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Select Agent Personnel Suitability Assessment Program

Policy

As required by federal regulations, all personnel who require access to Tier 1 biological select agents and toxins (BSAT) must be evaluated through the University Personnel Suitability Assessment Program (PSAP) for their suitability to access these agents and toxins.

Scope

The PSAP applies to all University of ÁùºÏ±¦µä, Reno faculty, staff, and students, and to personnel from other academic institutions, government agencies, or private companies, who have access to Tier 1 BSAT that are stored or used in University facilities, or as part of University sponsored work at non-University facilities.

Access to Tier 1 BSAT

Only personnel who have successfully completed the pre-access personnel suitability assessment and have current approval through the ongoing personnel suitability assessment program can be approved for access to Tier 1 BSAT. As allowed by federal regulations, persons who are approved for access to Tier 1 BSAT prior to April 3, 2013 do not have to complete the pre-access assessment; however, they must be included in the ongoing assessment program.

Visiting scientists who are approved for access to Tier 1 BSAT at another institution may be granted access to Tier 1 BSAT at University facilities based on their home institution’s PSAP under the following conditions.

  • Access to Tier 1 BSAT at University is requested for a limited period of time (usually less than 30 days).
  • The visiting scientist has successfully completed a pre-access suitability assessment at his or her home institution (or was excluded from this requirement based on pre-existing approval for access to Tier 1 BSAT prior to April 3, 2013). The home institution’s pre-access suitability assessment must be verifiable and meet the satisfaction of the University Select Agent Responsible Official (RO).
  • The visiting scientist is subject to ongoing suitability assessment at his or her home institution and has current approval to access Tier 1 BSAT. The home institution’s ongoing suitability assessment program and the current status of the visiting scientist must be verifiable and meet the satisfaction of the University RO.
  • The RO at the visiting scientist’s home institution will need to provide a written description of that institution’s PSAP. Additionally, a statement signed by the home institution’s RO must be provided which indicates that the visiting scientist is a participant in that institution’s PSAP and is currently approved for access to Tier 1 select agents.

Access Privileges for Tier 1 BSAT

Only personnel with a legitimate educational or occupational need for access to Tier 1 BSAT will be granted access. Educational or occupational need will be determined based on a request from the academic or occupational supervisor and a determination by the RO. Access to Tier 1 BSAT outside of normal business hours must be specifically approved by the RO.

Personnel Suitability Assessments

Personnel suitability assessments will consist of a pre-access assessment and on-going assessments.

Pre-access suitability assessments will consist of the following elements:

  • Security Risk Assessment (SRA) conducted by the Federal Bureau of Investigation, Criminal Services Information Services Division (CJIS), with approval by the federal Select Agent and Toxin Program.
  • Criminal History
  • Visa Status (as applicable).
  • Resume or Curriculum Vitae.
  • Home Address History –information to be collected for the past 7 years or from the age of 18, whichever represents a shorter period of time. History to be verified at the discretion of the RO.
  • Education History – all post-secondary institutions attended.
  • Work History - information to be collected for the past 7 years or from the age of 18, whichever is represents a shorter period of time. History to be verified at the discretion of the RO.
  • Professional License or Certification History – healthcare-related licenses or certifications for School of Medicine personnel to be verified. Other licenses or certifications to be verified at the discretion of the RO.
  • Reference Check.
  • Occupational Health Evaluation – any physical or mental health issues identified by the occupational health physician that may adversely affect an individual’s ability to safety and securely have access to Tier 1 BSAT.

Ongoing suitability assessments will normally occur every three years; however, they may be conducted more frequently if self- or peer-reporting indicates a concern. Ongoing suitability assessments will consist of the following elements:

  • RO annual evaluation of suitability based on RO observations and knowledge of person’s performance and behaviors, interviews with supervisors and peers, and any self- or peer-reports of incidents, behaviors, or conditions that could affect an individual’s ability to have access to, or work safely with, Tier 1 BSAT.
  • SRA conducted by the Federal Bureau of Investigation, Criminal Services Information Services Division (CJIS), with approval by the federal Select Agent and Toxin Program. A SRA is required by the federal Select Agent and Toxin Program at least every three years and can be required more frequently.
  • Criminal History every three years to coincide with SRA renewal.
  • Visa Status (as applicable) every three years to coincide with SRA renewal.
  • Self- and peer-reporting of incidents, behaviors, or conditions that could affect an individual’s ability to have access to or work safely with Tier 1 select agents and toxins.

Suitability to Access Tier 1 BSAT

Decisions regarding the suitability of personnel to have access Tier 1 BSAT will be made in consultation with the Certifying Official and will be based on a determination of the person as a risk to the security and safety of these agents and toxins. Information obtained through the PSAP will be evaluated in terms of the “whole person” and will consider favorable and unfavorable information, the circumstances of events causing concern (time passed, number of events, and the individual’s circumstances), mitigating factors, and relevance to security and safety of Tier 1 BSAT. Decisions to deny, suspend, or terminate an individual’s access to Tier 1 BSAT will be made by the RO in consultation with the Certifying Official (CO), Assistant Vice President, Human Resources or other appropriate Human Resources official, and University General counsel.

PSAP Certifying Official

The Vice President for Research and Innovation (VPRI) or Associate Vice President for Research and Innovation (AVPRI), as designated by the VPRI, will serve as the certifying official for the University PSAP. Responsibilities of the certifying official include ensuring that personnel meet the criteria established by the University PSAP for access to Tier 1 BSAT and notifying the RO on such matters.

Appeals

Individuals who are denied access to Tier 1 BSAT based on a negative decision regarding their suitability for access to Tier 1 BSAT can request an appeal of the decision. Request for an appeal must be made in writing to the RO and the Certifying Official. The decision is final and there is no further appeal.

Reference Regulations

42 CFR Part 73, Possession, Use, and Transfer of Select Agents and Toxins

7 CFR Part 331, Possession, Use, and Transfer of Select Agents and Toxins

9 CFR Part 121, Possession, Use, and Transfer of Select Agents and Toxins