# A New Approach for Environmental Risk Assessments of Living Modified Organisms in South Korea
## 1 Introduction  
Various living modified organisms (LMOs) have been developed owing to advances in modern biotechnology, but there is concern about their potential risks to human health and the environment [1]. As a result, the Cartagena Protocol on Biosafety (CPB) to the Convention on Biological Diversity has developed an international standard for the use of LMOs [2, 3, 4, 5, 6]. Therefore, the Transboundary Movement, Etc. of LMOs Act (hereafter, the LMOs Act) was enacted in South Korea [7]. In particular, the Ministry of Environment (MOE) is in charge of the overall development and use of LMOs for environmental remediation [8, 9, 10, 11]. The MOE is also responsible for the risk review and assessment of LMOs for other uses in natural ecosystems and LMOs for environmental remediation. The National Institute of Ecology (NIE), an LMO risk review agency and institute for LMO risk assessment under the MOE, has been handed responsibility for LMO safety management. The NIE establishes standards and methods for reviewing and assessing the risk of LMOs for environmental remediation. Furthermore, it consults on the effects of new LMOs on the natural ecosystem [10, 11, 12].  
The environmental risk assessment includes environmental exposure experiment results obtained from laboratory and field tests using submitted LMOs and their genetic products [13; 14]. Moreover, the risk review must be accompanied by a risk assessment of the environment of each participating country [8; 9; 10; 15]. However, the risk assessment of LMOs is not easy because of the closed technical trade secrets of manufacturers and practical limitations in time, methods, lack of human resources, and places to conduct an assessment within the review period in each participating country [6; 7; 8; 16; 17; 18]. Additionally, environmental risk assessments should consider the food chain in the ecosystem [19; 20]. Therefore, new domestically applicable ecological risk assessment tools are required to resolve these issues and complement risk assessment reviews.  
Traditional environmental risk assessment methods are performed in two distinct steps: a high-dose toxicity evaluation of recombinant LM proteins (laboratory trial) and an exposure assessment of LM plants in an isolated field (field trial) [19; 20; 21; 22]. However, all studies must confirm the equivalence between the recombinant and expressed proteins in the LM plant [22].  
The aim of this study was to propose a risk assessment tool for LMO proteins using an agroinfiltration method for the putative risks associated with LMO proteins in LM crop mimic plants. In particular, the focus was placed on developing evaluation techniques which can determine whether the valued general risk of an LMO protein is manageable in potentially diverse environments. The NIE dedicated this effort to examining the applicability of risk assessment in the case of the insectical Vip3 Aa LMO protein, with the process comprising a comprehensive laboratory and semi-field trial, as in the tiered system for risk assessment [19; 20; 21; 22; 23]. The Vip3 Aa-infiltrated _Nicotiana tabucum_ plant, as a new risk assessment tool, provided the advantage of stable LMO protein production and rapid risk validation against herbivous insects before producing transgenic plants. In addition, this approach provides the opportunity to consider the food chain relationship between target and non-target insects and the benefits in terms of the environmental risk assessment of LM crop mimic plants, despite the absence of LMO plants.  
This study supports the usefulness of agroinfiltrated plants as a rapid risk validation tool for LMO proteins in the context of quick LMO risk assessment before import approval during the risk review process.