Biological Agents Overview

General Information

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 Non-U.S. persons may purchase and use EAR export controlled pathogens and toxins for fundamental research. However, the “deemed” export rule applies to any technical information (proprietary, confidential or export controlled) provided by a third party to the University if the technical information is NOT publicly available. The PI may need a “deemed” export license to provide such information to a Non-U.S. person on campus.

In addition, the export of EAR controlled pathogen or toxin outside the U.S. is regulated by the Commerce Department, the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). The University must apply for the appropriate export license before shipment. The Bureau of Industry and Security provides cross references under the Commerce Control List (CCL) Category 1 – Materials Chemicals Microorganisms and Toxins to these other agency controls for convenience only. Therefore, please consult relevant FDA and DEA regulations for guidance related to the item you wish to export and do not rely solely on the EAR for information about other agency export control requirements. Please review UTSA Procedures on Shipping Biological, Chemical and Radiological Materials (PDF) if you are shipping these materials or contact the Office of Research Integrity for assistance.

Overview of ITAR Controlled Pathogens and Toxins

Unlike EAR controlled pathogens and toxins, Non-U.S. persons on campus may not access ITAR controlled chemical agents, biological agents and associated equipment (see Category XIV: Toxicological Agents Including Chemical, Biological Agents, and Associated Equipment, of the United States Munitions List USML) without a license. If you plan to work with a biological agent/substance on campus that is on the USML, please contact the ORI 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.

Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) reviews, approves and oversees the use of recombinant and / or synthetic nucleic molecules, potentially biohazardous materials, agents and toxins in research and educational activities conducted at UTSA. If you plan to work with a biological agent/substance on campus please visit the Institutional Biosafety Committee (IBC) website for additional information.

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