Select Agent Program

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.

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 website has more information about personnel restrictions, agent registration, laboratory security requirements, and strict criteria to receive or transfer select agents and toxins.

Failure to comply with the Select Agent regulations is considered a violation of federal law and may be associated with criminal and civil liability.

Select toxins and due diligence

For any transfer of select toxins in any amount to any intra- or extramural entity or individual requires documentation of due diligence.

Regulated select toxins include:

  1. Abrin
  2. Botulinum neurotoxins
  3. Short, paralytic alpha conotoxins
  4. Diacetoxyscirpenol (DAS)
  5. Ricin
  6. Saxitoxin
  7. Staphylococcal enterotoxins (subtypes A, B, C, D, and E)
  8. T2 toxin
  9. Tetrodotoxin

You must enroll in the UW Select Agent Program and obtain approval for work with select toxins at or above the permissible amounts.  Email uwsa@uw.edu to find out if you need to enroll.

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.

Dual use research of concern (DURC)

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 U.S. 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.

For more information, see Dual Use Research of Concern (DURC).

What you need to know

Research with select agents and toxins is highly regulated by the Federal Select Agent Program and requires increased oversight.

Contact the UW Select Agent Program at uwsa@uw.edu or 206.221.7770 if you have any plans to do research with select agents or toxins

Submit the UW Select Toxin Transfer Due Diligence Form to uwsa@uw.edu prior to any transfer of select toxins any amount..

Services available

EH&S administers and oversees all components of the UW Select Agent Program, including authorization, training, inventory management and biosecurity.

Biological Use Authorization (BUA) is required for all research involving select agents and toxins.

Frequently Asked Questions (FAQ)

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 document, implement an SOP for your work (template available) and train staff on procedures. Contact EH&S if you need assistance.