Announcement No. 1643 of the Ministry of Agriculture of the People's Republic of China
In accordance with the Seed Law of the People's Republic of China, the Regulations on the Safety Administration of Agricultural Genetically Modified Organisms, and the Measures for the Administration of Licenses for the Production and Operation of Crop Seeds, our Ministry has formulated the Provisions on the Administration of Licenses for the Production and Operation of Genetically Modified Cotton Seeds, which are hereby promulgated and shall come into force on October 7, 2011.
Hereby announced.
September 6, 2011
Provisions on the Administration of Licenses for the Production and Operation of Genetically Modified Cotton Seeds
Article 1 These Provisions are formulated in accordance with the Seed Law of the People's Republic of China, the Regulations on the Safety Administration of Agricultural Genetically Modified Organisms, and the Measures for the Administration of Licenses for the Production and Operation of Crop Seeds, in order to strengthen the administration of licenses for the production and operation of genetically modified cotton seeds.
Article 2 Licenses for the production and operation of genetically modified cotton seeds shall be examined by the administrative department of agriculture of the provincial-level people's government of the place where production is located, and issued by the Ministry of Agriculture.
Article 3 An applicant applying for a license for the production of genetically modified cotton seeds shall meet the following conditions:
(1) Registered capital of not less than 30 million yuan;
(2) The variety to be produced has obtained an agricultural genetically modified organism safety certificate and has passed variety approval; where seeds with plant variety rights are produced, the written consent of the variety rights holder shall also be obtained;
(3) Possession of at least 1 unit (set) each of a fully functional purity analysis table, electronic scale, placement bed equipment, electrophoresis apparatus, electrophoresis tank, sample grinder, oven, biological microscope, and refrigerator; at least 1 set of electronic balances (with sensitivities of one hundredth, one thousandth, and one ten-thousandth); at least 2 units (sets) each of a sampler, divider, and germination box; at least 1 unit (set) each of a PCR amplifier, pH meter, autoclave, magnetic stirrer, constant-temperature water bath, high-speed refrigerated centrifuge, complete set of pipettes, microplate reader, plate washer, and gel imaging system; a testing laboratory of not less than 150 sq m;
(4) A warehouse of not less than 500 sq m, a drying yard of not less than 1000 sq m, or corresponding seed drying facilities and equipment;
(5) At least 3 full-time seed production technicians, at least 3 full-time storage technicians, and at least 3 seed inspectors who have passed the assessment of the administrative department of agriculture of a people's government at or above the provincial level; and at least 1 full-time agricultural genetically modified organism safety administrator;
(6) The production site is within the area approved by the agricultural genetically modified organism safety certificate, with no quarantine pests;
(7) Isolation and production conditions that comply with the cotton seed production procedures and the safe production requirements for genetically modified cotton seeds;
(8) Corresponding agricultural genetically modified organism safety management and preventive measures;
(9) Other conditions specified by the Ministry of Agriculture.
Article 4 An applicant applying for a license for the production of genetically modified cotton seeds shall submit the following materials to the examining authority:
(1) An application form for a license for the production of genetically modified cotton seeds;
(2) Copies of capital verification reports, or annual accounting statements and audit reports issued by intermediary agencies within 1 year before the date of application, and other proof materials of registered capital; a list of seed testing and other equipment and copies of purchase invoices; copies of property right certificates for the seed testing laboratory and warehouse in the province (autonomous region, municipality directly under the Central Government) where the production site is located; copies of property right certificates (or lease agreements) for the drying yard in the province (autonomous region, municipality directly under the Central Government) where the production site is located, or copies of property right certificates for seed drying facilities; copies of calibration certificates issued by metrological verification institutions for testing equipment involving measurement; explanatory descriptions and actual photographs of the relevant facilities and equipment;
(3) Copies of qualification certificates and labor contracts of seed production, storage, and testing technicians; an explanatory description and copies of labor contracts of agricultural genetically modified organism safety administrators;
(4) A quarantine certificate for the seed production site;
(5) A copy of the variety approval certificate;
(6) Where seeds with plant variety rights are produced, a written proof of consent from the variety rights holder shall be submitted;
(7) An explanation of the safe isolation and production conditions for seed production;
(8) A copy of the agricultural genetically modified organism safety certificate;
(9) An explanation of agricultural genetically modified organism safety management and preventive measures;
(10) Other materials specified by the Ministry of Agriculture.
Where an applicant for a license for the production of genetically modified cotton seeds has already obtained a license for the operation of genetically modified cotton seeds, it shall be exempted from submitting the materials specified in item (2) of the preceding paragraph and the copies of qualification certificates and labor contracts of seed storage and testing technicians, but shall submit a copy of the license for the operation of genetically modified cotton seeds.
Article 5 An applicant applying for a license for the operation of genetically modified cotton seeds shall meet the following conditions:
(1) Registered capital of not less than 30 million yuan and fixed assets of not less than 10 million yuan;
(2) The variety to be operated has obtained an agricultural genetically modified organism safety certificate and has passed variety approval; where seeds with plant variety rights are operated, the written consent of the variety rights holder shall also be obtained;
(3) Seed testing facilities and equipment, warehouses, drying yards or corresponding drying facilities and equipment that meet the requirements of items (3) and (4) of Article 3 of these Provisions; a business premises of not less than 300 sq m, complete sets of seed processing equipment with a total processing capacity of not less than 1 ton/hour, equipped with cottonseed chemical delinting equipment; and a processing plant of not less than 500 sq m;
(4) At least 3 full-time seed processing technicians, at least 3 full-time storage technicians, and at least 3 seed inspectors who have passed the assessment of the administrative department of agriculture of a people's government at or above the provincial level; and at least 1 full-time agricultural genetically modified organism safety administrator;
(5) Corresponding agricultural genetically modified organism safety management and preventive measures;
(6) The operating area is within the area approved by the agricultural genetically modified organism safety certificate;
(7) Other conditions specified by the Ministry of Agriculture.
Article 6 An applicant applying for a license for the operation of genetically modified cotton seeds shall submit the following materials to the examining authority:
(1) An application form for a license for the operation of genetically modified cotton seeds;
(2) Copies of capital verification reports, or annual accounting statements and audit reports issued by intermediary agencies within 1 year before the date of application, and other proof materials of registered capital and fixed assets; proof materials of basic information such as the nature of the applicant unit and capital composition;
(3) A list of seed testing, processing, and other facilities and equipment and copies of purchase invoices; copies of property right certificates for the seed testing laboratory, processing plant, and warehouse; copies of property right certificates (or lease agreements) for the drying yard, or copies of property right certificates for seed drying facilities and equipment; copies of calibration certificates issued by metrological verification institutions for testing and packaging equipment involving measurement; explanatory descriptions and actual photographs of the relevant facilities and equipment;
(4) Copies of qualification certificates and labor contracts of relevant technicians for seed testing, processing, and storage; an explanatory description and copies of labor contracts of full-time agricultural genetically modified organism safety administrators;
(5) Copies of the variety approval certificate and the agricultural genetically modified organism safety certificate; where genetically modified cotton seeds with plant variety rights are operated, a written proof of consent from the variety rights holder shall also be submitted;
(6) An explanation of agricultural genetically modified organism safety management and preventive measures;
(7) Other materials specified by the Ministry of Agriculture.
Article 7 The examining authority shall complete the examination within 20 working days from the date of accepting the application, and shall sign examination opinions and report them to the issuing authority. During examination, it shall conduct on-site inspections of the business premises, processing and storage facilities, and testing facilities and equipment, and verify the originals of the relevant proof materials.
The issuing authority shall complete the issuance within 20 working days from the date of receiving the application materials and examination opinions. Where the issuing authority deems it necessary, it may conduct on-site inspections. Where conditions are met, it shall issue the license for the production and operation of genetically modified cotton seeds and make an announcement; where conditions are not met, it shall notify the applicant in writing and explain the reasons.
Article 8 The number of the license for the production of genetically modified cotton seeds shall be in the format of “__(X) Nong Zhong Sheng Xu Zi (X) No. X”, with “G” marked on “__”, the first bracket containing the abbreviation of the issuing authority, the second bracket containing the year of first issuance, and the third number being a four-digit serial number.
The number of the license for the operation of genetically modified cotton seeds shall be in the format of “__(X) Nong Zhong Jing Xu Zi (X) No. X”, with “G” marked on “__”, the first bracket containing the abbreviation of the issuing authority, the second bracket containing the year of first issuance, and the third number being a four-digit serial number.
Article 9 The license for the production of genetically modified cotton seeds shall be valid for 3 years, and the license for operation shall be valid for 5 years, and shall not exceed the validity period specified in the agricultural genetically modified organism safety certificate.
Article 10 Other matters concerning the licensing of the production and operation of genetically modified cotton seeds shall be handled in accordance with the relevant provisions of the Measures for the Administration of Licenses for the Production and Operation of Crop Seeds.
Article 11 These Provisions shall come into force on October 7, 2011. Where an enterprise has already obtained a license for the production and operation of genetically modified cotton seeds before the date these Provisions come into force, and the validity period expires between the date these Provisions come into force and October 7, 2012, the validity period of its license shall be automatically extended to October 7, 2012; however, where the validity period of the agricultural genetically modified organism safety certificate expires before October 7, 2012, the validity period of the enterprise's license for the production and operation of genetically modified cotton seeds shall be governed by the validity period of the safety certificate.