Regulation of Synthetic Biology: Developments Under the Convention on Biological Diversity and Its Protocols

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.

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

“…• International discussions on the development of further risk assessment guidance on GDMOs and their regulatory oversight are ongoing under the Cartagena Protocol on Biosafety and the Convention on Biological Diversity, respectively (e.g. AHTEG, 2020; Keiper and Atanassova, 2020).…”

“…Since organisms containing engineered gene drives are living modified organisms (LMOs) within the scope of the Cartagena Protocol on Biosafety, EFSA's scientific advice is expected to support the EU in its work under the Convention on Biological Diversity 4 and the Cartagena Protocol on Biosafety, where the development of further risk assessment guidance on engineered gene drives is under discussion (AHTEG, 2020; Keiper and Atanassova, 2020). 5 The Cartagena Protocol aims to ensure the safe 1 Recital 8 of Directive 2001/18/EC requires that the precautionary principle [.…”

“…Also termed: Selfish genes, ultra-selfish genes, selfish DNA, self-promoting elements, parasitic DNA and genomic outlaws.7 In early 2020, the European Parliament voted on a resolution calling on the European Commission and EU Member States to support a decision of the 15th Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity for a global moratorium on releases of organisms containing engineered gene drives into the environment, including in experimental field trials (reviewed byKeiper and Atanassova, 2020).…”

Advances in Synthetic Biology and Biosafety Governance

“…To limit the scope of application of the law, the EU has set up a special working group for considering applications of new biotechnology in plant breeding and other biological modifications. The European Union has formulated a series of directives for GMOs and emerging biotechnology covering labels, proper containment, trans-shipment, and safe use in research environments (Keiper and Atanassova, 2020).…”

Exploring the intersections of governance, constituencies, and risk in genetic interventions

“…National level considerations are also often influenced by intergovernmental processes. Because aspects of research, implementation, and potential outcomes can cross borders, multilateral agreements, notably the Convention on Biological Diversity and its Cartagena Protocol on Biosafety, have been focal points for discussions of the governance of genetic interventions in conservation (Convention on Biological Diversity, 2017; Keiper & Atanassova, 2020;Reynolds, 2020). Conversely, at the state or local level, planning and implementation occur within complex political environments where considerations and decisions often extend beyond what is regulated at both national and international scales.…”