Blockbuster! The Biosafety Law of the People's Republic of China was promulgated, making it clear that biosafety is an important part of national security
Biosafety Law of the People's Republic of China
(Adopted at the 22nd Session of the Standing Committee of the 13th National People's Congress on October 17, 2020)
catalogue
Chapter I General provisions
Chapter II Biosafety risk prevention and control system
Chapter III Prevention and Control of Major emerging infectious diseases and animal and plant outbreaks
Chapter IV: Safety of biotechnology research, development and application
Chapter V Biosafety of pathogenic microorganism laboratory
Chapter VI human genetic resources and biological resources security
Chapter VII Prevention of Bioterrorism and threat of biological weapons
Chapter VIII Biosafety capacity building
Chapter IX Legal liability
Chapter X Supplementary Provisions
Chapter I General provisions
Article 1 This Law is enacted with a view to safeguarding national security, preventing and responding to biosafety risks, safeguarding people's lives and health, protecting biological resources and the ecological environment, promoting the sound development of biotechnology, promoting the building of a community with a shared future for mankind and realizing harmonious coexistence between man and nature.
Article 2 "Biosafety" as used in this Law means that the State effectively prevents and responds to threats posed by dangerous biological agents and related factors, that biotechnology is capable of stable and healthy development, that people's life and health and the ecosystem are relatively free from danger and threat, and that the biological field is capable of safeguarding national security and sustainable development.
This Law shall apply to the following activities:
(1) Preventing and controlling major emerging infectious diseases and animal and plant outbreaks;
(2) Research, development and application of biotechnology;
(3) Biosafety management of pathogenic microorganism laboratories;
(4) Safe management of human genetic and biological resources;
(5) Preventing invasion of alien species and protecting biodiversity;
(6) Dealing with microbial resistance;
(7) Preventing bioterrorist attacks and defending against the threat of biological weapons;
(8) Other biosafety-related activities.
Article 3 Biosafety is an important component of national security. To maintain biosafety, we should implement the overall national security concept, coordinate development and security, and adhere to the principles of people-oriented, risk prevention, classified management, and coordination.
Article 4 Adhere to the leadership of the Communist Party of China over national biosafety work, establish and improve the national biosafety leadership system, strengthen the construction of the national biosafety risk prevention and control and management system, and improve the national biosafety management capacity.
Article 5 The State encourages innovation in biological science and technology, strengthens the construction of biosafety infrastructure and bioscience and technology personnel, supports the development of the biological industry, elevates the level of biotechnology driven by innovation, and enhances the ability to guarantee biosafety.
Article 6 The State shall strengthen international cooperation in the field of biosafety, fulfill the obligations stipulated in the international treaties concluded or acceded to by the People's Republic of China, support participation in exchanges and cooperation in biotechnology and international rescue of biosafety incidents, actively participate in the research and formulation of international rules on biosafety, and promote the improvement of global biosafety governance.
Article 7 People's governments at all levels and their relevant departments shall strengthen the publicity and popularization of biosafety laws and regulations and biosafety knowledge, guide grassroots self-governing organizations and social organizations to carry out publicity of biosafety laws and regulations and biosafety knowledge, and promote the promotion of biosafety awareness in the whole society.
Relevant scientific research institutions, medical institutions and other enterprises and institutions should incorporate biosafety laws and regulations and biosafety knowledge into education and training content, and strengthen the cultivation of students and practitioners' biosafety awareness and ethical awareness.
The news media should carry out public publicity of biosafety laws and regulations and biosafety knowledge, conduct public opinion supervision over biosafety violations, and enhance the public's awareness of social responsibility for maintaining biosafety.
Article 8 No unit or individual may endanger biosafety.
Any unit or individual has the right to report any act endangering biosafety; The department receiving the report shall promptly handle it according to law.
Article 9 Units and individuals that have made outstanding contributions to biosafety work shall be commended and rewarded by the people's governments at or above the county level and their relevant departments in accordance with state regulations.
Chapter II Biosafety risk prevention and control system
Article 10 The central leading agency for State security shall be responsible for the decision-making and coordination of the national biosafety work, study, formulate and guide the implementation of the national biosafety strategy and relevant major guidelines and policies, coordinate the major matters and important work of national biosafety, and establish a national biosafety coordination mechanism.
Provinces, autonomous regions and municipalities directly under the Central Government shall establish a biosafety coordination mechanism, organize, coordinate and supervise the promotion of biosafety related work within their respective administrative regions.
Article 11 The National biosafety coordination mechanism shall be composed of the competent departments of health, agriculture and rural affairs, science and technology, foreign affairs and relevant military organs under The State Council to analyze and judge the national biosafety situation, organize, coordinate, and urge the promotion of national biosafety related work. The National Biosafety Coordination Mechanism has set up an office to coordinate the daily work of the mechanism.
The member units of the National Biosafety coordination mechanism and other relevant departments under The State Council shall be responsible for biosafety-related work in accordance with the division of responsibilities.
Article 12 The National biosafety coordination mechanism shall establish an expert committee to provide decision-making consultation for the research, policy formulation and implementation of the national biosafety strategy.
Relevant departments of The State Council shall organize the establishment of biosafety technical advisory expert committees in relevant fields and industries to provide technical support for biosafety work such as consultation, assessment and demonstration.
Article 13 Local people's governments at various levels shall be responsible for the biosafety work within their respective administrative areas.
The relevant departments of the local people's governments at or above the county level shall be responsible for biosafety-related work according to the division of responsibilities.
Grassroots mass autonomous organizations shall assist local people's governments and relevant departments in biosafety risk prevention and control, emergency response and publicity and education.
Relevant units and individuals shall cooperate in the prevention and control of biosafety risks and emergency response.
Article 14 The State establishes a biosafety risk monitoring and early warning system. The National Biosafety coordination mechanism organizes the establishment of a national biosafety risk monitoring and early warning system to improve the ability to identify and analyze biosafety risks.
Article 15 The State shall establish a biosafety risk investigation and assessment system. The national biosafety coordination mechanism shall, on the basis of risk monitoring data, data and other information, regularly organize biosafety risk investigation and assessment.
Under any of the following circumstances, relevant departments shall promptly carry out biosafety risk investigation and assessment, and take necessary risk prevention and control measures according to law:
(A) through risk monitoring or receiving reports found that there may be biosafety risks;
(b) In order to determine the key areas of supervision and management, the formulation and adjustment of biosafety related lists or lists;
(3) Occurrence of major emergent infectious diseases, animal and plant epidemics and other incidents endangering biosafety;
(4) Other circumstances requiring investigation and evaluation.
Article 16 The State establishes a biosafety information sharing system. The National biosafety coordination mechanism shall organize the establishment of a unified national biosafety information platform, and relevant departments shall transfer biosafety data, materials and other information to the national biosafety information platform to achieve information sharing.
Article 17 The State shall establish a biosafety information release system. Major biosafety information, such as the overall situation of national biosafety, major biosafety risk warning information, major biosafety incidents and their investigation and handling information, shall be released by the member units of the national biosafety coordination mechanism according to the division of responsibilities; Other biosafety information shall be released by relevant departments under The State Council and local people's governments at or above the county level and their relevant departments in accordance with their functions and powers.
No unit or individual may fabricate or disseminate false biosafety information.
Article 18 The State establishes a biosafety list and inventory system. The State Council and its relevant departments shall, in accordance with the needs of biosafety work, formulate and publish lists or lists of materials, equipment, technologies, activities, data on important biological resources, infectious diseases, animal and plant epidemics, and invasive alien species related to biosafety, and dynamically adjust them.
Article 19 The State establishes a biosafety standard system. The standardization department under The State Council and other relevant departments under The State Council shall, in accordance with the division of responsibilities, formulate and improve relevant standards in the field of biosafety.
The National Biosafety coordination mechanism shall organize relevant departments to strengthen the coordination and convergence of biosafety standards in different fields, and establish and improve the biosafety standard system.
Article 20 The State establishes a biosafety review system. For major matters and activities in the biological field that affect or may affect national security, the relevant departments of The State Council shall conduct biosafety reviews to effectively prevent and defuse biosafety risks.
Article 21 The State shall establish a biosafety emergency response system under unified leadership, coordinated interaction, orderly and efficient.
The relevant departments of The State Council shall organize the formulation of emergency plans for biosafety incidents in relevant fields and industries, and carry out emergency drills, emergency handling, emergency rescue and post-event recovery in accordance with emergency plans and unified deployment.
Local people's governments at or above the county level and their relevant departments shall formulate, organize, guide and urge relevant enterprises and institutions to formulate emergency plans for biosafety incidents, strengthen emergency preparedness, personnel training and emergency drills, and carry out emergency handling, emergency rescue and post-event recovery of biosafety incidents.
The Chinese People's Liberation Army and the Chinese People's Armed Police Force shall, in accordance with the orders of the Central Military Commission, participate in emergency response and emergency rescue work in biosecurity incidents in accordance with law.
Article 22 The State establishes a biosafety incident investigation and traceability system. In the event of major emergent infectious diseases, animal and plant outbreaks, or biosecurity incidents of unknown cause, the national biosecurity coordination mechanism shall organize investigations and trace the source, determine the nature of the incident, comprehensively assess the impact of the incident, and put forward opinions and suggestions.
Article 23 The State establishes a state access system for animals and plants, animal and plant products, and high-risk biological factors that enter the country for the first time or resume entry after suspension.
Inbound and outbound personnel, means of transport, containers, goods, articles, packaging and ballast water discharge of international sailing ships shall meet the requirements of China's biosafety management.
The Customs shall deal with the inbound, outbound and transit biosafety risks discovered in accordance with law. Persons, means of transport, goods, articles, etc. that have been assessed as being of high biological safety risk shall enter the country through designated border ports and strict risk prevention and control measures shall be taken.
Article 24 The State establishes a response system for major biosafety incidents abroad. When a major biosafety incident occurs overseas, the Customs shall take emergency biosafety prevention and control measures according to law, strengthen certificate verification, increase the inspection ratio, and suspend the entry of relevant personnel, means of transport, goods and articles. When necessary, with the approval of The State Council, measures such as temporarily closing the relevant ports and blockading the relevant frontier may be taken.
Article 25 The relevant departments of the people's governments at or above the county level shall carry out biosafety supervision and inspection according to law, and the units and individuals under inspection shall cooperate, truthfully explain the situation and provide information, and may not refuse or obstruct.
The supervision and inspection work involving higher professional and technical requirements and greater difficulty in law enforcement shall involve professional and technical personnel of biosafety.
Article 26 The relevant departments of the people's governments at or above the county level may, in carrying out biosafety supervision and inspection, take the following measures according to law:
(1) entering the units or places under inspection or places suspected of carrying out biosafety violations for on-site monitoring, exploration, inspection or verification;
(2) Seeking information from relevant units and individuals;
(3) to consult and copy relevant documents, materials, archives, records, vouchers, etc.;
(4) to seal up sites and facilities suspected of carrying out biosafety violations;
(5) Seizing tools, equipment and related items suspected of committing biosafety violations;
(6) Other measures prescribed by laws and regulations.
The biosafety illegal information of relevant units and individuals shall be incorporated into the national credit information sharing platform according to law.
Chapter III Prevention and Control of Major emerging infectious diseases and animal and plant outbreaks
Article 27 The competent departments of public health, agriculture and rural areas, forestry and grassland, customs and ecological environment under The State Council shall establish a monitoring network for emerging infectious diseases, animal and plant epidemics, entry and exit quarantine, and biotechnology environmental safety, organize the layout and construction of monitoring stations, improve monitoring information reporting systems, and carry out active monitoring and pathogen detection. And incorporated into the national biosafety risk monitoring and early warning system.
Article 28 Disease prevention and control institutions, animal disease prevention and control institutions, plant disease and pest prevention and control institutions (hereinafter referred to as professional institutions) shall carry out active monitoring of infectious diseases, animal and plant diseases and diseases of unknown cause included in the scope of monitoring, collect, analyze and report monitoring information, and predict the occurrence and epidemic trend of new emergent infectious diseases and animal and plant diseases.
The relevant departments under The State Council, the local people's governments at or above the county level and their relevant departments shall issue early warnings in a timely manner and take corresponding prevention and control measures according to the forecast and their functions and powers.
Article 29 Any unit or individual that discovers an infectious disease or an animal or plant epidemic shall promptly report it to a medical institution or a specialized institution or department concerned.
Medical institutions, specialized institutions and their staff shall promptly report any infectious disease, animal or plant epidemic disease or any cluster of diseases of unknown cause, and take protective measures.
Where a report is required according to law, no unit or individual may conceal, falsely report, delay or miss the report, may not instruct others to conceal, falsely report or delay the report, and may not hinder others from reporting.
Article 30 The State establishes a joint prevention and control mechanism for major emerging infectious diseases and animal and plant outbreaks.
In the event of a major emergent infectious disease, animal or plant epidemic, control measures shall be taken in a timely manner in accordance with relevant laws and regulations and the provisions of the emergency plan; The competent departments of health, agriculture, rural areas, forestry and grassland under The State Council shall immediately organize a consultation, study and judgment on the epidemic situation, report the conclusion of the consultation, study and judgment to the central national security leading body and The State Council, and notify other member units of the national biosecurity coordination mechanism and other relevant departments under The State Council.
In the event of a major emergent infectious disease, animal or plant epidemic, local people's governments at all levels have unified their responsibilities for epidemic prevention and control within their respective administrative areas, strengthened organizational leadership, carried out mass prevention and control, and medical treatment, and mobilized and encouraged social forces to participate in epidemic prevention and control in an orderly manner according to law.
Article 31 The State strengthens capacity building for joint prevention and control of infectious diseases and animal and plant epidemics at borders and ports, establishes an international cooperation network for the prevention and control of infectious diseases and animal and plant epidemics, and enables early detection and control of major emerging infectious diseases and animal and plant epidemics.
Article 32 The State protects wildlife, strengthens animal epidemic prevention and prevents the spread of infectious diseases of animal origin.
Article 33 The State shall strengthen the control over the use and residue of antimicrobials such as antibiotics, and support basic research and scientific and technological research to deal with microbial resistance.
The competent department of health under the people's government at or above the county level shall strengthen the guidance and supervision of rational drug use in medical institutions and take measures to prevent the irrational use of antimicrobials. The competent departments of agriculture, rural areas, forestry and grassland under the people's governments at or above the county level shall strengthen the guidance and supervision of rational drug use in agricultural production, take measures to prevent the irrational use of antimicrobials and reduce the residue in agricultural production environment.
Health, agriculture and rural areas, forestry and grassland, ecological environment and other competent departments and drug regulatory departments under The State Council shall, according to the division of responsibilities, assess the harm of antimicrobial residues to human health and the environment, and establish an indicator evaluation system for antimicrobial pollutants.
Chapter IV: Safety of biotechnology research, development and application
Article 34 The State shall strengthen the safety management of research, development and application activities of biotechnology, and prohibit the activities of research, development and application of biotechnology that endanger public health, damage biological resources, destroy ecosystems and biological diversity and other hazards to biosafety.
The conduct of research, development and application of biotechnology shall conform to ethical principles.
Article 35 Units engaged in research, development and application of biotechnology shall conduct research and development of biotechnology within their own units
