Tier 1 Select Agents Suitability Program
Program Description:
The intent of this program is to provide a system for evaluating employees with access to Tier 1 Select
Agents. The scope of this document is all incoming personnel, both faculty, staff and students
(undergraduate or graduate) who intend to gain access to Tier 1 Select Agents, in addition to an annual
review of all approved personnel with access to Tier 1 Select Agents.
The assessment is designed to identify risk factors in the individuals either seeking approval or in those
with existing approval. Some areas of confidential consideration include but are not limited to the
following:
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Prior convictions
Personal behaviors
Financial stability
Personal relationships
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Derogatory behaviors
Criminal behaviors not resulting in
conviction
The program considers various elements which are weighed to determine an overall risk or granting or
renewing personnel access to Tier 1 Select Agents. Included in this program are a series of procedures
which outline the requirements of approval, the process of granting and withdrawing access,
anonymous reporting etc. The risk of an individual is assessed solely by an administered questionnaire
and/or follow-up interview. Responses to the questionnaire are assessed by a review panel and will
decide to renew or grant access based on a risk threshold determined by the applicant’s responses. The
panel does not deal in concrete facts of what a person will or will not do, merely a probability that an
individual has a higher risk factor and does not meet the threshold criteria.
Instructions to the Entity:
This program was developed by the office of Environmental Health and Safety of California State
Polytechnic University, Pomona. The roles of contributors are indicated below.
a) Responsible Official (RO)- The RO for the Select Agent Lab was responsible for advising and
providing critical information as this program was drafted.
b) Biosafety Specialist- Responsible for the development and integration of the program and
compliance with written guidance documents and regulations.
c) The (CO) will be satisfied by the Biosafety Specialist in collaboration with the RO.
d) Human Resources (HR) is the parent department for Environmental Health and Safety and was
available for consultation on issues pertaining to employee relations and handling of
information.
e) Security consultation and involvement was sought through the University Police Department.
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f)
Biosafety was again represented by the Biosafety Specialist with Environmental Health and
Safety.
g) Personnel enrolled in the Suitability Program are welcome to offer suggestions or insight to
further reinforce the program and improve its functions on our campus in an effort to further
promote safety.
Roles and Responsibilities:
In this section we outline the responsibilities of all program administrators, their involvement in the
program and which functions they will control.
a. RO (or designee) will be responsible for arranging assessment panel meetings to review
applicants and will schedule interviews as necessary. The RO shall designate duties to another
member of the panel if they so choose.
b. Certifying Official (CO) will be responsible of facilitating the duties of the RO when necessary.
The CO shall collaborate with other departments as necessary, (i.e. Human Resources). This role
shall also perform the duties of REV (reviewer) in facilitating the presentation of new applicants
to the panel for review.
c. Police Department (PD) will be responsible for attending panel meetings and facilitating
assessments with the applicant. A PD representative should be knowledgeable in behavioral
indicators such as body language, avoidance tactics etc.
d. Psychological Services Representative (CAPS) will be responsible for attending panel meetings
and offering expertise in conducting applicant interviews as needed. The CAPS rep should be
experienced in working with patients and qualified to make general psychological assessments
based on a questionnaire.
Elements of Pre-Access Suitability:
The Pre-Access Suitability Assessment is designed to assess one’s suitability to work with Tier 1 Select
Agents prior to being granted un-escorted access to the regulated material. Any individual who currently
has not been granted access to a Tier 1 Select Agent shall undergo a Pre-Access Suitability Screening
prior to being granted access to that material. Those seeking initial approval may be existing campus
employees (Faculty/ Staff) or in certain situations, newly hired employees may require approval to begin
research. In either situation, the review and evaluation of professional qualifications are not sufficient
and does not solely constitute suitability to have access to Tier 1 Select Agents. An assessment must be
made to certify that the individual possesses attributes that support public safety and security of the
Tier 1 BSAT. For additional information regarding Pre-Access Suitability, please contact Environmental
Health and Safety to obtain a copy of the Pre-Access Suitability Plan. A brief overview of the plan is
referenced in the Security Plan for Tier 1 BSAT.
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Elements of Ongoing Assessment of Personal Suitability:
Ongoing suitability assessments are performed in direct response to a regulatory requirement to
determine an individual’s suitability for access to Tier 1 BSAT and to ensure that the individual continues
to merit access. The ongoing assessment process shall be performed on an annual basis for all
employees enrolled in the BSAT program. All individuals with access to the Tier 1 BSAT are subject to the
ongoing suitability assessment program although for employees new to the program, it is not necessary
to assess their suitability more than once per calendar year. Therefore an employee who has undergone
a pre-access suitability assessment will not be required to undergo an ongoing assessment within the
same year, but shall be assessed on an annual basis. It is at the discretion of the Review Panel to assess
individuals under special circumstances which may require more than one assessment in a single
calendar year. There are a series of required elements within the ongoing assessment program which
include the following:
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A mechanism shall be in place to allow and support self and peer-reporting of any and all
behaviors of concern or questionable in nature. The program is concerned with incidents or
actions that could affect an individual’s ability or eligibility to work with/ or have access to Tier 1
BSAT, and safeguard those materials from loss, theft or release. Anonymous reporting shall be
available to protect peers from reprisal.
Ongoing monitoring of suitability shall be performed for all individuals with access to Tier 1
BSAT.
All ongoing candidates shall have annual training on entity policies and procedures for the
following areas:
o Reporting
o Evaluations
o Corrective Actions
A brief overview of these procedures is outlined in the Security Plan for Tier 1 BSAT. In addition, you
may contact Environmental Health and Safety for a copy of the Ongoing Suitability Assessment Plan.
Appendix:
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