A Framework for Assessing the Health Hazard Posed by Bioaerosols

Committee on Determining a Standard Unit of Measure for Biological Aerosols

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

Washington, D.C.
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A Framework for Assessing the Health Hazard Posed by Bioaerosols Committee on Determining a Standard Unit of Measure for Biological Aerosols Board on Chemical Sciences and Technology 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 the U.S. Department of Defense under Grant W911NF-06-C-0171. 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: 978-0-309-11150-8 International Standard Book Number 10: 0-309-11150-1 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 2008 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 DETERMINING A STANDARD UNIT OF MEASURE FOR BIOLOGICAL AEROSOLS J. PATRICK FITCH (CHAIR), National Biodefense Analysis & Countermeasures Center, Frederick, MD MIKE BRAY, National Institute of Allergy and Infectious Diseases, Bethesda, MD YUNG-SUNG CHENG, Lovelace Respiratory Research Institute, Albuquerque, NM KATHRYN L. CREEK, L-3 Communications, San Diego, CA JAY D. EVERSOLE, Naval Research Laboratory, Washington, DC RICHARD C. FLAGAN, California Institute of Technology, Pasadena, CA MICHAEL R. KUHLMAN, National Biodefense Analysis & Countermeasures Center, Frederick, MD STANLEY MALOY, San Diego State University, San Diego, CA I. GARY RESNICK, Los Alamos National Laboratory, Los Alamos, NM National Research Council Staff FRANCES SHARPLES, Director, Board on Life Sciences DOROTHY ZOLANDZ, Director, Board on Chemical Sciences and Technology KATHRYN HUGHES, Postdoctoral Fellow KELA MASTERS, Senior Program Assistant JESSICA PULLEN, Research Assistant ANN REID, Senior Program Officer MARILEE SHELTON-DAVENPORT, Senior Program Officer v

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BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY Chairpersons F. FLEMING CRIM (CO-CHAIR), University of Wisconsin, Madison, WI GARY S. CALABRESE (CO-CHAIR), Corning, Inc, Corning, NY Members BENJAMIN ANDERSON, Lilly Research Laboratories, Indianapolis, IN PABLO G. DEBENEDETTI, Princeton University, Princeton, NJ RYAN R. DIRX, Arkema Inc., King of Prussia, PA GEORGE W. FLYNN, Columbia University, New York, NY MAURICIO FUTRAN, Bristol-Myers Squibb Company, New Brunswick, NJ MARY GALVIN-DONOGHUE, Air Products and Chemicals, Allentown, PA PAULA T. HAMMOND, Massachusetts Institute of Technology, Cambridge, MA RIGOBERTO HERNANDEZ, Georgia Institute of Technology, Atlanta, GA JAY D. KEASLING, University of California Berkeley Center for Synthetic Biology, Berkeley, CA JAMES L. KINSEY, Rice University, Houston, TX MARTHA A. KREBS, California Energy Commission, Sacramento, CA CHARLES T. KRESGE, Dow Chemical Company, Midland, MI SCOTT J. MILLER, Yale University, New Haven, CT GERALD V. POJE, Independent Consultant, Vienna, VA DONALD PROSNITZ, Lawrence Livermore National Laboratory, Livermore, CA THOMAS H. UPTON, ExxonMobil Chemical Company, Houston, TX National Research Council Staff DOROTHY ZOLANDZ, Director KATHRYN J. HUGHES, Associate Program Officer TINA M. MASCIANGIOLI, Program Officer KELA MASTERS, Senior Program Assistant ERICKA M. MCGOWAN, Associate Program Officer SYBIL A. PAIGE, Administrative Associate JESSICA L. PULLEN, Research Assistant FEDERICO SAN MARTINI, Program Officer vi

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BOARD ON LIFE SCIENCES Chairperson KEITH YAMAMOTO (CHAIR), University of California, San Francisco Members ANN M. ARVIN, Stanford University School of Medicine, San Francisco, CA RUTH BERKELMAN, Princeton University, Princeton, NJ DEBORAH BLUM, University of Wisconsin, Madison, WI VICKI L. CHANDLER, University of Arizona, Tucson, AZ JEFFERY L. DANGL, University of North Carolina, Chapel Hill, NC PAUL R. EHRLICH, Stanford University, Stanford, CA MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL JO HANDELSMAN, University of Wisconsin, Madison, WI KENNETH H. KELLER, University of Minnesota, Minneapolis, MN JONATHAN D. MORENO, University of Pennsylvania, Philadelphia, PA RANDALL MURCH, Virginia Polytechnic Institute and State University, Alexandria, VA MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY JAMES REICHMAN, University of California, Santa Barbara BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY MARC T. TESSIER-LAVIGNE, Genentech Inc., South San Francisco, CA JAMES TIEDJE, Michigan State University, East Lansing, MI CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, MD National Research Council Staff FRANCES E. SHARPLES, Director KERRY BRENNER, Senior Program Officer ANN H. REID, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer ADAM P. FAGEN, Senior Program Officer ANNA FARRAR, Financial Associate MERCURY FOX, Program Assistant REBECCA L. WATER, Senior Program Assistant vii

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Preface The Committee on Determining a Standard of Measure for Biological Aerosols was convened by The National Academies in response to a request from the U.S. Department of Defense (DOD), Joint Program Executive Office for Chemical and Biological Defense (JPEO CBD), Joint Project Manager, Nuclear, Biological and Chemical Contamination Avoidance (JPM NBCCA), Product Director, Test Equipment, Strategy and Support (PD TESS).1 As the committee title indicates, PD TESS requested the evaluation of current units of measure of biological aerosols and, if necessary, the development of a new standard unit of measure to aid in the development and testing of biological warfare agent detectors. Specifically, an evaluation of the continued use of Agent-Containing Particles per Liter of Air (ACPLA) in test and evaluation of detectors was requested. The full statement of task for the committee can be found in Appendix B. In approaching the statement of task, the committee requested input from representatives of the Joint Program Manager for Biological Defense; the Joint Program Manager for Nuclear, Biological, and Chemical Contamination Avoidance; the Joint Requirements Office (JRO); Dugway Proving Ground (DPG); and the United States Army Medical Research Institute for Infectious Diseases (USAMRIID). These speakers brought important, complementary perspectives to the question, and gave the committee useful insights on the impact a new unit of measure would have on the testing and evaluation community. These presentations and discussions were instrumental in guiding the committee to the development of the framework for evaluating health risk described in the report. We believe the recommendations will strengthen the existing testing and evaluation community by creating a single unit based on the specific health risks presented by different biological agents. The committee met three times in person in Washington, DC, and numerous times by teleconference over the course of eight months. The timeline and workload required considerable attention from the committee, and this report would not have been possible without their consistent dedication and patience. Throughout the project, the staff of the sponsoring office, PD TESS, provided considerable support and interest in the study. The committee sincerely appreciated their willingness to answer questions and provide necessary background information. J. Patrick Fitch, Chair 1 The abbreviation PD TESS will be used to indicate this organization. ix

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Acknowledgment of Reviewers This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making the published report as sound as possible and to ensure that it meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Mark Buttner, University of Nevada, Las Vegas Richard Chang, Yale University Daniel Lucey, Georgetown University Medical Center Janet Macher, California Department of Health Services Joan Rose, Michigan State University D. Warner North, NorthWorks, Inc. Donald Prosnitz, Lawrence Livermore National Laboratory Edwin P. Przybylowicz, Eastman Kodak Company (retired) Chad Roy, Tulane National Primate Research Center Although the reviewers listed above 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 Dr. David Franz, Midwest Research Institute. Appointed by the National Research Council, he was 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. xi

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Contents SUMMARY 1 1. INTRODUCTION 9 Request to Committee, 9 Determining a Standard Unit of Measure, 10 The Health Protection Objective, 13 2. EXPLORING THE COMPLEXITY OF HEALTH RISK 15 Biological Warfare Agents, 15 Properties of Aerosols, 19 Biological Effects of Inhaled Particles, 22 Particle Size and Aerosol Collection, 26 Current Units of Measure and Health Hazard, 27 3. BUILDING THE FRAMEWORK FOR EVALUATING HEALTH HAZARD 29 The Framework in Words, 29 Proposed Framework for Evaluating Aerosolized Biothreat Agents, 31 A Mathematical Description of Bioaerosol Health Risk, 32 Application of the Equation to Detectors, 38 Comparison and Conversion of BAULADae to Other Units, 41 4. IMPLICATIONS OF BAULA FOR DETECTOR TEST AND EVALUATION 47 The Test and Evaluation Process, 47 The Current Test and Evaluation Process, 49 Limitations of the Current System for Implementing BAULADae, 57 Implementing BAULADae with Current Testing and Referee Systems, 58 Additional Considerations, 59 5. RECOMMENDATIONS 61 BIBLIOGRAPHY 65 APPENDIXES A Evaluating Detector Signals, 71 B Statement of Task, 79 C Committee Member Biographies, 81 D Acronyms and Abbreviations, 85 xiii

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