Keiper Felicity, Atanassova Ana
BASF Australia Ltd., Southbank, VIC, Australia.
BASF Belgium Coordination Center, Technologiepark-Zwijnaarde, Ghent, Belgium.
Front Bioeng Biotechnol. 2020 Apr 9;8:310. doi: 10.3389/fbioe.2020.00310. eCollection 2020.
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.
审议“合成生物学”监管问题的主要国际论坛是《生物多样性公约》（CBD），以及与之相关的关于转基因生物（LMOs；《生物多样性公约卡塔赫纳生物安全议定书》）生物安全和遗传资源获取与惠益分享（《生物多样性公约名古屋议定书》）的附属协定。在《生物多样性公约》“合成生物学”和“与生物多样性保护及可持续利用有关的新出现问题”议程项目下，这场讨论已经进行了近10年，最近又在《卡塔赫纳议定书》主题范围内展开，包括风险评估和风险管理，以及与《名古屋议定书》共同探讨的“数字序列信息”。目前尚无国际公认的“合成生物学”定义，在这个论坛中它被用作一个总括性术语，涵盖“新的”生物技术以及现有生物技术的“新”应用，无论这些是实际存在的还是概念上的。《生物多样性公约》的辩论特点是，对于包括当前监管框架范围以及风险评估和风险缓解及/或管理程序与工具在内的针对“新型”转基因生物的现有监管机制是否充分，存在两极分化的观点。本文概述了生物技术监管的国际发展情况，包括《卡塔赫纳议定书》的应用及相关政策发展，并回顾了在《生物多样性公约》及其议定书框架下合成生物学辩论的发展，包括在2020年生物多样性大会召开前及会议期间可能出现的主要问题。
