The FDA rule implementing Section 204 of the Food Safety Modernization Act, requiring persons who manufacture, process, pack or hold foods on the Food Traceability List to keep key data elements for critical tracking events and to provide them to the FDA within 24 hours of a request.
FSMA Section 204 Food Traceability Rule
Statute United States
The FSMA Section 204 rule is the FDA’s answer to outbreak investigations that used to take weeks. It requires anyone handling a food on the Food Traceability List to record key data elements at critical tracking events — growing, receiving, transforming, creating, shipping — and to hand them to the FDA within 24 hours of a request.
- Traceability lot codes - The identifier that links records across companies.
- Critical tracking events - The defined points at which records must be captured.
- 24-hour production - The obligation is speed of retrieval, which is what forces the data to be structured rather than filed.
- Sortable electronic spreadsheet - The rule’s stated expectation for how records are produced to the agency.
The design detail worth noting is the last one. The rule requires structured data produced fast, which is genuinely demanding, and then names a spreadsheet as the delivery mechanism. That is enough to force food companies to build real traceability data models and not quite enough to make them interoperable with each other. The State of Supply Chain APIs found the food-traceability vendors scoring above their segment on the strength of the data work, with the exchange layer still left to each pair of trading partners.
Referenced in API Evangelist papers
This regulation shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this regulation in the context of a real sector.
The State of Supply Chain APIs
A 24-hour traceability obligation that specifies records and a sortable spreadsheet — not an endpoint.
