An Overview of FSMA Section 204

By Todd Gilliam, North American CPG Industry Leader, Rockwell Automation, and Frederic Clulow, General Manager (Americas), Kezzler

The Food Safety Modernization Act (FSMA) Section 204 aims to create a more transparent supply chain, ensuring safer food for all Americans. As a part of the Smarter Food Safety initiative, the rule encourages companies in the food value chain to invest in digital traceability technology.

FSMA Section 204 requires the following:

• Collation of Key Data Elements (KDEs) and Critical Transformation Events (CTEs).
• Collation through a Traceability Lot Code (TLC) that remains unchanged with the product throughout its journey through the supply chain (or until a kill-step or relevant transformation event occurs).
• Delivery of necessary traceability information into an electronically sortable spreadsheet within 24 hours.

What are KDEs and CTEs?

KDEs are specific information points required to be maintained and provided by entities involved in the food supply chain. CTEs are pivotal stages in the movement of food products where this information must be documented and shared to facilitate effective tracing.

In short, KDEs include details of what happened and when, from harvesting or production through processing, distribution and receipt, facilitating effective tracing mandated by the Food Traceability Rule. KDEs and CTEs must be tied to the TLC.

KDEs to be collected may vary depending on the commodity tracked and the specific CTE. There are seven different recognized CTEs:

1. Harvesting.
2. Cooling before initial packing.
3. Initial packing of produce or aquaculture food.
4. First land-based receiver for food obtained from a fishing vessel.
5. Shipping.
6. Receiving.
7. Transformation.

What is a Traceability Lot Code?

TLCs are a cornerstone in achieving compliance with FSMA Section 204. These codes serve as identifiers, linking each product to three key elements:

1. The place of TLC application, to allow rapid tracking back to the source (known as the Traceability Lot Code Source).
2. Some form of batch/lot/item level construct (not defined, but implied by design).
3. KDEs specified within FSMA Section 204 for a particular CTE.

TLCs must be sufficiently unique to aid in identification. Such granular traceability is pivotal for meeting regulatory requirements and, more critically, for safeguarding public health.

What is a Transformation Event?

Whenever companies manufacture a new food product that’s on the Food Traceability List (FTL), they must assign it a new TLC. If a transformation process uses a food on the FTL as an ingredient, a reference to that food’s TLC has to be maintained.

Repacking is always considered a transformation event. However, a new TLC might not be necessary if there’s no commingling of lots and the repacking is done "like into like" (repacking the same product from one container into another without mixing different lots or when breaking down primary cases from the same lot into smaller units).

What Foods are Subject to FSMA Section 204?

The FSMA’s Section 204 Food Traceability List designates the initial foods subject to enforcement. This list includes cheeses, shell eggs, nut butters, leafy greens, tomatoes, tropical fruits, finfish, crustaceans, mollusks and more. The extensive list can be found on the FDA’s website and will evolve over time.

The Unspoken Challenge

It’s important to note that the rule does not recommend or suggest any particular technology to achieve its traceability aims, nor does it endorse a data format, database structure or data exchange standard.

FSMA Section 204 prescribes what data must be captured for particular events at specific points throughout an item’s life cycle. At a minimum, this data must be collated into an electronically sortable spreadsheet within 24 hours of a request. This requirement can rapidly scale in complexity with an increase in size, generating several hundred if not thousands of data points.

Strategic Approach is Key

While we’ve briefly covered what FSMA requires, it's important to note that navigating the complexities of FSMA Section 204 necessitates a strategic approach to data management and traceability. While the rule outlines the data that must be captured and the speed with which it must be accessible, it leaves the choice of technology up to the companies. This flexibility can be beneficial but also challenging, as ensuring comprehensive and timely traceability can become quite complex.

By understanding the requirements and planning accordingly, producers can achieve compliance and enhance their overall supply chain transparency and efficiency.

Kezzler is a Digital Partner in the Rockwell Automation PartnerNetwork^TM. The software company specialized in providing a cloud-based traceability platform and digital ID solutions for connected products. The Kezzler Connected Products Platform can digitize products to collect, structure and share secure, real-time value chain data at scale to enable traceability throughout a product’s lifetime to achieve regulatory compliance and supply chain visibility.

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