FSMA 204, the US food traceability rule

Section 204 of the US Food Safety Modernization Act led the FDA to adopt the Food Traceability Rule, codified in 21 CFR Part 1, Subpart S. This page sums up the facts that matter for your lots. It is not legal advice: check the official texts and, for your own obligations, a lawyer.

The compliance date has moved. As of October 2026, US law directs the FDA not to enforce the rule before 20 July 2028. Check the FDA page for the current date.

Which foods

Foods on the FDA's Food Traceability List, and foods that contain them: among others soft cheeses, shell eggs, nut butters, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, finfish, crustaceans, molluscan shellfish and ready-to-eat deli salads. The list goes by food category, not by customs code.

What the rule asks

Anyone who manufactures, processes, packs or holds these foods keeps records of key data elements for each critical tracking event:

• harvesting, cooling, initial packing and first land-based receiving;
• shipping and receiving;
• transformation, when a food is changed or used as an ingredient.

A traceability lot code is assigned at initial packing, first land-based receiving or transformation, and travels with the food. On request, the FDA must receive an electronic sortable spreadsheet of the records within 24 hours. Records are kept for two years.

Who it applies to

The rule covers firms that handle these foods for the US market, including suppliers outside the United States. Some farms and businesses are exempt or have partial requirements; the rule lists them.

How the console helps

• Harvests, receipts, deliveries and processing are recorded as you work, each with its date, quantity, unit, place and lot code. See Register your first lot and Processing.
• The FSMA 204 traceability records report produces the sortable spreadsheet with the key data elements per event, and lists the records still missing. See Reports.
• Check evidence on a lot or a delivery, with FSMA 204 traceability records, lists the key data elements the records hold and what is missing. See Evidence check.
• The certificate type FSMA 204 records complete marks a lot whose key data elements are complete.
• Traceability & recall shows one step back and one step forward for any lot.

The console helps you keep and present the records. It does not decide whether your business complies.