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

Abstract

In order to define the term GMO, different scientific definitions and legal explanations are available. In the
regulation process of GM foods, the US and EU legal frameworks are based on the methodologies
themselves. Currently, for the production of GMOs, several genome editing tools are available. Along with
different site-directed nucleases (ZFN, TALENs, etc.), RNAi and CRISPR/Cas9 have proven to be the very
effective 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 the
methodology of the process itself resembles the traditional breeding methods. In the past few years, a large
number 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 be
elaborated. Besides, a huge public pressure makes it difficult to develop and implement new methodologies
for GMO production. For this reason, ELSI society is responsible to investigate and question whether the
new genetic engineering techniques produce GMO food that is safe for human consumption.