FSMA Rule 204: How Does the New Traceability Rule Affect Raw Agricultural Commodity?

The FDA’s Traceability Rule, part of the Food Safety Modernization Act (FSMA), represents a significant shift in the traceability of foods listed on the Food Traceability List (FTL). This article examines its implications for First Packers of Raw Agricultural Commodities ...

FSMA Rule 204 Traceability Effect On Raw Agricultural Commodity

The FDA’s Traceability Rule, part of the Food Safety Modernization Act (FSMA), represents a significant shift in the traceability of foods listed on the Food Traceability List (FTL). This article examines its implications for First Packers of Raw Agricultural Commodities (RACs).

Frist Packers of Raw Agricultural Commodities (RACs) has been identified by the FDA as one of the Critical Tracking Events (CTEs) of the food supply chain.

The first Packer of RACs is the step in the supply chain where RACs , other than a food obtained from a fishing vessel, are packed for the first time.

The rule mandates detailed recordkeeping for Critical Tracking Events (CTEs) in the supply chain, and the goal is to enhance the FDA’s ability to trace food movement, mitigate foodborne illness outbreaks, and address health threats from adulterated or misbranded foods.

Under the FDA’s Traceability Rule, First Packers of RACs are given new responsibilities, particularly in the context of record-keeping. These responsibilities are critical for effective traceability, especially in outbreak investigations. 

These responsibilities include:

1. Assignment of Traceability Lot Codes: First Packers of RACs are deemed more suitable for assigning traceability lot codes to RACs than growers. This is because the packed product is often the first form of the food that has a production code assigned to it, making it critical for traceability​​.

2. Record-Keeping Requirements: First packers must maintain detailed records when they receive a RAC, other than food obtained from a fishing vessel, especially from entities exempt from subpart S requirements of the rule. The information that must be included in these records should include:

  • The commodity and variety of the food received.
  • The date the initial packer received the food.
  • The quantity and unit of measure of the received food.
  • The location description for the person from whom the food was received.
  • The Traceability Lot Code assigned by the initial packer.
  • The product description of the packed food.
  • The quantity and unit of measure of the packed food.
  • The location description for where the food was initially packed​​.


Must have all information from RAC and

  • Location description for the grower of seeds for sprouting and date of seed harvesting, if either is available.
  • Location description for the seed conditioner or processor, associated seed lot code, and date of conditioning or processing.
  • Location description for the seed packinghouse (including any repackers), date of packing (and repacking, if applicable), and any associated seed lot code assigned by the seed packinghouse
  • Location description for the seed supplier, any seed lot code assigned by the seed supplier (including master lot and sub-lot codes), and any new seed lot code assigned by the sprouter.
  • Description of the seeds, including seed type or taxonomic name, growing specifications, type of packaging, and (if applicable) antimicrobial treatment.
  • Date of receipt of the seeds by the sprouter.
  • Reference document type and reference document number.

3. Information from Harvesters and Coolers: Harvesters and coolers are required to provide initial packers with information about their activities. This includes details about the farm where the RAC came from, who harvested it, when it was harvested, and details about cooling (if applicable). This information is essential to shorten the time needed for tracebacks and support the public health benefits anticipated by the rule​​.

First Packers of RACs must adapt their systems to comply with these requirements. This might include upgrading technology for recordkeeping and training staff to ensure compliance. These businesses need to coordinate with other supply chain participants, like growers and shippers, to ensure seamless traceability throughout the food’s journey.

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 204 Rule, specifically for First Packers of Raw Agricultural Commodities (RACs), several best practices can be implemented:

  1. Implement Advanced Record-Keeping Systems: Adopt digital record-keeping solutions that can accurately and efficiently capture all required data points, including traceability lot codes, commodity types, quantities, and packing locations. These systems should allow for easy retrieval and sharing of information in case of a food safety investigation.
  2. Regular Training and Education: Conduct regular training sessions for staff to ensure they are aware of the new record-keeping requirements and understand the importance of accurate data entry. This includes training on how to assign traceability lot codes and maintain detailed records of all received RACs.
  3. Develop Strong Relationships with Supply Chain Partners: Establish clear communication channels with harvesters, coolers, and other supply chain entities. This is crucial to ensure that the necessary information, such as details about the farm of origin, harvest dates, and cooling processes, is accurately and promptly shared with the first packers.
  4. Use Technology for Enhanced Traceability: Leverage technology such as barcoding, RFID tags, or blockchain to streamline the traceability process. These technologies can offer more efficient ways to track and manage data associated with each traceability lot, reducing the risk of errors and improving the overall traceability of products.
  5. Regular Audits and Reviews: Periodically audit your record-keeping processes to ensure compliance with the Traceability Rule. Regular reviews can help identify any gaps or inefficiencies in the system, allowing for timely corrections and improvements.
  6. Collaboration on Best Practices: Collaborate with industry associations and other stakeholders to stay informed about best practices and emerging technologies in food traceability. This can provide insights into more efficient and effective ways to meet compliance requirements.
  7. Prepare for Traceback and Recall Procedures: Have a clear plan in place for traceback and recall procedures in the event of a foodborne illness outbreak. This includes having a system for quickly accessing and analyzing traceability data to identify and isolate affected products.
  8. Document Management and Retention: Ensure proper management and retention of records as required by the Traceability Rule. This includes keeping records organized and readily accessible for the stipulated period.
  9. Compliance Monitoring and Updates: Stay informed about any updates or changes to the Traceability Rule and FSMA regulations. Regular monitoring of regulatory changes can help in adapting practices to remain compliant.

In conclusion, the FDA’s Traceability Rule leads in a new era of responsibility and accountability for First Packers of Raw agricultural commodities (RACs). By mandating comprehensive record-keeping for the harvesting, cooling, and initial packing phases, the rule significantly enhances the traceability of food products in the supply chain.

This shift not only aims to safeguard public health by enabling quicker and more efficient tracebacks in the event of foodborne illness outbreaks but also aligns with broader efforts to modernize food safety systems. While these new requirements pose challenges in terms of implementation and adaptation, they offer substantial long-term benefits, including improved food safety, enhanced consumer trust, and a stronger, more resilient food supply chain.

Ultimately, the Traceability Rule reflects a proactive and collaborative approach to food safety, where each stakeholder, especially first packers, plays a crucial role in protecting public health.

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. 

With the support of our FSMA 204 consultants, discover more about how we can assist you in adhering to the new FSMA Rule 204, which mandates additional traceability records for certain foods. Our experts are here to guide you through the complexities of these regulations, ensuring that your business not only meets but exceeds the required standards.

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