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Decision of the Ministry of Agriculture and Rural Affairs on Amending the Administrative Measures for Safety Evaluation of Agricultural Genetically Modified Organisms and other regulations
I. Administrative Measures for Safety Assessment of Agricultural Genetically Modified Organisms (promulgated by Order No.8 of the Ministry of Agriculture on June 5, 2002, Order No.38 of the Ministry of Agriculture on July 65, 2004, Order No.7 of the Ministry of Agriculture on July 25, 2065, 438+06 and Order No.7 of the Ministry of Agriculture on July 25, 2065)

One paragraph is added as the second paragraph of Article 18: "Units engaged in agricultural genetically modified organisms are encouraged to establish or * * * enjoy special experimental bases."

(2) Make the following amendments to Appendix I.

1. Replace "variety and strain" in "II" with "variety and strain". The experimental scheme of transgenic plants was changed to "transformant".

2. Modify "three". The application requirements for transgenic plants in different stages "3.2" was changed to: "The number of transgenic plants tested: only 65,438+0 transformants can be applied for one application, and the name should correspond to the name or number of the previous experimental stage."

3.3.3 "It shall be carried out in the province (city, autonomous region) that has approved the environmental protection release". The requirements for the application of transgenic plants in each stage are revised to "should be carried out in the suitable ecological area of experimental plants".

4. Delete "3.5. 10".

5. Modify "3". "4. 1 to" project name is required for the application of transgenic plants at all stages: it should include the name of the target gene, the name of the transgenic plant and other parts, such as the safety certificate of transgenic insect-resistant cotton XY 12 with cry 1Ac gene. "

6. Modify "3". Requirements for application of transgenic plants in each stage "4.2" is changed to: "One application can only apply for one transgenic plant transformant, and its name should correspond to the name or number of the previous experimental stage."

7. Delete "III". Declaration requirements of genetically modified plants at different stages "4.3.

8. Modify 4.4 of "III". The application requirements for genetically modified plants at all stages are changed to: "The validity period of the first application for safety certificate shall not exceed five years; If an extension is needed, an application shall be submitted to the safety management office of agricultural genetically modified organisms within one year before the expiration of the validity period. After the assessment by the Agricultural Genetically Modified Organisms Safety Committee, the Ministry of Agriculture and Rural Affairs makes a decision on whether to grant the extension and extension of the validity period. "

9. Modify "three". 4.7 "Declaration Requirements for Genetically Modified Plants at Different Stages" is changed to: "The transformant combination obtained by crossing two or more transformants who have obtained the safety certificate of agricultural genetically modified organisms shall be declared for safety evaluation from the production test stage.

"If a transformant with a safety certificate is used for transfer, it shall report to the safety management office of agricultural genetically modified organisms; Before production and application, a test report on the consistency of transgenic target traits and transformant traits issued by a technical testing institution with testing conditions and capabilities should also be submitted. " 2. The Measures for the Examination and Approval of Main Crop Varieties (Order of the Ministry of Agriculture on July 8, 2006, Order of the Ministry of Agriculture on April 25, 2006, and Order of the Ministry of Agriculture and Rural Affairs on February 25, 2009) was revised.

(1) One paragraph is added as the second paragraph of Article 10: "Anyone who applies for variety approval of major genetically modified crops (except cotton) shall directly apply to the National Crop Variety Approval Committee."

(two) by deleting item fourth of article thirteenth; One paragraph is added as the second paragraph: "In addition to the materials specified in the preceding paragraph, the main varieties of genetically modified crops shall also provide the following materials:

"(1) Information about the transformant, including the target gene and the specific detection method of the transformant;

"(two) the license agreement of the owner of the transformed body;

"(three) the safety certificate of agricultural genetically modified organisms obtained in accordance with the provisions of Article 16 of the Regulations on the Safety Management of Agricultural Genetically Modified Organisms;

"(4) A test report on the consistency between the transgenic target traits and the transformant traits issued by a technical testing institution with testing conditions and capabilities;

(5) Where a non-recipient variety breeder applies for variety examination and approval, it shall also provide the license or cooperation agreement of the recipient variety owner.

(3) Article 15 is amended as: "The office of the Variety Approval Committee shall extract standard samples from the experimental seeds provided by the applicant and submit them to the standard sample bank of plant varieties designated by the Ministry of Agriculture and Rural Affairs for preservation."

(4) Paragraph 2 of Article 17 is amended as: "The organization and implementation unit of variety test shall fully listen to the opinions of the applicants and experts for variety approval, reasonably set up test groups, optimize the layout of test sites, establish and improve the management system, scientifically formulate the test implementation plan, and announce it to the public."

(5) Paragraph 1 of Article 18 is amended as: "Regional trials shall identify the high yield, stable yield, adaptability and stress resistance of varieties, and carry out quality analysis and DNA fingerprinting. Detecting transgenic components of non-transgenic varieties; The transgenic varieties were tested for the authenticity of transformants, and the consistency test report of transgenic target traits and transformant characteristics was verified. "

(6) One paragraph is added as the fifth paragraph of Article 21: "The undertaking unit of genetically modified variety test shall take corresponding safety management and preventive measures in accordance with the Regulations on the Safety Management of Agricultural Genetically Modified Organisms and other relevant laws, administrative regulations and departmental rules."

(seven) by deleting twenty-third.

(8) One article is added after Article 25: "Except for the target traits, the other traits of the transgenic varieties applied for examination and approval remain unchanged with the recipient varieties, and the recipient varieties have passed the examination and approval and have not been revoked. Variety test should be carried out in the following two cases:

"(a) the approved suitable planting area is in the suitable planting area of the recipient variety, which can simplify the test procedure and only need to carry out the production test for one year;

"(two) if the approved suitable planting area is not in the suitable planting area of the recipient variety, it shall carry out two-year regional test and one-year production test.

For the introduced new varieties, two-year regional test, one-year production test and DUS test should be carried out.

(nine) the "main crop varieties" in the first paragraph of article twenty-seventh shall be amended as "non-genetically modified varieties of main crops".

(10) Paragraph 1 of Article 28 is amended as: "For varieties that have completed the test procedures, the applicant for variety test, the organization and implementation unit and the seed enterprise integrating breeding, propagation and promotion shall submit the data, summary results, DNA fingerprint test report, DUS test report and transformant authenticity test report of each test site of rice, corn, cotton, soybean and wheat varieties to the office of the Variety Approval Committee before the end of February and the end of September respectively."

(eleven) the second paragraph of Article 32 is amended as: "Seed enterprises that integrate breeding, propagation and promotion shall independently carry out variety tests. After the varieties have passed the preliminary examination, the standard samples of varieties shall be submitted to the standard sample bank of plant varieties designated by the Ministry of Agriculture and Rural Affairs for preservation. "

(twelve) the "reproductive period" in the first paragraph of article thirty-fifth is amended as "reproductive period (group)"; One paragraph is added as the second paragraph: "Transgenic varieties shall also include the owner of transformant, the name of transformant, the number of safety certificate of agricultural genetically modified organisms, transgenic target traits, etc."

(13) One paragraph is added as the second paragraph of Article 36: "Genetically modified varieties shall also include the owner of the transformant, the name of the transformant and the number of the safety certificate of agricultural genetically modified organisms."

(14) One item is added as Item 5 of Article 44: "Where the safety certificate of agricultural genetically modified organisms expires."

(15) In the first paragraph of Article 47, the phrase "realizing the interconnection of online application, acceptance, variety test data, approved varieties, standard samples and other information" is amended as "realizing the online application, acceptance, review and release of national and provincial variety test approval, variety test data, approved varieties and revoked varieties."

(sixteen) by deleting article fifty-sixth.