FSMA Rule 204: How To Develop a Food Traceability Plan that Complies with the New Traceability Rule?

The new Traceability Rule requires those affected by its requirements to develop and implement a food traceability plan that adheres to the detailed provisions laid out in 21 CFR Pat 1 Subpart S § 1.1315 of the Food Traceability Rule. ...

FSMA rule 204 traceability plan

The new Traceability Rule requires those affected by its requirements to develop and implement a food traceability plan that adheres to the detailed provisions laid out in 21 CFR Pat 1 Subpart S § 1.1315 of the Food Traceability Rule. These guiding documents are designed to assist entities in establishing a traceability plan that fulfills the FDA’s requirements.

The examples provided herein demonstrate just a couple of the many approaches that can be taken to create such a plan. While the Food Traceability Rule does not prescribe a specific format for the traceability plan, it is imperative that the information contained within the plan meets the rule’s criteria and accurately reflects the current practices of the entity involved.

Creating a Food Traceability Plan (FTP) is a critical step for entities to effectively monitor and trace food products within their supply chain, ensuring the safety and reliability of food from farm to table.

The FDA’s Food Traceability Rule is a key element of its New Era of Smarter Food Safety initiative, which places significant emphasis on detailed record-keeping and systematic procedures. These are essential for enabling prompt and efficient traceability in the case of food safety concerns.

The spectrum of businesses impacted by this rule includes but is not limited to, manufacturers, processors, packers, and distributors. Each plays an integral role within the food supply chain. A comprehensive FTP is crucial not only for meeting regulatory obligations but also for empowering entities to quickly pinpoint and manage potential contamination sources. This ability to rapidly respond is pivotal in safeguarding public health and narrowing the impact of food recalls.

The FTP serves as a foundational document that outlines how traceability information will be gathered, stored, and accessed. It should articulate the procedures for identifying foods listed on the Food Traceability List (FTL), assigning traceability lot codes, and, if relevant, creating a farm map. Additionally, the plan must designate a point of contact for questions regarding the traceability plan and related records.

Entities are encouraged to personalize their FTPs to reflect the specific characteristics of their operations, including their size, complexity, and available technology.

The rule’s flexibility regarding the format of the FTP enables entities to adapt the plan to their unique operational needs while still achieving the overarching goal of ensuring traceable and safe food products in the market.

Through the adoption of such personalized traceability measures, businesses can significantly contribute to the ultimate aim of establishing a transparent, efficient, and trusted food supply system.

To develop and implement a FTP that complies with the Food Traceability Rule, businesses covered by the rule should follow these steps:

  1. Understand the Rule: Ensure a thorough understanding of the Food Traceability Rule, its requirements, and how it applies to your products and operations.
  2. Identify Foods on the Food Traceability List (FTL): Create a list of all the foods you manufacture, process, pack, or hold that are on the FTL. Implement procedures for consistently identifying these foods in your inventory and records.
  3. Record-Keeping Procedures: Decide on a digital or paper-based record-keeping system. Digital systems are often more efficient and easier to search. Keep records in a secure location with access controls to protect confidential information Establish routine procedures for updating records, including the frequency of updates and personnel responsibilities. Ensure that all relevant staff are trained in these procedures.
  4. Traceability Lot Codes: Create a system for assigning unique traceability lot codes to each batch of food on the FTL. This could be based on production dates, batches, or other distinguishing information. Document the method used for assigning lot codes and how they can be used to trace a product through the supply chain.
  5. Point of Contact: Designate a person or a team responsible for traceability and assign a general contact title such as “Traceability Coordinator” along with a phone number. Make sure the point of contact information is readily available to all stakeholders and regulatory bodies.
  6. Farm Map: For producers, create a detailed map of the farm showing the location and name of each field or growing area, including geographic coordinates. The map should include identifiers for each field or container used in aquaculture, like ponds or tanks. Add any relevant details that would aid in identifying the specific locations, such as landmarks or adjacent roads.
  7. Update and Review: Schedule periodic reviews of the FTP to ensure it remains accurate and reflects current practices. Update the FTP whenever there are changes in processes, products, or regulations that affect your traceability system.
  8. Retention of Records: Keep a copy of the previous traceability plan for at least two years after any update. Ensure that archived plans can be accessed if needed for regulatory compliance or audits.
  9. Implementation: Train all relevant staff on their roles within the FTP. Run traceability exercises to test the effectiveness of the plan. Integrate the FTP with other business systems such as inventory management or quality assurance programs.
  10. Technology Utilization: Consider investing in traceability software that can streamline the record-keeping and lot tracking process. Use data from the traceability system for continuous improvement and risk management.
  11. Compliance and Verification: Engage with third-party auditors to verify compliance with the FTP. Stay informed about changes to regulations that may affect your FTP.

By following these steps and ensuring that the FTP is a living document that adapts to changes in your business and the regulatory landscape, you can maintain compliance with the Food Traceability Rule and ensure food safety throughout your supply chain.

In conclusion, the establishment of a Food Traceability Plan (FTP) as necessitated by the Food Traceability Rule is not only a regulatory requirement but also a cornerstone in the edifice of food safety and public health.

By meticulously crafting an FTP that aligns with 21 CFR Part 1 Subpart S § 1.1315 of the rule, entities ensure that they are equipped to rapidly respond to and manage food safety incidents, thereby reinforcing consumer confidence in the safety of the food supply.

The examples and guidelines provided aim to serve as a starting point, from which entities can develop a customized plan that fits their specific operational framework while complying with the FDA’s directives. The flexibility in the format of the FTP is a testament to the FDA’s understanding of the diverse nature of the food industry and its commitment to fostering an adaptable approach to safety.

As the food industry continues to evolve with technological advancements and global supply chains become more intricate, the role of an effective FTP will only grow in importance.

Entities that invest in robust traceability systems are not just complying with current regulations; they are also investing in their future resilience and in the collective effort to maintain a safe food supply.

By keeping the FTP dynamic and up-to-date, entities can ensure that their practices remain in line with the best standards for food safety.

The commitment to transparency and traceability showcased through these efforts is invaluable, as it not only mitigates risks but also demonstrates a dedication to quality and safety to consumers and partners alike.

Therefore, the successful implementation of an FTP is a critical step forward for any entity within the food industry. It is an investment in consumer trust and in the assurance that the foods provided to the market are as safe as they are delicious.

Through proactive planning and continuous improvement, the food industry can achieve the highest standards of traceability and integrity, ensuring that food safety is never left to chance.

At FoodReady, our commitment goes beyond just updating our customers about new regulations. We are dedicated to providing effective solutions that help ensure full compliance with the latest requirements.

Find out how our FSMA 204 consultants can assist you with compliance under the new Rule 204, which requires additional traceability records for specific foods.


Digital record-keeping systems offer greater efficiency and ease in searching and updating records, alongside improved security features like access controls, which are crucial for protecting sensitive data and ensuring compliance.
Smaller entities can manage compliance costs by leveraging shared resources and technologies, engaging in cooperative agreements with similar small operations to share the burden of technological investments, and seeking government or industry grants available for compliance upgrades.
Immediately initiate the traceability protocol to identify and isolate the product batch involved. Inform all affected stakeholders, recall implicated products if necessary, and cooperate fully with regulatory authorities to resolve the issue promptly and prevent future occurrences.
A Food Traceability Plan should be reviewed at least annually or whenever there are significant changes to production processes, product lines, or regulatory requirements, to ensure that the plan remains effective and compliant with current standards.
Best practices include conducting comprehensive training sessions that cover all aspects of the FTP, regular drills to test understanding and readiness, updates on any changes to the plan, and ensuring that all new employees receive training as part of their onboarding process.

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Radojka Barycki

Radojka Barycki is an Award-Winning Quality Assurance, Food Safety, Training and Consulting Professional with 24+ years’ experience with demonstrated success in the development, implementation, and improvement of Quality and Food Safety Management Systems (SQF, BRCGS, FSSC2200)
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