Appendix A: Importation and Exportation of Infectious Biological 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 infectious biological agents, equipment and technologies used for study and processing of these agents. The following outlines two major requirements that must be followed.

Contact the EHS office for assistance in this matter. Laboratories that will import infectious or potentially infectious materials must first be registered with the IBC before the sample can be obtained and stored in the laboratory.

CDC Etiologic Agent Import Permit Program

Infectious biological 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.

Infectious biological agents, vectors, and materials containing infectious biological agents are recognized as hazardous materials. Materials containing infectious biological agents:

• are regularly transported from one location to another by common land and air carriers
• must be appropriately packaged to prevent breakage or leakage in order to avoid exposing the package contents to package handlers, transporters, and the general public
• must be packaged, labeled, and transported in accordance with all applicable regulations
• being imported into the United States must be accompanied by a U.S. Public Health Service importation permit

Importing Biological Agents and Materials into the United States

Before you decide to import biological materials or equipment associated with biological research into the United States, ensure that you review the U.S. import requirements to determine if an import permit or license is required. Securing an import permit may take months so it is critical that you start this process early. It is recommended that you contact the Export Control Officer and the Office of EHS in connection with license application.

All imports into the United States must be processed by a licensed Customs Broker. Most freight forwarders such as World Courier, FedEx etc. have customs brokers on staff to help you. Boston University customs broker is Watchpoint Logistics.

Contact information:
Linda Amiro
International Import Manager
Watchpoint Logistics Inc.
100 Griffin Brook Drive
Methuen, MA 01844
Phone: (617) 567-6800
Email:Linda.Amiro@Watchpointlogistics.com

Contact the University Export Control Officer if you need assistance with import shipments. Link here on detailed guidelines on Importing into the United States by US Customs and Border Protection.

You have approximately 10 days to file import paperwork with US Customs and Border Protection after your shipment has arrived into United States. If you don’t have permits and documentation in place, your shipment will be placed into Customs storage and you will be charged daily fees and penalties. The ultimate issue with biological shipments, of course, is that your materials may get destroyed during this process before you are able to secure an import permit.

Import Permits

Import permits are issued only to the importer on record who must be located in the United States. Import permits may take several months and must be secured prior to the importation of any material. The permit, with the proper packaging and labeling, will help expedite ensure 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 and Border Protection and U.S. Division of Quarantine personnel of the package contents.

Boston University researchers are encouraged to contact the Office of EHS and the Export Control Officer prior to submitting permit application.

Federal Regulation

The importation of infectious biological agents is governed by the following federal regulation: USPHS 42 CFR – Part 71 Foreign Quarantine. Part 71.54 Import regulations for infectious biological agents, infectious substances and vectors.

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 CDC Director.

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).

Items Requiring Permits

Infectious Biological Agents

It is impractical to list all etiologic agents here. 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 biological agent may require a permit in order to be imported.

If you are importing biological materials that are not infectious, you may be required to submit such declaration to U.S. Customs at the time of the import. This document should be on a sender’s university/hospital/company letterhead and signed by an individual who can legally bind the entity. It should accompany all import shipments into the United States to expedite Customs clearance.

Hosts and vectors

• Animals: any animal known or suspected of being infected with an organism capable of causing disease in humans requires 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.
• 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.
• Arthropods: any living insect or other arthropod that is known or suspected of containing an infectious biological agent 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:

• DOT 49 CFR PART 173 – General Requirements for Shipments and Packaging
• For international shipments, the International Air Transport Association’s (IATA) Dangerous Goods Regulations must be consulted.

Importation of Animal Pathogens and related biological materials

USDA and 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 infectious biological 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.

Principal Investigators must submit USDA/APHIS permit applications via IBC staff. More information about the application process can be found in the IBC Policies page.

Importation of Wildlife and Animals

U.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 here.

Importation of Select Agents

Individuals wishing to import select agents and toxins must be registered with the Federal Select Agent Program (FSAP) 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 FSAP Form 2 must be completed and submitted to the Federal 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 Form 2 Transfer Guidance.

Importation of Research Equipment

Research equipment: Some equipment used in biological and medical research must be approved by the Food and Drug Administration (FDA) and must have appropriate safety certificates. Before purchasing equipment abroad, ask the manufacturer if this equipment requires FDA approval and if the company has such approvals in the United States.

Exportation of Infectious Materials

There are two sets of export controls that govern the export of biological materials: the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). The EAR govern the export of dual-use agents, genetic material, vaccines and equipment used in biological research. Prior to the export, you should review the Commerce Control List (CCL) (Category 1) to determine if your material is controlled under an Export Control Classification Number (ECCN). If the material is listed on the CCL, contact the Export Control Officer to help you determine if a license is required. Licensing requirements are based on the material, customer and end-use. If the material is not listed on the CCL and is not controlled under the U.S. Munitions List, it is designated as EAR99. EAR99 material can be exported abroad without an export license unless your collaborator is listed on the “Consolidated Screening List” or you ship to a country where U.S. maintains a comprehensive embargo administered by the Office of Foreign Assets Control; or the end use will be weapons of mass destructions or military end use.

If you are unable to determine the ECCN of your material, the Export Control Officer will submit commodity classification request with the Department of Commerce, Bureau of Industry and Security on your behalf. Classification requests can take anywhere from few days to several months so it is important to plan ahead.

Biological agents, pathogens, toxins specifically modified, developed, configures or adapted for military use are controlled on the U.S. Munitions List (Category XIV) under the International Traffic in Arms Regulations (ITAR). Research with these agents is heavily regulated and licenses are required for you to share these materials with non-U.S. Persons whether abroad or in the United States. Contact the Export Control Officer before shipping ITAR controlled materials abroad as a license is required.

Link here for more information on export controls and biological materials. Export controls regulate more materials/agents than CDC and USDA regardless of quantity or attenuation; therefore, it is critical that you review the Commerce Control List and the US Munitions List prior to any export shipment. DO NOT ASSUME THAT YOUR MATERIAL IS NOT REGULATED.

In addition to the product/material based regulations, you may need an export license based on the destination and customer. Office of Foreign Assets Controls manages economic sanctions and embargoes and you may need an export license to ship to any of these countries. Before you make any export shipments, please verify by screening the Restricted Parties List that no license is required for the receiving researcher, entity or end-user. Some universities are on those lists.

Research Compliance developed guidelines to help you determine whether an export license is required. Please review the Export Control Website, International Shipping Training or contact the University Export Control Officer to provide assistance.

Export licenses or requests for material classifications may take months so you are encouraged to start this process early.

In addition, to the licensing requirements, you should understand that you will need to complete export shipping paperwork. Standard documents include Commercial Invoice and Air Waybill; however, additional documentation may be required depending on the importing country requirements. You should also verify the requirements of the importing country for licensing biological materials prior to dispatching export shipments. Contact the receiving entity or your freight forwarder to provide assistance with foreign country import requirements.

Foreign Trade Regulations

All export shipments valued over $2,500 per commodity classification or subject to an export license must be reported via the Automated Export System to U.S. Census Bureau prior to the export. Your freight forwarder will be able to handle the reporting, alternatively, you should contact the University Export Control Officer to provide assistance.

Recordkeeping

All shippers are required to keep records on file five (5) years from the date of the export or expiration of an export license whatever period is longer.