The FDA Food Safety Modernization Act (FSMA) enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. [1] Under this act the FDA just announced a new rule that will have the compliance date of January 20th, 2026. [2] This rule is on requirements for additional traceability records for certain foods and it is called Food Traceability Final Rule. What is this new rule, and who does this rule apply to?
The FDA released the Food Traceability List which breaks down all the foods that the Food Traceability Final Rule applies to, and it also has a description of each of these foods. [3] Examples of these foods include soft cheese, many different fresh vegetables, many different fresh fruits, and many kinds of seafood. [3] This list was developed by using the risk-ranking model for food tracing. [3] There are several different factors that contribute to this risk-ranking model, for example Frequency of outbreaks and occurrences of illness, severity of illness, and likelihood of contamination.
Now that we know who this rule applies to, we can break down what this rule is. The Food Traceability Final Rule is broken into four key features. [2] The four key features are “Critical Tracking Events”, “Traceability Lot Code”, “Traceability Plan”, and “Additional Requirements.”
The final rule identifies Critical Tracking Events for which records containing Key Data Elements will be required. [2] These major events are Harvesting, Cooling, Initial Packing, First Land-Based Receiver, Shipping, Receiving, and Transformation.
Traceability lot code means a descriptor used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code. All food that is listed in the Food Traceability List must have a Traceability Lot Code; this Code is required in each of the Critical Tracking Events. [2]
If your organization falls within the final rule, your organization must establish and maintain a traceability plan. This plan needs to contain several different things, for example a description of the procedures the organization uses to maintain the records that are required to be kept under the new rule, and a description of how you assign traceability lot codes to foods on the Food Traceability List. [2]
The last key feature of this new rule is the additional requirements that are created. All records must be maintained as original paper or electronic records, they must be stored in a safe location to prevent deterioration or loss. All of there records must be made available to the FDA within 24 hours after a request is made.
Here at EMMA International, we understand that new standards can be stressful and hard to implement. That’s why our team of experts is here to help! Give us a call at 248-987-4497 or email info@emmainternational.com for more information.
[1] Background on the FDA Food Safety Modernization Act (FSMA). (2018, January 30). Background on the FDA Food Safety Modernization Act (FSMA). https://www.fda.gov/food/food-safety-modernization-act-fsma/background-fda-food-safety-modernization-act-fsma
[2] FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. (2024, October 28). FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
[3] Food Traceability List. (2024, September 5). Food Traceability List. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list
