RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS

Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins

Board on Life Sciences

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins Board on Life Sciences Division on Earth and Life Studies

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW 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 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. International Standard Book Number-13: 978-0-309-14535-0 (Book) International Standard Book Number-10: 0-309-14535-X (Book) International Standard Book Number-13: 978-0-309-14536-7 (PDF) International Standard Book Number-10: 0-309-14536-8 (PDF) Library of Congress Control Number: 2009940166 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334- 3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2009 by the National Academies. All rights reserved. Printed in the United States of America

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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 examina - tion 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 Na - tional 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. www.national-academies.org

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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 Director, 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 President, 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 Co-Director, 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 

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Staff ADAM P. FAGEN, Study Director and Senior Program Officer JO L. HUSBANDS, Scholar/Senior Project Director RITA GUENTHER, Senior Program Associate CARL-GUSTAV ANDERSON, Senior Program Assistant i

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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 SEAN EDDY, 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 JO HANDELSMAN, 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 CAMILLE PARMESAN, 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 CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, MD MARY WOOLLEY, Research!America, Alexandria, VA Staff 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 ii

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Preface As a scientist who has worked for more than 40 years to find cures for in- fectious 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 labo - ratory 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 promot - ing 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 ix

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x PREFACE understanding of life and life processes benefits from study of these agents. Nevertheless, there is the possibility that we can be overzealous, implement - ing 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, profes - sionals in biosafety and facility design, and individuals with extensive experi - ence 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 pro - mote 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 dedica - tion and extraordinary efforts of study director Adam Fagen, Jo Husbands, Rita Guenther, and Carl-Gustav Anderson that we were able to complete this ambi - tious task is so short a time. The staff most impressively captured the conclu - sions 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 re- search 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

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xi PREFACE 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 1 Bruce Alberts and Robert M. May. 2002. Scientist Support for Biological Weapons Controls. Science 298(November 8): 1135.

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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 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 manu - script 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 Uniersity W. Seth Carus, National Defense Uniersity Wayne F. Cascio, Uniersity of Colorado Dener Elizabeth Casman, Carnegie Mellon Uniersity R. John Collier, Harard Medical School Nancy D. Connell, Uniersity of Medicine and Dentistry of New Jersey Penny H. Holeman, Loelace Respiratory Research Institute Joseph Kanabrocki, Uniersity of Chicago Joseph Krofcheck, Independent Consultant Thomas G. Ksiazek, Uniersity of Texas Medical Branch at Galeston Admiral Mike McConnell, Booz Allen Hamilton Denise A. Pettit, Virginia Diision of Consolidated Laboratory Serices William H. Press, Uniersity of Texas at Austin David A. Relman, Stanford Uniersity John F. Sopko, Akin Gump Strauss Hauer & Feld LLP Tilahun D. Yilma, Uniersity of California, Dais xiii

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xi ACKNOWLEDGMENTS 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, Proen Practices LLC, and David R. Challoner, Uniersity of Florida (emeritus). Ap- pointed 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 con - sidered. 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 Ex - cellence 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 Massachu- setts 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. Depart - ment of Agriculture’s National Plant Germplasm and Biotechnology Laboratory (Wayne Claus, Renee DeVries, Joseph Kozlovac, and Laurene Levy). A com- plete list of site visit participants and affiliations is available in Appendix B. Thanks also to those who provided or facilitated access to additional infor- mation 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.

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x ACKNOWLEDGMENTS 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 inter- agency 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).

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Contents EXECUTIVE SUMMARY 1 SUMMARY 7 1 Introduction 21 2 The Current Regulatory Environment 37 3 Guiding Principles for Science and Security 69 4 Issues Related to Personnel Reliability 73 5 Managing BSAT Research and the Select Agent Program 105 REFERENCES 135 APPENDIXES A Committee Member and Staff Biographies 145 B Information on Briefings and Site Visits 155 C Abbreviations and Acronyms 163 D Application for Security Risk Assessment 167 xii

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