신유전체기술(NGT) 적용 식물에 대한 EU 규제 논쟁의 최근 동향과 시사점

The current debate on the NGT (New Genomic Techniques) Regulation in the EU revolves around the question of how plants modified using new biotechnology should be regulated. These discussions will have significant implications for discussions on the revision of the “Act on Transboundary Movement of Genetically Modified Organisms” in Korea. However, since this law is mainly aimed at regulating existing GMOs and ensuring their safety, it is also necessary to consider enacting a new special law to respond to the rapid development of NGT technology and changes in global regulations. In other words, first, the existing GMO law is centered on traditional genetic modification technology and does not consider the specificity and differentiation of NGT; second, the impact on biodiversity, health, and industry due to the expansion of gene editing technology (such as CRISPR/Cas9) must be reflected; and third, consistency with international norms (Cartagena Protocol, EU's NGT policy) must be secured. For these reasons, there is a great need to enact a special law on so-called NGT plants. The author would like to draw attention to the following issues for future legislative discussions in Korea: First, NGT plants are divided into two categories: NGT-1 Plants considered equivalent to conventional plants (e.g. through mutations that can also be achieved through conventional breeding) and NGT-2 Plants with changes that go beyond NGT-1. It is worth considering this in Korea as well, in terms of differential regulation based on risk. Second, for NGT-1 plants should complex risk assessment no longer be necessary. NGT-2 plants should continue to be subject to a risk assessment, but this should be less extensive than for traditional GMOs. Third, NGT-2 plants should be marked as such. Fourth, there is the issue of patents. There is a debate about the patenting of NGT plants, with the EU Parliament calling for a ban. Finally, there is the question of coexistence. There are calls for regulations to ensure that NGT plants can coexist with non-GMO agriculture. The current changes to the NGT Regulation, which affect plants obtained using new genetic engineering techniques (NGT), have met with criticism. There are fears that deregulation could lead to non-transparent, unaudited and uncontrolled processes in the food production chain and the environment. Critics are calling for greater transparency, labeling requirements, and the assurance of coexistence with GMO-free agriculture. The EU Commission proposes deregulation for plants produced with Category 1 NGTs (deregulation of NGT plants). These plants should be exempted from the strict requirements of the current genetic engineering legislation. First, A legal opinion finds that the proposal is incompatible with the Cartagena Protocol on Biosafety, as NGT-1 plants are to be exempted from the labelling and reporting obligations laid down therein (violation of international law). Second, Critics complain that the proposals contain non-transparent processes and a lack of labelling requirements for foods made from NGT plants, which restricts consumers' freedom of choice (non-transparency and lack of labelling). Third, The proposal is seen as a threat to non-GMO agriculture, both conventional and organic, as coexistence with NGT plants is not sufficiently ensured (threat to non-GMO agriculture). Fourth, It is pointed out that NGT plants could cross-breed with natural plants and the consequences for the ecosystem cannot be estimated (risks for ecosystems). Finally, Critics argue that the proposed criteria for risk assessment of NGT plants are insufficient, especially with regard to the possibility of complex biological constructs that can arise through artificial intelligence (lack of risk assessment). In summary, the current amendment to the NGT Regulation is met with widespread criticism, particularly due to the feared deregulation and the associated risks for the environment, agriculture and consumers.