Determining Core Capabilities in
Chemical and Biological Defense
Science and Technology

Committee on Determining Core Capabilities in
Chemical and Biological Defense Research and Development

Board on Chemical Sciences and Technology
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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Determining Core Capabilities in Chemical and Biological Defense Science and Technology Committee on Determining Core Capabilities in Chemical and Biological Defense Research and Development Board on Chemical Sciences and Technology 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. HQ0034-10-D-0003, TO #5 between the National Academy of Sciences and US Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-26535-5 International Standard Book Number-10: 0-309-26535-5 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; 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 govern- ment 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 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. 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 pro- viding 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 DETERMINING CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE RESEARCH AND DEVELOPMENT MIRIAM E. JOHN (Chair), Private Consultant; Vice President, Emeritus, Sandia National Laboratories, Livermore, CA DAVID R. FRANZ, Former Commander, USAMRIID, Frederick, MD JILL M. HRUBY, Sandia National Laboratories, Albuquerque, NM ANNA JOHNSON-WINEGAR, retired, Office of the Secretary of Defense CHARLES E. KOLB, Aerodyne Research Inc., Billerica, MA C. RICK LYONS, Colorado State University, Fort Collins, CO JON MOGFORD, Texas A&M University, College Station, TX RANDALL S. MURCH, Virginia Polytechnic Institute and State University, Arlington, VA DONALD PROSNITZ, Private Consultant, Livermore, CA TOM SLEZAK, E.O. Lawrence Livermore National Laboratory, Livermore, CA HENRY H. WILLIS, RAND Corporation, Pittsburgh, PA PATRICK SCANNON, (Consultant) XOMA, Berkeley, CA GEORGE M. WHITESIDES, (Consultant) Harvard University, Cambridge, MA National Research Council Staff Board on Chemical Sciences and Technology DOROTHY ZOLANDZ, Director DOUGLAS FRIEDMAN, Program Officer KATHRYN HUGHES, Senior Program Officer AMANDA CLINE, Administrative Assistant SHEENA SIDDIQUI, Senior Program Associate RACHEL YANCEY, Senior Program Assistant Board on Life Sciences FRAN SHARPLES, Director INDIA HOOK-BARNARD, Senior Program Officer v

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BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY PABLO DEBENEDETTI (Co-Chair), Princeton University, Princeton, NJ C. DALE POULTER (Co-Chair), University of Utah, Salt Lake City, UT ZHENAN BAO, Stanford University, Stanford, CA ROBERT BERGMAN, University of California, Berkeley, CA HENRY BRYNDZA, E. I. du Pont de Nemours & Company, Wilmington, DE EMILY CARTER, Princeton University, Princeton, NJ DAVID CHRISTIANSON, University of Pennsylvania, Philadelphia, PA MARY JANE HAGENSON, Chevron Phillips Chemical Company, LLC, The Woodlands, TX CAROL J. HENRY, The George Washington University, Washington, DC JILL HRUBY, Sandia National Laboratories, Albuquerque, NM MICHAEL C. KERBY, ExxonMobil Chemical Company, Houston, TX CHARLES E. KOLB, Aerodyne Research, Inc., Billerica, MA JOSEF MICHL, University of Colorado, Boulder, CO SANDER G. MILLS, Merck, Sharp, & Dohme Corporation, Whitehouse Station, NJ DAVID MORSE, Corning Incorporated, Corning, NY ROBERT E. ROBERTS, Institute for Defense Analyses, Alexandria, VA DARLENE J. S. SOLOMON, Agilent Technologies, Santa Clara, CA JEAN TOM, Bristol-Myers Squibb, West Windsor, NJ DAVID WALT, Tufts University, Medford, MA National Research Council Staff DOROTHY ZOLANDZ, Director TINA MASCIANGOLI, Senior Program Officer DOUGLAS FRIEDMAN, Program Officer KATHRYN HUGHES, Senior Program Officer AMANDA CLINE, Administrative Assistant SHEENA SIDDIQUI, Senior Program Associate RACHEL YANCEY, Senior Program Assistant vi

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BOARD ON LIFE SCIENCES KEITH R. YAMAMOTO (Chair), University of California, San Francisco, CA BONNIE L. BASSLER, Princeton University, Princeton, NJ VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, CA SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, VA SARAH C.R. ELGIN, Washington University, St. Louis, MO MARK FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL DAVID R. FRANZ, Former Commander, USAMRIID, Frederick, MD LOUIS J. GROSS, University of Tennessee, Knoxville, TN RICHARD A. JOHNSON, Arnold & Porter, LLC, Washington, DC CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, CT ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC BERNARD LO, University of California, San Francisco, CA KAREN E. NELSON, J. Craig Venter Institute, Rockville, MD ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, GA MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY ALISON G. POWER, Cornell University, Ithaca, NY MARGARET RILEY, University of Massachusetts, Amherst, MA 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 National Research Council Staff FRANCES E. SHARPLES, Director JO L. HUSBANDS, Scholar/Senior Project Director JAY B. LABOV, Senior Scientist/Program Director for Biology Education KATHERINE W. BOWMAN, Senior Program Officer INDIA HOOK-BARNARD, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer KEEGAN SAWYER, Program Officer BETHLEHEM M. BANJAW, Financial Associate ORIN E. LUKE, Senior Program Assistant CARL G. ANDERSON, Program Associate SAYYEDA AYESHA AHMED, Senior Program Assistant vii

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Acknowledgment of Reviewers 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: R. Stephen Berry, University of Chicago W. Peter Cherry, Independent Consultant Joseph M. DeSimone, University of North Carolina Gerald L. Epstein, US Department of Homeland Security Thomas G. Ksiazek, University of Texas Medical Branch Stephen S. Morse, Columbia University Although the reviewers listed above have provided many con- structive 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 ix

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xACKNOWLEDGMENTS Ed Przybylowicz, Retired, Eastman Kodak Company, and Robert Frosch, Woods Hole Oceanographic Institution. Appointed by the National Research Council, they were responsible for making certain that an inde- pendent 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.

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Contents Summary 1 1Introduction13 Statement of Task and Purpose of Study, 13 Organization of the Report, 15 The Committee Process, 15 The Threat Is Amorphous, 16 Proposed Approach, 22 Findings and Recommendations, 23 2 Framework and Structure25 Organizational Concerns, 25 The Committee's Approach, 30 Findings and Recommendations, 33 3Core Science and Technology Capabilities for the Chemical and Biological Defense Program35 Enabling CBRN Intelligence, Surveillance, and Reconnaissance, 39 Chemical and Biological Agent Detection, 44 Individual and Collective Protection, 48 Medical Countermeasures, 50 Hazard Assessment, Management, and Decontamination, 55 Cross-Cutting Science and Technology, 58 Summary of CBDP Core Capabilities, 67 Findings and Recommendations, 68 xi

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xiiCONTENTS 4 Proposed Approach73 Capabilities-Based Strategic Planning for Chemical and Biological Defense, 73 Findings and Recommendations, 80 5 Management of Science and Technology at CBDP83 Maintaining a Connection to the End User, 84 Technology Transition within CBDP, 85 Laboratory Management, 90 Laboratory Management within CBDP, 95 Findings and Recommendations, 101 Appendixes A Schedule of Data-Gathering105 B Additional Thoughts on the Nature of the Chemical Threat111 Hard Intelligence Difficult to Obtain, 111 The Use Cases Have Changed, 112 Characteristics of Chemical Weapons, 114 General Concerns, 115 C Frameworks of the CBDP Enterprise Elements119 D Relationship Comparison of CBDP Enterprise Frameworks to the Committee's S&T Capability Categories123 E Committee Member Biographies127

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Acronyms AFRL US Air Force Research Laboratory ARIEM US Army Research Institute of Environmental Medicine ASARDA Assistant Secretary of the Army for Research, Development, and Acquisition ASD(NCB) Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs AT&L Acquisition, Technology, and Logistics BARDA Biomedical Advanced Research and Development Authority BSL Biological Safety Level BW Biological Weapon CB Chemical and Biological CBD Chemical and Biological Defense CBDP Chemical and Biological Defense Program CBRN Chemical, Biological, Radiological, and Nuclear CBW Chemical and Biological Weapons CDC Centers for Disease Control and Prevention COCOM US Combatant Command CONOPS Concept of Operations CRO Contract Research Organizations CRP Critical Reagents Program CTR Cooperative Threat Reduction xiii

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xivACRONYMS DARPA Defense Advanced Research Projects Agency DASD(CBD) Deputy Assistant Secretary of Defense for Chemical and Biological Defense DHS Department of Homeland Security DNA Deoxyribonucleic Acid DoD US Department of Defense DOE US Department of Energy DPG US Army Dugway Proving Ground DTRA Defense Threat Reduction Agency ECBC Edgewood Chemical Biological Center EFP Explosively Formed Projectile FDA US Food and Drug Administration FFRDC Federally Funded Research and Development Center FSU Former Soviet Union GEIS Global Emerging Infections Surveillance and Response System GPHIN Global Public Health Intelligence Network GLP Good Laboratory Practices GMP Good Manufacturing Practices HHS Department of Health and Human Services IC Intelligence Community IED Improvised Explosive Device IND Investigational New Drug IR&D Internal Research and Development ISR Intelligence, Surveillance, and Reconnaissance JCAD Joint Chemical Agent Detector JCS Joint Chiefs of Staff JPEO-CBD Joint Program Executive Office for Chemical and Biological Defense JPL Joint Priority List JPM Joint Program Manager JPO Joint Program Office JRO-CBRND Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense JSIG Joint Service Integration Group JSMG Joint Service Materiel Group

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ACRONYMS xv JSTO-CBD Joint Science and Technology Office for Chemical and Biological Defense LANL Los Alamos National Laboratory LLNL Lawrence Livermore National Laboratory MCMI Medical Countermeasures Initiative MDD Material Development Decision MRMC US Army Medical Research and Materiel Command NAS National Academy of Sciences NBACC National Biodefense Analysis and Countermeasures Center NCAR National Center for Atmospheric Research NCI National Cancer Institute NIH National Institutes of Health NIST National Institute of Standards and Technology NRC National Research Council NSRDEC US Army Natick Soldier Research, Development, and Engineering Center NSWC Naval Surface Warfare Center NTA Non-Traditional Agent OASD(NCB/CB) Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs/Chemical and Biological Defense OGA Other Government Agency OSD Office of the Secretary of Defense PET Positron Emission Tomography PI Principal Investigator PNNL Pacific Northwest National Laboratory POM Program Objective Memorandum R&D Research and Development R-D-AResearch-Development-Acquisition RDT&E Research, Development, Test, and Evaluation RNA Ribonucleic Acid RSDL Reactive Skin Decontamination Lotion S&T Science and Technology SNL Sandia National Laboratory

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xviACRONYMS T&E Test and Evaluation TMT Transformational Medical Technologies TMTI Transformational Medical Technologies Initiative US United States USAMRICD US Army Medical Research Institute of Chemical Defense USAMRIID US Army Medical Research Institute of Infectious Diseases USD Under Secretary of Defense USDA US Department of Agriculture USG United States Government USSOCOM US Special Operations Command UTMB University of Texas Medical Branch WDTC West Desert Test Center WRAIR Walter Reed Army Institute of Research