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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Controlling Dangerous Pathogens A Blueprint for U.S.-Russian Cooperation A Report to the Cooperative Threat Reduction Program of the U.S. Department of Defense U.S.-Russian Collaborative Program for Research and Monitoring of Pathogens of Global Importance Committee National Academy of Sciences/Institute of Medicine/National Research Council
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council. This study was supported by Contract/Grant No. DSWA01-96-C-0163 between the National Academy of Sciences and U.S. Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. Available from: The Committee on International Security and Arms Control National Academy of Sciences 2101 Constitution Ave., N.W. Washington, D.C. 20418 email@example.com Printed in the United States of America Copyright 1997 by the National Academy of Sciences. All rights reserved.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation U.S.-Collaborative Program for Research and Monitoring of Pathogens of Global Importance Committee JOSHUA LEDERBERG (NAS, IOM), chair, Professor Emeritus and Raymond and Beverly Sackler Foundation Scholar, JOHN D. STEINBRUNER, vice-chair, Senior Fellow, Foreign Policy Studies Program, Brookings Institution BARRY BLOOM (NAS, IOM), Investigator, Howard Hughes Medical Institute, Albert Einstein College of Medicine GAIL CASSELL (IOM), Chair of the Department of Microbiology and Charles H. McCauley Professor of Microbiology, University of Alabama-Birmingham ROBERT CHANOCK Chief of the Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health R. JOHN COLLIER (NAS), Professor of Microbiology and Molecular Genetics, Harvard Medical School MAURICE R. HILLEMAN (NAS), Director, Merck Institute, Merck Research Laboratories PETER B. JAHRLING, Scientific Advisor and Senior Research Scientist, United States Army Medical Research Institute of Infectious Diseases JAMES LEDUC, Associate Director for Global Health, National Center for Infectious Diseases, Centers for Disease Control and Prevention MATTHEW MESELSON (NAS, IOM), Thomas Dudley Cabot Professor of Natural Sciences, Harvard University THOMAS MONATH, Vice President, Research and Development, OraVax and Adjunct Professor, School of Public Health, Harvard University FREDERICK A. MURPHY, Professor, School of Veterinary Medicine, University of California-Davis PHILIP K. RUSSELL, Major General (retired U.S. Army), Professor of International Health, School of Hygiene and Public Health, Johns Hopkins University ALEXIS SHELOKOV, Director, Medical Affairs, Biologicals Development Center, The Salk Institute Staff CHRISTOPHER P. HOWSON, Director, Board on International Health, Institute of Medicine JO L. HUSBANDS, Director, Committee on International Security and Arms Control, National Academy of Sciences GLENN E. SCHWEITZER, Director, Office for Central Europe and Eurasia, National Research Council CHAARLES G. FOGELGREN, Research Assistant, Committee on International Security and Arms Control, National Academy of Sciences LA'FAYE LEWIS-OLIVER, Administrative Assistant, Committee on International Security and Arms Control, National Academy of Sciences STEPHANIE Y. SMITH, Project Assistant, Board on International Health, Institute of Medicine
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation ACRONYMS ACDA U.S. Arms Control and Disarmament Agency AG Australia Group BW biological weapons BWC Biological Weapons Convention CBW chemical and biological weapons CDC Centers for Disease Control and Prevention CTR Cooperative Threat Reduction CW chemical weapons DOD U.S. Department of Defense DOE U.S. Department of Energy FDA U.S. Food and Drug Administration EMC Division of Emerging and Other Communicable Diseases, Surveillance and Control FSU former Soviet Union GCC Gore-Chernomyrdin Commission IOM Institute of Medicine IPP U.S. Department of Energy Initiatives for Proliferation Prevention ISTC International Science and Technology Center MOD Russian Ministry of Defense NAS National Academy of Sciences NIH National Institutes of Health OTA Office of Technology Assessment USAMRIID U.S. Army Medical Research Institute of Infectious Diseases USDA U.S. Department of Agriculture WHO World Health Organization
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Contents Preface Executive Summary 1 The Context for a Program of Bilateral Cooperation 2 Establishing the Basis for Long-Term Cooperation 3 Phase 1: A Pathogens Initiative to Expand Cooperation 4 Phase 2: An Era of Sustained Cooperation Appendices A. Committee and Staff Biographies B. Extract from Statement of Work of DOD/NAS Contract C. Consultations and Visits D. Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous, or Other Gases and of Bacteriological Methods of Warfare E. Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction F. Australia Group G. Conclusions of Roundtable on Bilateral Cooperation to Address the Public Health Aspects of Dangerous Pathogens H. Report of the International Symposium on “Severe Infectious Diseases: Epidemiology, Express-Diagnostics, and Prevention” I. Descriptions of Pilot Projects
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation TABLES E-1 Selected Organizations with Program Interests Related to the Pathogens Initiative E-2 Proposed Phasing of Joint Research Projects E-3 Allocation of Funds per Fiscal Year During the Pathogens Initiative (in millions of dollars) BOXES E-1 Pilot Project Initiated by NAS and Financed by DOD 1-1 Confidence-Building Measures Adopted by the Second and Third BWC Review Conferences (1986 and 1991) 1-2 MOD Institutes with Biological Research Programs 1-3 Selected Biopreparat Institutes and Enterprises with Capabilities of Relevance to Dangerous Pathogens That Have Expressed Interest in International Cooperation 1-4 Selected Russian Civilian Institutions Having Experience with Dangerous Pathogens and Links with Former BW-Related Specialists That Have Expressed Interest in International Cooperation 1-5 ISTC Access Requirements for Individual Projects 2-1 Organizations Invited to Have Representatives on Working Group on Bilateral Cooperation Organized by Biopreparat 2-2 Highlights of ISTC Provisions on Intellectual Property Rights 3-1 Selected Russian Laws, Decrees, and Regulations on the Control of Dangerous Pathogens
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Preface ◆ ◆ ◆ ◆ ◆ The National Academy of Sciences (NAS) created the Committee on International Security and Arms Control (CISAC) in 1980 to bring the scientific and technical resources of the Academy to bear on urgent problems of international peace and security. The primary initial activity of CISAC was a dialogue with Soviet counterparts that helped keep communication on nuclear arms control issues open during a time of great tension in U.S.-Soviet relations. In 1986, CISAC created a special working group on biological weapons control, which focused on another critical problem—developing improved methods of verification of the Biological Weapons Convention (BWC). The group carried out bilateral discussions with a counterpart group established under the aegis of the Soviet Academy of Sciences and then supported by the Russian Academy of Sciences. Beginning in 1993 the working group became particularly concerned about potential proliferation of biological weapons (BW) know-how because of the economic difficulties that afflicted the former Soviet BW complex, along with other Russian institutions, after the collapse of the Soviet Union. At the same time, the group was impressed with the Russian expertise in the biological sciences and biotechnology. There appeared to be a good opportunity to draw on that experience in a cooperative effort to combat the global threat of emerging infectious diseases and promote U.S. national security interests. Members of the working group began to discuss this opportunity with appropriate officials of the U.S. government and encouraged efforts such as the decision of the International Science and Technology Center (ISTC) to fund appropriate research projects at former Soviet BW facilities. In 1995 the U.S. Department of Defense (DOD) asked CISAC for assistance in designing a program to expand bilateral cooperative efforts between U.S. scientists and their Russian counterparts who had been involved in the former Soviet BW program. For assistance in developing the project, CISAC turned to two other parts of the Academy complex—the Board on International Health (BIH) of the Institute of Medicine (IOM) and the Office for Central Europe and Eurasia (OCEE) of the National Research Council. Both had extensive experience in areas directly relevant to fulfilling the DOD request. IOM has been concerned with the spread of infectious diseases; its 1992 report Emerging Infections: Microbial Threats to Health in the United States helped spark increased national and international attention to the risks posed by new and reemerging diseases.1 For its part, OCEE had maintained contacts and exchanges with Soviet/Russian scientists for almost 40 years, acquiring unique experience and building an unmatched network of contacts. In October 1996, OCEE produced An Assessment of the International Science and Technology Center (ISTC), followed in 1997 by a related report, Proliferation Concerns: Assessing U.S. Efforts to Help Contain Nuclear and Other Dangerous Materials and Technologies in the Former Soviet Union. NAS presented a proposal to DOD for developing a plan to increase U.S.-Russian research cooperation directed to the public health aspects of dangerous pathogens while furthering U.S. nonproliferation objectives. In addition to advancing the public health agendas of the two countries, NAS 1 In 1997, BIH released a white paper, America's Vital Interest in Global Health, which argued for collaborative U.S. engagement in activities similar to those discussed in this report.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation believed that such cooperation also could build confidence at both the working and the government levels regarding compliance with international BW agreements. The project began in the fall of 1996, with funding from the Cooperative Threat Reduction (CTR) Program, commonly referred to as the Nunn-Lugar Initiative. DOD provided CTR funds for supporting pilot research projects at Russian institutes to examine the potential for collaborative research activities that could be carried out effectively at facilities involved in the former Soviet BW program. A 14-member committee, which included members of the CISAC working group, the co-chair of BIH, and additional experts on BW and international health issues, developed the plan presented in this report with assistance from CISAC, BIH, and OCEE staff. Appendix A contains biographies of committee members and staff. DOD charged the committee with emphasizing the conversion of former Soviet BW researchers to civilian work (see Appendix B for relevant excerpts from the contract). Since then, however, Congress has limited the mandate of the CTR program so that it no longer supports conversion activities as such. As a result, the committee focused on the related but broader nonproliferation goals that remain part of the CTR mandate. Early in its work and after discussions with DOD, the committee made two additional decisions. First, it decided to concentrate on Russia instead of the entire former Soviet Union. During the Soviet era there were limited BW facilities outside the Russian Federation; the major installation outside Russia, the Stepnogorsk standby production facility in Kazakhstan, is already the subject of a significant U.S. government redirection and dismantlement effort. Second, it focused its efforts on engaging the core of former Soviet BW personnel and facilities that had been involved in research on dangerous pathogens. The committee believes that U.S.-Russian cooperation in this domain—featuring direct laboratory-to-laboratory contacts and based on the principle of broad transparency—would benefit U.S. national security, public health, and economic interests as well as the advancement of fundamental science. The committee's rationale is presented in this report. The committee believed that engaging Russian scientists and officials early in the planning effort was essential to the success of a long-term program of cooperation. To carry out this consultation and to gain firsthand knowledge of conditions and resources in former Soviet BW research facilities, a number of committee members and staff traveled to Russia on several occasions. Their visits are described in this report. In developing the plan the committee was able to draw on the reports and studies of BW issues produced by many government agencies and nongovernment organizations, as well as individual policy and technical experts. Relevant U.S. government departments and organizations include the Department of State, Arms Control and Disarmament Agency, DOD, Department of Commerce, Central Intelligence Agency, and the Permanent Subcommittee on Investigations of the Governmental Affairs Committee of the U.S. Senate. Among the academic institutions and nongovernment organizations and projects that have been interested in BW-related issues are the Chemical and Biological Arms Control Institute, the Harvard-Sussex Program on Chemical and Biological Weapons (CBW) Armament and Arms Limitation, the Henry L. Stimson Center, the New York Academy of Sciences, the Federation of American Scientists, the American Society of Microbiology, the Stockholm International Peace Research Institute, the Pugwash Conferences on Science and International Affairs, the Department of Peace Studies at the University of Bradford, Sandia National Laboratories, Lawrence Livermore National Laboratory, and the Monterey Institute for International Studies. Also, European scientists have been leading North Atlantic Treaty Organization workshops and projects on this topic. The Declarations on Confidence-Building Measures submitted each April since 1987 to the Centre for Disarmament Affairs at the United Nations by parties to the BWC provided particularly useful background information since they include U.S. and Russian declarations of past and present activities.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Numerous books and articles, including many scientific reports, have been published by specialists at the Centers for Disease Control and Prevention and the U.S. Army Medical Research Institute of Infectious Diseases on the public health concerns associated with dangerous pathogens. The World Health Organization, the Food and Agriculture Organization, and many U.S. and foreign institutions and individuals have provided overview reports on global health concerns associated with new and reemerging infectious diseases. The U.S. Food and Drug Administration, U.S. Environmental Protection Agency, U.S. Department of Agriculture, and National Institutes of Health have published studies of the biosafety aspects of handling dangerous pathogens as part of the preparation of regulatory guidelines and requirements. Although this list is by no means exhaustive, it illustrates the varied and growing sources of information and expertise from which the committee was able to draw in preparing this report. Throughout the one-year project, many officials and other specialists in the United States and Russia took time to provide the committee and project staff with important information and insights relating to the complex issues under review. Representatives of DOD, the State Department, and the ISTC were particularly helpful in this regard. Appendix C identifies the formal consultations of the committee and staff. Equally important, informal discussions were arranged through numerous channels in both the United States and Russia. The committee expresses its appreciation to the many individuals and institutions that contributed to its efforts; it also is grateful for the assistance of CISAC, BIH, and OCEE staffs. In addition, the committee benefited greatly from the assistance of two experts who served as unpaid consultants to the project. Professor Roald Sagdeev, Distinguished Professor of Physics at the University of Maryland, was instrumental in the development of the project. Colonel W. Russell Byrne, Chief of the Genetics and Physiology Branch of the Bacteriology Division at the U.S. Army Medical Research Institute of Infectious Diseases, took part in two trips to Russia and assisted greatly in developing the pilot projects. The committee is deeply grateful for their assistance. Joshua Lederberg, Chair Committee on U.S.-Russian Cooperation on Dangerous Pathogens John Steinbruner, Vice-Chair Committee on U.S.-Russian Cooperation on Dangerous Pathogens