Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -30

Accepted - Volume 2

Comment Record
Commentor Mr. Marvin A. Blumberg Date/Time 2002-09-05 12:46:32
Organization AAC Consulting Group, Inc. Subsidary of Kendle Int
Category Other

Comments for FDA General
1. General Comments In the comment from Ms. Leslye Frazer at the Stakeholders Meeting: Consumer Groups August 1, 2002, the question of registration number being accessible to the public, Ms. Fraser stated The statue expressly provides that registration numbers are not disclosable under the FOI. Here is my problem with this. When a shipment of food is offered for importation and it consists of multiple manufacturer's products (commonly referred to as a Grocery Store Shopping List entry), each manufacturer's product will be identified separately for OASIS review. Under the procedures followed for electronic submission of information, the filer will identify as Affirmation of Compliance all references that deal with registration, listing, etc. (for foods it would include FCE number and Sid number, etc.). With the new legislation requiring every manufacturer to have a registration number before their product is acceptable for entry, this will mandate the shipper (who is not further processing the food products) to acquire from each supplier their Registration number to provide to the US importer. This registration number will probably be included as part of the invoice information for the filer to enter into the AofC listing. If the shipper does not have the manufacturer's registration number, that portion of the shipment will be detained. Once the shippers are aware of the need for the registration numbers to be included in their invoice information, I can see where misuse of the numbers could happen. This has happened in the past with FCE numbers being used to identify products that were not manufactured by the actual company so that substitute product could gain entry (China/Taiwan mushroom issue). The only real enforcement tool FDA has regarding the foreign manufacturer is to refuse admission to their products. I can see where products that are being miss-represented may cause major concerns for legitimate foreign companies. As a suggestion for dealing with the requirement to keep the CFSAN Food Registration confidential, I would propose the following for consideration. All establishments that have their names submitted as part of the entry documentation into OASIS are assigned a specific FDA Establishment Identification (FEI) number. This number is considered public information (not restricted from disclosure under FOI and is provided as part of the information in all current Import Alerts and Monthly Refusal notices). When a firm submits their information for registration, the Center should first determine if there is already in the FACTS/OASIS systems a FEI assigned to that establishment. This FEI number would then be cross referenced with the new CFSAN Foods Registration number provided to the foreign establishment. If no FEI number has been given to the firm, CFSAN would then refer the information to ORA for the OASIS program to provide the FEI number. This FEI number would be sent to the establishment along with their Food Registration number with instructions to only provide their FEI number for purposes of identifying themselves for exported products to the US. This information along with other required information, i.e., FCE, SID numbers, etc. would then be part of the company's information on their invoice/shipping records. When that company exports their products to the US, they will provide the US importer with their FEI number to be entered into the OASIS documentation by the filer. This number would be cross matched internally (OASIS system to CFSAN system) to verify the name of the establishment (plus address, etc.) is the same as the name in the CFSAN Registration database. In this way the CFSAN registration number is only known to the manufacturer and is not included in any documents that are referenced with the shipment. Over the years of the development of the OASIS program, congress has often asked why the OASIS system does not communicate with the other Agency databases. By having this cross matching link between OASIS and the CFSAN database, this communication between different part of the Agency is accomplished. Marvin A. Blumberg Senior Consultant FDA Import/Export Guidance, Procedures, and Policies AAC Consulting Group, Inc. Rockville, Maryland

EC -30