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Research Compliance and Tech Transfer

Appendix A: Importation and Exportation of Etiologic Agents

Multidisciplinary and multi-institutional research is a common practice that involves collaboration among faculty from various institutions and countries. At times, it is necessary to share biological samples or materials with collaborators. Federal regulations strictly control the importation and exportation of etiologic agents. The following outlines two major requirements that must be followed.

CDC Etiologic Agent Import Permit Program

Etiologic agents are materials known or reasonably expected to contain a pathogen. This includes microorganisms and biological toxins that cause disease in humans and include bacteria, bacterial toxins, viruses, fungi, rickettsia, 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 to avoid exposing the package contents to package handlers, transporters, and the public. 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 U.S. Public Health Service Division of Quarantine and release by U.S. Customs.

The importer is legally responsible for ensuring 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 importer’s address, 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.

Utilize the CDC IPP website for permitting questions and forms.

Federal Regulations

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 person may not import into the United States any infectious biological agent, infectious substance, or vector unless:

  1. It is accompanied by a permit issued by the Centers for Disease Control and Prevention (CDC). The possession of a permit issued by the CDC does not satisfy permitting requirements placed on materials by the U.S. Department of Agriculture that may pose hazards to agriculture or agricultural production in addition to hazards to human
  2. The importer is in compliance with all of the permit requirements and conditions that are outlined in the permit issued by the
  3. The importer has implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended
  4. The importer takes measures to help ensure that the shipper complies with all applicable legal requirements concerning the packaging, labeling, and shipment of infectious

Permitted materials may not be distributed or transported to other users unless accompanied by a separate permit.

Items Requiring Permits

To confirm if a permit is required, utilize the CDC’s IPP e-Tool.

Etiologic Agents

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’s Division of Global Migration and Quarantine (http://www.cdc.gov/ncidod/dq/).
  • 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 at CDC Importation of Animals website (http://www.cdc.gov/ncidod/dq/).
  • 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 CDC permit. 

Packaging Requirements

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

  • USPHS 42 CFR Part 72 - Interstate Shipment of Etiologic Agents
  • DOT 49 CFR PART 173 - Transportation of Etiologic Agents
  • For international shipments, the International Air Transport Association’s (IATA) Dangerous Goods Regulations should be consulted. 

Other Permits

USDA and APHIS permits are required for infectious agents of livestock and biological materials containing animal material and importing of plant and plant products. 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 because of the potential risk of introduction of exotic animal diseases into the United States. For more information, contact USDA/APHIS at their website.

  • S. Fish and Wildlife Service permits are required for certain live animals, including bats. For more information, call (800) 344-WILD or visit their website, http://www.fws.gov/.
  • Individuals wishing to import select agents and toxins must be registered with the 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 CDC website.

Animal Product Imports

The importation of animal products, byproducts, and materials exposed to animal-sourced substances is regulated to prevent the introduction of foreign animal diseases into the United States. Researchers must comply with all applicable U.S. Department of Agriculture (USDA) requirements before importing any animal-derived materials for research.

VS Import Permit Requirements: VS Permitting Assistant

In most cases, a VS import permit is required for:

  • Animal-derived materials (e.g., tissues, blood, sera)
  • Products exposed to animal-sourced materials
  • Animal byproducts or research samples originating from livestock, wildlife, or other animal species

Always verify permit requirements prior to arranging shipment.

Plant and Plant Product Imports

The USDA Animal and Plant Health Inspection Service (APHIS) regulates the importation of plants and plant-derived materials to prevent the introduction of plant pests, pathogens, and other agricultural threats into the United States. These regulations apply to a wide range of plant-related items, including:

  • Live plants and plant tissue
  • Seeds and cuttings
  • Soil, plant pests, and biological control organisms

Agricultural Commodity Import Requirements (ACIR)

Exportation of Infectious and other Biological Materials

United States export controls are a complex set of laws and regulations in place to ensure national security and economic stability, prevent the proliferation of weapons of mass destruction, and further U.S. foreign policy. U.S. export control laws govern the transfer of technology, information, and commodities overseas or to a foreign national within the U.S. These laws cover all types of entities, organizations, and individuals, including the University of Montana, its faculty, staff, students and visitors. As you navigate the export control website, please make use of our glossary for clarity on terms and vocabulary.

The export of a wide variety of etiologic agents of human, plant, and animal diseases may require a license from the Department of Commerce. To determine if a license is necessary, visit the BIS website.

UM’s Export Control Program will assist you in determining whether an export license is required for your shipment. If an export license is required, then you should anticipate and plan for a non-trivial delay while your license application is prepared by UM, and then reviewed by the Department of Commerce.

Export control regulations are rather complex and may have multi-agency jurisdictions that must approve activities. The Department of Commerce regulations state that:

“Activities subject to the Export Administration Regulations (EAR) may also be controlled under export-related programs administered by other agencies. Items and activities subject to the EAR are not necessarily exempted from the control programs of other agencies.”

Please contact both the Export Control and the Biosafety Program as soon as possible if you intend to export any biological materials. Together, these UM resources can help assist you in navigating the required processes and ensuring both you and UM remain legally compliant with applicable federal law.