2002N-0276 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Reopening of Comment Period
FDA Comment Number : EC366
Submitter : Ms. Iku Nagahori Date & Time: 05/19/2004 09:05:06
Organization : Government of Japan
International Government
Category :
Issue Areas/Comments
GENERAL
GENERAL
Comments by the Government of Japan on the United States' Interim Final Rule

The Government of Japan appreciates the opportunity to provide comments as follows on the United States' Interim Final Rule of 'Registration of Food Facilities' (hereinafter referred to as 'the Rule') under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, published in the United States' Federal Register dated October 10, 2003 and notified to the WTO Members dated April 16, 2004 (G/SPS/N/USA/691/Add.6) and April 19, 2004 (G/TBT/N/USA/32/Add.4).


1. The Rule provides that only one U.S. agent must be assigned to each foreign facility for its registration. Japanese small or medium-sized companies in Japan thus will be limited to do business only through a single agent and will most likely face difficulties in maintaining or expanding their market by approaching various agents. In this regard, the companies should be allowed to register more than one U.S. agents for each facility so that their export business to the U.S. will not be unreasonably undermined.


2. Due to the burden incurred by the registration process, some Japanese companies have actually been discouraged to export to the U.S. and consequently withdrawn from food export business to the U.S. While it is difficult, however, to estimate the specific magnitude of such negative effects, the Government of Japan believes that the huge workload related to customs clearance procedures has decreased the number of export enterprises as well as export opportunities. The Government of Japan thus requests the U.S. Government to ease these burdens as much as possible.