Ethical, legal and social implications of genetically modified organismin the shadow of advanced genetic tools

In order to define the term GMO, different scientific definitions and legal explanations are available. In theregulation process of GM foods, the US and EU legal frameworks are based on the methodologiesthemselves. Currently, for the production of GMOs, several genome editing tools are available. Along withdifferent site-directed nucleases (ZFN, TALENs, etc.), RNAi and CRISPR/Cas9 have proven to be the veryeffective tools for genome editing. According to the current EU legislative, introduced in 2018,CRISPR/Cas9 and RNAi techniques are regulated as methods that produce GMOs, because themethodology of the process itself resembles the traditional breeding methods. In the past few years, a largenumber of scientific publications have confirmed that CRISPR/Cas9 and RNAi technology produce GMOs,supporting and suggesting that the legislation policies in the EU and especially in the USA have to beelaborated. Besides, a huge public pressure makes it difficult to develop and implement new methodologiesfor GMO production. For this reason, ELSI society is responsible to investigate and question whether thenew genetic engineering techniques produce GMO food that is safe for human consumption.