FDA Establishes New System of Food Tracing Requirements For Certain Foods
According to the U.S. Centers for Disease Control and Prevention (CDC), it is estimated that 48 million Americans become sick with some type of foodborne illness each year, 128,000 of these people are hospitalized, and 3,000 of them die. Because of the growing number of people affected by foodborne illnesses, public health institutions, such as the U.S. Food and Drug Administration (FDA), have been working to develop more adequate systems that prevent and detect foods contaminated with harmful pathogens.
The FDA recently published a final rule on its new Requirements for Additional Traceability Records for Certain Foods. The Food Traceability Final Rule establishes new record keeping requirements for entities that manufacture, process, pack, or hold foods which are part of the Food Traceability List (FTL). The foods included in the Food Traceability List are considered prone or high-risk for carrying foodborne pathogens, for example, soft cheeses, eggs, fresh leafy greens, certain fresh fruits and vegetables, ready-to-eat deli salads, and certain types of fish. Poultry and beef are not included in the Food Traceability List because they fall under the jurisdiction of the U.S. Department of Agriculture (USDA).
The new record keeping system will require persons who manufacture, process, pack, or hold foods that are included in the FTL, to assign and keep record of Key Data Elements (KDEs) associated with each Critical Tracking Event (CTE). The CTEs are 1) Harvesting, 2) Cooling, 3) Initial Packing, 4) First Land-Based Receiver, 5) Shipping, 6) Receiving, 7) Transformation, and 8) Traceability Plan. The KDEs for the CTE of Harvesting include information such as the location of subsequent recipient of the food, the location and of harvest, and the quantity of food harvested, for example. Those subject to compliance with the Food Traceability Final Rule are responsible for providing this information to the FDA within 24 hours or within an agreed time frame.
The FDA hopes that the new record keeping requirements will allow for more efficient identification and removal of food that has been found to potentially be contaminated with harmful pathogens from the market. The concerned entities are required to comply with the Food Traceability Final Rule by Tuesday, January 20, 2026.