Suitability Assessment Program Guidance: Pre-Access Suitability Assessments

Section 11(f)(1) of the select agent regulations requires entities registered to possess, use, or transfer Tier 1 BSAT to include the procedures to evaluate person’s suitability for access to these materials in its security plan.

The entity should develop a policy for collecting, evaluating, and protecting personnel information based on institutional policy and federal, state, and local laws. Please see the sample Pre-Access Suitability Adjudication Flow for a detailed example procedure. The entity may have previously requested some or all of this information from an employee prior to hiring, with the information (such as criminal, work, and education history) maintained in the individual’s permanent employment record. HR personnel may coordinate with the RO to determine if the information has previously been collected and is sufficient for the person’s pre-access suitability assessment for access to Tier 1 BSAT.  A consideration could be to include the requirement for suitability assessments in a job announcement.

Pre-Access Suitability Assessment

A “whole person” assessment for each individual should consider both favorable and unfavorable information, along with mitigating circumstances, and overall qualities of credibility to determine suitability. The following are examples of information which could be   reviewed for each individual undergoing the pre-access suitability assessment, as appropriate and consistent with the time frame according to institutional policy, and federal, state, and local law:

1. Home Address History – This information could be used to corroborate local criminal conviction and arrest record checks and other information provided by the person. Include at minimum the states/countries where the individual has resided.
2. Work History – Assess prior work experiences for security concerns. Requesting multiple professional work references provide a more “whole person” assessment of this individual.  If a person is unwilling to provide any work references,  careful consideration should occur before issuing the person access approval to Tier 1 BSAT.
3. Education History – Consideration should be given to the accreditation of the educational institutions that the individual has claimed to have attended. Consider requesting records from  post-secondary institutions the individual claims to have attended, and any other applicable supporting documentation (e.g. if the person has not attended a post-secondary institution).
4. Criminal History – Be aware that in the context of a criminal conviction and arrest history, the outcome of the SRA will only be affected by indictments or convictions of crimes punishable by imprisonment for a term exceeding 1 year. Individuals may have been convicted of lesser crimes or have been arrested for activities that are not relevant to suitability assessments (i.e., misdemeanors). Remaining consistent with state and local laws, obtaining criminal records to:
   • Verify personal reports of criminal activity and determine deliberate withholding of information. Assess the person’s honesty and truthfulness in answering relevant questions. The person’s willingness to provide facts may be considered a ‘positive’, while an attempt to cover up an event would be assessed as a ‘negative.’
   • Determine the nature and seriousness of any offenses and their relevance to Tier 1 BSAT job duties.
   • Determine patterns of behavior that may be of concern to the security and safety of the program. For example, a record of multiple arrests, even without conviction, may point to an instability that may indicate a pattern of behavior not consistent with suitability for access to Tier 1 BSAT.
   • All events should be put into the context of the “whole person.” Consideration should be given to:
     • The nature of the event and whether the demonstrated behavior increases the risk in the laboratory.
     • An individual’s circumstances at the time of an event.
     • The time that has passed since the event of concern.
     • The total number of events causing concern.
   • Consider, as possible mitigating factors, positive information about the person, including work performance or education since any derogatory event(s), the interpretation of the event(s) by supervisors at the time (and supervisors since), and how the individual interprets the event(s) during his or her interview.
   • Utilizing security personnel and legal counsel to evaluate criminal conviction and arrest records to determine  suitability of an individual  will assist the RO in the evaluation.
5. Resume or Curriculum Vitae –  Entity can use this information to assess the person’s recent paid and unpaid work experiences, scientific publications, and affiliations for research with select agents or toxins, as applicable. Verification of  any degrees claimed on the resume or curriculum vitae with the registrar or other administrative body of each institution could be useful.
6. Professional License and Certification History – Consider verifying information with the relevant certifying body, if possible, for licenses or certifications an individual claims to have earned (e.g., technologists, medical doctors, doctors of veterinary medicine). Contacting State boards of licensure in each location where the individual has lived may  identify any negative information associated with each license possessed by the individual, since this information may not be routinely shared among state boards.
7. Visa Status (if applicable) – Establish procedures to verify the identity of the person. Typically, an individual’s visa status is tied to employment.
8. References and Contact Information – Consider requesting professional and peer references for each individual. Ask questions that elicit an impression of the person’s reliability, trustworthiness, honesty, judgment, emotional or mental stability, whether their interactions with colleagues have been inconsistent or unusual, if there are potential conflicting allegiances, and if there are any behaviors or personal characteristics that may point to vulnerabilities to coercion. If relevant, professional references should be able to discuss a person’s technical competency, including willingness and ability to adhere to administrative controls for safety and security.

Other optional information sources may already have been used by an entity as part of the initial hiring process and/or used to determine an individual’s suitability to access select agents or toxins, such as:

• Personnel records review (e.g., credit checks, driving records)
• Occupational health evaluation
• Evaluation by employee assistance program counselors
• Drug testing

If these information sources are used currently to assess an individual’s suitability for employment, an entity may decide to incorporate these information sources as a component of the entity’s suitability assessment program for access to Tier 1 BSAT.

Additional Information Requested for Individuals in a Supervisory Role

When considering Individuals acquiring access to Tier 1 BSAT who will be in a supervisory role (e.g., PIs, laboratory managers, RO, AROs, owners/controllers, etc.) may require further collection of information from sources such as

• Review of performance evaluations
• History of grievance/complaint records
• Information gathered upon exit interviews with staff
• History of retention of subordinate staff
• Record of previous or current collaborations
• History of compliance with the Federal Select Agent Regulations
• Life changing events (personal and professional)

Applicant Interview

The entity may  interview each person requesting access to Tier 1 BSAT to discuss the person’s views and ideas and to convey critical information to the person to encourage honesty and discourage unsuitable behavior. An interview also allows for the discussion of any missing or questionable information, and provides an opportunity for the entity to request additional information if there are concerns about incorrect, omitted or otherwise unfavorable information. See Example Interview Questions for more detailed recommendations.

Interviewers may  assess the individual’s responses and attitudes toward biosafety, security, and Tier 1 requirements outlined in the select agent regulations. Discussions with individuals could  include the benefits and challenges of work with Tier 1 BSAT, and the institutional expectations for self- and peer-reporting, incidents or conditions that may affect suitability, safety or security of Tier 1 BSAT.

Individuals repeatedly exhibiting behaviors that demonstrate they are incapable of adhering to safety or security practices should be denied access to Tier 1 BSAT. An entity may consider temporary and permanent access restrictions in accordance with entity policy. Individuals with access to Tier 1 BSAT should be able to support both the entity’s general and the laboratory-specific goals of safety, security, and compliance with the select agent regulations in the laboratory.