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Synthetic biology regulation in Europe: containment, release and beyond.

Published version
Peer-reviewed

Repository DOI


Change log

Authors

Sundaram, Lalitha S  ORCID logo  https://orcid.org/0000-0002-9595-9753
Ajioka, James W 
Molloy, Jennifer C 

Abstract

While synthetic biology is hoped to hold promise and potential to address pressing global challenges, the issue of regulation is an under-appreciated challenge. Particularly in Europe, the regulatory frameworks involved are rooted in historical concepts based on containment and release. Through a series of case studies including a field-use biosensor intended to detect arsenic in well water in Nepal and Bangladesh, and insects engineered for sterility, we explore the implications that this regulatory and conceptual divide has had on the deployment of synthetic biology projects in different national contexts. We then consider some of the broader impacts that regulation can have on the development of synthetic biology as a field, not only in Europe but also globally, with a particular emphasis on low- and middle-income countries. We propose that future regulatory adaptability would be increased by moving away from a containment and release dichotomy and toward a more comprehensive assessment that accounts for the possibility of varying degrees of 'contained release'. Graphical Abstract.

Description

Funder: Isaac Newton Trust; DOI: https://doi.org/10.13039/501100004815

Keywords

EU, biotechnology, containment, regulation, synthetic biology

Journal Title

Synth Biol (Oxf)

Conference Name

Journal ISSN

1939-7267
2397-7000

Volume Title

8

Publisher

Oxford University Press (OUP)
Sponsorship
Isaac Newton Trust