FDA Releases the Food Traceability Final Rule
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Collapse ▲The Food & Drug Administration released the Food Traceability Final Rule on November 17, 2022. The Rule requires covered companies to maintain records for foods on the Food Traceability List (FTL) in order to support more efficient and accurate traceability of potentially contaminated food. Benefits of this new Rule will include: averted foodborne illnesses, reduced food waste, avoiding costs of overly-broad recalls, and improved supply chain management and inventory control.
The FDA hosted a recorded webinar where traceability experts, regulatory officials and subject matter experts convened to cover the following topics:
- Overview of the Final Traceability Rule
- Exemptions to the Rule
- Food Traceability List
- Clarification Question Sessions
- Rule Requirements, including:
- Traceability Plans
- Assigning Traceability Lot Codes
- Critical Tracking Events and Key Data Elements
- Electronic Sortable Spreadsheet
- Records Maintenance and Availability
- Compliance Dates
Food Traceability List
Foods subject to the final rule requirements appear on the Food Traceability List and also include foods that contain listed foods as ingredients (provided the listed food remains in the same form in which it appears in the FTL, for example: fresh).
The Food Traceability List is anticipated to be updated approximately every 5 years.
| Cheese (made from pasteurized milk), fresh soft, soft unripened, soft ripened or semi-soft | Cheese (made from unpasteurized milk), other than hard cheese | Crustaceans (fresh and frozen) | Cucumbers (fresh) |
| Finfish (fresh and frozen) histamine-producing species | Finfish (fresh and frozen) species potentially contaminated with ciguatoxin | Finfish (fresh and frozen) species not associated with histamine or ciguatoxin | Fruits (fresh-cut) |
| Herbs (fresh) | Leafy greens (fresh) | Leafy greens (fresh-cut) | Melons (fresh) |
| Molluscan shellfish, bivalves (fresh and frozen) | Nut butters | Peppers (fresh) | Shell eggs |
| Smoked finfish (refrigerated and frozen) | Sprouts (fresh) | Tomatoes (fresh) | Tropical tree fruits (fresh) |
| Ready-to-eat deli salads (fresh and frozen) | Vegetables (fresh-cut) |
Critical Tracking Events and Key Data Elements
The Rule requires companies who manufacture, process, pack, or hold foods on the FTL to maintain and provide their supply-chain partners with information, or key data elements (KDEs), for certain critical tracking events (CTEs). The type of information that must be kept and forwarded will vary depending on the type of activities the company performs.
The FDA has created a document to help companies understand what KDEs are required for each CTE performed.
Exemptions to the Food Traceability Rule
Exemptions from the Food Traceability Rule are allowed for some companies due to their size, operations, type of processing and other food safety considerations.
The FDA has created an Exemption Tool that can help companies step-by-step through the exemption process.
Food Traceability Compliance Date:
Compliance date applies to all firms that manufacture, process, pack or hold foods on the Food Traceability List. The FDA plans on an “educate before and while we regulate” policy as firms move towards total implementation of the Traceability Rule.