Food Traceability Final Rule Overview
On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register. The Final Rule establishes additional traceability recordkeeping requirements for subject entities that manufacture, process, pack, or hold foods that are included on the Food Traceability List (FTL). FDA’s ultimate goal in these efforts is to reduce the time it takes to respond to foodborne illness outbreaks. These additional recordkeeping requirements are intended to enable FDA to quickly and efficiently track down potentially hazardous foods and ultimately reduce the number of people who are exposed and get sick.
The Final Rule identifies critical tracking events (CTEs) along the supply chain where records containing key data elements (KDEs) must be created and maintained for foods on the FTL. KDEs will vary for different CTEs but will contain information needed to effectively trace a product based on the CTE performed. CTEs include:
- Harvesting
- Cooling (before initial packing)
- Initial packing of raw agricultural commodities (other than food obtained from fishing vessel)
- First land-based receiving of food from fishing vessel
- Shipping
- Receiving
- Transforming
The Final Rule also requires subject entities to establish and maintain a traceability plan, which details how the traceability program records are maintained, how traceability lot codes are assigned, and other key information needed to understand the records.
Five Takeaways from the FDA Webinar
On Wednesday, December 7, 2022, FDA held an informational webinar on the recently released Food Traceability Final Rule issued pursuant to the FDA Food Safety Modernization Act (FSMA).
- All entities subject to the Final Rule must comply with its requirements by January 20, 2026. Because of the need for all entities to share information to achieve effective traceability, the compliance date for all entities is the same. To prepare for compliance with the Final Rule, FDA recommends that subject entities begin talking to their supply chain partners to better understand existing recordkeeping systems and efficient communication pathways.
- While the rule does not require subject entities to keep electronic records, for many companies the requirement to [describe the requirement to produce records to FDA in three days] will likely require a sophisticated and interoperable software solution to comply. The Final Rule does not prescribe software specifications or requirements for recordkeeping, and it is the responsibility of the subject entities to meet the requirements under the Final Rule with whatever technology they choose to use. FDA will not be validating or endorsing software systems.
- FDA anticipates updating the Food Traceability List (FTL) every five years. Updates to the FTL will be made through notice and comment rulemaking, and industry stakeholders will have opportunities to submit information for FDA to consider when contemplating updates. Any deletions of foods on the FTL will be effective immediately after the Final Rule updating the list is in effect, and any additions to the FTL will be effective two years after the Final Rule.
- FDA has begun the implementation planning phase for the Final Rule and is planning on incorporating stakeholder engagement throughout the process. It is actively working on ways for stakeholders to submit traceability information to it and is contemplating a database that allows subject entities to upload information. FDA intends to issue additional guidance in the future.
- In implementing and enforcing the Final Rule, FDA anticipates that education of industry stakeholders will go hand in hand with regulation. It understands that this is a new paradigm and that the industry will have questions going forward. It has stated it will continue to update the FAQs as more questions are received and emphasized that industry stakeholders may continue to submit questions to FDA’s Food and Cosmetics Information Center (FCIC) through its online inquiry page.