What is a Traceability Lot Code (TLC)?

A traceability lot code is a unique identifier that is much like a serial number or social security number for food. This unique descriptor, which typically contains both letters and numbers, is used to identify and track a specific batch of food throughout the food supply chain. The traceability lot code stays with a food product through the entire global food supply chain and links it to its initial lot, batch or source. 

In this blog post, we’ll cover traceability lot codes and a number of components related to it such as traceability lot and a traceability lot source. We’ll also look at how to assign a traceability lot code and who is responsible. But first, we’ll provide a quick refresh of how traceability lot codes relate to FSMA 204.

Background 

The goal of FSMA 204 is to make it easier for the FDA to track food across the global supply chain. These new measures are being brought in to combat the significant challenge of foodborne illnesses. 

If you are affected by FSMA 204, and need to comply, you will hear a lot about CTEs and KDEs. The new rule requires food businesses to record food traceability data at a number of crucial stages along the supply chain. These are known as Critical Tracking Events (CTEs) and include seven key stages; harvesting, cooling, initial packing, first land-based receiver, shipping, receiving and transformation. 

The traceability data that organizations are required to record at each of these stages are known as ‘Key Data Elements’(KDEs). There are a number of KDEs that are required for each of these key critical tracking events. This includes data such as the name of the product, the address, the date, product description and pack size. 

What is a Traceability Lot?

One of the most important KDEs from a traceability perspective is the assignment of a traceability lot code. As mentioned above, this is a unique identifier that links a food to its origin or source. To fully understand traceability lot codes it’s important to understand what we mean by a ‘traceability lot’. 

A traceability lot is a specific batch or ‘lot’ of food that is grouped together for tracking purposes. As the foods were batched together they share many of the same key characteristics such as where and when they were produced, the production methods used, the ingredients used etc. Traceability lots include when a raw agricultural commodity is initially packed at a farm, when a fish product is taken in by a fishing vessel from the first land-based receiver, or when an ingredient is transformed from one food to another e.g. turning tomatoes into canned sauce. When you assign a traceability lot code, you are connecting a food to its traceability lot. 

Attaching a traceability lot code to food allows the FDA to quickly identify the source of the food if an outbreak occurs, bypassing entire steps in the supply chain. It also enables the FDA to quickly determine the appropriate scope of a recall and prevent further infection. Traceability lot codes allow for greater harmonisation, while allowing firms the flexibility to integrate the requirements into their existing tracing systems. 

Traceability Lot Code Source and Source Reference

A Traceability Lot Code Source is the physical location where a food was assigned a TLC. The Food Traceability Rule may sometimes require a description of the location be provided. This description must include key contact information such as the name of the business, as well as their phone number and physical address. 

A Traceability Lot Code Source is an alternative to providing the FDA with the contact information and physical location of where the TLC was assigned. A TLC source reference can be used to allow greater anonymity. Examples of TLC source references include FDA Food Facility Registration Number for the traceability lot code source or a link to a secure website that contains the required information on the TLC source. 

When Do You Assign a Traceability Lot Code?

In order for a TLC to be easily traced through an entire supply chain, it is important that it remains the same. However, there are a number of instances where a new lot code will need to be assigned. 

First let’s look at when a TLC is first assigned. A TLC will first be assigned when it is first being packaged at its source. Which, in most cases, will be at the farm. In the case of seafood, the TLC is first assigned when it is collected from the fishing vessel. All businesses that need to comply with FSMA will assign lot codes at the start of the supply chain. However, there are businesses such as small farms that generate less than $25,000 per year that are exempt from complying with FSMA. If you procure food from these types of farms, they will not have an assigned TLC and the responsibility will rest with you.

The only time in which you would assign a new lot code to a food that already has one is in the case of that food being transformed. Transformation refers to a significant change in the food. In most cases, this occurs when a food is combined with other foods in a recipe. In this case, the recipe must now be assigned its own TLC, which must link back to the original TLCs of all of the foods within it.  

In summary a TLC is assigned:

                      • When a raw food is first packaged at source.
                      • When seafood is first received on land from a fishing vessel.
                      • When receiving food from a business that is exempt from the food traceability rule.
                      • When a food is transformed.

This system allows food to be efficiently and effectively traced back through the global supply chain to identify the source of an outbreak in the event of a foodborne illness investigation.

How to Assign a TLC

The FDA has intentionally left the description of how to create traceability lots open, in order to allow businesses the flexibility to adopt the rule to suit their own operational needs. 

The graphic below is provided by the FDA demonstrating possible methods for the creation of a TLC. Within your traceability plan, you must describe the process you use to assign traceability lot codes. 

Possible methods include using the product code plus the Julian date or a randomly generated code. If a business already has a lot code system in place, that should be sufficient to use as a TLC, as long as each code remains the same throughout the entire supply chain, and is only changed when a food is transformed. 

Global unique tracking numbers such as GS1 GTIN and GLN can be used alongside existing lot and date codes to create TLCs. 

FDA has provided examples of traceability lot codes here

The size of the ‘lot’ of food a traceability code is assigned to can be decided by the business themselves. However, the FDA has stated that the smaller the size of each lot, the less food that will need to be recalled in the event of an outbreak and food recall. 


Need Help Complying With FSMA 204?

If you are part of an organization that is impacted by FSMA 204 and need help to comply, we are here to help.

We can answer any questions you may have about the Food Traceability Rule, starting with whether or not you need to comply and what you need to get ready for the July 20th 2028 compliance date.

Book a consultation today and talk to a member of our FSMA 204 Compliance Support team. 

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