Guidelines for Importation of Microbially Produced Materials 1110

Guidelines for Importation of Microbially Produced Materials

GUIDELINES FOR IMPORTATION #1110  (Last Modified: May 16, 2014)

This Guideline applies to:                                                                                                                

Microbially produced materials such as: enzymes, plasmids, proteins, hormones, extracts, phages and/or DNA.


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 Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agricultural Specialists/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 foreign livestock and poultry diseases into the United States. However, microbes (usually E. coli or yeasts) that do not express material of a foreign livestock and/or poultry disease agent may enter the United States without USDA restrictions.


A USDA VS Import Permit will not be required for microbially produced biochemicals if DHS, CBP Agricultural Specialists/Inspectors are provided documentation which may include: manifests, invoices, foreign producer/shipper statements on letterhead, or other shipping documents which provide the following information:

  1. An 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 available for review by the DHS, CBP Agricultural Specialist/Inspector at the port of arrival. 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: /animal_health/permits/
       a. submit the permit application on-line
       b. e-mail the completed application to:
       c. fax the permit application

2. By writing to:
National Import Export Services (NIES)
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300 telephone, Option 1
(301) 734-8226 fax


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