Understanding the FDA’s Food Traceability Requirements
In response to increasing food safety concerns, the Food & Drug Administration enacted the Food Safety Modernization Act (FSMA) in 2011, with Section 204 specifically aimed at improving food traceability. In November 2022, the FDA finalized the Food Traceability Rule, which promotes the use of digital technologies and enhanced traceability to address the risks of food-borne illnesses and improve the effectiveness of recalls. By implementing a “digital twin” of the supply chain, businesses can quickly identify and remove contaminated food from the market, thereby increasing safety and efficiency.
What does this mean for your business?
The rule requires food companies to maintain detailed traceability records for specific high-risk foods listed in the FDA’s Food Traceability List (FTL). This list includes non-pasteurized cheeses, fresh produce, seafood, and ready-to-eat deli salads. Companies must capture and retain key data elements (KDEs) associated with critical tracking events (CTEs), such as the initial packing or first land-based receiving of food. By January 20th, 2026, these records must be kept:
- For at least two years and
- Be made available to the FDA in an electronic format within 24 hours of a request.
While certain exemptions apply to small businesses, the rule encompasses many entities, including grocery stores, restaurants, and online food retailers.
Implementing the Food Traceability Rule presents several challenges for companies, including:
Data Compliance
The rule mandates organizations develop a “digital twin” of their supply chain. This will require many organizations to assess and upgrade their current data infrastructure. The main concerns in this area involve outdated technologies and supply chain partners that rely on old systems or even paper instead of digital methods.
Process Improvements
Many suppliers do not follow traditional standards, resulting in gaps in lot-level visibility. Additionally, there is a concern regarding labeling, as many use pallet labeling instead of labeling at the lot level. It is crucial to coordinate with suppliers and identify the right partners to comply with the new standard operating procedures (SOPs).
Technology Upgrades
The main issue is that significant amounts of this information are spread across multiple systems, making it difficult for companies to compile and deliver data efficiently. There is a clear need for a system that can gather data from various vendors and platforms.
Conclusion
The growing volume of traceability data will require upgrades to your systems and processes to effectively manage and maintain this information.
WarehouseQuote is uniquely positioned to assist with these upgrades through our technology portal, which is designed to improve supply chain visibility. The portal allows our clients, carriers, and warehouses to communicate effectively and share these KDEs and CTEs across channels.
Despite these challenges, compliance with the Food Traceability Rule can unlock significant value for companies by enhancing environmental impact reporting, supporting sustainability claims, and improving supply chain visibility. With increasing consumer demand for transparency in food safety and sustainability, businesses that adopt these changes can differentiate themselves in the market while minimizing risks related to public trust and compliance.