Understanding the Food Safety Modernization Act (FSMA)204 and Its Impact on Emerging Market Producers

The Food and Drug Administration (FDA) is ushering in a new era of food safety with the implementation of the Food Safety Modernization Act (FSMA). One crucial component of this act is the Food Traceability Final Rule, which establishes stringent traceability recordkeeping requirements for certain foods. This rule is a significant step forward in enhancing food safety and will come into effect on Tuesday, January 20, 2026. It is vital for producers, especially those in emerging markets, to understand the implications of this rule and take proactive steps to comply with it.

The Food Traceability Final Rule

The Food Traceability Final Rule is a critical element of the FDA’s New Era of Smarter Food Safety Blueprint and is in line with Section 204(d) of the FSMA. This rule targets persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The primary objective is to expedite the identification and removal of potentially contaminated food from the market, reducing foodborne illnesses and fatalities.

Key Provisions of the Rule

Critical Tracking Events (CTEs): The rule identifies specific Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) are required. These events include harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation of food. Different KDEs will be necessary for each CTE.

Traceability Lot Code (TLC): The TLC is a unique identifier used to trace food within a firm’s records. It must be assigned to food on the FTL during initial packing, first land-based receiving from a fishing vessel, or transformation. If an exempt entity supplies FTL food, the recipient must assign a TLC if one doesn’t already exist. This code must be linked to relevant traceability lots.

Traceability Plan: Entities subject to the rule must establish and maintain a traceability plan that includes procedures for record-keeping, identification of FTL foods, assigning traceability lot codes, contact information for inquiries, and, if applicable, a farm map showing growing areas.

Additional Requirements: Records must be maintained as original paper or electronic records, ensuring legibility and prevention of deterioration or loss. These records, along with necessary information, must be available to the FDA within 24 hours upon request.

Critical Tracking Events and Key Data Elements

The Food Traceability Final Rule identifies Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) are mandatory. These KDEs vary depending on the specific CTE being performed. The CTEs covered by the final rule include:

Harvesting: This pertains to activities on farms and mixed-type facilities that involve removing raw agricultural commodities (RACs) from where they are grown or raised and preparing them for food use.

Cooling: Refers to the active temperature reduction of a RAC using various methods such as hydrocooling, icing (excluding seafood), forced air cooling, vacuum cooling, or similar processes.

Initial Packing: Involves the packing of a RAC, other than food obtained from a fishing vessel, for the first time.

First Land-Based Receiver: This applies to the first person to take possession of food directly from a fishing vessel on land.

Shipping: Occurs when food is arranged for transport from one location to another within the supply chain.

Receiving: Encompasses the event in which food is received by an entity other than a consumer after transportation from another location.

Transformation: Involves manufacturing, processing, or altering food or repacking food product that is on the Food Traceability List.

Produce on the Food Traceability List

Cashew nuts, along with various other products, are included in the Food Traceability List. This means that producers and entities involved in their production, processing, or distribution will need to adhere to the new regulations outlined in the Food Traceability Final Rule. This rule applies not only to domestic but also to foreign firms supplying food to the U.S., covering the entire farm-to-table continuum.

Preparing for Compliance

Producers in emerging markets must take steps to prepare for compliance with the Food Traceability Final Rule. This includes:

Understanding the Rule: Producers should thoroughly study the rule’s provisions and requirements, especially those related to their specific products and processes. The Food Traceability List is a good place to start to check if your produce is on the list.

Implementing Traceability Protocols: To comply with the rule, producers need effective traceability protocols in place. This involves recording KDEs at critical tracking events and maintaining traceability lot codes.

Creating a Traceability Plan

Description of Procedures: The traceability plan should include a detailed description of the procedures used to maintain the records required by the Food Traceability Final Rule. This description should cover the format and location of these records.

Identification of Foods on the FTL: The plan should outline the procedures used to identify foods on the Food Traceability List that your organization manufactures, processes, packs, or holds.

Assigning Traceability Lot Codes (TLC): If applicable, the plan should describe how your organization assigns traceability lot codes (TLC) to foods on the FTL. TLCs are essential for traceability.

Point of Contact: The traceability plan should specify a point of contact within your organization who can address any questions or concerns regarding the traceability plan and associated records.

Mapping for Growers: If you are a producer growing or raising foods on the Food Traceability List, you must include a farm map. This map should show the location and name of each field or growing area (or containers for aquaculture farms) and include geographic coordinates and any other necessary information to identify these locations.

Additionally, AGinimble, a procurement platform for agricultural commodities, is actively developing a digital solution to assist emerging market producers in achieving compliance with the Food Traceability Final Rule. We understand the importance of traceability in ensuring food safety and are committed to collaborating with producers to enhance their traceability processes.

As we work on this traceability tool, we invite producers to engage with us to share their current traceability protocols and challenges. Your valuable insights will help us tailor our solution to meet your specific needs and ensure seamless compliance with the new FDA requirements.

In conclusion, the Food Traceability Final Rule under FSMA is a significant step towards improving food safety in the United States. Producers of foods on the FTL, including cashew nuts and other commodities, must prepare to meet the new regulations by January 20, 2026. AGinimble is dedicated to assisting producers in emerging markets on this journey to enhance their traceability practices and ensure the safety of their products in the marketplace. Together, we can embrace this new era of smarter food safety.

Contact us today to learn more about the new FSMA Final Rule and how you can prepare for compliance.