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Pathogenic Microbiological Laboratory Biosafety Management Regulation

Original Language Title: 病原微生物实验室生物安全管理条例

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(November 5, 2004 the 69th meeting of the State Council on November 12, 2004, People's Republic of China promulgated by Decree No. 424 release come into force on the date of promulgation) Chapter I General provisions article in order to strengthen the pathogenic Microbiology Laboratory (hereinafter referred to as lab) biosafety management, protection of laboratory workers and the public's health, this Ordinance is enacted.
Article of People's Republic of China laboratory and experimental activities in biosafety management, application of this regulation.
Under this Ordinance the ostensible reason for pathogenic microorganisms, refers to the ability to make a person or animal pathogenic microorganisms.
    Experimental activities mentioned in these regulations refers to laboratory and pathogenic microorganisms (virus) strains, samples of related activities such as research, teaching, testing and diagnosis.
Third State health departments and health of laboratory and its activities related to the bio-safety supervision.
The State Council departments and animal laboratories and experimental activities relating to biological safety supervision work.
Other relevant departments under the State Council, within the scope of their respective duties responsible for biological safety management of laboratory and experimental activities.
    Local people's Governments at or above the county level and their departments in laboratory and experimental activities within the scope of their respective duties and responsibilities of the bio-safety management.
    Fourth national classification management of pathogenic microbes, classification management of laboratories. Fifth national unified laboratory bio-safety standards.
    Laboratories shall conform to the national standards and requirements.
    Article sixth laboratory units and the competent authorities responsible for the establishment of the laboratory management of the daily activities, building a sound safety management system, checking, maintenance of facilities, equipment, control laboratory duties.
    Chapter II of pathogenic micro-organisms classified and managed seventh State according to pathogenic microorganisms infectious, the degree of harm to individuals or groups after infection, pathogenic microorganisms are divided into four classes: first class of pathogenic microorganisms, refers to microbes can cause very serious human or animal disease, and China has not yet discovered or had announced the Elimination of microorganisms.
    Second type of pathogenic microorganisms, refers to the ability to cause serious human or animal disease, more likely to directly or indirectly from person to person, animal and human, animal and animal-borne microorganisms.
    Third type of pathogenic microorganisms, refers to the ability to cause disease in humans or animals, but normally not pose a serious hazard to people, animals or the environment, transmission limited lab after infections rarely cause severe disease, with effective treatment and preventive measures for micro-organisms.
    Fourth category of pathogenic microorganisms, refers to usually do not cause human or animal disease organisms.
    The first type, the second type of pathogenic microorganisms are collectively referred to as highly pathogenic microorganisms.
    Eighth list of Earth-borne pathogenic microorganisms by the Department of health under the State Council departments concerned under the State Council formulated, adjusted and made public; directory of animal-borne pathogenic microorganisms by the veterinary Administrative Department under the State Council departments concerned under the State Council formulated, adjusted and made public.
Nineth article collection disease original microbial sample should has following conditions: (a) has and collection disease original microbial sample by need of biological security protection level phase adapted of equipment; (ii) has master related expertise and operation skills of staff; (three) has effective of prevent disease original microbial diffusion and infection of measures; (four) has guarantee disease original microbial sample quality of technology method and means.
    Staff of highly pathogenic microbial samples collected in the collection process should prevent pathogen proliferation and infection, and the sample source, acquisition process and methods, and detailed records.
    Article tenth transport highly pathogenic microorganism (virus) strains or samples through land transport; no land access, must be transported by sea, by waterway transport; or in emergency situations need to be highly pathogenic microorganism (virus) strains or samples sent abroad, through civil air transport.
11th article transport high pathogenic STD original microbial bacteria (HIV) species or sample, should has following conditions: (a) transport purpose, and high pathogenic STD original microbial of uses and received units meet state health competent sector or veterinary competent sector of provides; (ii) high pathogenic STD original microbial bacteria (HIV) species or sample of container should sealed, container or packaging material also should meet waterproof, and anti-damaged, and anti-outside relief, and resistance high (low) temperature, and resistance high pressure of requirements;
(C) on the container or packaging material should be printed with State health authorities or veterinary authority provides for identification of biological risk, warning phrases and prompt language. Transport highly pathogenic microorganism (virus) strains or samples should be by the people's Governments above provincial level health departments or approved by veterinary authorities.
Transport within the administrative area of the provinces, autonomous regions and municipalities, provinces, autonomous regions and municipalities responsible for health or veterinary authorities approved across provinces, autonomous regions and municipalities directly under the transport or shipped out of the country, by the departure of the province, autonomous region or municipality responsible for health or veterinary authorities after the first trial, respectively responsible for health or veterinary authorities approved by the State Council.
In inspection and quarantine of entry-exit inspection and quarantine agencies need to transporting samples of pathogenic micro-organisms in the process, approved by the entry-exit inspection and quarantine Department under the State Council, and to inform the competent health authorities or veterinary authority.
By civil air transport highly pathogenic microorganism (virus) strains or samples, in accordance with the second and third paragraphs of this article require prior approval, should also be approved by the competent civil aviation authority under the State Council.
    Competent departments shall be submitted by the applicant with regard to the transport of high-risk pathogens microorganism (virus) kind of application materials or samples to review and to comply with the conditions prescribed in the first paragraph of this article, the prison shall approve.
12th transport highly pathogenic microorganism (virus) species or sample shall consist of not less than 2 persons special escort and take appropriate protective measures.
    Units or individuals concerned or by the public power (steam) and urban railway transport pathogenic microorganism (virus) strains or samples.
13th through rail, road transport, civil aviation and other modes of public transport highly pathogenic microorganisms (virus) strains or samples, the carrier should transport the approval documents specified in this section 11th.
    Should jointly take measures with escort carrier units, ensure that the transportation of highly pathogenic microorganisms (virus) strains or samples safety, prevention of theft, robbery, loss, leakage events.
14th health authorities under the State Council or designated by the veterinary authorities of bacterial (viral) kind of collections or laboratory (hereinafter referred to as preservation Agency), centralized storage of pathogenic microorganisms (virus) species and sample tasks.
Preservation agencies shall, in accordance with provisions of the health authorities or the veterinary administrative departments under the State Council, and storage laboratory to microbial pathogens (HIV) strains and samples, and to provide laboratory pathogenic microorganism (virus) species and sample. Preservation institutions should establish strict safety rules for storage make pathogenic microorganism (virus) species and sample access and storage of records, file system and specify the person in charge.
Highly pathogenic microorganism (virus) types and storage of samples shall be individually set or counter.
Preservation institution-storage, microbial pathogens (HIV) strains and samples shall not charge any fee, to be funded by the financial budget of the unit to protect it.
    Preserved bodies of management by the Department of health under the State Council in conjunction with the veterinary authorities.
    15th preserved body shall use laboratories in accordance with the provisions of this Ordinance made highly pathogenic Microbe of experimental activity approval documents, provide the laboratory with highly pathogenic microorganisms (virus) strains and samples, and register.
16th laboratory in experiments after the event, shall, in accordance with provisions of the health authorities or the veterinary administrative departments under the State Council, promptly of any pathogenic bacteria (HIV) strains and samples destroyed or sent to the collection agency for safekeeping.
    Preservation agencies transmitted by the receiving laboratory pathogenic bacteria (HIV) strains and samples, shall be registered, and receive a proof issued. 17th article high pathogenic STD original microbial bacteria (HIV) species or sample in transport, and store in the was stolen, and was Rob, and lost, and leak of, carrier units, and escort people, and preserved institutions should take necessary of control measures, and in 2 hours within respectively to carrier units of competent sector, and escort people where units and preserved institutions of competent sector report, while to location of County Government health competent sector or veterinary competent sector report, occurred was stolen, and was Rob, and lost of, also should to police organ report
; Received a report of the health authorities or veterinary authorities shall report within 2 hours of the people's Governments at the corresponding level, and at the higher level people's Government responsible for health or veterinary authorities and the State Council Department in charge of health or veterinary authorities reported. People's Governments at the county level shall, within 2 hours after receipt of the report to the municipal district people's Government or higher level Governments report district of the municipal people's Government shall, within 2 hours after receiving the report of provinces, autonomous regions and municipalities reported.
People's Governments of provinces, autonomous regions and municipalities should be within 1 hour after receiving the report, report to the competent health authorities or veterinary authority.
    No units or individuals found highly pathogenic microorganisms (virus) species or specimen containers or packaging materials, shall promptly report to nearby health authorities or the veterinary administrative departments; received a report of the health authorities or veterinary authorities shall organize investigation and verification, and to take the necessary control measures.
    Chapter III laboratory establishment and management article 18th National Laboratory for pathogenic microorganisms of biosafety level, and in accordance with the provisions of laboratory bio-safety standards, laboratories into the first tier, two-tier, three-tier, four-stage. 19th new construction, renovation or expansion of three-level and four-level laboratory or production, import mobile three-tier, four laboratories shall comply with the following provisions: (a) in line with the national bio-safety laboratory system and shall carry out the examination and approval procedures, (ii) approval by the State Council in charge of science, (iii) meet the national architectural and technical code for biosafety laboratories;

(D) in accordance with the People's Republic of China environmental impact assessment environmental impact assessment provisions of the Act and approved by the competent Department of environmental protection to review and (v) bio-safety level corresponding to its proposed activities. Mentioned in the preceding paragraph the national bio-safety laboratory system, developed by the investment Department under the State Council in conjunction with the relevant departments of the State Council.
    Planning should follow the national bio-safety laboratory system total amount control principle, reasonable layout, resource sharing, and should hold hearings or feasibility study meeting, listen to the public health, environmental protection, investment management and lab management, expert advice.
20th three-level and four-level laboratory should be through national accreditation. Authorized institution determined by the certification and accreditation Administration Department under the State Council shall, in accordance with the laboratory bio-safety standards, as well as the relevant provisions of this Ordinance, the three-level and four-level laboratory accreditation; lab approved by the appropriate level of biosafety laboratory certificate issued.
    The certificate is valid for 5 years. Article 21st level, second level laboratory may engage in highly pathogenic microbiology experimental activities.
Three level, and four level laboratory engaged in high pathogenic STD original microbial experiment activities, should has following conditions: (a) experiment purpose and intends engaged in of experiment activities meet state health competent sector or veterinary competent sector of provides; (ii) through laboratory national recognized; (three) has and intends engaged in of experiment activities phase adapted of staff; (four) engineering quality by building competent sector law detection acceptance qualified.
    State Department responsible for health or veterinary authorities in accordance with their respective functions on three levels, four laboratory review meets the above-mentioned conditions; conditions, issue of certificate of high pathogenic microbiology experimental activities. 22nd article engaged in highly pathogenic microbiology experimental activities certified laboratories, need to engage in some sort of high pathogenic microorganisms or suspected highly pathogenic microbial activities, shall be in accordance with State Council health authority or veterinary authorities reported to people's Governments above provincial level health departments or approved by veterinary authorities.
Experimental results and their work should be reported to the original authority.
    Lab report or receive research projects associated with highly pathogenic microorganisms shall conform to research and bio-safety requirements, with appropriate biosafety level, and agreed by the competent health authorities or veterinary authority.
Article 23rd entry-exit inspection and quarantine institutions, medical institutions, animal epidemic prevention agencies while working in a laboratory for detection, diagnosis, found that highly pathogenic microorganisms or related to highly pathogenic micro-organisms, need to be further engaged in this type of experiment activities related to highly pathogenic microorganisms shall, in accordance with the provisions of this Ordinance upon approval, and obtained the relevant qualification certificates in the lab.
    Laboratory specializing in the detection, diagnosis, shall be strictly in accordance with State Council health authority or veterinary regulations of the competent Department, establish and perfect rules and regulations to ensure laboratory biosafety.
24th people's Governments above provincial level health authorities or veterinary authorities shall receive needed to engage in highly pathogenic Microbe activity applications within 15th of whether to approve the decision.
On immigration test quarantine institutions to test quarantine work of emergency need, application in laboratory on high pathogenic STD original microbial or suspected high pathogenic STD original microbial carried out further experiment activities of, provincial above government health competent sector or veterinary competent sector should since received application of Shi up 2 hours within made whether approved of decided; 2 hours within not made decided of, laboratory can engaged in corresponding of experiment activities.
    Province-above people's Government responsible for health or veterinary authorities shall provide to the applicant by telegram, telex, fax, electronic data interchange and e-mail applications with ease. 25th new construction, reconstruction or expansion of a-grade, second-grade laboratory, shall apply to municipal people's Government district health authorities or veterinary departments.
    Municipal people's Government of the district health authorities or veterinary authorities shall record summary report after a year of provinces, autonomous regions and municipalities responsible for health or veterinary authorities.
    26th State health authorities and veterinary authorities shall regularly summarize and inform each other of the laboratory number and laboratory set up, distribution of experimental activities and access to highly pathogenic microorganisms qualification levels, four levels of laboratory and related activities. 27th has been built through national accreditation levels, four laboratory shall be filed with the county environmental protection authorities of the location of the record.
    The competent Department of environmental protection in accordance with the provisions of laws and administrative regulations on emissions in the laboratory waste water, waste gas and waste disposal to supervise and inspect.
28th in China has not been found or already announced the Elimination of pathogenic microorganisms, no unit or individual may engage in related experimental activities without approval.
    In order to prevent and control infectious diseases, need to be engaged in experimental activities related to pathogenic microorganisms referred to in the preceding paragraph shall be approved by the competent health authorities or veterinary authority and approval designated by specialized laboratories.
    29th laboratory using new technologies, new ways of doing experimental activities related to highly pathogenic microorganisms shall conform to prevent highly pathogenic microorganism proliferation, ensure the physical security requirements of the bio-safety and operations, and pathogenic Microbe labs by the State Committee of experts on Biosafety demonstration has been demonstrated viable, may be used.
    Article 30th needs highly pathogenic microorganisms in the animal experiments, animal laboratory bio-safety standards should be in line with the three-level laboratories.
31st laboratory biosafety management unit is responsible for the establishment of the laboratory.
Laboratory establishment of the unit in accordance with the provisions of this Ordinance to make scientific and strict management system and periodically check on the implementation of the bio-safety requirements, periodic laboratory facilities, equipment, materials inspection, maintenance and updates, to ensure their compliance with national standards.
    Laboratory establishment of the unit and its departments should strengthen the management of daily activities.
Article 32nd heads of laboratories for laboratory bio-safety in the first person. Laboratory experimental activities shall strictly comply with the relevant national standards and technical specifications for laboratory, operating rules.
    Lab Manager should designate inspection laboratory specifications and procedures implementation. Article 33rd highly pathogenic Microbe Lab of experimental activities the establishment of units shall establish a sound security system, security measures taken to prevent highly pathogenic microorganisms are theft, robbery, loss, leakage, ensure the safety of laboratory and its pathogenic microorganisms.
Laboratory in highly pathogenic microorganisms are theft, robbery, loss, leakage, laboratory establishment of the units should be carried out in accordance with the provisions of this section 17th report.
    Highly pathogenic Microbe Lab of experimental activities shall be filed with the local public security organ for the record, and accept supervision by the public security organs relating to laboratory safety and Security Guide. Article 34th laboratory or laboratory units should be the establishment of annual training of staff to ensure their mastering Labs, technical specifications, procedures, biological safety protection of knowledge and practical skills, and evaluation.
Staff qualified through examination and induction.
    Highly pathogenic Microbe Lab of experimental activities, should be rotated every six months training, examination and laboratory staff running to the provinces, autonomous regions and municipalities responsible for health or veterinary authorities reported.
Article 35th experimental activities related to highly pathogenic microorganisms should be 2 or more staff. Into highly pathogenic Microbe Lab of experimental activities of staff members or other persons, shall be approved by the head of laboratory. Laboratories should provide protective equipment which meets protection requirements and other occupational protection measures.
    Highly pathogenic Microbe Lab of experimental activities, should also be for health monitoring of laboratory staff, its annual physical examination, and establish health files, if necessary, of the laboratory personnel should be vaccinated.
    Article 36th in the same laboratory by the same independent within the security zone, but at the same time engaged in a kind of experimental activities related to highly pathogenic microorganisms. 37th laboratories shall establish archives and records laboratory usage and safety oversight.
    Laboratories engaged in highly pathogenic Microbe Lab of experimental archive retention period, shall not be less than 20 years.
    Article 38th laboratory shall, in accordance with the environmental protection-related laws, administrative regulations and the relevant departments under the State Council, to dispose of the waste water, waste gas, and waste, and developing appropriate environmental protection measures to prevent environmental pollution.
    39th third-level, four laboratories in the apparent position of State health authorities and Veterinary Department of biological risk identification and laboratory bio-safety level flags.
    40th engaged in highly pathogenic Microbe lab laboratories laboratory emergency response plan should be developed, and the laboratory is located of the province, autonomous region and municipalities responsible for health or veterinary departments. 41st State health authorities and veterinary authorities in conjunction with the relevant departments, etiology, immunology, laboratory medicine, epidemiology, preventive veterinary medicine, environmental protection and laboratory management specialist, pathogens of National Microbiology Laboratory bio-safety committees of experts. The Commission engaged in highly pathogenic Microbe Lab of experimental activities of establishment and operation of bio-safety assessment and technical advice, feasibility studies.

People's Governments of provinces, autonomous regions and municipalities directly under the Health Department and veterinary administrative departments of people's Governments of relevant departments, etiology, immunology, laboratory medicine, epidemiology, preventive veterinary medicine, environmental protection and laboratory management experts, composed of pathogen laboratory bio-safety committees of experts in the region.
    The establishment and operation of the Technical Advisory Committee in the territory laboratory work.
Fourth chapter lab infection in control 42nd lab set up unit shall assign special agency or laboratory infection control staff regularly inspect the Laboratory biosecurity, microbial pathogens (virus) species and sample preservation and use, safe operation, laboratory emissions of wastewater and waste gases and other waste disposal rules and regulations implementation.
    Bodies or persons in charge of laboratory infection control should be associated with pathogenic micro-organisms in the laboratory of infectious diseases prevention and control, and periodic surveys, understanding the health of lab workers. Article 43rd lab worker appears with the laboratories engaged in experimental activities related to highly pathogenic microorganisms infections related to the clinical symptoms or signs when laboratory heads to bodies or persons in charge of laboratory infection control report, while special treatment in a timely manner; Lab staff recently come into contact with pathogenic microorganisms should be kind and risk disclosure treatment of medical institutions.
    Reception of medical institutions should be timely treatment; does not have the conditions of treatment, infected lab workers should be in accordance with the provisions of condition of referral to appropriate treatment of infectious diseases medical institutions; treatment conditions of medical institutions should be dealt in the treatment of infectious diseases, may not refuse medical treatment.
    44th when highly pathogenic microorganisms leak laboratory, laboratory personnel should immediately take control measures and prevent the spread of highly pathogenic microbes, and in parallel to the bodies or persons in charge of laboratory infection control report. 45th article is responsible for laboratory infection control work of institutions or personnel received this Ordinance 43rd article, and 44th article provides of report Hou, should immediately started laboratory infection emergency disposal plans, and organization personnel on the laboratory biological security status, situation for survey; confirmed occurred laboratory infection or high pathogenic STD original microbial leak of, should in accordance with this Ordinance 17th article of provides for report, and while take control measures, on about personnel for medical observation or isolation treatment, closed laboratory,
    To prevent proliferation.
46th article health competent sector or veterinary competent sector received on laboratory occurred staff infection accident or disease original microbial leak event of report, or found laboratory engaged in disease original microbial related experiment activities caused laboratory infection accident of, should immediately organization disease prevention control institutions, and animal epidemic prevention supervision institutions and medical institutions and other about institutions law take following prevention, and control measures: (a) closed was disease original microbial pollution of laboratory or may caused disease original microbial diffusion of places;
    (B) carrying out epidemiological investigations; (c) to isolate the patient treatment, medical checks on people and (iv) close contacts were placed under medical observation, (v) on-site sterilization; (vi) infected or suspected infected animal quarantine, culling and other measures taken, (VII) other preventive and control measures to be taken. 47th medical or veterinary medical institution and its medical staff perform their duties found caused by laboratory infection associated with highly pathogenic microorganisms infectious disease patients or suspected patients of infectious diseases or suffer from disease, suspected to be suffering from diseases of animals, diagnosis and treatment of medical or veterinary medical institutions shall, within 2 hours of reports the location of the County Health Department or the veterinary authority ; Received a report of the health authorities or veterinary authorities shall inform the laboratory is located within 2 hours of the County Health Department or veterinary authorities.
    Receive informed health authorities or veterinary authorities shall, in accordance with the provisions of section 46th to take preventive and control measures.
    48th proliferation of pathogenic microorganisms, are likely to cause outbreaks of infectious diseases, epidemics, the people's Government above the county level responsible for health or veterinary authorities shall, in accordance with relevant laws, administrative regulations and emergency preparedness laboratory infection. Fifth chapter supervision management 49th article County above place Government health competent sector, and veterinary competent sector in accordance with their Division, perform following duties: (a) on disease original microbial bacteria (HIV) species, and sample of collection, and transport, and store for supervision check; (ii) on engaged in high pathogenic STD original microbial related experiment activities of laboratory whether meet this Ordinance provides of conditions for supervision check; (three) on laboratory or laboratory of established units training, and
His staff, as well as induction officer conducting supervision and inspection, (iv) to the laboratory in accordance with the relevant national standards, technical specifications and procedures involved in pathogen-related experimental activities carried out supervision and inspection.
    Local people's Governments at or above the county level departments in charge of health, veterinary authorities should primarily through the examination laboratory implementation of relevant State laws and administrative regulations as well as standards and requirements of the records, files, reports, carry out regulatory duties. 50th health authorities above the county level people's Governments, veterinary authorities, the Environmental Protection Department in the performance of duties of supervision and inspection, right to enter into the inspected unit and pathogenic microorganisms leakage or proliferation of on-site investigation, collecting samples, check out copies of relevant information. Need access to highly pathogenic Microbe lab laboratory investigation, collecting samples, should be specified or entrust a specialized agency.
    The units under inspection shall cooperate, and may not refuse or obstruct.
    51st state certification and accreditation supervision and management departments in accordance with the People's Republic of China certification and Accreditation regulations provide for supervision and inspection of laboratory accreditation activities.
    52nd health authorities, the veterinary authorities, the Environmental Protection Department shall perform their duties pursuant to statutory powers and procedures, be impartial, fair, open, civilized and efficient.
53rd health authorities, the veterinary authorities, departments in charge of environmental protection law enforcement officer in the execution of their duties, there should be 2 or more law enforcement personnel, produce their documents, and fill it in accordance with the provisions of a law enforcement instrument. Spot check after check, the notes, instruments such as sampling records, should be inspected by law enforcement officers and others, is the sample signatures.
    The inspected, sampled person refuses to sign the law enforcement personnel shall indicate the situation after his signature. 54th health authorities, the Veterinary Department, environmental protection Department and law enforcement personnel from performing their duties, should consciously accept the supervision of society and citizens. Citizens, legal persons and other organizations are entitled to higher level people's Governments and health authorities, the veterinary authorities, the Environmental Protection Department reported local people's Governments and their competent authorities perform their duties in accordance with the provisions of the conditions.
    Receives reports of Governments or the health authorities and the veterinary authorities, the Environmental Protection Department shall promptly investigate and deal with. 55th article superior government health competent sector, and veterinary competent sector, and environmental protection competent sector found belongs to subordinate government health competent sector, and veterinary competent sector, and environmental protection competent sector duties range within need processing of matters of, should timely told the sector processing; subordinate government health competent sector, and veterinary competent sector, and environmental protection competent sector not timely processing or not active perform this sector duties of, superior government health competent sector, and veterinary competent sector, and
    Environmental protection departments should be ordered to rectify; fails, higher people's Government departments in charge of health and veterinary authorities, the Environmental Protection Department has the right to be dealt with directly. Sixth chapter legal responsibility 56th article three level, and four level laboratory not in accordance with this Ordinance of provides made engaged in high pathogenic STD original microbial experiment activities of qualification certificate, or has made related qualification certificate but without approved engaged in a species high pathogenic STD original microbial or suspected high pathogenic STD original microbial experiment activities of, by County above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered stop about activities,
    Supervision its will for experiment activities of disease original microbial destroyed or sent preserved institutions, and give warning; caused infectious diseases spread, and popular or other serious consequences of, by laboratory of established units on main head, and directly is responsible for of competent personnel and other directly responsibility personnel, law give dismissed, and fired of disposition; has qualification certificate of, should revoked its qualification certificate; constitute crime of, law held criminal. 57th article health competent sector or veterinary competent sector violation this Ordinance of provides, granted not meet this Ordinance provides conditions of laboratory engaged in high pathogenic STD original microbial related experiment activities of, by made approved decided of health competent sector or veterinary competent sector revoked original approved decided, ordered about laboratory immediately stop about activities, and supervision its will for experiment activities of disease original microbial destroyed or sent preserved institutions, on directly is responsible for of competent personnel and other directly responsibility personnel law give administrative sanctions
Constitutes a crime, criminal responsibility shall be investigated according to law.
    Law making approval decisions caused damage to the legitimate rights and interests of the parties, approved the decision of the health authority or veterinary authorities shall bear the liability for damages. 58th article health competent sector or veterinary competent sector on meet statutory conditions of laboratory not issued engaged in high pathogenic STD original microbial experiment activities of qualification certificate, or on immigration test quarantine institutions to test quarantine work of emergency need, application in laboratory on high pathogenic STD original microbial or suspected high pathogenic STD original microbial carried out further detection activities, not in statutory term within made whether approved decided of, by its superior administrative organ or monitored organ ordered corrected, give warning Causing the spread of infectious diseases, epidemic, or other serious consequences, are directly responsible for the charge and other direct liable persons shall be given the sanction of dismissal, dismissal constitutes a crime, criminal responsibility shall be investigated according to law.

    59th article violation this Ordinance provides, in not meet corresponding biological security requirements of laboratory engaged in disease original microbial related experiment activities of, by County above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered stop about activities, supervision its will for experiment activities of disease original microbial destroyed or sent preserved institutions, and give warning; caused infectious diseases spread, and popular or other serious consequences of, by laboratory of established units on main head, and
    Managers directly responsible and other persons directly responsible for, and shall be subject to dismissal, punishment by expulsion constitutes a crime, criminal responsibility shall be investigated according to law.
60th article laboratory has following behavior one of of, by County above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered deadline corrected, give warning; late not corrected of, by laboratory of established units on main head, and directly is responsible for of competent personnel and other directly responsibility personnel, law give dismissed, and fired of disposition; has license pieces of, and by original sent card sector revoked about license pieces: (A) not in accordance with provides in obviously location marked State health competent sector and veterinary competent sector provides of biological dangerous identifies and biological security laboratory level logo of; (ii) not to original approved sector report experiment activities results and work situation of; (three) not in accordance with provides collection disease original microbial sample, or on by collection sample of source, and collection process and method, not for detailed records of; (four) new, and alterations or expansion a level, and
II level laboratory not to set district of city level government health competent sector or veterinary competent sector record of; (five) not in accordance with provides regularly on staff for training, or staff assessment not qualified allows its induction, or approved not take protection measures of personnel into laboratory of; (six) laboratory staff not comply with laboratory biological security technology specification and operation of; (seven) not in accordance with provides established or save experiment archives of;
    (VIII) not in accordance with the regulations laboratory emergency response plan and for the record. 61st article by law approved engaged in high pathogenic STD original microbial related experiment activities of laboratory of established units not established sound security defend system, or not take security defend measures of, by County above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered deadline corrected; late not corrected, led to high pathogenic STD original microbial bacteria (HIV) species, and sample was stolen, and was Rob or caused other serious consequences of,
    Revoked by the original licensing departments engaged in highly pathogenic microorganisms the laboratory experimental activities related qualifications; resulting in the spread of infectious diseases, epidemic, which set up a Department in charge of the unit should also be in charge of the laboratory unit is directly responsible for the establishment of personnel and other persons, shall be subject to punishment by demotion, dismissal, discharge constitutes a crime, criminal responsibility shall be investigated according to law. 62nd article without approved transport high pathogenic STD original microbial bacteria (HIV) species or sample, or carrier units by approved transport high pathogenic STD original microbial bacteria (HIV) species or sample not perform protection obligations, led to high pathogenic STD original microbial bacteria (HIV) species or sample was stolen, and was Rob, and lost, and leak of, by County above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered take measures, elimination hidden, give warning; caused infectious diseases spread, and
    Pandemic or other serious consequences, by authorities of the shipping unit and the carrier Unit Chief, managers directly responsible and other persons directly responsible for, and shall be subject to dismissal, punishment by expulsion constitutes a crime, criminal responsibility shall be investigated according to law. 63rd article has following behavior one of of, by laboratory location of set district of city level above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered units immediately stop illegal activities, supervision its will disease original microbial destroyed or sent preserved institutions; caused infectious diseases spread, and popular or other serious consequences of, by its where units or its superior competent sector on main head, and directly is responsible for of competent personnel and other directly responsibility personnel, law give dismissed, and fired of disposition
; Has license pieces of, and by original sent card sector revoked about license pieces; constitute crime of, law held criminal: (a) laboratory in related experiment activities end Hou, not in accordance with provides timely will disease original microbial bacteria (HIV) species and sample local destroyed or sent preserved institutions custody of; (ii) laboratory using technology, and new method engaged in high pathogenic STD original microbial related experiment activities without national disease original microbial laboratory biological security experts Committee argument of;
    (Three) without approved unauthorized engaged in in China yet found or has announced eradication of disease original microbial related experiment activities of; (four) in without specified of professional laboratory engaged in in China yet found or has announced eradication of disease original microbial related experiment activities of; (five) in with a laboratory of with a independent security regional within while engaged in two species or two species above high pathogenic STD original microbial of related experiment activities of. 64th article recognized institutions on not meet laboratory biological security national standards and this Ordinance provides conditions of laboratory be recognized, or on meet laboratory biological security national standards and this Ordinance provides conditions of laboratory not recognized of, by State certification recognized supervision management sector ordered deadline corrected, give warning; caused infectious diseases spread, and popular or other serious consequences of, by State certification recognized supervision management sector revoked its recognized qualification, has superior competent sector of,
    By its higher authorities directly responsible for directors, managers and other persons directly responsible shall be given the punishment of dismissal, dismissal constitutes a crime, criminal responsibility shall be investigated according to law. 65th article laboratory staff appeared the laboratory engaged in of disease original microbial related experiment activities about of infection clinical symptoms or signs, and laboratory occurred high pathogenic STD original microbial leak Shi, laboratory head, and laboratory staff, and is responsible for laboratory infection control of specialized or personnel not in accordance with provides report, or not in accordance with provides take control measures of, by County above place Government health competent sector, and veterinary competent sector in accordance with their duties, ordered deadline corrected, give warning
    Causing the spread of infectious diseases, epidemic, or other serious consequences, establish units for laboratories by the principals, managers directly responsible and other persons directly responsible for, and shall be subject to dismissal, punishment by expulsion; license, and the original issuing authorities revoke a license constitutes a crime, criminal responsibility shall be investigated according to law. 66th article refused to accept health competent sector, and veterinary competent sector law carried out about high pathogenic STD original microbial diffusion of survey forensics, and collection samples, activities or in accordance with this Ordinance provides take about prevention, and control measures of, by County above government health competent sector, and veterinary competent sector in accordance with their duties, ordered corrected, give warning; caused infectious diseases spread, and popular and other serious consequences of, by laboratory of established units on laboratory main head, and
    Managers directly responsible and other persons directly responsible for, and shall be subject to punishment by demotion, dismissal, discharge; license, and the original issuing authorities revoke a license constitutes a crime, criminal responsibility shall be investigated according to law. 67th article occurred disease original microbial was stolen, and was Rob, and lost, and leak, carrier units, and escort people, and preserved institutions and laboratory of established units not in accordance with this Ordinance of provides report of, by location of County Government health competent sector or veterinary competent sector give warning; caused infectious diseases spread, and popular or other serious consequences of, by laboratory of established units or carrier units, and preserved institutions of superior competent sector on main head, and directly is responsible for of competent personnel and other directly responsibility personnel,
    Shall be subject to dismissal, punishment by expulsion constitutes a crime, criminal responsibility shall be investigated according to law. 68th article preserved institutions not in accordance with provides store laboratory sent of bacteria (HIV) species and sample, or not in accordance with provides provides bacteria (HIV) species and sample of, by its specified sector ordered deadline corrected, recovered illegal provides of bacteria (HIV) species and sample, and give warning; caused infectious diseases spread, and popular or other serious consequences of, by its where units or its superior competent sector on main head, and directly is responsible for of competent personnel and other directly responsibility personnel, law give dismissed, and fired of disposition; constitute crime of,
    Criminal responsibility shall be investigated according to law.
    69th authorities above the county level people's Government, was not in accordance with these regulations carry out the duties of supervision and inspection of laboratories and experimental activities, within their respective mandates by the relevant people's Government ordered corrective action and informed criticism resulted in the spread of infectious diseases, epidemic, or other serious consequences, direct responsible personnel, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
    Seventh chapter by-laws 70th army laboratory reference by Chinese health authorities responsible for supervision and administration of this Ordinance.
    71st laboratory set up before the implementation of these regulations, shall, within 6 months from the date of enforcement of this Act, in accordance with the provisions of this Ordinance, the relevant procedures.
                                                  72nd these regulations come into force on the date of promulgation.