U.S. FDA Bioterrorism Act

Expeditors Tradewin, LLC ("TradewinŽ") is a wholly-owned subsidiary of Expeditors International of
Washington, Inc., providing creative and effective solutions in compliance, logistics and trade data management.
Our talented compliance staff includes licensed customs brokers and former senior managers of U.S. and
international Customs authorities. As a team, we work to assess complicated situations, maneuver through
regulatory hurdles and implement solutions that meet both the letter of the law and the spirit of a client's business.

F D A  B I O T E R R O R I S M  A C T

On December 12, 2003, the U.S. Food & Drug Administration (FDA) issued new rules pertaining to the importation of food products into the United States. The rules, issued under the Bioterrorism Act (BTA), are designed to achieve two goals:

• Minimizing the risk of contaminated food from being introduced into the U.S. marketplace.


• 
  
• Creating a structure where key points in the supply chain may be immediately alerted in the case where contaminated food has been introduced.

R E Q U I R E M E N T S

Under the BTA, requirements for food importations intersect the supply chain on two main fronts:

• Entities inside or outside the U.S. that pack, hold, manufacture or process food products for consumption in the U.S. must register with FDA prior to Dec. 12, 2002.


• 
  
• FDA must be given timely prior notification of any food arriving into the United States, regardless of whether the food is consumed in the U.S. or not.
• 
  

P O L I C I E S  A N D  P R O C E D U R E S  I M P L E M E N T A T I O N 

Tradewin can help prepare your company for these critical regulations, regardless of your place in the supply chain. Our services include:

• Conducting tailored training seminars specific to your situation and product line.


• 
  
• Performing an assessment of your current state of readiness for the FDA BTA.
• 
  
• Providing an internal procedure to ensure that all entities within your supply chain comply with the strict registration and time requirements within the BTA.
• 
  
• Verifying the accuracy of key data, such as FDA Product Codes and Harmonized Tariff Schedule classifications.
• 
  

C O N C L U S I O N

The FDA BTA will have an enormous impact on entities that play a role in the importation of food into the U.S., both from a global sourcing and financial standpoint. The question that must be asked is whether you can afford not to be ready for the "Copernican Revolution" in food importation after December 2003. Tradewin is available to help your company get a valuable head start and avoid the additional costs of delays, refusals and penalties.

More information on the FDA Bioterrorism Act:

• The Bioterrorism Act of 2002


• 
  
• Registration of Food Facilities
• 
  
• FDA Bioterrorism Act Regulations
• 
  
• National Institutes of Health - Bioterrorism Act

W H A T  T R A D E W I N   C A N  D O  F O R  Y O U 

• Conduct tailored training seminars specific to your situation and product lines


• 
  
• Perform an assessment of your current state of readiness for the FDA BTA
• 
  
• Analyze your supply chain to ensure that all entities that are required to register have done so
• 
  
• Provide internal procedures to ensure that all information and documentation is prepared and transmitted in a timely manner to meet FDA BTA time constraints
• 
  
• Review current information, such as FDA Product Codes and Harmonized Tariff Codes, to ensure accuracy


• 
  
• Provide internal documented mechanisms to ensure proper oversight and monitoring of the "Transmitter"
• 
  
• Provide other services required for "Reasonable Care" standards
• 
  

[ b a c k ]