Food traceability is no longer just a regulatory requirement—it’s now a standard set by the retail and foodservice industry itself. While the FDA’s Food Safety Modernization Act (FSMA) Section 204 mandates traceability for certain high-risk foods, major retailers, wholesalers, foodservice operators, and quick-service restaurants (QSRs) are demanding broader traceability practices across all product categories.
These organizations are setting expectations that include:
- Traceability for all food items, not only those on the FDA’s Food Traceability List (FTL)
- Additional Key Data Elements (KDEs) for every shipment
- Accelerated implementation timelines that often exceed federal deadlines
This evolution is reshaping supply chain collaboration and putting new pressure on suppliers and trading partners to modernize data exchange and visibility systems.
FSMA 204: Regulatory Overview
Under FSMA 204, entities that manufacture, process, pack, or hold foods listed on the FTL must:
- Capture and maintain Key Data Elements (KDEs) for each Critical Tracking Event (CTE) such as shipping, receiving, and transformation
- Exchange those KDEs with trading partners to ensure traceability continuity
- Provide complete traceability records to the FDA within 24 hours upon request, in a sortable electronic format
This rule affects food retailers, distributors, restaurants, and suppliers who handle any covered products.
ReposiTrak Traceability Network®: Scalable, Practical, and Error-Resistant
The ReposiTrak Traceability Network® is the world’s largest food traceability network, connecting:
- 12,000 retail stores
- 8,000 suppliers
- 36 distribution centers
The platform accepts supplier data in any format—manual entry, automated feeds, or system uploads—and runs each submission through a 500-point validation process before transmitting it to trading partners.
Key Advantages
- No changes to existing hardware, software, labeling, or scanning processes
- Electronic transmission of required KDEs, including data finalized post-labeling
- Data-agnostic ingestion that extracts and creates KDE records from shipping or receiving documents in any format
Why Labels Alone Are Not Sufficient for Compliance
Physical labels can include some traceability data, but not all information required for FSMA 204 is available when labels are printed. Shipment dates, receiver data, and event timestamps are finalized later in the logistics process.
To meet regulatory and industry traceability standards, certain KDEs must be transmitted electronically with each shipment. Relying on labels alone creates traceability gaps and delays in recall response.
Operational Value Beyond Compliance
Although FSMA 204 defines the compliance baseline, traceability delivers greater strategic value.
With a connected digital network, organizations can:
- Mitigate recall risk and respond faster to contamination events
- Improve supplier collaboration and accountability
- Enhance food safety verification and data integrity
- Increase visibility across the end-to-end supply chain
ReposiTrak enables full regulatory and industry compliance with minimal disruption, helping partners move beyond compliance into a proactive, data-driven food safety model.
FAQs
What is FSMA 204?
FSMA 204 is the FDA rule that requires companies handling high-risk foods to capture and share Key Data Elements (KDEs) for each Critical Tracking Event (CTE).
Who must comply with FSMA 204?
Manufacturers, processors, packers, distributors, and retailers handling foods on the FDA’s Food Traceability List must comply.
How does ReposiTrak simplify FSMA 204 compliance?
ReposiTrak’s Traceability Network automates KDE capture and exchange, validates supplier data, and integrates seamlessly with existing systems.
Click the Learn More links below to learn about traceability for Retailers and Wholesalers or for Suppliers.
