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How Do FDA’s New Traceability FAQs Apply to Your Link in the Chain?

With just over two years left for the industry to comply with the new Food Traceability Rule (FSMA 204), facilities are beginning to take a new look at their products to determine if any of their foods or ingredients are on the Food Traceability List (FTL) and figure out how much work it will take to comply by January 2026.

With that compliance in mind, FDA is continuing to provide new information, with the latest being two additions to its Food Traceability FAQ webpage, answering the why and what on its Product Tracing System and the how on initial inspections. Following are some key points from the new FAQs, along with additional background on the systems FDA will be using.

Product Tracing System. With FSMA directing the FDA to establish a product tracing system to receive information for the effective, rapid tracking and tracing of “high risk” food, the agency is developing an internal Product Tracing System (PTS) to receive and analyze industry’s food traceability data. The PTS will have very strict data security and network security protocols, with only permissioned government users able to access the data and all confidential information protected from disclosure. When FDA requests records:

  • Industry stakeholders can upload electronic sortable spreadsheets or other traceability records into FDA’s secure, web-based Safety Reporting Portal (SRP) or can send the spreadsheet/other record to FDA via email for FDA uploading. (Although an electronic sortable spreadsheet is required in certain situations, this is not always required, so FDA is also preparing to receive traceability records in other formats.)
  • Once the data are uploaded, the PTS will automatically process the information into a supply chain visibility data standard called EPCIS (Electronic Product Code Information Services), allowing for data interoperability within the PTS.
    • EPCIS can then be used by FDA and the industry to promote interoperability across the supply chain, but it is not required for either to use it. The system assigns a unique identifier (serial number) to each item, allowing for real-time monitoring of its location and status.
    • EPCIS is currently used by the pharmaceutical industry, as required by The Drug Quality and Security Act (DSCSA), to trace the transaction history of every medication that passes through a pharmacy. 
  • Once processed, the data are available to authorized government users in the open-sourced data visualization platform FoodChain Lab (FCL). FCL creates automatic end-to-end supply chain diagrams and can overlay the diagrams onto an interactive geographic map to identify potentially contaminated foods or ingredients during a foodborne outbreak investigation. 
    • Developed as a supply-chain data-visualization and analysis tool, FCL has evolved into a comprehensive toolbox for data management, data enrichment, visualization, data analysis and interactive reasoning.
    • It is applicable in food- or feed-borne disease outbreak investigations as well as in exposure assessment tasks related to feed or food supply chains.

The FDA has clearly given a lot of thought on how to implement the new traceability regulations and the use of a system that works for the pharmacy industry inherently makes sense.  However, the margins, resources, and systems available to the pharmaceutical industry are orders of magnitude greater than the resources the food industry has.  

Inspections. Although compliance is required by January 20, 2026, FDA plans to again follow its now-familiar “educate while we regulate” approach for the first year, with routine inspections beginning in 2027. The additional year is also intended to provide time for entities to work together and ensure that traceability information is being maintained and shared within supply chains per the requirements of the rule. Although routine inspections will be delayed, FDA asserts that “we may do inspections for compliance with the Food Traceability Rule on a for-cause basis, such as during an outbreak investigation” in 2026.

As is evidenced by the two new FAQs, along with the other 17, Traceability Rule compliance is not simple to accomplish. Even businesses that have thorough traceability systems in place will need to assess their program, implement new activities and even apply a new language (transformation step, CTEs, KDEs, etc.) to meet the requirements. While FDA is gradually providing additional information on compliance TAG has taken on the tasks of really understanding how to support companies with compliance for this new requirement, TAG’s hands-on, customized Traceability consultation can provide solutions focused directly on your processes and supply chain. Give us a call for more information.

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