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The Datacor Blog

FSMA 204 Compliance Rules & Requirements

August 1, 2024 by Jinelle Cioffi

New rules are placing even greater pressure on the food and beverage (F&B) industry to monitor and manage ingredients and account for their movement throughout the supply chain. With the U.S. Food and Drug Administration (FDA) issuing the Final Rule of the Food Safety Modernization Act and implementing Section 204, anyone involved in the processing, packing, storage, and shipping of foods now needs to follow very specific guidelines to ensure every ingredient is completely traceable.

These strict recordkeeping measures affect all parts of the supply chain from farmers to food processors, and require the rapid identification, tracking, and recall of any contaminated foodstuffs to help protect public health. The measures were first introduced in early 2023, although companies have until January 20, 2026, to comply.

In this post, we’ll break down everything you need to know about the Final Rule and guide you through five key ways software solutions can help you navigate this change. Here’s what we’ll cover:

What is FSMA 204 (Food Traceability Rule)?

 

Section 204 of the Food Safety Modernization Act (FSMA), known as the Food Traceability Rule, directs the U.S. Food and Drug Administration (FDA) to identify high-risk foods requiring enhanced recordkeeping and to establish the corresponding recordkeeping requirements. The primary goal of FSMA 204 is to expedite the identification and removal of potentially contaminated food from the market, reducing the incidence of foodborne illnesses and deaths.

FSMA 204 Requirements

The Food Traceability Rule mandates that businesses involved in manufacturing, processing, packing, storing, or shipping of foods on the Food Traceability List (FTL) maintain records with key data elements (KDEs) for specific supply chain activities, which the FDA has defined as critical tracking events (CTEs). This information must be captured, stored, and maintained for 24 months, and event data must made available to the FDA within 24 hours upon request. Additionally, shipping events must be shared with supply chain partners.

The Traceability Rule also requires that businesses establish and uphold a traceability plan, outlining procedures for record maintenance under the new requirements, identification of FTL foods handled, and the assignment of traceability lot codes to FTL foods.

When is the Compliance Date?

The FSMA 204 Final Rule was first introduced in January 2023, although companies have until January 20, 2026, to comply.

What is the Food Traceability List (FTL)?

The Food Traceability List (FTL) identifies the foods for which the additional traceability
records are required. The additional recordkeeping requirements apply not only to foods specifically listed on the FTL, but also to foods that contain foods on the list as ingredients.

The FDA has identified the following foods as high-risk and are subject to the Food Traceability Rule: cheeses, shell eggs, nut butters, cucumbers, herbs, fresh leafy greens, fresh-cut leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits, fresh-cut vegetables, finfish, and smoked finfish.

What are Critical Tracking Events (CTEs)?

Critical Tracking Events (CTEs) are the crucial points along the product journey of foods listed on the FTL where FSMA 204 will require increased traceability recordkeeping. For each type of event, the rule specifies what information (Key Data Element or KDE) must be recorded. These events represent key stages in the lifecycle of food products, and the accompanying records must contain the requisite KDEs as defined by the Food Traceability Rule.

FSMA_CTEs

What are Key Data Elements (KDEs)?

Key Data Elements refer to the data related to each CTE that companies are required to retain and share with supply chain partners and/or the FDA. The information that must be tracked varies depending on the type of supply chain activities they perform. Some examples include location name, date(s), quantity and unit of measure, and traceability lot code.

The traceability lot code, also referred to as the lot number, is a unique identification label assigned to a specific production batch. This code should also tie back to all reference documents associated with a specific food shipment.

How Can Software Solutions Help?

Lot Tracking, essential for managing inventory and identifying specific product batches, is crucial for meeting these requirements, says Teresa Finn, Datacor’s Product Manager for F&B. “Whether you’re a distributor, food processor, or retailer, you must trace all information by Lot,” she says. Full traceability is required throughout the food supply chain.

Anyone working with foods included in the FTL needs to keep comprehensive records – or Key Data Elements (KDEs) – and be able to quickly and accurately share production and shipment information with the FDA in the specified electronic format. For example, if handling peppers, you need to track them at every stage, from their original form to their inclusion in the final product, like a ready-to-eat pasta salad, adds Finn.

This means being able to provide data about forward and backward Lot Traceability – who handled these items before you and who you subsequently passed them on to. Finn explains, “If the FDA requests info, I need to trace the pepper’s origin, current stock, usage in products, and their destinations.” The FDA demands this data within 24 hours, but retailers often require it within 2 hours.

Without an efficient electronic system like Datacor’s Enterprise Resource Planning (ERP) Software, gathering this information is nearly impossible, warns Finn. Otherwise, you’re left searching warehouses and rifling through piles of paperwork to meet FDA’s electronic format requirements. Missing deadlines can lead to broader, costlier recalls and reputational damage. “Food processors should be electronically gathering their data, so they can process it correctly and communicate it accurately to their customers,” she says. “With the Food Traceability Final Rule 204 enforceable by early 2026, those not using software should start now.”

 While many software providers require integration with external systems to provide these capabilities, Datacor’s solution is completely standalone – a self-contained ecosystem that helps to avoid conflicts, unnecessary confusion, and duplicated entries. “Datacor ERP offers a comprehensive end-to-end solution,” says Finn. “Native to our system, we have the full capabilities required for the lifecycle of your products. That includes the labelling, receiving, shipping, and processing food, as well as facilitating electronic data exchange with your supply chain partners and enabling recipe formulation.

5 Critical Software Features to Navigate FSMA 204

1. Complete Item/Lot Life Cycle Management

Always know exactly where food and ingredients came from by collecting unique identifiers from your suppliers’ various farms or processing facilities. When shipping finished goods to your customers, you can also offer reassurance that this important data can easily be communicated to the FDA in the event of a recall.

Whether information is received electronically or on a bill of lading, Datacor makes it possible to readily record that information in your system so you can trace back to it and digitally label all received goods.

With products constantly being moved around warehouses, having the ability to scan and keep track of which lots they belong to is essential. Using digital labeling technology (typically QR codes or barcodes) means you can quickly and easily stay on top of everything with pinpoint accuracy. Our software also helps prevent unnecessary waste by ensuring ingredients are used in the right order – first in, first out (FIFO) or first expired, first out (FEFO).

Another critical feature is the digital labelling of finished goods. Once produced, you must be able to trace back and identify all its ingredients and be able to know exactly which lots a customer has purchased.

2. Inventory Tracking

Manually recording all this information can be fraught with problems. It’s all too easy to mistype, transpose, or have difficulty interpreting someone’s handwriting. Instead, it’s far easier, faster, and accurate to scan a barcode and capture the data through our dedicated mobile app.

Our asset management solution, TrackAbout, seamlessly integrates with our ERP so you can monitor and track products in real-time. Items can be quickly scanned into the system using handheld devices or the proprietary mobile app so each unique Lot – including its entire journey, who’s handled it, where and when, and any other criteria you need to track – is documented. This data is stored securely in the cloud and can be easily stored and shared.

3. Data Insights

Datacor ERP is intuitive and easy to use. From a single screen, users are presented with a clear summary of the ingredients used for finished products – along with Lot Numbers, where the goods were sent, and other vital information required for a quick and seamless recall.

The comprehensive system not only streamlines the workflow but also enhances traceability and accountability. By offering detailed insights and real-time data, Datacor ERP empowers businesses to maintain high standards of quality control and compliance. The user-friendly interface ensures that even those with limited technical expertise can navigate the system efficiently, making it an invaluable tool for manufacturers looking to optimize their operations and minimize risks. Whether managing inventory, tracking shipments, or ensuring regulatory compliance, Datacor ERP provides the robust functionalities necessary to handle the complexities of modern production with ease.

4. Reporting

Easily export FDA Traceability Rule 204 compliant reports. Your data, delivered in the format you need. Datacor ERP includes a selection of preconfigured reports and allows users to export sheets of data quickly and easily in a variety of formats, including csv files.

Easily export FDA Traceability Rule 204 compliant reports with Datacor ERP. Our system ensures your data is delivered in the format you need, whether it's for internal analysis or regulatory compliance. Datacor ERP includes a selection of preconfigured reports designed to meet various industry requirements, ensuring you have immediate access to essential data insights. Additionally, our platform allows users to export sheets of data quickly and easily in a variety of formats, including csv files, Excel spreadsheets, and more. This flexibility ensures that your data can seamlessly integrate with other systems and processes, enhancing your overall operational efficiency and compliance efforts. With Datacor ERP, managing your data and complying with FDA regulations has never been easier.

5. Electronic Data Interchange

How do you get this important data to your customers? Our solution includes native support to use electronic data interchange (EDI) to send advanced shipment notices (ASNs) with your item/lot information using GS1 data exchange standards. This ensures accurate and timely communication, which helps to strengthen supplier relationships. Additionally, it’s simple to import and export CSV files from suppliers, allowing for efficient data management and further enhancing collaboration. By streamlining these processes, our solution facilitates improved transparency and trust with your suppliers.



If you want to learn more about how Datacor’s software can help you navigate FSMA 204, get in touch or sign up for a free demo with one of our industry experts.

Topics: FDA, Software, Datacor ERP, Food & Beverage


Jinelle Cioffi

Written by Jinelle Cioffi

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