods in the United States. At the center of these requirements are Key Data Elements, commonly referred to as KDEs.
Key Data Elements are specific pieces of information that companies must record at different points in the food supply chain. These data points allow regulators and supply chain partners to trace food products quickly if a safety issue occurs.
For businesses handling foods on the Food Traceability List (FTL), capturing these data elements accurately is an essential part of complying with the FSMA 204 traceability rule. (For FSMA 204 background information, see FDA Food Traceability Rule: What Food Companies Need to Know.)
Key Data Elements are the individual data points that must be recorded when certain events occur in the lifecycle of a food product.
The FSMA 204 rule requires companies to capture KDEs during Critical Tracking Events (CTEs). These events represent key stages in the movement or transformation of food products throughout the supply chain.
Examples of Critical Tracking Events include:
At each of these events, companies must record specific KDEs that describe the product, its origin, and where it is going next.
The purpose of collecting Key Data Elements is to improve the speed and accuracy of food traceability.
When a food safety issue occurs, regulators must quickly determine where the affected products originated and where they were distributed. Without detailed records, tracing products through a complex supply chain can take days or even weeks.
KDEs help create a clear record of product movement so investigators can identify affected shipments quickly and remove contaminated products from the market.
Under the FSMA 204 rule, companies must also be able to provide these traceability records within 24 hours if requested by the FDA.
The specific KDEs required under FSMA 204 vary depending on the type of Critical Tracking Event. However, several types of information appear frequently across different events.
Examples of common Key Data Elements include:
These data elements help document how products move between trading partners and through different stages of production and distribution.
The following illustrates how KDEs may be recorded at different stages in the supply chain.
Receiving KDEs: supplier name, product description, lot code, quantity received
Transformation KDEs: input lot codes, output lot codes, processing location
Shipping KDEs: product identifier, shipment date, quantity shipped, destination
By capturing these data points consistently, companies create a traceable record of each product’s journey through the supply chain.
Many food companies already collect some traceability information through enterprise resource planning (ERP) systems, warehouse management platforms, or inventory tracking tools.
However, the FSMA 204 rule requires organizations to ensure that this information is captured consistently across the supply chain.
Common tools used to capture KDEs include:
For example, shipment data may be communicated through electronic documents such as EDI 856 Advance Ship Notices. These transactions can include shipment details, product identifiers, and lot numbers that support traceability across trading partners.
Companies must capture Key Data Elements whenever a Critical Tracking Event occurs for foods on the Food Traceability List.
The rule applies to businesses that:
If a company handles foods included on the Food Traceability List, it must ensure that KDEs are captured and maintained according to the requirements of the FSMA 204 rule.
The FSMA 204 Food Traceability Rule requires companies to maintain detailed records of how certain foods move through the supply chain. Key Data Elements play a central role in this process by documenting the information needed to trace products from origin to destination.
As organizations prepare for these requirements, many are evaluating systems that help capture and share shipment data across trading partners. Technologies such as ERP platforms, barcode tracking systems, and EDI solutions can help automate the exchange of traceability information and improve visibility across the supply chain.
If you are exploring how electronic shipment data supports traceability initiatives, you may also want to read:
Do You Need EDI for FSMA 204? How EDI 856 ASNs Support Food Traceability
Why Food Retailers Require EDI 856 Advance Ship Notices (ASNs)
Learn what FSMA 204 Key Data Elements (KDEs) are and how food companies must track traceability data during receiving, processing, and shipping events.
Why do retailers require EDI 856 Advance Ship Notices? Learn how ASNs help food suppliers share shipment data and support FSMA 204 traceability.
What foods are on the FDA Food Traceability List (FTL)? Learn which foods fall under FSMA 204 and what traceability requirements apply to food companies.
