Pathogen Laboratory Bio-Safety Environmental Management Approach

Original Language Title: 病原微生物实验室生物安全环境管理办法

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(March 8, 2006, the State environmental protection administration announced as of May 1, 2006, 32nd) first to standardize the laboratory of pathogenic microorganism (hereinafter "Lab") bio-safety environmental management of pathogenic microbiological laboratory biosafety management under the Ordinance and the laws and administrative regulations on environmental protection, these measures are formulated.
    Second approach applies to People's Republic of China bio-safety laboratory and experimental activities in environmental management.
    Of pathogenic microorganisms in these measures refers to the person or animal pathogenic microorganisms.
    Experimental activities mentioned in these measures refers to laboratory working with pathogenic microorganisms (virus) species, sample-related activities such as research, teaching, testing and diagnosis.
    Third national laboratory for pathogenic microorganisms of biosafety level, and in accordance with the provisions of laboratory bio-safety standards, the laboratory is divided into grade I, grade II or grade III and IV.
    Level, level II laboratory may engage in highly pathogenic microbiology experimental activities.
    Fourth national environmental protection agency pollution control laboratory developed and promulgated standards, technical specifications for environmental management and environmental supervision and inspection system. Fifth State environmental protection agency to set up laboratory bio-safety Committee of experts on environmental management of pathogenic microorganism.
    Committee of Experts consists of environmental protection, pathogenic microorganisms, as well as experts in laboratory management.
    Laboratory Biosafety Committee of experts on environmental management of pathogenic microorganism's main responsibilities are: consideration of the technical specifications for laboratory standard for pollution control and environmental management, consideration of recommendations; documents relating to laboratory environmental impact assessment review, review recommendations.
    The sixth laboratory of new construction, renovation or expansion, shall, in accordance with the national environmental protection regulations, implementation of the environmental impact assessment system.
    Laboratory of environmental impact evaluation of pathogenic microorganisms should be experimental activities on the potential environmental impact analysis and prediction, and prevention and control measures.
    Article three-level and four-level building, rebuilding, expansion of laboratory or production, import-style three-level and four-level laboratory, shall prepare an environmental impact report, and in accordance with the provisions of the program reported that the State General Administration of environmental protection for approval.
    Three levels, four laboratories of the environmental impact assessment and environmental impact assessment agencies, should have grade a qualification and the corresponding evaluation scope.
    Eighth laboratory should be in accordance with the national environmental protection regulations, the approved environmental impact assessment documents and the requirements for approval by the Administrative Department of environmental protection, or pollution prevention facilities, equipment installation.
    Pollution prevention facilities, equipment must be approved by the Administrative Department of environmental protection upon the acceptance of laboratory to be put into operation or use.
    Nineth has completed and passed State-approved three-level and four-level laboratories, should be made in bio-safety laboratory certificate in 15th after completing grade table, four pathogenic Microbe Labs (see attached table), local environmental protection Administrative Department of the people's Governments at the county level. Tenth Article County Government environmental protection administrative competent sector should since received three level, and four level disease original microbial laboratory record table of day up 10th within, reported set district of city level government environmental protection administrative competent sector; set district of city level government environmental protection administrative competent sector should since received three level, and four level disease original microbial laboratory record table of day up 10th within, reported provincial government environmental protection administrative competent sector; provincial government environmental protection administrative competent sector should since received three level, and
    Table four pathogenic Microbe Labs within 10th of, reported that the State General Administration of environmental protection.
    11th laboratory establishment of the unit on the experimental activities of waste water, waste gas and hazardous wastes bear the responsibility of pollution prevention.
    Laboratories should be in accordance with the provisions of national environmental protection and pollution control of laboratory standard, technical specification of requirements for environmental management, establish and improve laboratory waste water, waste gas pollution control and hazardous waste management rules and regulations, and to set up a special (and) staff of laboratory waste water, waste gas and hazardous waste disposal in accordance with national laws, administrative regulations, and the rules for inspection, supervision and implementation.
    12th laboratory waste water, exhaust gas emitted shall, in accordance with the relevant provisions of the State environmental protection administration, and implementation of sewage discharge registration scheme.
    Lab hazardous waste, in accordance with the relevant provisions of the prevention and control of environmental pollution by hazardous waste to the local competent administrative departments of local people's Governments at or above the county level environmental protection hazardous waste types, output, flow, storage, disposal and other relevant information.
    13th laboratories produce waste, harmless treatment must be in accordance with the relevant provisions of the State; comply with the relevant national emission standards, emission.
    14th lab activity, in accordance with the relevant provisions of the State air pollution control facilities to ensure the normal operation; emissions shall not be in violation of the relevant standards or regulations. 15th lab must be in accordance with the following provisions, and the proper collection, storage and disposal of hazardous waste generated by its activities, prevention of environmental pollution: (a) hazardous waste registration system established, the registration of its hazardous waste. Registration shall contain the sources of hazardous waste, species, weight or quantity, final destination and handling, disposal method signatures and other projects.
    Registration data for at least 3 years.
    (B) collect hazardous waste produced in the lab in a timely manner, and in accordance with the categories under seepage, preventing sharp penetrating comply with relevant environmental requirements, such as special packaging and containers, and according to the requirements prescribed by the State set up the obvious hazards warning labels and instructions.
    (C) equipped in accordance with national legislation, administrative regulations and related technical specifications of hazardous waste temporary storage cabinet (box), equipment or other facilities.
    (D) in accordance with the relevant provisions of the State hazardous waste for treatment, and according to the principles of centralized disposal of time after innocuous treatment of hazardous wastes to obtain operating permits for hazardous waste disposal.
    (E) the transfer of hazardous waste, shall, in accordance with the prevention and control of environmental pollution by solid waste Act and relevant regulations of the State environmental protection administration, do the movements of hazardous waste manifest system.
    (Vi) should not be dropped, dumped, piled up hazardous wastes, hazardous wastes must not be mixed with other wastes and domestic garbage.
    (VII) national environmental laws, administrative regulations and other regulations relating to hazardous waste management requirements.
    16th laboratory experimental archives shall establish and maintain records and bio-security-related activities and facilities, equipment status, and experimental activities of waste water, waste gas and hazardous waste treatment and disposal as well as test conditions.
    17th laboratory shall develop pollution emergency plan, reported to the competent administrative departments of people's Governments at the county environmental protection, and conduct regular drills.
    Lab hazardous waste, should be in accordance with the provisions of the prevention and control of environmental pollution by hazardous wastes, developing accident prevention measures and emergency plans, and to the local people's Governments above the county level administrative Department of environmental protection records.
    The pathogenic microbiological laboratory biosafety management regulation has been put into use before the coming into force of the three laboratories, should be requested by the administrative departments of people's Governments at the county environmental protection, deadline to develop environmental emergency planning and monitoring plans, and report to the Administrative Department of environmental protection records.
    18th laboratory leaks, or spread, has caused or may cause serious environmental pollution and ecological damage, should take immediate emergency measures to inform units and residents may be compromised, and report to the Administrative Department of environmental protection and the relevant local people's Government Department, for investigation and settlement.
    Local environmental protection Administrative Department of the people's Governments shall, in accordance with the State Environmental Protection Administration reported pollution incident reporting procedures superior environmental protection Administrative Department of the people's Government. 19th environmental protection Administrative Department of the people's Governments above the county level shall on a regular basis within the jurisdiction of laboratory waste water, waste gas and hazardous waste pollution prevention to supervise and inspect. Violations are found, shall order the rectification.
    Inspection and processing of the results shall be recorded and signed by Inspector archive and feedback after the unit under inspection.
    20th environmental protection Administrative Department of the people's Government at or above the county level shall perform duties of supervision and inspection, is entitled to enter into the inspected unit and pathogenic microorganisms to leak or spread the field investigation and evidence collection, collecting samples, check out, copy the relevant information, the units under inspection shall cooperate, and may not refuse or obstruct.
    Needs into three-or four-level laboratory investigation and evidence collection, samples should be specified or entrust a specialized agency.
    Administrative Department of environmental protection laboratory should be keep confidential the technological know-how and business secrets.
    21st article violation this approach about provides, has following case one of of, by County above government environmental protection administrative competent sector ordered deadline corrected, give warning; late not corrected of, at 1000 Yuan following fine: (a) not established laboratory pollution control management of regulations, or not set designed (and) vocational personnel of; (ii) not on produced of dangerous waste for registration or not save registration information of; (three) not developed pollution emergency plans of.
    Other acts in violation of these rules, the environmental protection provisions of laws and administrative regulations on punishment and application of its provisions.
    22nd environmental protection Administrative Department shall be announced to the public in a timely manner according to the list of laboratories was punished in these measures and punished the list inform China National Accreditation Board for laboratories.

    23rd these measures shall come into force on May 1, 2006.            附件:
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                          三级、四级病原微生物实验室备案表

  备案日期:                                            备案号:
┌───────┬───────────────┬────────┬──────┐
│   单位名称   │                              │ 法定代表人姓名 │ │
├───────┼───────────────┼────────┼──────┤
│   地    址   │                              │     邮  编     │            │
├───────┼───────────────┼────────┼──────┤
│  实验室名称  │                              │  实                              验室负责人  │            │
├───────┼─────┬───┬─────┼────────┼──────┤
│   电    话   │          │ 传真 │          │     联系人     │            │
├───────┼─────┴───┴─────┼────────┼──────┤
│   主管部门   │                              │     实验室     │   □三级   │
│              │                              │    安全等级    │   □四级   │
├───────┼───────┬───────┼────────┴──────┤
│   规划部门   │              │   批准日期   │              │
│ 审批文件编号 │              │              │                              │
├───────┼───────┼───────┼───────────────┤
│   主管部门   │              │   批准日期   │                              │
│ 审批文件编号 │                              │              │                              │
├───────┼───────┼───────┼───────────────┤
│ 科技主管部门 │              │   批准日期   │                              │
│ 审批文件编号 │              │              │

├───────┼───────┼───────┼───────────────┤
│ 环保主管部门 │              │   批准日期   │                              │
│ 审批文件编号 │              │              │                              │ ├───────┼───────┴───────┴───────────────┤
│  开展的实验  │                                                              │
│ 活动内容简述 │                                                              │
├───────┼────────                                                              ───────────────────────┤
│   应提交的   │          □环境应急预案                                      │
│ 备案附件材料 │          □废水、废气和危险废物的处理设施和技术方案          │
├───────┼───────────────────────────────┤
│   实验活动   │ │
│   变更情况   │                                                              │
├───────┴───────────────────────────────┤
│                                备案 Unit warranty │ │ declared in this application form and the attached information are true and valid.                                          If false, I willing to undertake the │ │ legal responsibility and accept any consequences resulting therefrom.                          │
│单位(盖章)                                                                  │
│法定代表人(签字)                                                            │
│实验室负责人(签字)                          日期:
                                                                                              │
└───────────────────────────────────────┘
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