Biological Agents Overview

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 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 of the United States Munitions List USML) without a license. ITAR controlled biological agents/substances will also require a license for export outside the U.S. If there is a pathogen that appears on both the ITAR and the EAR, ITAR controls govern 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 principal investigator (PI) receives confidential, proprietary, non-public domain, non-fundamental research or other 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. Please note that equipment used for the development or production of controlled biological agents in non-standard conditions, developing equipment for producing controlled biological agents, and, or the use of biological equipment may be considered a deemed export.

In addition, if a PI wishes to ship an EAR controlled pathogen, toxin, or equipment capable of producing a pathogen or toxin, outside the U.S. the PI must apply for the appropriate export license before shipment.

For export control questions, or to apply for a license, please contact Dr. Marcia Shelton at 936.261.1588.

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