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 Rule 204 Traceability 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 FMS 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.

Learn how our experts can help you become FSMA 204 compliant, and gain a competitive edge in the market by meeting and exceeding industry standards for food traceability and safety.

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