ILAR Journal Online, Volume 37(2) 1995: Laboratory Animal Care Policies and Regulations

Online Issues

<< All Back-issues

<< This Issue's Table of Contents

ILAR Journal V37(2) 1995
Laboratory Animal Care Policies and Regulations

Laboratory Animal Care Policies and Regulations

Japan
Tatsuji Nomura

Tatsuji Nomura, M.D., is director of the Central Institute for Experimental Animals, Kawasaki, Japan

OVERSIGHT

Animal protection in Japan is based more on ethical codes than on laws and regulations. The laws and regulations that do exist are not enforced by strict punitive measures as are the laws in most Western countries.

The Prime Minister's Office is the competent authority for animal protection laws and regulations in Japan. Japanese animal care and use legislation consists of the Law for the Protection and Management of Animals in 1973 (Law No. 105, October 1, 1973: hereinafter referred to as "the animal protection law") (Law for the Protection and Management of Animals, 1982) and the Standards Relating to the Care and Management of Experimental Animals (Notice No. 6 of the Prime Minister's office, March 27, 1980: hereinafter referred to as "the experimental animal standards") (Standards Relating to the Care and Management of Experimental Animals, 1982). Both the animal protection law and the experimental animal standards apply to all universities and other national and private research institutions, even though institutions may be under the jurisdiction of various government agencies. Japan has no other national or local laws or regulations related to animal care and use. Since the enactment of the animal protection law the Prime Minister's Office has made efforts to educate the public about the moral importance of animal protection.

The standards call for humane handling of laboratory animals during rearing, transport, and experimental procedures, as well as at the completion of experiments. Consideration is also given to conservation of the environment. Animals must be disposed of painlessly after the experiment is completed.

In 1987, the Ministry of Education, Science, and Culture issued a notification called "Animal Experimentation in Universities'' (Notification No. 141 of the Science and International Affairs Bureau, Ministry of Education, Science, and Culture, May 25, 1987; hereinafter referred to as "the ministry notification") (Science Council of Japan, 1981) to the deans of national, public, and private universities throughout Japan. This ministry notification, although not legally binding, is followed by the majority of Japanese universities. Among other measures, it calls for the establishment of an animal experimentation committee by the dean of the university. As a result, all medical schools in Japan have animal experimentation committees, and research protocols involving animals are reviewed in some manner in more than 80 percent of medical schools.

The Ministry of Education, Science, and Culture prepared the ministry notification after carefully deliberating on a 1980 recommendation submitted to the Prime Minister by the Science Council of Japan, to establish animal experimentation guidelines. In connection with the Science Council of Japan and the Ministry of Education, Science, and Culture, the Japanese Association for Laboratory Animal Science (JALAS) published its own "Guidelines on Animal Experimentation'' in 1987 (JALAS, 1987). These guidelines are used by various institutions for reference.

ENFORCEMENT

The animal protection law specifies that "any person who cruelly treats or who abandons a protected animal shall be liable to a fine of not more than 30,000 yen [approximately U.S. $360]." The experimental animal standards have no clear punitive measures. The laws and regulations are not aggressively enforced because animal protection in Japan is not based on legalism and the policy of the government is to promote animal protection through educational activities. However, if researchers do not follow the animal experimentation guidelines of their respective institutions, they are generally issued a severe warning or admonition by the animal experimentation committee. In extreme cases, the director may order research to be suspended. This is part of the "administrative guidance" system in Japan, which, although not legally binding, carries great weight in universities and other institutions with close government connections.

FUNDING

Because the animal protection law has no severe punitive measures or inspection systems, no particular funding is required for its administration.

APPLICABILITY

The experimental animal standards insist that humane animal care is the responsibility of managers of laboratory animal facilities, laboratory animal caretakers, and researchers.

ADMINISTRATIVE METHODS AND THEIR COSTS

As there is no formal requirement in Japanese law for reviewing animal experiments, there is very little administration required. However, the use of animal experimentation committees, as recommended by the ministry notification, has become widespread. The role of the animal experimentation committee is to provide guidance and advice so that animal experiments are performed in accordance with the respective guidelines. The committee must make important decisions concerning the scientific validity and adequacy of animal care in connection with particular protocols. Therefore, the members include several experts in laboratory animal science such as veterinarians, researchers with a wide range of experience in performing animal experiments, and others who are able to make decisions on conformity with related laws and regulations and who are knowledgeable in matters related to ethics and animal welfare. The members are usually appointed by the dean of the university or director of the institution, who bears final responsibility in all matters. Animal experimentation committees are generally made up of individuals from the institution concerned, and the meetings are not open to the public. Investigators must receive approval from the committee in order to conduct animal research.

There are no provisions in Japanese laws or regulations concerning who should pay for costs incurred from meeting the experimental animal standards. The costs concerned appear to be covered by the operating expenses of research institutions.

STRENGTHS AND WEAKNESSES

When viewed by the West, Japanese animal protection laws and regulations appear to contain many loopholes. Details of compliance are left up to the good judgment of the researchers, there are essentially no punitive measures, there is no formal approval system for animal researchers and animal experimentation facilities, and there is no formal system for reviewing animal experiment protocols. Japanese laws and regulations based on researchers' good will have been criticized by animal rights groups, animal welfare groups, and the media. There have also been demands that the laws and regulations be revised.

Japanese society, however, appears to support the level of protection afforded by the current laws and regulations, and it is a good system for ordinary researchers. However, many people connected with the management and operation of laboratory animal facilities would like to see the responsibilities of the heads of research institutions clarified concerning laboratory animal welfare, as well as the inclusion of stricter punitive measures and budgetary provisions.

Researchers in Japan tend to adopt the concept of the 3 Rs of reduction, refinement, and replacement of laboratory animals (Russell and Burch, 1959). At the same time social movements calling for animal rights and welfare are gradually becoming more active. Researchers, government officials, and executives are realizing that international harmonization of experimental animal welfare is becoming necessary. The animal protection law and the experimental animal standards will begin to be revised in the near future and will likely be similar in content to the ministry notification.

CONCLUSION

Japanese laws and regulations are basically ethical codes that rely on the good sense of the researchers and do not contain any strict punitive measures such as those seen in Western countries. While there are many details in the current system in Japan that should be improved, the basic policy as a whole is supported by the general public and functions well as it stands. Japan has a long tradition of animal protection based on the Buddhist teaching against senseless killing as part of its ethical system. Japanese people act according to this fundamental concept of personal morality with little need for laws or regulations. Although modern Japanese society is not known for its religious conviction, each year the biomedical faculties of universities and employees of research institutes that perform animal experiments hold a memorial service for the spirits of the animals sacrificed for biomedical research. This illustrates the widespread influence of Buddhist ethical concepts in Japanese society.

Because of this way of thinking, Japanese people generally accept the importance of living things but also recognize that in some cases, they must be sacrificed. It is not in the Japanese people's character to loudly proclaim their agreement or disagreement. This is perhaps one reason why the animal welfare movement has become vociferous and even extreme in Western countries but has always remained rather subdued in Japan.

REFERENCES

The Japanese Association for Laboratory Animal Science (JALAS). 1987. Guidelines for animal experimentation. Experimental Animals 36:285-288.

Law for the Protection and Management of Animals (in English). 1982. Experimental Animals 31:221-224.

Russell, W. M. S., and R. L. Burch. 1959. The Principles of Humane Experimental Technique (Special Edition). Hefts, England: Universities Federation for Animal Welfare.

Science Council of Japan. 1981. Recommendation for the establishment of animal experimentation guidelines. Experimental Animals 3(l: 173-178.

Standards Relating to the Care and Management of Experimental Animals (in English). 1982. Experimental Animals 31:228-231.