Biosecurity Law of the People's Republic of China

Biosecurity 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 and amended in accordance with the Decision on Amending the Agricultural Technology Promotion Law of the People's Republic of China, the Law of the People's Republic of China on the Protection of Minors, and the Biosecurity Law of the People's Republic of China at the 9th Session of the Standing Committee of the 14th National People's Congress on April 26, 2024)

Table of Contents

Chapter I: General Provisions

Chapter II: Biosecurity Risk Prevention and Control Systems

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

Chapter IV: Safety in the Research, Development, and Application of Biotechnology

Chapter V: Biosecurity in Pathogenic Microbiology Laboratories

Chapter VI: Security of Human Genetic Resources and Biological Resources

Chapter VII: Preventing the Threat of Bioterrorism and Biological Weapons

Chapter VIII: Biosecurity Capacity Building

Chapter IX: Legal Responsibility

Chapter X: Supplementary Provisions

Chapter I: General Provisions

Article 1: This Law is drafted so as to preserve national security, prevent and respond to biosecurity risks, safeguard people's lives and health, protect biological resources and the ecological environment, promote the healthy development of biotechnology, promote the building of a community with a shared future for mankind, and realize the harmonious coexistence of man and nature.

Article 2: "Biosecurity" as used in this Law refers to the state's effective prevention and response to threats from dangerous biological factors and related factors, where biotechnology can develop stably and healthily, where people's lives, health, and ecosystems are relatively free from danger and threat, and where the biological field has the capacity to preserve national security and sustainable development.

This Law shall apply to engaging in the following activities:

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

(2) Research, development and application of biotechnology;

(3) Biosecurity management of pathogenic microbiology laboratories;

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

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

(6) Responding to microbial resistance;

(7) Preventing bioterrorist attacks and defending against biological weapons threats;

(8) Other activities related to biosecurity.

Article 3: Biosecurity is an important component of national security. The preservation of biosecurity shall implement the overall national security concept, coordinate development and security, and adhere to the principles of people-centeredness, risk prevention, categorical management, and coordination.

Article 4: Persist in the Communist Party of China's leadership of national biosecurity efforts, establish and complete a national biosecurity leadership system, strengthen the establishment of a national biosecurity risk prevention and control and governance system, and increase the capacity of the national biosecurity governance.

Article 5: The state encourages innovation in biotechnology, strengthens biosecurity infrastructure and the establishment of biotechnology talent teams, supports the development of the biological industry, and uses innovation to increase the level of biotechnology, and strengthens the capacity for biosecurity safeguards.

Article 6: The state is to strengthen international cooperation in the field of biosecurity, perform obligations provided for in international treaties concluded or acceded to by the People's Republic of China, support participation in biotechnology exchanges and cooperation and international rescue of biosecurity incidents, actively participate in the research and drafting of international rules on biosecurity, and promote the improvement of global biosecurity governance.

Article 7: All levels of people's government and their relevant departments shall strengthen efforts to publicize and popularize biosecurity laws, regulations, and biosecurity knowledge, guiding basic-level mass autonomous organizations and social organizations to carry out publicity on biosecurity laws, regulations, and biosecurity knowledge, and promoting the increase of the entire society's awareness of biosecurity.

Relevant scientific research schools, medical establishments, and other enterprises and public institutions shall include biosecurity laws, regulations, and biosecurity knowledge in the content of education and training, and strengthen the cultivation of students' and practitioners' awareness of biosecurity and ethics.

The news media shall carry out public interest publicity on biosecurity laws and regulations and biosecurity knowledge, conduct public opinion oversight of biosecurity violations, and increase the public's awareness of social responsibility for preserving biosecurity.

Article 8: Biological security must not be endangered by any unit or individual.

All units and individuals have the right to report acts that endanger biosecurity; Departments receiving reports shall promptly handle them in accordance with law.

Article 9: People's governments at the county level or above and their relevant departments are to give commendations and awards to units and individuals that have made outstanding contributions to biosecurity efforts in accordance with state provisions.

Chapter II: Biosecurity Risk Prevention and Control Systems

Article 10: The central leading institution for national security is responsible for decision-making, deliberation and coordination of national biosecurity efforts, researching, formulating, and guiding the implementation of the national biosecurity strategy and relevant major guidelines and policies, planning and coordinating major national biosecurity matters and important work, and establishing a national coordination mechanism for biosecurity efforts.

Provinces, autonomous regions, and directly governed municipalities are to establish coordination mechanisms for biosecurity efforts, organizing, coordinating, and urging the advancement of biosecurity-related efforts within that administrative region.

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

On the basis of their duties and division of labor, member units of the National Coordination Mechanism for Biosecurity Work and other relevant departments of the State Council are responsible for work related to biosecurity.

Article 12: The National Coordination Mechanism for Biosecurity Work is to establish expert committees to provide decision-making consultation for national biosecurity strategy research, policy formulation, and implementation.

The relevant departments of the State Council are to organize the establishment of biosecurity technical advisory expert committees in relevant fields and industries, to provide technical support such as consultation, assessment, and demonstration for biosecurity efforts.

Article 13: All levels of local people's government are responsible for biosecurity efforts within that administrative region.

The relevant departments of local people's governments at the county level or above are responsible for work related to biosecurity on the basis of their duties and division of labor.

Basic-level mass autonomous organizations shall assist local people's governments and relevant departments in efforts such as biosecurity risk prevention and control, emergency response, and publicity and education.

Relevant units and individuals shall cooperate in efforts such as biosecurity risk prevention and control and emergency response.

Article 14: The state is to establish a monitoring and early warning system for biosecurity risks. The National Coordination Mechanism for Biosecurity Work is to organize the establishment of a national biosecurity risk monitoring and early warning system, increasing the capacity for identifying and analyzing biosecurity risks.

Article 15: The state is to establish a system for the investigation and assessment of biosecurity risks. The national coordination mechanism for biosecurity efforts shall periodically organize and carry out biosecurity risk investigations and assessments on the basis of risk monitoring data, materials, and other such information.

In any of the following circumstances, the relevant departments shall promptly carry out biosecurity risk investigations and assessments, and employ necessary risk prevention and control measures in accordance with law:

(1) Where it is discovered through risk monitoring or receipt of reports that there might be biosecurity risks;

(2) Draft or adjust biosecurity-related directories or lists so as to determine key areas and key projects for oversight and management;

(3) The occurrence of major emerging infectious diseases, animal and plant epidemics, or other incidents that endanger biological security;

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

Article 16: The state is to establish a biosecurity information sharing system. The National Coordination Mechanism for Biosecurity Work is to organize the establishment of a unified national biosecurity information platform, and relevant departments shall transfer biosecurity data, materials, and other information to the national biosecurity information platform to bring about information sharing.

Article 17: The state is to establish a system for the release of biosecurity information. Major biosecurity information, such as the overall national biosecurity situation, warning information on major biosecurity risks, and information on major biosecurity incidents and their investigation and handling, is to be released by member units of the national biosecurity coordination mechanism on the basis of their duties and division of labor; Other biosecurity information is to be released by the relevant departments of the State Council and local people's governments at the county level or above and their relevant departments on the basis of their duties and authority.

False biosecurity information must not be fabricated or disseminated by any unit or individual.

Article 18: The state is to establish a system of biosecurity directories and inventories. As needed for biosecurity efforts, the State Council and its relevant departments are to draft and publish directories or lists of materials, equipment, technologies, activities, data on important biological resources, infectious diseases, animal and plant diseases, invasive alien species, and so forth, and dynamically adjust them.

Article 19: The state is to establish a system of biosecurity standards. The State Council's departments for standardization and other relevant departments of the State Council are to draft and improve standards in the field of biosecurity on the basis of their duties and division of labor.

The National Coordination Mechanism for Biosecurity Work is to organize relevant departments to strengthen the coordination and convergence of biosecurity standards in different fields, and establish and improve a system of biosecurity standards.

Article 20: The state is to establish a biosecurity review system. The relevant departments of the State Council are to conduct biosecurity reviews of major matters and activities in the biological field that impact or might impact national security, to effectively prevent and resolve biosecurity risks.

Article 21: The state is to establish a biosecurity emergency response system with unified leadership, coordination and linkage, and orderly and efficient.

The relevant departments of the State Council shall organize the drafting of emergency response plans for biosecurity incidents in relevant fields and industries, and carry out efforts such as emergency drills, emergency response, emergency rescue, and post-event recovery on the basis of emergency response plans and uniform deployments.

Local people's governments at the county level or above and their relevant departments shall draft, organize, guide, and urge relevant enterprises and public institutions to draft emergency response plans for biosecurity incidents, strengthen emergency preparedness, personnel training, and emergency drills, and carry out efforts such as emergency response to biosecurity incidents, emergency rescue, and post-incident recovery.

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 for biosecurity incidents in accordance with law.

Article 22: The state is to establish systems for investigating and tracing the source of biosecurity incidents. In the event of major emerging infectious diseases, animal and plant epidemics, or biosecurity incidents of unknown cause, the national coordination mechanism for biosecurity efforts shall organize and carry out investigations and traces, determine the nature of the incident, comprehensively assess the impact of the incident, and submit opinions and recommendations.

Article 23: The State shall establish a national access system for animals and plants, animal and plant products, and high-risk biological factors that enter the country for the first time or resumed after the suspension.

Personnel, means of transport, containers, goods, articles, packaging, and ballast water discharge from ships entering or leaving the country shall comply with the mainland's biosecurity management requirements.

Customs shall handle the biosecurity risks discovered in entry, exit and transit in accordance with law. Persons, means of transport, goods, articles, and so forth that have been assessed as having a high risk of biosecurity shall enter the country through designated border ports, and strict risk prevention and control measures shall be employed.

Article 24: The state is to establish a system for responding to major overseas biosecurity incidents. Where major biosecurity incidents occur outside the borders, Customs is to employ emergency biosecurity prevention and control measures in accordance with law, strengthen the verification of documents, increase the proportion of inspections, and suspend the entry of relevant personnel, means of transport, goods, and articles. When necessary, with the consent of the State Council, measures such as temporarily closing relevant ports or sealing relevant national borders may be employed.

Article 25: The relevant departments of people's governments at the county level or above shall carry out biosecurity oversight and inspection efforts in accordance with law, and the units and individuals being inspected shall cooperate, truthfully explain the situation, provide materials, and must not refuse or obstruct it.

Supervision and inspection work involving higher professional and technical requirements and greater difficulty in law enforcement operations shall have biosecurity professional and technical personnel participating.

Article 26: The relevant departments of people's governments at the county level or above carrying out biosecurity oversight and inspections may employ the following measures in accordance with law:

(1) Entering the unit or location being inspected, or a site suspected of committing biosecurity violations, to conduct on-site monitoring, investigation, inspection, or verification;

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

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

(4) Seal up venues and facilities suspected of carrying out illegal biosecurity conduct;

(5) Seizure of tools, equipment, and related items suspected of committing biosecurity violations;

(6) Other measures provided for by laws and regulations.

Information on biosecurity violations by relevant units and individuals shall be included in the national credit information sharing platform in accordance with law.

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

Article 27: The State Council's departments in charge of health, agriculture and rural affairs, forestry and grasslands, customs, and ecology and the environment shall establish monitoring networks for emerging infectious diseases, animal and plant epidemics, entry and exit quarantine, and biotechnology environmental safety, organize the layout and construction of monitoring sites, improve monitoring information reporting systems, carry out active surveillance and pathogen testing, and include them in 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 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 scope of monitoring, collect, analyze, and report monitoring information, and predict the occurrence and epidemic trend of emerging infectious diseases, animal and plant diseases.

The relevant departments of the State Council, local people's governments at the county level or above, and their relevant departments, shall promptly issue early warnings on the basis of forecasts and their duties and authority, and employ corresponding prevention and control measures.

Article 29 Any unit or individual discovering an infectious disease, animal or plant disease shall promptly report it to a medical institution, relevant professional institution or department.

Where medical establishments, professional bodies, and their staffs discover infectious diseases, animal and plant diseases, or clusters of diseases of unknown causes, they shall promptly report them and employ protective measures.

Where a report shall be made in accordance with law, no unit or individual may conceal, falsely report, delay or omit to report, and must not incite others to conceal, falsely report, or delay reporting, and must not obstruct others from reporting.

Article 30: The State is to establish mechanisms for joint prevention and control of major emerging infectious diseases, animal and plant epidemics.

In the event of a major emerging infectious disease, animal or plant epidemic, control measures shall be taken in a timely manner in accordance with the provisions of relevant laws, regulations and emergency response plans; The State Council's departments in charge of health, agriculture and rural affairs, and forestry and grasslands shall immediately organize a consultation and assessment of the epidemic situation, report the conclusions of the consultation and assessment to the central leading institution for national security and the State Council, and notify other member units of the National Coordination Mechanism for Biosecurity Work and other relevant departments of the State Council.

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

Article 31: The State strengthens capacity building for the 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, animals and plants, and discovers and controls major emerging infectious diseases, animal and plant epidemics as soon as possible.

Article 32: The State protects wildlife, strengthens animal epidemic prevention, and prevents the spread of animal-borne infectious diseases.

Article 33: The State strengthens the management of the use and residues of antimicrobial drugs such as antibiotic drugs, and supports basic research and scientific and technological research to counter microbial resistance.

The competent health departments of the people's governments at or above the county level shall strengthen the guidance and supervision of the rational use of drugs by medical institutions, and take measures to prevent the irrational 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 guidance and supervision of the rational use of drugs in agricultural production, take measures to prevent the irrational use of antimicrobials, and reduce residues in the agricultural production environment.

The competent departments of health, agriculture and rural affairs, forestry and grassland, ecology and environment, and the drug regulatory department of the State Council shall, in accordance with the division of duties, assess the harm of antimicrobial drug residues to human health and the environment, and establish an index evaluation system for antimicrobial drug pollutants.

Chapter IV: Safety in the Research, Development, and Application of Biotechnology

Article 34: The State strengthens the safety management of biotechnology research, development, and application activities, and prohibits engaging in biotechnology research, development, and application activities that endanger biological security, such as endangering public health, harming biological resources, or destroying ecosystems and biodiversity.

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 be responsible for the safety of that unit's biotechnology research, development, and application, employing biosecurity risk prevention and control measures, drafting work systems such as biosecurity training, follow-up inspections, and periodic reports, and strengthening process management.

Article 36: The State implements categorical management of biotechnology research and development activities. According to the degree of risk of harm to public health, industry and agriculture, ecological environment, etc., biotechnology research and development activities are divided into three categories: high risk, medium risk, and low risk.

The standards for categorizing risks and directories of biotechnology research and development activities are to be formulated, adjusted, and published by the State Council's departments in charge of science and technology, health, agriculture and rural affairs, and other such departments, in conjunction with other relevant departments of the State Council, on the basis of their duties and division of labor.

Article 37: Those engaged in biotechnology research and development activities shall comply with the national biotechnology research and development safety management norms.

Those engaged in biotechnology research and development activities shall conduct a judgment on the risk category, pay close attention to changes in risks, and promptly employ response measures.

Article 38: Engaging in high-risk or medium-risk biotechnology research and development activities shall be conducted by a legal person organization lawfully established within the mainland territory, and approval or filing shall be obtained in accordance with law.

Those engaged in high-risk or medium-risk biotechnology research and development activities shall conduct risk assessments, formulate risk prevention and control plans and emergency response plans for biosecurity incidents, and reduce the risks of the implementation of research and development activities.

Article 39: The state is to carry out retrospective management of important equipment and special biological factors related to biological security. The purchase or introduction of important equipment and special biological factors included in the control list shall be registered to ensure traceability, and shall be reported to the relevant departments of the State Council for the record.

Individuals are not allowed to purchase or possess important equipment and special biological factors included in the control list.

Article 40: Engaging in clinical research on new biomedical technologies shall pass an ethics review and be conducted in a medical institution that has the appropriate capacity; Where human clinical research operations are conducted, they shall be carried out by health professional and technical personnel who meet the corresponding requirements.

Article 41: Where the relevant departments of the State Council conduct follow-up assessments of biotechnology application activities in accordance with law, and discover that there are biosecurity risks, they shall promptly employ effective remedial and control measures.

Chapter V: Biosecurity in Pathogenic Microbiology Laboratories

Article 42: The state is to strengthen management of biosecurity in pathogenic microbiology laboratories, drafting uniform laboratory biosecurity standards. Pathogenic microbiology laboratories shall comply with national standards and requirements for biosecurity.

Those engaged in pathogenic microorganism experiments shall strictly abide by relevant national standards, laboratory technical specifications, and operating procedures, and employ safety precautions.

Article 43: The state implements categorical management of pathogenic microorganisms based on their infectiousness and the degree of harm they pose to individuals or groups of humans and animals after infection.

Engaging in the collection, preservation, or transportation of samples of highly pathogenic or suspected highly pathogenic microorganisms shall have the corresponding conditions and comply with biosafety management specifications. The specific measures shall be formulated by the competent departments of health, agriculture and rural affairs under the State Council.

Article 44: The establishment of pathogenic microbiology laboratories shall obtain approval or conduct filing in accordance with law.

Individuals must not set up pathogenic microbiology laboratories or engage in pathogenic microbiology experiments.

Article 45: Based on the level of biosecurity protection for pathogenic microorganisms, the state is to carry out hierarchical management of pathogenic microbiology laboratories.

Experimenting with pathogenic microorganisms shall be conducted in laboratories of the corresponding level. Low-level pathogenic microbiology laboratories must not engage in pathogenic microbiology experiments that the National Catalog of Pathogenic Microbiology provides shall be conducted in high-level pathogenic microbiology laboratories.

Article 46: High-level pathogenic microbiology laboratories engaged in experimental activities on highly pathogenic or suspected highly pathogenic pathogenic microorganisms shall be approved by the competent departments for health or agriculture and rural affairs of people's governments at the provincial level or above, and report the experimental activities to the approving departments.

Pathogenic microorganisms that have not yet been discovered on the mainland or that have been declared eradicated must not be engaged in relevant experimental activities without approval.

Article 47: Pathogenic microbiology laboratories shall employ measures to strengthen the management of experimental animals, prevent experimental animals from escaping, and carry out harmless treatment of laboratory animals after use in accordance with national provisions, so that experimental animals can be traced. It is forbidden to enter the market after use.

Pathogenic microbiology laboratories shall strengthen the management of waste from experimental activities, disposing of wastewater, waste gas, and other wastes in accordance with law, and employing measures to prevent pollution.

Article 48: The units establishing pathogenic microbiology laboratories are responsible for the management of the laboratory's biosecurity, formulating scientific and strict management systems, periodically conducting inspections of the implementation of relevant biosecurity provisions, and conducting inspections, maintenance, and updates of laboratory facilities, equipment, materials, and so forth, to ensure that they comply with national standards.

The legally-designated representative and the person in charge of the laboratory for the establishment of pathogenic microbiology laboratories are responsible for the biological security of the laboratory.

Article 49: Units establishing pathogenic microbiology laboratories shall establish and improve security systems, employing security measures to ensure the safety of laboratories and their pathogenic microorganisms.

The state strengthens the security and protection of high-level pathogenic microbiology laboratories. High-level pathogenic microbiology laboratories shall accept oversight and guidance from public security organs and other departments related to laboratory safety and security efforts, to strictly prevent the leakage, loss, theft, or robbery of highly pathogenic pathogenic microorganisms.

The state is to establish a review system for the entry of personnel in high-level pathogenic microbiology laboratories. Personnel entering high-level pathogenic microbiology laboratories shall be approved by the person in charge of the laboratory. where it might impact laboratory biosafety, it is not to be approved; Security measures shall be taken for those who are allowed to enter.

Article 50: Units establishing pathogenic microbiology laboratories shall draft emergency response plans for biosecurity incidents, and periodically organize and carry out personnel training and emergency drills. Where leakage, loss, theft, or robbery of highly pathogenic pathogenic microorganisms occur, or other biosecurity risks, control measures shall be promptly employed in accordance with the provisions of the emergency response plan, and a report shall be made in accordance with national provisions.

Article 51: The provincial-level people's government for the location of the pathogenic microbiology laboratory and its competent health departments shall strengthen the allocation of medical resources for infectious diseases at the location of the laboratory, and increase the capacity for medical treatment of infectious diseases.

Article 52: Enterprises' biosecurity management of production workshops involving the operation of pathogenic microorganisms is to be carried out in accordance with the provisions of the relevant pathogenic microbiology laboratories and other biosecurity management norms.

The construction and management of biosafety laboratories involving the operation of biological toxins, plant pests, and other biological factors shall be carried out with reference to the provisions on pathogenic microbiology laboratories.

Chapter VI: Security of Human Genetic Resources and Biological Resources

Article 53: The state is to strengthen management and oversight of activities such as the collection, preservation, use, and external provision of human genetic resources and biological resources on the mainland, to ensure the security of human genetic resources and biological resources.

The State enjoys sovereignty over the human genetic resources and biological resources of the mainland.

Article 54: The state is to carry out surveys of human genetic resources and biological resources.

The competent health department under the State Council is to organize and carry out surveys of human genetic resources on the mainland, and draft measures for the declaration and registration of important genetic families and human genetic resources in specific regions.

The competent departments of health, science and technology, natural resources, ecology and environment, agriculture and rural affairs, forestry and grassland, and traditional Chinese medicine under the State Council shall, in accordance with their duties and division of labor, organize and carry out surveys of biological resources, and formulate measures for the declaration and registration of important biological resources.

Article 55: The collection, preservation, use, and external provision of mainland human genetic resources shall comply with ethical principles, and must not endanger public health, national security, or the societal public interest.

Article 56: Engaging in the following activities shall be subject to the approval of the competent health department under the State Council:

(1) Collecting important genetic families on the mainland or human genetic resources from specific regions, or collecting human genetic resources of the types and quantities provided for by the competent health departments under the State Council;

(2) Preserving human genetic resources on the mainland;

(3) Using the mainland's human genetic resources to carry out international scientific research cooperation;

(4) Transporting, mailing, or carrying mainland human genetic resources materials out of the country.

The provisions of the preceding paragraph do not include the collection and preservation of human genetic resources and related activities carried out for the purposes of clinical diagnosis and treatment, blood collection and supply services, investigation and handling of violations and crimes, doping testing, and funerals.

In order to obtain marketing authorization for relevant drugs and medical devices in mainland China, approval is not required for clinical trial institutions that use human genetic resources from mainland China to carry out international cooperative clinical trials that do not involve the export of human genetic resources; However, before carrying out clinical trials, the type, quantity, and use of human genetic resources to be used shall be filed with the competent health department under the State Council.

Foreign organizations and individuals, as well as the institutions they establish or actually control, must not collect or preserve mainland human genetic resources within the mainland, and must not provide mainland human genetic resources overseas.

Article 57: Where information on the mainland's human genetic resources is provided or open for use to foreign organizations or individuals, or to institutions established or actually controlled by foreign organizations, it shall be reported to the competent department of health under the State Council in advance and a backup of the information shall be submitted.

Article 58: The collection, preservation, use, and transportation of rare, endangered, or endemic species, as well as individuals, organs, tissues, cells, genes, and other genetic resources that can be used for regeneration or reproduction and generation, shall comply with relevant laws and regulations.

Overseas organizations, individuals, and institutions established or actually controlled by them shall obtain approval for the acquisition and use of mainland biological resources in accordance with law.

Article 59: The use of mainland biological resources to carry out international scientific research cooperation shall be approved in accordance with law.

The use of the mainland's human genetic resources and biological resources to carry out international scientific research cooperation shall ensure that the Chinese unit and its researchers participate in the research throughout the process and substantively, and share relevant rights and interests in accordance with law.

Article 60: The State is to strengthen prevention and response to the invasion of alien species, and protect biodiversity. The competent department for agriculture and rural affairs under the State Council, in conjunction with other relevant departments of the State Council, shall formulate a directory of invasive alien species and management measures.

On the basis of their duties and division of labor, the relevant departments of the State Council are to strengthen efforts such as the investigation, monitoring, early warning, control, assessment, and removal of invasive alien species, as well as ecological restoration.

Alien species must not be introduced, released, or discarded by any unit or individual without approval.

Chapter VII: Preventing the Threat of Bioterrorism and Biological Weapons

Article 61: The State shall employ all necessary measures to prevent bioterrorism and the threat of biological weapons.

It is prohibited to develop, manufacture or otherwise acquire, stockpile, possess and use biological weapons.

It is prohibited to instigate, finance, or assist others in the development, manufacture, or other acquisition of biological weapons in any way.

Article 62: The relevant departments of the State Council are to draft, revise, and publish lists of organisms, biotoxins, equipment, or technologies that may be used for bioterrorist activities or the manufacture of biological weapons, and strengthen regulation to prevent them from being used for the manufacture of biological weapons or terrorist purposes.

Article 63: On the basis of their duties and division of labor, the relevant departments of the State Council and relevant military organs are to strengthen monitoring and investigation of activities such as the entry, export, acquisition, manufacture, transfer, and delivery of organisms, biological toxins, equipment, or technologies that can be used for bioterrorism activities or the manufacture of biological weapons, and employ necessary measures to prevent and address them.

Article 64: The relevant departments of the State Council, provincial-level people's governments, and their relevant departments are responsible for organizing efforts such as the treatment and resettlement of persons who have suffered bioterrorist attacks or biological weapons attacks, environmental disinfection, ecological restoration, security monitoring, and restoration of social order.

The relevant departments of the State Council, provincial-level people's governments, and their relevant departments shall effectively guide public opinion to scientifically and accurately report on bioterrorist attacks and bioweapon attacks, promptly release information such as on evacuation, transfer, and emergency refuge, and conduct long-term environmental and health monitoring of areas and persons contaminated in the course of emergency response and restoration.

Article 65: The State organizes and carries out investigations of biological weapons left over from war on the mainland, their harmful outcomes, and potential impacts.

The State organizes the construction of facilities for the storage and disposal of biological weapons left over from war to ensure the safe disposal of biological weapons left over from war.

Chapter VIII: Biosecurity Capacity Building

Article 66: The state is to draft a development plan for the development of biosecurity, strengthen the capacity building of biosecurity, and increase the capacity and level of response to biosecurity incidents.

People's governments at the county level or above shall support the development of biosecurity undertakings, and include expenditures related to supporting the development of the following biosecurity undertakings in government budgets in accordance with the division of authority:

(1) monitoring the construction and operation of the network;

(2) Reserves of emergency response and prevention and control materials;

(3) Construction and operation of critical infrastructure;

(4) Research and development of key technologies and products;

(5) Investigation and preservation of human genetic resources and biological resources;

(6) Other important biosecurity undertakings provided for by laws and regulations.

Article 67: The state is to employ measures to support research on biosecurity science and technology, strengthen research on biosecurity risk prevention and control technologies, integrate superior forces and resources, establish mechanisms for joint research on key biological security technologies and major defense products, promote the output and transformation and application of core and key biosecurity technologies and major defense products, and increase the capacity for scientific and technological safeguards for biosecurity.

Article 68: The state is to make overall plans for the establishment of a national biosecurity infrastructure. On the basis of their duties and division of labor, the relevant departments of the State Council are to accelerate the establishment of national strategic resource platforms for biosecurity in areas such as bioinformatics, the preservation of human genetic resources, the preservation of bacteria (viruses), the preservation of animal and plant genetic resources, and high-level pathogenic microbiology laboratories, and establish mechanisms for sharing and utilization, to provide strategic safeguards and support for scientific and technological innovation in biosecurity.

Article 69: On the basis of their duties and division of labor, the relevant departments of the State Council are to strengthen the cultivation of personnel for basic biological scientific research and professional and technical personnel in the field of biology, and promote the establishment of basic biological science disciplines and scientific research.

Employees in important positions in the national biosecurity infrastructure shall have the qualifications that meet the requirements, and the relevant information shall be filed with the relevant departments of the State Council, and they shall receive on-the-job training.

Article 70: The State is to strengthen material reserves for the prevention and control of biosecurity risks such as major emerging infectious diseases, animal and plant epidemics, and so forth.

The state is to strengthen research, development, and technical reserves of biosecurity emergency medicines, equipment, and other materials. On the basis of their duties and division of labor, the relevant departments of the State Council are to implement measures related to research, development, and technical reserves of biosecurity emergency medicines, equipment, and other materials.

The relevant departments of the State Council and local people's governments at the county level or above and their relevant departments shall ensure the production, supply, and deployment of medical aid equipment, treatment drugs, medical devices, and other materials needed for emergency response to biosecurity incidents; The competent departments of transportation shall promptly organize and coordinate the priority transportation of transport business units.

Article 71: The state is to provide effective protective measures and medical safeguards for personnel engaged in high-risk biosecurity work such as experimental activities on highly pathogenic pathogenic microorganisms and on-site handling of biosecurity incidents.

Chapter IX: Legal Responsibility

Article 72: Where the provisions of this Law are violated by staff performing biosecurity management duties abusing their authority, dereliction of duty, twisting the law for personal gain, or having other illegal conduct in biosecurity work, sanctions are to be given in accordance with law.

Article 73: Where the provisions of this Law are violated by medical establishments, professional bodies, or their staffs concealing, falsely reporting, delaying, or omitting reporting, instigating others to conceal, falsely reporting, or delaying reporting, or obstructing others from reporting infectious diseases, animal and plant diseases, or clusters of diseases of unknown causes, the relevant departments of the people's governments at the county level or above are to order corrections and give warnings; The legally-designated representatives, principle responsible persons, directly responsible managers, and other directly responsible personnel are to be given sanctions in accordance with law, and may suspend practice activities for a set period of time in accordance with law, up to the revocation of relevant practice certificates.

Where the provisions of this Law are violated by fabricating or disseminating false biosecurity information, constituting a violation of the administration of public security, the public security organs are to give public security administrative sanctions in accordance with law.

Article 74: Where the provisions of this Law are violated by engaging in biotechnology research, development, or application activities prohibited by the state, the competent departments for health, science and technology, and agriculture and rural affairs of people's governments at the county level or above are to order that the illegal conduct be stopped, confiscate unlawful gains, technical materials, tools, equipment, raw materials, and other such items used in the illegal acts, and give a fine of between 1,000,000,000 and 10,000,000 RMB, and where the unlawful gains are between 1,000,000 and 20 times the value of the unlawful gains. and may lawfully prohibit engaging in corresponding biotechnology research, development, and application activities for a set period of time, and revoke relevant licenses; The legally-designated representatives, principle responsible persons, directly responsible managers, and other directly responsible personnel are to be given sanctions in accordance with law, with a fine of between 100,000 and 200,000 RMB, a 10-year or even lifelong ban on engaging in corresponding biotechnology research, development, and application activities, and the relevant practice certificates revoked in accordance with law.

Article 75: Where the provisions of this Law are violated by engaging in biotechnology research or development activities and failing to comply with the national norms for the safety management of biotechnology research and development, the relevant departments of people's governments at the county level or above are to order corrections and give warnings on the basis of their duties and division of labor, and may give a concurrent fine of between 20,000 and 200,000 RMB; and where corrections are refused or serious consequences are caused, they are to be ordered to stop research and development activities and given a concurrent fine of between 200,000 and 2,000,000 RMB.

Article 76: Where the provisions of this Law are violated by engaging in pathogenic microbiology experimentation activities without conducting them in a laboratory of the corresponding level, or by a high-level pathogenic microbiology laboratory engaging in experimental activities on highly pathogenic or suspected highly pathogenic microorganisms without approval, the competent departments for health, agriculture and rural affairs of the local people's governments at the county level or above are to order them to stop the illegal conduct, supervise their destruction of the pathogenic microorganisms used in the experimental activities, or send them to the preservation establishment, and give warnings; Where the spread or epidemic of infectious diseases or other serious consequences are caused, the legally-designated representatives, principle responsible persons, directly responsible managers, and other directly responsible personnel are to be removed from office or expelled from office in accordance with law.

Article 77: Where the provisions of this Law are violated by bringing used experimental animals into the market, the competent departments for science and technology of people's governments at the county level or above are to order corrections, confiscate unlawful gains, and give a concurrent fine of between 200,000 and 1,000,000 RMB, and where unlawful gains are between 200,000 and 10,000 RMB; If the circumstances are serious, the licensing department shall revoke the relevant permits.

Article 78: Where the provisions of this Law are violated by any of the following conduct, the relevant departments of people's governments at the county level or above are to order corrections, confiscate unlawful gains, give warnings, and may give a concurrent fine of between 100,000 and 1,000,000 RMB on the basis of their duties and division of labor:

(1) Purchasing or introducing important equipment or special biological factors included in the control list without registering, or failing to report to the relevant departments of the State Council for the record;

(2) Individuals purchasing or possessing important equipment or special biological factors included in the control list;

(3) Individuals setting up pathogenic microbiology laboratories or engaging in pathogenic microbiology experiments;

(4) Entering a high-level pathogenic microbiology laboratory without the approval of the person in charge of the laboratory.

Article 79: Where the provisions of this Law are violated by collecting or preserving mainland human genetic resources or using mainland human genetic resources to carry out international scientific research cooperation without approval, the competent departments for health under the State Council are to order that the illegal conduct be stopped, confiscate unlawful gains and illegally collected or preserved human genetic resources, and give a concurrent fine of between 500,000 and 5,000,000 RMB, and where unlawful gains are between 1,000,000 and 1,000,000 RMB; where the circumstances are serious, the legally-designated representatives, principle responsible persons, directly responsible managers, and other directly responsible personnel are to be given sanctions in accordance with law, and are prohibited from engaging in corresponding activities for five years.

Article 80: Where the provisions of this Law are violated by foreign organizations, individuals, or institutions established or actually controlled by them collecting or preserving mainland human genetic resources within mainland China, or providing mainland human genetic resources abroad, the competent department for health under the State Council is to order that the illegal conduct be stopped, confiscate unlawful gains and illegally collected or preserved human genetic resources, and give a concurrent fine of between 1,000,000,000 and 10,000,000 RMB; where unlawful gains are 1,000,000 RMB or more, a concurrent fine of between 10 and 20 times the unlawful gains is to be given.

Article 81: Where the provisions of this Law are violated by introducing alien species without approval, the relevant departments of people's governments at the county level or above are to confiscate the introduced alien species on the basis of their duties and division of labor, and give a concurrent fine of between 50,000 and 250,000 RMB.

Where the provisions of this Law are violated by releasing or discarding alien species without approval, the relevant departments of people's governments at the county level or above are to order the recapture or recovery of the released or discarded alien species within a set period of time on the basis of their duties and division of labor, and give a fine of between 10,000 and 50,000 RMB.

Article 82: Where violations of the provisions of this Law constitute a crime, criminal responsibility is pursued in accordance with law; and where harm to persons, property, or other harm is caused, civil liability is to be borne in accordance with law.

Article 83: Where this Law does not provide for legal responsibility for illegal biosecurity conduct that violates the provisions of this Law, and other relevant laws and administrative regulations have provisions, follow those provisions.

Article 84: Where foreign organizations or individuals enter the country by transporting, mailing, or carrying dangerous biological factors, or otherwise endanger the mainland's biological security, legal responsibility is pursued in accordance with law, and other necessary measures may be employed.

Chapter X: Supplementary Provisions

Article 85: The following terms in this Law have the following meanings:

(1) "Biological factors" refers to animals, plants, microorganisms, biotoxins and other biologically active substances.

(2) "Major emerging infectious diseases" refers to infectious diseases that appear for the first time in mainland China, or that have already been declared eradicated, or that occur suddenly, causing or likely to cause serious harm to public health and life safety, causing social panic, and affecting social stability.

(3) Major emerging animal epidemics refer to the recurrence of animal diseases that have occurred for the first time in the mainland or have been declared eradicated, or the sudden occurrence and rapid spread of latent animal diseases with high morbidity and mortality rates, causing serious threats and hazards to the production safety of the aquaculture industry, as well as situations that may cause harm to public health and life safety.

(4) Major emerging plant epidemics refer to the situation in which fungi, bacteria, viruses, insects, nematodes, weeds, rodents, molluscs, etc., which seriously endanger plants that occur for the first time in the mainland or have been declared eliminated, cause pests and diseases again, or where local pests suddenly occur on a large scale and spread rapidly, causing serious harm to crops, trees and other plants.

(5) "Research, development and application of biotechnology" refers to activities such as scientific research, technology development and application through the understanding, transformation, synthesis and utilization of living organisms through scientific and engineering principles.

(6) Pathogenic microorganisms refer to microorganisms that can invade humans and animals to cause infections or even infectious diseases, including viruses, bacteria, fungi, rickettsia, parasites, etc.

(7) Plant pests refer to fungi, bacteria, viruses, insects, nematodes, weeds, pests, molluscs and other organisms that can cause harm to crops, trees and other plants.

(8) Human genetic resources, including materials on human genetic resources and information on human genetic resources. Human genetic resources materials refer to organs, tissues, cells, and other genetic materials that contain human genomes, genes, and other genetic materials. Human genetic resources information refers to data and other information materials generated from the use of human genetic resources materials.

(9) Microbial resistance refers to the resistance of microorganisms to antimicrobial drugs, resulting in the inability of antimicrobial drugs to effectively control the infection of microorganisms.

(10) "Biological weapons" means microbial agents, other biological agents and biological toxins of any type and quantity that are not justifiably required for prevention, protection or other peaceful purposes, and which are produced from any source or by any method; It also includes weapons, equipment or means of delivery designed for the use of such biological agents or toxins for hostile purposes or in armed conflict.

(11) "Bioterrorism" refers to the deliberate use of pathogenic microorganisms, biotoxins, and so forth to carry out attacks, harming the health of humans, animals, and plants, causing social panic, and attempting to achieve specific political goals.

Article 86: Where biosecurity information is a state secret, secrecy management shall be carried out in accordance with the "Law of the People's Republic of China on Guarding State Secrets" and other relevant state secrecy provisions.

Article 87: The Central Military Commission is to make separate provisions on the biosecurity activities of the Chinese People's Liberation Army and the Chinese People's Armed Police Force in accordance with the principles provided for in this Law.

Article 88: This Law takes effect on April 15, 2021.