Bt Research 2024, Vol.15, No.1, 10-19 http://microbescipublisher.com/index.php/bt 13 4 Safety and Efficacy Assessments 4.1 Environmental impact studies Environmental impact studies are crucial for understanding the potential effects of Bacillus thuringiensis (Bt) biopesticides on non-target organisms and ecosystems. Research has shown that Bt biopesticides are generally considered safe for the environment. For instance, Bt formulations have been found to have minimal adverse effects on non-target organisms such as Daphnia magna, although some studies have reported nonmonotonic dose-response relationships indicating potential vulnerabilities at certain concentrations (Machado et al., 2017). Additionally, the development of advanced formulations, such as microencapsulations and microgranules, has been aimed at enhancing the environmental stability and efficacy of Bt biopesticides under various environmental conditions, including exposure to ultraviolet radiation, rain, and temperature fluctuations. 4.2 Human health risk assessments Human health risk assessments of Bt biopesticides have consistently demonstrated their safety. Bt is widely recognized as one of the safest microbial insecticides available, with no solid evidence linking it to human health issues such as diarrhea, despite concerns raised by regulatory bodies like the European Food Safety Authority (EFSA) (Raymond and Federici, 2017). Furthermore, the comprehensive framework for human health risk assessment of nanopesticides, which includes Bt-based formulations, suggests a tiered approach to evaluate potential risks. This framework tracks various entities, such as nanocarrier-active ingredient complexes and released active ingredients, to ensure thorough toxicity testing and safety evaluations (Kah et al., 2021). Overall, Bt biopesticides have a strong safety record, supported by extensive genotyping data that show no clinical infections associated with biopesticide genotypes. 4.3 Efficacy trials and field studies Efficacy trials and field studies are essential for validating the performance of Bt biopesticides under real-world conditions. Advancements in downstream processing and formulation development, such as the use of membrane separation technology, have improved the potency and marketability of Bt biopesticides, ensuring longer shelf life and ease of application (Figure 2) (Rad et al., 2016). Membrane separation technology has many advantages, including higher productivity of purified spore crystal compounds, more compact purification equipment, easier scalability - consideration of downstream processing steps, safer, cleaner and more reliable purification process and lower overall cost. These advantages make membrane separation technology play a vital role in the production of Bt-based biopesticides, improve production efficiency, reduce costs, and improve the market competitiveness and use effect of products. Bt formulations have been extensively tested and proven effective against a wide range of insect pests in agricultural and horticultural settings. The integration of nanotechnology into Bt formulations has further enhanced their efficacy, enabling better delivery, reduced dosage rates, and increased field persistence (Devi et al., 2019). These innovations have contributed to the growing acceptance and use of Bt biopesticides as a viable alternative to synthetic chemical pesticides (Ndolo et al., 2019). 5 Market Challenges 5.1 Market entry barriers The market entry barriers for Bt biopesticides are significant and multifaceted. One of the primary challenges is the regulatory framework, which is often designed for chemical pesticides and imposes burdensome costs on the biopesticide industry. This regulatory environment creates substantial hurdles for the commercialization of biopesticides, as seen in both the European Union and India (Sansinenea, 2016; Keswani et al., 2019). Additionally, the complex selling channels and the perceived lack of efficacy compared to conventional pesticides further complicate market entry. Despite these barriers, there is a growing recognition of the need for sustainable pest management solutions, which could drive regulatory reforms and facilitate market entry for biopesticides.
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