Biosecurity Law of the People's Republic of China (2024 Amendment)

Biosecurity Law of the People's Republic of China (2024 Amendment)

(Adopted at the 22nd session of the Standing Committee of the Thirteenth National People's Congress of the People's Republic of China on October 17, 2020; amended at the 9th Session of the Standing Committee of the Fourteenth National People's Congress of the People's Republic of China in accordance with the Decision of the Standing Committee of the National People's Congress to Amend the Law of the People's Republic of China on the Popularization of Agricultural Technology, 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 on April 26, 2024)

Contents
Chapter I General Provisions
Chapter II Biosecurity Risk Prevention and Control System
Chapter III Prevention and Control of Major New or Sudden Outbreaks of Infectious Diseases and Epidemics in Animals and Plants
Chapter IV Security of Biotechnology Research, Development, and Application
Chapter V Biosecurity of Pathogenic Microbe Laboratories
Chapter VI 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 Liability
Chapter X Supplemental Provisions
Chapter I General Provisions
Article 1 This Law is enacted for the purposes of maintaining national security, preventing and responding to biosecurity risks, safeguarding the lives and health of the people, protecting biological resources and the ecology and environment, promoting the sound development of biotechnology, boosting the construction of a community with a shared future for mankind, and achieving the harmonious coexistence of man and nature.
Article 2 For the purpose of this Law, "biosecurity" means that the state effectively prevents and responds to the threat of dangerous biological agents and related factors, biotechnology can develop steadily and healthily, neither the lives and health of the people nor the ecosystem is relatively in danger or under threat, and there is capability in the biological field to maintain national security and sustainable development.
This Law shall apply to the following activities:
(1) Preventing and controlling a major new or sudden outbreak of an infectious disease or an epidemic in animals or plants.
(2) Researching, developing, and applying biotechnology.
(3) Biosecurity management of pathogenic microbe laboratories.
(4) Biosecurity management of human genetic resources and biological resources.
(5) Preventing the invasion of alien species and protecting biodiversity.
(6) Responding to antimicrobial resistance.
(7) Preventing biological terrorist attacks and defending against biological weapon threats.
(8) Other biosecurity-related activities.
Article 3 Biosecurity is an integral part of national security. In maintaining biosecurity, the overall national security concept shall be implemented, development and security shall be coordinated, and the principles of people orientation, risk prevention, classification management, and coordination and cooperation shall be upheld.
Article 4 The leadership of the Communist Party of China over national biosecurity work shall be adhered to, a national biosecurity leadership system shall be established and improved, and the construction of the national biosecurity risk prevention and control and governance system shall be strengthened, so as to improve the capabilities for national biosecurity governance.
Article 5 The state shall encourage innovation in biotechnology, strengthen the building of biosecurity infrastructure and biotechnology workforce, support the development of the bioindustry, raise the level of biotechnology with innovation, and enhance the capabilities to guarantee biosecurity.
Article 6 The state shall strengthen international cooperation in the biosecurity field, perform the obligations provided by any international treaty concluded or acceded to by the People's Republic of China, support participation in biotechnology exchange and cooperation and international rescue in biosecurity incidents, and actively participate in the research on and formulation of international rules of biosecurity, and promote the improvement of global biosecurity governance.
Article 7 People's governments at all levels and their relevant departments shall strengthen the publicity on and dissemination of biosecurity laws and regulations and biosecurity knowledge and guide basic mass self-governing organizations and social organizations in publicity on biosecurity laws and regulations and biosecurity knowledge publicity, so as to promote the enhancement of whole society's awareness of biosecurity.
Relevant scientific research institutions, medical institutions, and other enterprises and public institutions shall incorporate biosecurity laws and regulations and biosecurity knowledge into the content of education and training and strengthen the building of students and professionals' awareness of biosecurity and ethics.
The news media shall give public welfare publicity to biosecurity laws and regulations and biosecurity knowledge, conduct public opinion supervision of biosecurity violations, and enhance the public awareness of social responsibility for maintaining biosecurity.
Article 8 Any entity or individual shall not endanger biosecurity.
Any entity or individual has the right to report an act that endangers biosecurity; and the department receiving the report shall handle it in a timely manner in accordance with the law.
Article 9 For entities and individuals that have made outstanding contributions to biosecurity work, the people's governments at or above the county level and their relevant departments shall commend and reward them in accordance with the provisions issued by the state.
Chapter II Biosecurity Risk Prevention and Control System
Article 10 The central national security leadership institution shall be responsible for decision-making and deliberative coordination in national biosecurity work, research on the formulation and guide the implementation of a national biosecurity strategy and relevant major policies, coordinate major matters and important work in relation to national biosecurity in an overall manner, and establish a National Biosecurity Work Coordination Mechanism.
Provinces, autonomous regions, and municipalities directly under the Central Government shall establish a biosecurity work coordination mechanism and organize the coordination and supervise the advancement of biosecurity-related work within their respective administrative areas.
Article 11 The National Biosecurity Work Coordination Mechanism, composed of the health, agriculture and rural affairs, science and technology, foreign affairs, and other competent departments of the State Council and relevant military agencies, shall analyze and judge the national biosecurity situation and organize the coordination and supervise the advancement of national biosecurity-related work. The National Biosecurity Work Coordination Mechanism shall establish an office responsible for the routine work of the coordination mechanism.
The member entities of the National Biosecurity Work Coordination Mechanism and other relevant departments of the State Council shall be responsible for biosecurity-related work according to the division of responsibilities.
Article 12 The National Biosecurity Work Coordination Mechanism shall establish an expert committee to provide decision-making advice on research on the national biosecurity strategy and the formulation and implementation of policies.
The relevant departments of the State Council shall organize the establishment of expert advisory committees on biosecurity technology in related fields and industries to provide advice, evaluation, demonstration, and other technical support for biosecurity work.
Article 13 All local people's governments shall be responsible for the biosecurity work in their respective administrative areas.
The relevant departments of local people's governments at or above the county level shall be responsible for biosecurity-related work according to the division of responsibilities.
Basic mass self-organizations shall assist local people's governments and relevant departments in effectively conducting work such as the prevention and control of biosecurity risks, emergency response, and publicity and education.
A relevant entity or individual shall cooperate in effectively conducting work such as the prevention and control of biosecurity risks and emergency response.
Article 14 The state shall establish a monitoring and early warning system of biosecurity risks. The National Biosecurity Work Coordination Mechanism shall organize the establishment of a national monitoring and early warning system of biosecurity risks to heighten capabilities to identify and analyze biosecurity risks.
Article 15 The state shall establish a biosecurity risk investigation and assessment system. The National Biosecurity Work Coordination Mechanism shall regularly organize investigation and assessment of biosecurity risks based on data, materials, and other information on risk monitoring.
Under any of the following circumstances, relevant departments shall promptly investigate and assess biosecurity risks and take necessary risk prevention and control measures in accordance with the law:
(1) Discovering a possibility of biosecurity risks via monitoring risks or receiving a report.
(2) Formulating or adjusting a biosecurity-related catalog or list in order to determine the key fields and key projects for supervision and administration.
(3) The occurrence of a major new or sudden outbreak of an infectious disease, an epidemic in animals or plants, or any other incident that endangers biosecurity.
(4) Other circumstances entailing investigation and assessment.
Article 16 The state shall establish a biosecurity information sharing system. The National Biosecurity Work Coordination Mechanism shall organize the establishment of a unified National Biosecurity Information Platform, and relevant departments shall submit biosecurity data, materials, and other information to the National Biosecurity Information Platform to achieve information sharing.
Article 17 The state shall establish a biosecurity information release system. Major biosecurity information such as the overall national biosecurity situation, major biosecurity risk alerts, major biosecurity incidents, and information on their investigation and handling shall be released by the member entities of the National Biosecurity Work Coordination Mechanism according to the division of responsibilities; and other biosecurity information shall be released by the relevant departments of the State Council and local people's governments at or above the county level and their relevant departments in accordance with their responsibilities and powers.
No entity or individual shall fabricate or spread false biosecurity information.
Article 18 The state shall establish a biosecurity catalog and list system. The State Council and its relevant departments shall, as needed for biosecurity work, formulate, release, and dynamically adjust catalogs or lists in relation to biosecurity-related materials, equipment, technology, activities, data on important biological resources, infectious diseases, animal and plant diseases, and invasive alien species, among others.
Article 19 The state shall establish a biosecurity standards system. The standardization department of the State Council and other relevant departments of the State Council shall formulate and improve relevant standards in the biosecurity field in accordance with the division of responsibilities.
The National Biosecurity Work Coordination Mechanism shall organize relevant departments to strengthen the coordination and connection of biosecurity standards in different fields and establish and improve the biosecurity standards system.
Article 20 The state shall establish a biosecurity review system. For major matters and activities in the biological field that affect or may affect national security, the relevant departments of the State Council shall conduct biosecurity review to effectively prevent and eliminate biosecurity risks.
Article 21 The state shall establish a coordinated, connected, orderly, and efficient biosecurity emergency response system providing unified leadership.
The relevant departments of the State Council shall organize the formulation of emergency plans for biosecurity incidents in related fields and industries and carry out emergency drills, emergency handling, emergency rescue, post-incident recovery, and other work in accordance with the emergency plans and unified arrangements.
Local people's governments at or above the county level and their relevant departments shall formulate and organize, guide, and supervise the formulation by relevant enterprises and public institutions of emergency plans for biosecurity incidents, strengthen emergency preparedness, personnel training, and emergency response drills, and conduct emergency response to biosecurity incidents, emergency rescue, post-incident recovery, and other work.
The Chinese People's Liberation Army and the Chinese People's Armed Police Force shall, in accordance with the order of the Central Military Commission, participate in the emergency response to and rescue in biosecurity incidents in accordance with the law.
Article 22 The state shall establish an investigation and source tracing system for biosecurity incidents. In the event of a major new or sudden outbreak of an infectious disease, epidemic in animals or plants, or unexplained biosecurity incident, the National Biosecurity Work Coordination Mechanism shall organize investigation and source tracing, determine the nature of the incident, comprehensively assess the impact of the incident, and give opinions and recommendations.
Article 23 The state shall establish national rules of access for animals and plants, products of animals and plants, and high-risk biological agents that enter the country for the first time or resume entry after a suspension.
Persons, means of transport, containers, goods, objects, packaging, and ballast water discharges by ships on international voyages entering and leaving China shall meet China's requirements of biosecurity management.
The Customs shall handle discovered inbound, outbound, and transit biosecurity risks in accordance with the law. Any person, means of transport, goods, object, or the like assessed as carrying a high biosecurity risk shall enter China through a designated border port and be subjected to strict risk prevention and control measures.
Article 24 The state shall establish a response system for major overseas biosecurity incidents. In the event of a major overseas biosecurity incident, the Customs shall take emergency biosecurity prevention and control measures in accordance with the law, strengthen document verification, increase the proportion of inspections, and suspend the entry of relevant persons, means of transport, goods, and objects, among others. When necessary, with the approval of the State Council, measures such as temporary closure of relevant ports and blockade of relevant borders may be taken.
Article 25 The relevant departments of people's governments at or above the county level shall carry out biosecurity supervision and inspection work in accordance with the law, and entities and individuals inspected shall cooperate, truthfully make explanations, and provide materials, without refusal or obstruction.
Supervision and inspection work related to high professional and technical requirements and difficult law enforcement business shall be participated in by biosecurity professional technicians.
Article 26 The relevant departments of people's governments at or above the county level may take the following measures in accordance with the law when exercising biosecurity supervision and inspection:
(1) Entering an entity inspected, location, or venue for a suspected biosecurity violation to conduct on-site monitoring, investigation, inspection, or verification.
(2) Requesting information from a relevant entity or individual.
(3) Consulting and copying relevant documents, materials, archives, records, vouchers, or the like
(4) Placing under seal a venue or facility for a suspected biosecurity violation.
(5) Impounding a tool, equipment, or related object for committing of a suspected biosecurity violation.
(6) Other measures prescribed by laws and regulations.
The information on biosecurity violations by relevant entities and individuals shall be included in the National Credit Information Sharing Platform in accordance with the law.
Chapter III Prevention and Control of Major New or Sudden Outbreaks of Infectious Diseases and Epidemics in Animals and Plants
Article 27 The health, agriculture and rural affairs, forestry and grasslands, customs, and ecology and environment departments of the State Council shall establish new or sudden outbreaks of infectious diseases, epidemics in animals and plants, entry and exit quarantine, and biotechnology environmental safety monitoring networks, organize the layout and construction of monitoring stations, improve the monitoring information reporting system, conduct active monitoring and pathogenic testing, and incorporate them into the national ......