FSMA 204 Key Data Elements: What to Record at Each Event

FDA's food traceability rule, FSMA 204, asks anyone who handles a food on its Food Traceability List to keep certain facts, the key data elements, at certain moments, the critical tracking events. A food maker meets three of those events: receiving a listed food, transforming it into something new, and shipping it. At each one the record ties the facts to a traceability lot code: what it is, how much, from whom or to whom, where, when, where the lot code came from, and which document backs it up. In the example below, a salsa maker receives fresh tomatoes, jalapeños and cilantro, makes a batch of fresh salsa under a new lot code, and ships it to three customers, with every element filled in. Below is each event, its elements, the example, and a free workbook with a sheet for each.

The short version

• The critical tracking events are harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation.
• A food maker meets three: receiving, transformation and shipping.
• Each event's key data elements are tied to a traceability lot code.
• A new lot code is assigned only at initial packing, first land-based receiving and transformation, never at shipping.
• When you ship, you send the first seven elements to your customer with the food.
• FDA can ask for the records within 24 hours, and in an outbreak or recall as an electronic sortable spreadsheet.
• TaroStack records the lots received, which lots each batch used, and which lots each customer got. More below.

The events and their elements

Receiving is set out in 21 CFR 1.1345, transformation in 21 CFR 1.1350, and shipping in 21 CFR 1.1340, which also says the first seven elements go to the customer with each lot. A new traceability lot code is assigned when you initially pack a raw agricultural commodity, first receive fish on land, or transform a food, and not when you ship it (21 CFR 1.1320). This is general information, not legal advice.

An example: a batch of fresh salsa

Saguaro Salsa Co., a made-up salsa maker in Tucson, Arizona, I use in these examples, makes fresh salsa from tomatoes, jalapeños and cilantro, all three on the Food Traceability List. On Tuesday, October 13, it receives:

On Wednesday it makes 480 tubs of fresh salsa, a transformation, so the salsa gets a new lot code, SSC-FS-261014-A, and the record lists what was used from each lot: 8 cases of the tomatoes, 1 of the jalapeños and 1 of the cilantro, with the batch record B-1014-A as the reference document. On Thursday it ships:

Each invoice carries the lot code, quantity, product, the customer's and Saguaro's locations, the date and the lot code source, the seven elements the customer needs for its own receiving record. The jarred salsa is cooked before it's sealed, a kill step, which comes with lighter records; how the exemptions work is in food traceability list exemptions.

When FDA asks

The records have to be available to FDA within 24 hours of a request, and when FDA needs them to help with an outbreak or a recall, as an electronic sortable spreadsheet, with exceptions for small farms and some retailers (21 CFR 1.1455). FDA has proposed moving the compliance date to July 20, 2028, and Congress directed it not to enforce the rule before then; FDA says it will comply. More on the date is in FSMA 204 compliance date, and how the whole chain fits together in how does food traceability work.

Get the workbook

Download the FSMA 204 key data elements workbook. Three sheets, one for each event a food maker does: receiving, transformation and shipping, with a column for each key data element the rule lists, and the salsa maker's rows as an example. Kept as it is, it's already a sortable spreadsheet. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.

Where this stops working

Three deliveries, one batch and three shipments fit on the sheets. A week of fresh salsa is a dozen deliveries, ten batches that each use parts of several lots, and fifty shipments, each typed in twice: once on the invoice and once in the sheet. One wrong lot code in the transformation sheet breaks the chain from the farm to the store, and nobody finds out until FDA asks.

How TaroStack does it

TaroStack records the lots received, which lots each batch used, and which lots each customer got.

Receiving. Each delivery is received with the supplier's lot code and your own, its dates and the document number, and scanning a supplier's GS1-128 case label fills in the lot.

Transformation. A batch of fresh salsa records the lots it consumed automatically, how much of each, and gets a lot of its own, so the new lot code and everything that went into it are on one record.

Shipping. Each order records the lots each customer got as it ships, so one recall report shows which supplier lots went into which batches, which customers got them and what's still on your own shelves. Every list exports to CSV, and timed, logged traceability drills show how fast you can answer.

Lots, batches, recalls and traceability drills are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.

Questions people also ask

What are key data elements in FSMA 204?

The facts the rule asks you to keep at each critical tracking event: the traceability lot code, quantity and unit, product description, locations, date, lot code source and reference document.

What are critical tracking events?

The moments the rule tracks: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation. A food maker meets receiving, transformation and shipping.

What do I have to send my customer when I ship?

The first seven elements: the lot code, quantity and unit, product description, the customer's location, your shipping location, the date, and the lot code source or its reference.

Do I assign a new lot code when I ship?

No. A new traceability lot code is assigned at initial packing, first land-based receiving and transformation, not at shipping.