1. BIOSAFETY CONCERNS IN THE CONTEXT OF BIOTECHNOLOGY. Presentation for Training Workshop for Regional Advisors Bangkok, 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