In an effort to standardize and digitize traceability in the supply chain, the FDA recently proposed a rule. The planned food traceability rule refers to the provision of section 204 of the Food Safety Modernization Act to assign the foods requiring additional record keeping for customer safety and sets out the corresponding criteria. The rule impacts those on the Food Traceability List (FTL) that make, process, pack, or keep foods, including soft cheese, shell eggs, nut butter, and other foods deemed high-risk by the FDA.
Based on several requirements, the FDA has listed foods to be included in the FTL. These include but are not limited to the following:
- Rate of diseases and disease occurrences
- Severity of ailments
- The capacity for pathogen formation, with shelf life considered
- Rate of consumption and quantity consumed
The organizations impacted by the regulation shall collect, retain, and preserve the necessary data points specified in the proposal electronically, in paper records, or true copies for 24 months. This information must be aggregated and provided in a 24-hour turnaround should the FDA demand for information.
The rule also demands that stakeholders exchange core aspects of the data with other supply chain participants. The requirements for recordkeeping apply to the goods and whether they are used as ingredients.
Key Data Elements (KDE) tied to what the FDA has identified as Critical Tracking Events need to be managed by businesses. These events have been characterized as an activity involving the development, receipt, transition, processing, or shipment of food. They explain when businesses should be collecting data in the supply chain.
KDEs are data attributes or data related to these events for which a database is created or preserved. KDE examples may include location details, the individuals involved when the events transpired, and reference documents such as sales orders.
For any questions about FDA registration or the various rules companies must abide by, please contact us.