Advances in genetic engineering: EFSA public consultations in 2020
One of the core tasks of the European Food Safety Authority (EFSA) is to assess risks to human and animal health and/or the environment from regulated products/stressors linked to food and feed production; this includes genetically modified organisms (GMOs). EFSA fulfils this role primarily in two ways: (i) providing scientific advice on the safety of GMO market registration applications to the European Commission (EC) and European Union (EU) Member States on whose shoulders rests the responsibility to decide on authorisation; and (ii) issuing guidance for applicants on how to compile and present their applications including, for example, the data and other information that should be included for a structured risk assessment.
In the field of biotechnology, EFSA is currently addressing three mandates from the European Commission that may have important implications for future GMO registrations in the EU and which are scheduled for completion by the end of 2020. The first of these is on gene drive which will be launched for public consultation in February 2020. Gene drives comprise genetic elements that can pass traits among sexually reproducing organisms at a frequency greater than the rate expected by simple Mendelian inheritance. The ability to engineer gene drives has sparked both enthusiasm and concerns among scientists and citizens. While engineered gene drives could be used to control agricultural pests and invasive species, rescue endangered species or supress disease vectors, there is concern that they may also have unintended effects and alter ecosystems in an irreversible manner. As potential future applications for the placement of GMOs on the EU market (including public use) may include the deliberate release of GMOs with engineered gene drives into the environment, the European Commission has identified the need for an in‐depth assessment of the adequacy of EFSA's existing guidelines for the molecular characterisation (MC) and environmental risk assessment (ERA) of gene drive‐modified organisms. EFSA organised a workshop1 in Brussels on 15 May 2019 to foster an open dialogue with stakeholders on the application of problem formulation methodology to the assessment of gene drives. The outcomes informed the EFSA GMO Panel's draft scientific opinion.
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