Notice of the Ministry of Science and Technology on Printing and Distributing the Measures for the Safety Management of Biotechnology Research and Development
National Science and Technology Publishing House [2017] No. 198
All provinces, autonomous regions, municipalities directly under the Central Government and cities with separate plans, sub-provincial city science and technology departments (committees and bureaus), Xinjiang Production and Construction Corps Science and Technology Bureau, relevant departments of science and technology departments of the State Council, all relevant units:
In order to standardize biotechnology research and development activities, promote and guarantee the healthy and orderly development of biotechnology research and development activities, and effectively maintain national biosafety, the Ministry of Science and Technology has formulated the “Biotechnology Research and Development Safety Management Measuresâ€. I am printing you now, please follow the instructions.
Ministry of Science
Biotechnology research and development safety management measures
The first one is to standardize biotechnology research and development activities, enhance the awareness of safety responsibility of natural persons, legal persons and other organizations engaged in biotechnology research and development activities, avoid direct or indirect biosafety hazards, and promote and guarantee the healthy and orderly biotechnology research and development activities. Develop and effectively maintain biosafety and formulate these measures.
Article 2 Natural persons, legal persons and other organizations engaged in biotechnology research and development activities within the territory of the People's Republic of China shall abide by these Measures.
Article 3: Engaging in biotechnology research and development activities shall abide by laws and administrative regulations, respect social ethics, and shall not damage national security, public interests and the legitimate rights and interests of others, and shall not violate the relevant international obligations and commitments of the People's Republic of China.
Article 4 The safety management of biotechnology research and development shall be managed hierarchically. According to the degree of potential risk of biotechnology research and development activities, it is divided into high risk level, higher risk level and general risk level.
High-risk level refers to the degree of potential risk of biotechnology research and development activities that can cause very serious or serious diseases in humans or animals, or cause serious harm to important agricultural and forestry crops, Chinese herbal medicines and the environment.
A higher risk level refers to the degree of potential risk of biotechnology research and development activities that can cause human or animal diseases, but generally do not pose serious harm to humans, animals, important agricultural and forestry crops, Chinese herbal medicines or the environment.
The general risk level refers to the degree of potential risk of biotechnology research and development activities that normally do not pose a hazard to humans, animals, important agricultural and forestry crops, Chinese herbal medicines or the environment.
Article 5 The competent department of science and technology under the State Council shall be responsible for the national safety guidance for biotechnology research and development, and jointly carry out relevant work related to the safety management of biotechnology research and development in conjunction with the relevant competent departments of the State Council, specifically:
(1) Preparing (repairing) safety management specifications for biotechnology research and development;
(2) Establishing a national expert committee for biotechnology research and development safety management;
(3) Studying and determining the risk level of biotechnology research and development activities, and organizing expert (repair) risk rating lists according to the development status of biotechnology research and development;
(4) Organizing experts to inspect and guide biotechnology research and development activities undertaken by legal persons and other organizations.
The relevant competent departments of the State Council are responsible for the safety supervision and management of biotechnology research and development within their respective areas of responsibility, and manage the occurrence of biotechnology research and development accidents.
Article 6 The main duties of the National Expert Committee on Biotechnology Research and Development Safety Management are:
(1) Conducting research on safety strategy of biotechnology research and development, and proposing decision-making references and consultation suggestions on safety management of biotechnology research and development;
(2) Proposing a list of risk grades for biotechnology research and development activities;
(3) Proposing for countermeasures and disposal procedures for safety accidents related to biotechnology research and development at high risk levels and higher risk levels;
(4) Cooperate with the inspection and guidance of biotechnology research and development activities.
Article 7 The relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall , in accordance with these Measures, formulate safety management norms for biotechnology research and development in their respective administrative regions, and carry out safety management of biotechnology research and development.
Article 8 Legal persons and other organizations engaged in biotechnology research and development activities bear the main responsibility for the safety research and development of biotechnology. The main duties are:
(1) Formulating the safety management norms for the research and development of biotechnology of the organization;
(2) Carrying out risk assessment and supervision and management of the organization's biotechnology research and development activities;
(3) Formulating emergency plans and disposal plans for the safety accidents of various types of risk biotechnology research and development in the Organization;
(4) To quickly and effectively dispose of the safety accidents of biotechnology research and development, and report to the higher authorities;
(5) Recording and effectively protecting related materials and data of biotechnology research and development safety accidents.
Article 9 Natural persons, legal persons and other organizations shall make full assessments when publicly, transferring, promoting or industrializing and commercializing the application of biotechnology research and development results to avoid causing major biosafety risks.
Article 10: Natural persons, legal persons and other organizations that involve international exchanges and cooperation in the research and development of biotechnology shall keep state secrets and safeguard state rights and interests in accordance with the law.
Article 11: In the biotechnology research and development activities, natural persons, legal persons and other organizations fail to comply with biosafety research and development safety management practices, resulting in biosafety accidents and failure to timely or effectively dispose of them or conceal them. The relevant competent departments or relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall make decisions in accordance with relevant laws and regulations, and shall be recorded in the credit files by the competent department of science and technology of the State Council for serious acts of dishonesty.
Article 12 The military's biotechnology research and development safety management shall be implemented by the military with reference to these Measures.
Article 13 The Ministry of Science and Technology is responsible for the interpretation of these Measures.
Article 14 These Measures shall be implemented as of the date of promulgation.
Attachment: Risk grading of biotechnology research and development activities
annex
Biotechnology research and development activity risk grading
High risk level
1. In the "List of Pathogenic Microorganisms Infected by Humans", research and development activities involving the first and second types of pathogenic microorganisms, and which must be carried out in biosafety level 4 or tertiary laboratories as required;
2. The "Catalogue of Animal Pathogenic Microorganisms", which involves the first and second types of pathogenic microorganisms, and must carry out research and development activities in the Biosafety Level 4 or Level 3 laboratories as required;
3. The "Inventory of Entering Animal Epidemic Diseases of the People's Republic of China" covers research and development activities of the first type of infectious diseases and parasitic diseases;
4. The Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on the Destruction of Such Weapons involves research and development activities of applicable biological warfare agents, pathogenic microorganisms or toxins;
5. Research and development activities involving newly developed highly pathogenic pathogenic microorganisms;
6. Synthetic activities involving various types of microorganisms with infectious activity;
7. Research and development activities involving genetic engineering such as human genetic editing with significant risks;
8. Other biotechnology research and development activities with the same potential risk level.
Higher risk level
1. The "List of Pathogenic Microorganisms Infected by Humans", which involves the third type of pathogenic microorganisms, and must carry out research and development activities in the Biosafety Secondary Laboratory in accordance with regulations;
2. The "Catalogue of Animal Pathogenic Microorganisms", which involves the third type of pathogenic microorganisms, and must carry out research and development activities in the Biosafety Secondary Laboratory in accordance with regulations;
3. The "Inventory of Entering Animal Epidemic Diseases of the People's Republic of China" covers research and development activities of the second category of infectious diseases and parasitic diseases;
4. Research and development activities involving genetic engineering such as human genetic editing with greater risks;
5. Other biotechnology research and development activities with the same potential risk level.
General risk level
1. The "List of Pathogenic Microorganisms Infected by Humans", which involves the fourth type of pathogenic microorganisms, and which must be carried out in the Biosafety Level 1 laboratory according to regulations;
2. The "Catalogue of Classification of Animal Pathogenic Microorganisms", which involves the fourth type of pathogenic microorganisms, and which must be carried out in the Biosafety Level 1 laboratory according to regulations;
3. Research and development activities involving other infectious diseases and parasitic diseases in the Catalogue of Animal Quarantine Diseases of the People's Republic of China;
4. Research and development activities involving genetic engineering such as human genetic editing with general risks;
5. Other biotechnology research and development activities with the same potential risk level
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