Decree No. 108/2011/ND-CP Amending Certain Articles of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms.

DECREE

Amending certain Articles of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms

concerning genetically modified organisms, genetic material, and products derived from genetically modified organisms

_____________________________

THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

The Prime Minister issues this Decision amending and supplementing certain provisions of the Regulation on Response Activities to Oil Spill Incidents issued together with Decision No. 02/2013/QĐ-TTg dated January 14, 2013 of the Prime Minister.

Pursuant to the Law on Biodiversity dated November 13, 2008;

Pursuant to the Food Safety Law dated June 17, 2010;

CONSIDERING THE PROPOSAL OF THE MINISTER OF NATURAL RESOURCES AND ENVIRONMENT,

DECREE:

Article 1. Amending certain Articles of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms (hereinafter referred to as Decree No. 69/2010/NĐ-CP)

格式要求：严格按照输入格式输出，每行前保留编号，不合并、不拆分、不增减行数。
"Article 28. Competence, procedures, and formalities for issuing and revoking Certificates confirming genetically modified organisms meet the conditions for use as food
1. The Ministry of Agriculture and Rural Development shall issue and revoke Certificates confirming genetically modified organisms meet the conditions for use as food.
2. Organizations and individuals applying for issuance of Certificates confirming genetically modified organisms meet the conditions for use as food shall submit three (03) sets of application files to the Ministry of Agriculture and Rural Development. The application file includes:
a) An application form for issuance of a Certificate confirming genetically modified organisms meet the conditions for use as food according to the model prescribed by the Ministry of Agriculture and Rural Development;
b) A risk assessment report of genetically modified organisms for human health as stipulated in Appendix V of Decree No. 69/2010/NĐ-CP;
c) In cases where genetically modified organisms are specified in Clause 2, Article 27 of Decree No. 69/2010/NĐ-CP, there must be documentation proving that the genetically modified organisms have been permitted for use as food in five (5) developed countries.
3. Within seven working days from the date of receipt of the application file, the Ministry of Agriculture and Rural Development shall notify organizations and individuals applying for issuance of Certificates confirming genetically modified organisms meet the conditions for use as food about acceptance of a valid application file or request for supplementation and completion of the application file in accordance with regulations; the time for supplementation and completion of the application file shall not be counted towards the time for reviewing the application file.
4. Within 180 days from the date of receipt of a valid application file, the Ministry of Agriculture and Rural Development shall organize a Genetically Modified Food Safety Council to review the application file for issuance of Certificates confirming genetically modified organisms meet the conditions for use as food. In cases where genetically modified organisms fall under the objects specified in Clause 2, Article 27 of Decree No. 69/2010/NĐ-CP, the maximum time for considering issuance or refusal to issue Certificates confirming genetically modified organisms meet the conditions for use as food is 60 days.
5. After receiving a valid application file, the Ministry of Agriculture and Rural Development shall post information on the Risk Assessment Report of genetically modified organisms for human health on its electronic information website to solicit public opinions and compile a report for the Genetically Modified Food Safety Council. The minimum period for soliciting public opinions is 30 days from the date the information is posted.
6. Within thirty days from the date of the review results, the Minister of Agriculture and Rural Development shall consider issuance of Certificates confirming genetically modified organisms meet the conditions for use as food. If refusal to issue Certificates confirming genetically modified organisms meet the conditions for use as food, the Ministry of Agriculture and Rural Development shall notify and clearly state the reasons to organizations and individuals applying for issuance of Certificates confirming genetically modified organisms meet the conditions for use as food.
7. Organizations and individuals applying for issuance of Certificates confirming genetically modified organisms meet the conditions for use as food must pay the application file review fee. The Ministry of Finance shall take the lead and coordinate with the Ministry of Agriculture and Rural Development to specify details regarding the fee amount, management, and use of the application file review fee.
8. The Ministry of Agriculture and Rural Development shall specify in detail the procedures and formalities for issuing Certificates confirming genetically modified organisms meet the conditions for use as food.
9. The Genetically Modified Food Safety Council shall advise the Minister of Agriculture and Rural Development on issuance of Certificates confirming genetically modified organisms meet the conditions for use as food. The Genetically Modified Food Safety Council shall include representatives from the Ministries of Agriculture and Rural Development, Industry and Trade, Science and Technology, Natural Resources and Environment, Health, and some experts. The Minister of Agriculture and Rural Development shall decide on establishment and specify in detail the functions, tasks, and operational mechanisms of the Genetically Modified Food Safety Council."

2. Clause 2 of Article 29 is amended as follows:
"The Ministry of Agriculture and Rural Development shall decide to revoke Certificates confirming genetically modified organisms meet the conditions for use as food; notify in writing organizations and individuals whose Certificates confirming genetically modified organisms meet the conditions for use as food have been revoked and publish the information on mass media."

3. Clause 2 of Article 30 is amended as follows:
"The Ministry of Agriculture and Rural Development shall prescribe the model of Certificates confirming genetically modified organisms meet the conditions for use as food."

4. Article 31 is amended as follows:
"Article 31. List of genetically modified organisms granted certificates confirming they meet the conditions for use as food
1. The Ministry of Agriculture and Rural Development shall establish a List of genetically modified organisms granted Certificates confirming they meet the conditions for use as food and publish the List on its electronic information website.

2. Within ten days from the date of issuance or revocation of Certificates confirming genetically modified organisms meet the conditions for use as food, the Ministry of Agriculture and Rural Development shall supplement or delete the name of genetically modified organisms in the List."

Article 2. Effectiveness

1. This Decree takes effect from January 15, 2012.

2. Certificates confirming genetically modified organisms meet the conditions for use as food issued before this Decree takes effect shall remain legally valid until the expiration date stated in the Certificates.

Article 3. The Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees under the direct jurisdiction of the central government shall be responsible for implementing this Decree.