The FDA's Food Traceability Rule is written as events and data. Each critical tracking event (CTE) is a moment in a food's supply chain, and each comes with a list of key data elements (KDEs) you must record. Read that way, the rule is close to a software specification. This article translates it for a distributor's systems. If you want an audit of your whole operation instead, use the FSMA 204 readiness checklist.
The details below come from the rule itself (21 CFR Part 1, Subpart S), summarized on the FDA's Food Traceability Rule page. The compliance date is July 20, 2028.
Seven events, and the three that matter to most distributors
The rule defines seven critical tracking events: harvesting, cooling (before initial packing), initial packing, first land-based receiving (for food from a fishing vessel), shipping, receiving and transformation. The first four belong to farms, packers and the first land-based receivers of seafood.
A distributor that buys and resells usually performs two: receiving and shipping. If you repack, relabel, cut, mix or commingle a covered food, you also perform transformation. A few definitions shape what your system has to log:
- A transfer between two of your own sites at different street addresses is a shipping event and a receiving event.
- Shipping does not include sales directly to consumers or donations of surplus food.
- Breaking down pallets is holding, not transformation. Repacking, according to the FDA's FAQ, is always transformation.
The vocabulary your data model needs
- Traceability lot code (TLC): the code that identifies a lot within the records of the business that assigned it.
- TLC source: the place where the code was assigned, such as the packer. Instead of its full address you can give a TLC source reference, such as its FDA Food Facility Registration Number or a web address that leads to it.
- Location description: business name, phone number, physical address (or coordinates), city, state and zip code. In software terms, a structured record for each supplier site, warehouse and customer delivery location, not a free-text field.
- Product description: product name (including brand, commodity and variety where they apply), packaging size and packaging style. This belongs on the item record.
- Reference document: the business document behind the event, such as a bill of lading, purchase order, advance ship notice, invoice or work order, plus its number.
Receiving: eight elements
| Key data element | Where your system should get it |
|---|---|
| Traceability lot code | The supplier's case label, bill of lading or advance ship notice, scanned or typed at the dock |
| Quantity and unit of measure | The receipt line |
| Product description | The item record |
| Location description of the immediate previous source (not the trucking company) | The supplier's ship-from site |
| Location description of where you received it | Your warehouse record |
| Date received | The receipt itself |
| TLC source, or TLC source reference | The supplier's paperwork for that lot |
| Reference document type and number | The bill of lading, invoice or PO number |
Two points trip up software. First, the TLC source is not always your supplier. If you buy from a wholesaler who bought from the packer, the previous source is the wholesaler, but the lot code source is still the packer. Second, you keep the code you were given. The rule says a new code is assigned only at initial packing, first land-based receiving or transformation, and the FDA's FAQ on the rule says plainly that a distributor should not change the code provided to it. Your own receipt or lot number can run the warehouse, but it must stay linked to the supplier's code. The exception: if a supplier is not subject to the rule and no code was assigned, you assign one when you receive it.
Shipping: the same eight, pointed the other way
For each lot you ship, you record the lot code, quantity and unit, product description, the location description of the immediate recipient (again, not the trucking company), the location you shipped from, the ship date, the TLC source or its reference, and the reference document type and number.
The first seven of those must also go to your customer, on paper or electronically, because they are your customer's receiving records. For software, that means two things. The lot has to be on the shipped line, so picking must record which lot each case came from; an order line filled from two lots produces two records. And the documents or data that travel with the shipment have to carry those fields.
Transformation: inputs, outputs and a new code
When you transform a covered food you record, for each input lot, its code, product description and the quantity used. For the output you record the new lot code, your location as the TLC source, the date the transformation was completed, the product description, the quantity and unit, and the reference document (such as a work order). The FDA's FAQ allows a like-into-like repack to keep the original code, but your site becomes the TLC source. In software terms, a repack is a work order that consumes input lots and creates an output lot linked to them.
What the system has to do with the data
- Record events as they happen. Data typed in at the end of the day from memory is where mistakes creep in.
- Link everything to the lot, so you can trace forward to customers and back to sources.
- Retrieve fast. Records must reach the FDA within 24 hours of a request, with whatever explains your internal codes. In an outbreak or recall, the FDA can ask for an electronic sortable spreadsheet for specific foods and date ranges or lot codes.
- Keep it two years from when the record was created or obtained.
The rule does not prescribe a technology, and the FDA says barcode scanning is not required. Paper is allowed. The test is whether the records are complete and can be produced on time. For more on those points, see the FSMA 204 FAQ and our FSMA 204 guide.
A quick test for your current system
Pick a covered lot received in the last few months. Ask the system for every customer who received any of it, with quantities, dates and invoice numbers. Then ask for the receiving record, the supplier's lot code and its source. If either answer depends on someone reading paper pick sheets or matching dates by hand, the gap is in your shipping records, and that is where to start.
How APFoodz records it
APFoodz records each lot's events as the work happens, from receipt to shipment, so a trace forward or back is a lookup. See FSMA 204 traceability and recalls.