Decree 118/2020/ND-CP amend Decree 69/2010/ND-CP on biosafety for genetically modified organisms

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms or genetic specimens and products of genetically modified organisms

^__________

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 request of the Minister of Natural Resources and Environment;

The Government promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms or genetic specimens and products of genetically modified organisms (Decree No. 69/2010/ND-CP).

            Article 1. To amend and supplement a number of articles of the Decree No. 69/2010/ND-CP as follows:

1. To add Clause 6 to Article 3 as follows:

“6. Gene transformation events mean the result of the process of recombination of the target DNA into a certain position in the genome of an organism to produce a corresponding genetically modified organism carrying the target gene, including: single transformation events being results of transformation of a gene specifying a desired trait and stacked transformation events being results of transformation of two or many genes specifying one or many desired traits by the transgenic technology.”

2. To add Clause 4 to Article 5 as follows:

“4. Genetically modified organism is the result of the process of convergence by traditional crossbreeding from two or more transgenic events that has been issued a certificate of biosafety, a written certification of genetically modified organisms’ eligibility for use as food, a written certification of genetically modified organisms’ eligibility for use as animal feed, and at the same time complies with regulations on investment and business conditions, it is permitted to be released into the environment and used as for food or animal feed.”

3. To amend Clause 2 Article 7 as follows:

“2. Reports on assessment of risks of genetically modified organisms to the environment, biodiversity and health of humans and domestic animals shall be made according to the forms provided in Appendices IV, V and VI to the Decree No. 69/2010/ND-CP.

For a genetically modified organism carrying a stacked transformation event, the additional data on the interaction of transmitted gene in the structure, the preservation of integrity of structure, function and expression of the target gene in the host organism is required in the risk assessment report.”

4. To amend and supplement Article 15 as follows:

“Article 15. Contents of testing of genetically modified organisms

1. Genetically modified organism testing is a process of monitoring and assessing the effects of genetically modified organisms on the environment and biodiversity in specific conditions in Vietnam.

2. Genetically modified organism testing includes the following contents:

a) The danger of becoming a harmful organism;

b) The danger of adversely affecting non-target organisms;

c) The danger of causing disadvantageous changes to the surrounding eco-system.

For the risk assessment of genetically modified plant, it includes: assessment of impacts on soil ecosystems; assessment of impacts of cultivation practices of genetically modified plants on the environment and biodiversity;

d) The danger of genetic drift;

dd) Other unfavorable impacts.”

5. To repeal Clause 2 Article 16.

6. To amend and supplement Article 17 as follows:

“Article 17. Competence, order and procedures for accreditation and revocation of decisions on accreditation of genetically modified organism-testing institutions

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

2. Organizations registering the accreditation of genetically modified organism-testing institutions shall be public non-business units.

3. An organization registering the accreditation of genetically modified organism-testing institutions shall submit a dossier to the Ministry of Agriculture and Rural Development directly, by post or via the network environment. Such a dossier must comprise:

a) An application of registration for accreditation of genetically modified organism-testing institution, made according to Form No. 01 in the Appendix issued together with this Decree;

b) A document explaining the capacity of genetically modified organism-testing institution, made according to Form No. 02 in the Appendix issued together with this Decree.

4. Within 05 working days from the date of receipt of the dossier, the Ministry of Agriculture and Rural Development shall notify in writing the registering organization of acceptance of the valid dossier or request for supplementation or completion of the dossier; the duration of supplementation or completion of the dossier is not included in the duration of dossier appraisal.

5. Within 45 days from the date of receipt of a valid dossier, the Ministry of Agriculture and Rural Development shall organize the appraisal of the dossier of registration for accreditation of genetically modified organism-testing institution.

The Ministry of Agriculture and Rural Development shall establish a genetically modified organism risk assessment and testing council in accordance with Article 17a of this Decree. The appraisal result of the Council shall be used as the basis for the Ministry of Agriculture and Rural Development to consider and decide the accreditation of genetically modified organism-testing institution.

6. Within 10 days from the date the appraisal result is issued, the Ministry of Agriculture and Rural Development shall consider and decide on the accreditation of genetically modified organism-testing institution. In case of refusal to accredit the genetically modified organism-testing institution, it must notify the registering organization in writing and clearly stating the reasons.

7. The Ministry of Agriculture and Rural Development shall assume the prime responsibility for, and coordinate with the Ministry of Natural Resources and Environment in, inspecting the operation of genetically modified organism-testing institution. In case of violation of one of the requirements specified in Article 16 of Decree No. 69/2010/ND-CP, the Ministry of Agriculture and Rural Development shall consider and revoke the decision on accreditation of genetically modified organism-testing institution.

8. Within 10 days from the date of issuance of the decision on accreditation or revocation of decision on accreditation of genetically modified organism-testing institution, the Ministry of Agriculture and Rural Development shall send 01 original of the decision to the Ministry of Natural Resources and Environment and publish the decision on the website of the Ministry of Agriculture and Rural Development.”

7. To add Article 17a and Article 17b after Article 17 as follows:

“Article 17a. Organization and operation of the genetically modified organism risk assessment and testing council

1. The Ministry of Agriculture and Rural Development shall decide to establish a genetically modified organism risk assessment and testing council with at least 09 members: The Chairperson is the representative of the specialized management agency under the Ministry of Agriculture and Rural Development, the Deputy Chairperson is the representative of the standing appraisal agency and members are the representatives of the Ministries of Natural Resources and Environment, Industry and Trade, Science and Technology, Health and professionals. In which, 02 members were selected as criticism members. The Council dissolves itself upon completion of its duties. The Ministry of Agriculture and Rural Development shall appoint an affiliated unit as the standing appraisal agency.

2. The genetically modified organism risk assessment and testing council shall:

a) Appraise dossiers of registration for accreditation of genetically modified organism-testing institutions and consult the Ministry of Agriculture and Rural Development for it to consider and decide the accreditation of genetically modified organism-testing institutions;

b) Appraise dossiers of registration of testing, assessment of testing results and advice to the Ministry of Agriculture and Rural Development for consideration and grant of testing licenses and recognition of testing results.

3. The Council works on the principles of democracy, objectivity; take personal responsibility for the scientificity and accuracy of independent comments and assessments and collective responsibility for general conclusions of the Council.

4. In a meeting of the Council, at least two thirds of total members of the Council must be present, under the presiding of the Chairperson of the Council or the Deputy Chairperson of the Council (in case the Chairperson is absent). The standing appraisal agency shall hold meetings of the Council for each dossier, and record minutes on each meeting’s contents. At the first meeting, the chairperson of the meeting shall assign 01 secretary of the Council and 02 criticism members. In case of necessity, the Council may additionally propose 02 to 03 scientists with experience in the relevant field as independent criticism members of dossiers.

5. In case of necessity, the Council may request the standing appraisal agency to invite the representative of the registering organization to attend the meeting in order to provide additional information, answer questions of the Council’s members or the opinions of the public.

6. On the basis of minutes of the meetings, the secretary of the Council shall complete the report on assessment of the dossiers and conclusions of the Council to report to the Ministry of Agriculture and Rural Development.

Article 17b. Competence, order and procedures for re-grant of decisions on accreditation of genetically modified organism-testing institutions

1. Decisions on accreditation of genetically modified organism-testing institutions shall be re-granted if they are lost, damaged or torn.

2. A dossier of request for re-grant must comprise:

a) A written request for re-grant, made according to Form No. 03 in the Appendix issued together with this Decree;

b) The granted decision on accreditation of genetically modified organism-testing institution that is damaged or torn.

3. The registering organization shall submit a dossier of request for re-grant specified in Clause 2 of this Article to the Ministry of Agriculture and Rural Development directly, by post or via the network environment.

4. Within 07 working days from the date of receiving a complete and valid dossier, the Ministry of Agriculture and Rural Development shall consider and re-grant the decision on accreditation of genetically modified organism-testing institution.”

8. Amending and supplementing Article 18 as follows:

“Article 18. Competence, order and procedures for grant and revocation of licenses for testing of genetically modified organisms

1. The Ministry of Agriculture and Rural Development shall grant and revoke licenses for testing of genetically modified organisms.

2. An organization registering for a license for testing of genetically modified organisms shall submit a dossier to the Ministry of Agriculture and Rural Development directly, by post or via the network environment. Such a dossier must comprise:

a) A written request for grant of a license for testing of genetically modified organisms, made according to Form No. 04 in the Appendix issued together with this Decree;

b) A document explaining the registration for testing of genetically modified organisms and testing plan as specified in Appendix II and Appendix III to the Decree No. 69/2010/ND-CP. For genetically modified plants, to apply Form No. 05 in the Appendix issued together with this Decree;

c) A copy of the decision on accreditation of genetically modified organism-testing institution;

d) In cases genetically modified organisms are imported for testing and risk assessment, documents proving that such genetically modified organisms have been permitted by other countries to be released into the environment are required. In cases genetically modified organisms are created in Vietnam, documents proving that the genetically modified organisms are the results of scientific research process and has been recognized by a competent state agency are required.

3. Within 07 working days from the date of receipt of the dossier, the Ministry of Agriculture and Rural Development shall notify in writing the registering organization of acceptance of the valid dossier or request for supplementation or completion of the dossier; the duration of supplementation or completion of the dossier is not included in the duration of dossier appraisal.

4. Within 30 days, for a dossier of registration for grant of limited testing license, and 45 days, for a dossier of registration for grant of extensive testing license, from the date of receiving a valid dossier, the Ministry of Agriculture and Rural Development shall organize a genetically modified organism risk assessment and testing council to appraise the dossier. The appraisal results of the genetically modified organism risk assessment and testing council shall be used as the basis for the Ministry of Agriculture and Rural Development to consider and grant the licenses for testing of genetically modified organisms.

5. Within 10 days from the date the appraisal result is issued, the Ministry of Agriculture and Rural Development shall consider and grant the license for testing of genetically modified organisms. In cases of refusal to grant the license, the Ministry of Agriculture and Rural Development shall notify in writing to the registering organization, clearly stating reasons.

6. The Ministry of Agriculture and Rural Development shall assume the prime responsibility for, and coordinate with the Ministry of Natural Resources and Environment in, inspecting the observance of the requirements of licenses for testing of genetically modified organisms.

7. The Ministry of Agriculture and Rural Development shall consider and revoke a license for testing of genetically modified organisms if the organization that is granted the license for testing of genetically modified organisms commits any of the following acts of violation:

a) Failing to provide the accurate information about the name of the genetically modified organisms;

b) Conducting the testing at testing times, places and with testing scales that are not permitted by the Ministry of Agriculture and Rural Development;

c) Failing to comply with the document explaining the registration for testing of genetically modified organisms.

8. Within 10 days from the date of issuance of the decision on grant or revocation of license for testing of genetically modified organisms, the Ministry of Agriculture and Rural Development shall send 01 original of the decision to the Ministry of Natural Resources and Environment and publish the decision on the website of the Ministry of Agriculture and Rural Development.”

9. To amend Article 19 as follows:

“Article 19. Licenses for testing of genetically modified organisms

Licenses for testing of genetically modified organisms shall be made according to Form No. 06 in the Appendix issued together with this Decree.”

10. To add Article 19a after Article 19 as follows:

“Article 19a. Competence, order and procedures for re-grant of licenses for testing of genetically modified organisms

1. A license for testing of genetically modified organisms shall be re-granted in the following cases:

a) There is a change in information on licensed organization stated in the license for testing of genetically modified organisms;

b) The license for testing of genetically modified organisms is lost, damaged or torn.

2. A dossier of request for re-grant must comprise:

a) A written request for re-grant, made according to Form No. 07 in the Appendix issued together with this Decree;

b) The granted license for testing of genetically modified organisms, for cases where there is a change in information about the organization or the certification is damaged or torn;

c) Documents proving the changed contents, for the case specified at Point a Clause 1 of this Article.

3. The registering organization shall submit a dossier of request for re-grant specified in Clause 2 of this Article to the Ministry of Agriculture and Rural Development directly, by post or via the network environment.

4. Within 07 working days from the date of receipt of a valid and complete dossier, the Ministry of Agriculture and Rural Development shall consider and re-grant the license for testing of genetically modified organisms.”

11. Amending and supplementing Article 21 as follows:

“Article 21. Recognition of results of genetically modified organism testing

1. The registering organization shall send a report on results of genetically modified organism testing, made according to the Form No. 08 in the Appendix issued together with this Decree, to the Ministry of Agriculture and Rural Development directly, by post or via the network environment.

2. Within 30 days, for the limited testing result recognition, and 45 days, for the extensive testing result recognition, from the date of receiving a valid report as specified in Clause 1 of this Article, the Ministry of Agriculture and Rural Development shall organize a genetically modified organism risk assessment and testing council to appraise the report on results of genetically modified organism testing.

3. Within 10 days from the issuance date of appraisal results of the genetically modified organism risk assessment and testing council, the Ministry of Agriculture and Rural Development shall consider and decide the recognition or refusal of recognition of results of genetically modified organism testing. In cases of refusal to recognize the results of genetically modified organism testing, the Ministry of Agriculture and Rural Development shall notify in writing to the registering organization, clearly stating reasons.

4. Within 10 days from the date of issuance of the decision on recognition of results of genetically modified organism testing, the Ministry of Agriculture and Rural Development shall send 01 original of the decision to the Ministry of Natural Resources and Environment and publish the decision on the website of the Ministry of Agriculture and Rural Development.”

12. To add Article 23a after Article 23 as follows:

“Article 23a. Competence, order and procedures for re-grant of certificates of biosafety

1. A certificate of biosafety shall be re-granted in the following cases:

a) There is a change in the information about the organization stated in the granted certificate of biosafety;

b) The certificate of biosafety is lost, damaged or torn.

2. A dossier of request for re-grant must comprise:

a) A written request for re-grant, made according to Form No. 09 in the Appendix issued together with this Decree;

b) The granted certificate of biosafety, for cases where there is a change in information about the organization or the certification is damaged or torn;

c) Documents proving the changed contents, for the case specified at Point a Clause 1 of this Article.

3. The registering organization shall submit a dossier of request for re-grant specified in Clause 2 of this Article to the Ministry of Natural Resources and Environment directly, by post or via the network environment.

4. Within 07 working days from the date of receipt of a complete and valid dossier, the Ministry of Natural Resources and Environment shall consider and re-grant the certificate of biosafety.”

13. To amend Point c, add Points d and dd to Clause 2, Article 28 as follows:

“c) For cases with genetically modified organisms specified in Clause 2 Article 27 of Decree No. 69/2010/ND-CP, to provide the original or a certified true copy and a notarized Vietnamese translation of the written certification or equivalent document of the competent agency on allowing the genetically modified organisms to be used as food in at least 5 developed countries;

d) A summary of report on assessment of genetically modified organisms’ risks to human health (attached to the electronic version), made according to Form No. 10 in the Appendix issued together with this Decree;

dd) Scientific documents for reference, unpublished research, data of evaluation, testing or other scientific evidence (if any) that the registering organization uses as a basis for concluding that the genetically modified organisms do not cause adverse effects on human health.”

14. To add Article 28a after Article 28 as follows:

“Article 28a. Competence, order and procedures for re-grant of certification of genetically modified organisms’ eligibility for use as food

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

a) There is a change in information about the organization stated in the granted certification of genetically modified organisms’ eligibility for use as food;

b) The certification of genetically modified organisms’ eligibility for use as food is lost, damaged or torn;

2. A dossier of request for re-grant must comprise:

a) A written request for re-grant, made according to Form No. 11 in the Appendix issued together with this Decree;

b) The granted certification of genetically modified organisms’ eligibility for use as food, for cases where there is a change in information about the organization or the certification is damaged or torn;

c) Documents proving the changed contents, for the case specified at Point a Clause 1 of this Article.

3. The registering organization shall submit a dossier of request for re-grant specified in Clause 2 of this Article to the Ministry of Agriculture and Rural Development directly, by post or via the network environment.

4. Within 07 working days from the date of receipt of a complete and valid dossier, the Ministry of Agriculture and Rural Development shall consider and re-grant the certification of genetically modified organisms’ eligibility for use as food.”

15. To amend Point c, add Points d and dd to Clause 2, Article 33 as follows:

“c) For cases with genetically modified organisms specified at Point b Clause 1 Article 32 of Decree No. 69/2010/ND-CP, to provide the original or a certified true copy and a notarized Vietnamese translation of the written certification or equivalent document of the competent agency on allowing the genetically modified organisms to be used as animal feed in at least 5 developed countries;

d) A summary of report on assessment of genetically modified organisms’ risks to animals (attached to the electronic version), made according to Form No. 12 in the Appendix issued together with this Decree;

dd) Scientific documents for reference, unpublished research, data of evaluation, testing or other scientific evidence (if any) that the registering organization uses as a basis for concluding that the genetically modified organisms do not cause adverse effects on animal.”

16. To add Article 33a after Article 33 as follows:

“Article 33a. Competence, order and procedures for re-grant of certifications of genetically modified organisms’ eligibility for use as animal feed

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

a) There is a change in information about the organization stated in the granted certification of genetically modified organisms’ eligibility for use as animal feed;

b) The certification of genetically modified organisms’ eligibility for use as animal feed is lost, damaged or torn;

2. A dossier of request for re-grant must comprise:

a) A written request for re-grant, made according to Form No. 13 in the Appendix issued together with this Decree;

b) The granted certification of genetically modified organisms’ eligibility for use as animal feed, for cases where there is a change in information about the organization or the certification is damaged or torn;

c) Documents proving the changed contents, for the case specified at Point a Clause 1 of this Article.

3. The registering organization shall submit a dossier of request for re-grant specified in Clause 2 of this Article to the Ministry of Agriculture and Rural Development directly, by post or via the network environment.

4. Within 07 working days from the date of receipt of a valid and complete dossier, the Ministry of Agriculture and Rural Development shall consider and re-grant the certification of genetically modified organisms’ eligibility for use as animal feed.”

17. To amend Clause 3 Article 42 as follows:

“For cases of transit of genetically modified organisms, products of genetically modified organisms other than subjects specified in Clause 1 Article 42 of Decree No. 69/2010/ND-CP via Vietnam’s territory, the procedures for transit of organisms shall comply with Point c Clause 1 Article 35 of the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018, detailing a number of articles of the Law on Foreign Trade Management.”

Article 2. Transitional provisions

1. Dossiers of registration for accreditation of genetically modified organism-testing institutions, grant of licenses for testing of genetically modified organisms, recognition of results of genetically modified organism testing that have been received before the effective date of this Decree shall continue to be settled in accordance with law regulations applicable at the time of receipt, except for cases where the submitting organizations request the application of this Decree.

2. Decisions on accreditation of genetically modified organism-testing institutions, licenses for testing of genetically modified organisms, recognition of results of genetically modified organism testing that are granted before the effective date of this Decree are still legally valid.

           Article 3. Implementation provisions

1. This Decree takes effect on October 02, 2020.

2. Ministers, Heads of ministerial-level agencies, Heads of government-attached agencies and Chairpersons of People’s Committees of provinces and centrally-run cities and relevant organizations, individuals shall take responsibility for the implementation of this Decree./.