Administrative Regulations on the Bio-safety of Pathogenic Microbe Laboratories (Revised in 2018)
Administrative Regulations on the Bio-safety of Pathogenic Microbe Laboratories (Revised in 2018)
Administrative Regulations on the Bio-safety of Pathogenic Microbe Laboratories (Revised in 2018)
Order of the State Council of the People's Republic of China No. 698
March 19, 2018
(Promulgated by the Order of the State Council of the People's Republic of China No.424 on November 12, 2004; revised for the first time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016; and revised for the second time in accordance with the Decision of the State Council on Revising and Repealing Certain Administrative Regulations on March 19, 2018)
Chapter I General Provisions
Article 1 The Regulations are 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 Regulations 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" herein refers to any microorganism capable of causing human or animal diseases.
The term "experimental activities" herein 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 health authority of the State Council shall be responsible for the supervision of the bio-safety of the laboratories relating to human health and the experimental activities which are conducted in the laboratories.
The veterinary authority of the State Council shall be responsible for supervision of 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 relevant 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 of the pathogenic microbes, and graded management of 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 that launches a lab and its administrative department shall be responsible for the management of the routine activities of the lab and shall perform 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 group:
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 China.
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 that are capable of causing human or animal diseases but usually cannot severely endanger the human, animals or environment, have limited risk of spreading and seldom cause severe diseases after laboratory infection, with effective treatment and prevention measures in place.
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 health authority 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 veterinary authority of the State Council in consultation with other relevant departments of the State Council.
Article 9 A lab shall meet the following conditions when collecting samples of pathogenic microbes:
(1) Having equipment up to the bio-safety protection level for collecting 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.
In the course of collecting samples of highly pathogenic microbes, the staff members shall prevent the spreading and infection of pathogenic microbes, and shall make detailed records of the source thereof as well as the collection process 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 passage, 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 health authority or the veterinary authority of the State Council;
(2) The container of strains or samples of highly pathogenic bacteria (virus) shall be sealed up, the container or packing materials shall meet 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 marked with the bio-risk signs, warnings and hints as provided by the health authority or the veterinary authority of the State Council.
The transport of strains of samples of highly pathogenic bacteria (virus) shall be subject to the approval of the health authority or the veterinary authority 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 health authority or the veterinary authority of the people's government of the said 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 health authority or the veterinary authority of the people's government of the province, autonomous region, or municipality directly under the Central Government at the place of departure, then respectively subject to the approval of the health authority or the veterinary authority 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 health authority or the veterinary authority of the State Council.
The transport of strains or samples of highly pathogenic bacteria (virus) through civil aviation shall, in addition to the approval in accordance with Paragraphs 2 and 3, be subject to 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, and shall promptly grant the applicant an approval if the aforesaid application materials meet the conditions as listed in Paragraph 1 of this Article.
Article 12 As to the transport of strains or samples of highly pathogenic bacteria (virus), two 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 Regulations.
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 health authority or the veterinary authority 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 health authority or the veterinary authority 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 health authority jointly with the veterinary authority 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 Regulations, 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 health authority or the veterinary authority 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 two hours and shall simultaneously report to the health authority or the veterinary authority of the local people's government at the county level and report to the public security organ if any such strains or samples are stolen, robbed or lost.
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Order of the State Council of the People's Republic of China No. 698
March 19, 2018
(Promulgated by the Order of the State Council of the People's Republic of China No.424 on November 12, 2004; revised for the first time in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016; and revised for the second time in accordance with the Decision of the State Council on Revising and Repealing Certain Administrative Regulations on March 19, 2018)
Chapter I General Provisions
Article 1 The Regulations are 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 Regulations 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" herein refers to any microorganism capable of causing human or animal diseases.
The term "experimental activities" herein 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 health authority of the State Council shall be responsible for the supervision of the bio-safety of the laboratories relating to human health and the experimental activities which are conducted in the laboratories.
The veterinary authority of the State Council shall be responsible for supervision of 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 relevant 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 of the pathogenic microbes, and graded management of 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 that launches a lab and its administrative department shall be responsible for the management of the routine activities of the lab and shall perform 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 group:
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 China.
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 that are capable of causing human or animal diseases but usually cannot severely endanger the human, animals or environment, have limited risk of spreading and seldom cause severe diseases after laboratory infection, with effective treatment and prevention measures in place.
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 health authority 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 veterinary authority of the State Council in consultation with other relevant departments of the State Council.
Article 9 A lab shall meet the following conditions when collecting samples of pathogenic microbes:
(1) Having equipment up to the bio-safety protection level for collecting 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.
In the course of collecting samples of highly pathogenic microbes, the staff members shall prevent the spreading and infection of pathogenic microbes, and shall make detailed records of the source thereof as well as the collection process 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 passage, 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 health authority or the veterinary authority of the State Council;
(2) The container of strains or samples of highly pathogenic bacteria (virus) shall be sealed up, the container or packing materials shall meet 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 marked with the bio-risk signs, warnings and hints as provided by the health authority or the veterinary authority of the State Council.
The transport of strains of samples of highly pathogenic bacteria (virus) shall be subject to the approval of the health authority or the veterinary authority 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 health authority or the veterinary authority of the people's government of the said 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 health authority or the veterinary authority of the people's government of the province, autonomous region, or municipality directly under the Central Government at the place of departure, then respectively subject to the approval of the health authority or the veterinary authority 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 health authority or the veterinary authority of the State Council.
The transport of strains or samples of highly pathogenic bacteria (virus) through civil aviation shall, in addition to the approval in accordance with Paragraphs 2 and 3, be subject to 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, and shall promptly grant the applicant an approval if the aforesaid application materials meet the conditions as listed in Paragraph 1 of this Article.
Article 12 As to the transport of strains or samples of highly pathogenic bacteria (virus), two 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 Regulations.
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 health authority or the veterinary authority 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 health authority or the veterinary authority 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 health authority jointly with the veterinary authority 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 Regulations, 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 health authority or the veterinary authority 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 two hours and shall simultaneously report to the health authority or the veterinary authority of the local people's government at the county level and report to the public security organ if any such strains or samples are stolen, robbed or lost.
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