PLEASE TAKE A MOMENT TO READ AND STAY UP-TO-DATE WITH THE BIOTERRORSM ACT REQUIREMENTS

Hello,

We wish you warm greetings.

The FDA and CBP are concentrating on Educating companies on their PN Submissions according to their time table to fully enforce the Prior Notice on August 12, 2004. Starting March 04, the FDA and CBP will become more strict with the PN Submissions. Although they will still be primarily Educating, they will not be as tolerant as before. Keep this in mind as we cross that threshold. We will provide more information concerning the new requirements in the March Newsletter.

Today, February 2, 2004 the FDA published corrections to the Interim Final Rule that appeared in the Federal Registry of October 10th, 2003. Some minor changes that primarily had to do with syntax and grammar, but nothing of any major concern or consequences. If you would like to view the changes, please go to www.fda.gov and press on Prior Notice Section. There on the left side menu you will see a link to "Corrections to Interim Final Rule". It is in a PDF Format.

We are helping all clients with a host of different requirements and information concerning their PN Submissions. If you have any questions or concerns, please notify us in order to help you. You can reach us at bio@gthub.com.

In every US Agent Newsletter from us, we will include a "Prior Notice Information" section. It will contain information to help you with your Prior Notice Submissions.

PRIOR NOTICE INFORMATION

Prior Notice Submissions

Prior Notice submissions are not by "Shipments", but rather by "Article of Food". The following is an actual FDA example on PN submissions.

"Article of Food" vs. Shipment of Food

1 Shipment; 4 Different Products; 4 Prior Notices

Presenting Prior Notice Confirmation on Shipment Arrival

FDA recommends that Prior Notice confirmation accompanies any shipment of imported food.

For Shipments Arriving:

By Commercial carrier If Prior Notice was submitted through the FDA Prior Notice System Interface, the carrier must have the Prior Notice confirmation number.In other cases, it is prudent for the carrier to have a copy of Prior Notice confirmation or the confirmation number in his/her possession when arriving at the port of arrival.

By International mail: The package must bear the Prior Notice confirmation number.

Carried by or otherwise accompanying an individual arriving in the U.S.: The individual must have a copy of Prior Notice confirmation.

PANAMA OFFICE

To provide all of our Clients with superior service and timely responses, starting on February 2nd, 2004, Management in the US decided to handle all Prior Notice requirements out of the Panama office. We have executives working there from the USA, Canada, France, Italy, Panama, Venezuela and other Latin American Countries. We can respond to your questions in 7 languages. The contact for that office is:

Tel: 507-264-7950
Fax: 507-264-4667
Email: bio@gthub.com

Please note that the Panama office will ONLY handle the Prior Notice requirements. The USA Office will specifically handle all the US Agent requirements, as stipulated by the FDA.

PRIOR NOTICE SUBMISSIONS

If you need help with your PN Submissions, we would like to help you, please visit our Prior Notice Site. It has complete information on the Prior Notice Submission requirements from the FDA. You will also see our automated and easy-to-use GTH PN SYSTEM®. With this simple system you will be able to make all your PN Submissions quickly and effortlessly. www.bioterrorismact.net

The GTH PN SYSTEM® is much more streamlined and faster to submit PN's than the FDA PNSI System. We use the ABI System through our interface with the US Customs and Border Patrol. It is feature rich to help you submit your PN with just clicks of your mouse. No lengthy and repetitive web entries required to submit your PN. The GTH PN SYSTEM® is intelligent and remembers all your data for "one click" section data entry.

FREE PN SUBMISSION TRIAL (No Obligation or Nothing to Buy!)

You can receive a Free Trial with no obligation or nothing to buy to test the GTH PN SYSTEM®. Go to www.bioterrorismact.net.

As your US Agent, we will continue to monitor the FDA and advise you of any news or up dates. If there is no new information, you will still hear from us at least once a month to stay in touch. Should you have any questions concerning the Bioterrorism Act, please email us at bio@gthub.com.

If you have any questions concerning our Electronic Food Trading Services and New Markets Development, please email us at marketing@gthub.com

Have a good day,

David Proenza
Vice President
Global Operations