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Synthetic Biology in Agriculture and Challenges for Risk Governance

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Synthetic Biology in Agriculture and Challenges for Risk Governance Synthetic biology in agriculture and challenges for risk governance STOA Workshop on Ethical and social challenges of agricultural technologies European Parliament, 25th January 2017 Helge Torgersen Synthetic biology, agriculture and risk govenance 1. What is synthetic biology? 2. Novel risk aspects – what relevance for agriculture? 3. Gene editing – the pertinent example: Definition: what is a GMO? Assessment: how to compare an edited organism? Containment: gene drive Public perception: edited animals 4. Risk governance 5. Strategies 1) What is Synthetic Biology? • Introducing into biotechnology concepts from computer science and systems engineering (Endy 2005) The design and construction of novel artificial biological pathways, organisms or devices, or the redesign of existing natural systems (UK Royal Society 2014) • ‘Extreme genetic engineering’ (ETC Group 2007) The application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms (SCHER/SCENIHR/SCCS 2015) Synthetic biology is a compilation of novel bio-engineering approaches with no clear distinction from genetic engineering, from which it evolves (1) Relevant fields (SCHER/SCENHIR/SCCS 2015) a. Genetic parts: pieces of DNA governing particular functions in an organism, to be deliberately combined b. Protocells: artificial cell-like devices that perform some functions of a living cell c. Minimal cells deprived of all non-essential genes used as a “chassis” for genetic parts d. Xenobiology: organisms with chemically ‘foreign’ elements that do not interfere with naturally occurring organisms e. Gene editing (and massive DNA sequencing/synthesis): specific, targeted and easy introduction of genetic changes in all organisms a-d: mostly in microorganisms => industrial microbiology, food industry e: also in crop plants and animals => agriculture 2) Novel risk aspects • Emerging properties from combining genetic elements • Combination of potential biological and chemical hazards • Large differences to ‘natural’ organisms and traditional GMOs due to multiple parallel genetic changes • Impacts from modified animals • Wide distribution of technologies (citizens’ science activities) (2) Risk assessment and management Existing risk assessment protocols are applicable but new aspects demand to • structure and standardize the information • develop computational tools to address emergent properties • combine methodologies to address different forms of risk • choose adequate comparators (including safe GMOs) to address additional properties of modified organisms • construct and test genetic firewalls for containment • research interactions of xenobiological with natural organisms 3) Gene editing and implications for agriculture “The acceleration of the genetic modification process … calls for accelerated procedures for risk assessment, especially where genetic modifications are introduced in a highly parallel manner” (Schmidt 2017) Problems arise due to, i.a., Definitions: untraceable alterations question the concept of GMO Assessment: multiple changes make comparisons difficult Containment: gene drive does away with established concepts Marketing: products from ‘edited’ animals may meet resistance (3) – Definition: what is a GMO? • Small, precise and specific gene editing (e.g. ‘knock out’) may not leave a track from the intervention in the genome of an organism • Epigenetic changes (without sequence alterations) become possible • Indistinguishable from traditional methods /natural processes • Deliberate modifications can not be proven, tracked nor sanctioned • Calls to exempt such gene editing from regulation (e.g. EASAC 2015) clash with definitions that stipulate that such organisms are ‘modified’ This may “… have a significant effect on shaping the industry, including the new non-GMO biotechnology space ...” (NCB 2016) (3) – Assessment: how to compare novel organisms? • Massive, multiple and parallel (‘multiplexed‘) modifications may result in organisms that are significantly different from their natural or traditional GM counterparts • They might contain large pieces of DNA that do not exist in nature and/or radically new properties • There is no comparator such organisms could be legitimately assessed against (3) – Containment: gene drive • Genetic elements are inserted into organisms and actively distributed among a population • Modified organisms are released to the environment to fight deadly diseases • This abolishes established concepts of containment • Alternative concepts are not fully developed or proven to be reliable and safe yet (3) – Marketing: modified animals and public perception • GM animals may become more common with gene editing • ‘Edited’ animals may give rise to questions of sustainability and animal welfare in a new dimension • Classification and regulation need to take into account public perception and interest • This is a major area of a potential public debate on synthetic biology (3) Lessons from gene editing for regulation • Gene editing will be easier, cheaper, more accessible and more widespread than traditional genetic engineering • Risk assessment methods exist but uncertainty will cause problems • The regulatory concept of GMO rests upon an obsolete technology • Current stopgaps are lists of technologies falling under/being exempt • Rapid development and distribution of technologies will cause constant definition problems 4) Risk governance New and rapid developments • make unfeasible projects come true • make hypothetical problems relevant • render functioning regulation problematic • render challenged legislation untenable Examples of responsible risk governance (e.g. with nanotechnology) show that public outrage, regulatory deadlock and lack of implementation are not inevitable … (4) Questions for responsibly introducing technology (Frewer et al. 2016) • Is there a societal need? • Are there similarities to contested technologies? • Are applications in different fields percieved differently? • Are there less controversial alternatives? • Are there additional, e.g. ethical issues? • If acceptable in principle, how to align with consumer priorities? • What can regulation do to ensure societal acceptance? => Demonstrating the absence of risk is not enough (4) Addressing both science and society Include societal priorities and preferences (Frewer et al. 2016) • Public engagement, provided its output is taken up • Consumer research, addressing preferences before marketing when designing first generation products • Application based risk/benefit frameworks => Risk assessment must be part of a larger concept 5) Strategy A: Business as usual • Keep the GMO / non-GMO divide, redefining differences • Regularly revise comprehensive lists of technologies and define whether they fall under the legislation • Devise assessment procedures according to technologies even if products are similar • Neglect the context of application (5) Strategy B: Reconsidering the framework • Give up the concept of GMO related to a technology • Focus on the properties of the organism • Perform assessments of substantially novel organisms • Regard the context of application • Compare alternatives and assess benefits and risks “The focus on technology tends to obscure rather than reveal the social and ethical issues.” (NCB 2016) “Synthetic biology might be regarded as an acceptable technology by society, if • appropriate societal benefits are delivered from its application, • ethical issues are addressed, and • transparent regulatory and governance structures are construed.” (Frewer et al. 2016) Thank you for your attention! References EASAC 2015, Statement on new breeding techniques, Leopoldina, Halle/Saale Endy D. 2005, Foundations for engineering biology, Nature 438, 449-453 ETC Group 2007, Extreme genetic engineering: an introduction to synthetic biology, Ottawa Frewer L.J.I. et al. 2016, Synthetic Biology applied in the agrifood sector: societal priorities and pitfalls, APSTRACT10/2-3, 89-96 Nuffield Council on Bioethics 2016, Genome editing: an ethical review, London SCHER/SCENIHR/SCCS 2015, Opinions on Synthetic biology I, II, III, Brussels Schmidt M. 2016, SCENHIR Opinion II Risk assessment methodologies, Biofaction, Vienna UK Royal Society 2014, Policy project on synthetic biology, https://royalsociety.org/topics- policy/projects/synthetic-biology/ Thanks to M. Schmidt (Biofaction Vienna) and B. Giese (BOKU Vienna) for helpful comments.
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