FSMA Rule 204: How Does the New Traceability Rule Affect First Land Receivers?

21CFR Part1 Subpart S details the Food and Drug Administration’s (FDA) final rule establishing additional recordkeeping requirements for entities involved in manufacturing, processing, packing, or holding foods listed on the Food Traceability List (FTL). This rule, known as the Traceability ...

FSMA 204 effect on first land receivers

21CFR Part1 Subpart S details the Food and Drug Administration’s (FDA) final rule establishing additional recordkeeping requirements for entities involved in manufacturing, processing, packing, or holding foods listed on the Food Traceability List (FTL). This rule, known as the Traceability Rule, became effective on January 20, 2023, and is part of the FDA’s implementation of the Food Safety Modernization Act (FSMA).

The Traceability Rule, also known as FSMA Rule 204, mandates the maintenance of records related to Critical Tracking Events in the supply chain of designated foods outlined in the Food Traceability List (FTL). The overall goal is the rule is to enhance the FDA’s ability to rapidly and effectively trace foods through the supply chain in case of foodborne illness outbreaks or threats to public health.

First Land Receiver is the person taking possession of a food for the first time on land directly from a fishing vessel.

This CTE must keep the following records:

Must be linked to the traceability lot for the food

  • Traceability Lot Code assigned by the First Land Receiver.
  • Species and/or acceptable market name for unpackaged food, or the product description for packaged food.
  • Quantity and unit of measure of the packed food.
  • Harvest date range and locations for the trip during which the food was caught.
  • Location description for the first land-based receiver (i.e., traceability lot code source), and (if applicable) traceability lot code source reference.
  • Date the food was landed.
  • 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 ensure compliance with FSMA Rule 204 (the Traceability Rule), First Land Receivers can implement the following best practices:

  1. Implement Robust Record-Keeping Systems: Utilize electronic record-keeping systems to manage and store information efficiently. This should include details like the traceability lot code, species/market name, quantity, harvest date range and locations, landing date, and reference documents.
  2. Accurate and Detailed Documentation: Maintain precise records of the harvested food, including species name, quantity, unit of measure, and harvest locations and dates. Ensure all documentation is clear and accurate to facilitate rapid traceability.
  3. Regular Training and Updates: Provide regular training to staff on the requirements of the Traceability Rule and any updates to the FTL or compliance procedures. This ensures that all team members are informed and competent in managing traceability requirements.
  4. Conduct Regular Audits and Reviews: Regularly audit and review traceability records and processes to ensure ongoing compliance. Identify and address any gaps or inconsistencies promptly.
  5. Collaborate with Supply Chain Partners: Work closely with other entities in the supply chain, including shippers and subsequent receivers, to ensure seamless traceability across the supply chain. Share best practices and maintain open communication channels for effective collaboration.

In conclusion, First Land Receivers play a critical role in ensuring food safety under FSMA Rule 204, the Traceability Rule. By developing a robust traceability plan, maintaining accurate and detailed records, employing efficient record-keeping systems, and engaging in regular training and audits, they can effectively meet compliance requirements.

Collaborative efforts with supply chain partners further enhance the traceability and safety of foods. Adherence to these best practices not only aligns with regulatory mandates but also significantly contributes to protecting public health by enabling rapid response to foodborne illness outbreaks.

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.


FSMA Rule 204 complements HACCP by adding specific traceability requirements. Entities should integrate these traceability protocols into their existing HACCP plans to enhance the overall effectiveness of food safety measures.
Beyond compliance, robust traceability systems can improve operational efficiencies, enhance brand trust among consumers, and potentially open new markets that require stringent traceability standards, thus giving compliant companies a competitive edge.
First Land Receivers can implement quality control measures such as regular data audits, training for data entry accuracy, and using digital tools that automatically capture and store data to minimize human error and ensure the reliability of traceability records.

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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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