Guidance Documents

Chapter III. Harvesting, Handling, Processing, Distribution

.03 Dealer Certification and the Interstate Certified Shellfish Shippers List (ICSSL)

Table of Contents

A principal objective of the ICSSL is to provide a mechanism for statehealth officials and consumers to receive information as to whether lots of shellfish shipped in interstate commerce meet acceptable sanitation criteria. This is achieved through criteria and procedures to allow a producing or receiving state to "certify" that the product from a specific dealer has been grown, harvested, transported, processed, or shipped in compliance with the National Shellfish Sanitation Program (NSSP) Model Ordinance (MO). Dealer certification depends on maintaining acceptable operational and sanitary conditions. This determination is based on nationally uniform inspections by standardized inspectors.

State health officials who certify dealers must fully comply with the administrative requirements for certification for the process to remain viable. For the certification process to be effective, dealers must fully comply with the applicable NSSP MO sanitation requirements pertaining to the type of operation involved.

The NSSP MO requires that dealers obtain certification from the Authority prior to shipping shellfish in interstate commerce. Only those shellfish dealers who meet the NSSP MO requirements are eligible to be listed in FDA's monthly publication of the ICSSL. A unique certification number that is used to mark his product identifies each dealer.

Use of the Interstate Shellfish Dealer's Certificate (FDA Form 3038)

The Interstate Shellfish Dealer's certificate, FDA Form 3038, is used by the Authority to place a dealer on the ICSSL, to report changes to a certificate, and to remove a dealer from the ICSSL. The certificate allows FDA to collect the necessary information to list certified dealers in the ICSSL. Dealers should be informed by the state officer of the probable date their names will appear on the ICSSL. Dealers should be advised against making interstate shipments prior to that date. If shipments need to be made before the appearance of the shipper's name on the ICSSL, the Authority in the dealer's state must notify the appropriate agency in each of the receiving states and the FDA regional and headquarters offices.

When the Authority cancels a dealer certification, the appropriate FDA Region or District Office must be notified and a completed Form FDA 3038 must be mailed to FDA. When a certificate is renewed, the certificate must be sent to FDA. A certificate will be withdrawn automatically from the ICSSL on the date of expiration unless FDA has received the new certificate.

Instructions For Completing the Interstate Shellfish Dealer's Certificate (FDA Form 3038)

The original copy, or Part 1, of the Shellfish Dealer's Certificate is mailed to FDA, Division of Cooperative Programs, Shellfish Safety Team, HFS-628, 5100 Paint Branch Parkway, College Park, Maryland 20740; Part 2 is mailed to FDA Regional Shellfish Specialist; and, Part 3 is retained by the state shellfish control Authority. The original certificate with the appropriate signatures shall be mailed not later than the first of the month for publication in the ICSSL.

To input information check the applicable box.

Section I - Completed by State Shellfish Certification Agency

1. Shellfish Dealer/Shipper: Name, Address (including Street, Number, City or Town) ZIP, Telephone
2. Certification:

a)	Certificate Number - Unique number assigned to each certified shellfish dealer.
b)	Date Certified - Date the dealer was certified as meeting the NSSP criteria.
c)	State - Two letter State code.
d)	Expiration Date - Date the certificate expires.
e)	Category Symbol - Two letter code designating dealer process (i.e. DP, SP, RP, SS, RS).

3. Date of On-Site Inspection: Date the plant was inspected for certification.
4. Standardized State Shellfish Plant Inspector: Print the name of the inspector who conducted the on-site inspection.
5. Expiration Date of Inspector's Certificate of Standardization: Print the expiration date that appears on the Inspector's certificate.
6. Cancellation Date: Date the firm has been either decertified or recommended for de-listing.
7. Reason for Cancellation: Check applicable box; Other denotes voluntary or seasonal suspension of activities.
8.

a)	State Shellfish Certification Officer: Printed name of official to authenticate information.
b)	Signature: Official's signature. In the case that a state has only one Standardized State Shellfish Plant Inspector, sign this block.
c)	Date Certificate sent to FDA: Self-explanatory.

Section II - Completed by Division of Cooperative Programs - FDA

9. Date Certificate Received: Date the signed original Form FDA 3038 is received by FDA.
10. Date Certificate Published: Date when the certified dealer's name is scheduled for publication on the ICSSL.