SearchWhat the source says
The FDA Food Traceability Rule applies to persons who manufacture, process, pack, or hold foods on FDA's Food Traceability List, subject to the rule's exemptions and partial exemptions.
Sources checked August 18, 2026 · 21 CFR Part 1, Subpart S (1.1300–1.1465); State and local rules are not included.
Conditions, thresholds, exceptions, and duties
Coverage triggerThe rule starts with a food on the Food Traceability List and a person who manufactures, processes, packs, or holds it. 21 CFR 1.1300
ExemptionsThe rule contains exemptions and partial exemptions for farms, small producers, small retailers and restaurants, transporters, and other classes, with conditions that must be checked. 21 CFR 1.1305
RecordsCovered persons may need a traceability plan, lot codes, critical-tracking-event data, and records that can be provided to FDA within 24 hours where the applicable provision requires it. 21 CFR 1.1315; 1.1320; 1.1455
What this source does not answer
- The source does not decide whether a particular farm, facility, food, or operation is covered or exempt.
- The Food Traceability List, sales thresholds, packaging, labeling, and direct-sale facts require separate checks.
- State and local requirements are outside this federal guide.
What to check next
- What occurs at each location?
- Which activities are harvesting, packing, holding, manufacturing, or processing?
- Does the operation satisfy the farm definition?
- Does a retail-food-establishment exclusion apply?
- Are off-farm activities part of a mixed-type facility?