Integrated document No. 10/VBHN-BTNMT dated December 24, 2020 Decree on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms

DECREE

BIOSAFETY FOR GENETICALLY MODIFIED ORGANISMS, GENETIC SPECIMENS AND PRODUCTS OF GENETICALLY MODIFIED ORGANISMS

Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms, which comes into force from August 10, 2010, is amended by:

1. Government’s Decree No. 108/2011/ND-CP dated November 30, 2011 on amendments to some Articles of Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms, which comes into force from January 15, 2012. 

2. Government's Decree No. 123/2018/ND-CP dated September 17, 2018 on amendments to certain Decrees on investment and business requirements in the agriculture sector, which comes into force from September 17, 2018.

3. Government’s Decree No. 118/2020/ND-CP dated October 02, 2020 on amendments to some Articles of Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms, which comes into force from October 02, 2020. 

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

Pursuant to the Law on Environmental Protection dated November 29, 2005;  

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At the proposal of the Minister of Natural Resources and Environment,

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree provides for biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms.

The biosafety management of genetically modified organisms, genetic specimens and products of genetically modified organisms used as pharmaceuticals shall comply with the law on pharmaceuticals.

Article 2. Regulated entities

This Decree applies to domestic and foreign organizations and individuals (herein referred to as “organizations and individuals”) engaged in activities related to genetically modified organisms, genetic specimens and products of genetically modified organisms in the territory of the Socialist Republic of Vietnam.

Article 3. Definition of terms

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1. Biosafety certificate means a document issued by a competent state agency, which certifies that genetically modified organisms are safe for the environment and biodiversity and permitted to be released into the environment under specific conditions.

2. Product of genetically modified organism means a product wholly or partly containing constituents that originate from genetically modified organisms, including genetic specimens of genetically modified organisms which cannot themselves create new individuals under natural conditions.

3. Donor organism means an organism which supplies a needed gene to be transmitted for creation of a genetically modified organism.

4. Host organism means an organism which receives a transmitted gene for creation of a genetically modified organism.

5. Biosafety means managerial measures to ensure safety for the environment, biodiversity and health of humans and domestic animals.

6. Gene transfer event means the result of reintegrating target DNA into a specific location in genome of a species to create a genetically modified organism bearing the target gen, including: single gene transfer event refers to the result of transferring a single gene which controls a desired characteristic and complex gene transfer refers to the result of transferring multiple genes which control one or multiple desired characteristics using genetic transfer technology.”

Article 4. Biosafety for genetic specimens of genetically modified organisms

1. Genetic specimens of genetically modified organisms which can themselves create new individuals under natural conditions shall be managed under the law on biosafety for genetically modified organisms.

2. Genetic specimens of genetically modified organisms which cannot themselves create new individuals under natural conditions shall be managed under the law on biosafety for products of genetically modified organisms.

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RISK ASSESSMENT AND MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS

Article 5. Principles of assessment of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals

1. Risk assessment of genetically modified organisms shall ensure scientificity and transparency and be conducted by methods and techniques nationally or internationally recognized by competent agencies.

2. Risk assessment of genetically modified organisms shall be conducted on a case-by-case basis, depending on genetically modified organisms, their use purposes and their receiving environments.

3. Risks of genetically modified organisms shall be assessed on the basis of comparison of disparities between genetically modified organisms and host organisms under the same conditions.

4. Genetically modified organism that is the result of traditional backcross process with multiple gene transfer events issued with Biosafety certificate, certification of genetically modified organisms’ eligibility for use as food and certification of genetically modified organisms’ eligibility for use as animal feed while conforming to regulations on investment and business conditions shall be released into the environment, and used as food and/or animal feed.

Article 6. Contents of assessment of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals

1. Identifying potential hazards and possible risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals.

2. Identifying safety measures to prevent, handle and deal with risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals.

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1. Information on the assessment of risks of genetically modified organisms shall be presented in reports on assessment of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals.

2. Risk assessment reports of genetically modified organisms for the environment, biodiversity, human health and domestic animal health shall be prepared using forms under Annex IV, Annex V and Annex VI of Decree No. 69/2010/ND-CP. If a genetically modified organism bears complex gene transfer event, risk assessment reports shall provide additional data on interaction of transferred genes in the structure, structural integrity, functions and behavior of target genes in host organism.

3. Reports on assessment of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals shall be appraised by competent state agencies.

4. A report on assessment of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals serves as a basis for the issuance of a biosafety certificate; a certification of genetically modified organisms' eligibility for use as food and a certification of genetically modified organisms' eligibility for use as animal feed.

Article 8. Responsibility for management of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals

1. Organizations and individuals engaged in scientific research, technological development; assay, production, trading, import, export, transportation or storage of genetically modified organisms shall take risk management measures to ensure biosafety under law.

2. When risks occur, organizations and individuals shall promptly take measures to deal with such risks and report them to People’s Committees of provinces where risks occur. 

3. Organizations and individuals that fail to comply with risk management measures shall, according to the severity of their violations, incur administrative penalties, be liable to criminal prosecution or pay compensation under law.

4. Line ministries and provincial-level People's Committees shall direct and organize risk management and report it to the Ministry of Natural Resources and Environment when risks occur.

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1. Line ministries and provincial-level People's Committee shall conduct periodic or adhoc inspection and examination of the application of risk management measures to genetically modified organisms under their management and promptly handle violations under law.

2. The Ministry of Natural Resources and Environment shall conduct inter-branch or adhoc examination and inspection of the application of risk management measures to genetically modified organisms.

Chapter III

SCIENTIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT RELATED TO GENETICALLY MODIFIED ORGANISMS AND PRODUCTS THEREOF

Article 10. Requirements for scientific research and technological development related to genetically modified organisms and products thereof

1. Scientific research and technological development related to genetically modified organisms and products thereof shall comply with applicable regulations on scientific and technological management and other relevant regulations.

2. Research activities for creation, analysis and testing in isolation of genetically modified organisms and products thereof may be carried out only in genetically modified organism laboratories accredited by the Ministry of Science and Technology under Articles 11 and 12 of this Decree.

Article 11. Conditions on genetically modified organism laboratories

1.  A genetically modified organism laboratory shall fully satisfy the following conditions:

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b) Having suitable equipment for scientific research and technological development related to genetically modified organisms and products thereof;

c) Having an operating process which satisfies biosafety requirements.

2. The Ministry of Science and Technology shall provide specific guidance on contents specified Clause 1 of this Article.

Article 12. Authority and procedures for accreditation or revocation of decisions on accreditation of genetically modified organism laboratories

1. The Ministry of Science and Technology shall accredit or revoke decisions on accreditation of genetically modified organism laboratories.

2. An applicant for accreditation of a genetically modified organism laboratory shall submit three (3) applications to the Ministry of Science and Technology.  An application includes:

a) A written application for accreditation of the genetically modified organism laboratory, made according to the form set by the Ministry of Science and Technology;

b) Copies of all decisions on the applicant's functions and tasks;

c) Explanations about the laboratory's capability, made according to the form set by the Ministry of Science and Technology;

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3. Within 07 working days after receiving applications, the Ministry of Science and Technology shall notify its acceptance of valid applications to the applicant or request the applicant to supplement and complete applications under regulations. The time for supplementation and completion will not be included in the time for appraisal of these applications.

4. Within 45 days after receiving valid applications for accreditation of a genetically modified organism laboratory, the Ministry of Science and Technology shall set up a council to appraise such applications.

The council's appraisal result serves as a basis for the Minister of Science and Technology to decide to accredit the genetically modified organism laboratory.

5. Within 30 days after obtaining the appraisal result, the Minister of Science and Technology shall examine it and accredit a genetically modified organism laboratory. In case of refusal, he/she shall issue a written notice that clearly states the reason to the applicant.

6. The Ministry of Science and Technology shall provide guidance on procedures for accreditation of genetically modified organism laboratories and periodically examine the operation of these laboratories.  If a genetically modified organism laboratory fails to satisfy any of the conditions specified in Article 11 of this Decree, the Ministry of Science and Technology shall consider the case and revoke the decision on accreditation of such laboratory.

7. The Ministry of Science and Technology shall notify the Ministry of Natural Resources and Environment and relevant line ministries of the accreditation of or revocation of decisions on accreditation of genetically modified organism laboratories.

Article 13. Biosafety in scientific research and technological development related to genetically modified organisms and products thereof

1. Scientific research and technological development related to genetically modified organisms and products thereof shall be conducted within the framework of projects that have been approved by competent authorities under law. A project on scientific research and technological development related to genetically modified organisms created from donor organisms and host organisms which are likely to greatly affect the environment, biodiversity or health of humans and domestic animals shall be licensed by the Ministry of Science and Technology.

2. An explanatory document on a project on scientific research and technological development related to genetically modified organisms and products thereof shall contain biosafety details. In case a project requires import of genetically modified organisms for scientific research and technological development, its explanatory document shall contain the information specified in Appendix 1 to this Decree.

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The Ministry of Science and Technology shall specify contents of biosafety in genetically modified organism laboratories.

Chapter IV

ASSAY OF GENETICALLY MODIFIED ORGANISMS

Article 14. Requirements for assay of genetically modified organisms

1. Genetically modified organisms used for release, including culture, growing and purposeful release into the environment, shall be assayed.

2. The assay of genetically modified organisms shall be conducted step by step, from restricted assay to wide-area assay. Assay zones shall be far enough from conservation zones and densely populated areas according to regulations.

Restricted assay shall be conducted under isolation conditions according to regulations.

Wide-area assay shall be conducted in different eco-zones. It is not required to have isolation but management and supervision measures are required.

3. Upon detecting that genetically modified organisms cause uncontrollable risks to the environment, biodiversity or health of humans or domestic animals, organizations or individuals issued with Licenses for assay and assaying institutions shall terminate the assay of genetically modified organisms and take emergency measures to deal with risks and concurrently destroy such genetically modified organisms.

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Article 15. Contents of assay of genetically modified organisms

1. Genetically modified organism assay refers to the process of monitoring and assessing impact of genetically modified organisms on the environment and biodiversity in specific conditions of Vietnam.

2. Genetically modified organism assay consists of the following primary contents:

a) Risk of becoming harmful organisms;

b) Risk of unintentionally affecting organisms in a negative manner;

c) Risk of negatively altering surrounding ecosystem.

Risk assessment of genetically modified organisms includes assessment of impact on soil ecosystem and assessment of impact of cultivation method for genetically modified plan on the environment and biodiversity;

d) Risk of genetic drift;

dd) Other unfavorable impacts.

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1. To be accredited as a genetically modified organism-assaying institution, an organization shall fully satisfy the following conditions:

a) Having suitable material and technical foundations and equipment for the assay of genetically modified organisms;

b) Having suitable professional staff for the assay of genetically modified organisms:

c) Having an assay process which satisfies biosafety requirements.

2. (Annulled)

Article 17. Authority and procedures for accreditation and revocation of decisions on accreditation of genetically modified organism-assaying institutions

1. The Ministry of Agriculture and Rural Development shall accredit and revoke decisions on accreditation of genetically modified organism-assaying institutions.

2. Organizations applying for accreditation of genetically modified organism-assaying institutions shall be public service providers.

3. An organization applying for accreditation of a genetically modified organism- assaying institution shall submit an application to the Ministry of Agriculture and Rural Development in person, by post or via the internet. An application includes:

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b) Explanation for capacity for accreditation of the genetically modified organism- assaying institution using Form No. 2 under Annex attached to this Decree.

4. Within 05 working days from the date in which the application is received, the Ministry of Agriculture and Rural Development shall inform the applicant in writing about acceptance of the application or request the applicant to revise and complete the application; the revision period shall not be included in the appraisal period.

5. Within 45 days from the date in which the valid application is received, the Ministry of Agriculture and Rural Development shall appraise the application.

The Ministry of Agriculture and Rural Development shall establish a Council for assay and assessment of the risk of genetically modified organism according to Article 17a of this Decree. The council's appraisal result serves as a basis for the Ministry of Agriculture and Rural Development to decide to accredit a genetically modified organism-assaying institution.

6. Within 10 days from the date in which the appraisal result is available, the Ministry of Agriculture and Rural Development shall consider and decide to accredit the genetically modified organism--assaying institution. In case of refusal, he/she shall issue a written notice that clearly states the reason to the applicant.

7. The Ministry of Agriculture and Rural Development shall take charge and cooperate with the Ministry of Natural Resources and Environment in examining operation of genetically modified organism- assaying institutions. If a genetically modified organism-assaying institution fails to satisfy any of the conditions specified in Article 16 of Decree No. 69/2010/ND-CP, the Ministry of Agriculture and Rural Development shall consider revoking the decision on accreditation of such institution.

8. Within 10 days from the date of issuance of the decision on accreditation or revocation of the decision on accreditation of a genetically modified organism- assaying institution, the Ministry of Agriculture and Rural Development shall send an original copy of the decision to the Ministry of Natural Resources and Environment and publicize the decision on website of the Ministry of Agriculture and Rural Development.

Article 17a. Organization and operation of Council for assay and assessment of risks of genetically modified organisms

1. The Ministry of Agriculture and Rural Development shall decide to establish a Council for assaying and assessing risks of genetically modified organisms, which includes at least 9 members. The Chairperson shall be representative of the professional regulatory authority affiliated to the Ministry of Agriculture and Rural Development, the Vice Chairperson shall be representative of the standing assessment agency and members shall be representatives of the Ministry of Natural Resources and Environment, the Ministry of Industry and Trade, the Ministry of Science and Technology, the Ministry of Health and experts.  In which, 02 members shall be chosen to be Review panel. The Council shall dissolve after completing assigned tasks. The Ministry of Agriculture and Rural Development shall assign an affiliated entity to be the standing assessment agency.

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a) Appraising applications for accreditation of genetically modified organism- assaying institutions and providing advice for Ministry of Agriculture and Rural Development to consider and accredit genetically modified organism- assaying institutions;

b) Appraising applications for assaying and assessing assay results and providing advice for the Ministry of Agriculture and Rural Development to consider issuing Licenses for assaying and accrediting assay results.

3. The Council operates on the basis of democracy and transparency; is personally responsible for scientificity and accuracy for feedback and assessment and is collectively responsible for general conclusion of the Council. 

4. A council meeting shall have at least 2/3 of the members and be hosted by the Chairperson or Vice Chairperson (in case of absence of the Chairperson). The standing assessment agency shall hold Council meetings for each application and write up the minutes of each meeting.  In the first meeting, the host of the meeting shall assign 01 Council secretary and 2 Review panel members. If necessary, the Council may request addition of 2 to 3 scientists experienced in relevant fields to independently review applications.

5. If necessary, the Council may request the standing assessment agency to invite representatives of the applicants to participate in the meetings to provide additional information and answer questions of the Council members of public opinions.

6. According to meeting minutes, Council secretary shall complete application and Council conclusion assessment reports to report to the Ministry of Agriculture and Rural Development.

Article 17b. Authority and procedures for reissuance of decisions on accreditation of genetically modified organism-assaying institutions

1. A decision on accreditation of a genetically modified organism- assaying institution shall be reissued in case of loss, damage or wearing out.

2. An application for reissuance includes:

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b) Decision on accreditation of the genetically modified organism- assaying institution that has been previously issued in case of damage or wearing out.

3. An applicant shall submit 01 application for reissuance according to regulations of Clause 2 of this Article to the Ministry of Agriculture and Rural Development in person, by post or via the internet.

4. Within 07 working days from the date in which the valid application is received, the Ministry of Agriculture and Rural Development shall consider reissuing the decision on accreditation of the genetically modified organism-assaying institution.”

Article 18. Authority and procedures for issuance and revocation of Licenses for assaying genetically modified organisms

1. The Ministry of Agriculture and Rural Development may issue or revoke licenses for assaying genetically modified organisms.

2. An applicant shall submit 01 application to the Ministry of Agriculture and Rural Development in person, by post or via the internet. An application includes:

a) Written application for issuance of License for assaying genetically modified organisms using Form No. 4 under Annex attached to this Decree;

b) Explanation of application for assaying genetically modified organisms and Plan for assay specified under Annex II and Annex III of Decree No. 69/2010/ND-CP. With respect to genetically modified plants, Form No. 5 under Annex attached to this Decree shall be used.

c) A photocopy of Decision on accreditation of the genetically modified organism-assaying institution;

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3. Within 07 working days from the date in which the application is received, the Ministry of Agriculture and Rural Development shall inform the applicant in writing about acceptance of the application or request the applicant to revise and complete the application; the revision period shall not be included in the appraisal period.

4. Within 30 days for the application for issuance of License for restricted assay and 45 days for the application for issuance of License for wide-area assay, from the date in which the valid application is received, the Ministry of Agriculture and Rural Development shall organize the Council to appraise such application. The appraisal result of the Council for assaying and assessing risks of genetically modified organisms serves as the basis for the Ministry of Agriculture and Rural Development to consider issuing License for assaying genetically modified organisms.

5. Within 10 days from the date in which the appraisal result is available, the Ministry of Agriculture and Rural Development shall consider issuing License for assaying genetically modified organisms. In case of rejection, the Ministry of Agriculture and Rural Development shall inform the applicant and specify the reason in writing.

6. The Ministry of Agriculture and Rural Development shall take charge and cooperate with the Ministry of Natural Resources and Environment in examining compliance with requirements of License for assaying genetically modified organisms.

7. The Ministry of Agriculture and Rural Development shall consider revoking License for assaying genetically modified organisms if the organization issued with the License commits any of the following violations:

a) Providing false information on name of genetically modified organisms;

b) Conducting assay at the wrong time, in the wrong place with scale not agreed upon by the Ministry of Agriculture and Rural Development;

c) Failing to comply with explanation for application for assaying genetically modified organisms.

8. Within 10 days from the date of issuance of the decision on issuance or revocation of License for assaying genetically modified organisms, the Ministry of Agriculture and Rural Development shall send an original copy of the decision to the Ministry of Natural Resources and Environment and publicize the decision on website of the Ministry of Agriculture and Rural Development.”

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License for assaying genetically modified organisms shall follow Form No. 06 under Annex attached to this Decree.”

Article 19a. Authority and procedures for reissuance of License for assaying genetically modified organisms

1. License for assaying genetically modified organisms shall be reissued in following cases:

a) Changes to information on organization issued with License for assaying genetically modified organisms;

b) Lost, damaged or worn-out License for assaying genetically modified organisms.

2. An application for reissuance includes:

a) Written application using Form No. 7 under Annex attached to this Decree;

b) License for assaying genetically modified organisms previously issued in case of changes to information on the organization or damaged or worn-out license;

c) Documents proving changes for case specified under Point a Clause 1 of this Article.

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4. Within 07 working days from the date in which the valid application is received, the Ministry of Agriculture and Rural Development shall consider reissuing License for assaying genetically modified organisms.”

Article 20. Responsibility for assaying genetically modified organisms

1. An organization or individual issued with License for assaying genetically modified organisms shall follow contents of the License and approved Plan for assaying genetically modified organisms and periodically report on the assay under approved assay Plan to the Ministry of Agriculture and Rural Development.

2. An organization or individual issued with License for assaying genetically modified organisms shall, after completing or ceasing the assay, take measures to ensure biosafety.

3. Within 60 days after completing the assay of genetically modified organisms, the organization or individual issued with License for assaying genetically modified organisms shall send a report on the assay result to the Ministry of Agriculture and Rural Development for consideration and recognition.

Within 30 days after ceasing the assay of genetically modified organisms, the organization or individual issued with License for assaying genetically modified organisms shall send to the Ministry of Agriculture and Rural Development a report on the assay process, and clearly state the reason for such cessation.

4. The organization or individual issued with License for assaying genetically modified organisms shall take responsibility for contents of the report on the assay result and provide assay-related data to the competent state agency upon request.

Article 21. Acknowledging assay results of genetically modified organisms

1. An applicant shall submit the assay result of genetically modified organisms using Form No. 8 under Annex attached to this Decree to the Ministry of Agriculture and Rural Development in person, by post or via the internet.

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3. Within 10 days from the date in which the appraisal result is available, the Ministry of Agriculture and Rural Development shall consider acknowledging or rejecting the assay result of genetically modified organisms. In case of rejection, the Ministry of Agriculture and Rural Development shall inform the applicant and specify reasons in writing.

4. Within 10 days from the date of issuance of the decision on acknowledging the assay result of genetically modified organisms, the Ministry of Agriculture and Rural Development shall send 01 original copy of the decision to the Ministry of Natural Resources and Environment and publicize the decision on website of the Ministry of Agriculture and Rural Development.”

Chapter V

BIOSAFETY CERTIFICATES

Article 22. Conditions for issuance of biosafety certificates

To be granted a biosafety certificate, genetically modified organisms shall satisfy the following conditions:

1. Having been assayed under Vietnam's specific conditions. Their assay results have been recognized as satisfactory by the Ministry of Agriculture and Rural Development.

2. Having been concluded by the Biosafety Council as safe organisms for the environment and biodiversity.

Article 23. Authority and procedures for issuance or revocation of biosafety certificates

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2. An applicant for a biosafety certificate shall submit three (3) applications to the Ministry of Natural Resources and Environment.  An application includes:

a) A written application for the certificate, made according to the form set by the Ministry of Natural Resources and Environment;

b) A report on assay result recognized by the Ministry of Agriculture and Rural Development as satisfactory:

c) A report on assessment of risks of genetically modified organisms to the environment and biodiversity, made according to Appendix IV to this Decree.

3. Within 07 working days after receiving applications, the Ministry of Natural Resources and Environment shall notify its acceptance of valid applications to the applicant or request the applicant to supplement and complete these applications under regulations. The time for supplementation and completion will not be included in the time for the appraisal of such applications.

4. Within 180 days after receiving valid applications, the Ministry of Natural Resources and Environment shall set up a biosafety council to appraise such applications.

5. After receiving valid applications, the Ministry of Natural Resources and Environment shall publish information on the report on assessment of risks of genetically modified organisms to the environment and biodiversity on the biosafety website for public comment. Public comments shall be summarized and reported to the Biosafety Council. The maximum duration for collection of public comments is 30 days after information is published.

6. Within 30 days from the date in which assay results are available, the Minister of Natural Resources and Environment shall consider reissuing biosafety certificates. In case of refusal, he/she shall issue a notice clearly stating the reason to the applicant.

7. An applicant for biosafety certificate shall pay a charge. The Ministry of Finance shall take charge and cooperate with the Ministry of Natural Resources and Environment in specifying charge, management and use of the charge for appraisal of applications for biosafety certificates.

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9. The Biosafety Council shall advise the Minister of Natural Resources and Environment to consider issuing biosafety certificates. This Council shall be composed of representatives of the Ministry of Industry and Trade; the Ministry of Science and Technology; the Ministry of Agriculture and Rural Development; the Ministry of Natural Resources and Environment; and the Ministry of Health and some experts.

The Minister of Natural Resources and Environment shall decide to set up and define functions, tasks and operation mechanism of the Biosafety Council.

Article 23a. Authority and procedures for reissuance of biosafety certificates

1. A biosafety certificate shall be reissued in following cases:

a) Changes to information of the organization in the issued biosafety certificate;

b) Lost, damaged or worn-out biosafety certificate.

2. An application for reissuance includes:

a) Written application for reissuance using Form No. 09 under Annex attached to this Decree;

b) Issued biosafety certificate in case of changes to information of the organization or damaged, worn-out biosafety certificate;

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3. An applicant shall submit 01 application for reissuance as specified under Clause 2 of this Article to the Ministry of Natural Resources and Environment in person, by post or via the internet.

4. Within 07 working days from the date in which the valid application is received, the Ministry of Natural Resources and Environment shall consider reissuing the biosafety certificate.”

Article 24. Revocation of biosafety certificates

1. A biosafety certificate shall be revoked in the following cases:

a) There is a new scientific proof of risks of genetically modified organisms granted a biosafety certificate:

b) The organization or individual intentionally provides untruthful information which is decisive to the issuance of the biosafety certificate;

c) There is a proof that the Biosafety Council's conclusions lack scientific grounds.

2. The Ministry of Natural Resources and Environment shall decide to revoke biosafety certificates, issue written notices to organizations or individuals that have such biosafety certificates and publish the revocation in the mass media.

3. From the date of issuance of decisions on revocation of biosafety certificates, organizations and individuals shall not release genetically modified organisms with revoked biosafety certificates into the environment.

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1. A biosafety certificate contains:

a) Names of genetically modified organisms: scientific names, common names, gene transmission events and sole identification numbers, if any;

b) Detailed information on the organization or individual that is issued with the certificate;

c) Specific requirements for assurance about biosafety during the use of genetically modified organisms.

2. The Ministry of Natural Resources and Environment shall set the form of biosafety certificate.

Article 26. List of genetically modified organisms granted a biosafety certificate

1. The Ministry of Natural Resources and Environment shall make a list of genetically modified organisms granted the biosafety certificate and publish this list on its biosafety website.

2. Within 10 days after granting or revoking a biosafety certificate, the Ministry of Natural Resources and Environment shall add or delete names of genetically modified organisms to or from such list.

Chapter VI

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Section 1. GENETICALLY MODIFIED ORGANISMS ELIGIBLE FOR USE AS FOOD

Article 27. Conditions for issuance of a certification of genetically modified organisms’ eligibility for use as food

To be granted a certification of genetically modified organisms’ eligibility for use as food, genetically modified organisms shall satisfy either of the following conditions:

1. The application for issuance of a certification of genetically modified organisms’ eligibility for use as food shall be appraised by the Genetically Modified Food Safety Council, which concludes that such genetically modified organisms have no uncontrollable risks to human health.

Genetically modified organisms shall be permitted by at least five (5) developed countries for use as food and no risk has been seen in these countries.

Article 28. Authority and procedures for issuance or revocation of a certification of genetically modified organisms’ eligibility for use as food

1. The Ministry of Agriculture and Rural Development may issue and revoke certifications of genetically modified organisms’ eligibility for use as food.

2. An applicant for a certification of genetically modified organisms' eligibility for use as food shall submit three (3) applications to the Ministry of Agriculture and Rural Development. An application includes:

a) A written application for a certification of genetically modified organisms' eligibility for use as food, made according to the form specified by the Ministry of Agriculture and Rural Development;

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c) An original copy or a verified true copy and certified Vietnamese translation of confirmation document or equivalent document of a competent agency permitting genetically modified organisms to be used as food in at least 5 developing countries in case of genetically modified organisms specified under Clause 2 Article 27 of Decree No. 69/2010/ND-CP;

d) Summary of the risk assessment report (together with electronic form) of genetically modified organisms for human health using Form No. 10 under Annex attached to this Decree;

dd) Reference and research scientific texts that have not been published, other assessment, test or scientific figures (if any) which are used by the applicant as the basis to conclude that genetically modified organisms do not negatively affect human health.”

3. Within 07 working days after receiving applications, the Ministry of Agriculture and Rural Development shall notify the applicant of its acceptance of valid applications or request the applicant to supplement and complete such applications under regulations. The time for supplementation and completion will not be included in the time for appraisal of applications.

4. Within 180 days after receiving valid applications, the Ministry of Agriculture and Rural Development shall establish a Genetically Modified Food Safety Council to appraise such applications. Regarding genetically modified organisms specified in Clause 2, Article 27 of Decree No. 69/2010/ ND-CP, the duration for issuance of, or refusal to issue, such a certification is 60 days.

5. After receiving valid applications, the Ministry of Agriculture and Rural Development shall publish information on the report on assessment of risks of genetically modified organisms to human health on its website for public comment. Public comments shall be summarized and reported to the Genetically Modified Food Safety Council. The duration for collection of public comments is 30 days after information is published.

6. Within 30 days after obtaining the appraisal result, the Minister of Agriculture and Rural Development shall consider issuing a certification of genetically modified organisms' eligibility for use as food. In case of refusal, he/she shall issue a notice clearly stating the reason to the applicant.

7. The applicant for a certification of genetically modified organisms' eligibility for use as food shall pay a charge for appraisal of applications. The Ministry of Finance shall take charge, and cooperate with the Ministry of Agriculture and Rural Development in specifying charge, management and use of the charge for application appraisal.

8. The Ministry of Agriculture and Rural Development shall specify procedures for issuance of a certification of genetically modified organisms' eligibility for use as food.

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The Minister of Agriculture and Rural Development shall decide to set up and define functions, tasks and operation mechanism of, the Genetically Modified Food Safety Council."

Article 28a. Authority and procedures for reissuance of certification of genetically modified organisms’ eligibility for use as food

1. A certification of genetically modified organisms’ eligibility for use as food shall be reissued in following cases:

a) Changes to information of the organization in the issued certification of genetically modified organisms’ eligibility for use as food;

b) Lost, damaged or worn-out certification of genetically modified organisms’ eligibility for use as food.

2. An application for reissuance includes:

a) Written application for reissuance using Form No. 11 under Annex attached to this Decree;

b) Certification of genetically modified organisms’ eligibility for use as food previously issued in case of changes to information on the organization or damaged or worn-out certification;

c) Documents proving changes for case specified under Point a Clause 1 of this Article.

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4. Within 07 working days from the date in which the valid application is received, the Ministry of Agriculture and Rural Development shall consider reissuing certification of genetically modified organisms’ eligibility for use as food.”

Article 29. Revocation of a certification of genetically modified organisms’ eligibility for use as food

1. A certification of genetically modified organisms’ eligibility for use as food shall be revoked in the following cases:

a) There is a new scientific proof of risks of genetically modified organisms granted such certification;

b) The organization or individual intentionally provides untruthful information which is decisive to the issuance of such certification;

c) There is a proof that the Genetically Modified Food Safety Council's conclusions lack scientific grounds.

2. The Ministry of Agriculture and Rural Development shall decide to revoke a certification of genetically modified organisms' eligibility for use as food and issue a written notice to the organization or individual that has the revoked certification and publish the revocation in the mass media.

3. From the date of issuance of the decision on revocation of a certification of genetically modified organisms’ eligibility for use as food, the organization or individual shall not use genetically modified organisms and products thereof as food.

Article 30. Contents of a certification of genetically modified organisms' eligibility for use as food

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a) Names of genetically modified organisms: scientific names, common names, gene transmission events and the sole identification numbers, if any;

b) Detailed information on the organization or individual that is issued with the certification;

c) Specific requirements for assurance about safety during the use of genetically modified organisms.

2. The Ministry of Agriculture and Rural Development shall stipulate the form of a written certification of genetically modified organisms' eligibility for use as food."

Article 31. List of genetically modified organisms granted a certification of eligibility for use as food

1. The Ministry of Agriculture and Rural Development shall make a list of genetically modified organisms granted a written certification of eligibility for use as food and publish this list on its website.

2. Within 10 days after granting or revoking a certification of genetically modified organisms' eligibility for use as food, the Ministry of Agriculture and Rural Development shall add or delete names of genetically modified organisms to or from such list.

Section 2. GENETICALLY MODIFIED ORGANISMS ELIGIBLE FOR USE AS ANIMAL FEED

Article 32. Conditions for issuance of a certification of genetically modified organisms' eligibility for use as animal feed

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a) The application for a certification of genetically modified organisms' eligibility for use as animal feed shall be appraised by the Genetically Modified Animal Feed Safety Council, which concludes that such genetically modified organisms have no uncontrollable risks to domestic animals.

b) Genetically modified organisms have been permitted by at least five (5) developed countries for use as animal feed and no risk has been seen in these countries.

2. Genetically modified organisms that are granted a certification of eligibility for use as animal feed may be used as animal feed.

Article 33. Authority and procedures for issuance or revocation of a certification of genetically modified organisms' eligibility for use as animal feed

1. The Ministry of Agriculture and Rural Development may issue and revoke a certification of genetically modified organisms’ eligibility for use as animal feed.

2. An applicant for a certification of genetically modified organisms’ eligibility for use as animal feed shall submit three (3) applications to the Ministry of Agriculture and Rural Development.  An application includes:

a) A written application for such certification, made according to the form specified by the Ministry of Agriculture and Rural Development;

b) A report on assessment of risks of genetically modified organisms to domestic animals, made according to Appendix VI to this Decree;

c) An original copy or a verified true copy and certified Vietnamese translation of confirmation document or equivalent documents of a competent agency permitting genetically modified organisms to be used as animal feed in at least 5 developing countries in case of genetically modified organisms specified under Point b Clause 1 Article 32 of Decree No. 69/2010/ND-CP.

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dd) Reference and research scientific texts that have not been published, other assessment, test or scientific figures (if any) which are used by the applicant as the basis to conclude that the genetically modified organisms do not negatively affect domestic animals.”

3. Within 07 working days after receiving applications, the Ministry of Agriculture and Rural Development shall notify its acceptance of valid applications to the applicant or request the applicant to supplement and complete these applications under regulations. The time for supplementation and completion will not be included in the time for appraisal of applications.

4. Within 180 working days from the date in which valid applications are received, the Ministry of Agriculture and Rural Development shall establish a Genetically Modified Animal Feed Safety Council to appraise such applications.” Regarding genetically modified organisms specified at Point b, Clause 1, Article 32 of this Decree, the maximum duration for issuance of such certification is 60 days.

5. After receiving valid applications, the Ministry of Agriculture and Rural Development shall publish information on the report on assessment of risks of genetically modified organisms to domestic animals on its website for public comment. Public comments shall be summarized and reported to the Genetically Modified Animal Feed Council Safety.  The maximum duration for collection of public comments is 30 days after information is published.

6. Within 30 days after obtaining appraisal results, the Minister of Agriculture and Rural Development shall examine them and grant a written certification of genetically modified organisms' eligibility for use as animal feed. In case of refusal, he/she shall issue a notice clearly stating the reason to the applicant.

7. An applicant for a certification of genetically modified organisms' eligibility for use as animal feed shall pay a charge for appraisal of applications. The Ministry of Finance shall take charge and cooperate with the Ministry of Agriculture and Rural Development in specifying charge, management and use of the charge for appraisal of applications.

8. The Ministry of Agriculture and Rural Development shall specify procedures for issuance of a certification of genetically modified organisms' eligibility for use as animal feed.

9. The Genetically Modified Animal Feed Safety Council shall advise the Minister of Agriculture and Rural Development to consider granting a written certification of genetically modified organisms’ eligibility for use as animal feed. This Council is composed of representatives of the Ministry of Industry and Trade; the Ministry of Science and Technology; the Ministry of Agriculture and Rural Development, the Ministry of Natural Resources and Environment, the Ministry of Health, and some experts.

The Minister of Agriculture and Rural Development shall decide to set up and define functions, tasks and operation mechanism of the Genetically Modified Animal Feed Safety Council.

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1. A certification of genetically modified organisms’ eligibility for use as animal feed shall be reissued in following cases:

a) Changes to information of the organization under issued certification of genetically modified organisms’ eligibility for use as animal feed;

b) Lost, damaged or worn-out certification of genetically modified organisms’ eligibility for use as animal feed.

2. An application for reissuance includes:

a) Written application for reissuance using Form No. 13 under Annex attached to this Decree;

b) Certification of genetically modified organisms’ eligibility for use as animal feed previously issued in case of changes to information on the organization or damaged or worn-out certification;

c) Documents proving changes for case specified under Point a Clause 1 of this Article.

3. The applicant shall submit 01 application for reissuance according to regulations of Clause 2 of this Article to the Ministry of Agriculture and Rural Development in person, by post or via the internet.

4. Within 07 working days from the date in which the application is received, the Ministry of Agriculture and Rural Development shall consider reissuing certification of genetically modified organisms’ eligibility for use as animal feed.

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1. A certification of genetically modified organisms' eligibility for use as animal feed shall be revoked in the following cases:

a) There is a new scientific proof of risks of genetically modified organisms that have been granted such certification:

b) The organization or individual intentionally provides untruthful information which is decisive to the issuance of such certification;

c) There is a proof that the Genetically Modified Animal Feed Safety Council's conclusions lack scientific grounds.

2. The Ministry of Agriculture and Rural Development shall decide to revoke a certification of genetically modified organisms' eligibility for use as animal feed and issue a written notice to the organization or individual having the revoke certification and publish the revocation in the mass media.

3. From the date of issuance of the decision on revocation of a certification of genetically modified organisms’ eligibility for use as animal feed, the organization or individual shall not use genetically modified organisms and products thereof as animal feed.

Article 35. Contents of a certification of genetically modified organisms’ eligibility for use as animal feed

1. A certification of genetically modified organisms’ eligibility for use as animal feed contains:

a) Names of genetically modified organisms: scientific names, common names, gene transmission events and sole identification numbers, if any;

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c) Specific requirements to ensure safety during the use of genetically modified organisms.

2. The Ministry of Agriculture and Rural Development shall stipulate the form of a certification of genetically modified organisms' eligibility for use as animal feed.

Article 36. List of genetically modified organisms granted a certification of eligibility for use as animal feed

1. The Ministry of Agriculture and Rural Development shall make a list of genetically modified organisms granted a certification of eligibility for use as animal feed and publish this list on its website.

2. Within 10 days after granting or revoking a certification of genetically modified organisms' eligibility for use as animal feed, the Ministry of Agriculture and Rural Development shall add or delete names of genetically modified organisms to or from such list.

Chapter VII

PRODUCTION, TRADE, IMPORT, EXPORT, TRANSPORTATION AND STORAGE OF GENETICALLY MODIFIED ORGANISMS AND PRODUCTS THEREOF

Article 37. Conditions for production and trade in genetically modified organisms for release

In addition to complying with laws on production and trade, organizations and individuals producing and trading genetically modified organisms for purposeful release (culture, growing or release) into the environment shall ensure that genetically modified organisms have been granted the biosafety certificate or have been present in the list of genetically modified organisms granted the biosafety certificate, except those specified in Article 24 of this Decree."

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In addition to complying with laws on food production and trading, organizations and individuals producing and trading genetically modified organisms or products of genetically modified organisms for use as food shall ensure that (i) genetically modified organisms have been granted the certification of eligibility for use as food or have been present in the list of genetically modified organisms granted that certification; (ii) products are made from genetically modified organisms which have been granted the certification of eligibility for use as food or have been present in the list of genetically modified organisms granted that certification, except those specified in Article 29 of this Decree."

Article 39. Conditions for production and trade in genetically modified organisms and products thereof for use as animal feed

In addition to complying with laws on animal feed production and trade, organizations and individuals producing and trading genetically modified organisms or products of genetically modified organisms for use as animal feed shall ensure that (i) genetically modified organisms have been granted the certification of eligibility for use as animal feed or have been present in the list of genetically modified organisms granted that certification; (ii) products are made from genetically modified organisms which have been granted the certification of eligibility for use as animal feed or have been present in the list of genetically modified organisms granted that certification, except those specified in Article 34 of this Decree.

Article 40. Import of genetically modified organisms and products thereof

1. Genetically modified organisms and products thereof imported into Vietnam for research shall be included in approved scientific research or technological development projects and such import has been approved in writing by competent authorities.

2. Regarding genetically modified organisms imported into Vietnam for assay, Licenses for assaying genetically modified organisms are required.

3. Genetically modified organisms and products of genetically modified organisms imported into Vietnam for release shall meet conditions specified in Article 37 of this Decree.  Genetically modified organisms and products thereof imported into Vietnam for use as food or animal feed or for being processed into food or animal feed shall satisfy the conditions specified in Articles 38 and 39 of this Decree.

4. (Annulled).

5. (Annulled).

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Export of genetically modified organisms and products thereof shall comply with Vietnamese law on goods export and international treaties to which the Socialist Republic of Vietnam is a signatory.

Article 42. Storage, packing and transportation of genetically modified organisms and products thereof

1. The storage, packing and transportation of genetically modified organisms that have been granted the biosafety certificate, the certification of genetically modified organisms' eligibility for use as food or the certification of genetically modified organisms' eligibility for use as animal feed, and products thereof shall comply with law.

2. The storage, packing and transportation of genetically modified organisms and products thereof other than those specified in Clause 1 of this Article shall take environmentally safe measures, not causing incidents or losses during transportation, and information thereon shall be provided according to Appendix I to this Decree.

In case incidents occur, organizations and individuals that store, pack or transport genetically modified organisms and products thereof shall collect and destroy them by appropriate measures, mark places where incidents occur and notify such incidents to the Ministry of Natural Resources and Environment, People's Committees of provinces where incidents occur and relevant line ministries for remedies.

3. In case of transporting and transiting genetically modified organisms or products of genetically modified organisms other than those specified under Clause 1 Article 42 of Decree No. 69/2010/ND-CP via Vietnam territory, transiting procedures shall comply with Point c Clause 1 Article 35 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government on elaboration of Law on Foreign Trade Management.”

4. The Ministry of Natural Resources and Environment shall specify storage, packing and transportation of genetically modified organisms and products thereof other than those specified in Clause 1 of this Article.

Chapter VIII

INFORMATION ON GENETICALLY MODIFIED ORGANISMS AND PRODUCTS THEREOF

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1. Organizations and individuals that circulate on the market goods containing genetically modified organisms or products thereof exceeding 5% of each constituent shall, apart from complying with the law on labeling goods, show information related to genetically modified organisms on the goods labels.

2. Line ministries shall take charge and cooperate with the Ministry of Science and Technology in provide specific guidance on labeling goods containing genetically modified organisms or products thereof under their management.

Article 44. Confidentiality of information on genetically modified organisms

1. Organizations and individuals that carry out activities related to genetically modified organisms may request line ministries to keep information in their dossiers.

2. Information requested by organizations and individuals to be kept confidential shall be recognized as necessary to be kept confidential under law by a council set up by a line ministry.

3. Competent state agencies shall keep information specified in Clause 1 of this Article confidential. Regarding organizations and individuals that have been granted protection titles for genetically modified organisms, information on such genetically modified organisms shall be kept confidential under the law on intellectual property.

Article 45. Publishing information on genetically modified organisms for the environment, biodiversity and health of humans and domestic animals

1. Information on genetically modified organisms other than those specified in Article 44 of this Decree shall be published on the biosafety website of the Natural Resources and Environment Ministry and websites of relevant line ministries.

2. Organizations or individuals providing information on genetically modified organisms shall take responsibility for the accuracy of such information.

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1. The Ministry of Natural Resources and Environment shall uniformly manage databases on genetically modified organisms and maintain a website on biosafety for genetically modified organisms.

2. Line ministries that manage databases on genetically modified organisms in the domains under their management shall provide and exchange information and data on genetically modified organisms to and with the Ministry of Natural Resources and Environment.

3. The People's Committees that manage databases on genetically modified organisms in their provinces shall provide information and data to the Ministry of Natural Resources and Environment.

4. The Ministry of Natural Resources and Environment shall provide specific guidance on exchange and provision of information specified in Clauses 1, 2 and 3 of this Article.

Chapter IX

IMPLEMENTATION PROVISIONS

Article 47. Implementation provisions

1. This Decree takes effect on August 10, 2010 and annuls the Prime Minister's Decision No. 212/2005/QD-TTg of August 26, 2005 on promulgation of the Regulation on biosafety management of genetically modified organisms and products and goods originating from genetically modified organisms.

2. Organizations and individuals licensed before the effective date of this Decree by competent state agencies to conduct activities of scientific research, technological development, assay or release into the environment of genetically modified organisms may continue these activities and shall register for re-licensing within one year after this Decree takes effect.

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CERTIFIED BY

PP. MINISTER
DEPUTY MINISTER




Vo Tuan Nhan