Traceability Lot Codes Explained for Fresh Produce Operations

1. What Is a Traceability Lot Code?

A Traceability Lot Code, or TLC, is a descriptor—often alphanumeric—used to uniquely identify a traceability lot within the records of the location where the code was assigned. FDA describes it as similar to what the food industry already calls a lot or lot code.

Under the Food Traceability Rule, the TLC acts as a link between a specific lot and the Key Data Elements (KDEs) recorded at relevant Critical Tracking Events (CTEs).

For a produce distributor, that makes the TLC different from many familiar operational identifiers. A warehouse may use purchase order numbers, receiving numbers, pallet IDs, inventory lots, license plate numbers, sales orders, or shipment numbers. Those identifiers can continue to exist, but they should remain connected to the TLC rather than replacing it.

The requirement applies to foods on FDA's Food Traceability List (FTL), subject to applicable exemptions and modified requirements. Fresh produce on the list includes categories such as fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits, and fresh-cut vegetables.

2. When Is a TLC Assigned?

FDA deliberately limits when a new TLC can be established.

Under 21 CFR § 1.1320, a TLC is assigned when a covered entity:

• initially packs a raw agricultural commodity, other than food obtained from a fishing vessel;
• performs the first land-based receiving of food obtained from a fishing vessel; or
• transforms a food.

For example, if a wholesaler receives packed tomatoes with an upstream TLC, placing those tomatoes into inventory does not allow the wholesaler to substitute its own lot code as the regulatory TLC. The existing TLC continues with that traceability lot.

There is an exception when a covered receiver obtains an FTL food from a person to whom the rule does not apply and the food arrives without a TLC. In that situation, the receiver generally must assign one, except where the receiver is a retail food establishment or restaurant.

3. What Happens to the TLC Inside a Produce Warehouse?

Ordinary warehouse handling does not automatically create a new traceability lot.

Suppose a distributor receives 80 cases of cucumbers under one TLC. The cases are unloaded, put away, divided between two storage locations, later picked for multiple customer orders, and staged on different outbound pallets. Those inventory movements do not by themselves constitute transformation.

The warehouse may create several pallet IDs or other internal identifiers during that process. The original TLC should remain linked to the cases represented by those identifiers.

This becomes particularly important when a single inbound lot feeds multiple outbound shipments. The warehouse needs to preserve which shipments contained product from that TLC without treating every operational movement as a new regulatory lot.

Repacking changes the analysis

Under the Food Traceability Rule, repacking is a transformation activity. Transformation also includes activities such as manufacturing, processing, commingling, relabeling, or changing packaging or packing when the resulting food remains on the FTL.

When transformation produces a new traceability lot, the resulting product receives a TLC that must remain linked in the transformation records to the incoming TLC or TLCs and associated quantities.

The essential relationship is therefore not merely “old code versus new code.” Transformation records must preserve how the output relates to the traceability lots that went into it.

4. The TLC Travels With More Than a Lot Number

Capturing the TLC at receiving is only one part of the traceability record.

For covered receiving events, 21 CFR § 1.1345 requires the TLC to be linked with other KDEs, including information such as the product description, quantity and unit of measure, receiving date and location, immediate previous source, reference document, and the TLC source or TLC source reference.

FDA also permits a TLC source reference—an alternative way for FDA to obtain the required location description. Examples include an FDA Food Facility Registration Number or a web address that provides access to the source information.

When the food is later shipped, the shipping records must maintain the appropriate relationship to the same TLC, and specified information must be provided to the immediate subsequent recipient.

The result is continuity: the lot is connected to successive traceability events instead of being renamed every time custody changes.

5. Does the TLC Have to Be Printed on Every Case?

No. The Food Traceability Rule does not require the TLC itself to be physically printed on the food package.

FDA allows the required information to be communicated through different methods, including a bill of lading, invoice, Advance Shipment Notice (ASN), separate electronic communication, or a QR code on packaging or associated documentation.

The rule also does not require GS1, RFID, a particular barcode format, or a specific warehouse technology.

A produce company can therefore use an ERP, warehouse management system, EDI exchange, spreadsheet, paper records, scanning workflow, or a combination of systems. Industry standards such as GS1 can make information exchange easier, but they are not themselves an FDA requirement.

6. TLCs and Internal Lot Numbers Can Coexist

FSMA 204 does not require produce companies to abandon the identifiers they already use to operate their warehouses.

One supplier TLC may be associated with several warehouse pallets. Those pallets may occupy different locations and later feed several sales orders or outbound shipments. Each pallet can have its own internal identifier while the underlying cases remain associated with the original TLC.

The model changes when transformation occurs. If product from several incoming TLCs is commingled into a new traceability lot, the records must preserve the relationship between those inputs and the resulting output.

A useful way to think about the distinction is:

Operational identifiers describe how the business manages inventory. The TLC preserves the regulatory identity and history of the traceability lot.

A traceability system works only if those two layers remain connected.

7. Current FSMA 204 Compliance Timing

The original compliance date for the Food Traceability Rule was January 20, 2026.

FDA subsequently proposed extending that date by 30 months to July 20, 2028. Congress separately directed FDA not to enforce the Food Traceability Rule before July 20, 2028, and FDA has stated that it intends to comply with that directive.

The timing does not change how the TLC concept works. For produce businesses preparing their traceability systems, the fundamental requirement remains the ability to follow a traceability lot through receiving, inventory handling, shipping, and—when applicable—transformation without losing the relationship between the product and its required records.