Introduction

The U.S. Congress included in the National Defense Authorization Act of 2007 a provision calling for a study by the National Academy of Sciences of programs carried out under the Cooperative Threat Reduction Program (CTR) of the U.S. Department of Defense (DOD) that have been designed to prevent the proliferation of biological weapons (Pub. L. 109-364, Title XIII, Section 1304). These biology-oriented activities are currently referred to by DOD as the Biological Threat Reduction Program (BTRP). The legislation calls for the study to

  • assess relevant cooperative activities that have been carried out in Russia and other states of the former Soviet Union (FSU) with support by BTRP and other U.S. government programs, and

  • identify activities that should be considered for further cooperation, particularly BTRP activities, within the interagency context.

The National Research Council (NRC), acting on behalf of the National Academy of Sciences, has followed closely the evolution of BTRP during the past decade and has observed substantial progress through BTRP and other U.S. government-supported activities in containing biological weapon capabilities within the FSU. At the same time the NRC has from time to time made a number of suggestions to DOD for enhancing BTRP approaches. Therefore, the NRC welcomed the opportunity to undertake this study of the critical role of BTRP in promoting U.S. security interests.

In February 2007, the NRC entered into a contract with the Defense Threat Reduction Agency (DTRA), acting on behalf of DOD, to carry out the study. This report sets forth the findings and recommendations of the Committee on Prevention of Proliferation of Biological Weapons established by the NRC to undertake this study (see Appendix A for biographical information on the committee members).

DOD and the U.S. Congress will be important audiences for this report. At the same time, BTRP has far reaching implications for many governmental and nongovernmental organizations in the United States and abroad. Thus, the report should also be of wide interest to officials, health and agriculture practitioners, researchers, entrepreneurs, industrialists, foundation leaders, and policy analysts in a number of countries.

Addressing the Dual-Use Dilemma

The rapid diffusion of scientific knowledge and technical capabilities has enabled many countries to benefit from recent advances in biological science and biotechnology. These developments have improved medications and medical procedures, increased agricultural productivity, diversified sources of energy, and spawned new industrial processes. But research directed to dangerous human, animal, and plant pathogens and to biotechnology activities in a variety of fields has also led to dual-use technologies that can be employed not only for the betterment of the lives of people but also for the development of advanced biological weapons for use by military forces, terrorist groups,



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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships Introduction The U.S. Congress included in the National Defense Authorization Act of 2007 a provision calling for a study by the National Academy of Sciences of programs carried out under the Cooperative Threat Reduction Program (CTR) of the U.S. Department of Defense (DOD) that have been designed to prevent the proliferation of biological weapons (Pub. L. 109-364, Title XIII, Section 1304). These biology-oriented activities are currently referred to by DOD as the Biological Threat Reduction Program (BTRP). The legislation calls for the study to assess relevant cooperative activities that have been carried out in Russia and other states of the former Soviet Union (FSU) with support by BTRP and other U.S. government programs, and identify activities that should be considered for further cooperation, particularly BTRP activities, within the interagency context. The National Research Council (NRC), acting on behalf of the National Academy of Sciences, has followed closely the evolution of BTRP during the past decade and has observed substantial progress through BTRP and other U.S. government-supported activities in containing biological weapon capabilities within the FSU. At the same time the NRC has from time to time made a number of suggestions to DOD for enhancing BTRP approaches. Therefore, the NRC welcomed the opportunity to undertake this study of the critical role of BTRP in promoting U.S. security interests. In February 2007, the NRC entered into a contract with the Defense Threat Reduction Agency (DTRA), acting on behalf of DOD, to carry out the study. This report sets forth the findings and recommendations of the Committee on Prevention of Proliferation of Biological Weapons established by the NRC to undertake this study (see Appendix A for biographical information on the committee members). DOD and the U.S. Congress will be important audiences for this report. At the same time, BTRP has far reaching implications for many governmental and nongovernmental organizations in the United States and abroad. Thus, the report should also be of wide interest to officials, health and agriculture practitioners, researchers, entrepreneurs, industrialists, foundation leaders, and policy analysts in a number of countries. Addressing the Dual-Use Dilemma The rapid diffusion of scientific knowledge and technical capabilities has enabled many countries to benefit from recent advances in biological science and biotechnology. These developments have improved medications and medical procedures, increased agricultural productivity, diversified sources of energy, and spawned new industrial processes. But research directed to dangerous human, animal, and plant pathogens and to biotechnology activities in a variety of fields has also led to dual-use technologies that can be employed not only for the betterment of the lives of people but also for the development of advanced biological weapons for use by military forces, terrorist groups,

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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships or disgruntled individuals. For example, research to understand the characteristics of anthrax or foot-and-mouth disease, while important for public health and agriculture, can also attract the attention of groups or individuals who are interested in using these pathogens as weapons of terrorism. This dual-use dilemma underlies the concerns set forth in the legislation calling for the study and this report. As is widely recognized, many naturally occurring diseases continue to threaten health and agriculture on local, regional, and international scales. Each day, tens of thousands of people throughout the world die from infections, and untold quantities of animals and food supplies are lost on every continent due to the spread of lethal diseases. A global consensus has emerged that all nations need to work together to prevent pandemics due to naturally occurring diseases and to respond vigorously when outbreaks occur. The recent national responses to the outbreaks of Severe Acute Respiratory Syndrome (SARS) and avian influenza, within a framework of coordination established by several international organizations, are good examples of constructive international efforts. Experience from these efforts should help shape responses to bioterrorist-instigated diseases, particularly those that cross international borders. Still, effective international responses to the threat of deliberately introduced diseases by terrorist groups are not easy to mount. Perceptions of different governments as to the severity and the nature of emerging threats differ. Also, overcoming the bureaucratic challenges and the technical uncertainties in formulating international policies and programs that cut across many government agencies at the national level is formidable. Several decades ago, concerned governments responded to the potential threat of biological weapons by taking initial steps in constructing a legally binding international regime to ban the use, development, stockpiling, and production of such weapons and to prevent countries and sub-national groups from acquiring them. This regime is based on the Geneva Protocol (entered into force in 1928) and the Biological and Toxin Weapons Convention (entered into force in 1975), supplemented by the Australia Group’s export control guidelines (updated on a regular basis). At the time the components of the regime were initially developed, the primary concern was over hostile states, not terrorist groups, acquiring biological weapons. However, even with regard to activities of states party to the agreements, let alone to amorphous terrorist groups, effective measures for ensuring that illicit activities are not being carried out have been elusive, and there are only limited procedures for addressing suspected violations of the agreements. In recent years, the U.S. government has led the international effort to develop new approaches to address the threat of bioterrorism while advocating compliance with treaty obligations. To this end, and in response to an initiative of the U.S. Congress in 1991 to establish the CTR program, during the 1990s DOD developed a number of programs that are now carried out through BTRP. BTRP is a very important component of the U.S. government’s programmatic approach for preventing the proliferation of biological weapons consistent with its legislative charge. BTRP is the primary focus of this report.

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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships Scope of the Study The tasks set forth in the legislation and in the subsequent contract between NRC and DTRA to be addressed in the study are as follows: An NRC committee of experts will be formed to conduct a study and prepare a report that identifies areas for future cooperation with Russia and other states of the FSU under the CTR program of DOD in the specific area of prevention of proliferation of biological weapons. Specifically, the study will include the following: A brief review of any ongoing or previously completed U.S. government program (whether conducted through the CTR program or otherwise) in the area of prevention of proliferation of biological weapons. An identification of further cooperative work between the United States government and foreign governments, including technical scientific cooperation, that could effectively be pursued in the area of prevention of proliferation of biological weapons, related materials, technologies, and expertise and the objectives that such work would be designed to achieve. An identification of any obstacles to designing and implementing a nonproliferation program (whether conducted through the CTR program or otherwise) that could successfully accomplish the objectives identified pursuant to paragraph (2), together with recommendations for overcoming such obstacles, including recommendations in the area of coordination among relevant United States government departments and agencies. BTRP has been carried out within the framework of an interagency effort directed to the prevention of proliferation of biological weapons. According to BTRP officials, the interagency guidance from the National Security Council advocates a comprehensive approach to the prevention, detection, control, and therapy of human and agricultural diseases through the strengthening of relevant physical, human, and administrative infrastructures in the countries of interest. The approach involves programs administered by the Departments of State, Health and Human Services, Agriculture, and Energy and by the Environmental Protection Agency in addition to DOD, as discussed in Chapter 3. In this report, the nonproliferation activities of these departments and agencies, including DOD activities beyond BTRP, are referred to as “related” programs. The legislative charge emphasizes that the study should concentrate on programs undertaken in cooperation with the governments of the states of the FSU. At the same time, the committee also recognized the potential for proliferation in other geographical areas. Of particular concern is Southeast Asia. Officials of the Department of State have informed the committee that there have been indications of terrorist groups exploring access to inadequately controlled biological facilities and materials. Clearly, the challenges in countering proliferation in countries beyond the former Soviet Union deserve additional study beyond the effort associated with this report.1 As called for in the legislation, the committee reviewed the nonproliferation programs of not only DOD but also other U.S. departments and agencies. However, as to 1 Senate Report 110-77, National Defense Authorization Act for Fiscal Year 2008, Section 1306, calls for a subsequent study by the National Academy of Sciences to identify areas for cooperation with states other than states of the former Soviet Union under the CTR program to prevent the proliferation of biological weapons and dual-use materials. Available on-line at http://origin.www.gpoaccess.gov/serialset/creports/. Accessed June 14, 2007. This proposal is still being discussed by Congress.

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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships recommendations for future programs, the focus is on BTRP. While the future of related programs is also important, the NRC committee considered that its limited financial resources and time could be most effectively used by concentrating on BTRP, which is the primary interest of the Congressional committees responsible for the legislation that calls for this report. Consultations with relevant Congressional staff members confirmed the appropriateness of this orientation. DOD has concurred with this approach. Other U.S. departments and agencies will continue to support relevant activities in the FSU and elsewhere through their nonproliferation programs and through other international programs for which they have important responsibilities in promoting U.S. interests, thus offering the possibility of synergies with BTRP activities. The committee also took note of relevant programs, including foreign assistance programs, supported by (1) other governments and particularly Canada and the countries of the European Union, (2) international organizations such as the World Health Organization and the World Organization for Animal Health, (3) international development banks, (4) private foundations, (5) professional scientific societies, and (6) international medical and agricultural companies. However, the committee did not consider the details of these activities. They deserve further study. Over the years, BTRP has supported hundreds of individual projects. Committee members have personally observed implementation of a number of these projects. Also, they have participated in annual reviews of BTRP’s overall research program. This close scrutiny of BTRP activities provides a good basis for committee comments on the quality and impact of the programs. Nevertheless, as the program continues to grow, more intensive evaluations of the program are highly desirable. Such evaluations should include involvement of carefully selected specialists from partner countries. The legislation calls for the study to address proliferation of “biological weapons.” The committee has interpreted “biological weapons” to include any biological materials that could be deliberately misused to cause significant harm to human health or agricultural resources. This definition includes a very broad spectrum of pathogens. The committee was asked to address the “prevention” of proliferation of biological weapons. In recent years, much of the prevention effort supported by the U.S. government in the former Soviet Union and elsewhere has been directed to (1) encouraging redirection of research activities of former defense scientists to civilian pursuits, (2) strengthening international agreements, national export control regulations, and internationally acceptable biosafety guidelines, (3) consolidating strains of dangerous pathogens dispersed in many locations into a limited number of secure locations, and (4) upgrading the configuration of facilities and the security practices at those facilities where dangerous pathogens of concern are located. All of these steps are important, particularly in reducing the threat of establishment of covert offensive biological weapons programs, and should be encouraged. At the same time, the committee recognized that scientists and engineers with potential dual-use skills, equipment with dual-use applications, and materials that could be used for illicit as well as appropriate applications are widespread. Also, many of these intellectual and technical assets are integral to the successful operation of public health and agriculture infrastructure facilities. Thus, the committee considered a wide range of approaches that are needed to effectively address concerns over deliberate misuse of pathogens.

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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships This report draws on information about U.S. government programs and plans that was available as of July 15, 2007. In responding to the tasks set forth in the legislation, this report is organized into six chapters. Chapter 1 discusses the international security context for considering BTRP activities. Chapter 2 identifies BTRP achievements to date and discusses reasons for successful activities. Chapter 3 describes other U.S.-sponsored cooperative programs carried out by a variety of U.S. government departments and agencies (i.e., related programs). It gives particular attention to the importance of an interagency approach that integrates BTRP with these related programs. Chapter 4 discusses the obstacles encountered in the carrying out of BTRP and suggests steps that can be taken to reduce these obstacles. Chapter 5 presents suggestions for expanding the positive impacts on national security of BTRP in the years ahead with particular attention to the importance of ensuring sustainability of activities initiated through BTRP that build on established collaboration and research partnerships. Chapter 6 consolidates the recommendations set forth in earlier chapters. Information Sources The committee and staff reviewed many relevant reports and studies prepared by officials and scientists from throughout the FSU and by American and other international officials and observers interested in the topics considered in this report. A few of the key documents are cited in the text, footnotes, and appendixes of this report. Two recent reports prepared by the National Research Council are of particular relevance. The reports are Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security, National Academies Press, 2005; and Letter Report on the Threat Agent Detection and Response System Database, 2006. The recommendations included in these reports are set forth in Appendix B. Also, the Institute of Medicine and other components of the National Academies have prepared a number of reports that address many programs to enhance global health research and surveillance. Particularly relevant reports are identified in Appendix C. During the past decade, the Government Accountability Office (previously named the General Accounting Office) has also prepared a number of reports on the nonproliferation efforts of the U.S. government, including efforts to prevent the proliferation of biological weapons. Recent reports of interest are identified in Appendix D. Complementing the literature review were important consultations in the United States and abroad during early 2007 by committee members and staff with participants in the activities of BTRP and related programs. In Washington, discussions were carried out with key officials, BTRP contractor employees, and American collaborators on BTRP projects (See Appendix G). Overseas, the committee organized structured discussions concerning BTRP with more than 100 specialists and officials from the six countries where BTRP has been active (See, for example, Appendix H). These recent consultations

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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships complemented more than a decade of related discussions by committee members and staff with U.S. officials and foreign colleagues concerning BTRP. The committee considers that the individual comments set forth in the boxes throughout the report are a good sampling of commonly held views about the strengths and weaknesses of the program.