USDA United States
Department of
Agriculture
Animal and
Plant Health
Inspection
Service
Veterinary Services
National Center For Import And Export
Import/Export Animals
4700 River Road, Unit 40
Riverdale, MD 20737-1231

Microbially Produced Materials
Effective April 14, 1998 (revised June 28, 2007)

GUIDELINES FOR IMPORTATION #1110

Including:
enzymes, plasmids, proteins, antibiotics, hormones, extracts, phages, DNA.

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 import permit is required for animal material that may pose a risk of introducing epizootic livestock or poultry diseases exotic to the United States.  However, microbes (usually E. coli or yeasts) that do not express material of an exotic livestock or poultry disease agent may enter the country without USDA restrictions.

Procedures:

A USDA import permit will not be required for microbially produced biochemicals if the following is provided in the shipping documents:

  1. A detailed and accurate description of the material.
  2. A declaration, if applicable, indicating that the material is produced by microbial fermentation.
  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.

This information must be supplied as statements on producer/shipper letterhead 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 memo or letter be included with the shipping documents, such as U.S. Customs declaration and invoice.  Do not put documents INSIDE shipping containers.

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, 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) 734-3277 telephone
    (301) 734-8226 fax


VS - Safeguarding Animal Health
Phone (301) 734-3277, FAX (301) 734-8226
http://www.aphis.usda.gov
An Equal Opportunity Employer


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