Regulation and management of the biosecurity for synthetic biology

Synthetic biology (SynBio) is a high-profile interdiscipline combining engineering with science. As a dualpurpose 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.

Automated summary

Synthetic biology is a multidisciplinary field that combines engineering with science, bringing significant changes and benefits to various fields. However, due to its complexity and uncertainty, synthetic biology also poses potential biosecurity risks. Therefore, it is crucial to establish regulations and management practices to ensure biosecurity in synthetic biology. In this paper, the sources of biosecurity risks in synthetic biology are summarized, and the current situation of regulation and management in the international community and China is reviewed. Suggestions for Chinese-specific regulation and management of biosecurity in synthetic biology are proposed, including a top-to-bottom governing framework, implementation mechanism, safeguarding system, and strengthening biosecurity education.