The U.S. Food and Drug Administration (FDA) has finalised its traceability rules under the Food Safety Modernization Act (FSMA). The ‘Final Rule on Requirements for Additional Traceability Records for Certain Foods’ regulation (hereon in referred to as the ‘final rule) aims to enhance the FDA’s ability to efficiently track and trace certain high-risk foods in the event of contamination or foodborne illness outbreaks.
Below, we break down some of the key aspects of the rule, including technology requirements, data expectations, and the key concerns stakeholders have regarding compliance.
What sort of data requirements does the final rule enforce?
The traceability rule introduces a ‘Food Traceability List’ (FTL), which includes foods deemed to require enhanced tracking due to their risk profile. Businesses handling these foods must maintain records containing specific key data elements (KDEs) and critical tracking events (CTEs), such as growing, receiving, transforming, creating, and shipping.
Key data requirements include:
- Lot codes for improved product identification
- Time-stamped records of food movement
- Shipping and receiving information to establish traceability through the supply chain
- Data standardisation to ensure compatibility across systems
Businesses will be required to retain these records and provide them to the FDA upon request within 24 hours. This requirement aims to enhance transparency and speed up response times in the event of food safety incidents.
Will businesses have to use specified technologies to meet requirements?
The final rule does not mandate the use of any specific technology. Companies can use existing traceability systems or adopt new technologies, such as blockchain, enterprise resource planning (ERP) software, or other digital tracking tools, so long as data collection and recordkeeping requirements are met. The flexibility is designed to accommodate businesses of various sizes and technological capabilities while ensuring that traceability data is accessible and actionable. A report by the Reagan-Udall Foundation for the FDA did however note that while the final rule does not require electronic recordkeeping, it is likely that companies will need to employ new technology to comply with the rule.
WHAT are the compliance challenges for stakeholders?
According to the same report, participants in industry round-tables noted several major concerns regarding the final rule including lack of awareness of the rule, mixed interpretations of its application, the onerous TLC and labelling requirements. For exporters, the final rule may pose a number of difficulties, including:
Alignment with existing international regulations: Many exporters already comply with traceability requirements under the European Union’s General Food Law or similar frameworks in other countries. However, differences in reporting formats and data expectations may require additional compliance efforts.
Technology gaps: In regions where digital traceability tools are not widely implemented, businesses may need to invest in new systems to meet U.S. requirements.
Supply chain coordination: Ensuring that all supply chain partners—such as growers, processors, and distributors—maintain the required data can be complex.
In light of these concerns, the FDA has indicated a willingness to work with stakeholders to ensure a smooth transition. Many companies are leveraging industry groups and trade associations to seek clarity on compliance strategies.
Routine inspections under the final rule will not begin until 2027, providing affected businesses additional time to develop traceability systems that meet the FDA’s requirements.
The FDA has developed a Q & A page which provides further information on the final rule’s requirements and enforcement.
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