NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

National Research Council (US) Institute for Laboratory Animal Research. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington (DC): National Academies Press (US); 2004.

Cover of The Development of Science-based Guidelines for Laboratory Animal Care

The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop.

Show details

Japanese Regulations on Animal Experiments: Current Status and Perspectives

Naoko Kagiyama and Tatsuji Nomura

In terms of ethics in animal experimentation, advanced countries have adopted the 3R principles of humane experimental technique first espoused by Russell and Burch in 1959, namely, replacement, reduction, and refinement. Twenty-six years later, in 1985, the 3Rs were translated into 11 basic principles by the Council of International Organizations for Medical Sciences (CIOMS). These items have become international principles that govern animal experimentation.

INTERNATIONAL COMPARISON OF REGULATIONS ON ANIMAL EXPERIMENTATION

Europe

The year 1986 was important in terms of the following: (1) the Council of Europe concluded the convention for the protection of vertebrate animals used for experimental and other scientific purposes; (2) the European Union formulated directives on the approximation of laws, regulations, and administrative provisions to rectify disparities in welfare policies among member states; and (3) in the United Kingdom, the Cruelty to Animals Act of 1876 was amended and its title changed to the Animals (Scientific Procedures) Act (Figure 1, left). The regulatory agency in the United Kingdom, the Home Office, issues three licenses—for the project, the personnel, and the premises where the animal experiment is to be conducted. All three licenses must be obtained before starting the animal experiment. Thus, the UK regulatory authority directly controls animal experimentation.

FIGURE 1. Comparison between regulations on animal experiments in the United Kingdom, the United States, and Japan.

FIGURE 1

Comparison between regulations on animal experiments in the United Kingdom, the United States, and Japan. USDA, US Department of Agriculture; IRAC, Interagency Research Animal Committee; DHHS, Department of Health and Human Services; AWA, Animal Welfare (more...)

United States

In the United States, the Animal Welfare Act was enacted in 1966. The amendment in 1985 required research facilities to appoint an institutional animal care and use committee (IACUC) as well as to ensure the qualifications of personnel involved in animal experiments (Figure 1, center). Animal experiments can be performed based on a review and approval of the IACUC and the final approval of the institutional official. The regulatory agency, the US Department of Agriculture (USDA), conducts unannounced inspections of facilities every year.

Japan

In Japan, animal experimentation is also regulated by laws. The types of regulations in Japan (Figure 1, right) resemble the US system, which holds each institution responsible for self-regulation. However, the designation of an equivalent of the IACUC, registration, and legal inspections of laboratory animal facilities are not stipulated in the law.

LEGAL SYSTEMS IN JAPAN

The detailed legal system in Japan is described in Figure 2 from an historical viewpoint. The Law Concerning the Protection and Control of Animals enacted in 1973 was amended in 1999 and given the new title of the Law for the Humane Treatment and Management of Animals. This law protects all species of animals from cruelty (Investigative Committee 2001).

FIGURE 2. Regulations related to animal experiments in Japan.

FIGURE 2

Regulations related to animal experiments in Japan.

The law emphasizes respect for life, companionship with animals, and well-being of animals. It specifies the responsibility of the owner of the animal, and calls for the alleviation of pain and distress as well as the humane death of animals used for scientific purposes. Based on the law, the Standards Relating to the Care and Management of Experimental Animals were specified in 1980 (Figure 2, left). The Standards cover the care and management of laboratory animals, but not the use of animals (Investigative Committee 1980). The same year that the Standards were announced, the Science Council of Japan advised the Prime Minister to prepare administrative guidance for the use of animals for scientific purposes (Science Council of Japan 1981).

In 1987, in accordance with the advice of the Science Council of Japan, the Ministry of Education notified universities and other institutions to establish voluntary guidelines on animal experimentation (Ministry of Education 1987) (Figure 2, right). As a result of the notification, universities and even private research institutes formulated their own principles, guidelines, manuals, and other materials in accordance with the laws and with administrative guidance. Similarly, the scientific associations concerned have compiled guidelines for individual research fields to encourage members to balance science and animal welfare (JALAS 1987). Thus, animal experiments in Japan are regulated by a combination of legal and scientific developments.

CURRENT STATUS

Current regulations regarding animal experimentation in Japan are summarized in Table 1. The three categories include the following: laws consisting of the law, the standards, and the guide; administrative guidance issued by the Head of Science and International Affairs Bureau through their bulletin, which includes the notification; and voluntary guidelines formulated by individual scientific associations. Laboratory animal scientists in Japan have observed all three categories of regulations equally without the force of law but with a moral sense. The law, the standards, and the guide in the first category consist of 31, 10, and 4 articles, respectively. Each has an associated explanatory handbook with 302, 115, and 68 pages of texts, respectively. The handbook for the Standards was edited by seven laboratory animal scientists, one medical doctor, and one representative of the Japan Animal Welfare Society to reflect the opinions of animal advocates.

TABLE 1. List of Regulations Regarding Animal Experiments in Japan.

TABLE 1

List of Regulations Regarding Animal Experiments in Japan.

In Table 2, the characteristics of Japanese regulations on animal experiments are listed. Our ethical principles, known as the 3Rs, are the same as in Western countries. The law emphasizes refinement that focuses on the alleviation of pain and distress as well as the humane death of animals.

TABLE 2. Characteristics of Regulations on Animal Experiments in Japan.

TABLE 2

Characteristics of Regulations on Animal Experiments in Japan.

The law adopts the self-regulation system for animal experimentation, and the notification only recommends designation of an IACUC (Ministry of Education 1987). Nevertheless, according to survey results, almost all medical schools and pharmaceutical companies as well as about one-third of breeders have established IACUCs even though the law does not mandate it. Laboratory animal and livestock facilities are exempted from registration and legal inspection. Instead, the Japanese Association for Laboratory Animal Science voluntarily conducts surveys every 3 years on the number of animals used for scientific purposes (CLACU 2003). It is therefore evident that laboratory animal scientists in Japan recognize the importance of replacement of live animals with insentient materials and reduction in the number of animals involved.

Although our regulations may appear somewhat lenient and ambiguous from the Western viewpoint (Nomura 1995) (a feeling that has sometimes annoyed Japanese scientists when collaborating with Western colleagues), the authors believe that certain religious implications may underlie animal experimentation ethics and the structure of regulations in individual countries, as described below.

RELIGIOUS IMPLICATIONS

A Thai venerable who graduated from medical school made a presentation about the philosophy of Karma in Buddhism at the 2003 annual meeting of the American Association of Laboratory Animal Sciences. Researchers in Buddhist countries regard animals as existing on the same level as humans and generally treat animals based on the philosophy of Karma. Buddha rewards or punishes people based on their deeds (Karma). The logic of reincarnation is called samsara, the endless round of rebirth and redeath based on the impersonal judge of the Natural World, on which the destiny of humans depends.

Researchers in historically Christian countries, by comparison, appear to handle laboratory animals from the standpoint of the Lord of Creation. Researchers in Western countries give the impression of conducting animal experiments based on phylogenic domination of the animal. Therefore, they often cite the expression “humane care and responsible use.”

PERSPECTIVE OF ANIMAL EXPERIMENTS IN JAPAN

In Japan, we seek to combine Buddhist and Christian assumptions and to reach a point where humans should take responsibility for laboratory animals so that they can accomplish good Karma while using the animals for scientific purposes. If animals are suffering from infectious diseases, for example, they will not be able to provide reliable experimental data as their good Karma. Thus, microbiological control of the animal environment should be the responsibility as well as good Karma for people engaged in animal experimentation. Investigators in Japan may achieve the 3Rs principle in practice without any strict regulations because of the fear of samsara. However, the need to collaborate with Western colleagues requires compromise with the Western system. For this reason, we have been discussing appropriate strategies.

There is current disagreement over whether we should aim toward more stringent regulations, similar to European countries, or continue the current self-regulation system as in the United States and Canada. To ensure a convincing self-regulation system, we will need to clarify the responsibility of persons who engage in animal experiments, define the role of the IACUC, and implement animal welfare practices compatible with scientific needs, as shown in Figure 3. As mentioned above, none of these elements are strictly stipulated by the law but are regulated by administrative guidance and voluntary guidelines to encourage flexible animal research. It is now time for us to consider a certain mechanism to defend animal research as well as a validation system for self-regulation to reach a social consensus on the necessity of animal experimentation.

FIGURE 3. Reinforcement of the self-regulation system within animal research facilities in Japan.

FIGURE 3

Reinforcement of the self-regulation system within animal research facilities in Japan.

REFERENCES

  1. CLACU [Committee for Laboratory Animal Care and Use, Japanese Association for Laboratory Animal Science] The number of live animals used in experiments in 2001 [text in Japanese, summary in English] Exp Anim. 2003;52:143–158.
  2. Investigative Committee [Investigative Committee on the Law for the Humane Treatment and Management of Animals] Explanatory Handbook on the Law [text in Japanese]. Tokyo: Seirin Shoin; 2001.
  3. Investigative Committee [Investigative Committee on the Standards Relating to the Care and Management of Experimental Animals] Explanatory Handbook on the Standards [in Japanese]. Tokyo: Gyousei; 1980.
  4. JALAS [Japanese Association for Laboratory Animal Science] Guidelines on Animal Experimentation [in Japanese] Exp Anim. 1987;36:285–288.
  5. Ministry of Education [Ministry of Education, Science and Culture, Science and International Affairs Bureau] Notification on Animal Experimentation in Universities [in Japanese] 1987
  6. Nomura T. Laboratory animal care policies and regulations in Japan. ILAR J. 1995;37:60–61. [PubMed: 11528025]
  7. Science Council of Japan. Recommendation for the establishment of animal experiment guideline [in Japanese] Exp Anim. 1981;30:173–178.
Copyright © 2004, National Academy of Sciences.
Bookshelf ID: NBK25422

Views

  • PubReader
  • Print View
  • Cite this Page
  • PDF version of this title (3.2M)

Related information

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...