REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EX-PERIMENTAL ANIMALS

REGULATIONS FOR THE ADMINISTRATION OF AFFAIRS CONCERNING EX-PERIMENTAL ANIMALS 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.