Zhejiang laboratory animal management
(August 17, 2009, Zhejiang Province people's Government promulgated as of October 1, 2009, order No. 263) Chapter I General provisions
First in order to standardize the laboratory animal management, ensuring the quality of laboratory animals and animal experiments, maintain public health and safety, meet the needs of scientific research and economic and social development, in accordance with the relevant laws and regulations, combined with the facts of the province, these measures are formulated.
Article experimental animals in these measures refers to artificial feeding, breeding, microbes and parasites carried by its controls, clear clear genetic background or origin, for scientific research, teaching, testing and other scientific experiments in animals. Article experimental animals within the administrative area of the province of manufacture, use, supervision and management, application of this approach.
Otherwise provided by laws and regulations, from its provisions.
Animal production, including animal conservation, breeding, feeding, supply, management and other activities.
The use of experimental animals, including scientific research, teaching, testing and experimental animals as raw material or a carrier of production and other activities.
Fourth animal work should follow the overall planning, rational division of labor, market, resources sharing principle. Article fifth province Department of science and Technology Administration (hereinafter referred to as the provincial science and Technology Department) supervisor provincial laboratory animals.
Work commissioned by the provincial science and Technology Department laboratory animal management office is responsible for the province.
City, County (city, district) shall assist in the administration of the Department of science and technology management of experimental animals.
Sixth people's Governments above the county level health, education, quality and technical supervision, food and drug administration, environmental protection, agriculture, forestry, industrial and commercial departments, shall, within their respective mandates to do laboratory animal management.
Article seventh encourages and supports animal research, technology development and knowledge in laboratory animal science, universal.
Chapter II administration of production and use Eighth in laboratory animal production of units and individuals shall obtain the laboratory animal production license.
Apply for laboratory animal production license shall meet the following conditions:
(A) animal production environment, facilities and equipment to meet the national standards for laboratory animals of different grades, with guaranteed quality of laboratory animal testing methods;
(B) animal feed, litter, cages, drinking water in line with national standards and related requirements;
(C) ensure the quality of animals and production needs of professionals;
(D) have a sound and effective quality management system and the corresponding standard operating procedures;
(E) seed sources in laboratory animals national animal conservation center or State-approved conservation units, provenance;
(F) the production quality of animals in accordance with national standards. Nineth apply for laboratory animal production license for units and individuals shall make application to the provincial science and Technology Department.
Provincial Science and Technology Department shall review within 10 business days from the date of acceptance of the application is completed, in line with article eighth of this approach (a) through (d) conditions of provision, notify its pilot; do not meet the conditions, and shall inform the applicant in writing. After the end of trial production of experimental animals, production units and individuals should apply for acceptance to the provincial science and Technology Department.
Provincial Science and Technology Department within 10 working days from the date of receipt of the application to organize for inspection meets the article eighth paragraph (v) and (vi) the conditions prescribed, make the decision to grant permission; does not meet the conditions, and shall inform the applicant in writing. Article tenth of laboratory animal use units and individuals shall obtain the laboratory animal use permits.
Apply for an experimental animal use permit shall meet the following conditions:
(A) the laboratory animal environment, facilities and equipment to meet the national standards for laboratory animals of different grades;
(B) animal feed, litter, cages, drinking water in line with national standards and related requirements;
(C) professional training of qualified laboratory animal breeding and animal experimenter;
(D) sound management system and the corresponding standard operating procedures. 11th apply for laboratory animals using license units and individuals shall make application to the provincial science and Technology Department.
Provincial Science and Technology Department shall, within 20 working days from the date of acceptance of the application, in conjunction with relevant departments to review, make a decision whether or not to grant permission, and shall inform the applicant. 12th laboratory animal production permits, use permits are valid for five years. Needs to extend validity period shall be 60 days before the expiry of the validity period, make application to the provincial science and Technology Department.
Provincial Science and Technology Department in accordance with the procedure as provided herein.
13th engaged in animal conservation, breeding units and individuals should use domestic and internationally-recognized species, strains and breeding methods.
To complement the provenance, the development of new experimental animal species or for scientific research is captured, the introduction of wild animals, shall, in accordance with the relevant provisions of laws and regulations on wildlife protection and approval procedures. 14th animal transport should be done by the person in charge.
Transport of laboratory animals and cages shall conform to the transported laboratory animal microbiology and environmental quality control standards.
Different species, strain, sex, and level of animal shipment shall not be mixed in the same cage.
Article 15th animal units and individuals shall, depending on the objective, meet the standards of the corresponding experimental animal and laboratory facilities and equipment and feed, cages and other related products; experimental animals should be derived from the use of experimental animals in the production license of units and individuals, along with quality certificates.
16th research involving animal subjects reporting, scientific acceptance, verification and experiment of carrier animals as raw materials or products, should the use of experimental animals and corresponding levels of animal experiment facility, as a basic condition of equipment.
17th article not made experiment animal production license, and using license of units and personal engaged in experiment animal production, and using of, or has made experiment animal production license, and using license of units and personal not according to license conditions, and range and requirements engaged in experiment animal production, and using of, its made of animal experiment results invalid, research subject not project, research not acceptance, and awards, production of products shall not sold, and using.
18th import and export administration of laboratory animal in accordance with the relevant provisions of the State.
Chapter III quality and quarantine management
19th laboratory animals in accordance with standard practices classified administration.
Quality monitoring the implementation of national standards of laboratory animal; States have not yet developed standards, the implementation of industry standards; national, industry had not yet established standards, implementation of local standards. 20th production units and individuals engaged in experimental animals should be based on genetics, microbiology, parasitology, nutrition and production environment, facilities and equipment, such as standards, quality testing of the experimental animals on a regular basis.
The operation and testing data should be complete and accurate records.
21st engaged in laboratory animals in the production of units and individuals when the supply or sale of laboratory animals, experimental production certificate shall produce and provide quality certificates.
Quality certificate shall indicate the name of the animal, specification, grade, quantity, quality, purchase company name, sale date, license number; provided, signed by the head of unit and seal; individuals, signed and sealed by the individual.
22nd in the quality of animals and related environmental facility inspection of inspection bodies shall be subject to the conditions of quality and technical supervision departments measurement certification qualified.
Testing institution should strictly enforce the standards, methods and procedures, test reports issued by the law.
Article 23rd engaged in animal production, the use of units and individuals shall be in accordance with the relevant provisions of the State and the special requirements of laboratory animals, animal epidemic prevention work.
24th legally captured wildlife as experimental animals shall be subject to capture the supervising agencies for animal health quarantine and before entering the animal feed, further isolated for observation.
Livestock and poultry as experimental animals shall be subject to output the supervising agencies for animal health quarantine and before entering the animal feed, further isolated for observation. 25th engaged in laboratory animal production units and individuals, the use of experimental animals infected, suspected of infected or contaminated with zoonotic diseases, shall, in accordance with provisions of laws and regulations on animal epidemic prevention, immediately to the local veterinary authorities, the animal health supervision agency, the Administrative Department of public health and science and technology sector reports and take control measures such as quarantine to prevent the spread of the epidemic.
Major animal epidemic, should be in accordance with the relevant provisions of the State and province, immediately start the appropriate contingency plans.
The fourth chapter biosecurity and animal welfare
26th animal production, use units and individuals shall be in accordance with State regulations on Biosafety management, establish and improve the safety management system, and take effective measures, infection prevention and control laboratory, prevent likely to endanger human health, public safety and loss of ecological safety of experimental animals and pathogens leaks.
Pathogen infection, exposure to chemicals and radioactive animal experiments should be conducted within the laboratory facilities and equipment to meet safety standards, and follow the bio-safety level and other relevant provisions of the categories. Laboratory animal corpses and waste shall be subject to harmless treatment and prevent environmental pollution.
Not the animal into the consumer market.
27th experimental animal genetic modification, genetic engineering safety management in accordance with their relevant provisions. 28th engaged in animal production, use units and individuals should be kind to animals, animal welfare, not mocked, abused animals; in accordance with scientific, rational and humane requirements, try to reduce the amount of laboratory animal use, reduce animal suffering by disposal.
Encourage research and use of alternatives to animal experiments.
Animal experiments involving specific ethical issues, should be implemented in accordance with the relevant provisions of the State.
The fifth chapter in experimental animal work units and personnel
29th engaged in experimental animal work units should strengthen management of experimental animals; the establishment of the experimental animal control agencies responsible for animal's daily management, project management and the ethical review of animal experiments.
30th staff members engaged in experimental animals should be in accordance with the relevant provisions of the State examinations and certificates.
Experimental animal work units should strengthen staff training and continuing education, improving the business skills of the staff.
Units engaged in experimental animals should be based on professional and technical personnel of job characteristics and professional, timely and professional staff to participate in relevant professional title appraisal, promotion activities, organizing participation of skilled workers in technical rank examination.
31st engaged in experimental animal work units shall take protective measures, ensure the health and safety of staff; staff members is in no condition to engage in experimental animals, should adjust its work.
Supervision and administration of the sixth chapter
Article 32nd province sci-tech departments shall establish and improve supervision and inspection system, to strengthen the production and use of experimental animals and personal supervision and inspection of the production, use, inspection and processing of the results shall be recorded and published. Article 33rd provincial science and Technology Department when conducting supervision and inspection, right to enter into the inspected unit and individual production, site investigation, collecting samples, check out copies of relevant information.
Inspected unit and individual shall cooperate, and may not refuse or obstruct.
Article 34th provincial scientific and technological departments should establish and improve the reporting system, published reports, reception, verification of public reporting on illegal production, the use of experimental animals, should be dealt with promptly according to law.
35th provincial science and Technology Department shall establish a sound credit management system, announced the license of laboratory animal production, use information about the units and individuals, public inquiries and surveillance.
36th provincial health, education, agriculture, forestry, food and drug regulation and other relevant departments shall assist the provincial science and Technology Department of the industry (System) the guidance and supervision of the management of experimental animals and animal experiments.
The seventh chapter legal liability
37th acts in violation of these rules, laws and regulations on administrative penalties from its provisions.
38th experimental animals without production permits, use permits, engaged in the production and use of experimental animals, by the provincial science and Technology Department be ordered to desist from the illegal act, be shut down, and a fine of less than 20,000 yuan and 50,000 yuan.
39th obtained the animal production unit and individual permits, use permits, is not in accordance with permit conditions, scope and requirements in production and use of experimental animals, ordered to rectify by the provincial science and Technology Department, given a warning and a fine of less than 2000 Yuan and 20,000 yuan in serious cases, the fines of between 50,000 yuan and 20,000 yuan; it refuses to be shut down.
40th forge, alter, resell, lease, lend or in any other form of illegal transfer of laboratory animal production permits, use permits, collected by provincial science and technology department licenses, and a fine of less than 20,000 yuan and 50,000 yuan; breach of security regulations, the public security organs shall be investigated and prosecuted.
41st article violates this article 14th, 20th, 21st article, by the provincial science and Technology Department ordered corrective action and give a warning, and can be used for animal production, units and individuals of less than 2000 Yuan and 20,000 yuan fine.
42nd disobey article 26th, causing serious consequences, by their work units or by the competent departments on the main principals, managers directly responsible and other persons directly responsible, be removed from Office or dismissal in accordance with law.
Article 43rd Provincial Science and Technology Department and other departments concerned have one of the following acts, the authority shall order rectification are serious, the directly responsible person in charge and other direct liable persons shall be given administrative sanctions:
(A) an administrative license;
(B) does not perform its duty of supervision and inspection;
(C) the unlawful imposition of administrative penalty;
(D) other acts of dereliction of duty, abuse of authority or engages in.
44th acts in violation of these rules constitutes a crime, criminal responsibility shall be investigated according to law.
The eighth chapter by-laws 45th article of the rules take effect on October 1, 2009.