Chương 5 Nghị định 69/2010/NĐ-CP : Giấy chứng nhận an toàn sinh học

Chapter V

BIOSAFETY CERTIFICATES

Article 22. Conditions for grant of biosafety certificates

To be granted a biosafety certificate, genetically modified organisms must satisfy the following conditions:

1. Having been assayed under Vietnam's specific conditions. Their assay results have been recognized as satisfactory by the Ministry of Agriculture and Rural Development.

2. Having been concluded by the Biosafety Council as safe for the environment and biodiversity.

Article 23. Competence, order and procedures for grant or revocation of biosafety certificates

1. The Ministry of Natural Resources and Environment may grant and revoke biosafety certificates.

2. An applicant for a biosafety certificate shall submit three (3) dossier sets to the Ministry of Natural Resources and Environment. Such a dossier comprises:

a/ An application for the certificate, made according to the form set by the Ministry of Natural Resources and Environment:

b/A report on assay results recognized by the Ministry of Agriculture and Rural Development as satisfactory:

c/ A report on assessment of risks of genetically modified organisms to the environment and biodiversity, made according to Appendix IV to this Decree.

3. Within 7 working days after receiving a dossier, the Ministry of Natural Resources and Environment 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 180 days after receiving a valid dossier of application for a biosafety certificate, the Ministry of Natural Resources and Environment shall set up a biosafety council to appraise the dossier.

5. After receiving a valid dossier, the Ministry of Natural Resources and Environment shall publish information on the report on assessment of risks of genetically modified organisms to the environment and biodiversity on the biosafety website for public comment. Public comments shall be summarized and reported to the Biosafety Council. The maximum duration for collecting public comments is 30 days after information is published.

6. Within 30 days after obtaining appraisal results, the Minister of Natural Resources and Environment shall examine them and grant a biosafety certificate. In case of refusal, it shall issue a notice clearly stating the reason to the applicant.

7. Applicants for biosafety certificates shall pay a charge. The Ministry of Finance shall assume the prime responsibility for, and coordinate with the Ministry of Natural Resources and Environment in, specifying rates, management and use of the charge for appraisal of dossiers of application for biosafety certificates.

8. The Ministry of Natural Resources and Environment shall specify the order and procedures for grant of biosafety certificates.

9. The Biosafety Council shall advise the Minister of Natural Resources and Environment on whether to grant biosafety certificates. This Council shall be composed of representatives of the Ministries of Industry and Trade; Science and Technology; Agriculture and Rural Development; Natural Resources and Environment; and Health, and some experts.

The Minister of Natural Resources and Environment shall decide to set up. and define the functions, tasks and operation mechanism of. the Biosafety Council.

Article 24. Revocation of biosafety certificates

1. A biosafety certificate shall be revoked in the following cases:

a/ There is a new scientific proof of the risks of genetically modified organisms that have been granted a biosafety certificate:

b/ Organizations or individuals intentionally provide untruthful information which is decisive to the grant of the biosafety certificate:

c/ There is a proof that the Biosafety Council's conclusions lack scientific grounds.

2. The Ministry of Natural Resources and Environment shall decide to revoke biosafety certificates, issue written notices to organizations or individuals having such biosafety certificates and publish the revocation in the mass media.

3. From the date of issuance of decisions revoking biosafety certificates, organizations and individuals are disallowed to release into the environment genetically modified organisms with revoked biosafety certificates.

Article 25. Contents of a biosafety certificate

1. A biosafety certificate contains:

a/Names of genetically modified organisms: scientific names, common names, gene transmission events and the sole identification numbers, if any;

b/ Detailed information on the organization or individual who is granted the certificate;

c/ Specific requirements to ensure biosafety during the use of genetically modified organisms.

2. The Ministry of Natural Resources and Environment shall set the form of biosafety certificate.

Article 26.-List of genetically modified organisms eligible for biosafety certificates

1. The Ministry of Natural Resources and Environment shall make a list of genetically modified organisms eligible for biosafety certificates and publish this list on its biosafety website.

2. Within 10 days after granting or revoking a biosafety certificate, the Ministry of Natural Resources and Environment shall add or delete the names of genetically modified organisms to or from such list.