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Recombinant Microbes and Their Products

Effective October, 1998 (revised June 28, 2007)

GUIDELINES FOR IMPORTATION #1114

Including:
microbes (bacteria, viruses, yeasts/fungi), proteins, hormones, extracts, plasmids, DNA, RNA.

Not Including:
materials produced by cell culture techniques.

Introduction:

Materials derived from any animal or produced with animal products or extracts of microorganisms are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by USDA inspectors at the port of arrival before entry into the United States is authorized.  A USDA permit is required for any material that may pose a risk of introducing epizootic livestock diseases exotic to the United States .  However, recombinant non-pathogenic bacteria/yeasts (such as E. coli & Saccharomyces cerevisiae) and their products that are not related to livestock or avian species or disease causing agents and that do not contain animal products such as albumin or serums may be brought into the country without USDA veterinary restrictions.

Procedures:

A USDA veterinary import permit will not be required for recombinant microbes or their products if the following is provided in the shipping documents:

  1. A detailed name or description of the microbe/recombinant product, including genetic insert.
  2. For recombinant products, a declaration with the shipment confirming that the material is produced by recombinant microbial expression (vector must not be considered pathogenic for livestock* or avian species) AND that the organism does not contain genes or express antigens of livestock or poultry disease agents.
  3. A declaration stating the preparation does not contain any animal derived additives, such as albumin, OR, if the preparation does contain animal derived additives, a declaration identifying the additives and stating that the product will be used only in vitro.

The above information should be supplied with each shipment in a clear and concise manner and be available for review by the USDA Inspector at the port of arrival.  We recommend that a separate memorandum or letter be included with the shipping documents, such as U.S. Customs declaration and invoice.

Please instruct your shippers to provide this information.

If the above information is not supplied, the shipment will be subject to delays.  If the material to be imported cannot meet these criteria, 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) 734-8226 fax

*The term, livestock, includes any bovine, ovine, caprine, porcine, and equine animal



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