实验动物管理条例(附英文)
实验动物管理条例(附英文)
1988年11月14日，国务院
第一章 总 则
第一条 为了加强实验动物的管理工作，保证实验动物质量，适应科学研究、经济建设和社会发展的需要，制定本条例。
第二条 本条例所称实验动物，是指经人工饲育，对其携带的微生物实行控制，遗传背景明确或者来源清楚的，用于科学研究、教学、生产、检定以及其他科学实验的动物。
第三条 本条例适用于从事实验动物的研究、保种、饲育、供应、应用、管理和监督的单位和个人。
第四条 实验动物的管理，应当遵循统一规划、合理分工，有利于促进实验动物科学研究和应用的原则。
第五条 国家科学技术委员会主管全国实验动物工作。
省、自治区、直辖市科学技术委员会主管本地区的实验动物工作。
国务院各有关部门负责管理本部门的实验动物工作。
第六条 国家实行实验动物的质量监督和质量合格认证制度。具体办法由国家科学技术委会另行制定。
第七条 实验动物遗传学、微生物学、营养学和饲育环境等方面的国家标准由国家技术监督局制定。
第二章 实验动物的饲育管理
第八条 从事实验动物饲育工作的单位，必须根据遗传学、微生物学、营养学和饲育环境方面的标准，定期对实验动物进行质量监测。各项作业过程和监测数据应有完整、准确的记录，并建立统计报告制度。
第九条 实验动物的饲育室、实验室应设在不同区域，并进行严格隔离。
实验动物饲育室、实验室要有科学的管理制度和操作规程。
第十条 实验动物的保种、饲育应采用国内或国外认可的品种、品系，并持有效的合格证书。
第十一条 实验动物必须按照不同来源，不同品种、品系和不同的实验目的，分开饲养。
第十二条 实验动物分为四级：一级，普通动物；二级，清洁动物；三级，无特定病原体动物；四级，无菌动物。
对不同等级的实验动物，应当按照相应的微生物控制标准进行管理。
第十三条 实验动物必须饲喂质量合格的全价饲料。霉烂、变质、虫蛀、污染的饲料，不得用于饲喂实验动物。直接用作饲料的蔬菜、水果等，要经过清洗消毒，并保持新鲜。
第十四条 一级实验动物的饮水，应当符合城市生活饮水的卫生标准。二、三、四级实验动物的饮水，应当符合城市生活饮水的卫生标准并经灭菌处理。
第十五条 实验动物的垫料应当按照不同等级实验动物的需要，进行相应处理，达到清洁、干燥、吸水、无毒、无虫、无感染源、无污染。
第三章 实验动物的检疫和传染病控制
第十六条 对引入的实验动物，必须进行隔离检疫。
为补充种源或开发新品种而捕捉的野生动物，必须在当地进行隔离检疫，并取得动物检疫部门出具的证明。野生动物运抵实验动物处所，需经再次检疫，方可进入实验动物饲育室。
第十七条 对必须进行预防接种的实验动物，应当根据实验要求或者按照《家畜家禽防疫条例》的有关规定，进行预防接种，但用作生物制品原料的实验动物除外。
第十八条 实验动物患病死亡的，应当及时查明原因，妥善处理，并记录在案。
实验动物患有传染性疾病的，必须立即视情况分别予以销毁或者隔离治疗。对可能被传染的实验动物，进行紧急预防接种，对饲育室内外可能被污染的区域采取严格消毒措施，并报告上级实验动物管理部门和当地动物检疫、卫生防疫单位，采取紧急预防措施，防止疫病蔓延。
第四章 实验动物的应用
第十九条 应用实验动物应当根据不同的实验目的，选用相应的合格实验动物。申报科研课题和鉴定科研成果，应当把应用合格实验动物作为基本条件。应用不合格实验动物取得的检定或者安全评价结果无效，所生产的制品不得使用。
第二十条 供应用的实验动物应当具备下列完整的资料：
（一）品种、品系及亚系的确切名称；
（二）遗传背景或其来源；
（三）微生物检测状况；
（四）合格证书；
（五）饲育单位负责人签名。
无上述资料的实验动物不得应用。
第二十一条 实验动物的运输工作应当有专人负责。实验动物的装运工具应当安全、可靠。不得将不同品种、品系或者不同等级的实验动物混合装运。
第五章 实验动物的进口与出口管理
第二十二条 从国外进口作为原种的实验动物，应附有饲育单位负责人签发的品系和亚系名称以及遗传和微生物状况等资料。
无上述资料的实验动物不得进口和应用。
第二十三条 实验动物工作单位从国外进口实验动物原种，必须向国家科学技术委员会指定的保种、育种质量监控单位登记。
第二十四条 出口实验动物，必须报国家科学技术委员会审批。经批准后，方可办理出口手续。
出口应用国家重点保护的野生动物物种开发的实验动物，必须按照国家的有关规定，取得出口许可证后，方可办理出口手续。
第二十五条 进口、出口实验动物的检疫工作，按照《中华人民共和国进出口动植物检疫条例》的规定办理。
第六章 从事实验动物工作的人员
第二十六条 实验动物工作单位应当根据需要，配备科技人员和经过专业培训的饲育人员。各类人员都要遵守实验动物饲育管理的各项制度，熟悉、掌握操作规程。
第二十七条 地方各级实验动物工作的主管部门，对从事实验动物工作的各类人员，应当逐步实行资格认可制度。
第二十八条 实验动物工作单位对直接接触实验动物的工作人员，必须定期组织体格检查。对患有传染性疾病，不宜承担所做工作的人员，应当及时调换工作。
第二十九条 从事实验动物工作的人员对实验动物必须爱护，不得戏弄或虐待。
第七章 奖励与处罚
第三十条 对长期从事实验动物饲育管理，取得显著成绩的单位或者个人，由管理实验动物工作的部门给予表彰或奖励。
第三十一条 对违反本条例规定的单位，由管理实验动物工作的部门视情节轻重，分别给予警告、限期改进、责令关闭的行政处罚。
第三十二条 对违反本条例规定的有关工作人员，由其所在单位视情节轻重，根据国家有关规定，给予行政处分。
第八章 附 则
第三十三条 省、自治区、直辖市人民政府和国务院有关部门，可以根据本条例，结合具体情况，制定实施办法。
军队系统的实验动物管理工作参照本条例执行。
第三十四条 本条例由国家科学技术委员会负责解释。
第三十五条 本条例自发布之日起施行。
REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EX-PERIMENTAL ANIMALS
Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
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 (法规全文)
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.