National Biosafety Framework of theKingdom of Bhutan, August 2006

Karma C. Nyedrup
National Environment Commission
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Introduction• The Royal Government of Bhutan
ratified the Convention on
Biological Diversity on 25th August1995• The government acceded to theCartagena Protocol on 26th August
2002

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Current Situation• There is no biotechnology activities inBhutan• Arrangement for safe use ofbiotechnology is also non-existent• Surveys revealed that Bhutan imports
35 percent of its food from neighboringcountries• These imports could potentially contain
GMO products• Imports are both in bulk, maize and rice
and as processed and packaged foods
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Current Situation• Agencies involved in import offoods are Food Corporation of
Bhutan and some private importhousesNational Environment Commission

4Biosafety Policy• Ministerial decree was issued by
the Ministry of Agriculture in 2000
banning all imports of GMOs into
the country• Environmental policy– Is to avoid over exploitation of its
forests, minerals and naturalresources– Maintain 60 percent of forest cover at
all times to comeNational Environment Commission5

Biosafety Policy• Agriculture Policy– Achieve food self-sufficiency throughintensification, diversification andintegrated nutrient and pestmanagement– Promotion of superior breeds ofhigher productivity and reduction of
total livestock– Develop and promote high value low
volume cash crops– To conserve the country’s rich floral
and faunal diversity
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Biosafety Policy• Health Policy– Established drug regulatory authority– Issued rules and regulations onimports of drugs and vaccines tosafeguard the health of citizens• Trade Policy– Promote and expand trade within theregion and other countries– Creation of conducive policy and legal
framework for promoting trade andindustrial development
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Regulatory Regime• Existing Biosafety Related
Legislation– Food Act 2005
• Chapter VII, section 59 and 60 directly
address issue of food safety resulting
from genetically modified food

– Livestock Act 2000
• Ensure that only quality and appropriate
breeds of livestock, poultry and fish are
introduced and to ensure the units used
for semen and embryo production andstorage are free from diseases
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Regulatory Regime– Plant Quarantine Act 1993
• Safeguard agricultural and wild flora frompests, defined as “any form of plant or
animal life, or any pathogenic agent,
injurious or potentially injurious to plants
or plant product.” in particular, it ensuresthat all imported plants are quarantinedand screened prior to entry into thecountry.

– Seed Act 2000
• Regulate import and export of agricultural
seeds, to prevent introduction of plants
and diseases and to promote seedindustry in the country aimed at rural
income and livelihood
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9Regulatory Regime– Biodiversity Act 2003
• Safeguard the genetic resources in termsof bio-prospecting and export• Ensure national sovereignty over geneticresources– Environmental Assessment Act 2000
• EIA
– Risk assessment– Public consultation

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System to Handle Application• National Environment Commissionis the Biosafety Focal Point• Bhutan Agricultural and Food
Authority is the National
Competent Authority under theMinistry of Agriculture

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System to Handle Application• Pre-application consultation
between the BAFRA and theapplicant• Applicant prepares an application• Applicant will be responsible forcarrying out risk assessment,
Environmental Impact Assessment
and Public Consultation• Applications will be submitted toBAFRA
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12System to Handle Application• BAFRA– NEC for policy advise– NCB for technical advise– BAFRA may seek clarification or
additional information– BAFRA approves the application– BAFRA denies the application– If approved, applicant seeks trade
license of permits– The applicant may appeal to theMinistry of Agriculture
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Timeframe for Decision MakingActivity

Timeframe1

Acknowledgement of receipt of notificationand how to proceed with an application for apermit for import of a GMO

90 working days

2

Communicate a decision on an application

270 working days fromdate ofacknowledgement

3

Inform the BCH of a decision to approve a
GMO for domestic use as food feed orprocessing including placing on the market

15 working days

4

Notify an applicant of a change in decision on 30 working days
transboundary movement

5

Party of imports’ response to changed
decision on transboundary movement

90 working days

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Notification of unintentional transboundary
movement likely to have significant adverse
effectImmediate

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Key Agencies• National Environment Commission– Provide central direction, leadership andcoordination, and formulate policies,
programs and projects to support
implementation of NBF– Ensure that best available science is appliedin making biosafety decisions– Highest decision making body on
environmental related issues– Focal point for MEAs
– Make policy decision on GMO related
activities/research etc.
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Key Agencies• Ministry of Agriculture– BARFA• Main responsible authority regarding
monitoring, inspection and enforcement• Safety control of placing on the market ofGMOs and their products, including
control of food products• Border control and market surveillance ofGM animals, plants, seeds, reproductive
materials, GM containing products
including those of animal origin, andindustrial feedstuffs
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16Key Agencies• Ministry of Health– Advise BAFRA on• Import of drugs, vaccines and pharmaceuticals• Research on GMO drugs and vaccines on humansubjects• Genetic research of the Bhutanese genome• Effect of GMO foods on human health– Stop unauthorized research of GMOs onhuman subjects– Seize and destroy illegal drugs and vaccines– Regulate movement of human genetic
resources out of the country and require all
research results to be declared and require
benefits accruing from the research to be
the sovereign rights of the people of Bhutan
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Key Agencies• Ministry of Trade and Industry– Will be involved in the issuance ofimport licenses/permit to FFP
importers– Coordinate with BAFRA to monitor andcontrol the labeling and packaging ofimported FFPs• Department of Revenue andCustoms– Inspection at the checkpoints
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Conclusion• Regulation on Biosafety

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