Regulations on the Licensing of Genetically Modified Cotton Seed Production and Operation Officially Promulgated

Announcement of the Ministry of Agriculture of the People's Republic of China

No. 1643

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 Licensing for Crop Seed Production and Operation," our Ministry has formulated the "Regulations on the Licensing of Genetically Modified Cotton Seed Production and Operation," which are hereby promulgated and shall take effect as of October 7, 2011.

It is hereby announced.

September 6, 2011

Regulations on the Licensing of Genetically Modified Cotton Seed Production and Operation

Article 1 In order to strengthen the administration of licensing for the production and operation of genetically modified cotton seeds, these Regulations 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 Licensing for Crop Seed Production and Operation."

Article 2 Licenses for the production and operation of genetically modified cotton seeds shall be reviewed by the competent agricultural administrative department of the provincial people's government where the production site is located, and issued by the Ministry of Agriculture.

Article 3 Applicants for a genetically modified cotton seed production license shall meet the following conditions:

(1) A registered capital of no 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; for the production of seeds with plant variety rights, the written consent of the variety rights holder shall also be obtained;

(3) At least one unit (set) each of the following in good working condition: purity analysis bench, electronic scale, seed placement equipment, electrophoresis apparatus, electrophoresis tank, sample grinder, oven, biological microscope, and refrigerator; at least one set of electronic balances (with sensitivities of one hundredth, one thousandth, and one ten-thousandth); at least two units (sets) each of seed samplers, sample dividers, and germination cabinets; at least one unit (set) each of 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 no less than 150 sq m;

(4) A warehouse of no less than 500 sq m, a drying yard of no less than 1,000 sq m, or corresponding seed drying facilities and equipment;

(5) At least three full-time seed production technicians, storage technicians, and seed inspectors who have passed the assessment of the competent agricultural administrative department of the people's government at or above the provincial level, respectively; at least one full-time agricultural genetically modified organism safety management officer;

(6) The production site is within the area approved by the agricultural genetically modified organism safety certificate and is free of quarantine pests;

(7) Isolation and production conditions that comply with cotton seed production procedures and the safety production requirements for genetically modified cotton seeds;

(8) Corresponding agricultural genetically modified organism safety management and preventive measures;

(9) Other conditions stipulated by the Ministry of Agriculture.

Article 4 Applicants for a genetically modified cotton seed production license shall submit the following materials to the reviewing authority:

(1) An application form for a genetically modified cotton seed production license;

(2) A capital verification report or copies of registered capital certification materials such as the annual accounting statements and audit reports from an intermediary agency within 1 year prior to the date of application; 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 the property right certificate (or lease agreement) for the drying yard in the province (autonomous region, municipality directly under the Central Government) where the production site is located, or copies of the property right certificate for seed drying facilities and equipment; copies of calibration certificates issued by metrological verification institutions for testing equipment involving measurement; a description of the relevant facilities and equipment and actual photographs;

(3) Copies of qualification certificates and labor contracts for seed production, storage, and testing technicians; a description of the agricultural genetically modified organism safety management officer and a copy of their labor contract;

(4) A quarantine certificate for the seed production site;

(5) A copy of the variety approval certificate;

(6) For the production of seeds with plant variety rights, a written proof of consent from the variety rights holder;

(7) A description of the safe isolation and production conditions for seed production;

(8) A copy of the agricultural genetically modified organism safety certificate;

(9) A description of agricultural genetically modified organism safety management and preventive measures;

(10) Other materials stipulated by the Ministry of Agriculture.

If an applicant for a genetically modified cotton seed production license has already obtained a genetically modified cotton seed operation license, it is exempt from submitting the materials specified in item (2) of the preceding paragraph and the copies of qualification certificates and labor contracts for seed storage and testing technicians, but shall submit a copy of the genetically modified cotton seed operation license.

Article 5 Applicants for a genetically modified cotton seed operation license shall meet the following conditions:

(1) A registered capital of no less than 30 million yuan and fixed assets of no 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; for the operation of seeds with plant variety rights, 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 Regulations; a business premises of no less than 300 sq m, a complete set of seed processing equipment with a total processing capacity of no less than 1 ton/hour, equipped with cottonseed chemical delinting equipment; a processing plant of no less than 500 sq m;

(4) At least three full-time seed processing technicians, storage technicians, and seed inspectors who have passed the assessment of the competent agricultural administrative department of the people's government at or above the provincial level, respectively; at least one full-time agricultural genetically modified organism safety management officer;

(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 stipulated by the Ministry of Agriculture.

Article 6 Applicants for a genetically modified cotton seed operation license shall submit the following materials to the reviewing authority:

(1) An application form for a genetically modified cotton seed operation license;

(2) A capital verification report or copies of registered capital and fixed asset certification materials such as the annual accounting statements and audit reports from an intermediary agency within 1 year prior to the date of application; certification materials for basic information such as the nature and capital composition of the applicant unit;

(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 the property right certificate (or lease agreement) for the drying yard, or copies of the property right certificate for seed drying facilities and equipment; copies of calibration certificates issued by metrological verification institutions for testing and packaging equipment involving measurement; a description of the relevant facilities and equipment and actual photographs;

(4) Copies of qualification certificates and labor contracts for relevant technical personnel in seed testing, processing, and storage; a description of the full-time agricultural genetically modified organism safety management officer and a copy of their labor contract;

(5) Copies of the variety approval certificate and the agricultural genetically modified organism safety certificate; for the operation of genetically modified cotton seeds with plant variety rights, a written proof of consent from the variety rights holder shall also be submitted;

(6) A description of agricultural genetically modified organism safety management and preventive measures;

(7) Other materials stipulated by the Ministry of Agriculture.

Article 7 The reviewing authority shall complete the review within 20 working days from the date of accepting the application, sign the review opinion, and report it to the issuing authority. During the review, it shall conduct on-site inspections of the business premises, processing and storage facilities, and testing facilities and equipment, and verify the originals of relevant certification materials.

The issuing authority shall complete the issuance within 20 working days from the date of receiving the application materials and review opinion. If the issuing authority deems it necessary, it may conduct an on-site inspection. If the conditions are met, the genetically modified cotton seed production or operation license shall be issued and announced; if the conditions are not met, the applicant shall be notified in writing with reasons stated.

Article 8 The number of the genetically modified cotton seed production license shall be in the format of “__ (x) Nong Zhong Sheng Xu Zi (x) No. x”, with “g” marked on the “__”, 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 sequential number.

The number of the genetically modified cotton seed operation license shall be in the format of “__ (x) Nong Zhong Jing Xu Zi (x) No. x”, with “g” marked on the “__”, 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 sequential number.

Article 9 The validity period of a genetically modified cotton seed production license shall be 3 years, and that of an operation license shall be 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 genetically modified cotton seed production and operation shall be handled in accordance with the relevant provisions of the "Measures for the Administration of Licensing for Crop Seed Production and Operation."

Article 11 These Regulations shall take effect as of October 7, 2011. For enterprises that have obtained a genetically modified cotton seed production or operation license before the effective date of these Regulations and whose license expires between the effective date of these Regulations and October 7, 2012, the validity period of their license shall be automatically extended to October 7, 2012; however, if the validity period of the agricultural genetically modified organism safety certificate expires before October 7, 2012, the validity period of the enterprise's genetically modified cotton seed production or operation license shall be based on the validity period of the safety certificate.