ANIMAL MODELS
FOR ASSESSING COUNTERMEASURES
TO BIOTERRORISM AGENTS

Committee on Animal Models for Assessing Countermeasures
to Bioterrorism Agents



Institute for Laboratory Animal Research
Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL
                          OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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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.

This study was supported by the U.S. Department of Defense through Contract Number W911NF-09-C-0046. 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. The content of this publication does not necessarily reflect the views or policies of the Department of Defense, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.

International Standard Book Number-13: 978-0-309-21909-9
International Standard Book Number-10: 0-309-21909-4

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COMMITTEE ON ANIMAL MODELS FOR ASSESSING COUNTERMEASURES TO BIOTERRORISM AGENTS

Members

GEORGE W. KORCH, JR. (Co-Chair), Johns Hopkins University, Baltimore, MD

STEVEN M. NIEMI (Co-Chair), Massachusetts General Hospital, Charlestown, MA

NICHOLAS H. BERGMAN, Battelle National Biodefense Institute, Frederick, MD

DANIEL J. CARUCCI, Global Health Consulting, Washington, DC

SUSAN A. EHRLICH, Arizona Court of Appeals (retired), Phoenix, AZ

GIGI KWIK GRONVALL, University of Pittsburgh Medical Center, Baltimore, MD

THOMAS HARTUNG, Johns Hopkins University School of Public Health, Baltimore, MD

ELIZABETH HEITMAN, Vanderbilt University Medical Center, Nashville, TN

MALAK KOTB, University of Cincinnati College of Medicine, Cincinnati, OH

JENS H. KUHN, National Institutes of Health, Frederick, MD

C. RICK LYONS, Colorado State University, Fort Collins, CO

STEPHEN S. MORSE, Columbia University School of Public Health, New York, NY

FREDERICK A. MURPHY, University of Texas Medical Branch, Galveston, TX

VIKRAM S. PATEL, Food and Drug Administration, Silver Spring, MD

JAMES R. SWEARENGEN, Battelle National Biodefense Institute, Frederick, MD

Staff

LIDA ANESTIDOU, Study Director

FRANCES SHARPLES, Acting Director, Institute for Laboratory Animal Research

CARL-GUSTAV ANDERSON, Program Associate

RUTH CROSSGROVE, Senior Editor

INDIA HOOK-BARNARD, Program Officer

MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center

RADIAH ROSE, Manager of Editorial Projects

INSTITUTE FOR LABORATORY ANIMAL RESEARCH

Council Members

FLOYD BLOOM (IOM) (Chair), Molecular and Integrative Neuroscience Department (emeritus), Scripps Research Institute, La Jolla, CA

KATHRYN A. BAYNE, Association for Assessment and Accreditation of Laboratory Animal Care International, Frederick, MD

MYRTLE A. DAVIS, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD

NELSON L. GARNETT, Laboratory Animal Care and Use Programs, Dickerson, MD

JUDY A. MACARTHUR CLARK, Animals in Scientific Procedures Inspectorate, Home Office, London, United Kingdom

DANIEL S. MARSMAN, Procter & Gamble, Mason, OH

GARRY NEIL, Corporate Office of Science and Technology, Johnson & Johnson, New Brunswick, NJ

TIMO OLAVI NEVALAINEN, Professor Emeritus, University of Eastern Finland, Kuopio

STEVEN M. NIEMI, Center for Comparative Medicine, Massachusetts General Hospital, Charlestown

MELINDA A. NOVAK, Department of Psychology, University of Massachusetts, Amherst

MENELAS PANGALOS, Innovative Medicines, AstraZeneca, Alderley Park, United Kingdom

BERNARD E. ROLLIN, Departments of Philosophy, Behavioral Sciences, and Animal Sciences, Colorado State University, Fort Collins

JAMES A. ROTH, Center for Food Security and Public Health, College of Veterinary Medicine, Iowa State University, Ames

Staff

FRANCES SHARPLES, Acting Director

LIDA ANESTIDOU, Senior Program Officer

CAMERON H. FLETCHER, Managing Editor, ILAR Journal

JASON WORTHY, Senior Program Assistant

INSTITUTE FOR LABORATORY ANIMAL RESEARCH PUBLICATIONS

Guidance for the Description of Animal Research in Scientific Publications (2011)

Animal Research in a Global Environment – Meeting the Challenges (2011)

Guide for the Care and Use of Laboratory Animals: Eighth Edition (2011)

Recognition and Alleviation of Pain in Laboratory Animals (2009)

Scientific and Humane Issues in the Use of Random Source Dogs and Cats for Research (2009)

Recognition and Alleviation of Distress in Laboratory Animals (2008)

Toxicity Testing in the 21st Century: A Vision and a Strategy (2007)

Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents: Appropriate Use of Animal Models (2006)

Guidelines for the Humane Transportation of Research Animals (2006)

Science, Medicine, and Animals: Teacher’s Guide (2005)

Animal Care and Management at the National Zoo: Final Report (2005)

Science, Medicine, and Animals (2004)

The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop (2004)

Animal Care and Management at the National Zoo: Interim Report (2004)

National Need and Priorities for Veterinarians in Biomedical Research (2004)

Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research (2003)

International Perspectives: The Future of Nonhuman Primate Resources, Proceedings of the Workshop Held April 17-19, 2002 (2003)

Occupational Health and Safety in the Care and Use of Nonhuman Primates (2003)

Definition of Pain and Distress and Reporting Requirements for Laboratory Animals: Proceedings of the Workshop Held June 22, 2000 (2000)

Strategies That Influence Cost Containment in Animal Research Facilities (2000)

Microbial Status and Genetic Evaluation of Mice and Rats: Proceedings of the 1999 US/Japan Conference (2000)

Microbial and Phenotypic Definition of Rats and Mice: Proceedings of the 1998 US/Japan Conference (1999)

Monoclonal Antibody Production (1999)

The Psychological Well-Being of Nonhuman Primates (1998)

Biomedical Models and Resources: Current Needs and Future Opportunities (1998)

Approaches to Cost Recovery for Animal Research: Implications for Science, Animals, Research Competitiveness and Regulatory Compliance (1998)

Chimpanzees in Research: Strategies for Their Ethical Care, Management, and Use (1997)

Occupational Health and Safety in the Care and Use of Research Animals (1997)

Guide for the Care and Use of Laboratory Animals (1996)

Rodents (1996)

Nutrient Requirements of Laboratory Animals, Fourth Revised Edition (1995)

Laboratory Animal Management: Dogs (1994)

Recognition and Alleviation of Pain and Distress in Laboratory Animals (1992)

Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs (1991)

Companion Guide to Infectious Diseases of Mice and Rats (1991)

Infectious Diseases of Mice and Rats (1991)

Immunodeficient Rodents: A Guide to Their Immunobiology, Husbandry, and Use (1989)

Use of Laboratory Animals in Biomedical and Behavioral Research (1988)

Animals for Research: A Directory of Sources, Tenth Edition and Supplement (1979)

Amphibians: Guidelines for the Breeding, Care and Management of Laboratory Animals (1974)

Acknowledgments

This report, Animal Models for Assessing Countermeasures to Bioterrorism Agents, has been reviewed in draft form by individuals chosen for their diverse perspectives and expertise in accordance with procedures approved by the Report Review Committee of the National Research Council (NRC). The purpose of this independent review is to provide candid and critical comments that will assist the Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents 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 integrity of the deliberation process. The Committee thanks the following individuals for their review of the draft report:

Joy Cavagnaro, Access BIO, LC

Donald R. Drake, III, VaxDesign Corporation

James Estep, Battelle Memorial Institute

Thomas Geisbert, University of Texas Medical Branch

Charles H. Hobbs, Lovelace Respiratory Research Institute

Nancy King, Wake Forest University School of Medicine

Terry McElwain, Washington State University

Nathaniel Powell, Jr., Centers for Disease Control and Prevention

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 Leslie Z. Bennett, University of California-San Francisco and Ann Arvin, Stanford University School of Medicine. Appointed by the NRC, 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.

The Committee expresses its appreciation to Karen Goldenthal who served on this panel until July 2011. The Committee also extends its appreciation to Judith Hewitt for the white paper Developing Animal Models for Use in Animal Rule Licensure: The NIAID Approach. Finally, the Committee thanks the speakers who addressed the Committee in the public meetings of September and November 2009, and February 2010.

Lastly, and certainly most importantly, the Committee wishes to thank the diligent efforts of the ILAR leadership and staff who provided many levels of support to this endeavor. We are especially thankful to Dr. Lida Anestidou for her tireless work in guiding and helping craft this report while concomitantly assuming unanticipated extra duties for ILAR. The Committee very much appreciated the technical input and teamwork provided by Dr. India Hook-Barnard from the Board on Life Sciences. We also want to posthumously recognize the great support the Committee received from Ms. Kathy Beil, who made sure we got to the right places at the right time during the active period of the committee’s meetings in Washington D.C.

George W. Korch, Jr., Co-Chair
Steven M. Niemi, Co-Chair
Committee on Animal Models for Assessing
Countermeasures to Bioterrorism Agents

Contents

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