Suitability Assessment Program Guidance:
Access Privileges for Tier 1 BSAT
An enhancement to the biosafety and security of Tier 1 BSAT can be made through an evaluation of the needs of the workforce for physical access to these materials. By evaluating the needs of personnel based on their job duties and/or specific project status, entities should be able to divide their personnel into three categories:
- Personnel who currently do not need access to the Tier 1 BSAT
- Personnel who only need access during regular working hours (e.g., Monday-Friday, 6A -7P)
- Personnel who need access to Tier 1 BSAT 24 hours, 7 days a week (24/7)
Evaluation of personnel access privileges will serve two goals:
- Optimize the number of users with access to Tier 1 BSAT based on each individual’s work objectives.
- Limit the duration of time Tier 1 BSAT can be accessed.
By optimizing the number of people who have access and/or limiting the time frame for access to Tier 1 BSAT, there are fewer opportunities for potential biosafety or security incidents to occur. An active evaluation of Tier 1 BSAT users’ need for access privileges further delineates the personnel who are handling select agents or toxins most frequently, and involves laboratory personnel, supervisors, and entity leadership in access decisions on a continual basis. All entities will require some individuals to have access to Tier 1 BSAT at all times as in accordance with emergency response procedures. However, not all Tier 1 BSAT users will require access at all times to the select agents or toxins. An evaluation could be conducted by an individual’s supervisor or the person most knowledgeable of the individual’s project or required job duties, and capable of providing justification for unlimited access to reviewers/approvers.
Review of access privileges and justifications involving access to Tier 1 BSAT may involve multiple persons, preferably in a hierarchy, with the final access approval decisions made by the RO.
The SRA approval process will serve as the first step for limiting access to select agents or toxins at the entity. Pre-access suitability assessments should serve to further limit the personnel approved to access Tier 1 BSAT. Once individuals have been approved for Tier 1 BSAT access, and have been accepted into an ongoing suitability assessment program, access privileges – particularly unlimited access – may be granted based upon job duty requirements and overall project needs.
Individuals with Access to Tier 1 BSAT
Individuals with access to Tier 1 BSAT have a responsibility to monitor their own suitability, as well as the suitability of their colleagues performing duties that require access to Tier 1 BSAT. Individuals should advise entity leadership of any issues that could have an adverse impact on their performance, suitability, or safety while performing Tier 1 BSAT duties. The entity should establish policies for the following Individual responsibilities:
- Follow institutional policies and procedures for the safe and secure use of Tier 1 BSAT and comply with the select agent regulations.
- Participate in and understand training associated with the suitability assessment program.
- Report any situations that may affect safety and/or security of Tier 1 BSAT.
- Respect the privacy and confidentiality of colleagues, and support an environment where direct or indirect retribution is not tolerated.