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National Biosafety Policy

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

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National Biosafety Policy

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  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

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