Synthetic biology eludes straightforward definition.747 Essentially it involves the
application of engineering principles to biology.748 It is ‘the rational design and
construction of new biological parts, devices and systems with predictable and reliable functional behaviour that do not exist in nature, and the re-design of
746 Stokes, ‘Nanotechnology’ (n 81); Elen Stokes and Diana M Bowman, ‘Looking back to the
Future of Regulating New Technologies: The Cases of Nanotechnology and Synthetic Biology’ (2012) 2 European Journal of Risk Regulation 235; Stokes, ‘Recombinant Regulation’ (n 131).
747 On different definitions, see Jan C Schmidt, ‘Philosophy of Late-Modern Technology;
Towards a Clarification and Classification of Synthetic Biology’ in Joachim Boldt (ed),
Synthetic Biology: Metaphors, Worldviews, Ethics, and Law (Springer VS 2016) 14–19.
748 EASAC (ed), Realising European Potential in Synthetic Biology: Scientific Opportunities
137
existing, natural biological systems for basic research and useful purposes’,749 for
example for social or commercial benefit.750 Research in the field of synthetic
biology is profoundly interdisciplinary751 and covers a range of approaches, some of
which may eventually involve the creation of life from non-living materials.752
Much of synthetic biology involves working with nucleic acids, the building blocks of genes, and therefore exhibits strong links with genetic modification (GM), prompting controversy over whether it is in fact a new technology or simply a new label.753 What distinguishes it then is arguably less its techniques and processes
(though developments in techniques increase the extent to which biological systems can be manipulated754) but its conceptual framework; its philosophy,
assumptions and ambitions, complete with epic narratives about ‘creating life’.755
With synthetic biology, ‘engineering stops being a metaphor to become a veritable methodology…’ thus, instead of thinking in terms of DNA, RNA and proteins, synthetic biologists think in terms of parts, devices and systems.756 This constitutes
a shift in conceptual framing away from the trial and error of traditional biotechnology towards rational design on the assumption that the component parts employed are predictable.757 This in turn suggests an ontological blurring
between organism and machine (encapsulated in the metaphor ‘living machine’758)
and perhaps therefore a fading of the distinction from which ethical values are
749 Katia Pauwels and others, ‘Synthetic Biology: Latest Developments, Biosafety
Considerations and Regulatory Challenges’ (ISP-WIV 2012) D/2012/2505/46 3.
750 EASAC (n 472) 4.
751 Commission, Synthetic Biology (n 56) 20. 752 EASAC (n 472) 3.
753 Joachim Boldt, ‘Swiss Watches, Genetic Machines and Ethics: An Introduction to
Synthetic Biology’s Conceptual and Ethical Challenges’ in Joachim Boldt (ed), Synthetic
Biology: Metaphors, Worldviews, Ethics, and Law (Springer VS 2016) 1.
754 Harald König and others, ‘Synthetic Biology’s Multiple Dimensions of Benefits and Risks:
Implications for Governance and Policies’ in Joachim Boldt (ed), Synthetic Biology:
Metaphors, Worldviews, Ethics, and Law (Springer VS 2016) 220.
755 See contributions to Joachim Boldt (ed), Synthetic Biology: Metaphors, Worldviews,
Ethics, and Law (Springer VS 2016).
756 ERASynBio (n 130) 2. 757 Boldt (n 753) 2.
758 Harald Matern and others, ‘Living Machines. On the Genesis and Systematic Implications
of a Leading Metaphor in Synthetic Biology’ in Joachim Boldt (ed), Synthetic Biology:
138
derived.759 This chapter treats synthetic biology as different to GM and for this
reason I use the term ‘synthetic organism’ (SO) to acknowledge that approach, despite the fact that many SOs are technically ‘genetically modified’.
Synthetic biology promises multiple, diverse outputs including biosensors, biomaterials, biofuels, biomedicine, food ingredients and fine chemicals, improving nutrition, healthcare and decontaminating the environment.760 Specific outputs
include artemisinic acid, a precursor to the anti-malarial drug artemisinin, vanillin, fragrances, palm oil, spider silk and biological adhesives. Agricultural applications include modifying plants to photosynthesise and use water and nitrogen more efficiently while increasing yields and reducing CO2 emissions, to enhance product
quality (in terms of flavour, fibre etc.), improve processing characteristics or create in planta production of raw materials, for example sugar, cellulose, starch etc.761
Much of the field remains at a basic research phase,762 is contained and mostly
involves the use of well-characterised micro-organisms and genetic material, although longer-term developments may result in the production of SOs which fundamentally differ from naturally occurring organisms.763 It will be some time
before an SO will be ready for introduction into the environment, or available as a commercial environmental application.764 Concerns often relate to the release of
poorly characterised and unpredictable new biological machines, their numerous potential hazardous qualities and possible effects on the environment or human
759 Oliver Müller, ‘Synthetic Biology: On Epistemological Black Boxes, Human Self-Assurance,
and the Hybridity of Practices and Values’ in Joachim Boldt (ed), Synthetic Biology:
Metaphors, Worldviews, Ethics, and Law (Springer VS 2016) 34.
760 EASAC (n 748) 7; Commission, Synthetic Biology (n 56) 13–17; Pauwels and others (n 749)
9–12.
761 Johnjoe McFadden, ‘Synthetic Biology: The Best Hope for Mankind’s Future?’ The
Guardian (29 March 2012)
<https://www.theguardian.com/commentisfree/2012/mar/29/synthetic-biology-best- hope-mankind> accessed 30 March 2017; Stuart John Dunbar, ‘Synthetic Biology
Opportunities in Agriculture’ (Syngenta, 2010)
<rosbnet.org/wiki/images/c/c1/Rosbnet_SDunbar.pdf> accessed 30 March 2017.
762 Giese and others (n 57) 195. 763 Pauwels and others (n 749) 3. 764 ibid.
139
health, exacerbated by unpredictable multiplication rates.765 There is, for example,
the potential for horizontal transfer of synthetic genes to other organisms or the colonisation and take-over of natural microbial communities766 which further
challenge risk assessment processes.
These risks exist alongside equally important questions regarding socio-economic and ethical implications, the correct approach to intellectual property rights in the processes and products of synthetic biology and the distribution of risks and benefits. For example, there is concern that mass synthesis of vanillin will put vanilla producers in developing countries out of work.767 A bioeconomy which increases
demand for biomass to process into industrial products could encourage land grab in the search for farmland to meet demand and destroy biodiversity at the expense of local communities.768 Synthetic biology’s promise of speed, efficiency and ease
in doing so in particular could exacerbate problems with food security already associated with competition between biofuels and food.769 The distribution of
power between corporations and Western and developing nations is a concern. For example, a shift from cultivated to synthetic artemisinin could, inter alia, concentrate power in western pharmaceutical companies by shifting formerly local production westwards,770 while intellectual property frameworks could prevent
developing countries accessing the benefits they produce.771 The implications of
synthetic biology for the relationship between man and nature,772 or the distinction
between man and machine773 raise ethical concerns. Finally, the inherently
765 Giese and others (n 57) 198.
766 Victor de Lorenzo, ‘Environmental Biosafety in the Age of Synthetic Biology: Do We Really
Need a Radical New Approach?’ (2010) 32 BioEssays 926, 927.
767 FoE, ‘Synthetic Biology: GMOs 2.0’ (Friends of the Earth) 1–2 <http://webiva-
downton.s3.amazonaws.com/877/88/b/5292/Issue_brief_-_Synbio_GMOs_2_2015.pdf> accessed 24 September 2015.
768 ETC Group, ‘The New Biomassters: Synthetic Biology and the Next Assault on Biodiversity
and Livelihoods’ (2010).
769 ETC Group, ‘Extreme Genetic Engineering: An Introduction to Synthetic Biology’ (2007)
28–31.
770 ibid 40–42, 52–55.
771 König and others (n 754) 219 and references therein. 772 DG SANCO (n 130) 26.
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industrial and commercial end of synthetic biology774 leads to questions about the
kind of world we are trying to create, how widely shared visions of the future are and the purpose of this research.775
3. Uncharted territories: regulating synthetic biology