关键词: 合成生物学, 生物风险, 软法治理, 科学家自治, 行业自律

Abstract:

The enabling capabilities of synthetic biology (SynBio) are advancing at a rapid pace, with its applications increasingly integrated into daily life and generating significant social and economic impacts. Around the world, countries are intensifying policy efforts and resource investments to gain a strategic advantage in SynBio, aiming to harness its potential for biotechnology innovation and bioeconomy development. However, the development and application of SynBio are accompanied by emerging biorisks that may pose threats to human health and ecological security. These biorisks can be broadly categorized into two types: first, subjective biorisk arising from the intentional misuse of technology, such as illegal germline gene editing, bioterrorism, and the development of biological weapons; and second, objective biorisk resulting from non-intentional factors, including technical errors, negligence, or the inherent uncertainty of the technology itself, such as pathogenic leaks, gene escape, and biological invasions. Striking a balance between fostering innovation and ensuring safety has become a critical challenge for policymakers. In China, both hard law and soft law mechanisms respond to SynBio-related biorisks through different pathways. However, hard law-based governance faces structural difficulties, including gaps or delays in existing legislation and the practical challenges of enacting timely amendments or developing specialized laws. These obstacles reflect a fundamental tension between the stability and conservatism of law and the rapid evolution of SynBio. In this context, soft law has emerged as a promising alternative. Its flexibility, inclusiveness, and non-binding nature make it particularly well-suited to the dynamic and complex nature of SynBio and its associated risk governance needs. This paper analyzes the nature of biorisks in SynBio, and the regulatory challenges posed by current hard law frameworks. It then proposes a soft law-based approach to address these gaps. Through a comparative analysis of extraterritorial practices—primarily those of the United States—in the soft law governance of biorisks in SynBio, this paper identifies three strategic pathways for advancing soft law governance in SynBio: (1) developing soft law instruments that align with existing legal and ethical principles; (2) fostering a collaborative governance model centered on scientist self-governance + government guidance for the R&D phase; and (3) promoting a co-governance structure of industry self- discipline + government oversight for the application phase. The overarching goal is to enable innovation in SynBio while effectively protecting the public interest.

Key words: synthetic biology, biorisks, soft law governance, scientist self-governance, industry self- discipline