合成生物学时代的生物安全治理

Biosafety and Biosecurity Governance in the Era of Synthetic Biology

20世纪中后期,基因重组技术的产生及其在遗传育种等领域的应用,结合致病性微生物实验室研究安全问题的显现,不仅引发了科技界对生物安全问题的关注,也推动了系列管理规范与措施的建立。21世纪以来,合成生物学的发展为资源、能源、健康、环境等领域带来了全新的解决方案,但因其技术、研发与应用存在生物安全相关的不确定性风险,给生物安全治理带来了新挑战。本文在梳理生物安全/安保的概念、相应的监管政策制定及演变的基础上,对合成生物学时代的生物安全风险的成因、治理策略进行探讨,并为我国生物安全治理体系的建设提供建议。

In the second half of the 20th century,the development of gene recombination technology and its application in genetic breeding and other fields,combined with the emergence of safety issues associated with pathogenic microbial research laboratory,not only have caught the attention of the scientific community to biosafety,but also promoted the establishment of a series of biorisk measures and management system.Since the 21st century,the development of synthetic biology has brought new solutions to the fields of resources,energy,health,and the environment.However,the uncertain risks associated with biosafety/biosecurity in its technology,products and applications have brought new challenges to biosafety and biosecurity governance.On the basis of sorting out the formation and evolution of biosafety/biosecurity concepts and corresponding regulatory policies,this article discusses the underlying causes and governance strategies of biosafety/biosecurity risks in synthetic biology,and provides practical for the construction of biosafety and biosecurity governance system in China.