Current Biosafety Scenario in Bhutan

• Bhutan ratified the Cartagena Protocol on Biosafety in August 2002 and enacted the Biosafety Act of Bhutan in 2015. Bhutan has adopted a precautionary policy concerning Genetically Modified Organisms (GMOs) or Living Modified Organisms (LMOs), with the aim to protect, conserve and safeguard the biodiversity in the country and promote organic agriculture. BAFRA under the Ministry of Agriculture and Forests is the designated national competent authority for the implementation and enforcement of biosafety-related activities.

• 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.

SCOPE This Act applies 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.

EXEMPTIONS This Act does not apply to:

1. Traditional and domestic methods of animal and plant breeding;
2. Traditional and domestic exchange and sale of local seeds, plants, and livestock;
3. Gene sequencing, tissue culture, and other similar methods, which do not involve the use of modern biotechnology; and
4. Products derived from genetically modified organisms for pharmaceuticals for human and veterinary use.

PROHIBITIONS The following activities are prohibited in the Kingdom:

1. Import of any genetically modified organism capable of reproducing;
2. Transit of genetically modified organisms capable of reproducing;
3. Intentional introduction into environment of genetically modified organisms capable of reproducing;
4. Any use, including contained use, of genetically modified organisms capable of reproducing; and
5. Research and development that involves genetically modified organisms capable of reproducing.

SUMMARY

1. 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.
2. 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).