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《实验动物管理条例》(English)


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实验动物管理条例(英文)

 

    【名称】  REGULATIONS FOR  THE  ADMINISTRATION  OF  AFFAIRS  CONCERNING  EX-PERIMENTAL ANIMALS

    【题注】 

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&n