Human, animal, and plant pathogens and toxins, and the organisms modified to produce them, are controlled under the Export Administration Regulations (EAR) or the International Traffic in Arms Regulations (ITAR). The level of control and the potential flexibilities that can be exercised, will depend on many factors, including the jurisdiction under which the item in question falls, as well as the amount and intended recipients. Most pathogens and toxins are controlled by the United States in response to agreements in multilateral forums--i.e., groups of other nations looking to set similar controls. The Department of Commerce has a specific division, the Chemical and Biological Controls Division, that liases with industry and implements the dual use aspects of export controls.

EAR Controlled Pathogens and Toxins

For sales and transfers completely within the United States, the EAR does not preclude foreign nationals from purchasing or using export controlled pathogens and toxins, as well as any genetically modified organisms that produce them (together "biological agents"). Other government agencies, most relevantly the Federal Select Agent Program, do regulate the use, transfer and storage of biological agents. And most research universities will have an office separate from export controls, that oversees safe use and transfer of dangerous biological materials.

Yet, there can be aspects inherent in the technology and associated equipment that, from the perspective of deemed export compliance, may require a license, depending on the specific facts. For example, if a researcher receives significant non-public information to enhance the production capabilities in relation to an EAR controlled biological agent, then a license may be needed prior to allowing access to a foreign national working in that lab.

If a researcher wishes to ship an EAR controlled biological agent outside the United States, the traditional export compliance approach applies, and the researcher should contact the Office of Export Controls to apply for the appropriate export license prior to shipment. Please note that export controls also apply to genetic elements and genetically modified organisms that contain DNA associated with the pathogenicity of these biological materials. Severe civil and/or criminal penalties apply to unauthorized international shipments of ANY export controlled biological agent. Export licenses take 4-6 weeks for approval, so please plan in advance.

ITAR Controlled Pathogens and Toxins

Foreign nationals on campus may not purchase, use, or access ITAR controlled biological agents/substances (see Category XIV: Toxicological Agents Including Chemical, Biological Agents, and Associated Equipment, of the United States Munitions List USML) without a license. The ITAR treats as a defense article any of the following:

  • "Biological agent or biologically derived substance specifically developed or modified to increase its capability to produce casualties in humans or livestock or to degrade equipment or damage crops"
  • "Equipment and its components, parts, accessories, and attachments specifically designed or modified for military operations and compatibility with military equipment. . . ."

Note that equipment used with biological materials may be included under this category.

If you plan to work with a biological agent/substance on campus that is on the USML contact the Export Controls Coordinator for assistance before you bring the item onto campus.  ITAR controlled biological agents/substances will also require a license for export outside the United States.