Bt Research 2024, Vol.15, No.1, 65-75 http://microbescipublisher.com/index.php/bt 70 7 Policy and Regulatory Frameworks 7.1 International guidelines and standards The international regulatory landscape for biopesticides, including Bacillus thuringiensis (Bt) biopesticides, is shaped by various guidelines and standards aimed at ensuring safety and efficacy. The European Pesticide Regulation (EC) No. 1107/2009 is a significant framework that encourages the use of less harmful active substances, including biopesticides, while maintaining stringent safety standards (Villaverde et al., 2014). This regulation underscores the importance of zonal evaluations and cut-off criteria to balance the need for effective pest control with environmental and human health considerations. Additionally, international agreements such as the Cartagena Protocol on Biosafety (CPB) play a crucial role in regulating the transboundary movement of genetically modified organisms, including Bt crops, to ensure biosafety and minimize potential risks (Raybould and Quemada, 2010). 7.2 National regulatory approvals National regulatory frameworks vary significantly across countries, reflecting different levels of scientific capacity and regulatory stringency. In many developing countries, the establishment of functional regulatory systems is challenging, which can hinder the deployment of Bt biopesticides and other transgenic crops (Raybould and Quemada, 2010). For instance, the regulatory process in the United States involves rigorous pre-market notification, risk assessment, and approval procedures, followed by labelling and post-market monitoring to ensure compliance with safety standards (Grillo et al., 2020). Similarly, the European Union's regulatory framework requires comprehensive risk assessments and adherence to strict guidelines for the approval and use of biopesticides (Fletcher et al., 2020). These national regulations are designed to ensure that biopesticides are safe for human health and the environment while providing effective pest control solutions (Grillo et al., 2020). 7.3 Compliance and enforcement Compliance and enforcement are critical components of the regulatory framework for Bt biopesticides. Effective enforcement mechanisms are necessary to ensure that manufacturers and users adhere to regulatory requirements, including proper labelling, usage instructions, and post-market surveillance (Grillo et al., 2020). In the European Union, compliance is monitored through a combination of national and EU-level inspections and audits to ensure that biopesticides are used safely and effectively (Rodríguez et al., 2019). In the United States, the Environmental Protection Agency (EPA) oversees the compliance of biopesticides with federal regulations, conducting regular inspections and taking enforcement actions against non-compliance. Additionally, the development of robust quality control measures and policy support is essential to maintain the integrity and efficacy of biopesticides in the market (Keswani et al., 2016). 8 Case Studies of Successful Bt Biopesticide Use 8.1 Agricultural applications Bacillus thuringiensis (Bt) has been extensively utilized in agriculture due to its potent insecticidal properties, primarily attributed to the production of Cry proteins. These proteins target specific insect pests, making Bt an environmentally friendly alternative to chemical pesticides. For instance, Bt has been successfully incorporated into transgenic crops such as Bt cotton, potato, and maize, which express Cry proteins to protect against lepidopteran and coleopteran pests (Sanchis and Bourguet, 2011; Kumar et al., 2021; Li et al., 2022). Additionally, Bt-based biopesticides have been employed in the management of pests in vegetable legumes and brassicas in Asia and Africa, significantly reducing the reliance on chemical pesticides and mitigating their associated health and environmental risks (Ansari et al., 2012; Srinivasan et al., 2019) (Figure 2). 8.2 Public health programs Bt biopesticides have also found applications in public health programs, particularly in controlling disease vectors. Bt israelensis (Bti) is a strain specifically used to target mosquito larvae, which are vectors for diseases such as malaria and dengue fever. The use of Bt in these programs has proven effective in reducing mosquito populations without harming non-target organisms, thereby offering a safer alternative to chemical insecticides (Sanchis and
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