Introduction

Etiologic agents are those microorganisms and microbial toxins that cause disease in humans and include bacteria, bacterial toxins, viruses, fungi, rickettsiae, protozoans, and parasites. These disease-causing microorganisms may also be referred to as infectious agents. Arthropods and other organisms that transmit pathogens to animals (including humans) are called vectors.

Etiologic agents, vectors, and materials containing etiologic agents are recognized as hazardous materials. Materials containing etiologic agents are regularly transported from one location to another by common land and air carriers. Materials containing etiologic agents must be appropriately packaged to prevent breakage or leakage in order to avoid exposure of the package handlers, transporters, and the general public to the package contents. Materials containing etiologic agents must be packaged, labeled, and transported in accordance with all applicable regulations. Material containing etiologic agents being imported into the United States must be accompanied by a U.S. Public Health Service importation permit.

Importation Permits

Importation permits are issued only to the importer, who must be located in the United States. The importation permit, with the proper packaging and labeling, will expedite clearance of the package of infectious materials through the United States Public Health Service Division of Quarantine and release by U.S. Customs.

The importer is legally responsible for assuring that the foreign personnel package, label, and ship the infectious materials according to Federal and International regulations. Shipping labels with the universal biohazard symbol, the address of the importer, the permit number, and the expiration date, are also issued to the importer with the permit. The importer must send the labels and one or more copies of the permit to the shipper. The permit and labels inform the U.S. Customs Service and U.S. Division of Quarantine Personnel of the package contents.

Federal Regulation

The importation of etiologic agents is governed by the following federal regulation:

USPHS 42 CFR - Part 71 Foreign Quarantine. Part 71.54 Etiologic agents, hosts, and vectors.
(a) A person may not import into the United States, nor distribute after importation, any etiologic agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accompanied by a permit issued by the Director.
(b) Any import coming within the provisions of this section will not be released from custody prior to receipt by the District Director of U.S. Customs Service of a permit issued by the Director (Centers for Disease Control and Prevention).

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Items Requiring Permits

Etiologic agents

It is impractical to list all etiologic agents on this website. In general, an import permit is needed for any infectious agent known or suspected to cause disease in humans.

Biological materials

Unsterilized specimens of human and animal tissues (such as blood, body discharges, fluids, excretions or similar material) containing an infectious or etiologic agent require a permit in order to be imported.

Hosts and Vectors

• Animals. Any animal known or suspected of being infected with an organism capable of causing disease in humans may require a permit issued by CDC. Importation of live turtles of less than 4 inches in shell length and live nonhuman primates is regulated by the CDC, Division of Global Migration and Quarantine (www.cdc.gov/ncidod/dq/). Telephone (404) 498-1600 for further information.

• Bats. All live bats require an import permit from the CDC and the U.S. Department of Interior, Fish and Wildlife Services. The application for a CDC import permit for live exotic bats is on this website.

• Arthropods. Any living insect or other arthropod that is known or suspected of containing an etiologic agent (human pathogen) requires a CDC import permit.

• Snails. Snail species capable of transmitting a human pathogen require a permit from the Centers for Disease Control.

Packaging Guidelines

Infectious materials imported into this country must be packaged to withstand breakage and leakage of contents, and labeled, as specified in the following federal regulations:

• DOT 49 CFR PART 173 - Transportation of Etiologic Agents

For international shipments, the International Air Transport Association (IATA) Dangerous Goods Regulations should be consulted.

Additional helpful information regarding shipping and packaging guidelines:

1. Guidance on regulations for the Transport of Infectious Substances 2007-2008 (World Health Organization):
   
   
2. The IATA Dangerous Goods Regulations (International Air Transport Association):
   
   
3. Title 49 Code of Federal Regulations, Parts 100 - 185. Hazardous materials regulations (Department of Transportation):
   
   
4. Biosafety in Microbiological and Biomedical Laboratories, 5th Ed. (CDC/NIH):

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Other Permits

• United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) permits are required for infectious agents of livestock and biological materials containing animal material. Tissue culture materials and suspensions of cell culture grown viruses or other etiologic agents containing growth stimulants of bovine or other livestock origins are controlled by the USDA due to the potential risk of introduction of exotic animal diseases into the U.S. Further information may be obtained by calling the USDA/APHIS at (301) 734-7834 (see www.aphis.usda.gov/vs).

• U.S. Fish and Wildlife Service permits are required for certain live animals, including bats. Please call 1-800-344-WILD for further information (www.fws.gov/).

• Individuals wishing to import select agents and toxins must be registered with CDC's Select Agent Program in accordance with 42 CFR Part 73 (Possession, Use, and Transfer of Select Agents and Toxins; Interim Final Rule) for the select agent(s) and toxin(s) listed on the import permit application. Also, In accordance with 42 CFR Part 73.16(a), an APHIS/CDC Form 2 must be completed and submitted to the CDC Select Agent Program and granted approval prior to the shipment of the select agents or toxins under the import permit. Additional information can be found at www.cdc.gov/od/sap.

Exports of Infectious Materials

The export of a wide variety of etiologic agents of human, plant, and animal diseases may require a license from the Department of Commerce. Information may be obtained by calling the Department of Commerce Bureau of Export Administration at 202-482-4811 or through the internet at: www.bis.doc.gov/Licensing/.

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