Biosecurity Law of the People's Republic of China

Biosecurity Law of the People's Republic of China
[Lexis China Comments]
According to the Decision of the Standing Committee of the National People's Congress on Amending the Law of the People's Republic of China on the Promotion 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 (Order of the President of the People’s Republic of China No.24), this document has been amended.

Biosecurity Law of the People's Republic of China

Order of the President of the People's Republic of China No.56

October 17, 2020

The Biosecurity Law of the People's Republic of China, which was adopted at the 22nd Session of the Standing Committee of the 13th National People's Congress of the People's Republic of China on October 17, 2020, is hereby promulgated with effect from April 15, 2021.

Xi Jinping, President 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)

Table of Contents
Chapter I General Provisions
Chapter II Prevention and Control System of Biosecurity Risks
Chapter III Prevention and Control of New Serious Communicable Diseases and Animal and Plant Epidemics
Chapter IV Biotechnological Research, Development and Application Security
Chapter V Laboratory Biosecurity of Pathogenic Microorganisms
Chapter VI Security of Human Genetic Resources and Biological Resources
Chapter VII Prevention of Bioterrorism and Biological Weapon Threats
Chapter VIII Biosecurity Capability Building
Chapter IX Legal Liability
Chapter X Supplementary Provisions

Chapter I General Provisions

Article 1 The Law is hereby formulated in a bid to maintain state security, prevent and respond to biosecurity risks, guarantee people's life and health, protect biological resources and the ecological environment, promote the sound development of biotechnology, propel the construction of a shared future for mankind, and achieve the harmonious coexistence of mankind and nature.

Article 2 For the purpose of the Law, biosecurity means that the State effectively prevents and responds to threats from dangerous biological factors and the relevant elements, maintains the stable and sound development of biotechnology, relatively falls into a situation of no danger or threat in terms of people's life and health and ecosystem, and is capable of guaranteeing state security and sustainable development in the biological field.
The Law shall apply to the following activities:
1. preventing and controlling new serious communicable diseases and animal and plant epidemics;
2. researching, developing and applying biotechnology;
3. managing the laboratory biosecurity of pathogenic microorganisms;
4. managing the security of human genetic resources and biological resources;
5. preventing the invasion of alien species and protecting biodiversity;
6. coping with microbial resistance;
7. preventing bioterrorism and defending against biological weapon threats; and
8. any other activity related to biosecurity.

Article 3 Biosecurity is an important ingredient of the state security. In order to maintain biosecurity, it is imperative to carry out the overall national security outlook, coordinate development and security, and insist on the principles of being oriented by people, risk prevention, classified management and collaboration.

Article 4 It is necessary to persist in the leadership of the Communist Party of China for the state biosecurity work, establish and perfect a state biosecurity leadership system, intensify the construction of the state biosecurity risk prevention and control and governance systems, and improve the state biosecurity governance capability.

Article 5 The State encourages biotechnology innovation, intensifies biosecurity infrastructure and biotechnology talent team building, supports the development of the biological industry, is improving the level of biotechnology by innovation, and enhancing biosecurity guarantee capability.

Article 6 The State shall reinforce the international cooperation in the biosecurity field, fulfill the obligations set out in international treaties that the People's Republic of China has concluded or joined, support the participation in biotechnology exchanges and cooperation and international rescue during biosecurity events, actively take part in the research and formulation of international rules for biosecurity, and promote the improvement of global biosecurity governance.

Article 7 People's governments at all levels and the relevant departments thereof shall reinforce the publicity and popularization of biosecurity laws, regulations and knowledge, guide grassroots mass self-governance organizations and social organizations to publicize biosecurity laws, regulations and knowledge, and promote the improvement of the sense of biosecurity of the whole of society.
The relevant scientific research institutions, medical institutions, and other enterprises and public institutions shall include biosecurity laws, regulations and knowledge in education and training contents, and reinforce the cultivation of the sense and ethical consciousness of biosecurity of students and practitioners.
News media shall conduct public welfare publicity for biosecurity laws, regulations and knowledge, supervise biosecurity illegal behaviors in the light of public opinion, and intensify the public's sense of social responsibilities for maintaining biosecurity.

Article 8 No entity or individual shall harm biosecurity.
Any entity or individual is entitled to report any behavior that is harming biosecurity; the department receiving a report shall carry out handling of such behavior according to the law in due time.

Article 9 People's governments at or above the county level and the relevant departments thereof shall commend and reward any entity or individual who makes outstanding contributions to biosecurity work in accordance with the national provisions.

Chapter II Prevention and Control System of Biosecurity Risks

Article 10 The central leadership organ of state security shall be responsible for the decision and agenda coordination of the state biosecurity work, research, formulate, guide and implement the state biosecurity strategies and the relevant major guidelines and policies, generally coordinate the major matters and important work of state biosecurity, and establish a coordination mechanism for state biosecurity.
Provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism for biosecurity, and organize, coordinate, urge and impel biosecurity-related work within their respective administrative regions.

Article 11 The coordination mechanism for state biosecurity, composed of the competent departments of hygiene and health, agriculture and villages, scientific technology, diplomacy, etc. and the relevant military organ under the State Council, analyzes and judges the state biosecurity situation, and organizes, coordinates, urges and impels state biosecurity-related work. The coordination mechanism for state biosecurity has set up an office to be responsible for its daily work.
Members of the coordination mechanism for state biosecurity and other relevant departments under the State Council shall take charge of the biosecurity-related work as per their respective duties.

Article 12 The coordination mechanism for state biosecurity shall establish an expert committee to provide decision consultations for the study, formulation and implementation of state biosecurity strategies and policies.
The relevant department under the State Council shall organize and establish a committee of biosecurity technology consulting experts in the relevant fields and industries to provide consultations, evaluations, demonstrations and other technical supports for biosecurity.

Article 13 Local people's governments at all levels are responsible for the biosecurity within their respective administrative regions.
The relevant departments of local people's governments at or above the county level are responsible for biosecurity-related work as per their respective duties.
Grassroots mass self-governance organizations shall assist local people's governments and the relevant departments thereof in the prevention and control of biosecurity risks, emergency response, publicity and education.
The relevant entities and individuals shall cooperate in the prevention and control of biosecurity risks and emergency response.

Article 14 The State shall establish a biosecurity risk monitoring and early warning system. The coordination mechanism for state biosecurity shall organize the establishment of a state biosecurity risk monitoring and early warning system, and enhance the capabilities of biosecurity risk identification and analysis.

Article 15 The State shall establish a state biosecurity risk investigation and evaluation system. The coordination mechanism for state biosecurity shall, as per risk monitoring data, materials and other information, regularly organize biosecurity risk investigations and evaluations.
In any of the following circumstances, the relevant departments shall conduct biosecurity risk investigations and evaluations in a timely manner, and take necessary risk prevention and control measures according to the law:
1. it is found through risk monitoring or any report received that there may be any biosecurity risk;
2. any biosecurity-related directory or list is worked out or adjusted in order to determine major fields and projects of supervision and administration;
3. any new serious communicable disease or animal or plant epidemic or any other event that harms biosecurity occurs; or
4. other circumstances under which it is necessary to conduct investigations and evaluations.

Article 16 The State shall establish a biosecurity information sharing system. The coordination mechanism for state biosecurity shall organize and establish a unified state biosecurity information platform, and the relevant departments shall submit information such as biosecurity data and materials to the aforesaid platform, to realize information sharing.

Article 17 The State shall establish an issue system of biosecurity information. Members of the coordination mechanism for state biosecurity shall, as per their respective duties, release major biosecurity information such as the overall situations of state biosecurity, warning information about major biosecurity risks, major biosecurity events and their investigation and treatment information; the relevant departments under the State Council, and local people's governments at or above the county level and the relevant departments thereof shall, as per their respective duties, shall release other biosecurity information.
No entity or individual shall fabricate or spread any false biosecurity information.

Article 18 The State shall establish a biosecurity directory and list system. The State Council and the relevant departments under the State Council shall, as per biosecurity work demands, prepare and publish directories or lists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant epidemics, alien invasive species and so on relating to biosecurity, and dynamically adjust them.

Article 19 The State shall establish a biosecurity standard system. The competent department of standardization under the State Council, and other relevant departments under the State Council shall, as per their respective duties, work out and improve the relevant standards in the biosecurity field.
The coordination mechanism for state biosecurity shall organize the relevant departments to intensify the coordination and connection among biosecurity standards in different fields, and establish and perfect the biosecurity standard system.

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

Article 21 The State shall establish a biosecurity emergency system with unified leadership, collaborative linkage, orderliness and efficiency.
The relevant departments under the State Council shall organize and work out biosecurity event emergency plans in the relevant fields and industries, and conduct emergency drills, emergency disposal, emergency rescue, ex post restoration and other work as per the emergency plans and unified deployments.
Local people's governments at or above the county level and the relevant departments thereof shall work out and organize, guide and urge the relevant enterprises and public institutions to work out biosecurity event emergency plans, intensify emergency preparations, personnel training and emergency drills, and conduct biosecurity event emergency disposal, emergency rescue, ex post restoration and other work.
The Chinese People's Liberation Army and the Chinese People's Armed Police Force shall take part in the biosecurity event emergency disposal and emergency rescue according to the law, as per the orders of the Central Military Commission.

Article 22 The State shall establish a biosecurity event investigation and tracing system. The coordination mechanism for state biosecurity shall organize and conduct investigations and tracing for new serious communicable diseases, animal and plant epidemics and biosecurity events of unknown origin, determine event natures, comprehensively evaluate event impact, and give comments and suggestions.

Article 23 The State shall establish a state access system for animals, plants, animal and plant products and high-risk biological factors imported for the first time or with import restored after suspension.
Inbound and outbound persons, transportation tools, containers, goods, articles, packaging materials, and the discharge of ballast water of international navigation ships shall satisfy China's biosecurity administration requirements.
The Customs shall dispose of biosecurity risks of entry, exit and transit found by it according to the law. The persons, transportation tools, goods, articles and so on with high biosecurity risk as evaluated shall enter the country from the designated frontier port, and strict risk prevention and control measures shall be taken.

Article 24 The State shall establish a response system for major biosecurity events overseas. In the event of any major biosecurity event overseas, the Customs shall, according to the law, take biosecurity emergency prevention and control measures, strengthen the check of certificates, enhance the proportion of inspection, and suspend the entry of the relevant persons, transportation tools, goods, articles and so on. When necessary, the Customs may, upon approval by the State Council, take such measures as temporarily shutting down the port or blockading the related border.

Article 25 The relevant departments of people's governments at or above the county level shall conduct the biosecurity supervision and inspection according to the law. Inspected entities and individuals shall cooperate, explain situations faithfully, and provide materials, and shall not refuse or impede the supervision and inspection.
Professionals of biosecurity technology shall participate in the supervision and inspection work with high professional technical requirements and a great difficulty in law enforcement.

Article 26 The relevant departments of people's governments at or above the county level may take the following measures according to the law to carry out the supervision and inspection of biosecurity:
1. conduct on-site monitoring, exploration, inspection or verification at the place of an inspected entity, an inspected place or a place suspected of any biosecurity illegal behavior;
2. learn about the relevant conditions from the relevant entity or individual;
3. consult or copy the relevant documents, materials, archives, records, and vouchers, etc.;
4. seize any place or facility suspected of any biosecurity illegal behavior;
5. detain any tool, equipment or relevant article suspected of any biosecurity illegal behavior; and
6. any other measure stipulated under laws and regulations.
The biosecurity illegality information of the relevant entities and individuals shall be included on the national credit information sharing platform according to the law.

Chapter III Prevention and Control of New Serious Communicable Diseases and Animal and Plant Epidemics

Article 27 Competent departments of hygiene and health, agriculture and villages, forestry and grassland, customs and ecological environment under the State Council shall establish environmental security monitoring networks of new communicable diseases, animal and plant epidemics, entry and exit inspection and quarantine and biotechnology, organize the distribution and construction of monitoring sites, improve the reporting system for monitoring information, conduct active monitoring and pathogen detection, and include the aforesaid monitoring and detection in the state biosecurity risk monitoring and early warning system.

Article 28 Prevention and control institutions of diseases, animal epidemics and plant diseases and pests (the "professional institutions") shall proactively monitor communicable diseases, animal and plant epidemics and unknown diseases included in the monitoring scope, collect, analyze and report monitoring information, and forecast the outbreak and epidemical tendency of new communicable diseases and animal and plant diseases.
The relevant departments under the State Council, and local people's governments at or above the county level and the relevant departments thereof shall give an early warning as per forecasts, duties and authority, and adopt the corresponding prevention and control measures.

Article 29 Any entity or individual that finds any communicable disease or animal or plant epidemic shall responsively report it to the relevant medical institution, professional institution or department.
Any medical institution, professional institution or functionary thereof that finds any communicable disease, animal or plant epidemic or unknown clustered disease shall responsively report it, and take protective measures.
Concerning any matter which should be reported according to the law, no entity or individual shall conceal, falsely report, delay or omit the report of the said matter, or incite others to do so, or hinder others from reporting.

Article 30 The State shall establish a joint prevention and control mechanism for new serious communicable diseases and animal and plant epidemics.
In the case of any new serious communicable disease or animal or plant epidemic, control measures shall be adopted according to the relevant laws, regulations and provisions under an emergency plan in a timely manner.
  ......
请先同意《服务条款》和《隐私政策》