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

The FSMA Rule 204, part of the Food Safety Modernization Act, requires additional recordkeeping for specific foods to enhance traceability. This rule, effective from January 2023, mainly targets foods on the Food Traceability List (FTL). It expects activities identified as ...

Traceability rule impact on food distributors

The FSMA Rule 204, part of the Food Safety Modernization Act, requires additional recordkeeping for specific foods to enhance traceability. This rule, effective from January 2023, mainly targets foods on the Food Traceability List (FTL). It expects activities identified as Critical Tracking Events (CTEs) to maintain detailed records that track the movement of foods through the supply chain.

Distributors conduct the receiving and shipping of foods. Receiving and Shipping are considered CTEs.

“Receiving” in a food supply chain refers to the act of acquiring a food product at one location by a party other than the final consumer, following its transportation (such as via truck or ship) from a different place. This definition encompasses the internal transfer of food between different street addresses of the same company.

“Shipping” in the context of a food supply chain is defined as the process where food is prepared for transportation from one location to another, such as by truck or ship. This term does not encompass direct sales or shipments to consumers, nor does it include food donations. Shipping does, however, cover internal transfers of food items between different street addresses of the same company.

Distributors must keep the following records to comply with the Traceability Rule requirements”

Receiving

When receiving food from the Traceability List (FTL) Information must be linked to the traceability lot for the food.

  • Traceability Lot Code for the food
  • Quantity and unit of measure of the food
  • Product description for the food
  • Location description for the immediate subsequent recipient (other than a transporter) of the food
  • Location description for the location from where the food was received
  • Date you received the food
  • Location description for the traceability lot code source or the traceability lot code source reference
  • Reference document type and reference document number

This section does not apply to receipt of a food that occurs before the food is initially packed (if the food is a raw agricultural commodity not obtained from a fishing vessel) or to the receipt of a food by the first land-based receiver (if the food is obtained from a fishing vessel)

When receiving food exempt from the Traceability Rule

Information must be linked to the traceability lot for the food.

  • Traceability lot code for the food, which you must assign if one has not already been assigned (does not apply to RFEs or restaurants)
  • Quantity and unit of measure of the food
  • Product description for the food
  • Location description for the immediate previous source (other than a transporter) for the food
  • Location description for where the food was received (i.e., traceability lot code source) and (if applicable) traceability lot code source reference
  • Date you received the food
  • Reference document type and reference document number

Shipping

Information must be linked to the traceability lot for the food.

  • Traceability Lot Code for the food
  • Quantity and unit of measure of food
  • Product description for the food
  • Location description for the immediate subsequent recipient (other than a transporter) of the food
  • Location description for the location from which you shipped the food
  • Date you shipped the food
  • Location description for the traceability lot code source or the traceability lot code source reference
  • Reference document type and reference document number

This section does not apply to the shipment of a food that occurs before the food is initially packed (if the food is a raw agricultural commodity not obtained from a fishing vessel)

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.

Best practices that distributors can establish to comply with the FSMA 204 Rule

  1. Accurate Record-Keeping for Receiving and Shipping: Beyond just tracking, records should be easily retrievable and auditable. They should capture the entire journey of the food, from origin to final destination, and should be regularly reviewed for accuracy and completeness.
  2. Records: KDEs must be consistently updated and verified for accuracy. They should be integrated into the company’s data system for easy correlation with other tracking data, and regularly audited for consistency and compliance.
  3. Document Management: Efficient document management includes digitizing records where possible, implementing a systematic filing system, and ensuring easy access for authorized personnel. Regular backups of these documents should be maintained to prevent data loss.
  4. Train Staff: Training should be ongoing, adapting to changes in regulations and technology. Staff should be empowered to identify and report discrepancies in record-keeping, and encouraged to contribute to process improvements.
  5. Technological Integration: Embrace advanced tracking systems like RFID and blockchain for real-time tracking. This technology can greatly enhance the accuracy of data collected and streamline the process of data entry and retrieval.
  6. Regular Audits and Updates: Audits should be comprehensive, covering not just the records but also the processes and technology used. Feedback from these audits should be used to continuously improve the traceability system. Regular updates to the system should be made in response to technological advancements or regulatory changes.

In conclusion, FSMA Rule 204 significantly enhances food safety by implementing stringent traceability requirements for distributors. This rule mandates meticulous record-keeping and tracking of foods on the Food Traceability List and/or exempt from the rule, ensuring rapid response to food safety incidents.

Distributors must adapt to these new regulations through improved data management and staff training. This proactive approach towards food safety not only protects public health but also reinforces the integrity of the food supply chain, ultimately benefiting both the industry and consumers.

At FoodReady, our commitment goes beyond just updating our customers about new regulations. With the help of our FSMA 204 experts, we are dedicated to providing effective solutions that help ensure full compliance with the latest requirements. Reach out to our team and discover more about how we can assist you in adhering to the new FSMA Rule 204, which mandates additional traceability records for certain foods.

FAQs

Under FSMA Rule 204, small-scale distributors must comply with the same traceability requirements as larger entities. This includes maintaining detailed records for foods on the Food Traceability List, which could require adjustments in their current tracking systems.
Regular audits are recommended to ensure compliance with FSMA Rule 204. These audits should assess both the records’ accuracy and the recording processes’ efficacy. The frequency of audits can vary, but annual or bi-annual reviews are typically advisable.
Distributors must identify which items are exempt from the traceability requirements and ensure that exemption criteria are documented and justified according to FSMA Rule 204 guidelines. This includes understanding specific exemptions like those for certain types of raw agricultural commodities.

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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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