Foreword

Abstract

Modern biotechnologies are applied to plants species (crops, flowers, trees), animals and microorganisms. The safety of the resulting transgenic organisms when released in the environment for their use in agriculture, forestry, the food and feed industry or for other applications represents a challenging issue. Genetically engineered products are rigorously assessed by their developers during their elaboration, and by governments when ready for release, to ensure high safety standards. This remains essential with new biotechnology developments using insects to fight against disease outbreaks: engineered mosquitoes need to be evaluated through a scientifically sound approach to risk/safety assessment that will inform biosafety regulators and support the decision concerning the release of these novel organisms in the environment. The OECD offers a long-standing recognised expertise in biosafety and contributes to facilitating an harmonised approach. The OECD's Working Group on Harmonisation of Regulatory Oversight in Biotechnology (WG-HROB) was established in 1995. The WG-HROB gathers national authorities responsible for the environmental risk/safety assessment of products of modern biotechnology in OECD countries and other economies. International organisations and experts involved in biosafety activities are associated with this programme. The primary goals of the WG-HROB are to promote international regulatory harmonisation, to ensure that methods used in the risk/safety assessment of genetically engineered products are as similar as possible. This may open the way to possible recognition and even acceptance of information from the assessments of other countries. The benefits of harmonisation are multiple: it strengthens mutual understanding among countries, avoids duplication, saves resources and increases the efficiency of the risk assessment process. Overall, it improves safety while reducing unnecessary barriers to trade. The environmental risk/safety assessment of transgenic organisms (biosafety assessment) is usually based on the information collected on the characteristics of the host organism, the introduced traits, the environment into which the organism will be released, the interaction between these, and the intended use of the organism for agriculture, forestry, food and feed industry, health improvement or other purposes. Since its establishment, the WG-HROB decided to focus its work on identifying parts of this information which could be commonly used among countries when conducting environmental risk/safety assessment, aiming to encourage information sharing and prevent duplication of effort among countries. Biosafety consensus documents are one of the major outputs of its work. The OECD Biosafety consensus documents are intended to be a "snapshot" of current information on a specific host organism or trait, for use during regulatory assessments of organisms considered for their release in the environment. These publications are not designed to be a comprehensive source of information on everythin...