Circular No. 29/2014/TT-BNNPTTN amending and supplementing Article 7 of Circular No. 23/2010/TT-BNNPTNT dated April 7, 2010 on recognizing biotechnology technical advances in the Agriculture and Rural Development sector.

CIRCULAR

Amending and supplementing Article 7 of Circular No. 23/2010/TT-BNNPTNT

dated April 7, 2010 on recognizing technological advances in biotechnologyin the agriculture and rural development sector

Pursuant to the Law on Science and Technology promulgated on June 18, 2013;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Based on Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions

Pursuant to 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;

Pursuant to Decree No. 199/2013/NĐ-CP dated November 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decision No. 11/2006/QĐ-TTg dated January 12, 2006 of the Prime Minister approving the "Key Program for Developing and Applying Biotechnology in Agriculture and Rural Development until 2020";

Pursuant to Decision No. 97/2007/QĐ-TTg dated June 29, 2007 of the Prime Minister approving the "Program for Developing and Applying Biotechnology in Aquaculture until 2020";

At the proposal of the Director of the Crop Production Department and the Head of the Science, Technology, and Environment Department;

The Minister of Agriculture and Rural Development issues this Circular amending and supplementing Article 7 of Circular No. 23/2010/TT-BNNPTNT dated April 7, 2010 on recognizing technological advances in biotechnology in the agriculture and rural development sector.

Article 1. Amending and supplementing Clause 2 and adding Clauses 3, 4, 5, and 6 of Article 7 of Circular No. 23/2010/TT-BNNPTNT on recognizing technological advances in biotechnology in the agriculture and rural development sector

"Article 7. Special Recognition

2. For biotechnological advances registered as crop varieties that are included in the list of crop varieties permitted for production and business in Vietnam (hereinafter referred to as the base variety) containing one or a combination of several gene events already granted Biosafety Certificates and Certificates confirming that genetically modified crops meet the conditions for use as food and feed (hereinafter referred to as genetically modified crop varieties), special recognition shall be considered when the genetically modified crop variety meets the following conditions:

a) Meeting the conditions stipulated in Clause 1 and Clause 2 of Article 6 of this Circular;

b) The genetically modified crop variety is similar to the base variety in major morphological traits, except for those traits affected by the gene event.

3. In cases where the genetically modified crop variety has been compared with the base variety during the risk assessment process: The organization holding the genetically modified crop variety shall prepare a special recognition application according to the provisions of Clause 5 of this Article.

4. In cases where the genetically modified crop variety has not been compared with the base variety:

a) The organization holding the genetically modified crop variety shall develop a comparison testing plan, including narrow and wide-scale comparison tests according to the model specified in Appendix 7 issued together with this Circular and send it to the Crop Production Department;

b) The organization holding the genetically modified crop variety shall contract with designated testing facilities to conduct at least one cropping season of narrow-scale comparison tests at two locations;

c) The organization holding the genetically modified crop variety shall conduct wide-scale comparison tests in recommended agricultural ecological zones, each zone with at least one cropping season at one location, with a minimum scale of one hectare per location;

d) Narrow-scale comparison tests may be conducted before or simultaneously with wide-scale comparison tests;

đ) During the comparison testing process, the Crop Production Department shall lead and coordinate with the Science, Technology, and Environment Department and the Department of Agriculture and Rural Development to inspect and record at the testing sites;

e) Upon completion of the testing, the organization holding the genetically modified crop variety shall prepare a special recognition application according to the provisions of Clause 5 of this Article.

5. Application for Special Recognition

The organization holding the genetically modified crop variety shall directly submit or send via postal service to the Crop Production Department one set of application for special recognition of genetically modified crop varieties. The application includes:

a) An application form for special recognition of genetically modified crop varieties according to the model specified in Appendix 8 issued together with this Circular;

b) A report on the results of comparing genetically modified crop varieties and base varieties according to the model specified in Appendix 9 issued together with this Circular;

c) Other related documents (if any).

6. Procedure and Timeframe for Special Recognition:

a) Within five working days from the date of receipt of the application, the Crop Production Department shall examine the application and notify the applicant in writing whether the application is accepted or requires supplementation and completion. The time for supplementation and completion of the application is not counted within the examination period;

b) Within twenty working days from the date of receipt of a complete and valid application, the Crop Production Department shall review the application, establish a Committee to evaluate the special recognition of biotechnological advances as genetically modified crop varieties.

The composition of the Committee is regulated in Clause 1 of Article 9 of this Circular. Members of the Committee shall evaluate the application according to the form specified in Appendix 4 issued together with this Circular and send it to the Crop Production Department at least one day before the Committee meeting. The procedure for the Committee's work is regulated in Clause 2 of Article 9 of this Circular. The Crop Production Department shall consider the Committee's opinions; if the conditions for special recognition are not met, a written response must be sent to the applicant, specifying the reasons;

c) Within five working days from the date the application has been completed according to the Committee's conclusion, the Crop Production Department shall send the application to the Science, Technology, and Environment Department for submission to the Minister for comments on the special recognition of biotechnological advances as genetically modified crop varieties. The application includes: A report to the Minister, detailing the necessity, implementation process, summary of testing results, evaluation, and recommendation for special recognition; Minutes of the Committee meeting; Report on the review by the Crop Production Department; Application for special recognition; Draft Decision on special recognition of biotechnological advances as genetically modified crop varieties;

d) Within five working days from the date of receiving the dossier submitted to the Minister, the Department of Science, Technology and Environment shall take the lead and coordinate with the Legal Department to examine and verify the completeness and validity of the dossier; the implementation of the procedures and time limits for recognizing special cases of biotechnology techniques as genetically modified crop varieties. In case the requirements are met, the Department of Science, Technology and Environment shall submit to the Minister for approval to recognize the special case of biotechnology techniques as genetically modified crop varieties.

đ) Within three working days from the date the Minister approves, the Crop Production Department shall issue a Decision recognizing the special case of biotechnology techniques as genetically modified crop varieties; in case the conditions for recognition are not met, a written response must be provided to the registering organization, specifying the reasons.

Article 2. Implementation clause

1. This Circular takes effect from October 20, 2014.

2. During the implementation process, if there are difficulties or obstacles, organizations and individuals are requested to report to the Ministry of Agriculture and Rural Development (Crop Production Department) for timely coordination in examination and resolution./.