REVIEW OF TESTING AND EVALUATION METHODOLOGY FOR BIOLOGICAL POINT DETECTORS
ABBREVIATED SUMMARY
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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.
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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.
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
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
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
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.
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
“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.