Bhutan | BCH-NR3-BT-109644 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)
  |  
BCH-NR3-BT-109644-2   |   PDF   |   Print   |  
published: 29 Jan 2016 last updated: 17 Feb 2016
General Information


Bhutan Food and Regulatory Authority; Department of Forest and Park Services; National Biodiversity Centre;  Department of Livestock; Department of Agriculture; Wildlife Conservation Division, Department of Forest and Park Services; and National Environment Commission Secretariat.
EN

01 Jan 2011
31 Dec 2015
Party to the Cartagena Protocol on Biosafety
Yes
EN
Article 2 – General provisions
A domestic regulatory framework is partially in place
EN
2008
EN
  • One or more national biosafety laws
No
EN
Yes
EN
Less than 5
EN
Partially
EN
Bhutan has enacted the Biosafety Act of Bhutan in 2015. This Act applies to all genetically modified organisms, products derived from genetically modified organisms, and all stages of import, export, and direct use of products that have gentically modified content within Bhutan.
EN
Article 5 - Pharmaceuticals
No
EN
The Biosafety Act of Bhutan 2015 does not apply to products derived from GMOs for pharmaceuticals for human and veterinary use.
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
No
EN
The Biosafety Act of Bhutan has a provision prohibiting transit and contained use of GMOs in Bhutan.
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
No
EN
No
EN
Yes, to some extent
EN
No
EN
No
EN
None
EN
None
EN
As per the provisions under the Biosafety Act of Bhutan 2015, the intentional introduction of LMOs into the environment is prohibited.
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes, to some extent
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
The Bhutan Agriculture and Food Regulatory Authority has been designated as the Competent National Authority for implementation and administration of Biosafety related activities. As per the Biosafety Act of Bhutan 2015, the Scientific Techinical review will be conducted by Biosafety Advisory Body (Biosafety Technical Working Group) and the highest decision-making body is the National Biosafety Board.
EN
Article 12 – Review of decision
No
EN
No
EN
No
EN
None
EN
The Royal Government has not received any application or notification to date.
EN
Article 13 – Simplified procedure
Yes, to some extent
EN
No
EN
None
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
The Royal Government of Bhutan has not engaged in the transboundary movement of any LMOs with other countries nor has received any request or notification to date.
EN
Articles 15 & 16 – Risk Assessment and Risk Management
Yes
EN
Yes
EN
10 or more
EN
One or more
EN
One or more
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
No
EN
No
EN
No
EN
No
EN
No
EN
No
EN
No
EN
No
EN
No
EN
Yes, to some extent
EN
No
EN
Yes
EN
Bhutan considers development of capacity for risk assessment as a priority for effective conservation and management of natural resources in the country. Bhutan would like to abide by the provisions of the Protocol but has not received any notification from other Parties. Administrative system for risk review and application procedure is in plance. However, further capacity building in the area of risk review/assessment and management is required.  The risk assessment and management trainings availed in-country by some of the concerned officials were very basic or preliminary or introductory in nature .
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes, to some extent
EN
No
EN
No
EN
Never
EN
The Biosafety Act of Bhutan 2015 requires establishement of procedures for emergency control. This will be instituted in due course.
EN
Article 18 – Handling, transport, packaging and identification
Yes, to some extent
EN
Yes, to some extent
EN
Yes, to some extent
EN
Existing types of documentation
EN
No
EN
No
EN
Yes
EN
Yes, to some extent
EN
One or more
EN
Yes, to some extent
EN
One or more
EN
Yes
EN
None
EN
Bhutan has one GMO detection laboratory at the National Food Testing Laboratory, Thimphu where identificaiton, detection and quantification of GMOs can be done. Currently, two officials have been trained in this field. <br /><br />Bhutan has a detection GMO laboratory at the National Food Testing Laboratory but it is not yet certified.
EN
Article 19 – Competent National Authorities and National Focal Points
Yes, to some extent
EN
The National Environment Commission is the National Focal Point as per the provisions of the National Environment Protection Act 2007 whereas Bhutan Agriculture and Food Regulatory Authority is designated as the Competent National Authority for dealing with activities related to LMOs/GMOs under the National Biosafety Framework of Bhutan.
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available but only partially available in the BCH
EN
Information available but only partially available in the BCH
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but only partially available in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
No
EN
Yes, to some extent
EN
Yes, in some cases
EN
No
EN
Yes
EN
One or more
EN
One or more
EN
  • National website
The Royal Government of Bhutan has enacted the Biosafety Act in 2015 and relevant technical guidelines for risk assessment, management, inspection and monitoring, applicaiton handling, laboratory protocols and manuals. In May 2014, Bhutan organized regional workshop on Strengthening Biosafety and Harmonization of Biosafety Regulation participated by Six South Asian Countries.
EN
Article 21 – Confidential information
Yes, to some extent
EN
Yes, always
EN
The Environmental Assessment Act 2000 and the Regulation for the Environmental Clearance of Projects 2002 have provisions that protect the confidential information, if identified by the applicants. Further, the guidelines for biosafety provides provision for the applicant to declare confidential information.
EN
Article 22 – Capacity-building
No
EN
Yes, to some extent
EN
Bilateral channels
EN
No
EN
Yes
EN
Average
EN
  • Development of national biosafety frameworks
  • Implementation of national biosafety frameworks
Yes, to some extent
EN
  • Human resources capacity development and training
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Identification of LMOs, including their detection
Yes
EN
Yes
EN
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
Yes
EN
Yes
EN
1 per year or more
EN
No
EN
Bhutan has now required laws and mechanism in place but urgently requires assistance for implementation and enforcement. So far, Bhutan has received some assistance from Korean Biosafety Clearing-House.
EN
Article 23 – Public awareness and participation
Yes, to some extent
EN
Yes
EN
Yes
EN
Bhutan Agriculture and Food Regulatory Authority conducts awareness programs through regional, district level offices on biosafety.&nbsp; An effective strategy is also in place to reach the schools on the importance of biosafety.
EN
Yes
EN
One or more
EN
Yes, to some extent
EN
Yes, to some extent
EN
Yes
EN
Yes, to some extent
EN
  • National website
  • Newspaper
  • Forums
  • Mailing lists
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (National broadcasting television and radios)
National website
EN
Yes
EN
One or more
EN
5 or more
EN
Yes, to some extent
EN
Yes
EN
Less than 5
EN
The Environmental Assessment Act 2000 and the Regulation for the Environmental Clearance of Projects 2002 have provisions for conducting public consultation on activities/projects that may have any implication/impact on public. Further, the provisions under the National Environment Protection Act 2007 and the Constitution of the Kingdom of Bhutan give rights to the public for information.&nbsp; Lastly, the Biosafety Act of Bhutan 2015 also requires to carry out public consultation.
EN
Article 24 – Non-Parties
No
EN
No
EN
No
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes, to some extent
EN
Never
EN
The Royal Government of Bhutan has had no experience on illegal transboundary movement of LMOs so far.
EN
Article 26 – Socio-economic considerations
Yes
EN
Not applicable
EN
None
EN
No
EN
Article 27 – Liability and Redress
No
EN
No
EN
No
EN
Yes
EN
Article 28 – Financial Mechanism and Resources
500,000 USD or more
EN
Article 33 – Monitoring and reporting
Yes
EN
Yes
EN
Yes
EN
Other information
Comments on reporting format