Genetically modified organisms safety regulations
(May 23, 2001 the State Council Order No. 304)
Chapter I General Provisions
In order to strengthen the safety management of agricultural GMOs to protect human health and animal and plant, microbial safety, protect ecological environment and promoting agricultural genetically modified organisms technology research, the enactment of this Ordinance.
Article in the PRC engaged in agricultural genetically modified organisms in research, testing, production, processing, management and import and export activities, must comply with the regulations.
Article 3 The term genetically modified organisms, refers to the use of genetic engineering techniques to change the composition of the genome, used for agricultural production or processing of agricultural products, plants and animals, microorganisms and their products, including:
(A) transgenic animals and plants (including seeds, breeding livestock and poultry, aquatic fry) and micro-organisms;
(B) the genetically modified plants and animals, microbial products;
(C) genetically modified agricultural products directly processed;
(D) contains genetically modified plants and animals, microorganisms or their products ingredients seeds, breeding livestock and poultry, aquatic fry, pesticides, veterinary drugs, fertilizers and additives and other products.
The term genetically modified organisms safety, is to prevent genetically modified organisms to humans, animals, plants, microorganisms and ecological environment of the danger or potential risks.
Article IV of the State Council administrative department responsible for national agricultural genetically modified organisms safety supervision and management.
Local people's governments above the county level agricultural administrative departments in charge of administrative regions of genetically modified organisms safety supervision and management. People's governments at or above the county level health administrative department in accordance with "Food Hygiene Law of the PRC," the relevant provisions, is responsible for the safety of genetically modified food hygiene supervision and management.
Article V of the State Council established the Department of genetically modified organisms safety management joint conference system.
Department of genetically modified organisms safety management by the joint meeting of agriculture, science and technology, environmental protection, health, foreign trade, inspection and quarantine departments in charge, is responsible for research coordination in the management of genetically modified organisms safety a major issue.
The State of genetically modified organisms safety levels of management evaluation system.
Agricultural genetically modified organisms in accordance with its human, animal, microbial and ecological risk, divided into Ⅰ, Ⅱ, Ⅲ, Ⅳ four grades. Specific criteria for the classification by the State Council administrative department of agriculture.
Article 7 The establishment of genetically modified organisms safety evaluation system.
Evaluation of genetically modified organisms safety standards and technical specifications by the State Council administrative department of agriculture.
Article 8 The State introduces a labeling system for GMOs.
Implementation of identity management directories of agricultural GMOs, by the State Council administrative department of agriculture business of the State Council departments to develop, adjust and publish.
Chapter II Research and
Article IX of the State Council administrative department of agriculture to enhance agricultural genetically modified organisms should be the safety evaluation of research and test management, and the establishment of genetically modified organisms safety committee responsible for the safety evaluation of GMOs.
Safety Committee consists of genetically modified organisms in genetically modified organisms in research, production, processing, inspection and quarantine, health and environmental protection experts.
Article department of agriculture administration department under the safety evaluation of GMOs need to be entrusted with the technical ability to test conditions and testing organization for testing of agricultural genetically modified organisms.
Article 11 When agricultural genetically modified organisms research and testing units, and security level should be compatible with the safety facilities and measures to ensure agricultural genetically modified organisms safety research and testing, and the establishment of genetically modified organisms safety team, the unit responsible for agricultural genetically modified organisms security research and testing work.
Article XII in Ⅲ, Ⅳ-level study of agricultural genetically modified organisms should be before the start of the study to the State Council administrative department of agriculture report.
Article XIII of agricultural genetically modified biological test, should generally be through the middle of testing, environmental release and production test in three stages. The middle of trial, is in the control system or under controlled conditions on a small scale test. Environmental release, under natural conditions is to take appropriate security measures for the medium-scale experiments. Production test, production and application is carried out before the larger-scale trials.
Article XIV agricultural genetically modified organisms in the laboratory after the end of the study need to test into the middle of the test unit shall apply to the State Council administrative department of agriculture report.
Article XV requires testing of agricultural GMOs from a pilot phase to the next phase of testing, the test unit shall department of agriculture administration department to make an application; by genetically modified organisms safety committee qualified safety evaluation by the competent administrative departments of agriculture approval to the next testing stage.
Test units made in the preceding paragraph apply, shall provide the following materials:
(A) agricultural genetically modified organisms and to determine the level of security based on security level;
(B) genetically modified organisms technology test reports issued by testing organizations;
(C) the appropriate safety management, prevention measures;
(D) on a pilot phase of the test report.
Article XVI of units engaged in agricultural genetically modified organisms in the production of test after test, to the State Council administrative department of agriculture apply for genetically modified organisms safety certificates.
Test units made in the preceding paragraph apply, shall provide the following materials:
(A) agricultural genetically modified organisms and to determine the level of security based on security level;
(B) genetically modified organisms technology test reports issued by testing organizations;
(C) production test summary report;
(D) department of agriculture administration department under the other materials.
Department of agriculture administration department after receiving the application, shall organize agricultural genetically modified organisms safety committee safety evaluation; safety evaluation of qualified, be issued by genetically modified organisms safety certificates.
Article XVII of genetically modified seeds, breeding livestock and poultry, fish fry, the use of the production of agricultural genetically modified organisms or contain biological components of agricultural genetically modified seeds, breeding livestock and poultry, aquatic fry, pesticides, veterinary drugs, fertilizers and additives, in accordance with relevant laws and administrative regulations for approval, registration or evaluation prior to approval shall be in accordance with the provisions of this Article 16 to obtain genetically modified organisms safety certificates.
Article 18 Sino-foreign cooperative joint venture or wholly foreign-funded agricultural genetically modified organisms in the PRC engaged in research and testing, shall be subject to approval of the State Council administrative department of agriculture.
Chapter III Production and Processing
Article 19 The production of transgenic plant seeds, breeding livestock and poultry, aquatic fry, should be made of the State Council issued the administrative department of agriculture seeds, breeding livestock and poultry, aquatic fry production license.
Production units and individuals to apply for genetically modified seeds, breeding livestock and poultry, aquatic fry production license, in addition shall comply with relevant laws and administrative regulations of the conditions, should also meet the following conditions:
(A) to obtain genetically modified organisms safety certificates and approval by the species;
(B) planting in the designated area or farming;
(C) have appropriate safety management, prevention measures;
(D) department of agriculture administration department under other conditions.
Diershitiao production of transgenic plant seeds, breeding livestock and poultry, aquatic fry units and individuals, shall establish a production file showing the location of production, genes and their sources, methods and genetically modified seeds, breeding livestock and poultry, aquatic fry the flow and so on.
Twenty-one units and individuals engaged in the production of agricultural genetically modified organisms, processing shall be by the State Council administrative department of agriculture or the provinces, autonomous regions and municipalities approved by the administrative department of agriculture. The specific measures by the State Council administrative department of agriculture.
Article 22 farmers farming, planting of genetically modified plants and animals, from the seeds, breeding livestock and poultry, aquatic fry sales units in accordance with the provisions of Article 21 of the agency approval process. Approval of department and agency units shall be charged to farmers for approval, agency costs.
Article 23 engaged in the production of agricultural genetically modified organisms, processing units and individuals shall be in accordance with the approved variety, scope, security management requirements and appropriate technical standards for production, processing, and regularly to the local county government administrative departments of agriculture production, processing, safety management and product flow of the report.
Article 24 of the GMOs in the production, process safety incidents occurring gene, production, processing units and individuals should take immediate safety remedial measures and to the county level people's government agricultural administrative department.
Article 25 The agricultural genetically modified organisms in the transportation, storage units and individuals, and genetically modified organisms should be taken to adapt the security level security control measures to ensure that GMOs transport, storage and security.
Chapter Business
Article 26 The management of genetically modified seeds, breeding livestock and poultry, aquatic fry units and individuals shall obtain the State Council issued the administrative department of agriculture seeds, breeding livestock and poultry, aquatic fry license.
Individual business units and application of genetically modified seeds, breeding livestock and poultry, aquatic fry license, in addition shall comply with relevant laws and administrative regulations of the conditions, should also meet the following conditions:
(A) have a dedicated management and business files;
(B) appropriate safety management, prevention measures;
(C) the department of agriculture administration department under other conditions.
Article 27 The management of genetically modified seeds, breeding livestock and poultry, aquatic fry units and individuals, should be established to operate files contain seeds, breeding livestock and poultry, aquatic fry the source, storage, transportation and sale of the whereabouts of such content.
Article 28 The sale included the territory of the People's Republic of agricultural genetically modified organisms GMOs directory, there should be a clear identity.
Included in the directory of agricultural genetically modified organisms GMOs, from production, packing units and individuals responsible for the identification; not identified, may not be sold. Operating units and individuals in the purchase, and the identification of goods should be checked. Operating units and individuals open the original packaging for sale, should be re-identification.
Article 29 shall contain the identification of agricultural GMOs genetically modified products contain the name of the main raw material; special sales range requirements, it shall set forth the scope of sales, and sales in designated areas.
Article 30 GMOs advertising, should be approved by the State Council examined and approved by the administrative department of agriculture, before published, broadcast, set up and posting.
Chapter import and export
第 三十一条 imported from outside the People's Republic of agricultural genetically modified organisms for research, testing, introduction to the State unit shall apply the administrative department of agriculture; following conditions are met, the State Council administrative department of agriculture to the approval of:
(A) with department of agriculture administration department under the eligibility criteria;
(B) the introduction of GMOs in the country (territory) have been carried out relevant research, pilot;
(C) have appropriate safety management, precautions.
Article 32 People's Republic of offshore companies to export genetically modified seeds, breeding livestock and poultry, aquatic fry production and use of agricultural genetically modified organisms or contain biological components of agricultural genetically modified plant seeds, breeding livestock and poultry, aquatic fry, pesticides, veterinary drugs, fertilizers and additives, should be to the State Council administrative department of agriculture applications; following conditions are met, the State Council administrative department of agriculture approved experimental material to enter and be in accordance with the provisions of this Ordinance, the middle of testing, environmental release and production of test:
(A) the exporting country or region has allowed the use and market as appropriate;
(B) the exporting country or region through scientific testing to prove humans, animals, plants, microorganisms and environment friendly;
(C) have appropriate safety management, precautions.
Production test after passing through the safety evaluation, and obtain genetically modified organisms safety certificates, the only in accordance with relevant laws and administrative regulations for approval, registration or evaluation, examination and approval procedures.
Article 33 The foreign companies exporting to the People's Republic of agricultural genetically modified organisms used as raw materials, it should be to the State Council administrative department of agriculture applications; meet the following conditions, and safety evaluation by a qualified, competent administrative department of agriculture by the State Council issued agricultural genetically modified bio-security certificate:
(A) the exporting country or region has allowed the use and market as appropriate;
(B) the exporting country or region through scientific testing to prove humans, animals, plants, microorganisms and environment friendly;
(C) by genetically modified organisms technology at the testing to confirm human beings, animals and plants, microorganisms and ecological environment is not dangerous;
(D) appropriate security management, prevention measures.
Article 34 introduced from outside the People's Republic of agricultural genetically modified organisms, or export to the People's Republic of agricultural genetically modified organisms, the introduction of unit or with foreign companies should be issued by the State Council administrative department of agriculture of genetically modified organisms safety certificates and relevant documents of approval, to the port of entry and exit inspection and quarantine institution; by the quarantine, only apply to the customs procedures.
Article 35 of transboundary movements of GMOs in the Republic of China, the owner should advance to the national entry-exit inspection and quarantine departments to apply; transit movements through approval and comply with the relevant PRC laws and administrative regulations.
Article 36 The State Council administrative department of agriculture, national entry-exit inspection and quarantine department shall apply from the date of receipt of the applicant 270 days to approve or not approve the decision and notify the applicant.
Article 37 The export of agricultural products to outside the PRC, foreign requests for evidence of non-genetically modified agricultural products, the port inspection and quarantine authorities of the State Council administrative department of agriculture of genetically modified agricultural products released information to detect and issue a proof of non-genetically modified agricultural products.
Article 38 The import of GMOs, there is no department of agriculture administration department of genetically modified organisms safety certificates issued and the relevant approval documents, or with the certificate does not match the approval documents for return or destroyed. Imports of agricultural genetically modified organisms which are not identified in accordance with the provisions of re-identification before entry.
Chapter VI Supervision and inspection
Article 39 The administrative departments of agriculture to perform supervision and inspection duties, to take the following measures:
(A) asked to be checked for research, testing, production, processing, management, or the import, export units and individuals, stakeholders, references, and be required to provide and genetically modified organisms safety-related evidence or other information;
(B) to inspect or copy the agricultural genetically modified organisms research, testing, production, processing, management, or import and export of the files, books and materials, etc.;
(C) request the relevant units and individuals on issues related to genetically modified organisms safety instructions;
(D) order the violation of genetically modified organisms safety management units and individuals to stop illegal activities;
(E) In case of emergency, illegal research, testing, production, processing, management, or importing, exporting of agricultural GMOs implementation of sequestration or seizure.
Article 40 The administrative department of agriculture staff in the supervision and inspection shall produce law enforcement credentials.
第 四十一条 relevant units and individuals for agricultural administrative departments of supervision and inspection, should be supported, with, shall not refuse, hinder the supervision and inspection personnel from performing their duties.
Article 42 found that genetically modified organisms to humans, animals and plants and the environment there is danger of the State Council administrative department of agriculture to declare ban on the production, processing, management and import to recover genetically modified organisms safety certificates, the dangerous destruction of the agricultural genetically modified organisms.
Chapter VII Penalties
Article 43 violation of these regulations, in Ⅲ, Ⅳ grade agricultural genetically modified organisms for research or pilot tests, not to the State Council administrative department of agriculture reported by the department of agriculture administration department shall suspend the research or pilot test, within a time limit.
Article 44 violation of these regulations, without approval in environmental release, production testing, has been approved but not adopted in accordance with safety regulations, precautions, or exceed the approved scope of testing by the competent administrative departments of agriculture departments or provinces, autonomous regions and municipalities according to the administrative department of agriculture authority, ordered to stop testing, and impose 1 million to 5 million fine.
Article 45 Whoever violates these regulations, in the production end of the experiment, without obtaining genetically modified organisms safety certificates, without the production and application of genetically modified organisms, the State Council administrative department of agriculture ordered to stop production and application, and impose 2 yuan to 100,000 yuan shall be imposed.
Article 46 violates the provisions of Article 18 without the approval of the State Council administrative department of agriculture, agricultural genetically modified organisms in research and testing by the department of agriculture administration department shall immediately stop the study and test, the deadline go through approval procedures.
Article 47 violation of these regulations, unauthorized production, processing agricultural genetically modified organisms, or not in accordance with the approved variety, scope, security management requirements and technical standards of production, processing, and by the State Council administrative department of agriculture or the provinces, autonomous regions and municipalities government administrative departments of agriculture based on authority, and ordered to stop production or processing, confiscate the illegal production or processing of products and illegal income; illegal income of 10 million yuan, more than double the illegal income and impose a fine of five times; no illegal income or the illegal proceeds are less than 100,000 yuan, 100,000 yuan and impose a fine of 200,000 yuan.
Article 48 violation of these regulations, genetically modified seeds, breeding livestock and poultry, aquatic fry production, business units and individuals failing to produce, save the production, management file, by the people's governments above the county level administrative departments of agriculture, ex officio corrective actions and 1,000 yuan to 10,000 yuan shall be imposed.
Article 49 violation of these regulations, genetically modified seeds, breeding livestock and poultry, aquatic fry sales unit, does not fulfill obligations or agency approval procedures during the collection agency in the agency fee, the department of agriculture administration department shall order rectification 20,000 yuan fine.
Article 50 violation of these regulations, without the approval of the State Council administrative department of agriculture, the unauthorized import of agricultural genetically modified organisms, and by the department of agriculture administration department shall order to stop the import, imported products have been confiscated and the illegal income; illegal income of more than 10 million , times the illegal income and impose a fine of more than five times; there is no illegal income or the illegal income is less than 100,000 yuan, 100,000 yuan and impose a fine of 200,000 yuan.
第 五十一条 violation of these regulations, import, carry mail to the port of GMOs are not entry-exit inspection and quarantine institution, or without the approval of national transit entry-exit inspection and quarantine department of the transfer of agricultural genetically modified organisms, the port entry and exit entry and exit inspection and quarantine institution or the State cf entry-exit inspection and quarantine department of the Animal and Plant Quarantine Law shall be punished.
Article 52 violates the provisions of regulations on genetically modified organisms identified, by the people's governments above the county level agricultural administrative departments of authority, ordered to make corrections, you can confiscate the illegal sale of products and illegal income, and can be more than 10,000 yuan 50,000 yuan fine.
Article 53 of the counterfeit, forged, transfer or sale of genetically modified organisms on that instrument, by the people's governments above the county level agricultural administrative departments of authority, the collection of appropriate supporting documentation, and impose a 20,000 yuan to 100,000 yuan shall be imposed ; constitute a crime shall be held criminally responsible.
Article 54 violation of these regulations, in research, testing, production, processing, storage, transport, sell or import, export agricultural genetically modified organisms safety incidents occurred during the gene, resulting in damage, according to the law of liability.
Article 55 of the State Council administrative department of agriculture or the provinces, autonomous regions and municipalities agricultural administrative department in violation of the regulations issued by the license, genetically modified organisms safety certificates and other documents of approval, or license of, genetically modified organisms safety certificates and other approved documents do not fulfill their supervisory management responsibilities, the directly responsible person in charge and other directly responsible persons shall be given administrative sanctions; constitutes a crime, be held criminally responsible.
Chapter VIII Supplementary Provisions
Article 56 These Regulations shall come into force from the date of publication.