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.
Highlights
This paper provides an overview of major developments in biotechnology regulation and relevant policy developments, examines what “synthetic biology” is, and reviews the development of the synthetic biology debate under the Convention on Biological Diversity (CBD) and its Protocols, including the major issues expected in the lead up to and during the Biodiversity Conference in 2020
In this paper we have provided an overview of the major developments in biotechnology regulation since the first discussions on this topic at the 1975 Asilomar conference on recombinant deoxyribonucleic acid (DNA)
These concerns are at the heart of most of the synthetic biology-related discussions that are anticipated at the 2020 Biodiversity Conference, and these are further conflated with broader political and societal issues
Summary
The world of “synthetic biology” is an optimistic and ambitious one, with its claims of transformative and paradigm-shifting developments, and promises of providing solutions for global challenges such as food security, energy security, clean water, human and animal health, environmental contamination, species conservation, and even climate change A process-based trigger for LMO regulation is consistent with a precautionary approach, as its basis lies in the presumption that the technology is inherently risky, with all organisms resulting from biotech captured within regulatory scope regardless of their characteristics and the actual risks (if any) they present Another key feature of the Cartagena Protocol is the “advance informed agreement” procedure, which requires countries to be provided with the information necessary to enable them to undertake a risk assessment before deciding whether or not to permit the import of an LMO for intentional release into the environment (Articles 7, 10, 15, and Annex III). New types of LMOs may present resource and capacity challenges for less experienced regulators, and developing country Parties who have not yet, or are still in the process of, implementing the Cartagena Protocol at the national level Another often proposed distinction between recombinant DNA technology and synthetic biology is that the former involves the transfer of individual genes, whereas the latter involves the assembly of new DNA sequences (Science Communication Unit UWE, 2016). They considered that it is the ease of using the technology and potential speed of development of new organisms that could present regulatory challenges in terms of adequate risk assessment (Scientific Committees, 2015b), rather than the technology or characteristics of the resulting organisms
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
