RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS
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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 Contract No. N01-OD-4-2139 (Task Order #218) between the National Academy of Sciences and the National Institutes of Health. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
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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. Charles M. Vest 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
COMMITTEE ON LABORATORY SECURITY AND PERSONNEL RELIABILITY ASSURANCE SYSTEMS FOR LABORATORIES CONDUCTING RESEARCH ON BIOLOGICAL SELECT AGENTS AND TOXINS
RITA R. COLWELL (Chair), Distinguished University Professor,
University of Maryland, College Park, MD, and Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD; and
President and Chief Executive Officer,
CosmosID, Inc., Bethesda, MD
RONALD M. ATLAS, Professor of Biology and Public Health and Co-Director,
Center for Health Preparedness, University of Louisville, Louisville, KY
JOHN D. CLEMENTS, Professor and Chair,
Department of Microbiology and Immunology, and
Tulane Center for Infectious Diseases, Tulane University, New Orleans, LA
JOSEPH A. DiZINNO, Technical Director,
Homeland Security and Law Enforcement, BAE Systems, Washington, DC
ADOLFO GARCÍA-SASTRE, Professor of Microbiology, Fischberg Chair and Professor of Medicine, and Co-Director,
Global Health and Emerging Pathogens Institute, Mount Sinai School of Medicine, New York, NY
MICHAEL G. GELLES, Senior Manager,
Deloitte Consulting LLP, Washington, DC
ROBERT J. HAWLEY, Senior Advisor for Science,
Midwest Research Institute, Frederick, MD
SALLY KATZEN, Executive Managing Director,
The Podesta Group, Washington, DC
PAUL LANGEVIN, Director of Laboratory Design,
Merrick and Company, and
Merrick Canada ULC, Kanata, Ontario, Canada
TODD R. LaPORTE, Professor Emeritus of Political Science,
University of California, Berkeley, CA
STEPHEN S. MORSE, Professor of Clinical Epidemiology and Founding Director,
Center for Public Health Preparedness, Columbia University Mailman School of Public Health, New York, NY
KATHRYN NEWCOMER, Professor and Director,
Trachtenberg School of Public Policy and Public Administration, and
Midge Smith Center for Evaluation Effectiveness, George Washington University, Washington, DC
ELIZABETH RINDSKOPF PARKER, Dean,
McGeorge School of Law, University of the Pacific, Sacramento, CA
PAUL R. SACKETT, Beverly and Richard Fink Distinguished Professor of Psychology and Liberal Arts,
University of Minnesota, Minneapolis, MN
BOARD ON LIFE SCIENCES
KEITH YAMAMOTO (Chair),
University of California, San Francisco, CA
ANN M. ARVIN,
Stanford University, Stanford, CA
BONNIE L. BASSLER,
Princeton University, Princeton, NJ
VICKI L. CHANDLER,
Gordon and Betty Moore Foundation, Palo Alto, CA
Janelia Farm Research Campus, Howard Hughes Medical Institute, Ashburn, VA
MARK D. FITZSIMMONS,
John D. and Catherine T. MacArthur Foundation, Chicago, IL
DAVID R. FRANZ,
Midwest Research Institute, Frederick, MD
LOUIS J. GROSS,
University of Tennessee, Knoxville, TN
University of Wisconsin, Madison, WI
CATO T. LAURENCIN,
University of Connecticut Health Center, Farmington, CT
JONATHAN D. MORENO,
University of Pennsylvania, Philadelphia, PA
ROBERT M. NEREM,
Georgia Institute of Technology, Atlanta, GA
University of Texas, Austin, TX
MURIEL E. POSTON,
Skidmore College, Saratoga Springs, NY
ALISON G. POWER,
Cornell University, Ithaca, NY
BRUCE W. STILLMAN,
Cold Spring Harbor Laboratory, Cold Spring Harbor, NY
Johns Hopkins University School of Medicine, Baltimore, MD
Research!America, Alexandria, VA
FRANCES E. SHARPLES, Director
JO L. HUSBANDS, Scholar/Senior Project Director
ADAM P. FAGEN, Senior Program Officer
ANN H. REID, Senior Program Officer
MARILEE K. SHELTON-DAVENPORT, Senior Program Officer
INDIA HOOK-BARNARD, Program Officer
ANNA FARRAR, Financial Associate
CARL-GUSTAV ANDERSON, Senior Program Assistant
AMANDA P. CLINE, Senior Program Assistant
AMANDA MAZZAWI, Program Assistant
As a scientist who has worked for more than 40 years to find cures for infectious disease, I find the idea that terrorists would use biological agents as a weapon to be anathema. It violates the fundamental values of the life sciences that I and my colleagues hold dear: that science is a vital tool for improving life and the health of our planet and enhancing our understanding of the natural world.
My own work has focused on cholera, a disease responsible for the death of thousands of people around the world every year. During the past 40 years, research carried out through international collaboration of scientists has saved many thousands of lives.
At the same time, we are firm in the belief that this research should be conducted safely and responsibly. The incidence of either laboratory workers or members of the public being infected is vanishingly small, whether from laboratory accidents or intentional action. Through the years, safety and security practices and procedures have been developed that have successfully prevented accidental or intentional misuse of biological materials.
While research with select agents and toxins introduces another level of potential risk, the same sense of responsibility applies. Scientists have not only demonstrated concern about these issues, but also recognize that they have the most at stake should an incident occur. They are best able to identify potential risk, whether from a laboratory door left unsecured or the unusual behavior of a laboratory worker. It is for these reasons that this report focuses on promoting a culture of responsibility, enabling and empowering scientists to be vigilant stewards of their science.
Research with select agents and toxins is both necessary and important. Our nation’s health and security depend upon our understanding of these potentially dangerous pathogens and their mechanisms of virulence. Our fundamental
understanding of life and life processes benefits from study of these agents. Nevertheless, there is the possibility that we can be overzealous, implementing procedures only thought to enhance security. While many current policies and practices are effective, some actions suggested to enhance security are not likely to make select agent research more secure, just more difficult to conduct; this may yield the opposite result: that overall security will be diminished, not strengthened.
The authoring committee for this report represents a broad cross-section of stakeholders, including select agent researchers, experts in psychology, professionals in biosafety and facility design, and individuals with extensive experience in the issues of science and security. The report represents a consensus of the committee and our best judgment on the most effective ways to both promote security and foster scientific knowledge and a rapid biological response in the event of an emergency.
With such a challenging task, the committee was given only 3½ months to complete a full report. As such, the committee had to make choices about which issues to address, concentrating on those it felt to be most important, most critical, and most effective for enhancing security and enabling research. Thanks to the dedication of both the committee and staff, analysis of the issues included in the report can be considered no less thorough and documented than if we had been given the luxury of time. The study was conducted at the request of the leadership of the National Interagency Biodefense Campus and the White House Homeland Security Council staff through a contract with the National Institute of Allergy and Infectious Diseases.
On behalf of the entire committee, I wish to extend our sincere gratitude to the excellent staff at the National Academies. This report represents a full year’s worth of work conducted in less than four months. It is because of the dedication and extraordinary efforts of study director Adam Fagen, Jo Husbands, Rita Guenther, and Carl-Gustav Anderson that we were able to complete this ambitious task is so short a time. The staff most impressively captured the conclusions of the committee’s discussions and ensured access to the information and expertise we needed. The committee was able to identify the most important issues and reach consensus with relative ease because of the superb work of the staff. The tasks were facilitated by a knowledgeable, dedicated, and insightful committee, and I thank my fellow committee members for their commitment that made the study process an enjoyable and rewarding opportunity.
In closing, “every researcher, whether in academia, in government research facilities, or in industry, needs to be aware of the potential unintended consequences of their own and their colleagues’ research. In 1975, scientists agreed to the ‘Asilomar moratorium,’ which gave guidance to researchers in the emerging field of recombinant DNA research. 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.”1 The committee sincerely hopes that its work will contribute usefully to ongoing discussion of the Select Agent Program and, especially, to the safety and security of select agent research.
Rita R. Colwell, Chair
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 National Academies’ 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 integrity of the process.
We wish to thank the following individuals for their review of this report:
Burt S. Barnow, Johns Hopkins University
W. Seth Carus, National Defense University
Wayne F. Cascio, University of Colorado Denver
Elizabeth Casman, Carnegie Mellon University
R. John Collier, Harvard Medical School
Nancy D. Connell, University of Medicine and Dentistry of New Jersey
Penny H. Holeman, Lovelace Respiratory Research Institute
Joseph Kanabrocki, University of Chicago
Joseph Krofcheck, Independent Consultant
Thomas G. Ksiazek, University of Texas Medical Branch at Galveston
Admiral Mike McConnell, Booz Allen Hamilton
Denise A. Pettit, Virginia Division of Consolidated Laboratory Services
William H. Press, University of Texas at Austin
David A. Relman, Stanford University
John F. Sopko, Akin Gump Strauss Hauer & Feld LLP
Tilahun D. Yilma, University of California, Davis
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by W. Emmett Barkley, Proven Practices LLC, and David R. Challoner, University of Florida (emeritus). Appointed by the National Academies, they 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 committee and the institution.
The committee is grateful for those who provided expertise and assistance throughout the study process. This includes those experts who spoke to the committee at one of its meetings: Jeffrey Adamovicz, LouAnn Burnett, Sheldon Cohen, M. Colleen Crowley, Diane Damos, Robert Fein, Kelley Krokos, Bruce Landry, H. Clifford Lane, J. William Leonard, Carol Linden, Richard Meserve, Dennis Metzger, Kevin Murphy, Ben Petro, Mary Rowe, Bryan Vossekuil, Robbin Weyant, and Linda Wilcox. Meeting agendas and speaker affiliations are listed in Appendix B.
The committee is also thankful to those who helped organize or participate in one of the committee’s site visits at the New England Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research at Harvard Medical School (Christine Anderson, Gerald Beltz, Mary Corrigan, Robert Dickson, Sara Heninger, Andrew Onderdonk, and Jeff Seo); the MIT Nuclear Reactor Laboratory (John Bernard, David Carpenter, Patricia Drooff, Edward Lau, William McCarthy, Thomas Newton, Jr., and Kathleen O’Connell) and Environmental, Health and Safety Office (Claudia Mickelson) at the Massachusetts Institute of Technology; George Mason University’s National Center for Biodefense and Infectious Diseases (Saira Ahmad, Lilian Amer, Charles Bailey, John Blacksten, Calvin Carpenter, Jessica Chertow, Myung Chung, Meghan Durham-Colleran, Suhua Han, Jessica Kidd, Nathan Manes, Beth McKenney, Marjorie Musick, Tony Pierson, Kathleen Powell, Meena Rajan, Ian Reynolds, Diann Stedman, Anne Taylor, Patty Theimer, Monique van Hoek, Anne Verhoeven, Paul Wieber, James Willett, and Ron Witt); and the U.S. Department of Agriculture’s National Plant Germplasm and Biotechnology Laboratory (Wayne Claus, Renee DeVries, Joseph Kozlovac, and Laurene Levy). A complete list of site visit participants and affiliations is available in Appendix B.
Thanks also to those who provided or facilitated access to additional information and input to the committee including Lida Anestidou, Dennis Ausiello, Charles Bailey, Kavita Berger, Steve Brooks, Matthew Burch, M. Colleen Crowley, David Tutrong Diec, Peter Emanuel, Deborah Glickstein, Gigi Kwik Gronvall, Bauke Houtman, James LeDuc, Carol Linden, Jean Patterson, Ben Petro, Paul Stern, Eric Utt, Raymond Webber, Robbin Weyant, and Carrie Wolinetz.
A factual review of Chapter 2 was conducted by the Department of Health and Human Services (Laura Kwinn and Carol Linden on behalf of the interagency working group on these issues), the Centers for Disease Control and Prevention (Robbin Weyant, Director of the Division on Select Agents and Toxins), the U.S. Department of Agriculture (coordinated by Julia Kiehlbauch in the Animal and Plant Health Inspection Service), and the Federal Bureau of Investigation (Edward You, Supervisory Special Agent on the Bioterrorism Team, and the staff of the Criminal Justice Information Service).