Biosafety Law of the People's Republic of China

 

Standing Committee of the National People's Congress

 

 

 

 

 

 

 

 

 

Order of the President of the People's Republic of China

 

 

 

Number fifty-six

 

 

 

The Biosafety Law of the People's Republic of China, adopted at the 22nd Meeting of the Standing Committee of the 13th National People's Congress of the People's Republic of China on October 17, 2020, is hereby promulgated and shall come into force on April 15, 2021.

 

 

 

President of the People's Republic of China xi Jinping

 

 

 

17 October 2020

 

 

 

 

 

Biosafety Law of the People's Republic of China

 

 

 

(Adopted at the 22nd Meeting of the Standing Committee of the 13th National People's Congress on October 17, 2020)

 

 

 

directory

 

 

 

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 epidemics

 

 

 

Chapter IV Safety of biotechnology research, development and application

 

 

 

Chapter V Biosafety of pathogenic microorganism laboratory

 

 

 

Chapter vi security of human genetic resources and biological resources

 

 

 

Chapter seven: Prevention of bioterrorism and biological weapons

 

 

 

Chapter VIII Biosafety capacity building

 

 

 

Chapter IX Legal Liability

 

 

 

Chapter X Supplementary Provisions

 

 

 

Chapter I General Provisions

 

 

 

Article 1 This Law is formulated for the purpose of safeguarding national security, preventing and responding to biosafety risks, safeguarding people's lives and health, protecting biological resources and ecological environment, promoting the healthy 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 from dangerous biological factors and related factors, that biotechnology can develop steadily and healthily, that people's lives and health and the ecosystem are relatively free from danger and threats, and that the biological field has the capability to maintain national security and sustainable development.

 

 

 

This Law shall apply to the following activities:

 

 

 

(1) to prevent and control major emerging infectious diseases and animal and plant epidemics;

 

 

 

(2) research, development and application of biotechnology;

 

 

 

(3) Biosafety management of pathogenic microorganism laboratory;

 

 

 

(4) Safe management of human genetic and biological resources;

 

 

 

(5) Preventing the invasion of alien species and protecting biodiversity;

 

 

 

(6) Dealing with microbial resistance;

 

 

 

(7) To guard against bioterrorist attacks and threats of biological weapons;

 

 

 

(8) Other activities related to biosafety.

 

 

 

Article 3 Biosecurity is an important component of state security. In safeguarding biosafety, an overall national security concept shall be implemented, development and safety shall be coordinated, and the principles of people-orientation, risk prevention, classified management and coordination shall be adhered to.

 

 

 

Article 4 Adhere to the leadership of the Communist Party of China over the national biosafety work, establish and improve the national biosafety leadership system, strengthen the construction of the national biosafety risk prevention and control system, and improve the national biosafety governance capacity.

 

Article 5 The State encourages innovation in biological science and technology, strengthens the construction of biosafety infrastructure and personnel in biological science and technology, supports the development of biological industry, promotes the level of biological science and technology through innovation, and enhances the capability of ensuring biological safety.

 

 

 

Article 6 the state shall strengthen international cooperation in the field of biological safety, to fulfill the People's Republic of China in accordance with the international treaties concluded or acceded to the obligation to support involved in biological science and technology exchanges and cooperation with international aid biological safety events, actively participate in biological safety rules of the international research and develop, promote the global biological security 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 enhancement of biosafety awareness of the whole society.

 

 

 

 

 

 

 

Relevant scientific research institutions, medical institutions and other enterprises and institutions shall incorporate biosafety laws and regulations and biosafety knowledge into education and training, and strengthen the cultivation of biosafety awareness and ethical awareness among students and employees.

 

 

 

The news media shall 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 in maintaining biosafety.

 

 

 

Article 8 No unit or individual may endanger biological safety.

 

 

 

Any unit or individual has the right to report activities endangering biosafety; The departments receiving such reports shall promptly handle them according to law.

 

 

 

Article 9 The people's governments at or above the county level and their relevant departments shall commend and award units and individuals that have made outstanding contributions to the work of biosafety according to the regulations of the State.

 

 

 

Chapter II Biosafety risk prevention and control system

 

 

 

Article 10 The central leading agency for state security shall be responsible for decision-making, deliberation and coordination of the national biosafety work, study, formulate and guide the implementation of national biosafety strategies and relevant major principles and policies, plan and coordinate major issues and work of national biosafety, and establish a coordination mechanism for national biosafety work.

 

 

 

Provinces, autonomous regions and municipalities directly under the Central Government shall establish coordination mechanisms for biosafety work, organize, coordinate and urge the promotion of biosafe-related work within their respective administrative regions.

 

 

 

Article 11 The national coordination mechanism for biosafety work shall be composed of the competent departments of health, agriculture and rural affairs, science and technology, foreign affairs and other relevant military organs under The State Council to analyze and make judgments on the national biosafety situation, organize, coordinate and urge and promote the work related to national biosafety. The national biosafety coordination Mechanism shall establish an office to be responsible for the daily work of the coordination mechanism.

 

 

 

Member units of the National Coordination mechanism for biosafety work and other relevant departments of The State Council shall be responsible for biosafety-related work according to the division of responsibilities.

 

 

 

Article 12 The national coordination mechanism for biosafety shall establish an expert committee to provide decision-making consultation for the study of national biosafety strategy, policy formulation and implementation.

 

 

 

Relevant departments under The State Council shall organize and establish expert committees for biosafety technical advisory in relevant fields and industries to provide consultation, evaluation and demonstration and other technical support for biosafety work.

 

 

 

Article 13 Local people's governments at various levels shall be responsible for the work of biosafety 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 their functions and duties.

 

 

 

Grass-roots self-governing organizations of mass nature shall assist local people's governments and relevant departments in biosafety risk prevention and control, emergency response, 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 establishes a biosafety risk investigation and assessment system. The national coordination mechanism for biosafety work shall, on the basis of risk monitoring data, materials and other information, organize and carry out biosafety risk investigation and assessment on a regular basis.

 

 

 

Under any of the following circumstances, relevant departments shall timely carry out biosafety risk investigation and assessment and take necessary risk prevention and control measures according to law:

 

 

 

(1) Discovering possible biosafety risks through risk monitoring or receiving reports;

 

 

 

(2) To formulate and adjust lists or lists related to biosafety in order to determine key areas and projects of supervision and management;

 

 

 

(3) occurrence of major emerging infectious diseases, animal and plant epidemics and other events endangering biosecurity;

 

 

 

(4) other circumstances that need to be investigated and evaluated.

 

 

 

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 share biosafety data, materials and other information with the national biosafety information platform to realize information sharing.

 

 

 

Article 17 The State shall establish a biosafety information dissemination system. Major biosafety information, such as the general situation of national biosafety, warning information of major biosafety risks, major biosafety incidents and their investigation and processing 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 of The State Council and local people's governments at or above the county level and other relevant departments according to their functions and powers.

 

 

 

No unit or individual may fabricate or disseminate false biosafety information.

 

 

 

Article 18 The State shall establish a system of biosafety lists and lists. The State Council and its relevant departments shall, according to the needs of biosafety work, formulate and publish lists or lists of materials, equipment, technologies, activities, data of important biological resources, infectious diseases, animal and plant epidemics, invasive alien species, etc. related to biosafety, and make dynamic adjustments.

 

 

 

Article 19 The State shall establish a system of biosafety standards. The standardization department under The State Council and other relevant departments under The State Council shall, in accordance with their respective functions and duties, formulate and improve relevant standards in the field of biosafety.

 

 

 

The National biosafety coordination mechanism organizes relevant departments to strengthen coordination and connection of biosafety standards in different fields, and establish and improve biosafety standard systems.

 

 

 

Article 20 The State shall establish a biosafety review system. Relevant departments of The State Council shall conduct biosafety reviews of major matters and activities in the biological field that affect or may affect national security, so as to effectively prevent and defuse biosecurity risks.

 

 

 

Article 21 The State shall establish a biosafety emergency system under unified leadership, coordinated and coordinated, orderly and efficient.

 

 

 

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 treatment, emergency rescue and post-event recovery according to the emergency plans and unified deployment.

 

 

 

The 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 biosafety incident emergency plans, strengthen emergency preparedness, personnel training and emergency drills, and carry out biosafety incident emergency response, emergency rescue and post-event recovery.

 

 

 

The People's Liberation Army and the Chinese People's Armed Police Force, in accordance with the order of the Central Military Commission, participate in the emergency response and rescue work of biosafety incidents in accordance with law.

 

 

 

Article 22 The State establishes a traceability system for the investigation of biosafety incidents. In the event of a major emerging infectious disease, animal and plant epidemic, or a biosafety incident of unknown cause, the national coordination mechanism for biosafety work 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 national admission system for animals and plants, their products and high-risk biological factors that enter the country for the first time or resume after suspension.

 

 

 

Inbound and outbound personnel, means of transport, containers, goods, articles, packaging and the discharge of ballast water from international sailing vessels shall comply with China's biosafety management requirements.

 

 

 

The Customs shall deal with any inbound, outbound and transit biosecurity risks discovered by it according to law. Persons, means of transport, goods and articles that have been assessed as having a high biosecurity risk shall enter the country at 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 outside China. If a major biosafety incident occurs outside China, the Customs shall take emergency biosafety prevention and control measures according to law, strengthen the verification of certificates, increase the proportion of inspection, and suspend the entry of relevant personnel, means of transport, goods and articles. When necessary, with the consent of The State Council, relevant ports or borders may be temporarily closed or blockaded.

 

 

 

 

 

 

 

Article 25 The relevant departments of the people's governments at or above the county level shall carry out the work of biosafety supervision and inspection according to law. The inspected units and individuals shall cooperate, truthfully explain the situation and provide materials, and may not refuse or obstruct the work.

 

 

 

The supervision and inspection work involving high professional and technical requirements and high difficulty in law enforcement shall be attended by professional and technical personnel of biosafety.

 

 

 

Article 26 Relevant departments of the people's governments at or above the county level may take the following measures according to law to carry out biosafety supervision and inspection:

 

 

 

(1) To conduct on-site monitoring, exploration, inspection or verification by entering the unit or place under inspection or the place suspected of carrying out biosafety illegal acts;

 

 

 

(2) to seek information from relevant units and individuals;

 

 

 

(3) to consult and copy relevant documents, materials, archives, records and vouchers;

 

 

 

(4) Sealing up sites and facilities suspected of carrying out biosafety violations;

 

 

 

(5) Detaining tools, equipment and related articles suspected of carrying out biosafety violations;

 

 

 

(6) other measures as prescribed by laws and regulations.

 

 

 

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 epidemics

 

 

 

Article 27 of the health of public health under the State Council, agriculture and rural areas, forestry, grassland, customs, ecological environment departments should establish new emergent infectious diseases, animal or plant epidemic, entry and exit inspection and quarantine, biological safety monitoring network technology environment, organization monitoring site layout, construction, and improve the monitoring information reporting system, carry out active monitoring and pathogen detection, And included in the national biosecurity risk monitoring and early warning system.

 

 

 

Article 28 of institution of disease prevention and control, animal disease prevention and control institution, plant diseases and insect pests prevention and control institution (hereinafter generally referred to as the professional institutions) shall, animal or plant epidemic of infectious diseases and included in the monitoring range of unknown causes disease active surveillance, information collection, analysis, reporting, monitoring, forecasting the occurrence of new hair abrupt, animal or plant epidemic of infectious diseases, the popular trend.

 

 

 

 

 

 

 

Relevant departments under The State Council, local people's governments at or above the county level and their relevant departments shall timely issue early warnings and take corresponding prevention and control measures according to their forecasts, functions and powers.

 

 

 

Article 29 Any unit or individual that discovers an infectious disease, animal or plant epidemic shall promptly report it to a medical institution, a specialized institution or a department concerned.

 

 

 

Medical institutions, professional institutions and their staff shall promptly report infectious diseases, animal and plant epidemics or clusters of diseases of unknown cause and take protective measures.

 

 

 

Where a report should be made according to law, no unit or individual may conceal, falsely report, delay or omit the report, or instruct others to conceal, falsely report or delay the report, or prevent others from reporting.

 

 

 

Article 30 The State establishes a mechanism for joint prevention and control of major emerging infectious diseases and animal and plant epidemics.

 

 

 

Timely control measures shall be taken in accordance with relevant laws and regulations and the provisions of emergency preplans in the event of a major emerging epidemic disease, animal or plant epidemic; The competent authorities in charge of health, agriculture, rural areas and forestry and grassland under The State Council shall immediately organize a consultation and evaluation of the epidemic situation, report the consultation and evaluation conclusion to the state security leading agency of the CPC Central Committee and The State Council, and notify other members of the National biosafety coordination mechanism and other relevant departments under The State Council.

 

 

 

In the event of a major emerging epidemic of infectious diseases, animals and plants, local people's governments at all levels shall uniformly fulfill their duties of epidemic prevention and control within their respective administrative areas, strengthen organization and leadership, carry out mass prevention and control and medical treatment, and mobilize and encourage nongovernmental forces to participate in epidemic prevention and control in accordance with the law and in an orderly manner.

 

 

 

Article 31 The State shall strengthen the capacity building for the joint prevention and control of infectious diseases and animal and plant epidemic diseases at frontier and port, establish an international cooperation network for the prevention and control of infectious diseases and animal and plant epidemic diseases, and detect and control major emerging infectious diseases and animal and plant epidemic diseases as soon as possible.

 

 

 

Article 32 The State shall protect wildlife, strengthen animal epidemic prevention and prevent the spread of animal-borne infectious diseases.

 

 

 

Article 33 The State shall strengthen control over the use and residues of antibiotics and other antimicrobials and support basic research and scientific and technological breakthroughs in response to microbial drug resistance