REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EX-PERIMENTAL ANIMALS
REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EX-PERIMENTAL ANIMALS
Important Notice:
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document
REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EX-
PERIMENTAL ANIMALS
(Approved by the State Council on October 31, 1988 and promulgated
by Decree No. 2 of the State Science and Technology Commission on November
14, 1988)
Chapter I General Provisions
Article 1
These Regulations are formulated for the purpose of strengthening the
administration of and guaranteeing the quality of experimental animals so
as to meet the needs of scientific research, economic construction and
social development.
Article 2
The term "experimental animals" used in these Regulations refers to
animals which are artificially fed and bred, the micro-organisms on or in
whose bodies are kept under control, whose genetic backgrounds are
definite or whose sources are clear, and which are to be used in
scientific research, teaching, production, examination and verification
and other scientific experiments.
Article 3
These Regulations shall apply to units and individuals that are engaged in
the research in, and the conservative of breeds, feeding and breeding,
supply, use, administration and supervision of experimental animals.
Article 4
The administration of experimental animals shall be guided by the
principle of unified planning, rational division of work and being
beneficial to the promotion of the scientific research in, and the
utilization of, experimental animals.
Article 5
The State Science and Technology Commission shall be in charge of the work
throughout China with respect to experimental animals.
The science and technology commissions of the provinces, autonomous
regions and municipalities directly under the Central Government shall be
in charge of the work in their respective regions with respect to
experimental animals.
The various departments under the State Council of the People's Republic
of China shall be in charge of the administration of the work in their
respective departments with respect to experimental animals.
Article 6
The State shall institute a system of supervision over the quality of
experimental animals and of attestation of the up-to-standard quality of
experimental animals. The specific procedures in this respect shall be
separately formulated by the State Science and Technology Commission.
Article 7
The national standards in respect of genetics, microbiology, nutriology
and the feeding and breeding environment concerning experimental animals
shall be formulated by the State Bureau of Technology Supervision.
Chapter II The Administration of the Feeding and Breeding of Ex- perimental Animals
Article 8
Units that are engaged in the work of feeding and breeding experimental
animals shall, in accordance with the standards in respect of genetics,
microbiology, nutriology and the feeding and breeding environment,
exercise regular quality monitoring over experimental animals.
Comprehensive and accurate records shall be kept of the various work
processes and of the data derived from the monitoring and a statistical
report system shall be established.
Article 9
Feeding and breeding rooms and laboratories for experimental animals shall
be built in different areas and each shall be kept in strict isolation.
There shall be scientific management systems and operating rules for
feeding and breeding rooms and laboratories for experimental animals.
Article 10
With respect to the conservation of breeds and the feeding and breeding of
experimental animals, breeds and strains of breeds that are domestically
or internationally approved shall be adopted, with certificates attesting
their being up to standard.
Article 11
Experimental animals shall be fed separately in accordance with their
different sources, different breeds, different strains of breeds and
different experimental purposes.
Article 12
Experimental animals shall be fed with wholesome feed that is up to
standard in quality, animals, the second, clean animals, the third,
animals carrying no specific pathogens and the fourth, animals carrying no
bacteria.
Experimental animals of different classes shall be administered in
accordance with the corresponding standards for controlling micro-
organisms.
Article 13
Experimental animals shall be fed with wholesome feed that is up to
standard in quality. No feed that has become mouldy and rotten, or
deteriorated in quality, or moth-eaten or polluted may be used for feeding
experimental animals. Green vegetables and fruit that are to be fed
directly to experimental animals shall be washed clean and sterilized and
shall be kept fresh.
Article 14
The drinking water for experimental animals of the first class shall
measure up to the hygiene standards of urban drinking water. The drinking
water for experimental animals of the second, third and fourth classes
shall measure up to the hygiene standards of urban drinking water and
undergo treatment to kill bacteria.
Article 15
The cushioning materials for experimental animals shall, based on the
needs of different classes of experimental animals, be treated accordingly
so that they shall be clean, dry, absorptive of water, poison-free, pest-
free, infection-free and pollution-free.
Chapter III The Quarantine of Experimental Animals and the Control of Their Infectious Diseases
Article 16
Experimental animals that are newly introduced shall be subject to
quarantine in isolation. Wild animals that are captured for the purpose of
supplementing the sources of breeds or developing new breeds shall be
subject to quarantine in isolation in the very localities where they are
captured and a certificate to that effect issued by the animal quarantine
department shall be obtained. When a wild animal is carried to the place
where experimental animals are kept, it shall be subject to quarantine
once again before it is allowed into a feeding and breeding room for
experimental animals.
Article 17
Experimental animals that must take preventive inoculations shall, in
accordance with the requirements of experiments or with the relevant
provisions of the Regulations for the Immunization of Poultry and Other
Domestic Animals, undergo such inoculations, with the exception of those
experimental animals that are to be used as materials for biological
products.
Article 18
When an experimental animal dies of an illness, the cause shall be
investigated and ascertained in good time, and the case shall be properly
handled and kept on file. When an experimental animal contracts an
infectious disease, it shall, depending on the circumstances, be destroyed
or given medical treatment in isolation immediately. Experimental animals
that are likely to be infected shall undergo emergency preventive
inoculations. Strict sterilization measures shall be taken for areas
inside and outside the feeding and breeding room and the case shall be
reported to the higher authority for the administration of experimental
animals and to the local animal quarantine and epidemic prevention unit so
that emergency preventive measures shall be taken to prevent the spread of
the disease.
Chapter IV The Utilization of Experimental Animals
Article 19
In the utilization of experimental animals, only the related ones that are
up to standard shall be selected in accordance with the different purposes
of the respective experiments. The use of up-to-standard experimental
animals shall be taken as one of the basic requirements in the research
projects submitted for approval and in assessing the results of such
projects. If experimental animals that come short of standard are used,
the results of examination and safety assessment thus obtained shall be
null and void and the products thus made shall not be used.
Article 20
With respect to an experimental animal that is to be utilized, the
following comprehensive data shall be required:
1) the exact names of the breed, strain and subline;
2) its genetic background or its source;
3) the state concerning the examination of the micro-organisms it carries;
4) a certificate attesting its being up to standard; and
5) the signature of the person in charge of the feeding and breeding unit.
In default of the aforesaid data, no experimental animals may be used.
Article 21
The transport of experimental animals shall be put in the charge of
persons specially appointed therefor. The means of transport for
experimental animals shall be safe and reliable. No experimental animals
of different breeds, strains or sublines may be mixed together in
transportation.
Chapter V Administration of the Import and Export of Experimental Animals
Article 22
An experimental animal that is imported from abroad as an element breed
shall be accompanied by data duly signed by the person in charge of the
feeding and breeding unit, concerning the names of the breed and the
strain and the information concerning its heredity and the micro-organisms
it carries.
In default of the aforesaid data, no experimental animals may be imported
or used.
Article 23
When importing from abroad experimental animals as element breeds, units
dealing with experimental animals shall register with the unit designated
by the State Science and Technology Commission for the conservation of
breeds, breeding and quality control with respect to the said animals.
Article 24
The export of experimental animals shall be subject to examination and
approval by the State Science and Technology Commission. The export
procedures shall be handled only after such approval has been obtained.
With respect to the export of experimental animals developed from using
wild animals that enjoy the priority of State protection, the export
procedures shall be handled only after an export licence has been obtained
in accordance with the pertinent provisions of the State.
Article 25
The quarantine of import and export experimental animals shall be handled
in accordance with the provisions of the Regulations of the People's
Republic of China Concerning the Quarantine of Import and Export of
Animals and Plants.
Chapter VI Personnel Dealing with Experimental Animals
Article 26
Units dealing with experimental animals shall, according to the needs, be
staffed with technical personnel and specially trained personnel for the
feeding and breeding thereof. Personnel of various kinds shall all abide
by the various rules and regulations concerning the administration of the
feeding and breeding of experimental animals and shall be acquainted with,
and have a good mastery of, the operating rules.
Article 27
Competent authorities at various levels in various localities in charge of
the work with respect to experimental animals shall gradually institute a
qualifying system for personnel of various kinds dealing with experimental
animals.
Article 28
Units dealing with experimental animals shall regularly organize physical
check-ups for the working personnel who are in direct contact with
experimental animals. Those who have contracted infectious diseases and
are no longer suitable for their jobs shall be transferred in good time.
Article 29
Personnel dealing with experimental animals shall protect these animals
and may not play with or maltreat them.
Chapter VII Rewards and Penalties
Article 30
Units and individuals that are long engaged in the feeding and breeding
and administration of experimental animals and have scored remarkable
achievements shall be praised or rewarded by the department in charge of
the administration of the work with respect to experimental animals.
Article 31
With respect to units that violate the provisions of these Regulations,
the department in charge of the administration of the work with respect to
experimental animals shall, in accordance with the seriousness of the
cases, impose on them such administrative sanctions as giving a warning,
setting a deadline for them to improve their work or ordering them to
close down.
Article 32
Working personnel concerned who violate the provisions of these
Regulations shall be given administrative sanctions by the units where
they belong in accordance with the seriousness of the cases and with the
pertinent provisions of the State.
Chapter VIII Supplementary Provisions
Article 33
The people's governments of the provinces, autonomous regions and
municipalities directly under the Central Government and the departments
concerned under the State Council of the People's Republic of China may,
in accordance with these Regulations and in line with the actualities,
formulate procedures of implementation. The administration of the work
with respect to experimental animals in the armed forces shall be governed
with reference to these Regulations.
Article 34
The State Science and Technology Commission shall be responsible for the
interpretation of these Regulations.
Article 35
These Regulations shall go into effect as of the date of promulgation.
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