Circular No. 02/2014/TT-BNNPTNT stipulates the procedures and formalities for issuing and revoking certificates confirming genetically modified plants meet the conditions for use as food and animal feed.

CIRCULAR

Regulations on the procedures for issuing and revoking Certificates confirming genetically modified plants meeting conditions for use as food and animal feed biến đổi gen đủ điều kiện sử dụng làm thực phẩm, thức ăn chăn nuôii

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

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. 108/2011/NĐ-CP dated November 30, 2011 of the Government amending certain articles of Decree No. 69/2010/NĐ-CP on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms;

Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

Pursuant to the proposal of the Director of the Department of Science, Technology and Environment;

The Minister of Agriculture and Rural Development issues this Circular stipulating the procedures for issuing and revoking Certificates confirming genetically modified plants meeting conditions for use as food and animal feed.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the procedures for issuing and revoking Certificates confirming genetically modified plants meeting conditions for use as food and animal feed.

Article 2. Applicability

This Circular applies to organizations and individuals within Vietnam and abroad (hereinafter referred to as organizations and individuals) involved in activities related to the issuance and revocation of Certificates confirming genetically modified plants meeting conditions for use as food and animal feed (hereinafter referred to as Certificates) within the territory of Vietnam.

Article 3. Explanation of Terms

In this Circular, the following terms shall be understood as follows:

1. Genetically modified plant means a plant, genetic material, or direct product of a plant carrying one or more new genes created through recombinant DNA technology.

2. Risk assessment of genetically modified plants for human and animal health (hereinafter referred to as risk assessment) means activities aimed at identifying potential hazards and the likelihood of risks associated with the use of genetically modified plants as food and animal feed.

3. Gene transfer event is the result of the targeted recombination of DNA into a specific position in the genome of a plant species to create a corresponding plant carrying the target gene.

4. Developed country means a country with advanced biotechnology in the group of countries belonging to the Organization for Economic Cooperation and Development (OECD) and the group of major economies G20.

5. Unique identification code is a code determined by the Organization for Economic Cooperation and Development for each gene transfer event.

Article 4. Criteria for assessing risks of genetically modified plants meeting conditions for use as food and animal feed

1. Nutritional component comparison between genetically modified plants and equivalent traditional plants.

2. Evaluation of the ability to metabolize nutritional components, especially new substances produced by transferred genes if used as food and animal feed.

3. Evaluation of the toxicity potential of new substances produced by transferred genes if used as food and animal feed.

4. Evaluation of the allergenic potential of new substances produced by transferred genes if used as food and animal feed.

5. Evaluation of the potential to form new compounds, disease-causing potential, or other adverse effects on human and animal health (such as: potential impacts from processing; changes in nutritional quality and function; accumulation of new substances; antibiotic resistance marker genes).

Chapter II

ISSUANCE AND REVOCATION OF CERTIFICATES

Article 5. Cases requiring registration for issuance of Confirmation Certificate

1. Genetically modified plants carrying a single transformation event resulting from the process of transferring a gene specifying a desired trait using genetic engineering technology.

2. Genetically modified plants carrying a vector stacked transformation event resulting from the process of transferring two or more genes specifying one or more desired traits using genetic engineering technology.

Article 6. Conditions for Issuance of Confirmation Certificate

Genetically modified plants must meet one of the following conditions to be issued a Confirmation Certificate:

1. The genetically modified plant has been approved for use as food and animal feed by at least five (5) developed countries and no risks have occurred in those countries.

2. The genetically modified plant has been reviewed by the Food Safety and Animal Feed Council (hereinafter referred to as the Council) on the application for issuance of the Confirmation Certificate for that genetically modified plant, concluding that it meets the conditions for use as food and animal feed and that there are no unmanageable risks to human and animal health.

3. Other cases.

a) In the case where a genetically modified plant event has been issued a Confirmation Certificate for use as food, that genetically modified plant event may be used as animal feed.

b) In the case where a genetically modified plant carrying a vector stacked transformation event is the result of traditional crossbreeding from two or more single transformation events that have been issued a Confirmation Certificate, that genetically modified plant may be used as food and animal feed.

Article 7. Application Documents for Issuance of Confirmation Certificate

1. Number of sets: three (3) sets, including one (1) original set and two (2) copies.

2. For applications for issuance of Confirmation Certificate for objects specified in Clause 1 of Article 6 of this Circular, the application documents shall include:

a) An application form for issuance of Confirmation Certificate as prescribed in Appendix 1 of this Circular;

b) A risk assessment report (with electronic version attached) of the genetically modified plant concerning human and animal health (hereinafter referred to as the risk assessment report) as prescribed in Appendix 2 of this Circular;

c) A summary of the risk assessment report as prescribed in Appendix 3 of this Circular (with electronic version attached);

d) A public information disclosure form as prescribed in Appendix 4 of this Circular;

đ) The original or certified copy and Vietnamese translation (with notarized translation) of the Confirmation Certificate or equivalent document issued by the competent authority allowing its use as food and animal feed in at least five (5) developed countries.

3. For applications for issuance of Confirmation Certificate for objects specified in Clause 2 of Article 6 of this Circular, the application documents shall include:

a) The documents prescribed in points a, b, c, and d of Clause 2 of this Article;

b) The original or certified copy and Vietnamese translation (with notarized translation) of the Confirmation Certificate or equivalent document issued by the competent authority allowing its use as food and animal feed in other countries (if applicable);

c) Scientific reference materials, unpublished studies, data from evaluations, trials, or other scientific evidence (if applicable) used by the organization or individual applying as a basis for concluding that if the genetically modified plant is issued a Confirmation Certificate, it will not have adverse effects on human and animal health.

4. For applications for issuance of Confirmation Certificate for objects specified in Clause 2 of Article 5 of this Circular, the application documents shall include:

a) The documents prescribed in Clause 2 of this Article (for applications for issuance of Confirmation Certificate for objects specified in Clause 1 of Article 6 of this Circular);

b) The documents prescribed in Clause 3 of this Article (for applications for issuance of Confirmation Certificate for objects specified in Clause 2 of Article 6 of this Circular);

c) Additional data in the risk assessment report regarding the interaction of transferred genes in structure, structural integrity, function, and expression of the target gene in the recipient plant.

Article 8. Acceptance and Review of Application for Issuance of Confirmation Certificate

1. Organizations and individuals applying for issuance of the Confirmation Certificate shall submit the application directly or via postal service to the permanent office of the Ministry of Agriculture and Rural Development (Science, Technology and Environment Department).

2. The Science, Technology and Environment Department shall examine the application and notify in writing (in accordance with the form prescribed in Appendix 5 of this Circular) to the organization or individual applying within 07 (seven) working days from the date of receipt of the application regarding acceptance of a valid application or request for supplementation and completion of the application. The time for supplementation and completion of the application shall not be counted towards the examination period for a valid application.

3. After receiving a valid application, the Science, Technology and Environment Department shall post information and a summary of the risk assessment report on the Ministry of Agriculture and Rural Development's electronic information website to solicit public opinions; compile and submit to the Council. The period for soliciting public opinions shall not exceed 30 (thirty) days from the date of posting the information.

4. After receiving a valid application, the Science, Technology and Environment Department shall organize the Council to evaluate the application for issuance of the Confirmation Certificate within 30 (thirty) days for applications under Clause 1, Article 6 of this Circular and 180 (one hundred eighty) days for applications under Clause 2, Article 6 of this Circular.

Article 9. Issuance of Confirmation Certificate

1. Based on the Council's review results, the Science, Technology and Environment Department shall submit to the Minister of Agriculture and Rural Development for consideration and decision to issue the Confirmation Certificate to the organization or individual applying.

2. In cases where the application meets the conditions for issuance of the Confirmation Certificate, the Minister of Agriculture and Rural Development shall issue the Decision to issue the Confirmation Certificate (in accordance with the form prescribed in Appendix 6 of this Circular) within 30 (thirty) days from the date of the Council's review results.

3. In cases where the application does not meet the conditions for issuance of the Confirmation Certificate, the Science, Technology and Environment Department shall notify in writing and specify the reasons to the organization or individual applying.

Article 10. Revocation of Confirmation Certificate

1. The Confirmation Certificate may be considered for revocation in the cases stipulated in Clause 1, Article 29 and Clause 1, Article 34 of Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material and products of genetically modified organisms (referred to as Decree No. 69/2010/ND-CP).

2. Depending on each specific case, the Ministry of Agriculture and Rural Development shall consider and decide on the revocation of the Confirmation Certificate.

a) For cases stipulated in Point a and Point b, Clause 1, Article 29 and Point a and Point b, Clause 1, Article 34 of Decree No. 69/2010/ND-CP, the Ministry of Agriculture and Rural Development shall organize the Council to review the file and consider the revocation of the Confirmation Certificate;

b) For cases stipulated in Point c, Clause 1, Article 29 and Point c, Clause 1, Article 34 of Decree No. 69/2010/ND-CP, the Science, Technology and Environment Department shall submit to the Minister of Agriculture and Rural Development for consideration and decision.

3. The Science, Technology and Environment Department shall perform the following tasks:

a) Organize meetings of the Council or independent advisory boards (in cases of violations as prescribed in Point c, Clause 1, Article 29 and Point c, Clause 1, Article 34 of Decree No. 69/2010/ND-CP) to review the file for revocation of the Confirmation Certificate in cases of violation;

b) Based on the Council's review results, submit to the Minister of Agriculture and Rural Development for consideration and issue the Decision to revoke the Confirmation Certificate;

c) Announce on mass media and relevant agencies within no more than 03 (three) days from the date of the revocation Decision, and send the Decision (original copy) to the organization or individual whose Confirmation Certificate has been revoked.

Article 11. Establishment, supplementation, and deletion of names of genetically modified plants in the list of genetically modified plants that have been issued with Confirmation Certificates

The Department of Science, Technology, and Environment shall perform the following tasks:

1. Establish and publish on the electronic information website of the Ministry of Agriculture and Rural Development the list of genetically modified plants that have been issued with Confirmation Certificates.

2. Supplement and publish on the electronic information website of the Ministry of Agriculture and Rural Development the names of genetically modified plants that have been issued with Confirmation Certificates into the list of genetically modified plants that meet the conditions for use as food and animal feed within ten (10) days from the date of the decision to issue the Confirmation Certificate.

3. Delete and publish on the electronic information website of the Ministry of Agriculture and Rural Development the names of genetically modified plants that fall under the cases of violation in the list of genetically modified plants that meet the conditions for use as food and animal feed within ten (10) days from the date of the decision to revoke the Confirmation Certificate.

Chapter III

FOOD SAFETY AND FEED SECURITY COUNCIL GENETICALLY MODIFIED ORGANISMS

Article 12. Organization of the Council

1. The Council is an organization established by the Minister of Agriculture and Rural Development through a Decision to provide advisory services to the Minister of Agriculture and Rural Development regarding the issuance and revocation of Confirmation Certificates.

2. The Council consists of eleven (11) members including the Chairman, Vice-Chairman, who are representatives of the Ministry of Agriculture and Rural Development; one representative of the Ministry of Industry and Trade; one representative of the Ministry of Science and Technology; one representative of the Ministry of Natural Resources and Environment; one representative of the Ministry of Health, and some experts in related fields. The term of office of the Council is three (3) years.

3. The operating expenses of the Council shall be implemented in accordance with current laws.

Article 13. Activities of the Council

1. The Council operates based on the principles of democracy and objectivity; each member is individually responsible for the scientific accuracy of their independent comments and evaluations, while collectively responsible for the Council's final conclusions.

2. A meeting of the Council must have at least two-thirds of its members present, chaired by the Chairman or Vice-Chairman (in the absence of the Chairman). The Council meets at least twice.

3. In addition to the general conditions stipulated in Clauses 1 and 2 of this Article, the second meeting of the Council can only proceed when: the Secretary of the Council and the Administrative Secretary are present; two opposing committee members; written comments from independent opposing experts (if any).

4. If necessary, the Council may request the permanent agency to invite representatives of organizations or individuals registered to attend the meeting to provide additional information or answer questions raised by Council members or public opinions.

Article 14. Content and procedures of Council meetings

1. First Meeting:

a) The Administrative Secretary (representative of the permanent agency of the Ministry of Agriculture and Rural Development) introduces the participants, states the purpose of the meeting, and reports briefly on the validity of the file.

b) The Chairman of the Council chairs the meeting, assigns one (1) Council Secretary and two (2) opposing committee members to review the file. If necessary, the Council may recommend supplementing two to three independent opposing experts with relevant experience.

c) The Council elects a counting board consisting of three (3) Council members, including one (1) Head of the Board.

d) The Council agrees on the time for the second meeting and the work plan.

2. Second Meeting:

a) The Administrative Secretary reads the summary report on public comments on the registration file and the comments of independent opposing experts according to the model specified in Appendix 7 of this Circular (if any).

b) The Council member reviews the registration file according to the form specified in Appendix 7 of this Circular.

c) The Council exchanges and discusses the registration file for the issuance of Confirmation Certificates according to the requirements set out in this Circular.

d) The Council votes to evaluate the registration file according to the form specified in Appendix 8.

đ) The Counting Board summarizes and reports the voting results according to the form specified in Appendix 9 of this Circular.

e) The registration file meets the requirements if it receives at least three-quarters (3/4) of the "meets requirements" evaluation votes from participating Council members.

g) The Council discusses, concludes, and recommends any necessary additions or modifications to the contents mentioned in the file (if any), and approves the Minutes of the meeting according to the model specified in Appendix 10 of this Circular.

3. In addition to the two meetings mentioned above, the Council may recommend to the Minister of Agriculture and Rural Development to organize extraordinary meetings and other activities to directly serve the assessment work.

4. Based on the minutes of the meetings, the Council Secretary completes the summary report for each evaluated file and advises the Minister of Agriculture and Rural Development on the examination of the issuance of Confirmation Certificates (according to the model specified in Appendix 11 of this Circular).

5. In case of revoking Confirmation Certificates, the Council convenes to examine each specific case based on the file and advises the Minister of Agriculture and Rural Development on the revocation of Confirmation Certificates.

Article 15. Responsibilities and Authorities of Council Members

1. Study the application files for issuing and revoking the Certificate of Genetically Modified Organisms (GMOs) Suitable for Food and Feed Use and related documents provided by the Ministry of Agriculture and Rural Development.

2. Fully participate in all Council meetings during the review process of the application files; provide written comments according to the model specified in this Circular and other comments as requested by the Ministry of Agriculture and Rural Development.

3. Manage the provided documents, ensuring they are not lost or transferred to third parties, and return them to the Ministry of Agriculture and Rural Development upon completion of the tasks as required.

4. Evaluate and review the application files objectively and independently based on scientific grounds and be ready to exchange with the community regarding their scientific opinions.

5. Receive remuneration as stipulated by current laws.

Chapter IV

IMPLEMENTATION

Article 16. Responsibilities of the Science, Technology and Environment Department

1. Take the lead and coordinate with relevant agencies and units to organize and implement this Circular.

2. Coordinate with relevant agencies to collect and use fees for reviewing application files in accordance with current legal regulations.

3. Summarize and report to the Ministry on the situation of issuing and revoking Certificates of GMOs Suitable for Food and Feed Use as prescribed.

Article 17. Responsibilities of Organizations and Individuals Applying for the Certificate

1. Pay the review fee for the application file as prescribed. The review fee will not be refunded even if the product is refused the Certificate.

2. Be responsible for the authenticity of the information in the application file for the Certificate.

3. Provide additional information as requested by the Ministry of Agriculture and Rural Development.

4. Bear legal responsibility if they fail to comply with the conditions of the Certificate.

5. Organizations and individuals granted the Certificate must inform the Ministry of Agriculture and Rural Development about adverse effects and new scientific information on the risks of GMOs (if any).

6. Notify relevant organizations and individuals about the withdrawal of the Certificate.

Article 18. Effective Date

1. This Circular takes effect from March 10, 2014.

3. During implementation, if there are difficulties or issues, they should be promptly reported to the Ministry of Agriculture and Rural Development for consideration and resolution./.