Safety Assurance for Environmental Introductions of Genetically-Engineered Organisms

The purpose of this book is to investigate the suitability and applicability of available methods for analyzing the human and ecological risks involved in the release of genetically-modified microorganisms. Main topics include: - risk analysis and assessment; approach to safety assurance; - inventory of available scientific risk assessment methods for biotechnology; - identification of methodology gaps and research needs in biology, ecology or other disciplines; - development of a general framework to guide future biotechnology risk assessment efforts; - international regulatory activities.

I: Workshop Summary.- Recommendations for a Scientific Approach to Safety Assurance for Environmental Introductions of Genetically-Engineered Organisms.- II: Risk Analysis Perspectives.- “Old” Biotechnology to “New” Biotechnology: Continuum or Disjunction?.- Potential Applications of Knowledge System Technology to Biotechnology Safety Assurance.- Assessing Human Health Risks of Environmentally Released, Genetically Engineered Microorganisms.- Risk Assessment Strategies for Biotechnology.- A Biological Approach to Assessing Environmental Risks of Engineered Microorganisms.- Informing People About the Risks of Biotechnology: A Review of Obstacles to Public Understanding and Effective Risk Communication.- III: Scientific Perspectives.- Application of Genetically-Engineered Micro-Organisms in the Environment.- Ecology and Biotechnology: Expectations and Outliers.- Plasmid Transfer in a Freshwater Environment.- L-Form Bacteria and Somatic Associations with Eucaryotes.- Deliberate Release of Genetically Engineered Organisms in the Environment.- IV: Regulatory Perspectives.- Status of United States Government Regulatory Activities for Environmental Applications of Genetically Engineered Organisms.- The Oversight of Planned Release in the UK.- Regulation and Risk Assessment for Environmental Release of Genetically Engineered Microorganisms in Denmark.- Evolution of Recombinant DNA Guidelines in Japan.- International Regulatory Issues for Modern Biotechnology.