FSMA Rule 204: How Does the New Traceability Rule Affect Processors?

In the FDA Traceability Rule’s framework, processors are categorized under the Transformation Critical Tracking Event (CTE) in the food supply chain. Transformation pertains to manufacturing or processing foods, or altering them or their packaging, especially if the end product is ...

How does FSMA 204 affect a food processor

In the FDA Traceability Rule’s framework, processors are categorized under the Transformation Critical Tracking Event (CTE) in the food supply chain.

Transformation pertains to manufacturing or processing foods, or altering them or their packaging, especially if the end product is listed on the Food Traceability List (FTL). Transformation, as defined, excludes initial packing and activities preceding it, like harvesting or cooling. Notably, repacking or repackaging as part of breaking down a master case is considered a transformation.

Processors are provided the following record-keeping responsibilities:

  1. Assignment of Traceability Lot Codes: Processors must assign traceability lot codes to foods used as ingredients and the new food produced.
  2. Record-Keeping Requirements: Processors must maintain detailed records when they transform the food. These records should include:
    1. Food used as ingredients:
      1. Product description for the food to which the traceability lot code applies.
      2. For each traceability lot used, the quantity and unit of measure of the food used from that lot.
    2. New Foods:
      1. Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference
      2. Date transformation was complete.
      3. Product description for the food.
      4. Quantity and unit of measure of the food.
      5. Reference Document type and reference document number.

A Traceability Plan must be established and maintained. This plan should detail the procedures for the maintenance of records under the new requirements and the identification of FTL foods handled.

To comply with the FSMA Section 204 Rule, particularly for the Transformation Critical Tracking Event (CTE), food processors can adopt several best practices:

  1. Effective Assignment of Traceability Lot Codes: Implement a robust system for assigning traceability lot codes to both ingredients and final products. This system should be consistent and easily understandable, facilitating traceability throughout the food supply chain.
  2. Comprehensive Record-Keeping Strategy: Develop a detailed strategy for maintaining records, which includes:
    1. Documenting the product description, quantity, and unit of measure for each ingredient used, linked to its traceability lot code.
    2. Keeping precise records of the transformation process, including the location, date, product description, quantity, and unit of measure of the new food produced.
    3. Ensuring that each step of the transformation process is documented and linked to the appropriate traceability lot code and reference documents.
  3. Development of a Traceability Plan: Establish a traceability plan that outlines procedures for record maintenance. This plan should:
    1. Clearly identify FTL foods handled in the process.
    2. Detail the methods for assigning and tracking traceability lot codes.
    3. Include protocols for regular review and updates to ensure compliance with evolving FDA requirements.
  4. Training and Awareness: Ensure that staff are adequately trained in the new requirements. Regular training and awareness programs can help in maintaining compliance and understanding the importance of traceability.
  5. Technology Integration: Utilize technology, such as traceability software or enterprise resource planning (ERP) systems, to streamline the record-keeping process. This can lead to more accurate and efficient data management.
  6. Regular Audits and Reviews: Conduct regular audits of the traceability system and records to ensure compliance and identify areas for improvement.
  7. Collaboration with Suppliers and Customers: Work closely with suppliers and customers to ensure that traceability information is accurately shared throughout the supply chain.
  8. Emergency Response Plan: Have an emergency response plan in place in case of a food safety issue. This plan should include procedures for quickly identifying and isolating affected products to minimize public health risks.

In conclusion, the FSMA Traceability Rule significantly impacts food processors, particularly under the transformation CTE. This rule mandates stringent recordkeeping, enhancing traceability and food safety. Processors must now meticulously document each transformation step, ensuring that any changes in food or packaging are accurately recorded.

This increased oversight not only supports the ability to swiftly address foodborne illnesses but also demands a higher level of operational precision and accountability from processors. The rule, thus, represents a critical shift towards greater transparency and safety in the food supply chain.

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.

Discover more about how we can assist you in adhering to the new FSMA Rule 204, which mandates additional traceability records for certain foods. Click here to learn how we can support your compliance journey.


Beyond regulatory compliance, robust traceability systems can enhance business value by improving operational efficiency, building consumer trust through transparency, and facilitating quicker responses to quality issues, leading to better market positioning and business resilience.
Regular audits, at least annually or biannually, are recommended to ensure ongoing compliance with FSMA Rule 204. These audits help identify any discrepancies in the record-keeping process and areas that need improvement to maintain the integrity of the traceability system.
Small-scale processors must also comply with FSMA Rule 204 but may face challenges due to resource constraints. They must adopt scalable traceability solutions that fit their operation size while still meeting the regulatory requirements.

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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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