Bt Research 2024, Vol.15, No.3, 131-140 http://microbescipublisher.com/index.php/bt 133 data on the product's efficacy and safety. Similarly, in other countries, regulatory bodies impose strict guidelines to ensure the safe use of biopesticides, often mirroring the requirements for synthetic pesticides (Gupta and Dikshit, 2010; Rodríguez et al., 2019). 3.3 Comparative analysis of approval procedures A comparative analysis of the approval procedures reveals both commonalities and differences across international and national frameworks. For instance, while the European Union and India both require extensive data on the safety and efficacy of biopesticides, the specific requirements and the stringency of the approval process can vary. The European framework, under Regulation (EC) No. 1107/2009, emphasizes zonal evaluations and cut-off criteria, which can complicate the approval process for biopesticides (Villaverde et al., 2014). In India, the focus is on ensuring that biopesticides meet the same rigorous standards as synthetic pesticides, which includes detailed assessments of their chemistry and bioefficacy (Gupta and Dikshit, 2010; Kumar et al., 2019). Moreover, the regulatory innovation in some countries has led to the development of new policy spaces and proactive stances by regulatory agencies to promote the use of biopesticides. This is evident in the efforts to streamline the approval processes and reduce the regulatory burden on manufacturers, thereby encouraging the adoption of more sustainable pest control methods (Greaves, 2009). In summary, while there is a global trend towards the increased use of biopesticides, the regulatory approval processes remain complex and varied. Harmonizing these processes and reducing the regulatory burden could facilitate the broader adoption of Bt-based biopesticides, contributing to more sustainable agricultural practices (Greaves, 2009; Villaverde et al., 2014; Sansinenea, 2016; Kumar et al., 2019). 4 Risk Assessment for Bt-based Biopesticides 4.1 Environmental risk assessment The environmental risk assessment of Bt-based biopesticides involves evaluating their impact on non-target organisms, soil health, and overall ecosystem stability. Studies have shown that Bt proteins, which are the active components in Bt biopesticides, can be released into the soil through root exudates, pollen, and plant residues, potentially affecting soil microbial diversity and physical-chemical properties (Figure 1) (Li et al., 2022). Additionally, the nonmonotonic dose-response observed in Daphnia magna suggests that even low concentrations of Bt biopesticides can have significant effects on non-target aquatic organisms, challenging the assumption of their universal safety (Machado et al., 2017). Regulatory frameworks must therefore ensure comprehensive environmental safety evaluations, including the potential for gene flow and the stability of gene expression in genetically modified Bt crops (Then et al., 2022). 4.2 Health and safety risk assessment Health and safety risk assessments for Bt-based biopesticides focus on their potential impacts on human and animal health. The introduction of new food safety regulations in the European Union has highlighted the need for stringent safety criteria for biopesticides, similar to those applied to synthetic pesticides (Czaja et al., 2015). Despite the general perception of biopesticides as safer alternatives, there are concerns regarding the stability and safety of Bt toxins produced in genetically engineered crops, such as Bt cowpea, which necessitate thorough evaluations to ensure food safety (Then et al., 2022). Moreover, the development of RNAi-based biopesticides, which involve the use of double-stranded RNA (dsRNA), requires careful consideration of their health impacts, although current evidence suggests minimal risks to human health (Fletcher et al., 2020). 4.3 Socioeconomic risk assessment The socioeconomic risk assessment of Bt-based biopesticides involves analyzing their market adoption, regulatory challenges, and potential benefits to agriculture and public health. The market share of biopesticides remains relatively low, partly due to the stringent regulatory requirements and the need for extensive data on chemistry, bioefficacy, and toxicity for registration (Gupta and Dikshit, 2010). In India, for example, the adoption of biopesticides is hindered by regulatory barriers and the need for farmer education to maximize their benefits
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