Personnel Reliability

S3: Science Safety Security

One of the fundamental aspects of a biosecurity plan is personnel management, which aims to keep biological agents and toxins out of the possession of individuals who might intend to misuse them. It is in the best interest of every facility working with biological agents and toxins to have a complete biosecurity plan, including policies and procedures to screen and evaluate individuals. Personnel reliability measures for biological facilities must consider both insider and outsider threats. These factors should be considered as part of a comprehensive biosecurity risk assessment process when developing a biosecurity plan.

Insider threats occur when a person who has gained legitimate access to biological agents and toxins for research chooses to misuse his/her access for nefarious purposes. In many cases, the existing screening procedures and risk assessments may not suffice. Although it is important to address these biosecurity concerns, life sciences research should not be unduly hindered in the process. The potential benefits of enhanced personnel reliability measures must be carefully weighed against the potential negative consequences that such measures would likely have on the research community. It is equally important to establish a culture of responsibility within the life sciences research community.

Personnel are required to be screened prior to being granted access to biological select agents and toxins (BSAT). A Security Risk Assessment (SRA) is one method of evaluating personnel reliability and it is specifically required for those individuals who wish to possess, use, or transfer BSAT. This is completed by the Federal Bureau of Investigation (FBI) in coordination with the Federal Select Agent Program. For Tier 1 BSAT, personnel must also undergo ongoing suitability assessments and the entity has increased responsibilities for personnel monitoring, reporting, and coordination with security and safety officials. More information on Federal Select Agent Program procedures.

The Federal Select Agent Program has also published Guidance for Suitability Assessment, which is intended for laboratories working with Tier 1 BSAT.

Biosafety in Microbiological and Biomedical Laboratories (BMBL) provides some standard voluntary guidance for what should be included when a laboratory or other facility with any biological agents and toxins considers their personnel management plan:

“Personnel management includes identifying the roles and responsibilities for employees who handle, use, store, and transport pathogens and/or other important assets. The effectiveness of a laboratory biosecurity program against identified threats depends, first and foremost, on the integrity and awareness of those individuals who have access to pathogens, toxins, sensitive information and/or other assets. Employee vetting/screening policies and procedures are used to help evaluate these individuals. To maintain a personnel reliability and violence prevention plan, management should conduct periodic reviews of staff, establish an anonymous peer and threat reporting system, institute an Employee Health and Wellness Program, and foster leadership accountability to address submitted reports. Policies should also be developed for personnel and visitor identification, visitor management, access procedures, and reporting of security incidents.”

The BMBL provides these recommendations, but there are no distinct requirements or prescriptive measures for personnel reliability. Background checks and security clearances may be required before employees are granted access to certain containment facilities. Procedures should be developed for approving and granting visitors access to controlled areas. In this capacity, the access to agents and toxins storage facilities can be limited to individuals having a legitimate need to access such areas. Biosecurity training should be provided to all personnel who are given access to laboratory facilities.

Personnel Reliability Programs

Certain research facilities, including those owned and/or operated by the federal government, have instituted formal Personnel Reliability Programs (PRPs) to provide additional measures to help ensure that individuals with access to Tier 1 BSAT meet additional standards of reliability. Current PRPs are modeled after those within the traditional reliability programs and may include extensive background investigations with interviews of character references, security clearances, medical evaluations that may include a review of complete medical records, psychological testing, drug and alcohol testing, polygraph examinations, credit checks, and a comprehensive review of service and employment records.

PRPs usually also involve formal mechanisms for ongoing monitoring that can include requirements for self-reporting, peer-reporting, ongoing monitoring by supervisors, and penalties for noncompliance. Individuals enrolled in a PRP typically undergo periodic reassessments including annual physical examinations, random drug tests, re-evaluation of medical records and medications, recurring psychological evaluations, and renewal of security clearances. Importantly, personnel reliability measures can help reduce but cannot eliminate the risk of an insider threat.

In addition, strong institutional and laboratory leadership, clear articulation of priorities and expectations, and an institutional framework that provides relevant education, training, performance review, and employee support will facilitate responsible practices, personnel reliability, safety, and security, while allowing research on BSAT to flourish. Many of the principles of a culture of responsibility that underlie these recommendations can be applied to all biological facilities and other scientific endeavors.

Resources

The report Enhancing Personnel Reliability Among Individuals with Access to Select Agents details specific guidance for personnel reliability programs related to entities registered with Federal Select Agent Program. The report notes that BSAT are unlike nuclear and chemical surety material in fundamental ways that make them unsuitable for the traditional surety programs in place. BSAT can be naturally occurring; large quantities of bacteria and viruses may be cultured from a minimal starting sample and then disseminated.​