Food & Beverage

Food Safety Modernization Act (FSMA) 204: Enhanced Food Traceability Rules

FSMA Rule 204 intends to create a more transparent supply chain that ensures 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.

The rule requires:

→ The 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 the journey through the supply chain (or until a kill-step or relevant transformation event occurs)

→ The delivery of necessary traceability information into an electronically sortable spreadsheet within 24 hours

What are KDEs and CTEs?

Key Data Elements may vary depending on the Critical Tracking Event, and even, the product in question. In general, KDEs denote what product was involved, in which activity (for example, harvesting, shipping, receiving, transforming), where the activity took place and when it did.

What foods are subject to the FSMA 204 rule?

The FSMA’s Section 204 Food Traceability List designates the initial foods subject to enforcement. The extensive list can be found on the FDA’s website. This list will evolve over time. 

Cheeses

Shell eggs

Nut butters

Leafy greens

Tomatoes

Tropical fruits

Finfish

Crustaceans

Mollusks

and more…

Navigating the Future of Food Traceability

Making food safer and smarter by combining traceability technology and product digitization.

The unspoken challenge of FSMA 204

It is important to highlight that the rule does not recommend or suggest any particular technology to achieve its traceability aims. It does not endorse a data format, database structure, or data exchange standard. 

FSMA 204 prescribes what data is to 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, to generate several hundred if not thousands of data points.

Achieving FSMA 204 traceability compliance

Compliance with section 204 and expanded traceability requirements means a multiplication of data elements to be managed, data elements that often are in separate systems (many of which may not be interoperable), and even entities; from records relating to the production, handling, and shipment of finished goods. 

Rapid production of records across CTEs with a multiplication of KDEs thus requires coordination of data elements collation into a single digital source. This challenge, along with achieving an incredibly low supply-chain data latency rate, is exactly what the Kezzler Connected Product Platform was designed to solve.

→ Read more about our partnership with Provision & DNV on powering food traceability at scale.

Food traceability

Applying GS1 standards

Kezzler is proud to have worked with industry partners under the auspices of GS1 US on the GS1 US FSMA 204 Implementation Guidelines. These and additional resources are available for download.

→ Read more on the blog on “Why GS1 standards for traceability?

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Frederic Clulow

Kezzler’s US General Manager

Frequently asked questions

What is the purpose of FSMA Rule 204?


FSMA Rule 204 aims to establish a more transparent supply chain to enhance food safety for all Americans. As part of the Smarter Food Safety initiative, the rule encourages investments in digital traceability technology within the food value chain.

Who is subject to the FSMA 204 rule?


The FSMA’s Section 204 Food Traceability List designates initial foods subject to enforcement, including cheeses, shell eggs, nut butters, leafy greens, tomatoes, tropical fruits, finfish, crustaceans, mollusks, and more. The list is available on the FDA’s website and may evolve over time.

How can companies achieve compliance with FSMA 204 traceability requirements?


Compliance involves collating Key Data Elements (KDEs) and Critical Transformation Events (CTEs) into an electronically sortable spreadsheet within 24 hours of a request. This requirement can be challenging due to the potential scale of data points, the need for coordination across various systems and entities, and achieving a low supply-chain data latency rate. The Kezzler Connected Product Platform is designed to address these challenges and streamline compliance efforts.