The Biosafety Act of Bhutan 2015, passed in July 2015 has been cautiously drafted considering the Kingdom’s current interest and keeping in view the country’s food security needs. The Biosafety Act addresses the regulation and safety management of GM organisms and GM products in the Kingdom.
The Biosafety Act and relevant technical guidelines has been drafted with financial and technical support from UNEP-GEF through the National Biosafety Framework Project (2012-2014) under Bhutan Agriculture and Food Regulatory Authority (BAFRA) of the Ministry of Agriculture and Forests (MoAF). BAFRA has been designated as the National Competent Authority to regulate and co-ordinate all Biosafety related activities in the Kingdom. For ease in implementation of the provisions of the Act, the Biosafety Rules and Regulations have been readied; it is yet to be formalized.
In fulfilment of the Bhutan’s obligation to the Cartagena Protocol on Biosafety and to address the trans-boundary movement, transit, handling and use of all GMOs and their products that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account the risks to human and animal health.
This Act applies to:
- All genetically modified organisms;
- Products derived from genetically modified organisms;
- All stages of import, export, and direct use of products that have genetically modified content within the Kingdom.
This Act does not apply to:
- Traditional and domestic methods of animal and plant breeding;
- Traditional and domestic exchange and sale of local seeds, plants, and livestock;
- Gene sequencing, tissue culture, and other similar methods, which do not involve the use of modern biotechnology; and
- Products derived from genetically modified organisms for pharmaceuticals for human and veterinary use.
The following activities are prohibited in the Kingdom:
- Import of any genetically modified organism capable of reproducing;
- Transit of genetically modified organisms capable of reproducing;
- Intentional introduction into environment of genetically modified organisms capable of reproducing;
- Any use, including contained use, of genetically modified organisms capable of reproducing; and
- Research and development that involves genetically modified organisms capable of reproducing.
- The Biosafety Act prohibits the cultivation/environmental release of GMOs. Also, the GMOs that are capable of reproducing are restricted for import, transit, intentional introduction, contained use, research and development.
- The Biosafety Act allows the import of GMOs and/or GM products for direct use as food, feed and processing (FFP) if its safety has been reviewed (By the technical Working Group on Biosafety) and is approved (by the National Biosafety Board of Bhutan). It has to follow the prior approval system to obtain approval and permit.
The GM Food safety review would be conducted by the Technical Working Group on Biosafety in line with the national safety guidelines for the assessment of GM foods/feeds. These safety guidelines have been adapted based on the internationally established scientific guidelines and principles of Codex Alimentarius Commission (CAC), Joint Food and Agriculture Organization (FAO) and World Health Organisation (WHO) Expert Consultations, United Nations Environment Program (UNEP) and Organisation for Economic Co-operation and Development (OECD).