Excerpt

International standardization of rats was undertaken first by this US/Japan Cooperative Program and subsequently by the International Council for Laboratory Animal Science (ICLAS). These activities have reached a global scale with the ICLAS International Rat Genetic Nomenclature Committee, which met first in 1994 in Sapporo, Japan; second in 1996 in Toulouse, France; and third in 1998 in Halifax, Canada.

Recently, biotechnology has made remarkable progress using transgenic animals, and international collaborative studies have used these animals widely. International harmonization of drug safety data for new drug development is also under way. Therefore, international standardization of the quality of laboratory animals as tools for obtaining reproducible data has become even more important.

Contents

• THE NATIONAL ACADEMIES
• INTERNATIONAL COMMITTEE OF THE INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL
• INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL
• COMMISSION ON LIFE SCIENCES
• Preface
• Opening Remarks
  Judith L. Vaitukaitis.
• Opening Remarks
  Shin-Ichi Ota.
• Introductory Comments on Microbiologic Testing of Laboratory Mice and Rats: Uniformity of Results
  Anton M. Allen.
• Development of a Performance Assessment Program for Research Animal Diagnostic Laboratories and Defining Microbiologic Testing Standards
  Lela K. Riley.
• Standardization of Rodent Health Surveillance: Regulation Versus Competition
  William Shek.
  • INTRODUCTION
  • ANIMAL HEALTH
  • HEALTH SURVEILLANCE
  • SUMMARY
  • REFERENCES
• Factors Causing Difficulties in Uniformity of Results Among Testing Facilities in Microbiologic Monitoring of Laboratory Animals
  Toshio Itoh.
  • DISCREPANCIES IN RESULTS
  • CONCLUSION
• Necessity of Reexamining the Pathogenicity and Elimination of Parasites in Rats and Mice
  Toshiyuki Shibahara.
  • MICROBIOLOGIC CONTAMINATION IN LABORATORY RATS AND MICE
  • PINWORMS AS POSSIBLE INDICATORS OF BIOLOGICALLY CONTAMINATED ANIMAL FACILITIES
  • NEED FOR ELIMINATION OF PARASITES
  • CONCLUSION AND RECOMMENDATIONS
  • REFERENCES
• Emerging (and Reemerging) Viruses of Laboratory Mice and Rats
  Abigail L. Smith.
  • INTRODUCTION
  • AGENTS OF CONCERN
  • CONCLUSIONS
  • REFERENCES
• Emerging Infections as a Cause of Concern
  Stephen Morse.
  • IMPERFECTLY CONTROLLED ENVIRONMENT
  • RECOGNIZED THREATS
  • OPPORTUNITIES TO LEARN
  • PAST SURPRISES
  • FUTURE DISCOVERIES
  • DARPA
• Emerging Diseases in Mice and Rats
  Toshio Itoh.
  • H. HEPATICUS CONTAMINATION OF HUMAN TUMOR TISSUES PASSAGED IN IMMUNODIFICIENT MICE
  • ESTABLISHMENT OF TEST AGENTS
  • REFERENCE
• Survey of Helicobacter Species in Laboratory Mice and Gerbils in Japan
  Kazuo Goto.
  • MATERIALS AND METHODS
  • RESULTS
  • CONCLUSION
  • REFERENCES
• Genetic Evaluation of Outbred Rats
  Joseph J. DeGeorge.
  • REGULATORY PERSPECTIVE AND INFORMATION
  • NEW TECHNOLOGY
  • GENETICALLY ENGINEERED MICE
  • SUMMARY
  • QUESTION AND ANSWER
• Genetic Evaluation of Outbred Rats from the Breeder’s Perspective
  William J. White.
  • POPULATION MANAGEMENT
  • SUPPLY AND DEMAND
  • VARIABLES AFFECTING COMPARISONS OF SUBPOPULATIONS BY GENETIC MONITORING
  • CAUSES AND AMELIORATION OF GENETIC DIVERGENCE
  • DEVELOPMENT OF A FOUNDATION COLONY-BASED OUTBRED PRODUCTION SYSTEM
  • CONCLUSION
  • REFERENCES
  • QUESTIONS AND ANSWERS
• Concept for Establishment of Rat Outbred Global Standard Strains
  Tatsuji Nomura.
  • INTRODUCTION
  • HISTORY OF GENETIC QUALITY CONTROL
  • QUALITY STANDARDS
  • CONCEPT OF GLOBAL STANDARDS FOR OUTBRED RATS
  • SELECTION OF A GLOBAL STANDARD OUTBRED RAT STRAIN
  • SUMMARY
  • REFERENCES
• Necessity of Genetic and Microbiologic Quality Network from the Pharmaceutical Industry’s Perspective
  Naoko Kagiyama.
  • BACKGROUND
  • ISSUES RELATED TO THE QUALITY OF OUTBRED MICE AND RATS
  • CONCLUSION
  • REFERENCES
• International Harmonization of Laboratory Animals
  Hideki Katoh.
  • STRAINS AND COLONIES USED IN ANIMAL EXPERIMENTATION
  • SAFETY STUDIES AND LABORATORY ANIMALS
  • INTERNATIONAL HARMONIZATION OF LABORATORY ANIMALS
  • CONCLUSION
  • REFERENCES
• Rat Genetics and Toxicology
  Michael F.W. Festing.
  • SUMMARY
  • INTRODUCTION
  • FROM THE LITERATURE
  • CONCLUSIONS
  • REFERENCES
• A Phenotype-driven Approach to the Molecular and Functional Analysis of the Mouse Genome
  Dabney K. Johnson, Donald A. Carpenter, Cymbeline T. Culiat, Karen A. Goss, Mitchell L. Klebig, Edward J. Michaud, Darla R. Miller, Liane B. Russell, Yun You, and Eugene M. Rinchik.
  • BACKGROUND
  • EXPERIENCE APPLIED TO NEW EXPERIMENTS
  • ROBUST AND BROAD-SPECTRUM PHENOTYPE SCREENING
  • SUMMARY
  • ACKNOWLEDGMENT
  • REFERENCES
  • QUESTIONS AND ANSWERS
• Evaluation of Targeted Mutations
  Eugenia Floyd.
• Defining Behavioral Phenotypes in Transgenic and Knockout Mice
  Jacqueline N. Crawley.
  • INTRODUCTION
  • CRITICAL ISSUES PRECEDING BEHAVIORAL PHENOTYPING
  • BEHAVIORAL TESTS
  • REFERENCES
• Defining Phenotype in Genetically Engineered Mice
  Norikazu Tamaoki.
  • INTRODUCTION
  • HISTORICAL DEVELOPMENT
  • CONCLUSIONS
  • REFERENCES
• Development of the Mouse Model Dramatype for Human Clinical Benefit
  Kazunori Nakajima.
• Concluding Remarks
  Tatsuji Nomura.
• Implication of Wild-derived Genes, Mitochondria, and Chromosomes in the Genetic Background of Mouse Models for Diseases and Biologic Functions
  Kazuo Moriwaki.
  • INTRODUCTION
  • GENETIC POSITION OF ASIAN WILD MICE
  • USE OF THE ASIAN WILD-DERIVED RECOMBINATION HOST-SPOT GENE FOR SURVEYING NOVEL GENES THAT DETERMINE SUSCEPTIBILITY TO DIABETES
  • USE OF ASIAN WILD-DERIVED MITOCHONDRIA FOR STUDYING MOUSE BEHAVIOR
  • USE OF ASIAN WILD-DERIVED CHROMOSOMES FOR DEVELOPING NEW CONSOMIC MOUSE STRAINS
  • REFERENCES
• Concluding Comments
  John Strandberg.
• Concluding Comments
  John Vandenbergh.
• Appendix A U.S./Japan Meeting
• Appendix B Meeting Participants

This study was supported by Grant No. N01-OD-4-2139 between the National Academies and the National Institutes of Health of the U.S. Department of Health and Human Services.

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.

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.