Bt_2025v16n4

Bt Research 2025, Vol.16, No.4, 157-167 http://microbescipublisher.com/index.php/bt 165 as markers and needs to evaluate its possibility of spread in non-target microorganisms. To reduce risks, new generation Bt engineering often uses resistance-free marker technologies, such as suicide vectors or exogenous gene integration and eliminating markers. These measures should be strictly verified before the environment is released. 7.3 Challenges of synthetic biology in agricultural biosafety regulation With the continuous emergence of new Bt-engineering strains driven by synthetic biology, regulatory authorities are facing new challenges and issues. First of all, the update of regulatory standards. The traditional GMO safety evaluation framework mainly targets single exogenous genetically modified organisms. Synthetic biological products are often multi-gene and multi-path transformation, and more complete evaluation indicators are needed. The second is detection and traceability. Once engineering Bt strains are widely used, how to distinguish them from natural strains and monitor their spread in the environment is a focus of regulatory attention. It is necessary to develop specific molecular detection tools (such as specific PCR primers, antibody reagents) for field sample detection. Although synthetic biology modification of Bt strains provides new weapons in resistance governance, a resistance risk management plan is still needed from a regulatory perspective. Ethical and public acceptance, although the use of Bt-engineered bacteria in open environments has not caused public opinion turmoil like GM crops, the public may have doubts as synthetic biology becomes increasingly bold in creating new forms of life. Regulators should take the initiative to carry out risk communication and popularize the safety advantages of Bt strains in science projects. Acknowledgements In the course of completing this study, we would like to thank the members of my research group for their support and collaboration. We also wish to express my gratitude to the two experts for their valuable review comments. Conflict of Interest Disclosure The authors confirm that the study was conducted without any commercial or financial relationships and could be interpreted as a potential conflict of interest. References Abbas M.S.T., 2020, Interactions between Bacillus thuringiensis and entomophagous insects, Egyptian Journal of Biological Pest Control, 30(1): 51. https://doi.org/10.1186/s41938-020-00255-8 Avetisyan S., Hovsepyan A., Saghatelyan L., Koloyan H., Chizhik O., Hovhannisyan S., and Paronyan M., 2024, Obtaining melanin-synthesizing strains of Bacillus thuringiensis and their use for biological preparations, Frontiers in Bioscience, 16(3): 27. https://doi.org/10.31083/j.fbe1603027 Bravo A., Pacheco S., Gómez I., Garcia-Gómez B., Onofre J., and Soberón M., 2017, Insecticidal proteins fromBacillus thuringiensis and their mechanism of action, Springer International Publishing, 2017: 53-66. https://doi.org/10.1007/978-3-319-56678-8_4 Chakrabarty S., Chakraborty P., Islam T., Islam A., Datta J., Bhattacharjee T., Minghui J., and Xiao Y., 2022, Bacillus thuringiensis proteins: structure mechanism and biological control of insect pests, Bacilli in Climate Resilient Agriculture and Bioprospecting, 2022: 581-608. https://doi.org/10.1007/978-3-030-85465-2_25 Chelliah R., Wei S., Park B., Park J., Park Y., Kim S., Jin Y., and Oh D., 2019, New perspectives on Mega plasmid sequence (poh1) in Bacillus thuringiensis ATCC 10792 harbouring antimicrobial insecticidal and antibiotic resistance genes, Microbial Pathogenesis, 126: 14-18. https://doi.org/10.1016/j.micpath.2018.10.013 Chen H., Verplaetse E., Slamti L., and Lereclus D., 2022, Expression of the Bacillus thuringiensis vip3A insecticidal toxin gene is activated at the onset of stationary phase by VipR an autoregulated transcription factor, Microbiology Spectrum, 10(4): e01205-22. https://doi.org/10.1128/spectrum.01205-22 Duan F., Zhan H., Ge S., Wang Z., Liu Y., Xiao Z., Tan F., Wang J., and Shu Y., 2025, Bacillus thuringiensis (Bt) rice straw mulching and earthworms mediated changes in soil N2OandCO2 emissions driven by N-cycling and C-utilizing microbial communities, Applied Soil Ecology, 206: 105814. https://doi.org/10.1016/j.apsoil.2024.105814 Dubois T., Perchat S., Verplaetse E., Gominet M., Lemy C., Aumont-Nicaise M., Grenha R., Nessler S., and Lereclus D., 2013, Activity of the Bacillus thuringiensis NprR–NprX cell–cell communication system is co‐ordinated to the physiological stage through a complex transcriptional regulation, Molecular Microbiology, 88(1): 48-63. https://doi.org/10.1111/mmi.12168

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