SearchWhat the rule 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.
Human content review
The person responsible for this guide, its completed human content-review date, and its next review due date are not recorded.
Source retrieval dates identify the saved copies; they are not human content-review dates or publication approval. Check the current official text and the guide’s scope before relying on it. How to assess a guide.
Official sources
Important conditions, 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.
What to check next
- Is each food on the current Food Traceability List?
- Which growing, harvesting, cooling, packing, shipping, receiving, or transformation steps occur?
- Which exemption or partial exemption and records provision fits those facts?
- What is the current official compliance date, and where is the applicable FDA text?