What Is FSMA 204 and What Records Does It Require?

FSMA 204, the FDA Food Traceability Rule, asks food companies to capture traceability records for high-risk foods. Here is what the rule covers, which records and data elements it requires, who has to comply, and how to keep the records without drowning in paperwork.

If you make, pack, or distribute food in the United States, FSMA 204 has probably landed on your desk as a compliance project with a deadline and a long list of records nobody is sure how to keep. The rule pushes the whole supply chain toward faster recalls by asking companies to capture specific traceability data on certain foods and hand it to the FDA within 24 hours when asked. This guide explains what FSMA 204 is, which records and data elements it requires, who has to comply, and a practical way to keep the records without burying your quality team in spreadsheets.

What is FSMA 204?

FSMA 204 is the FDA Food Traceability Rule, issued under section 204 of the Food Safety Modernization Act. It sets additional recordkeeping requirements for anyone who manufactures, processes, packs, or holds foods on the Food Traceability List, so a contaminated lot can be traced through the supply chain quickly during an outbreak or recall. The goal is simple to state and hard to do: when the FDA asks, a company should be able to produce a clean record of where a lot came from and where it went, fast enough to pull the right product and protect people.

What is the Food Traceability List?

The Food Traceability List (FTL) is the FDA's list of foods that carry a higher risk of causing illness, and only foods on that list (or made with an FTL ingredient) fall under the rule's extra recordkeeping. It includes categories such as soft and semi-soft cheeses, shell eggs, nut butters, fresh-cut fruits and vegetables, certain leafy greens, fresh herbs, melons, sprouts, tomatoes, peppers, cucumbers, finfish and crustaceans, and ready-to-eat deli salads. If a food on the list is an ingredient in a product you make, the finished product generally stays in scope, which is why most food and beverage manufacturers end up touching the rule somewhere in their bill of materials.

What records does FSMA 204 require?

FSMA 204 requires you to keep records of traceability data tied to specific events in a food's journey, and to maintain a traceability plan that describes how you do it. In practice that means capturing lot codes and the data that links each lot to its supplier, its receiving date, the production that used it, and the customer it shipped to. The records have to be kept for two years and be available to the FDA, in many cases as a sortable electronic spreadsheet, within 24 hours of a request. The 24-hour clock is the part that trips companies up, because data scattered across emails, PDFs, and binders cannot be assembled that quickly by hand.

What are critical tracking events and key data elements?

The rule is built around two ideas: critical tracking events (CTEs) and key data elements (KDEs). A critical tracking event is a point where food is handled in a way worth recording, such as harvesting, cooling, initial packing, receiving, transforming, or shipping. A key data element is the specific information you record at each of those events, such as the traceability lot code, the product description, the quantity and unit, the location identifier, and the date. The combination is what lets investigators follow a lot backward to its source and forward to every customer, one event at a time, instead of guessing.

Who has to comply with FSMA 204?

FSMA 204 applies to people who manufacture, process, pack, or hold foods on the Food Traceability List, across the supply chain: growers, processors, manufacturers, co-packers, distributors, and many retailers and restaurants that handle listed foods. There are exemptions, including some small producers, certain farms, and specific commodities and processes, so the first step in any compliance project is mapping which of your products and ingredients are actually in scope. Most food and beverage manufacturers find that at least part of their catalog is covered, even if their flagship product is not.

When is the FSMA 204 compliance date?

The FDA originally set the compliance date for January 20, 2026, then moved to extend it by 30 months, to July 20, 2028, to give the supply chain more time to build the systems and align trading partners. Treat the extension as breathing room, not a reason to stop, because the work of capturing lot codes and linking events takes months to roll out across suppliers and plants. Always confirm the current date on the FDA's own FSMA 204 page before you plan around it, since compliance timelines can change.

How do you keep FSMA 204 traceability records?

You keep FSMA 204 records by capturing the key data elements at each critical tracking event and storing them so a lot can be traced both directions on demand. The hard part is rarely the storage; it is getting clean lot codes and dates out of the documents that flow through receiving and production in the first place. Incoming certificates of analysis, receiving records, bills of lading, and production logs all carry the lot and date information you need, but they arrive as PDFs, scans, and hand-completed paper in dozens of supplier formats. Our step-by-step guide on how to extract data from a certificate of analysis covers the lot and specification fields worth capturing at receiving. If a person has to read each one and type the codes into a spreadsheet, the data is slow to gather and easy to get wrong, which is exactly what falls apart under a 24-hour request.

How does document extraction help with FSMA 204 traceability?

Document extraction helps by reading the lot codes, supplier and receiving data, and dates off your incoming and production documents automatically, so the traceability data is structured and searchable instead of buried in files. Software classifies each document, pulls the key data elements as named fields, validates them, and links every value to the source document and lot with an audit trail. When a recall or a mock recall starts, you can trace a lot back to its certificate and forward through production in minutes. This is one workflow inside a broader food and beverage document processing software setup that also reads supplier specs, HACCP records, and nutrition panels, and it starts with document classification to sort a mixed file before the data is pulled, all built on intelligent document processing. Because so much traceability data rides on inbound and shipping paperwork, teams often pair it with logistics document processing software to capture the receiving and transport records that tie each lot to its movement. Capturing the lot data cleanly at receiving is what turns a 24-hour FDA request from a fire drill into a query.