Heavy! The Biosecurity Law of the People's Republic of China is promulgated, clarifying that biosecurity is an important part of national security

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)
Table of contents

Chapter 1 General Provisions

Chapter II Biosecurity Risk Prevention and Control System

Chapter III Prevention and Control of Major Emerging Infectious Diseases, Animal and Plant Epidemic

Chapter 4 Biotechnology Research, Development and Application Safety

Chapter 5 Laboratory Biosafety of Pathogenic Microorganisms

Chapter VI Human Genetic Resources and Biological Resource Security

Chapter VII Prevention of Bioterrorism and Bioweapon Threats

Chapter VIII Biosafety Capacity Building

Chapter IX Legal Liability

Chapter X Supplementary Provisions

Chapter 1 General Provisions

Article 1 This Law is formulated for the purpose of maintaining national security, preventing and responding to biosecurity risks, safeguarding people's lives and health, protecting biological resources and the ecological environment, promoting the healthy development of biotechnology, promoting the building of a community with a shared future for mankind, and realizing the harmonious coexistence of man and nature.

Article 2 The term "biosafety" as mentioned in this Law refers to the state effectively preventing and responding to the threat of dangerous biological factors and related factors, the stable and healthy development of biotechnology, the relatively safe and unthreatening state of people's life and health and the ecosystem, the biological The field has the ability to maintain national security and sustainable development.

This law applies to the following activities:

(1) Prevention and control of major emerging infectious diseases, animal and plant epidemics;

(2) Biotechnology research, development and application;

(3) Biosafety management of pathogenic microorganism laboratories;

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

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

(6) Response to microbial resistance;

(7) Preventing biological terrorist attacks and defending against the threat of biological weapons;

(8) Other activities related to biosecurity.

Article 3 Biosecurity is an important part of national security. To maintain biosecurity, 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 the national biosecurity work, establish and improve the national biosecurity leadership system, strengthen the construction of the national biosecurity risk prevention and control system, and improve the national biosecurity governance capability.

Article 5 The state encourages biotechnology innovation, strengthens biosafety infrastructure and the construction of biotechnology talent teams, supports the development of the biotechnology industry, promotes the level of biotechnology through innovation, and enhances the ability to guarantee biosafety.

Article 6 The state strengthens international cooperation in the field of biosafety, fulfills its obligations under the international treaties concluded or acceded to by the People's Republic of China, supports participation in biotechnology exchanges and cooperation and international rescue of biosafety incidents, and actively participates in the research and formulation of international biosafety rules. Promote the improvement of global biosecurity 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 grass-roots mass autonomous organizations and social organizations to carry out biosafety laws and regulations and biosafety knowledge dissemination, and promote the biosafety of the whole society. Awareness raising.

Relevant scientific research institutions, medical institutions, and other enterprises and institutions shall incorporate biosafety laws and regulations and biosafety knowledge into the content of education and training, and strengthen the cultivation of students and practitioners' awareness of biosafety and ethics.

News media should carry out public welfare publicity of biosafety laws and regulations and biosafety knowledge, conduct public opinion supervision on biosafety violations, and enhance the public's awareness of social responsibility for maintaining biosafety.

Article 8 No unit or individual shall endanger biological safety.

Any unit or individual has the right to report behaviors that endanger biological safety; the department that receives the report shall deal with it in a timely manner according to law.

Article 9 For units and individuals who have made outstanding contributions to biosecurity work, the people's governments at or above the county level and their relevant departments shall commend and reward them in accordance with state regulations.

Chapter II Biosecurity Risk Prevention and Control System

Article 10 The central national security leading agency is responsible for the decision-making, deliberation and coordination of national biosecurity work, researching, formulating, and guiding the implementation of the national biosecurity strategy and relevant major guidelines and policies, coordinating and coordinating major issues and important work on national biosecurity, and establishing national biosecurity Work coordination mechanism.

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

Article 11 The national biosecurity work coordination mechanism is composed of the State Council's health, agriculture and rural affairs, science and technology, foreign affairs, and other competent departments and relevant military agencies to analyze and judge the national biosecurity situation, organize, coordinate, and urge the advancement of national biosecurity-related work. The National Biosafety Work Coordination Mechanism has set up an office to be responsible for the daily work of the coordination mechanism.

Member units of the National Biosafety Work Coordination Mechanism 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 Biosafety Work Coordination Mechanism shall establish an expert committee to provide decision-making consultation for national biosafety strategy research, policy formulation and implementation.

Relevant departments of the State Council organize and establish biosafety technical advisory expert committees in relevant fields and industries to provide technical support such as consultation, evaluation, and demonstration for biosafety work.

Article 13 Local people's governments at all levels are responsible for the biosecurity work within their respective administrative regions.

The relevant departments of the local people's government at or above the county level shall be responsible for the work related to biosecurity according to the division of responsibilities.

Grassroots mass self-governing organizations shall assist local people's governments and relevant departments to do well in biosafety risk prevention and control, emergency response, publicity and education, etc.

Relevant units and individuals should cooperate in the prevention and control of biosecurity risks and emergency response.

Article 14 The state establishes a biosecurity risk monitoring and early warning system. The National Biosafety Work Coordination Mechanism organizes the establishment of a national biosafety risk monitoring and early warning system to improve biosafety risk identification and analysis capabilities.

Article 15 The state establishes a biosafety risk investigation and assessment system. The national biosafety work coordination mechanism shall regularly organize and conduct biosafety risk investigations and assessments based on the data, materials and other information of risk monitoring.

Under any of the following circumstances, the relevant departments shall conduct a timely investigation and assessment of biosecurity risks, and take necessary risk prevention and control measures in accordance with the law:

(1) It is found that there may be biosecurity risks through risk monitoring or receiving reports;

(2) To determine the key areas and key projects for supervision and management, formulate and adjust biosafety-related directories or lists;

(3) The occurrence of major new emergent infectious diseases, animal and plant epidemics, and other events endangering biological safety;

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

Article 16 The state establishes a biosafety information sharing system. The national biosafety work coordination mechanism organizes the establishment of a unified national biosafety information platform, and relevant departments shall submit biosafety data, materials and other information to the national biosafety information platform to achieve information sharing.

Article 17 The state establishes a biosafety information release system. Major biosafety information such as the overall national biosafety situation, major biosafety risk warning information, major biosafety incidents and their investigation and handling information shall be released by member units of the national biosafety work coordination mechanism according to the division of responsibilities; other biosafety information shall be released by the relevant departments of the State Council and local people's governments at or above the county level and their relevant departments according to their duties and powers.

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

Article 18 The state establishes a biosafety directory and list system. The State Council and its relevant departments shall, according to the needs of biosecurity work, formulate and publish lists or lists of materials, equipment, technologies, activities, important biological resources, infectious diseases, animal and plant diseases, invasive alien species, etc. related to biosecurity, and adjust them dynamically. .

Article 19 The state establishes a biosafety standard system. The standardization department of the State Council and other relevant departments of the State Council shall, according to the division of responsibilities, formulate and improve relevant standards in the field of biosafety.

The National Biosafety Work Coordination Mechanism organizes relevant departments to strengthen the coordination and connection of biosafety standards in different fields, and establish and improve the biosafety standard system.

Article 20 The state establishes a biosecurity review system. For major events and activities in the biological field that affect or may affect national security, relevant departments of the State Council shall conduct biosecurity review to effectively prevent and resolve biosecurity risks.

Article 21 The state establishes a biosecurity emergency response system with unified leadership, coordination and linkage, orderly and efficient.

Relevant departments of the State Council shall organize the formulation of emergency plans for biosecurity incidents in relevant fields and industries, and carry out emergency drills, emergency response, emergency rescue and post-event recovery according to the emergency plans and unified deployment.

Local people's governments at or above the county level and their relevant departments shall formulate and organize, guide and urge relevant enterprises and institutions to formulate emergency plans for biosecurity incidents, strengthen emergency preparedness, personnel training and emergency drills, and conduct emergency response, emergency rescue and post-mortem biosecurity incidents recovery etc.

The Chinese 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 emergency rescue of biosecurity incidents in accordance with the law.

Article 22 The state establishes a system for investigation and traceability of biosecurity incidents. In the event of major emerging infectious diseases, animal and plant epidemics, and unexplained biosecurity incidents, the National Biosecurity Work Coordination Mechanism shall organize investigations to 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 access system for animals and plants, animal and plant products, and high-risk biological factors that are imported for the first time or resumed after being suspended.

Entry and exit personnel, means of transport, containers, goods, articles, packaging, and ballast water discharge from ships on international voyages shall comply with my country's biosafety management requirements.

The customs shall handle the biosecurity risks found in entry, exit and transit in accordance with the law. Persons, means of transport, goods, articles, etc. that are assessed to be at high risk of biosecurity shall enter the country from designated border ports and take strict risk prevention and control measures.

Article 24 The state establishes a system for responding to major overseas biosecurity incidents. In the event of a major biosecurity incident overseas, the customs shall take emergency biosecurity prevention and control measures in accordance with the law, strengthen document verification, increase the inspection ratio, and suspend the entry of relevant personnel, means of transport, goods, and articles. If necessary, with the approval of the State Council, measures such as temporarily closing relevant ports and blocking relevant borders 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 work according to law, and the units and individuals under inspection shall cooperate, truthfully explain the situation and provide materials, and shall not refuse or obstruct.

For supervision and inspection work involving high professional and technical requirements and difficult law enforcement operations, professional and technical personnel in biosafety shall participate.

Article 26 The relevant departments of the people's governments at or above the county level may take the following measures in accordance with the law when implementing biosafety supervision and inspection:

(1) Entering the unit or place under inspection or a place suspected of committing illegal biosecurity acts to conduct on-site monitoring, survey, inspection or verification;

(2) Inquire about the situation from relevant units and individuals;

(3) Access and copy relevant documents, materials, archives, records, vouchers, etc.;

(4) Sealing up places and facilities suspected of committing illegal biosecurity acts;

(5) Seizing the tools, equipment and related items suspected of committing illegal biosecurity acts;

(6) Other measures prescribed by laws and regulations.

Biosecurity illegal information of relevant entities and individuals shall be included in the national credit information sharing platform in accordance with the law.

Chapter III Prevention and Control of Major Emerging Infectious Diseases, Animal and Plant Epidemic

Article 27 The competent departments of 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 and environmental safety, and organize the layout of monitoring sites, Build and improve the monitoring information reporting system, carry out active monitoring and pathogen detection, and incorporate it into the national biosecurity risk monitoring and early warning system.

Article 28 Disease prevention and control institutions, animal disease prevention and control institutions, and plant disease and insect pest prevention and control institutions (hereinafter collectively 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 monitoring scope, collect, Analyze and report monitoring information, and predict the occurrence and trend of emerging infectious diseases, animal and plant diseases.

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

Article 29 If any unit or individual discovers an infectious disease, animal or plant disease, it shall report it to a medical institution, relevant professional institution or department in a timely manner.

Medical institutions, professional institutions and their staff who discover infectious diseases, animal and plant diseases, or cluster diseases of unknown cause shall report them in a timely manner and take protective measures.

No unit or individual may conceal, falsely report, delay reporting, or omit a report that should be reported according to law, and must not incite others to conceal, falsely report, or delay reporting, and must not obstruct others from reporting.

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

In the event of a major emerging infectious disease, animal or plant epidemic, control measures should be taken in a timely manner in accordance with relevant laws and regulations and emergency plans; the State Council's health, agriculture and rural, forestry and grassland authorities should immediately organize a consultation on the epidemic situation, and consult with The conclusions of the study are reported to the central national security leading agency and the State Council, as well as to other member units of the National Biosecurity Work Coordination Mechanism and other relevant departments of the State Council.

In the event of a major new outbreak of infectious diseases, animal and plant epidemics, the local people's governments at all levels uniformly perform the epidemic prevention and control responsibilities within their respective administrative regions, strengthen organizational leadership, carry out mass prevention and control, medical treatment, mobilize and encourage social forces in an orderly manner Participate in epidemic prevention and control.

Article 31 The state strengthens the capacity building of joint prevention and control of border and port infectious diseases, animal and plant epidemics, establishes an international cooperation network for the prevention and control of infectious diseases, animal and plant epidemics, and early detection and control of major emerging infectious diseases, animal and plant epidemics .

Article 32 The state protects wild animals, strengthens animal epidemic prevention, and prevents the spread of animal-derived infectious diseases.

Article 33 The state strengthens the management of the use and residues of antimicrobial drugs such as antibiotics, and supports basic research and scientific and technological breakthroughs in response to microbial resistance.

The competent health department of 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 unreasonable use of antimicrobial drugs. The competent departments of agriculture and rural affairs, forestry and grassland of 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 unreasonable use of antimicrobial drugs, and reduce their residues in the agricultural production environment.

The competent departments of health, agriculture and rural areas, forestry and grassland, ecological environment, etc. and the drug supervision and administration department of the State Council shall, according to the division of responsibilities, evaluate the harm of antimicrobial drug residues to human health and the environment, and establish an evaluation system for antimicrobial drug pollutant indicators.

Chapter 4 Biotechnology Research, Development and Application Safety

Article 34 The state strengthens the safety management of biotechnology research, development and application activities, and prohibits biotechnology research, development and application activities that endanger public health, damage biological resources, destroy ecosystems and biodiversity and other activities that endanger biosafety .

Engaging in biotechnology research, development and application activities shall comply with ethical principles.

Article 35 Units engaged in biotechnology research, development, and application activities shall conduct research and development on their own biotechnology