1
Regulations on Administration of Agricultural Genetically Modified
Organisms Safety
Full text
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 competent public health administrative departments of local people's governments at or above the county level are, in accordance with the relevant provisions of the Food Hygiene Law of the People's Republic of China, responsible for the supervision and administration of the hygiene and safety of genetically modified food within their respective administrative areas.
Article 5 The State Council establishes a system of inter-ministerial joint conference for administration of
2
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
3
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) (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) (1)the safety class of agricultural genetically modified organisms and the justifications therefor; (2) (2)the inspection report issued by a technical inspection body of agricultural genetically modified
organisms; (3) a summary report of the productive testing; (4) (4)other materials as provided for by the competent agricultural administrative department of the
State Council.
After receiving the application, the competent agricultural administrative department of the State Council shall organize the bio-safety committee on agricultural genetically modified organisms to conduct the safety evaluation; only after the safety evaluation has been passed may a safety certificate of agricultural genetically modified organisms be issued.
Article 17 Before the examination, registration, evaluation or approval is conducted as provided for in relevant laws and administrative regulations, the safety certificate of agricultural genetically modified organisms shall, as provided for in Article 16 of these Regulations, be obtained for genetically modified
4
plant seeds, breeding livestock and poultry, as well as aquatic fry and seeds, and for the seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers, additives and others, which are either produced by using agricultural genetically modified organisms or contain ingredients of agricultural genetically modified organisms.
Article 18 Research into and testing of agricultural genetically modified organisms within the territory of the People's Republic of China conducted by means of Chinese-foreign contractual cooperation, joint capital or sole foreign capital shall be approved by the competent agricultural administrative department of the State Council.
Chapter III Production and Processing
Article 19 A production license shall be obtained for the production of genetically modified seeds, breeding livestock and poultry, or aquatic fry and seeds from the competent agricultural administrative department of the State Council. In addition to the conditions provided for in relevant laws and administrative regulations, any unit or person applying for the production license of genetically modified seeds, breeding livestock and poultry, or aquatic fry and seeds shall meet the following conditions:
(1) having obtained a safety certificate of agricultural genetically modified organisms and passed variety examination;
(2) planting or breeding in the designated areas; (3) having adopted appropriate safety administration and precautionary measures; (4) (4)other conditions provided for by the competent agricultural administrative department of the
State Council.
Article 20 Any unit or person producing genetically modified plant seeds, breeding livestock and poultry, or aquatic fry and seeds shall keep production files to clearly record the places of production, genes and their sources and methods for genetic modification, as well as the whereabouts of seeds, breeding livestock and poultry, or aquatic fry and seeds, etc.
Article 21 Any unit or person engaged in the production and processing of agricultural genetically modified organisms shall obtain approval from the competent agricultural administrative department of the State Council or the competent agricultural administrative department of a province, an autonomous region and a municipality directly under the Central Government. The specific measures are to be formulated by the competent agricultural administrative department of the State Council.
Article 22 Where farmers breed genetically modified animals or plant genetically modified plants, the units selling seeds, breeding livestock and poultry, or aquatic fry and seeds shall, on behalf of the farmers, go through the examination and approval formalities as provided for in Article 21 of these Regulations. The examination and approval department and the selling unit shall not charge any fees from the farmers.
Article 23 Any unit or person engaged in the production or processing of agricultural genetically modified organisms shall organize the production and processing in accordance with the approved varieties, scopes, safety administration requirements and appropriate technical standards, and shall regularly report the production, processing, safety administration and the whereabouts of the products to the local
5
competent agricultural administrative department of the people's government at the county level.
Article 24 When any genetic accident happens during the process of production and processing of agricultural genetically modified organisms, the unit or person engaged in such production and processing shall immediately take remedial measures and make a report to the competent agricultural administrative department of the people's government at the county level of the place where it or he is situated.
Article 25 The unit or person engaged in the transportation and storage of agricultural genetically modified organisms shall take safety control measures commensurate with the safety class of agricultural genetically modified organisms in order to ensure the safety of transportation and storage of agricultural genetically modified organisms.
Chapter IV Marketing
Article 26 Any unit or person intending to market genetically modified plant seeds, breeding livestock and poultry, or aquatic fry and seeds shall obtain a marketing license from the competent agricultural administrative department of the State Council. In addition to the conditions provided for in relevant laws and administrative regulations, any marketing unit or person applying for the marketing license of genetically modified seeds, breeding livestock and poultry, or aquatic fry and seeds shall meet the following conditions:
(1) having full-time managerial personnel and marketing files; (2) having adopted appropriate safety administration and precautionary measures; (3) other conditions provided for by the competent agricultural administrative department of the
State Council.
Article 27 Any unit or person marketing genetically modified plant seeds, breeding livestock and poultry, or aquatic fry and seeds shall keep marketing files to clearly record the sources, transportation, storage and the whereabouts of the seeds, breeding livestock and poultry, or aquatic fry and seeds, etc.
Article 28 Agricultural genetically modified organisms listed in the catalogue of agricultural genetically modified organisms shall be clearly labeled when they are sold in the territory of the People's Republic of China. Agricultural genetically modified organisms listed in the catalogue of agricultural genetically modified organisms shall be labeled by the unit or person producing or repacking the products. Unlabeled products shall not be sold. When replenishing the stocks of such products, the marketing unit or person shall check the products and their labels. The marketing unit or person shall re-label the products if their original packages have been opened for sale.
Article 29 The label of agricultural genetically modified organisms shall clearly indicate the names of the main raw materials containing genetically modified ingredients in the product. If there are special requirements with respect to the area in which the product can be sold, the area shall also be indicated in the label, and the product in question shall only be sold within such area.
Article 30 Advertisements for agricultural genetically modified organisms may be published, broadcasted, set and posted only after they have been examined and approved by the competent agricultural
6
administrative department of the State Council.
Chapter V Import and Export
Article 31 When introducing agricultural genetically modified organisms into the territory of the People's Republic of China for the purpose of research and testing, the introducing unit shall make an application to the competent agricultural administrative department of the State Council; only the application that meets the following conditions may be approved by the competent agricultural administrative department of the State Council:
(1) having the application qualifications as provided for by the competent agricultural administrative department of the State Council;
(2) the relevant research into and testing of agricultural genetically modified organisms to be introduced has been completed at abroad ( or outside the territory of China);
(3) having adopted appropriate safety administration and precautionary measures.
Article 32 Any company outside the territory of China that exports to the People's Republic of China genetically modified plant seeds, breeding livestock and poultry, or aquatic fry and seeds, and plant seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers and additives produced by using agricultural genetically modified organisms or containing ingredients of agricultural genetically modified organisms, shall make an application to the competent agricultural administrative department of the State Council; where the following conditions are met, the competent agricultural administrative department of the State Council shall approve the importation of testing materials, and the restricted field testing, enlarged field testing or productive testing shall be conducted in accordance with the provisions of these Regulations.
(1) the exporting country or region has permitted the usage for the same purpose and the putting into market thereof;
(2) the exporting country or region has, through scientific experiment, proved that they are harmless to human beings, animals and plants, microorganisms and ecological environment;
(3) having adopted appropriate safety administration and precautionary measures.
With the completion of the productive testing, only after passing the safety evaluation and obtaining the safety certificate of agricultural genetically modified organisms may the formalities of examination, registration or evaluation and approval be gone through in accordance with the provisions of relevant laws and administrative regulations.
Article 33 Any company outside the territory of China that exports to the People's Republic of China agricultural genetically modified organisms to be used as raw materials for processing shall make an application to the competent agricultural administrative department of the State Council; for those meeting the following conditions and passing the safety evaluation, the competent agricultural administrative department of the State Council shall issue a safety certificate of agricultural genetically modified organisms:
(1) the exporting country or region has permitted the usage for the same purpose and the putting into market thereof;
(2) the exporting country or region has, through scientific experiment, proved that they are harmless to human beings, animals and plants, microorganisms and ecological environment;
7
(3) the technical inspection body of agricultural genetically modified organisms has confirmed, upon inspection, that there is no danger to human beings, animals, plants, microorganisms and ecological environment;
(4) having adopted appropriate safety administration and precautionary measures.
Article 34 When introducing agricultural genetically modified organisms from outside the territory of the People's Republic of China or exporting agricultural genetically modified organisms to the People's Republic of China, the introducing unit or the company outside the territory of China shall make a declaration for inspection and quarantine to the exit-entry inspection and quarantine agency at the port on the strength of the safety certificate of agricultural genetically modified organisms issued by the competent agricultural administrative department of the State Council and the relevant documents of approval. Only for those passing the quarantine an application may be made to the Customs for going through relevant formalities.
Article 35 When agricultural genetically modified organisms are to be transferred via the territory of the People's Republic of China, the owner of the goods shall in advance make an application to the exit-entry inspection and quarantine department of the State; such transfer may be carried out only after it has been approved and shall comply with the provisions of the relevant laws and administrative regulations of the People's Republic of China.
Article 36 The competent agricultural administrative department of the State Council and the exit-entry inspection and quarantine department of the State shall, within 270 days from the date of receipt of the application, make a decision of approval or disapproval, and notify the applicant of the result.
Article 37 When agricultural products are exported to outside the territory of the People's Republic of China and the foreign party requests a certificate of non-agricultural agricultural genetically modified organisms, the exit-entry inspection and quarantine agency at the port shall undertake the inspection and issue a certificate of non-agricultural agricultural genetically modified organisms in accordance with the information of genetically modified agricultural products published by the competent agricultural administrative department of the State Council.
Article 38 Agricultural genetically modified organisms that are imported without a safety certificate of agricultural genetically modified organisms issued by the competent agricultural administrative department of the State Council and the relevant documents of approval, or not conforming to the certificate or the documents of approval, shall be rejected or destroyed. Where agricultural genetically modified organisms to be imported are not labeled as required, the goods cannot enter the territory of China until being re-labeled.
Chapter VI Supervision and Inspection
Article 39 When performing its functions and duties of supervision and inspection, a competent agricultural administrative department has the power to take the following measures:
(1) enquiring the units, individuals, interested parties or witnesses that are being inspected and involved in the research, testing, production, processing, marketing, importation or exportation, and requesting
8
them to provide certifying materials relating to agricultural genetically modified organisms or other materials; (2) consulting or duplicating the files, account books or materials relating to the research, testing, production, processing, marketing, importation or exportation of agricultural genetically modified organisms; (3) requesting the units or individuals concerned to make explanations on issues relating to agricultural genetically modified organisms safety; (4) ordering the units or individuals violating the safety administration of agricultural genetically modified organisms to stop illegal activities; (5) under emergency circumstances, sealing up or seizing agricultural genetically modified organisms involved in illegal research, testing, production, processing, marketing, importation or exportation.
Article 40 Staff members of competent agricultural administrative departments shall present their credentials for law enforcement when undertaking supervision and inspection.
Article 41 The units or individuals concerned shall support and cooperate with the competent agricultural administrative departments in their supervision and inspection, and shall not refuse and obstruct the supervision and inspection personnel to perform their duties according to law.
Article 42 When discovering that agricultural genetically modified organisms endanger human beings, animals, plants or ecological environment, the competent agricultural administrative department of the State Council has the power to make a declaration to prohibit the production, processing, marketing or importation thereof, to take back the safety certificate of agricultural genetically modified organisms, or to destroy the dangerous agricultural genetically modified organisms in question.
Chapter VII Penalty Provisions
Article 43 Those who, in violation of these Regulations, conduct research into agricultural genetically modified organisms classified as Class III or IV or conduct restricted field testing without making a report to the competent agricultural administrative department of the State Council shall be ordered by the competent agricultural administrative department of the State Council to suspend the research or restricted field testing, and to make corrections within the specified time limit.
Article 44 Those who, in violation of these Regulation, conduct enlarged field testing or productive testing without approval, or with approval but failing to take safety administration and precautionary measures in accordance with the relevant provisions, or conduct testing beyond the approved scope, shall be ordered to stop the testing, and shall be imposed a fine of not less than 10,000 yuan but not more than 50,000 yuan by the competent agricultural administrative department of the State Council or the competent agricultural administrative department of the people's government of the province, autonomous region and municipality directly under the Central Government in accordance with their respective functions and powers.
Article 45 Those who, in violation of these Regulations, put agricultural genetically modified organisms into production or application after the completion of productive testing but without obtaining the safety certificate of agricultural genetically modified organisms, shall be ordered to stop the production or
9
application, and shall be imposed a fine of not less than 20,000 yuan but not more than 100,000 yuan by the competent agricultural administrative department of the State Council.
Article 46 Those who, in violation of the provisions of Article 18 of these Regulations, conduct research into or testing of agricultural genetically modified organisms without the approval of the competent agricultural administrative department of the State Council, shall be ordered by the competent agricultural administrative department of the State Council to stop the research and testing, and to undergo anew examination and approval formalities within the specified time limit.
Article 47 Those who, in violation of these Regulations, produce or process agricultural genetically modified organisms without approval, or conduct the production or processing not conforming to the approved varieties, scopes, requirements for safety administration and technical standards, shall be ordered to stop the production or processing by the competent agricultural administrative department of the State Council or the competent agricultural administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with their respective functions and powers. The illegally produced or processed products and the illegal income shall be confiscated. If the illegal income is not less than 100,000 yuan, a fine of not less than one but not more than five times the illegal income shall be imposed concurrently; if there is no illegal income or the illegal income is less than 100,000 yuan, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed concurrently.
Article 48 If a unit or person engaged in the production or marketing of genetically modified plant seeds, breeding livestock and poultry, or aquatic fry and seeds, in violation of these Regulations, fails to make and keep production or marketing files, it or he shall be ordered to make corrections and imposed a fine of not less than 1,000 yuan but not more than 10,000 yuan by the competent agricultural administrative department of the people's government at or above the county level in accordance with its functions and powers.
Article 49 If a marketing unit of genetically modified plant seeds, breeding livestock and poultry, or aquatic fry and seeds, in violation of these Regulations, fails to fulfill the obligations of going through the examination and approval formalities on behalf of the farmers or charges fees for such fulfillment, it or he shall be ordered to make corrections and imposed a fine of not more than 20,000 yuan by the competent agricultural administrative department of the State Council.
Article 50 Those who, in violation of these Regulations, import agricultural genetically modified organisms without the approval of the competent agricultural administrative department of the State Council, shall be ordered to stop the importation by the competent agricultural administrative department of the State Council. The imported products and the illegal income shall be confiscated. If the illegal income is not less than 100,000 yuan, a fine of not less than one but not more than five times the illegal income shall be imposed concurrently; if there is no illegal income or the illegal income is less than 100,000 yuan, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed concurrently.
Article 51 Those who, in violation of these Regulations, import, carry or post agricultural genetically modified organisms without making a declaration for inspection and quarantine to the exit-entry
10
inspection and quarantine agencies at the ports, or transfer agricultural genetically modified organisms via the territory of China without the approval of the exit-entry inspection and quarantine department of the State, shall be punished by the exit-entry inspection and quarantine agencies at the ports or by the exit-entry inspection and quarantine department of the State by applying mutates mutandis the relevant provisions of the law on the entry and exit animal and plant quarantine.
Article 52 Those who violate the provisions of these Regulations on labeling management of agricultural genetically modified organisms shall be ordered to make corrections within the specified time limit by the competent agricultural administrative departments of the people's governments at or above the county level in accordance with their respective functions and powers, the illegally marketed products and illegal income may be confiscated and a fine of not less than 10,000 yuan but not more than 50,000 yuan may be imposed.
Article 53 Those who forge, falsify, transfer or sell and buy any relevant certifying documents relating to agricultural genetically modified organisms shall have the certifying documents in question confiscated and be imposed a fine of not less than 20,000 yuan but not more than 100,000 yuan by the competent agricultural administrative department of the people's governments at or above the county level in accordance with their respective functions and powers; if a crime is constituted, criminal liability shall be investigated according to law.
Article 54 Those who, in violation of these Regulations, cause an accident in the process of research, testing, production, processing, storage, transportation, marketing, import or export of agricultural genetically modified organisms, thus resulting in any damage, shall bear the liability for compensation according to law.
Article 55 Where the competent agricultural administrative department of the State Council or the competent agricultural administrative department of the people's government of a province, an autonomous region or a municipality directly under the Central Government, in violation of these Regulations, issues licenses, safety certificates of agricultural genetically modified organisms or other documents of approval, or fails to perform the duties of supervision and administration after issuing the licenses, safety certificates of agricultural genetically modified organisms or other documents of approval, the person in charge who has direct responsibility and other direct responsible persons shall be given administrative sanctions according to law; if a crime is constituted, criminal liability shall be investigated according to law.
Chapter VIII Supplementary Provisions
Article 56 These Regulations shall be effective as of the date of promulgation.
《农业转基因生物安全管理条例》
全文
第一章 总则
第一条 为了加强农业转基因生物安全管理，保障人体健康和动植物、微生物安全，保护生态环境，促进农业转基因生物技术研究，制定本条例。
第二条 在中华人民共和国境内从事农业转基因生物的研究、试验、生产、加工、经营和进口、出口活动，必须遵守本条例。
第三条 本条例所称农业转基因生物，是指利用基因工程技术改变基因组构成，用于农业生产或者农产品加工的动植物、微生物及其产品，主要包括：
（一）转基因动植物（含种子、种畜禽、水产苗种）和微生物；
（二）转基因动植物、微生物产品；
（三）转基因农产品的直接加工品；
（四）含有转基因动植物、微生物或者其产品成份的种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂等产品。
本条例所称农业转基因生物安全，是指防范农业转基因生物对人类、动植物、微生物和生态环境构成的危险或者潜在风险。
第四条 国务院农业行政主管部门负责全国农业转基因生物安全的监督管理工作。
县级以上地方各级人民政府农业行政主管部门负责本行政区域内的农业转基因生物安全的监督管理工作。
县级以上各级人民政府卫生行政主管部门依照《中华人民共和国食品卫生法》的有关规定，负责转基因食品卫生安全的监督管理工作。
第五条 国务院建立农业转基因生物安全管理部际联席会议制度。
农业转基因生物安全管理部际联席会议由农业、科技、环境保护、卫生、外经贸、检验检疫等有关部门的负责人组成，负责研究、协调农业转基因生物安全管理工作中的重大问题。
第六条 国家对农业转基因生物安全实行分级管理评价制度。
农业转基因生物按照其对人类、动植物、微生物和生态环境的危险程度，分为Ⅰ、Ⅱ、Ⅲ、Ⅳ四个等级。具体划分标准由国务院农业行政主管部门制定。
第七条 国家建立农业转基因生物安全评价制度。
农业转基因生物安全评价的标准和技术规范，由国务院农业行政主管部门制定。
第八条 国家对农业转基因生物实行标识制度。
实施标识管理的农业转基因生物目录，由国务院农业行政主管部门商国务院有关部门制定、调整并公布。
第二章 研究与试验
第九条 国务院农业行政主管部门应当加强农业转基因生物研究与试验的安全评价管理工作，并设立农业转基因生物安全委员会，负责农业转基因生物的安全评价工作。
农业转基因生物安全委员会由从事农业转基因生物研究、生产、加工、检验检疫以及卫生、环境保护等方面的专家组成。
第十条 国务院农业行政主管部门根据农业转基因生物安全评价工作的需要，可以委托具备检测条件和能力的技术检测机构对农业转基因生物进行检测。
第十一条 从事农业转基因生物研究与试验的单位，应当具备与安全等级相适应的安全设施和措施，确保农业转基因生物研究与试验的安全，并成立农业转基因生物安全小组，负责本单位农业转基因生物研究与试验的安全工作。
第十二条 从事Ⅲ、Ⅳ级农业转基因生物研究的，应当在研究开始前向国务院农业行政主管部门报告。
第十三条 农业转基因生物试验，一般应当经过中间试验、环境释放和生产性试验三个阶段。
中间试验，是指在控制系统内或者控制条件下进行的小规模试验。
环境释放，是指在自然条件下采取相应安全措施所进行的中规模的试验。
生产性试验，是指在生产和应用前进行的较大规模的试验。
第十四条 农业转基因生物在实验室研究结束后，需要转入中间试验的，试验单位应当向国务院农业行政主管部门报告。
第十五条 农业转基因生物试验需要从上一试验阶段转入下一试验阶段的，试验单位应当向国务院农业行政主管部门提出申请；经农业转基因生物安全委员会进行安全评价合格的，由国务院农业行政主管部门批准转入下一试验阶段。
试验单位提出前款申请，应当提供下列材料：
（一）农业转基因生物的安全等级和确定安全等级的依据；
（二）农业转基因生物技术检测机构出具的检测报告；
（三）相应的安全管理、防范措施；
（四）上一试验阶段的试验报告。
第十六条 从事农业转基因生物试验的单位在生产性试验结束后，可以向国务院农业行政主管部门申请领取农业转基因生物安全证书。
试验单位提出前款申请，应当提供下列材料：
（一）农业转基因生物的安全等级和确定安全等级的依据；
（二）农业转基因生物技术检测机构出具的检测报告；
（三）生产性试验的总结报告；
（四）国务院农业行政主管部门规定的其他材料。
国务院农业行政主管部门收到申请后，应当组织农业转基因生物安全委员会进行安全评价；安全评价合格的，方可颁发农业转基因生物安全证书。
第十七条 转基因植物种子、种畜禽、水产苗种，利用农业转基因生物生产的或者含有农业转基因生物成份的种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂等，在依照有关法律、行政法规的规定进行审定、登记或者评价、审批前，应当依照本条例第十六条的规定取得农业转基因生物安全证书。
第十八条 中外合作、合资或者外方独资在中华人民共和国境内从事农业转基因生物研究与试验的，应当经国务院农业行政主管部门批准。
第三章 生产与加工
第十九条 生产转基因植物种子、种畜禽、水产苗种，应当取得国务院农业行政主管部门颁发的种子、种畜禽、水产苗种生产许可证。
生产单位和个人申请转基因植物种子、种畜禽、水产苗种生产许可证，除应当符合有关法律、行政法规规定的条件外，还应当符合下列条件：
（一）取得农业转基因生物安全证书并通过品种审定；
（二）在指定的区域种植或者养殖；
（三）有相应的安全管理、防范措施；
（四）国务院农业行政主管部门规定的其他条件。
第二十条 生产转基因植物种子、种畜禽、水产苗种的单位和个人，应当建立生产档案，载明生产地点、基因及其来源、转基因的方法以及种子、种畜禽、水产苗种流向等内容。
第二十一条 单位和个人从事农业转基因生物生产、加工的，应当由国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门批准。具体办法由国务院农业行政主管部门制定。
第二十二条 农民养殖、种植转基因动植物的，由种子、种畜禽、水产苗种销售单位依照本条例
第二十一条 的规定代办审批手续。审批部门和代办单位不得向农民收取审批、代办费用。
第二十三条 从事农业转基因生物生产、加工的单位和个人，应当按照批准的品种、范围、安全管理要求和相应的技术标准组织生产、加工，并定期向所在地县级人民政府农业行政主管部门提供生产、加工、安全管理情况和产品流向的报告。
第二十四条 农业转基因生物在生产、加工过程中发生基因安全事故时，生产、加工单位和个人应当立即采取安全补救措施，并向所在地县级人民政府农业行政主管部门报告。
第二十五条 从事农业转基因生物运输、贮存的单位和个人，应当采取与农业转基因生物安全等级相适应的安全控制措施，确保农业转基因生物运输、贮存的安全。
第四章 经营
第二十六条 经营转基因植物种子、种畜禽、水产苗种的单位和个人，应当取得国务院农业行政主管部门颁发的种子、种畜禽、水产苗种经营许可证。
经营单位和个人申请转基因植物种子、种畜禽、水产苗种经营许可证，除应当符合有关法律、行政法规规定的条件外，还应当符合下列条件：
（一）有专门的管理人员和经营档案；
（二）有相应的安全管理、防范措施；
（三）国务院农业行政主管部门规定的其他条件。
第二十七条 经营转基因植物种子、种畜禽、水产苗种的单位和个人，应当建立经营档案，载明种子、种畜禽、水产苗种的来源、贮存、运输和销售去向等内容。
第二十八条 在中华人民共和国境内销售列入农业转基因生物目录的农业转基因生物，应当有明显的标识。
列入农业转基因生物目录的农业转基因生物，由生产、分装单位和个人负责标识；未标识的，不得销售。经营单位和个人在进货时，应当对货物和标识进行核对。经营单位和个人拆开原包装进行销售的，应当重新标识。
第二十九条 农业转基因生物标识应当载明产品中含有转基因成份的主要原料名称；有特殊销售范围要求的，还应当载明销售范围，并在指定范围内销售。
第三十条 农业转基因生物的广告，应当经国务院农业行政主管部门审查批准后，方可刊登、播放、设置和张贴。
第五章 进口与出口
第三十一条 从中华人民共和国境外引进农业转基因生物用于研究、试验的，引进单位应当向国务院农业行政主管部门提出申请；符合下列条件的，国务院农业行政主管部门方可批准：
（一）具有国务院农业行政主管部门规定的申请资格；
（二）引进的农业转基因生物在国（境）外已经进行了相应的研究、试验；
（三）有相应的安全管理、防范措施。
第三十二条 境外公司向中华人民共和国出口转基因植物种子、种畜禽、水产苗种和利用农业转基因生物生产的或者含有农业转基因生物成份的植物种子、种畜禽、水产苗种、农药、兽药、肥料和添加剂的，应当向国务院农业行政主管部门提出申请；符合下列条件的，国务院农业行政主管部门方可批准试验材料入境并依照本条例的规定进行中间试验、环境释放和生产性试验：
（一）输出国家或者地区已经允许作为相应用途并投放市场；
（二）输出国家或者地区经过科学试验证明对人类、动植物、微生物和生态环境无害；
（三）有相应的安全管理、防范措施。
生产性试验结束后，经安全评价合格，并取得农业转基因生物安全证书后，方可依照有关法律、行政法规的规定办理审定、登记或者评价、审批手续。
第三十三条 境外公司向中华人民共和国出口农业转基因生物用作加工原料的，应当向国务院农业行政主管部门提出申请；符合下列条件，并经安全评价合格的，由国务院农业行政主管部门颁发农业转基因生物安全证书：
（一）输出国家或者地区已经允许作为相应用途并投放市场；
（二）输出国家或者地区经过科学试验证明对人类、动植物、微生物和生态环境无害；
（三）经农业转基因生物技术检测机构检测，确认对人类、动植物、微生物和生态环境不存在危险；
（四）有相应的安全管理、防范措施。
第三十四条 从中华人民共和国境外引进农业转基因生物的，或者向中华人民共和国出口农业转基因生物的，引进单位或者境外公司应当凭国务院农业行政主管部门颁发的农业转基因生物安全证书和相关批准文件，向口岸出入境检验检疫机构报检；经检疫合格后，方可向海关申请办理有关手续。
第三十五条 农业转基因生物在中华人民共和国过境转移的，货主应当事先向国家出入境检验检疫部门提出申请；经批准方可过境转移，并遵守中华人民共和国有关法律、行政法规的规定。
第三十六条 国务院农业行政主管部门、国家出入境检验检疫部门应当自收到申请人申请之日起270日内作出批准或者不批准的决定，并通知申请人。
第三十七条 向中华人民共和国境外出口农产品，外方要求提供非转基因农产品证明的，由口岸出入境检验检疫机构根据国务院农业行政主管部门发布的转基因农产品信息，进行检测并出具非转基因农产品证明。
第三十八条 进口农业转基因生物，没有国务院农业行政主管部门颁发的农业转基因生物安全证书和相关批准文件的，或者与证书、批准文件不符的，作退货或者销毁处理。进口农业转基因生物不按照规定标识的，重新标识后方可入境。
第六章 监督检查
第三十九条 农业行政主管部门履行监督检查职责时，有权采取下列措施：
（一）询问被检查的研究、试验、生产、加工、经营或者进口、出口的单位和个人、利害关系人、证明人，并要求其提供与农业转基因生物安全有关的证明材料或者其他资料；
（二）查阅或者复制农业转基因生物研究、试验、生产、加工、经营或者进口、出口的有关档案、账册和资料等；
（三）要求有关单位和个人就有关农业转基因生物安全的问题作出说明；
（四）责令违反农业转基因生物安全管理的单位和个人停止违法行为；
（五）在紧急情况下，对非法研究、试验、生产、加工、经营或者进口、出口的农业转基因生物实施封存或者扣押。
第四十条 农业行政主管部门工作人员在监督检查时，应当出示执法证件。
第四十一条 有关单位和个人对农业行政主管部门的监督检查，应当予以支持、配合，不得拒绝、阻碍监督检查人员依法执行职务。
第四十二条 发现农业转基因生物对人类、动植物和生态环境存在危险时，国务院农业行政主管部门有权宣布禁止生产、加工、经营和进口，收回农业转基因生物安全证书，销毁有关存在危险的农业转基因生物。
第七章 罚则
第四十三条 违反本条例规定，从事Ⅲ、Ⅳ级农业转基因生物研究或者进行中间试验，未向国务院农业行政主管部门报告的，由国务院农业行政主管部门责令暂停研究或者中间试验，限期改正。
第四十四条 违反本条例规定，未经批准擅自从事环境释放、生产性试验的，已获批准但未按照规定采取安全管理、防范措施的，或者超过批准范围进行试验的，由国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门依据职权，责令停止试验，并处1万元以上5万元以下的罚款。
第四十五条 违反本条例规定，在生产性试验结束后，未取得农业转基因生物安全证书，擅自将农业转基因生物投入生产和应用的，由国务院农业行政主管部门责令停止生产和应用，并处2万元以上10万元以下的罚款。
第四十六条 违反本条例第十八条规定，未经国务院农业行政主管部门批准，从事农业转基因生物研究与试验的，由国务院农业行政主管部门责令立即停止研究与试验，限期补办审批手续。
第四十七条 违反本条例规定，未经批准生产、加工农业转基因生物或者未按照批准的品种、范围、安全管理要求和技术标准生产、加工的，由国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门依据职权，责令停止生产或者加工，没收违法生产或者加工的产品及违法所得；违法所得10万元以上的，并处违法所得1倍以上5倍以下的罚款；没有违法所得或者违法所得不足10万元的，并处10万元以上20万元以下的罚款。
第四十八条 违反本条例规定，转基因植物种子、种畜禽、水产苗种的生产、经营单位和个人，未按照规定制作、保存生产、经营档案的，由县级以上人民政府农业行政主管部门依据职权，责令改正，处1000元以上1万元以下的罚款。
第四十九条 违反本条例规定，转基因植物种子、种畜禽、水产苗种的销售单位，不履行审批手续代办义务或者在代办过程中收取代办费用的，由国务院农业行政主管部门责令改正，处2万元以下的罚款。
第五十条 违反本条例规定，未经国务院农业行政主管部门批准，擅自进口农业转基因生物的，由国务院农业行政主管部门责令停止进口，没收已进口的产品和违法所得；违法所得10万元以上的，并处违法所得1倍以上5倍以下的罚款；没有违法所得或者违法所得不足10万元的，并处10万元以上20万元以下的罚款。
第五十一条 违反本条例规定，进口、携带、邮寄农业转基因生物未向口岸出入境检验检疫机构报检的，或者未经国家出入境检验检疫部门批准过境转移农业转基因生物的，由口岸出入境检验检疫机构或者国家出入境检验检疫部门比照进出境动植物检疫法的有关规定处罚。
第五十二条 违反本条例关于农业转基因生物标识管理规定的，由县级以上人民政府农业行政主管部门依据职权，责令限期改正，可以没收非法销售的产品和违法所得，并可以处1万元以上5万元以下的罚款。
第五十三条 假冒、伪造、转让或者买卖农业转基因生物有关证明文书的，由县级以上人民政府农业行政主管部门依据职权，收缴相应的证明文书，并处2万元以上10万元以下的罚款；构成犯罪的，依法追究刑事责任。
第五十四条 违反本条例规定，在研究、试验、生产、加工、贮存、运输、销售或者进口、出口农业转基因生物过程中发生基因安全事故，造成损害的，依法承担赔偿责任。
第五十五条 国务院农业行政主管部门或者省、自治区、直辖市人民政府农业行政主管部门违反本条例规定核发许可证、农业转基因生物安全证书以及其他批准文件的，或者核发许可证、农业转基因生物安全证书以及其他批准文件后不履行监督管理职责的，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任。
第八章 附则
第五十六条 本条例自公布之日起施行。