FSMA 204 (FDA)

When a foodborne outbreak hits, the FDA needs to trace contaminated food from retail shelf back to the originating farm or processor within hours — not weeks. That speed requirement is the driving force behind FSMA Section 204 (21 CFR Part 1, Subpart S), which mandates electronic traceability records for every entity handling foods on the Food Traceability List (FTL). Following an industry-wide 30-month extension, the July 2028 compliance deadline applies to growers, manufacturers, processors, distributors, and retailers alike. Each must capture Key Data Elements (KDEs) at defined Critical Tracking Events (CTEs): growing, receiving, transforming, creating, shipping, and first land-based receiving.

The rule's specificity is what trips up most food industry participants. It is not enough to have general lot records — the FDA prescribes exact data fields for each CTE, including traceability lot codes, quantities, locations, and dates in formats that enable rapid electronic sorting. Records must be available within 24 hours of an FDA request, and they must connect seamlessly across supply chain partners so the agency can follow a contaminated ingredient from its origin through every transformation and handoff to the point of sale.

Sustalium maps each CTE to a structured input form aligned with the FDA's published KDE requirements. Your team enters receiving, transformation, and shipping data through forms that enforce field completeness — preventing the gaps that cause traceability chains to break during an investigation. Records are searchable by lot code, product, date range, or supplier, meeting the 24-hour access mandate. For companies operating across US and EU jurisdictions simultaneously, the same underlying lot data can feed both FSMA 204 records and EUDR due diligence statements where commodity overlap exists.

For an overview of how FSMA 204 and EU PPWR work together for food and packaging companies, read our packaging and food compliance guide.