Regulation on the Bio-safety Management of Pathogenic Microbe Labs (2018 Amendment)

Regulation on the Bio-safety Management of Pathogenic Microbe Labs (2018 Amendment) Regulation on the Bio-safety Management of Pathogenic Microbe Labs (Promulgated by Order No. 424 of the State Council of the People's Republic of China on November 12, 2004; revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016; and amended in accordance with the Decision of the State Council to Amend and Repeal Certain Administrative Regulations on March 19, 2018) Chapter I General Provisions Article 1 The present Regulation is formulated for the purpose of further strengthening the bio-safety management of pathogenic microbe labs (hereinafter referred to as the labs) 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 labs within the territory of the People's Republic of China as well as the experimental activities which are conducted in the labs. 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 labs, 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 labs relating to human health and the experimental activities which are conducted in the labs. The administrative department of veterinary of the State Council shall be responsible for supervision over the bio-safety of labs relating to animals and the experimental activities conducted in the labs. The other relevant departments of the State Council shall, under their respective functions, be responsible for the bio-safety management of the labs and the experimental activities which are conducted in the labs. 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 labs and the experimental activities which are conducted in the labs. Article 4 The state adopts categorized management over the pathogenic microbes, and graded management over the labs. 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 labs 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 labs, and shall provide the labs 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 Labs Article 18 The state shall classify the labs 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 labs. 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 labs 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 Environmental Impact Evaluation Law of the People's Republic of China 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 labs" 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 labs 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 labs 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. Art......