Introduction

Per FDA, the goal of the Food Traceability rule is to ensure Key Data Elements (KDEs) can be maintained across the supply chain for more efficient and effective tracing while providing firms flexibility within their existing tracing systems. 

Requiring documentation of traceability lot codes (TLCs) and traceability lot code sources (TLC Sources) for foods on the Food Traceability List (FTL) enables FDA to identify the source of the food faster – by enabling FDA to skip steps in the supply chain, link a food to the firms that have handled it, and ultimately lead FDA back to the source of the food during an outbreak investigation. Click here to learn more about the Food Traceability List (FTL), Traceability Lot Codes (TLCs), and Traceability Lot Code Sources (TLC Sources). 

Wholechain is GDST capable and EPCIS compliant, ensuring your supply chain data is handled in accordance with the latest traceability requirements, including the Food Traceability Rule. Wholechain integrates with your systems to streamline, capture, and share the critical tracking events and key data elements with your customers as required under the rule. To learn more about how Wholechain ensures your traceability is compliance with FSMA 204, see below. 

Key FSMA 204 Definitions and Concepts To Understand:

The Food Traceability List (FTL) identifies the foods for which the additional traceability records are required by FDA.

A traceability lot code means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the traceability lot code source.

A traceability lot code source refers to the physical location where a food was assigned a traceability lot code. In certain situations, the Food Traceability Rule requires documentation of either the location description for the traceability lot code source, or the traceability lot code source reference. 

Location description means key contact information for the location where a food is handled, specifically the business name, phone number, physical location address (or geographic coordinates), and city, State, and zip code for domestic locations and comparable information for foreign locations, including country. The location description for a traceability lot code source would be this key contact information for the place where the food was assigned a traceability lot code.

A traceability lot code source reference means an alternative method for providing FDA with access to the location description for the traceability lot code source. Examples of a traceability lot code source reference include, but are not limited to, the FDA Food Facility Registration Number (FFRN) for the traceability lot code source or a web address that provides FDA with the location description for the traceability lot code source. 

Per FSMA 204, a Traceability Lot Code can only be applied or changed at specific events: 

1. Initially pack a raw agricultural commodity other than a food obtained from a fishing vessel

2. First land-based receiving of a food obtained from a fishing vessel

3. Transforming a food

FSMA 204 also states that you must not establish a new traceability lot code when you conduct other activities (e.g., receiving or shipping) for a food on the Food Traceability List.

Additionally, FSMA 204 has a specific definition for what type of events are considered transformation:

Transformation means an event in a food's supply chain that involves manufacturing/processing a food or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List. Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling).

Note that more broadly in event-based traceability, the term ‘transform’ is used to describe an activity that irreversibly changes an item, transforming it into a new, traceable output item with a new Primary ID (i.e. a new serial number or lot number).

For example, when a lot code is changed for internal inventory management as it moves between different companies, a transform event would be utilized to change the lot number. The input lot number and the output lot number are recorded in the transform event. It is important to note that a transform event that is used to change the lot code of an item is not considered a FSMA 204 transformation event. 

As FDA has stated:

Firms that wish to do so may assign their own internal lot codes to FTL foods for the purposes of internal tracing, but they must comply with the subpart S requirement to keep the traceability lot code unchanged except under specified circumstances… Assigning a new traceability lot code for a food that has not been transformed can lead to confusion that can hinder traceback and traceforward efforts during investigation of foodborne illness outbreaks.

To ensure compliance with FSMA 204, Wholechain will work with your team to ensure Traceability Lot Codes (TLCs) and Traceability Lot Code Sources (TLC Sources) are properly mapped, both upstream and downstream, and shared with your supply chain partners.

Wholechain Integrations

When integrating your system with Wholechain, our team will ensure your Traceability Lot Codes (TLCs) and Traceability Lot Code Sources (TLC Sources) are correctly mapped in your critical tracking event records.

Traceability Lot Code (TLC)

The FSMA 204 KDEs - Traceability Lot Code, Traceability Lot Code Source, Traceability Lot Code Source Reference - are key data elements that will be included on all of your Critical Tracking Events (CTEs) [e.g., moments in time identified in event-based traceability where Key Data Elements (KDEs) should be recorded). 

Wholechain captures both the LotSerial (or Primary ID) as well as the TLC for all events. This allows you to link internal lot codes (LotSerials) to the TLC, maintain the TLC through your Critical Tracking Events (CTEs), and share the correct TLC with your buyer.

If you receive a processed food directly from the processor, the TLC is the lot/production code the processor applied during the transformation/packing event and the TLC Source is the processor. Wholechain will facilitate supplier engagement to ensure that on the ship event from the supplier to your location, the TLC applied by the processor (i.e. the TLC source) is carried through and linked to your receive event, which might have a different LotSerial. 

If you receive a processed or initially packed food from a broker or repacker (who is NOT the TLC source), Wholechain will facilitate supplier engagement to ensure the supplier is passing on the appropriate TLC in accordance with the Food Traceability Rule.

Receiving from Your Vendor

On your receive event, Wholechain will work with you to ensure that the TLC is aligned with the TLC from your supplier. If you or your 3PLs apply an internal lot code (LotSerial) at receipt (that is different than the supplier’s internal lot code on the ship event), Wholechain will link the events to connect the supplier’s lot code, in the ship event, with the posted receive lot codes while keeping the TLC in place. 

Transforming 

If your company performs a transform event per the FSMA 204 definition of transformation, such as manufacturing or processing, your company would apply a new lot code to the output item. Wholechain will automatically update the TLC on the output item to the new lot code supplied on the output item and your location where you performed the transform event would become the TLC Source. Otherwise, if you do not perform a transform according to the FSMA 204 definition of transformation you must pass the TLC and TLC Source KDEs through your Critical Tracking Transform Event unchanged.

Shipping to Your Customer

On your ship event to your customer, Wholechain will work with you to ensure that the TLC for the lot you received and / or transformed (depending on your operation) is shared with your customer through the TLC Key Data Elements on the ship event.

Traceability Lot Code Source

The TLC Source refers to the physical location where a food was assigned a Traceability Lot Code (TLC). Similar to a TLC, the TLC Source also needs to be mapped, captured, and shared in your Critical Tracking Events (CTEs). 

In Wholechain, there are multiple ways to capture the TLC Source in your Critical Tracking Events:

• Use a TLC Source Reference: Provide a reference, such as a Global Location Number (GLN), DUNS number, or an FDA Food Facility Registration Number (FFRN), to identify the location.

• Using TLC Source Location Details: Provide the full location address information (e.g., country, street address, city, etc.) to specify the location.

Click here for important info regarding implementing TLC Source or TLC Source Reference in your Wholechain payloads on a receive event.

In general,

1. Your receive event should capture the TLC and the TLC Source (i.e. the location where the TLC was applied). 

2. If a transform event was used to change the internal lot code (LotSerial), the TLC Source (in addition to the TLC) should be mapped to the location where the TLC was applied, which may or may not be your direct supplier. 

3. Similarly, your ship event to your customer should capture the TLC and TLC Source of the item you received. 

Note: if your company performs manufacturing or processing per the FSMA 204 definition of transformation, you would apply a NEW TLC to the output item and your location would become the TLC Source. Otherwise, you must pass the TLC and TLC Source KDEs through your Critical Tracking Events (CTEs) unchanged.

Wholechain will work with your team to determine the best option for capturing and sharing TLC sources within your Critical Tracking Events (CTEs).