Decree No. 118/2020/ND-CP amending and supplementing certain articles of Decree No. 69/2010/ND-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, moved specimens, and products of genetically modified organisms.

DECREE

Amending and supplementing some articles of Decree No. 69/2010/NĐ-CP
dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms The Government promulgates this Decree to amend and supplement some articles of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic material, and products derived from genetically modified organisms (Decree No. 69/2010/NĐ-CP).

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||| Pursuant to the Law on Organization of the Government dated June 19, 2015;

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

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

Article 1. Amend and supplement some articles of Decree No. 69/2010/NĐ-CP as follows:

1. Clause 6 shall be added to Article 3 as follows:

"6. A gene transfer event is the result of the process of recombining target DNA into a specific position within the genome of a living organism to create a corresponding genetically modified organism carrying the target gene, including: a single gene transfer event resulting from the transfer of a gene specifying a desired trait and a composite gene transfer event resulting from the transfer of two or more genes specifying one or more desired traits using gene transfer technology."

2. Clause 4 shall be added to Article 5 as follows:

"4. A genetically modified organism is the result of traditional hybridization from two or more gene transfer events that have been issued with a Biosafety Certificate, a Certificate confirming that the genetically modified organism is suitable for food use, a Certificate confirming that the genetically modified organism is suitable for animal feed use, and must comply with investment and business conditions, may be released into the environment, used as food, or animal feed."

3. Clause 2 of Article 7 shall be amended as follows:

"2. The risk assessment report of genetically modified organisms on the environment, biodiversity, human and animal health shall be prepared according to the forms specified in Appendices IV, V, and VI of Decree No. 69/2010/NĐ-CP. In cases where the genetically modified organism carries a composite gene transfer event, the risk assessment report must provide additional data on the interaction of transferred genes in structure, structural integrity, function, and expression of the target gene in the recipient organism."

4. Article 15 shall be amended and supplemented as follows:

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

1. Field trials of genetically modified organisms are the process of monitoring and evaluating the impact of genetically modified organisms on the environment and biodiversity under specific conditions in Vietnam.
2. Field trials of genetically modified organisms include the following main contents:

a) Risk of becoming harmful organisms;
b) Risk of adverse effects on non-target organisms;
c) Risk of adverse changes to surrounding ecosystems. For the risk assessment of genetically modified plants, it includes: evaluation of impacts on soil ecosystems; evaluation of the impact of genetically modified plant cultivation practices on the environment and biodiversity;
d) Gene flow risk; d) Other adverse impacts."
5. Repeal Clause 2 of Article 16.

6. Article 17 shall be amended and supplemented as follows:

"Article 17. Competence, procedures, and formalities for recognizing and revoking decisions to recognize testing facilities for genetically modified organisms

1. The Ministry of Agriculture and Rural Development recognizes and revokes decisions to recognize testing facilities for genetically modified organisms.
2. Organizations registering to recognize testing facilities for genetically modified organisms are public service units.

3. Organizations registering to recognize testing facilities for genetically modified organisms must submit one set of application documents to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal mail, or online submission. The application package includes:

a) An application form for recognizing testing facilities for genetically modified organisms according to Form No. 01 attached to this Decree;

b) A description of the capabilities of the testing facility for genetically modified organisms according to Form No. 02 attached to this Decree.

4. Within five working days from the date of receipt of the application, the Ministry of Agriculture and Rural Development will notify the applicant organization in writing about the acceptance of a valid application or request for supplementation and completion of the application; the time for supplementation and completion of the application does not count towards the review period.

5. Within forty-five days from the date of receipt of a valid application, the Ministry of Agriculture and Rural Development will organize the review of the application for recognition of testing facilities for genetically modified organisms. The Ministry of Agriculture and Rural Development will establish a Biosafety Testing Evaluation Committee according to Article 17a of this Decree. The review results of the Committee will serve as the basis for the Ministry of Agriculture and Rural Development to consider and decide on the recognition of testing facilities for genetically modified organisms.

6. Within ten days from the date of the review results, the Ministry of Agriculture and Rural Development will consider and decide on the recognition of testing facilities for genetically modified organisms. If the testing facility for genetically modified organisms is not recognized, the Ministry of Agriculture and Rural Development must notify the applicant organization in writing and specify the reasons.

7. The Ministry of Agriculture and Rural Development will take the lead and coordinate with the Ministry of Natural Resources and Environment to inspect the activities of testing facilities for genetically modified organisms. If there is a violation of any of the requirements stipulated in Article 16 of Decree No. 69/2010/NĐ-CP, the Ministry of Agriculture and Rural Development will consider revoking the decision to recognize the testing facility for genetically modified organisms.

8. Within ten days from the date of issuance of the decision to recognize or revoke the decision to recognize the testing facility for genetically modified organisms, the Ministry of Agriculture and Rural Development will send one original copy of the decision to the Ministry of Natural Resources and Environment and publish the decision on the Ministry's electronic information website."

7. Add Article 17a and Article 17b after Article 17 as follows:

"Article 17a. Organization and operation of the Biosafety Testing Evaluation Committee

"Article 17a. Organization and operation of the Biosafety Risk Assessment Council"

1. The Ministry of Agriculture and Rural Development decides to establish the Risk Assessment Council for Genetically Modified Organisms, consisting of at least nine members: the Chairman being the representative of the specialized agency under the Ministry of Agriculture and Rural Development, the Vice-Chairman being the representative of the permanent examination agency, and the other Members being representatives of the Ministries of Natural Resources and Environment, Industry and Trade, Science and Technology, Health, and experts. Among them, two Members will be selected as independent reviewers. The Council will dissolve itself upon completion of its tasks. The Ministry of Agriculture and Rural Development designates a subordinate unit to serve as the permanent examination agency.

2. The Risk Assessment Council for Genetically Modified Organisms shall have the responsibility to:

a) Examine the application for recognition of a testing facility for genetically modified organisms and advise the Ministry of Agriculture and Rural Development on the decision to recognize such a facility;

b) Examine the application for testing, evaluate the results of testing, and advise the Ministry of Agriculture and Rural Development on issuing a Testing Permit and recognizing the results of testing.

3. The Council operates based on democratic and objective principles; each member is individually responsible for the scientific accuracy of their independent opinions and evaluations, while collectively responsible for the Council's final conclusions.

4. A meeting of the Council must have at least two-thirds of its members present, chaired by the Chairman or the Vice-Chairman (in case the Chairman is absent). The permanent examination agency organizes meetings of the Council for each application, records the minutes of each session. At the first meeting, the chairperson assigns one Secretary and two independent reviewers. If necessary, the Council may recommend supplementing from two to three experienced scientists in the relevant field as independent reviewers for the application.

5. If necessary, the Council may request the permanent examination agency to invite representatives of the registering organization to attend the meeting to provide additional information, answer questions from Council members, or address public comments.

6. Based on the minutes of the meetings, the Council Secretary completes the report on the evaluation of the application and the Council's concluding opinion to report to the Ministry of Agriculture and Rural Development.

Article 17b. Competence, Procedure, and Formalities for Reissuing the Decision Recognizing a Testing Facility for Genetically Modified Organisms

1. The decision recognizing a testing facility for genetically modified organisms shall be reissued in cases where it is lost, torn, or damaged.

2. The reissue application includes:

a) An application form for reissuance according to Form No. 03 attached to this Decree;

b) The original decision recognizing the testing facility for genetically modified organisms that was issued in cases of tearing or damage.

3. The registering organization submits one set of the reissue application in accordance with Clause 2 of this Article to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal service, or online environment.

4. Within seven working days from the date of receiving a complete and valid application, the Ministry of Agriculture and Rural Development reviews and reissues the Decision Recognizing a Testing Facility for Genetically Modified Organisms.

8. Article 18 is amended and supplemented as follows:

"Article 18. Competence, Procedure, and Formalities for Issuing and Revoking the Testing Permit for Genetically Modified Organisms

1. The Ministry of Agriculture and Rural Development issues and revokes the Testing Permit for Genetically Modified Organisms.

2. The registering organization submits one set of the application for the Testing Permit for Genetically Modified Organisms to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal service, or online environment. The application includes:

a) An application form for the Testing Permit for Genetically Modified Organisms according to Form No. 04 attached to this Decree;

b) A description of the application for testing genetically modified organisms and the testing plan specified in Appendices II and III of Decree No. 69/2010/NĐ-CP. In the case of genetically modified plants, apply Form No. 05 attached to this Decree;

c) A copy of the Decision Recognizing the Testing Facility for Genetically Modified Organisms;

d) In the case of imported genetically modified organisms for risk assessment testing, proof that these organisms have been approved for release into the environment by countries around the world is required. For genetically modified organisms created domestically, proof that these organisms are the result of scientific research recognized by competent state authorities is required.

3. Within seven working days from the date of receipt of the application, the Ministry of Agriculture and Rural Development notifies the registering organization in writing about the acceptance of a valid application or requests for supplementation and completion of the application; the time for supplementation and completion of the application does not count towards the examination period.

4. Within thirty days for applications for limited testing permits and forty-five days for applications for wide-scale testing permits, from the date of receipt of a valid application, the Ministry of Agriculture and Rural Development organizes the Risk Assessment Council for Genetically Modified Organisms to examine the application. The examination results of the Risk Assessment Council for Genetically Modified Organisms serve as the basis for the Ministry of Agriculture and Rural Development to issue the Testing Permit for Genetically Modified Organisms.

5. Within ten days from the date of the examination results, the Ministry of Agriculture and Rural Development considers issuing the Testing Permit for Genetically Modified Organisms. In case of refusal, the Ministry of Agriculture and Rural Development notifies the registering organization in writing, providing specific reasons.

6. The Ministry of Agriculture and Rural Development leads and coordinates with the Ministry of Natural Resources and Environment to inspect compliance with the requirements of the Testing Permit for Genetically Modified Organisms.

7. The Ministry of Agriculture and Rural Development considers revoking the Testing Permit for Genetically Modified Organisms when the permit holder violates any of the following situations:

a) Providing incorrect information regarding the name of the genetically modified organism;

b) Conducting field trials outside the agreed time, location, and scale without the consent of the Ministry of Agriculture and Rural Development;

c) Failing to comply with the description of the application for field testing of genetically modified organisms. 8. Within ten days from the date of issuance of the decision to grant or revoke the Field Testing Permit for Genetically Modified Organisms, the Ministry of Agriculture and Rural Development shall send one original copy of the decision to the Ministry of Natural Resources and Environment and publish the decision on its electronic information website."

9. Article 19 is amended as follows:

"Article 19. Field Testing Permit for Genetically Modified Organisms

The Field Testing Permit for Genetically Modified Organisms shall be in accordance with Form No. 06 attached hereto."

10. Add Article 19a after Article 19 as follows:

"Article 19a. Competence, Procedure, and Formalities for Reissuing the Field Testing Permit for Genetically Modified Organisms

1. The Field Testing Permit for Genetically Modified Organisms shall be reissued in the following cases:
a) Change of information about the entity granted the permit in the Field Testing Permit for Genetically Modified Organisms already issued;
b) Loss or damage of the Field Testing Permit for Genetically Modified Organisms already issued.

2. The reissue application includes:
a) Application for reissue in accordance with Form No. 07 attached hereto;
b) The Field Testing Permit for Genetically Modified Organisms already issued in case of change of information about the entity or loss or damage;
c) Documentation proving the content of the change in the case provided for in point a Clause 1 of this Article.

3. The registering organization submits one set of the reissue application in accordance with Clause 2 of this Article to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal service, or online environment.

4. Within seven working days from the date of receipt of complete and valid files, the Ministry of Agriculture and Rural Development shall consider and issue the Field Testing Permit for Genetically Modified Organisms."

11. Article 21 is amended and supplemented as follows:

"Article 21. Recognition of Results of Field Testing of Genetically Modified Organisms

1. The organization that has registered shall submit the report on the results of field testing of genetically modified organisms in accordance with Form No. 08 attached hereto to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal service, or online environment.

2. Within thirty days for limited field testing recognition and forty-five days for wide-scale field testing recognition, from the date of receipt of a valid report as stipulated in Clause 1 of this Article, the Ministry of Agriculture and Rural Development shall organize the Risk Assessment Board for Field Testing to evaluate and review the report on the results of field testing of genetically modified organisms.

3. Within ten days from the date of receiving the assessment result of the Risk Assessment Board for Field Testing, the Ministry of Agriculture and Rural Development shall consider and decide to recognize or reject the results of field testing of genetically modified organisms. In case of rejection, the Ministry of Agriculture and Rural Development shall notify the registering organization in writing, specifying the reasons.

4. Within ten days from the date of issuance of the decision recognizing the results of field testing of genetically modified organisms, the Ministry of Agriculture and Rural Development shall send one original copy of the decision to the Ministry of Natural Resources and Environment and publish the decision on its electronic information website."

12. Add Article 23a after Article 23 as follows:

"Article 23a. Competence, Procedure, and Formalities for Reissuing the Biosafety Certificate

1. The Biosafety Certificate shall be reissued in the following cases:
a) Change of information about the entity in the Biosafety Certificate already issued;
b) Loss or damage of the Biosafety Certificate already issued.

2. The reissue application includes:
a) Application for reissue in accordance with Form No. 09 attached hereto;
b) The Biosafety Certificate already issued in case of change of information about the entity or loss or damage;
c) Documentation proving the content of the change in the case provided for in point a Clause 1 of this Article.

3. The registering organization shall submit one set of reissue files in accordance with Clause 2 of this Article to the Ministry of Natural Resources and Environment through one of the following methods: direct submission, postal service, or online environment.

4. Within seven working days from the date of receipt of complete and valid files, the Ministry of Natural Resources and Environment shall consider and issue the Biosafety Certificate."

13. Article 28 is amended at point c, supplemented with points d and đ of Clause 2 as follows:

"c) In the case of genetically modified organisms specified in Clause 2 of Article 27 of Decree No. 69/2010/NĐ-CP, provide the original or certified copy and Vietnamese translation of the confirmation document or equivalent document issued by the competent authority allowing the genetically modified organism to be used as food in at least five developed countries;

d) Summary of the risk assessment report (with electronic version) of the genetically modified organism concerning human health in accordance with Form No. 10 attached hereto;

đ) Scientific references, unpublished research data, evaluation figures, test results, or other scientific evidence (if any) used by the registering organization as a basis to conclude that the genetically modified organism does not have adverse effects on human health."

14. Add Article 28a after Article 28 as follows:

"Article 28a. Competence, Procedure, and Formalities for Reissuing the Confirmation of Genetically Modified Organisms Suitable for Food Use

1. The Confirmation of Genetically Modified Organisms Suitable for Food Use shall be reissued in the following cases:
a) Change of information about the entity in the Confirmation of Genetically Modified Organisms Suitable for Food Use already issued;
b) Loss or damage of the Confirmation of Genetically Modified Organisms Suitable for Food Use already issued.

2. The reissue application includes:
a) Application for reissue in accordance with Form No. 11 attached hereto;
b) The Confirmation of Genetically Modified Organisms Suitable for Food Use already issued in case of change of information about the entity or loss or damage;
c) Documentation proving the content of the change in the case provided for in point a Clause 1 of this Article.

3. The registering organization submits one set of the reissue application in accordance with Clause 2 of this Article to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal service, or online environment.

4. Within seven working days from the date of receipt of complete and valid files, the Ministry of Agriculture and Rural Development shall consider and issue the Confirmation of Genetically Modified Organisms Suitable for Food Use."

15. Article 33 is amended at point c, supplemented with points d and đ of Clause 2 as follows:

"c) In the case of genetically modified organisms (GMOs) as stipulated in point b, Clause 1, Article 32 of Decree No. 69/2010/NĐ-CP, they must provide the original or certified copy and notarized Vietnamese translation of the confirmation letter or equivalent document issued by the competent authority allowing the GMO to be used as animal feed in at least five developed countries;"

"d) A summary of the risk assessment report (with electronic version) of the GMO for animals according to Model No. 12 attached to this Decree;"

"đ) Scientific references, unpublished research data, evaluation figures, test results, or other scientific evidence (if any) that the registering organization uses as the basis to conclude that the GMO does not have adverse effects on animals;"

16. Add Article 33a following Article 33 as follows:

"Article 33a. Competence, procedure, and formalities for reissuing the Certificate confirming that genetically modified organisms (GMOs) meet the conditions for use as animal feed

1. The Certificate confirming that genetically modified organisms (GMOs) meet the conditions for use as animal feed shall be reissued in the following cases:
a) Changing information about the organization in the Certificate confirming that genetically modified organisms (GMOs) meet the conditions for use as animal feed that has been issued;
b) The Certificate confirming that genetically modified organisms (GMOs) meet the conditions for use as animal feed is lost or torn, deteriorated;"

2. The reissue application includes:
"a) An application for reissuance according to Model No. 13 attached to this Decree;"
"b) The Certificate confirming that genetically modified organisms (GMOs) meet the conditions for use as animal feed that has been issued in the case of changing information about the organization or being torn, deteriorated;"
c) Documentation proving the content of the change in the case provided for in point a Clause 1 of this Article.

3. The registering organization submits one set of the reissue application in accordance with Clause 2 of this Article to the Ministry of Agriculture and Rural Development through one of the following methods: direct submission, postal service, or online environment.

"4. Within seven working days from the date of receiving complete and valid files, the Ministry of Agriculture and Rural Development will consider issuing the Certificate confirming that genetically modified organisms (GMOs) meet the conditions for use as animal feed;"

17. Amend Clause 3 of Article 42 as follows:

"In the case of transiting genetically modified organisms (GMOs) or products derived from GMOs that are not subject to the provisions of Clause 1 of Article 42 of Decree No. 69/2010/NĐ-CP through the territory of Vietnam, the transit procedures shall be carried out in accordance with the provisions of point c, Clause 1, Article 35 of Decree No. 69/2018/NĐ-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Management of Foreign Trade;"

Article 2. Transitional Provisions

"1. Applications for recognition of testing facilities for genetically modified organisms (GMOs), issuance of permits for testing GMOs, and recognition of testing results for GMOs received before the effective date of this Decree shall continue to be processed according to the legal regulations in effect at the time of receipt, except where the organization that submitted the application requests implementation according to this Decree;"

"2. Decisions recognizing testing facilities for genetically modified organisms (GMOs), permits for testing GMOs, and recognition of testing results for GMOs issued before the effective date of this Decree remain legally valid;"

Article 3. Implementation Provisions

"1. This Decree takes effect from October 2, 2020;"

"2. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of provincial People's Committees under central cities, and related organizations and individuals are responsible for implementing this Decree./."