Food Safety Modernization Act 204

A New FDA Regulation

In January 2023, the FDA issued the Food Traceability Final Rule, requiring additional traceability records for manufacturers, processors, packers, and holders of foods on the Food Traceability List (FTL). While targeting higher-risk products, this rule will likely influence broader food supply chain practices. It mandates rapid identification and removal of contaminated food, reducing foodborne illness risks. Companies must record key data elements (KDEs) for critical tracking events (CTEs) and share information with FDA within 24 hours. The rule applies to domestic and foreign firms supplying the U.S. and requires full compliance across the supply chain by 2028.

Software-Driven Solutions for FSMA 204 Compliance

The Food Safety Modernization Act (FSMA) 204 aims to enhance food traceability, prevent outbreaks, and modernize safety measures across the food industry. GE Vernova’s software solutions are designed to help food manufacturers meet regulatory requirements with ease and efficiency.

A Comprehensive Integrated Approach

Regulatory agencies and retailers are raising requirements for preventative strategies, pushing food safety and quality programs to emphasize improved processing and quality initiatives. A holistic, integrated approach enhances production control and fosters collaboration among suppliers, producers, customers, regulators, and consumers. Leveraging real-time intelligence, analytics, standard practices, and traceability delivers deep operational insights, helping identify risks early. This enables proactive, real-time corrective actions when processes deviate, ensuring consistent food safety, high quality, and productivity gains across the production environment.

Manufacturing KnowHow: FSMA 204 Podcast Series

FSMA 204 Podcast
Episode 1 of 3

How does this new regulation affect you?
Industry leaders explain FSMA 204, the new FDA rule impacting all food manufacturers. The time to prepare is now.

Listen Here

FSMA 204 Podcast
Episode 2 of 3

Food Transparency and compliance to the FDA
FSMA 204 experts dive deeper into FDA rules and how MES helps food manufacturers boost compliance, traceability, and efficiency.

Listen Here

Coming soon!
FSMA 204 Podcast Episode 3 of 3

MES Supports Food Safety & Traceability
Integrate MES with ERP systems, generate FDA-required electronically sortable spreadsheets (ESS) and optimize processes for traceability.

Critical Software Capabilities

Real-time, mobile intelligence delivers relevant, contextualized information to operators and decision-makers anytime, anywhere. By providing role- and location-based insights, it enables faster, more informed decisions. This technology helps navigate today’s overwhelming data landscape, enhancing operational efficiency and improving decision-making on the plant floor.

Trending and analytics help eliminate product risks by supporting “right the first time” quality. For example, temperature trends alerted a food manufacturer to inconsistent oven performance, posing a safety risk. Real-time data enabled operators to adjust ovens before reaching critical limits, preventing failures and ensuring product safety through proactive, on-the-fly corrections.

The Future of Food Safety: Core Elements of FSMA 204 Compliance

End-to-end transparency with Proficy Smart Factory – With Proficy Smart Factory software, F&B companies can accurately document what happened during all phases of production to help ensure compliance with new and existing regulations and use this data for continuous process improvement. In addition, the software provides:

Holistic data collection and storage
A structured model – data in context (batch, product type, grade, etc.)
Enforced digitized work processes/SOPs
A complete collection of relevant data (for operational technology/information technology)

Inventory and genealogy

Accurately document what happened during all phases of production

To meet traceability requirements, it is important to have full knowledge of the origin and quantities of the materials flowing through the system, along with precise knowledge of when these materials were used in the process.

Detailed documentation of material usage is particularly important when one lot of ingredients can flow to multiple batching systems over an extended period of production.

View genealogy links for serials/lots/batches with complete parent/child hierarchies represented
View details of each link (lot/serial) and where and when it is used

Outcomes

Minimize Food Safety Risks

Minimizing food safety risks requires a proactive, tech-driven approach. By enabling end-to-end traceability, utilizing AI-powered tools for rapid analysis, and fostering a strong food safety culture, organizations can prevent outbreaks, respond faster to recalls, and protect consumers effectively.

Enhance Process Control & Consistency

Enhancing process control and consistency involves leveraging smarter tools, predictive analytics, and real-time data to streamline food safety operations. Strengthening root cause analysis and adopting modern inspection methods ensure uniform standards, reducing variability and improving outcomes.

Improving OEE and Quality with Analytics

Improving OEE and quality with analytics means using advanced data tools to identify inefficiencies, predict issues, and optimize production. AI-driven insights boost equipment effectiveness, reduce downtime, and enhance product quality by enabling faster, data-backed decisions.

Track and Trace

Track and Trace leverages tech-enabled traceability to monitor products from farm to table. By capturing and analyzing data at every step, businesses can quickly address recalls, enhance food safety, and ensure compliance, while providing transparency and confidence to consumers.

End of Result

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