The 60-second summary
FSMA 204 is the FDA Food Traceability Rule. It requires any business that manufactures, processes, packs or holds a food on the Food Traceability List to record standardized data at each key step and hand it to the FDA within 24 hours of a request. Compliance begins July 20, 2028.
Last reviewed: September 27, 2026
What is FSMA 204?
Section 204 of the Food Safety Modernization Act is the FDA's Food Traceability Rule, officially titled “Requirements for Additional Traceability Records for Certain Foods.” It requires businesses that handle foods on the Food Traceability List to keep standardized records that let the FDA quickly trace a contaminated food back to its source and forward to where it went.
The goal is to cut outbreak response time from weeks to hours, by requiring records that can be searched, sorted and handed over on demand.
Compliance date: July 20, 2028
The original compliance date was January 20, 2026. In 2025 the FDA extended it by 30 months to July 20, 2028, and Congress directed the FDA not to enforce the rule before that date. The extra time is for putting recordkeeping systems in place, not a reason to wait: the systems behind traceability take months to roll out across sites.
Key dates
Original compliance date: January 20, 2026. Current compliance date: July 20, 2028. Records must reach the FDA within 24 hours of a request, in an electronic sortable spreadsheet where required.
Who FSMA 204 covers
The rule applies to any domestic or foreign business that manufactures, processes, packs or holds a food on the Food Traceability List for U.S. consumption, along the whole supply chain. Restaurants and retail food establishments are covered too, with modified requirements and some exemptions by size (see below).
The Food Traceability List
The Food Traceability List (FTL) is the set of higher-risk foods the rule applies to, chosen with a risk-ranking model based on outbreak history and other factors. If a food is on the list, foods that contain it as an ingredient are generally covered too, unless the ingredient has been changed so it is no longer on the list.
Categories on the Food Traceability List
- Cheeses, other than hard cheeses
- Shell eggs
- Nut butters
- Cucumbers, herbs, leafy greens, melons, peppers and tomatoes
- Tropical tree fruits
- Fresh-cut fruits and vegetables
- Sprouts
- Finfish, crustaceans and molluscan shellfish
- Ready-to-eat deli salads
Critical Tracking Events and Key Data Elements
A Critical Tracking Event (CTE) is a point in the supply chain where a food is handled in a way the rule tracks. The FDA names seven. For each CTE you perform, you record its Key Data Elements (KDEs), the specific pieces of information that describe what happened. The KDEs differ by event, and each links back to a traceability lot code.
Harvesting
Removing a raw agricultural commodity on the list from where it is grown. Applies to FTL foods not obtained from a fishing vessel.
Cooling
Actively lowering the temperature of a raw agricultural commodity before initial packing, for example hydrocooling or forced-air cooling.
Initial packing
Packing a raw agricultural commodity for the first time. This is where a traceability lot code is assigned for produce.
First land-based receiving
Taking possession of a food for the first time on land, directly from a fishing vessel. The lot code is assigned here for seafood.
Shipping
Arranging a food for transport from one location to another. The final shipment to a consumer is not a shipping CTE.
Receiving
Taking possession of a food after it has been transported, by anyone other than a consumer.
Transformation
Manufacturing, processing or changing a food or its packaging when the output is a food on the list. A new traceability lot code is assigned.
Traceability lot codes and labels
A traceability lot code (TLC) is a unique identifier for a lot of food. It is assigned at initial packing, at first land-based receiving of seafood, or at transformation, and it stays with that lot through every later event. The lot code and the data tied to it have to travel with the product, which in practice means they belong on the case or pack label.
This is where printing matters. A printed label keeps the lot code legible, consistent and machine-readable, and lets it link straight back to the digital record. Handwritten codes are slow to apply, easy to misread and hard to search during a recall, exactly when the 24-hour clock is running.
Dill prints the traceability lot code onto the label at the point it is assigned and links it to the underlying record, so the code on the box matches the data you can hand to the FDA.
Exemptions for restaurants and retailers
The rule scales its requirements by size. Two thresholds matter most for restaurants and retail food establishments:
- $250,000 or less in average annual food sales: fully exempt from the rule.
- Under $1 million in average annual food sales: exempt from providing records as an electronic sortable spreadsheet, but records must still be kept.
- Certain farms, small producers and foods that are changed so they leave the list have their own exemptions.
What changed in 2026
The rule is still being refined ahead of the 2028 date. The main developments in 2026:
February 20, 2026
The FDA finalized an exemption for Grade “A” cottage cheese products on the Interstate Milk Shippers list, which are already covered by the Pasteurized Milk Ordinance.
May 27, 2026
The FDA released a discussion paper seeking input on potential flexibilities for the lot-level tracking requirements.
June 15, 2026
The FDA held a public meeting on traceability implementation.
July 15, 2026
The comment deadline on the discussion paper (Docket FDA-2014-N-0053) closed.
How to prepare
Preparing for FSMA 204 is mostly about knowing what you handle and being able to produce records fast. A practical order to work in:
- 1Check which of the foods you handle appear on the Food Traceability List.
- 2Identify which Critical Tracking Events you perform for those foods.
- 3Assign traceability lot codes and make sure they print on the case and pack labels.
- 4Capture the Key Data Elements for each event in a system that can export a sortable spreadsheet.
- 5Test that you can produce the records for the FDA within 24 hours.
Dill handles the labelling side of this: it assigns and prints traceability lot codes, captures the KDEs tied to each printed label, and exports them as a sortable record. Book a demo to see it on your own products.
Frequently asked questions
What is FSMA 204?
FSMA 204 is the FDA Food Traceability Rule. It requires businesses that manufacture, process, pack or hold foods on the Food Traceability List to keep extra records and give them to the FDA within 24 hours of a request.
When is the FSMA 204 deadline?
The compliance date is July 20, 2028. It was extended by 30 months from the original date of January 20, 2026, and Congress directed the FDA not to enforce the rule before July 20, 2028.
Does FSMA 204 apply to restaurants?
Yes, with modified requirements. Restaurants and retail food establishments with $250,000 or less in average annual food sales are fully exempt. Those under $1 million are exempt from the electronic sortable spreadsheet requirement but must still keep records.
What foods are on the Food Traceability List?
Soft and fresh cheeses, shell eggs, nut butters, cucumbers, herbs, leafy greens, melons, peppers, tomatoes, tropical tree fruits, fresh-cut produce, finfish, crustaceans, molluscan shellfish, sprouts and ready-to-eat deli salads.
What is a traceability lot code?
A traceability lot code (TLC) is a unique identifier assigned to a lot of food when it is initially packed, received on land from a fishing vessel, or transformed. It links every record for that lot across the supply chain.
What are KDEs and CTEs?
Critical Tracking Events (CTEs) are the points in the supply chain where a food is handled: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation. Key Data Elements (KDEs) are the specific pieces of information you record for each event.
How do labels help with FSMA 204?
The traceability lot code has to travel with the product. Printing it on the case or pack label keeps the code legible and consistent, and lets it link back to the digital record the FDA can pull within 24 hours.