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Risk assessment and the broader process of risk analysis are central to regulatory decision-making for GMOs. However, the process has tended to become rather complex, particularly as GMOs with several gene-trait combinations (e.g. stacked events) reach later stages of development. Fit-for-purpose, practical and integrated risk analysis methods are required to ensure effective and efficient regulatory decision-making, and to make rigorously scientific risk analysis more broadly accessible to diverse stakeholder groups. Given the need to enhance biosafety regulatory decision-making capacity, since the mid-1990s the International Centre for Genetic Engineering and Biotechnology (ICGEB) has organised 5-day workshops on the assessment of safety of GMOs. This has led to the development of a practical strategy for risk assessment, which has proved to be useful not only from a regulatory perspective, but also for the evaluation of potential risks early in the development of a GMO. This chapter presents the risk assessment methodology that has been continuously refined in the ICGEB workshops, including an outline on how this can be integrated into the broader context of risk analysis.
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