FSMA 204: records within 24 hours. No enforcement before 20 July 2028.
The FDA's Food Traceability Rule (21 CFR Part 1, Subpart S) requires anyone who manufactures, processes, packs or holds a food on the Food Traceability List to keep key data at each step and hand it to FDA within 24 hours of a request.
- FSMA 204 · THE CLOCK
- Jan 2023final rule in force
- 20 Jan 2026original date
- 20 Jul 2028earliest enforcement
- 24 hoursto answer FDA
- Congress directiveFDA complies
Where it stands.
Each line names the source it was checked against.
- Compliance date
- FDA will not enforce the rule before 20 July 2028. FDA proposed a 30-month extension and Congress then directed it not to enforce before that date; FDA says it intends to comply. FDA
- Who it covers
- Anyone who manufactures, processes, packs or holds a food on the Food Traceability List, including foods that contain a listed food as an ingredient, with some exemptions. 21 CFR 1.1300–1.1465
- Records
- Traceability records go to FDA within 24 hours of a request, or a reasonable time FDA agrees to. In an outbreak or recall, FDA can ask for an electronic sortable spreadsheet. 21 CFR 1.1455
- Plan
- Each covered firm keeps a written plan: how its records are kept, how it identifies foods on the list, how it assigns lot codes, and a contact. 21 CFR 1.1315
What to record, and when.
Critical tracking events
Harvesting, cooling, initial packing, first land-based receiving for seafood, shipping, receiving and transformation.
Key data elements
For each event: the traceability lot code, the food, the quantity, the locations involved and the date, plus the reference document.
Traceability lot codes
Assigned at initial packing, first land-based receiving or transformation, and passed along with the food so the next firm can record it.
Technology-neutral
Paper, spreadsheets or software all count. What counts is producing the records in 24 hours, in a sortable form when FDA asks.
Your food, in detail.
The Food Traceability List covers soft and fresh cheeses, shell eggs, nut butters, fresh produce such as leafy greens, tomatoes, peppers, cucumbers, melons, herbs and sprouts, fresh-cut fruit and vegetables, finfish, crustaceans and molluscs, and ready-to-eat deli salads.
FSMA 204 for produce
Leafy greens, tomatoes, peppers and the rest of the list.
Read the guide →SeafoodFSMA 204 for seafood
From vessel to counter, with first land-based receiving.
Read the guide →CheeseFSMA 204 for cheese & dairy
Which cheeses are on the list, and which are not.
Read the guide →Shell eggsFSMA 204 for shell eggs
From layer house to carton.
Read the guide →Nut buttersFSMA 204 for nut butters
A recall-prone category, lot by lot.
Read the guide →Ready-to-eatFSMA 204 for deli salads & RTE
Transformation records for multi-ingredient foods.
Read the guide →How Aeroz answers FDA in hours, not days.
One record per lot
Every critical tracking event becomes a signed, timestamped entry against the lot, in GS1 EPCIS 2.0, so nothing is rebuilt from invoices.
The spreadsheet, on demand
The sortable spreadsheet FDA asks for comes straight out of the event log for any lot, date range or location.
A narrower recall
Unit- and lot-level records show exactly which product touched the suspect lot, so a recall can be sized to it.
FSMA 204, answered.
When is the FSMA 204 compliance date?
FDA will not enforce the Food Traceability Rule before 20 July 2028. The original date was 20 January 2026; FDA proposed a 30-month extension and Congress directed it not to enforce before July 2028.
Which foods are covered?
Foods on FDA's Food Traceability List, such as soft cheeses, shell eggs, nut butters, leafy greens and other fresh produce, fresh-cut fruit and vegetables, finfish, crustaceans, molluscs and ready-to-eat deli salads, plus foods that contain them as an ingredient.
How fast do records have to reach FDA?
Within 24 hours of a request, or a reasonable time FDA agrees to. In an outbreak, recall or other threat to public health, FDA can ask for an electronic sortable spreadsheet.
Does FSMA 204 require RFID or chips?
No. The rule is technology-neutral. It asks for key data elements at critical tracking events and the ability to produce them on time.
Sources: FDA: FSMA final rule on traceability records · 21 CFR Part 1, Subpart S. Checked 23 October 2026. Not legal advice.
From the Aeroz blog
- 19 Million Eggs, One Carton Code: The 2026 Shell Egg Recall
- The Fallacy of the Batch Perimeter: Why Modern Supply Chains Require Item-Level Serialization
More answers: FSMA 204 questions in the compliance FAQ
The FDA Food Traceability Rule (FSMA section 204) covers foods on the Food Traceability List. FDA will not enforce it before 20 July 2028. Records go to FDA within 24 hours of a request.
- Rule
- 21 CFR 1 Subpart S
- Enforcement
- 20 Jul 2028
- Response
- 24 hours
- Format
- sortable spreadsheet