AN INTERNATIONAL PERSPECTIVE ON ADVANCING TECHNOLOGIES AND STRATEGIES FOR MANAGING DUAL-USE RISKS

REPORT OF A WORKSHOP

Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats

Development, Security, and Cooperation

Policy and Global Affairs

Board on Global Health

INSTITUTE OF MEDICINE

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop AN INTERNATIONAL PERSPECTIVE ON ADVANCING TECHNOLOGIES AND STRATEGIES FOR MANAGING DUAL-USE RISKS REPORT OF A WORKSHOP Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats Development, Security, and Cooperation Policy and Global Affairs Board on Global Health INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 study was supported by contracts between the National Academies and the Department of Homeland Security; Centers for Disease Control; Food and Drug Administration; the NIAID; the National Science Foundation; and the Intelligence Technology Innovation Center. The views presented in this report are those of the National Research Council and Institute of Medicine Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats and are not necessarily those of the funding agencies. International Standard Book Number 0-309-09682-0 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and 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. Ralph J. Cicerone 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. Wm. 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. Harvey V. Fineberg 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. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop COMMITTEE ON ADVANCES IN TECHNOLOGY AND THE PREVENTION OF THEIR APPLICATION TO NEXT GENERATION BIOTERRORISM AND BIOLOGICAL WARFARE THREATS Stanley Lemon, Co-chair, The University of Texas Medical Branch at Galveston David Relman, Co-chair, Stanford University Roy Anderson, Imperial College London Steven Block, Stanford University Christopher Chyba,* Stanford University and SETI Institute Nancy Connell, University of Medicine and Dentistry of New Jersey Freeman Dyson, Princeton University Joshua Epstein, Brookings Institution Stanley Falkow, Stanford University Stephen S. Morse, Columbia University Randall Murch, Virginia Polytechnic Institute and State University Paula Olsiewski, Alfred P. Sloan Foundation Kumar Patel, Pranalytica, Inc. Clarence Peters, The University of Texas Medical Branch at Galveston George Poste, Arizona State University Kameswara Rao, Foundation for Biotechnology Awareness and Education, Bangalore Julian Perry Robinson, University of Sussex Peter Singer, University of Toronto Christopher Waller, Pfizer Global Research and Development Staff Eileen Choffnes, Senior Program Officer Stacey Knobler,** Senior Program Officer Kate Giamis, Senior Program Assistant *   Princeton University after July 1, 2005 **   Until April 2005

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop Preface Life sciences knowledge, materials, and technologies are advancing worldwide at a dizzying and ever-accelerating rate.1 It is undeniable that this new scientific knowledge and these advancing technologies hold extraordinary potential to improve public health and the quality of life for people worldwide, strengthen national economies, and close the development gap between the North and South. However, as with all scientific revolutions, there is a potential dark side to the advancing power and global spread of biotechnology. Every major new technology has been used for hostile purposes, and many experts believe it naive to think that the extraordinary growth in the life sciences and its associated technologies might not be similarly exploited for malevolent purposes. The global spread of expertise in biotechnology and biological manufacturing processes raises concerns about how these advancing technological capabilities could not only alter the research and development landscape in the life sciences, but also enable the creation and production of new agents of biological origin with unique and unpredictable characteristics. The Committee on Advances in Technology and the Prevention of Their 1   The pace of technological change has often been referred to as “Moore’s-like.” Moore’s Law pertains to the rapid rate of technological development and advances in the semiconductor industry, specifically the doubling of the number of transistors on integrated circuits that occurs approximately every 18 months. Although advances in the life sciences occur in a discontinuous and random fashion and are driven by new conceptual breakthroughs in understanding of biological processes, it is a useful metaphor for the exponential growth of knowledge related to biology.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop Application to Next Generation Biowarfare Threats, an ad hoc committee of the National Research Council and the Institute of Medicine, is examining current trends and future objectives of research in the life sciences, as well as converging technologies from other fields such as materials science, bioinformatics, and nanotechnology, that may enable the development of a new generation of biological threats over the next five to ten years, with the aim of identifying ways to anticipate, identify and mitigate this danger. ABOUT THE WORKSHOP As part of its study, the committee held a workshop at the Instituto Nacional de Salud Publica (National Institute of Public Health) in Cuernavaca, Mexico, in September 2004. The purpose of the workshop was to sample global perspectives on the current advancing technology landscape. Experts from different fields and from around the world presented their diverse outlooks on advancing technologies and forces that drive technological progress; local and regional capabilities for life sciences research, development, and application (both beneficial and malevolent); national perceptions and awareness of the risks associated with advancing technologies; and measures that have been taken, or could or should be taken, to reduce the potential for misapplication of technology(ies) for malevolent purposes. This report summarizes the formal and informal discussions held at the workshop. Rather than an exhaustive analysis, the workshop was designed to take a limited number of snapshots of the current global technological landscape, the forces that drive it, and new capabilities that may emerge from it, particularly with respect to the dual-use risk of advancing technologies (as used in this discussion, “dual-use” refers to the potential of beneficial research advances to be exploited for malevolent purposes). The workshop was not intended to spawn recommendations or conclusions. The information summarized in these five chapters was gathered in the expectation that it would help inform the committee concerning the range of perspectives on this issue, which is of global importance and which can only be dealt with in a global context, as it seeks to develop its report on advancing technologies and the prevention of their application to next-generation bioterrorism and biological warfare threats. The final release of that report is planned for September 2005. The workshop provided strong evidence that the global technology landscape is shifting dramatically and rapidly, in terms of the types of technological advances being made, the capabilities being acquired, and the geographical spread and distribution of these advances and capabilities. While some of the most recent advances in biotechnology, such as

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop control of gene expression through RNA interference or the development of entirely new genes using combinatorial approaches coupled with biological selection, have remained relatively restricted in their use, the proceedings from this workshop make it abundantly clear that advances in genomic sequencing, DNA synthesis, computing, and bioinformatic techniques have already profoundly shaped the international technology landscape of today. As highlighted in Cuernavaca, the global spread of these technologies has led to the establishment of globally dispersed, national genomic medicine platforms; high throughput microbial sequencing; efforts to develop novel high capacity, low cost production methods, such as plant-based manufacturing of vaccines, antibodies, and other pharmaceuticals; and advances in transgenic crop bioengineering. This burgeoning genetic knowledge base and technological growth is unequivocally global. China has some 20,000 people working in 200 biotechnology laboratories nationwide, has created 150 transgenic crops, and is a world leader in the production of protein-enhanced materials. Cuba supports a major drug and biotechnology program, which includes the production of a meningococcal serotype B vaccine and a number of other pharmaceuticals that are being sold worldwide. South Korea performed what may be the world’s first successful human cloning experiment, and is positioning itself as a leader in stem cell research. Singapore is investing billions of dollars in biotechnology, declaring it to be the “fourth pillar” of its economy. More than 76 sequencing centers worldwide, including centers in Brazil and China, have participated in sequencing at least one complete microbial genome. The global dissemination of life sciences knowledge and advancing technological capacity is being driven not only by the growing use of international subcontracting and technology cooperation agreements but, as much or more by national decisions to strengthen economy, public health, and national security, as well as international decisions to close the development gap between developed and less developed economies. It is accelerated by both long-term and short-term exchanges of life scientists between lesser developed countries and countries such as the United States and those in Western Europe and Asia. This rapid growth and dispersion of tools, technology, and knowledge in the life sciences enterprise will likely accelerate in the first decade of the 21st century. This phenomenon is to be expected and welcomed, since the application of these advancing technologies research and development activities in the life sciences holds tremendous potential for ensuring the security of the global food supply and advancing human health worldwide. As with all technological revolutions, the potential always exists for intentional or inadvertent misapplication. It is inevitable that these rapid

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop technological advances, accompanied by a growing understanding of human life at the level of systems biology, will place the potential for greater destructive power into the hands of the technologically able and point the way to dangerous, subtle, and insidious novel ways to cause human, animal, and plant disease, create economic and political chaos, and catalyze societal disruption. The United States, and the global community, need to consider in a collective fashion how they may best cope with the increasing risks posed by the global proliferation of knowledge, technology, equipment, and materials. Some analysts argue that the difficulties inherent in creating, manufacturing, and delivering bioweapons are prohibitive and limit the utility (and thus the threat) of such weapons.2 Others argue that, on the contrary, bioweapons are the “poor man’s atomic bomb” and thus have the potential to create as much, if not more, human misery and terror than any other weapon of mass destruction (WMD).3 Either way, the unpredictability of future state and non-state efforts to acquire and employ biological weapons poses a serious vulnerability to national and global stability and security. On the first day of the workshop, presentations and discussions were divided into two sessions. In the first session, “Drivers of Global Technological Development,” the goal was to address the following questions: Why have advancing technologies grown in the directions that they have, and what are some of the obstacles that groups, nations, and regions face in their pursuit of the positive aspects of technology growth? In the second session, “The Global Landscape of Technology/Efforts to Mitigate Risks for Misapplication,” presentations and discussion focused on how advancing technological opportunities are being exploited for beneficial purposes. 2   Guillemin, J. 2005. Biological Weapons: From the Invention of State-Sponsored Programs to Contemporary Bioterrorism; Columbia University Press, New York; Cohen, H. W. 2004. “The pitfalls of bioterrorism preparedness: the anthrax and smallpox experiences.” American Journal of Public Health 94:1667-71, October; Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical and Biological Attacks: Report to Congressional Requesters. Washington, DC: US General Accounting Office; 1999:1-35. GAO publication NSIAS-99-163; Squassoni, S. 2004. “Nuclear, Biological, and Chemical Weapons and Missiles: Status and Trends.” CRS Report for Congress, July 2 (RL30699). 3   S. Squassoni et al., “Proliferation Control Regimes: Background and Status,” Report for Congress RL31559. The term “weapons of mass destruction” has been defined by the United Nations to include “atomic explosive weapons, radio-active materials weapons, lethal chemical and biological weapons, and any weapons developed in the future which have characteristics comparable in destructive effect to those of the atomic bomb….” United Nations Security Council, Commission for Conventional Armaments: “Resolution Adopted by the Commission at its Thirteenth Meeting, 12 August 1948, and a Second Progress Report of the Commission,” S/C.3/32/Rev.1; 12 August 1948, at page 2.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop On the second day of the workshop there were also two sessions: “Safeguarding the Benefits of Technology—Addressing the Dual-Use Dilemma” and “Emerging and Converging Technologies.” The goal of the former was to provide a global perspective on the wide range of measures currently being implemented or explored as viable strategies for managing the dual-use dilemma. The goal of the latter was to explore some emerging technologies, future technological trajectories, and the dynamic evolution of new dual-use risks with time. ACKNOWLEDGMENTS The Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats, an ad hoc committee of the National Research Council and the Institute of Medicine, wishes to express its warmest appreciation to the individuals and organizations who gave valuable time to provide information and advice to the Committee through their participation in the workshop. A full list of presenters can be found in Appendix B. The Committee is also indebted to the NRC and IOM staff who contributed during the course of the workshop and to the production of this workshop summary. On behalf of the Committee we gratefully acknowledge the efforts led by Eileen Choffnes and Stacey Knobler, co-Study Directors of the Committee, Elizabeth Kitchens, research associate, and Kate Giamis, senior program assistant, who dedicated much effort and time to developing this workshop’s agenda and final report of the workshop, and our technical writer Leslie Pray, for her thoughtful and insightful approach and skill in translating the workshop proceedings and discussion into this workshop summary. We would also like to thank the following staff at the Instituto National de Salud Publica: Mauricio Hernandez Ávila, Executive Director of the National Institute of Public Health; Jaime Sepúlveda Amor, Director of the National Institutes of Health; and Juan Manuel Álvarez Iraizos, Logistics Coordinator. Without their generous offer of a venue for this meeting and logistical support throughout the planning and execution of this activity the workshop would not have been possible. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for quality and objectivity. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop report: Uri Dadush, The World Bank; Stephen Johnston, University of Texas; Michael Oborne, Organisation for Economic Co-operation and Development; and Terry Taylor, The International Institute for Strategic Studies. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the content of the report, nor did they see the final draft before its release. The review of this report was overseen by Gail Cassell, Eli Lilly and Company. Appointed by the National Research Council, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. Finally, the Committee also thanks sponsors that supported this activity. Financial support for this project was provided by the U.S. Department of Health and Human Services’ National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration; the Intelligence Technology Innovation Center; the Department of Homeland Security; and the National Science Foundation. The views presented in this workshop summary are those of the editors and workshop participants and are not necessarily those of the funding organizations. Stanley M. Lemon Co-Chair David A. Relman Co-Chair

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop Contents 1   INTRODUCTION   1      About the Workshop,   2      Organization of This Report,   5 2   THE INTERNATIONAL PERSPECTIVE ON THE BIOTECHNOLOGY LANDSCAPE   7      Genomic Technology,   8      Plants as a Manufacturing Platform,   19      Transgenic Crops,   28 3   DRIVERS OF INTERNATIONAL BIOTECHNOLOGY DEVELOPMENT   25      Economic Drivers,   36      Social Drivers,   43      Political Drivers,   51 4   EMERGING AND CONVERGING TECHNOLOGIES   57      Bioregulators and Innate Immunity,   59      DNA Nanotechnology,   64      Converging Technologies,   67 5   MODELS FOR MANAGING CHANGE   73      Arms Control,   75      Non-BWC Tools,   92      Informal Strategies,   95

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop     APPENDIXES         A  WORKSHOP AGENDA   113     B  PARTICIPANTS LIST   119     C  COMMITTEE MEMBER AND PARTICIPANTS BIOSKETCHES   121