Zeng Xiaomei, Jiang Hailun, Yang Guangying, Ou Yakun, Lu Shan, Jiang Jia, Lei Ruipeng, Su Li
College of Science and Technology, Huazhong University of Science and Technology, Wuhan, Hubei, 430074, China.
School of Marxism, Huazhong University of Science and Technology, Wuhan, Hubei, 430074, China.
Synth Syst Biotechnol. 2022 Mar 25;7(2):784-790. doi: 10.1016/j.synbio.2022.03.005. eCollection 2022 Jun.
Synthetic biology (SynBio) is a high-profile interdiscipline combining engineering with science. As a dual-purpose discipline, SynBio is bringing large changes to many fields and providing great benefits to humans. However, due to its characteristic of complexity and uncertainty, SynBio also presents potential biosafety and biosecurity risks. Biosecurity risks refer to unauthorized access, loss, theft, misuse, diversion or intentional release. If a biosecurity accident happens, it would pose a huge threat to humans and nature. Therefore, it is crucial to establish a set of regulations and management practices for the biosecurity risks of SynBio. In this paper, we summarized the sources of the biosecurity risks of SynBio, from its research materials, products, technologies, information to Do-it-yourself synthetic biology. We reviewed and analyzed the current situation of regulation and management of biosecurity for SynBio in the international community and in China. We found that in most countries and regions, SynBio risks commonly follow the regulation and management of Genetically Modified Organisms which has loopholes if applied to the regulation for SynBio without any amendments. Here, we proposed suggestions for the Chinese-featured regulation and management of biosecurity for SynBio, including a top-to-bottom governing framework, a think-tank implementation mechanism, a Synthetic Biology Laboratory Biosecurity Manual safeguarding system, and strengthening biosecurity education on synthetic biology and self-regulation awareness among relevant personnel. Through this work, we aim to improve the standardized process of biosecurity regulation and management for SynBio in China and thereby map out a peaceful, profitable, and practical development path for synthetic biology.
合成生物学（SynBio）是一门备受瞩目的跨学科领域，它将工程学与科学相结合。作为一门具有双重用途的学科，合成生物学正在给许多领域带来巨大变革，并为人类带来诸多益处。然而，由于其复杂性和不确定性的特点，合成生物学也带来了潜在的生物安全和生物安保风险。生物安保风险是指未经授权的获取、丢失、盗窃、滥用、转移或故意释放。如果发生生物安保事故，将对人类和自然构成巨大威胁。因此，为合成生物学的生物安保风险建立一套法规和管理措施至关重要。在本文中，我们总结了合成生物学的生物安保风险来源，涵盖其研究材料、产品、技术、信息以及自制合成生物学。我们回顾并分析了国际社会和中国合成生物学的生物安保监管与管理现状。我们发现，在大多数国家和地区，合成生物学风险通常遵循转基因生物的监管和管理方式，但如果不经修改直接应用于合成生物学监管，则存在漏洞。在此，我们针对中国特色的合成生物学生物安保监管与管理提出建议，包括自上而下的治理框架、智库实施机制、合成生物学实验室生物安保手册保障体系，以及加强合成生物学的生物安保教育和相关人员的自我监管意识。通过这项工作，我们旨在完善中国合成生物学生物安保监管与管理的标准化流程，从而为合成生物学规划一条和平、有益且切实可行的发展道路。
