How we determine coverage and build your records
Every determination in the report traces to a section of 21 CFR Part 1 Subpart S and the FDA pages that publish the list and guidance. Here is exactly how we get from your answers to your obligations.
Facts checked July 12, 2026
1. The coverage test
The rule applies to persons who manufacture, process, pack, or hold a food on the Food Traceability List, at each point in the supply chain, unless a specific exemption applies. So we ask two things: whether you handle an FTL food (including a food that contains a listed food as an ingredient, where that ingredient stays in the same form it takes on the list), and your role. If you handle no FTL food, the rule adds no records for you. If you do, we move to your role and any exemption.
2. Exemptions come first, and they are cited
Before mapping records, we test your answers against the exemptions in 21 CFR 1.1305. Where a self-reported figure triggers one, we name it, cite the subsection, and state that it depends on your numbers. The two dollar thresholds we keep separate: $25,000 average annual produce sales for small produce farms (1.1305(a)(1)), and $250,000 average annual food sales for small retail food establishments and restaurants over the previous 3 years (1.1305(i)). Both are inflation-adjusted from a 2020 baseline. We also apply the transporter (1.1305(n)), direct-to-consumer (1.1305(b)), and kill-step and commercial-processing (1.1305(d)) carve-outs, among others.
3. Role to Critical Tracking Event map
The rule attaches records to events, not to companies. We use this canonical map, drawn from 21 CFR 1.1325 through 1.1350:
| Your role | Critical Tracking Events that apply |
|---|---|
| Grower / harvester | Harvesting; Cooling (if you cool before initial packing) |
| Cooler | Cooling |
| Initial packer | Initial Packing (assigns the traceability lot code) |
| Seafood first land-based receiver | First Land-Based Receiving (assigns the lot code) |
| Manufacturer / processor | Transformation; Shipping; Receiving |
| Distributor / warehouse (holder) | Receiving; Shipping |
| Importer | Receiving (and Shipping onward) |
| Retailer / restaurant (not exempt) | Receiving; Shipping if it ships FTL foods to another location |
4. Where the Key Data Elements come from
For each event that applies to you, the report lists the specific fields you must record as a fill-in template. These are taken directly from the CFR: harvesting and cooling from 1.1325, initial packing from 1.1330, first land-based receiving from 1.1335, shipping from 1.1340, receiving from 1.1345, and transformation from 1.1350. The traceability lot code is the spine that links each event's records, so it is called out at every step. We cross-check the consolidated view against FDA's own Critical Tracking Events and Key Data Elements reference.
5. The traceability plan and the 24-hour rule
The plan starter is laid out against the five required elements of 21 CFR 1.1315: records procedures and where records live, how you identify FTL foods, how you assign or receive lot codes, a point of contact, and, for growers, a farm map. We include the requirement to keep the plan current and retain prior versions for 2 years. The records-to-FDA section is built from 21 CFR 1.1455: the 24-hour availability rule and the electronic sortable spreadsheet FDA can request during an outbreak or recall, with the small-entity alternative.
6. What we do not do
We do not verify your self-reported figures, inspect your operation, or issue a compliance certificate. We do not invent data. The report is a screening built from your answers and the published rule. It is not legal advice, and it is not a substitute for qualified counsel or, where a measurement is needed, an accredited lab.
7. Dating facts that can change
We stamp the check date on every page and in the report. The enforcement date, the contents of the Food Traceability List, and the exemption dollar thresholds are treated as decaying facts and re-verified on a schedule. See sources for each authority and its check date.