Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -12

Accepted - Volume 2

Comment Record
Commentor Mr. Kazuhisa Takahashi Date/Time 2002-08-30 16:48:41
Organization Japanese Embassy
Category International

Comments for FDA General
Questions
1. General Comments Section 303 (1) FDA should ensure transparent implementation of this section in order to prevent this section from becoming unnecessary trade barrier or restrictions on the activities of private businesses. Especially, when FDA orders the detention of food based on this section, FDA should immediately show the reasons and the period of the detention to the stakeholders. FDA should also notify the related countries of these facts expeditiously. As soon as FDA confirms that the detained article is safe, FDA should release it immediately. (2) In addition to (1) above, when FDA orders the detention of the products at the port of unloading, FDA should publish the fact of detention through the Import Refusal Report. (3) When FDA gets any information relating to the detention, it should provide such information to stakeholders immediately. (4) When a stakeholder such as an importer or an exporter, files a complaint against the detention, FDA should deal with it expeditiously within fixed date to avoid hampering the activities of private businesses. (5) The regulation should ensure that enough compensation for the detention should be paid when the detention is found to be unjust. (6) The regulation should ensure that when an article from a registered manufacturer is detained due to a violation on the part of the exporters or importers, any article that is directly imported to the United States by that registered manufacturer, or imported via other exporters or importers that are properly registered should not be detained.




EC -12