DoD is developing defensive capability against biological agents and toxins. This study addresses these themes: Are current and proposed policies in DoD biological safety, security and biological personnel reliability programs adequate to safeguard against accidental or intentional loss/misuse of Biological Select Agents and Toxins (BSAT)? Are current DoD assoc. labs. that use or store BSAT meeting stringent standards for safety, security and personnel reliability? How do DoD programs compare with other gov¿t. agency, academic, and industry programs? How can DoD usefully employ experience in other areas requiring the utmost safety and reliability when handling dangerous material for biosurety policy dev¿t. and implementation?

Since renouncing the development, production, stockpiling, and use of biological weapons in 1969, the Department of Defense (DoD) has invested in militarily relevant biological defense. Also in 1969, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) was created to develop medical defensive countermeasures. Medical biological defensive research has focused mainly on the development of vaccines, drugs, and diagnostics as defensive countermeasures. DoD maintains a network of laboratories and centers dedicated to developing defensive capabilities to protect against biological select agents and toxins (BSATs). Most of these facilities evolved from small specialized laboratories that focused on a particular area of today's modern research and development-performing work that ranges from basic science and technology to supporting systems in biological defense. All laboratories participating in DoD research, development, test, and evaluation (RDT&E) are required to comply with the code of federal regulations and DoD directives, policies, and regulations. These sets of regulations specify safety and security policy, responsibilities, and procedures for service and contract laboratories conducting research and development in support of the DoD biological defense program. In general, biosafety encompasses risk assessment, safe practices, and containment equipment to protect researchers from exposure to infectious agents and facility barrier systems that prevent the release of an agent into the environment to ensure protection of the public health. Biosecurity includes physical security, select agent accountability, and personnel reliability in an effort to prevent unauthorized access to biological select agents and toxins. There is obvious overlap between the two terms. The DoD labs employ an in-depth approach to securing BSATs during operations that require manipulation, storage, or transport of these hazardous materials. Layers of security include physical security of facilities, secured storage equipment, secured transportation of BSATs, surveillance systems, and personnel security processes that assure only the most reliable and skilled personnel have access to the materials necessary to conduct research appropriate to the mission. There are numerous directives and regulations, established by different government agencies that govern biological safety and security (see list of References and Regulations at the end of this report).

This report examines the biological safety, security, and personnel reliability programs of Department of Defense's (DoD's) biological labs, compares these labs with other similar operations in academia, industry and the federal government. The report offers recommendations for improvements in the DoD program based on this comparison. The task force found that safety and security of the DoD facilities that they assessed are as good or better than those in comparably sized facilities in other government, industry and academic sectors and that DoD regulations exceed those imposed by the Centers for Disease Control and Prevention. While the program remains sound, the task force does provide recommendations to further improve computer systems security, lab activity monitoring, inspection compliance and biological select agent and toxin transportation. These recommendations are detailed in the report and serve to further enhance current biological safety and security operations, while minimizing the impact on missions of the DoD laboratories.

This Congressionally-mandated report identifies areas for further cooperation with Russia and other states of the former Soviet Union under the Cooperative Threat Reduction (CTR) program of the Department of Defense in the specific area of prevention of proliferation of biological weapons. The report reviews relevant U.S. government programs, and particularly the CTR program, and identifies approaches for overcoming obstacles to cooperation and for increasing the long-term impact of the program. It recommends strong support for continuation of the CTR program.

The National Academies of Sciences, Engineering, and Medicine was asked to articulate a 5-year strategic vision for international health security programs and provide findings and recommendations on how to optimize the impact of the Department of Defense (DOD) Biological Threat Reduction Program (BTRP) in fulfilling its biosafety and biosecurity mission. Because BTRP is just one of several U.S. government programs conducting international health security engagement, both the strategic vision and the success of the program rely on coordinating actions with the U.S. government as a whole and with its international partners. This report provides several recommendations for optimizing BTRP success in its current mission and the wider-looking strategic vision it proposes.

The objectives of this project were to: assess the uniform application of biosafety and biosecurity policy and directives, plans, orders, and guidance across DoD component laboratories that were conducting research using biological select agents and toxins and to evaluate DoD biological safety and security at laboratories. We found that DoD had not maintained biosafety and biosecurity program management, oversight, and inspections of its BSAT laboratories according to applicable Federal regulations. BSAT laboratories in Military Services were inspected according to different guidance, standards, and procedures, risking dangerous lapses in biosafety practices. Lack of coordinated oversight of DoD laboratories led to multiple, missing, and duplicative inspections, and, therefore, an excessive administrative burden that could interfere with scientific research performance.

Examines the biological safety, security, and personnel reliability programs of DoD's biological labs, and compares these labs with other similar operations in academia, industry, and the federal government. Offers recommendations for improvements in the DoD program based on this comparison.