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EFSA advises on risk assessment of engineered gene drives

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EFSA’s existing guidelines for the risk assessment  A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. of genetically modified animals are adequate for evaluating risks associated with gene drive Genetic engineering technology designed to speed up the transmission of specific genetic elements of interest in a target population. modified insects. However, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring, say EFSA’s experts on Genetically Modified Organisms.

A gene drive refers to a technology used in genetic engineering which is designed to bias – and therefore speed up – the transmission of certain genetic elements in a target population Section of the healthy population defined by a specified age range and gender. Because of their particular physiological status, pregnant and lactating women are specific target populations.. Current research is looking at deploying engineered gene drives in insect populations, although it will take several years before the use of this technology can be applied in practical, real-life situations.

There are already proposals to use engineered gene drives to suppress or modify mosquito populations, control agricultural pests, eradicate invasive species Animal, plant or other organism introduced by man into places out of its natural range of distribution., and rescue endangered species A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the species..

However, there is concern that this emerging technology may lead to undesired side effects and alter ecosystems irreversibly.

The European Commission asked EFSA to assess whether its existing guidelines for the risk assessment of genetically modified animals can be used for the risk assessment of gene drive modified insects. EFSA's work will also support the EU in discussions on the biosafety of genetically modified organisms in international fora such as the United Nations.

To carry out this work, EFSA engaged with stakeholders and scientists at various points in the development of its scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment.. A stakeholder workshop in 2019 allowed EFSA to gather views on the subject, and the draft opinion was published for a nine-week public consultation earlier this year.

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