KYB CHINA(1988年10月31日国务院批准 1988年11月14日国家科学技术委员会令第2号发布 根据2011年1月8日《国务院关于废止和修改部分行政法规的决定》第一次修订 根据2013年7月18日《国务院关于废止和修改部分行政法规的决定》第二次修订 根据2017年3月1日《国务院关于修改和废止部分行政法规的决定》第三次修订)
(Approved by the State Council on October 31, 1988; Promulgated by Decree No. 2 of the State Science and Technology Commission on November 14, 1988; First revision in accordance with the Decision of the State Council on Repealing and Amending Certain Administrative Regulations on January 8, 2011; Second revision in accordance with the Decision of the State Council on Repealing and Amending Certain Administrative Regulations on July 18, 2013; Third revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 1, 2017)
总则
General Provisions
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。
These Regulations are formulated to strengthen the management of laboratory animals, ensure the quality of laboratory animals, and meet the needs of scientific research, economic construction, and social development.
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。
For the purposes of these Regulations, 'laboratory animals' refer to animals that are artificially bred, with controlled microorganisms, clear genetic background or known origin, and used for scientific research, teaching, production, testing, and other scientific experiments.
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。
These Regulations apply to units and individuals engaged in the research, conservation, breeding, supply, application, management, and supervision of laboratory animals.
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。
The management of laboratory animals shall follow the principles of unified planning, reasonable division of labor, and facilitation of scientific research and application of laboratory animals.
国家科学技术委员会主管全国实验动物工作。
The State Science and Technology Commission is responsible for the nationwide work on laboratory animals.
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。
The science and technology commissions of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the work on laboratory animals in their respective regions.
国务院各有关部门负责管理本部门的实验动物工作。
The relevant departments of the State Council are responsible for the work on laboratory animals within their respective departments.
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员会另行制定。
The State implements a quality supervision and quality certification system for laboratory animals. Specific measures shall be formulated separately by the State Science and Technology Commission.
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。
National standards for laboratory animal genetics, microbiology, nutrition, and breeding environment shall be formulated by the State Bureau of Technical Supervision.
实验动物的饲育管理
Breeding Management of Laboratory Animals
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。
Units engaged in the breeding of laboratory animals must conduct regular quality monitoring of laboratory animals in accordance with standards for genetics, microbiology, nutrition, and breeding environment. Complete and accurate records of all operational processes and monitoring data shall be maintained, and a statistical reporting system shall be established.
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。
Laboratory animal breeding rooms and laboratories shall be located in separate areas and strictly isolated.
实验动物饲育室、实验室要有科学的管理制度和操作规程。
Laboratory animal breeding rooms and laboratories shall have scientific management systems and operating procedures.
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。
The conservation and breeding of laboratory animals shall use domestically or internationally recognized strains and stocks, and hold valid certificates of qualification.
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。
Laboratory animals must be raised separately according to different sources, different strains and stocks, and different experimental purposes.
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。
Laboratory animals are classified into four grades: Grade I, conventional animals; Grade II, clean animals; Grade III, specific pathogen-free animals; Grade IV, germ-free animals.
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。
Laboratory animals of different grades shall be managed according to corresponding microbial control standards.
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。
Laboratory animals must be fed with qualified complete feed. Moldy, deteriorated, insect-infested, or contaminated feed shall not be used for feeding laboratory animals. Vegetables, fruits, etc., directly used as feed shall be washed and disinfected and kept fresh.
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。
Drinking water for Grade I laboratory animals shall meet the hygienic standards for urban domestic drinking water. Drinking water for Grade II, III, and IV laboratory animals shall meet the hygienic standards for urban domestic drinking water and be sterilized.
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。
Bedding for laboratory animals shall be treated according to the needs of different grades of laboratory animals, achieving cleanliness, dryness, absorbency, non-toxicity, freedom from insects, freedom from sources of infection, and freedom from contamination.
实验动物的检疫和传染病控制
Quarantine and Infectious Disease Control of Laboratory Animals
对引入的实验动物，必须进行隔离检疫。
Introduced laboratory animals must undergo quarantine isolation.
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。
Wild animals captured for supplementing breeding stock or developing new breeds must undergo quarantine isolation locally and obtain a certificate issued by the animal quarantine department. After being transported to the laboratory animal facility, wild animals shall undergo quarantine again before entering the laboratory animal breeding room.
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《中华人民共和国动物防疫法》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。
Laboratory animals that must be vaccinated shall be vaccinated according to experimental requirements or in accordance with the relevant provisions of the Animal Epidemic Prevention Law of the People's Republic of China, except for laboratory animals used as raw materials for biological products.
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。
If a laboratory animal dies of disease, the cause shall be promptly identified, properly handled, and recorded.
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。
If a laboratory animal suffers from an infectious disease, it must be immediately destroyed or isolated for treatment depending on the situation. Emergency vaccination shall be given to animals that may have been infected, strict disinfection measures shall be taken in areas that may have been contaminated inside and outside the breeding room, and the superior laboratory animal management department and local animal quarantine and health epidemic prevention units shall be reported to take emergency prevention measures to prevent the spread of the epidemic.
实验动物的应用
Application of Laboratory Animals
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。
When applying laboratory animals, corresponding qualified laboratory animals shall be selected according to different experimental purposes. When applying for scientific research projects and appraising scientific research achievements, the use of qualified laboratory animals shall be a basic condition. The results of inspection or safety evaluation obtained using unqualified laboratory animals are invalid, and the products produced shall not be used.
供应用的实验动物应当具备下列完整的资料：
Laboratory animals for application shall have the following complete data:
(一)品种、品系及亚系的确切名称；
(1) Exact name of breed, strain, and substrain;
(二)遗传背景或其来源；
(2) Genetic background or source;
(三)微生物检测状况；
(3) Microbiological testing status;
(四)合格证书；
(4) Certificate of qualification;
(五)饲育单位负责人签名。
(5) Signature of the person in charge of the breeding unit.
无上述资料的实验动物不得应用。
Laboratory animals without the above data shall not be used.
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。
The transportation of laboratory animals shall be handled by designated personnel. The transport tools for laboratory animals shall be safe and reliable. Different breeds, strains, or grades of laboratory animals shall not be mixed and transported.
实验动物的进口与出口管理
Import and Export Management of Laboratory Animals
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。
For laboratory animals imported from abroad as original stock, data such as the name of the strain and substrain signed by the person in charge of the breeding unit, as well as genetic and microbiological status, shall be attached.
无上述资料的实验动物不得进口和应用。
Laboratory animals without the above data shall not be imported or used.
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。
For the export of laboratory animals developed from wild animal species under national key protection, an export license must be obtained in accordance with the relevant national regulations before going through the export procedures.
进口、出口实验动物的检疫工作，按照《中华人民共和国进出境动植物检疫法》的规定办理。
The quarantine of imported and exported laboratory animals shall be handled in accordance with the provisions of the Law of the People's Republic of China on the Quarantine of Entry and Exit Animals and Plants.
从事实验动物工作的人员
Personnel Engaged in Laboratory Animal Work
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。
Laboratory animal work units shall, as needed, equip scientific and technical personnel and breeding personnel who have received professional training. All types of personnel shall abide by the various systems of laboratory animal breeding management and be familiar with and master the operating procedures.
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。
Laboratory animal work units must regularly organize physical examinations for personnel who directly contact laboratory animals. Personnel who suffer from infectious diseases and are unsuitable for the work they are doing shall be transferred to other jobs in a timely manner.
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。
Personnel engaged in laboratory animal work must care for laboratory animals and shall not tease or abuse them.
奖励与处罚
Rewards and Penalties
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。
Units or individuals that have been engaged in laboratory animal breeding management for a long time and have achieved remarkable results shall be commended or rewarded by the department managing laboratory animal work.
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。
For units that violate the provisions of these regulations, the department managing laboratory animal work shall, depending on the severity of the circumstances, impose administrative penalties such as warnings, orders to make improvements within a time limit, or orders to close down.
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。
Staff members who violate the provisions of these Regulations shall be given administrative sanctions by their units according to the seriousness of the case and in accordance with relevant state regulations.
附则
Supplementary Provisions
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。
The people's governments of provinces, autonomous regions, and municipalities directly under the Central Government, as well as the relevant departments of the State Council, may formulate implementation measures based on these Regulations and in light of specific local conditions.
军队系统的实验动物管理工作参照本条例执行。
The management of laboratory animals in the military system shall be implemented with reference to these Regulations.
本条例由国家科学技术委员会负责解释。
These Regulations shall be interpreted by the State Science and Technology Commission.
本条例自发布之日起施行。
These Regulations shall come into force on the date of promulgation.