Decree No. 43/2026/NĐ-CP Amending and supplementing some articles of decrees in the field of natural conservation and biodiversity.

DECREE

AMENDING AND SUPPLEMENTING CERTAIN ARTICLES OF DECREE

IN THE FIELD OF NATURAL CONSERVATION AND BIODIVERSITY

 Pursuant to the Law on Government Organization No. 63/2025/QH15;

Pursuant to the Law on Biodiversity No. 20/2008/QH12 amended and supplemented by Law No. 35/2018/QH14 and Law No. 146/2025/QH15; THE GOVERNMENT ISSUES THE DECREE AMENDING AND SUPPLEMENTING CERTAIN ARTICLES OF DECREES IN THE FIELD OF NATURAL CONSERVATION AND BIODIVERSITY.

At the proposal of the Minister of Agriculture and Rural Development;

AMENDING AND SUPPLEMENTING

PART I

CERTAIN ARTICLES OF DECREE NO. 65/2010/NĐ-CP OF THE GOVERNMENT DATED JUNE 11, 2010 PROVIDING DETAILS AND GUIDELINES FOR IMPLEMENTATION OF CERTAIN PROVISIONS OF THE LAW ON BIODIVERSITY AMENDED AND COMPLEMENTED BY,DECREE NO. 59/2017/NĐ-CPOF THE GOVERNMENT DATED MAY 12, 2017 ON MANAGEMENT OF ACCESS TO GENETIC RESOURCES AND SHARING BENEFITS FROM THE USE OF GENETIC RESOURCESAMENDING AND SUPPLEMENTING ARTICLE 8 AS FOLLOWS: 

Article 1. "ARTICLE 8. ESTABLISHMENT OF NATIONAL CONSERVATION AREAS

1. PRINCIPLES OF ESTABLISHMENT:

a) There must be an establishment project consistent with the overall biodiversity conservation plan, forestry planning, fishery resource protection and exploitation planning, and provincial planning approved by the competent authority;

b) Meet the criteria for establishing national conservation areas as stipulated in Article 17, Clause 2 of Article 18, Clause 2 of Article 19, Clause 2 of Article 20 of the Law on Biodiversity and other criteria prescribed by specialized laws.

2. AUTHORITY TO ESTABLISH:

a) The People's Committee of the province shall organize the preparation and review of the establishment project for a national conservation area within its administrative jurisdiction; the Chairman of the People's Committee of the province shall decide to establish a national conservation area within its administrative jurisdiction;

b) The Ministry of Agriculture and Rural Development shall organize the preparation and review of the establishment project for a national conservation area covering an area from two provinces or centrally-administered cities and above in the forestry and wetland sectors; the Minister of Agriculture and Rural Development shall decide to establish a national conservation area covering an area from two provinces or centrally-administered cities and above in the forestry and wetland sectors;

c) The organization responsible for preparing, reviewing the project file, and deciding to establish a marine conservation area shall comply with the provisions of the law on fisheries.

3. CONTENT OF THE ESTABLISHMENT PROJECT SHALL BE IMPLEMENTED IN ACCORDANCE WITH THE PROVISIONS OF Article 21 of the Law on Biodiversity or the provisions of the forestry law or the fisheries law.

4. DOCUMENTATION FOR THE ESTABLISHMENT OF A NATIONAL CONSERVATION AREA SHALL BE IMPLEMENTED IN ACCORDANCE WITH THE PROVISIONS OF Clause 3 of Article 22 of the Law on Biodiversity or the provisions of the forestry law or the fisheries law.

5. PROCEDURES FOR REVIEWING THE ESTABLISHMENT PROJECT AND DECIDING TO ESTABLISH A CONSERVATION AREA SHALL BE IMPLEMENTED IN ACCORDANCE WITH THE PROVISIONS OF THE LAW ON BIODIVERSITY OR THE FORESTRY LAW OR THE FISHERIES LAW.

6. CONTENT OF THE DECISION TO ESTABLISH A NATIONAL CONSERVATION AREA SHALL BE IMPLEMENTED IN ACCORDANCE WITH THE PROVISIONS OF Clause 2 of Article 23 of the Law on Biodiversity."

AMENDING AND SUPPLEMENTING ARTICLE 9 AS FOLLOWS:

Article 2. "ARTICLE 9. RESPONSIBILITIES FOR MANAGING CONSERVATION AREAS:

1. The People's Committee of the province shall manage the conservation area within its administrative jurisdiction.

2. The Ministry of Agriculture and Rural Development shall manage the national conservation area covering an area from two provinces or centrally-administered cities and above."

REPLACING THE PHRASE AT POINT d CLAUSE 2 ARTICLE 10 AS FOLLOWS:

Article 3.Replacing the phrase "law on forest protection and development" with the phrase "forestry law".

AMENDING AND SUPPLEMENTING CERTAIN ARTICLES OF DECREE NO. 69

Chapter II

/2010/NĐ-CPDATED SEPTEMBER 21YEAR2010 OF THE GOVERNMENT ON BIOLOGICAL SAFETY FOR GENETICALLY MODIFIED ORGANISMS, GERMLINE MATERIALS, AND PRODUCTS OF GENETICALLY MODIFIED ORGANISMS6AMENDED AND COMPLEMENTED BY DECREE NO. 123/208/NĐ-CP DATED SEPTEMBER 17, YEAR 2018 OF THE GOVERNMENT AMENDING AND SUPPLEMENTING1CERTAIN PROVISIONS ON CONDITIONS FOR INVESTMENT AND BUSINESS IN THE AGRICULTURE SECTORAMENDING AND SUPPLEMENTING ARTICLE 1 AS FOLLOWS: This Decree provides for biological safety for genetically modified organisms, gene-edited organisms, germinal materials, and products of genetically modified organisms.The management of biological safety for genetically modified organisms, germinal materials, and products of genetically modified organisms used as drugs and veterinary medicines shall be carried out in accordance with the provisions of the drug and veterinary medicine laws."

Article 4. AMENDING AND SUPPLEMENTING CLAUSE 2 OF ARTICLE 3

"Article 1. Scope of Regulation

"2. Products of genetically modified organisms are products created from genetically modified organisms containing genetic material or proteins from genetically modified genes."

ADDING ARTICLE 4a AFTER ARTICLE

Article 5. "ARTICLE 4a. IDENTIFICATION AND MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS AND GENE-EDITED ORGANISMS as follows:

1. IDENTIFICATION OF GENETICALLY MODIFIED ORGANISMS AND GENE-EDITED ORGANISMS

Article 6. a) The owner shall carry out the identification of genetically modified organisms and gene-edited organisms. In case it is identified as a genetically modified organism, risk assessment and risk management shall be conducted in accordance with the regulations; in case it is identified as a gene-edited organism, a report shall be submitted to the Ministry of Agriculture and Rural Development in accordance with Model No. 01 of Appendix I issued together with this Decree;b) The owner of a gene-edited organism shall be responsible for retaining related documents for a period of ten years from the date of publication. 4 as follows:

2. MANAGEMENT OF GENETICALLY MODIFIED ORGANISMS AND GENE-EDITED ORGANISMS

a) Management of genetically modified organisms includes risk assessment and risk management in accordance with Chapters II, III, IV, V, VI, and VII of Decree No. 69/2010/NĐ-CP amended and supplemented by this Decree;

b) Gene-edited organisms shall be managed in accordance with the provisions of this clause and relevant specialized laws."

AMENDING AND SUPPLEMENTING CLAUSE 4 OF ARTICLE 5 AS FOLLOWS:

4. Risk assessment shall not be repeated for genetically modified organisms that are the result of traditional crossbreeding from two or more genetically modified events already granted a Certificate of Biological Safety or a Certificate of Genetically Modified Organism Suitable for Food or Feed Use."

ARTICLE 12 AS FOLLOWS:

b) Gen-edited organisms shall be managed in accordance with the provisions of Clause 1 of this Article and relevant specialized laws.”

Article 7. Amend and supplement Clause 4 of Article 5 as follows:

“4. There shall be no re-risk assessment for genetically modified organisms resulting from traditional breeding processes involving two or more gene transfer events that have already been issued with a Biosafety Certificate or a Confirmation of Genetically Modified Organism Suitable for Food and Feed Use.”

Article 8. AmendingsupplementArticle 12 as follows:

“Article 12. Recognition of Genetically Modified Organism Research Laboratories

1. The Ministry of Science and Technology shall recognize or revoke the Decision recognizing Genetically Modified Organism Research Laboratories.

2. "The Minister of the Ministry of Science and Technology shall stipulate this provision."

Article 9. Amend and supplement Clause 2 of Article 13 as follows:

“2. The description of scientific and technological tasks and innovation on genetically modified organisms and products of genetically modified organisms must include biosafety content. In cases where research projects require the importation of genetically modified organisms for scientific research and technology development, the project descriptions must provide information according to Model No. 02 attached as Appendix I to this Decree.”

Article 10. Amend and supplement Article 14 as follows:

"Article 14. Principles for the conduct of field trials of genetically modified organisms

1. Genetically modified organisms must be tested before being intentionally raised, cultivated, or released into the environment.

2. Field trial facilities for genetically modified organisms must meet requirements as prescribed in Article 16 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 12 of this Decree.

3. Field trials of genetically modified organisms must be conducted in stages, from narrow-scale trials to wide-scale trials in accordance with the Field Trial Permit issued by the competent authority.

4. When genetically modified organisms pose risks to the environment, biodiversity, human health, and livestock that cannot be controlled, the organization holding the Field Trial Permit for genetically modified organisms must immediately notify the local authorities at the commune level where the trial is being conducted and the Ministry of Agriculture and Rural Development to take timely action."

Article 11. Amend and supplement Article 15 as follows:

"Article 15. Content of field trials of genetically modified organisms

1. Field trials of genetically modified organisms involve monitoring and evaluating the impact of genetically modified organisms on the environment and biodiversity under specific conditions in Vietnam. Field trials of genetically modified crops include narrow-scale trials and wide-scale trials:

a) Narrow-scale trials are conducted under isolation conditions to ensure the maintenance of risk control and management. Narrow-scale trials must be carried out for at least two consecutive short-term crop cycles or one growth cycle for long-term crops;

b) Wide-scale trials are conducted under expanded conditions across various ecological zones to assess the impact of genetically modified organisms. Wide-scale trials must be conducted for at least one short-term crop cycle or one growth cycle for long-term crops.

2. Field trials of genetically modified organisms include evaluations of:

a) Risk of becoming harmful organisms;

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

c) Risk of unfavorable changes to surrounding ecosystems. For genetically modified crops, this includes assessing impacts on soil ecosystems and evaluating the effects of cultivation practices for genetically modified crops on the environment and biodiversity;

d) Risk of gene flow;

e) Other adverse impacts on human health, livestock, the environment, and biodiversity."

Article 12. Amend and supplement Article 16 as follows:

"Article 16. Requirements for Biotech Testing Facilities

1. Possess material resources, technical facilities, and equipment to conduct biotech testing activities registered for testing.

2. For plant biotech testing facilities, the following requirements must be met:

a) For narrow-scale testing: have greenhouses or glasshouses or isolated areas that ensure preventing the spread of genetically modified plants and genetic samples of genetically modified plants to the external environment; have surrounding fences ensuring prevention of unauthorized entry by people and animals; the area of the testing site depends on the content of each experiment but shall not exceed 500 m² for one narrow-scale testing;

b) For large-scale testing: have testing sites suitable for the growth and development conditions of the tested crop species; the total area of large-scale testing points shall not exceed 02 ha/crop season for agricultural crops.

3. Have staff trained professionally and with experience appropriate to the registered biotech testing activities. In the case of plant biotech testing, the testing facility must have specialized staff:

a) Hold a bachelor's degree or higher in one of the fields of crop production, genetics-breeding, biotechnology, plant protection, or related fields;

b) Have practical experience in plant biotech testing and have been trained in risk management during testing.

4. Have risk management plans, monitoring, and emergency response measures for the environment, biodiversity, human and animal health during the testing process."

Article 13. Amend and supplement Article 18 as follows:

"Article 18. Issuance, Reissuance, and Revocation of Biotech Testing Permits

1. The Minister of Agriculture and Rural Development decides on the issuance, reissuance, and revocation of biotech testing permits.

2. Organizations and individuals eligible to register for biotech testing include:

a) Genetically modified organisms created from the results of scientific research accepted by competent state authorities;

b) Genetically modified organisms that have been issued release permits by the exporting country.

3. Paper or digital files, including:

a) Original Application Form for Risk Assessment of Genetically Modified Organisms Testing according to Model No. 03 attached as Appendix I to this Decree;

b) Original Registration Description Form for Testing according to Model No. 04 attached as Appendix I to this Decree;

c) Copy of Patent Certificate, decision recognizing scientific research results, or documentation proving ownership of genetically modified organisms created from the results of scientific research accepted by competent state authorities in the case stipulated in point a, Clause 2 of this Article;

d) Copy of release permit for the case stipulated in point b, Clause 2 of this Article;

e) Original Description of the Testing Facility’s Capacity for Genetically Modified Organisms.

4. Procedure for implementation:

a) Organizations and individuals submit one set of files as prescribed in Clause 3 of this Article to the Ministry of Agriculture and Rural Development through one of the following methods: Directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal;

b) The Ministry of Agriculture and Rural Development checks and accepts the file immediately when it ensures completeness for direct submission; checks and accepts the file within one working day for submissions via postal service or online at the National Public Service Portal, if the file is not valid, they respond in writing and specify the reasons;

c) Within five working days from receiving valid files, the Minister of Agriculture and Rural Development establishes a Biosafety Council;

d) Within twenty working days from establishment, the Council organizes meetings, conducts field inspections (if necessary), completes the report on the assessment of the file according to Model No. 05 attached as Appendix I to this Decree, and sends it to the specialized agency assigned by the Ministry of Agriculture and Rural Development to present to the Minister of Agriculture and Rural Development for decision.

If the Council requests organizations and individuals to provide additional information or explanations, the specialized agency sends a request in writing but not exceeding fourteen working days for foreign organizations and individuals, and not exceeding five working days for domestic organizations and individuals. After the time limit for providing additional information or explanations, the Ministry of Agriculture and Rural Development continues to assess based on the current file. The time for providing additional information or explanations does not count towards the file assessment period;

e) Within five working days from receiving the Biosafety Council's report and the file as prescribed in Clause 3 of this Article, the Minister of Agriculture and Rural Development issues a biotech testing permit in paper or electronic form according to Model No. 06 attached as Appendix I to this Decree; if not issued, they respond in writing and specify the reasons.

5. Reissue of Biotech Testing Permit

a) A biotech testing permit can be reissued in cases where there is a change in information about the organization holding the biotech testing permit;

b) Paper or digital files, including:

Original Application Form for Reissuing a Biotech Testing Permit according to Model No. 07 attached as Appendix I to this Decree.

Copy of documentation proving the content of the change in information about the organization holding the biotech testing permit;

c) Procedure:

Organizations and individuals submit one set of reissue files as prescribed in point b of this clause to the Ministry of Agriculture and Rural Development through one of the following methods: Directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal.

The Ministry of Agriculture and Rural Development shall immediately examine and accept the file when it ensures completeness for cases submitted directly; examine and accept the file within 01 working day when it ensures completeness for cases submitted through postal services or online at the National Public Service Portal; if the file is not valid, reply in writing and specify the reasons.

Within 07 working days from the date of receiving complete valid files, the Minister of Agriculture and Rural Development decides to reissue the Gene Experimentation Permit in paper or electronic form; if not reissued, reply in writing and specify the reasons.

6. Revocation of the Gene Experimentation Permit

Within 05 working days from the date of identifying a violation in one of the following cases: providing incorrect information about genetically modified organisms or failing to comply with the contents approved by the competent authority or failing to meet one of the requirements stipulated in Article 16 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 12 of this Decree, the Minister of Agriculture and Rural Development decides to revoke the Gene Experimentation Permit in paper or electronic form.

7. The Ministry of Agriculture and Rural Development shall publicly disclose information on issuing, reissuing, and revoking the Gene Experimentation Permit on the Ministry's Electronic Information Website.

Article 14. Amend and supplement Article 20 as follows:

"Article 20. Risk Management in Genetically Modified Organism Experimentation

1. Transporting, packaging, labeling genetically modified organisms and genetic material of genetically modified organisms during experimentation

a) Genetically modified organisms and genetic material of genetically modified organisms imported for experimentation must be inspected according to regulations and ensure transportation, packaging, and labeling requirements;

b) Genetically modified organisms and genetic material of genetically modified organisms during transportation must be separately packaged and clearly labeled;

c) In case of damage or breakage during transportation, the organization holding the Gene Experimentation Permit must recover all materials and destroy them using appropriate methods, mark the location of the incident for monitoring and thorough handling, and report to the Ministry of Agriculture and Rural Development;

d) The organization holding the Gene Experimentation Permit must complete the transport tracking form as prescribed in Form No. 08 of Appendix I issued together with this Decree.

2. Storing and preserving genetically modified organisms and genetic material of genetically modified organisms during experimentation

a) Genetically modified organisms and genetic material of genetically modified organisms must be stored and preserved under safe conditions unaffected by external factors;

b) The storage area for genetically modified organisms and genetic material of genetically modified organisms must be clearly labeled;

c) The organization holding the Gene Experimentation Permit is responsible for regularly inspecting and inventorying the storage and preservation process. Inspection and inventory results must be kept in the storage and preservation file of genetically modified organisms and genetic material of genetically modified organisms;

d) In case of incidents, the organization holding the Gene Experimentation Permit must recover all materials and destroy them using appropriate methods, mark the location of the incident for monitoring and thorough handling, and report to the Ministry of Agriculture and Rural Development as prescribed in Form No. 09 of Appendix I issued under this Decree.

3. Implement isolation measures for genetically modified organisms and genetic material of genetically modified organisms during experimentation: Genetically modified organisms being experimented upon must be isolated from the same species in nearby areas. For genetically modified crops, isolation measures proposed in the experimentation plan must be suitable for each plant subject, as follows:

a) Spatial isolation: Genetically modified crop experimental fields must be spatially isolated from the same species or related species. Isolation distance depends on the reproductive characteristics of the experimental plant and is proposed in the experimentation plan. The organization holding the Gene Experimentation Permit is responsible for inspecting and removing the same species or related species within the isolation range using appropriate methods and completing the spatial isolation tracking form as prescribed in Form No. 10 of Appendix I issued together with this Decree;

b) Temporal isolation: Genetically modified plants are temporally isolated by planting experimental plants earlier or later than other plants of the same or related species in the vicinity, so that the flowering and pollination period of the experimental plants does not coincide with those of the same or related species. The organization holding the Gene Experimentation Permit is responsible for inspecting and removing the same species or related species within the isolation range if temporal isolation is not ensured, using appropriate methods and completing the temporal isolation tracking form as prescribed in Form No. 11 of Appendix I issued together with this Decree.

4. Risk management at the end of experimentation

a) Genetically modified organisms and genetic material of genetically modified organisms after experimentation must be destroyed using appropriate methods, except for retention for subsequent research;

b) In case genetically modified organisms and genetic material of genetically modified organisms obtained from experimentation are used as food or animal feed, there must be a certificate confirming compliance with food and animal feed standards and ensuring the processing of genetically modified organisms and genetic material of genetically modified organisms so they cannot reproduce new individuals in natural conditions.

c) For plant genetic engineering trials, the organization granted the Genetic Engineering Trial Permit shall complete the harvest monitoring form in accordance with Form No. 12 of Appendix I issued together with this Decree;

d) Conduct post-trial monitoring to control unexpected growth of the genetically engineered organisms tested; for plants, the organization granted the Genetic Engineering Trial Permit shall implement field trial monitoring for at least three months from the end date of the trial, depending on the reproductive characteristics and dormancy period of the tested plants;

đ) In cases where the field trial plot is reused for other trials of genetically engineered plants of the same species, the post-harvest monitoring period shall be calculated from the last day of the final trial on that plot;

e) The organization granted the Trial Permit shall complete the post-harvest monitoring form in accordance with Form No. 13 of Appendix I issued together with this Decree;

5. Reports during the trial process;

a) Within thirty working days from the completion date of the narrow-scale trial, the organization granted the Genetic Engineering Trial Permit shall submit the narrow-scale trial completion report to the Ministry of Agriculture and Rural Development in accordance with Form No. 14 of Appendix I issued together with this Decree before implementing the wide-scale trial;

b) Within thirty working days from the completion date of the trial, the organization granted the Genetic Engineering Trial Permit shall submit the wide-scale trial completion report to the Ministry of Agriculture and Rural Development in accordance with Form No. 15 of Appendix I issued together with this Decree;

c) In case of stopping the genetic engineering organism trial, within thirty working days from the stop date of the trial, the organization granted the Genetic Engineering Trial Permit must submit a report to the Ministry of Agriculture and Rural Development regarding the cessation of the trial and clearly state the reasons;

6. The organization granted the Genetic Engineering Trial Permit shall be responsible for:

a) Being responsible for managing and supervising risks during the trial according to the Genetic Engineering Trial Permit already issued and reporting to the Ministry of Agriculture and Rural Development in case of incidents to handle them promptly;

b) Being liable under the law if they fail to comply with the permitted contents and cause biological safety incidents affecting the environment, biodiversity, and human health;

c) Providing full, truthful information and being responsible for the information required by this Decree and related updates during the trial process to the Ministry of Agriculture and Rural Development;

d) In case of risk occurrences in other countries on the genetically modified crops being tested, the organization granted the Genetic Engineering Trial Permit shall immediately notify the trial site to implement risk control measures and report new risks and the measures taken to control them to the Ministry of Agriculture and Rural Development.";

Article 15. Amend and supplement Article 23 as follows:

"Article 23. Issuing, Reissuing, and Revoking the Biosafety Certificate, 1. The Minister of Agriculture and Rural Development decides on issuing, reissuing, and revoking the Biosafety Certificate.

2. Genetically modified organisms released into the environment with a Biosafety Certificate are those that have completed trials under specific conditions in Vietnam.

3. Issuing a Biosafety Certificate for genetically modified organisms

a) Paper or digitalized electronic files, including:

Original Application Form for Issuing the Biosafety Certificate in accordance with Form No. 16 of Appendix I issued together with this Decree.

Original Report on the Results of Trials in accordance with Form No. 17 of Appendix I issued together with this Decree.

Original Risk Assessment Report on the Environment and Biodiversity of Genetically Modified Organisms (hereinafter referred to as the Risk Assessment Report) in accordance with Form No. 18 of Appendix I issued together with this Decree.

Original Summary Risk Assessment Report in accordance with Form No. 19 of Appendix I issued together with this Decree;

The organization or individual submitting the application shall submit one set of the above-mentioned documents to the Ministry of Agriculture and Rural Development through one of the following methods: Directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal.

b) Procedures for implementation:

Within five working days from the date the application is deemed valid, the organization or individual applying shall be responsible for paying the registration fee for the Biosafety Certificate issuance application in accordance with current regulations.

The Ministry of Agriculture and Rural Development shall immediately examine and accept the file when it ensures completeness for cases submitted directly; examine and accept the file within 01 working day when it ensures completeness for cases submitted through postal services or online at the National Public Service Portal; if the file is not valid, reply in writing and specify the reasons.

Within five working days from the date the organization or individual completes the payment of the registration fee, the specialized agency designated by the Ministry of Agriculture and Rural Development shall establish an Expert Team to review the Biosafety Certificate issuance application and publish the Summary Risk Assessment Report on the Ministry's website for public comments within twenty working days from the publication date. The activities of the Expert Team shall be carried out in accordance with Appendix II issued together with this Decree.

Within five working days from the end of the public comment period, the Ministry of Agriculture and Rural Development shall complete the compilation of comments (if any) in accordance with Form No. 20 of Appendix I issued together with this Decree.

Within thirty working days from the establishment date, the Expert Team shall complete the Evaluation Report on the Application in accordance with Form No. 21 of Appendix I issued together with this Decree and submit it to the Biosafety Council through the specialized agency designated by the Ministry of Agriculture and Rural Development.

Within five working days from the receipt of the Expert Team's Evaluation Report, the Minister of Agriculture and Rural Development shall establish the Biosafety Council.

Within five working days from the date of receipt of the Expert Group's dossier evaluation report, the Minister of Agriculture and Rural Development shall establish a Biosafety Council.

Within twenty-five working days from the date of establishment of the Council, the Biosafety Council shall convene to review and complete the Review Report in accordance with Model No. 22 attached as Appendix I to this Decree, and submit it to the specialized agency designated by the Ministry of Agriculture and Rural Development for submission to the Minister of Agriculture and Rural Development for decision.

In cases where the Council requests organizations or individuals to supplement or explain information, the specialized agency shall issue a written request within twenty-two working days for foreign organizations or individuals, and within five working days for domestic organizations or individuals. Upon expiration of the time limit for supplementation or explanation of information, the Ministry of Agriculture and Rural Development shall continue to review based on the existing file. The time for supplementation or explanation of information shall not be counted towards the review period of the file.

Within ten working days from the date of receipt of the Review Report and the file specified in point a of this clause, the Minister of Agriculture and Rural Development shall decide to issue a Biosafety Certificate in paper or electronic form in accordance with Model No. 23 attached as Appendix I to this Decree; in case of non-issuance, a written response shall be provided with clear reasons stated.

Within five working days from the date of issuance of the Biosafety Certificate, the Ministry of Agriculture and Rural Development shall publicly disclose information about the Biosafety Certificate on the Ministry's official website.

4. Reissue of Biosafety Certificate

a) The Biosafety Certificate shall be reissued in cases where there is a change in the information of the organization that has been issued the Biosafety Certificate.

b) The paper or electronic file, digitized, includes: the original Application Form for Reissuance in accordance with Model No. 24 attached as Appendix I to this Decree; copies of documents proving the changed content.

c) Procedure:

Organizations or individuals shall submit one set of the file specified in point b of this clause to the Ministry of Agriculture and Rural Development through one of the following methods: directly at the One-Stop Service Center, or via postal service, or online at the National Public Service Portal.

The Ministry of Agriculture and Rural Development shall check and accept the file immediately upon receipt if submitted directly; check and accept the file immediately within one working day if submitted via postal service or online at the National Public Service Portal, and provide a written response with clear reasons in case the file is not valid.

Within seven working days from the date of receipt of a valid file, the Minister of Agriculture and Rural Development shall decide to reissue the Biosafety Certificate in paper or electronic form; in case of non-reissuance, a written response with clear reasons shall be provided.

5. Revocation of Biosafety Certificate

a) The Biosafety Certificate may be subject to revocation in the following cases:

There is new scientific evidence regarding the risks of genetically modified organisms that have been issued a Biosafety Certificate.

Organizations or individuals intentionally provide false information that is critical to the issuance of the Biosafety Certificate.

b) Within five working days from the date of determination of violation as stipulated in point a of this clause, the Minister of Agriculture and Rural Development shall decide to revoke the Biosafety Certificate in paper or electronic form, and simultaneously publicize it on the Ministry's official website.

c) From the date of the revocation decision, organizations or individuals shall not release genetically modified organisms that have had their Biosafety Certificates revoked into the environment.

Article 16. Amend and supplement Article 32 as follows:

"Article 32. Conditions for Genetically Modified Organisms to be Used as Food or Feed

1. A Genetically Modified Organism (GMO) shall be eligible for issuance of a Certificate confirming its suitability for use as food or feed when it meets one of the following conditions:

a) The GMO has been reviewed by the Food Safety and Feed Safety Genetic Modification Review Council (hereinafter referred to as the Food Safety Council) and concluded that the GMO does not pose unmanageable risks to human health or animal health.

b) The GMO has been approved for use as food or feed in at least five advanced biotechnology developing countries within the Organization for Economic Cooperation and Development (OECD) or the Group of Twenty (G20), and no risks have occurred in those countries.

2. A GMO that has been issued a Certificate confirming its suitability for use as food may also be used as feed."

Article 17.Amend and supplement Article 33 as follows:

"Article 33. Issuance, Reissuance, and Revocation of Certificates Confirming Suitability of Genetically Modified Organisms for Use as Food or Feed

1. The Minister of Agriculture and Rural Development shall decide on the issuance, reissuance, and revocation of Certificates confirming the suitability of genetically modified organisms for use as food or feed.

2. Issuance of Certificates Confirming Suitability for Use as Food or Feed

a) The application file for issuing a Certificate for the object of genetically modified organism as specified in point a of Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 16 of this Decree is a paper or electronic file, including:

The original Application Form for Issuing a Certificate in accordance with Model No. 25 attached as Appendix I to this Decree.

The original Risk Assessment Report on the genetically modified organism concerning human and animal health (hereinafter referred to as the Risk Assessment Report) (with an electronic copy) in accordance with Model No. 26 attached as Appendix I to this Decree.

The original Summary of the Risk Assessment Report (with an electronic copy) in accordance with Model No. 27 attached as Appendix I to this Decree.

b) The application file for issuing a Confirmation Certificate for genetically modified organisms as specified in point b, Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 16 of this Decree shall include: the components as prescribed in point a, Clause 2 of this Article, and the original or copy with attached Vietnamese translation of the confirmation certificate or equivalent document issued by the competent authority permitting use as food or feed in at least five developed countries.

c) Procedure:

Organizations and individuals submit one set of application files as prescribed in point a or point b of this clause to the Ministry of Agriculture and Rural Development through one of the following methods: directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal.

The Ministry of Agriculture and Rural Development shall check and accept the application immediately when it is complete for applications submitted directly; check and accept the application within one working day when it is complete for applications submitted via postal service or online at the National Public Service Portal. In case the application is not valid, the Ministry shall respond in writing and specify the reasons.

Within five working days from the date the application is valid, the organization or individual applying shall be responsible for paying the registration fee according to current regulations.

Within five working days from the date of receiving a valid application, the Minister of the Ministry of Agriculture and Rural Development shall establish the Food Safety and Feed Genetically Modified Organisms Council (hereinafter referred to as the Council). The operation of the Council shall be governed by Appendix III promulgated together with this Decree.

Within three working days from the date of receiving a valid application and the completion of financial obligations by organizations and individuals, the Ministry of Agriculture and Rural Development shall publish the Summary Risk Assessment Report on the Ministry's website to solicit wide-ranging opinions. For applications registered under point a, Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 16 of this Decree, the Ministry of Agriculture and Rural Development shall compile comments (if any) within twenty working days from the date the information is published, or ten working days for
applications registered under point b, Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 16 of this Decree, according to Model No. 28 of Appendix I promulgated together with this Decree and send them to the Council.

Within seventeen working days from the date of establishing the Council for applications registered under point b, Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 16 of this Decree, and sixty-seven working days from the date of establishing the Council for applications registered under point a, Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP amended and supplemented by Article 16 of this Decree, the Council shall convene to review and complete the Review Report according to Model No. 29 of Appendix I promulgated together with this Decree to evaluate the application for issuing the Confirmation Certificate.

In cases where the Council requests organizations or individuals to supplement or explain information, the specialized agency shall issue a written request within twenty-two working days for foreign organizations or individuals, and within five working days for domestic organizations or individuals. Upon expiration of the time limit for supplementation or explanation of information, the Ministry of Agriculture and Rural Development shall continue to review based on the existing file. The time for supplementation or explanation of information shall not be counted towards the review period of the file.

Within three working days from the date of receiving the Council's review results, the Ministry of Agriculture and Rural Development shall send a request for the opinion of the Ministry of Health regarding the Confirmation Certificate for genetically modified organisms suitable for food use. The Ministry of Health shall be responsible for responding within seven working days from the date the Ministry of Agriculture and Rural Development sends the request.

Within five working days from the date of receiving the Ministry of Health's response, the Minister of the Ministry of Agriculture and Rural Development shall decide to issue the Confirmation Certificate for genetically modified organisms suitable for food use in paper or electronic form according to Model No. 30 of Appendix I promulgated together with this Decree; if not issued, the decision shall be made in writing and the reasons specified.

Within ten working days from the date of receiving the Council's review results, the Minister of the Ministry of Agriculture and Rural Development shall decide to issue the Confirmation Certificate for genetically modified organisms suitable for feed use in paper or electronic form according to Model No. 30 of Appendix I promulgated together with this Decree; if not issued, the decision shall be made in writing and the reasons specified.

Within five days from the date of deciding to issue the Confirmation Certificate for genetically modified organisms suitable for food or feed use, the Ministry of Agriculture and Rural Development shall publicly disclose the information about the Confirmation Certificate on its website.

3. Reissuing the Confirmation Certificate for genetically modified organisms suitable for food or feed use

a) The Confirmation Certificate for genetically modified organisms suitable for food or feed use shall be reissued in cases where there is a change in the information about the organization or individual.

b) The application file in paper or electronic format, including: the original Application Form for Reissuance as prescribed in Model No. 31 of Appendix I promulgated together with this Decree; a copy of the document proving the changes.

c) Procedure:

Organizations and individuals shall submit one set of application files as prescribed in point b of this clause to the Ministry of Agriculture and Rural Development through one of the following methods: directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal.

The Ministry of Agriculture and Rural Development shall check and accept the application immediately when it is complete for applications submitted directly; check and accept the application within one working day when it is complete for applications submitted via postal service or online at the National Public Service Portal. If the application is not valid, the Ministry shall respond in writing and specify the reasons.

Within seven working days from the date of receiving a valid application, the Minister of the Ministry of Agriculture and Rural Development shall decide to reissue the Confirmation Certificate for genetically modified organisms suitable for food or feed use in paper or electronic form; if not reissued, the decision shall be made in writing and the reasons specified.

4. Revoking the Confirmation Certificate for genetically modified organisms suitable for food or feed use

a) The Confirmation Certificate for genetically modified organisms suitable for food or feed use shall be subject to revocation in the following cases:

New scientific evidence regarding the risks of genetically modified organisms has been obtained for those GMOs that have already been issued with a Certificate confirming their suitability for use as food or animal feed.

Organizations or individuals intentionally providing false information that is critical to the issuance of a Certificate confirming the suitability of genetically modified organisms for use as food or animal feed;

b) Within five working days from the date of identifying a violation as stipulated in point a of this clause, the Ministry of Agriculture and Rural Development shall decide to revoke the Certificate confirming the suitability of genetically modified organisms for use as food or animal feed in either paper or electronic form, and simultaneously publish such revocation on the Ministry's official website;

c) From the date of the revocation decision, organizations or individuals may not use genetically modified organisms or products derived from them as food or animal feed.

Article 18. Supplement Article 37a following Article 37 as follows:

"Article 37a. Issuance, reissuance, and revocation of Certificates confirming the suitability of genetically modified organisms for use in closed production systems

1. The Minister of Agriculture and Rural Development decides on the issuance, reissuance, and revocation of Certificates confirming the suitability of genetically modified organisms for use in closed production systems.

2. Genetically modified organisms suitable for use in closed production systems must meet the following requirements:

a) They must originate from recipient and donor organisms that do not cause disease in humans, animals, plants, and do not affect the environment or biodiversity;

b) They must have a history of safe use in closed production systems according to standards of at least one country belonging to the Organization for Economic Co-operation and Development (OECD) or the Group of Twenty (G20).

3. Conditions for closed production facilities

a) They must have a closed production system ensuring that genetically modified organisms do not spread to the external environment;

b) They must have a waste treatment system for exhaust gases and wastewater that has been authorized by environmental authorities;

c) They must operate according to closed production technology standards of at least one country belonging to the Organization for Economic Co-operation and Development (OECD) or the Group of Twenty (G20).

4. Issuance of Certificates confirming the suitability of genetically modified organisms for use in closed production systems

Original Application Form for Issuing the Biosafety Certificate in accordance with Form No. 16 of Appendix I issued together with this Decree.

The original Application Form for issuing a Certificate confirming the suitability of genetically modified organisms for use in closed production systems as specified in Model No. 32 of Appendix I accompanying this Decree.

The original Supplementary Information Form for applying for a Certificate confirming the suitability of genetically modified organisms for use in closed production systems as specified in Model No. 33 of Appendix I accompanying this Decree;

b) Procedures for implementation:

Within five working days from the date the application is deemed valid, the organization or individual applying shall be responsible for paying the registration fee for the Biosafety Certificate issuance application in accordance with current regulations.

The Ministry of Agriculture and Rural Development shall immediately examine and accept the file when it ensures completeness for cases submitted directly; examine and accept the file within 01 working day when it ensures completeness for cases submitted through postal services or online at the National Public Service Portal; if the file is not valid, reply in writing and specify the reasons.

Within five working days from the date of receiving a valid application, the Minister of Agriculture and Rural Development shall establish a Biosafety Review Committee.

Within fifty working days from the date of establishment, the Committee shall convene a meeting and complete a report on the review of the application as specified in Model No. 34 of Appendix I accompanying this Decree, and submit it to the specialized agency designated by the Ministry of Agriculture and Rural Development for submission to the Minister of Agriculture and Rural Development.

In cases where the Council requests organizations or individuals to supplement or explain information, the specialized agency shall issue a written request within twenty-two working days for foreign organizations or individuals, and within five working days for domestic organizations or individuals. Upon expiration of the time limit for supplementation or explanation of information, the Ministry of Agriculture and Rural Development shall continue to review based on the existing file. The time for supplementation or explanation of information shall not be counted towards the review period of the file.

Within five working days from the date of receiving the Committee’s report and the application as specified in point a of this clause, the Minister of Agriculture and Rural Development shall decide to issue a Certificate confirming the suitability of genetically modified organisms for use in closed production systems in either paper or electronic form as specified in Model No. 35 of Appendix I accompanying this Decree; if not issued, a written response with reasons shall be provided.

5. Reissuance of Certificates confirming the suitability of genetically modified organisms for use in closed production systems

a) A Certificate confirming the suitability of genetically modified organisms for use in closed production systems shall be reissued when there is a change in information about the organization that received the Certificate;

b) The application file, either paper or digital, must include: The original Application Form for reissuing the Certificate as specified in Model No. 36 of Appendix I accompanying this Decree; a copy of the document proving the changes;

c) Procedure:

Organizations and individuals shall submit one set of application files as prescribed in point b of this clause to the Ministry of Agriculture and Rural Development through one of the following methods: directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal.

The Ministry of Agriculture and Rural Development shall check and accept the file immediately upon receipt if submitted directly; check and accept the file immediately within one working day if submitted via postal service or online at the National Public Service Portal, and provide a written response with clear reasons in case the file is not valid.

Within seven working days from the date of receiving a complete and valid application, the Minister of Agriculture and Rural Development shall decide to reissue the Certificate confirming the suitability of genetically modified organisms for use in closed production systems in either paper or electronic form; if not reissued, a written response with reasons shall be provided.

6. Revocation of Certificates confirming the suitability of genetically modified organisms for use in closed production systems

a) A Certificate confirming the suitability of genetically modified organisms for use in closed production systems shall be revoked when the competent authority determines a violation of the conditions set forth in the permit;

b) Procedures for implementation:

Within three working days from the date of identifying the violation as stipulated in point a of this clause, the Minister of Agriculture and Rural Development shall decide to revoke the Certificate confirming the suitability of genetically modified organisms for use in closed production systems.

7. The Ministry of Agriculture and Rural Development shall publicly disclose information about genetically modified organisms that have been issued, reissued, or revoked Certificates confirming their suitability for use in closed production systems on its official website."

Article 19. Supplement Clause 4 of Article 40 as follows:

"4. Genetically modified organisms imported into Vietnam for use in closed production systems must have a Certificate confirming their suitability for use in closed production systems."

Article 20. Amend and supplement Article 42 as follows:

"Article 42. Storage, packaging, transportation of genetically modified organisms and products derived from genetically modified organisms

1. The storage, packaging, and transportation of genetically modified organisms that have been issued with a Biosafety Certificate or a Certificate confirming their suitability for use as food or animal feed, and their products, must comply with relevant laws."

2. The storage, packaging, and transportation of genetically modified organisms (GMOs) and products derived from GMOs, which are not subject to the provisions of Clause 1 of this Article, must ensure environmental safety measures, preventing accidents and loss during transportation.

3. In case of an accident, the organization or individual responsible for storage, packaging, and transportation shall be responsible for collecting and destroying the affected materials using appropriate methods, marking the location of the accident, and reporting it to the Ministry of Agriculture and Rural Development, the People's Committee of the province where the accident occurred, and relevant sector management bodies to take remedial measures.

4. In cases where GMOs or products derived from GMOs, which are not subject to the provisions of Clause 1 of this Article, are transported through Vietnam’s territory, transit procedures shall be carried out in accordance with the regulations on foreign trade management.

Article 21. Replace certain phrases in the clauses and articles ofDecree No. 69DATED SEPTEMBER 21

1. Replace the phrase "Ministry of Natural Resources and Environment" with the phrase "Ministry of Agriculture and Rural Development" in Clause 4, Article 8; Clause 2, Article 9; Clause 7, Article 12; Clause 1, Article 45; and Article 46.

2. Replace the phrase "meeting conditions for use as animal feed" with the phrase "meeting conditions for use as food and animal feed" in Article 39.

3. Replace the phrase "meeting conditions for use as food" with the phrase "meeting conditions for use as food and animal feed" in Article 38.

Article 22. Repeal certain phrases in the articles ofDecree No. 69DATED SEPTEMBER 21

1. Repeal the phrase "or listed in the Register of Genetically Modified Organisms granted Biosafety Certificates" in Article 37.

2. Repeal the phrase "or listed in the Register of Genetically Modified Organisms granted Certificates of Meeting Conditions for Food Use" in Article 38.

3. Repeal the phrase "or listed in the Register of Genetically Modified Organisms granted Certificates of Meeting Conditions for Animal Feed Use" in Article 39.

Chapter III

AMEND AND SUPPLEMENT CERTAIN ARTICLES OF OF THE GOVERNMENT DATED MAY 12, 2017 ON MANAGEMENT OF ACCESS TO GENETIC RESOURCES AND SHARING BENEFITS FROM THE USE OF GENETIC RESOURCESISSUED ON MAY 12, 2017 BY THE GOVERNMENT ON MANAGEMENT OF ACCESS TO GENETIC RESOURCES AND SHARING BENEFITS FROM THE USE OF GENETIC RESOURCES

Article 23. Amend and supplement Article 6 as follows:

"Article 6. Issuance of Access Permit to Genetic Resources

1. The subjects as stipulated at point a and point b of Clause 1 of Article 57 of the Law on Biodiversity, amended at Clause 13 of Article 4 of the Law Amending and Supplementing Certain Provisions of 15 Laws in the Field of Agriculture and Environment.

2. The Chairman of the People's Committee of the province shall decide on the issuance of the Access Permit to Genetic Resources.

3. Paper or digital files, including:

a) Original Application Form for Issuing Access Permit to Genetic Resources according to Model No. 01 attached as Appendix IV to this Decree;

b) Copies of documents proving the implementation of access to genetic resources approved by competent authorities, including Programs, Projects, Tasks, Cooperation Minutes, Scientific and Technological Contracts;

c) Copies of documents proving the legal status of the organization according to the laws of the country where the organization was established;

d) Copies of Access Contract to Genetic Resources and Benefit-Sharing Agreement;

đ) Report on the results of the review by the Review Board according to Model No. 02 attached as Appendix IV to this Decree;

e) Minutes of the Review Board meeting according to Model No. 03 attached as Appendix IV to this Decree;

g) Evaluation forms of the Review Board members according to Model No. 04 attached as Appendix IV to this Decree;

h) Vietnamese translations of foreign language documents and papers (if any).

4. Procedure for implementation:

a) Organizations and individuals submit one set of documents as stipulated at points a, b, c, d, and h of Clause 3 of this Article to the specialized agency assigned by the People's Committee of the province directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal;

b) The specialized agency assigned by the People's Committee of the province shall check and accept the documents immediately upon submission if submitted directly; check and accept the documents within one working day if submitted via postal service or online at the National Public Service Portal, and respond in writing with reasons if the documents are not valid;

c) Within three working days from the date of receiving valid documents, the specialized agency assigned by the People's Committee of the province shall establish the Review Board. The composition of the Review Board includes representatives of provincial specialized agencies, related specialized agencies, representatives of the People's Committee of the commune where the natural genetic resources are located, and experts in related fields;

d) Within ten working days from the date of establishment, the Review Board shall convene a meeting and complete the Review Report as stipulated at point đ of Clause 3 of this Article and send it to the specialized agency assigned by the People's Committee of the province;

đ) Within two working days from the date of receipt of the Review Report, the specialized agency assigned by the People's Committee of the province shall submit the application file as stipulated at Clause 3 of this Article to the Chairman of the People's Committee of the province;

e) Within three working days from the date of receipt of the application file, the Chairman of the People's Committee of the province shall issue the Access Permit to Genetic Resources in paper or electronic form according to Model No. 05 attached as Appendix IV to this Decree; if not issued, respond in writing with reasons.

5. The validity period of the Access Permit to Genetic Resources shall be determined by the competent state authority based on the objectives and plans for accessing genetic resources in the application for the Access Permit to Genetic Resources, but shall not exceed five years."

Article 24. Amend and supplement Article 7 as follows:

"Article 7. Reissuance of Access Permit to Genetic Resources

1. The Access Permit to Genetic Resources shall be reissued in cases where there is a change in information on the permit.

2. The application file in paper or electronic form, digitized, includes: Original Registration Form for Reissuance according to Model No. 06 attached as Appendix IV to this Decree; copies of documents proving the changes.

3. Procedures for implementation:

a) Organizations and individuals submit one set of documents as stipulated in Clause 2 of this Article to the specialized agency assigned by the People's Committee of the province directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal;

b) The competent agency assigned by the Provincial People's Committee shall immediately check and accept the file when it ensures completeness for cases submitted directly; check and accept the file within one working day for cases submitted through postal service or online at the National Public Service Portal, and respond in writing with specific reasons if the file is not valid;

c) Within three working days from the date of receiving a complete and valid file, the Chairman of the Provincial People's Committee shall decide to reissue the Genetic Resource Access Permit in paper or electronic form; if not reissued, provide a written response with specific reasons.

Article 25. "ARTICLE 8. ESTABLISHMENT OF NATIONAL CONSERVATION AREAS

Article 8. Extension of the Genetic Resource Access Permit

1. The Genetic Resource Access Permit may be extended in cases where organizations or individuals have a need to continue accessing genetic resources that have been permitted after the permit expires.

2. The Chairman of the Provincial People's Committee shall decide on extending the Genetic Resource Access Permit.

3. Paper or digital files, including:

a) Original Application for Extension of the Genetic Resource Access Permit as prescribed in Model No. 07 of Appendix IV issued together with this Decree;

b) Original document of the provider's consent regarding the continued implementation of genetic resource access activities between both parties;

c) Original Report on the Implementation Status of Genetic Resource Access Activities already granted the Genetic Resource Access Permit as prescribed in Model No. 08 of Appendix IV issued together with this Decree;

d) Vietnamese translation of foreign language documents and texts (if any).

4. Procedures for Implementation:

a) Within thirty working days before the Genetic Resource Access Permit expires, organizations or individuals submit one set of files as stipulated in Clause 3 of this Article to the competent agency assigned by the Provincial People's Committee either directly at the One-Stop Service Center or through postal service or online at the National Public Service Portal;

b) The specialized agency assigned by the People's Committee of the province shall check and accept the documents immediately upon submission if submitted directly; check and accept the documents within one working day if submitted via postal service or online at the National Public Service Portal, and respond in writing with reasons if the documents are not valid;

c) Within seven working days from the date of receiving a complete and valid file, the competent agency assigned by the Provincial People's Committee shall organize an assessment and report to the Chairman of the Provincial People's Committee for decision;

d) Within three working days from the date of receiving the submitted file, the Chairman of the Provincial People's Committee shall decide to extend the Genetic Resource Access Permit in paper or electronic form as prescribed in Model No. 09 of Appendix IV issued together with this Decree; if the extension is refused, provide a written response with specific reasons.

Article 26. Amend and supplement Article 9 as follows:

Article 9. Revocation of the Genetic Resource Access Permit

1. The Chairman of the Provincial People's Committee shall decide to revoke the Genetic Resource Access Permit.

2. The Genetic Resource Access Permit shall be revoked when the competent state authority determines there is a violation of laws on information provision, misuse contrary to the purpose stated in the Genetic Resource Access Permit, use of genetic resources harmful to humans, the environment, national security, defense, and national interests.

3. Procedures for implementation:

a) Immediately upon receiving evidence of violation, the competent agency assigned by the Provincial People's Committee shall report to the Chairman of the Provincial People's Committee for decision to revoke the Genetic Resource Access Permit;

b) Within three working days from the date of receiving the report, the Chairman of the Provincial People's Committee shall decide to revoke the Genetic Resource Access Permit in paper or electronic form.

Article 27. Amend and supplement Article 10 as follows:

Article 10. Exporting Genetic Resources for Non-commercial Educational and Research Purposes

1. Vietnamese organizations or individuals who wish to access genetic resources for educational and scientific research purposes as provided for in point c, Clause 1, Article 57 of the Law on Biodiversity amended in Clause 13, Article 4 of the Law Amending and Supplementing Certain Provisions of 15 Laws in the Agriculture and Environment Sector, except for specimens listed in the Catalogue of Endangered, Precious, and Rare Species and Wild Species under Appendices of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); plant varieties, animal breeds, and disease samples approved for export by the competent authority.

2. Paper or electronic files digitized, including:

a) Original Application for Exporting Genetic Resources for Non-commercial Educational and Research Purposes as prescribed in Model No. 10 of Appendix IV issued together with this Decree;

b) Copy of documents proving the approval of the competent authority for Programs, Topics, Projects, Tasks, Memorandums of Understanding, Scientific and Technological Contracts;

c) Vietnamese translation of foreign language documents and texts (if any).

3. Procedures for implementation:

a) Organizations and individuals submit one set of documents as stipulated in Clause 2 of this Article to the specialized agency assigned by the People's Committee of the province directly at the One-Stop Service Center or via postal service or online at the National Public Service Portal;

b) The competent agency assigned by the Provincial People's Committee shall immediately check and accept the file when it ensures completeness for cases submitted directly; accept and check the file within one working day for cases submitted through postal service or online at the National Public Service Portal, and respond in writing with specific reasons if the file is not valid;

c) Within seven working days from the date of receiving a complete and valid file, the competent agency assigned by the Provincial People's Committee shall assess the file and report to the Chairman of the Provincial People's Committee for decision to allow exporting genetic resources out of the country in paper or electronic form as prescribed in Model No. 11 of Appendix IV issued together with this Decree; if the request is denied, provide a written response with specific reasons.

Article 28. Amend and supplement Article 11 as follows:

Article 11. Contract for Access to Genetic Resources and Benefit-Sharing

1. The contract for access to genetic resources and benefit-sharing shall be implemented in cases stipulated in Clause 1, Article 6 of Decree No. 59/2017/NĐ-CP amended and supplemented in Article 23 of this Decree.

2. The contract for access to genetic resources and benefit-sharing shall be implemented according to the provisions in Model No. 12 of Appendix IV issued together with this Decree.

Article 29. Amend and supplement Article 24 as follows:

Article 24. Publication of International Compliance Certificates for Access to Genetic Resources and Benefit-Sharing

1. Within two working days from the date of issuance of the document or decision to issue, reissue, extend or revoke the Permit for Accessing Genetic Resources, the specialized agency assigned by the Provincial People's Committee shall update the information into the National Biodiversity Database.

2. Within five working days from the date the Chairman of the Provincial People's Committee issues, reissues, extends or revokes the Permit for Accessing Genetic Resources, the Ministry of Agriculture and Environment shall be responsible for publishing, announcing, or canceling the International Compliance Certificate on Access to Genetic Resources and Benefit-Sharing, and related issues on the International Exchange Portal on Access to Genetic Resources and Benefit-Sharing of the Secretariat of the Convention on Biological Diversity as prescribed in the Nagoya Protocol.”

Article 30. Amend and supplement Article 25 as follows:

“Article 25. Reporting on the Results of Implementing Access to Genetic Resources and Benefit-Sharing

1. The entities specified in Clause 1 of Article 6 of Decree No. 59/2017/ND-CP, amended and supplemented by Article 23 of this Decree, shall be responsible for reporting in writing according to the Model Form No. 08 attached as Appendix IV to this Decree, to the Chairman of the Provincial People's Committee or the competent state agency that issued the permit, as follows:

a) Report on activities during the period of accessing genetic resources as recorded in the Permit for Accessing Genetic Resources;

b) Annually, report on the situation and results of using genetic resources;

c) Report promptly when requested by the competent state agency.

2. The entities specified in Clause 1 of Article 10 of Decree No. 59/2017/ND-CP, amended and supplemented by Article 27 of this Decree, shall submit a written report to the competent state agency that permitted the export of genetic resources abroad within three months from the end of the study program, as stipulated in Model Form No. 13 attached as Appendix IV to this Decree.”

Article 31. Replace the phrase ofDecree No. 59/2017/ND-CP

Replace the phrase "Ministry of Natural Resources and Environment" with "Ministry of Agriculture and Environment" in Clause 1 of Article 5 and Clause 1 of Article 26.

Chapter IV

AMEND AND SUPPLEMENT CERTAIN PROVISIONS OF DECREE NO. 66/2019/ND-CP ISSUED ON JULY 29, 2019 BY THE GOVERNMENT ON CONSERVATION AND SUSTAINABLE USE OF WETLAND AREAS

Article 32. Amend and supplement Article 13 as follows:

“Article 13. Establishment of National Wetland Conservation Areas

a) There must be an establishment project consistent with the overall biodiversity conservation plan, forestry planning, fishery resource protection and exploitation planning, and provincial planning approved by the competent authority;

a) Have a project to establish a national wetland conservation area that is consistent with the overall biodiversity conservation plan and provincial planning;

b) Meet the criteria for national wetland conservation areas as prescribed in Article 17, Clause 2 of Article 18, Clause 2 of Article 19, and Clause 2 of Article 20 of the Law on Biodiversity.

2. Competent authority for establishment:

a) The Ministry of Agriculture and Environment shall organize the preparation and review of projects to establish national wetland conservation areas covering areas in two provinces or centrally-administered cities or more; the Minister of Agriculture and Environment shall decide to establish national wetland conservation areas covering areas in two provinces or centrally-administered cities or more;

b) The People's Committee of a province shall organize the preparation and review of projects to establish national wetland conservation areas covering the entire area under its management; the Chairman of the People's Committee of a province shall decide to establish national wetland conservation areas covering the entire area under its management.

3. Content of the project to establish a wetland conservation area includes:

a) Purpose of biodiversity conservation; compliance with criteria for establishing a wetland conservation area;

b) Current status of natural and artificial ecosystems, unique ecosystems; endangered, precious, rare species; species listed in the Catalogue of Endangered, Precious, and Rare Species Prioritized for Protection; other wild species; landscape, cultural, historical values, unique beauty of nature, and wetland ecosystem services in the proposed conservation area;

c) Assessment of current management and use of wetlands; economic and social conditions in the proposed conservation area, threats to wetlands and plans for land use conversion;

d) Extracts from maps, geographical location, and area of the proposed wetland conservation area;

đ) Geographical location, area, boundaries of strictly protected zones, ecological restoration zones, service-administrative zones; boundaries of each zone; plans for stabilizing the lives or relocating households and individuals out of the proposed conservation area;

e) Management plan for the conservation area;

g) Management organization of the conservation area;

h) Geographical location, area, and boundaries of buffer zones in the proposed conservation area;

i) Implementation organization of the project to establish the conservation area.

4. Paper or digitized electronic files include:

a) A proposal to establish a wetland conservation area according to Model Form No. 01 attached as Appendix V to this Decree;

b) Project to establish a wetland conservation area according to Model Form No. 02 attached as Appendix V to this Decree;

c) Draft decision to establish a wetland conservation area according to Model Form No. 03 attached as Appendix V to this Decree;

d) Report on the results of reviewing the project to establish a wetland conservation area according to Model Form No. 04 attached as Appendix V to this Decree.

5. Procedures for establishing national wetland conservation areas within the competence of the Minister of Agriculture and Environment

a) The specialized agency tasked with preparing the project to establish a national wetland conservation area (Specialized Agency) shall submit to the Minister of Agriculture and Environment the dossier for review of the project to establish a national wetland conservation area. The dossier includes: a proposal for reviewing the project to establish a wetland conservation area according to Model Form No. 05 attached as Appendix V to this Decree and other documents as stipulated in point b and point c of Clause 4 of this Article;

b) Within five working days from the date of receiving a complete and valid dossier for review, the Minister of Agriculture and Environment shall assign the specialized state management agency (Permanent Agency) to submit to the Minister of Agriculture and Environment a proposal to establish the Review Board. The Board operates according to the Regulation prescribed in Appendix VI attached to this Decree;

c) Within fifteen working days from the date of the decision to establish, the Council shall convene a meeting and report on the results of the assessment of the project to establish a national wetland conservation area according to Model No. 04 attached as Appendix V of this Decree. The content of the assessment includes: the purpose of biodiversity conservation in the conservation area; the level of compliance with criteria for establishing a conservation area; the geographical location, boundaries, area, functional zones, and buffer zone of the conservation area; management plan for the conservation area; organization managing the conservation area and opinions of relevant parties.

d) Within fifteen working days from the date of the Assessment Report, the specialized agency shall complete the project to establish a national wetland conservation area and submit it to the Standing Agency for the establishment proposal file according to points a, b, and c of Clause 4 of this Article.

đ) Within five working days from the date of receiving the completed file, the Standing Agency shall submit to the Ministry of Agriculture and Rural Development a document seeking the consensus opinion of the People's Committee of the province whose territory falls within the wetland conservation area established by the Minister of Agriculture and Rural Development. Within seven working days from the date of receipt of the document from the Ministry of Agriculture and Rural Development, the People's Committee of the province shall issue a reply.

e) Within five working days from the date of receipt of the consensus document from the People's Committee of the province, the Standing Agency shall submit to the Minister of Agriculture and Rural Development a decision to establish a national wetland conservation area. The establishment proposal file for a national wetland conservation area according to Clause 4 of this Article and the consensus document of the People's Committee of the province according to point đ of this clause.

g) Within five working days from the date of receipt of the submission file, the Minister of Agriculture and Rural Development shall decide to establish a national wetland conservation area in the form of a paper or electronic document.

6. Procedures for establishing a national wetland conservation area within the jurisdiction of the Chairman of the Provincial People's Committee.

a) The provincial specialized agency assigned to establish the project to establish a wetland conservation area (provincial specialized agency) shall submit to the Chairman of the Provincial People's Committee the file requesting the assessment of the project to establish a wetland conservation area. The file includes the request for assessment of the project to establish a wetland conservation area according to Model No. 05 attached as Appendix V of this Decree and other documents according to points b and c of Clause 4 of this Article.

b) Within five working days from the date of receipt of a valid and complete assessment file according to regulations, the Chairman of the Provincial People's Committee shall assign the provincial state management agency (provincial Standing Agency) to submit to the Chairman of the Provincial People's Committee a decision to establish the Assessment Council. The Council operates according to the Charter stipulated in Appendix VI attached to this Decree.

c) Within fifteen working days from the date of the decision to establish, the Council shall convene a meeting and report on the results of the assessment of the project to establish the conservation area according to Model No. 04 attached as Appendix V of this Decree. The content of the assessment includes: the purpose of biodiversity conservation in the conservation area; the level of compliance with criteria for establishing a conservation area; the geographical location, boundaries, area, functional zones, and buffer zone of the conservation area; management plan for the conservation area; organization managing the conservation area and opinions of relevant parties.

d) Within fifteen working days from the date of the Assessment Report, the provincial specialized agency shall complete the project to establish a wetland conservation area and submit it to the provincial Standing Agency for the establishment proposal file according to points a, b, and c of Clause 4 of this Article.

đ) Within five working days from the date of receiving the completed file, the provincial Standing Agency shall submit to the Provincial People's Committee a document seeking the consensus opinion of the Ministry of Agriculture and Rural Development regarding the establishment of a wetland conservation area within the jurisdiction of the Chairman of the Provincial People's Committee. Within seven working days from the date of receipt of the document from the Provincial People's Committee, the Ministry of Agriculture and Rural Development shall issue a reply.

e) Within five working days from the date of receipt of the consensus document from the Ministry of Agriculture and Rural Development, the provincial Standing Agency shall submit to the Chairman of the Provincial People's Committee a decision to establish a wetland conservation area. The establishment proposal file for a wetland conservation area according to Clause 4 of this Article and the consensus document of the Ministry of Agriculture and Rural Development according to point đ of this clause.

g) Within five working days from the date of receipt of the submission file, the Chairman of the Provincial People's Committee shall decide to establish a wetland conservation area in the form of a paper or electronic document.

7. Decision to establish a wetland conservation area according to Model No. 03 attached as Appendix V of this Decree.”

Article 33. Amend and supplement Article 14 as follows:

“Article 14. Establishment of a provincial wetland conservation area.

a) There must be an establishment project consistent with the overall biodiversity conservation plan, forestry planning, fishery resource protection and exploitation planning, and provincial planning approved by the competent authority;

a) There must be a project to establish a provincial wetland conservation area that is consistent with the overall biodiversity conservation planning and provincial planning.

b) It must meet the criteria for a provincial conservation area as stipulated in Clauses 2, 3, and 4 of Article 7 of Government Decree No. 65/2010/NĐ-CP dated June 11, 2010, detailing and guiding the implementation of certain provisions of the Law on Biodiversity.

2. The Provincial People's Committee shall take the lead and direct specialized agencies to prepare projects, submit to the Chairman of the Provincial People's Committee decisions to establish the Assessment Council and decisions to establish a provincial wetland conservation area.

3. The content of the project to establish a wetland conservation area shall be implemented according to Clause 3 of Article 13 of Government Decree No. 66/2019/NĐ-CP amended and supplemented by Article 32 of this Decree.

4. The file for establishing a provincial wetland conservation area shall be implemented according to Clause 4 of Article 13 of Government Decree No. 66/2019/NĐ-CP amended and supplemented by Article 32 of this Decree.

5. The procedure for establishing provincial wetland conservation areas shall be carried out in accordance with the provisions of Clause 6, Article 13 of Decree No. 66/2019/ND-CP, amended and supplemented by Article 32 of this Decree.

6. The decision to establish a wetland conservation area shall be made in accordance with Model No. 03 attached as Appendix V to this Decree.”

Article 34. Supplement Clause 5 following Clause 4 of Article 17 as follows:

“5. The management plan for wetland conservation areas shall be implemented in accordance with the provisions of Model No. 06 attached as Appendix V to this Decree.”

Article 35. Supplement Clause 4 following Clause 3 of Article 18 as follows:

“4. The management regulations for wetland conservation areas shall be implemented in accordance with the provisions of Model No. 07 attached as Appendix V to this Decree.”

Article 36. Supplement Clause 3 following Clause 2 of Article 24 as follows:

“3. The coordination management regulations for important wetlands outside conservation areas shall be implemented in accordance with the provisions of Model No. 08 attached as Appendix V to this Decree.”

Article 37. Amend and supplement Clause 3 of Article 31 as follows:

“3. The Ministry of Finance shall have the responsibility:

a) To guide the management, use, and settlement of funds allocated for activities related to the management, conservation, and sustainable use of important wetlands;

b) To allocate capital for tasks and projects using public investment funds to manage and develop important wetlands in accordance with current laws.”

Article 38. Replace certain phrases ofDecree No. 66/2019/ND-CP

1. Replace the phrase “Ministry of Natural Resources and Environment” with “Ministry of Agriculture and Environment” in Clause 3, Article 7, Clause 2, Point a, Point b, Clause 3, Article 9, Clause 2, Clause 3, Article 11, Clause 4, Article 17, Clause 1, Point a, Clause 3, Article 18, Clause 2, Clause 3, Article 23, Clause 1, Clause 5, Article 31, and Clause 5, Article 32.

2. Replace the phrase “environmental protection” with “agriculture and environment” in Clause 1, Article 24.

3. Replace the phrase “environment management agency” with “agriculture and environment management agency” in Point b, Clause 1, Article 29.

Article 39. Repeal certain phrases ofDecree No. 66/2019/ND-CP

1. Repeal the phrase “at district level,” in Point d, Clause 2, Article 18 and Clause 3, Article 19.

2. Repeal the phrase “organize the Appraisal Council to review project establishment files; organize the management of wetland conservation areas or important wetlands outside conservation areas” in Point c, Clause 1, Article 31.

Chapter V

IMPLEMENTING PROVISIONS

Article 40. Effectiveness

1. This Decree shall take effect from the date of issuance.

2. The following provisions shall cease to be effective from the date this Decree takes effect:

a) Article 3, Article 4, Article 5, Article 6, Clause 5, Article 7, Article 11, Article 17 of Decree No. 65/2010/ND-CP dated June 11, 2010 of the Government detailing and guiding the implementation of some articles of the Law on Biological Diversity;

b) Article 6, Article 7, Article 17, Article 19, Article 21, Article 22, Article 24, Article 25, Article 26, Article 27, Article 28, Article 29, Article 30, Article 31, Article 34, Article 35, Article 36, Appendices I, II, III, IV, V, and VI issued together with Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms;

c) Decree No. 108/2011/ND-CP dated November 30, 2011 of the Government amending some articles of Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms;

d) Decree No. 160/2013/ND-CP dated November 12, 2013 of the Government on criteria for determining species and management regimes for species listed in the Catalogue of Species in Need of Priority Conservation;

đ) Article 12, Article 13, Article 14, Article 15, Article 16, Article 17, Article 18, Article 19, Article 20, Clause 2, Clause 6, Article 26, Article 27, and the Appendix of Decree No. 59/2017/ND-CP dated May 12, 2017 of the Government on management of access to genetic resources and sharing benefits arising from the utilization of genetic resources;

e) Decree No. 64/2019/ND-CP dated July 16, 2019 of the Government amending Article 7 of Decree No. 160/2013/ND-CP dated November 12, 2013 of the Government on criteria for determining species and management regimes for species listed in the Catalogue of Species in Need of Priority Conservation;

g) Article 12, Clause 2, Clause 4, Article 31 of Decree No. 66/2019/ND-CP dated July 29, 2019 of the Government on conservation and sustainable use of wetlands;

h) Decree No. 118/2020/ND-CP dated October 2, 2020 of the Government amending and supplementing some articles of Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms;

i) Article 41, Article 42, Article 43, Clause 1, Clause 2, and Clause 3, Article 44, Clause 1, Article 45, Clause 1, Clause 2, Clause 3, Clause 4, and Clause 5, Article 46, and Appendix VIII of Decree No. 136/2025/ND-CP dated June 12, 2025 of the Government on decentralization and delegation of authority in the field of agriculture and environment;

k) Item 9 of Decree No. 131/2025/ND-CP dated June 12, 2025 of the Government on delineation of authority of two-level local governments in the field of state management by the Ministry of Agriculture and Environment.

Article 41. Transitional Provisions

1. For applications for recognition of testing facilities for genetically modified organisms received before the effective date of this Decree, they shall continue to be processed according to the law at the time of receipt.

2. For applications for registration of certificates confirming genetically modified plants meet conditions for use as food and feed received before the effective date of this Decree, they shall continue to be processed according to the law at the time of receipt.

3. In cases where genetically modified organisms are used in closed production systems without having been granted certificates confirming their suitability for use in such systems under this Decree, organizations and individuals wishing to continue using genetically modified organisms in closed production systems must register in accordance with the provisions of this Decree.

4. For applications for issuance and reissuance of permits for accessing genetic resources received before the effective date of this Decree, they shall continue to be processed according to the law at the time of receipt.

5. For applications for the export of genetic resources for educational and research purposes without commercial intent submitted before this Decree takes effect, they shall continue to be processed in accordance with the laws in force at the time of submission.

6. In cases where a project for establishing a wetland conservation area has been initiated but not yet reviewed before this Decree takes effect, the review of the project and the decision on establishing the wetland conservation area shall be carried out in accordance with the provisions of this Decree.

7. In cases where the project for establishing a wetland conservation area has been completed and reviewed before this Decree takes effect, the decision on establishing the wetland conservation area shall be made in accordance with the provisions of this Decree.

Article 42. Responsibility for Implementationimplementation clause

1. The Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees, and related organizations and individuals are responsible for implementing this Decree.

2. The Ministry of Agriculture and Rural Development shall be responsible for:

a) Providing guidance on the implementation of this Decree and monitoring its enforcement;

b) Organizing inspections of the implementation of risk management measures for genetically modified organisms;

c) Inspecting the implementation of notifications regarding the identification of genetically modified organisms and gene-edited organisms;

d) Establishing a Biosafety Council in accordance with the provisions of Clause 4, Article 18, Clause 3, Article 23, and Clause 4, Article 37a of Decree No. 69/2010/NĐ-CP as amended and supplemented respectively by Articles 13, 15, and 18 of this Decree. The Biosafety Council shall consist of at least eleven members representing relevant ministries in the fields of public security, industry and trade, science and technology, agriculture and rural development, health, and experts in related fields. The operations of the Biosafety Council shall be conducted in accordance with Appendix II attached to this Decree;

đ) Establishing a Food Safety and Feed Safety Council in accordance with the provisions of Clause 2, Article 33 of Decree No. 69/2010/NĐ-CP as amended and supplemented by Article 17 of this Decree. The Food Safety and Feed Safety Council shall consist of at least eleven members representing relevant ministries in the fields of industry and trade, science and technology, agriculture and rural development, health, and experts in related fields. The operations of the Food Safety and Feed Safety Council shall be conducted in accordance with Appendix III attached to this Decree;

e) Directing inspections of the trial process of genetically modified organisms in accordance with the provisions of this Decree; promptly identifying and cooperating in handling violations or risks during the trial process;

3. Organizations and individuals engaged in scientific research, technological trials, production, business, import, export, transportation, storage of genetically modified organisms shall be responsible for:

a) Implementing risk management measures to ensure biosafety in accordance with the law;

b) Promptly taking remedial measures when risks occur and immediately reporting to the provincial People's Committee where the risk occurs;

c) Organizations and individuals holding a Certificate of Genetically Modified Organisms meeting the conditions for closed-loop production must report to the Ministry of Agriculture and Rural Development if there is a change in the production location, while ensuring compliance with regulations prohibiting the release of genetically modified organisms from closed-loop use into the environment;

4. Organizations and individuals who fail to comply with risk management measures will be subject to administrative penalties, criminal prosecution, or compensation for damages depending on the severity of the violation, in accordance with the law.