2003D-0554 - Compliance Policy Guide Sec. 110.310 -
FDA Comment Number : EC7
Submitter : Mr. Robert Maxwell Date & Time: 12/15/2004 11:12:58
Organization : National Association of Beverage Importers, Inc.
Food Association
Category :
Issue Areas/Comments
This comment is being submitted on behalf of the members of the National Association of Beverage Importers, Inc. ('NABI'). NABI is a national trade association that represents importers of beer, wine and distilled spirits.

NABI members recently learned of the Food and Drug Administration's ('FDA') decision to eliminate the requirement that importers show the registration number of the foreign supplier when submitting a 'prior notice.' NABI members believe that eliminating this requirement is a grave mistake and in fact, significantly reduces the effectiveness of the Bioterrorism Act of 2002 ('the Act'). Allowing importers to substitute the producer's name and address for the registration number destroys the traceability of the product shipment in question and weakens the FDA's ability to enforce the registration requirements of the Bioterrorism Act on foreign producers. Most alcohol beverage producers list their name and address on the bottle label. This information is therefore available to everyone, including those who would seek to do us harm. Without a registration number, how can the FDA be sure where a shipment of food has been or who had access to such shipment if the producer is not required to say that it came directly from him/her.

We understand the FDA has made this change because some importers are not able to obtain the producer's registration number. That rationale makes no sense to us. In order to protect the American public from bioterrorism, the United States Congress decided that producers of food, both foreign and domestic, must register their facilities with FDA before shipping certain food products into the United States. The law further required FDA to assign a unique registration number to each registered facility. In the FDA Interim Final Rules, FDA made the determination that the registration number was an integral part of 'prior notice' and a necessary enforcement tool. In addition, FDA has determined that showing the FDA registration number in a 'prior notice' submission was an essential tool that FDA needed to enforce effectively the registration provisions pertaining to foreign producers.

We agree with the need for a registration number and with the original FDA thinking that if made a part of a 'prior notice' filing, it would be an effective and efficient enforcement tool. FDA has not in our opinion made the case to reverse its original thinking and rationale.

The safeguards contained in the registration and prior notice provisions of the Bioterrorism Act speak for themselves. If an importer cannot supply the registration number, then most likely the product is not coming directly through a secure supply chain, is probably not C-TPAT compliant, and the integrity of the system established by FDA abd CBP has been violated. This concern far outweights any paperwork problem that an importer may have. NABI members have no problem/objection with being required to show the registrtion number of our foreign suppliers when filing a prior notice. We believe the inability of certain importers to obtain the registration number from the producer speaks to the strength and effectiveness of the regulations. It is exactly what Congress and the FDA regulations intended and is designed to present exactly the obstacle to which some people are objecting. Simply because some importers complain is not reason enough for changing the rule and weakening the traceability of a shipment of food destined for sale to U.S. consumers. In fact that is a clear signal that the program works!

Additionally, FDA should be aware that many NABI members are members of the U.S. Customs and Border Protection program C-TPAT (Customs and Trade Partnership Against Terrorism) and have invested a substantial amount of money making their supply chains secure and C- TPAT compliant. In doing so, they have taken steps to modify systems and documentation to ensure that the FDA registration number (to be continued)