(1) Cell fusion technology and protoplast fusion technology;
(2) Traditional cross breeding technology;
(3) Mutation technology, in vitro fertilization technology, cell culture or embryo culture technology. Article 3 These Measures shall apply to all genetic engineering work carried out within the territory of People's Republic of China (PRC), including experimental research, intermediate experiments, industrial production, release of genetically engineered bodies and use of genetically engineered products.
Those who introduce genetic engineering bodies from abroad and carry out genetic engineering work in China shall abide by these measures. Article 4 The State Science and Technology Commission is in charge of the national genetic engineering safety work, and establishes the National Genetic Engineering Safety Committee, which is responsible for the supervision and coordination of genetic engineering safety.
The relevant administrative departments of the State Council shall, in accordance with relevant regulations, conduct safety management of genetic engineering within their respective responsibilities. Article 5 The safety management of genetic engineering shall implement the system of safety grade control and grading centralized examination and approval. Chapter II Safety Levels and Safety Evaluation Article 6 Genetic engineering work is divided into four safety levels according to the degree of potential danger:
Safety level I, this kind of genetic engineering work does not pose danger to human health and ecological environment;
Safety level II, this kind of genetic engineering work has low risk to human health and ecological environment;
Safety level ⅲ, this kind of genetic engineering work has moderate danger to human health and ecological environment;
Safety level Ⅳ, this kind of genetic engineering work is highly dangerous to human health and ecological environment; Seventh technical standards and environmental standards for the safety level of various genetic engineering work shall be formulated by the relevant administrative departments of the State Council and reported to the National Genetic Engineering Safety Committee for the record. Article 8 Units engaged in genetic engineering shall conduct safety evaluation, assess potential dangers, determine safety levels and formulate safety control methods and measures. Article 9 To carry out experimental research on genetic engineering, the safety of DNA donors, vectors, hosts and genetic engineering bodies shall be evaluated. The safety evaluation focuses on the pathogenicity, carcinogenicity, drug resistance, metastasis and eco-environmental effects of target genes, vectors, hosts and genetic engineering bodies, as well as determining the level of biological control and physical control. Article 10 Whoever engages in pilot or industrial production of genetic engineering shall, according to the safety assessment of the genetic engineering body used, conduct safety assessment on the physical barriers of equipment and facilities in the process of culture, fermentation, separation and purification, and determine the safety level of pilot or industrial production. Eleventh before the release of genetic engineering, the safety of genetic engineering, the purpose of release, the ecological environment of the release area, the release mode, monitoring methods and control measures should be evaluated to determine the safety level of the release work. Article 12 The use of genetically modified products shall be subject to biosafety inspection and safety evaluation to determine the possible impact of genetically modified products on public health and ecological environment. Chapter III Application and Examination and Approval Article 13 Units engaged in genetic engineering shall make classified application according to the applicable nature and safety grade of genetic engineering products, and can only carry out it after approval. Fourteenth belongs to the safety level I, II genetic engineering experimental research, shall be approved by the administrative person in charge of the unit; Belong to the safety level 3 work, by the administrative person in charge of the unit review, reported to the relevant administrative departments in the State Council for approval; Belonging to the safety level 4, it shall be reviewed by the relevant administrative department of the State Council and reported to the National Genetic Engineering Safety Committee for approval. Fifteenth belongs to the safety level I work of genetic engineering pilot, approved by the administrative person in charge of the unit; Work that belongs to safety level II shall be reported to the relevant administrative department of the State Council for approval; Belong to the safety level 3 work, approved by the relevant administrative departments of the State Council, and reported to the National Genetic Engineering Safety Committee for the record; Belonging to the safety level 4, it shall be reviewed by the relevant administrative department of the State Council and reported to the National Genetic Engineering Safety Committee for approval. Sixteenth industrial production of genetic engineering, the release of genetic engineering bodies and the use of genetic engineering products belong to the work of safety level one to three, which shall be examined and approved by the relevant administrative departments in the State Council and reported to the National Genetic Engineering Safety Committee for the record; Belonging to the safety level 4, it shall be reviewed by the relevant administrative department of the State Council and reported to the National Genetic Engineering Safety Committee for approval. Seventeenth units engaged in genetic engineering shall perform the following reporting procedures:
(a) the person in charge of the project carries out safety evaluation on genetic engineering work and fills in the application form;
(two) the academic committee of the unit to conduct technical review of the application materials;
(3) Submit an application and relevant technical materials. Eighteenth genetic engineering work that meets the following conditions shall be approved, and a certificate shall be issued:
(a) The reliability of the declared safety assessment of genetic engineering work is beyond doubt;
(two) to ensure that the declared genetic engineering work meets the requirements of the safety level, to take safety control measures suitable for the existing scientific and technological level, and to judge that it will not cause serious harm to public health and ecological environment;
(three) the person in charge of the project and the staff have the necessary professional knowledge and safe operation knowledge to engage in genetic engineering work, and can undertake the obligations stipulated in these measures;
(4) Conforming to relevant national laws and regulations.