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.