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.
The second mandate that EFSA is currently working on relates to synthetic biology (SynBio), an interdisciplinary field at the interface of engineering and biology. It employs an engineering-based approach to build novel biological systems which have potential food and feed applications that would require authorisation in Europe. Some of those applications may include the deliberate release of genetically modified (GM) plants or GM microorganisms into the environment. As this is a fast-evolving field, the European Commission has asked EFSA to evaluate the adequacy of its existing guidelines for the MC and ERA of GM plants and GM microorganisms obtained by SynBio. The mandate has been addressed via a case study approach, focusing on SynBio products that could reach the EU market within the next decade. This review is due for public consultation by the end of March 2020 and will address GM plants and GM microorganisms separately.
The third mandate asks EFSA to assess its guidelines in relation to the biosafety of plants developed through type 1 and type 2 Site-Directed Nucleases (SDN-1 and SDN-2) and oligonucleotide directed mutagenesis (ODM). These new genome editing tools form part of a broad range of molecular methods that can be used to introduce mutations into the plant genome, whereas Site-Directed Nucleases type 3 (SDN-3) facilitate the insertion of new pieces of DNA at a precise spot in the genome. In 2012, EFSA delivered a scientific opinion on SDN-3 (EFSA GMO Panel, 2012). A ruling2 of the Court of Justice of the European Union (CJEU) in 2018 clarified that the 2001 Directive on GMOs covered newer organisms obtained by mutagenesis techniques that have emerged since its adoption. EFSA has been mandated to assess whether its previous opinion on the safety of plants derived from SDN-3 is still valid for those obtained through SDN-1, SDN-2 and ODM. The public consultation on this opinion is due to start in April 2020 at the latest, and the final output is scheduled for adoption by EFSA's GMO Panel by the end of October 2020.
EFSA's scientific advice on gene drive, SynBio and genome editing will inform the EU's position under the Convention on Biological Diversity and the Cartagena Protocol on Biosafety. Considering the broader societal debate on the potential applications of these advances in genetic engineering, EFSA aims to consult the widest possible number of stakeholders and interested parties and looks forward to receiving your inputs.
To keep up to date with EFSA public consultations on these and other food safety topics, please visit https://www.efsa.europa.eu/en/calls/consultations
