Sci Eng Ethics DOI 10.1007/s11948-014-9602-4 ORIGINAL PAPER

Standardising Responsibility? The Significance of Interstitial Spaces Fern Wickson • Ellen-Marie Forsberg

Received: 14 April 2014 / Accepted: 16 October 2014  Springer Science+Business Media Dordrecht 2014

Abstract Modern society is characterised by rapid technological development that is often socially controversial and plagued by extensive scientific uncertainty concerning its socio-ecological impacts. Within this context, the concept of ‘responsible research and innovation’ (RRI) is currently rising to prominence in international discourse concerning science and technology governance. As this emerging concept of RRI begins to be enacted through instruments, approaches, and initiatives, it is valuable to explore what it is coming to mean for and in practice. In this paper we draw attention to a realm that is often backgrounded in the current discussions of RRI but which has a highly significant impact on scientific research, innovation and policy—namely, the interstitial space of international standardization. Drawing on the case of nanoscale sciences and technologies to make our argument, we present examples of how international standards are already entangled in the development of RRI and yet, how the process of international standardization itself largely fails to embody the norms proposed as characterizing RRI. We suggest that although current models for RRI provide a promising attempt to make research and innovation more responsive to societal needs, ethical values and environmental challenges, such approaches will need to encompass and address a greater diversity of innovation system agents and spaces if they are to prove successful in their aims. Keywords Responsible research and innovation
Standardisation
Nanotechnology
CEN
ISO
Innovation systems

F. Wickson (&) GenØk Centre for Biosafety, Forskningsparken, PB 6418, 9294 Tromsø, Norway e-mail: [email protected] F. Wickson
E.-M. Forsberg Oslo and Akershus University College of Applied Sciences, Postboks 4, St. Olavs plass, 0130 Oslo, Norway e-mail: [email protected]

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Introduction In the late 1980s and throughout the 1990s, faced with mounting social and environmental challenges, academic and policy worlds rushed to embrace, debate and functionalise a new concept of ‘‘sustainable development’’ (see World Commission on Environment and Devlopment 1987; Beder 1993). This overarching concept was to influence technological advance, shape socio-economic structures and guide political decision-making towards a brighter future. At the turn of the new millennium, however, as the interpretive flexibility of this concept and its operationalization became increasingly apparent (e.g. see Giddings et al. 2002; Hopwood et al. 2005), the original allure and promise in which so many had invested their hopes began to fade. Now as climate and economic crises loom large and weigh increasingly heavily upon the world, it seems that academic and policy circles may have found a new darling upon which to lavish their attention and invest their dreams. ‘‘Responsible Research and Innovation’’ (RRI) has rapidly gained political currency within Europe in recent years (see Von Schomberg 2013) and the momentum seems set to continue with RRI as a cross-cutting theme in the new European Commission research funding programme Horizon 2020. While sustainable development has now had decades of conceptual development and practical experimentation, RRI is still a nascent notion emerging and proliferating largely through dispersed contributions rather than concerted action (with the possible exception of coordinated work that has been taking place within research councils of the UK and the ‘Science with and for Society’ (previously Science in Society) programme of the EC). The dispersed sprouting of work around RRI has created a call for investment in further conceptual development and an investigation of the potential for harmonization (Jacob et al. 2013; Stilgoe et al. 2013). Indeed, a new international effort to consolidate RRI definitions, approaches and best practices has now begun with the establishment of the Virtual Institute of Responsible Innovation (VIRI) (see http://cns.asu.edu/viri). As the concept of RRI begins to be explored and enacted through a range of devices, instruments, approaches, and initiatives, it is valuable to reflect on how this emerging concept is being imagined and what it is coming to mean for and in practice. In this paper we wish to draw attention to a realm that we believe is often backgrounded in the current discussions of RRI but which has a highly significant impact on research, innovation and policy. Exploring the space of international standardization, we will specifically present examples of how international standards are entangled in the development of RRI and yet, how the process of international standardization and its dominant organisations largely fail to embody the norms proposed as characterizing RRI. In doing so, we will draw on the case of nanoscale sciences and technologies to demonstrate and support our argument. The development of nanoscale sciences and technologies represents one of the first areas in which there has been a dedicated effort to articulate and functionalise the concept of RRI (Kjølberg 2010). Here a lack of specific regulatory frameworks, the existence of widespread scientific uncertainties, and a potential for social controversy, have combined to generate a willingness to experiment with governance mechanisms such as soft law, public engagement, and the new notion

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of responsible innovation (RI). New governance mechanisms are necessary as the existence of a master narrative in which innovation is inherently desirable and indispensible for solving societal ills (Felt et al. 2007), as arguably represented in the Europe 2020 strategy and its vision of an ‘‘Innovation Union’’ (see EC 2013), collides against a ‘‘risk society’’ (Beck 1986) in which there exists a high level of awareness and sensitivity to the fact that technologies also come with down sides and the potential for unintended negative consequences. For nanoscale sciences and technologies, the desire to have innovation and its commercialization advance in a field filled with novelty, complexity and uncertainty, has therefore required a legitimating force or discourse capable of quelling public concern. Here an emphasis on cultivating ‘responsible’ development has blossomed into prominence. Within the field of nanotechnology, there have been some corporate initiatives to specifically advance more thoughtful and responsible forms of innovation. This includes, for example, the collaboration between DuPont and Environmental Defense to develop a framework for improved risk identification and management (2007) and the efforts of BASF to implement a code of conduct for nanotechnology (BASF 2014). The work to develop RRI within corporations has naturally tended to specifically focus on the activities of that corporation and its role in the value chain. Publicly funded efforts to advance RRI in nanoscale sciences and technologies have also, perhaps rather naturally, primarily focused on the (public) scientific laboratory as the primary site of innovation and national funding bodies as significant actors shaping innovation trajectories. This means that despite activities taking place within both private and public spheres around the advance of RRI, some of the more intermediary spaces such as that of international standardization have tended to fall between the cracks. International standards play a significant role in shaping: (a) scientific research (e.g. through defining agreed methods for researching the risks new technologies may pose to human health and the environment), (b) technological innovation (e.g. through their explicit aim to facilitate international trade through technical harmonisation), and (c) regulation (e.g. through their use in defining quality in science for policy). Given the significance of international standards in the shaping of research, innovation and policy, it seems untenable to us that RRI can be achieved without the norms it purports to represent also penetrating this domain of action. While the current discourse on RRI has given some scant attention to the potential for standards as products to function as a potential device advancing RRI (e.g. see Jacob et al. 2013), to date no significant attention has been paid to the process of standardization and the extent to which it embodies the characteristics of the emerging concept of RRI. Questions concerning the quality and legitimacy of the process of standardization have been studied by Forsberg (2012) and Kica and Bowman (2012) among others. However, this work has not related such issues directly to the discourse of RRI. In this article, our contribution is targeted towards understanding the emerging notion of RRI, and specifically to understand how it is operating within the context of standardization. This includes examining a specific initiative within Europe to create a standard for responsible nanotechnology development, but also exploring more generally the challenges and opportunities available for having the

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characteristic principles of RRI apply to the processes and practices of standardization as they influence the innovation process. This arguably represents a novel perspective and focus, both within the RRI discourse and the existing work on standardization. In this paper, we therefore begin by surveying some of the emerging definitions surrounding RRI and conceptualisations of what the term can be taken to encompass. We then outline what role RRI has been playing within our case study area of the development of nanoscale science and technology. This then leads into a description of an ongoing process to develop a specific standard for responsible nanotechnology development within the European Committee for Standardisation (CEN). On the basis of this case study, we then ask questions concerning how the characteristic principles of RRI relate to the process of standardization. Finally, in querying why the practice of developing international standards has been sidelined in the search for RRI, we suggest that this may be connected to the concept of innovation that has dominated current RRI discourse, which we think has failed to adequately articulate and handle its distributed, often incremental, and always socio-technical nature. We then conclude by outlining some of the areas at this intersection between RRI and standardization that we think deserve further attention and research in the future. The aim of this paper is therefore not to answer a specific and pre-defined research question, but rather, to serve as exploratory agenda-setting work that begins to map and imagine how these two different realms of scholarship and action can be brought into a more fruitful and integrated union. We strongly believe that such an elevated emphasis on standardization is essential if a truly responsible approach to research and innovation is to be advanced.

Responsible Innovation The concept of RI or RRI is rapidly gaining currency in European policy discourse. This emphasis on having the knowledge economy and the innovation union develop in a ‘responsible’ way is arguably the latest manifestation of a longer historical trend in reimagining the relationship between science and society away from the traditional ‘linear model’ or ‘received view’ (Guston 2000). This historical development of attempts to reimagine the science-society relationship and indeed, to enact it in new ways, has been described by Stilgoe et al. (2013) as observable through the development of practices such as technology assessment in its various forms (e.g. see Rip et al. 1995; Guston and Sarewitz 2002), the increasing institutionalization of upstream public engagement (Wilsdon and Willis 2004; Delgado et al. 2011), the embedding of research on ethical, legal and social aspects (ELSA) into large technology development initiatives (Zwart and Nelis 2009; Stegmaier 2009), and enhanced use of ethical or socio-technical integration in laboratories (van der Burg and Swierstra 2013) and midstream modulation (Schuurbiers and Fisher 2009; Fisher et al. 2006). Despite a sense in which RRI is an amalgamation or a culmination of all of these efforts in recent decades, a universally accepted definition of RRI is yet to fully sediment. Various actors and

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initiatives have proposed definitions in recent years, however, and while they may not completely converge, they do arguably have clearly overlapping features that allow core characteristics to be identified. The following three definitions can be used as illustrative of this point. Rene von Schomberg, an employee of the European Commission, has chosen to define RRI in the following way (2013): Responsible Research and Innovation is a transparent, interactive process by which societal actors and innovators become mutually responsive to each other with a view to the (ethical) acceptability, sustainability and societal desirability of the innovation process and its marketable products (in order to allow a proper embedding of scientific and technological advances in our society). Three British academics (Richard Owen, Phil Macnaghten and Jack Stilgoe) that have worked together to develop a framework for responsible innovation, particularly within the context of the Engineering and Physical Sciences Research Council of the UK, and (here together with colleagues from the US) have defined it as (Owen et al. 2013): Responsible innovation is a collective commitment of care for the future through responsive stewardship of science and innovation in the present. This is a process said to require that innovation be: a. Anticipatory; b. Reflective; c. Deliberative; d. Responsive. In 2012, the European Commission released a kind of position statement entitled ‘‘Responsible Research and Innovation: Europe’s ability to respond to societal challenges’’ (EC 2012). Within this document, the work of the ‘Science in Society’ programme since 2010 to develop a framework for RRI is emphasized, for which six keys are described: engagement, gender equality, science education, open access, ethics, and governance. In addition to outlining these six keys, the following definition for RRI is provided: Responsible Research and Innovation means that societal actors work together during the whole research and innovation process in order to better align both the process and its outcomes, with the values, needs and expectations of European society. RRI is an ambitious challenge for the creation of a Research and Innovation policy driven by the needs of society and engaging all societal actors via inclusive participatory approaches. Following this, in 2013 an expert group established by the European Commission released its report on ‘‘Options for Strengthening Responsible Research and Innovation’’ (Jacob et al. 2013). This group was chaired by Dutch moral philosopher Jeroen van den Hoven, and had Linda Nielsen, Francoise Roure, Laima Rudze and Jack Stilgoe as members, Knut Blind, Anna-Lena Guske and Carlos Martinez Riera as contributors, and Klaus Jacob as rapporteur. A definition that this expert group has provided is:

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Responsible Research and Innovation refers to the comprehensive approach of proceeding in research and innovation in ways that allow all stakeholders that are involved in the processes of research and innovation at an early stage (A) to obtain relevant knowledge on the consequences of the outcomes of their actions and on the range of options open to them and (B) to effectively evaluate both outcomes and options in terms of societal needs and moral values and (C) to use these considerations (under A and B) as functional requirements for design and development of new research, products and services. While each of these definitions differ in the terminology they use, the orientation they adopt, the depth of description they provide and where emphasis is placed, the characteristics that are shared across them and can therefore be identified as central to the emerging concept of RRI include: 1. 2. 3. 4.

A specific focus on addressing significant societal needs and challenges A research and development process that actively engages and responds to a range of stakeholders A concerted effort to anticipate potential problems, identify alternatives, and reflect on underlying values, and A willingness from relevant actors to act and adapt according to 1–3.

Questions such as how this is to be achieved in practice, what the motivations of the different actors involved are, and how progress towards a new paradigm of innovation might be measured, are important issues that all remain open. Despite these open issues, the challenge of developing RRI is arguably being taken up through a range of initiatives, particularly in the area of emerging technologies. One of the fields in which experiments to functionalise RRI in practice have been particularly prominent is that of nanoscale sciences and technologies.

Responsible Innovation and Nanoscale Sciences and Technologies The language of responsibility is threaded throughout European policy documents on nanoscale sciences and technologies. From its first communication ‘‘Towards a European strategy for nanotechnology’’ (EC 2004), the European Commission emphasized the importance that nanotechnology develop in a ‘‘responsible’’ manner, which was described as entailing adherence to ethical principles, addressing health, safety, environmental and societal concerns at an early stage, and including dialogue with stakeholders and members of the public (EC 2004). This sentiment was echoed and strengthened through the Action Plan that followed in which the overarching strategy for nanotechnology was characterized as safe, integrated and responsible (EC 2005). These policy documents were then followed by the development of a specific code of conduct for ‘responsible’ nanosciences and nanotechnologies research, which contained the following list of core principles: meaning, sustainability, precaution, inclusiveness, excellence, innovation and

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accountability (EC 2008). While the support for and uptake of this specific code of conduct has certainly varied amongst the member states and Directorates-General (with significant debate over whether nanotechnology deserved a specific code of conduct and considerable contestation around the strongly worded principle of accountability), the EC rhetoric surrounding nanotechnology over the last decade has consistently involved the notion of ‘responsible’ development. Interestingly, and in parallel, another code of conduct for responsible nanoscale science and technology was also developed in the same year as that recommended by the EC, spearheaded by the UK Royal Society, Insight Investment and the Nanotechnology Industries Association and generated in collaboration with a number of companies with a commercial interest in nanotechnology. This ‘Responsible NanoCode’ listed the following as its characterising principles: board accountability, stakeholder involvement, worker health and safety, public health, safety and environmental risks, wider social, health, ethical and environmental implications and impacts, engaging with business partners, transparency and disclosure (Responsible NanoCode 2008). Around the same time that these European policy documents and industry initiatives demonstrating a specific interest in advancing responsible innovation in nanoscale sciences and technologies emerged, the international standards community also began to develop activities in the field. The OECD developed a working party on manufactured nanomaterials in 2006, which was focused on developing international cooperation and harmonization on human health and environmental safety testing. It then established a broader working party on nanotechnology in 2007 with the explicit intent to ‘‘advise upon emerging policy issues of science, technology and innovation related to the responsible development of nanotechnology’’ (OECD 2007). The International Organisation for Standardisation (ISO) created its technical committee on nanotechnologies (TC 229) in 2005, with a specific objective to ‘‘support the sustainable and responsible development of global dissemination of these emerging technologies’’, alongside aims to facilitate global trade in nanotechnologies, ensure their health and environmental safety and promote good practices in their production, use and disposal (ISO 2011). The European Committee for Standardisation (CEN) also established a technical committee on nanotechnologies (TC 352) in 2004, which has expressed a specific commitment to liasing with and coordinating its standards with the work taking place in both ISO and the OECD. In 2011, Working Group 2 of CEN’s TC 352 on ‘‘Commercial and other stakeholder aspects’’ began a specific new work item on ‘‘Nano- responsible development: integration of risk and benefit assessment in the production, marketing, and use of nanotechnologies, nanomaterials and/or products incorporating nanomaterials’’ (for a useful description of the origins of this initiative see Laurent 2011). This initiative to develop a specific standard for responsible nano development (currently formally conceived as a technical specification) is still in progress and we will come back to present a more detailed discussion of this initiative later in the paper. While this CEN initiative represents an example in which there is an attempt to create a specific international standard for responsible innovation in nanoscale sciences and technologies, other standards being developed

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within these international bodies also have significant capacity to influence science, technology and innovation, in more or less responsible directions.

International Standards In a recent work, Lawrence Busch has referred to standards as forming our ‘‘recipes for reality’’ (Busch 2012), highlighting their omnipresent (although typically not overtly obvious) status, as well as the interconnected, multilayered way in which they evolve across spheres and emerge as fundamental factors performing our realities. While Busch defines standards in a broad way, usefully providing a typology for assisted navigation, in this contribution we are focused on international standards being developed by international bodies like the Organisation for Economic Cooperation and Development (OECD), the International Organisation for Standardisation (ISO) and the European Committee for Standardisation (CEN) that have the capacity to shape, influence and impact research and innovation. In this article we will concentrate on processes occurring in organisations dedicated to standardization, namely the ISO and CEN. This focus is motivated by the fact that the authors have direct experience participating in the work of these organisations, particularly in the field of nanotechnology, and that these organisations follow somewhat different procedures than groups with wider governance mandates. The development of international standards is a scientific and political space in which governments, industry representatives, researchers and civil society organisations all engage in the negotiation of outcomes according to their own expertise, interests and values. The standards that emerge as the outcomes of these negotiations represent an agreed way of doing something, e.g. how to name, define or specify something, how to measure, test or report something, or how to manage or control something. Although it can often be assumed that standards developed for scientific research and/or technology development have been primarily agreed on the basis of scientific criteria alone, it is important to understand that social, economic and political factors will almost always play an equally significant role of influence in the negotiation process. Furthermore, as Busch (2012) notes, standards are not only technical but often also moral projects, given how they come to define and shape who we are, what is right to do and how we should live. This dual nature, combined with their performative quality, means that international standards are and will always be, deeply political projects requiring negotiation across competing interests. This will arguably only be heightened when concepts such as ‘responsibility’ are in play, where there is likely to be broad general support for the terminology, but fierce divergence concerning its underlying philosophy and ideals of interpretation and implementation. The development of standards is not simply ‘‘the passive terrain of negotiations among parties with identifiable stakes’’, it is ‘‘a process through which a whole market is shaped’’ (Laurent 2011) and while formally voluntary in nature, in practice strong economic, scientific and regulatory incentives work to generate and enforce compliance with such international standards (Thoreau 2011). International standards have typically and historically emerged to help facilitate international business, trade and markets. While there was therefore an original focus on

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developing shared technical specifications to enable internationally interlinked innovation, production and distribution chains, international standardization bodies and practices have increasingly branched out to also include the development of standards for quality management, as well as health, safety and environmental testing. This extension into developing international standards not just for engineering but also for health, safety and environmental testing has seen these standards not just work to shape innovation and research but to also become crucial factors influencing regulation and legislation. Within ISO TC229’s Business Plan (ISO 2011), it has been argued that international standardization efforts will ‘‘support technological development, societal acceptance and market expansion’’ in the nanoscale sciences and technologies by: • • • • • • • • • •

identifying gaps in knowledge identifying needs for, and encouraging the development of, instruments and test methods for use at the nanoscale developing test methods to detect and identify nanoparticles, and to characterize nanoscale materials and devices developing protocols for bio and eco toxicity testing developing protocols for whole life cycle assessment of nanoscale materials, devices and products developing risk assessment tools relevant to the field of nanotechnologies developing protocols for containment, trapping and destruction of nanoparticles and nanoscale entities developing occupational health protocols relevant to nanotechnologies, in particular for industries dealing with nanoparticles and nanoscale devices supporting regulation in the area of nanotechnologies supporting communication of accurate and quantifiable information on nanotechnologies.

This extensive list demonstrates the potential significance of standards for shaping research, innovation and policy and emphasises the role that standards can play not only in supporting and shaping technical development and harmonization but also for understanding and regulating impacts on human health and environmental safety (practices that then inter alia influence innovation). Despite their scope for significant influence, the practice of developing international standards has typically remained black-boxed and backgrounded in the emerging discourse of responsible research and innovation.

Standards and RRI: Products and Process International standards have been presented as a possible device through which RRI may be articulated and facilitated in a harmonized manner (e.g. see Jacob et al. 2013). In the European context, it has been proposed that this could first be pursued through an

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initial initiative within CEN that could then later be translated into ISO (Jacob et al. 2013). As we have indicated above, in the field of nanoscale sciences and technologies, such an initiative has in fact already begun with the new work item on ‘‘Nanoresponsible development: integration of risk and benefit assessment in the production, marketing, and use of nanotechnologies, nanomaterials and/or products incorporating nanomaterials’’. This initiative has a roadmap for the work beginning in June 2012 and ending with the adoption of a technical specification in December 2015. We are currently engaged in this CEN initiative as Norwegian expert delegates to the process. While serving in this role, we have consistently remained curious about the unfolding of the work and the part that different actors are playing, while also seeking to bring our existing knowledge of innovation governance, risk and uncertainty, and the socio-economic and political dimensions of science and technology to bear on the process. We have also specifically explored the possibility to bring this initiative into a closer dialogue with the emerging ideas of RRI in academic literature. Although the work on this new work item remains ongoing, in the spirit of the exploratory agenda setting nature of this article, some of our preliminary impressions are given below. In the terms of reference for the initiative and the first draft of the technical specification document developed for discussion within the group, produced by the secretariat AFNOR, it was suggested that for responsible development of nanotechnologies, there was a need for developers along the value chain to consider health and environmental risks at an early stage and to weigh these against an explicit assessment of benefits. Given the substantial technical, economic, societal and scientific uncertainties that pervade the field of nanotechnology, developers and particularly SMEs were said to require guidelines to help ensure a transparent, safe and accountable development of nano-products and markets. Such guidelines were proposed as necessary to avoid partial or total rejection of nanotechnology products and were suggested as needing to have a specific focus on the identification and management of critical uncertainties when assessing both benefits and risks. The initial aims of the new work item were therefore to: ‘‘allow users to characterise and reduce uncertainties related to both benefits and risks of nanomaterial products, help users make better informed decisions regarding production and/or marketing of these products (‘‘go-no-go’’ type of decisions), support and improve traceability of information across the entire value chain of nanomaterial products’’ (AFNOR 2012). In this way, the initiative initially meant to offer assistance to both industries and concerned groups of consumers in understanding and managing the uncertainties associated with nanotechnology products along the value chain (Laurent 2011). However, there was also already disagreement during its early framing concerning the extent to which it should provide a form of certification scheme or remain for the information of industry actors involved in a value chain (Laurent 2011). Following an open call for the nomination of expert delegates to this initiative, in February 2012 29 experts were listed as confirmed participants. These participants came from the following nations: Belgium, Czech Republic, France, Germany, Ireland, Italy, Norway, Portugal, Romania, Switzerland, and the United Kingdom. The experts listed as participants at this time came from industry (11), research institutes (7), government agencies (3), national standards bodies (2), the secretariat organization AFNOR (2), the European commission (1), consultancy firms (1), a consumer organisation (1) and an unknown affiliation (1).

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At the time of submission of this paper, five meetings have been held in the working group through which the following themes and topics of discussion had emerged and been pursued: Theme Scope and aims

Topics of discussion The appropriate target audience for the technical specification (TS) The relevant terminology and definitions for nano-materials and—objects Whether natural, incidental and engineered nanomaterials were all included within the scope Whether materials in use for many years but newly labeled nanotechnology would fall within the scope Whether the TS aims towards an accreditation or certification process Whether the TS should have a product or process orientation, or both Whether the TS aims to provide something more than guidance for performing risk/benefit assessment

Procedural aspects

The appropriate format for a TS and the required approach to developing these within CEN The value of progressing from a pre-new work item to a new work item (which would enhance the available timeframe from 3 to 5 years) Whether the role of participants was primarily envisaged as one of coproducers of the TS or only a group providing critical feedback The importance of developing a transparent standardization process that stakeholders could engage in

Relationship to other documents and initiatives

The need to understand the relationship between this TS and related standards already developed (such as ISO 26000 on corporate social responsibility and ISO/TR 13121 on nanomaterial risk evaluation) The unique offering of this particular TS in comparison to others already available for risk assessment and cost/benefit analysis The relationship to the Responsible NanoCode (providing guidance on process) and the Nanokommission (guidance on risk–benefit assessment) The relationship to the European Commission Code of Conduct for Responsible Research in Nanoscience and Nanotechnology, and the Responsible Care initiative of the chemical industry

Meaning and operationalisation of terms

The meaning of ‘responsible development’ within this initiative How to define and measure ‘benefit to society’, particularly the level of interest (e.g. individuals, companies, communities, nations etc.) Whether there should be a single scoring parameter for both risks and benefits The relevant comparators for use in proposed assessments The types of uncertainty to be addressed and the role of the precautionary principle How to deal with ambiguity (e.g. diverging methods and results) in scientific evidence during an assessment of risks and benefits Whether the results of any use of the proposed guidelines for assessment by companies should be made public or not The appropriate role for stakeholders in the proposed assessments The appropriateness of a decision-tree model with go-no go options The relevant timescale for assessments

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Through the ongoing discussions, the approach to what responsible nano development means and entails has begun to shift. At the outset of the work on this initiative as a new work item within CEN, for example, it had adopted the position that responsible development essentially entails an integration of risk and benefit assessment, with emphasis placed on the fact that benefits of new technologies are simply assumed rather than explicitly assessed and that this was not appropriate for responsible development. While it was recognized that handling uncertainties would be an important component of any integrated risk/benefit assessment, upon facing the criticism from the authors that risk and benefit assessments typically fail to adequately address how not only quantitative but also qualitative uncertainties are to be handled (and that these uncertainties are substantial within risk-based science on nanosafety, e.g. see Wickson et al. 2010), the TS has begun to more explicitly relate to the challenge of handling scientific ambiguity. Additionally, the initiative is now also giving enhanced attention to the Responsible NanoCode and its principles as developed through a cooperative initiative between industry and stakeholders in the United Kingdom (thanks to the suggestions from one of the institutional actors involved in that work that was also present within the CEN working group). While the TS initiative has yet to specifically consider or relate to the broader academic literature or discourse on responsible development as presented at the start of this paper, since the TS remains in development (at the time of writing), there certainly seems to be scope for this to also be directly integrated into the discussions and the ongoing work should this gain the support/interest of other delegates. As indicated by the range of topics taken up in the discussions to date, work to develop a standard for the responsible development of nanotechnologies is clearly not a purely technical task. Who has responsibility to ensure responsible nano development (e.g. what kinds of companies along the value chain are relevant? Does the size of the company matter? Are commercial companies the only relevant actors? Etc); What counts as nano (e.g. are incidental nanoparticles in a product sufficient to bring it into the scope? Are well-established products recently relabeled as nano part of the scope? Etc) and; Should the guidelines lead to a publically transparent accreditation system or not? None of these issues are solely technical in nature nor is there any requirement for a specific expertise to discuss them in a meaningful way. Additionally, in discussing the meaning of responsible development or social benefit, in defining the appropriate scope and target audience, and in considering how to deal with uncertainties and ambiguity and what relevant comparators might be, it would seem particularly essential that the process is ‘opened up’ for participation from a broad range of involved or implicated actors (Stirling 2008). A broader base for the negotiations would serve to bring a wider range of relevant perspectives into the discussion and thereby enhance the quality and legitimacy of any final product and/or decision. While it appears that this kind of broad base for the negotiation and development of the document was desired by the initiators of the new work item (see Laurent 2011), it has yet to manifest in practice. As it currently stands, the group seeking to define and develop the guidelines for responsible nano development under this CEN initiative is dominated by industry and research organisations that directly stand to commercially benefit from the development of nanotechnology and the process arguably fails to engage the type of broad range of stakeholders that the norms of RRI would seem to require.

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While establishing a broader base of participation in this particular initiative to develop a specific standard for RRI is important, it is also a significant issue concerning work to develop all international standards influencing research, innovation and policy. One of the areas of substantial significance here is the way in which international standards have now moved beyond advocating particular technical specifications into the provision of standards for health, safety and environmental testing. This kind of testing has traditionally performed a kind of gate keeping function that allows both innovators and regulators to decide what can be commercialized. Therefore, defining standards for how such testing is to be conducted clearly has a huge influence over what innovations are developed and come to shape our societies. The development of standards for the health, safety and environmental testing of nanoscale sciences and technologies is being conducted within the OECD, ISO and more recently, in an FP7 large-scale coordinating project NANoREG (a large coordinating project (with over 60 partners from 16 nations that aims to develop a common European approach to the testing of nanomaterials in liaison with the work taking place in both OECD and ISO). In the expansion of the realm of international standards bodies, it is crucial to realize that ‘‘Each standard and each category valorises some point of view and silences another. This is not inherently a bad thing—indeed it is inescapable. But it is an ethical choice’’ (Bowker and Star 1999, p. 5–6). When the ethical dimension of such choices is recognized, together with an appreciation of the currently highly ambiguous state of nano(eco)toxicology (Wickson 2012), the requirement for a reflective, inclusive, and transparent process for standardization takes on additional importance. This has, for example, been eloquently articulated by the international NGO network on ISO, which was established with the goal of ensuring that any ISO-created environmental standards are in the public and environmental interest and which appears to been in active operation between 2002 and 2007. […] ISO’s quiet transformation from creating technical engineering standards to developing standards related to environmental and social policy has gone virtually unnoticed and unchecked by environmental and social justice organizations. Like the World Trade Organization (WTO), the rules established by ISO will have a major impact on national and local environmental issues—from the environmental management standards deployed by major multinational corporations to eco-labeling, water privatization, global warming and corporate social responsibility. Environmentalists and social justice advocates cannot continue to ignore ISO; we must get involved in shaping these standards and guiding the direction of their implementation. (http://inni. pacinst.org/inni/)

Responsibility and Legitimacy in the Process of Standardisation The European Commission states in its new approach to regulation (see e.g. 2000) that technical harmonisation is a prerequisite for establishing an internal market based on the free movement of goods. Moreover, national governments and the EC

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rarely regard it as necessary to develop their own technical vocabulary for regulation, but rather refer (or defer) to those developed through international standards bodies. OECD/ISO/CEN standards are therefore often adopted in the public policy and regulatory authority of nation states. In some cases decision makers do not see a need to double check the validity of the substance of the standards, nor the validity of the specific process used to generate them (Forsberg 2012, p. 725). Rather, such standards seem to possess a kind of a priori legitimacy, a legitimacy that rests on the institutions from which they emerge and in some cases, from the government mandates that may have stimulated their development. Franck (1999) defines legitimacy as: ‘the aspect of governance that validates institutional decisions as emanating from right process’ (p. 1). Van den Berghe (2006) adds: ‘In secularized, democratic societies, the primary source of legitimacy lies in the involvement of those impacted by a decision in the decision-making process leading to it.’ (p. 6). Without possessing the authority of elected representatives, organisations like the CEN, ISO and OECD often argue for the legitimacy of their process by emphasizing the consensus driven approach to decision-making and/or the democratic approach of ‘one nation-one vote’ styles of decision-making. This, however, has a tendency to mask the realities and constraints of practice. Forsberg (2012) evaluated the processes of standardization within the ISO technical committee on nanotechnology (TC 229) with regard to legitimacy in general, and more specifically in terms of participation, transparency and scientific robustness. Kica and Bowman (2012) have performed a similar analysis of the legitimacy of TC229 and compared this with the OECD working party on manufactured nanomaterials. Both studies draw attention to the significant problem of limited participation and transparency in standardization processes and discuss how this relates to problems with ensuring the scientific robustness of the standards generated. Achieving balanced and broad-based participation is a well-known problem within ISO (see ISO/IEC/CEN 2001). The main challenge for enhancing participation is arguably that following standardization processes requires significant resources. This includes the time necessary to keep up with a constant stream of draft documents and technical discussions, and not least to attend regular meetings. The latter also requires significant financial resources as the meetings of a body like ISO are held in a different country around the globe every 6–10 months. In addition to this, membership fees are required from participating nations (Kica and Bowman 2012). There is also a significant level of knowledge required to actively participate in standardization processes, not only in terms of the desirability of expertise on the topic under negotiation, but also more concretely in terms of knowledge about the specific terminology and formal processes that structure how participants can contribute and how documents need to be structured and approached throughout the process. The high level of resources required to participate means that only those organizations and actors with a particular interest (often financial) in the standards being developed are likely to invest the time, money and energy required. As has been indicated for the CEN initiative, the actors that dominate such standardization processes therefore can tend to come from industry (with the possible exception of

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the OECD within which negotiations are more typically dominated by governmental representatives). In the nanotechnology field, Forsberg (2012) and Kica and Bowman (2012) both point to low participation of stakeholders such as NGOs and consumer organizations in the standardization process. This has been echoed by Blind and Gauch (2009) who report problems with recruiting non-industrial researchers to nanotechnology standardization in Germany (and, indirectly, also to ISO). Werle and Iversen (2006) and Jakobs (2006) report similar problems in ICT standardization, indicating that this is not a problem specific to TC 299, but rather a structural problem connected to ISO. A further open question relates to the impact that individuals representing such organizations have on the discussions and decisions in the process. In addition to participation, transparency has also been identified by Forsberg (2012) and Kica and Bowman (2012) as problematic for the process of developing standards for nanoscale sciences and technologies. In the first instance, for organisations like the ISO with a specific business orientation and motivation, you have to pay to access the standards produced. Moreover, as several standardization scholars have pointed out (Jakobs 2010; Lee 2009) standardization is as much about negotiation as about rational discussion, however the content of the actual negotiations are rarely documented or accessible, even to fellow members of the committees. While there may be public transparency related to official drafts, this does not apply to the reasoning, power plays or corridors deals that lead to the drafts. For nations, stakeholders or members of the public sitting outside actual standardization negotiations, access to information about who the participants are, their backgrounds and affiliations, as well as the content of discussions and points of contention, is near impossible to attain. With regard to scientific robustness, this is affected by the constitution of the working groups, as well as the extent to which the standards are subject to peer review. As indicated above, working group membership may have a bias towards industry-oriented researchers, to the potential exclusion of a wider range of scientific perspectives. Or as highlighted by Kica and Bowman, various actors may participate in the process but this does not necessarily correlate with a variety of interests. Moreover, institutional practices and economic incentives in (at least some of) the national mirror committees indicate that standards are voted for (in contrast to an ‘abstain’ vote) even if there is a lack of expertise to evaluate the content. The scientific robustness therefore cannot be assumed even if a standard is produced by these well-recognized international bodies. This clearly becomes a particularly serious problem in fields such as nanoscale sciences and technologies where a select group of interested actors may be being given the authority to set standards for health, safety and environmental testing despite extensive scientific uncertainties and widespread ambiguity in the available knowledge base. The tendency for such a select group of interested actors to then also circulate amongst the different bodies and spaces involved in science/technology/policy development and standardization (e.g. see Demortain 2011), advancing their interests and facilitating the sedimentation of their position is further cause for concern. The issue of the responsiveness of the system also emerges as particularly crucial here. Given that agreement on international standards are hard fought and won over

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years of intense political negotiations, once agreed, standards tend to sediment and stagnate rather than remain flexible and open to change as new information or developments emerge. Given the nascent nature of nano(eco)toxicology research, considering how responsiveness can be cultivated in the standardization processes taking place in this arena seems particularly challenging yet crucial. Returning to the emerging dimensions of RRI then, we can make the following observations. International standards arguably can be oriented towards addressing societal needs and challenges, although these are often defined within the scope of a particular field of technology development or application market (e.g. in this case, nanotechnology). ISO and CEN standards are open for participation from a range of stakeholders, however in practice, constraints on resources of time and money appear to seriously restrict the involvement of certain actors and there are limited mechanisms for overcoming this, on either a national or an international level. There also appears to be no systematic frameworks to anticipate potential problems, articulate alternatives or reflect on underlying values within these standardization bodies. Although ISO has a Code of Ethics and an ISO Guide 82 on Sustainability that are supposed to assist people involved in standard-making, their actual uptake and use has not been documented. In addition, although ISO TC 229 on nanotechnology has a task group on Consumer and Societal Dimensions that in 2010 developed an ethical checklist for reflecting on ethical implications of current work in the working groups and New Work Item proposals (work that one of the current authors has been involved in), this has not yet been implemented in the technical committee. Finally, some stakeholders claim that even if they participate in the standardization process they have little impact on the results of standardization (Forsberg 2010, p. 39), which could indicate a lack of responsiveness. This compounds the lack of responsiveness that can be found in standards generally as outlined above. While ISO 26,000 appears to be the standardization project with the most focus on stakeholder involvement and responsiveness, and could be seen as a current best practice related to respecting RRI principles in standardization processes, this may be seen as a standard that is most typically directed outwards towards other organisations and businesses rather than reflexively applied back onto standard organisations themselves. The procedural challenges to legitimacy, participation, transparency, scientific robustness and responsiveness in processes of international standardization indicate that if research and innovation really is it to be ‘responsible’ (as this is coming to be defined within the European policy discourse on RRI), this important component of the innovation system also needs to be actively engaged and mobilized. Creating responsible standardization practices to support RRI is, as indicated above, urgent for managing the large uncertainties related to the development of emerging technologies. If flawed definitions, measures or methods become standardized for the development of nanotechnology, consumer products may enter the market, the body and the environment in potentially harmful ways. The scientific ambiguities and complexities involved in a field such as nanotechnology and in understanding and controlling its potential negative impacts on human health and the environment, makes it necessary to have a broad-based and inclusive process, capable of anticipating potential futures, imagining alternatives and reflecting on underlying

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values, limitations and assumptions to make sure that the resulting standards are socially responsible and scientifically robust. For this to be achieved, there is a need to mobilize RRI characteristics in the to-date neglected interstitial spaces.

The Need for Addressing the Distributed, Socio-technical, Character of Innovation Given the significance standards can have as a political space shaping research, innovation and policy, one might wonder why the realm, and particularly its procedural dimension, is not subject to more attention in the emerging RRI discourse. A simple argument may be that the nascent and fragmented nature of the current discourse means that this is simply a gap waiting to be filled and/or that few of those currently developing the concept of RRI have direct experiential knowledge of standardization processes. However, we wonder if the limited attention may also be partially attributable to the concept of innovation that is being adopted and advanced in the current discourse. If we look more closely at the RRI approaches we reference above, we find that none of them give any specific attention to the concept or definition of innovation, nor an account of the details of innovation as a system. In a recent book collating important contributions on RRI (Owen et al. 2013), very few of the authors give specific attention to the concept of innovation as opposed to the concept of responsibility. Bessant (2013) is an exception and is particularly careful to outline the difference between incremental and radical innovation, and to discuss the power and importance of distributed and open innovation, where innovators ally with a range of users and stakeholders (NGOs, other actors in the value chain, etc.) to innovate better, more sustainably or more responsibly. We support such a systems-based approach to innovation, and believe that this perspective also opens up for considering other institutions in the innovation system (Lundvall 1992). We would suggest that the perspectives on innovation offered so far in RRI need to better take into account innovation systems in all their complexities. Focusing only on specific categories of actors, such as research funders, industrial innovators, citizens and legislators/regulators (e.g. see Jacob et al. 2013) fails to acknowledge and account for the kinds of interstitial space that standardization represents. Standardization can be thought of as a kind of interstitial space because it effectively occupies a location somewhere between what are currently recognized as key domains, e.g. those of science, policy, civil society and industry. At the same time, however, standardization as an ‘in between’ space also provides an essential medium through which actors from across the domains interact, exchange ideas and develop products that are then, through a dynamic interplay, fed back into each of the domains and actually come to play a fundamental role in shaping their core activities (see also Delemarle and Throne-Holst 2012). This characteristic of existing between what is currently identified as apparently separate core spheres of action, but effectively functioning as a space in which crucial information and materials are exchanged across the domains and developed into products that come to define operational parameters in all spheres, can be said to be a defining feature of

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what we wish to describe as an interstitial space in this paper. It is arguably their ‘in between’ feature that often sees such spaces become backgrounded in discussions about the governance of science and technology, while their ‘interaction and influence across’ feature makes them crucial in any quest for responsible research and innovation. It is also important to recognize that due to the characteristic of containing actors from different domains engaged in developing outcomes that come to shape the activities of each domain, such interstitial spaces also tend to be highly political spaces as actors from each sphere seeks to represent and negotiate outcomes on the basis of their institutional and/or individual interests. This feature also makes them particularly important spaces for considering the implementation of the types of process-based norms currently being advocated by emerging RRI frameworks (e.g. for reflective and deliberative forms of discussion across a range of relevant stakeholders). To help include attention on the types of interstitial spaces that standardization arguably represents, there appears to be potential value for the emerging RRI discourse to more fully integrate work and scholars from innovation studies (Zwart et al. 2014) and to specifically draw on and relate to the corpus of existing work on system oriented innovation research, with its concepts such as sectoral (Malerba 2006) or technological innovation systems (Bergek et al. 2008). Considering the innovation system and its dynamics in a more nuanced, specific and detailed way can open up for better analytical understanding and more proactive policies. We see at least three learning points available from these approaches, opening up important avenues for further research. First, these approaches to understanding innovation acknowledge a heterogeneity of agents involved in producing and diffusing innovation, which potentially enables interstitial spaces such as standardization to more clearly come to the fore. Further research should therefore be directed towards studying such interstitial spaces within innovation systems in order to create a knowledge base for understanding potential bottlenecks for pursuing, advancing and implementing responsible actions across the innovation system. Second, scholars of this tradition also acknowledge that the system of agents differs across the different sectors and technologies studied. This means, for example, that in a case like that of biotechnology, the patent system may emerge as a highly relevant target for thinking about RRI whereas other sciences and technologies may have other key interstitial spaces. This insight into differences across sectors provides a corrective to attempts to discuss innovation—and responsible innovation—in a too generic way. According to this view, attempts to implement RRI need to include an analysis of the different technology innovation systems one wants to target. Research that combines the empirical basis of innovation studies with the emerging theoretical articulation of RRI should therefore be conducted. Furthermore, research should also be performed to further interrogate the specific versus general nature of the role that interstitial spaces (such as international standards and patents regimes) play in innovation systems oriented towards different types of technologies, sectors and/or applications. Thirdly, such systems based approaches to innovation highlight the complex relationships between institutions and their members. Malerba (2006) points out that in some systems, individual innovators may be the most crucial agents, while in

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others, the institutional level will be more important. In the case of standardization of nanoscale sciences and technologies, the working procedures and informal processes in the organizations (i.e. the institutional infrastructure and culture, see Scott 1987) may be important. However, even here there will be several levels involved; the institutional infrastructure is determined at an ISO level, while the informal processes develop at the level of the technical committee (TC). In a practical perspective in this case then, this means that if one wants to induce change, one needs to target standardization principles and practices both at the ISO level and at the TC level, as well as working with the individuals engaged in the institutions. Creating more robust knowledge of the distribution of responsibility across different institutional levels should therefore be a target for further research at the interface between RRI and standardization. Furthermore, comparative studies looking across the institutional actors, practices and cultures of different standardization organizations (e.g. the ISO versus CEN versus OECD) and/or the work of different national delegations involved in such organizations, would be useful.

Conclusion International standards have been presented as a possible device for facilitating and advancing RRI. In the field of nanoscale sciences and technologies, this approach to standardizing responsibility is currently being pursued through a CEN initiative on ‘‘Nano-responsible development’’. While the emerging discourse of RRI has therefore placed a spotlight on the potential of standards as products, the characteristic principles emerging for RRI have not yet been advanced within the process of standardization itself and have received little commentary by standardization scholars to date. The backgrounded interstitial political space of international standardization activities, in which various categories of innovation actors engage in a dynamic dance of interest-based negotiation, has to date largely escaped the attention of actors seeking to develop the concept of RRI and remained outside attempts to experiment with its implementation in practice. This is despite the fact that analyses have indicated that the practice of standardization processes is a long way from embodying the norms of RRI and that shifting the dominant institutional culture in this space faces some serious challenges that would require significant effort and investment to overcome. The authors of this article have a scholarly interest in the emerging notion of RRI and have directly taken part in standardization activities, actively seeking to influence these activities in the direction of enhanced RRI. This article is a kind of meta-reflection on such work. We have explicitly adopted the perspective of RRI to observe, analyse and engage in standardization practices. Our main intention in this article has been to raise awareness of standardization as an important interstitial space between research, innovation and policy, to explore the interface between RRI and international standardization as an interstitial space, to call for considering innovation system specific interstitial spaces in discussions of responsibility, and to encourage more research and action in these areas of interest.

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In this article we have sought to argue that although current RRI models provide a promising attempt to make research and innovation more responsive to societal needs, ethical values and environmental challenges, such models need to be further developed in order to incorporate and address a greater diversity of innovation system agents and spaces. To do this, the innovation half of the ‘responsible innovation’ idea needs to be subject to as much critical reflection, conceptual development and empirical analysis as that currently being directed towards the notion of responsibility. Additionally, the serious challenge of achieving transparency across both public and private actors operating in a range of political spaces needs to be confronted. Without this kind of extension into the types of backgrounded spaces that we see standardization representing, RRI seems destined to constitute little more than window dressing used to sell business as usual.

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