FDA Traceability Records Rule: New Documentation Requirements Ahead
The FDA is tightening its grip on food supply chain documentation. New traceability recordkeeping requirements are coming—and food importers need to act now. If your supply chain records are incomplete, you could face serious compliance failures during FDA inspections.
What Is the FDA Traceability Rule?
The FDA's Food Traceability Rule is part of the Food Safety Modernization Act (FSMA). It establishes stricter recordkeeping requirements for foods on the Food Traceability List (FTL). This list includes high-risk foods like leafy greens, fresh tomatoes, shell eggs, nut butters, and certain fresh herbs.
The rule is codified under 21 CFR Part 1, Subpart S. It requires businesses handling FTL foods to capture and maintain specific traceability lot codes, key data elements (KDEs), and critical tracking events (CTEs) throughout the supply chain.
For importers, this means documenting each step—from the point of origin to the moment goods enter U.S. commerce.
What Records Must Importers Keep?
Under the new requirements, importers handling FTL foods must track and record:
Traceability lot codes assigned to each shipment
Key data elements at critical tracking events, including harvesting, cooling, packing, and shipping
Supply chain contact information for each trading partner
Quantity and unit of measure for each lot
Location descriptions for the originating farm or facility
Records must be available to the FDA within 24 hours of a request. Delays or gaps in documentation can trigger enforcement action.
Why Importers Face Unique Challenges
Domestic producers control their own facilities. Importers do not. Your foreign suppliers may use different lot-coding systems, different languages, or different recordkeeping formats. Bridging that gap is your responsibility—not theirs.
The FDA will hold the U.S. importer accountable. If your foreign supplier fails to provide required data, the liability falls on you.
This creates a critical need for structured communication with overseas partners before shipments arrive at the U.S. border.
How This Connects to FSVP
The FDA's Foreign Supplier Verification Program (FSVP) already requires importers to verify that foreign suppliers produce food in a manner that meets U.S. safety standards. The traceability rule adds another layer.
Your FSVP plan must now align with traceability recordkeeping obligations. If your plan was written before these requirements took shape, it likely needs an update. An outdated FSVP plan is a liability.
The FDA can inspect your FSVP records at any time. Inspectors look for completeness, accuracy, and current compliance with applicable regulations.
Steps to Prepare Right Now
Do not wait for the compliance deadline to arrive. Start with these actions:
Audit your product list. Determine which of your imported foods appear on the FDA's Food Traceability List.
Contact your foreign suppliers. Confirm they can provide traceability lot codes and required KDEs.
Update your FSVP documentation. Ensure your plan reflects current FDA requirements.
Establish a record retrieval system. You must produce records within 24 hours on FDA request.
Train your team. Everyone handling import documentation must understand these requirements.
Get Your FSVP Plan in Order
Compliance with the FDA Traceability Records Rule starts with a solid FSVP plan. US Imports helps food importers build, review, and update FSVP documentation that meets current FDA standards. Do not let outdated paperwork put your import operation at risk.
Start with a professionally prepared FSVP plan today: https://www.usimports.us/store/p/fsvp-plan
