The arguments of this thesis, as indicated above, rest on three foundations. Section 4 above, established the third foundation. Chapter Two discusses the
123 For example, Bijker (n 22). 124 For example, ibid 75–76, 270. 125 ibid 280.
126 For a discussion of three different models, see Snell (n 98). 127 Bijker (n 22) 281.
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arguments behind the normative claims in the first foundation. It reviews STS (and related) literature which criticises risk assessment as a regulatory tool, contextualised in the broader relationship between science and society both in general, and more specifically, in relation to risk. The review examines the appeal of risk-based governance methods and gives an account of the now (academically) uncontroversial conclusion that risk assessment is not necessarily the value-free and objective endeavour it has been touted as.128 It identifies the importance of
values both in assessing risk and in governing technologies. This forms a basis for picking out certain problems and problematic assumptions embedded in the current paradigm of risk governance in the EU, for example the narrowness of risk assessment as a decision-making tool and the tendency to reduce all concerns about a technology to questions of safety resolvable by science,129 often combined
with a lack of acknowledgment of the diversity of values and concerns which constitute individual or societal attitudes to risk. This chapter does not aim to break new ground but rather provides context and acts as a springboard into the analysis and arguments contained in the rest of the thesis.
Chapter Three establishes the second foundation, i.e. that EU policy relating to the governance of risky technologies displays a commitment to socio-technical integration. It does so through a survey of European policy, specifically concerning pesticide use and synthetic biology. It also considers European innovation policy more broadly, highlighting the relevance of innovation governance for downstream risk regulation. In relation to synthetic biology, it focuses on the EU’s adoption of ‘Responsible Research and Innovation’ (RRI) as a governance framework for synthetic biology.130 It argues that this approach demonstrates a general
commitment to opening up a range of synthetic biology-specific concerns to early and ongoing public debate and greater socio-technical integration. In relation to pesticides, it argues that a commitment to exploring both the social and economic
128 Royal Society (n 5) 97. 129 EGSG (n 6) 31.
130 DG SANCO, ‘Synthetic Biology: From Science to Governance’ (2010) 15; ERASynBio, ‘Next
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dimensions in the broadest terms, as well as the environmental dimension of the technology, is implicit in the EU’s employment of the language of sustainability in the relevant policy and legislation.
Section II comprises Chapters Four and Five which discuss pesticide use and synthetic biology regulation respectively. Together, they bolster the third foundation of this thesis and identify some technology-specific reasons for the persistence of the policy-practice gap.
Chapter Four provides an in-depth examination of one of the primary pieces of legislation regulating pesticides in the European Union: the SUD. It discusses the various problems and concerns related to pesticide use. It recalls the argument in Chapter Three that employment of the language of ‘sustainability’ implies that the elements commonly associated with sustainability will influence the regulation of pesticides under this Directive. Finally, it examines the detail of the SUD in light of the foregoing discussions. It argues that while there is some flexibility and potential for consideration of broader issues, the unambitious approach taken, which equates sustainable use with risk reduction and efficiency, overall limits potential for the substance of decision-making under this directive to reflect the various elements of sustainability and therefore represents a failure by the EU to close, or even narrow, the policy-practice gap. It attributes this failure to, amongst other things, the narrowness of the consultation process leading to the SUD and the EU’s current overall lack of ambition for sustainable development.
Chapter Five reviews the current regulatory regime governing synthetic biology and, with reference to the EU’s policy ambitions discussed in Chapter Three, assesses the potential of the regime to meet those ambitions. The chapter focuses on opportunities for public and other stakeholder participation as the main legislative instrument capable of implementing the principles of RRI, in addition to other opportunities for values other than safety to influence decision-making processes. I argue that the legislation examined cannot implement the EU’s policy ambitions, primarily due to the weakness of its provision for participation. Returning to policy, I argue that overall confusion as to the goals of participation in the governance of synthetic biology renders it unlikely that legislation will be
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amended to reflect increased ambition. That confusion, I argue, is exacerbated by the fact that discussion relating to the governance and regulation of synthetic biology is conditioned by its inheritance of a regime designed for a different technology131 which further restricts opportunities to enhance socio-technical
integration.
Section III comprises Chapters Six, Seven and Eight, which present an analysis of reasons for the persistence of the policy-practice gap from the angles of trade law and the ideational context.
Chapter Six tackles the EU internal market and focuses on opportunities in internal market law for Member States to regulate on the basis of a range of social values and uncertainty through analysis of Articles 36 and 114 TFEU, the mandatory requirements132 and the precautionary principle. It considers the degree to which
these provisions restrict or support socio-technical integration. It argues that when adjudicating a Member State’s justification for maintaining a trade-restrictive measure, the EU Courts tend to grant scientific or technical expertise priority of agency in determining whether a problem justifying regulation actually exists. This approach pre-empts the use of other forms of (non-scientific) evidence and reasoning as to the existence of a problem, inhibiting fulfilment of the EU’s policy commitments discussed in Chapter Three and reinforcing the policy-practice gap. Chapter Seven considers the World Trade Organisation rules within which EU risk regulation regimes operate. Focusing on the General Agreement on Tariffs and Trade (GATT), the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPSA), the Technical Barriers to Trade Agreement (TBTA) and associated case law it performs a similar analysis to that in the previous chapter. It examines, in particular, scope to restrict trade in risky technologies for reasons other than
131 Elen Stokes, ‘Recombinant Regulation: EU Executive Power and Expertise in Responding
to Synthetic Biology’ in A De Ruijter and M Weimer (eds), Regulating Risks in the European
Union: The Co-Production of Expert and Executive Power (Hart forthcoming) (manuscript on
file with author).
132 Case 120/78 Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein (Cassis de
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safety, such as public morals or on the basis of scientific evidence inflected by the culture, values and concerns of the regulating Member. I argue that, while the GATT and TBTA recognise a broad range of justifications for national regulation, their availability may still be restricted. With respect to the SPSA, there is little scope for the EU to justify its regulation on the basis of risk assessment as defined by its own values and concerns. I argue that in these ways, the interpretation of these agreements contributes to constraining the EU’s own progress towards closing the policy-practice gap.
Chapter Eight examines reasons, outside the realm of regulation and trade law, for the difficulty in closing the policy-practice gap. I focus almost exclusively on analysing EU policy on innovation, governance and the regulation of technology in order to describe the ideational context for the EU’s approach to regulating risky technologies. I save the analysis of the relationship between this context and the law examined in the rest of the thesis for Chapter Nine. I use this policy analysis to construct a picture of the EU’s ambitions by identifying various imaginaries and master narratives which permeate EU policy. I argue that the EU is committed to the idea that its future survival and success depend upon economic competitiveness and growth which in turn are contingent upon science and technological innovation and a well-functioning internal market. Furthermore, this commitment is reinforced by the depoliticising effect of these imaginaries and narratives and their potential to shut down wider democratic debate on, for example, what the future of Europe should be and the direction research and innovation should take.133 Instead, a narrow debate about safety in relation to
specific technologies134 occurs in which regulatory science is granted priority of
agency in identifying which implications of technological innovation warrant a regulatory response. Implicit in these arguments is the contention that while EU policy presents its vision as the only option for its future, the direction it pursues is still very much a matter of choice.
133 EGSG (n 6) 76.
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Chapter Nine attempts to demonstrate the manifestation of the EU’s commitments discussed in Chapter Eight in the fine detail of the policy and legislation explored in Chapters Three to Five. I argue it is these commitments to which we may, at least partially, ascribe the lack of ambition in these fields and locate the source of obstacles to greater socio-technical integration, deriving therefrom an explanation for the persistence of the policy-practice gap. With respect to pesticides, I link the EU’s overarching commitment to the reconciliation of environmental and social/economic goals through innovation-aided resource efficiency, discussed in Chapter Eight, with its equation of sustainability with risk reduction and efficiency identified in the policy and regulation of pesticide use. With respect to synthetic biology, I link the EU’s commitment to an imaginary of governable emergence of innovation and search for consensus, discussed in Chapter Eight, with the priority of agency granted to science to define problems worth regulating and the narrow provision for, and expectations of, public participation established in the policy and legislation. I also highlight broader themes and patterns pervading EU policy on innovation, governance and technology which contribute to maintaining the policy- practice gap. Much of the analysis throughout the thesis, particularly Chapter Eight, shows or implies the difficulty of taking substantive steps towards realising the EU’s commitment to increasing socio-technical integration due to, for example, the longevity, appeal and resilience of its commitment to innovation and its commercialisation as guarantor of future well-being. However, this chapter concludes by highlighting the potential for change enlivened by an inextinguishable flame of choice.
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