The Federal Select Agent Program regulates all work with select agents and toxins, including possession, use and transfer. Researchers at the UW working with select agents and toxins are required to enroll in the UW Select Agent Program before they can begin work.
Select agents and toxins can pose a severe threat to public, animal or plant health, or to animal or plant products. The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention and the Animal and Plant Health Inspection Services. At the UW, EH&S oversees and administers the UW Select Agent Program. Failure to comply with the Select Agent regulations is considered a violation of federal law and may be associated with criminal and civil liability.
Regulated Select Toxins
Use of select toxins requires approval enrollment in the UW Select Agent Program unless at or below the permissible amounts specified by the Federal Select Agent Program. Email uwsa@uw.edu to find out if you need to enroll.
Regulated select toxins include:
- Abrin
- Botulinum neurotoxins
- Short, paralytic alpha conotoxins
- Diacetoxyscirpenol (DAS)
- Ricin
- Saxitoxin
- Staphylococcal enterotoxins (subtypes A, B, C, D, and E)
- T2 toxin
- Tetrodotoxin
Requirements for Work with Select Toxins in Any Amount
The U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC-PEPP Policy) requires that federally funded research involving select toxins is assessed for Dual Use Research of Concern (DURC). Familiarize yourself with the Principal Investigator requirements as outlined in “DURC-PEPP Policy” on the EH&S DURC-PEPP webpage. A Self-Assessment WorksheetPDF is available to help you assess your research.
Any transfer of select toxins in any amount to any intra- or extramural entity or individual requires documentation of due diligence. If you plan to transfer any of the above toxins, complete the UW Select Toxin Transfer Due Diligence Form and submit to uwsa@uw.edu prior to transfer. The Principal Investigator sending the toxin is responsible for documenting due diligence and maintaining records for three years. The Federal Select Agent Program’s Due Diligence Frequently Asked Questions has more information.
Because biotoxins may be extremely toxic in very small quantities, manage them as hazardous chemicals. Visit the Biotoxin Safety webpage for guidance on the safe use and handling of biotoxins, template SOPs, and more.
Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic PotentialPDF (DURC-PEPP Policy) goes into effect on May 6, 2025. The DURC-PEPP Policy applies to federally funded research that involves certain biological agents and toxins or modification of pathogens.
All select agents and toxins are included in the biological agents and toxins within the scope of Category 1 ResearchPDF as defined in the DURC-PEPP Policy.
Category 2 or PEPP research includes some select agents as well as other pathogens:
- An existing pathogen with pandemic potential (PPP) (i.e., SARS-CoV, SARS-CoV-2, Ebolaviruses)
- Any pathogen that will be modified so as to reasonably result in a PPP
- Generation, use, reconstitution, or transfer of an extinct or eradicated PPP (i.e., Variola major, Variola minor, 1918 influenza virus)
If your research involves any of these biological agents and toxins, familiarize yourself with the Principal Investigator requirements as outlined in “DURC-PEPP Policy” on the EH&S DURC-PEPP webpage. A Self-Assessment WorksheetPDF is available to help you assess your research.
More About the UW BSL-3 and Select Agent Program
Working with select agents and toxins requires higher scrutiny and increased responsibility for biosecurity. Researchers in the UW Select Agent Program must comply with all components of the program, including federal security clearance, ongoing training, inventory management and authorization. The Federal Select Agent Program has more information about personnel restrictions, agent registration, laboratory security requirements, and strict criteria to receive or transfer select agents and toxins.
EH&S Biosafety administers and oversees all components of the UW Biosafety Level 3 (BSL-3) and Select Agent Program, including authorization, training, inventory management and biosecurity. Biological Use Authorization (BUA) is required for all research involving select agents and toxins.
All select agents and toxins are within the scope of the DURC-PEPP Policy and require PI self-assessment.
Select toxins when used at or below the permissible limits still have additional oversight and safety requirements including assessment for DURC-PEPP and due diligence procedures.
Emergency Response and Reporting
UW personnel are required to submit an incident report to Environmental Health & Safety for any work-related event that results in an injury, illness, exposure to hazardous materials, property damage, or fire, regardless of the work location. UW personnel are highly encouraged to submit work-related near-miss events. Visit the Incident Reporting page for more information.
Notify EH&S immediately (after first aid/medical care/emergency services) if the incident involves recombinant or synthetic nucleic acids or genetically modified organisms.
- During EH&S business hours: (8:00 a.m. to 5:00 p.m., Monday to Friday) call (206) 221-7770.
- Outside of EH&S business hours: call the UW Police Department at (206) 685-8973 to reach EH&S on-call staff.
Frequently asked question
Yes, if you plan to transfer your toxin in any amount, submit the UW Select Toxin Transfer Due Diligence Form to uwsa@uw.edu prior to any transfer of select toxins any amount.
You also need to implement safety procedures for work with toxins, even if your select toxin is below the permissible limit. Review the Biological Toxin Safe Work Practices guidance documentPDF, implement an SOP for your work (template available upon request) and provide training. Contact EH&S if you need assistance.