U.S. Provides Updates and FAQs Supporting Compliance with Food Traceability Rule

U.S. FDA further perfects its rules on additional traceability records for certain foods, applicable to both U.S. domestic and foreign companies. These improvements involve various aspects such as batch codes, exemption information, etc.

On November 30, 2023, the U.S. Food and Drug Administration (FDA) introduced new tools and FAQs regarding the final rule on requirements for Additional Traceability Records for Certain Foods (shortly the “Food Traceability Final Rule”), helping stakeholders come into compliance.

Based on the Food Traceability Final Rule, stakeholders engaged in the manufacturing, processing, packaging, or storage of certain food are required to maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs). Furthermore, relevant information shall be provided to the FDA within 24 hours or within a reasonable time agreed upon by the FDA.

Key updates:

1. New webpage about traceability lot codes, showcasing invoice and bill of lading examples with KDEs;

2. Video highlighting some technological components of product tracing systems;

3. Traceability plan examples;

While there is no specific format mandated, the plans must be compliant to the rule's requirements and reflect the current practices procedure.

4. New supply chain examples for deli salads;

5. Information on the waiver or exemption application process for eligible cases;

The FDA provides additional clarification on exemption requirements, which includes the eligibility criteria for exemption applications, the email address for submitting applications, and the subsequent feedback process.

6. Newly added Frequently Asked Questions (FAQs);

The FDA updates four questions about dairy, seafood and fruit products.

Implementation rules:

The scope of “Certain Foods” subject to additional traceability records are identified in the Food Traceability List. Up to now, the list recorded 18 types of food including cheeses, shell eggs, nut butters, cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fruits, vegetables other than leafy greens, finfish, smoked finfish, crustaceans, molluscan shellfish, and ready-to-eat deli salads.

Additionally, the final rule is in accordance with the best practices currently followed by the industry. It applies to both U.S. domestic and foreign food companies involved in the production of food for consumption in the United States, encompassing the entire food supply chain from farm to table.

As requested, the compliance date for the required recordkeeping requirements is January 20, 2026. However, the FDA announced in September of 2023 that routine inspections for this rule will not begin until 2027, providing enterprises with a transition period of approximately one year to enhance their product information.