Event-Based TraceabilityFSMA 204 and Wholechain

FSMA 204 and Wholechain

How the U.S. FDA Food Traceability Rule (FSMA 204) relates to Wholechain's events, critical tracking events and traceability lot codes.

This article explains how the U.S. FDA Food Traceability Rule (FSMA 204) relates to Wholechain's events. For the basics of Wholechain events, start with Understanding Event-Based Traceability in Wholechain. To record events in the app, see the Wholechain Events Overview.

What FSMA 204 is

FSMA 204 is the common name for the U.S. Food and Drug Administration's (FDA) final rule on Requirements for Additional Traceability Records for Certain Foods, known as the Food Traceability Rule. It implements Section 204(d) of the FDA Food Safety Modernization Act.

The rule is a regulation. It requires certain businesses to keep specific traceability records. It is not a data-exchange standard like EPCIS or GDST, and it doesn't require any particular data format. Records can be paper or electronic. On request, covered businesses must give FDA the records within 24 hours, or within another reasonable time FDA agrees to.

Compliance date. FSMA 204 has been delayed until July 20, 2028. Check FDA's page for the rule for the current status.

Who it applies to

The rule applies to people who manufacture, process, pack, or hold foods on the Food Traceability List (FTL). It also reaches foods that contain a listed food as an ingredient, in some cases. Some businesses and foods are exempt or have modified requirements. Check FDA's Food Traceability List and its exemption guidance to see how the rule applies to you.

How FSMA 204 relates to Wholechain

FSMA 204 organizes its requirements around critical tracking events (CTEs), the points in a food's journey where records are required, and key data elements (KDEs), the information recorded at each CTE. Wholechain's events are a more general way of describing what happened. Many CTEs line up directly with a Wholechain event.

Using Wholechain does not by itself make you compliant with FSMA 204. Compliance depends on your foods, your role, and your records. Check the rule and FDA's guidance for your situation.

How the FSMA 204 events map to Wholechain events

FDA names seven CTEs:

FSMA 204 CTEWho it applies to (summary)Wholechain event
HarvestingHarvesters of raw agricultural commodities not obtained from a fishing vesselCommission
Cooling (before initial packing)Those who cool raw agricultural commodities before initial packingObserve
Initial packingThose who initially pack raw agricultural commodities (not from a fishing vessel)Transform
First land-based receivingThe first land-based receiver of food from a fishing vesselReceive
ShippingThose who ship covered food (with limited exceptions, such as raw agricultural commodities before initial packing)Ship
ReceivingThose who receive covered food (with limited exceptions)Receive
TransformationThose who create a new listed food from one or more listed ingredientsTransform

Wholechain's Aggregate, Disaggregate, and Decommission events aren't mapped to FSMA 204 CTEs. You use them when they describe what happened in your operation.

Traceability lot codes

The traceability lot code (TLC) is central to FSMA 204. FDA defines it as a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the TLC source. In everyday terms, it's similar to a lot code.

Key points from FDA:

  • When a new TLC is assigned. A TLC is assigned when food is initially packed (for raw agricultural commodities not from a fishing vessel), when it's received by the first land-based receiver (for fishing-vessel food), or when it's transformed. Businesses must not establish a new TLC for other activities, such as shipping. One exception: a business that receives food from an exempt person must assign a TLC if there isn't one, unless it's a retail food establishment or restaurant.
  • It stays the same. Once a TLC is assigned, it must stay the same as the food moves through the supply chain. It changes only if the food is transformed.
  • TLC source. The TLC source is the physical location where the food was assigned its TLC. The rule may require a description of that location or a reference to it, such as an FDA Food Facility Registration number.
  • Uniqueness. The TLC must identify a lot uniquely within the records of the TLC source. The rule doesn't dictate how to build codes.
  • Traceability plan. Covered businesses must describe how they assign TLCs in their traceability plan.

TLC and your Wholechain lot identifier

Your Wholechain lot or serial identifier and the FSMA 204 TLC are related, but they aren't always the same thing. Many companies assign their own ERP lot number at receipt. Under FSMA 204, a TLC shouldn't change except through transformation, so a plain relabel at receipt doesn't match what the rule expects.

Wholechain supports maintaining both through its Traceability Lot Code feature, which you switch on in Organization Settings > Account (see Account settings). In Wholechain, the way to change a lot or serial identifier is a transform. See Transform Events and, for the steps in the app, Change the lot or serial number of a product.

What information FSMA 204 asks for

KDEs vary by CTE. Across CTEs they commonly include the traceability lot code, quantity and unit of measure, a product description, the location of the previous source or immediate recipient, dates, the TLC source (or a reference to it), and a reference document type and number, such as a purchase order or bill of lading.

The five core Wholechain categories (location, item, quantity, lot or serial identifier, and event date and time) are a baseline, and FSMA 204 asks for more. Wholechain's Event Resolver helps link a supplier's ship event to your receive event when each side logs on its own schedule. See Direct Ship and Direct Receive and Link Trace Info.

FDA's CTE and KDE guidance lists the KDEs for each CTE. Ask support@wholechain.com if you'd like help mapping your process.

Examples

  • A distributor. Receives lettuce from a grower, then ships it to a retailer. The distributor records receive and ship events. The lot code stays the same.
  • A fresh-cut processor. Receives several lots of a listed food and creates a new packaged product. It records a transform, and the output gets a new traceability lot code.
  • A retailer. Receives goods and sells them to consumers. It records receive, and may decommission at its terminal step if its policy calls for it.

These are illustrations. Which events your operation needs depends on what you do and which foods you handle.

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