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Guide for the Care and use of Laboratory Animals: Eighth Edition
GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS
Eighth Edition
Committee for the Update of the Guide for the Care and Use of Laboratory Animals
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
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Guide for the Care and use of Laboratory Animals: Eighth Edition
THE NATIONAL ACADEMIES PRESS
500 Fifth Street, NW
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 the Office of Extramural Research, Office of the Director, National Institutes of Health/Department of Health and Human Services under Contract Number N01-OD-4-2139 Task Order #188; the Office of Research Integrity, Department of Health and Human Services; the Animal and Plant Health Inspection Service, U.S. Department of Agriculture; Association for Assessment and Accreditation of Laboratory Animal Care International; American Association for Laboratory Animal Science; Abbott Fund; Pfizer; American College of Laboratory Animal Medicine; American Society of Laboratory Animal Practitioners; Association of Primate Veternarians.
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 National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.
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Copyright 2011 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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Guide for the Care and use of Laboratory Animals: Eighth Edition
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. Ralph J. Cicerone 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. Charles Vest 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
www.national-academies.org
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Guide for the Care and use of Laboratory Animals: Eighth Edition
COMMITTEE FOR THE UPDATE OF THE GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS
Members
Janet C. Garber (Chair),
Garber Consulting
R. Wayne Barbee,
Virginia Commonwealth University
Joseph T. Bielitzki,
University of Central Florida
Leigh Ann Clayton,
National Aquarium, Baltimore
John C. Donovan,
BioResources, Inc.
Coenraad F. M. Hendriksen,
Netherlands Vaccine Institute, Bilthoven, The Netherlands (until March 2009)
Dennis F. Kohn,
Columbia University (retired)
Neil S. Lipman,
Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College
Paul A. Locke,
Johns Hopkins Bloomberg School of Public Health
John Melcher,
U.S. Senate (retired)
Fred W. Quimby,
Rockefeller University (retired)
Patricia V. Turner,
University of Guelph, Canada
Geoffrey A. Wood,
University of Guelph, Canada
Hanno Würbel,
Justus Liebig University of Giessen, Germany
Staff
Lida Anestidou, Study Director
Frances Sharples, Acting Director
Kathleen Beil, Administrative Coordinator
Cameron H. Fletcher, Senior Editor
Ruth Crossgrove, Senior Editor
Radiah Rose, Manager of Editorial Projects
Rhonda Haycraft, Senior Project Assistant
Joanne Zurlo, Director (until April 2010)
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Guide for the Care and use of Laboratory Animals: Eighth Edition
INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL
Members
Stephen W. Barthold (Chair),
Center for Comparative Medicine, University of California-Davis
Kathryn A. Bayne,
Association for Assessment and Accreditation of Laboratory Animal Care International, Frederick, Maryland
Myrtle A. Davis,
National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Jeffrey I. Everitt,
Comparative Medicine and Investigator Support, GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina (until June 2010)
James G. Fox,
Division of Comparative Medicine, Massachusetts Institute of Technology, Cambridge
Nelson L. Garnett,
Laboratory Animal Care and Use Programs, Dickerson, MD
Estelle B. Gauda,
Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, Maryland (until June 2010)
Joseph W. Kemnitz,
Institute for Clinical and Translational Research and Department of Physiology, University of Wisconsin-Madison
Judy A. MacArthur Clark,
Animals in Scientific Procedures Inspectorate, Home Office, London, United Kingdom
Martha K. McClintock,
Institute for Mind and Biology, University of Chicago, Illinois
Leticia V. Medina,
Animal Welfare and Compliance, Abbott Laboratories, Abbott Park, Illinois
Timo Olavi Nevalainen,
National Laboratory Animal Center, University of Eastern Finland, Kuopio, Finland
Bernard E. Rollin,
Department of Animal Sciences, Colorado State University, Fort Collins
Abigail L. Smith,
School of Veterinary Medicine, University of Pennsylvania, Philadelphia (until June 2010)
Stephen A. Smith,
Department of Biomedical Sciences and Pathobiology, Virginia Polytechnic Institute and State University, Blacksburg
James E. Womack,
Department of Veterinary Pathology, Texas A&M University, College Station (until June 2010)
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Staff
Frances Sharples, Acting Director
Lida Anestidou, Senior Program Officer
Kathleen Beil, Administrative Coordinator
Cameron H. Fletcher, Managing Editor, ILAR Journal
Rhonda Haycraft, Program Associate
Joanne Zurlo, Director (until April 2010)
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INSTITUTE FOR LABORATORY ANIMAL RESEARCH PUBLICATIONS
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)
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Guide for the Care and use of Laboratory Animals: Eighth Edition
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)
Copies of these reports may be ordered from the National Academies Press
(800) 624-6242 or (202) 334-3313
www.nap.edu
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Guide for the Care and use of Laboratory Animals: Eighth Edition
Reviewers
This eighth edition of the Guide for the Care and Use of Laboratory Animals 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. The purpose of this independent review is to provide candid and critical comments that will assist the Committee 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:
Michael B. Ballinger, Amgen
Philippe J.R. Baneux, PreLabs
Stephen W. Barthold, University of California-Davis
Linda C. Cork, Stanford University
Jann Hau, University of Copenhagen, Denmark
Michael J. Huerkamp, Emory University
Michael D. Kastello, sanofi-aventis
Arthur L. Lage, Harvard Medical School
Christian Lawrence, Children’s Hospital Boston
Randall J. Nelson, University of Tennessee College of Medicine-Memphis
Steven M. Niemi, Massachusetts General Hospital
Melinda A. Novak, University of Massachusetts-Amherst
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Guide for the Care and use of Laboratory Animals: Eighth Edition
Overview
This eighth edition of the Guide is divided into five chapters and four appendices.
Chapter 1 presents the goals and intended audiences of the Guide as well as key concepts and terminology essential to its premise and use. Incorporating some of the material from the Introduction to the last edition, the chapter highlights a commitment to the concepts of the Three Rs—Replacement, Reduction, and Refinement—and provides an enhanced discussion of the ethics of animal use and investigator/institutional obligations.
Chapter 2 focuses on the overall institutional animal care and use program (Program), in addition to many of the topics previously covered in Chapter 1 of the seventh edition. It defines the evolved concept of Program and provides a framework for its intra-institutional integration, taking into account institutional policies and responsibilities, regulatory considerations, Program and personnel management (including training and occupational health and safety), and Program oversight. Discussions of the latter include institutional animal care and use committee (IACUC) functions, protocol and Program review, postapproval monitoring (a new section), and considerations such as humane endpoints and multiple survival surgical procedures. The Committee endorses the American College of Laboratory Animal Medicine’s “Guidelines for Adequate Veterinary Care.”
Chapter 3 focuses on the animals themselves and, unlike previous editions, addresses terrestrial and aquatic species in separate sections, reflect-
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ing the growing role of aquatic animals in biomedical research. The chapter provides recommendations for housing and environment, discusses the importance of social housing, and includes enhanced sections on environmental enrichment, animal well-being, and scientific validity.
Space recommendations were nominally expanded based on the Committee’s professional and expert opinion and on current housing methods. Cage sizes have historically been interpreted as minimum space needs by users of the Guide, and were labeled as such (“recommended minimum space”) in this edition. The use of the word “minimum” does not further restrict users of the Guide because, although the space requirements are numbers (i.e., engineering standards), they are used in a performance standards framework. The Committee recommends minimum space for female rodents with litter and an increase of the cage height for rabbits to 16”. Further, in light of many comments submitted to the Committee requesting more information on performance goals and how to achieve them, rodent breeding recommendations are accompanied by substantial guidance.
With respect to nonhuman primates (NHPs), the Committee endorses social housing as the default and has provided some species-specific guidance. An additional group has been added for monkeys, and chimpanzees are separated in a new category. These changes were motivated by the Committee’s recognition (affirmed in comments solicited from NHP experts) that these animals need more floor and vertical space, at least in some groups, to exercise their natural habits.
Chapter 4 discusses veterinary care and the responsibilities of the attending veterinarian. It introduces the concept of animal biosecurity and upholds its central role in ensuring the health of laboratory animals. The chapter includes recommendations relative to animal procurement, transportation, and preventive medicine, and expands the sections on clinical care and management, surgery (with a new section on intraoperative monitoring), pain and distress, and euthanasia.
Chapter 5 discusses physical plant–related topics and includes updated and new material on vibration control; physical security and access control; hazardous agent containment; and special facilities for imaging and whole body irradiation, barrier housing, behavioral studies, and aquatic species housing. The chapter provides detailed discussion of centralized versus decentralized animal facilities and introduces the concept of variable-volume HVAC systems with a nod toward energy conservation and efficiency.
Appendix A is the updated bibliography; Appendix B presents the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training; Appendix C presents the Statement
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of Task; and Appendix D provides the biographical sketches of the Committee members.
In accordance with the Statement of Task (“In addition to the published report, the updated Guide will be posted on the Internet in a pdf or equivalent format such that users will be able to search the entire document at one time”), the Guide is available in searchable pdf format on the National Academies Press website, www.nap.edu.
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Contents
1
KEY CONCEPTS
1
Applicability and Goals,
2
Intended Audiences and Uses of the Guide,
3
Ethics and Animal Use,
4
The Three Rs,
4
Key Terms Used in the Guide,
5
Humane Care,
6
Animal Care and Use Program,
6
Engineering, Performance, and Practice Standards,
6
Policies, Principles, and Procedures,
7
Must, Should, and May,
8
References,
8
2
ANIMAL CARE AND USE PROGRAM
11
Regulations, Policies, and Principles,
12
Program Management,
13
Program Management Responsibility,
13
The Institutional Official,
13
The Attending Veterinarian,
14
The Institutional Animal Care and Use Committee,
14
Collaborations,
15
Personnel Management,
15
Training and Education,
15
Occupational Health and Safety of Personnel,
17
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Personnel Security,
23
Investigating and Reporting Animal Welfare Concerns,
23
Program Oversight,
24
The Role of the IACUC,
24
IACUC Constitution and Function,
24
Protocol Review,
25
Special Considerations for IACUC Review,
27
Postapproval Monitoring,
33
Disaster Planning and Emergency Preparedness,
35
References,
35
3
ENVIRONMENT, HOUSING, AND MANAGEMENT
41
Terrestrial Animals,
42
Terrestrial Environment,
42
Microenvironment and Macroenvironment,
42
Temperature and Humidity,
43
Ventilation and Air Quality,
45
Illumination,
47
Noise and Vibration,
49
Terrestrial Housing,
50
Microenvironment (Primary Enclosure),
50
Environmental Enrichment,
52
Sheltered or Outdoor Housing,
54
Naturalistic Environments,
55
Space,
55
Terrestrial Management,
63
Behavioral and Social Management,
63
Husbandry,
65
Population Management,
75
Aquatic Animals,
77
Aquatic Environment,
77
Microenvironment and Macroenvironment,
77
Water Quality,
78
Life Support System,
79
Temperature, Humidity, and Ventilation,
80
Illumination,
81
Noise and Vibration,
81
Aquatic Housing,
82
Microenvironment (Primary Enclosure),
82
Environmental Enrichment and Social Housing,
82
Sheltered, Outdoor, and Naturalistic Housing,
83
Space,
83
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Aquatic Management,
84
Behavior and Social Management,
84
Husbandry,
84
Population Management,
87
References,
88
4
VETERINARY CARE
105
Animal Procurement and Transportation,
106
Animal Procurement,
106
Transportation of Animals,
107
Preventive Medicine,
109
Animal Biosecurity,
109
Quarantine and Stabilization,
110
Separation by Health Status and Species,
111
Surveillance, Diagnosis, Treatment, and Control of Disease,
112
Clinical Care and Management,
113
Medical Management,
114
Emergency Care,
114
Recordkeeping,
115
Surgery,
115
Training,
115
Presurgical Planning,
116
Surgical Facilities,
116
Surgical Procedures,
117
Aseptic Technique,
118
Intraoperative Monitoring,
119
Postoperative Care,
119
Pain and Distress,
120
Anesthesia and Analgesia,
121
Euthanasia,
123
References,
124
5
PHYSICAL PLANT
133
General Considerations,
133
Location,
134
Centralization Versus Decentralization,
134
Functional Areas,
135
Construction Guidelines,
136
Corridors,
136
Animal Room Doors,
137
Exterior Windows,
137
Floors,
137
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Drainage,
138
Walls and Ceilings,
138
Heating, Ventilation, and Air Conditioning (HVAC),
139
Power and Lighting,
141
Storage Areas,
141
Noise Control,
142
Vibration Control,
142
Facilities for Sanitizing Materials,
143
Environmental Monitoring,
143
Special Facilities,
144
Surgery,
144
Barrier Facilities,
145
Imaging,
146
Whole Body Irradiation,
147
Hazardous Agent Containment,
148
Behavioral Studies,
149
Aquatic Species Housing,
150
Security and Access Control,
151
References,
151
ADDENDUM
155
APPENDICES
A ADDITIONAL SELECTED REFERENCES
161
Subject Matter,
161
Use of Laboratory Animals,
162
Alternatives,
162
Ethics and Welfare,
163
Experimental Design and Statistics,
164
Research and Testing Methodology,
165
Program Management,
167
General References,
167
Laws, Regulations, and Policies,
168
Education,
169
Monitoring the Care and Use of Animals,
169
Occupational Health and Safety,
170
Environment, Housing, and Management,
172
General References,
172
Environmental Enrichment,
173
Genetics and Genetically Modified Animals,
175
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Species-Specific References—Environment, Housing, and Management,
176
Agricultural Animals,
176
Amphibians, Reptiles, and Fish,
178
Birds,
179
Cats and Dogs,
180
Exotic, Wild, and Zoo Animals,
181
Nonhuman Primates,
182
Rodents and Rabbits,
184
Other Animals,
187
Veterinary Care,
188
Transportation,
188
Anesthesia, Pain, and Surgery,
188
Disease Surveillance, Diagnosis, and Treatment,
190
Pathology, Clinical Pathology, and Parasitology,
190
Species-Specific References—Veterinary Care,
191
Agricultural Animals,
191
Amphibians, Reptiles, and Fish,
192
Birds,
193
Cats and Dogs,
193
Exotic, Wild, and Zoo Animals,
193
Nonhuman Primates,
194
Rodents and Rabbits,
194
Design and Construction of Animal Facilities,
196
B U.S. GOVERNMENT PRINCIPLES FOR THE UTILIZATION AND CARE OF VERTEBRATE ANIMALS USED IN TESTING, RESEARCH, AND TRAINING
199
C STATEMENT OF TASK
201
D ABOUT THE AUTHORS
203
INDEX
209
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