The Food Safety Modernization Act (FSMA) Section 204 is bringing significant updates to the way food companies track and trace the movement of food products throughout the supply chain.
The new recordkeeping requirements in the Food Traceability Final Rule — effective January 20, 2026 — will impact how manufacturers track, document, manage, and report information on specific food ingredients.
Whether you’re a small manufacturer or a global corporation, if you work with foods on the FSMA 204 traceability list, you will be impacted.
To ensure compliance and minimize disruptions to your business, now is the time to prepare — with help from Rain Engineering!
REACH OUT TO RAIN ENGINEERING
EXECUTE
BE READY FOR JANUARY 2026!
FSMA Section 204 focuses on mandatory recordkeeping for traceability, designed to enhance the ability to quickly track and trace food products through all stages of the supply chain.
The purpose of this ruling is to establish a more robust and proactive approach to food safety, shifting the focus from reactive measures to preventive strategies, addressing the limitations of traditional food safety practices.
The updates will require impacted food companies to:
1. Keep detailed records of the supply chain, including suppliers, manufacturers, and retailers.
2. Track and report on key data points, like lot numbers, batch codes, and other unique identifiers
3. Be able to access and report within 24 hours of an FDA investigation or food recall.
The FSMA 204 Food Traceability List (FTL) identifies high-risk foods, including soft and semi-soft cheese, nut butters, eggs, finfish and fresh produce, for enhanced recordkeeping. These foods are prioritized due to their susceptibility to contamination, ensuring a more accurate and efficient traceability process.
In addition, the rule establishes specific recordkeeping requirements for facilities handling foods on the FTL. These records must track the movement of certain food products through critical tracking events (CTEs) in the supply chain, including:
.
To prepare, you must take steps to maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs). Information must be available and maintained and stored in an electronic, sortable format for quick retrieval during investigations or outbreaks.
At Rain Engineering, we specialize in helping food manufacturers, processors, packaging companies and distributors adapt to evolving regulations like FSMA Section 204 while also providing operational and efficiency gains.
It all starts with our company wide expertise and experience and is quickly followed up by our GE Proficy Smart Factory Platinum Solution Provider status.
Within this winning combination, Rain Engineering’s Subject Matter Experts utilize GE Proficy as the foundation for helping manufacturers achieve their tracking and reporting requirements.
Ultimately, our team is here to help your team adapt to these updates, ensuring overall FSMA Section 204 compliance.
Rain Engineering is here to provide you the information you need — combined with our years of industry knowledge.
… All in an effort to help make sure you and your team are prepared when the regulations take effect in the coming months.
As part of the compliance requirements, impacted companies must have a documented Traceability Plan that includes record-keeping procedures, traceability lot codes and designated points of contacts.
GE Proficy Smart Factory Plant Applications provides robust traceability and record keeping features that align with FSMA 204 traceability requirements.
The Proficy Production Management & Tracking module enables real-time production tracking and maintains detailed records of process orders.
It can capture and store Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs) throughout the manufacturing process while the system allows for tracking across multiple sites at the granular lot level.
This helps to provide the detailed traceability required by FSMA 204.
Raw Material Intermediates
With Rain Engineering by your side, you will have the ability to combine your raw material data from your WMS or ERP with your Proficy Smart Factory data to enable a full traceability view – from start to finish. You can then monitor and view your data in convenient dashboards and/or reports.
At Rain Engineering, we are proud to not only offer coverage of raw material intermediates with finished product but are able to go a step further and include data on the traceability of the equipment itself!
Often times, when we are working on FSMA 204 compliance, we find ways to leverage the GE Proficy solution to provide OEE gains.
It’s like getting twice the benefits with only one system!
FSMA Section 204 requirements are just around the corner. The sooner you prepare, the easier it will be to meet the January 2026 compliance deadlines and avoid costly penalties.
Rain Engineering has helped clients ranging from small to Fortune 500 on their FSMA journey and can do the same for you.
Let Rain Engineering help you navigate the changes and ensure your company is ready to stay ahead of the curve.
Our dedicated team will work with you to ensure that your systems, processes, and team are fully prepared for the FSMA Section 204 traceability and reporting requirements – helping to keep your business compliant, efficient, and ready for the future.
Reach out to our team at Rain Engineering to learn more about how we can help by scheduling a consultation with one of Subject Matter Experts today.
REACH OUT TO RAIN ENGINEERING
EXECUTE
BE READY FOR JANUARY 2026!