2002N-0278 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Extension of Comment Period
FDA Comment Number : EC501
Submitter : Mr. Gerard Depayre Date & Time: 07/28/2004 06:07:17
Organization : European Commission Delegation
Other Government
Category :
Issue Areas/Comments
GENERAL
GENERAL
Comments to FDA on the interim final rule on Prior Notice of Imported Food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Docket No. 2002N-0278

The European Commission welcomes this opportunity to provide additional comments on the implementation process associated with the Public Health Security and Bioterrorism Preparedness and Response Act (BTA) of 2002.

We appreciate the flexible introduction of the rules and the educational outreach effort the FDA has undertaken to prepare the international business community to comply with these rules. Our main concern, however, remains the possible distortive effects of the new rules on international trade. These effects can be fully assessed only after the system is enforced in its entirety and the long-term changes in trade patterns have become clear. The comments below are based on problems which we can identify already now.

Companies have complained that the required data are very complex for the average customer and the system is not very customer-friendly: entries take a long time and each single item has to be registered separately; the system goes down from time to time and all the time-consuming entry work has to be repeated. This especially creates a burden on small exporters and it is difficult to see how the requirement of prior notice for small deliveries by mail efficiently addresses the objectives of the BTA. Therefore, we would continue to suggest that consumers and small businesses could continue to send food items in accordance with the international mail system that has been developed over the years.

As regards trade and analytical samples, we would repeat our comments that these should be formally excluded from the requirement of prior notice, considering the overall objective of the BTA.

In addition, we would like to invite the U.S. authorities to continue the work on the synchronisation of the different filing systems so as to ensure that all notices can be made via Automated Manifest System (AMS). Moreover, CBP and FDA codes as well as the deadlines of submission of notices should be harmonised.

As regards C-TPAT, it should be open to all foreign operators willing to participate. Companies participating in C-TPAT should be dispensed of the procedures prescribed under the BTA. The European Commission would like to remind that any possible controls by U.S. authorities in third countries must be subject to prior agreement with the competent authorities of that country. The European Commission would also like to refer to the work currently taken forward by a Customs expert group comprised of EC and U.S. customs experts. This expert group was launched following the EC-U.S. agreement on expanded customs co-operation with the tasks to compare existing EC Authorised trader programs and C-TPAT with
the aim of striving for mutual recognition of industry partnerships and reciprocity. This will provide the possibility to mutually recognize EC and U.S. programs and take away the need for U.S. officials to control EU traders.

While some of these concerns may not be addressed within the existing authority of FDA, the European Commission would like to reiterate its wish that these issues be reported to Congress so that it can take the necessary steps to amend the Act accordingly.