Biosecurity Law of the People’s Republic of China

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

No. 58

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

 

President of the People’s Republic of China

Xi Jinping

October 17, 2020

 

Biosecurity Law of the People’s Republic of China

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

 

Contents

Chapter I  General Provisions

Chapter II  Biosecurity Risk Prevention and Control System

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

Chapter IV  Security of Biotechnology Research, Development and Application

Chapter V  Biosecurity of Pathogenic Microorganism Laboratories

Chapter VI  The Security of Human Genetic Resources and Biological Resources

Chapter VII  Prevention of Bioterrorism and Biological Weapon Threats

Chapter VIII  Biosecurity Capacity Building

Chapter IX  Legal Liabilities

Chapter X  Supplementary Provision

Chapter I  General Provisions

 

Article 1  This Law is enacted for the purpose of maintaining national security, preventing and responding to biosecurity risks, safeguarding lives and health of the people, protecting biological resources and ecological environment, advancing the sound development of biotechnology, pursuing the building of a community with a shared future for humankind and realizing the harmony between humanity and nature.

Article 2  For purposes of this law, “Biosecurity” refers to the status that the state effectively prevents and responds to threats of dangerous biological agents and related factors, that stable and sound development can be achieved in biotechnology, that people’s lives, health and ecosystems are not threatened or jeopardized, and that the state has the capacity to maintain national security and sustainable development in the biological field.

This Law shall apply to the following activities:

(1) Prevention and control of the outbreak of the major emerging infectious diseases as well as animal and plant epidemics;

(2) Research, development and application of biotechnology;

(3) Biosecurity management of pathogenic microorganism laboratories;

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

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

(6) Responding to resistance of microorganism;

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

(8) Other biosecurity-related activities.

Article 3  Biosecurity is an important part of national security. It shall be maintained by adopting a holistic approach to national security, coordinating development and security, and adhering to the principles of people first, risk prevention, classified management, and coordination and cooperation.

Article 4  Under the leadership of the Communist Party of China over national biosecurity work, national biosecurity leadership system shall be established and improved, the construction of national biosecurity risk prevention, control and governance system shall be strengthened so as to improve the capacity for national biosecurity governance.

Article 5  The state encourages biotechnology innovation, strengthens construction of biosecurity infrastructure and training of biotechnology talents, supports development of bioindustry,  and improves biotechnology by innovative drive,so as to enhance the capacities for guaranteeing biosecurity.

Article 6  The state shall strengthen international cooperation in the field of biosecurity, fulfill obligations provided by international treaties that the People’s Republic of China has concluded or acceded to, support participation in biotechnology exchanges and cooperation as well as international rescue in biosecurity incidents, take an active part in research and formulation of international biosecurity rules, and promote improvement of global biosecurity governance.

Article 7  The people’s governments at all levels and relevant departments thereof shall strengthen publicity and popularization of biosecurity laws, regulations and biosecurity knowledge, guide community-level people’s self-governing organizations and social organizations in publicizing biosecurity laws, regulations and biosecurity knowledge, and enhance biosecurity awareness in the whole society.

Relevant scientific institutes, medical institutions and other enterprises and public institutions shall incorporate biosecurity laws, regulations and biosecurity knowledge into their education and training programs so as to strengthen students’ and professionals’ awareness of biosecurity and ethics.

The news media shall publicize knowledge on biosecurity laws, regulations and biosecurity, uncover violations of biosecurity by media supervision, and enhance the sense of social responsibility for safeguarding biosecurity among the general public.

Article 8  No entities or individuals shall jeopardize biosecurity.

Any entity or individual shall have the right to report acts that jeopardize biosecurity; the departments that receive such a report shall promptly handle it in accordance with law.

Article 9  For entities and individuals making outstanding contributions to biosecurity, honors and rewards shall be commended and rewarded by people’s governments at or above the county level and the relevant departments in accordance with the relevant regulations of the state.

Chapter II  Biosecurity Risk Prevention and Control System

Article 10  The central leading body for national security shall be responsible for deliberating, deciding on, and coordinating the national biosecurity work, studying and formulating national biosecurity strategies and relevant major policies, guiding the implementation of these strategies and policies, coordinating major matters and important work concerning national biosecurity, and establishing a National Biosecurity Work Coordination Mechanism.

Provinces, autonomous regions, and municipalities directly under the Central Government shall establish their biosecurity coordination mechanisms to organize, coordinate, supervise and promote biosecurity-related work within their administrative areas.

Article 11 The National Biosecurity Work Coordination Mechanism shall be composed of competent departments of health, agriculture and rural affairs, science and technology, and foreign affairs of the State Council, and relevant military organs, and shall analyze and evaluate the national biosecurity situation, organize, coordinate, supervise and advance national biosecurity-related work. The National Biosecurity Work Coordination Mechanism shall establish an office responsible for the routine work.

Member entities of the Mechanism and other relevant departments of the State Council shall be responsible for their respective biosecurity-related work in accordance with the division of duties.

Article 12  An expert committee shall be established by the National Biosecurity Work Coordination Mechanism to provide consultation for decision-making on the research into national biosecurity strategies and formulation and implementation of relevant policies.

Relevant departments of the State Council shall organize and establish technical expert advisory committees in related fields and industries to provide technical supports such as consultation, evaluation, and demonstration for biosecurity work.

Article 13  Local People’s Governments at all levels shall be responsible for biosecurity work within their administrative regions.

Relevant departments of local people’s governments at or above the county level shall be responsible for biosecurity-related work in accordance with the division of duties.

Community-level people’s self-governing organizations shall assist local people’s governments and relevant departments in prevention and control of biosecurity risk, emergency response as well as biosecurity-related publicity and education.

Relevant entities and individuals shall cooperate in the prevention and control of biosecurity risks, emergency response and other relevant work.

Article 14  The state shall establish a biosecurity risk monitoring and alert framework. The National Biosecurity Work Coordination Mechanism shall organize the establishment of a national biosecurity risk monitoring and alert system so as to strengthen the capability in identifying and analyzing biosecurity risks.

Article 15  The state shall establish a biosecurity risk investigation and assessment system. The National Biosecurity Work Coordination Mechanism shall regularly organize and conduct biosecurity risk investigations and assessments based on data, materials and other information collected through risk monitoring.

Relevant departments shall promptly investigate and assess biosecurity risk and, in accordance with law, take necessary risk prevention and control measures under any of the following circumstances:

(1) Identifying possible biosecurity risks via risk monitoring or reports received;

(2) Formulating or adjusting a biosecurity-related directory or list to determine key fields and key projects that should be subjected to supervision and administration;

(3) Outbreak of major emerging infectious diseases, animal and plant epidemics, or other incidents that jeopardize biosecurity; and

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

Article 16  The state shall establish a biosecurity information sharing system. The National Biosecurity Work Coordination Mechanism shall organize and establish a unified national biosecurity information platform and relevant departments shall submit biosecurity data, materials and other information to the platform for sharing.

Article 17  The state shall establish a biosecurity information releasing system. Major biosecurity information such as the overall situations of national biosecurity, major biosecurity risk alerts, major biosecurity incidents and relevant investigations and handling shall be released by the member entities of the National Biosecurity Work Coordination Mechanism in accordance with the division of duties. Other biosecurity information shall be released by the relevant departments of the State Council, and the local people’s governments at or above the county level and their relevant departments in accordance with their respective authorities and duties.

No entity or individual may fabricate or spread false biosecurity information.

Article 18  The state shall establish a biosecurity directory and list system. In accordance with the requirement of biosecurity work, the State Council and its relevant departments shall formulate, release and adjust the directories or lists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant epidemics, invasive alien species or otherwise in relation to biosecurity.

Article 19  The state shall establish a system for biosecurity standards. The competent department of standardization and other relevant departments of the State Council shall, in accordance with the division of duties, establish and improve relevant standards in the field of biosecurity.

The National Biosecurity Work Coordination Mechanism shall organize relevant departments to strengthen coordination and consistency of biosecurity standards in different fields, and establish and improve the biosecurity standard system.

Article 20  The state shall establish a biosecurity review system. Relevant departments of the State Council shall be responsible for biosecurity review over major matters and activities in the biological field that affects or may affect national security to effectively prevent and eliminate biosecurity risks.

Article 21  The state shall establish a coordinated, orderly and efficient biosecurity emergency response system with a unified leadership.

The relevant departments of the State Council shall organize the formulation of emergency response plans for biosecurity incidents in related fields and industries, and in accordance with the emergency response plans and unified arrangements, carry out emergency response drills, emergency response, emergency rescue, and rehabilitation.

Local people’s governments at or above the county level and their relevant departments shall formulate emergency response plans for biosecurity incidents, organize, guide and supervise relevant enterprises and institutions to formulate emergency response plans for biosecurity incidents, strengthen emergency response preparedness, personnel training and emergency response drills, and carry out emergency response to biosecurity incidents, emergency rescue, and rehabilitation and other relevant work.

The Chinese People’s Liberation Army and the Chinese People’s Armed Police Force shall act upon the orders of the Central Military Commission and participate in the emergency response to biosecurity incidents and the rescue operations in accordance with law.

Article 22  The state shall establish a biosecurity incident investigation and source-tracing system. In case of the outbreak of a major emerging infectious disease, an animal or plant epidemic, or an unexplained biosecurity incident, the National Biosecurity Work Coordination Mechanism shall organize investigation and source-tracing, identify the nature of the incident, comprehensively assess the impact of the incident, and provide suggestions and recommendations.

Article 23  The state shall establish a national access system for animals, plants and the products thereof, and high-risk biological agents that enter into China for the first time or resume entry after a suspension.

Persons, means of transport, containers, goods, articles and packaging, which enter into or exit from China, and ballast water discharged from ships on international voyages in the territory of China shall meet the requirements of China’s biosecurity management.

The customs shall deal with biosecurity risks discovered in entry, exit and transit processing in accordance with relevant laws. Persons, means of transport, goods, articles, among others, assessed as high biosecurity risks shall enter the country through designated border ports and shall be subject to strict measures for risk prevention and control.

Article 24  The state shall establish a response system for major overseas biosecurity incidents. In the event of a major biosecurity incident abroad, the customs shall take emergency measures for prevention and control of biosecurity risks in accordance with law, strengthen document verification, increase the inspection ratio, and suspend the entry of relevant persons, means of transport, goods, and articles, among others. When necessary, with the approval of the State Council, measures such as temporary closure of relevant ports and relevant borders may be adopted.

Article 25  Relevant departments of people’s governments at or above the county level shall carry out biosecurity supervision and inspection in accordance with law. The inspected entities and individuals shall cooperate with the government departments, truthfully report on the situation and provide materials as required. Refusal or obstruction is prohibited.

Where supervision and inspection require highly professional and technical support, and the lack of which may result in difficulty in law enforcement, such supervision and inspection shall be conducted with the participation of biosecurity professionals.

Article 26  In case of implementing biosecurity supervision and inspection, relevant departments of people’s governments at or above the county level may take the following measures in accordance with law:

(1) Entering the entities or locations subjected to inspection, or the sites related to suspected violations which jeopardize biosecurity for on-site surveillance, monitoring, inspection or verification;

(2) Inquiring relevant entities or individuals;

(3) Consulting and copying relevant documents, materials, archives, records, vouchers or otherwise;

(4) Sealing up sites and facilities related to suspected violations which jeopardize biosecurity;

(5) Seizing tools, equipment or related articles related to suspected violations which jeopardize biosecurity; and

(6) Other measures provided by laws and regulations.

The information on violations jeopardizing biosecurity by relevant entities and individuals shall be included in the National Credit Information Sharing Platform in accordance with law.

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

 

Article 27  The competent departments of health, agriculture and rural affairs, forestry and grassland, customs and ecological environment of the State Council shall establish the networks monitoring major emerging infectious diseases, animal and plant epidemics, entry and exit quarantine, and biotechnological environmental safety, organize layout and construction of monitoring sites, establish and improve the monitoring and information reporting system, actively carry out monitoring and pathogen testing, and incorporate the aforementioned monitoring networks into the national biosecurity risk monitoring and alert system.

Article 28  Disease prevention and control institutions, animal disease epidemic prevention and control institutions, and plant disease and pest prevention and control agencies (hereinafter collectively referred to as specialized institutions) shall carry out active monitoring of infectious diseases, animal and plant epidemics and diseases of unknown causes included in the monitoring scope, collect, analyze and report  information obtained during monitoring, and predict the occurrence and trends of emerging infectious diseases as well as animal and plant epidemics.

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

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

A medical institution, specialized institution or any of its staff member that discovers an infectious disease, an animal or a plant epidemic, or a disease cluster of unknown causes, shall promptly report it and take protective measures.

No entity or individual may conceal what is required to be reported under the law, or make a false report, delay or omit a report on it, or instruct others to conceal it, or make a false report, delay or omit a report on it, or obstruct others from reporting it.

Article 30  The state shall establish joint prevention and control mechanisms against the outbreak of major emerging infectious diseases and animal and plant epidemics.

In the event of the outbreak of a major emerging infectious disease, or an animal or a plant epidemic, control measures shall be taken in a timely manner in accordance with relevant laws, regulations, and emergency response plans; the competent departments of the State Council of health, agriculture and rural affairs, and forestry and grassland shall immediately organize a meeting to discuss and assess the epidemic situation, submit conclusions thereon to the central leading body of national security and the State Council, and notify other member entities of the National Biosecurity Work Coordination Mechanism and other relevant departments of the State Council.

In the event of the outbreak of a major emerging infectious disease, or an animal or a plant epidemic, local people’s governments at all levels shall uniformly perform the duties of epidemic prevention and control within their administrative regions, strengthen organization and leadership, implement epidemic prevention and control by involving the efforts of the public, provide medical treatment, mobilize and encourage various sectors of the society to participate in epidemic prevention and control in an orderly manner in accordance with law.

Article 31  The state enhances the overall capacity building in prevention of and control over infectious diseases and animal and plant epidemics at borders and ports, and establish an international cooperation network for prevention of and control over infectious diseases and animal and plant epidemics, so as to detect and control the outbreak of major infectious diseases and animal and plant epidemics as early as possible.

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

Article 33  The state strengthens the management of the use of antimicrobial drugs such as antibiotics and their residues, and supports fundamental researches and researches tackling key scientific and technological problems concerning microbial resistance.

Competent departments of health of the people’s governments at or above the county level shall strengthen the guidance for and supervision of rational use of drugs by medical institutions, and take measures to prevent irrational use of antimicrobial drugs. The competent departments of agriculture and rural affairs and those of forestry and grassland of the people’s governments at or above the county level shall strengthen the guidance for and supervision of rational use of agricultural chemicals in agricultural production, take measures to prevent irrational use of antimicrobial chemicals and reduce their residues in the environments for agricultural production.

The competent departments of health, agriculture and rural affairs, forestry and grassland, and ecological environment of the State Council, and the department for medical products administration of the State Council shall assess the harm of the residues of antimicrobial chemicals to human health and the environment according to the division of duties, and establish a system for evaluating pollutant indicators of antimicrobial chemicals.

Chapter IV Security of Biotechnology Research, Development and Application

 

Article 34  The state strengthens the security management of biotechnology research, development and application activities, and prohibits those activities  that may threaten the public health, damage the living resources or threaten biodiversity.

Biotechnology research, development and application shall follow ethical principles.

Article 35  Entities that engage in biotechnology research, development and application shall be responsible for the security of their own activities in biotechnology research, development and application, adopt measures for the prevention and control of biosecurity risks, formulate working procedures for biosecurity-related training, follow-up inspection, and regular report so as to strengthen the process management.

Article 36  The state adopts classified management as regards biotechnology research and development activities. These activities shall be classified as high-risk, medium-risk, and low-risk activities according to the degree of potential harm to the public health, industry, agriculture, and ecological environment.

The competent departments of science and technology, health, and agriculture and rural affairs of the State Council shall, in conjunction with other relevant departments of the State Council, formulate, adjust and issue risk classification standards and directories of biotechnology research and development activities according to the division of duties.

Article 37  Biotechnology research and development activities shall be in compliance with the national security management norms for biotechnology research and development.

Those who engage in biotechnology research and development shall identify the class of a risk, pay close attention to any change in the risk, and take response measures in a timely manner.

Article 38  High-risk and medium-risk biotechnology research and development activities may be conducted only by the legal persons lawfully established within the territory of China with approval or after being put on record in accordance with law.

Risk assessments shall be conducted when carrying out medium-risk and high-risk biotechnology research and development activities; risk prevention and control plans and biosecurity incident emergency response plans shall be adopted to reduce risks thereof.

Article 39  The state adopts traceability management as regard important equipment and special biological factors that involve biosecurity. Purchase or import of important equipment and special biological factors included in the control lists shall be registered to ensure traceability and be reported to the relevant departments of the State Council for record.

An individual shall not buy or hold any important equipment or special biological factors which are included in the control lists.

Article 40  Clinical researches on new biomedical technologies shall, after passing the ethical review, be conducted in medical institutions with necessary and sufficient conditions. Clinical research operations on humans shall be performed by medical professionals with relevant qualifications.

Article 41  Relevant departments of the State Council shall, in accordance with law, carry out follow-up evaluations on biotechnology application activities and, if any biosecurity risk is detected, effective remedial and control measures shall be adopted in a timely manner.

Chapter V Biosecurity of Pathogenic Microorganism Laboratories

Article 42  The state strengthens biosecurity management in pathogenic microorganism laboratories by formulating uniform standards for laboratories biosecurity. Pathogenic microorganism laboratories shall follow the national biosecurity standards and requirements.

Those who engage in pathogenic microorganisms experiments shall strictly follow relevant national standards, and laboratory technical specifications as well as operating rules and procedures, and adopt preventive measures.

Article 43  The state adopts classified pathogenic microorganisms management in accordance with the infectivity of pathogenic microorganisms and the degree of harm on individuals or groups of humans and on individual animal or groups of animals.

To engage in activities of collecting, preserving and transporting the samples of highly pathogenic or suspected highly pathogenic microorganisms, the corresponding requirements shall be met and the biosecurity management norms shall be complied with. Specific procedures shall be formulated by the competent departments of health as well as agricultural and rural affairs of the State Council.

Article 44  Establishment of pathogenic microorganism laboratories shall be subject to approval or be filed for record in accordance with law.

No individual shall establish any pathogenic microorganism laboratory or engage in any pathogenic microorganism experiment.

Article 45  The state adopts pathogenic microorganism laboratory hierarchical management in accordance with the level of biosecurity protection in relation to pathogenic microorganism.

Pathogenic microorganism experiments shall be conducted in laboratories at the corresponding levels. Pathogenic microorganism experiments which should be conducted in high-level pathogenic microorganism laboratories as are specified in the national pathogenic microorganism lists shall not be conducted in low-level pathogenic microorganism laboratories.

Article 46  To engage in a highly pathogenic or suspected highly pathogenic microorganism experiment, a high-level pathogenic microorganism laboratory shall acquire approval from the competent department of health or agricultural and rural affairs of the people’s government at or above provincial level and report the circumstance of experiments to the department that approves the experiment.

Relevant pathogenic microorganism experiments shall not be conducted without approval if said pathogenic microorganisms have not yet been found or have been declared eradicated in China.

Article 47  Pathogenic microorganism laboratories shall take measures to strengthen experimental animal management,  preventing animal escape, conducting disposal of harmful materials of used experimental animals, and ensuring the traceability of experimental animals. Used experimental animals are not allowed to enter into market.

Pathogenic microorganism laboratories shall strengthen experimental waste management, dispose of waste water, waste gas and other wastes in accordance with law, and take measures to prevent pollution.

Article 48  Entities with pathogenic microbiology laboratories shall be responsible for the biosecurity management of their laboratories, adopt scientific and strict management systems, make regular inspection in terms of the implementation of relevant biosecurity regulations, and check, maintain, and update laboratory facilities, equipment and materials to ensure compliance with the national standards.

The legal representatives of the entities with pathogenic microorganism laboratories and the directors of the laboratories shall be responsible for laboratory biosecurity.

Article 49  The entities with pathogenic microorganism laboratories shall establish and improve their rules of security, and adopt measures to ensure the security of the laboratories and pathogenic microorganisms thereof.

The state shall strengthen the security of high-level pathogenic microorganism laboratories. The high-level pathogenic microorganism laboratories shall be subject to supervision and guidance from public security organs and other departments in respect of their laboratory safety and security, and take strict precautions against the leakage, loss, theft and robbery of highly pathogenic microorganisms.

The state shall establish a review and approval system for personnel entering high-level pathogenic microorganism laboratories. Personnel entering high-level pathogenic microorganism laboratories shall be subject to the approval of directors thereof. The entrance of those who may affect laboratory safety and security shall not be approved; for those who are approved to enter, security and protective measures shall be taken.

Article 50  The entities with pathogenic microorganism laboratories shall formulate emergency response plans for biosecurity incidents, organize and carry out personnel training and emergency response drills regularly. Where highly pathogenic micro-organisms are leaked, lost, stolen, or robbed of or there is any  other biosecurity incident, control measures shall be adopted in accordance with the emergency response plans and a report thereon shall be made in accordance with the regulations of the state.

Article 51  The provincial people’s governments and their competent departments of health of the provinces which host pathogenic microorganism laboratories shall strengthen medical  resource allocation against infectious diseases so as to improve treatment capacity.

Article 52  Enterprises shall adopt biosecurity management on their plants involving operation of pathogenic microorganisms in accordance with relevant regulations for pathogenic microorganism laboratories and other biosecurity management norms.

Biosecurity laboratories involving operation of biotoxin, plant pests or other biology factors shall be constructed and managed with reference to the relevant regulations for pathogenic microbiological laboratories.

Chapter VI The Security of Human Genetic Resources and Biological Resources

Article 53  The state strengthens management and supervision over the activities such as the collection, preservation and utilization of, as well as the providing anyone outside China with, the human genetic resources and biological resources of China, so as to ensure the security of human genetic resources and biological resources.

The state has sovereignty over human genetic resources and biological resources of China.

Article 54  The state shall carry out investigation on human genetic resources and biological resources.

The competent department of science and technology of the State Council shall organize surveys on human genetic resources in China, and formulate the application and registration procedures for important genetic families and for the human genetic resources in specific areas.

The competent departments of the State Council for science and technology, natural resources, ecological environment, health, agriculture and rural affairs, forestry and grassland, and traditional Chinese medicine, according to the division of duties, shall organize surveys on biological resources, and formulate the application and registration procedure for important biological resources.

Article 55  The collection, preservation and utilization of, as well as providing anyone outside China with, the human genetic resources of China shall conform with ethical principles, and shall not jeopardize public health, national security, and the public interest.

Article 56  The following activities may only be conducted upon approval of the competent department of science and technology of the State Council :

(1) Collecting important genetic families or human genetic resources in specific areas in China, or collecting genetic resources of a specific species or reaching a specific quantity as prescribed by the competent department of the State Council for science and technology;

(2) Preserving the human genetic resources of China;

(3) Utilizing the human genetic resources of China to carry out international cooperation in scientific research;

(4) Delivering, mailing and taking China’s human genetic resources out of the border of China.

The preceding paragraph does not apply to the collection and preservation of human genetic resources and related activities for the purpose of clinical treatment, blood collection and supply services, investigation and punishment of crimes, doping tests, and funerals.

Approvals are not required for international cooperative clinical trials carried out in clinical trial institutions for the purpose of obtaining the marketing authorization of relevant drugs and medical devices in China, which involves the use but does not involve the export of China’s human genetic resources; however, the types, quantity, and purpose of use of the human genetic resources to be used shall be filed for record with the competent department of science and technology of the State Council before clinical trials are conducted.

Overseas organizations and individuals, as well as the institutions established by them or under their de facto control, shall not collect or preserve the human genetic resources of China within the territory of China, and shall not provide China’s human genetic resources for anyone outside China.

Article 57  To provide information on the human genetic resources of China, or provide access to such information for overseas organizations or individuals, or the institutions established by them or under their de facto control, reports shall be submitted, along with a duplicate of the information, to the competent department of science and technology of the State Council in advance.

Article 58  Collecting, preserving, utilizing, or transporting to overseas, China’s precious, endangered, or endemic species, or their genetic resources such as the individuals, organs, tissues, cells, genes available for regeneration or reproduction, shall comply with relevant laws and regulations.

Obtaining and utilizing the biological resources of China by overseas organizations or individuals, or the institutions established by them or under their de facto control shall be subject to approval in accordance with law.

Article 59  Using China’s biological resources to carry out international cooperation in scientific research shall be subject to, approval in accordance with law.

Where China’s human genetic resources or biological resources are used for international cooperative scientific research, it shall be guaranteed that the entities and researchers of the Chinese side  participate in the whole process of the research in a substantive manner and share the relevant rights and interests in accordance with law.

Article 60  The state strengthens prevention of and response to invasive alien species and protects biodiversity. The competent department of agriculture and rural affairs of the State Council, in collaboration with other relevant departments of the State Council, shall formulate a directory of invasive alien species and the management procedures.

The relevant departments of the State Council shall, in accordance with the division of duties, strengthen the investigation, monitoring, alerting, control, evaluation, and removal of invasive alien species as well as the related ecological restoration.

No entity or individual shall introduce, release or discard alien species without approval.

Chapter VII Prevention of Bioterrorism and Biological Weapon Threats

Article 61  The state takes all necessary measures to prevent bioterrorism and biological weapons.

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

It is prohibited to instigate, finance, or assist others to develop, manufacture, or otherwise acquire biological weapons in any way.

Article 62  Relevant departments of the State Council shall formulate, amend and publish the lists of living organisms, biotoxin, equipment or technology that may be used in bioterrorism activities or in the manufacture of biological weapons, and strengthen supervision and control to prevent the listed items from being used for manufacturing biological weapons or for bioterrorism purpose.

Article 63  Relevant departments of the State Council and relevant military organs shall, in accordance with the division of duties, strengthen the monitoring and investigation of activities such as the entry in or exit from China, import or export, obtaining, manufacture, transfer, or release of living organisms, biotoxin, equipment or technologies that may be used in bioterrorist activities or in the manufacture of biological weapons, and shall take necessary prevention and disposal measures.

Article 64  Relevant departments of the State Council, and the provincial people’s governments and their competent departments shall be responsible for organizing the rescue and placement of victims inflicted by bioterrorism attacks or biological weapons attacks, environmental disinfection, ecological restoration, security monitoring, and social order restoration.

Relevant departments of the State Council, and the provincial people’s governments and their competent departments shall effectively guide the media in rationally and accurately reporting bioterrorist attacks and biological weapons attacks, release in time the information on evacuation, relocation, emergency shelter or otherwise, and conduct long-term monitoring of the environment  and people’s health in the contaminated areas during emergency response and rehabilitation.

Article 65  The state organizes investigations into the biological weapons left behind from wars within the territory of China, as well as the harmful consequences caused thereby and the potential effects.

The state organizes the construction of facilities for the storage and disposal of biological weapons left behind from wars in the territory of China to ensure the safe disposal of biological weapons.

Chapter VIII Biosecurity Capacity Building

Article 66  The state shall formulate a development plan for biosecurity undertakings, enhance the biosecurity capacity building, and improve the capacity responding to biosecurity incidents.

People’s governments at or above the county level shall support the development of biosecurity undertakings, and in accordance with the division of authorities, incorporate in their government budgets the relevant expenditures supporting the development of the following biosecurity undertakings:

(1) Construction and operation of the monitoring network;

(2) Storage of materials used for emergency response and risk prevention and control;

(3) Construction and operation of key infrastructures;

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

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

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

Article 67  The state takes measures to support biosecurity technology research,  promote the development of technology for biosecurity risk prevention and control, optimize resources, establish a interdisciplinary and multidepartmental collaborative mechanism for innovation and research in key issues, and promote the output, transfer and application of core and key biosecurity technologies and major biosecurity defense products, so as to improve the scientific and technological capabilities for safeguarding biosecurity.

Article 68  The state makes an overall layout of national biosecurity infrastructure. Relevant departments of the State Council shall, in accordance with the division of duties, accelerate the development of a national strategic resources platform for preserving biological information, human genetic resources, bacterial (viral) species, and animal and plant genetic resources, as well as the construction of high-level pathogenic microorganism laboratories, etc.; and shall establish a mechanism sharing the aforementioned resources, so as to provide strategic safeguard and support for biosecurity-related scientific and technological innovations.

Article 69  Relevant departments of the State Council shall, in accordance with the division of duties, strengthen training of talents in terms of researchers in the basic science of biology and technicians in the field of biology, so as to promote the development of academic disciplines of the basic science of biology and enhance research in the basic science of biology.

Personnel holding important positions in the entities managing national biosecurity infrastructures shall have the required qualifications, with relevant information filed with the relevant departments of the State Council, and shall receive on-the-job training.

Article 70  The state increases the reserves of materials for preventing and controlling the outbreak of major emerging infectious diseases, animal and plant disease epidemics, and other biosecurity risks.

The state enhances the research and development of  medicines and equipment, among others, for biosecurity emergency response,and the development of  technology in case of need. Relevant departments of the State Council shall, in accordance with the division of duties, take relevant measures for launching the aforementioned research and development.

Relevant departments of the State Council, and the people’s governments at or above the county level and their relevant departments shall guarantee the production, supply, and allocation of the materials required for responding to biosecurity emergencies, such as medical equipment, drugs, and medical devices; and the competent departments of transportation shall organize and coordinate in time the transport business entities to deliver such materials in priority.

Article 71  The state provides effective protection and medical guarantee for personnel engaging in highly pathogenic microorganisms experiments, on-site response to biosecurity incidents, and other high risk biosecurity work.

Chapter IX Legal Liabilities

Article 72  Where a staff member performing the duties of biosecurity management, in violation of the provisions hereof, abuses power, neglects duty, or engages in malpractices for personal gain or commits any other illegal act in biosecurity management, sanctions shall be imposed thereupon in accordance with law.

Article 73  Where a medical institution, specialized institution or any of its staff member, in violation of the provisions hereof, conceals, makes a false report on, or delays or omits the report on an infectious disease, an animal or a plant epidemic, or any other disease cluster, or instructs others to conceal, make a false report on, delay or omit a report on such a case, or obstructs others from reporting such a case, the institution or staff member shall be ordered to make rectification and be given a warning by the relevant department of the people’s government at or above the county level; the legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible shall be sanctioned in accordance with law, and they may also be punished ranging from suspension of practice for a certain period up to revocation of relevant practicing certificates.

Where anyone, in violation of the provisions hereof, fabricates or spreads false biosecurity information, which constitutes a violation of public security administration, public security administration penalty shall be imposed thereupon by the public security organ in accordance with law.

Article 74  Where anyone, in violation of the provisions hereof, conducts biotechnological research, development, or application activities prohibited by the state, the competent departments of health, science and technology, or agriculture and rural affairs of the people’s government at or above the county level shall, pursuant to the division of duties, give the order ceasing the illegal activities, confiscate the illegal gains, technical materials, tools, equipment, raw materials and other items used therefor, and impose a fine of not less than one million yuan but not more than ten million yuan. If the illegal gains are one million yuan or more, a fine of not less than ten times but not more than twenty times the illegal gains shall be imposed, and the relevant biotechnology research, development or application activities may be prohibited for a certain period of time and the relevant practicing certificates may be revoked in accordance with law. The legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible shall be sanctioned in accordance with law, be fined not less than 100,000 yuan but not more than 200,000 yuan, and be banned from engaging in relevant biotechnological research, development and application activities for a period of ten years or even for life with their relevant practicing certificates revoked in accordance with law.

Article 75  Where anyone, in violation of the provisions hereof, fails to conduct research or development of biotechnology in compliance with the national security management norms for biotechnology research and development, the relevant departments of the people’s government at or above the county level shall, in accordance with the division of duties, order the violator to make rectification, impose a warning, and may also impose a fine of not less than 20,000 yuan but not more than 200,000 yuan. Where the violator refuses to make rectification or causes serious consequences, an order ceasing the research and development activities shall be given, and a fine of not less than 20,000 yuan but not more than 200,000 yuan yuan shall be imposed.

Article 76  Where anyone, in violation of the provisions hereof, fails to conduct a pathogenic microorganism experiment in a laboratory at the required level, or conducts, without approval, a highly pathogenic or suspected highly pathogenic microorganism experiment in a high-level pathogenic microorganism laboratory, the competent departments of health as well as agricultural and rural affairs of the people’s government at or above the county level shall, in accordance with the division of duties, order the violator to cease the illegal acts, see to it that the violator destroys the pathogenic microorganisms used for experiment or delivers them to a preservation institution, and impose a warning. Where the aforementioned violation causes the spread or prevalence of an infectious diseases or any other serious consequence, the legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible  shall be removed from their posts or discharged from employment in accordance with law.

Article 77  Where anyone, in violation of the provisions hereof, releases the used laboratory animals into market, the competent department of science and technology of the people’s government at or above the county level shall order the violator to make rectification, confiscate the illegal gains, and impose a fine of not less than 200,000 yuan but not more than one million yuan, or a fine of not less than five times but not more than ten times the illegal gains if the illegal gains are 200,000 yuan or more; if the case is serious, the relevant permits shall be revoked by the issuing department.

Article 78  Where anyone, in violation of the provisions hereof, commits any of following acts, the relevant departments of the people’s governments at or above the county level shall order the violator to make rectification, confiscate the illegal gains, and impose a warning, and may also impose a fine of not less than 100,000 yuan but not more than one million yuan:

(1) Purchasing or importing important equipment or special biological factors specified in the control lists without registration or reporting to the relevant departments of the State Council for record;

(2) Purchasing or possessing in the name of an individual person, important equipment or special biological factors specified in the control lists ;

(3) Establishing pathogenic microorganisms laboratories or engaging in pathogenic microorganism experiments in the name of an individual person; or

(4) Entering into high-level pathogenic microorganism laboratories without approval of the director of laboratories.

Article 79  Where anyone, in violation of the provisions hereof, collects or preserves the human genetic resources of China or conducts international joint research using the human genetic resources of China without approval, the competent department of science and technology of the State Council shall order the violator to cease the illegal acts, confiscate the illegal gains and the human genetic resources illegally collected or preserved, and impose a fine of not less than 500,000 yuan but not more than five million yuan, or a fine of not less than five times but not more than ten times the illegal gains if the illegal gains are more than one million yuan; if the circumstances are serious, the legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible shall be sanctioned and prohibited from engaging in corresponding activities within five years  in accordance with law.

Article 80  Where an overseas organization or individual, or an institution established by or under the de facto control of such an organization or individual, in violation of the provisions hereof,  collects and preserves China’s human genetic resources within the territory of China or provides China’s human genetic resources for anyone outside China, the competent department of science and technology of the State Council shall order the aforesaid organization, individual or institution to cease the illegal acts, confiscate the illegal gains and the human genetic resources illegally collected and preserved, and impose a fine of not less than one million yuan but not more than ten million yuan, or a fine of not less than ten times but not more than twenty times the illegal gains if the illegal gains are one million yuan or more.

Article 81  Where anyone, in violation of the provisions hereof, introduces alien species into China without approval, the relevant departments of the people’s government at or above the county level shall, in accordance with the division of duties, confiscate the alien species introduced and impose a fine of not less than 50,000 yuan but not more than 250,000 yuan.

Where anyone, in violation of the provisions hereof, releases or discards alien species without approval, the relevant departments of the people’s governments at or above the county level shall, in accordance with the division of duties, order the violator to recapture or recover the alien species released or discarded within the specified time limit, and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan.

Article 82  Anyone acting in violation of the provisions hereof, which constitutes a crime, shall be held criminally liable; where bodily harm, property damage or any other harm is caused, the violator shall bear civil liability according to law.

Article 83  Where there are biosecurity violations of this Law but entails no corresponding legal liability under this Law, other relevant laws or administrative regulations, if applicable, shall apply in accordance with the provisions thereof.

Article 84  Where an overseas organization or individual, by transporting, mailing, or carrying dangerous biological factors into China or by other means endangers China’s biosecurity, the said organization or individual shall be held legally liable in accordance with law and, may be subjected to other necessary measures.

Chapter X Supplementary Provisions

Article 85  For purposes of this Law, the following terms shall have the following meanings:

(1) “Biological factors” refer to animals, plants microorganisms, biotoxin, and other bioactive substances.

(2) “An outbreak of a major emerging infectious disease” refers to an infectious disease appearing in China for the first time, or re-appearing after having been declared eradicated, or appearing suddenly, which has caused or may cause serious damage to people’s health or life, and leads to social panic to the detrimental of social stability.

(3) “An outbreak of a major emerging animal epidemic” refers to an animal epidemic appearing in China for the first time or re-appearing after having been declared eradicated, or a potential animal epidemic with high incidence or mortality appearing suddenly and spreading rapidly, which threatens or endangers the safety of the breeding industry production or may cause damage to people’s health or life.

(4) “An outbreak of a major emerging plant epidemic” refers to the induction of a plant disease or pest caused by a fungus, bacterium, virus, insect, nematode, ruderal, rodent, mollusc or otherwise with serious damages to plants, appearing in China for the first time or re-appearing after having been declared eradicated, or a situation in which local pests suddenly occur on a large scale and spread rapidly, and cause serious harm to crops, forests and other plants.

(5) “Research, development and application of biotechnology” refer to such activities as scientific research as well as technological development and application by recognizing, transforming, synthesizing and using creatures through science and engineer philosophy.

(6) “Pathogenic microorganisms” refer to the microorganisms which may invade human or animals and cause infectious diseases, including virus, bacterium, fungus, rickettsias, parasites, among others.

(7) “Plant pests” refer to such creatures as Fungus, Bacterium, virus, insects, nematodes, ruderals, rodents and molluscs which may endanger crops and woods, among others.

(8) “Human genetic resources” include human genetic resource materials and information.

“Human genetic resource materials” refer to genetic materials such as organs, tissues and cells which contain human genome, gene or otherwise.

“Human genetic resource information” refers to data or other information originated from human genetic resource materials.

(9) “Microorganism resistance” refers to that microorganisms resist to antimicrobial drugs, causing the fact that antimicrobial drugs may not effectively control the infection of microorganisms.

(10) “Biological weapons” refer to the types and quantities of microbial agents, other biological agents or biotoxin which are not required for prevention, protection or other peaceful purpose or are produced from any source or by any method, including the above-mentioned biological agents or biotoxin used for weapons, equipment or vehicles designed for hostile purpose or armed conflicts.

(11) “Bioterrorism” refers to the act that, by intentionally using pathogenic microorganisms and biotoxin, among others, endangers the health of humans, animals or plants and causes social panic, so as to achieve certain political purpose .

Article 86  Biosecurity information classified as national secrets shall be managed confidentially in accordance with the Law of People’s Republic of China on Guarding National Secrets and other relevant confidentiality provisions of China.

Article 87  Biosecurity activities of the Chinese People’s Liberation Army and the Chinese People’s Armed Police Force shall be separately regulated by the Central Military Commission under the principles provided by this Law.

Article 88  This Law shall come into force as of April 15, 2021.

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