Regulation on Administration of Safety of Agricultural Genetically Modified Organisms (2017 Revision)

Regulation on Administration of Safety of Agricultural Genetically Modified Organisms (2017 Revision) Regulation on Administration of Safety of Agricultural Genetically Modified Organisms (Issued by the Order No. 304 of the State Council of the People's Republic of China on May 23, 2001, revised in accordance with the Decision of the State Council on Abolishing and Amending Some Administrative Regulations by the Order No. 588 of the State Council on January 8, 2011; and amended in accordance with the Decision of the State Council to Amend Certain Administrative Regulations by the Order No. 687 of the State Council on October 7, 2017) Chapter I General Provisions Article 1 These Regulations are formulated for the purposes of strengthening the administration of agricultural genetically modified organisms safety, safeguarding the health of human bodies and the safety of animals, plants and microorganisms, protecting the ecological environment, and promoting the research into technologies of agricultural genetically modified organisms. Article 2 The activities of research, experiment, production, processing, marketing, import and export with respect to agricultural genetically modified organisms within the territory of the People's Republic of China must conform to these Regulations. Article 3 Agricultural genetically modified organism, as referred to in these Regulations, means animals, plants, microorganisms and their products whose genomic structures have been modified by genetic engineering technologies for the use in agricultural production or processing, which mainly include: (1) genetically modified animals, plants (including plant seeds, breeding livestock and poultry, aquatic fry and seeds) and microorganisms; (2) products of genetically modified animals, plants and microorganisms; (3) products directly processed from genetically modified agricultural products; (4) seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers, additives and other products containing ingredients of genetically modified animals, plants and microorganisms or their products. Agricultural genetically modified organisms safety, as referred to in these Regulations, means the protection of human being, animals, plants and microorganisms and the ecological environment against the danger or potential risk arising from agricultural genetically modified organisms. Article 4 The competent agricultural administrative department of the State Council is responsible for the nationwide supervision and administration of agricultural genetically modified organisms safety. The competent agricultural administrative departments of local people's governments at or above the county level are responsible for the supervision and administration of agricultural genetically modified organisms safety within their respective administrative areas. The relevant departments of the people's governments at and above the county level shall be responsible for the supervision and administration of safety of genetically modified food according to the relevant provisions of the Food Safety Law of the People's Republic of China . Article 5 The State Council establishes a system of inter-ministerial joint conference for administration of agricultural genetically modified organisms safety. The inter-ministerial joint conference for administration of agricultural genetically modified organisms safety shall be composed of responsible persons from the departments of agriculture, science and technology, environmental protection, public health, foreign trade and economic cooperation, inspection and quarantine, and from other relevant departments as well, and shall be responsible for the discussion and coordination of major issues involved in the administration of agricultural genetically modified organisms safety. Article 6 The State institutes a class-based administration and evaluation system for agricultural genetically modified organisms safety. Agricultural genetically modified organisms are classified into Classes I, II, III and IV according to the extent of their risks to human beings, animals, plants, microorganisms and the ecological environment. The specific standards for the classification are to be formulated by the competent agricultural administrative department of the State Council. Article 7 The State establishes a safety evaluation system for agricultural genetically modified organisms. The standards and technical norms for safety evaluation of agricultural genetically modified organisms are to be formulated by the competent agricultural administrative department of the State Council. Article 8 The State institutes a labeling system for agricultural genetically modified organisms. The catalogue of agricultural genetically modified organisms subject to labeling administration shall be determined, adjusted and published by the competent agricultural administrative department of the State Council in consultation with the other relevant departments of the State Council. Chapter II Research and Testing Article 9 The competent agricultural administrative department of the State Council shall strengthen the safety evaluation administration of research into and testing of agricultural genetically modified organisms, and set up a bio-safety committee on agricultural genetically modified organisms responsible for safety evaluation of agricultural genetically modified organisms. The bio-safety committee on agricultural genetically modified organisms shall be composed of the experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural genetically modified organisms, as well as those in the fields of public health and environmental protection, etc. Article 10 Based on the needs of the safety evaluation of agricultural genetically modified organisms, the competent agricultural administrative department of the State Council may entrust the inspection of agricultural genetically modified organisms to technical inspection bodies with necessary inspecting facilities and capability. Article 11 Units engaged in research into and testing of agricultural genetically modified organisms shall have facilities and measures commensurate with the safety class so as to ensure the safety of research into and testing of agricultural genetically modified organisms, and shall establish bio-safety groups of agricultural genetically modified organisms which shall be responsible for the safety of the research into and testing of agricultural genetically modified organisms in the units concerned. Article 12 A unit conducting research into agricultural genetically modified organisms classified as Classes III and IV shall make a report to the competent agricultural administrative department of the State Council prior to the commencement of the research. Article 13 The testing of agricultural genetically modified organisms shall normally go through three stages, i.e. restricted field testing, enlarged field testing and productive testing. Restricted field testing means a small-scale test conducted within a controlled system or under controlled conditions. Enlarged field testing means a medium-scale test conducted under natural conditions with appropriate safety measures. Productive testing means a large-scale test prior to production and application. Article 14 Where a testing of agricultural genetically modified organisms needs to move on to the stage of restricted field testing after completion of research in the laboratory, the testing unit shall make a report to the competent agricultural administrative department of the State Council. Article 15 Where a testing of agricultural genetically modified organisms needs to move on from one testing stage to the next one, the testing unit shall make an application to the competent agricultural administrative department of the State Council; if the testing passes the safety evaluation conducted by the bio-safety committee on agricultural genetically modified organisms, the moving on the next testing stage shall be approved by the competent agricultural administrative department of the State Council. When making the application referred to in the preceding paragraph, the testing unit shall provide the following materials: (1) the safety class of agricultural genetically modified organisms and the justifications therefor; (2) the inspection report issued by a technical inspection body of agricultural genetically modified organisms; (3) appropriate safety administration and precautionary measures; (4)the summary report of the previous testing stage. Article 16 After the completion of productive testing, the unit engaged in testing of agricultural genetically modified organisms may make an application to the competent agricultural administrative department of the State Council for a safety certificate of agricultural genetically modified organisms. When making the application referred to in the preceding paragraph, the testing unit shall provide the following materials: (1)the safety class of agricultural genetically modified organisms and the justifications therefor; (2) a summary report of the productive testing; (3)the experimental materials, testing methods, and other materials prescribed by the agriculture administrative department of the State Council. After receiving an application, the agriculture administrative department of the State Council shall authorize a technical inspection institution meeting the ......