This video demo was produced by FDA for the International Association for Food Protection’s European Symposium in May 2023. The video was developed to highlight FDA’s early exploration of important technological components of product tracing systems and to showcase collaboration with international government counterparts to improve global food traceability missions. This video is intended to educate international government agencies, state and local health authorities, technology providers, and industry on some of the technological components of a Product Tracing System (PTS). 

FDA is currently developing an internal PTS like the one shown in the video. The purpose of FDA’s PTS is to receive and analyze industry’s traceability data and more effectively and rapidly trace food within the United States. This is consistent with requirements in Section 204(c) of the FDA Food Safety Modernization Act (FSMA). FDA’s PTS will enhance existing foodborne outbreak response processes, especially those by the FDA Coordinated Outbreak Response and Evaluation (CORE) Network. 

Upon FDA request, industry stakeholders will have the option to upload electronic sortable spreadsheets or other traceability records into FDA’s Safety Reporting Portal (SRP), which is a secure web-based portal that will be updated to include a traceability-specific landing page. Alternatively, industry stakeholders could send their electronic sortable spreadsheets or other traceability records to FDA via email and have FDA upload their data directly into the PTS.  Under the Food Traceability Rule, which has a compliance date of January 20, 2026, an electronic sortable spreadsheet will be required in certain situations, as outlined in § 1.1455(c)(3)(ii). But the SRP and the PTS are not just for records requests that are made under the Food Traceability Rule. We are designing these systems to be used by anyone who is submitting food traceability information to FDA, regardless of whether the situation is covered by the Food Traceability Rule or not. Furthermore, even under the Rule, a sortable spreadsheet is not always required. FDA is therefore preparing to receive traceability records in a variety of 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). While this openly accessible data standard is one option available for use by industry to promote interoperability across their supply chains, it is not a requirement to comply with the Food Traceability Rule and it is not a requirement to send FDA food traceability data in EPCIS format.

After data processing, the data are available for use by authorized government users in an open-sourced data visualization platform called FoodChain Lab (FCL). FCL creates automatic end-to-end supply chain diagrams from the processed data and can overlay these supply chain diagrams onto an interactive geographic map. This automated visualization functionality will assist FDA in identifying potentially contaminated foods or ingredients during a foodborne outbreak investigation.   

The PTS will have very strict data security and network security protocols. Only permissioned government users can access the data and FDA will protect confidential information from disclosure in accordance with all applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 CFR part 20, as it does for confidential information on other FDA-regulated products.   

Industry firms are not required to build their own product tracing systems.  However, it is helpful for the public to understand how the Agency will be capturing and analyzing industry’s traceability data and the technological components built into the system, including with the use of interoperable data standards and other low-cost software technologies.