Transcript National Biosafety Policy

National Biosafety Policy
Prof. Athula Perera
National Coordinator
National Biosafety Framework
Development Project
Ministry of Environment & Natural
Resources
Why NBF ?
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One of the elements of the framework:
Regulatory system
Administrative structure
Risk assessment & management
Public participation
Biosafety Policy related to Biotechnology
The Need
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Biotechnology
Any technological application that uses biological systems, living
organisms or derivatives thereof, to make or modify products or
processes for a specific use:
Traditional plant breeding
Old biotechnology – tissue culture, fermentation
Recently: Modern biotechnology:
In vitro nucleic acid techniques including
Recombinant DNA technology – direct injection of DNA into cells
or organelles, fusion of cells beyond taxonomic family -
overcome natural physiological, reproductive or recombination
barriers….. Not used in traditional breeding & selection
Advances & Risks
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Advances in :
Medicine
Agriculture
Industry
Risks!!!!
Biological diversity
Human health
Not yet known!
Uncertainty about potential risks
Long-term research required.
Costs of mitigating or reversing damage/harm – immense & farreaching
Government of Sri Lanka: responsible for health status & food
security of our people
Urgent need
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Establish biosafety measures :
GMO/FFP locally produced, imported
National Policy on Biosafety
Minimize possible risks
Extract maximum benefit
Ensure protection of our traditional
biotechnology – knowledge, practices &
benefits
Principle
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If there is any perceived threat of
serious or irreversible damage, lack of
scientific certainty shall not be used as
a reason to postpone measures to
prevent adverse effects on human
health and the environment.
Safety First!
Prove safety prior to use.
Our obligations
International Conventions
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Sri Lanka – ratified –
Convention on Biological Diversity (CBD)
Cartagena Protocol (CP) on Biosafety
Conservation of Biological diversity
Sustainable use of its components
Sharing of benefits – fair & equitable
Protection in safe transfer, handling and use
of GMO/LMO
Policy Framework
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The national policy on biosafety shall
conform to the National Development
Objectives of the Government of Sri
Lanka
Policy Objectives
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Based on precautionary principle
Supports other related policies – complementary
Implementation of biosafety measures
Ensure effective regulation & management of
GMO/FFP imported to Sri Lanka – based on AIA
Regulate & manage local products
Promote dissemination of knowledge in safe use &
probable hazards of Mod. Biotech.
Emphasize biosafety & bioethical considerations
Provide institutional framework for decision making,
networking, monitoring R&D, international
cooperation in all biosafety matters
Policy Principles
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Biosafety regulations based on precautionary
principle & AIA
Develop our own capabilities in all aspects of
biosafety
Manufacture, use, import, export, sale or
transboundary movement of MB applications,
practices and products shall conform fully to all
relevant national legislations
Public awareness, education and participation in
decision-making processes – essential
RA&M of GMO/FFP : according to national biosafety
regulations
Industries using MB shall reveal all relevant data – for
consumer protection
Safety test data – fully disclosed and made public
Decisions on biosafety issues shall not be overruled in
fora that favour other considerations
Policy Statements
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Recognizes the importance of protecting its people,
environment and biodiversity while promoting a
sustainable social and economic development
through the safe use of MB
Recognizes the human health and environmental
risks that may be incurred by careless &
unscrupulous development of MB and the use of its
products for agriculture, health, waste management
& other purposes
Realizes the need for developing our own capabilities
in biosafety through research & development and
training
Reaffirms the commitment to the obligations of CBD
& CP
Recommendations
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A committee appointed by the Ministry of
E&NR shall be the controlling authority for all
issues relating to biosafety in Sri Lanka
Labeling of genetically modified products shall
be made mandatory – free and informed
choice for consumers
National safety guidelines and implementation
practices shall be adopted by industries using
MB
GM detection laboratories as well as
resources for RA&M shall be identified,
established and supported. They shall be
accredited
Recommendations….contd.
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Assess, identify and develop priorities in
human resource development
Enhance public awareness of MB and
potential risks/benefits & RA&M techniques
Support research into risks to environment &
human health (different envts./organisms.,
food habits….)
Review and update safety standards to
incorporate changes in MB
More……
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Establish & develop knowledge bases &
infrastructure for information exchange
Establish a Master Plan for Biosafety –
implement policy matters
Interim period: enact existing
legislations to regulate & manage
GMP/FFP
How did we do this?
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National sub-committee appointed by NCC
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Director/NASTEC; Director Biotech. Centres/
Chairpersons of CARP & NSF; DG/Agric.; Ministry
of Health; Dept. of Fisheries, Animal prod. &
Health, Min. of Finance, Director/Biodiversity,
Director, Planning, M of E&NR, Chairpersons of
other national sub-committees:
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Regulations
Administrative structure
Technology & techniques
Report to NCC
03 National Consultative Meetings with ALL
stakeholders
Newspaper notices, website
Absolute transparency
National database on B&B
National Survey
1. Policies, Strategies, Action Plans, Research
and Development
2. Collecting Legal Documents
3. Experts/ Resource persons
4. Physical Resources and Education & Training
Facilities
5. Existing Techniques, Technologies and
Knowledge
6. Existing Biotechnology Industries
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Existing import/ export items related
to biotechnology/biosafety
Existing service sector related to
biotechnology and biosafety
Media
Existing framework for importation of
materials relevant to Biosafety
Health sector: ministry/
hospitals/nursing homes/ ayurvedic
hospitals & dispensaries
Libraries
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90
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70
60
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43
50
40
20
6
2
Phamaceutical
s
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30
Food
No of e xpe rts
Major Fields of Expertise
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0
Microbes
Human
Plants
Animal
Major area
50
Techniques
ELISA Assays
32
Nucleic acid
hybridization
Radio labeling
of DNA/RNA
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DNA
sequences
30
Cloning of DNA
sequences
35
Cloning vector/
host systems
No of Experts
Technological Capacity
46
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40
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28
25
25
20
15
10
5
0
Research Activities
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12
23
29
25
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22
Production of microbes
DNA markers in plant/animal breeding
DNA fingerprinting
Development of DNA probes
DNA/RNA based desease diagnostics
Industrial biotechnology
Fermentation technology
Educational Qualifications
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143
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Basic Degree
M.Sc.
M.Phill
Ph.D.
Distribution of Basic Degree
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5
5
B.Sc.(Agriculture)
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66
B.Sc.
B.Sc.Engeeniaring
B.Veterinary Science
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MBBS
B.Dental Science
Name of The Institute
Agricultural Biotechnology Centre.
Available Techniques
Available Equipments
Extraction of DNA, cloning vector, DNA
Sequencing, PCR Assays, None –isotopic
labelling of DNA/RNA, gene gun, Tissue
culture, ELISA Assays,
Fermenter/Bioreactor, Electrophorosis,
Bio- processing, Bio-leaching, Bio pulping,
Bio-bleaching.
UV Visible Spectrophotometer,
ELISA Reader, Thermo cycle
(PCR machine), Polaroid
Camera, Autoclave, UV
transilluminor, Freeze dryer,
Freezer, Laminar Flow, Ice
Machine, Vertical
Electrophoresis Apparatus,
Thermal Cycler, Gene gun, Bio
reader, Confocal Imaging
System, UPS.
Rajarata University of Sri Lanka
Department of Molecular Biology And
Biotechnology
Laminar Flow hood
Extraction of DNA, Cloning vector, DNA
Sequencing, ELISA Assays,
Electrophoresis.
BOC Freezers, Centrifuges,
Spectrophotometers, DNA
Sequencing Apparatus, Gel
electrophoresis units
(Horizontal/Vertical), PCR
Machine, ELISA Plate Reader/
Washer, Incubator/Oven,
Autoclave, Ice Machine,
Shaker water bath, Co2
incubator, Shaker incubator.
Plant Virus Indexing Centre.
Molecular based virus diagnostic
Techniques, Serological virus detection
techniques.
Ultra Centrifuge, Benchtop
Centrifuges, Thermo Cycler,
Electrophoresis app, UV
Spectrometer, UV
Transilluminator, Polaroid
Camera, Liquid N dewars,
Tissue culture, Fermentation techniques.
Microscopes, ELISA Reader,
High Speed Centrifuge,
Thermo Cycler, Fermentor.
Industrial Technology Institute
Sugarcane Research Institute
National Science Foundation
Regional Agricultural Research and Development
Centre.
Hector Kobbekaduwa Agrarian Research and
Training Institute.
Central Environmental Authority.
Auto Clave, Dry oven,
Incubators (Single Door and
Double Door)
Institute of Post Harvest Technology.
Oven, Incubator, Auto clave,
HPLC, Spectrophotometer,