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BIOSAFETY CONCERNS IN THE CONTEXT OF BIOTECHNOLOGY. Presentation for Training Workshop for Regional Advisors Bangkok, Thailand 15-27 May 2006. STARTING POINT. Conference on the Environment and Development Convention on Biological Diversity Cartagena Protocol on Biosafety.

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  1. BIOSAFETY CONCERNS IN THE CONTEXT OF BIOTECHNOLOGY.Presentation for Training Workshop for Regional AdvisorsBangkok, Thailand 15-27 May 2006.

  2. STARTING POINT • Conference on the Environment and Development • Convention on Biological Diversity • Cartagena Protocol on Biosafety

  3. WHAT IS BIOTECHNOLOGY? Processing of substances by biological agents to produce goods and services. • Biological agents: mainly microbes, animal and plant cells and enzymes. • Substances: renewable materials as well as those produced by microbes. • Goods and services: food, beverages, pharmaceuticals, etc.

  4. EARLY BIOTECHNOLOGY • Exploited microbes capable of producing useful substances by fermentation • Gave rise to industries associated with manufacture of wine, cheese, etc.

  5. FIRST WAVE OF BIOTECHNOLOGY • Fermentation process deciphered and manipulated to produce useful substances • Substances include industrial chemicals: acetone, glycerol, citric acid, etc. • Production of industrial chemicals represents first wave of biotechnology

  6. SECOND WAVE OF BIOTECHNOLOGY • Production of antibiotics (also fermentation products) ushered in the second wave of biotechnology • Use of antibiotics became the cornerstone of infectious disease control

  7. THIRD WAVE OF BIOTECHNOLOGY • Brought about by the advent of genetic engineering • Made possible by discovery of DNA-modifying enzymes • Basis of genetic engineering is gene transfer, gene alteration and gene regulation • Gave rise to GMOs, LMOs or transgenic organisms

  8. DRIVERS OF BIOTECHNOLOGY • Fermentation technology • Plant and animal cell culture • Enzyme technology • Genetic engineering

  9. REVIEW: BIOSAFETY PROTOCOL • Concerns about potential negative impact of development on the environment • Concerns about GMOs (LMOs) • UN System for managing trade in GMOs

  10. WHAT ARE THESE CONCERNS? • Environmental concerns • Animal and public health concerns

  11. ROOT OF CONCERNS • New technology • Status of knowledge on effects • Complexity of GMOs and their products • Uniqueness of each GMO

  12. ENVIRONMENTAL CONCERNS • Spreading of transgenes by GMOs to closely related domesticated or wild relatives • Spreading and invasion into natural ecosystems by GMOs • Spreading of transgenes from GMOs to unrelated species

  13. ENVIRONMENTAL CONCERNS • Development of herbicide-resistant weeds • Development of insecticide-resistant pests • Damage to non-target organisms interacting with GMOs

  14. Spreading of GMO transgenes to relatives • GMOs targeted • Possible effects on biodiversity • Potential contamination of conventional crops by GMOs • Potential for development of herbicide-resistant weeds

  15. Transgene spread to unrelated species Spreading of transgenes by plants to microbes with potential implications for: • Infectious diseases controlled by antibiotics • Potential for resistance to antibiotics • Increases in the number of antibiotic resistance genes

  16. Potential for development of insecticide-resistant pests of plant crops

  17. Transgene effects on non-target species • GMOs targeted • Potential for toxicants • Potential effects on non-targets and biodiversity

  18. ANIMAL AND PUBLIC HEALTH CONCERNS Effects of DNA, food and feed derived from GMOs • Possible pathological effects

  19. ANIMAL AND PUBLIC HEALTH CONCERNS Differences between transgene sequences in notification and in actual insert • Rearrangements of transgene in genome • Appropriateness of risk assessment data based on notifications

  20. ANIMAL AND PUBLIC HEALTH CONCERNS Persistence and uptake of foreign DNA and protein in gut of mammals • DNA and protein escaping digestion • DNA fragments [ for example the cry1(A) gene] shed in faeces and incorporated in manure

  21. ANIMAL AND PUBLIC HEALTH Transgenic or altered proteins • Difficulty in predicting plant gene expression due to environmental control, insertion sites and stability of inserts • Possibility of producing allergens, toxicants, biologically active compounds, etc

  22. ANIMAL AND PUBLIC HEALTH Production of chemicals and pharmaceuticals by plants • Potential for producing harmful substances • Plant species selected • Unintended mixture of GMO crops and conventional ones

  23. RESPONSE ADVOCATED Proactive action encouraged before GMOs are placed on the market • Case by case risk assessment • Notification procedures( for example, the Advanced Informed Agreement)

  24. BIOSAFETY AND THE BCH The BCH is the Information System of the Biosafety Protocol and caters for biosafety as follows: • Source of information on biosafety laws • Contact information on administrators of biosafety regime • Source of information on GMOs ( types, uses, risk assessment, risk management, decisions taken, etc ). • Roster of experts

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