Biosecurity Challenges of the Global Expansion of
High-Containment Biological Laboratories

Summary of a Workshop

 

 

Alison K. Hottes, Benjamin Rusek, and Fran Sharples, Rapporteurs

Committee on Anticipating Biosecurity Challenges of the Global Expansion of High-
containment Biological Laboratories

Committee on International Security and Arms Control
Policy and Global Affairs
Board on Life Sciences
Division on Earth and Life Studies

NATIONAL ACADEMY OF SCIENCES AND
           NATIONAL RESEARCH COUNCIL
                                             OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories Summary of a Workshop Alison K. Hottes, Benjamin Rusek, and Fran Sharples, Rapporteurs Committee on Anticipating Biosecurity Challenges of the Global Expansion of High- containment Biological Laboratories Committee on International Security and Arms Control Policy and Global Affairs Board on Life Sciences Division on Earth and Life Studies THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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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. This study was supported by Contract/Grant No. STAT-8740 / S-L-MAQM-08-CA-140 and STAT-6253 / S-LMAQM-09-GR-056 between the National Academy of Sciences and the United States Department of State’s Biosecurity Engagement Program. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 13: 978-0-309-22575-5 International Standard Book Number 10: -0-309-22575-2 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 2012 by the National Academy of Sciences. 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 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. www.national-academies.org

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COMMITTEE ON ANTICIPATING BIOSECURITY CHALLENGES OF THE GLOBAL EXPANSION OF HIGH-CONTAINMENT BIOLOGICAL LABORATORIES ADEL A. F. MAHMOUD (Chair), Princeton University MICHAEL V. CALLAHAN, DARPA TECK-MEAN CHUA, Asia-Pacific Biosafety Association DAVID R. FRANZ, MRIGlobal KATSUHISA FURUKAWA, Rebuild Japan Initiative JENNIFER GAUDIOSO, Sandia National Laboratories, International Biological Threat Reduction BARBARA JOHNSON, Barbara Johnson & Associates, LLC INGEGERD KALLINGS, Swedish Institute for Infectious Disease Control SERHIY KOMISARENKO, Palladin Institute of Biochemistry JAMES W. LE DUC, The University of Texas Medical Branch at Galveston ANWAR NASIM, Ministerial Standing Committee on Scientific and Technological Cooperation (COMSTECH) PETER PALESE, Mount Sinai School of Medicine J. CRAIG REED, Inspirion Biosciences WILLY TONUI, Kenya Medical Research Institute STAFF ALISON HOTTES, Consultant, CISAC BENJAMIN RUSEK, Program Officer, CISAC FRAN SHARPLES, Director, Board on Life Sciences HEATHER CHIARELLO, Senior Program Assistant, CISAC JO HUSBANDS, Scholar/Senior Project Director, Board on Life Sciences v

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COMMITTEE ON INTERNATIONAL SECURITY AND ARMS CONTROL RAYMOND JEANLOZ (Chair), University of California, Berkeley JOHN F. AHEARNE, Sigma Xi, The Scientific Research Society CHRISTOPHER CHYBA, Princeton University STEPHEN COHEN, The Brookings Institution DAVID FRANZ, MRIGlobal RICHARD L. GARWIN, IBM Corporation ALASTAIR IAIN JOHNSTON, Harvard University JAMES W. LE DUC, Galveston National Laboratory and The University of Texas Medical Branch at Galveston RICHARD MIES, Independent Consultant NORMAN NEUREITER, American Association for the Advancement of Science PETER PALESE, Mount Sinai School of Medicine CISAC STAFF MICAH LOWENTHAL, Director RITA GUENTHER, Program Officer BENJAMIN RUSEK, Program Officer LA’FAYE LEWIS-OLIVER, Administrative Coordinator HEATHER CHIARELLO, Senior Program Assistant ALISON HOTTES, Christine Mirzayan Policy Fellow vi

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BOARD ON LIFE SCIENCES KEITH R. YAMAMOTO (Chair), University of California, San Francisco, California BONNIE L. BASSLER, Princeton University, Princeton, New Jersey VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, California SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, Virginia MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, Illinois DAVID R. FRANZ, MRIGlobal, Frederick, Maryland LOUIS J. GROSS, University of Tennessee, Knoxville, Tennessee RICHARD A. JOHNSON, Arnold and Porter (retired), Washington, DC CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, Connecticut BERNARD LO, University of California, San Francisco, California ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, Georgia CAMILLE PARMESAN, University of Texas, Austin, Texas MURIEL E. POSTON, Skidmore College, Saratoga Springs, New York ALISON G. POWER, Cornell University, Ithaca, New York MARGARET RILEY, University of Massachusetts, Amherst, Massachusetts BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, New York CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, Maryland MARY WOOLLEY, Research!America, Alexandria, Virginia BLS STAFF FRANCES E. SHARPLES, Director JO L. HUSBANDS, Scholar/Senior Project Director JAY B. LABOV, Senior Scientist/Program Director for Biology Education KATHERINE BOWMAN, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer INDIA HOOK-BARNARD, Program Officer ANNA FARRAR, Financial Associate CARL-GUSTAV ANDERSON, Program Associate AMANDA MAZZAWI, Senior Program Assistant SAYYEDA AYESHA AHMED, Program Assistant vii

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Preface and Acknowledgments The project, Anticipating Biosecurity Challenges of the Global Expansion of High- containment Biological Laboratories, culminated in a workshop that took place in Istanbul, Turkey from July 10-13, 2011. The workshop would not have been possible without the contributions of many individuals. The members of the United States National Research Council (NRC) committee, which was chaired by Adel Mahmoud of Princeton University, offered numerous suggestions and guided the selection of the agenda, participants, and speakers. The country study writers, many of whom attended the workshop and presented their work (see Appendix E), provided invaluable assistance in advance of the workshop as the project was developed. The committee and the National Research Council staff were fortunate to have the Turkish Academy of Sciences (TÜBA) as a partner in this endeavor. TÜBA Vice President Tarik Çelik, TÜBA member and Dean of Koç University’s School of Medicine Sevket Ruacan, and Professor Onder Ergonul of Koç University’s School of Medicine provided invaluable assistance in organizing and arranging for the participation of Turkish experts in the workshop. We are grateful to Ayşe Selma İyisan of the Turkish Ministry of Agriculture and Rural Affairs (MARA) who along with Ayşen Gargili of Marmara University, Sevil Erdenlig of MARA, and Naci Sivri of Gebze Plastic Manufacturer Organization (HTL) organized and led an informative tour of Pendik Veterinary Control and Research Institute’s new biosafety level 3 laboratory immediately following the conclusion of the workshop. We would also like to acknowledge the contributions of those who gave presentations, chaired sessions, served as rapporteurs, and participated in discussions during the workshop as their reflections, deliberations, and insights form the foundation for this document. This report has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. The planning committee’s role was limited to planning and convening the workshop. The views contained in the report are those of individual workshop participants and do not necessarily represent the views of all workshop participants, the planning committee, or the National Research Council. 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 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 report: Stuart Blacksell, Mahidol University, Thailand; Mohammed Hassar, Institut Pasteur du Maroc, Morocco; Alemka Markotic, University Hospital for Infectious Disease, Croatia; Piers Millett, United Nations Office at Geneva; Uwe Mueller-Doblies, Institute for Animal Health, UK; Alfred Sommer, Johns Hopkins University; Mark Smolinski, Skoll Global Threats Foundation; and Victoria Sutton, Texas Tech University. 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. Responsibility for the final content of this report rests entirely with the rapporteurs and the institution. ix

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CONTENTS Overview 1 Chapter 1 Introduction 5 Chapter 2 Framing the Issue (Plenary Sessions) 17 Chapter 3 Assessments of Needs, Challenges, and Resources (Plenary Session) 27 Chapter 4 Available Resources, Regulations, and Guidelines (Plenary Session) 31 Chapter 5 Paths from Assessments to Functional Labs (Breakout Sessions) 39 Chapter 6 Public Health Needs: Costs, Effectiveness, and Biosafety Requirements for Diagnostic Procedures (Breakout Sessions) 53 Chapter 7 Identifying Areas for Action (Breakout Sessions) 65 Chapter 8 Requirements for and Challenges Associated with BSL-4 Labs (Plenary Session) 81 Chapter 9 Concluding Plenary Discussion: Major Themes and Next Steps 89 Abbreviations and Acronyms 93 References 97 Appendix A Workshop Agenda 101 Appendix B Committee, Participant, and Staff List 109 Appendix C Committee, Participant, and Staff Biographies 113 Appendix D Description of Tour of Pendik Veterinary Control and Research Institute 137 Appendix E Country and Region Overviews 141 E1: Brazil, 143 E2: European Union, 151 E3: Pakistan, 159 E4: Russia, 161 E5: Sweden, 165 E6: Turkey, 169 E7: Ukraine, 171 E8: United Kingdom, 175 E9: United States, 193 xi

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