How FDA’s New Food Traceability Rule Will Work

In November 2022, FDA published the long-anticipated final rule addressing food traceability. The rule, titled “Requirements for Additional Traceability Records for Certain Foods,” establishes certain traceability recordkeeping requirements for a variety of foods. This rule continues FDA’s work to implement the Food Safety Modernization Act (FSMA), and the additional traceability requirements imposed are due to the requirements of FSMA. These additional requirements go beyond the standard “one up, one down” tracking that currently occurs to better allow FDA to respond to and investigate foodborne illnesses.

The requirements of the rule apply only to the foods identified by FDA as high risk and listed by FDA on the Food Traceability List (FTL). FDA evaluated a comprehensive list of foods based on historical illnesses associated with the food, the potential for contamination and pathogen growth within the food, and consumption rates of the food, among other factors. From that evaluation, FDA identified certain types of food that presented a higher risk of foodborne illness. The FTL generally includes products such as soft and semi-soft cheese, shell eggs, nut butters, fresh produce items, deli salads, and fish and shellfish. Unless an exception exists, foods that contain even a single item on the FTL are also subject to the requirements of the traceability rule.

What’s Required in the Food Traceability Rule

Companies subject to the additional requirements must develop a traceability plan that applies to each food on the FTL that is manufactured, processed, packed, or held by the company. The traceability plan must include procedures for maintaining the required records, procedures used to identify which foods are subject to the requirements, procedures to assign traceability lot codes (when applicable), and a statement identifying a point of contact for questions about the traceability plan. In addition, for farms or aquaculture operations, a farm map must be included showing the location and name of each separate growing area or container, including geographic coordinates and other information necessary to identify the specific growing location.

Traceability lot codes are assigned only at three points of operations: the initial packing of a raw agricultural commodity (other than food obtained from a fishing vessel), the first land-based receiving of a food obtained from a fishing vessel, and every time the food is transformed. Transformation is any point in a food’s supply chain that involves changing a food through manufacturing, processing, packing, or labeling, for example, where the output food is also on the FTL. When the processing of a food listed on the FTL results in an output food that is not on the FTL, records are required under the rule for receipt of the food, but generally speaking, the food is no longer subject to the requirements of the rule after such processing.

Records required under the rule depend on the stage of the supply chain. Generally, however, records must include the location information for the immediate subsequent recipient, for the immediate previous recipient, and for any processing that occurred. In addition, quantity and product descriptors are required. Finally, for each transfer throughout the supply chain, a specific reference document must be associated with the transfer. Reference documents are business transaction documents that reflect the transaction or process, and may include purchase orders, invoices, batch logs, or production logs.

After a request by FDA, companies subject to the requirements of the Rule must provide an electronic sortable spreadsheet with the required data. Certain companies with annual values of sales below designated levels do not need to provide the electronic spreadsheet (and can instead provide the information in any format). After a request by FDA, the spreadsheet (or alternative data formats) must be provided within 24 hours unless FDA has agreed to a longer timeframe.