FDA’s Proposed Food Traceability Rule: Everything Food Processors Should Know

The FDA has been modernizing food safety processes and procedures since 2002. This effort started with the Bioterrorism Act of 2002 and was expanded with the Food Safety Modernization Act of 2011 (FSMA). The FDA observed areas where FSMA could be augmented to require more adequate food traceability measures. Although the proposed food traceability rule is only in its first iteration, American food and meat processors can get a head start by educating themselves, and their staff, about the changes to ensure compliance with FDA standards. The new regulations only apply to certain foods; however, they were developed by the FDA to fit all FDA-regulated food products.

What is the objective of the new proposed rule?

Anytime a new rule or regulation is being proposed, it is important to look at the objective behind the new rule. So, why is the FDA proposing a new set of regulations?

Since the passage of the 2011 Food Safety Modernization Act, the FDA has shifted its food safety and food traceability approach. Instead of simply being reactive to food-borne illness events, they decided to implement a more proactive approach that focuses on preventing food-borne illness altogether. The new regulations that have been proposed are part of a larger proactive effort that the FDA is undertaking. This new effort is called, The New Era of Smarter Food Safety. The New Era of Smarter Food Safety includes a New Era Blueprint. The blueprint provides a framework for how the FDA plans to implement its New Era of Smarter Food Safety over the next decade.

The new proposed set of regulations is part of the FDA’s New Era Blueprint. This blueprint emphasizes the importance of food traceability, and a processor’s responsibility to collect and pass along relevant information that can be used in the event of a food recall. Here is how the FDA’s Deputy Commissioner for Food Policy and Response, Frank Yiannas has described the importance of these new regulations.

“When there’s an outbreak of foodborne illness, it’s critical to rapidly identify where the contamination occurred. Having this information allows us to alert the public and the food industry about which food to avoid, remove the contaminated food from the market, and evaluate what may have caused the contamination so that actions can be taken to prevent this from happening again.” – Requirements for Additional Traceability FSMA Section 204 – YouTube

What is the FDA’s new proposed food traceability rule? 

The new rule is called “Requirements for Additional Traceability Records for Certain Foods,” but it is more commonly being called “The Food Traceability Proposed Rule.” The original name best describes what the new rule encompasses. This isn’t a new rule for all foods that are currently regulated by the FDA. Instead, the FDA has found that some of the processes they introduced with FSMA did not sufficiently cover all of the areas of risk for food-borne illnesses. Therefore, the new rule was created to address those concerns. The proposed rule only focuses on a select group of food products. These food products can be found in the Food Traceability List figure below.

Due to the high-risk nature of some foods, the FDA is recommending that FSMA is extended to include regulations on other foods that weren’t included in the original FSMA act. The FDA has put together a Food Traceability List (FLT) of foods that are impacted by this proposed rule change. Farmers, processors, and distributors that deal with foods from the FLT will be required to capture Key Data Elements (KDE’s) at key points throughout the food supply chain. These key points are called Critical Tracking Events (CTE). The Critical Tracking Events include: growing, receiving, creating, transforming, and shipping events. Multiple KDE’s need to be recorded at each of those stages. For more information on KDE’s requirements, find out more here. The types of Key Data Elements that are required are very similar to what is already expected for the meat industry. These include things like lot numbers, weights, and reference numbers like purchase order numbers and invoice numbers. For a comprehensive look at the new proposed rules, check out the FDA’s website FSMA Proposed Rule for Food Traceability | FDA .