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 : EC504
Submitter : Mr. Wim Tacken Date & Time: 07/28/2004 06:07:17
Organization : Netherlands Ministry of Ag., Nature, Food Quality
Category :
Issue Areas/Comments
Comments to the 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

With full respect for the United States' objectives to protect itself and its citizens from possible acts of bioterrorism, the Netherlands Ministry of Agriculture, Nature and Food Quality wishes to make the following comments:

1. 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, have been allowed to enter US commerce. Only after August 12, 2004, we expect to understand the full impact of the Prior Notice requirement.
2. After August 12th, 2004 failure to provide accurate or timely prior notice might not only be cause for refusal of the product, but the exporter might be charged with an additional financial burden due to CBP Civil Monetary Penalties. We are concerned about the potential financial and trade consequences.
3. The FDA and CBP must examine every prior notice, whether to see if the information provided is accurate, and make a decision based on this information. We are very concerned about how much time this whole process will take after August 12 - keeping in mind that fruit and vegetables are perishable products.
4. We encourage partnerships between the US and EU, similar to C-TPAT, that would facilitate trade in food and feed between the EU and US and avoid delays at the US border, especially with respect to perishable products.