Section 204 of the Food Safety Modernization Act (FSMA) requires entities that manufacture, process, pack, or hold foods on the FDA Food Traceability List to maintain enhanced traceability records and provide them to the FDA within 24 hours of a request. Enforcement begins July 20, 2028.
Compliance deadline: July 20, 2028
All covered entities must maintain Key Data Elements (KDEs) for Critical Tracking Events (CTEs). Records must be accessible to the FDA within 24 hours — in an electronic sortable spreadsheet format.
What is FSMA Section 204?
Section 204 of FSMA is the FDA's Food Traceability Rule — officially titled “Requirements for Additional Traceability Records for Certain Foods.” It mandates that businesses handling foods on the Food Traceability List (FTL) keep standardised electronic records that enable the FDA to rapidly identify and remove contaminated food from the market during outbreaks.
The rule is designed to compress outbreak response time from weeks to hours — by requiring records that can be searched, sorted, and handed to the FDA on demand.
What does it require?
- Maintain Key Data Elements (KDEs) for each Critical Tracking Event (CTE) — receiving, transforming, creating, and shipping
- Provide records to the FDA within 24 hours of a request
- Records must be producible as an electronic sortable spreadsheet
- Assign and maintain Traceability Lot Codes (TLCs) for all covered foods
- Applies to any entity that manufactures, processes, packs, or holds foods on the FTL
Critical Tracking Events (CTEs)
A Critical Tracking Event is any point in the supply chain where a food's status, location, or ownership changes. FSMA 204 defines four CTEs, each with specific Key Data Elements that must be captured and retained.
Receiving
When covered foods arrive at your facility — lot code, quantity, location, and the identity of the previous entity in the chain.
Transforming
When a covered food is processed or converted into a new product — linking the new product's lot code back to its source.
Creating
When a new food on the FTL is first produced — capturing the Traceability Lot Code and production date at the point of creation.
Shipping
When covered foods leave your facility — destination, lot code, quantity, and contact info for the recipient entity.
Who does it apply to?
FSMA 204 applies to any domestic or foreign entity that manufactures, processes, packs, or holds foods on the FDA Food Traceability List. The FTL targets high-risk foods linked to major foodborne illness outbreaks.
Foods on the FDA Food Traceability List — partial list
- Leafy greens (fresh-cut and whole head)
- Soft cheeses (ricotta, brie, camembert, queso fresco)
- Shell eggs
- Cucumbers, herbs, peppers, sprouts, tomatoes
- Tropical tree fruits and melons
- Deli salads (egg, potato, pasta, seafood)
- Nut butters
- Ready-to-eat fish products (smoked, raw, salted)
- Ready-to-eat sandwiches and salads
How Dill helps
Dill captures the labelling-side traceability KDEs that FSMA 204 demands. Every label printed across every site is timestamped, signed by the staff member who produced it, tied to the source recipe, and exportable as a sortable electronic record.
When the FDA requests traceability records, your team exports a complete audit report in seconds — not days. Every Traceability Lot Code assigned at production is captured on the label. Every Critical Tracking Event that touches a label is logged.
- Lot code captured and printed on every label
- Full digital footprint per label — who, when, which site
- Exportable as sortable spreadsheet — FDA-ready format
- Recipe and ingredient linkage for ingredient-level traceability
- Multi-site visibility from one central dashboard