REVIEW OF TESTING AND EVALUATION METHODOLOGY FOR BIOLOGICAL POINT DETECTORS

ABBREVIATED SUMMARY

Committee on the Review of Testing and Evaluation Methodology for Biological Point Detectors

Board on Chemical Sciences and Technology

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary REVIEW OF TESTING AND EVALUATION METHODOLOGY FOR BIOLOGICAL POINT DETECTORS ABBREVIATED SUMMARY Committee on the Review of Testing and Evaluation Methodology for Biological Point Detectors Board on Chemical Sciences and Technology Division on Earth and Life Studies NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary 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. Support for this study was provided by the U.S. Department of Defense under contract number MD972-03-1-0009. All 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 this project. International Standard Book Number 0-309-09179-9 Additional copies of this report are available from: The National Academies Press 500 Fifth Street, N.W. Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary 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. Bruce M. Alberts 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. Wm. A. Wulf 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary COMMITTEE ON THE REVIEW OF TESTING AND EVALUATION METHODOLOGY FOR BIOLOGICAL POINT DETECTORS J. PATRICK FITCH, Lawrence Livermore National Laboratory, Chair MARK P. BUTTNER, University of Nevada, Las Vegas WYETT COLCLASURE II, Booz Allen Hamilton MARGARET E. COLEMAN, Syracuse Research Corporation* PHILIP E. COYLE III, Science Strategies HERBERT H. HILL, JR., Washington State University NANCY B. JACKSON, Sandia National Laboratories DARRELL L. JAN, Jet Propulsion Laboratory, California Institute of Technology BERNADETTE JOHNSON, Massachusetts Institute of Technology Lincoln Laboratory TIMOTHY MOSHIER, Massachusetts Institute of Technology Lincoln Laboratory STEPHEN N. RUDNICK, Harvard University BASIL I. SWANSON, Los Alamos National Laboratory DAVID R. WALT, Tufts University Staff CHRISTOPHER K. MURPHY, Program Officer TINA MASCIANGIOLI, Program Officer DAVID C. RASMUSSEN, Program Assistant DOROTHY ZOLANDZ, Director, Board on Chemical Sciences and Technology *   Formerly U.S. Department of Agriculture.

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY Co-chairs ARNOLD F. STANCELL (NAE), Georgia Institute of Technology, Atlanta, GA (emeritus) A. WELFORD CASTLEMAN, JR. (NAS), Pennsylvania State University, University Park, PA Members PAUL T. ANASTAS, Green Chemistry Institute, Washington, DC DENISE M. BARNES, Independent Consultant, Snellville, GA ANDREA W. CHOW, Caliper Life Sciences, Mountain View, CA MARK E. DAVIS (NAE), California Institute of Technology, Pasadena, CA JEAN DE GRAEVE, Université de Liège, Liège, Belgium MILES P. DRAKE, Air Products & Chemical Company, Allentown, PA CATHERINE C. FENSELAU, University of Maryland, College Park, MD GEORGE W. FLYNN (NAS), Columbia University, New York, NY MAURICIO FUTRAN (NAE), Bristol-Myers Squibb Company, New Brunswick, NJ LOU ANN HEIMBROOK, Merck & Company, Inc., Rahway, NJ ROBERT HWANG, Brookhaven National Laboratory, Upton, NY JAY V. IHLENFELD, 3M Research & Development, St. Paul, MN JAMES L. KINSLEY (NAS), Rice University, Houston, TX MARTHA A. KREBS, Science Strategies, Los Angeles, CA WILLIAM A. LESTER, JR., University of California, Berkeley, CA GREGORY O. NELSON, Eastman Chemical Company, Kingsport, TN DONALD PROSNITZ, Lawrence Livermore National Laboratory, Livermore, CA ELSA REICHMANIS (NAE), Lucent Technologies, Murray Hill, NJ MATTHEW V. TIRRELL (NAE), University of California, Santa Barbara, CA National Research Council Staff KAREN LAI, Research Associate, Christine Mirzayan Graduate Fellow (through December 2004) TINA M. MASCIANGIOLI, Program Officer ERICKA M. MCGOWAN, Research Associate CHRISTOPHER K. MURPHY, Program Officer SYBIL A. PAIGE, Administrative Associate DAVID C. RASMUSSEN, Project Assistant DOROTHY ZOLANDZ, Director

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary Acknowledgment of Reviewers 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 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 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 deliberative process. We wish to thank the following individuals for their review of this report: Robert J. Cotter, Johns Hopkins School of Medicine Stephen W. Drew, Merck & Company, Inc. (retired) Emil Gotschlich, The Rockefeller University Michael Ladisch, Purdue University Janet M. Macher, California Department of Health Services Edwin P. Przybylowicz, Eastman Kodak Company (retired) Dean Wilkening, Stanford University 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 Royce W. Murray, University of North Carolina, and Warner D. North, NorthWorks, Inc. Appointed by the National

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary Research Council, 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.

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary Preface The Department of Defense Joint Program Executive Office for Chemical and Biological Defense (DoD JPEO-CBD) requested that a committee of the National Research Council review current biological point-detection system testing protocols and integrated evaluation methodologies. Specific consideration of the Joint Biological Point Detection System (JBPDS) and a whole system live agent test and evaluation (T&E) strategy were requested. The focus of the final report is a specific proposal from the West Desert Test Center, Dugway Proving Ground (DPG) for a whole system live agent testing facility (WSLAT). The committee considered scientific, technological and regulatory aspects of the WSLAT proposal in its critique and offers suggestions for improvement if WSLAT were selected as part of the near term test and evaluation strategy. Because of identified schedule and scientific risks, we suggest an alternate approach that focuses test and evaluation efforts on leveraging existing data, improving agent simulants, representing appropriate inhibitors and backgrounds, and modeling for performance prediction to extrapolate from relatively controlled environments with simulant testing to complex environments with live agent operations. The committee believes that the DOD, in fact, needs significant resources to expand the T&E strategy to include elements of both approaches. The committee’s report was originally transmitted to the sponsor on July 23, 2004, requesting confirmation that the report is in fact unclassified and can be made available to the public without restriction, to include the possibility of posting it on the National Academy of Sciences’ (NAS) world wide web site. On September 24, 2004, BG Stephen V. Reeves, U.S. Army, Joint Program Executive Officer for Chemical and Biological Defense, informed the NAS that JPEO-CBD

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary “recommends that the distribution of the subject report be restricted to U.S. Government Agencies and their contractors only.”1 Further, the letter states “Though the report is unclassified, per Department of Defense Directive 5230.24, the distribution must be restricted because it contains information concerning keystone test equipment, characterized in the regulation as “critical technology.” Additionally, potential military applications, system test and evaluation limitations, and biological defense vulnerabilities are discussed throughout the document. The document should also be marked export-controlled per Department of Defense Directive 5230.25.” Section 15 of the Federal Advisory Committee Act (FACA) provides that the Academy shall make its final report available to the public unless the Academy determines that the report would disclose matters described in one or more of the exemption provisions under the Freedom of Information Act (FOIA). If the Academy determines that the report would disclose matters described in one or more of the FOIA exemptions, “the Academy shall make public an abbreviated version of the report that does not disclose such matters.” Paragraph 4.5 of DoD Directive 5230.25 states “The authority provided herein may not be used to withhold from public disclosure unclassified information regarding DoD operations, policies, activities, or programs, including the costs and evaluations of performance and reliability of military and space equipment. When such information does contain technical data subject to this Directive, the technical data shall be excised from that which is disclosed publicly.” Accordingly, all technical data has been excised from the attached Summary. The Academy has determined that this Summary does not disclose matters described in any of the FOIA exemptions. All of the committee’s recommendations remain identical to the recommendations in the version of the report delivered to JPEO-CBD. 1   Letter, BG Stephen V. Reeves, U.S. Army, Joint Program Executive Officer for Chemical and Biological Defense to Mr. Kevin Hale, Director, Program Security, The National Academies, September 24, 2004.

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   6 2   OVERVIEW AND HIGH-LEVEL RECOMMENDATIONS   10 3   EVALUATION OF THE WSLAT FEASIBILITY STUDY   16 4   RECOMMENDED EVALUATION STRATEGIES   19     APPENDIX STATEMENT OF WORK   23

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Review of Testing and Evaluation Methodology for Biological Point Detectors: Abbreviated Summary Review of Testing and Evaluation Methodology for Biological Point Detectors Final Report

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