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

The Traceability Rule, as detailed in the FDA’s final rule document, establishes additional recordkeeping requirements for certain foods designated on the Food Traceability List (FTL). This rule, effective from January 20, 2023, is part of the FDA’s implementation of the ...

Traceability rule 204 impact on farms

The Traceability Rule, as detailed in the FDA’s final rule document, establishes additional recordkeeping requirements for certain foods designated on the Food Traceability List (FTL). This rule, effective from January 20, 2023, is part of the FDA’s implementation of the Food Safety Modernization Act (FSMA).

It mandates entities that manufacture, process, pack, or hold FTL foods to maintain detailed records, referred as Key Data Elements (KDEs), for critical tracking events (CTEs) in the supply chain. These CTEs include activities like harvesting, shipping, receiving, and transforming these foods.

The rule aims to enhance the FDA’s ability to rapidly identify and respond to foodborne illness outbreaks by improving traceability of foods in the supply chain, especially those associated with higher risks of causing illness.

It also includes provisions for exemptions and modified requirements based on specific criteria. Compliance with this rule is expected to improve public health outcomes by facilitating more effective tracking and management of foodborne illness risks, but it also imposes new recordkeeping burdens on farms and other entities in the food supply chain.

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A Farm is a place where crops are grown, animals (including seafood) are raised, or both, all under one management. It doesn’t have to be in one connected area. For those who produce shell eggs, a farm includes all the poultry houses and the area around them that are part of the same biosecurity program.

For farm operations, this rule implies significant changes.

Farms growing or raising FTL foods must maintain a traceability plan and records including farm maps with geographic coordinates of the growing areas.

The Traceability Rule identifies Harvesting as a Critical Tracking Event (CTE). This applies to both pure farms and mixed-type facilities that operate as farms. Harvesting encompasses the range of activities traditionally conducted on farms for crops or animals, aimed at removing Raw Agricultural Commodities (RACs) from their growing or raising locations and preparing them for consumption.

Under the Traceability Rule, harvesting operations that handle foods on the Food Traceability List (FTL) must comply with specific recordkeeping requirements. The KDEs include:

  1. Farms: Name of the field or animal raising area from which the food was harvested (must correspond to the name used by the grower) OR other information identifying the harvest location at least as precisely as field or growing area name.
  2. Aquaculture: Name of the container (e., pond, pool, tank, cage) from which the food was harvested (must correspond to the container name used by the aquaculture farmer), OR other information identifying the harvest location at least as precisely as the container name.
  3. For both, farms and aquaculture:
    • Location and description of the immediate subsequent recipient (other than a transporter) of the food.
    • Commodity and, if applicable, variety of the food.
    • Quantity and unit of measure of the food.
    • Location of the food where the food was harvested from.
    • Date of harvesting
    • Reference document type and reference document number.
  4. Traceability Lot Codes: Farms involved in harvesting must also work with initial packers of Raw Agricultural Commodities (RACs), who must assign a traceability lot code to the food. This ensures accurate identification of the food as it moves through the supply chain.

Confidentiality Measures: To protect confidential information about suppliers, shippers can provide a traceability lot code source “reference” instead of directly identifying the source. This could be an FDA Food Facility Registration number or a web address that allows FDA to identify and contact the traceability lot code source for the food.
Finally, 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 effectively implement the FDA’s Traceability Rule and manage Critical Tracking Events (CTEs) within the food supply chain, several best practices can be adopted by entities handling foods on the Food Traceability List (FTL). These practices not only ensure compliance with the rule but also enhance overall food safety and traceability:

  1. Establish Comprehensive Recordkeeping Systems: Develop and maintain a robust recordkeeping system that can accurately capture and store Key Data Elements (KDEs) for each CTE. This system should be easily accessible, secure, and capable of handling large volumes of data over time.
  2. Implement Digital Tracking Technologies: Utilize advanced technologies like barcode scanning, RFID tags, or blockchain for real-time tracking of food products. These technologies can significantly improve the accuracy and efficiency of tracking food items through various stages of the supply chain.
  3. Standardize Data Collection and Reporting: Adopt standardized formats and protocols for collecting and reporting data. This ensures consistency in the information captured across different stages and entities within the supply chain.
  4. Train Staff and Stakeholders: Provide comprehensive training to employees and stakeholders on the importance of traceability, the details of the Traceability Rule, and the procedures for recording and managing KDEs. Regular training updates should also be conducted to keep everyone informed of any changes in regulations or practices.
  5. Ensure Accurate Harvest and Processing Documentation: For farms and aquaculture operations, maintain precise records of harvest locations, including geographical coordinates, and ensure accurate documentation of processing activities.
  6. Collaborate with Supply Chain Partners: Work closely with suppliers, distributors, and other partners in the supply chain to ensure they are also compliant with the Traceability Rule and can provide necessary KDEs.
  7. Regular Audits and Compliance Checks: Conduct regular internal audits to ensure compliance with the Traceability Rule. These audits can help identify any gaps in the recordkeeping process and areas for improvement.
  8. Implement Confidentiality Measures: Adopt measures to protect confidential information while still complying with traceability requirements, such as using traceability lot code sources or FDA Food Facility Registration numbers.
  9. Develop a Rapid Response Plan: Have a plan in place for rapid response in case of a food safety incident. This plan should include procedures for identifying the source of the problem, recalling affected products, and communicating with regulatory authorities and the public.

In conclusion, the FDA’s Traceability Rule represents a significant step forward in ensuring the safety and traceability of foods in the supply chain, particularly those on the Food Traceability List (FTL). By mandating detailed recordkeeping for Critical Tracking Events (CTEs) and the maintenance of Key Data Elements (KDEs), the rule enhances the FDA’s ability to swiftly respond to and manage foodborne illness outbreaks.

Farms and aquaculture operations are now required to implement comprehensive traceability plans, including precise recordkeeping of harvest locations, subsequent recipients, and other critical information. While this introduces new challenges and responsibilities for these entities, it ultimately serves a crucial role in protecting public health.

The Traceability Rule aligns with the broader goals of the Food Safety Modernization Act (FSMA) by prioritizing the traceability and safety of food products from farm to table, thereby aiming to reduce the incidence and impact of foodborne illnesses across the United States.

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 how our FSMA 204 experts can assist you in adhering to the new FSMA Rule 204, which mandates additional traceability records for certain foods.


Foods included in the FTL are those identified by the FDA as having a higher risk of causing foodborne illness. The selection criteria focus on historical outbreak data, the potential for contamination, and the food’s perishability.
Implementing digital tracking technologies like RFID, barcode scanning, or blockchain can significantly boost the accuracy and efficiency of traceability systems, ensuring real-time updates and secure data management across the supply chain.
Regular, comprehensive training sessions should be conducted to educate staff on the importance of compliance, the specific requirements of FSMA 204, and the operational impact. Updates should be provided whenever there are regulatory changes or improvements in technology.
Entities must balance transparency in traceability with the protection of confidential business information. Techniques like using coded traceability lot numbers, which can reference more detailed data accessible only to authorized users, help achieve this.
A rapid response plan should outline clear steps for identifying and isolating affected food items, recalling products if necessary, and notifying regulatory bodies and the public. It should also detail the roles and responsibilities of all stakeholders involved in the response process.

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Picture of Radojka Barycki

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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