Circular No. 08/2013/TT-BTNMT stipulates the procedures and conditions for issuing and revoking the Certificate of Biosafety for genetically modified plants.

CIRCULAR

Regulations on the procedures for issuing and revoking certificates of biosafety for genetically modified plants

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Pursuant to Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety regarding genetically modified organisms, genetic material, and products derived from genetically modified organisms;

Pursuant to Decree No. 21/2013/NĐ-CP dated March 4, 2013, promulgated by the Government, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Natural Resources and Environment;

Upon the proposal of the Director General of the Department of Environment and the Head of the Legal Department;

The Minister of Natural Resources and Environment stipulates the procedures for issuing and revoking certificates of biosafety for genetically modified plants.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular prescribes the procedures for issuing and revoking certificates of biosafety for genetically modified plants (hereinafter referred to as certificates of biosafety).

Genetically modified plants created as a result of crossing two or more plants carrying single gene transfer events that have been issued certificates of biosafety are not within the scope of this Circular.

Article 2. Applicability

This Circular applies to organizations and individuals within the country; foreign organizations and individuals (hereinafter referred to as organizations and individuals) engaged in activities related to the issuance and revocation of certificates of biosafety on the territory of Vietnam.

Article 3. Groups of genetically modified plants subject to consideration for issuance of certificates of biosafety

1. Genetically modified plants carrying single gene transfer events (single transformation event) created as a result of transferring one or more genes specifying a desired trait using genetic engineering technology.

2. Genetically modified plants carrying stacked gene transfer events (stacked transformation event) created as a result of one of the following processes:

a) Simultaneously transferring multiple genes specifying several desired traits using genetic engineering technology into non-genetically modified plants;

b) Transferring genes or multiple genes specifying one or more desired traits into a genetically modified plant.

Chapter II

ISSUANCE AND REVOCATION OF BIOSAFETY CERTIFICATES

Article 4. Procedures for issuing and revoking biosafety certificates

1. The registration for issuing biosafety certificates shall be carried out in accordance with the provisions of Article 5 of this Circular.

2. The acceptance, examination of files, and issuance of biosafety certificates shall be carried out in accordance with the provisions of Articles 6, 7, and 8 of this Circular.

3. The revocation of biosafety certificates shall be carried out in accordance with the provisions of Article 9 of this Circular.

Article 5. Registration for Issuing Biosafety Certificates

1. The registration file for issuing biosafety certificates includes:

a) One (01) application form for issuing biosafety certificates according to the model prescribed in Appendix 1 of this Circular;

b) Ten (10) copies of reports on the results of field trials recognized by the Ministry of Agriculture and Rural Development as meeting requirements (including one (01) original copy and nine (09) duplicate copies), accompanied by one (01) copy of the recognition document from the Ministry of Agriculture and Rural Development regarding the field trial results;

c) Ten (10) copies of risk assessment reports of genetically modified plants for the environment and biodiversity (hereinafter referred to as risk assessment reports) accompanied by an electronic file according to the model prescribed in Appendix 2 of this Circular;

d) One (01) electronic file containing information about the risk assessment report of genetically modified plants for the environment and biodiversity according to the model prescribed in Appendix 3 of this Circular.

2. Organizations and individuals registering are responsible for:

a) Paying the examination fee for the registration file for issuing biosafety certificates according to current regulations no later than five (05) days from the date of receiving the written notification from the file acceptance agency accepting the registration file as valid;

b) Providing additional information upon request in writing from the file acceptance agency.

Article 6. Receiving Applications

1. The agency responsible for receiving applications is the General Department of Environment. The General Department of Environment designates a subordinate unit to serve as the Permanent Appraisal Agency to assist in organizing activities related to processing, appraising applications, issuing, and revoking the Biosafety Certificate. The responsibilities of the Permanent Appraisal Agency are stipulated in Article 16 of this Circular.

2. Within seven (07) working days from the date of receipt of the application for issuance of the Biosafety Certificate, the agency receiving the application shall be responsible for sending a notification letter to the organization or individual applying for the Biosafety Certificate regarding the acceptance of the application as valid or requesting additional or completed information. The time required to complete the application is not included in the appraisal period.

Article 7. Appraisal of Application for Issuance of the Biosafety Certificate

1. Within five (05) working days from the date of receipt of a valid application, the agency receiving the application shall post information on the Environmental Impact Assessment Report of genetically modified plants on the website http://www.antoansinhhoc.vn to solicit public opinions. The public opinion solicitation period is thirty (30) days from the date of posting the information. Within no more than five (05) working days after the end of the public opinion solicitation period, the agency receiving the application shall complete a summary of public opinions for the purpose of appraisal.

2. Within ten (10) working days from the date of receipt of a valid application, the General Department of Environment shall be responsible for:

a) Deciding to establish the Expert Group. The organization and operation of the Expert Group are stipulated in Article 20 of this Circular;

b) Reporting to the Minister of Natural Resources and Environment for consideration and decision to establish the Biosafety Council. The composition and structure of the Biosafety Council are stipulated in Article 10 of this Circular.

3. Within ninety (90) days from the date of the decision to establish the Biosafety Council, the Permanent Appraisal Agency shall be responsible for organizing technical support activities to review and assess the application for issuance of the Biosafety Certificate and to compile and submit the results to the Biosafety Council.

In case of necessity, the Permanent Appraisal Agency shall report to the General Department of Environment to send a request in writing to the organization or individual applying for additional information on risk assessment of genetically modified plants; the time taken by the organization or individual to provide additional information is not included in the assessment period.

4. Within seventy (70) days from the date of receipt of the summary of technical support results as stipulated in Clause 3 of this Article, the General Department of Environment shall organize meetings of the Biosafety Council to appraise the application for issuance of the Biosafety Certificate.

Article 8. Issuing the Biosafety Certificate

1. Within thirty (30) days from the date of the Biosafety Council's appraisal result, the Minister of Natural Resources and Environment shall consider and decide to issue the Biosafety Certificate for the registered genetically modified plants according to the model specified in Appendix 4 attached to this Circular.

In case of refusal to issue the Biosafety Certificate, the General Department of Environment shall notify the opinion of the Ministry of Natural Resources and Environment in writing, clearly stating the reasons for the organization or individual to know.

2. Within ten (10) working days from the date of issuance of the Biosafety Certificate, the Ministry of Natural Resources and Environment shall be responsible for:

a) Announcing on the website http://www.antoansinhhoc.vn

b) Adding the genetically modified plant to the List of Genetically Modified Plants Issued with the Biosafety Certificate.

Article 9. Revocation of the Biosafety Certificate

1. The Biosafety Certificate shall be revoked in cases prescribed in Clause 1, Article 24 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.

2. The General Department of Environment shall be responsible for organizing the verification of information specified in Clause 1 of this Article to submit to the Minister of Natural Resources and Environment for consideration and issuance of a decision to revoke the Biosafety Certificate.

3. In case of a decision to revoke the Biosafety Certificate, the Ministry of Natural Resources and Environment shall be responsible for:

a) Within no more than three (03) working days from the date of the revocation decision, sending the Decision (original copy) to the organization or individual who has been issued the Biosafety Certificate; publishing the information on the website http://www.antoansinhhoc.vn and other mass media.

b) Within no more than ten (10) working days from the date of the revocation decision, removing the name of the genetically modified crop from the list of genetically modified crops that have been issued the Biosafety Certificate.

4. From the date of the revocation decision, organizations and individuals shall not release genetically modified crops that have had their Biosafety Certificate revoked into the environment.

Chapter III

ORGANIZATION AND ACTIVITIES OF THE BIOSAFETY COUNCIL, PERMANENT REVIEWING AUTHORITY, AND EXPERT GROUP

Article 10. Composition and Structure of the Biosafety Council

1. The Minister of Natural Resources and Environment decides to establish the Biosafety Council (hereinafter referred to as the Council) according to the model prescribed in Appendix 5 of this Circular. The Council shall include at least nine (09) members, including:

a) The Chairman of the Council is the leader of the General Department of Environment;

b) The Vice-Chairman of the Council is the leader of the Permanent Reviewing Authority;

c) The Secretary member is an officer of the Permanent Reviewing Authority;

d) Six (06) member representatives from the Ministries of Industry and Trade, Science and Technology, Agriculture and Rural Development, Health, and two (02) experts. Among them, two (02) members are selected as Review Members.

2. Costs for the activities of the Council shall be implemented in accordance with current laws.

Article 11. Responsibilities and Authorities of the Chairman of the Council

In addition to the responsibilities and authorities of the Council member stipulated in Article 13 of this Circular, the Chairman of the Council shall also have the following responsibilities and authorities:

1. Chairing meetings of the Council.

2. Handling opinions raised during meetings and concluding meetings of the Council.

3. Signing minutes of Council meetings and bearing responsibility before the Ministry of Natural Resources and Environment and the law for conclusions made during Council meetings.

Article 12. Responsibilities and Authorities of the Vice-Chairman of the Council

In addition to the responsibilities and authorities of the Council member stipulated in Article 13 of this Circular, the Vice-Chairman of the Council shall also have the responsibilities and authorities of the Chairman of the Council when authorized by the Chairman of the Council.

Article 13. Responsibilities and Authorities of the Council Member

1. Responsibilities of Council Members:

a) Studying and providing opinions on related documents provided by the Permanent Reviewing Authority; writing comments on the application dossier for the Biosafety Certificate according to the model prescribed in Appendix 6 of this Circular and submitting it to the Permanent Reviewing Authority before the formal meeting of the Council;

b) Participating in Council meetings and other activities during the review process of the dossier as arranged by the Permanent Reviewing Authority;

c) Managing provided documents to ensure they are not lost or transferred to third parties, and returning these documents to the Permanent Reviewing Authority upon request after completing the assigned tasks;

d) Bearing responsibility under the law for the objectivity and honesty of comments and evaluations on the application dossier for the Biosafety Certificate and the contents of work assigned during the review process.

2. Rights and Benefits of the Council Member:

a) Requesting the Permanent Reviewing Authority to provide complete documents and information related to the application dossier for the Biosafety Certificate; organizing meetings and other activities directly serving the review work;

b) Directly dialoguing with organizations and individuals at Council meetings;

c) Reserving opinions and recording them in the Council meeting minutes if they differ from the Council's conclusion;

đ) Receiving remuneration according to the current financial regulations when performing tasks such as writing comments on the application dossier, participating in Council meetings, and other activities and tasks assigned during the review process; being reimbursed travel, food, accommodation, and other expenses according to the law when participating in Council activities.

Article 14. Responsibilities and Authorities of the Secretary Member

In addition to the responsibilities and authorities of the Council Member stipulated in Article 13 of this Circular, the Secretary Member shall have the following responsibilities and authorities:

1. Provide sample review forms and evaluation sheets for the application for the Biosafety Certificate to the Council members.

2. Report to the Chairman of the Council on the main issues of the application based on the study and synthesis of opinions from the Council Members, the Expert Group; read the reviews of the Council members who did not attend the Council meeting.

3. Record, complete, sign, and submit the minutes of the Council meetings for the Chairman to review and sign.

4. Perform other tasks serving the activities of the Council at the request of the Chairman of the Council and the Permanent Office for Appraisal.

5. In case of absence from the Council meeting, the Secretary Member shall report to the Chairman of the Council to appoint one (01) Council member to serve as the secretary for that meeting.

Article 15. Representatives Participating in Council Meetings

1. The composition of representatives participating in Council meetings is selected and invited by the Permanent Office for Appraisal. Representatives attending the meeting do not vote during the Council session.

2. Members of the Expert Group are invited to participate in Council meetings and present independent scientific opinions, but do not vote during the Council session.

3. Representatives participating in the meetings may express their opinions, subject to the control of the session chairperson, and are entitled to remuneration as prescribed by law.

Article 16. Tasks of the Permanent Office for Appraisal

1. Propose to the General Department of Environment to report to the Minister of Natural Resources and Environment to decide on the establishment of the Council.

2. Report to the General Director of the General Department of Environment to decide on the establishment of the Expert Group.

3. Assist the General Department of Environment in performing the following tasks:

a) Publish information about the risk assessment report of genetically modified plants on the environment and biodiversity on the website http://www.antoansinhhoc.vn, collect public opinions according to Clause 1, Article 7 of this Circular;

b) Organize Council meetings and activities of the Expert Group in accordance with the procedures stipulated in Articles 17, 18, and 20 of this Circular;

c) Draft decisions on issuing the Biosafety Certificate for submission to competent authorities for consideration and decision;

d) Keep records and documents related to the biosafety certificate issuance process;

đ) Monitor, compile, and report to competent authorities information on the management of genetically modified plants that have been issued the Biosafety Certificate;

e) Perform other tasks assigned by the General Department of Environment related to the issuance and revocation of the Biosafety Certificate.

Article 17. Conditions for Holding Official Sessions of the Council

Official sessions of the Council shall only be held when the following conditions are met:

1. Participation (either physically present at the session or participating via online meeting) of at least two-thirds (2/3) of the Council members as decided upon establishment. Among them, it is mandatory to have: the Chairman of the Council or the Vice-Chairman in the absence of the Chairman, and at least one (01) Reviewing Member.

2. Presence of the authorized representative of the organization or individual applying for the application or a person authorized in writing by the organization or individual.

3. The organization or individual applying has paid the appraisal fee for the application as prescribed by law.

Article 18. Content and sequence of formal meetings of the Council

The Chairman or Vice-Chairman of the Council shall preside over the meeting in accordance with the authority stipulated in Article 11 of this Circular when the Chairman of the Council is absent, and control the meeting according to the following procedure:

1. The Secretary member reads the decision establishing the Council, introduces the participants, and reports briefly on the process of handling the registration file, provides a summary of the opinions of the Expert Group, and informs about the activities of the Permanent Approval Authority that occurred prior to the Council meeting.

2. The organization or individual who has registered presents a summary of the contents of the Risk Assessment Report.

3. The Council members and other members of the Council present their comments.

4. The Secretary member reads the comments of the absent Council members.

5. Feedback from the authorized representative of the registering organization or individual (if any).

6. Opinions of the delegates (if any).

7. The Council continues to meet (without delegates' participation) focusing on the following matters:

a) The Council exchanges and discusses the registration file based on the criteria for assessing biosafety of genetically modified plants regarding the environment and biodiversity;

b) The Council members fill out and submit evaluation ballots in accordance with Appendix 7 of this Circular;

c) The Secretary member counts the ballots, compiles, and reports the results of the ballot counting;

d) The Council discusses and agrees on the draft conclusion.

8. The chairperson of the meeting approves the Council's conclusion and declares the end of the meeting.

Article 19. Principles for issuing conclusions by the Council

The Council's conclusion is officially approved when at least three-quarters (3/4) of the Council members participating in the meeting agree as reflected on the evaluation ballots.

Article 20. Organization and Activities of the Expert Group

1. The Expert Group is established by the General Director of the Environmental Protection Agency pursuant to the model specified in Appendix 8 of this Circular and consists of at least three (03) members who are experts with sufficient expertise and experience related to the registration file. The costs for the activities of the Expert Group are implemented in accordance with current laws.

2. The Expert Group is responsible for conducting technical support activities for the Council through the Permanent Approval Authority during the process of reviewing the application for a Biosafety Certificate, including: studying the registration file for the Biosafety Certificate; proposing content for responding to public opinions; completing the summary of the Expert Group's opinions through specialized meetings.

3. Responsibilities of the Expert Group members:

a) Studying and providing technical advice to the Council on the registration file for the Biosafety Certificate according to the model specified in Appendix 9 of this Circular;

b) In case of necessity, requesting the receiving agency to require the registering organization or individual to provide additional necessary documents for technical support activities;

c) Returning all files and documents provided by the Permanent Approval Authority after completing the task; not disclosing information about the review results or file information to third parties, and not using the review results contrary to intellectual property laws.

Chapter IV

IMPLEMENTATION

Article 21. Responsibilities of organizations and individuals

After being issued a Biosafety Certificate, organizations and individuals shall annually report on the implementation of biosafety measures as required by the Biosafety Certificate, to be submitted to the Ministry of Natural Resources and Environment, the Ministry of Agriculture and Rural Development, and the People's Committee of the province where genetically modified plants are released into the environment.

Article 22. Implementation Provisions

1. This Circular takes effect from July 1, 2013.

2. During implementation, if there are difficulties or obstacles, organizations and individuals shall promptly reflect them to the Ministry of Natural Resources and Environment for consideration and resolution./.