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Dangerous pathogens not only pose severe threats to human, plant, and animal health, but can also be used for ill-intended purposes. Such pathogens are listed as Select Agents and Toxins (SAs). The 2001 anthrax letter attacks prompted the creation of new regulations to increase security for research with dangerous pathogens. Are these measures adequate? This report evaluates the physical security of SA laboratories and the personnel reliability measures designed to ensure the trustworthiness of those with access to SAs. The book offers guiding principles and recommends changes to minimize security risks and facilitate research productivity.
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Consensus
·2009
The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine—including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe thre...
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Description
An ad hoc committee will assess the efficacy of regulations, procedures and oversight that have been instituted to safeguard the public and national security against the deliberate use of biological select agents and toxins (BSAT). The assessment will specifically take into account programs for laboratory security to protect against external threats and, in particular, personnel reliability assurance programs (protection against internal threats). The committee will not address biosafety (protection against accidental releases) except to the extent that biosecurity impinges on biosafety measures. The committee will also assess the impact of biosecurity policies and regulations on the ability of the scientific community to conduct BSAT research. The committee will evaluate progress since 2001 and identify opportunities for the United States Government to optimize the balance between controlling and mitigating security risks associated with BSAT research and ensuring the benefits of BSAT research for force and public health protection. The committee's conclusions and recommendations will be designed to inform policy discussions in the U.S. regarding necessary steps to balance the security risks and benefits of BSAT research and to harmonize policies across the government, including government funded extramural research. Based on expert knowledge of the current oversight systems for BSAT research, on information gathered in the course of the study about the specifics of the programs that have been implemented by each of the federal agencies with active BSAT research programs, and information about personnel assurance programs outside the federal government that might offer useful models or practices, the committee should: 1. Develop a set of principles and questions to be addressed in developing a framework to guide programs that provide and oversee laboratory security and personnel reliability systems for BSAT research. This framework should optimize benefits, minimize risk, and facilitate the productivity of research. 2. Review and assess the efficacy and cost/benefit of similar laboratory security, personnel reliability, and BSAT accountability programs of federal agencies to explore best practices across the federal government. The review should consider the implementation of existing legislation, regulations, guidance, policies, and practices as they relate to both federal laboratories or programs and research facilities at representative extramural laboratories funded by government programs. The assessment will include potential impacts on the ability to attract and sustain quality scientists to conduct research on BSAT and identification of factors responsible for barriers to research on BSAT in the extramural environment. The committee will make recommendations for refining existing programs and procedures affecting both intramural and extramural facilities that will achieve greater productivity in research objectives, optimize management to reduce risk, and produce improved uniformity, transparency, and efficiency in research on BSAT. 3. Make recommendations to inform policy decisions for achieving an effective system for oversight to ensure compliance with these programs and procedures. The Committee may consider examples of facility security and personnel assurance programs in other settings, including those from outside the BSAT domain and those outside the federal government, that might offer lessons or best practices.PROJECT SPONSOR: National Institutes of HealthPROJECT DURATION: 9 monthsThe approximate starting date for the project is 4/27/2009.The final report is expected approximately 5 months after the project start.For more information, see the project website at http://www.nationalacademies.org/bsatlabs.
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Conflict of Interest Disclosure
Disclosure of Conflict of Interest: John Clements
In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who has current experience in the management of research programs involving select agents and laboratory compliance with select agent regulations.
To meet the need for this expertise and experience, Dr. John Clements is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because the department he chairs and the center he directs both carry out research with biological select agents and toxins and therefore are subject to the select agent regulations and procedures to be examined in this study.
As his biographical summary makes clear, Dr. Clements is a recognized expert in the development of vaccines against infectious diseases, has been trained as a U.N. Weapons Inspector, and served as Professor and Chair of the Department of Microbiology and Immunology, and Vice Dean for Research at Tulane University School of Medicine. This familiarity with the practical aspects of the management of select agent research, including compliance with select agent regulations, is critical for the committee in meeting its task. We believe that Dr. Clements can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.
After an extensive search, we have been unable to find another individual with the equivalent current practical experience and expertise as Dr. Clements who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.
Disclosure of Conflict of Interest: Adolfo GarcÃa-Sastre
In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who has current practical experience and expertise in laboratory compliance with select agent regulations.
To meet the need for this expertise and experience, Dr. Adolfo GarcÃa-Sastre is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is currently engaged in research with biological select agents and toxins and therefore is subject to the select agent regulations and procedures to be examined in this study.
As his biographical summary makes clear, Dr. GarcÃa-Sastre is a recognized expert in research on influenza viruses and other negative strand RNA viruses. This familiarity with the practical aspects of select-agent research and compliance with select agent regulations is critical for the committee in meeting its task. We believe that Dr. GarcÃa-Sastre can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.
After an extensive search, we have been unable to find another individual with the equivalent current practical experience and expertise as Dr. GarcÃa-Sastre who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.
Disclosure of Conflict of Interest: Robert J. Hawley
In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who has current practical experience with the development and management of integrated systems for assuring compliance with biosafety and biosecurity regulations and procedures in both public and private settings.
To meet the need for this expertise and experience, Dr. Robert Hawley is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because his employer conducts select agent research that is subject to the select agents regulations to be examined in this study.
As his biographical summary makes clear, Dr. Hawley is a recognized expert in biosafety, biosecurity, and biosurety for microbial agents in a variety of environments. Before his current private sector employment, he served as a safety official in one of the nation’s preeminent government select agent laboratories for 15 years. This familiarity with safety and security in government and contract research environments is critical for the committee in meeting its task. We believe that Dr. Hawley can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.
After an extensive search, we have been unable to find another individual with the equivalent current practical experience and expertise as Dr. Hawley who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.
Sponsors
National Institutes of Health
Staff
Adam Fagen
Lead
Major units and sub-units
Division on Earth and Life Studies
Lead
Board on Life Sciences
Lead