Decree No. 69/2010/NĐ-CP on biosafety for genetically modified organisms (GMOs), genetic material, and products derived from GMOs.

DECREE

On biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms

genetically modified organisms, genetic material, and products derived from genetically modified organisms

^{___________________________________________}

THE GOVERNMENT

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

The Prime Minister issues this Decision amending and supplementing certain provisions of the Regulation on Response Activities to Oil Spill Incidents issued together with Decision No. 02/2013/QĐ-TTg dated January 14, 2013 of the Prime Minister.

Pursuant to the Law on Biodiversity dated November 13, 2008;

CONSIDERING THE PROPOSAL OF THE MINISTER OF NATURAL RESOURCES AND ENVIRONMENT,

DECREE:

PART I

GENERAL PROVISIONS

This Decree stipulates on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms.

The management of biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms used as pharmaceuticals shall be carried out in accordance with the provisions of the Pharmaceutical Law.

Article 2. Applicability

This Decree applies to organizations and individuals within the country; foreign organizations and individuals (hereinafter referred to as organizations and individuals) engaged in activities related to genetically modified organisms, genetic material, and products derived from genetically modified organisms on the territory of the Socialist Republic of Vietnam.

Article 3. Explanation of Terms

In this Decree, the following terms are understood as follows:

1. A biosafety certificate is a document issued by a competent state agency certifying that a genetically modified organism is safe for the environment and biodiversity and is permitted to be released into the environment under specific conditions.

3. Donor organism means an organism providing the gene to be transferred to create a genetically modified organism.

4. Recipient organism means an organism receiving the transferred gene to create a genetically modified organism.

5. Biosafety refers to management measures to ensure safety for the environment, biodiversity, human health, and animal health.

1. Genetic material of genetically modified organisms capable of forming new individuals under natural conditions shall be managed in accordance with the provisions of the law on biosafety for genetically modified organisms.

2. Genetic material of genetically modified organisms incapable of forming new individuals under natural conditions shall be managed in accordance with the provisions of the law on biosafety for products derived from genetically modified organisms.

Chapter II

RISK ASSESSMENT AND RISK MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS

1. Risk assessment of genetically modified organisms must ensure scientific rigor and transparency; it shall be conducted using methods and techniques recognized by competent authorities both domestically and internationally.

2. Risk assessment of genetically modified organisms shall be conducted on a case-by-case basis depending on the genetically modified organism, its intended use, and the receiving environment.

3. Risks of genetically modified organisms shall be assessed based on the comparison of differences between the genetically modified organism and the recipient organism under the same conditions.

1. Identifying potential hazards and the likelihood of risks posed by genetically modified organisms to the environment, biodiversity, human health, and animal health.

2. Identifying safety measures to prevent, address, and mitigate risks posed by genetically modified organisms to the environment, biodiversity, human health, and animal health.

Clause 1. Information on the risk assessment of genetically modified organisms shall be reflected in the Report on risk assessment of genetically modified organisms for the environment, biodiversity, human health, and animal health.

Clause 2. The Report on risk assessment of genetically modified organisms for the environment, biodiversity, human health, and animal health shall be prepared according to the model prescribed in Appendix IV, Appendix V, and Appendix VI of this Decree.

Clause 3. The Report on risk assessment of genetically modified organisms for the environment, biodiversity, human health, and animal health must be reviewed by the competent state agency.

Clause 4. The Report on risk assessment of genetically modified organisms for the environment, biodiversity, human health, and animal health serves as the basis for issuing the Certificate of biosafety; the Certificate confirming that genetically modified organisms meet the conditions for use as food; the Certificate confirming that genetically modified organisms meet the conditions for use as animal feed.

Article 8. Responsibilities for managing risks of genetically modified organisms for the environment, biodiversity, human health, and animal health

Clause 1. Organizations and individuals engaged in scientific research, technological development; testing, production, business, import, export, transportation, storage of genetically modified organisms must implement risk management measures to ensure biosafety in accordance with the provisions of the law.

Clause 2. When a risk occurs, organizations and individuals must promptly implement measures to mitigate the risk and immediately report to the People's Committee of the province where the risk occurred.

Clause 3. Organizations and individuals who fail to comply with risk management measures will be subject to administrative penalties, criminal liability pursued, or compensation for damages depending on the level of violation, as provided by law.

Article 9. Inspection and supervision of the implementation of risk management measures for genetically modified organisms

Clause 1. Ministries and sectors in charge, People's Committees of provinces shall periodically or at random inspect and supervise the implementation of risk management measures for genetically modified organisms under their jurisdiction; promptly handle violations according to the provisions of the law.

Chapter III

RESEARCH AND DEVELOPMENT OF TECHNOLOGY ON GENETICALLY MODIFIED ORGANISMS, PRODUCTS OF GENETICALLY MODIFIED ORGANISMS

GEN MODIFICATION, PRODUCTS OF GENETICALLY MODIFIED ORGANISMS

Article 10. Requirements for scientific research and technological development activities on genetically modified organisms, products of genetically modified organisms

Clause 1. Scientific research and technological development activities on genetically modified organisms, products of genetically modified organisms must comply with current regulations on science and technology management and other relevant legal provisions.

Clause 2. Research activities creating, analyzing, and isolated testing genetically modified organisms, products of genetically modified organisms may only be conducted in a Genetically Modified Organism Research Laboratory recognized by the Ministry of Science and Technology in accordance with Articles 11 and 12 of this Decree.

Article 11. Conditions for Genetic Engineering Research Laboratories

1. Genetic engineering research laboratories must satisfy the following conditions:

a) Having specialized staff suitable for scientific research and technological development activities related to genetic engineering organisms and products derived from genetic engineering organisms;

b) Having equipment suitable for scientific research and technological development activities related to genetic engineering organisms and products derived from genetic engineering organisms;

c) Having laboratory operation procedures ensuring biosafety requirements.

2. The Ministry of Science and Technology shall provide detailed guidance on the contents stipulated in Clause 1 of this Article.

1. The Ministry of Science and Technology recognizes and revokes recognition decisions of genetic engineering research laboratories.

2. Organizations applying for recognition of genetic engineering research laboratories must submit three (03) sets of application files to the Ministry of Science and Technology. The application file includes:

a) An application form for recognizing genetic engineering research laboratories according to the model provided by the Ministry of Science and Technology;

b) Copies of decisions regarding the functions and tasks of the organization;

c) A description of the laboratory's capacity for genetic engineering research according to the model provided by the Ministry of Science and Technology;

d) Relevant documents proving that the genetic engineering research laboratory meets the conditions specified in Article 11 of this Decree.

3. Within seven working days from the date of receiving the application file, the Ministry of Science and Technology shall notify the organization whether the application file is accepted or requires supplementation and completion according to regulations; the time for supplementation and completion of the file does not count towards the review period.

4. Within forty-five days from the date of receiving a valid application file, the Ministry of Science and Technology shall organize a Review Board to examine the application file for recognizing genetic engineering research laboratories.

The Review Board's findings serve as the basis for the Minister of Science and Technology to decide on recognizing genetic engineering research laboratories.

5. Within thirty days from the date of receiving the review results, the Minister of Science and Technology shall consider and decide on recognizing genetic engineering research laboratories. In cases where recognition is not granted, the organization applying for recognition must be notified in writing with specific reasons stated.

6. The Ministry of Science and Technology shall provide detailed guidance on the procedures and formalities for recognizing genetic engineering research laboratories; periodically inspect the operations of genetic engineering research laboratories. If any condition stipulated in Article 11 of this Decree is violated, the Ministry of Science and Technology shall consider revoking the recognition decision for genetic engineering research laboratories.

Article 13. Biosafety for scientific research and technological development activities on genetically modified organisms (GMOs) and products derived from GMOs

1. Scientific research and technological development activities on GMOs and products derived from GMOs must be conducted within the framework of projects approved by competent authorities in accordance with the provisions of the law. In cases where research and development projects on GMOs created from donor and recipient organisms have the potential to significantly impact the environment, biodiversity, human health, and animal health, such projects must be permitted by the Ministry of Science and Technology.

3. Research laboratories dealing with GMOs must comply with biosafety regulations.

The Ministry of Science and Technology shall specify the biosafety content in research laboratories dealing with GMOs.

Chapter IV

FIELD TRIALS OF GENETICALLY MODIFIED ORGANISMS

1. Genetically modified organisms intended for release, including cultivation, planting, and intentional release into the environment, must undergo field trials.

2. Field trials of genetically modified organisms must be conducted in stages, from limited field trials to wide-scale field trials. The trial areas must be located away from conservation zones and densely populated areas as prescribed.

Limited field trials must be carried out under isolation conditions as prescribed.

Wide-scale field trials may be implemented in various ecological regions without requiring isolation but must have appropriate management and monitoring measures in place.

3. When genetically modified organisms pose risks to the environment, biodiversity, human health, and animal health that cannot be controlled, the entity holding the Field Trial Permit and the trial site must terminate the field trials of genetically modified organisms and implement emergency measures to address the risk, while destroying the genetically modified organisms.

4. The Ministry of Agriculture and Rural Development shall provide detailed guidance on the contents stipulated in Clause 2 of this Article.

1. Field trials of genetically modified organisms involve monitoring and evaluating the impacts of genetically modified organisms on the environment and biodiversity under specific conditions in Vietnam.

2. Field trials of genetically modified organisms include the following main contents:

a) Risk of becoming weeds or pests;

b) Risk of adverse effects on non-target organisms;

c) Risk of adversely affecting surrounding ecosystems;

d) Other adverse effects.

3. The Ministry of Agriculture and Rural Development shall provide detailed guidance on the contents stipulated in Clause 2 of this Article.

1. An organization recognized as a Field Trial Site for Genetically Modified Organisms must meet all of the following conditions:

a) Possess physical facilities, technical equipment, and tools suitable for field trials of genetically modified organisms;

b) Have specialized staff suitable for field trials of genetically modified organisms;

c) Have a trial process ensuring biosafety requirements.

2. The Ministry of Agriculture and Rural Development shall provide detailed guidance on the conditions for recognizing Field Trial Sites for Genetically Modified Organisms as stipulated in Clause 1 of this Article.

1. The Ministry of Agriculture and Rural Development shall recognize and revoke decisions recognizing Genetically Modified Organism Testing Facilities.

2. Organizations applying for recognition of Genetically Modified Organism Testing Facilities must submit three (03) sets of application files to the Ministry of Agriculture and Rural Development. The files include:

a) Application form for recognition of Genetically Modified Organism Testing Facilities;

b) A copy of the decision on the functions and tasks of the organization;

c) An explanation of the capabilities of the Genetically Modified Organism Testing Facility according to the model provided by the Ministry of Agriculture and Rural Development;

d) Relevant documents proving that the Genetically Modified Organism Testing Facility meets the conditions stipulated in Article 16 of this Decree.

3. Within seven working days from the date of receiving the application files, the Ministry of Agriculture and Rural Development shall notify the organization whether the application files are accepted or require supplementation and completion in accordance with regulations; the time for supplementation and completion of the files shall not be counted towards the time for reviewing the application files.

4. Within forty-five days from the date of receiving the complete application files, the Ministry of Agriculture and Rural Development shall organize a Review Board to review the application files for recognition of Genetically Modified Organism Testing Facilities.

The results of the Review Board's review shall serve as the basis for the Minister of Agriculture and Rural Development to decide on recognizing Genetically Modified Organism Testing Facilities.

5. Within thirty days from the date of the Review Board's results, the Minister of Agriculture and Rural Development shall consider and decide on recognizing Genetically Modified Organism Testing Facilities. In case of non-recognition, the Ministry must notify the organization applying for recognition in writing and specify the reasons.

6. The Ministry of Agriculture and Rural Development shall provide detailed guidance on the procedures and formalities for recognition and regularly inspect the activities of Genetically Modified Organism Testing Facilities. If there is a violation of any condition stipulated in Article 16 of this Decree, the Ministry of Agriculture and Rural Development shall consider revoking the recognition decision for Genetically Modified Organism Testing Facilities.

7. The Ministry of Agriculture and Rural Development shall inform the Ministry of Natural Resources and Environment and other relevant ministries managing related sectors about the recognition or revocation of the recognition decision for Genetically Modified Organism Testing Facilities.

1. The Ministry of Agriculture and Rural Development shall issue and revoke Research Permits for Genetically Modified Organisms.

2. Organizations and individuals applying for Research Permits for Genetically Modified Organisms must submit three (03) sets of application files to the Ministry of Agriculture and Rural Development. The files include:

a) Application form for issuing a Research Permit for Genetically Modified Organisms according to the model prescribed by the Ministry of Agriculture and Rural Development;

b) A description of the research plan for Genetically Modified Organisms including information specified in Appendix II of this Decree;

c) A research plan for Genetically Modified Organisms as prescribed in Appendix III of this Decree;

d) A copy of the decision recognizing the Genetically Modified Organism Testing Facility;

đ) In cases where Genetically Modified Organisms are imported for research purposes, proof must be provided that such organisms have been permitted for use by the exporting country for the same purpose within its territory. In cases where Genetically Modified Organisms are produced domestically, proof must be provided that such organisms are the result of scientific research recognized by competent state authorities.

e) A document from the Ministry of Agriculture and Rural Development recognizing the limited research results in cases of applying for wide-scale research.

3. Within seven working days from the date of receiving the application files, the Ministry of Agriculture and Rural Development shall notify the organizations and individuals applying for the permit whether the application files are accepted or require supplementation and completion in accordance with regulations; the time for supplementation and completion of the files shall not be counted towards the time for reviewing the application files.

4. Within sixty days from the date of receiving the complete application files, the Ministry of Agriculture and Rural Development shall organize a Review Board to review the application files for issuing Research Permits for Genetically Modified Organisms.

The results of the Review Board's review shall serve as the basis for the Minister of Agriculture and Rural Development to issue Research Permits for Genetically Modified Organisms.

5. Within thirty days from the date of the Review Board's results, the Minister of Agriculture and Rural Development shall consider issuing Research Permits for Genetically Modified Organisms. In case of refusal to issue a Research Permit for Genetically Modified Organisms, the Ministry of Agriculture and Rural Development shall notify the organizations and individuals applying for the permit in writing and specify the reasons.

6. The Ministry of Agriculture and Rural Development shall provide detailed guidance on the procedures and formalities for issuing Research Permits for Genetically Modified Organisms; regularly inspect compliance with requirements set out in Research Permits for Genetically Modified Organisms. In case of violation of any requirement in the Research Permit for Genetically Modified Organisms, the Ministry of Agriculture and Rural Development shall consider revoking the Research Permit for Genetically Modified Organisms.

7. The Ministry of Agriculture and Rural Development shall inform the Ministry of Natural Resources and Environment and other relevant ministries managing related sectors about the issuance or revocation of Research Permits for Genetically Modified Organisms.

8. Organizations and individuals applying for Research Permits for Genetically Modified Organisms must pay the application file review fee. The Ministry of Finance shall take the lead and coordinate with the Ministry of Agriculture and Rural Development to specify the amount of the fee, management, and use of the application file review fee for Research Permits for Genetically Modified Organisms.

1. The Gene Experiment Permit includes the following main contents:

a) Name of the gene-modified organism: scientific name, common name, gene transfer event and unique identification code, if applicable;

b) Time, location, and scale of the experiment;

c) Quantity and volume of the gene-modified organisms used for the experiment and the number of importations in cases where the gene-modified organisms are imported into Vietnam for experimentation;

d) Specific requirements for compliance with the approved Gene Experiment Plan.

2. The Ministry of Agriculture and Rural Development shall provide detailed regulations on the model of the Gene Experiment Permit.

1. Organizations and individuals granted the Gene Experiment Permit must comply with the provisions in the Permit and the approved Gene Experiment Plan; regularly report to the Ministry of Agriculture and Rural Development on the implementation status of the experiment according to the approved Experiment Plan.

2. After completing or ceasing the experiment, organizations and individuals granted the Gene Experiment Permit must implement measures to ensure biosafety.

3. Within sixty days from the completion date of the gene-modified organism experiment, organizations and individuals granted the Gene Experiment Permit must prepare a report on the results of the gene-modified organism experiment and submit it to the Ministry of Agriculture and Rural Development for recognition.

In cases where the experiment is ceased, within thirty days from the cessation date, organizations and individuals granted the Gene Experiment Permit must send a report on the experimental process and clearly state the reasons for ceasing the experiment to the Ministry of Agriculture and Rural Development.

4. Organizations and individuals granted the Gene Experiment Permit are responsible for the content of the report on the results of the gene-modified organism experiment and must provide data related to the gene-modified organism experiment to competent state agencies upon request.

Within sixty days from the receipt date of the report on the results of the gene-modified organism experiment, the Ministry of Agriculture and Rural Development will examine and recognize the results of the gene-modified organism experiment and notify the organization or individual who registered for the gene-modified organism experiment in writing; simultaneously notifying the Ministry of Natural Resources and Environment and the People's Committee of the province where the gene-modified organism experiment was conducted.

Chapter V

BIOSAFETY CERTIFICATE ISSUANCE

A gene-modified organism that meets the following conditions shall be issued a Biosafety Certificate:

1. The gene-modified organism has been tested under specific conditions in Vietnam. The results of the gene-modified organism experiment have been recognized by the Ministry of Agriculture and Rural Development as meeting the requirements.

2. The gene-modified organism has been concluded by the Biosafety Council as safe for the environment and biodiversity.

1. The Ministry of Natural Resources and Environment issues and revokes the Biosafety Certificate.

2. Organizations and individuals applying for the Biosafety Certificate must submit three (03) sets of application files to the Ministry of Natural Resources and Environment. The file includes:

a) An application form for the Biosafety Certificate according to the model prescribed by the Ministry of Natural Resources and Environment;

b) A report on the results of the experiment recognized by the Ministry of Agriculture and Rural Development as meeting the requirements;

c) A risk assessment report of the gene-modified organism for the environment and biodiversity as stipulated in Appendix IV of this Decree.

3. Within seven working days from the date of receiving the file, the Ministry of Natural Resources and Environment shall notify the organization or individual applying for the Biosafety Certificate about the acceptance of a valid file or request for supplementation and completion of the file in accordance with the regulations; the time for supplementation and completion of the file does not count towards the review period of the file.

4. Within one hundred eighty days from the date of receiving a valid file, the Ministry of Natural Resources and Environment shall organize the Biosafety Council to review the application file for the Biosafety Certificate.

5. After receiving a valid file, the Ministry of Natural Resources and Environment shall post information on the risk assessment report of the gene-modified organism for the environment and biodiversity on the electronic website on biosafety to solicit public opinions and compile a report for the Biosafety Council. The maximum time for soliciting public opinions is thirty days from the date of posting the information.

6. Within thirty days from the date of the review result, the Minister of the Ministry of Natural Resources and Environment shall consider issuing the Biosafety Certificate. If the issuance of the Biosafety Certificate is refused, the reason must be notified to the organization or individual applying for the Biosafety Certificate.

7. Organizations and individuals applying for the Biosafety Certificate must pay the registration fee for the Biosafety Certificate. The Ministry of Finance shall take the lead and coordinate with the Ministry of Natural Resources and Environment to specify the amount of the fee, management, and use of the fee for reviewing the application file for the Biosafety Certificate.

8. The Ministry of Natural Resources and Environment shall provide detailed procedures and formalities for issuing the Biosafety Certificate.

9. The Biosafety Council is an advisory body to the Minister of the Ministry of Natural Resources and Environment for issuing the Biosafety Certificate. The Biosafety Council includes representatives from the Ministries of Industry and Trade; Science and Technology; Agriculture and Rural Development; Natural Resources and Environment; Health, and some experts.

The Minister of the Ministry of Natural Resources and Environment decides to establish and specify the functions, tasks, and operational mechanisms of the Biosafety Council.

1. The Bio-safety Certificate shall be subject to revocation in the following cases:

a) There is new scientific evidence regarding the risks of genetically modified organisms that have been issued a Bio-safety Certificate;

b) Organizations or individuals intentionally provide false information that is crucial for issuing the Bio-safety Certificate;

c) There is evidence proving that the conclusion of the Bio-safety Council lacks scientific basis.

2. The Ministry of Natural Resources and Environment decides on the revocation of the Bio-safety Certificate; it shall notify in writing the organization or individual whose Bio-safety Certificate has been revoked and publish the information on mass media.

3. From the date of the decision to revoke the Bio-safety Certificate, organizations and individuals are not allowed to release genetically modified organisms into the environment that have had their Bio-safety Certificate revoked.

1. The Bio-safety Certificate includes the following main contents:

a) Name of the gene-modified organism: scientific name, common name, gene transfer event and unique identification code, if applicable;

b) Detailed information about the organization or individual applying for issuance of the Bio-safety Certificate;

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

2. The Ministry of Natural Resources and Environment prescribes the model of the Bio-safety Certificate.

1. The Ministry of Natural Resources and Environment compiles the List of Genetically Modified Organisms Issued with a Bio-safety Certificate and publishes the List on its electronic information website on bio-safety.

2. Within ten days from the date of issuance or revocation of the Bio-safety Certificate, the Ministry of Natural Resources and Environment supplements or deletes the name of the genetically modified organism in the List.

Chapter VI

GENETICALLY MODIFIED ORGANISMS MEETING THE CONDITIONS FOR USE

AS FOOD AND FEED

Section 1

GENETICALLY MODIFIED ORGANISMS MEETING THE CONDITIONS FOR USE AS FOOD

A genetically modified organism must meet one of the following conditions to be issued a certificate confirming it meets the conditions for use as food:

1. The genetically modified organism is assessed by the Genetically Modified Food Safety Council, which concludes that the genetically modified organism does not pose unmanageable risks to human health.

2. The genetically modified organism is permitted for use as food in at least five (05) developed countries and no risks have occurred in those countries.

1. The Ministry of Health issues and revokes the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food.

2. An organization or individual applying for issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food submits three (03) sets of application files to the Ministry of Health. The file includes:

a) An application form for issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food according to the model prescribed by the Ministry of Health;

b) A risk assessment report of the genetically modified organism concerning human health as stipulated in Appendix V of this Decree;

c) In the case of genetically modified organisms specified in Clause 2 of Article 27 of this Decree, there must be documentation proving that the genetically modified organism has been permitted for use as food in five (05) developed countries.

3. Within seven working days from the date of receipt of the application file, the Ministry of Health notifies the organization or individual applying for issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food about acceptance of a valid application or request for supplementation and completion of the application file according to regulations; the time for supplementation and completion of the application file is not counted towards the time for reviewing the application file.

4. Within 180 days from the date of receipt of a valid application file, the Ministry of Health organizes the Genetically Modified Food Safety Council to review the application file for issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food. In the case of genetically modified organisms specified in Clause 2 of Article 27 of this Decree, the maximum time for considering issuance or refusal of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food is 60 days.

5. After receiving a valid application file, the Ministry of Health posts information on the risk assessment report of the genetically modified organism concerning human health on its electronic information website to solicit public opinions and compile a report for the Genetically Modified Food Safety Council. The time for soliciting public opinions is a maximum of 30 days from the date of posting the information.

6. Within thirty days from the date of the review result, the Minister of Health considers issuing the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food. If the issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food is refused, the Ministry of Health shall notify the organization or individual applying for issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food and clearly state the reasons.

7. The organization or individual applying for issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food must pay the application file review fee. The Ministry of Finance, in coordination with the Ministry of Health, prescribes specific details on the fee amount, management, and use of the application file review fee.

8. The Ministry of Health prescribes specific procedures and formalities for issuing the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food.

9. The Genetically Modified Food Safety Council advises the Minister of Health on the issuance of the Certificate Confirming Genetic Modified Organisms Meeting the Conditions for Use as Food. The Genetically Modified Food Safety Council includes representatives from the Ministries of Industry and Trade, Science and Technology, Agriculture and Rural Development, Natural Resources and Environment, Health, and some experts.

The Minister of Health decides on the establishment of the Genetically Modified Food Safety Council and prescribes specific functions, tasks, and operational mechanisms of the Genetically Modified Food Safety Council.

1. The Certificate Confirming GMO Suitable for Food Use shall be considered for revocation in the following cases:

a) There is new scientific evidence regarding the risk of the GMO that has been issued with the Certificate Confirming GMO Suitable for Food Use;

b) Organizations or individuals intentionally provide false information that is decisive for issuing the Certificate Confirming GMO Suitable for Food Use;

c) There is evidence proving that the conclusion of the Food Safety Council on GMO lacks scientific basis.

2. The Ministry of Health decides to revoke the Certificate Confirming GMO Suitable for Food Use; notify in writing the organization or individual whose Certificate Confirming GMO Suitable for Food Use is revoked and publicize the information through mass media.

3. From the date of the decision to revoke the Certificate Confirming GMO Suitable for Food Use, organizations and individuals may not use the GMO or products derived from the GMO as food.

1. The Certificate Confirming GMO Suitable for Food Use includes the following main contents:

a) Name of the GMO: scientific name, common name, gene transfer event and unique identification code, if applicable;

b) Detailed information about the organization or individual applying for the Certificate Confirming GMO Suitable for Food Use;

c) Specific requirements to ensure safety during the use of the GMO.

2. The Ministry of Health prescribes the model of the Certificate Confirming GMO Suitable for Food Use.

1. The Ministry of Health establishes the List of GMOs granted Certificates Confirming GMO Suitable for Food Use and publishes the List on the Ministry of Health's electronic information website.

2. Within ten days from the date of issuance or revocation of the Certificate Confirming GMO Suitable for Food Use, the Ministry of Health supplements or deletes the name of the GMO in the List.

Section 2

GENETICALLY MODIFIED ORGANISMS MEETING THE CONDITIONS FOR USE USED FOR FEEDING ANIMALS

1. A GMO eligible for the Certificate Confirming GMO Suitable for Animal Feed Use must meet one of the following conditions:

a) The GMO has been reviewed by the Animal Feed Safety Council on GMO, which concludes that the GMO does not pose unmanageable risks to animals;

b) The GMO is permitted for use as animal feed in at least five (05) developed countries without any risks occurring in those countries.

2. In case the GMO has already been issued with the Certificate Confirming GMO Suitable for Food Use, then such GMO can be used as animal feed.

1. The Ministry of Agriculture and Rural Development shall issue and revoke certificates confirming genetically modified organisms suitable for use as livestock feed.

2. Organizations and individuals applying for certificates confirming genetically modified organisms suitable for use as livestock feed shall submit three (03) sets of application files to the Ministry of Agriculture and Rural Development. The application file shall include:

a) An application form for issuing certificates confirming genetically modified organisms suitable for use as livestock feed as prescribed by the Ministry of Agriculture and Rural Development;

b) A risk assessment report on genetically modified organisms concerning livestock as stipulated in Appendix VI of this Decree;

c) In cases where genetically modified organisms are specified in point b, Clause 1, Article 32 of this Decree, there must be documentation proving that the genetically modified organisms have been permitted for use as livestock feed in five (05) developed countries.

3. Within seven working days from the date of receipt of the application file, the Ministry of Agriculture and Rural Development shall notify organizations and individuals applying for certificates confirming genetically modified organisms suitable for use as livestock feed about the acceptance of the valid application file or request for supplementary and completion of the application file according to regulations; the time for supplementary and completion of the application file shall not be counted towards the time for reviewing the application file.

4. Within 180 days from the date of receipt of the valid application file, the Ministry of Agriculture and Rural Development shall organize a Genetically Modified Livestock Feed Safety Council to review the application file for issuing certificates confirming genetically modified organisms suitable for use as livestock feed. In cases where genetically modified organisms fall under the objects specified in point b, Clause 1, Article 32 of this Decree, the maximum time for considering the issuance of certificates confirming genetically modified organisms suitable for use as livestock feed is 60 days.

5. After receiving the valid application file, the Ministry of Agriculture and Rural Development shall post information on the risk assessment report on genetically modified organisms concerning livestock on its electronic information website to solicit public opinions and compile reports for the Genetically Modified Livestock Feed Safety Council. The time for soliciting public opinions shall not exceed thirty days from the date of posting the information.

6. Within thirty days from the date of the review results, the Minister of Agriculture and Rural Development shall consider issuing certificates confirming genetically modified organisms suitable for use as livestock feed. If the issuance of certificates confirming genetically modified organisms suitable for use as livestock feed is refused, the Ministry of Agriculture and Rural Development shall notify the organizations and individuals applying for certificates confirming genetically modified organisms suitable for use as livestock feed and specify the reasons.

7. Organizations and individuals applying for certificates confirming genetically modified organisms suitable for use as livestock feed shall pay the application file review fee. The Ministry of Finance shall take the lead and coordinate with the Ministry of Agriculture and Rural Development to specifically define the amount of the fee, management, and use of the application file review fee.

8. The Ministry of Agriculture and Rural Development shall specifically define the procedure and formalities for issuing certificates confirming genetically modified organisms suitable for use as livestock feed.

9. The Genetically Modified Livestock Feed Safety Council shall advise the Minister of Agriculture and Rural Development on issuing certificates confirming genetically modified organisms suitable for use as livestock feed. The Genetically Modified Livestock Feed Safety Council includes representatives from the Ministries of Industry and Trade, Science and Technology, Agriculture and Rural Development, Natural Resources and Environment, Health, and some experts.

The Minister of Agriculture and Rural Development shall decide on the establishment and specifically define the functions, tasks, and operational mechanisms of the Genetically Modified Livestock Feed Safety Council.

1. The Certificate Confirming GMO Suitable for Use as Livestock Feed shall be subject to revocation in the following cases:

a) There is new scientific evidence regarding the risk of the GMO that has been issued with the Certificate Confirming GMO Suitable for Use as Livestock Feed.

b) Organizations or individuals intentionally provide false information that is critical to the issuance of the Certificate Confirming GMO Suitable for Use as Livestock Feed.

c) There is evidence proving that the conclusion of the Livestock Feed Safety Council on genetically modified organisms lacks scientific basis.

2. The Ministry of Agriculture and Rural Development decides to revoke the Certificate Confirming GMO Suitable for Use as Livestock Feed; notify in writing the organization or individual whose Certificate Confirming GMO Suitable for Use as Livestock Feed has been revoked and publicize this information through mass media.

3. From the date of the decision to revoke the Certificate Confirming GMO Suitable for Use as Livestock Feed, organizations and individuals may not use GMOs or products derived from GMOs as livestock feed.

1. The Certificate Confirming GMO Suitable for Use as Livestock Feed includes the following main contents:

a) Name of the GMO: scientific name, common name, gene transfer event and unique identification code, if applicable;

b) Detailed information about the organization or individual applying for the Certificate Confirming GMO Suitable for Use as Livestock Feed.

c) Specific requirements to ensure safety during the use of GMOs.

2. The Ministry of Agriculture and Rural Development stipulates the format of the Certificate Confirming GMO Suitable for Use as Livestock Feed.

1. The Ministry of Agriculture and Rural Development establishes the List of GMOs granted Certificates Confirming Suitability for Use as Livestock Feed and publishes the List on its electronic information website.

2. Within ten days from the date of issuance or revocation of the Certificate Confirming GMO Suitable for Use as Livestock Feed, the Ministry of Agriculture and Rural Development supplements or deletes the name of the GMO from the List.

Chapter VII

PRODUCTION, BUSINESS, IMPORT, EXPORT TRANSPORTATION AND STORAGE OF GMOs, PRODUCTS DERIVED FROM GMOs

Organizations or individuals producing and trading GMOs intended for deliberate release (cultivation, planting, release) into the environment must meet the following conditions:

1. The GMO has been issued a Biosafety Certificate or is listed in the List of GMOs granted Biosafety Certificates, except as provided for in Article 24 of this Decree.

2. Comply with legal regulations on production and business.

Organizations and individuals producing and trading GMOs and products derived from GMOs used as food must comply with the following conditions:

1. The GMO has been issued a Certificate confirming its suitability for use as food or is listed in the Catalogue of GMOs issued a Certificate confirming their suitability for use as food; products derived from such GMOs that have been issued a Certificate confirming their suitability for use as food or are listed in the Catalogue of GMOs issued a Certificate confirming their suitability for use as food, except in cases provided for in Article 29 of this Decree;

2. Comply with the provisions of laws on production and trade of food.

Organizations and individuals producing and trading GMOs and products derived from GMOs used as animal feed must comply with the following conditions:

1. The GMO has been issued a Certificate confirming its suitability for use as animal feed or is listed in the Catalogue of GMOs issued a Certificate confirming their suitability for use as animal feed; products derived from such GMOs that have been issued a Certificate confirming their suitability for use as animal feed or are listed in the Catalogue of GMOs issued a Certificate confirming their suitability for use as animal feed, except in cases provided for in Article 34 of this Decree;

2. Comply with the provisions of laws on production and trade of animal feed.

Article 40. Importation of genetically modified organisms (GMOs) and products derived from GMOs

1. GMOs and products derived from GMOs imported into Vietnam for research purposes must belong to scientific research topics or projects approved by competent authorities and permitted for importation in writing.

2. GMOs imported into Vietnam for field trials must have a Field Trial Permit for GMOs.

3. GMOs imported into Vietnam for release must have a Biosafety Certificate or be listed in the Catalogue of GMOs issued a Biosafety Certificate.

5. Procedures for importing GMOs and products derived from GMOs shall be carried out in accordance with the provisions of laws.

Article 41. Exportation of genetically modified organisms (GMOs) and products derived from GMOs

The exportation of GMOs and products derived from GMOs must comply with the provisions of laws on exportation of goods in Vietnam and international treaties to which the Socialist Republic of Vietnam is a member.

1. The storage, packaging, and transport of genetically modified organisms that have been issued a Biosafety Certificate, a Confirmation of Genetically Modified Organism Suitable for Food Use, a Confirmation of Genetically Modified Organism Suitable for Animal Feed Use, and products derived from such organisms must comply with the provisions of the law.

2. The storage, packaging, and transport of genetically modified organisms and products derived therefrom not covered under Clause 1 of this Article must ensure environmental safety measures, prevent accidents and loss during transportation, and provide information as prescribed in Appendix I of this Decree.

In case of an accident, the organization or individual responsible for storage, packaging, and transport shall be responsible for collecting and destroying the affected material using appropriate methods, marking the location of the accident, and reporting to the Ministry of Natural Resources and Environment, the People's Committee of the province where the accident occurred, and the relevant sectoral management ministry to take remedial measures.

3. In cases where genetically modified organisms and products derived therefrom not covered under Clause 1 of this Article are transported through Vietnam's territory and require unloading at a port, the consignor must submit a document containing the information prescribed in Appendix I of this Decree to the Ministry of Natural Resources and Environment for review and approval. Customs clearance procedures will only be carried out after approval by the Ministry of Natural Resources and Environment.

4. The Ministry of Natural Resources and Environment shall specify detailed regulations on the storage, packaging, and transport of genetically modified organisms and products derived therefrom not covered under Clause 1 of this Article.

Chapter VIII

INFORMATION ON GENETICALLY MODIFIED ORGANISMS AND PRODUCTS OF GENETICALLY MODIFIED ORGANISMS

Article 43. Labeling of Goods Containing Genetically Modified Organisms and Products Derived Therefrom

1. Organizations and individuals circulating goods containing genetically modified organisms and products derived therefrom on the market at a rate exceeding 5% of each component must, in addition to complying with the provisions of the law on labeling of goods, also indicate information related to genetically modified organisms on the product label.

2. The sectoral management ministry shall lead and coordinate with the Ministry of Science and Technology to issue detailed guidelines on the labeling of goods containing genetically modified organisms and products derived therefrom within their respective areas of management.

Article 44. Confidentiality of Information on Genetically Modified Organisms

1. Organizations and individuals conducting activities related to genetically modified organisms may request the sectoral management ministry to keep confidential the information contained in the dossier.

2. Information requested to be kept confidential by organizations and individuals must be recognized by the Council established by the sectoral management ministry as confidential information according to the law.

3. Competent state agencies must implement confidentiality of the information specified in Clause 1 of this Article. If an organization or individual has been granted intellectual property protection for a genetically modified organism, the confidentiality of the information about that genetically modified organism shall be implemented in accordance with the law on intellectual property.

Article 45. Disclosure of information on genetically modified organisms concerning the environment, biodiversity, human and animal health

2. Organizations and individuals providing information on genetically modified organisms shall be responsible for the accuracy of the provided information.

1. The Ministry of Natural Resources and Environment shall uniformly manage the database on genetically modified organisms; maintain the electronic information website on biosafety concerning genetically modified organisms.

2. Sectoral ministries managing the database on genetically modified organisms according to their respective areas of management shall be responsible for providing and exchanging information and data on genetically modified organisms with the Ministry of Natural Resources and Environment.

3. Provincial People's Committees shall manage the database on genetically modified organisms within their jurisdiction and be responsible for providing information and data to the Ministry of Natural Resources and Environment.

4. The Ministry of Natural Resources and Environment shall provide detailed guidance on the exchange and provision of information as stipulated in Clause 1, Clause 2, and Clause 3 of this Article.

Chapter IX

IMPLEMENTING PROVISIONS

Article 47. Implementation Provisions

1. This Decree takes effect from August 10, 2010, and revokes Decision No. 212/2005/QĐ-TTg dated August 26, 2005 of the Government Chairman on the issuance of regulations on the management of biosafety concerning genetically modified organisms; products and goods derived from genetically modified organisms.

2. Organizations and individuals permitted by competent state agencies to conduct scientific research, develop technology, trial, and release genetically modified organisms into the environment before the effective date of this Decree may continue to implement these activities and reapply for permits within a period not exceeding one year from the effective date of this Decree.

3. Relevant sectoral ministries within the scope of their functions and tasks shall provide detailed guidance on the implementation of this Decree./.