Bt Research 2025, Vol.16, No.6, 259-268 http://microbescipublisher.com/index.php/bt 259 Research Article Open Access Regulatory Framework and Risk Assessment of Bt Transgenic Crops Zhonggang Li 1, Xiaojie Liu 2 1 Tropical Specialty Crops Research Center, Hainan Institute of Tropical Agricultural Resouces, Sanya, 572025, Hainan, China 2 Institute of Life Science, Jiyang College of Zhejiang AandF University, Zhuji, 311800, Zhejiang, China Corresponding email: zhonggang.li@hitar.org Bt Research, 2025, Vol.16, No.6 doi: 10.5376/bt.2025.16.0029 Received: 06 Oct., 2025 Accepted: 10 Nov., 2025 Published: 15 Dec., 2025 Copyright © 2025 Li and Liu, This is an open access article published under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Preferred citation for this article: Li Z.G., and Liu X.J., 2025, Regulatory framework and risk assessment of Bt transgenic crops, Bt Research, 16(6): 259-268 (doi: 10.5376/bt.2025.16.0029) Abstract With the extensive cultivation of genetically modified crops worldwide, Bacillus thuriensis (Bt) genetically modified crops have become an important biotechnology achievement in modern agriculture due to their highly efficient pest resistance and yield-increasing potential. However, the commercial promotion of Bt crops has also sparked widespread controversies regarding biosecurity, environmental impact and regulatory governance. This study systematically analyzed the regulatory framework and risk assessment mechanism of Bt genetically modified crops at the international and national levels, introduced the biological basis of Bt technology, and then conducted a comparative analysis of the regulatory systems in major countries and regions such as the United States, the European Union, China, and India. It also focused on discussing core risk assessment dimensions such as environmental safety, food safety, gene drift, and resistance management. Through the case studies of Bt cotton in India and Bt corn in the United States, this research reveals the key challenges and policy implications of Bt crops in practical promotion, and further analyzes public concerns, long-term ecological impacts and ethical issues. This study offers a comprehensive perspective that combines science, policy and public awareness for the governance of Bt crops, aiming to promote the establishment of globally unified regulatory standards, dynamic risk assessment mechanisms and effective public communication systems to facilitate the sustainable development of Bt transgenic technology. Keywords Bt crop; Genetically modified organisms; Regulatory policies; Risk assessment; Environmental safety 1 Introduction Not all agricultural technologies were widely accepted from the very beginning, and Bt crops were no exception. These crops, which express insecticidal proteins derived from Bacillus suyuniensis (Bt) through genetic engineering, were initially developed to deal with some long-standing pests, such as lepidoptera larvae. Controlling pests and reducing the use of chemical pesticides were the main selling points when they were launched. Over the past decade or so, Bt cotton, Bt rice, Bt cowpea and other crops have gradually entered the fields. The output has indeed increased in many places and the environmental pressure has also been alleviated. The use of Cry insecticidal proteins in agriculture is not new either, and its safety record can be traced back a long time. Moreover, with the optimization of the plant expression system, nowadays Bt crops can resist pests while having relatively less impact on non-target organisms (Koch et al., 2015). However, despite the fact that these advantages have been incorporated into numerous papers and evaluation reports, the global promotion situation remains uneven. Sometimes, it is not a problem with the technology itself, but rather gets stuck at the "human" stage - including policies, regulations, and public acceptance. In fact, the regulatory system behind Bt crops has long been no longer standing still. From environmental impact, food safety to gene flow, relevant risk assessment tools and frameworks are constantly being updated. International agreements like the Cartagena Biosafety Protocol do indeed provide an assessment reference for many countries (Then et al., 2022). But execution is execution, but putting it into practice is another matter. The degree of prudence, regulatory transparency and resource allocation among countries vary greatly, which also leads to different promotion speeds and scopes of Bt crops. However, regarding the details of risk assessment, controversies surrounding non-target organisms, resistance management, and long-term ecological impacts have not yet reached a complete consensus (Carriere et al., 2019). What is even more intractable is that in some
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