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Chemically Synthesized Materials

 

 

Effective April 14, 1998 (Revised August 10, 2006 )

GUIDELINES FOR IMPORTATION #1105

Including:

biochemicals, materials not containing or derived from animal products including cell culture derived products.

Introduction:

Materials derived from any animal, including those materials produced with animal products or extracts of microorganisms, are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DSH, CBP) Agricultural Specialists at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing exotic animal diseases into the United States.  However, chemically synthesized biochemicals and chemically synthesized materials that do not contain and were not derived from animal products may enter the country without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.

Procedures:

A USDA import permit will not be required for chemically synthesized biochemicals, chemically synthesized materials that do not contain animal products, or chemically synthesized materials that were not derived from animal products.  In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation accompany each shipment:

  1. A written statement identifying the material (name).
  2. A written statement confirming the material is chemically synthesized.
  3. A written statement confirming the material does not contain any animal or cell culture derived products.
  4. A written statement confirming the material was not derived from any animal or cell culture derived products.

USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, with the letterhead containing the physical address of the foreign producer/shipper.  USDA, APHIS, VS further recommends that the document, written in a clear and concise manner, accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agricultural Specialists at the U.S. port of arrival.  We do not recommend that the foreign producer/shipper place this document inside the shipping containers.

We further recommend that you provide a copy of this guideline to your foreign producer/shipper.

If the chemically synthesized material to be imported cannot meet these criteria, then a USDA import permit may be required.  Permit applications may be obtained several ways:

  1. On-line at: http://www.aphis.usda.gov/animal_health/permits/
  2. By writing to:
    USDA, APHIS, VS
    National Center for Import and Export
    4700 River Road, Unit 40
    Riverdale, MD 20737
    (301) 851-3300 telephone
    (301) 734-6402 fax

 



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