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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. doi: 10.17226/25772.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

PREPUBLICATION COPY Necessity, Use, and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs Committee on Assessment of the Use and Care of Dogs in Biomedical Research Funded by or Conducted at the U.S. Department of Veterans Affairs Institute for Laboratory Animal Research Division on Earth and Life Studies Board on Health Sciences Policy Health and Medicine Division A Consensus Study Report of Prepublication Copy: Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by Contract No. 36C24E18C0058 with the U.S. Department of Veterans Affairs. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25772 Additional copies of this publication are available 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 2020 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested Citation: National Academies of Sciences, Engineering, and Medicine. 2020. Necessity, use, and care of laboratory dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. https://doi.org/10.17226/25772 Prepublication Copy: Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. Prepublication Copy: Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process, and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. Prepublication Copy: Uncorrected Proofs

COMMITTEE ON ASSESSMENT OF THE USE AND CARE OF DOGS IN BIOMEDICAL RESEARCH FUNDED BY OR CONDUCTED AT THE U.S. DEPARTMENT OF VETERANS AFFAIRS RHONDA CORNUM (Chair), TechWerks, Paris, KY W. RON DEHAVEN (Vice Chair), Dehaven Veterinary Solutions, LLC, El Dorado Hills, CA DONNA K. ARNETT, University of Kentucky, Lexington WARREN CASEY, National Institute of Environmental Health Sciences, Durham, NC CHRIS GREEN, Harvard University, Cambridge, MA JOAN C. HENDRICKS, University of Pennsylvania, Philadelphia (Emerita) KATHRIN HERRMANN, Johns Hopkins University, Baltimore, MD (until June 2019) JONATHAN KIMMELMAN, McGill University, Montreal, QC LEWIS B. KINTER, GLP Scientific Consulting, Kennett Square, PA SARAH L. LATHROP, University of New Mexico, Albuquerque NANCY FIGLER MARKS, University of Iowa, Iowa City CHRISTIAN E. NEWCOMER, Independent Consultant, Brookeville, MD WILLIAM Z. POTTER, Independent Consultant, Philadelphia, PA DAVID M. POWELL, Saint Louis Zoo, Saint Louis, MO MARGARET (MIMI) FOSTER RILEY, University of Virginia, Charlottesville RODNEY A. WHITE, Long Beach MemorialCare Heart & Vascular Institute, Long Beach, CA Staff REBECCA A. ENGLISH, Study Director, Board on Health Sciences Policy (as of June 2019) LIDA ANESTIDOU, Study Director, Institute for Laboratory Animal Research (until May 2019) CAMILLA YANDOC ABLES, Senior Program Officer, Board on Agriculture and Natural Resources JENNA BRISCOE, Research Associate, Board on Agriculture and Natural Resources ALEX REPACE, Senior Program Assistant, Board on Health Sciences Policy (from November 2019) KEIONA JONES, Senior Program Assistant, Institute for Laboratory Animal Research (until August 2019) Science Writer/Editor CAROL BERKOWER ROBERT POOL Prepublication Copy: Uncorrected Proofs v

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 thank the following individuals for their review of this report: Bonnie Beaver, Texas A&M University-College Station Matthew Breen, North Carolina State University Kathleen Conlee, The Humane Society of the United States Linda C. Cork, NAM1, Stanford Medicine Candace L. Floyd, University of Utah David K. Johnson, Diplomate of the American College of Laboratory Animal Medicine Jeffrey Kahn, NAM2, Johns Hopkins University Margaret Landi, GSK Pharmaceuticals Paul Locke, Johns Hopkins Bloomberg School of Public Health Daniel Myers, University of Michigan Jeff Sebo, New York University Jennifer Smith, Henry Ford Health System Norman Stockbridge, Food and Drug Administration Charles H. Vite, University of Pennsylvania School of Veterinary Medicine Paul Waldau, Canisius College Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by Steve Barthold, NAM3, University of California, Davis, and Eli Adashi, NAM4, Brown University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. 1 National Academy of Medicine. 2 National Academy of Medicine. 3 National Academy of Medicine. 4 National Academy of Medicine. Prepublication Copy: Uncorrected Proofs vii

Contents SUMMARY.................................................................................................................................................. 1 1 INTRODUCTION .............................................................................................................................. 13 Origin of this Study, 14 Recent Legislation Concerning the Use of Laboratory Dogs at the Veterans Affairs, 16 Study Process, 17 The Committee’s Interpretation of its Task, 19 Terminology Used in this Report, 19 Organization of the Report, 21 References, 21 2 LEGAL, SOCIAL, AND ETHICAL CONSIDERATIONS ........................................................... 24 Historical Overview of Research Using Dogs, 24 Legal Context for Using Laboratory Dogs in Biomedical Research, 26 Standards for the Use and Welfare of Dogs in Biomedical Research, 30 Social and Ethical Considerations, 31 Ethical Considerations on the Use of Dogs in Veterans Affairs Research, 31 References, 37 3 DETERMINING THE NECESSITY OF LABORATORY DOGS IN BIOMEDICAL RESEARCH FUNDED BY OR CONDUCTED AT THE U.S. DEPARTMENT OF VETERANS AFFAIRS ...................................................................................................................... 41 Trends in Dog Use in U.S. Research Facilities, 41 Laboratory Dog Use in Biomedical Research at the Veterans Affairs, 43 Next Steps for the Use of Laboratory Dogs in Biomedical Research Related to the Veterans Affairs Mission, 62 Veterans Affairs Biomedical Research Review Process, 65 Operationalizing “Necessary” Areas of Agreement and Disagreement Within the Committee, 68 Opportunities to Improve Biomedical Research Protocols and Review Processes at the Veterans Affairs, 74 References, 77 4 ALTERNATIVES TO THE USE OF LABORATORY DOGS ..................................................... 98 Current Status of Alternatives Development, 98 Companion Dogs, 99 Other Animal Models, 104 Non-Animal Models: New Approach Methodologies, 112 Human Clinical Trials, 119 References, 120 Prepublication Copy: Uncorrected Proofs ix

Contents 5 CARE AND WELFARE OF LABORATORY DOGS USED IN BIOMEDICAL RESEARCH FUNDED BY OR CONDUCTED AT THE U.S. DEPARTMENT OF VETERANS AFFAIRS.............................................................................................................. 134 Current Knowledge in the Science of Animal Welfare: A Brief Overview, 134 Additional Considerations for Enhancement of the Welfare of Laboratory Dogs, 137 Relationship of Current Standards, Requirements, and Recommendations to Developments in Animal Welfare Science, 138 Assessment of Current Veterans Affairs Practices: Do They Meet Current Standards, Requirements, and Recommendations With Regard to the Care and Welfare of Dogs?, 140 Considerations for Enhancement at the Veterans Affairs, 143 References, 144 APPENDIXES A METHODS ................................................................................................................................. 148 B USDA STATISTICS ON THE USE OF DOGS AND OTHER ANIMALS IN RESEARCH .......................................................................................................................... 156 C BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS ........................................ 162 BOXES, FIGURES AND TABLE BOXES S-1 Statement of Task, 1 1-1 Statement of Task, 15 1-2 Terminology Related to Weighing the Risk of Harm Against Potential Benefit, 20 3-1 Other Research Areas Previously Investigated by the U.S. Department of Veterans Affairs (VA) Using Laboratory Dogs, 63 FIGURES 3-1 Annual dog usage in the United States from 1973 to 2018, based on data collected by the U.S. Department of Agriculture, 42 3-2 VA intramural canine research review process, 66 B-1 Annual dog, non-human primate, and pig usage 1973 to 2018 in the United States, 157 TABLE B-1 Distribution of dog, non-human primate, and pig usage across United States sectors in 2017, 159 x Prepublication Copy: Uncorrected Proofs

Preface This Consensus Study Report represents the culmination of almost 2 years of hard work and dedication of an exceptionally diverse committee of professionals, including industry and academic scientists, physicians, veterinarians, lawyers, and bioethicists. Initially we thought it would be fairly straightforward to answer the primary question, “whether dogs are or will continue to be necessary for any type of biomedical research directly related to the VA’s [U.S. Department of Veterans Affairs’] mission.” We heard from panels of experts and individual experts, conducted independent data analysis, and were addressed by the senior leadership of the VA research program. Committee subgroups also visited two VA research facilities. Based on those collective experiences, we initially believed that it would be possible to reach conclusions and make recommendations that all members of the committee could support. What we all learned is that while facts are always facts, the emphasis that each individual places on each fact and the interpretation of a collection of facts leading to conclusions were widely disparate within this group. The differences seemed dependent on the discipline, each committee member’s personal and professional experiences and values, the prevailing attitude of the member’s usual constituency, and other, undefined factors. Despite sincere efforts by all to reach consensus, it was not possible. We believe the readers of this report will recognize the intellectual and professional honesty that went into both the majority, and the minority, conclusions and recommendations. We want to thank all of the committee members and the experts who generously gave of their time and expertise. Additionally, we wish to thank the entire staff at the National Academies of Sciences, Engineering, and Medicine for their tireless efforts to forge a path for us, their outstanding research ability, and their timeliness. Special recognition goes to our study director, Rebecca English, for her calming influence and leadership. Camilla Yandoc Ables and Jenna Briscoe were similarly indispensable in facilitating our requests and requirements for more and more data mining. Keiona Jones and Alex Repace were masters of getting everyone where they needed to be, every time, with all of the support that was needed. The National Academies Research Center also provided invaluable research support with special thanks to Jorge Mendoza-Torres. Sincerely, Rhonda Cornum, Chair W. Ron DeHaven, Vice Chair Committee on Assessment of the Use and Care of Dogs in Biomedical Research Funded by or Conducted at the U.S. Department of Veterans Affairs Prepublication Copy: Uncorrected Proofs xi

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For many years, laboratory dogs have served as important animal models for biomedical research that has advanced human health. Conducted at the request of the U.S. Department of Veterans Affairs (VA), this report assesses whether laboratory dogs are or will continue to be necessary for biomedical research related to the VA’s mission. The report concludes that using laboratory dogs in research at the VA is scientifically necessary for only a few areas of current biomedical research. The report recommends that the VA adopt an expanded set of criteria for determining when it is scientifically necessary to use laboratory dogs in VA biomedical research; that the VA promote the development and use of alternatives to laboratory dogs; and highlights opportunities for the VA to enhance the welfare of laboratory dogs that are being used in biomedical research areas for which they have been deemed necessary.

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