1. National Biosafety Policy
Prof. Athula Perera
National Coordinator
National Biosafety Framework Development Project
Ministry of Environment & Natural Resources

2. Why NBF ? One of the elements of the framework: Regulatory system
Administrative structure
Risk assessment & management
Public participation
Biosafety Policy related to Biotechnology

3. 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

4. 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

5. 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

6. 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.

7. 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

8. Policy Framework
The national policy on biosafety shall conform to the National Development Objectives of the Government of Sri Lanka

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. National database on B&B
National Survey
Policies, Strategies, Action Plans, Research and Development
Collecting Legal Documents
Experts/ Resource persons
Physical Resources and Education & Training Facilities
Existing Techniques, Technologies and Knowledge
Existing Biotechnology Industries

17. 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

18. Major Fields of Expertise

19. Technological Capacity

20. Research Activities

21. Educational Qualifications

22. Distribution of Basic Degree

23. Available Techniques Available Equipments
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.

24. 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.