Section 204(d) of the Food Safety Modernization Act (or FSMA 204) is part of the FDA’s broader New Era of Smarter Food Safety Blueprint, a forward-focused initiative whose primary pillar is “tech-enabled traceability.”

The regulation defines a set of Key Data Elements (KDEs) that food supply chain operators must capture for each Critical Tracking Event (CTE) in a product’s journey from its point of origin to the end consumer.

FSMA 204 defines a set of Key Data Elements (KDEs) that food supply chain operators must capture for each Critical Tracking Event (CTE) in a product’s journey from its point of origin to the end consumer. KDEs are to be created, collected and stored in a format that can be retrieved and sent to the FDA within 24 hours when requested.

Previously, the Bioterrorism Act only required data from one-up and one-back events.

As a product changes hands or changes form, its string of KDEs grows and must be transferred between trading partners, to create full, end-to-end traceability. ReposiTrak estimates that retailers alone will be responsible for thousands – if not millions – of traceability records per year.

Here are some examples of KDE records. Each time a Food Traceability List (FTL) food changes hands or changes form, this information must travel along with it. The information must always be connected to the food or ingredient’s original traceability lot code.

The days of one-up, one-back tracking are behind us. The FMSA 204 regulation now requires the creation, collection and storage of more information than ever before and the long list of Key Data Elements (KDEs) that are required cannot be printed, exchanged or modified with traditional labeling and scanning methods.

Your retailer and wholesaler customers are required to take in more data now as well. This information must be available to them in a format that can be retrieved and organized into a sortable spreadsheet per the FDA requirement within 24 hours’ notice.

Anyone who manufactures, processes, packs or holds foods on the Food Traceability List (FTL) is responsible for creating, collecting and/or sharing KDEs. The FDA has refers to these nodes of the food supply chain “Critical Tracking Events” or “CTEs”.

Here are the CTEs defined by FSMA 204:
• Harvesting
• Cooling (before initial packing)
• Initial Packing (RAC)
• First Land-Based Receiver
• Shipping
• Receiving
• Transformation

Learn more about each CTE HERE.

The FDA has grouped the FTL into three main product categories: cheese, produce and seafood. The KDEs required for each category do vary, because the CTEs in their supply chains vary. Take a few minutes to watch the video that pertains to your supply chain (each video is under 10 minutes).

FDA Videos
• Cheese
• Produce
• Seafood

For more than 20 years, ReposiTrak has been solving supply chain collaboration challenges that involve tracking products from manufacturer and grower, through warehouses and distribution centers, all the way to the retail store.

Food traceability is a part of our widely deployed and proven supply chain and compliance platform.

Through the thought leadership of leading industry organizations and retailers, we’ve created the ReposiTrak Traceability Network, a solution that is:

• Easy to implement
• Meets and exceeds the FDA’s FSMA 204 guidelines
• The lowest cost with little impact to consumer pricing

All while fully complying with FSMA 204.

The ReposiTrak Traceability Network is backed by the industry and was most recently selected by the National Grocers Association’s as its exclusive traceability solution.