Section 204(d) of the Food Safety Modernization Act (or FSMA 204) is part of the FDA’s broader New Era of Smarter Food Safety Blueprint, a forward-focused initiative whose primary pillar is “tech-enabled traceability.”
The regulation defines a set of Key Data Elements (KDEs) that food supply chain operators must capture for each Critical Tracking Event (CTE) in a product’s journey from its point of origin to the end consumer. These KDE records are to be created, collected and stored in a format that can be retrieved and sent to the FDA within 24 hours when requested. Previously, the regulation only required data only from one-up and one-back events.
As a product changes hands or changes form, its string of KDE records grows and must be transferred between trading partners, to create full, end-to-end traceability. ReposiTrak estimates that retailers alone will be responsible for thousands – if not millions – of traceability records per year.