INDUSTRY NEWS
FDA BIOTERRORISM ACT

As part of our service to our valued clients, we would like to advise some new regulations that may affect your business. These regulations pertain to the importation and handling of imported food and food products. The attached document explains, in detail, these 2 new regulations.

As an overview, these new regulations fall under the changes required by the passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). There are two major changes that all concerned parties should be aware of. The first is the requirement that facilities, both domestic and foreign, which handle food and food products that are for export to or have been imported into the United States, register their facilities with the Food and Drug Administration (FDA) before December 12, 2003. Registration of both domestic and foreign facilities will be required in order for shipments to be released from Customs. It is therefore strongly advisable that all Importers of food or food products immediately register all of their US facilities and also discuss this regulation with all of their suppliers and demand their compliance with this requirement. It is further suggested that importers require notification of “registration numbers” for all of their suppliers to be notated on all documentation associated with the importation of these items and that Importers keep a record of all of their and their supplier’s registration numbers.

Also required by these regulations is the need to send prior notice (P/N) electronically to the FDA of all shipments to be imported into the United States. This notice must be submitted within the timeframes mentioned in the attached document. FDA has advised that there will be two mechanisms that will be used to submit this data. One will be an Internet based FDA site which allows any party with knowledge of the shipment details to submit P/N directly to FDA. The second is an interface that is currently in development and will allow transmission of P/N data to FDA via the current system used to transmit Customs Entry data, namely “ABI”. Although the details and functionality of this system are still in development, FDA has stated that it is likely that this method will be used in most cases to fulfill the P/N requirement.

Yusen Air & Sea Service (USA) Inc. is already working with our software developers to ensure that all necessary data is capable of being transmitted to FDA as required. It is, however, only upon receipt of the accurate, complete and timely data, that Yusen Air & Sea Service (USA) Inc. will be able to assist our clients in their compliance with this regulation. It is therefore advisable that this new regulation be discussed in detail both internally and with all suppliers of food and food products in order to determine how this data will be controlled and provided to Yusen Air & Sea Service (USA) Inc., so that the criteria of this transmission can be met, should you wish us to transmit the data to FDA on your behalf.

Full details of these new regulations can be found in the attached document. Please feel free to contact your local Yusen representative with any questions you may have. As always, Yusen Air & Sea Service (USA) Inc. will support and assist our clients to prepare for and meet these new requirements as necessary.