Biosecurity Law (Draft) (Second Deliberation Draft)

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Title: P.R.C. Biosecurity Law (Draft) (Second Deliberation Draft)
Period for Solicitation of Comments:2020-04-30 through 2020-06-13
Address for submitting comments online:http://www.npc.gov.cn/flcaw/
Source:http://www.npc.gov.cn/flcaw/userIndex.html?lid=ff808081713927d10171be91e1b818ce

P.R.C. Biosecurity Law (draft) (Second Deliberation Draft)

Chapter I: General Provisions

Article 1: This Law is drafted so as to protect national security, to prevent and respond to biological threats, to safeguard the people's lives and health, to promote the healthy development of biological technology, to protect biological resources and the ecological environment, to promote harmonious societal development, and to promote the contruction of common destiny for humanity.

Article 2: "Biological security" as used in this Law refers to the State's ability to effectively respond to threats caused by biological and related factors, to maintain the stable and healthy development of the biological sector, keeping interests relatively free of risk and unthreatened, and safeguarding continued development and security.

This law applies to engagement in any of the following activities:

(1) the prevention and control of major emergent infectious diseases, and outbreaks in animals and plants;

(2) the research, development, and use of biological technologies;

(3) the management of laboratory biological security;

(4) the management of security in human genetic resources and biological resources;

(5) preventing encroachment by foreign species and the preservation of biodiversity;

(6) responding to microbial drug resistance;

(7) preventing bioterrorist attacks and defending against the threat of biological weapons;

(8) other activities related to biological security.

Article 3: Biological security is an important component of national security. The preservation of the country's biological security shall implement an overall national security perspective, equally emphasizing continued development and security, using innovation to drive improvements in the level of biotechnology and strengthening capacity for preventing and responding to threats. It is to put people first by safeguarding the public's security in their lives and physical health; and prioritize prevention through cautious oversight, and timely adoption of preventative measures to respond to potential threats and effectively control biosecurity risks. Overall planning and coordination is to strive to give play to the role of each relevant department, region, and professional body, to widely mobilize participation by social forces.

Article 4: Uphold the leadership of the Chinese Communist Party over the nation's biological security efforts by establishing and completing a national leadership system for biological security, strengthening the establishment of a system for the prevention, control and government response to biosecurity threats; to increase the nation's ability govern biological security.

Article 5: The state encourages innovation in biotechnology by strengthening the establishment of a corps of biotechnology professionals and supporting the development of the biological technology industries, to increase our nation's ability to ensure biological security.

Article 6: The state is to strengthen international cooperation in the biological security sector by performing obligations provided for in international treaties with the P.R.C. has concluded or participates in, supporting participation in exchanges and cooperation on biological science and technology and in international aid for biological security incidents, and actively participating in research and drafting of international biological security rules.

Article 7: All levels of people's government and their relevant departments shall strengthen efforts to publicize and spread information on biological security laws and regulations, and biosecurity, leading the basic-level mass autonomous organizations and social organizations in carrying out publicity on biological security laws and regulations, and on biosecurity, to increase the entire society's awareness of biosecurity.

Related scientific and research institutes or schools, enterprises, and public institutions, shall include biological security laws and regulations and biosecurity information in their educational or training curricula to strengthen the cultivation of students' and practitioners' awareness of biosecurity and ethics.

The news media shall carry out public interest publicity on biological security laws and regulations, and on biosecurity, to carry out public opinion oversight on conduct in violation of biological security laws, and increase public awareness of social responsibility for preserving biological security.

Article 8: The nation's biological security must not be threatened by any units or individuals.

All Units and individuals have the right to report conduct threatening the nation's biosecurity, and departments receiving reports shall promptly investigate and address them in accordance with law.

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

Chapter II: Biosecurity Risk Prevention and Control Systems

Article 10: The Central Leading Group on National Security is responsible for major decision-making, deliberations, and coordination of national biological security efforts; for researching, drafting, and guiding the implementation of the national biosecurity strategy and major, related directives and policies; planning and coordinating major national biosecurity matters and work; and for establishing a National Coordination Mechanism for Biosecurity Work.

Article 11: The National Coordination Mechanism for Biosecurity Work is to consist of the State Council's departments in charge of health, rural affairs, science and technology, and foreign affairs, and organs responsible for military affairs; and is to analyze and assess trends in biosecurity, and is to organize, coordinate, and prompt advancements in the nation's biological security work.

The member units of the National Coordination Mechanism for Biosecurity Work and other relevant departments of the State Council are responsible for work related to biological security based on their duties and division of labor.

Article 12: The National Coordination Mechanism for Biosecurity Work is to set up an experts committee and joint offices.

The National Biosecurity Experts Committee is to provide consultation on decision making for the research, policy-drafting, and implementation of the national biosecurity strategy.

The relevant departments of the State Council are to organize and establish expert biological security technical consultative committees for related sectors and industries to provide consultation, assessment, debate, and technical support for biological security work.

Article 13: The state is to establish a biosecurity risk monitoring and early warning system.

the National Coordination Mechanism for Biosecurity Work is to establish a uniform national biosecurity risk monitoring and early warning system with relevant departments responsible for risk monitoring and early warning work based on their duties and the division of labor.

Article 14: Based on information such as risk monitoring data and reports, the National Coordination Mechanism for Biosecurity Work shall periodically organize and carry out biosecurity risk investigations and assessments, determining risk levels, and promptly implementing early warning and publishing relevant information:

In any of the following circumstances, a biosecurity threat investigation and assessment shall be promptly conducted:

(1) A potential biosecurity threat is discovered through risk monitoring pr receiving a report;

(2) in order to determine the key sectors or key projects for oversight and management, and formulate catalogs or lists related to biological security;

(3) Major emerging infectious diseases or outbreaks in animals and plants are discovered;

(4) Other situations that member units of the National Coordination Mechanism for Biosecurity Work find are necessary to investigate and assess.

Article 15: The State is to establish a biosecurity information sharing system. The National Coordination Mechanism for Biosecurity Work is the organize the construction of a uniform national biosecurity information platform, and relevant departments shall aggregate information such as biosecurity data, materials, reports, tables, and so forth onto the national biosecurity information platform.

The state is to implement a uniform system for publishing biosecurity information. The National Coordination Mechanism for Biosecurity Work is to organize its constituent members to act based on their duties and division of labor to publish nation's overall biosecurity situation, information on major biosecurity risks and warnings, information on major biosecurity incidents and their investigation and handling, as well as other information that needs to be uniformly published, and when necessary, it may also authorize local people's governments to publish relevant information. The information described above must not be collected by any unit or individual without authorization.

Fake biosecurity information must not be fabricated or disseminated by any units or individuals.

Article 16: The state is to establish a biological security catalog and list system. As needed for biosecurity efforts, the relevant departments of the State Council shall draft and publish catalogs and lists of materials, equipment, technology, activities, data on important biological resources, contagious diseases, animal and plant diseases, quarantined species, etc. that are related to biological security, and dynamically adjust them.

Article 17: The National Coordination Mechanism for Biosecurity Work is to organize relevant departments in strengthening the cooridnation and linkage between biosecurity standards in different sectors, and establishing and completing the national biosecurity standards system.

The State Council departments in charge of standardization, together with the other relevant State Council departments are to draft and improve each standard in the biological security sector.

Article 18: The State is to establish a Bio-safety emergency response system with uniform leadership, coordinated linkages, that is orderly and highly effective.

The relevant departments of the State Council shall organize and draft emergency response plans for biosecurity incidents in relevant sectors and industries, carrying out emergency drills, emergency handling, emergency rescue, and post-incident recovery efforts based on the emergency response plans and uniform deployments.

Local people's governments at the county level or above and their relevant departments shall draft, and also organize, guide, and urge related enterprises and public institutions to draft, emergency response plans for biosecurity incidents and strengthening emergency preparedness, personnel training, and emergency drills for routine biosecurity risk prevention, and carryout efforts on biosecurity incident emergency handling, emergency rescue, and post-incident recovery.

The Chinese People's Liberation Army and Chinese People's armed police forces are to lawfully participate in emergency handling and rescue efforts for biosecurity incidents as ordered by the central military commission.

Article 19: The state is to establish a biosecurity incident investigation and tracing system. The National Coordination Mechanism for Biosecurity Work shall organize the carrying out of investigations and tracing of biosecurity incidents such as major emerging infectious diseases and animal and plant diseases of unclear origin, to fully assess and determine the nature of the incident and to lawfully employ necessary measures to address it.

Article 20: The relevant departments of the State Council are to establish a national entry approval system based on risk analysis for animals and plants entering, animal and plant products, or high risk biological factors that are entering the country for the first time or are resuming entry after a temporary suspension, and indicate the relevant quarantine requirements, and lawfully carry out registration or filing for foreign producers, processors, or storage units and export businesses.

The National Coordination Mechanism for Biosecurity Work is to organize relevant departments to draft and publish catalogs and lists related to biosecurity for border crossings, and dynamically update them. Customs shall make the national catalogs and lists related to border-crossing biological security a basis for regulating border-crossing biosecurity.

Where customs discovers that items not on the catalogs and lists related border-crossing biosecurity might cause biosecurity risks, they shall promptly make a decision such as for seizure or emergency disposal, and when necessary carry out disposal in conjunction with other departments. Where the relevant departments of the State Council issue administrative approval documents, customs shall conduct allow clearance after conducting a safety inspection.

Article 21: Personnel, vehicles, containers, goods, articles, packaging materials, crossing the borders, and water discharged from ships in international navigation, shall comply with our nation's biosecurity management requirements, and lawfully make declarations to customs. Without customs' permission, they must not cross the borders or transit through the country, must not discharge ballast water while staying in port. Where customs discovers biological security risks for border crossings or transit, they shall handle them in accordance with law.

Personnel, vehicles, goods, articles, and so forth that have been assessed as high biological security risks shall enter the country through designated ports of entry and employ strict risk prevention measures.

Customs may lawfully initiate biological security emergency prevention and control measures for major biological security risks occurring outside our nation's borders, to verify relevant documents, increase the ration of inspections, or suspending entry by relevant persons, vehicles, goods, or items; and when necessary may temporarily close relevant ports or seal off relevant borders with the consent of the State Council.

Article 22: Local people's governments of all levels are responsible for biological security work in that administrative region.

The relevant departments of local people's governments at the county level or above are responsible for relevant biological security work based on their duties and division of labor.

Article 23: The relevant departments of people's governments at the county level or above shall lawfully carry out efforts on biological security oversight and inspections, and the units and individuals being inspected shall cooperate by truthfully explaining circumstances and providing materials, and must not refuse or obstruct.

Oversight and inspection work that involves a higher level of specialized technology or higher difficulty of enforcement operation, shall have biological security technical research professionals participate.

Article 24: Relevant departments at the county level or above that are conducting oversight and investigations may employ the following measures:

(1) Enter the units or locations being inspected, or venues where it is suspected that unlawful biosecurity conduct is being conducted, to carry out on-site monitoring, exploration, inspection or verification;

(2) Learn about circumstances from relevant units and individuals;

(3) Access or reproduce relevant documents, materials, files, records, credentials, etc.;

(4) Inspect venues and facilities where there is suspected unlawful biosecurity conduct;

(5) Seize tools, equipment, and items related to suspected unlawful biosecurity conduct;

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

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

Chapter III: Prevention and Control of Major Emergent Infectious Diseases, and Diseases in Animals and Plants

Article 25: The State Council departments in charge of health, rural affairs, forestry and grasslands, customs, and the ecological environment shall establish a network for monitoring major emergent infectious diseases and plant and animal diseases, border crossing quarantine and inspections, and biotechnology environmental security, organizing the arrangement and construction of monitoring stations, improving systems for direct reporting from the monitoring information network, carrying out active monitoring and pathogen testing, and uniformly entering this into the national biological security risk monitoring system.

Article 26: Establishments for the prevention of diseases, establishments for the prevention and control of animal and plant diseases, and establishments for the prevention of plant pests (hereinafter called 'professional bodies) shall actively monitor infectious diseases, animal and plant diseases, and illnesses of unknown cause within the scope of monitoring; and shall collect, analyze, and report monitoring information to predict new emergence of infectious diseases, animal and plant diseases, and contagion trends.

The relevant departments of the State Council and local people's governments at the county level or above shall promptly publish warnings based on predictions, and employ corresponding measures for prevention and control.

Article 27: Where any unit or individual discovers infectious diseases or plant and animal diseases, they shall promptly report it to the medical establishments and relevant professional bodies or departments. Where medical establishments, professional bodies, and their staffs discover infectious diseases, plant and animal diseases, or illnesses of unknown causes that are within the scope for monitoring, they shall promptly report them and employ protective measures; and where they have the capacity for direct online reporting, shall do so. Relevant local people's governments and departments shall immediately organize and conduct an investigation to verify and confirm matters reported to them, employ necessary control measures, and promptly report on the investigation.

Where a report shall be made in accordance with law, units and individuals must not conceal, falsify, delay, or have omissions in the reporting, must not suggest that others conceal, falsify, or delay reports, and must not obstruct reporting by others.

Article 28: The state is to establish a joint prevention and control mechanism for major emergent infectious diseases and plant and animal diseases.

Where major new outbreaks of infectious diseases or plant and animal diseases occur, control measures shall be promptly employed in accordance with laws, regulations, and emergency response plans. The State Council departments for health, rural affairs, forestry and grasslands, shall immediately organize an epidemic committee to discuss and evaluate, and report its conclusions to the State Council; and also notify the member units of the National Coordination Mechanism for Biological Security Work and other relevant departments of the State Council.

Where major new outbreaks of infectious diseases or plant and animal diseases occur, the relevant departments of the State Council and relevant local people's governments shall organize and carry out epidemiological surveys, pathogen tracing, and research of transmission routes.

Article 29: The State is to strengthen capacity for the prevention and control of infectious diseases and animal and plant diseases at borders and ports, supporting international exchanges and cooperation, participating in international rescue and aid as needed, and establishing a collaborative international network for infectious diseases and animal and plant diseases to discover and control major emergent infectious diseases and plant and animal diseases as early as possible.

Article 30: The state is to protect wildlife by strengthening the prevention of animal diseases and preventing the transmission of animal-borne illnesses.

Article 31: The State is to strengthen the management of antibiotic drug residues. The State Council departments for ecology and the environment and drug administration shall assess the harm of antibiotic drug residues to the environment and human health, and draft targets for antibiotic drug pollution to be incorporated into pollutant emission standards.

The departments for rural affairs of people's governments at the county level or above shall strengthen prevention and control of antibiotic drug residue from agricultural production, and employ necessary measures to lead, educate, and guide persons involved in agriculture, breeding, and cultivation, to reduce the use of antibiotics and their residues in agricultural environments.

Chapter IV: Security in Biotechnology Research, Development and Applications

Article 32: Units engaged in the research, development, and application of biotechnologies shall be responsible for the safety of those activities in that unit, shall employ measures to control biosecurity risks, and shall formulate work mechanisms for biosecurity training, follow-up inspections, periodic reporting, and so forth, to strengthen management in the course of these activities.

Article 33: It is prohibited to engage in research, development, and applications of biotechnology that harm national security such as by threatening public health, harming biological resources, or undermining ecosystems and biological diversity.

Engagement in research, development, and application of biotechnologies shall comply with ethical principles.

Article 34: The state is to carry out registration for purchases or import of important equipment or special biological factors involving biosecurity. Units engaged in biotechnology research, development, and applications that purchase or bring in important equipment or special biological factors involving biosecurity shall carry out registration in accordance with the management and control list for important equipment or special biological factors and report this for recording with the relevant departments of the State Council. The relevant departments of the State Council are to formulate the management and control list for important equipment or special biological factors.

It is prohibited for individuals to purchase or possess important equipment or special biological factors involving biosecurity.

Article 35: The state is to conduct categorical management for biotechnology research and development activities. Based on the level of threat caused to public health, industry, and agriculture, and the ecological environment, biotechnology research and development activities are to be divided into three levels: high-risk, medium-risk, and low-risk.

The State Council departments in charge of science and technology, together with relevant departments of the State Council, are to draft the standards for risk categories and lists for biotechnology research and development activities.

Article 36: Those engaged in biotechnology research and development activities shall comply with state specifications on safety management in biotechnology research and development.

Those engaged in biotechnology research and development activities shall conduct risk categorization assessments, pay close attention to changes in the risks, and promptly employ corresponding measures.

Article 37: Those engaged in high-risk and medium-risk biotechnology research and development activities shall be lawfully established and organized as legal persons in our country, shall lawfully obtain approvals, and carry our filings.

Those engaged in high-risk and medium-risk biotechnology research and development activities shall conduct risk assessments, draft risk control plans, and emergency response plan for biosecurity incidents, to reduce the risk of carrying out the research and development activities.

Article 38: Engagement in clinical research on new medical technologies should follow an ethics review and be conducted in medical establishments with the corresponding capacities; clinical research operations on humans shall be conducted by professional health technicians that meet the relevant requirements.

Article 39: Based on their duties and division of labor, the relevant departments of the State Council are to conduct follow-up assessments of biotechnology applications, and where discovering biosecurity risks shall promptly organize and assessment and employ effective remedial and control measures.

Chapter V: Laboratory Biosecurity

Article 40: The state is to strengthen biosecurity management of pathogenic microbiology labs and draft uniform standards for laboratory biological security. Pathogenic microbiology laboratories shall meet the national biosecurity standards and requirements.

Pathogenic microbiology laboratories engaged in experiments of pathogenic microbes shall strictly follow relevant national standards, laboratory technical regulations and operational procedures, and shall employ safety and prevention measures.

Article 41: The state is to implement categoric management of pathogenic microbes. Pathogenic microbes are to be divided into types 1,2,3, and 4, based on the contagiousness of the pathogenic microbes and the extend of harm they do to infected people and animals as individuals or populations. Type 3 and 4 pathogenic microbes are collectively referred to as 'highly pathogenic microbes'.

Those engaged in the collection, storage, or transport of highly pathogenic microbes or suspected highly pathogenic microbes shall have corresponding capacity meeting biological security management specifications. The specific measures are to be formulated by State Council departments for health and rural affairs.

Article 42: Approvals shall be obtained or filings completed in accordance with law, for setting up pathonogenic microbiology laboratories. The state is to conduct security reviews for the establishment of pathogenic microbiology laboratories by foreign investors. Approval is not to be given where review shows potential impact on public health, national security, and societal public interest. Individuals must not set up biological security laboratories or engage in pathogenic microbiology laboratory activities.

Article 43: The state is to carry out graded management of pathogenic microbiology laboratories. Base on the pathogenic microbiology laboratories' biosecurity protection levels, the laboratories are to be divided into levels 1,2,3, and 4.

Research, development, and use of pathogenic microbiology shall be conducted in an appropriate level of laboratory.

Article 44: Level 1 and 2 laboratories must not engage in laboratory activities with highly pathogenic, or suspected highly pathogenic, microbes.

Level 3 and 4 laboratories engaging in laboratory activities with highly pathogenic, or suspected highly pathogenic, microbes. shall be approved by the department of health or rural affairs of a provincial-level people's governments, and report on the experimental activities to the approving department.

Experimental activities with pathogenic microbes that have not yet been discovered in our country or that have been announced as eradicated must not be conducted without approvals.

Article 45: Pathogenic microbiology laboratories shall employ measures to strengthen the management of experimental animals and prevent their escape, making it so that experimental animals can be traced; and dispose of experimental animals after use in a manner that renders them harmless. It is forbidden for experimental animals to enter consumer markets after use.

Pathogenic microbiology laboratories shall strengthen the management of waste from experimental activities, lawfully disposing of waste fluids, gases, and other wastes and employing measures to prevent contamination.

Article 46: The units setting up pathogenic microbiology laboratories are responsible for managing the laboratories' biological security by formulating scientific and strict management systems, periodically conducting reviews of the implementation of related biosecurity rules, and reviewing and updating the laboratories' facilities, equipment, and materials, to ensure they meet state standards.

The principle responsible person for units setting up pathogenic microbiology laboratories have overall responsibility for biological security in the laboratory.

Article 47: The units setting up pathogenic microbiology laboratories shall establish and improve security and defense systems by employing measures to safeguard the security of the laboratory and its pathogenic microbes.

The state is to strengthen security and defense of level 3 and 4 laboratories. Level 3 and 4 laboratories shall accept oversight and guidance from the public security organs on laboratory security and defense work, to strictly prevent leaks, loss, and theft or robbery of highly pathogenic microbes.

The state is to conduct a review system for personnel entering level 3 and 4 laboratories. Entry of personnel into level 3 and 4 laboratories shall be approved by the person responsible for the laboratory. Where it might impact laboratory biosecurity, it should be approved; and those that are approved to enter shall employ security protection measures.

Article 48: The units setting up pathogenic microbiology laboratories shall draft emergency response plans for biological security incidents, and periodically organize personnel in carrying out training and emergency response drills. Where biological threats such as leaks, loss, and theft or robbery of highly pathogenic microbes occur, control measures shall be promptly employed in accordance with the emergency response plan, and reported as provided.

Article 49: The provincial-level people's governments where pathogenic microbiology laboratories are located, and their departments for health, shall strengthen allocation of infectious disease resources for the laboratories' regions, to increase the ability to treat infectious diseases.

Article 50: Production enterprises involving operations with pathogenic microbes are to be managed in accordance with this Law's provisions on pathogenic microbiology laboratories.

The construction and management of biosecurity laboratories involved with biotoxins, plant pests, and other biological elements are to be implemented with reference to the provisions of this Law on pathogenic microbiology laboratories.

Chapter VI: Security of Human Genetic Resources and Biological Resources

Article 51: The state is to strengthen the management and oversight of the collection, storage, use, and external provision of our nation's human genetic resources to ensure the security of human genetic resources and other biological resources.

Article 52: The state is to develop surveys of human genetic resources and biological resources.

The State Council's administrative departments for science and technology are responsible for organizing surveys of our nations' human genetic resources, and for formulating measures for implementing the human genetic resources reporting and registration system for important gene families and specified regions.

Based on their duties and division of labor, the State Council departments in charge of science and technology, natural resources, the environment, health, rural affairs, forests and plains, and Chinese medicine are to organize and carry out surveys of biological resources and draft measures for declarations and registration of important biological resources.

Article 53: The collection, preservation, use, or external provision of our nation's human genetic resources shall comply with ethical principles, and must not endanger public health, national security, or the public societal interest.

Article 54: Those engaging in the following activities shall get approval from the State Council regulatory departments for science and technology:

(1) Those collecting of our nation's important gene families or human genetic resources from specified regions, and collecting types and volumes of human genetic resources provided for by the State Council regulatory departments for science and technology;

(2) Preservation of our nation's human genetic resources;

(3) Using our nation's human genetic resources to carry out international research collaboration;

(4) transporting, mailing, or carrying our nation's human genetic resources out of the mainland.

The provisions of the preceding paragraph do not include the collection and storage of human genetic resources for the purposes of clinical diagnosis and treatment, education, blood collection and supply services, the investigation of violations and crimes, testing for stimulants, funerals, or other such activities.

Approvals are not required for the use of our nations human genetic resources by clinical experimentation institutions to carry out of collaborative international clinical experiments, so as to obtain approvals for obtaining permits for the sale of drugs and medical instruments in our nation where it does not involve sending human genetic resources overseas; but before the clinical experiment is carried out, the types and amounts of human resources to be used, as well as their usages, shall be sent for filing to the State Council departments for science and technology.

Foreign [non-mainland] organizations and individuals, as well as institutions they establish or are the actual controllers of, must not collect or preserve human genetic resources within the territory of our nation, and must not provide out nations' human genetic resources outside the territory.

Article 55: The provision or opening for use of our nation's human genetic resources to foreign organizations, individuals, or the institutions they have set up or are the actual controllers of, shall be first reported to the State Council departments for science and technology with a back up of the information submitted; where it might impact national security and the societal public interest, it shall also go through a security review by the State Council departments for science and technology.

Article 56: The collection, storage, use, or transport abroad of species unique to China, or that are endangered or rare, as well as specimens, organs, tissues, cells, genes or other genetic resources that might be used for regeneration or reproduction, shall be in compliance with relevant laws and regulations.

Approvals shall be lawfully obtained from relevant departments for the acquisition or use of our nation's biological resources by foreign organizations and individuals and bodies that they have established or control in fact.

Article 57: The use of our nation's human genetic resources or biological resources to carry out international scientific research collaboration shall ensure that the Chinese-side units and their researchers participate substantively in the entire course of research, and lawfully share in the relevant interests.

Use of our nation's biological resources to carry out international scientific research collaboration shall lawfully obtain approvals from the relevant departments.

Article 58: The state is to strengthen protection and responses to invasion by foreign species to protect biological diversity. Based on their duties and division of labor, the relevant departments of the State Council are to formulate directories of invasive species.

Based on their duties and division of labor, the relevant departments of the State Council are to strengthen investigations, monitoring, warnings, control, assessment, elimination, environmental restoration, and other such efforts on the foreign invasive species listed in the catalog, to effectively prevent and respond to invasion by foreign species.

Units and individuals must not introduce, release, or discard foreign species without approval.

Chapter VII: Preventing Bioterrorism and Biological Weapons Threats

Article 59: It is prohibitted for any unit or individual to develop, create, or use other methods to obtain, store, possess, or use biological weapons. It is prohibited for any unit or individual to instigate, fund, or assist in the development, creation, or use of other methods to obtain biological weapons by any means.

The state is to employ all necessary measures to prevent biological terrorism and the threat of biological weapons.

Article 60: The relevant departments of the State Council are to draft, revise, and publish a list of organisms, biotoxins, equipment or technologies that can be used for bioterrorist activities or production of biological weapons, and strengthen regulation to prevent their use in the creation of biological weapons or for terrorist goals.

Article 61: Based on their duties and division of labor, the relevant departments of the State Council and related military organs are to strengthen the investigation of activities such as cross-the border, importing or exporting, obtaining, creating, transferring or placement of organisms, biotoxins, equipment or technologies that can be used for bioterrorist activities or production of biological weapons, and are to take all necessary preventative and disposal measures.

Article 62: After bioterrorist incursions or attacks by biological weapons, the relevant departments of the State Council, provincial-level governments, and their relevant departments are responsible for rescue and placement of persons, environmental disinfection, ecological restoration, security monitoring, and restoring social order. The relevant departments of the State Council, provincial-level people's governments and their relevant departments, shall effectively guide public opinion by scientifically and accurately reporting on bioterrorist attacks and incidents of attacks by biological weapons, promptly reporting information such as on evacuation, transfer, and emergency shelter, and carrying our emergency response and longterm environmental and health monitoring for areas and persons that were contaminated.

Article 63: The state is to organize and carry out investigations into the consequences and latent impact of biological weapons behind from wars in our country.

The state is to organize the construction of facilities for placement and disposal of biological weapons left behind from wars in our country, to ensure that such weapons are safely disposed of.

Chapter VIII: Building Biosecurity Capacity

Article 64: People's governments at the county level or above shall support the development of biological security affairs by strengthening biosecurity capacity, increasing the capacity for responding to biosecurity incidents, and increasing the level of response.

People's governments at the county level or above shall increase investment in biological security affairs, including support for the development of the following biosecurity affairs into government budgets:

(1) Constructing and utilizing a monitoring network;

(2) Reserve supplies for emergency response and prevention and control materials;

(3) Construction and utilization of critical infrastructure;

(4) the research and development of key technologies and products;

(5) development of surveys and storage of human genetic resources and biological resources;

(6) Other important biological security affairs as provided for by laws and regulations.

Article 65: The state is to expand the extent of support for scientific research by supporting technological research into biological security risk prevention and control, bringing together advantageous forces and resources to establish multi-discipline, multi-departmental mechanisms for joint research that are cooperative and innovative, promoting the inversion and application of scientific and technical payoffs in core critical biosecurity technologies and major defensive products to increase the capacity of technological safeguards for biosecurity.

Article 66: The state is to strengthen reserves of biosecurity prevention and control supplies for major emergent infections diseases and plant and animal diseases.

The state is to strengthen research, development, and technological reserves of drugs, gear, and other supplies for biological security. Based on their duties and division of labor, the relevant departments of the State Council are to implement measures related to the research, development, and technological reserves of drugs, gear, and other supplies for biological security.

The relevant departments of the State Council and local people's governments at the county level or above and their relevant departments shall ensure production and supply of all medical aid equipment, medications, medical instruments, and other supplies necessary for emergency response to biosecurity incidents; and the departments for transport shall promptly organize and coordinate priority transport for businesses shipping them..

Article 67: The state is to make overall plans for the construction of national biosecurity infrastructure. Based on their duties and division of labor, the relevant departments of the State Council are to establish a National Biological Information Center, a National Human Genetic Resources Preservation Center, and National High-level Pathogenic Organism Laboratory, a National Bacteria (Virus) Preservation Center, an Animal and Plant Genetic Resource Preservation Center, and other resource platforms for the national biosecurity strategy, to provide strategic safeguards and support for technical innovation in biological security.

Article 68: Based on their duties and division of labor, the relevant departments of the State Council are to strengthen the cultivation of talent in basic biological research and specialized technical research in the biological areas, to promote the establishment of foundational science and scientific research.

Practitioners in important positions in the state's critical biosecurity infrastructure shall possess the required credentials and accept relevant training for the post; other relevant information shall be filed with the relevant departments of the State Council.

Article 69: The state is to provide effective preventative measures and medical safeguards, and give subsidies, for personnel engaged in high-risk biosecurity work such as research on highly pathogenic microbes and on-site handling of biosecurity incidents. The specific measures are to be formulated by the financial departments of the State Council in conjunction with other relevant State Council departments.

Chapter IX: Legal Responsibility

Article 70: Where violations of this Law constitute a crime, criminal liability is to be pursued in accordance with law.

Article 71: Where this Law is violated by staff performing biosecurity management duties abusing their authority, derelicting their duties, twisting the law for personal gain, or otherwise violating the law in biosecurity efforts, sanctions are to be given in accordance with law.

Article 72: Where this Law is violated by medical establishments, professional bodies, or their staff conceal, fabricate, or delay reports or have omissions in them, or instruct others to do so, or obstruct others from reporting infectious diseases, plant and animal diseases, or diseases of unknown cause that have been entered in the scope of monitoring, then the relevant departments of people's governments at the county level or above are to order rectification and give warnings; the legal representatives, principle responsible person, and directly responsible managers and other directly responsible personnel are to be lawfully demoted, removed from their posts, or dismissed, and the relevant professional credentials of responsible persons may be revoked in accordance with law.

Article 73: Where this law is violated by engaging in biotechnological research, development, or applications that endanger national security, then based on their duties and the division of labor, the departments in charge of health, science and technology, and rural affairs of people's governments at the county level or above are to order that the illegal conduct be stopped and confiscate illegal income, technical materials, any tools, equipment, raw materials, and other items used in the illegal activities, and concurrently give a fine of between 1,000,000 and 10,000,000 RMB, and where the value of unlawful gains is above 1,000,000, give a fine of between 5 and 10 times the value; and sanction the legal representative, principle responsible person, and directly responsible managers and other directly responsible personnel in accordance with law by prohibiting their engagement in corresponding biotechnology research, development, and applications for between 10 years to life.

Article 74: Where this Law is violated by units engaging in biotechnology research, development, or applications without employing biosecurity risk control measures, the relevant departments of people's governments at the county level or above are to order corrections and give warnings; where corrections are refused, a fine of between 20,000 and 100,000 RMB is to be given; where the circumstances are serious, order that the research, development, or applications are to be stopped, and give a fine of between 100,000 and 500,000 RMB.

Article 75: Where this Law is violated by engaging in activities such as the research, development, or applications of pathogenic microbes outside of an laboratory at the corresponding level, or by level 3 or 4 laboratories engaging in experimental acivilites on high-risk or suspected high-risk pathogenic microbes without approvals, then based on their duties and division of labor, the departments for health and rural affairs of people's governments at the county level or above are to order that the illegal conduct be stopped and oversee the destruction of the pathogens used in the experimental activities or their delivery to a preservation establishment, and give warnings; where serious consequences such as transmission or spread of infectious disease result, the principle responsible person and directly responsible managers and other directly responsible personnel for the unit that established the laboratory are to be removed from their posts or dismissed in accordance with law.

Article 76: Where this Law is violated by allowing experimental animals to enter the consumer marketplace after use, the departments in charge of science and technology of people's governments at the county level or above are to order corrections, confiscate unlawful gains, and give a fine of between 100,000 and 500,000 RMB; where the value of unlawful gains is more than 100,000, give a fine of between five and ten times the value; and where the circumstances are serious, the permits are to be revoked by the departments that them.

Article 77: In any of the following stations where this law is violated, based on their duties and division of labor, the relevant departments of people's governments at the county level or above are to order that the illegal behavior be stopped, confiscate unlawful gains, and give warnings, and a fine of between 100,000 and 1,000,000 RMB may be given concurrently:

(1) Purchasing or bringing in important equipment or special biological factors related to biosecurity without conducting registration in accordance with the management and control list, or without reporting for filing to the relevant departments of the state council;

(2) Individuals purchase or possess important equipment or special biological factors related to biosecurity;

(3) Conducting clinical research on new biotechnologies in medical establishments that do not have the corresponding requirements, or having unqualified personnel conduct clinical research operations.

(4) Entering level 3 or 4 laboratories without the permission of the person in charge of the laboratory.

Article 78: Where this law is violated by collecting or preserving our nation's human genetic resources or by using out nation's human genetic resources or biological resources to carry out international scientific research collaboration, then based on their duties and the division of labor, the relevant departments of people's governments at the provincial-level or above are to order that the illegal conduct be stopped and confiscate illegal income and illegally collected or preserved human genetic resources, and concurrently give a fine of between 500,000 and 5,000,000 RMB, and where the value of unlawful gains is above 1,000,000, give a fine of between 5 and 10 times the value; and sanction the legal representative, principle responsible person, and directly responsible managers and other directly responsible personnel in accordance with law by prohibiting their engagement in the corresponding activity for up to 5 years.

Article 79: Where this law is violated by the collection or preservation of our nation's human genetic resources by foreign organizations, individuals, or the organizations they control in fact, or by providing our nation's human genetic resources abroad, the State Council department for science and technology is to order that the illegal activity be stopped, confiscate the unlawful gains and illegally collected or preserved human genetic resources, and give a concurrent fine of between 1,000,000 and 10,000,000 RMB; where the value of unlawful gains is more than 1,000,000 RMB, give a fine of between five to ten times the value.

Article 80: Where this law is violated by bringing in foreign species without permission or authorization, then based on their duties and division of labor, the relevant departments of people's governments at the county level or above are to confiscate the inported foreign species, and give a fine of between 50,000 and 250,000 RMB.

Where this Law is violated by releasing or discarding foreign species without permission or authorization, then based on their duties and division of labor, the relevant departments of people's governments at the county level or above are to order that the released or discarded foreign species be recaptured or recovered within a set time, and a fine of between 10,000 and 50,000 RMB is to be given.

Article 81: Where this Law does not have provisions on unlawful biosecurity acts that violate this Law and other laws or administrative regulations do have provisions, follow those provisions.

Chapter X: Supplemental Provisions

Article 82: The meaning of the following terms as used in this Law:

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

(2) Major emergent infectious diseases refers to infectious diseases appearing for the first time in our nation's borders or appearing suddenly, that cause or might cause serious injury to public health and lives, cause panic, or impact social stability.

(3) Major emergent animal diseases refers to the first appearance of animal diseases in our nation's borders or a reoccurrence after it was announced to be eradicated, or the sudden rapid transmission of a latent animal disease that has relatively high morbidity and mortality rates, causing a serious threat or danger to the security of the livestock industry, and that might also cause a threat to public health and lives.

(4) Major emergent plant diseases refers to the first appearance of plant diseases in our nation's borders or the reoccurrence of fungi, bacteria, viruses, insects, nematodes, weeks, vermin, mollusks, and other pests that cause disease with were previously announced as eradicated, or the sudden large scale rapid emergence and transmission in a local area, causing serious harm to crops, forests, and other plant life.

(5) Research, development, and use of biological technology refers to engaging in scientific research, technological development, application, and other activities using scientific and engineering principles to understand, exploit, and modify organisms.

(6) Pathogenic microbes refers to microorganisms that can invade humans and animals to cause infection or even contagion, including viruses, bacteria, fungi, rickettsia, parasites, and so forth.

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

(8) Human genetic resources include both human genetic resource materials and human genetic resource information. Human genetic resource materials refers to genetic materials such as organs, tissues, and cells, that contain the human genome, genes and other genetic materials. Human genetic resource information refers to data and other information materials produced from human genetic resource materials.

(9) Microbial drug resistance refers to the resistance of microorganisms to antibiotic drugs, resulting in the inability of antibiotics to effectively control the contagion by microorganisms.

(10) Biological weapons refers to microbial agents, biological agents, and biotoxins from any source or produced in any fashion that are of a type or quantity outside legitimate needs for prevention, protection, or other peaceful uses; and also includes weapons, equipment, or transport designed for using the above mentioned biological agents or biotoxins for hostile purposes or for armed conflict.

(11) Bioterrorism [or Biological Terrorism] refers to the intentional use of pathogenic microbes, biotoxins, and so forth to carry out attacks harming the health of people, plants, or animals, causing public panic, in an attempt to achieve certain political objectives.

Article 83: Where information related to biosecurity is a state secret, the "P.R.C. Law on the Protection of State Secrets" and other national provisions on secrecy should be referenced in implementing a secrecy management.

Article 84: Biological security activities of the Chinese People's Liberation Army and Chinese people's armed police forces are to be provided for separately by the Central Military Commission in accordance with the principles of this Law.

Article 85: This Law shall take effect on xx-xx-xxxx.

 

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