What is FSMA 204 and how do you comply?

What You Need to Know About FSMA 204

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The FDA has issued the final rule for food traceability under FSMA – here’s how to get ready

What is FDA’s Section 204(d) of the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA) 204 rule establishes traceability record-keeping requirements for organizations and their respective sites that have food(s) on the FDA’s Food Traceability List. The new requirements enable faster identification and rapid removal of contaminated food(s) from the marketplace, protecting consumers and industry stakeholders.

Persons subject to the rule are required to maintain records containing Key Data Elements associated with specific Critical Tracking Events and must provide information to the FDA within 24 hours. Persons must capture data that track specific events in a food’s “farm-to-fork” journey, from harvesting/packing, shipping, receiving, processing/manufacturing, and distribution to the retailer or restaurant, and finally, to the consumer. The compliance date for record-keeping requirements is January 20, 2026.

Given the complexity of capturing and managing this data, that does not leave much time to find, validate, and implement a FSMA compliant solution.

Supply Chain Complexity Has Increased

Supply chains have become more complex with accelerating omnichannel demand, increased mix, broader assortment, smaller lot sizes, and global sourcing.

What You Need to Know About FSMA 204: Siloed technologies make it challenging to trace issues across complex supply networks and to quickly respond when there is an issue. Click To Tweet

Siloed technologies make it challenging for stakeholders to trace issues across complex supply networks. Digitization has exacerbated the challenge by increasing data volume, making decision-making and rapid response difficult. End-to-end traceability across every node necessitates end-to-end track-and-trace with integrated execution capabilities.

Meeting FSMA 204 Compliance is Not a Data Challenge…

The FSMA 204 rule establishes requirements for end-to-end food traceability. This is an expansion of “one-up, one-back” traceability, known as a “hub-and-spoke” supply chain structure. Traditional system architectures are designed to support hub-and-spoke but providing end-to-end traceability across each step requires the capabilities of a network platform.

Enabling end-to-end, track-and-trace capabilities needed to deploy chain of custody across each step of a food’s journey, is not a data challenge, it’s a network challenge.

…FSMA Compliance is a Network Challenge

A supply chain network platform provides end-to-end visibility, as well as actionability, tracking, and transaction execution. This is enabled by a network-wide common integrated data model and master data management infrastructure featuring n-tier visibility, traceability, and legacy system integration. A multi-party network approach is required to effectively manage and optimize chain of custody, informed by real-time data flow.

What You Need to Know About FSMA 204: A multi-party network approach is required to effectively manage and optimize chain of custody… Click To Tweet

An optimal network solution generates a reference record used to identify key events, including growing, shipping, receiving, and data (e.g., bills of lading, purchase orders, advance shipping notices, invoices, batch logs, production logs, and receipts). It requires lot aggregation and dis-aggregation (box, batch, and pallet), temperature tracking, shelf-life, serialized lot tracking, and chain of custody capabilities.

If your current capabilities are limited to “one-up, one-back” data interaction, or some level of logistics visibility, a platform upgrade will be required. A digital supply chain network solution delivering chain of custody enables stakeholders to become rule 204 compliant immediately.

And remember, 2026 will be here sooner than we think!

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Keith Olscamp