Regulations for Animal Experiments
Central Institute for Experimental Animals[Chapter 1: General Rules](Purpose and Basic Principles)
Article 1 These Regulations specify the items required for proper conductof animal experiments from the scientific, animal welfare andenvironmental safety aspects and the aspect of safety assurance ofresearchers conducting the animal experiments by the Central Institutefor Experimental Animals (CIEA) based on Basic Policies on AnimalExperiments conducted in Research Institutions.(Basic Policies)(Notice No. 71 of the Ministry of Education, Culture, Sports, Scienceand Technology, June 2006).
2. The regulations for handling laboratory animals in animal experiments
are specified in the Standards Relating to the Care and Management ofLaboratory Animals and Relief of Pain (Care and Management Standards)(Notice No. 88, Ministry of the Environment, April 2006) based on theLaw for the Humane Treatment and Management of Animals.
3. When animal experiments are performed, consideration must be given
to the 3R-Principle for humane experimental technique (Replacement:
use of methods to replace living whole animals, Reduction: decreasein the number of animals used and Refinement: reduction of pain in theanimals) within the range of achieving the scientific purpose ofutilization in all cases.
4. Researchers performing animal experiments in CIEA must comply withthese Regulations.

(Definitions)
Article 2 In these Regulations, the definitions of terms are as specified
below.
(1) Animal experiments: These refer to provision of animals for use
in education, experimental research, collection of biological samples
or other scientific purposes. The utilization of animals formaintenance of strains, production or testing is included.
(2) Facilities: These refer to facilities and equipment for the conductof animal experiments.
(3) Laboratory animals: These refer to mammals, birds or reptiles bredor maintained for use in animal experiments (including those duringtransport to facilities).
(4) Animal experiment protocols: These are protocols for performing
animal experiments.
(5) Researchers performing animal experiments: These are persons whoperform animal experiments.
(6) Principal investigators: Among the researchers performing animalexperiments, the investigator is the researcher in charge of the animalexperiment.
(7) Manager: This is the person who supervises the laboratory animals
and facilities as an assistant to the director.
(8) Laboratory animal manager: This is the person in charge of thelaboratory animals and facilities in each facility as an assistant tothe manager.
(9) Animal technicians: These are persons who undertake care andmanagement or maintenance of laboratory animals under the laboratory
animal manager or researchers performing animal experiments.

(10) Manager, etc.: This refers to the manager, laboratory animalmanager, researchers performing animal experiments and animaltechnicians.

[Chapter 2: Range of Application]
Article 3 These Regulations apply to all animal experiments performedin CIEA.
2. When CIEA contracts animal experiments to outside institutions, itconfirms that the animal experiments are performed appropriately by
the contract research facility based on the Basic Policies or policies
on animal experiments specified by other Ministries.
3. When CIEA receives contracts to perform animal experiments from outsideinstitutions, it explains to the contracting institution that all
animal experiments in CIEA are performed appropriately in compliancewith the Basic Policies and based on regulations of CIEA specified onthe basis of the Basic Policies.

[Chapter 3: Organization](Responsibilities of the Director)
Article 4 The Director bears final responsibility for conduct of all
animal experiments in CIEA.
2. The Director establishes the Institutional Animal Care and Use
Committee (IACUC) and requires IACUC to review animal experimentprotocols.
3. The Director either gives or denies approval based on the report ofIACUC.
4. After completion of the animal experiment, the Director verifies theresults obtained in the animal experiment and points out improvements
to the principal investigator or the manager based on the advice ofIACUC.
5. The Director retains the animal experiment protocols, the results
obtained in the animal experiments, minutes of IACUC meetings,application for approval of establishment of animal facilities.
6. The Director takes particular care to ensure the safety and maintainthe health of managers, etc. in animal experiments that handle physicalor chemical materials or pathogens, in animal experiments that might
affect human safety or health, and in animal experiments that might
affect the proximate environment.
7. Within the range that does not hinder research activities as well as
to protect individual and research information, the Director shall
publish the results of research and projects.
8. The Director shall provide education and training to improve the qualityof managers, etc.
9. The Director shall be able to transfer authority specified in Item
3 of this Article to the manager.

[Chapter 4: Institutional Animal Care and Use Committee (IACUC)](Role of IACUC)
Article 5 IACUC receives inquiries from the Director and undertakes thefollowing tasks.
(1) IACUC conducts reviews on whether or not the animal experiment
protocol submitted by the principal investigator complies with theBasic Policies and these Regulations, and reports the results to theDirector.

(2) IACUC receives reports on the results of execution of the animalexperiment protocol from the Director and offers advice as required.
(3) IACUC checks the facilities, performs surveys as required andreports the results to the Director.
(4) IACUC determines the status of education and training related toanimal experiments and participates in the planning as required.
(5) IACUC reviews all items required for the proper conduct of animalexperiments.

(IACUC Membership)
Article 6 IACUC shall be composed of the following members appointed bythe Director.
(1) Two or more persons with excellent knowledge related to animalexperiments.
(2) Two or more persons with excellent knowledge related to laboratory
animals.
(3) One or more persons with other knowledge and experience(4) An IACUC chair elected from among the members.

(Term of Office of IACUC Members)
Article 7 The term of office of IACUC members shall be one year and they
may be reelected.
2. The period of office for IACUC members who are appointed when a vacancy
on IACUC arises shall be the remainder of the term of the former member.
3. The members in Item 2 above can be reelected.

(IACUC Meetings)
Article 8 IACUC meetings shall be held when at least two thirds of themembers are present.
2. The agenda shall be decided by at least two thirds of the members whoare present.
3. IACUC chair shall lead the IACUC meetings.

(Obligation of Secrecy)
Article 9 IACUC members shall not disclose to outside parties any
information on animal experiments obtained in IACUC meetings.

(Office)
Article 10 The Office of IACUC shall be established in the General Affairs
Department.
2. The Office shall arrange the schedule for holding IACUC meetings andshall record the minutes of the meetings.

(Miscellaneous Provisions)
Article 11 In addition to the specifications in these Regulations, theitems required for reviews by the IACUC meetings are as specified in
the “Guidelines for Review of Animal Experiment Protocols” specified
by IACUC.

[Chapter 5: Conduct of Animal Experiments](Drafting of Animal Experiment Protocols)
Article 12 The principal investigator drafts the animal experiment
protocol based on the following items from the standpoint of assurance

of the reliability of data obtained from animal experiments and performs
the animal experiment properly.
(1) Objective and significance of the animal experiment.
(2) Investigation on the use of alternatives: When animal experiments
are performed, the method shall be replaced by an alternative as muchas possible within the range of achieving the scientific purpose ofutilization.
(3) Rational selection of laboratory animals: When animal experiments
are performed, the number of animals used must be as few as possible
within the range of achieving the scientific purpose of utilization.
In such cases, the animal experiment protocol must be drafted inconsideration of selection of the species, etc. of laboratory animals
that comply with the objective of the animal experiment; selection of
the number of laboratory animals based on the expected accuracy andreproducibility of the results of the animal experiments; genetic andmicrobiological quality; and rearing conditions.
(4) Measures to predict and to minimize the severity of pain applied
to laboratory animals: When animal experiments are performed, methods
must be used that do not inflict pain on the animals as much as possible
within the range of achieving the scientific purpose of utilization.
(5) Final disposal method of laboratory animals.
(6) For lethal experiments in carcinogenicity studies, infection
studies and studies using radiation, humane endpoints must beconsidered.

(Submission of Animal Experiment Protocols)
Article 13 The principal investigator must submit to the Director
beforehand the draft animal experiment protocol when an animal
experiment is planned. The results of the debate by other committees(Genetic Recombinant Safety Committee, etc.) must be confirmed asrequired.

(Changes in Animal Experiment Protocols)
Article 14 When approved animal experiment protocols are changed, thenecessary procedures as specified in the Guidelines for Review of Animal
Experiment Protocols must be taken.

(Experimental Procedures)
Article 15 The principal investigator must instruct the researchers
performing the animal experiment and the animal technicians involvedthat the animal experiment must be performed in accordance with theapproved animal experiment protocol.
(1) When surgical procedures are performed, anesthetics and analgesics
must be administered based on the animal experiment protocol andappropriate postoperative management of pain, heat retention, etc. isrequired.
(2) Application of humane endpoints must be considered to relieve
laboratory animals from pain resulting from irreversible damage due
to disease or experimental procedures.
(3) When laboratory animal managers, researchers performing animalexperiments or animal technicians undertake disposal of laboratory
animals used in experiments that have been completed or discontinued
or laboratory animals subjected to irreversible damage due todiseases,they shall use chemical or physical methods such asadministration of anesthetics at higher than the lethal dose, cervicaldislocation or exsanguination under anesthesia based on the “Care andManagement Standards.”(4) When highly invasive major surgery is performed, it must besupervised by persons with sufficient experience and knowledge who havebeen trained in the experimental techniques to perform theseprocedures.
(5) When animal experiments are performed that might affect theecosystem, such as animal experiments using genetically modified
animals, care must be taken to prevent escape of the geneticallymodified animals.

(Reporting of Results)
Article 16 Principal investigators shall report the number of laboratory
animals used and results of animal experiments to the Director oncompletion of the experiments (when continued, at the end of the year)
using the forms for animal experiment reports after completion of theanimal experiment and retain the raw data .

[Chapter 6: Facilities](Establishment of Facilities)
Article 17 When facilities are established, the Department Head submits
to the Director via the Division Head an “Animal Facility Establishment
Application Form” with the cooperation of the Manager. After IACUC
completes a status survey and review, approval of the Director isobtained.

(Requirements for Facilities)
Article 18 The facilities shall have the following requirements.
(1) The facilities must have equipment and structures for rearing,
sanitation and prevention of escape based on the species of laboratory
animals concerned.
(2) Consideration must be given to odor, noise, handling of wastematerials, etc. so that there will be no adverse effects on local
residents or the proximate environment of the facilities.
(3) A laboratory animal manager must be appointed.

(Maintenance Control of Facilities)
Article 19 The manager must endeavor to maintain the facilities so thatthe laboratory animals are not injured by contamination of the rearing
environment, and also maintain the facilities required for proper
management of the laboratory animals and the conduct of animalexperiments.

(Handling of closure of the facilities)
Article 20
When facilities are closed, the Department Head shall submit
to the Director via the Division Head an “Animal Facility Closure
Application Form” and obtain approval.
2. When facilities are closed, efforts shall be made to transfer laboratory
animals that are bred and maintained in the closed facilities to otherfacilities either in or outside of CIEA in cooperation with the manger.
When the animals must be sacrificed, efforts must be made to comply
with the provisions of “Policies for Disposal of Animals” (Notice No.
40 of the Prime Minister’s Office, July 1995).

[Chapter 7: Care and Management of Laboratory Animals]
Article 21 The manager specifies operating procedures related to animalcare and management and conduct of experiments to maintain thelaboratory animals in good health and safety, and informs the laboratory
animal manager, researchers performing animal experiments and animal
technicians of these specifications.
2. The manager gives consideration to maintaining the health of thelaboratory animals by performing quarantine as required, as well as
microbiologic monitoring or periodic health checks.
3. Facilities shall be provided with the structure and strength to prevent
escape of laboratory animals based on the “Care and ManagementStandards.” Measures to be taken when animals escape or in emergencies
shall be specified beforehand and efforts shall be made to prevent
problems related to danger to humans and maintenance of the environment.
4. The manager shall take the necessary measures to prevent the laboratory
animal manager, researchers performing animal experiments and animal
technicians from contracting diseases originating from laboratory
animals (zoonoses).
5. The manager must endeavor to specify measures for emergencies to takein cases of major disasters such as earthquakes, fires and typhoons
to prevent danger caused by the laboratory animals and protect thelaboratory animals.
6. The manager must take the required measures to prevent persons notrelated to the rearing of the laboratory animals or conducting animal
experiments from coming into contact with the laboratory animals.
7. The manager shall endeavor to maintain proper records related tolaboratory animals including receipt of the animals, rearing anddisease histories, and record books related to the rearing environment,
to aid in the care and management of laboratory animals in thefacilities.

[Chapter 8:

Education and Training]

Article 22 The Director shall endeavor to ensure the education andtraining required for the manager, etc. The education and training mustbe undertaken before the managers, etc. take part in animal experiments
and regular education and training courses must be conducted thereafteras required.
2. When education and training are performed, records of the dates,
contents, names of instructors and trainees must be kept and retainedas specified in the Regulations.

[Chapter 9:

Self-inspections, Evaluations and Validation]

Article 23 The Director shall periodically undertake inspections andevaluations related to the responsibilities of the Director, role ofIACUC, etc. specified in these Regulations at the request of theCompliance Committee of CIEA to assure social transparency in theconduct of animal experiments.

[Chapter 10: Publishing of Information]
Article 24 The Director shall publish information related to animalexperiments in CIEA (examples: related regulations; results ofinspections and evaluations of animal experiments;conditions of careand management of laboratory animals) once a year in a research andproject report, on a webpage or by another appropriate method.

[Amendment or Abolition of These Regulations]
These Regulations shall be amended or abolished via deliberation by
the “Executive Board.”[Additional Provision]
These Regulations shall come into effect from December 11, 2006.