‘Blue Book’: Recombinant DNA Safety Considerations, OECD 1986

1. Basic framework for risk assessment of transgenic plants developed by OECD:history and evolution of OECD’s risk/safety assessment frameworkHans BergmansNational Institute for Public Health and the EnvironmentThe Netherlands

2. 1983: Biotechnology: international trends and perspectives ‘Blue Book’: Recombinant DNA Safety Considerations, OECD 1986 • Authors • scientists, academia, advisory committees • scientists, regulators • representatives of governments • representatives of industry

3. ‘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)

4. ‘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

5. ‘Blue Book’: Safety considerations • Appendices: ‘parameters’ • General scientific considerations (characterization) • Human health considerations • Environmental and agronomic considerationsEcological 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)

6. Use existing data on environmental and human health effects of living organisms to guide risk assessments ‘Blue Book’: Recommendations • 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

7. Risk/safety assessment frameworkCase-by-caseStep-by-stepFurther discussions step-by-step: safe way for GM plant development case-by-case: yes, but there is a common approach

8. step-by-steplab, greenhouse  small scale field  scale-up‘Good developmental principles’ (GDP)Safety considerations for biotechnology 1992scientific guidance to the performance oflow or negligible risk small-scale field research,including basic and applied researchconfinement‘trap of GDP’:there are no other lessons from such ‘safe’ experimentsthan that the approach is indeed safe

9. step-by-steplab, greenhouse  small scale field  scale-upSafety 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

10. 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

11. ‘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

12. 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

13. 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

14. Consensus Documents “snapshots” of current information, for use during the regulatory assessment of products of biotechnology ‘An Introduction to the Biosafety Consensus Documents of OECD’s Working Group for Harmonisation in Biotechnology’ ‘Points to Consider for Consensus Documents on the Biology of Cultivated Plants’ (2006)

15. Developments thought starter: Blue Book science-based risk assessment familiarity, baseline for risk/safety evaluation Risk assessment ‘Preamble’ Familiarity GDP, Scale up document Baseline Traditional crop breeding practices Consolidation Consensus documents New developments Biology documents: Points to consider Trait documents Environmental risk parameters Molecular characterisation

16. These documents are not written in stone, they are snapshots in time of a developing framework Blue Book:http://www.oecd.org/dataoecd/45/54/1943773.pdf GDP:http://www.oecd.org/dataoecd/8/3/2375496.pdf Scale-up:http://www.oecd.org/dataoecd/26/26/1958527.pdf Traditional breeding and other guidance:http://www.oecd.org/document/17/0,2340,en_264_34385_1891281_1_1_1_1,00.html Consensus documents http://www.oecd.org/document/51/0,2340,en_2649_34385_1889395_1_1_1_1,00.html