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Molluscan Shellfish (Bivalves)

Bivalve mollusks including oysters, clams, and mussels. Subject to additional shellfish sanitation requirements.

Last verified: February 2026 against 21 CFR Part 1 Subpart S

Foods on the FTL (3)

Oysters
eastern oysterpacific oysterkumamoto oysterolympia oystershucked oysters
Clams
littleneck clamscherrystone clamsquahogmanila clamsrazor clamsgeoducksurf clamsocean quahog
Mussels
blue musselsgreen-lipped musselsmediterranean musselspei mussels

What's NOT on the FTL

These items are explicitly excluded from the Molluscan Shellfish (Bivalves) category and do not require FSMA 204 traceability records.

×Scallop adductor muscle only — what's sold as 'scallops' is NOT on the FTL
×Canned or shelf-stable shellfish
×Cephalopods (squid, octopus) — not bivalves

Required Critical Tracking Events (4)

Each CTE requires specific records to be created and maintained for Molluscan Shellfish (Bivalves).

Harvesting

Receiving

The act of receiving a food at a facility other than a farm.

Applies to: All entities in the supply chain except farms

Transforming (processing, packing)

An event that changes the Traceability Lot Code (TLC) of a food, including manufacturing, processing, packing, re-packing, and labeling.

Applies to: Processors, packers, manufacturers

Creating (first TLC assignment)CoolingPacking/Re-packingManufacturing/Processing

Shipping

The act of shipping a food from one location to another.

Applies to: All entities shipping FTL foods

Required Key Data Elements (8)

These data fields must be recorded and maintained for each Critical Tracking Event involving Molluscan Shellfish (Bivalves).

Traceability Lot Code
Quantity and Unit of Measure
Product Description
Harvest area/location
Harvest date
Shellstock shipper tag number
Date of receipt/shipment
Reference Document Number

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