Jacob Olson, Senior Director of Solutions at Cleo
Key Takeaways
- FDA’s new food tracing rules under FSMA require detailed records to be kept of critical tracking events (CTEs) and key data elements (KDEs) throughout the food supply chain, and the information must be provided within 24 hours upon request.
- Electronic Data Interchange (EDI) technology is essential for complying with new regulations because it automates data exchange, increases supply chain visibility, and streamlines record-keeping processes.
- Implementing EDI not only ensures compliance with FSMA regulations, it also improves operational efficiency, speeds up outbreak response, strengthens supplier management, and prepares companies for food industry audits.
Earlier this year, the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act Final Rule (FSMA) is a groundbreaking regulation designed to expedite the detection and removal of potentially contaminated foods from the market. This important update highlights the growing need for robust traceability throughout the food supply chain. The impact of the FDA’s new food traceability rule highlights the vital role that supply chain integration technology plays in ensuring food safety and compliance.
This latest update strengthens record-keeping for the production and distribution of food and beverages. Under the revised FSMA regulations, food manufacturing, processing, and packing parties must: Food Traceability List The FTL maintains records of Key Data Elements (KDEs) associated with specific Key Tracking Events (CTEs). If requested, these parties must provide this information to the FDA within 24 hours. They must also retain these records for two years to ensure readiness.
The final food traceability rule requires companies to share information with other parties throughout the supply chain, ensuring that all parties, from suppliers to retailers, are aware of potential food safety issues and can address them in a timely manner.
Definition of a Significant Tracking Event (CTE)
CTEs are defined as key milestones as food moves from production to consumption. These markers serve as tracks and indicators of progress as food moves throughout the supply chain. These milestones include:
- Procurement of raw materials and ingredients from suppliers
- Food processing and production (including manufacturing)
- Packaging and labelling food for distribution
- Shipping and transportation of food to distribution centers
- Receipt of such food by a retailer or service establishment
- Sale and distribution of those products to consumers
Key Data Element (KDE) Definitions
FDA considers KDEs to be important information related to a particular CTE. For example, these indicators provide important information related to a food and its movement throughout the supply chain. KDEs include:
- Product identifier: Lot, batch, or serial numbers that allow you to trace a particular food product
- Key data attributes: Ingredients, packaging materials, manufacturing date, expiration date, storage conditions
- Chain of Custody: Information and documentation regarding food handling and transportation entities
- contact address: Details of the organisation responsible for food safety management and emergency response
Important Record-Keeping Obligations
The latest guidelines for FSMA include strict instructions on how and for how long records related to CTE and KDE should be kept. These obligations include timelines (such as the 24-hour rule) and storage of information in specific formats. For example, FDA requires that these documents be stored in their original format and that records be available for electronic sorting upon request. This requires organizations to develop and articulate recordkeeping procedures and strategies for identifying product and assigning procedures for delegating traceability lot codes.
Electronic Data Interchange Enables Food Traceability
Ensuring compliance with CTE and KDE requirements requires integration technology such as Electronic Data Interchange (EDI). EDI systems can automatically extract traceability from Enterprise Resource Planning (ERP) or Warehouse Management Systems (WMS) and accurately populate KDE on critical and time-sensitive documents. This technology allows organizations to comply with regulatory standards for proactive monitoring and mapping. This eliminates the need for manual data entry and reduces the chance of costly mistakes. Different suppliers and customers have different levels of technical aptitude. So keep in mind that you can leverage all types of EDI such as traditional X12 EDI, EDIFACT EDI, TRADACOMS EDI, as well as other electronic data such as APIs, JSON or XML, flat files, spreadsheets, and web portals to achieve these outcomes.
This integrated technology not only facilitates the receipt, conversion, and transmission of lot information, but also the direct capture of lot numbers into the ERP system. Supply chain stakeholders benefit from this integrated technology, which is essential to provide the information needed when faced with FDA inquiries regarding food traceability and safety.
EDI is essential to streamline food traceability within the supply chain and ensure proper collection of KDE and CTE. Specifically, EDI enables:
- Automate data exchange: EDI streamlines information exchange between companies by automating processes, reducing errors from manual data entry and making data management easier to scale. EDI also ensures accurate tracking of food products by incorporating detailed information such as purchase orders, invoices and shipping notices with lot numbers and expiration dates.
- Increase visibility: EDI is the foundation for providing real-time insight into the movement of food throughout the supply chain. Combined with a modern integration platform, it enables companies to track the location of products at every stage, from origin to the end consumer.
- Ensure regulatory compliance: EDI helps companies meet food safety regulations, such as FSMA in the U.S. By enabling the electronic recording and transmission of critical traceability data, EDI simplifies the audit process.
EDI Technology for FSMA Compliance
EDI not only improves food traceability, it also prepares organizations for changing regulatory guidelines. Investing in integrated EDI technology positions organizations to comply with upcoming FSMA regulations. Ensuring FSMA compliance requires future processes and procedures enabled by technology that integrates and automates the exchange of critical information. Specifically, EDI integration allows for:
- Faster response to outbreaks: FSMA requires better traceability to pinpoint the source of contamination in the event of an outbreak. EDI allows for the electronic exchange of standardized documentation such as electronic traceability records, certificates of analysis, and product specifications. This digital tracing makes it easier to track the movement of food throughout the supply chain, allowing for faster response in the event of an outbreak.
- Streamlined record keeping: FSMA requires detailed record keeping to prove compliance. EDI automates the generation, storage and sharing of electronic records such as production data, quality control information and supplier documents. This streamlines record keeping, ensures data accuracy and makes information easily accessible.
- Enhanced supplier and carrier management: FSMA requires verification of suppliers and carriers to ensure safe ingredients, food storage, and transportation. EDI facilitates seamless communication between suppliers, customers, carriers, and other key components of the supply chain, enabling real-time exchange of information such as product specifications, ingredient lists, allergen details, and safe delivery temperatures. This improves management of the food supply chain and simplifies FSMA compliance.
- Data-Driven Risk Management: FSMA emphasizes preventive controls based on identified risks. EDI can integrate with other systems such as ERP and WMS to enable data-driven risk assessment and management, allowing you to monitor critical control points, shelf life and temperature controls to mitigate foodborne hazards.
- Audit Preparation: Complying with FSMA requires preparation for inspection by the FDA. EDI simplifies the capture and presentation of electronic records, making companies audit-ready and able to demonstrate compliance during inspection.
A key aspect of food traceability under FSMA’s new rules relies on identifying and recording CTEs and KDEs. An integrated, accessible technology such as EDI streamlines the data collection process, reduces errors, and ensures all critical information is available in real time. By automating these processes, EDI not only aids in compliance, but also improves operational efficiency and response times in food safety incidents.
The implementation of the latest FSMA food traceability rules marks a major step forward in protecting the food supply chain. By mandating detailed record-keeping and rapid data access, the rules aim to quickly identify and address potential food safety issues to protect public health. Supply chain integration technologies such as EDI are essential for compliance and operational efficiency. These systems automate data exchange, increase visibility, and enable all parties in the supply chain to connect and share information. As the food industry adapts to these stringent requirements, leveraging technology not only ensures compliance but also fosters a more resilient and responsive supply chain that can quickly respond when food safety concerns arise.
Jacob Olson is Senior Director of Solutions. Cleois a pioneer and global leader in the ecosystem integration software space. Jacob leads Cleo’s presales solutions organization and is responsible for supply chain market intelligence. He has over 15 years of experience in supply chain integration solutions with deep expertise in technical sales, presales, product management and industry analysis. He holds a BS in Computer Science from the University of Wisconsin-Milwaukee.
