20 years Blue Book, ISBGMO, Jeju Island Basic framework for risk assessment of transgenic plants developed by OECD: history and evolution of OECDs risk/safety assessment framework Hans Bergmans National Institute for Public Health and the Environment The Netherlands

20 years Blue Book, ISBGMO, Jeju Island Blue Book: Recombinant DNA Safety Considerations, OECD 1986 Authors scientists, academia, advisory committees scientists, regulators representatives of governments representatives of industry 1983: Biotechnology: international trends and perspectives

20 years Blue Book, ISBGMO, Jeju Island Blue Book: Recombinant DNA Safety Considerations, OECD 1986 Focus on new developments Large scale industrial applications Agricultural and environmental applications Micro-organisms, and plants Input from experience GMOs contained use Non-GMOs large scale industrial applications environmental applications (plant protection, breeding)

20 years Blue Book, ISBGMO, Jeju Island Blue Book: Safety considerations Science-based risk assessment: Hazards/risks identified on basis of: properties of the recipient organism technique of modification properties of the GMO Conjectured hazards vs. evidence for safety change in pathogenic effects e.g. host range toxicity weediness

20 years Blue Book, ISBGMO, Jeju Island Blue Book: Safety considerations Appendices: parameters General scientific considerations (characterization) Human health considerations Environmental and agronomic considerations Ecological Traits Relating to the Donor and Recipient Application of the Engineered Organism in the Environment Survival, Multiplication and Dissemination in the Environment Interactions of Engineered Organism(s) with Biological Systems Potential Environmental Impacts Potential risks to humans, plants and animals (of microorganisms)

20 years Blue Book, ISBGMO, Jeju Island Use existing data on environmental and human health effects of living organisms to guide risk assessments Ensure that recombinant DNA organisms are evaluated for potential risk, prior to applications in agriculture and the environment … … by means of an independent review of potential risks on a case-by-case basis Conduct the development of rDNA organisms … in a stepwise fashion Encourage further research to improve the prediction, evaluation and monitoring of applications of rDNA organisms Blue Book: Recommendations

20 years Blue Book, ISBGMO, Jeju Island Risk/safety assessment framework Case-by-case Step-by-step Further discussions step-by-step: safe way for GM plant development case-by-case: yes, but there is a common approach

20 years Blue Book, ISBGMO, Jeju Island step-by-step lab, greenhouse small scale field scale-up Good developmental principles (GDP) Safety considerations for biotechnology 1992 scientific guidance to the performance of low or negligible risk small-scale field research, including basic and applied research confinement trap of GDP: there are no other lessons from such safe experiments than that the approach is indeed safe

20 years Blue Book, ISBGMO, Jeju Island step-by-step lab, greenhouse small scale field scale-up Safety considerations for biotechnology: Scale-up of crop plants (1993) The concept of Familiarity: knowledge and experience that can be used for Risk/safety analysis Applying risk management Indicating where more knowledge is needed

20 years Blue Book, ISBGMO, Jeju Island Common approach to risk/safety evaluation Preamble (1993) in: Safety considerations for biotechnology: Scale-up of crop plants Risk/safety analysis hazard identification and, if hazard identified: risk/safety assessment based on knowledge and experience: familiarity familiarity is not the same as safety Based on characteristics of the recipient organism, the introduced trait, the environment into which the organism is introduced, the interaction between these, and the intended application

20 years Blue Book, ISBGMO, Jeju Island Preamble in: Safety considerations for biotechnology: Scale-up of crop plants Risk/safety analysis is based on familiarity is typically an ongoing component of research, development and testing of new organisms is a scientific procedure; does not imply or exclude regulatory oversight Operational principles step-by-step: next step is determined by risk/safety analysis: the steps are not fixed

20 years Blue Book, ISBGMO, Jeju Island Familiarity: For risk/safety evaluation: baseline information Traditional crop breeding practices (1993) A historical review to serve as a baseline for assessing the role of modern biotechnology Soybean, Wheat, Rice, Cucurbits, Cotton, Tobacco, Sunflower, Maize, Sugar beet, Alfalfa, Oilseed rape, Onion, Cassava, Potato, Prunus

20 years Blue Book, ISBGMO, Jeju Island Working Group for Harmonisation of Biotechnology Consensus Documents Biology documents Crop plants, trees, microorganisms Trait documents Virus resistance, herbicide tolerance Guidance documents Use of bacterial taxonomy in risk assessment

20 years Blue Book, ISBGMO, Jeju Island Consensus Documents snapshots of current information, for use during the regulatory assessment of products of biotechnology An Introduction to the Biosafety Consensus Documents of OECDs Working Group for Harmonisation in Biotechnology Points to Consider for Consensus Documents on the Biology of Cultivated Plants (2006)

20 years Blue Book, ISBGMO, Jeju Island Developments thought starter: Blue Bookscience-based risk assessment familiarity, baseline for risk/safety evaluation Risk assessmentPreamble FamiliarityGDP, Scale up document BaselineTraditional crop breeding practices Consolidation Consensus documents New developmentsBiology documents: Points to consider Trait documents Environmental risk parameters Molecular characterisation

20 years Blue Book, ISBGMO, Jeju Island These documents are not written in stone, they are snapshots in time of a developing framework Blue Book: GDP: Scale-up: Traditional breeding and other guidance: tml tml Consensus documents html