national biosafety policy
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National Biosafety Policy. Prof. Athula Perera National Coordinator National Biosafety Framework Development Project Ministry of Environment & Natural Resources. Why NBF ?. One of the elements of the framework: Regulatory system Administrative structure Risk assessment & management - PowerPoint PPT PresentationTRANSCRIPT
National Biosafety Policy
Prof. Athula Perera
National CoordinatorNational Biosafety Framework
Development ProjectMinistry of Environment &
Natural Resources
Why NBF ? One of the elements of the
framework:
Regulatory system Administrative structure Risk assessment & management Public participation Biosafety Policy related to
Biotechnology
The Need
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 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 & far-reaching
Government of Sri Lanka: responsible for health status & food security of our people
Urgent need 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
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
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
The national policy on biosafety shall conform to the National Development Objectives of the Government of Sri Lanka
Policy Objectives 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 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 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 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.
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……
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?
National sub-committee appointed by NCC
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:
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
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
Major Fields of Expertise
44
79
9
43
6 20
10
20
30
40
50
60
70
80
90
Animal
Plants
Human
Microbes
Food
Phamaceuticals
Major area
No o
f exp
erts
Technological Capacity
3128
32
25
34
46
0
5
10
15
20
25
30
35
40
45
50
Clo
nin
g v
ect
or/
ho
st s
yste
ms
Clo
nin
g o
f DN
A
se
qu
en
ces
DN
A
se
qu
en
ces
Ra
dio
lab
elin
g
of D
NA
/RN
A
Nu
cle
ic a
cid
hyb
rid
iza
tion
EL
ISA
As
sa
ys
Techniques
No
of
Ex
pe
rts
Research Activities
12
29
33
22
25
23
13
Production of microbes DNA markers in plant/animal breeding
DNA fingerprinting Development of DNA probes
DNA/RNA based desease diagnostics Industrial biotechnology
Fermentation technology
143
71
29
24
Basic Degree M.Sc. M.Phill Ph.D.
Educational Qualifications
66
52
114 5 5
B.Sc.(Agriculture)
B.Sc.
B.Sc.Engeeniaring
B.Veterinary Science
MBBS
B.Dental Science
Distribution of Basic Degree
Name of The Institute Available Techniques Available Equipments
Agricultural Biotechnology Centre. 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 Laminar Flow hood
Department of Molecular Biology And Biotechnology
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.
Grain Legume and Oil Crop Research and Development Centre
Tissuculture (Shoot tip culture, Callus culture etc.
Laminar Flow, Autoclave.
Department of Microbiology PCR, Cloning, Microbial biotechnology,
Thermal cycler, Ultra Freezer, ELISA Reader, Spectrophotometer, Transilluminator, Micro centrifuge, BOD Apparatus, Fermenter, Laminar flow.
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,
Industrial Technology Institute
Sugarcane Research Institute Tissue culture, Fermentation techniques.
Microscopes, ELISA Reader, High Speed Centrifuge, Thermo Cycler, Fermentor.
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, Colorimeter, Viscometer, Refrigerator, Rotary Evaporator, Kjeldahl, Ebiliometer, Moisture Balance, Whiteness Meter.