What is the FSMA Final Rule?

The FSMA (Food Safety Modernization Act) Final Rule establishes new traceability recordkeeping requirements for anyone who manufactures, processes, packs or holds foods on the Food Traceability List (FTL). These requirements aim to speed up the identification and removal of contaminated food from the market, reducing foodborne illnesses and deaths.

A key requirement is for these entities to maintain records with Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs) and provide this information to the FDA within 24 hours or within a reasonable time agreed upon by the FDA.

Who is Concerned, and What is the Compliance Date?

FSMA Rule 204 affects all entities in the food supply chain, including:

• Food manufacturers
• Processors
• Packagers
• Distributors
• Retailers

All entities must comply with the recordkeeping requirements by January 2026.

What Information Should Be Provided to the Government Under the Rule?

Businesses must maintain and provide detailed traceability records, which include:

• Origin Information: Source of the food, such as the farm or production facility.
• Movement Records: Details of each point where the food is handled, processed, or stored.
• Lot or Batch Numbers: Identifiers for each lot or batch of food.
• Shipping Details: Information about shipments, including dates, quantities, and recipient information.
• Transformation Data: Information on how the food has been processed or transformed at each stage.

This data must be readily available and provided to the FDA upon request to quickly trace the food's journey through the supply chain.

What Are the Consequences of Non-Compliance?

Non-compliance with FSMA Rule 204 can result in severe consequences, including:

• Product recalls
• Suspension of production
• Repeated inspections from the FDA
• Suspension of the license to operate
• Loss of productivity and revenue

In severe cases, non-compliance can lead to the company's registration being suspended, temporarily halting its ability to produce and sell products. Additionally, companies may face re-inspections, guidance document reevaluations, and fines, potentially up to $250,000 for serious injuries. In extreme cases involving consumer deaths or serious hospitalizations, companies could be permanently shut down.

What are the Main Challenges Businesses will Face?

Complying with the FSMA Final Rule presents several challenges:

• Speed: Records must be provided to the FDA within 24 hours.
• Centralization: Data must be stored in a single, accessible location.
• Accuracy: Ensuring all data is accurate and complete.
• Integration: Seamlessly integrating data from various sources and partners.

How Can Businesses Simplify Compliance with FSMA?

A practical solution for simplified FSMA compliance is using Electronic Data Interchange (EDI).

When a Critical Tracking Event happens, businesses typically input the KDEs into their manufacturing system, ERP system, or other internal platforms. This creates an electronic record, fulfilling one aspect of the rule’s requirements. Businesses must also receive tracking data and KDEs from upstream partners like farmers or suppliers and deliver it to downstream partners.

Integrated technology plays a key role. For example, creating an EDI 856 Advance Shipping Notice (ASN) without integration would require manually typing in product traceability KDEs into each ASN field for each shipment. This process is time-consuming, costly, and prone to errors. Errors in KDE reporting could result in severe consequences during foodborne illness outbreaks, such as broader mandatory recalls, increased product and sales losses, and potential FDA audits.

Integrated technology like cloud-based EDI helps prevent these issues and protect your business. An integrated EDI solution can pull traceability information from ERP and automatically insert KDEs on documents like an ASN. Proactive monitoring and mapping updates ensure ASNs have the required fields properly filled before sending, reducing manual data entry errors and enhancing compliance with trading partners and the FDA.

In the context of EDI, several standard documents and transactions can contain the data required to comply with FDA regulations regarding high-risk foods. The Purchase Order (EDI 850) includes product identification, supplier information, and batch/lot numbers. The Invoice (EDI 810) details product identification, supplier information, and batch/lot numbers. The Advance Shipping Notice (ASN) (EDI 856) provides descriptions and quantities of shipped goods, supplier information, and batch/lot numbers. The Functional Acknowledgment (EDI 997) confirms the receipt of other EDI documents, ensuring data integrity and compliance. Inventory Advice (EDI 846) offers product identification, inventory levels, and movements, including batch/lot numbers. Finally, The Quality Inspection (EDI 861) includes reports and documentation related to quality inspections and testing results if applicable.

What are the benefits of Compliance Using EDI?

EDI (Electronic Data Interchange) provides an efficient and reliable way for businesses to comply with FSMA Rule 204 by:

• Automating Data Exchange: Streamlining the exchange of traceability data and other records with the FDA and supply chain partners.
• Ensuring Accuracy: Reducing errors associated with manual data entry and ensuring all required information is accurately captured and transmitted.
• Enhancing Traceability: Facilitating the creation of a detailed traceability chain by integrating seamlessly with existing ERP systems and other business software.
• Providing Quick Access: Ensuring traceability records are readily available and can be quickly retrieved during audits or inspections.

What is the Role of Advanced Shipping Notice in FSMA Compliance?

The Advanced Shipping Notice (ASN) is a critical document for FSMA Rule 204 compliance due to its detailed shipment information, including:

• Shipment Details: Descriptions, quantities, weights, and the origin and destination of the shipped products.
• Lot or Batch Numbers: Identifiers that help trace products throughout the supply chain.
• Carrier Information: Details about the transportation used for shipping the products.
• Dates: Shipment and expected delivery dates, ensuring timely tracking of the products.

Using ASN helps companies maintain a comprehensive traceability chain, which is essential for quick identification and response during food safety incidents.

What Non-EDI Documents Can be Used to Simplify Compliance with the FSMA Final Rule?

Businesses can use a wide range of essential documents that contain information required by the FSMA Rule. These documents include:

- Quality Assurance Documents: Certificates of Analysis (COA) and Quality Control (QC) Reports that verify the safety and quality of food products.

- Traceability Reports: Detailed records that trace the movement and transformation of food products through the supply chain.

- Inventory Management Documents: Inventory Reports and Stock Transfer Documents that track the quantities and movements of products in and out of storage facilities.

- Shipping and Receiving Documents: Bills of Lading (BOL) and Receiving Reports that document the shipment and receipt of goods, ensuring transparency and accountability.

- Audit and Compliance Documents: Audit Reports and Compliance Checklists that help businesses prepare for inspections and maintain regulatory compliance.

- Supplier and Partner Documentation: Supplier Compliance Reports and Partnership Agreements that ensure all partners in the supply chain adhere to FSMA requirements.

- Production and Transformation Records: Those document food product processing and modification at various stages.

By automating and exchanging these non-EDI documents, businesses can enhance their compliance with FSMA Rule 204, reduce manual effort, and ensure that all necessary documentation is readily available for audits and inspections. 

How Can DocStudio Help Businesses Comply with FSMA?

DocStudio can be useful for Food Retailers in the context of the recently introduced Food Traceability Final Rule, as we help automate various Supply Chain documents, including the Advanced Shipping Notice, to improve traceability and ensure food safety for certain high-risk foods. DocStudio offers comprehensive EDI and e-document management solutions that simplify compliance with FSMA Rule 204:

• Integration and Automation:
  • Seamless Integration: Integrates with existing ERP systems to manage EDI documents like Purchase Orders (EDI 850), Invoices (EDI 810), and ASNs (EDI 856) efficiently.
  • Automated Processes: Automates the generation, sending, and receiving of EDI documents, reducing manual effort and ensuring data accuracy.
• Web-EDI Accessibility:
  • Easy Onboarding: Provides a user-friendly Web-EDI portal for suppliers to quickly submit ASNs and other necessary documents.
  • Accessible Anywhere: Ensures stakeholders can access the portal from anywhere, enhancing convenience and efficiency.
• Data Standardization and Compliance:
  • Standards Compliance: Adheres to ANSI X12 or EDIFACT standards, ensuring interoperability and regulatory compliance.
  • Data Validation: Validates EDI documents for completeness and accuracy, ensuring all required information is present.
• Traceability and Documentation:
  • Comprehensive Traceability: Maintains detailed traceability records for all supply chain events, facilitating quick and accurate data retrieval.
  • Documentation Storage: Stores all EDI documents securely, ensuring they are readily available for audits or inspections.
• Flexibility and Customization:
• Inbuilt Document Template Editor: Easily customizes format and data fields to comply with company requirements and policies.
• Advanced Mapping Tool: Supports and adapts to different formats used by the company and its partners ensuring flexibility and ease of use.

Conclusion

By leveraging DocStudio’s EDI solutions, businesses can streamline their compliance processes, reduce risks, and focus on their core operations with the confidence that they are meeting FSMA Rule 204 requirements.

Don't wait until the last minute—start preparing now to ensure your business is compliant by the January 2026 deadline. For more information on how our EDI solutions can help your business meet the new traceability requirements efficiently, reach out to the DocStudio team at hello@docstudio.com or fill out our form here.