Administrative Regulations on the Bio-safety of Pathogenic Microbe Laboratories (Revised in 2016)

Order of the State Council No. 666

February 6, 2016

(Promulgated by the Order of the State Council of the People's Republic of China No.424 on November 12, 2004; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016)

Chapter I General Provisions

Article 1 The present Regulation is formulated for the purpose of further strengthening the bio-safety management of pathogenic microbe laboratories (hereinafter referred to as the laboratories) and protecting the health of the laboratory technical personnel and the general public.

Article 2 The present Regulation shall apply to the bio-safety management of laboratories within the territory of the People's Republic of China as well as the experimental activities which are conducted in the laboratories.
The term "pathogenic microbe" as mentioned in the present Regulation refers to any microorganism capable of causing human or animal diseases.
The term "experimental activities" as mentioned in the present Regulation refers to the activities which are conducted in the laboratories, such as research, teaching, testing and diagnosis relating to the strains or samples of pathogenic bacterium (viruses).

Article 3 The administrative department of health of the State Council shall be responsible for the supervision over the bio-safety of the laboratories relating to human health and the experimental activities which are conducted in the laboratories.
The administrative department of veterinary of the State Council shall be responsible for supervision over the bio-safety of laboratories relating to animals and the experimental activities conducted in the laboratories.
The other relevant departments of the State Council shall, under their respective functions, be responsible for the bio-safety management of the laboratories and the experimental activities which are conducted in the laboratories.
The people's governments at the county level or above and their pertinent departments shall, under their respective functions, be responsible for the bio-safety management of the laboratories and the experimental activities which are conducted in the laboratories.

Article 4 The state adopts categorized management over the pathogenic microbes, and graded management over the laboratories.

Article 5 The state adopts the uniform lab bio-safety standards. A lab shall conform to the national standards and specifications.

Article 6 The entity, which launched a lab, and its administrative department shall be responsible for the management of the routine activities of the lab and shall conduct the duties of establishing a sound safety management system, checking and maintaining the experimental apparatus and equipment as well as controlling the laboratory infection.

Chapter II Classification and Management of Pathogenic Microbes

Article 7 The state classifies the pathogenic microbes into four categories according to the infectivity and the degree of harm to the infected individual or to the mass:
The pathogenic microbes in Category I refer to the microbes capable of causing very severe human or animal diseases, and the microbes undiscovered or declared as eliminated in our country.
The pathogenic microbes in Category II refer to the microbes capable of causing serious human or animal diseases, which can be easily transmitted from person to person, animal to person or animal to animal, directly or indirectly.
The pathogenic microbes in Category III refer to the microbes capable of causing human or animal diseases, but they usually cannot severely endanger the human, animals or environment, have limited risk of spreading and seldom cause severe diseases after laboratory infection, moreover, we have got effective treatment and prevention measures against them.
The pathogenic microbes in Category IV refer to the microbes that are usually incapable of causing human or animal disease.
The pathogenic microbes in Categories I and II are generally called highly pathogenic microbes.

Article 8 The directory of pathogenic microbes capable of spreading from person to person shall be formulated, modified and issued by the administrative department of health of the State Council in consultation with other relevant departments of the State Council. The directory of pathogenic microbes capable of spreading from animal to animal shall be formulated, modified and issued by the administrative department of veterinary of the State Council in consultation with other relevant departments of the State Council.

Article 9 A lab shall meet the following conditions when gathering samples of pathogenic microbes:
(1) Having equipment up to the bio-safety protection level for gathering pathogenic microbes;
(2) Having personnel with the relevant professional knowledge and operating skills;
(3) Having effective measures to prevent the spreading and infection of pathogenic microbes; and
(4) Having technical methods and approaches to ensure the quality of samples of pathogenic microbes.
During the course of gathering samples of highly pathogenic microbes, the personnel shall prevent the spreading and infection of pathogenic microbes, and shall make detailed records of the source thereof as well as the gathering course and approach.

Article 10 The strains or samples of highly pathogenic bacteria (virus) shall be transported by way of land transportation. If there is no land road, they may be transported through waterway. In emergency or when it is necessary to transport them abroad, they may be transported through civil aviation.

Article 11 For the transport of strains or samples of highly pathogenic bacteria (virus), the following conditions shall be met:
(1) The purpose of transport, use of highly pathogenic bacteria (virus) and acceptance entity shall meet the provisions of the administrative department of health or the administrative department of veterinary of the State Council;
(2) The container of strains or samples of highly pathogenic bacteria (virus) shall be sealed up, moreover, the container or packing materials shall satisfy the requirements for prevention of water, breakage and leakage as well as endurance of high (low) temperature and high pressure; and
(3) The container or packing materials shall be printed with the bio-risk signs, warnings and hints as provided by the administrative department of health or the administrative department of veterinary of the State Council.
The transport of strains of samples of highly pathogenic bacteria (virus) shall be subject to the approval of the administrative department of health or the administrative department of veterinary of the people's government at or above the province level. If such transport is within the administrative area of a province, autonomous region, or municipality directly under the Central Government, it shall be subject to the administrative department of health or the administrative department of veterinary of the people's government of this province, autonomous region, or municipality directly under the Central Government. If such transport goes beyond a province, autonomous region, or municipality directly under the Central Government, or heads abroad, it shall be subject to the preliminary examination of the administrative department of health or the administrative department of veterinary of the people's government of the province, autonomous region, or municipality directly under the Central Government where the place of departure is located, then respectively subject to the approval of the administrative department of health or the administrative department of veterinary of the State Council.
If the entry-exit inspection and quarantine institution needs, during the process of inspection and quarantine, to transport any samples of pathogenic microbe, it shall be subject to the approval of the entry-exit inspection and quarantine department of the State Council and shall be simultaneously reported to the administrative department of health or the administrative department of veterinary of the State Council.
The transport of strains or samples of highly pathogenic bacteria (virus) through civil aviation shall, in addition to obtaining the approval in accordance with Paragraphs 2 and 3, obtain the approval of the administrative department of civil aviation of the State Council.
The relevant administrative departments shall examine the application materials relating to the transport of strains and samples of highly pathogenic bacteria (virus) submitted by an applicant, it shall promptly grant the applicant an approval if the aforesaid application materials meet the conditions as listed in the first Paragraph of this Article.

Article 12 As to the transport of strains or samples of highly pathogenic bacteria (virus), 2 or more persons shall be specially assigned for escorting it, and the corresponding safety protection measures shall be taken.
No entity or individual may transport any strains or samples of pathogenic bacteria (virus) by trolley (bus) or city railway.

Article 13 Where it is necessary to transport strains or samples of highly pathogenic bacteria (virus) through a public transport tool of railway, road or civil aviation, the carrier shall transport them upon the approval documents as required in Article 11 of the present Regulation.
The carrier and the escorts shall jointly take measures to ensure the safety of the strains or samples of highly pathogenic bacteria (virus) and prevent them from being stolen, robbed, lost and leaked.

Article 14 The bacteria (virus) strain preservation centers or special laboratories designated by the administrative department of health or the administrative department of veterinary of the State Council (hereinafter referred to the preservation institutions) shall conduct the task of preserving the pathogenic bacteria (virus) strains and samples in a centralized manner.
A preservation institution shall, in compliance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, preserve the pathogenic bacteria (virus) strains and samples delivered by the laboratories, and shall provide the laboratories with the pathogenic bacteria (virus) strains and samples.
A preservation institution shall formulate strict safety and preservation system, make good records of the ins, outs and preservation of pathogenic bacteria (virus) strains and samples, establish an archives system and assign special responsible persons. It shall prepare special storerooms or tanks to preserve the highly pathogenic bacteria (virus) strains and samples in a separate way.
No preservation institution may charge any fee for the preservation or supply of pathogenic bacteria (virus) strains and samples, the expenses shall be guaranteed by the public finance of the same level from the budget of entity.
The administrative measures for the preservation institutions shall be formulated by the administrative department of health jointly with the administrative department of veterinary of the State Council.

Article 15 A preservation institution shall, upon the strength of the approval documents obtained by a lab for conducting the experimental activities relating to the highly pathogenic microbes in accordance with the present Regulation, provide the lab with the highly pathogenic bacteria (virus) strains and samples, and shall make records on this.

Article 16 After a lab completes its relevant experimental activities, it shall, in accordance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, timely destroy the pathogenic bacteria (virus) strains and samples on the spot or deliver them to the preservation institution for preservation.
Where a preservation institution accepts the pathogenic bacteria (virus) strains and samples delivered by a lab, it shall make records and shall issue a certification of acceptance.

Article 17 Where any highly pathogenic bacteria (virus) strains or samples are stolen, robbed, lost or leaked during the course of transportation or storage, the carrying entity, escorts or preservation institution shall take necessary control measures, shall report to the administrative department in charge of the carrying entity, the entity for which the escorts are working and the administrative department in charge of the preservation institution within 2 hours and shall simultaneously report to the administrative department of health or the administrative department of veterinary of the local people's government at the county level, as well as report to the public security organ if any such strains or samples are stolen, robbed or lost. After receiving such a report, the administrative department of health or the administrative department of veterinary shall report to the people's government at the same level within 2 hours and shall simultaneously report to the superior administrative department of health or the administrative department of veterinary, as well as the administrative department of health or the administrative department of veterinary of the State Council.
After receiving such a report, the people's government at the county level shall report to the people's government of the city divided into district or the superior people's government. The people's government of the city divided into district shall, within 2 hours after receiving such a report, report to the people's government of the province, autonomous region, or municipality directly under the Central Government. The people's government of the province, autonomous region, or municipality directly under the Central Government shall report to administrative department of health or the administrative department of veterinary of the State Council within 1 hour after receiving such a report.
Any entity or individual who discovers the container or packing materials of highly pathogenic bacteria (virus) shall timely report to the nearby administrative department of health or the administrative department of veterinary, which shall organize an investigation and shall take necessary control measures in good time.

Chapter III Establishment and Management of Laboratories

Article 18 The state shall classify the laboratories into Level 1, Level 2, Level 3 and Level 4 in light of their pathogenic microbe bio-safety protection levels as well as in accordance with the national standards for the bio-safety of laboratories.

Article 19 The newly building, rebuilding or expanding a Level 3 or 4 lab or importing a Level 3 or 4 movable lab, the following provisions shall be complied with:
(1) It shall be in compliance with the national planning on the bio-safety laboratories and shall go through the relevant examination and approval formalities;
(2) It has been examined and approved by the science and technology administrative department of the State Council;
(3) It meets the technical standards for building a national bio-safety lab;
(4) It has undergone the environmental impact evaluation pursuant to the Law of the People's Republic of China on Environment Impact Assessment as well as has been examined and approved by the environmental protection administrative department; and
(5) The bio-safety protection level is in keeping with the experimental activities which it will conduct.
The "national planning on the bio-safety laboratories" as mentioned in the preceding paragraph shall be formulated by the investment administrative department of the State Council jointly with other relevant departments of the State Council. When formulating such planning, the principle of controlling the aggregate number, distributing reasonably and sharing the resources shall be observed, and hearings or argumentations shall be held for soliciting the opinions of the experts in public health, environmental protection, investment management and lab management.

Article 20 The laboratories of Level 3 and 4 shall be subject to the national accreditation for laboratories.
The accreditation agencies determined by the certification accreditation supervisory department of the State Council shall, in pursuance of the national standards for laboratory bio-safety and the relevant provisions of the present Regulation, complete the accreditation process for the Levels 3 and 4 laboratories and shall issue a corresponding bio-safety lab certificate to each bio-safety lab that has passed the accreditation. Such a certificate has a five-year valid period.

Article 21 No Level 1 or 2 lab may conduct experimental activities relating to highly pathogenic microbes. A Level 3 or 4 lab may conduct such activities, but it shall satisfy the following requirements:
(1) The experimental purpose and the planned experimental activities shall meet the requirements of the administrative department of health or the administrative department of veterinary of the State Council;
(2) It has passed the national accreditation for laboratories;
(3) It has personnel who can meet the needs of the planned experimental activities; and
(4) Its quality of construction project is up to the standards upon check of the construction administrative department.
The administrative department of health or the administrative department of veterinary of the State Council shall, in light of its own functions, check whether the Levels 3 and 4 laboratories meet the above-mentioned requirements and shall issue to the qualified laboratories the qualification certificates for conducting experimental activities relating to highly pathogenic microbes.

Article 22 Where a lab, which has obtained a qualification certificate for conducting experimental activities relating to highly pathogenic microbes, needs to conduct experimental activities relating to any highly pathogenic microbes or suspected highly pathogenic microbes, it shall, in accordance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, report to the administrative department of health or the administrative department of veterinary of the people's government at or above the province level for approval. It shall report the results and particulars of such experimental activities to the original approval department.
When a lab applies for or accepts a scientific research project involving any highly pathogenic microbes, it shall meet the needs of scientific research and the bio-safety requirements, and shall be up to the corresponding bio-safety protection level. A scientific research project involving any highly pathogenic microbes capable of spreading from animal to animal shall be subject to the approval of the administrative department of veterinary under the State Council; and as for a scientific research project involving highly pathogenic microbes relating to human health, the relevant lab shall inform the administrative department of health of the people's governments at the provincial level or above of the project establishment results.

Article 23 When an entry-exit inspection and quarantine institution, medical health institution or animal disease prevention institution carries out inspection or diagnosis work, if it discovers any highly pathogenic microbes or suspected highly pathogenic microbes and needs to further conduct experimental activities relating to such highly pathogenic microbes, it shall obtain an approval as required by the present Regulation and shall conduct the pertinent experimental activities in a lab with the corresponding qualification certificate.
A lab, which specially conducts the testing and diagnostic work, shall, in accordance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, formulate a set of bylaws so as to ensure the bio-safety of the lab.

Article 24 The administrative department of health or the administrative department of veterinary of the people's government at or above the province level shall, within 15 days from the day when it receives an application for conducting experimental activities relating to highly pathogenic microbes, make a decision of approval or disapproval.
Where an entry-exit inspection and quarantine institution applies, due to an emergent inspection and quarantine task, for further conducting experimental activities relating to any highly pathogenic microbes or suspected highly pathogenic microbes in a lab, the administrative department of health or the administrative department of veterinary of the people's government at or above the province level shall, within 2 hours after it receives the application, make a decision of approval or disapproval. If it fails to make a decision within 2 hours, the lab may conduct the relevant experimental activities.
The administrative department of health or the administrative department of veterinary of the people's government at or above the province level shall provide convenience for the applicant's filing of an application by telegraph, telex, fax, electronic data interchange or e-mail.

Article 25 When any entity newly builds, rebuilds or expands a Level 1 or 2 lab, it shall file the issue for archival purposes with the administrative department of health or the administrative department of veterinary of the people's government of the city divided into districts. The administrative department of health or the administrative department of veterinary of the people's government of the city divided into districts shall collect the archival information of each year, and then report it to the administrative department of health or the administrative department of veterinary of the people's government of the province, autonomous region, or municipality directly under the Central Government.

Article 26 The administrative department of health of the State Council and the administrative department of veterinary of the State Council shall regularly collect and notify each other of the information about the number, establishment and distribution of the laboratories as well as the information about the Levels 3 and 4 laboratories that have obtained the qualification certificate for conducting experimental activities relating to highly pathogenic microbes and about their experimental activities.

Article 27 A Level 3 or 4 lab, which has been built and has passed the national accreditation for laboratories, shall undergo the formalities for archival filing with the local environmental protection administrative department of the people's government at the county level. The environmental protection administrative department shall, in accordance with the relevant laws and administrative regulations, supervise and check how the lab disposes of its waste water, waste gas and other wastes.

Article 28 No entity or individual may, without approval, conduct experimental activities relating to any pathogenic microbe that is undiscovered by our country or has been declared eliminated.
For the purpose of preventing or controlling an epidemic disease, if it is necessary to conduct experimental activities relating to the pathogenic microbe as mentioned in the preceding Paragraph, such experimental activities shall be subject to the approval of the administrative department of health or the administrative department of veterinary of the State Council and shall be conducted in the professional lab as designated by the approval department.

Article 29 Where a lab intends to employ a new technology or new approach to conduct experimental activities relating to any highly pathogenic microbes, it shall comply with the requirements for preventing the spreading of the highly pathogenic microbes, ensuring the bio-safety and the operators' personal safety and shall be subject to the argumentation of the National Bio-safety Expert Board for Pathogenic Microbe Laboratories. The new technology or new approach may not be used unless it proves feasible upon argumentation.

Article 30 Where it is necessary to conduct experiments relating to highly pathogenic microbes on animals, such experiments shall be carried out in a lab of Level 3 or above that meets the national standards for the bio-safety of animal laboratories.

Article 31 The entity that launched a lab shall be responsible for the bio-safety management of the lab.
The entity that launched the lab shall, under the present Regulation, formulate scientific and strict management system, shall regularly check the implementation of the relevant provisions on bio-safety, shall regularly check, maintain and change the facilities, equipment and materials of the lab so as to ensure that the lab meet the national standards.
The entity that launched the lab and its administrative department shall strengthen the management of the routine activities of the lab.

Article 32 The person-in-charge of a lab shall be the first responsible person for the bio-safety of the lab.
When a lab conducts experimental activities, it shall strictly comply with the pertinent national standards and laboratorial technical specifications and operating procedures. The person-in-charge of the lab shall assign special persons to supervise and inspect how the lab implements the laboratorial technical requirements and operating procedures.

Article 33 The entity, which launched a lab conducting experimental activities relating to highly pathogenic microbes, shall establish a sound security control system, take security control measures, strictly prevent the highly pathogenic microbes from being stolen, robbed, lost or leaked, and ensure the safety of lab and its pathogenic microbes. Where any highly pathogenic microbes of the lab are stolen, robbed, lost or leaked, the entity that launched the lab shall report it to the pertinent departments in accordance with Article 17 of the present Regulation.
A lab conducting experimental activities relating to highly pathogenic microbes shall go through the formality for archival filing with the local public security organ and shall accept its supervision and guidance on the security control of the lab.

Article 34 Every year, a lab or entity that launched a lab shall regularly train its workers so as to ensure that they grasp the technical specifications, operating procedures, bio-safety protection knowledge and practical operating skills, and shall conduct examinations. Among the workers, only those who pass the examination may take up their jobs.
Every half a year, a lab conducting experimental activities relating to highly pathogenic microbes shall report the information about the training and examination of its workers and about the operations of the lab to the administrative department of health or the administrative department of veterinary of the people's government of the province, autonomous region, or municipality directly under the Central Government.

Article 35 An experimental activity relating to highly pathogenic microbes shall be jointly conducted by 2 or more personnel.
Before the laboratory technical personnel or other related persons enter a lab conducting experimental activities relating to highly pathogenic microbes, they shall be subject to the approval of the person-in-charge of the lab. The lab shall provide them with protection articles that meet the relevant requirements as well as take other occupational protection measures. Moreover, if the lab conducts experimental activities relating to highly pathogenic microbes, it shall monitor the health of its laboratory technical personnel. It shall organize them to accept medical examination each year and shall establish health archives. Where necessary, they shall be vaccinated.

Article 36 Within the same one independent safety area of the same lab, the experimental activities relating to merely one species of highly pathogenic microbes are allowed.

Article 37 A lab shall establish experimental archives, which shall keep records of the information about the uses of the lab and safety supervision. The preservation period of the experimental archives of a lab conducting experimental activities relating to highly pathogenic microbes shall be not less than 20 years.

Article 38 A lab shall dispose of the waste water, waste gas and other wastes in accordance with the environmental protection laws, administrative regulations, and the provisions of the relevant departments of the State Council, and shall formulate the corresponding environment protection measures so as to prevent environmental pollution.

Article 39 A Level 3 or 4 lab shall put the bio-risk mark and bio-safety lab level mark as provided by the administrative department of health or the administrative department of veterinary of the State Council in an eye-catching place.

Article 40 A lab conducting experimental activities of highly pathogenic microbes shall formulate an emergency preparation plan on laboratorial infection and submit it to the administrative department of health or the administrative department of veterinary of the people's government of the province, autonomous region, or municipality directly under the Central Government where the lab is located.

Article 41 The administrative department of health or the administrative department of veterinary of the State Council shall, jointly with the pertinent departments of the State Council, organize the experts in etiology, immunology, science of laboratory medicine, epidemiology, preventive veterinary science, environmental protection and laboratorial management to form the National Bio-safety Expert Board for Pathogenic Microbe Laboratories. This board shall be responsible for bio-safety evaluation, technical consultation and argumentation of the establishment and operation of the laboratories conducting experimental activities relating to highly pathogenic microbes.
The administrative department of health and the administrative department of veterinary of the people's government of a province, autonomous region or municipality directly under the Central Government shall, jointly with the relevant departments of the people's government at the same level, organize the experts in etiology, immunology, science of laboratory medicine, epidemiology, preventive veterinary science, environmental protection and laboratorial management to form the bio-safety expert board for local pathogenic microbe laboratories. This board shall be responsible for the technical consultation of establishment and operation of local laboratories.

Chapter IV Control of Laboratorial Infection

Article 42 The entity that launched a lab shall assign a special department or person to be responsible for controlling the laboratorial infection. It (he) shall regularly check the implementation of the rules and regulations on the bio-safety protection of the lab, preservation and use of the strains and samples of pathogenic bacteria (virus), safety operations, and disposal of the waste water, waste gas and other wastes of the lab.
The department or the person responsible for the laboratorial infection work shall have the knowledge about the prevention and control of contagious diseases relating to the pathogenic microbes of the lab and shall regularly investigate into and get to know the status of health of the laboratory technical personnel of the lab.

Article 43 Where any of the laboratory technical personnel of a lab shows a clinical symptom or pathological signs of infection relating to the highly pathogenic microbes used in the experimental activities of the lab, the person-in-charge of the lab shall report it to the department or person who is responsible for the control of laboratorial infection and shall simultaneously assign a special person to escort the patient to see a doctor without delay. The patient as one of the laboratory technical personnel of the lab shall faithfully tell the medical institution, in which he seeks medical treatment, about the species and risk degree of the pathogenic microbe that he has recently contacted. The medical institution that accepts the patient shall offer him medical treatment in good time. If the aforesaid medical institution hasn't the corresponding medical conditions, it shall transfer the patient to an eligible medical institution that has the corresponding conditions for infectious disease treatment. The eligible medical institution that has the corresponding conditions for infectious disease treatment shall accept the patient and offer him medical treatment. It may not refuse to cure him.

Article 44 Where the highly pathogenic microbes of a lab are leaked, the laboratory technical personnel of the lab shall immediately take control measures so as to prevent the spreading of highly pathogenic microbes and shall simultaneously report to the department or person who is responsible for the control of laboratorial infection.

Article 45 After the department or person who is responsible for the control of laboratorial infection receives a report as mentioned in Articles 43 and 44 of the present Regulation, it (he) shall promptly initiate the emergency preparation plan on laboratorial infection and shall organize some persons to investigate the status of the bio-safety of the lab. If it is ascertained that the lab is polluted or the highly pathogenic microbes of a lab are leaked, it (he) shall report to the relevant departments under Article 17 of the present Regulation and shall simultaneously take control measures to prevent the spreading of infection, such as taking medical observations over the relevant personnel or providing them with isolated treatment, closing the lab, etc.

Article 46 After the administrative department of health or the administrative department of veterinary receives a report about the accident of lab worker's infection or of highly pathogenic microbes' leakage, or after it discovers that a lab's experimental activities relating to pathogenic microbes result in an accident of laboratorial infection, it shall promptly organize the disease prevention and control institution, animal quarantine supervisory institution, medical institution and other relevant institutions to take the following prevention and control measures:
(1) Closing the lab polluted by pathogenic microbes or other places that are likely to cause the spreading of pathogenic microbes;
(2) Conducting epidemiology investigation;
(3) Offering the patients isolated treatment, conducting medical check over other relevant persons;
(4) Conducting medical observations over the persons who have close contact with them;
(5) Disinfecting the pertinent locales;
(6) Isolating or killing the infected or suspect infected animals; and
(7) Taking other necessary prevention and control measures.

Article 47 Where a medical institution or veterinary medical institution and its in-service workers discover any patient, suspected patient, sick animal or suspected sick animal with an epidemic disease resulted from laboratorial infection relating to highly pathogenic microbes, the medical institution or veterinary medical institution that accepts such patient or animal shall, within 2 hours, report to the local administrative department of health or the administrative department of veterinary of the people's government at the county level. After the administrative department of health or the administrative department of veterinary receives such a report, it shall, within 2 hours, report to the administrative department of health or the administrative department of veterinary of the people's government at the county level where the lab is located. The administrative department of health or the administrative department of veterinary that receives such a report shall take prevention and control measures in pursuance of Article 46 of the present Regulation.

Article 48 Where an accident of spreading the pathogenic microbes is likely to result in a break or epidemic of an epidemic disease, the administrative department of health or the administrative department of veterinary of the people's government at the county level or above shall tackle the accident in compliance with the relevant laws, administrative regulations as well as the emergency preparation plan on laboratorial infection.

Chapter V Supervision and Management

Article 49 The administrative department of health or the administrative department of veterinary of the people's government at the county level or above shall, under their respective functions, perform the following duties:
(1) Supervising and checking the gathering, transportation and preservation of pathogenic bacterial (virus) strains and samples;
(2) Supervising and checking whether each lab's experimental activities relating to highly pathogenic microbes meet the conditions as required in the present Regulation;
(3) Supervising and checking the information about the training and examination of the workers organized by each lab or the entity launched the lab, as well as the information about the workers' taking up of the pertinent jobs of the lab or the entity launched the lab; and
(4) Supervising and checking whether each lab complies with the national standards, technical specifications and operating procedures in the experimental activities relating to pathogenic microbes.
The administrative department of health or the administrative department of veterinary of the people's government at the county level or above shall mainly check the records, archives and reports that reflect the implementation by the lab of the pertinent laws, administrative regulations as well as national standards and requirement to actually perform its supervisory duties.

Article 50 When the administrative department of health, administrative department of veterinary or administrative department of environmental protection of the people's government at the county level or above performs its duty of supervision and check, it shall be empowered to enter the entity being checked and the locale of the leakage or spreading of pathogenic microbes to conduct investigations for evidence, gather samples and consult and copy the relevant materials. If it is necessary to enter a lab engaged in experimental activities relating to highly pathogenic microbes to conduct investigations for evidence or gather samples, a professional institution shall be designated or entrusted to do so. The entity being checked shall show cooperation, may not refuse or hinder the above-mentioned efforts.

Article 51 The certification accreditation supervisory department of the State Council shall supervise and check the laboratory accreditation activities in accordance with the Regulation of the People's Republic of China on Certification and Accreditation.

Article 52 The administrative department of health, administrative department of veterinary or administrative department of environmental protection shall perform its duties in compliance with the statutory functions and procedures. It shall be impartial, fair, open, polite and highly efficient.

Article 53 When the law enforcers of the administrative department of health, administrative department of veterinary or administrative department of environmental protection perform their duties, there shall be 2 or more law enforcers. They shall show their law enforcement certificate and shall fill out the law enforcement documents in accordance with the relevant provisions.
After the on-the-spot check transcripts, sample-gathering records and other documents are verified as inerrant, they shall be signed by the law enforcers, the persons being checked and persons from whom the samples are taken. If the persons being checked and persons from whom the samples are taken refuse to sign the aforementioned documents, the law enforcers shall make notes after their own signatures.

Article 54 The administrative department of health, administrative department of veterinary, administrative department of environmental protection and their law enforcers shall, on their own initiative, accept the supervision of the society and general public, when they are performing their duties. Any citizen, legal person or any other organization shall be entitled to expose the information about the relevant local administrative department's failure to perform its functions to the superior people's government and its administrative department of health, administrative department of veterinary and administrative department of environmental protection. After receiving such information, the relevant people's government or its administrative department of health, administrative department of veterinary or administrative department of environmental protection shall investigate into and deal with the case in good time.

Article 55 If the administrative department of health, administrative department of veterinary, administrative department of environmental protection of the superior people's government finds a matter that needs to be tackled by the administrative department of health, administrative department of veterinary or administrative department of environmental protection of inferior people's government within its functions, it shall timely inform this department of this matter. If the administrative department of health, administrative department of veterinary or administrative department of environmental protection of the inferior people's government fails to deal with it in good time or to perform its functions, the administrative department of health, administrative department of veterinary, administrative department of environmental protection of the superior people's government shall order it to get right within a time limit; if it fails to do so, the administrative department of health, administrative department of veterinary, administrative department of environmental protection of the superior people's government shall be empowered to deal with the matter directly.

Chapter VI Legal Liabilities

Article 56 If a Level 3 or 4 lab fails to obtain a qualification certificate for conducting experimental activities relating to highly pathogenic microbes in accordance with the present Regulation, or if it has obtained the relevant qualification certificate but conducts any experimental activities relating to highly pathogenic microbes or suspected highly pathogenic microbes without approval, the administrative department of health, administrative department of veterinary of the local people's government at or above the county level shall, under its own functions, order it to stop the relevant activities, direct it to destroy the pathogenic microbes used for experimental activities or transfer them to the preservation institution, and give it a warning. If it results in the spreading or epidemic of an epidemic disease or any other serious consequence, the entity that launched the lab shall dismiss the major person-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If the lab has a qualification certificate, this qualification certificate shall be revoked. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 57 Where the administrative department of health or the administrative department of veterinary permits, by violating the present regulation, a lab that doesn't meet the requirements of the present Regulation to conduct experimental activities relating to highly pathogenic microbes, the administrative department of health or the administrative department of veterinary that made the approval decision shall revoke the approval decision, order the lab to stop the relevant activities immediately, direct it to destroy the pathogenic microbes used for experimental activities or transfer them to the preservation institution, give the direct person-in-charge and other direct liable persons an administrative sanction. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.
If the legitimate rights and interests of a party concerned are damaged by an approval decision in violation of the law, the administrative department of health or the administrative department of veterinary that made the approval decision shall be liable for the compensations.

Article 58 If the administrative department of health or the administrative department of veterinary refuses to issue a qualification certificate for conducting experimental activities relating to highly pathogenic microbes to a lab that meets the statutory requirements, or if it fails to make a decision of approval or disapproval within the statutory time limit to the entry-exit inspection and quarantine institution, which, for the reason of the urgent needs in the inspection and quarantine work, applies for carrying out further testing activities in a lab relating to highly pathogenic microbes, its superior administrative organ or the supervisory organ shall order it to get right and give it a warning. If it causes the spreading or epidemic of an epidemic disease or any other serious consequence, the direct person-in-charge and other direct liable persons shall be dismissed from their respective post or disemployed. If any crime is constituted, o the criminal liabilities shall be investigated for in accordance with the law.

Article 59 Where a lab that doesn't meet the bio-safety requirements conducts experimental activities relating to highly pathogenic microbes by violating the present Regulation, the administrative department of health or the administrative department of veterinary shall, under its own functions, order it to stop the relevant activities, direct it to destroy the pathogenic microbes used for experimental activities or transfer them to the preservation institution, and give it a warning. If it causes the spreading or epidemic of an epidemic disease or any other serious consequence, the entity that launched the lab shall dismiss the major person-in-charge, the direct person-in-charge and other direct liable persons from their respective post or disemploy them. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 60 Where a lab has any of the following acts, it shall be ordered to get right within a time limit and given a warning by the administrative department of health or the administrative department of veterinary of the people's government at the county level or above under its own functions. If it fails to get right within the time limit, the entity that launched the lab shall dismiss the major person-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If the lab has a corresponding license, the department that issued the license shall revoke the license.
(1) Failing to put the bio-risk mark and bio-safety lab level mark in an eye-catching place as provided for by the administrative department of health or the administrative department of veterinary of the State Council;
(2) Failing to report to the original approval department the experimental results and the information about the work;
(3) Failing to gather samples of pathogenic microbes in accordance with the provisions, or failing to make detail records of the sources, course of gathering and approaches;
(4) Failing to go through the archive filing formalities with the administrative department of heath or the administrative department of veterinary of the people's government of the city divided into districts for the newly building, rebuilding or expanding of a Level 1 or 2 lab;
(5) Failing to regularly train the workers under the relevant provisions, or allowing a worker who fails to pass the examination to take up his post, or permitting any person without taking protection measures to enter the lab;
(6) The laboratory technical personnel of the lab failing to comply with the laboratory bio-safety technical specifications and operating procedures;
(7) Failing to establish or preserve the experimental archives under the relevant provisions; or
(8) Failing to formulate an emergency preparation plan on laboratorial infection.

Article 61 Where an entity, which launched a lab with an approval for conducting experimental activities relating to highly pathogenic microbes, fails to establish a sound security system or fails to take security protection measures, it shall be ordered to get right within a time limit by the administrative department of health or the administrative department of veterinary of the local people's government at the county level or above within its own functions. If it fails to do so and leads to the result that the strains or samples of the highly pathogenic bacteria (virus) are stolen or robbed, or results in any other serious consequence, the department that issued the certificate shall revoke the qualification certificate of the lab for conducting the experimental activities relating to highly pathogenic microbes. If it causes the spreading or epidemic of an epidemic disease, the administrative department of the entity that launched the lab shall degrade or dismiss the direct person-in-charge of the entity that launched the lab and other direct liable persons from their respective post or disemploy them. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 62 Where anyone transports any strains or samples of a highly pathogenic bacteria (virus) without approval or a carrying entity with an approval to transport highly pathogenic bacteria (virus) fails to fulfill its protection obligation and causes the result that the highly pathogenic bacteria (virus) is stolen, robbed, lost or leaked, the administrative department of health or the administrative department of veterinary of the local people's government at the county level or above shall, under its own functions, order it to take measures to eliminate the potential risks and give it a warning. If it leads to the spreading or epidemic of an epidemic disease or any other serious consequence, the administrative departments of consigning entity and the carrying entity shall dismiss the major persons-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 63 As to any of the following acts, the administrative department of health or the administrative department of veterinary of the people's government of the city divided into districts where the lab is located shall, under its own functions, order the entity (lab) involved to stop its illegal activity, direct it to destroy the pathogenic microbes or transfer them to the preservation institution. If it causes the spreading or epidemic of an epidemic disease or any other serious consequence, the entity of the lab or its superior administrative department shall dismiss the major person-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If the lab has a license, the department that issued the license shall revoke the license. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law:
(1) After the lab completes the relevant experimental activities, it fails to destroy the strains and samples of pathogenic bacteria (virus) or transfer them to the preservation institution in accordance with the relevant provisions;
(2) Without undergoing the argumentation by the National Bio-safety Expert Board for Pathogenic Microbe Laboratories, the lab applies any new technology or approach to conduct experimental activities relating to highly pathogenic microbes;
(3) Without approval, conducting experimental activities relating to any pathogenic microbes undiscovered by our country or has been declared eliminated;
(4) Conducting experimental activities relating to any pathogenic microbes undiscovered or been declared eliminated by our country in an un-designated professional lab; or
(5) Conducting experimental activities relating to 2 or more species of highly pathogenic microbes within the same one independent safety area of the same lab simultaneously.

Article 64 If the accreditation institution grants accreditation to a lab that doesn't satisfy the national standards for lab bio-safety and the requirements as listed in the present Regulation, or if it refuses to grant accreditation to a lab that satisfies the national standards for lab bio-safety and the requirements as listed in the present Regulation, the certification accreditation supervisory department of the State Council shall order it to get right within a time limit and give it a warning. If this results in the spreading or epidemic of an epidemic disease or any other serious consequence, the certification accreditation supervisory department of the State Council shall revoke its accreditation qualification, and its superior administrative department (if there is) shall dismiss the major person-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 65 If any of the laboratory technical personnel of a lab shows a clinical symptom or pathological signs of infection relating to the pathogenic microbes used in the experimental activities of the lab, or if a leakage of highly pathogenic microbes occurs in a lab, and the person-in-charge of the lab, laboratory technical personnel, or the special department or person responsible for laboratorial infection fails to report the leakage of the highly pathogenic microbes of the lab to the relevant departments or fails to take control measures in accordance with the relevant provisions, the administrative department of health or the administrative department of veterinary of the local people's government at the county level or above shall, under its own functions, order the lab to get right within a time limit and give it a warning. If this results in the spreading or epidemic of an epidemic disease or any other serious consequence, the entity that launched the lab shall dismiss the person-in-charge of the lab, the direct person-in-charge and other direct liable persons from their respective post or disemploy them. If the lab has a license, the department that issued the license shall revoke its license. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 66 Where a lab refuses to cooperate with the administrative department of health or the administrative department of veterinary in the activities relating to the spreading of highly pathogenic microbes such as investigations for evidence, gathering samples, or taking prevention or control measures under the present Regulation, it shall be ordered to get right or given a warning by the administrative department of health or the administrative department of veterinary of the people's government at the county level or above under its own functions. If it causes the spreading or epidemic of an epidemic disease or any other serious consequence, the entity that launched the lab shall degrade or dismiss the major person-in-charge, direct person-in-charge and other direct liable persons of the lab from their respective post or disemploy them. If the lab has a license, the department that issued the license shall revoke its license. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 67 Where any pathogenic microbes are stolen, robbed, lost or leaked, if the carrying entity, escorts, preservation institution or the entity that launched the lab fails to report to the relevant departments under the present Regulation, the administrative department of health or the administrative department of veterinary of the local people's government shall give it (them) a warning. If the spreading or epidemic of an epidemic disease or any other serious consequence is caused, the entity that launched the lab or the superior administrative department of the carrying entity or preservation institution shall dismiss the major person-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 68 Where a preservation institution fails to preserve the strains and samples of bacteria (virus) sent by a lab in pursuance of the relevant provisions, or fails to supply strains and samples of bacteria (virus) in accordance with the relevant provisions, the department that designated it shall order it to get right within a time limit and to withdraw the illegally supplied strains and samples of bacteria (virus) and give it a warning. If the spreading or epidemic of an epidemic disease or any other serious consequence is caused, the entity to which it belongs or its superior administrative department shall dismiss the major person-in-charge, direct person-in-charge and other direct liable persons from their respective post or disemploy them. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Article 69 Where any of the relevant administrative departments of the people's government at the county level or above fails to perform its duty of supervising or inspecting the laboratories and their experimental activities in accordance with the present Regulation, the relevant people's government shall, within its own functions, order it to get right and criticize it by circulating a notice. If the spreading or epidemic of an epidemic disease or any other serious consequence is caused, the direct person-in-charge shall be given an administrative sanction. If any crime is constituted, the criminal liabilities shall be investigated for in accordance with the law.

Chapter VII Supplementary Provisions

Article 70 A military lab shall be supervised and managed by the administrative department of health of the People's Liberation Army of China by referring to the present Regulation.

Article 71 A lab established before the present Regulation comes into effect shall handle the relevant formalities in compliance with the present Regulation within 6 months from the date when the Regulation comes into effect.

Article 72 The present Regulation shall come into effect as of the promulgation date.