Select Agents and Toxins
Biological Select Agents and Toxins are a specific class of research that includes organisms, viruses and toxins that could be weaponized and used as a biological weapon. The agents, artificial derivatives, genetic elements, or nucleic acids of any agent or agent vaccine are tightly regulated and possession of such material without registration, bonafide need or notification of the proper authorities is a violoation of Federal Law, punishable by fines and/or imprisonment.
All proposed work with select agents is dependent on IBC approval which is also contingent on registration with the Federal Select Agent Program, initial site inspections by EH&S and possibly the Center for Disease Control (CDC).
Security measures must be considered for the area of intended research which includes but may not be limited to the following items:
- Personnel Security Risk Assessment and Initial Screening
- Enrollment in the Personnel Suitability Program for Pre-Access and Ongoing Screening
- Development and implementation of an approved Biosafety Plan
- Development and implementation of an approved Security Access Plan
- Development and implementation of an approved Incident Response Plan
- All required training has been completed, and;
- All required Standard Operating Procedures have been approved through EH&S.
*Note all programs and corresponding plans can be found on the Programs page
Enforcement of U.S. Laws: Title 18, United States Code (U.S.C.)
18 USC 175(a)
Crime to knowingly possess a biological agent, toxin, delivery system for use as a weapon.
18 USC 175(b)
Crime to knowingly possess a biological agent, toxin or delivery system if not for peaceful, bona fide or prophylactic research purposes.
18 USC 175b
Crime to knowingly possess select agent, regardless of intent, if not registered with U.S. Select Agent Program.
18 USC 175c
Crime to produce, engineer, or synthesize smallpox.
Weapons of Mass Destruction (WMD) and WMD Terrorism
18 USC 806
Enhances ability to seize assests of those with Weapons of Mass Destruction (WMD) Intent
18 USC 842
Crime to teach or demonstrate the making or use of a Weapon of Mass Destruction (WMD)
18 USC 2332a
Crime to use (or conspire, threaten, or attempt to use) a Weapon of Mass Destruction (WMD)
Biosafety Plan Template
A template biosafety plan compliant with Select Agents and Tier 1 Select Agents is available through EH&S and includes working SOP's. The template must be completed, properly formatted and submitted to EH&S for final review prior to preparing a registration to the Federal Select Agents Program or a submission to the IBC.
Security Plan Template
A template security plan is available for Select Agents and an amendment is available for Tier 1 Select Agents and can be obtained through EH&S. The template must be completed, properly formatted and submitted to EH&S for review.
Incident Response Plan Template
A template incident response plan is available for Select Agents and for Tier 1 Select Agents and can be obtained through EH&S. The template must be completed, properly formatted and submitted to EH&S for review.
A copy of the EH&S Tier 1 Pre-access Suitability Plan is available for review below and outlines the requirements and policies associated with bringing new authorized users into the select agent program for Tier 1 BSATs. Tier 1 Pre-access Suitability Plan
Ongoing Suitability Plan
A copy of the EH&S Tier 1 Ongoing Suitability Plan is available for review below and outlines the requirements and policies associated with maintaining the Tier 1 BSAT program. All employees are subjected to routine ongoing assessments. Tier 1 Ongoing Suitability Plan
Please visit the Programs section to view an active listing of current programs and written plans. Please note that due to the sensitivity of Select Agent Research, some documentation may only be available by contacting EH&S.
BSAT Approval Process
- Notify EH&S of interest to conduct Select Agent research.
- Schedule a Site Specific Risk Assessment of any intended location of research. Use results to generate the specific parameters for the "Required Documentation."
- Complete all "Required Documentation" as stated above and retain any exemption letters, approval notices and notices of revisement from EH&S. You should immediately create a comprehensive Select Agent Program file.
- EH&S will provide FD-961 form for a security risk assessment, fingerprints and audit of criminal background. If approved, the employee will be enrolled in the suitability program.
- Enroll in the suitability program and take an assessment with the review panel. (if Tier 1)
- Upon successfully completing the assessment (if Tier 1) consult with EH&S on an IBC submission.
- Make a submission to the campus IBC and supply any additional information if requested.
- If approved, submission to CDC for formal registration will be granted and, grant funding will be released (if applicable).