1. General Principles Persons in charge, etc. should understand the physiology, ecology and habits etc of experimental animals and should care for them with affection, and ensure that they be used for scientific purposes; persons in charge, etc. should also care for experimental animals responsibly and prevent them from doing harm to human life, body or property,and polluting or damaging the living environment.
2. Definitions In these standards,the meanings of the terms listed below shall conform to the following definitions:
   1. "Experimental animal" means a mammal or bird reared or kept at a facility (including an animal being transported to a facility) for use in experiments, etc.
   2. "Experiment, etc." means use of an animal for educational purpose, experimental research or manufacture of biotics or other scientific applications.
   3. "Facility" means a facility where experimental animals are reared, cared for or used in experiments.
   4. "Persons in charge.etc."means the person in charge, person in charge of experimental animals,experimenters and caretakers.
   5. "The person in charge" means the person in charge of experimental animals and the facility.
   6. "Person in charge of experimental animals" means a person who assists the person in charge and who is responsible for the experimental animals.
   7. ''Experimenter'' means a person who conducts experiments.
   8. ''Caretaker'' means a person employed in the care or custody of experimental animals under the person in charge of experimental animals or the experimenter.
3. Considerations when Bringing in Experimental Animals
   1. The person in charge and the person in charge of experimental animals should bring in experimental animals on the basis of the operational program of the facility decided after taking into account its location and the condition of its equipment, and care and management capacity as well as plans for experiments, etc . drawn up by the experimenter, and other factors.
   2. Persons transporting experimental animals should ensure the health and safety of, and prevent accidents due to, experimental animals, bearing in mind the following matters:
      1. In order to minimise fatigue and discomfort of the experimental animals, a means of transportation involving the shortest possible time should be selected.
      2. During transportation, experimental animals should be supplied with food and water as necessary at appropriate intervals.
      3. Experimental animals should be transported by a means that separates the experimental animals appropriately, taking into account the physiology, ecology, and habits, etc. of the experimental animals; and vehicles and containers, etc. used in transportation should be of a size and construction, etc. necessary to assure the safety and health of, and prevent the escape of experimental animals.
      4. Measures necessary to prevent pollution of the environment by microorganisms and feces, urine, etc. from experimental animals should be taken.
   3. The person in charge of experimental animals should, on bringing experimental animals into the facility, conduct appropriate quarantine measures as required, and should ensure that there is no damage to the health of experimenters, caretakers or other experimental animals.
4. Maintenance of the Health and safety of Experimental Animals
   1. The person in charge should appoint a person with knowledge and experience concerning experimental animals as the person in charge of experimental animals.
   2. The person in charge should establish appropriate facilities for the care and management of the experimental animals in accordance with the physiology, ecology, and habits, etc. of the experimental animals.
   3. The person in charge of experimental animals, experimenters and caretakers should maintain the health and safety of experimental animals, bearing in mind the following matters:
      1. Food and water should be supplied in a proper manner in accordance with the physiology, ecology, and habits, etc. of the experimental animals insofar as it does not interfere with the purpose of the experiments, etc.
      2. Prevention of disease in experimental! animals other than disease relating to the purpose of the experiment, and other necessary health control measures should be taken.
5. Matters to Be Considered in the Performance of Experiments, etc. of, and Measures to Be Taken after Experiments, etc.
   1. The experimenter should use the experimental animal in a proper manner within the scope necessary to achieve the purposes of the experiments, etc.
   2. The person in charge of experimental animals or the experimenter should conduct the experiments, etc. and dispose of the experimental animals after the experiments, bearing in mind the following matters:
      1. In conducting the experiments, etc. pain to experimental animals should be minimized as much as possible by giving the experimental animal anesthetics, etc. insofar as this is not detrimental to the purpose of the experiment, etc.; and appropriate measures should be taken to ensure that the experimental animal is kept warm.
      2. When disposing of animals for which the experiments have been concluded or discontinued,disposal should be carried out immediately with the minimum possible pain by more than the lethal dose of anesthetic, dislocation of the cervical vertebra or other such means.
      3. Appropriate measures should be taken to dispose of the carcasses of experimental animals so as not to damage human health or the living environment.
6. Prevention of Damage
   1. The person in charge, etc. should take whatever measures are necessary to ensure that persons unconnected with the care and management of the experimental animals or with the experiments, etc. do not come in contact with the experimental animals.
   2. The person in charge of experimental animals, the experimenters and caretakers should provide each other with the information necessary to prevent damage by experimental animals as specified hereinafter.
      1. The person in charge of experimental animals should provide the experimenters with information concerning the handling of experimental animals, and should provide the caretakers with the guidance necessary concerning the care and management of experimental animals.
      2. Experimenters should provide the person in charge of experimental animals with information concerning the experimental animals being used in experiments, etc., and should provide caretakers with the guidance necessary concerning the care and management of experimental animals.
      3. Caretakers should report the state of the experimental animals to the person in charge of experimental animals and the experimenters.
   3. The person in charge should take the steps necessary to maintain the health of persons in charge of experimental animals and caretakers in order to prevent them from contracting diseases from experimental animals.
   4. The in charge, etc. should take such measures as are necessary to ensure that experimental animals do not escape from the place where they are kept.
   5. The person in charge should prevent accidents by taking measures in case an experimental animal escapes.
   6. The person in charge should specify emergency measures to be taken in case of earthquake fire or other emergencies, and should immediately endeavour to protect, and prevent accidents due to, experimental animals when an emergency occurs.
7. Conservation of the Living Environment The persons in charge, etc. should conserve the living environment by appropriate disposal of the feces and urine, etc. of the e.experimental animals; by keeping the facility clean at all times to prevent pollution of the environment by microorganisms, etc. and obnoxious odors; and by taking steps to prevent noise by equipping the facilities to that purpose.
8. Measures to Be Taken by Breeders of Experimental Animals Persons breeding mammals ,and birds for the purposes of experiments, etc. should care for the animals responsibly with an understanding of the physiology, ecology, and habits, etc. of the animals,and with affection. bearing in mind the following matters: (1) Said persons should establish facilities appropriate to the physiology, ecology, and habits, etc. of the animals ; should provide food and water as appropriate; and should take such measures as are necessary to prevent the animals from contracting diseases. (2) To conserve the living environment , said persons should prevent pollution of or damage to the environment by disposing of the feces and urine , etc. of the animals; should maintain at ,all times the cleanliness of the places where the animals are bred; and should take such Steps as are necessary to maintain the health of persons employed in the breeding of animals by preventing persons so employed from contracting diseases from the animals.
9. Supplementary Provisions The persons in charge. etc. should adhere to the spirit of these standards even when using animals other than mammals and birds in experiments, etc.
10. Exemptions
    1. These standards shall not apply to persons in charge, etc. of experimental animals kept for the purposes of education or experimental research in livestock husbandry or for the purpose of livestock breeding.
    2. These standards shall not apply to persons in charge, etc. of experimental animals f the purpose of observing their ecology. However the provisions of the Standards Relating to the Care and Management of Animals for Exhibition, etc (Notification No. 7 1976 of the Prime Minister's Office)III(except 1),IV(except 1--(3)and 4 ) VI and VII-2 shall apply mutatis mutandis for care and management of said experimental animals.

Animal experiments have made a great contribution to the formation and advance of human culture and will continue to do so in the future. Their contribution to natural science has been especially remarkable. However, animal experiments should be conducted taking into consideration the maintenance of animal welfare from the basic viewpoint that the life of animals should be respected, but, at the same time, fulfilling various experimental requirements so that reproducibility, which forms the basis of objective results and evaluations, can be obtained by conforming to the general principles of scientific research.

The necessity of thoughtful consideration for animal welfare has been specified in the "Law Concerning the Protection and Control of Animals" (Law No. 105, October 1, 1973) and in "Standards Relating to the Care and Management, etc. of Experimental Animals" (Notification No. 6, 1978 of the Prime Minister's Office), and furthermore this necessity has been stated specifically in connection with animal welfare and animal experimentation in the recommendation entitles "Concerning the Establishment of Guidelines for Animal Experimentation" resolved at the 80th General Assembly of the Science Council of Japan and in the report named "Concerning the Basic Policy of the Performance of Animal Experimentation in Universities, etc.," issued by the Scientific Data Section of the Scientific Information and Data Subcommittee, Science Council.

Nagasaki University lays down the Guidelines for Animal Experimentation, duly recognizing the fact that the animal experiments performed by researchers of the University should conform to these principles.

1. (Purpose)

   The purpose of the Guidelines is to prescribe matters to be observed at the time of planning and executing animal experiments at Nagasaki University (hereafter called "the University") so that experiments can be conducted properly not only from a scientific viewpoint but also from an ethical one with due consideration for animal welfare.

2. (Range of Application)

   The Guidelines should be applied to all the experiments conducted at the University using mammals and birds. It is to be desired that experiments using animals other than mammals and birds should be conducted in adherence to the spirit of the Guidelines.

3. (Basic Principle)

   Persons who conduct animal experiments (hereafter called "experimenters") should take the responsibility for entire experiments including formulation of experimental plans, execution of experiments and adoption of necessary post-experimental measures, and pay close attention to the maintenance of proper experimental environments.

4. (Consolidation of Facilities, Equipment and Organization Structure)
   1. Sections properly equipped for the right and smooth execution of experimental animal care and animal experimentation (hereafter called "exclusive sections") should be secured.
   2. Appropriate facilities for the care and use of animals in experiments should be established taking into consideration the habits, ecology, etc. of the animals.
   3. The deans, etc. in whose faculties, etc. animal experiments are conducted should endeavor to consolidate experimental facilities, equipment organizational structure necessary for the management and operation of them.

5. (Formulation of Experimental Plans)
   1. Experimenters should refer to literature, etc. when planning animal experiments, and endeavor to refrain from experiments conducted for the mere reconfirmation of established facts.
   2. Experimenters should formulate experimental plans after making a close examination of respective research purpose and taking into careful consideration the presence of any possible alternative to animal experiments
   3. Experimenters, when selecting animals suitable for experimental purposes, should take into account their species, strain, quality, numbers and the conditions of their care and use in experiments, in order to reduce the scope of animal experiments to the minimum necessary for the achievement of research purposes.
   4. Experimenters should also give careful attention to the methods and environment of experiments from an ethical viewpoint, endeavoring, for instance, to alleviate as much as possible the anguish inflicted on animals, throughout experiments.
   5. Experimenters should check experimental plans on each of the items in the annexed list. In addition, experimenters should, in case of nee, seek the advice of experts on laboratory animals or animal experiments (hereafter called "experts") or the judgment of the Animal Care and Use Committee, Nagasaki University, organized according to the provision of paragraph 1, Article 12 (hereafter called "the Committee") as to the conformability of the experimental plans with the Guidelines.
   6. Experimenters should keep written experimental plans in custody and either submit them to the Committee or report the progress of the experiments, etc. to the Committee in compliance with the Committee's request.

6. (Introduction of Experimental Animals into Facilities)
   1. Experimenters should not only confirm the condition of order given for animals and the presence of abnormalities of deaths, but also record the sate of animals and the means and time of transportation, etc. when the animals state introduced into the facilities.
   2. Experimenters should quarantine experimental animals when they are brought in. In case of abnormalities are found in some animals, experimenters should take proper measures and avoid using the abnormal animals until the abnormalities have become extinct.
   3. Experimenters should endeavor to acclimatize to new environments, as occasion arise.
   4. Experimenters may substitute certificates of general and microbiological quality issued by animal breeders for part of quarantine work, in case of breeder are highly reliable.
   5. Experimenters may seek the advice or cooperation of experts regarding the confirmations and records provided for in paragraph 1 and the quarantine work prescribed in paragraph 2.

7. (Care and Rearing of Experimental Animals)
   1. Experimenters should make a close observation of the state of animals all the time from the time of their introduction until the completion of experimenters and take proper measures according to the needs of the case.
   2. Experimenters should endeavor to maintenance and manage exclusive sections and facilities for animal rearing and experimentation. To secure this end, experimenters should pay attention to physico-environmental factors---atmospheric conditions (temperature, humidity, air-flow, wind velocity, ventilation, light, smell, dust, etc.) of animal rooms and laboratories; living conditions (species, strains, sex, age, number, density of animal population, etc.); microbiological contamination; unnecessary addition of stress; etc.
   3. Experimenters should endeavor to attend to the care and rearing of experimental animals, supplying food water, etc. in an appropriate manner.
   4. Experimenters may seek the advice or cooperation of experts regarding the care and rearing stipulated in the three preceding paragraphs.

8. (Access to Exclusive Section)

   Persons other than experimenters, experts and others related to experiments should, as a role, be prohibited from entering exclusive sections.

9. (Experimental Procedures)

   Experimenters should take care not to inflict unnecessary anguish on animals by using proper restrains and anesthetics. To ensure this end, experimenters should seek the advice of experts or the judgment of the Committee, as occasion requires.

10. (Measures to Be Taken after Experiments, etc.)
    1. When disposing of experimental animals on which experiments have been concluded or discontinued, experimenters should endeavor to release the animals from anguish immediately by administration of a lethal dose of an anesthetic, cervical dislocation, inhalation of carbon dioxide, or other proper means of euthanasia.
    2. Experimenters should endeavor to prevent environmental pollution by the carcasses, etc., of experimental animals.
    3. Experimenters may seek advice or cooperation from experts regarding the measures provided for in the two preceding paragraphs.

11. (Experiments using Hazardous Substances, etc.)
    1. Experimenters using pathogens or recombinant DNA should be under the application of "Regulations Concerning the Prevention of Biohazards, Nagasaki University" (Regulation No. 14, September 16, 1983) or "Regulations Concerning the Safety Control of Recombinant DNA Experimentation, Nagasaki University" (Regulation No. 15, September 16, 1983) respectively.
    2. Experimenters using radioactive substances and radiation should be under the application of "Radiation Injury by X-ray Units for Educational and Research Purposes, Nagasaki University" (Regulation No. 16, October 25, 1983).
    3. When conducting animals experiments using hazardous substances for carcinogenecity or mutagenecity tests, etc., or substances whose safety is not yet confirmed, or other hazardous substances, experimenters should take appropriate measures to prevent the contamination of the environments using hazardous substances, experimenters should seek advice from experts, or submit plans to the Committee for deliberation.

12. (Animal Care and Use Committee)
    1. The Committee shall be organized in the University in order to enforce the Guidelines in an appropriate manner.
    2. The items necessary for the operation of the Committee shall be prescribed elsewhere.

Supplementary Provision

The Guidelines shall come into forces from December 22, 1989.

1. Environmental conditions of exclusive sections
2. Duration of animal experiments
3. Conditions for the introduction of animals into facilities
4. Experimental animals used; species; strain; general and microbiological quality; sex; age; number; etc.
5. Methods of experiments: administrational; sampling; observational; surgical; etc.
6. Methods used for the alleviation and elimination of animal's anguish: kinds and doses of anesthetics/analgesics, etc.; methods of administration; restraints; etc.
7. Methods of animal disposal after experiments: euthanasia; etc.
8. Preventive procedures against any possible interanimal and environmental contamination by physically, chemically, and biologically hazardous substances used for animal experiments
9. Reasons for the necessity of animal experiments (Reasons for not using alternatives to animal experiments)

The regulation shall stipulate the item necessary for the organization and man agent of the Animal Care and Use Committee, Nagasaki University (hereafter called "the Committee") according to the provision of Paragraph 2, Article 12, of the Guidelines for Animal Experimentation, Nagasaki University (hereafter called "the Guidelines") (Decision of the University Council, December 22, 1989).

Article 2 (Office)

The Committee shall take charge of matters relating to the Guidelines.

Article 3

The Committee shall deliberate on the conformity to the Guidelines of experimental plans submitted for approval to the Committee by persons who conduct animal experiments (hereafter called "experimenters"), and may request them to present reports on the progress of the experiments as occasion demands.

2. In the case the Committee deems it necessary after following the procedure stipulated in the preceding paragraph, it may give experimenters advice, request them to make some change in the plan, urge them to suspend the experiments, or order a complete ban on them.

3. As for animal experiments whose plans have not been submitted for approval, in case the Committee deems it necessary, it may request experimenters to present experimental plans or report on experimental progress, and may take the measures stipulated in the preceding paragraph.

Article 4 (Organization)

The Committee shall consist of persons stipulated in the following items.

1. One person each who is elected from among the professors, associate professors and full-time lectures of each Faculty (Faculty of Economic excepted), Faculty of Liberal Art, Institute of Tropical Medicine, Hospital attached to School of Medicine, Hospital attached to School of Dentistry, and School of Allied Medical Sciences.
2. A certain number of persons who are elected from among the experts on laboratory animals or animal experiments stipulated in paragraph 5, Article 5, of the Guidelines.
3. Some others whom the President of Nagasaki University deems it necessary to appoint.

Article 5 (Term of Office)

The term of office shall be two years. However, reappointment may be made.

2. In case a vacancy occurs in the members provided for in paragraph 1 of the preceding Article, the term of office for the substitute member shall be the remainder of the predecessor's term.

Article 6 (Chairperson)

A chairperson shall be appointed to the Committee through the mutual election of the members.

2. The chairperson shall call a Committee meeting and preside over the meeting.

3. In case the chairperson is unable to attend a Committee meeting, the member appointed in advance by the chairperson shall act in his/her place.

Article 7 (Preceding)

A Committee meeting may not be held without the attendance of simple majority.

2. The decision of matters shall be made with the consent of two-thirds or more of the members present.

Article 8 (Hearing)

In case the Committee deems it necessary, it may request the attendance of persons other than the members in order to listen to their explanation or options.

Article 9 (General Affairs)

The general affairs of the Committee shall be transacted at the General Affairs Department, Nagasaki University.

Article 10 (Addition)

The items necessary for the Committee but not yet stipulated here shall be prescribed elsewhere.

Supplementary provisions

1. The Regulations shall become effective from December 22, 1989.
2. The term of office for the first Committee members to be appointed after the establishment of the Regulation shall be until March 31, 1991, notwithstanding the provision of paragraph 1, Article 5.