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Il I ll 'I' I ~' II N 4l In ~~ ~~ \r N AN AGE OF TERRORISM Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology Development, Security, and Cooperation Policy and Global Affairs NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.eclu

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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. The development of this report was supported by the Alfred P. Sloan Foundation and the Nuclear Threat Initiative. Any opinions, findings, conclusions, or recommenda- tions expressed in this publication are those of the authoress and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-08977-8 (Book) International Standard Book Number 0-309-52613-2 (PDF) Library of Congress Control Number 2003115100 Additional copies of this report are available from The National Academies Press, 2101 Constitution Avenue, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, www.nap.edu Copyright 2004 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medirine The National Academy of Sciences is a private, nonprofit, self-perpetuating soci- ety of distinguished scholars engaged in scientific and engineering research, dedi- cated 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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 technol- ogy 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 operat- ing agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the pub- lic, and the scientific and engineering communities. The Council is adminis- tered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www. nationa l-academies.org

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COMMITTEE ON RESEARCH STANDARDS AND PRACTICES TO PREVENT THE DESTRUCTIVE APPLICATION OF BIOTECHNOLOGY Gerald R. Fink (chair), Professor of Genetics, Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology Ronald Atlas, Professor of Biology and Graduate Dean, University of Louisville W. Emmett Barkley, Director, Office of Laboratory Safety, Howard Hughes Medical Institute R. John Collier, Maude and Lillian Presley Professor of Microbiology and Molecular Genetics, Harvard Medical School Susan E. Cozzens, Professor and Chair, School of Public Policy, Georgia Institute of Technology Ruth Faden, Philip Franklin Wagley Professor of Biomedical Ethics and Executive Director, The Phoebe R. Berman Bioethics Institute, Johns Hopkins University David R. Franz, Vice President of Chemical & Biological Defense Division, Southern Research Institute Robert Kadlec,a Professor of Military Strategy and Operations, National Defense University Barry Kellman, Director of the International Weapons Control Center, DePaul University College of Law Marc Kirschner, Chair and Carl W. Walter Professor of Cell Biology, Department of Cell Biology, Harvard Medical School Erin O'Shea, Professor and Vice Chair, Department of Biochemistry and Biophysics, University of California, San Francisco Clarence J. Peters, Professor, Department of Microbiology and Immunology and Pathology, University of Texas, Galveston Judith V. Reppy, Professor, Department of Science and Technology Studies and Associate Director, Peace Studies Programs, Cornell University Elizabeth Rindskopf Parker, Dean, McGeorge School of Law, University of the Pacific Matthew Scharff, Professor of Cell Biology, Albert Einstein College of Medicine Morton Schwartz,b Head of Applied and Diagnostic Biochemistry, Sloan Kettering Institute a Until August 2003. b Until November 2002. IV

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Edward Scolnick, President Emeritus, Merck Research Laboratories Joseph L. Goldstein, ax-officio, Regental Professor and Chairman, Department of Molecular Genetics, University of Texas Southwestern Medical Center Committee Staff Eileen Choffnes, Study Director lo Husbands, Director, Committee on International Security and Arms Control La'Faye Lewis-Oliver, Financial Associate Amy Giamis, Program Assistant Board on Life Sciences Liaisons R. Alla Charo, Professor of Law and Medical Ethics, University of Wisconsin, Madison lames M. Gentile, Dean for Natural Sciences, Kenneth G. Herrick Professor of Biology, Hope College Gregory A. Petsko, Tauber Professor of Biochemistry and Molecular Pharmacodynamics and Director, Rosenstiel Basic Medical Sciences Research Center, Brandeis University v

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Board on Life Sciences Liaisons R. Alta Charo, Professor of Law and Medical Ethics, University of Wisconsin, Madison James M. Gentile, Dean for Natural Sciences, Kenneth G. Herrick Professor of Biology, Hope College Gregory A. Petsko, Tauber Professor of Biochemistry and Molecular Pharmacodynamics and Director, Rosenstie! Basic Medical Sciences Research Center, Brandeis University Vl Prepublication Copy Uncorrected Proofs

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Preface The charge to our Committee was to consider ways to minimize threats from biological warfare and bioterrorism without hindering the progress of biotechnology, which is essential for the health of the nation. This task is complicated because almost all biotechnology in service of human health can be subverted for misuse by hostile individuals or nations. The major vehicles of bioterrorism, at least in the near term, are likely to be based on materials and techniques that are available throughout the world and are easily acquired. Most importantly, a critical element of our defense against bioterrorism is the accelerated development of biotechnology to advance our ability to detect and cure disease. Since the development of biotechnol- ogy is facilitated by the sharing of ideas and materials, open communica- tion offers the best security against bioterrorism. The tension between the spread of technologies that protect us and the spread of technologies that threaten us is the crux of the dilemma. Although the National Academies have had many reports on national security, this is the first to deal specifically with national security and the life sciences. The thoughtful report on Scientific Communication and Na- tional Security (National Academy Press, 1982) had as its charge "to exam- ine the relation between scientific communication and national security in light of the growing concern that foreign nations are gaining military ad- vantage from such research"; however, it did not deal with the life sci- ences. Since that report, much has happened to justify an examination of the life sciences in this context the discovery of nations with clandestine research programs dedicated to the creation of biological weapons, the anthrax attacks of 2001, the rapid pace of progress in biotechnology, and . . v''

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vIll PREFFACE the accessibility of these new technologies via the Internet. All of these developments have prompted the current report. The goal of this report is to make recommendations that achieve an appropriate balance between the pursuit of scientific advances to improve human health and welfare and national security. In preparing this report our Committee examined ways by which the spread of technology, methods, materials and information could be lim- ited to constructive activities concerned with medical progress. The dual use nature of these advances strongly argues that any initiative must de- monstrably increase our net security. Erring on the side of prudence and favoring the inhibition of information flow could retard the development of successful defenses and seriously compromise our nation's health. Therefore, the challenge is for the scientific community to develop a sys- tem that permits fundamental research to proceed unimpeded, while identifying research with great potential for misuse. The scientific community historically has demonstrated its ability to lead the way in the responsible development of new technologies. After the Asilomar conference in 1975, scientists designed and followed a set of guidelines for work with recombinant DNA, then a novel technology of unexplored potential. These guidelines, keyed to the risk of exposure to genetically modified organisms, have prevented any untoward events, reassured the public, and allowed the rapid and efficient progress of academic and commercial applications of these technolo- gies. The recombinant DNA guidelines were established to prevent un- intended creation of harmful recombinant organisms. But now the na- tion faces a different problem: the intentional use of biotechnology for destructive purposes. This challenge must engage the entire community of biologists nationally and internationally. In a joint statement issued on November 8, 2002, and printed in the journal Science, the presidents of the U.S. National Academy of Sciences and the U.K. Royal Society called on scientists to assist their governments in combating the threat of bioterrorism: "Today, researchers in the biological sciences again need to take responsibility for helping to prevent the potential misuses of their work, while being careful to preserve the vitality of their disciplines as required to contribute to human welfare." To consider ways to balance national security and scientific openness, the Committee had six meetings held in Washington, D.C. between April 1, 2002 and lanuary 29, 2003. Representatives from the National Institutes of Health, the Executive Office of the President, governmental and non- governmental technical and policy experts, and educators and private consultants briefed the Committee. The Committee also reviewed infor- mation available from the open literature as well as new materials pre- pared by experts (see Appendix C).

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PREFACE During the course of our deliberations, Committee members recom- mended that scientific, policymaking, and intelligence communities be brought together to focus on the challenges raised by advances in biotech- nology. To this end the National Academies and the Center for Strategic and International Studies convened a one-day meeting on "Scientific Openness and National Security" in Washington, D.C., on lanuary 9, 2003. This meeting emphasized the importance of a continuing dialogue be- tween the life sciences and the intelligence communities both nationally and internationally. It is our hope that this report provides the basis for this dialogue. The Committee wishes to express its sincere appreciation to the de- voted project staff. As study director, Eileen Choffnes ensured the success of this project through her expertise, dedication, and creativity. This study would not have been possible without Dr. Choffnes' oversight and coor- dination of the work of the Committee and her insightful editing of the report. Amy Giamis was outstanding in her great finesse in the organiza- tional work of the Committee, and her numerous contributions to sup- porting the research and editing of the report. Finally, the Committee wishes to express its appreciation to I Husbands, who brought to our deliberations considerable insights from her experience as Director of the NAS Committee on International Security and Arms Control. Through- out the study we were encouraged by the support of NAS President Bruce Alberts. I want to express my personal thanks to the individual members of the Committee for the dedication and energy with which they tackled this difficult problem. The report would not have been possible without the perspectives of these experts, who represented their diverse disciplines so eloquently. Gerald R. Fink Chair

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Acknowledgments This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with pro- cedures 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 objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integ- rity of the deliberative process. We wish to thank the following individuals for their review of this report: Kenneth Berns, Mount Sinai Medical Center; lames Cook, Wash- ington State University; Malcolm Dando, University of Bradford; Catherine DeAngelis, Journal of the American Medical Association; Stanley Falkow, Stanford University; Claire Fraser, The Institute for Genomic Re- search; Michael Friedman, City of Hope; Robert Haselkorn, University of Chicago; Michael McGeary, McGeary and Smith; Michael Moodie, Chemi- cal and Biological Arms Control Institute; Harley Moon, Iowa State Uni- versity; Stephen S. Morse, Columbia University; lerome Schultz, Univer- sity of Pittsburgh; Jonathan Tucker, Center for Nonproliferation Studies, Monterey Institute of International Studies; and Mark Wheelis, Univer- sity of California, Davis. Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the con- clusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Gilbert Omenn, University of Michigan Medical School, and R. Stephen Berry, University of Chicago. Appointed by the National Research Council, they Xl

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X11 ACKNOWLEDGMENTS were 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 com- mittee and the institution.

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Contents Executive Summary 1 Introduction The Life Sciences Today, 16 The "Dual Use" Dilemma, 18 A Brief History of Modern Biological Warfare, 19 U.S. Policy and the Creation of the Biological and Toxin Weapons Convention, 21 The New Threat, 22 Recent Examples of "Contentious Research" in the Life Sciences, 24 The Response of the Life Sciences Community to Previous Challenges, 29 Committee Charge and Process, 30 Annex: Biological Warfare in History, 33 2 The Evolving Regulatory Environment for Life Sciences Research in the 21st Century Introduction, 41 The U.S. Regulatory Environment, 44 Framework for Implementation of the NIH Guidelines for rDNA Research, 46 Types of Experiments That Require IBC, RAC and NIH Director Review, 49 Physical and Biological Containment Strategies for NIH-Funded rDNA Research Activities, 49 . . . x''' 1 15 41

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XIV Compliance with and Enforcement of the NIH Guidelines, 52 Regulation of Microbial Agents (Listed Agents and Toxins), 52 Possession of Select Agents, 58 Importation and Interstate Shipment of Etiologic Agents, 58 Oversight of Foreign Nationals, 59 Professional Education and Responsibilities of Life Scientists, 62 The International Situation, 63 Conclusions, 67 Annex, 69 Information Restriction and Control Regimes Introduction, 79 Past as Prologue?, 80 Secret and Sensitive Information, 86 Publication of Sensitive Information in the Life Sciences, 96 Conclusions, 99 4 Conclusions and Recommendations Introduction, 107 Key Assumptions, 108 Recommendations, 110 Conclusion, 126 Appendixes A Acronyms B Biographical Sketches of Committee Members C Committee Meetings CONTENTS 79 107 131 135 143

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