For additional details, kindly consult the following national instruments and guidelines currently in force: the Biosafety Act of Bhutan, 2015; the Biosafety Rules and Regulations, 2018; the Safety Assessment Guidelines; the National Biodiversity Strategy and Action Plan (NBSAP); the GMO Detection Manual; and other relevant regulatory documents.

Bhutan has established the Biosafety Act of Bhutan, 2015, and the Biosafety Rules and Regulations, 2018. Field inspectors are knowledgeable about genetically modified organisms (GMOs) and actively conduct surveillance activities. Revised Safety Assessment Guidelines are in place. A Biosafety Technical Working Group (TWG) has been established, and laboratory facilities are available for the detection of GMO elements.

While pharmaceutical products are governed under the Bhutan Medicines Rules and Regulations, 2019, and the Product Registration Guidelines, the scope of the Biosafety Act of Bhutan does not extend to the regulation of pharmaceuticals.

Under national law, the import, transit, contained use, and any research and development involving genetically modified organisms or modified biological materials capable of reproduction are prohibited. These provisions are implemented through regulatory controls, surveillance activities, and enforcement by competent authorities.

In accordance with national legislation, any intentional introduction of living modified organisms (LMOs) into the environment is prohibited.

Under the Biosafety Rules and Regulations, prior authorization is required for the import of GMOs or products derived from GMOs for food, feed, or processing. Applications are reviewed by the Biosafety Technical Working Group in accordance with the Guidelines on Safety Assessment of Food and Feed Derived from Genetically Modified (GM) Plants, and import approval is subject to the safety assessment and decision of the Governing Board of the Bhutan Food and Drug Authority (BFDA). To date, no applications have been received by the Authority for such imports and hence there is no approved GMO in Bhutan for feed and food purpose.

Under the Biosafety Act of Bhutan, the import of genetically modified organisms (GMOs) in viable or reproducible form is prohibited. However, in accordance with the Biosafety Rules and Regulations of Bhutan, 2018, the competent authority retains the right to revoke any permit or authorization granted for the import of GMOs intended for food or feed use if new information emerges indicating potential adverse effects on human health, animal health, or the environment that were not anticipated at the time of approval.

Bhutan has not yet established a formal mechanism for the application of a simplified procedure regarding the intentional transboundary movement of Genetically Modified Organisms. In accordance with national biosafety legislation, the intentional transboundary movement of Genetically Modified Organisms (GMOs) capable of reproduction is prohibited. All applications for transboundary movement of GMO for further processing will be assessed through the standard regulatory procedures outlined in the Biosafety legislations.

While Bhutan is a Party to the Cartagena Protocol on Biosafety, no bilateral or regional agreements specifically addressing the transboundary movement of living modified organisms (LMOs) have been concluded to date. All transboundary movements of LMOs into Bhutan if any will be regulated under national legislation, including the Biosafety Act of Bhutan, 2015, and the Biosafety Rules and Regulations, 2018.

Bhutan currently prohibits all activities involving viable genetically modified organisms (GMOs). However, the import and use of GMOs for food, feed, or processing purposes are permitted following a safety assessment and approval by the Board of the Bhutan Food and Drug Authority (BFDA). At present, Bhutan has limited capacity to detect GMOs, particularly for identifying stacked GMO events, underscoring the need for capacity-building in this area. To date, BFDA has not received any applications for the import of GMOs; consequently, no risk assessments have been conducted and no approvals granted. In the event of a transboundary movement or unintended release of GMOs capable of reproduction into the environment, the Authority shall: (1) contain the GMOs at the release site; (2) communicate with relevant authorities; (3) remove the GMOs from the site or render them non-viable; (4) prevent GMOs from being consumed by humans or animals; and (5) prevent GMOs from becoming established or persisting in the environment.

An incident management plan in place for low-level presence of unauthorized GMOs.

To date, no importer in Bhutan has imported genetically modified organisms (GMOs) for food or feed purposes. Nevertheless, under the national biosafety legislation, the Bhutan Food and Drug Authority (BFDA) is mandated with regulatory oversight of GMOs intended for food and feed. This mandate includes the review and management of import applications in accordance with guidelines, maintenance of records related to transport of GMOs, and enforcement of requirements for proper storage, containment, and waste management at processing facilities. To ensure compliance, the BFDA is also authorized to inspect transport vehicles and collect samples from import consignments. While the National Food Testing Laboratory has the technical capacity to detect GMO elements using real-time polymerase chain reaction (PCR) techniques, operational efficiency is constrained by full reliance on the importation of Certified Reference Materials (CRMs) and other analytical reagents.

Under the Biosafety Act, BAFRA (now BFDA) is the competent authority for implementing biosafety measures, with the National Biosafety Board/BFDA Governing Board serving as the country’s highest decision-making body on biosafety.

Since no applications for the import of genetically modified organisms (GMOs) for food or feed purposes have been received to date, no decisions have been made. However, the relevant legislation and guidelines are in place to regulate and manage the import of GMOs for food and feed use.

Relevant guidelines and legislation are made available through the Biosafety Clearing-House (BCH) website, and a designated National Focal Point has been appointed to coordinate and facilitate information exchange.

Under the Biosafety Rules and Regulations (2018), the categories of information deemed to be Confidential Business Information are defined, and the regulations explicitly indicate which types of information are not treated as confidential.

No funds have been secured from the GEF allocation for biosafety-related capacity-building activities. A competency-based framework has been developed for regulatory and quarantine officers to assess capacity gaps..

In the absence of active biosafety-related activities in Bhutan, the BFDA undertakes biosafety awareness initiatives on an ad hoc basis, utilizing suitable platforms like training/workshop avenue to create awareness on Biosafety.

Bhutan prohibits all activities involving genetically modified organisms (GMOs) capable of reproduction, including activities such as import, transit, environmental release, contained use, and research and development.

As per the Biosafety legislations, transboundary movement or unintended release of LMOs are prohibited. In case of incidents, the Authority shall take immediate measures to contain the release site. It shall coordinate and communicate with relevant authorities, remove the GMOs or render them non-viable, and ensure that they are not consumed by humans or animals. The Authority shall also take necessary actions to prevent the GMOs from establishing and persisting in the environment.

The National Biosafety Framework highlights that social, economic, ethical, cultural, and religious impacts of modern biotechnology, including socio-economic considerations, should complement environmental and human health factors in biosafety decision-making. While transparency and stakeholder participation are emphasized, the actual use of socio-economic assessments in LMO decision-making remains limited due to the absence of relevant activities.

Regional biosafety assessment guidelines have been developed collaboratively by Bangladesh, Bhutan, India, and Sri Lanka. Bhutan also hosted the Seventh Regional Biosafety Workshop on ‘Advancing Biosafety in Asia: Strengthening National Capacities and Catalyzing Regional Cooperation for the Effective Implementation of the Cartagena Protocol on Biosafety.’ In addition, Bhutanese officials participated in a GMO detection workshop in Slovenia, a capacity-building program on GM food and feed safety assessment, and the Meeting of the Expert Working Group under the South Asia Harmonization Initiative held in Sri Lanka.

In accordance with the Biosafety Act of Bhutan (2015) and the Biosafety Rules and Regulations (2018), individuals or entities are held strictly liable for any intentional or negligent harm caused to human health, animals, or the environment resulting from genetically modified organisms (GMOs). This liability includes covering all medical expenses, compensation for disability or death, and the full cost of environmental restoration for affected flora and fauna. Additionally, as a condition of approval, importers may be legally required to conduct continuous risk monitoring and evaluation for any GMO products placed on the market or held in containment. Bhutan has not yet acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress but intends to do so upon completion of internal processes.