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Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
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THE DEVELOPMENT OF SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE

Proceedings of the November 2003 International Workshop

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.
www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

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 Grant No. RR0118801-01 and Contract No. N01-OD-4-2139, TO 72 between the National Academy of Sciences and the National Institutes of Health. Other contributors were the Association for Assessment and Accreditation of Laboratory Animal Care International, Canadian Council on Animal Care, Centre for Best Practice for Animals in Research (Medical Research Council, UK), Federation of European Laboratory Animal Science Associations, International Council for Laboratory Animal Science, Laboratory Animals, Ltd., and the U.S. Environmental Protection Agency. 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.

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Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

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

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

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Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

INTERNATIONAL WORKSHOP ON THE DEVELOPMENT OF SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE PROGRAM COMMITTEE

Hilton J. Klein, VMD (Chair),

Merck Research Laboratories, West Point, Pennsylvania

Stephen W. Barthold, DVM, PhD,

University of California, Davis

Coenraad F.M. Hendriksen, DVM, PhD,

Netherlands Vaccine Institute, Bilthoven, Netherlands

William Morton, VMD,

National Primate Research Center, University of Washington, Seattle, Washington

Randall J. Nelson, PhD,

University of Tennessee Health Science Center, Memphis, Tennessee

Emilie F. Rissman, PhD,

University of Virginia Medical School, Charlottesville, Virginia

William S. Stokes, DVM,

National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina

Staff

Joanne Zurlo, PhD, Director,

Institute for Laboratory Animal Research

Marsha Barrett, Senior Project Assistant

Kathleen Beil, Administrative Assistant

Jennifer Obernier, Program Officer

Susan Vaupel, Editor

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL

Peter A. Ward (Chair),

Department of Pathology, University of Michigan Medical School, Ann Arbor, Michigan

Stephen W. Barthold,

Center for Comparative Medicine, University of California, Davis, California

William C. Campbell,

Drew University, Madison, New Jersey

Rosemary W. Elliott,

Department of Molecular and Cellular Biology, Roswell Park Cancer Institute, Buffalo, New York

Michael F. Festing,

MRC Toxicology Unit, University of Leicester, Leicester, United Kingdom

Janet C. Gonder,

Pinehurst, North Carolina

Coenraad F.M. Hendriksen,

Netherlands Vaccine Institute, Bilthoven, Netherlands

Jay R. Kaplan,

Department of Comparative Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina

Hilton J. Klein,

Department of Laboratory Animal Resources, Merck Research Laboratories, West Point, Pennsylvania

William Morton,

National Primate Research Center, University of Washington, Seattle, Washington

Randall J. Nelson,

Department of Anatomy and Neurobiology, University of Tennessee, Memphis, Tennessee

Emilie F. Rissman,

Department of Biochemistry and Molecular Genetics, University of Virginia Medical School, Charlottesville, Virginia

William S. Stokes,

Environmental Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina

Michael K. Stoskopf,

College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina

Thomas Wolfle,

Cambridge, Maryland

Staff

Joanne Zurlo, Director

Marsha Barrett, Senior Project Assistant

Kathleen Beil, Administrative Assistant

Jennifer Obernier, Program Officer

Susan Vaupel, Managing Editor, ILAR Journal

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

Preface

Each country or group of countries addresses the regulation of laboratory animal care in its own way, and even within a single country, there may be different agencies exerting separate regulations or guidelines (e.g., the US has regulations through the Animal Welfare Act administered through the Department of Agriculture and through the Health Extension Act administered through the Department of Health and Human Services as Public Health Service Policy). In Europe, the member nations of the European Union (EU) are governed by Directive 86/609 on the protection of animals used for experimental and other scientific purposes which provides a minimum standard of care for animals in these countries. Each country, in turn, can add more stringent regulations for its own research community, and this has been done. The Council of Europe (CoE), which has 45 member states, adopted the European Convention ETS 123 for the protection of vertebrate animals in 1986. Since the CoE is not a regulatory body, Conventions do not have the force of law, but they do exert a considerable moral pressure, especially in CoE countries for which the Convention is the only pan-European agreement. Nevertheless, once a Member State ratifies a Convention, it becomes a “party” and is bound to be implemented as national law. The standards of housing and care for laboratory animals outlined in Appendix A of ETS 123 served as the basis for these standards in the EU Directive 86/609. These standards are very similar to those specified in the 1996 revision of the Guide for the Care and

Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
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Use of Laboratory Animals, which was written by an ILAR committee and which serves as the basis of Public Health Service Policy.

The Council of Europe is currently revising Appendix A of ETS 123 during the process known as a Multilateral Consultation, whose participants include representatives from member nations as well as “observers.” Nations that are “parties” to the Convention (i.e. have ratified it) play the largest role in acceptance or rejection of the proposed changes recommended by appointed expert working groups for each species or group of species. Observers represent non-member countries, including the US, Canada, and Japan, and non-governmental organizations (NGO), such as the Federation of European Laboratory Animal Science Associations (FELASA), the Eurogroup for Animal Welfare, the European Federation of Pharmaceutical Industries and Associations (EFPIA), and Institute for Laboratory Animal Research (ILAR) of the National Academies (as the authoring body for the Guide). The proposed revision of ETS 123 includes changes that may result in substantial differences in recommended housing and care conditions for laboratory animals between Europe and the US. Consequently, many discussions have focused on whether these differences will impact the interchange of research results among countries, and have questioned the value and/or need for harmonization of guidelines among countries.

Arguments may be made for and against harmonization of guidelines for laboratory animal care throughout the world. Intuitively, one might assume that results from studies on animals kept under identical conditions would be more comparable and that harmonization of standards would lead to more collaboration among countries. However, some research has shown that this is not necessarily the case. It is generally agreed that guidelines that incorporate the newest scientific evidence for the best conditions for laboratory animals should also ensure that the data generated are the most reliable. However, if the standards proposed in one country or group of countries are not scientifically based, they are not likely to be freely adopted globally. Financial constraints associated with making major changes could seriously impede the ability to perform animal research at current levels. There is also a concern that in order to avoid making costly changes, institutions may choose to “export” their animal research to countries that have more questionable standards of laboratory animal care, thus generating genuine animal welfare concerns.

There is widespread agreement in the laboratory animal community that these issues need to be continually examined on an international basis. Since ILAR is one of the few organizations with the international reputation and credibility to bring together experts and interested parties from around the world, it was logical that ILAR should host a meeting to discuss these issues. Consequently, an international workshop was held

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

in Washington, DC, in November 2003 to bring together experts from around the world to discuss the available knowledge that can positively influence current and pending guidelines for laboratory animal care, identify gaps in that knowledge in order to encourage future research endeavors, and discuss the scientific evidence that can be used to assess the benefits and costs of various regulatory approaches affecting facilities, research, and animal welfare. This workshop brought together experts from 15 countries over three days to share information, discuss future endeavors, and consider the question of whether or not to harmonize standards. Many fruitful discussions took place during the workshop and the outcome was a better understanding of the cultural influences that serve as a backdrop to regulation and guideline development. The proceedings from this workshop are reported in the pages of this publication.

ILAR wishes to acknowledge and thank the following sponsors of this workshop: the National Institutes of Health (National Center for Research Resources and Office of Laboratory Animal Welfare), Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), Canadian Council on Animal Care, Centre for Best Practice for Animals in Research (Medical Research Council, UK), Federation of European Laboratory Animal Science Associations, International Council for Laboratory Animal Science, and Laboratory Animals, Ltd.

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×

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Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
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Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
×
Page xiii Cite
Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
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Breakout Session: Rats and Mice

 

103

 

 

Effects of Housing Density and Cage Type on Young Adult C57BL/6J Mice

 

107

 

 

New Housing Standards for Rats and Mice Developed with Focus on the Needs of the Animals

 

114

 

 

Breakout Session: Approaches for Implementing Current US and European Guidelines for Housing Standards for Dogs and Cats

 

120

 

 

Breakout Session: Nonhuman Primates

 

124

 

 

Breakout Session: Rabbit Housing

 

128

SESSION 4:   ENVIRONMENTAL CONTROL FOR ANIMAL HOUSING

 

131

 

 

Environmental Controls (US Guidance)
Bernard Blazewicz and Dan Frasier

 

133

 

 

European Guidelines for Environmental Control in Laboratory Animal Facilities
Harry J. M. Blom

 

140

 

 

Breakout Session: Lighting

 

147

 

 

Breakout Session: Effects of Sound on Research Animals

 

153

 

 

Breakout Session: Environmental Control for Animal Housing—Impact on Metabolism and Immunology

 

156

 

 

Breakout Session: Environmental Controls/Engineering Issues

 

164

DINNER SPEAKER: KAY E. HOLEKAMP

 

167

 

 

A View from the Field: What the Lives of Wild Animals Can Teach Us About Care of Laboratory Animals
Kay E. Holekamp

 

169

SESSION 5:  ENVIRONMENTAL ENRICHMENT ISSUES

 

175

 

 

Enriching the Housing of the Laboratory Rodent: How Might It Affect Research Outcomes?
William T. Greenough and Ann Benefiel

 

177

 

 

Search for Optimal Enrichment
Timo Nevalainen

 

184

 

 

Breakout Session: Environmental Enrichment Issues: Mice/Rats/Rabbits

 

189

 

 

Breakout Session: Environmental Enrichment for Dogs and Cats

 

191

 

 

Breakout Session: Assessment of Nonhuman Primate Enrichment—Science Versus Welfare Concerns

 

193

Suggested Citation:"Front Matter." National Research Council. 2004. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11138.
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The Development of Science-based Guidelines for Laboratory Animal Care is the summary of an international workshop held in Washington, DC, in November 2003 to bring together experts from around the world to discuss the available knowledge that can positively influence current and pending guidelines for laboratory animal care, identify gaps in that knowledge in order to encourage future research endeavors, and discuss the scientific evidence that can be used to assess the benefits and costs of various regulatory approaches affecting facilities, research, and animal welfare.

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