Circular No. 29/2014/TT-BNNPTNT amends and supplements Article 7 of Circular No. 23/2010/TT-BNNPTNT dated April 7, 2010 on recognizing biotechnology technical progress 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 biotechnology technical progress in the sector

agriculture and rural development

____________

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

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

Pursuant to Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing certain provisions of the Law on Technical Standards and Regulations;

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 biotechnology technical progress in agriculture and rural development.

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 biotechnology technical progress in agriculture and rural development.

“Article 7. Special Recognition

2. For biotechnology technical progress registered as plant varieties that are included in the List of Plant 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 plants meet the conditions for use as food and animal feed (hereinafter referred to as genetically modified plant varieties), such genetically modified plant varieties shall be considered for special recognition if they satisfy the following conditions:

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

b) Genetically modified plant varieties are similar to the base variety in major morphological characteristics, except for those traits affected by the gene event.

3. In cases where genetically modified plant varieties have been concurrently tested in comparative trials with the base variety during the risk assessment process: The entity holding the genetically modified plant variety shall prepare the application for special recognition according to the provisions of Clause 5 of this Article.

4. In cases where genetically modified plant varieties have not yet been tested in comparative trials with the base variety:

a) The entity holding the genetically modified plant variety shall develop a plan for comparative testing, including narrow and wide-scale comparative trials according to the model specified in Appendix 7 issued together with this Circular and submit it to the Crop Production Department;

b) The entity holding the genetically modified plant variety shall contract with designated testing facilities to conduct at least one crop production cycle of narrow-scale comparative trials at two locations;

c) The entity holding the genetically modified plant variety shall conduct wide-scale comparative trials in recommended agricultural ecological zones, each zone with at least one crop production cycle at one location, with a minimum scale of one hectare per location;

d) Narrow-scale comparative trials may be conducted before or simultaneously with wide-scale comparative trials;

đ) During the comparative trial 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 trial sites;

e) Upon completion of the trials, the entity holding the genetically modified plant variety shall prepare the application for special recognition according to the provisions of Clause 5 of this Article.

5. Application for Special Recognition

The entity holding the genetically modified plant variety shall directly send or mail to the Crop Production Department one set of the application for special recognition of genetically modified plant varieties. The application includes:

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

b) A report on the results of comparative trials between genetically modified plant varieties and the base variety 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 does not count towards 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 biotechnology technical progress as genetically modified plant 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 submit their evaluations to the Crop Production Department at least one day prior to 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 recognition are not met, a written response must be provided to the applicant, specifying the reasons;

c) Within five working days from the date the application has been completed according to the Committee's conclusions, the Crop Production Department shall forward the application to the Science, Technology, and Environment Department for submission to the Minister for comments on the special recognition of biotechnology technical progress as genetically modified plant varieties. The application includes: A report to the Minister, detailing the necessity, implementation process, summary of trial 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 biotechnology technical progress as genetically modified plant varieties.

c) Within five working days from the date the registration dossier has been completed according to the conclusion of the Council, the Crop Production Department shall send to the Science, Technology and Environment Department the dossier for submission to the Minister for comments on recognizing a biotechnology technical advancement as a genetically modified plant variety. The dossier includes: A request to the Minister, clearly stating the necessity, implementation process, summary of trial results, evaluation, and proposal for special recognition; Minutes of the Council meeting; The Crop Production Department's assessment report; The special recognition registration dossier; A draft Decision on recognizing a biotechnology technical advancement as a genetically modified plant variety.

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 Department of Legal Affairs 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, clearly stating 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./.