What a Traceability Plan must contain
Every covered person keeps a written traceability plan. It is short, it has five required parts, and it is the document an FDA representative is most likely to ask for first.
The event records are where the daily work is, but the traceability plan is the document that ties your program together and explains how it runs. Under 21 CFR 1.1315, every covered person establishes and maintains one. It does not have to be long. It has to be complete and current.
The five required parts
- Your records procedures. A description of the procedures you use to maintain the required records, including the format and location of those records. In plain terms: what systems hold your records, and where someone would go to find them.
- How you identify FTL foods. A description of the procedures you use to identify the foods on the Food Traceability List that you manufacture, process, pack, or hold. This forces you to be explicit about which of your products are in scope.
- How you assign lot codes. A description of how traceability lot codes are assigned to FTL foods per the lot-code rules, if you assign them. If you are an initial packer, a first land-based receiver, or a transformer, this is where you document your scheme.
- A point of contact. A statement identifying a point of contact for questions about your traceability plan and records. One named person or role, so FDA and your partners know who to ask.
- A farm map, for growers. Farms that grow or raise an FTL food, other than eggs, include a map showing the areas where the food is grown or raised, with the name and geographic coordinates (or other identifying information) of each field or growing area. For aquaculture, the location and name of each container (pond, pool, tank, or cage) is shown.
Keep it current, and keep the old versions
The plan must be kept up to date. If you change your systems, your product mix, or your lot-code scheme, the plan changes with it. And you must retain previous versions for 2 years. That retention requirement is easy to miss: when you revise the plan, do not overwrite the old one, archive it.
Why the plan is worth doing first
Writing the plan is a useful forcing function even before you build the event records, because each of its five parts asks a question you have to answer anyway. Which of my products are FTL foods? Where do my records live, and in what format? Do I assign lot codes, and how? Who owns this? Answering those on paper surfaces the gaps in your program while there is still time to fix them, which matters given the runway to the July 20, 2028 enforcement date. See our compliance-date guide for why building now is the right move.
The plan supports the 24-hour demand
The plan also sets up the back end of the rule. When FDA asks, you have to make the required records available within 24 hours, and during an outbreak or recall FDA can ask for them as an electronic sortable spreadsheet within 24 hours. A plan that clearly states the format and location of your records is what makes that pull possible rather than a scramble. Smaller entities that meet the criteria in the rule may provide the information in a form other than an electronic sortable spreadsheet.
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