From: GLOVER, Stephanie [stephanie.glover@canadapost.postescanada.ca] Sent: Friday, May 14, 2004 5:42 PM To: 'FDADockets@oc.fda.gov' Cc: ONEILL, Peter J.; BARTLETT, Patrick J. Subject: Docket Number 2002N-0278 The Canadian Postal Administration (Canada Post) has previously expressed comments on this issue verbally to the FDA but would like to reiterate some specific items relative to mail and small package express items entering the U.S. We understand the need to protect the U.S food chain and the provisions set forth in the requirements under Prior Notice. We do however feel that there is or would be little or minimal threats posed with the small individual parcel and packet traffic carried by the Small Package Express Industry or by Foreign Postal Administrations. The bulk of the business that is transacted through this method is primarily individual packages that are sent between a Business direct to a Consumer (B to C) or individual packages sent between a Consumer direct to a Consumer (C to C) of a mainly social nature. Given the nature of the traffic profile, incident risk is mitigated through the bill of lading and mailing process supporting the direct shipment to the end-use US Consumer. Issues with the current process: The current Prior Notice web application process does not provide an adequate solution for a direct interface of a large base of shippers and mailers. For commercial shipments imported into the U.S. a Customs Broker may electronically interface with the FDA to satisfy the requirements and minimize the number of applications. A direct mail shipper cannot easily or automatically process applications for volumes of individual packages requiring Prior Notice numbers. There is no capability to import Customer file data to the FDA application host and continuously apply for the individual PN package numbers. Direct mailers require a mechanism supporting the application process that contemplates a direct and timely interaction with the FDA since a Customs Broker is not usually involved in mail import processes. When one compares the nature of a commercial or wholesale shipment of goods requiring PN numbers (e.g. truckloads of poultry for retail trade) versus individual packages containing small quantities of food items that were ordered by or shipped socially between the sender and recipient (e.g. a bottle of jam), there is a clear divergence of utility required from the FDA. Parcels emanating from Canada to the USA enter our postal system at one of 30,000 points in a direct transaction between the postal administration and the shipper. Under the current FDA process architecture, these transactions will generate thousands of individual PN requests on the FDA Web system since a Customs Broker is not involved. Within the 30,000 mailing points noted above, we have mail order shippers that require thousands of PN numbers each day to satisfy the FDA requirements. The mail order segment have voiced concerns that there is not an adequate process, and the relevance of the threat for their shipping segment. We anticipate periods whereby 30-40 million individual requests would be generated over a 1 week period. Thank you for this opportunity to comment on behalf of our postal customers. Kind Regards, Stephanie Glover Manager, International Customs Canada Post Corporation 2701 Riverside Drive Suite N0184 Ottawa, Ontario K1A 0B1 Canada 613-734-8945