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Abstract：
The primary international forum deliberating the regulation of \"synthetic biology\" is the Convention on Biological Diversity (CBD), along with its subsidiary agreements concerned with the biosafety of living modified organisms (LMOs; Cartagena Protocol on Biosafety to the CBD), and access and benefit sharing in relation to genetic resources (Nagoya Protocol to the CBD). This discussion has been underway for almost 10 years under the CBD agenda items of \"synthetic biology\" and \"new and emerging issues relating to the conservation and sustainable use of biological diversity,\" and more recently within the scope of Cartagena Protocol topics including risk assessment and risk management, and \"digital sequence information\" jointly with the Nagoya Protocol. There is no internationally accepted definition of \"synthetic biology,\" with it used as an umbrella term in this forum to capture \"new\" biotechnologies and \"new\" applications of established biotechnologies, whether actual or conceptual. The CBD debates are characterized by polarized views on the adequacy of existing regulatory mechanisms for \"new\" types of LMOs, including the scope of the current regulatory frameworks, and procedures and tools for risk assessment and risk mitigation and/or management. This paper provides an overview of international developments in biotechnology regulation, including the application of the Cartagena Protocol and relevant policy developments, and reviews the development of the synthetic biology debate under the CBD and its Protocols, including the major issues expected in the lead up to and during the 2020 Biodiversity Conference.
摘要：
讨论“合成生物学”法规的主要国际论坛是《生物多样性公约》（CBD），及其与改性活生物体生物安全有关的附属协定（LMO；《生物多样性公约》卡塔赫纳生物安全议定书），遗传资源的获取和惠益分享(《生物多样性公约》名古屋议定书)。在《生物多样性公约》议程项目“合成生物学”和“与生物多样性的保护和可持续利用有关的新问题”下，这一讨论已经进行了近10年。“最近在卡塔赫纳议定书的主题范围内，包括风险评估和风险管理，和“数字序列信息”与名古屋协议联合使用。没有国际公认的“合成生物学”定义，在本论坛中，它被用作一个总称，以捕获已建立的生物技术的“新”生物技术和“新”应用，无论是实际的还是概念性的。CBD辩论的特点是对“新”类型的LMO的现有监管机制是否足够存在两极分化的观点，包括当前监管框架的范围，风险评估和风险缓解和/或管理的程序和工具。本文概述了生物技术监管的国际发展，包括《卡塔赫纳议定书》的适用和相关政策发展，并回顾了《生物多样性公约》及其议定书下合成生物学辩论的发展，包括2020年生物多样性会议之前和期间预期的主要问题。
