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The Need for Defined Rats and Mice in Biomedical Research: Problems, Issues, and the Current State of Affairs

Tatsuji Nomura

Director, Central Institute for Experimental Animals

Kawasaki, Japan

Introduction

Over the years, discussions held during the US/Japan Meetings have provided a technical basis for the genetic and microbiological testing conducted by the International Council for Laboratory Animal Science (ICLAS) monitoring center. They also have made a major contribution toward establishing the concept of quality standards of laboratory animals on an international level.

Participants and Format

Originally the two main participants in this meeting were the Veterinary Resources Branch (VRB), Division of Research Services (DRS), at the National Institutes of Health (NIH) on the US side and the Central Institute for Experimental Animals (CIEA) on the Japanese side. At present, the original US participant has been replaced by the Comparative Medicine Program of the NIH National Center for Research Resources (NCRR) with assistance from the Institute for Laboratory Animal Research (ILAR), National Research Council (NRC), National Academy of Sciences (NAS). The basic concept of the US/Japan Meeting has always been an exchange of experience and technology concerning important problems related to laboratory animals of mutual interest to both countries. In 1996, Dr. Leo Whitehair of the NCRR assumed responsibility in place of the VRB, and the meeting was given a new start under a new format with ILAR Director Dr. Ralph Dell participating.

This 19th US/Japan Meeting is the first meeting under the new format. The



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The Need for Defined Rats and Mice in Biomedical Research: Problems, Issues, and the Current State of Affairs Tatsuji Nomura Director, Central Institute for Experimental Animals Kawasaki, Japan Introduction Over the years, discussions held during the US/Japan Meetings have provided a technical basis for the genetic and microbiological testing conducted by the International Council for Laboratory Animal Science (ICLAS) monitoring center. They also have made a major contribution toward establishing the concept of quality standards of laboratory animals on an international level. Participants and Format Originally the two main participants in this meeting were the Veterinary Resources Branch (VRB), Division of Research Services (DRS), at the National Institutes of Health (NIH) on the US side and the Central Institute for Experimental Animals (CIEA) on the Japanese side. At present, the original US participant has been replaced by the Comparative Medicine Program of the NIH National Center for Research Resources (NCRR) with assistance from the Institute for Laboratory Animal Research (ILAR), National Research Council (NRC), National Academy of Sciences (NAS). The basic concept of the US/Japan Meeting has always been an exchange of experience and technology concerning important problems related to laboratory animals of mutual interest to both countries. In 1996, Dr. Leo Whitehair of the NCRR assumed responsibility in place of the VRB, and the meeting was given a new start under a new format with ILAR Director Dr. Ralph Dell participating. This 19th US/Japan Meeting is the first meeting under the new format. The

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Japanese side would like to propose that quality control of laboratory animals continue as the main topic in the future under the basic concept of the US/Japan Cooperative Program on Science and Technology. This year the topic will be quality standards. Recently animals introduced into Japan from overseas have been the cause of microbiological contamination, and we want to discuss this problem under the topic of microbiological quality. Standardization and Quality With respect to genetic quality, the International Conference of Harmonization of Technical Requirements for International Registration for Pharmaceuticals for Human Use (ICH) has decided that one set of animal experimentation data will be used in all countries when applying for new drug approvals. However, global standardization of rat closed colony stock and a genetic monitoring system for use in 2-year carcinogenicity bioassays has still not been established. Therefore, these problems must be solved as soon as possible. Quality control has become a significant international issue, and I hope we will have a fruitful discussion on this and other issues related to laboratory animal science of interest to the two countries. Among our topics of discussion will be global health issues of experimental animals and the need for defining laboratory animals. CIEA is supported financially by the Ministry of Education, Science, and Culture because the monitoring center undertakes genetic and microbiological monitoring for universities under the control of the Ministry. In addition, CIEA has 44 supporting members from industry that pay an annual fee and also give donations because toxicology is one of the most critical animal studies for the pharmaceutical industry. Their requirements are very strict, which has increased the level of animal experimentation. Laboratory animal science is a very broad field, covering many disciplines, and it requires good collaboration between industry and academia. From the Japanese view, I wonder why the United States pharmaceutical industry does not support laboratory animal science. I also would like to know where the laboratory animal centers are and who are the US opinion leaders. Questions and Answers T. GILL: Certainly there is a large number of organisms that can be monitored and genes that can be tested. I believe the critical issue is how to select the microorganisms or genes. A second category is local problems, some of which must also be monitored. I believe this group should generate recommendations about what is essential and what are special local needs.