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 Bureau 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.
REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EXPERIMENTAL
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 Experimental
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 or the Immunization of Poultry and
Other Domestic Animals, undergo such inoculations, with the exception
of those experimental animals that 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;
5) And 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 promulgatio
Source: en.ivdc.gov.cn
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