Permits for Import or Export of Biological Materials

In recent years, the concern over the safe and secure transport of hazardous material has intensified in an effort to ensure personal and public safety during transport of etiological agents, their vectors, animals and plants, and for the exportation of biological materials. In the United States, all hazardous material packages that are offered for domestic transport are subject to the Department of Transportation (DOT) regulations. All hazardous material packages shipped internationally are subject to the requirements established by the United Nations International Civil Aviation Organization (ICAO) whose guidelines are adopted by the International Air Transport Association (IATA). Both regulatory bodies establish definitions and requirements for the classification, packaging, marking, labeling, and documentation of hazardous material packages. Personal, civil and criminal penalties have been established for willful violation of these regulations.

Failure to comply with import and export requirements may result in shipment release delays or shipment confiscation and destruction by the Quarantine Officer at the port of entry.

All packages being offered for transport must comply with all Federal and international regulations for ground and air transport in order to protect the safety of the laboratory staff, support staff, the environment, and the public.

No person shall make arrangements to receive or ship an etiological agent, vector, animal, or plant before ascertaining the necessity for a permit and obtaining a permit when required.

Etiological agents and vectors of human or animal disease cannot be transported in a privately owned vehicle (POV). All applicable packaging requirements of the U. S. Department of Transportation (DOT) regulations must be followed (49 CFR Parts 171- 178).

Any person wanting to personally transport etiological agents and/or vectors of human or animal disease via air must have the material packaged by an appropriately trained and certified individual, following IATA packaging instructions. The material must be declared prior to departure.

Legislative Sources:

1. Department of Health and Human Services, Public Health Service quarantine regulations task the Centers for Disease Control and Prevention (CDC) with management of human etiological agent import/transfer program. The regulation states: "A person may not import into the United States, nor distribute after importation, any etiological 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." (42 CFR 71.54).
2. U.S. Department of Agriculture (USDA) regulations state: "No organisms or vectors shall be imported into the United States or transported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof...." (9 CFR 122.2).
   Note: The USDA will not permit the importation of cell cultures, monoclonal antibodies, ascites fluid or bovine serum from countries where rinderpest and foot-and-mouth disease are present unless the imported materials are determined to be virus-free.
3. Similar USDA regulations are concerned with agents and vectors of plant disease (7 CFR 330). These regulations seldom affect the work of biomedical investigators but are applicable.
4. The United States Fish and Wildlife Service (USFWS), U.S. Department of Interior, is responsible for regulations involving the prevention and control of wildlife diseases and for the importation of wildlife and eggs thereof (50 CFR 23). In addition, the USFWS represents the United States to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). If biomedical investigators wish to use biological materials or tissues derived from fauna or flora listed in Appendices I, II or III of the convention, a CITES permit is required (50 CFR 23).
5. The U. S. Department of Commerce (DOC), Bureau of Industry and Security, is responsible for implementing and enforcing the Export Administration Regulations, which regulate the export and re-export of most commercial items.
6. Biological materials and etiological agents are subject to packaging and shipping requirements of various Federal and International regulations. Proper packaging is the primary consideration and of utmost importance in the safe transportation of hazardous materials. The DOT regulations (49 CFR 171 - 178) and IATA's Dangerous Goods Regulations dictate the proper packaging requirements necessary for most biological materials.

Imports:

1. A person wanting to apply for an import/export/re-export permit of wildlife samples and/or biomedical samples collected from an endangered species must complete USFWS Form 3-200-29, "Import, Export, Re-export of Wildlife Samples and/or Biomedical Samples". This permit application is submitted directly to USFWS and is available online at: http://www.fws.gov/permits/ . Applicants should be prepared to wait 60-90 days for a determination and be aware that an application fee applies.
2. A person wanting to apply for a USDA Animal and Plant Health Inspection Service permit must submit the permit application directly to the USDA using the ePermit system available at http://www.aphis.usda.gov/permits/. Both USDA and Public Health Service permits may be required for the importation of some biological materials. An application fee applies.
3. No person shall distribute a permitted etiological agent or vector of human disease unless the intended recipient provides a copy of the appropriate permit authorizing the receipt of the material.

Exports:

In general, biological materials may be exported to most countries under the provisions of the Export Administration Regulations, DOC.

The recipient's country may impose import restrictions or require that the recipient obtain an import permit from the appropriate issuing agency in the recipient's country.

Interstate Shipments: In general, indigenous etiological agents and vectors are not subject to control by Federal or other agencies for U.S. interstate shipments, however there are exceptions (e.g., establishment of a colony of Aedes aegypti mosquitoes, interstate transport of plant pests, blue tongue virus, etc.).

Packaging Requirements: Biological materials, including diagnostic specimens, are subject to packaging requirements described in the DOT regulations (49 CFR 171 - 178) and the IATA Dangerous Goods Regulations. Shipments known or suspected to contain a pathogen or toxin are subject to additional packaging and shipping requirements described in these regulations.

Only a person that has been properly trained may package hazardous materials for shipping. All packaging must follow DOT and IATA regulations. For information on packaging and shipping training, visit the Department of Homeland Security website at http://dohs.ors.od.nih.gov/Resources_main.htm.