Biosafety Act of Bhutan 2015.

The present Act provides for the protection, conservation and safeguarding of biodiversity in Bhutan. In particular, the Act shall apply to: 1) All genetically modified organisms; 2) Products derived from genetically modified organisms; 3) All stages of import, export, and direct use of products that have genetically modified content within the Kingdom. Section 5 establishes that the Act establishes a Board, to be known as the National Biosafety Board. The Board is the highest decision making body for issues related to biosafety. The Board shall exercise the jurisdiction and powers and discharge the mandates conferred or imposed by or under this Act. The Board shall: 1) Periodically review and recommend to the Royal Government on the national biosafety policy; 2) Endorse rules and regulations pertaining to the implementation of this Act; 3) Approve overall plans and programmes of the agencies involved in the administration of the biosafety related activities; 4) Ensure smooth coordination among the stakeholder agencies in the implementation of the provisions of this Act; 5) Approve mechanisms and procedures to address any intentional or unintentional transboundary movement of genetically modified organism into the Kingdom; 6) Serve as an appellate body to address grievances expressed by any person or corporation against the decision of the Authority; 7) Make decisions on the approval of genetically modified organisms and/or products derived from genetically modified organisms; and 8) Oversee the performance of the Authority on matters related to administration of biosafety activities. Section 14 establishes that the Bhutan Agriculture and Food Regulatory Authority is the national competent authority for the implementation and enforcement of this Act and all other biosafety related activities in the Kingdom.
The text consists of 33 sections divided into 7 chapters as follows: Preliminary (I); Organization of biosafety administration (II); Principle and prohibitions (IIII); Risk assessment, management and communication (IV); Labelling and compliance monitoring (V); Public awareness and access to information (VI); Liability, compensation, enforcement and penalties (VII).