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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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IN AN AGE OF TERRORISM
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