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Microbial and Phenotypic Definition of Rats and Mice
Proceedings of the 1998 US/Japan Conference
International Committee of the Institute for Laboratory Animal Research
National Research Council
NATIONAL ACADEMY PRESS
Washington, D.C.
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NATIONAL ACADEMY PRESS
2101 Constitution Avenue, NW Washington, DC 20418
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. P40-RR-11611 between the National Academy of Sciences and the National Institutes of Health. 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.
International Standard Book Number 0-309-06591-7
Copyright 1999 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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INTERNATIONAL COMMITTEE OF THE INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL
Christian R. Abee (Chair),
Department of Comparative Medicine, University of South Alabama, Mobile, AL
Hilton J. Klein,
Department of Laboratory Animal Resources, Merck Research Laboratories, West Point, PA
William Morton,
Regional Primate Research Center, University of Washington, Seattle, WA
Robert J. Russell,
Harlan Sprague Dawley, Inc., Indianapolis, IN
William S. Stokes,
Environmental Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC
John L. VandeBerg,
Southwest Foundation for Biomedical Research, San Antonio, TX
Peter A. Ward,
Department of Pathology, University of Michigan Medical School, Ann Arbor, MI
Staff
Ralph B. Dell, Director
Kathleen A. Beil, Administrative Assistant
Susan S. Vaupel, Managing Editor,
ILAR Journal
Marsha K. Williams, Project Assistant
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The National Academy of Sciences is a private, non-profit, 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. William 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. Kenneth I. Shine 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. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.
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Preface
US-Japan meetings on laboratory animal science have been held virtually every year since 1980 under the US-Japan Cooperative Program on Science and Technology. Over the years these meetings have resulted in a number of important documents including the Manual of Microbiologic of Monitoring of Laboratory Animals published in 1994 and the article Establishment and Preservation of Reference Inbred Strains of Rats for General Purposes published in 1991. In addition to these publications, these meetings have been instrumental in increasing awareness of the need for microbiologic monitoring of laboratory rodents and the need for genetic definition and monitoring of mice and rats.
In cooperation with the Comparative Medicine section of NCRR/NIH, ILAR Council and staff are pleased to become the host for this important annual meeting and look forward to participating in future meetings. The support and sponsorship of NCRR (P40 RR 11611) in the United States and the Central Institute for Experimental Animals in Japan are gratefully acknowledged. These meetings have increased understanding of American and Japanese approaches to laboratory animal science and should continue to strengthen efforts to harmonize approaches aimed at resolving common challenges in the use of animal models for biomedical research and testing. This effort to improve understanding and cooperation between Japan and the United States should also be useful in developing similar interaction with other regions of the world including Europe, Australia, and Southeast Asia.
CHRISTIAN R. ABEE, CHAIR
INTERNATIONAL COMMITTEE OF THE INSTITUTE FOR LABORATORY ANIMAL RESEARCH
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Contents
Opening Remarks
Shin-ichi Ota
1
Historical Overview
1
Expectations
2
References
2
Opening Remarks
Judith L Vaitukaitis
3
The Need for Defined Rats and Mice in Biomedical Research: Problems, Issues, and the Current State of Affairs
Tatsuji Nomura
5
Introduction
5
Participants and Format
5
Standardization and Quality
6
Questions and Answers
6
The Need for Defined Rats and Mice in Biomedical Research: Problems, Issues, and the Current State of Affairs
Norikazu Tamaoki
7
Global Health Issue and the Necessity of Laboratory Animals
7
Importance of Laboratory Animals for Human Health
7
Laboratory Animal Models in Major Disease Categories
8
Aspects of Future Laboratory Animal Use
10
Questions and Answers
10
References
11
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The Biological Integrity of Laboratory Rodents
Robert O. Jacoby
12
References
14
Quality Testing System for SPF Animals in Japan and Problems in the Management of Such Systems
Toshio Itoh
15
Role of the ICLAS Monitoring Center in the Quality Control System of Laboratory Animals
15
Microbiological Monitoring System of the ICLAS Monitoring Center
16
Microbiological Contamination of Laboratory Animals in Japan
17
Conclusion
22
References
23
Definition of Microbiological Status of Rats and Mice / The Need for Methods of Defining Flora / International Standards for Terminology
Kazuaki Mannen
24
Current Status of Microbiological Quality of Laboratory Animals in University Animal Centers in Japan
24
Importance of Identifying Contamination
25
Development of Rodent Pathogen Profiles and Adequacy of Detection Technology
Steven H. Weisbroth
28
Problematic Issues
36
References
38
Current Status of Pathogen Status in Mice and Rats
J. Russell Lindsey
39
Past Progress toward Reducing Pathogens
39
Pathogens Still Pose Pervasive Risks in the United States
40
Pathogen Status Gets Lost in the Terminology Morass
40
Principles of Pathogen Status Are Being Compromised
41
Scientists Have Little Appreciation of Pathogen Status
41
References
42
Genetic Background and Phenotypes in Animal Models of Human Diseases
Kuzuo Moriwaki
44
Development of Experimental Mouse Strains
44
Transgenic and Knockout Mice
45
Recombinant Inbred Strains
45
Common Disease Models
46
Conclusion
46
Reference
47
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Genetic and Phenotypic Definition of Laboratory Mice and Rats / What Constitutes an Acceptable Genetic-Phenotypic Definition
Hideki Katoh
48
Genetic Studies on Closed Colonies of the Rat
48
Human Ancestry
48
Laboratory Animals
51
Demonstration of the Existence of Closed Colonies Using Genetic Monitoring
52
Summary and Discussion
54
References
57
Phenotype Assessment Requires More Than a Casual Observation
Philip A. Wood
58
Primary Level Assessment: Find Abnormalities
59
Secondary Level Assessment: Evaluate and Quantify Abnormalities
59
Environmental Influences
61
Examples
61
References
62
Genetic and Phenotypic Definition of Laboratory Mice and Rats / What Constitutes an Acceptable Genetic-Phenotypic Definition
Muriel T. Davisson
63
Genetically Defined Mice
63
Genetic Standardization
63
Genetic Nomenclature
64
Definition and Value of Different Kinds of Strains
65
Genetic Monitoring
67
Genetic Databases
68
Training Scientists to Use Genetically Defined Mice
70
References
70
Genetic and Phenotypic Definition of Laboratory Mice and Rats / What Constitutes an Acceptable Genetic-Phenotypic Definition
Joseph DeGeorge
71
Necessity for Globally Standardized Outbred Rats for Carcinogenicity Bioassay
71
Change in Laboratory Animal Science
71
Globalization of Drug Development
72
Segmentation of Toxicology Testing
72
Need for Integrated Findings
74
Managing Changes Over Time
74
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CIEA/NCRR/NIH Genetic and Microbiological Monitoring of Mouse and Rat Resources: Directions for the Future
Tatsuji Nomura
76
Differences Between Countries
76
Questions and Answers
77
CIEA/NCRR/NIH Genetic and Microbiological Monitoring of Mouse and Rat Resources: Directions for the Future
Neal West
78
NIH Structure
78
NCRR's Mission
78
Database Recommendation
80
Questions and Answers
80
Learning from Each Other
81
Policy Setting
81
Reference
82
Closing Comments / Summary of Presentations
Thomas J. Gill III
83
Introduction
83
Need for Genetically Defined Animals
83
Development of Genetically Engineered Animals
84
Importance of Disease Models
86
Standardization and Monitoring
87
Rat Repository Workshop
87
National Rat Genetics Resources Center
88
Recommendations
89
Summary of Presentations
Steven P. Pakes
90
Current Status of Laboratory Animal Science
90
Revitalization of Original Focus
90
Future Cooperation
91
Summary of Presentations
Tatsuji Nomura
92
Laboratory Animal Science: 1950s to 1990s
92
Genetically Engineered Animals
93
Conclusion
94
Appendix A:
US/Japan Meeting Agenda
95
Appendix B:
Meeting Participants
98