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Approval to Safety Assessment and Safety Management of Agricultural Genetically Modified Organisms

DATE:2013-05-03       SOURCE:MOA
 

Subject:

 

Approval to Safety Assessment and Safety Management of Agricultural Genetically Modified Organisms

 

Handling approach:

 

Examination and approval

 

Contents to be examined:

 

1. Safety assessment and safety level of the GMO

2. Safety management measures for the GMO

3. Contents of the GMO safety study and testing

4. Related qualifications of the applicant

 

Legal basis:

 

1. Regulations on Administration of Agricultural GMO Safety  

2. Administrative Measures for Safety Assessment of Agricultural GMOs (promulgated by Decree No. 8 of the Ministry of Agriculture (MOA) in 2002 and revised by Decree No. 38 of MOA in 2004)

(i) Safety assessment of genetically modified microorganisms for animals; ii) safety assessment of genetically modified microorganisms for plants; iii) safety assessment of other genetically modified microorganisms; iv) safety assessment of genetically modified animals; and v) safety assessment of genetically modified plants.)

 

Requirements:

 

The following documents are required ( in ten photocopies):

1. Application for Safety Assessment of Agricultural GMOs

2. Safety level of the agricultural GMO and basis for determination of its safety level

3. Test report produced by the institution for technical testing of agricultural GMOs entrusted by MOA for the GMO that is not in the phase of experimental research or restricted field testing.

4. Description on corresponding safety research, safety management and preventive measures

5. Test report of the last testing phase

 

Procedures:

 

1. Acceptance of application documents. The General Office for Administrative Examination and Approval of MOA accepts and preliminarily examines the Application for Safety Assessment of Agricultural GMO and related documents submitted by the applicant.

2. Expert examination. The Office for Agricultural GMO Safety of MOA designates the National Agricultural GMO Safety Committee to examine the application documents.

3. Reply. The Office for Agricultural GMO Safety makes a proposal according to the examination results, submits it to the minister for final examination and then gives a written reply to the applicant.

 

Promised time limit: Year-round acceptance, 3 times of examination every year with respective deadline of March 1, July 1 and November 1, safety assessment to be finished within 6 months after the acceptance deadline and reply to be given within 20 workdays after safety assessment.

Charges: Environmental release: 2500 yuan/time (800 yuan/time for teaching and research organizations)

 

Productive testing: 3000 yuan/time (1000 yuan/time for teaching and research organizations)

1. Circular of the National Development and Reform Commission and the Ministry of Finance on Charges for Safety Assessment and Testing of Agricultural GMOs and Related Issues (Fagaijiage [2007] No. 3704)

 

Contact Information

Mail:  To: Agricultural Science & Technology Desk

Address: Administrative Examination and Approval Office

Ministry of Agriculture

No.11 Nongzhanguan Nanli, Chaoyang District, Beijing, China

Postcode: 100125  

 

(All information posted in this website is authentic in Chinese. English version is provided for reference only.)

 

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