Chapter IV
ASSAY OF GENETICALLY MODIFIED ORGANISMS
Article 14. Requirements on assay of genetically modified organisms
1. Genetically modified organisms used for release, including culture, growing and purposeful release into the environment, must be assayed.
2. Assay of genetically modified organisms must be conducted step by step, from restricted assay to wide-area assay. Assay zones must be far enough from conservation zones and densely populated areas as stipulated.
Restricted assay shall be conducted under isolation conditions under regulations.
Wide-area assay shall be conducted in different eco-zones for which appropriate management and supervision measures are required, but not isolation.
3. Upon detecting that genetically modified organisms cause uncontrollable risks to the environment, biodiversity or health of humans or domestic animals, licensed assaying organizations or individuals or assaying institutions shall terminate the assay of genetically modified organisms and take emergency measures to deal with the risks and concurrently destroy such genetically modified organisms.
4. The Ministry of Agriculture and Rural Development shall guide in detail Clause 2 of this Article.
Article 15. Contents of assay of genetically modified organisms
1. Assay of genetically modified organisms means the process of monitoring and assessing genetically modified organisms' effects on the environment and biodiversity under Vietnam's specific conditions.
2. Assay of genetically modified organisms covers the following principal contents:
a/ Their danger of becoming weeds or pests;
b/ Their danger of adversely affecting non-target organisms;
c/ Their danger of causing disadvantageous changes to the surrounding eco-system;
d/ Other unfavorable impacts.
3. The Ministry of Agriculture and Rural Development shall guide in detail Clause 2 of this Article.
Article 16. Conditions for accreditation of genetically modified organism-assaying institutions
1. To be accredited as a genetically modified organism-assaying institution, an organization must fully satisfy the following conditions:
a/ Having suitable material and technical foundations and equipment for the assay of genetically modified organisms;
b/ Having suitable professional staff for the assay of genetically modified organisms:
c/ Having an assay process which satisfies biosafcty requirements.
2. The Ministry of Agriculture and Rural Development shall guide in detail conditions for accreditation of genetically modified organism-assaying institutions specified in Clause 1 of this Article.
Article 17. Competence, order and procedures to accredit, and revoke decisions accrediting, genetically modified organism-assaying institutions
1. The Ministry of Agriculture and Rural Development may accredit, and revoke decisions accrediting, genetically modified organism-assaying institutions.
2. An organization registering for accreditation of a genetically modified organism-assaying institution shall submit three (3) dossier sets to the Ministry of Agriculture and Rural Development. Such a dossier comprises:
a/ A written registration for accreditation of a genetically modified organism-assaying institution:
b/ A copy of the decision on the organization's functions and tasks;
c/ An explanatory document on the institution's capability, made according to the form set by the Ministry of Agriculture and Rural Development;
d/ Relevant documents evidencing the institution's satisfaction of the conditions specified in Article 16 of this Decree.
3. Within 7 working days after receiving a dossier, the Ministry of Agriculture and Rural Development shall notify its acceptance of the valid dossier to the registering organization or request the organization to supplement and complete the dossier under regulations. The time for dossier supplementation and completion will not be included in the time for dossier appraisal.
4. Within 45 days after receiving a valid dossier of registration for accreditation of a genetically modified organism-assaying institution, the Ministry of Agriculture and Rural Development shall set up a council to appraise dossier.
The council's appraisal results serve as a basis for the Minister of Agriculture and Rural Development to decide to accredit a genetically modified organism-assaying institution.
5. Within 30 days after obtaining appraisal results, the Minister of Agriculture and Rural Development shall examine them and accredit a genetically modified organism-assaying institution. In case of refusal, he/she shall issue a written notice clearly stating the reason to the applying organization.
6. The Ministry of Agriculture and Rural Development shall guide in detail the order and procedures for accrediting genetically modified organism-assaying institutions and periodically examine the operation of these institutions. In case a genetically modified organism-assaying institution fails to satisfy any of the conditions specified in Article 16 of this Decree, the Ministry of Agriculture and Rural Development shall consider the case and revoke the decision accrediting such institution.
7. The Ministry of Agriculture and Rural Development shall notify the Ministry of Natural Resources and Environment and relevant line ministries of the accreditation of. or revocation of decisions accrediting, genetically modified organism-assaying institutions
Article 18. Competence, order and procedures for grant or revocation of assay licenses
1. The Ministry of Agriculture and Rural Development may grant or revoke licenses for assay of genetically modified organisms.
2. An applicant for a license for assay of genetically modified organisms shall submit three (3) dossier sets to the Ministry of Agriculture and Rural Development. Such a dossier comprises:
a/ An application for the license, made according to the form set by the Ministry of Agriculture and Rural Development;
b/ An explanatory document about registration of the assay of genetically modified organisms, containing the information specified in Appendix II to this Decree;
c/ A plan on the assay of genetically modified organisms, made according to Appendix III to this Decree;
d/ A copy of the decision accrediting the genetically modified organism assaying institution;
e/ For genetically modified organisms imported for assay, they must have documents evidencing that they are permitted by the exporting country for use for the same purpose in the territory of this country. For genetically modified organisms created domestically, they must have documents evidencing that they are scientific research outcomes recognized by a competent state agency;
f/ The Agriculture and Rural Development Ministry's document recognizing restricted assay results, in case of registration of wide-area assay.
3. Within 7 working days after receiving a dossier, the Ministry of Agriculture and Rural Development shall notify its acceptance of the valid dossier to the applicant or request the applicant to supplement and complete the dossier under regulations. The time for dossier supplementation and completion will not be included in the time for dossier appraisal.
4. Within 60 days after receiving a valid dossier of application for a license for assay of genetically modified organisms, the Ministry of Agriculture and Rural Development shall set up a council to appraise the dossier.
The council's appraisal results serve as a basis for the Minister of Agriculture and Rural Development to grant a license for assay of genetically modified organisms.
5. Within 30 days after obtaining appraisal results, the Minister of Agriculture and Rural Development shall examine them and grant a license for assay of genetically modified organisms. In case of refusal, the Ministry of Agriculture and Rural Development shall issue a written notice clearly stating the reason to the applicant.
6. The Ministry of Agriculture and Rural Development shall guide in detail the order and procedures for granting a license for assay of genetically modified organisms and periodically examine the compliance with the requirements indicated in this license. In case of noncompliance with any of the requirements indicated in a license, the Ministry of Agriculture and Rural Development shall consider the case and revoke the license.
7. The Ministry of Agriculture and Rural Development shall notify the Ministry of Natural Resources and Environment and relevant line ministries of the grant or revocation of licenses for assay of genetically modified organisms.
8. Applicants for licenses for assay of genetically modified organisms shall pay a charge for appraisal of application dossiers. The Ministry of Finance shall assume the prime responsibility for. and coordinate with the Ministry of Agriculture and Rural Development in. specifying rates, management and use of the charge for appraisal of dossiers of application for licenses for assay of genetically modified organisms.
Article 19. Contents of a license for assay of genetically modified organisms
1. A license for assay of genetically modified organisms contains:
a/ Names of genetically modified organisms: scientific names, common manes, gene transmission events and the sole identification numbers, if any;
b/ Time, place and scale of assay;
c/ Quantity and volume of genetically modified organisms used for assay and the number of importations, for genetically modified organisms imported into Vietnam for assay;
d/ Specific requirements on compliance with the approved plan on assay of genetically modified organisms.
2. The Ministry of Agriculture and Rural Development shall provide in detail the form of license for assay of genetically modified organisms.
Article 20. Responsibility for assaying genetically modified organisms
1. Organizations and individuals licensed to assay genetically modified organisms shall observe the contents of their licenses and approved plans on assay of genetically modified organisms and periodically report on assays under approved assay plans to the Ministry of Agriculture and Rural Development.
2. Organizations and individuals licensed to assay genetically modified organisms shall, after completing or ceasing an assay, lake measures to ensure biosafety.
3. Within 60 days after completing an assay of genetically modified organisms, organizations or individuals licensed to assay genetically modified organisms shall send reports on assay results to the Ministry of Agriculture and Rural Development for consideration and recognition.
Within 30 days after ceasing an assay of genetically modified organisms, organizations or individuals licensed to assay genetically modified organisms shall send to the Ministry of Agriculture and Rural Development reports on the assay process, clearly stating the reason for such cessation.
4. Organizations and individuals licensed to assay genetically modified organisms shall take responsibility for the contents of reports on assay results and provide assay-related data to competent state agencies upon request.
Article 21. Recognition of assay results
Within 60 days after receiving a report on results of an assay of genetically modified organisms, the Ministry of Agriculture and Rural Development shall examine it and recognize assay results and notify in writing such results to the organization or individual registering for assay of genetically modified organisms and concurrently to the Ministry of Natural Resources and Environment and the provincial-level People's Committee of the locality where the assay is conducted.
Tìm kiếm
Nghị định 69/2010/NĐ-CP (Bản Word)
Nghị định 69/2010/NĐ-CP (Bản Pdf)