Regulations on license for production and Management of genetically modified Cotton Seeds promulgated

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

No. 1643

According to 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 Licensing of crop seed production and Operation, our Ministry has formulated the provisions on the license for the production and Operation of genetically modified Cotton Seeds, which are hereby promulgated and shall enter into force as of October 7, 2011.

It is hereby announced.

September 6, 2011

Provisions on the license for the production and Operation of transgenic Cotton Seeds

Article 1 in order to strengthen the license management of the production and operation of genetically modified cotton seeds, these provisions are formulated in accordance with the seed Law of the people's Republic of China, the regulations on the Safety of Agricultural genetically modified organisms and the measures for the Licensing Administration of crop seed production and Operation.

Article 2 the license for the production and operation of genetically modified cotton seeds shall be examined and approved by the agricultural administrative department of the people's government at the provincial level where it is produced, and issued by the Ministry of Agriculture.

Article 3 whoever applies for a license for the production of genetically modified cotton seeds shall meet the following conditions:

(1) the registered capital is not less than 30 million yuan

(2) the varieties produced have obtained the safety certificate of agricultural genetically modified organisms and passed the variety approval; the written consent of the variety owner shall also be obtained for the production of seeds with the right of new plant varieties.

(3) more than 1 set of cleanliness analysis table, electronic scale, bed setting equipment, electrophoresis apparatus, electrophoresis tank, sample grinder, oven, biological microscope and refrigerator, and more than 1 set of electronic balance (sensitivity 1%, 1/1000 and 1/10000). More than 2 sets of sampler, sampler and germination box More than 1 set of pcr expander, acidity meter, high pressure sterilizer, magnetic mixer, constant temperature water bath pot, high speed freezing centrifuge, complete set of liquid transfer, enzyme label meter, plate washer and gel imaging system. The laboratory is more than 150 square meters

(4) having a warehouse of more than 500m2 and a drying field of more than 1000 sq m or corresponding seed drying facilities

(5) there are three or more full-time seed production technicians, storage technicians and seed inspection personnel who have passed the examination by the agricultural administrative department of the people's government at or above the provincial level; there is more than one full-time safety manager of agricultural genetically modified organisms.

(6) the place of production is in the area approved by the safety certificate of agricultural genetically modified organisms, and there are no quarantine pests.

(7) isolation and production conditions that meet the cotton seed production regulations and the requirements for the safe production of transgenic cotton seeds

(8) there are corresponding safety management and preventive measures for agricultural genetically modified organisms.

(9) other conditions prescribed by the Ministry of Agriculture.

Article 4 when applying for a license for the production of genetically modified cotton seeds, the following materials shall be submitted to the examination and approval organ:

(1) Application form for production license of genetically modified cotton seeds

(2) photocopies of registered capital certificates such as annual accounting statements and intermediary audit reports within one year prior to the date of application; photocopies of seed inspection equipment lists and purchase invoices; photocopies of property rights certificates in seed inspection rooms and warehouses in the provinces (autonomous regions and municipalities directly under the Central Government) where they are located. A copy of the property right certificate (or lease agreement) of the drying field in the province (autonomous region or municipality directly under the Central Government) where the production is located, or a copy of the property right certificate of the seed drying facilities and equipment; a copy of the verification certificate of the inspection equipment related to measurement issued by the metrological verification institution; the description of the relevant facilities and equipment and real-world photos

(3) qualification certificate of technical personnel for seed production, storage and inspection and photocopy of labor contract; description of safety management personnel of agricultural genetically modified organisms and copy of labor contract

(4) Quarantine certificate at the place of seed production

(5) A copy of the variety approval certificate

(6) to produce seeds with the right of a new plant variety and submit a written consent certificate of the owner of the variety

(7) Safety isolation and description of production conditions for seed production

(8) photocopy of safety certificate for agricultural genetically modified organisms

(9) explanation of safety management and preventive measures of agricultural genetically modified organisms

(10) other materials prescribed by the Ministry of Agriculture.

If the applicant for the production license of genetically modified cotton seeds has obtained the license for the operation of genetically modified cotton seeds, he shall be exempted from submitting the certificate of qualification of technical personnel and a copy of the labor contract for the storage and inspection of materials and seeds specified in paragraph 2 of the preceding paragraph, however, a copy of the license for the operation of genetically modified cotton seeds shall be submitted.

Article 5 the following conditions shall be met in applying for a license for the operation of genetically modified cotton seeds:

(1) not less than 30 million yuan in registered capital and not less than 10 million yuan in fixed assets

(2) the operating variety shall obtain the safety certificate of agricultural genetically modified organisms and pass the variety approval; the operation of seeds with the right of new plant varieties shall also obtain the written consent of the variety owner.

(3) there are seed testing facilities and equipment, warehouses, drying grounds or corresponding drying facilities that meet the requirements of subparagraphs 3 and 4 of Article 3 of these provisions; there are more than 300 square meters of business premises, the total processing capacity of complete sets of seed processing equipment is more than 1 ton per hour, equipped with cottonseed chemical unlocking equipment, and the processing plant is more than 500 square meters.

(4) there are three or more full-time seed processing technicians, storage technicians and seed inspection personnel who have passed the examination by the agricultural administrative department of the people's government at or above the provincial level; there is more than one full-time safety manager of agricultural genetically modified organisms.

(5) there are corresponding safety management and preventive measures for agricultural genetically modified organisms

(6) the operating area is within the area approved by the safety certificate of agricultural genetically modified organisms

(7) other conditions prescribed by the Ministry of Agriculture.

Article 6 when applying for a license for the operation of genetically modified cotton seeds, the following materials shall be submitted to the examination and approval organ:

(1) Application form for license for genetically modified cotton seed management

(2) photocopies of registered capital and fixed assets certificates such as the annual accounting statements and intermediary audit reports within one year prior to the date of the application; and the basic certification materials such as the nature and capital composition of the applicant

(3) List of facilities and equipment for seed inspection and processing and copies of purchase invoices; copies of property rights certificates of seed inspection rooms, processing plants and warehouses; copies of property rights certificates (or lease agreements) of drying fields or copies of property rights certificates of seed drying facilities and equipment; copies of verification certificates issued by measurement and verification institutions for inspection and packaging equipment involving measurement; descriptions and real photos of relevant facilities and equipment;

(4) Qualification certificates and copies of labor contracts of technical personnel related to seed inspection, processing and storage; descriptions of full-time agricultural genetically modified organisms safety management personnel and copies of labor contracts;

(5) Copies of the certificate of variety examination and approval and the certificate of safety of agricultural genetically modified organisms; for the operation of genetically modified cotton seeds with new plant variety rights, the written consent certificate of the variety owner shall also be submitted;

(6) Description of safety management and preventive measures for agricultural genetically modified organisms;

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

Article 7 The examining and approving organ shall complete the examination and approval within 20 working days from the date of accepting the application, and sign the examination opinions and submit them to the issuing organ. During the examination and verification, on-the-spot investigation shall be conducted on the business premises, processing and storage facilities, inspection facilities and equipment, and the original documents of relevant certificates shall be inspected.

The issuing authority shall complete the issuance work within 20 working days from the date of receiving the application materials and examination opinions. If the issuing authority deems it necessary, it may conduct on-the-spot investigation. If the conditions are met, a license for the production and operation of genetically modified cotton seeds shall be issued and announced; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained.

Article 8 The number of the production license for genetically modified cotton seeds shall be "__(x) Nongzhongshengxu Zi (x) No. x", marked with "g", the first bracket shall be the abbreviation of the license issuing authority, the second bracket shall be the year of the first issuance, and the third number shall be the four-digit sequential number.

The license number of genetically modified cotton seed operation is "__(x) Agricultural Seed Jing Xu Zi (x) No. x", marked with "g" on "__", the first bracket is the abbreviation of the issuing authority, the second bracket is the first issuance year, and the third number is the four-digit sequence number.

Article 9 The valid period of the production license for genetically modified cotton seeds is 3 years, and the valid period of the business license is 5 years, which shall not exceed the valid period stipulated in the agricultural genetically modified organism safety certificate.

Article 10 Other matters concerning the production and operation license of transgenic cotton seeds shall be implemented in accordance with the relevant provisions of the Measures for the Administration of Production and Operation License of Crop Seeds.

Article 11 These Provisions shall come into force as of October 7, 2011. For enterprises that have obtained the production and operation license of genetically modified cotton seeds before the effective date of these Provisions and whose validity period expires from the effective date of these Provisions to October 7, 2012, the validity period of the license shall be automatically extended to October 7, 2012. However, if the validity period of the safety certificate of agricultural genetically modified organisms expires before October 7, 2012, the validity period of the production and operation license of genetically modified cotton seeds of the enterprise shall be subject to the validity period of the safety certificate.