Zeng Xiaomei, Zhu Zexi, Weng Jun
College of Life Science and Technology, Huazhong University of Science and Technology, Wuhan 430074, Hubei, China.
Sheng Wu Gong Cheng Xue Bao. 2024 Mar 25;40(3):758-772. doi: 10.13345/j.cjb.230320.
With the rapid development of synthetic biology, lots of synthetic biology technology achievements in various application fields have been commercialized, generating broad market prospects. The commercialization of products employing synthetic biology technology (hereinafter referred as synthetic biology products) has brought benefits to human beings, but it has also produced potential safety risks. At present, relevant laws and standards for regulation of biotechnology or genetically modified organisms have been adopted to regulate the safety risks of commercialization of synthetic biology products (CSBP). However, due to the complexity and uncertainty of synthetic biology, the safety risks of CSBP cannot be comprehensively regulated by these laws and standards. Therefore, it is of great significance to formulate specific supervision and management measures for regulating the safety risks of CSBP. This paper summarized the situation of CSBP in the fields of food, medical care, agriculture, environment, energy and materials, analyzed the safety risks existing in the CSBP, and sorted out current supervision situation of its safety risks in European countries, United States, as well as in China. We further proposed suggestions on the safety supervision and management measures on the safety risks of CSBP, including classified examination and approval, classified identification of products, and strict screening and approval of market entities before entering the market, and strengthening safety supervision and emergency treatment as well as accident responsibility investigation after entering the market. This whole-process safety regulation might provide support for the safety of CSBP and promote the healthy and long-term development of synthetic biology industry.
随着合成生物学的快速发展，众多合成生物学技术成果在各个应用领域实现了商业化，展现出广阔的市场前景。采用合成生物学技术的产品（以下简称合成生物学产品）商业化给人类带来了益处，但也产生了潜在的安全风险。目前，已采用相关生物技术或转基因生物的监管法律和标准来管控合成生物学产品商业化（CSBP）的安全风险。然而，由于合成生物学的复杂性和不确定性，这些法律和标准无法全面管控CSBP的安全风险。因此，制定专门的监管措施来管控CSBP的安全风险具有重要意义。本文总结了CSBP在食品、医疗、农业、环境、能源和材料等领域的情况，分析了CSBP存在的安全风险，并梳理了欧洲国家、美国以及中国目前对其安全风险的监管情况。我们进一步针对CSBP安全风险的监管措施提出了建议，包括分类审批、产品分类识别、市场主体入市前严格筛选审批，以及入市后加强安全监管、应急处理和事故责任调查。这种全过程安全监管可为CSBP的安全提供支撑，促进合成生物学产业健康长远发展。
