An independent read on the FDA Food Traceability Rule, built for your role

Section 204 of the FDA Food Safety Modernization Act directed FDA to require additional records for foods it identifies as higher-risk. The result is the Food Traceability Rule, at 21 CFR Part 1 Subpart S, which makes anyone who manufactures, processes, packs, or holds a food on the Food Traceability List keep new records at defined points in the supply chain. FDA will not enforce the rule before July 20, 2028 (as at July 12, 2026).

The rule is not long, but it is exacting. It turns on a traceability lot code that has to be assigned, recorded, and passed along the chain, and on a set of Key Data Elements that differ by the event and by your role. A grower records different things from a distributor, who records different things from a manufacturer who transforms an input into a new product. Reading the whole subpart to work out which lines apply to you is where the time goes.

What we do

You tell us the foods you handle and your role. We return a coverage determination (covered or likely exempt, with the exemption subsection cited), a map of the Critical Tracking Events that apply to you, a ready-to-fill data-element template for each of those events, and a traceability-plan starter laid out against the five parts of 21 CFR 1.1315. Every point cites its CFR section and the FDA page, with the date we checked it.

Who it is for

Food-safety and quality leads, owner-operators, and compliance managers at packers, coolers, distributors, warehouses, importers, seafood receivers, manufacturers, and retailers that handle foods on the Food Traceability List. If you are working out what FSMA 204 means for your specific operation and you want a document you can put in front of an auditor or a supplier, this is built for you.

How we keep it current

Some of the facts here can change. The enforcement date rests on a proposed extension and an appropriations directive, the Food Traceability List can be revised by FDA, and the exemption dollar thresholds are inflation-adjusted from a 2020 baseline. We date every fact that can decay and re-verify the enforcement date and the list on a schedule before any relaunch. See our methodology and sources.

Independence

We are an independent tool. We are not affiliated with, endorsed by, or acting on behalf of the U.S. Food and Drug Administration or any government agency. We cite 21 CFR Part 1 Subpart S and FDA guidance as public sources. The report is an educational screening briefing, not legal advice or an official compliance determination.

Methodology · Sources · FAQ