Food Safety Modernization Act (FSMA) and the new Food Traceability Rule (FSMA 204)
Section 204 introduces mandatory traceability requirements, including standardized recordkeeping across the entire supply chain. It facilitates faster identification and recall of products and expands the authority of the U.S. Food and Drug Administration (FDA) to prevent foodborne illness outbreaks.
The regulation applies to all companies that manufacture, process, pack, or hold foods on the Food Traceability List (FTL).
Domestic operators
U.S. companies that handle foods on the Food Traceability List (FTL).
Foreign exporters
International operators exporting food products to the U.S. market.
Entire supply chain
From production to final distribution.
Examples of foods on the Food Traceability List (FTL)
Fresh produce
Fresh vegetables and ready-to-eat salads and leafy greens
Seafood products
Fish, crustaceans, and mollusks
Nut butters
Products derived from tree nuts and peanuts
Soft cheeses
Fresh dairy products and eggs
Recordkeeping requirements
Minimum retention period
Records must be kept for at least two years, ensuring full historical traceability.
Traceability Plan
A mandatory document that explains traceability procedures, including how information is managed and shared.
Flexible format
Records may be kept in paper or electronic format. The key requirement is that data are readily accessible and immediately available upon request.
Mandatory Traceability Plan
Critical Tracking Events (CTEs)
Critical Tracking Events are key moments in the supply chain where traceability data must be collected.
Harvesting
Initial packing
Receiving and transformation
Final shipping
Key Data Elements (KDEs)
Key Data Elements are the specific pieces of information that must be recorded for each Critical Tracking Event.
Product description
Traceability lot code
Quantity and date
Location and trading partners
Deadlines and compliance
FDA extension
An additional compliance period has been announced, giving companies time to align their systems with the requirements.
Quick response
The deadline to provide data to the FDA during food safety investigations is 24 hours.
Final deadline
July 20, 2028 is the new deadline for implementing traceability.
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