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    December 8, 2023

    FSMA 204 Tools for Success: Creating a Food Traceability Plan

    In its continuous support for industry compliance with the FSMA 204 Food Traceability Rule, the FDA has unveiled a third wave of tools and FAQs, further enhancing resources available to stakeholders grappling with the intricacies of the rule. This reinforces the FDA's dedication to informing covered entities about the rule's requirements and assisting them on the path to compliance. Accessible on the FDA’s food traceability webpage, these resources provide comprehensive guidance for entities striving to align with the final rule.

    FDA's Latest FSMA 204 FAQs and Tools

    On November 30, 2023, the FDA announced several new resources on the FDA's resource center page: FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. Some of the most notable updates include:

    • New Traceability Lot Code Resource Page: A dedicated webpage explaining traceability lot codes, providing clarity on a crucial aspect of compliance.
    • Video Highlights: An insightful video showcases technological components integral to product tracing systems, enhancing understanding for stakeholders.
    • Sample Traceability Plans: Practical examples of traceability plans for Farms and Restaurants providing tangible models for entities working to establish their own plans in line with the rule.
    • Expanded FAQ Page: The Frequently Asked Questions: FSMA Food Traceability Rule page has been enriched with questions and answers spanning the entire supply chain, covering topics from packing and shipping to farms, retail establishments, restaurants, recordkeeping, importing, and more. Recent updates include information regarding the FDA’s Safety Reporting Portal (SRP), which is a secure web-based portal where companies can upload their sortable spreadsheets in the event of an investigation, details of routine inspections, and auditing of foreign food businesses.  
    • Supply Chain Examples: The addition of new supply chain examples, specifically for deli salads, broadens the scope of understanding for entities at various points in the supply chain.
    • Waiver or Exemption Information: The inclusion of information on applying for waivers or exemptions offers a nuanced perspective on compliance flexibility.

    FSMA 204 Traceability Plans Explained

    The FDA's release of Traceability Plan examples is of particular importance, offering valuable insights into how entities in the food supply chain can navigate the complexities of the Food Traceability Rule. In this section, we focus on the Traceability Plan specifically, providing a detailed breakdown of the key requirements outlined in the FDA documents. This emphasis is crucial for organizations aiming to ensure compliance and enhance their traceability practices, aligning with the evolving standards set by regulatory authorities.

    What is a Food Traceability Plan?

    The purpose of the traceability plan is to guide entities in not only complying with FSMA 204—but also preparing companies to be able to effectively execute a recall. While there is no specific format mandated, the plan must meet the requirements of the rule and align with the current practices of the covered entity.

     What are the Components of the Food Traceability Plan?

    There are a few main components that are required to be included in a Food Traceability plan. 

    1. Description of Record-Keeping Procedures. A description of the procedures you use to maintain the records you are required to keep, including the 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. 
      • Objective: Maintain records required by the subpart, ensuring traceability data can be provided to the FDA in a sortable spreadsheet within 24 hours.
      • Considerations: Document how records are created, managed, and stored. This includes details on personnel responsibilities, creation locations, systems used, and storage access.
      • Examples from the FDA:
        Farm Example Restaurant Example
        Digital records of all required KDEs are captured and stored in our commercial software solution. Records are maintained for two years. Hard copies of Bills of Lading are provided to subsequent recipients containing all KDEs except TLC/ TLC Source Reference, which is barcoded on product case labels. Some companies also receive digital advanced shipment notices containing all required KDEs. Hard copies of Invoices and Bills of Lading are scanned and stored in an electronic filing system located on our local computer system. Digital advance shipment notices that have been received are also maintained in an electronic filing system located on our local computer system. Records are maintained for two years. 
    2. Procedures to Identify Foods on the Food Traceability List. A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold.
      • Objective: Establish ongoing processes to identify foods on the FTL.
      • Considerations: Develop procedures for recognizing FTL products, especially for entities relying on suppliers. This becomes even more complex when an FTL item is used as an ingredient, so trading partner communication will be key to identification. Address questions about the transformation of non-FTL products.
      • Examples from the FDA:
        Farm Example Restaurant Example
        All products packed at this facility are on the FTL. All suppliers to Sammy’s Sandwich Shoppe are obligated by contract to identify FTL Foods on the records provided when shipments are received (either paper copies provided at receiving or electronically sent ahead of shipment receipt).
    3. Assignment of Traceability Lot Codes. A description of how you assign traceability lot codes to foods on the Food Traceability List, if applicable.
      • Objective: Ensure stakeholders understand how and when to assign traceability lot codes.
      • Considerations: Incorporate procedures for creating and assigning lot codes. Define processes for ensuring accuracy and avoiding mislabeling during shipping or reworking.
      • Examples from the FDA:
        Farm Example Restaurant Example
        Unique products/pack sizes are assigned a 14-digit case GS1 GTIN. Internal lot codes are assigned using date (MMDDYY) and packing line (“AAA” – “ZZZ”). Together the case GTIN and Internal Lot code represent our traceability lot code. We do not assign TLCs.
    4. Point of Contact Identification. A statement identifying a point of contact for questions regarding your traceability plan and records.
      • Objective: Designate a point of contact for inquiries related to the traceability plan and records.
      • Considerations: Decide whether a specific individual or a team will serve as the contact. Provide contact details for seamless communication.
      • Examples from the FDA:
        Farm Example Restaurant Example
        Sarah Tree, Traceability Manager, 123-456-7899 Steve McGee, Manager, 456-789-1233
    5. Farm Map for Growers or Raisers. If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
      • Objective: If applicable, create a farm map displaying the areas where foods on the FTL are grown or raised.
      • Considerations: For each field or growing area, include names, geographic coordinates, and any necessary details. For aquaculture farms, specify locations of containers (ponds, pools, tanks, cages) raising seafood.
      • Examples from the FDA:
        Farm Example Restaurant Example

        See Appendix. 

        In the appendix, show the location and name of each field (or other growing area) in which you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area such as field images or maps. 

         Does not Apply.
    6. Plan Updates and Compliance. A statement outlining how you plan to keep your traceability plan current and compliant.
      • Objective: Keep the traceability plan current to reflect evolving practices and ensure compliance.
      • Considerations: Establish a regular review schedule, potentially annually, and designate responsible parties for updates. Implement version control processes, validate plan accuracy, and develop protocols for corrective actions.
      • Examples from the FDA:
        Farm Example Restaurant Example
        This plan is reviewed annually as part of our management review of our food safety system, as well as whenever something changes in our traceability procedures. Each previous traceability plan is kept in a folder on SharePoint for at least two years after it is updated. This plan is reviewed annually as part of our management review of our food safety program, as well as whenever something changes in our traceability procedures. Each previous traceability plan is kept in a folder on our local computer system for at least two years after it is updated.


    Trustwell's Role in Compliance

    Building a robust traceability plan is pivotal for navigating the Food Traceability Rule. It not only ensures compliance with regulatory requirements but also serves as a tool for evaluating and improving traceability processes. For organizations seeking guidance in this journey, Trustwell offers consulting services tailored to the unique needs of the fresh food supply chain, providing expert assistance in achieving compliance with FSMA 204.

    As the FDA continues to refine the rule and entities work towards compliance, the combined insights from the FDA's latest resources and Trustwell's consulting services offer a robust framework for a smoother transition into the New Era of Smarter Food Safety. By leveraging these resources and partnerships, stakeholders can contribute to a safer and more transparent food supply chain, aligning with the overarching goals of the FDA's visionary approach to food safety.

    If you have traceability plan needs and are eager to explore Trustwell's FSMA 204 Consulting packages, you can arrange a discovery call with one of their representatives. This personalized support is designed to streamline the compliance journey, providing entities with tailored solutions to meet the requirements of the Food Traceability Rule.

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