Suitability Assessment Program Guidance: Denial, Termination, or Suspension of Tier 1 BSAT Access

Section 10 of the select agent regulations requires that the RO immediately notify FSAP when an entity has terminated an individual’s access to select agents or toxins, regardless of whether or not this person had access to Tier 1 BSAT. The notification must include the reason for termination of access. Notification should be submitted in writing via mail, fax, or email to FSAP.

Termination of access privileges to Tier 1 BSAT may occur when an individual:

• Is no longer employed by the institution.
• Has job duties that no longer require access to Tier 1 BSAT.
• Voluntarily requests to have Tier 1 BSAT access privileges removed.
• Is found unsuitable for access to Tier 1 BSAT based on an entity’s assessment of suitability.

In some instances, an individual may retain access privileges to non-Tier 1 BSAT following termination of his/her access to Tier 1 BSAT.

Appeal Consideration

Although not required by the select agent regulations, the entity might consider developing a policy in accordance with state and local law, implementing an administrative procedure allowing an individual to appeal a negative suitability assessment decision. This process could involve representatives from administrative and other areas of institutional oversight (i.e., security, HR, legal, etc.) to provide an independent review of the final decision.

Voluntary Removal from Access to Tier 1 BSAT

Entity leadership is encouraged to develop a mechanism for individuals to temporarily “opt out” of having access to Tier 1 BSAT for defined periods of time. The “opt out” provision should be a voluntary act initiated by the person having Tier 1 BSAT access through the self-reporting process, and granted by entity leadership for individuals who otherwise would be deemed suitable for access to Tier 1 BSAT. Examples of circumstances in which an “opt out” would be appropriate include extended periods of illness or other leave. Individuals who are removed from Tier 1 BSAT access as a result of an ongoing suitability assessment could  be routed through a separate process initiated by the entity. These types of “opt outs” are not required to be reported to the Federal Select Agent Program.

Denial, Termination, or Suspension of Individual’s Access to Tier 1 BSAT

During the pre-access suitability assessment, an individual may be denied access to Tier 1 BSAT based on the results of the assessment. Information collected or reported (self or peer) as a result of the ongoing suitability assessment program may lead to the termination or suspension of an individual’s access to Tier 1 BSAT. Information related to the safety and security of Tier 1 BSAT could result in a temporary suspension of an individual’s access to allow for further evaluation of the situation. It is unrealistic to attempt to describe every possible situation that may arise. The procedures in place for the gathering, interpretation, sharing of information, and decision making should be consistent and allow for the uniform treatment of negative information obtained or reported to entity leadership. Denial, termination, or suspension of an individual’s access to Tier 1 BSAT can potentially have severe consequences for the individual’s work objectives and/or career. Therefore, would recommend these decisions  be made by entity leadership in consultation with the entity’s legal counsel utilizing existing entity resources for technical assistance and guidance.

Further, if during the ongoing monitoring of suitability the entity discovers evidence of statutory prohibitors identified as a restricted person listed above or information that might warrant the rescinding of SRA approval, the RO should immediately remove the individual’s access to select agents or toxins and immediately notify FSAP.

Visitors for short term training with Tier 1 BSAT

A visitor may visit a registered entity to receive specific training on Tier 1 BSAT. Typically in these circumstances a visitor for training (“trainee”) is hosted by another entity (the “host” entity) on a one-time basis of a limited duration for training. These individuals will have access to Tier 1 BSAT as part of their training. Their access is not specifically limited to any time period, but it is usually less than 30 days.

The regulatory requirements do not change for this situation but there are additional personnel security options. Host entities must still verify that each trainee has an SRA, is on the host entity’s registration, and has a justification for the training. Since the training involves access to Tier 1 BSAT, trainees must receive entity specific training on the host entity’s policies and procedures concerning personnel suitability, however this may be specific training for trainees and different than training for permanent employees.  All personnel who have access to the Tier 1 BSAT must have gone through pre- access suitability and are subject to on-going assessments. However, with trainees, entities have options when addressing pre-access suitability and ongoing assessment.

The hosting entities have options on how to address pre-access suitability for trainees. Host entities can always enroll trainees into its pre-access suitability program. However, if that is not feasible, an entity can rely on the home entity’s checks. This may include:

• Verify with the home entity or organization that the trainee has gone through a pre-access suitability program and is subject to ongoing assessment.
• Verify with the home entity or organization that the trainee has gone through similar pre-access checks (references, employment, criminal) and accept those checks as sufficient.
• Verify with home entity which pre-access checks have been accomplished and work with the home entity to complete any checks which were not done. Hosting entities are strongly encouraged to adjudicate any new derogatory information with the home entity prior to making an access decision.

Note: The host entity can deny access to Tier 1 BSAT to any trainee if the host entity cannot verify the trainee’s status.
Options for the ongoing assessment requirement in for trainees include:

• Ensure training is monitored. For example, an instructor observes the work and verifies that the trainee in engaged only in that work.
• Limit access to the registered area. Trainees should only have access to the registered area during specific work or training times.
• Limit access within the registered areas. Trainees should not be given access to storage freezers or other registered areas not directly involved in the training program.

If a trainee demonstrates a behavior which may compromise safety or security, their access to select agents and toxins should be removed.

The host entity is responsible for maintaining records outlined in Section 17. If an entity chooses to rely on the home entity’s checks, that must be documented and retained as well.