Personnel reliability refers to programs intended to reduce the “insider threat”; the prospect that researchers who are permitted to work on hazardous biological agents might misuse that access. This has been a major topic in biosecurity since the 2001 Anthrax attacks, which have been attributed to a researcher at Fort Detrick. They were also the focus of a 2009 NSABB report, which did not recommend that a formal personnel reliability program be instituted for research. This panel sought to evaluate whether these measures are sufficient.
Joe Kanabrocki – Chair
Assistant Dean for Biosafety, Biological Sciences Division
The University of Chicago
As a practicing biosafety professional with 20 years of experience, Dr. Kanabrocki argued that the role of a biosafety officer is to promote a culture of responsibility. Biosafety has expanded from safeguarding labs to broader concerns about biosecurity and biosurety – ensuring the reliability of personnel. With the expansion of facilities and the increase in security concerns, there have been increased calls for more oversight over biomedical research.
Director, Select Agent Program, Animal and Plant Health Inspection Service
Director Firko, who oversees the programs for plant and animal pathogens, described the current procedures within the US Select Agent program. The Select Agent program was created in 1996 and refined in 2001 and 2002. The program authorizes CDC and USDA to regulate human, animal, and plant pathogens and toxins. All researchers are subject to a security risk assessment administered by the FBI, designed to exclude individuals from working with dangerous pathogens if the candidate has concerning criminal or mental health history, or certain other risk factors defined by US law.
In addition to these requirements, biosafety lab procedures can impose specific requirements on the containment of pathogens, such as requiring a facility biosecurity plan on top of biosafety plans required to protect researchers from accidental exposure. For example, the USDA BSL-3 requirements include personnel security levels for all employees within a facility, with increased scrutiny of individuals with more access to pathogens.
Director, Select Agent Program
Centers for Disease Control and Prevention
Dr. Weyant is Dr. Firko’s counterpart at the CDC, and is responsible for overseeing human select agent pathogens. He discussed the physical security requirements of the select agent program. Facilities must have a security plan based on a site-specific risk assessment. These assessments evaluate the agents present in a facility, along with ways that these agents are being used. The security plan must address physical security to the building and labs, digital security surrounding information systems, and accurate inventory control of the stored pathogens. The requirements also mandate the training of all employees in biosafety and security procedures and reporting of any incidents.
Details on these policies, and how to comply with them, are available at the National Select Agent Program website: http://www.selectagents.gov
Chief Operating Officer, National Emerging Infectious Disease Laboratories
Dr. Nash presented a hands-on view of how his facility, the new BSL-4 lab under construction at Boston University, has implemented the regulations in practice. The facility is intended to permit cutting-edge investigator-initiated research on pathogens that cannot be studied in less secure facilities. In addition to the federal regulations described by Drs. Firko and Weyant, the BU lab has to comply with Boston city public health regulations, and Nuclear Regulatory Commission requirements imposed on most biomedical research labs for the use of radioisotopes.
The biosecurity policy aims to protect against outsider threats from external individuals, insider threats from employees, and accidental threats from any containment breaches. Suitability requirements for employees include criminal background checks, the FBI security risk assessment, financial background checks and medical clearances. An additional policy covers visiting scientists, who must be supervised at all times, and must meet the same requirements for access to the facility as permanent employees (a process that Dr. Nash concedes is lengthy, but believes to be necessary).
Senior Director for Risk and Global Security
Vertex Pharmaceuticals, Inc.
Mixon offers the perspective of small to medium-sized companies that would like to work on select agents. He praised communication tools, such as the select agent website, for helping to clarify requirements. The need to comply with formal regulations helps corporate safety officers make the case to their corporations for the resources they need to ensure safety.