What documents do I need to prepare when shipping biotechnology products to the U.S.?

When shipping biotechnology products to the U.S., USDA (U.S. Department of Agriculture) regulations may require the importer obtain an import approval number in advance or may require a document prepared by the shipper based on USDA guidelines, even though an import approval number is not required. 

 In addition, when shipping non-infectious materials of human origin, the necessary documentation must be submitted to the Centers for Disease Control and Prevention (CDC).

How to check the USDA's requirements

1. Go to the No Import Permit Required page on the USDA website. 
2. Identify the category number to which the shipment corresponds from the list of biotechnology products displayed by category number. 
3. Click on the appropriate category number (in blue) to view the USDA requirements for each category.  
4. If it is indicated that an Original Statement from the shipper is required, please prepare an air waybill, commercial invoice and a letter on company letterhead containing answers to the questions listed in each guideline. When attaching a document prepared in accordance with USDA guidelines, please include the following statement on the commercial invoice: "Original statement is attached on package according to USDA regulation."
   
   Information to be included in the Original Statement
   1. Air waybill number
   2. Company name, contact person's name, address, telephone number, date and personal signature. 
5. Please make a photocopy of the document you have prepared. 
6. Please hand over the original and one copy of the prepared documents along with the shipment, air waybill and commercial invoice to the courier at the time of shipment pickup. 
7. You will be asked to obtain an import approval number for any items that do not meet the USDA requirements listed on each category page. An import approval number must be applied for and obtained online by the importer, so please discuss this with the importer prior to shipment. When shipping packages for which an Import approval number has been obtained, please indicate it on the air waybill and commercial invoice. 

Regardless of whether or not an import approval number is required, the following information should be clearly indicated in the Commodity Description of the Shipment Information section of the air waybill and on the commercial invoice. 

• Country of origin (country of origin of goods to be shipped) 
• Reason for importation (purpose of shipment: for diagnostic testing, etc.) 
• Origin of Material-Human or type of animals (origin of goods to be shipped: human or type of animals) 
• Infectious or non-infectious 
• Environmental Control Method (Dry Ice, Blue Ice, etc.)¹
• Recombinant or non-recombinant (genetically modified or not)²

^{[1] If shipping with Dry Ice packaging, packing, labeling, marking, etc. must be prepared in accordance with the IATA (International Air Transportation Association) Dangerous Goods (DG) regulations.} 
[2] Genetically modified microorganisms may be classified as DG for air transportation under the IATA DG regulations. In such cases, documentation and packaging in accordance with the IATA DG regulations are required.

Documents to be submitted to the Center for Disease Control (CDC)

1. Please prepare a document on company letterhead that includes the following information. 
   • Air waybill number
   • Details of contents
   • The following statement "The material is not known or suspected to contain an infectious biological agent."
   • Answers to any of the following questions
     • How the person knows that the material does not contain an infectious biological agent, or
     • Why there is no reason to suspect that the material contains an infectious biological agent, or
     • A detailed description of how the material was rendered noninfectious.
   • The name of the company, name of the contact person, address, telephone number, date and personal signature.
     
     If you attach a document prepared in accordance with CDC's guidelines, please include the following statement on the commercial invoice: "Original statement is attached on package according to CDC regulation"
2. Please make one copy of the documents you have prepared. 
3. Please give the original and one copy of the prepared documents together with the shipment, air waybill and commercial invoice to the person in charge of the shipment at the time of shipment pickup.

External website
USDA website (English)
CDC website (English)

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