Outcome of a public consultation on the draft adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives

The European Food Safety Authority (EFSA) carried out an online public consultation to receive input from interested parties/persons on the draftscientific opinion on the adequacy and sufficiencyevaluation of existing guidelines for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of genetically modified insects containing engineered gene drives. This draft scientific opinion was endorsed by the EFSA Panel on Genetically Modified Organisms (GMOs) for public consultation on 29 January 2020, and prepared by EFSA’sGene Drive expert Working Group and scientific officers. The public consultation was open from 17 February 2020 until 24 April 2020. EFSA received comments from 36 different interested parties/persons. Overall, comments raised reveal different, often contrasting, opinions and perspectives toward the deliberate release into the environment of gene drive modified insects for insect disease vector/pest control, and on the adequacy and sufficiency of current risk assessment frameworks for the MC, ERA and PMEM of such insects.The public consultation comments were analysed and taken into consideration by the GMO Panel, the Gene Drive expert Working Group and EFSA’s scientific officers during the revision and finalisation of the scientific opinion.EFSA,the Gene Drive expert Working Group and the GMO Panel wish to sincerely thank all contributors to the public consultation for their invaluableinput. This technical report contains the comments received and clarifies how they have been considered for the revision and finalisation of the scientific opinion. The final scientific opinion was adopted by the GMO Panel on 14 October 2020, and published in the EFSA Journal.

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