FSMA 204: what to do before July 2028.
A plain-language guide to FDA's Food Traceability Rule (FSMA 204): who is covered, critical tracking events, key data elements, traceability lot codes, the 24-hour records request, and a readiness plan before July 20, 2028.
FDA's Food Traceability Rule, often called FSMA 204, adds traceability recordkeeping on top of the one-step-forward, one-step-back records most plants already keep. The original compliance date was January 20, 2026. FDA proposed moving it to July 20, 2028, and Congress directed FDA not to enforce the rule before that date. That is extra time, not an exemption.
Who is covered
The rule applies to foods on the Food Traceability List (FTL), including many fresh-cut fruits and vegetables, leafy greens, fresh herbs, tomatoes, peppers, cucumbers, melons, sprouts, shell eggs, nut butters, soft and fresh cheeses, finfish, crustaceans and mollusks, and ready-to-eat deli salads. It can also apply when an FTL food is an ingredient in your product, unless an exemption applies, such as certain foods that receive a kill step. Check the current list and exemptions on FDA's site before deciding you're out of scope.
The three building blocks
1. Critical tracking events (CTEs)
These are the points in the supply chain where records are required: harvesting, cooling, initial packing, first land-based receiving for seafood, shipping, receiving and transformation. Most manufacturers deal mainly with receiving, transformation and shipping.
2. Key data elements (KDEs)
Each CTE has required data: what the food is, how much, where it came from or went, dates, and the traceability lot code. Much of this already lives in your receiving logs, batch records and bills of lading. The work is usually connecting it.
3. Traceability lot codes
A traceability lot code is assigned at initial packing, first land-based receiving and transformation. When you transform an FTL food, such as cutting, mixing or cooking it into a new product, you assign a new code and keep the link back to the incoming lots.
The 24-hour test
When FDA requests records, for example during an outbreak investigation, you must provide them within 24 hours or an agreed reasonable time, and in some cases as an electronic sortable spreadsheet. Plants that pass easily have rehearsed it.
A readiness plan you can start now
- Confirm scope. List every FTL food you receive, make, pack or ship, including ingredients.
- Map your CTEs. Walk the flow from receiving dock to shipping and mark where each event happens.
- Gap your KDEs. For each event, check which data elements you already capture and where.
- Set your lot-code logic. Decide how transformation lots link back to incoming lots.
- Write the traceability plan. It must describe your procedures, how you identify FTL foods and who to contact.
- Run a 24-hour drill. Produce a sortable spreadsheet for one product across a date range and time it.
Pair the drill with your annual mock recall and you meet two expectations with one exercise. Track the latest dates on our Regulatory Watch.
Source: FDA, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods