Biological Agents

Both the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR) have provisions for the control of pathogens and toxins. The control level is different depending on which regulations control the item.

Overview of EAR Controlled Pathogens and Toxins

Inside the United States, any person, including foreign nationals may purchase and use EAR export controlled pathogens and toxins for fundamental research. However, the "deemed" export rule applies to technical information about the controlled item. For example, if a PI receives confidential, proprietary or export controlled information about the development or production of an EAR controlled biological, then the PI may need a "deemed" export license to provide such information to a foreign national on campus. Contact the Export Controls Coordinator for assistance.

In addition, if a PI wishes to ship an EAR controlled pathogen or toxin outside the U.S. the PI must apply for the appropriate export license before shipment. Contact the Export Controls Coordinator for assistance.

Department of Commerce dual-use export control-listed pathogens and toxins are listed below. These pathogens and toxins are found on the Commerce Control List (CCL) in Category 1 at ECCNs 1C351 through 1C360. 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 international shipments without an export license of ANY export controlled pathogen or genetic material containing the controlled DNA.

You will need to contact CU Boulder's Export Controls Coordinator if your research requires an export controlled pathogen or genetic material containing the controlled DNA to be sent outside of the U.S. so that an export license application can be prepared. Export licenses take 4-6 weeks for approval, so please plan in advance.

Overview of ITAR Controlled Pathogens and Toxins

Unlike EAR controlled pathogens and toxins, foreign nationals on campus may not 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 U.S.. MULTIPLE Export Controls, INCLUDING a License will be required to use or possess the following:

Commerce Control List (microorganisms and toxins)

USML (Category XIV)