2003D-0554 - Compliance Policy Guide Sec. 110.310 -
FDA Comment Number : EC8
Submitter : Mr. Robert Maxwell Date & Time: 12/15/2004 11:12:12
Organization : National Association of Beverage Importers, Inc.
Food Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
(Continuation of Temporary Comment Number: 11779)
is included on shipping papers in an effort to facilitate completion of a prior notice. This program has created an enormous burden of paperwork and maintenance, a burden that NABI members have willingly accepted. Although the additional paperwork is cumbersome and expensive, it engenders a level of safety and security that our country demands, and NABI members are willing to provide. This spirit of cooperation should be embraced by all in the overriding interest of homeland security. NABI members, who are also the authorized importers for their suppliers, have also expended capital to insure that they and their foreign suppliers are properly registered. We believe the registration number is necessary because it is the only assurance that the registered foreign supplier is the entity that actually produced the product.

If the registration number is not an essential component of the supplier chain security system, then why did Congress and the FDA require the foreign supplier to register and obtain a registration number? Registration seems to be a useful exercise without the registration number. The law has not changed and the FDA has not changed its interpretation of the law with respect to registration requirements.

Summary

The FDA should not eliminate the requirement for showing the registration number of the foreign suppplier in a 'prior notice.' The registration number is an integral component of the system designed to protect the integrity of the food supply chain. Eliminate the need, and you invite 'any' third party shipper in the world, to buy product, alter it, and ship it to the U.S. without a problem. The FDA cannot say that making our food supply chain secure is our prime objective if the food product is imported by an unauthorized importer who cannot obtain the foreign supplier's registration number. Security must be our number one concern and not secondary to the economic concerns of an unauthorized importer. Authorized importers, who are members of NABI, have demonstrated their concern for food safety and product integrity by quickly becoming members of C-TPAT and ensuring that their foreign suppliers are properly registered with FDA.

Sincerely,


Robert J. Maxwell
President
National Association of Beverage Importers, Inc.