Work involving select agents and toxins is strictly regulated by the Federal Select Agent Program.
The Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins which have the potential to pose a severe
threat to public, animal or plant health, or to animal or plant products. The program is jointly comprised of the Centers for Disease Control and
Prevention (CDC)/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Services (APHIS)/Agriculture Select Agent Services.
See the regulated Select Agents and Toxins List.
Researchers working with select agents and toxins are under heightened scrutiny and have increased responsibility for biosecurity. They are required to enroll
in the UW Select Agent Program prior to work and must comply with all requirements of the program including
federal security clearance, ongoing training, inventory management, and authorization. More information about personnel restrictions, agent registration,
laboratory security requirements, and strict criteria to receive or transfer select agents and toxins can be found on the Federal Select Agent Program website.
Environmental Health and Safety (EH&S) oversees and administers the University of Washington's Select Agent Program. The University's Responsible Official (RO) for the Select Agent Program is the EH&S Director.
If you have any questions about select agents and toxins, please contact EH&S Research and Occupational Safety at 206.221.7770 or firstname.lastname@example.org. For agent or medical monitoring
information, see BSL-3 and Select Agents.
Failure to comply with the Select Agent Regulations is considered a violation of Federal Law and may be associated with criminal and civil liability.
Due to changes in the federal regulations, documentation of due diligence is now required for any transfer of
select toxins in any amount (intramurally or extramurally),
to any entity or individual. Regulated select toxins include:
- Botulinum neurotoxins
- Short, paralytic alpha conotoxins
- Diacetoxyscirpenol (DAS)
- Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)
- T2 toxin
Researchers who plan to transfer these toxins must complete the UW Select Toxin Transfer Due Diligence Form
and submit a copy to EH&S Biosafety at email@example.com prior to the transfer. It is the responsibility of the Principal Investigator sending the toxin to perform due
diligence and to keep records for three years.
Please note that Federal Select Agent Program approval and enrollment in the UW Select Agent Program is required for
anyone in possession of select toxins at or above the permissible amounts.
Refer to the Federal Select Agent Program's Due Diligence Frequently Asked Questions for more information.
Dual use research of concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge,
information, products, or technologies that could be directly misused to pose a significant threat with broad consequences to public health and safety,
agricultural crops and other plants, animals, the environment, or national security. The
United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
describes the policies, practices, and procedures required to ensure that DURC is identified and risk mitigation measures are implemented. See the
EH&S DURC website for UW policies and procedures.