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 : EC363
Submitter : Mr. Wim Tacken Date & Time: 05/19/2004 09:05:51
Organization : Netherlands Min. of Ag., Nature and Food Quality
International Government
Category :
Issue Areas/Comments
GENERAL
GENERAL
Comments to the FDA on the interim final rule on Registration of Food Facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Docket No. 2002N-0276

With full respect for the United States' objectives to protect itself and its citizens from possible acts of bioterrorism, the Netherlands wishes to make the following comment:

Whether a foreign facility meets the registration requirement, including the requirement to hire a US agent, is observed through inspection of the prior notice by Customs and Border Patrol before a food product is imported into the United States. In accordance with the time frames stipulated in FDA's Compliance Policy Guide, the past several months have been directed at education and communication. During this period shipments with inadequate prior notices, including food shipments coming from unregistered facilities, have been allowed to enter US commerce.
On May 13 the next phase of FDA's compliance policy for enforcing prior notice will begin, during which enforcement will become more strict. After August 12, 2004, shipments from unregistered facilities will be refused. Therefore, only after August 12, 2004, the Netherlands government expects to understand the full impact of the registration requirement, including the requirement to hire a US agent. The Netherlands government is very concerned that exports to the United States of small and medium-sized enterprises will be negatively affected due to the added cost of hiring a US agent.
The Netherlands government would like to formally request an extension of the comment period. This will enable us to receive feedback from Netherlands exporters on registration requirements, including the costs associated with hiring a US agent, during the next phases of FDA's compliance policy.