(Promulgated on November 12, 2004, by Order No. 424 of the State Council of the People’s Republic of China; amended in accordance with the Decision of the State Council on Amending Certain Administrative Regulations dated February 6, 2016; further revised pursuant to the Decision of the State Council on Amending and Repealing Certain Administrative Regulations dated March 19, 2018.)

Chapter I General Provisions

Article 1 This Regulation is hereby enacted to strengthen biosafety management in pathogenic microorganism laboratories (hereinafter referred to as “laboratories”) and to protect the health of laboratory personnel and the general public.

Article 2 This Regulation applies to laboratories within the territory of the People’s Republic of China and to the biosafety management of their experimental activities.

For the purposes of these Regulations, “pathogenic microorganisms” refer to microorganisms capable of causing disease in humans or animals.

For the purposes of these Regulations, “experimental activities” refer to research, teaching, testing, diagnosis, and other related activities conducted in laboratories involving pathogenic microorganisms, strains (or toxins), and samples.

Article 3 The health authority under the State Council shall be responsible for the biosafety oversight of laboratories and their experimental activities that are related to human health.

The veterinary authority under the State Council is responsible for overseeing biosafety in laboratories related to animals and their experimental activities.

Other relevant departments of the State Council shall, within their respective areas of responsibility, be responsible for the biosafety management of laboratories and their experimental activities.

Local people’s governments at or above the county level and their relevant departments shall, within the scope of their respective responsibilities, be responsible for the biosafety management of laboratories and their experimental activities.

Article 4 The State shall implement classified management of pathogenic microorganisms and tiered management of laboratories.

Article 5 The State shall implement unified biosafety standards for laboratories. Laboratories shall comply with the relevant national standards and requirements.

Article 6 The institution establishing the laboratory and its competent authority shall be responsible for managing the laboratory’s daily operations, and shall undertake the duties of formulating and improving safety management systems, inspecting and maintaining laboratory facilities and equipment, and controlling laboratory‑acquired infections.

Chapter 2: Classification and Management of Pathogenic Microorganisms

Article 7: The State shall classify pathogenic microorganisms into four categories based on their transmissibility and the degree of harm they pose to individuals or populations upon infection.

Category I pathogenic microorganisms refer to those that can cause extremely severe diseases in humans or animals, as well as microorganisms that have not yet been detected in China or have already been officially declared eradicated.

Category II pathogenic microorganisms are those that can cause severe disease in humans or animals and are relatively easily transmitted, directly or indirectly, between humans, between animals and humans, or between animals.

Category III pathogenic microorganisms are those capable of causing disease in humans or animals, but which, under normal circumstances, do not pose a serious threat to humans, animals, or the environment, have a limited risk of transmission, rarely cause severe illness following laboratory exposure, and for which effective treatments and preventive measures are available.

Category IV pathogenic microorganisms are those that, under normal circumstances, do not cause disease in humans or animals.

Pathogenic microorganisms of Category I and Category II are collectively referred to as highly pathogenic microorganisms.

Article 8 The list of pathogenic microorganisms transmissible between humans shall be formulated, amended, and promulgated by the health authority under the State Council in consultation with the relevant departments of the State Council; the list of pathogenic microorganisms transmissible between animals shall be formulated, amended, and promulgated by the veterinary authority under the State Council in consultation with the relevant departments of the State Council.

Article 9: The collection of pathogenic microorganism samples shall meet the following conditions:
　　(1) Possess equipment that is commensurate with the biosafety containment level required for collecting pathogenic microorganism samples;
　　(2) Personnel who possess the relevant professional knowledge and operational skills;
　　(3) Possessing effective measures to prevent the spread and transmission of pathogenic microorganisms;
　　(4) Possessing the technical methods and means to ensure the quality of pathogenic microorganism samples.
　　Personnel collecting samples of highly pathogenic microorganisms shall, during the collection process, prevent the spread and transmission of such pathogens and maintain detailed records of the sample’s origin, the collection procedure, and the methods employed.
　　Article 10: The transport of highly pathogenic microbial strains (or toxins) or samples shall be conducted by land; where no land route is available and waterway transport is unavoidable, such transport may be carried out by water. In emergency situations or when it is necessary to export highly pathogenic microbial strains (or toxins) or samples, transport by civil aviation may be permitted.
　　Article 11: The transport of highly pathogenic microbial strains (viruses) or samples shall meet the following conditions:
　　(1) The purpose of transport, the intended use of highly pathogenic microorganisms, and the receiving entity shall comply with the regulations of the State Council’s health authority or veterinary authority;
　　(2) Containers for highly pathogenic microbial strains or samples shall be hermetically sealed, and the containers or packaging materials shall also meet requirements for water resistance, resistance to breakage, prevention of leakage, and tolerance to high (or low) temperatures and high pressure.
　　(3) Containers or packaging materials shall bear biohazard symbols, warning statements, and precautionary statements as prescribed by the State Council’s health authority or veterinary authority.
　　The transportation of highly pathogenic microbial strains or samples shall be subject to approval by the health or veterinary authorities of the people’s government at or above the provincial level. For transportation within the administrative boundaries of a province, autonomous region, or directly administered municipality, approval shall be granted by the corresponding health or veterinary authority of that local people’s government. Where transportation involves crossing provincial, autonomous regional, or directly administered municipal boundaries, or is destined for overseas, the transport shall first undergo a preliminary review by the health or veterinary authority of the originating locality, after which the matter shall be submitted, respectively, to the State Council’s health or veterinary authority for final approval.
　　When entry‑exit inspection and quarantine agencies require the transportation of pathogenic microorganism samples during inspection and quarantine procedures, such transport shall be approved by the State Council’s entry‑exit inspection and quarantine authority and simultaneously reported to the State Council’s health or veterinary administrative department.
　　Transportation of highly pathogenic microbial strains or samples by civil aviation shall, in addition to obtaining approval in accordance with paragraphs 2 and 3 of this Article, also be subject to the approval of the civil aviation authority under the State Council.
　　The competent authorities shall review the application materials submitted by the applicant for the transport of highly pathogenic microbial strains (or toxins) or samples, and shall grant immediate approval to those that meet the conditions set forth in paragraph 1 of this Article.
　　Article 12: The transport of highly pathogenic microbial strains (viruses) or samples shall be escorted by at least two designated personnel, who shall implement appropriate protective measures.
　　Relevant entities or individuals shall not transport pathogenic microorganism strains (or toxins) or samples by public buses, trams, or urban railways.
　　Article 13: Where highly pathogenic microbial strains (or toxins) or samples are to be transported by public transportation means such as railways, highways, or civil aviation, the carrier shall transport them only upon presentation of the approval documents specified in Article 11 of these Regulations.
　　The carrier shall, in conjunction with the escort, implement measures to ensure the safety of the highly pathogenic microbial strains or toxins, or samples thereof, being transported, and shall strictly prevent incidents of theft, robbery, loss, or leakage.
　　Article 14. The strain (or toxin) preservation centers or specialized laboratories designated by the State Council’s health authority or veterinary authority (hereinafter referred to as “preservation institutions”) shall be responsible for the centralized storage of pathogenic microorganism strains (or toxins) and samples.
　　Biological resource repositories shall, in accordance with the regulations of the State Council’s health or veterinary authorities, store pathogenic microorganisms and samples submitted by laboratories and provide such microorganisms and samples to the laboratories.
　　Biological resource repositories shall establish stringent security‑storage procedures, maintain detailed records of the entry, exit, and storage of pathogenic microbial strains (including toxins) and samples, implement a comprehensive archival system, and designate dedicated personnel to oversee these activities. High‑pathogenicity pathogenic microbial strains (including toxins) and samples shall be stored separately in dedicated storage facilities or on dedicated shelves.
　　Microbial pathogen strains (including viruses) and samples stored and provided by preservation institutions shall be made available free of charge, with funding secured through the budgetary allocations of the corresponding-level fiscal authorities.
　　The administrative measures for preservation institutions shall be formulated by the health authority under the State Council in conjunction with the veterinary authority under the State Council.
　　Article 15: The preservation institution shall, upon presentation of the approval document issued to the laboratory in accordance with the provisions of these Regulations for conducting experimental activities involving highly pathogenic microorganisms, provide the laboratory with strains (or toxins) and samples of such microorganisms and maintain a corresponding record.
　　Article 16: Upon completion of the relevant experimental activities, laboratories shall, in accordance with the provisions of the State Council’s health or veterinary authorities, promptly destroy pathogenic microorganisms and their strains (or toxins) and samples on-site, or submit them to a designated preservation institution for safekeeping.
　　When a preservation institution receives pathogenic microorganism strains (or toxins) and samples submitted by a laboratory, it shall register them and issue a receipt.
　　Article 17: In the event that highly pathogenic microbial strains (viruses) or samples are stolen, robbed, lost, or leaked during transportation or storage, the carrier, the escort, and the preservation institution shall immediately implement necessary control measures and, within two hours, report separately to the competent authority of the carrier, the employer of the escort, and the competent authority of the preservation institution. At the same time, they shall also report to the health or veterinary administrative department of the county-level people’s government where the incident occurred; if the incident involves theft, robbery, or loss, a report shall further be made to the public security organ. Upon receiving such reports, the health or veterinary administrative department shall, within two hours, report to the people’s government at its own level and simultaneously to the higher-level health or veterinary administrative department and to the health or veterinary administrative department under the State Council.
　　The people’s government at the county level shall, upon receipt of a report, submit it to the people’s government at the prefectural level or to the next higher-level people’s government within two hours; the people’s government at the prefectural level shall, upon receipt of a report, submit it to the people’s government of the province, autonomous region, or directly administered municipality within two hours. The people’s government of the province, autonomous region, or directly administered municipality shall, upon receipt of a report, submit it to the competent health authority or veterinary authority under the State Council within one hour.
　　Any organization or individual that discovers a container or packaging material containing highly pathogenic microbial strains or samples shall promptly report it to the nearest health authority or veterinary authority; upon receipt of such a report, the relevant health or veterinary authority shall promptly organize an investigation and verification and, in accordance with the law, take the necessary control measures.

Chapter 3: Establishment and Management of Laboratories

　　 Article 18: The State shall classify laboratories into four levels—Level 1, Level 2, Level 3, and Level 4—based on their biosafety containment levels for pathogenic microorganisms and in accordance with the provisions of the national standards for laboratory biosafety.
　　Article 19: The construction, renovation, or expansion of Level 3 and Level 4 laboratories, as well as the production or importation of mobile Level 3 and Level 4 laboratories, shall comply with the following provisions:
　　(1) Comply with the national biosafety laboratory system plan and duly fulfill the relevant approval procedures in accordance with the law;
　　(2) Subject to review and approval by the State Council’s competent authority for science and technology;
　　(3) Complies with the National Technical Specifications for Biosafety Laboratory Buildings;
　　(4) Conduct an environmental impact assessment in accordance with the provisions of the Environmental Impact Assessment Law of the People’s Republic of China, and obtain review and approval from the competent environmental protection authority;
　　(5) The biosafety containment level shall be commensurate with the intended experimental activities.
　　The national biosafety laboratory system plan referred to in the preceding paragraph shall be formulated by the State Council’s investment authority in conjunction with the relevant departments of the State Council. The formulation of such a plan shall adhere to the principles of overall quantity control, rational spatial planning, and resource sharing, and shall include the convening of public hearings or expert review meetings to solicit the views of specialists in public health, environmental protection, investment management, and laboratory administration.
　　Article 20: Level-3 and Level-4 laboratories shall obtain national accreditation.
　　The accreditation body designated by the State Council’s administrative department for certification and accreditation shall, in accordance with the national standards for laboratory biosafety and the relevant provisions of these Regulations, accredit Level 3 and Level 4 laboratories; upon successful accreditation, the laboratory shall be issued a biosafety laboratory certificate corresponding to its level. The certificate shall be valid for a period of five years.
　　Article 21: Level 1 and Level 2 laboratories shall not conduct experimental activities involving highly pathogenic microorganisms. Level 3 and Level 4 laboratories engaging in experimental activities involving highly pathogenic microorganisms shall meet the following conditions:
　　(1) The purpose of the experiment and the proposed experimental activities comply with the regulations of the State Council’s health or veterinary authorities;
　　(2) Obtaining national accreditation for the laboratory;
　　(3) Possessing personnel who are qualified to carry out the proposed experimental activities;
　　(4) The project quality has been duly inspected and accepted as compliant by the competent construction authority in accordance with the law.
　　Article 22: Laboratories of Biosafety Level 3 and Level 4 that intend to conduct experimental activities involving highly pathogenic microorganisms or suspected highly pathogenic microorganisms shall, in accordance with the regulations of the State Council’s health or veterinary authorities, submit an application for approval to the health or veterinary authority of the people’s government at or above the provincial level. The results of such experimental activities and the status of the work shall be reported to the original approving authority.
　　Laboratories that apply for or undertake research projects involving highly pathogenic microorganisms shall comply with both scientific research needs and biosafety requirements and maintain an appropriate level of biosafety protection. Research projects involving highly pathogenic microorganisms that can be transmitted between animals must obtain approval from the veterinary authority under the State Council; for research projects involving highly pathogenic microorganisms that pose a risk to human health, the laboratory shall notify the health authorities of the people’s government at or above the provincial level of the project’s approval.
　　Article 23: When entry‑exit inspection and quarantine agencies, medical and health institutions, and animal disease prevention agencies conduct testing or diagnostic activities in laboratories and detect highly pathogenic microorganisms or suspected highly pathogenic microorganisms, any further experimental activities involving such highly pathogenic microorganisms shall be subject to approval in accordance with the provisions of these Regulations and carried out in laboratories that meet the relevant requirements.
　　Laboratories specializing in testing and diagnosis shall, in strict accordance with the regulations of the State Council’s health or veterinary authorities, establish and improve relevant rules and procedures to ensure laboratory biosafety.
　　Article 24: The health or veterinary administrative departments of the people’s governments at or above the provincial level shall, within fifteen days from the date of receipt of an application to conduct experimental activities involving highly pathogenic microorganisms, make a decision on whether to grant approval.
　　Where an entry‑exit inspection and quarantine agency, for the urgent needs of inspection and quarantine work, applies to conduct further experimental activities in a laboratory involving highly pathogenic microorganisms or suspected highly pathogenic microorganisms, the health or veterinary administrative department of the people’s government at or above the provincial level shall, within two hours of receiving the application, make a decision on whether to grant approval; if no decision is rendered within that two‑hour period, the laboratory may proceed with the relevant experimental activities.
　　The health or veterinary administrative departments of people’s governments at or above the provincial level shall facilitate applicants in submitting applications by telegraph, telex, fax, electronic data interchange, and e‑mail.
　　Article 25: The construction, renovation, or expansion of Level I and Level II laboratories shall be filed with the health or veterinary administrative department of the people’s government at the prefectural level. The said health or veterinary administrative department shall, on an annual basis, compile and submit a summary of such filings to the health or veterinary administrative department of the people’s government of the province, autonomous region, or directly administered municipality.
　　Article 26 The health and veterinary authorities under the State Council shall, on a regular basis, compile and mutually exchange information on the number of laboratories, their establishment and geographical distribution, as well as on the activities conducted by Biosafety Level 3 and Level 4 laboratories involving experiments with highly pathogenic microorganisms.
　　Article 27 Laboratories at Levels III and IV that have been completed and accredited by the national laboratory accreditation body shall file with the environmental protection authority of the county-level people’s government in their jurisdiction. The environmental protection authority shall, in accordance with laws and administrative regulations, conduct supervision and inspection over the treatment and disposal of wastewater, exhaust gases, and other wastes discharged by such laboratories.
　　Article 28: With respect to pathogenic microorganisms that have not yet been detected in China or have already been declared eradicated, no organization or individual may engage in any related experimental activities without prior approval.
　　To prevent and control infectious diseases, any activities involving pathogenic microorganisms as specified in the preceding paragraph shall be subject to approval by the State Council’s health authority or veterinary authority and conducted in specialized laboratories designated by the approving authority.
　　Article 29: When a laboratory employs new technologies or methods to conduct experimental activities involving highly pathogenic microorganisms, such activities shall comply with requirements for preventing the spread of these pathogens, ensuring biosafety, and safeguarding the personal safety of operators, and shall be subject to review by the National Biosafety Expert Committee for Pathogen Laboratories. Only after such review concludes that the activities are feasible may they be carried out.
　　Article 30: Any experimental activities involving highly pathogenic microorganisms that are to be conducted on animals shall be carried out in a laboratory at Biosafety Level 3 or above that complies with the national standards for biosafety in animal laboratories.
　　Article 31 The entity establishing the laboratory shall be responsible for its biosafety management.
　　The institution establishing the laboratory shall, in accordance with the provisions of these Regulations, formulate scientific and stringent management systems, and shall conduct regular inspections to ensure compliance with relevant biosafety requirements. It shall also carry out periodic inspections, maintenance, and upgrades of laboratory facilities, equipment, materials, and other resources to ensure that they meet national standards.
　　The institution establishing the laboratory and its competent supervisory authority shall strengthen the management of the laboratory’s day-to-day operations.
　　Article 32: The laboratory director is the primary person responsible for biosafety within the laboratory.
　　Laboratories conducting experimental activities shall strictly comply with relevant national standards, laboratory technical specifications, and operating procedures. The head of the laboratory shall designate a dedicated person to oversee and verify the implementation of these technical specifications and operating procedures.
　　Article 33 The entity establishing a laboratory engaged in experimental activities involving highly pathogenic microorganisms shall establish and improve security and safeguarding systems, implement appropriate security measures, and take stringent precautions to prevent the theft, robbery, loss, or leakage of such microorganisms, thereby ensuring the safety of the laboratory and its pathogenic microorganisms. In the event of theft, robbery, loss, or leakage of highly pathogenic microorganisms, the laboratory’s establishing entity shall submit a report in accordance with the provisions of Article 17 of these Regulations.
　　Laboratories engaged in experimental activities involving highly pathogenic microorganisms shall file a record with the local public security authorities and shall be subject to the supervision and guidance of those authorities regarding laboratory safety and security.
　　Article 34: Laboratories or the entities establishing them shall conduct regular annual training for their staff to ensure that they are proficient in laboratory technical standards, operating procedures, biosafety protection knowledge, and practical operational skills, and shall administer assessments. Only personnel who pass such assessments may be assigned to duty.
　　Laboratories engaged in experimental activities involving highly pathogenic microorganisms shall, every six months, report to the health or veterinary authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government on the training and assessment of their personnel, as well as on the laboratory’s operational status.
　　Article 35: Any experimental activities involving highly pathogenic microorganisms shall be conducted by at least two personnel working together.
　　Personnel entering a laboratory engaged in experimental activities involving highly pathogenic microorganisms, or other relevant personnel, shall obtain approval from the laboratory director. The laboratory shall provide them with protective equipment that meets applicable safety standards and implement other occupational protection measures. Laboratories conducting experiments involving highly pathogenic microorganisms shall also conduct health monitoring of their staff, arrange annual medical examinations, and maintain health records; where necessary, they shall administer preventive vaccinations to laboratory personnel.
　　Article 36: Within the same independent biosafety containment area of a laboratory, only one type of experimental activity involving a highly pathogenic microorganism may be conducted at any given time.
　　Article 37 Laboratories shall establish laboratory records to document the use of laboratory facilities and safety oversight. For laboratories conducting experimental activities involving highly pathogenic microorganisms, the retention period for such records shall be no less than 20 years.
　　Article 38: Laboratories shall, in accordance with relevant laws and administrative regulations on environmental protection and the provisions of the competent departments under the State Council, treat wastewater, waste gases, and other wastes, and shall formulate corresponding environmental protection measures to prevent environmental pollution.
　　Article 39: Level 3 and Level 4 laboratories shall conspicuously display the biohazard symbols and the biosafety laboratory level markings prescribed by the State Council’s health and veterinary authorities.
　　Article 40 Laboratories engaged in experimental activities involving highly pathogenic microorganisms shall formulate an emergency response plan for laboratory-acquired infections and file it with the health or veterinary administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government where the laboratory is located.
　　Article 41 The health and veterinary authorities under the State Council, in conjunction with relevant departments of the State Council, shall organize experts in pathogen biology, immunology, laboratory medicine, epidemiology, preventive veterinary medicine, environmental protection, and laboratory management to establish the National Biosafety Expert Committee for Pathogenic Microorganism Laboratories. This Committee shall undertake biosafety assessments and provide technical consultation and expert review for the establishment and operation of laboratories engaged in experimental activities involving highly pathogenic microorganisms.
　　The health and veterinary authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government, in coordination with relevant departments of the same-level people’s governments, shall convene experts in fields such as pathogenology, immunology, laboratory medicine, epidemiology, preventive veterinary medicine, environmental protection, and laboratory management to establish a regional biosafety expert committee for pathogenic microorganism laboratories. This committee shall undertake technical advisory functions related to the establishment and operation of laboratories within the region.

Chapter 4: Laboratory Infection Control

　　 Article 42: The entity establishing a laboratory shall designate a specialized institution or personnel to oversee laboratory infection control, and shall conduct regular inspections of the implementation of relevant regulations and procedures concerning biosafety protection, the storage and use of pathogenic microorganisms and strains (or toxins) and samples, safe operating practices, the treatment of wastewater and exhaust gases discharged from the laboratory, and the disposal of other waste materials.
　　The institution or personnel responsible for laboratory infection control shall possess knowledge of the prevention and control of infectious diseases associated with the pathogenic microorganisms handled in the laboratory, and shall conduct regular surveys to monitor and assess the health status of laboratory staff.
　　Article 43: When laboratory personnel exhibit clinical symptoms or signs of infection that are associated with experimental activities involving highly pathogenic microorganisms conducted in this laboratory, the laboratory director shall report to the institution or individual responsible for laboratory infection control and arrange for a designated person to accompany the individual to seek medical attention without delay. Laboratory personnel shall truthfully disclose to the treating medical institution the types of pathogenic microorganisms they have recently been exposed to and their corresponding risk levels. The receiving medical institution shall provide timely treatment; if it lacks the necessary conditions for such treatment, it shall, in accordance with applicable regulations, refer the infected laboratory personnel to a medical institution equipped to manage the relevant infectious disease. Medical institutions possessing the requisite capabilities for managing such infectious diseases shall accept and treat the patient and may not refuse care.
　　Article 44: When a laboratory experiences a leakage of highly pathogenic microorganisms, the laboratory personnel shall immediately implement control measures to prevent the spread of such pathogens and simultaneously report the incident to the institution or individual responsible for laboratory infection control.
　　Article 45: Upon receiving reports as stipulated in Articles 43 and 44 of these Regulations, the institution or personnel responsible for laboratory infection control shall immediately activate the laboratory infection emergency response plan and organize personnel to investigate the laboratory’s biosafety conditions and other relevant matters. If a laboratory infection or a leakage of highly pathogenic microorganisms is confirmed, a report shall be submitted in accordance with Article 17 of these Regulations, and at the same time, appropriate control measures shall be implemented, including medical observation or isolation treatment of affected personnel, closure of the laboratory, and prevention of further spread.
　　Article 46: Upon receiving reports of occupational infections or pathogenic microorganism leakage incidents in a laboratory, or upon discovering that laboratory activities involving pathogenic microorganisms have resulted in laboratory-acquired infections, the competent health authority or the competent veterinary authority shall promptly organize disease prevention and control institutions, animal epidemic prevention and supervision agencies, medical institutions, and other relevant entities to take, in accordance with the law, the following preventive and control measures:
　　(1) Close off laboratories contaminated by pathogenic microorganisms or premises that may facilitate the spread of such pathogens;
　　(2) Conduct epidemiological investigations;
　　(3) Isolate and treat patients, and conduct medical examinations of relevant personnel;
　　(4) Conduct medical observation of close contacts;
　　(5) Conduct on-site disinfection;
　　(6) Implement measures such as isolation and culling with respect to animals that are infected or suspected of being infected;
　　(7) Other preventive and control measures that need to be implemented.
　　Article 47: When a medical institution or a veterinary medical institution, together with its personnel performing official duties, identifies patients with infectious diseases associated with highly pathogenic microorganisms, suspected cases of such diseases, or animals suffering from or suspected of suffering from such diseases that are attributable to laboratory-acquired infections, the medical or veterinary medical institution providing diagnosis and treatment shall, within two hours, report the case to the health authority or the veterinary authority of the county-level people’s government where it is located. The receiving health authority or veterinary authority shall, within two hours, notify the health authority or the veterinary authority of the county-level people’s government where the laboratory is located. The notified health authority or veterinary authority shall, in accordance with the provisions of Article 46 of these Regulations, take preventive and control measures.
　　Article 48: When the spread of pathogenic microorganisms occurs and there is a risk of an outbreak or epidemic of infectious diseases, the health or veterinary administrative departments of people’s governments at or above the county level shall, in accordance with relevant laws and administrative regulations and the laboratory‑acquired infection emergency response plan, take appropriate measures.

Chapter Five: Supervision and Management

Article 49 The health and veterinary administrative departments of the people’s governments at or above the county level shall, in accordance with their respective divisions of responsibility, perform the following duties:
　　(1) Conduct supervision and inspection over the collection, transportation, and storage of pathogenic microorganism strains (or toxins) and samples;
　　(2) To conduct supervision and inspection to determine whether laboratories engaged in experimental activities involving highly pathogenic microorganisms meet the conditions stipulated in these Regulations;
　　(3) Conduct supervision and inspection of the training, assessment, and on-the-job qualification of laboratory personnel and the personnel of the laboratory’s sponsoring institution.
　　(4) Conduct supervision and inspection to ensure that laboratories carry out pathogenic microorganism‑related experimental activities in accordance with relevant national standards, technical specifications, and operating procedures.
　　The health and veterinary authorities of local people’s governments at or above the county level shall, by means primarily of inspecting records, archives, and reports that document the laboratory’s compliance with relevant national laws, administrative regulations, and national standards and requirements, effectively fulfill their supervisory and administrative duties.
　　Article 50: The health, veterinary, and environmental protection authorities of the people’s governments at or above the county level, when performing their duties of supervision and inspection, shall have the authority to enter the premises of the entities being inspected and the sites where pathogenic microorganisms have leaked or spread to conduct investigations and collect evidence, take samples, and review and duplicate relevant materials. Where it is necessary to enter laboratories engaged in experimental activities involving highly pathogenic microorganisms to conduct investigations and collect samples, such activities shall be carried out by a designated or entrusted specialized agency. The entities being inspected shall cooperate and may not refuse or obstruct.
　　Article 51 The certification and accreditation supervisory authority under the State Council shall, in accordance with the provisions of the Regulations of the People’s Republic of China on Certification and Accreditation, conduct supervision and inspection of laboratory accreditation activities.
　　Article 52 The competent departments for health, veterinary medicine, and environmental protection shall perform their duties in accordance with their statutory powers and procedures, ensuring impartiality, fairness, transparency, civility, and efficiency.
　　Article 53: When law enforcement officers of the health administrative department, the veterinary administrative department, and the environmental protection administrative department perform their duties, they shall be accompanied by no fewer than two officers, present their law enforcement credentials, and complete the required law enforcement documents in accordance with applicable regulations.
　　After the on-site inspection records, sampling records, and other documents have been verified as accurate, they shall be signed by the law enforcement officers and the person being inspected or sampled. If the person being inspected or sampled refuses to sign, the law enforcement officer shall sign the document and make a note of the circumstances.
　　Article 54. The health authorities, veterinary authorities, and environmental protection authorities, as well as their law enforcement personnel, shall, in the performance of their duties, conscientiously accept oversight from the public and citizens. Citizens, legal persons, and other organizations have the right to report to the higher-level people’s government and its health, veterinary, and environmental protection authorities any instances where local people’s governments and their relevant competent departments fail to perform their duties in accordance with the provisions. The people’s government or the relevant health, veterinary, or environmental protection authority that receives such a report shall promptly investigate and take appropriate action.
　　Article 55: When the health, veterinary, and environmental protection authorities of a higher-level people’s government discover matters within the purview of the corresponding departments of a lower-level people’s government that require handling, they shall promptly notify such departments to take action. If the lower-level departments fail to act in a timely manner or do not actively perform their duties, the higher-level authorities shall order them to make corrections within a specified time limit; if they fail to comply by the deadline, the higher-level authorities shall have the power to handle the matters directly.

Chapter VI Legal Liability

Article 56: If a Level 3 or Level 4 laboratory conducts experimental activities involving a highly pathogenic microorganism or a suspected highly pathogenic microorganism without approval, the health and veterinary authorities of the local people’s government at or above the county level shall, in accordance with their respective duties, order the cessation of the relevant activities, supervise the destruction of the pathogenic microorganisms used in such activities or their transfer to a preservation institution, and issue a warning. If such conduct results in the transmission or outbreak of an infectious disease or other serious consequences, the entity that established the laboratory shall impose disciplinary measures—such as removal from office or dismissal—on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable, in accordance with the law; if the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 57: If the health administrative department or the veterinary administrative department, in violation of the provisions of these Regulations, permits a laboratory that does not meet the conditions stipulated herein to conduct experimental activities involving highly pathogenic microorganisms, the approving health administrative department or veterinary administrative department shall revoke the original approval decision, order the relevant laboratory to immediately cease such activities, and supervise the destruction of the pathogenic microorganisms used in the experiments or their transfer to an authorized preservation institution. In addition, the directly responsible persons in charge and other persons directly liable shall be subject to administrative disciplinary measures in accordance with the law; if the act constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Where an unlawful approval decision causes damage to the lawful rights and interests of the party concerned, the health administrative department or the veterinary administrative department that issued the approval shall bear liability for compensation in accordance with the law.
　　Article 58: If the competent health authority or veterinary authority fails to make a decision on whether to approve, within the statutory time limit, an application submitted by an entry‑exit inspection and quarantine institution to conduct additional testing in a laboratory on highly pathogenic microorganisms or suspected highly pathogenic microorganisms for urgent purposes related to inspection and quarantine work, the superior administrative organ or the supervisory organ shall order it to make corrections and issue a warning. If such failure results in the transmission or outbreak of an infectious disease or other serious consequences, the directly responsible principal officials and other persons directly liable shall be subject to administrative sanctions of removal from office or dismissal in accordance with the law; if the act constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 59: Any entity that, in violation of the provisions of these Regulations, conducts pathogenic microorganism‑related experimental activities in a laboratory that does not meet the applicable biosafety requirements shall, by the health and veterinary authorities of the local people’s government at or above the county level in accordance with their respective duties, be ordered to cease the relevant activities, supervised to destroy the pathogenic microorganisms used in such activities or to transfer them to a designated preservation institution, and issued a warning. If such conduct results in the transmission or outbreak of an infectious disease or other serious consequences, the institution that established the laboratory shall, in accordance with law, impose disciplinary measures of removal from office or dismissal on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with law.
　　Article 60: If a laboratory engages in any of the following acts, the health and veterinary authorities of the local people’s government at or above the county level shall, within their respective jurisdictions, order it to make corrections within a specified time limit and issue a warning; if the corrections are not made by the deadline, the institution that established the laboratory shall impose disciplinary measures—such as removal from office or dismissal—on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable, in accordance with the law; where a license is required, the original licensing authority shall also revoke the relevant license.
　　(1) Failure to conspicuously display, as required, the biohazard symbols and the biosafety laboratory level markings prescribed by the State Council’s health and veterinary authorities;
　　(2) Failure to report the results of experimental activities and the status of work to the original approving authority;
　　(3) Failure to collect pathogenic microorganism samples in accordance with the prescribed requirements, or failure to maintain detailed records regarding the source of the collected samples, the collection process, and the methods employed;
　　(4) Failure to file with the health or veterinary administrative department of the people’s government at the prefectural level for newly constructed, renovated, or expanded Level 1 or Level 2 laboratories;
　　(5) Failing to conduct regular training for personnel as required, or allowing personnel who have failed their performance evaluations to take up their posts, or approving the entry of individuals into the laboratory without appropriate protective measures;
　　(6) Laboratory personnel fail to comply with laboratory biosafety technical specifications and operating procedures;
　　(7) Failure to establish or maintain experimental records in accordance with the relevant regulations;
　　(8) Failure to formulate and file a laboratory infection emergency response plan in accordance with the relevant regulations.
　　Article 61: If the entity establishing a laboratory that has been legally approved to conduct experimental activities involving highly pathogenic microorganisms fails to establish and improve security and safeguarding systems, or fails to implement appropriate security measures, the health and veterinary authorities of the local people’s government at or above the county level shall, in accordance with their respective responsibilities, order it to make corrections within a specified time limit. If the corrections are not made by the deadline and such failure results in the theft or robbery of strains (or toxins) or samples of highly pathogenic microorganisms, or causes other serious consequences, the authorities shall order the suspension of the relevant experimental activities, and the laboratory shall be prohibited from applying to conduct experiments involving highly pathogenic microorganisms for a period of two years. If the incident leads to the transmission or outbreak of an infectious disease, the competent authority of the laboratory’s sponsoring entity shall also impose disciplinary sanctions—such as demotion, removal from office, or dismissal—on the directly responsible persons in charge and other persons directly liable, in accordance with the law. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 62: Any entity that transports highly pathogenic microbial strains or samples without approval, or any carrier that, having obtained approval to transport such strains or samples, fails to fulfill its duty of protection, thereby causing the theft, robbery, loss, or leakage of these strains or samples, shall be subject, by the health and veterinary authorities of the people’s governments at or above the county level in accordance with their respective responsibilities, to an order to take measures to eliminate the hazard and a warning. If such actions result in the transmission or outbreak of infectious diseases or other serious consequences, the competent authorities of both the consignor and the carrier shall impose disciplinary sanctions—such as removal from office or dismissal—on the principal persons in charge, the directly responsible supervisors, and other persons directly liable, in accordance with the law. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 63: Any of the following acts shall, by the health and veterinary authorities of the local people’s government at or above the prefectural level where the laboratory is located, in accordance with their respective duties, result in an order to the relevant entity to immediately cease the unlawful activity and to supervise the destruction of pathogenic microorganisms or their transfer to a preservation institution; if such acts cause the transmission or outbreak of an infectious disease or other serious consequences, the entity concerned or its superior competent authority shall, in accordance with law, impose disciplinary measures of removal from office or dismissal on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable; where a license is required, the original licensing authority shall revoke the relevant license; if the act constitutes a crime, criminal liability shall be pursued in accordance with law.
　　(1) After completing the relevant experimental activities, the laboratory fails to promptly destroy pathogenic microorganisms and samples on-site or transfer them to a designated preservation institution for safekeeping as required;
　　(2) The laboratory conducts experimental activities involving highly pathogenic microorganisms using new technologies or methods without prior review and approval by the National Biosafety Expert Committee for Pathogen Laboratories;
　　(3) Conducting, without approval, experimental activities involving pathogenic microorganisms that have not yet been detected in China or have already been declared eradicated;
　　(4) Conducting experimental activities involving pathogenic microorganisms that have not yet been detected in China or have already been declared eradicated, without the authorization of a designated specialized laboratory;
　　(5) Conducting, within the same laboratory and in the same independent biosafety containment area, two or more types of experimental activities involving highly pathogenic microorganisms simultaneously.
　　Article 64: If a conformity assessment body accredits a laboratory that does not meet the national standards for biosafety or the conditions stipulated in these Regulations, or fails to accredit a laboratory that does meet such standards and conditions, the State Council’s department responsible for the supervision and administration of certification and accreditation shall order it to make corrections within a specified time limit and issue a warning. If such actions result in the transmission or outbreak of an infectious disease, or other serious consequences, the State Council’s department responsible for the supervision and administration of certification and accreditation shall revoke its accreditation; where there is a competent superior authority, that authority shall, in accordance with law, impose disciplinary measures of removal from office or dismissal on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 65: If laboratory personnel develop clinical symptoms or signs suggestive of infection related to pathogenic microorganism–associated experimental activities conducted in the laboratory, or if a laboratory experiences a leakage of highly pathogenic microorganisms, and the laboratory director, laboratory personnel, or the specialized institution or individual responsible for laboratory infection control fails to report such incidents as required or to implement prescribed control measures, the health or veterinary administrative departments of the local people’s government at or above the county level shall, in accordance with their respective duties, order rectification within a specified time limit and issue a warning. If such failure results in the transmission or outbreak of an infectious disease or other serious consequences, the entity that established the laboratory shall impose disciplinary sanctions—such as removal from office or dismissal—on the laboratory’s principal person in charge, the directly responsible supervisory personnel, and other persons directly liable, in accordance with the law; where a license is involved, the original licensing authority shall revoke the relevant license. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 66: Any entity that refuses to cooperate with the health authorities or veterinary authorities in conducting, in accordance with the law, investigations and evidence collection, sample collection, or other activities related to the spread of highly pathogenic microorganisms, or that fails to implement the preventive and control measures prescribed in these Regulations, shall, by the health or veterinary authorities of the people’s government at or above the county level within their respective jurisdictions, be ordered to make corrections and issued a warning. If such refusal results in the transmission or outbreak of an infectious disease or other serious consequences, the institution that established the laboratory shall, in accordance with the law, impose disciplinary sanctions—such as demotion, removal from office, or dismissal—on the principal person in charge of the laboratory, the directly responsible supervisory personnel, and other persons directly liable. Furthermore, if the entity holds relevant permits, the original issuing authority shall revoke such permits. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 67: If pathogenic microorganisms are stolen, robbed, lost, or leaked, and the carrier, escort, preservation institution, or the entity that established the laboratory fails to report in accordance with the provisions of these Regulations, the health authority or veterinary authority of the county-level people’s government where the incident occurred shall issue a warning. If such failure results in the transmission or outbreak of an infectious disease, or other serious consequences, the superior competent authority of the laboratory‑establishing entity, the carrier, or the preservation institution shall impose disciplinary measures—such as removal from office or dismissal—on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable, in accordance with the law. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 68: If a preservation institution fails to store the microbial (or viral) strains and samples submitted by laboratories in accordance with the relevant regulations, or fails to provide such strains and samples as required, the competent authority shall order it to make corrections within a specified time limit, reclaim any strains or samples provided in violation of the regulations, and issue a warning. If such failure results in the transmission or outbreak of an infectious disease or other serious consequences, the institution’s employing entity or its superior supervisory authority shall, in accordance with law, impose disciplinary measures of removal from office or dismissal on the principal person in charge, the directly responsible supervisory personnel, and other persons directly liable. Where the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.
　　Article 69: If the competent departments of people’s governments at or above the county level fail to perform their duties of supervising and inspecting laboratories and their experimental activities in accordance with the provisions of these Regulations, the relevant people’s governments shall, within their respective spheres of responsibility, order rectification and issue public criticism. If such failure results in the transmission or outbreak of an infectious disease or other serious consequences, the directly responsible persons in charge shall be subject to administrative disciplinary measures in accordance with the law; if the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

Chapter VII Supplementary Provisions

　　  Article 70: Military laboratories shall be subject to supervision and administration by the health authorities of the Chinese People’s Liberation Army, in accordance with the provisions of these Regulations.
　　 Article 71 Laboratories established prior to the entry into force of these Regulations shall, within six months from the date of such entry into force, complete the relevant procedures in accordance with the provisions of these Regulations.
　　 Article 72 This Regulation shall enter into force on the date of its promulgation.

Source: National Health Commission of the People’s Republic of China