FSMA 204 Compliance and EDI Integration

Insights on FSMA 204 and Leveraging the Power of EDI

Popularly known as FSMA 204, the FDA’s FSMA (Food Safety Modernization Act) Final Rule established new traceability recordkeeping requirements for entities that manufacture, process, pack or hold foods on the FDA Food Traceability List (FTL).

The goal of the FSMA 204 Traceability Rule is to speed up response to food-borne illness by quickly identifying the source(s) and then tracking distribution for rapid removal of potentially contaminated food from the market.

The FSMA 204 Final Rule went into effect January 2023, and the compliance deadline is January 20, 2026.

FDA does not require or recommend specific applications or technologies for keeping records. However, Electronic Data Interchange systems offer potent capabilities and are already widely used across the food industry supply chain. It makes regulatory and financial sense to leverage your EDI systems to streamline and meet initial and ongoing FSMA 204 compliance.

Overview and Summary of FSMA 204 Requirements

Entities who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) are required to:

• Develop a Traceability Plan
• Assign Traceability Lot Codes
• Maintain Records of Critical Tracking Events (CTEs)
  • Electronic and/or paper records
• Meet Requirements for Records Maintenance and Availability
  • Within 24 hours of the request, supply the FDA with CTE traceability information in an electronic sortable spreadsheet
  • Maintain records accessibility and availability – 2 year minimum.

FSMA 204 CTE and KDE Traceability Framework

Critical Tracking Events (CTEs)

FSMA 204 requires maintaining specific Critical Tracking Events (CTEs) and Key Data Elements (KDEs) defined in the rule. The data that must be kept and shared depends on the entity’s role in the supply chain.

• Critical Tracking Events (CTEs) are Harvesting, Cooling, Initial Packing, First Land-based Receiving FTL Food from a Fishing Vessel, Shipping, Receiving and Transforming

Key Data Elements (KDEs)

• Required CTE records must contain specific Key Data Elements (KDEs). The KDEs depend on the CTE being performed.

New FSMA 204 KDEs: Traceability Lot Codes and Traceability Lot Code Source or Reference

FSMA 204 requires two new traceability KDEs. The traceability lot code (TLC) links to the other KDEs required, including the TLC Source, which provides the physical location where the traceability lot code for an FTL food was assigned.

Traceability Lot Code

A unique identifier, usually alphanumeric, assigned to a traceability lot within the records of the TLC source

[Traceability Lot means the batch or lot of food that has been 1) initially packed (for raw agricultural commodities), 2) received by the first land-based receiver, or 3) transformed. New TLC traceability lot codes can only be established or assigned for these activities, not at any other points in the supply chain, e.g., shipping, receiving.]

Traceability Lot Code Source or Reference

Where the TLC was assigned or pointer to a reference that provides that information to the FDA

Example: Eight Required Shipping KDEs

• Traceability lot code for the food
• Quantity and unit of measure of the food
• Product description for the food
• Location description for the immediate subsequent recipient (other than a transporter) of the food
• Location description for the location from which you shipped the food
• Date you shipped the food
• Location description for the traceability lot code source or the traceability lot code source reference
• Reference document type and reference document number

Leverage EDI Integration to Meet FSMA 204 Requirements

Standard EDI supply chain transactions that contain data that can be used to comply with FSMA 204 include EDI 850 Purchase Order, EDI 810 Invoice, EDI 856 Advance Shipping Notice (ASN), and EDI 997 Functional Acknowledgement as a core group.

How EDI 856 ASN Offers Easier FSMA 204 Compliance

With its detailed shipment information, EDI 856 Advanced Shipping Notice (ASN) is a critical document in meeting FSMA Rule 204 requirements for Shipping and Receiving. Its electronic format makes sending information easy and fast. Additionally, EDI 856 is already required by most food industry major retailers as well as other FSMA 204 specified recipients. (To be clear, it is not required by FSMA 204.) Testing, updates and maintenance of ASNs support confidently meeting ongoing compliance with trading partners and the FDA.

In short, a robust, modern EDI Integration solution is a massive advantage in accessing traceability information from your ERP or other systems to automatically integrate into required KDEs in EDI transactions.

How PilotFish X12 EDI Integration Helps Support FSMA 204 Traceability
Rule Compliance

PilotFish’s modular and configuration-driven approach, coupled with its comprehensive X12 EDI standards support, positions PilotFish as a strategic asset in supply chain technology. PilotFish enables the integration of systems, applications, equipment and devices – anything to anything.

PilotFish’s eiConsole for X12 EDI integration process and tools are specifically engineered for:

• Advanced Parsing and Mapping: Quickly interpret, validate and organize X12 messages, enhancing data flow, accuracy and quality.
• Seamless Validation and Production: Ensure transactions are error-free and meet compliance standards, increasing trust and reliability across your network.
• Cost-effective Integration Solutions: Leverage our expertise to implement cost-efficient processes that reduce overhead and increase profitability.
• Improved Operational Insights: Achieve end-to-end visibility from a single interface platform across trading partner transactions and into back-end EDI integrations.
• Real-Time Transaction Management: Leverage real-time data synchronization to manage supply chain dynamics instantly. Our solutions enable on-the-fly adjustments to inventory levels, order statuses, and shipping schedules.
• Predictive Analytics Integration: Integrate sophisticated predictive analytics to forecast demand trends, manage risks, and optimize supply chain decisions based on actionable insights.
• Enhanced Compliance and Security: Meet the latest regulatory requirements with robust security protocols and compliance checks embedded within every transaction.

PilotFish consistently wins in side-by-side evaluations ranking higher in overall ease-of-use, depth of functionality and time to configure, test and deploy integrations.

PilotFish EDI Solutions Architected to Meet Modern Challenges

• Graphical Interface & No Coding: PilotFish offers a Graphical Integrated Development Environment (IDE). No coding or scripting required, making it more straightforward for users to implement interfaces even if they lack a deep technical background.
• Template-Driven Approach: Users can capitalize on the ready-to-use templates and configurations for numerous EDI standards. This allows for a swift integration setup that is tailored to specific industry requirements.
• Comprehensive Validation & Rigorous Testing: PilotFish provides validation tools that ensure the EDI messages adhere to the requisite standards. Moreover, the progressive testing functionality allows users to test and rectify interfaces throughout the development phase, ensuring accuracy.
• Enhanced Connectivity: With PilotFish, users can seamlessly connect to any endpoint or system. Be it databases, applications, or platforms, the tool’s connectors, adapters and support for virtually any communications protocol you might encounter streamlines the EDI data integration process. (40+ Listeners, 30+ Transports and 140+ Processors built-in at no additional charge.)

PilotFish EDI solutions are specifically designed to handle the complexities of modern supply chains, including:

• Customizable Workflows: Adapt to specific industry needs with customizable workflows that support a variety of EDI transactions, such as EDI 810 (Invoice), EDI 850 (Purchase Order), and EDI 856 (Advance Shipment Notice).
• Scalable Architecture: Our architecture scales effortlessly with your business growth, accommodating increased transaction volumes without compromising performance.

Supply Chain X12 EDI Demo with EDI 850 and 855 transactions. (4 min)

PilotFish Leads in Innovative Interface Solutions

PilotFish’s technology extends beyond traditional X12 EDI support—generative AI, machine learning, IoT, tracking and tracing innovations, and more. Our platform addresses evolving needs in supply chain transaction management:

• AI Integration Built-In: Harness the power of AI and ML technologies without the burden of complex integration processes with PilotFish’s Open AI Processor.
• IoT Integration: Connect with Internet of Things (IoT) devices to monitor goods in transit, manage warehouse operations, and improve asset tracking with unprecedented accuracy.
• Sustainability Tracking: Support sustainability initiatives that track and manage the environmental impact of supply chain activities, aligning with global standards and consumer expectations.

Choose PilotFish for FSMA 204 Compliance and Beyond

• Innovative Approach: Stay ahead of industry trends with continuously evolving tools and technologies.
• Comprehensive Support: Rely on our expert team for seamless implementation and ongoing operational support.
• Global Compliance: Ensure global supply chain compliance with our extensive knowledge of US and international trade regulations and standards.

By choosing PilotFish, organizations align themselves with a technology partner that evolves in tandem with their needs, ensuring sustained success in a digitally advancing supply chain landscape.

FDA Resources

FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods

Food Traceability List

Traceability Lot Code

Disclaimer: This information on the FDA and FSMA 204 is intended for informational purposes only and should not be construed as legal advice. It is recommended to consult with legal and regulatory experts to ensure compliance with FSMA 204 and other relevant regulations.

X12, chartered by the American National Standards Institute for more than 35 years, develops and maintains EDI standards and XML schemas.