Nanotechnology: Regulation and Public Discourse 1786608944, 9781786608949

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Nanotechnology

Philosophy, Technology and Society Series Editor: Sven Ove Hansson Technological change has deep and often unexpected impacts on our societies. Sometimes new technologies liberate us and improve our quality of life, sometimes they bring severe social and environmental problems, sometimes they do both. This book series reflects philosophically on what new and emerging technologies do to our lives and how we can use them more wisely. It provides new insights on how technology continuously changes the basic conditions of human existence: relationships among ourselves, our relations to nature, the knowledge we can obtain, our thought patterns, our ethical difficulties, and our views of the world.

Titles in the Series: The Ethics of Technology: Methods and Approaches, edited by Sven Ove Hansson Nanotechnology: Regulation and Public Discourse, edited by Iris Eisenberger, Angela Kallhoff, and Claudia Schwarz-Plaschg On the Morality of Urban Mobility, Shane Epting (forthcoming) Human Beings, Robots and Agency: The Ethics of Responsible Human-Robot Interaction, Sven Nyholm (forthcoming) Water Ethics: An Introduction, Neelke Doorn (forthcoming)

Nanotechnology Regulation and Public Discourse

Edited by Iris Eisenberger, Angela Kallhoff, and Claudia Schwarz-Plaschg

Published by Rowman & Littlefield International Ltd. 6 Tinworth Street, London, SE11 5AL, United Kingdom www.rowmaninternational.com Rowman & Littlefield International Ltd. is an affiliate of Rowman & Littlefield 4501 Forbes Boulevard, Suite 200, Lanham, Maryland 20706, USA With additional offices in Boulder, New York, Toronto (Canada), and Plymouth (UK) www.rowman.com Selection and editorial matter © Iris Eisenberger, Angela Kallhoff, and Claudia Schwarz-Plaschg 2019 Copyright in individual chapters is held by the respective chapter authors. All rights reserved. No part of this book may be reproduced in any form or by any electronic or mechanical means, including information storage and retrieval systems, without written permission from the publisher, except by a reviewer who may quote passages in a review. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library ISBN: HB 978-1-78660-893-2 Library of Congress Cataloging-in-Publication Data Names: Eisenberger, Iris, editor. | Kallhoff, Angela, editor. | Schwarz-Plaschg, Claudia, 1982- editor. Title: Nanotechnology : regulation and public discourse / edited by Iris Eisenberger, Angela Kallhoff and Claudia Schwarz-Plaschg. Description: London ; New York : Rowman & Littlefield International, 2019. | Series: Philosophy, technology and society | Includes bibliographical references and index. Identifiers: LCCN 2018058283 (print) | LCCN 2019000369 (ebook) | ISBN 9781786608949 (Electronic) | ISBN 9781786608932 (cloth : alk. paper) Subjects: LCSH: Nanotechnology—Moral and ethical aspects. | Nanotechnology— Government policy. | Nanotechnology—Law and legislation. | Nanotechnology— Social aspects. Classification: LCC T174.7 (ebook) | LCC T174.7 .N345575 2019 (print) | DDC 174/.96205—dc23 LC record available at https://lccn.loc.gov/2018058283 The paper used in this publication meets the minimum requirements of American National Standard for Information Sciences—Permanence of Paper for Printed Library Materials, ANSI/NISO Z39.48-1992. Printed in the United States of America

Contents

List of Figures, Tables, and Boxes

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Prefaceix 1 Rethinking Ethical, Legal and Societal Frameworks for Assessing and Governing Nanomaterials Angela Kallhoff, Claudia Schwarz-Plaschg and Elias Moser PART I: EVALUATION AND STANDARDISATION

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2 Ecocentric Evaluation of Nano-Release: Risk, Precaution and Imagination17 Angela Kallhoff and Elias Moser 3 Standardising Responsibility? The Significance of Interstitial Spaces35 Fern Wickson and Ellen-Marie Forsberg 4 Standardisation and Patenting in Nanotechnology: Better Balancing for a Necessary Nuisance Thomas Jaeger 5 Standardisation: Enabler for Nanotechnology Innovation Henk J. de Vries PART II: NORMS AND REGULATION

59 91 101

6 Science, Democracy, Industry: Who Is in Charge of Regulating Nanomaterials?103 Diana M. Bowman and Lucille M. Tournas v

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7 Pros and Cons of Nano-Regulation and Ways toward a Sustainable Use Juliane Filser

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8 Nanotechnology and Fundamental Rights: Regulating Dual-Use Research  Iris Eisenberger and Franziska Bereuter

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9 Monitoring the Value of Responsible Research and Innovation in Industrial Nanotechnology Innovation Projects Emad Yaghmaei, Andrea Porcari, Elivio Mantovani and Steven M. Flipse PART III: POLITICS AND PUBLICS

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10 The Politics and Public Imagination of Nano-Labelling in Europe179 Claudia Schwarz-Plaschg 11 Emerging Technologies and the Problem of Representation Lotte Krabbenborg

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12 Nanotechnology: Democratising a Hyped-Up Technology? Franz Seifert

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References247 Index285 About the Contributors

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List of Figures, Tables, and Boxes

FIGURES Figure 6.1 Key constituents in the regulation of nanotechnologies Figure 6.2 Example of a “nano” label compliant with Regulation (EC) No. 1223/2009 Figure 6.3 Examples of negative labelling for GMOs Figure 7.1 Pressure groups associated with nanotechnology Figure 9.1 Workshop for the companies participating in the PRISMA project Figure 9.2 Example of company dashboard comparing four projects on four possible (random) criteria Figure 9.3 Example of dashboard for users indicating performance development of a sample innovation project Figure 9.4 Point distribution over clusters of indicators per company

107 120 121 131 154 156 157 161

TABLES Table 3.1 Themes and topics of discussion 46 Table 6.1 Regulatory principles being deployed for nanotechnologies 114 Table 9.1 Methodological steps to monitor the value of RRI in companies and R&I projects 152 Table 9.2 Overview of total number of indicators 159 Table 9.3 Identified organisational and RRI indicators (topics and cluster) from literature study 159

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List of Figures, Tables, and Boxes

Table 9.4

Categorised indicators for the two nanotechnology companies 161 Table 9.5 Clusters of indicators as identified per company (data also reported in figure 9.4) 162 Table 9.6 Comparison of our framework (table 9.3) with the indicators identified by the two nanotechnology companies 163 Appendix A Complete set of identified indicators 169 BOXES Box 7.1

Box 10.1 Box 10.2 Box 11.1

Summary of the main community interactions and resulting trophic cascades that potentially lead to underestimating the toxicity of metal-based nanoparticles (NP) in soil Nanocapsules as transporters of healthy nutrients, reducing calories with nanoparticles Interactive food Interactive process of dramatic rehearsal

130 191 193 215

Preface

Nanotechnologies are among the most rapidly developing technologies of our day. Nanoparticles are in industrialised materials; they are in our food and our cosmetics and have made their way into the natural environment. Due to their size, they cannot easily be tracked. In particular, these particles are melted into materials; they cluster with other chemicals, and once released into the environment, they are hard to detect. This situation leaves researchers, policy makers, and ethicists with a lot of worries and expectancies about the causal impact of these particles. Yet, they did not come up with final answers to the question of how we should deal with the production and distribution of nanotechnological products. This volume aims at filling this gap. Although it may not provide final answers, it presents proposals for scientific methods that share the same objective: to serve as backdrop for practices, norms, and guidelines that help make the best of nanotechnologies for future societies. Since the first chapter is dedicated to a more comprehensive overview on the themes of this volume, I wish to express my gratitude to various persons here. This volume results from conferences and workshops conducted by the interdisciplinary research platform Nano Norms Nature, which was provided with an initial grant from the University of Vienna in order to perform research at the interface of nanotechnology and nature. The research at the platform quickly set off into different fields at the interface of normative orders in society, public discourse, legal instruments, and ethics. Its work was based on the insight that in modern complex societies the prospects and the risks caused by new technologies cannot be handled without also accounting for the various levels of evaluation. This volume gives an impression of what this conception includes and to what conclusions one may arrive at when sharing this insight. The arguments brought up in this volume are not only ix

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applicable to an evaluation of nanotechnologies, but to reach beyond this scope, toward an assessment of new and emerging technologies. Furthermore, I wish to thank the many researchers who have come to Vienna in order to discuss topics such as “safer by design,” “good nano–bad nano,” and “standardisation in the nano-field.” Some of the presentations and talks are the basis for the contributions in this volume. Many thanks go to Iris Eisenberger for prolific cooperation. I wish to thank also Claudia SchwarzPlaschg and Elias Moser, who have been post-doc researchers at the research platform. Without their dedication, this volume would not be in existence. An integral part of the editing process was also carried out by Daniel Romanchenko. Finally, I am thankful to the publisher, especially Natalie Bolderston, who has accompanied the publication process through all of its stages. Angela Kallhoff Nano Norms Nature Vienna, October 2018

Chapter 1

Rethinking Ethical, Legal and Societal Frameworks for Assessing and Governing Nanomaterials* Angela Kallhoff, Claudia Schwarz-Plaschg and Elias Moser Over the last two decades, nanotechnology has been considered a central means for fostering positive technological and economic developments in the European Union (EU), the United States, and other industrialised countries. At the same time, it is widely recognised that nanomaterials could have potentially negative impacts on human health, animal health, and the environment. Hence, various societal actors, such as natural scientists, ethicists, policy makers, lawyers, social scientists, and civil society organisations (CSOs), have conducted assessments and come up with governance proposals. Yet, there are still unanswered questions of whether and under what conditions specific nanomaterials may include risks for humans, animals, and the environment. The development and refinement of ethical standards, legal regulation, and societal integration mechanisms for nanomaterials remains a work in progress. On 1–2 December 2016, the Research Platform Nano-Norms-Nature at the University of Vienna, in cooperation with the Institute of Law of the University of Natural Resources and Life Sciences, Vienna (BOKU), held an interdisciplinary, international conference titled “Good Nano–Bad Nano: Who Decides?” The conference sought to explore the current state of the art and the role of evaluative processes and normative assessments in the academic  We would like to thank all speakers from the conference “Good Nano–Bad Nano: Who Decides?” for their contributions (Bernadette Bensaude-Vincent, Diana M. Bowman, Christopher Coenen, Iris Eisenberger, Juliane Filser, Andreas Huber, Lotte Krabbenborg, and Franz Seifert), in particular Iris Eisenberger and Juliane Filser for their invaluable comments on this introduction. The necessary funding for the conference was provided by the University of Vienna, the University of Natural Resources and Life Sciences, and the Österreichische Forschungsgemeinschaft. Furthermore, we are thankful to all the participants in the workshop “Standardisation in the Nano-Field: For the Common Good?” especially Henk de Vries, Knut Blind, Fern Wickson, Thomas Jaeger, and Karsten Fischer.

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and societal debate on nanotechnology. For this purpose, scholars from the fields of ecology, ethics, philosophy, and law, as well as social and political sciences, convened and discussed how shortcomings of the existing ethical, legal, and societal frameworks could be addressed and countered. In this volume, we collect some of the core ideas and opinions that were brought up at the conference as well as selected contributions from an interdisciplinary workshop on “Standardisation in the Nano-Field: For the Common Good?” (19 May 2017), which was also organised by the editors of this volume. Standardisation serves as one of the most important tools for channelling further development in nanotechnology. In doing so, it attracts particular scholarly attention. In this introductory chapter, we distil and further develop central arguments raised in these two academic discussion settings. Moreover, based on our explorations, we also formulate normative calls for rethinking current ethical, legal, and societal frameworks in order to strengthen reflexivity among stakeholders in the area of nanotechnology. We thereby seek to contribute timely insights for those actively involved in the governance of nanotechnology. The consideration of the ethical, legal, and social aspects (ELSA) of new and emerging technologies has gained increasing relevance since 1988, the year in which the director of the US Human Genome Project (HGP), James Watson, announced that work on the ethical and social implications of genomics should accompany the research of natural scientists. In the HGP, a specific funding programme was established which was dedicated to this kind of research. It received 3 to 5 percent of the annual HGP budget, with similar programmes following in other countries. In the context of the EU, ELSA was integrated into European research policy from the second Framework Programme onward (FP2, 1987–1991),1 starting with expert committees and research on bioethics and later turning into a more fundamental and integrated element of science and engineering research projects. Over the last fifteen years, both policy and academic discourse have shifted toward the concept of “responsibility,” which incorporates and further develops ELSA and other previous governance approaches, such as technology assessment, applied and engineering ethics, or stakeholder and public engagement. In contrast to ELSA, the responsibility framework is less restricted to mapping and assessing impacts. Rather, its interest lies in early collaboration and reflexivity among stakeholders in research and development processes. Nanotechnology is one of the first fields in which this shift took place (­Grunwald 2014; Shelley-Egan, Bowman, and Robinson 2017). The “responsible development” of nanotechnology has been on the policy agenda since the US 21st Century Nanotechnology Research and Development Act2 (2003) and the UK Royal Society and Royal Academy of Engineering report (RS-RAE 2004) made it a central objective alongside technological and

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economic achievements. Later, the concept of “Responsible Research and Innovation” (RRI) became a cross-cutting element in the EU’s Horizon 2020 framework programme (2014–2020). The focus on responsibility in all these cases conveys the commitment that research and innovation activities should not simply follow the objectives of scientific progress and economic profits, but also enhance human health and contribute to environmental and social sustainability (van den Hove et al. 2012). In our view, such an understanding of responsible research, innovation, and development needs to be established in an interdisciplinary framework in which regulation is evolving within an extensive research process, including an investigation of ethical and sociopolitical issues, and a broad societal debate. This introductory chapter provides not only an overview of current research but also attempts to interpret its background and to provoke further discussions. It starts with reflections on definitional attempts with respect to nanomaterials (section 1) and with suggestions on how to improve regulatory frameworks (section 2). Subsequently, we discuss ways in which societal perspectives can be integrated into governance processes and explain why self-reflection among researchers in ELSA and the RRI domain is necessary (section 3). Lastly, we develop a specific ethical framework for assessing nanomaterials (section 4) before giving a general overview of the structure and the chapters of this volume (section 5). Overall, we hope that this volume will provide concepts, ideas, and theories not only of value for the reassessment of nanotechnology, but more generally for rethinking the regulation and societal shaping of contested new technologies. 1. TOWARD DEFINING NANOMATERIALS The existing regulation of nanomaterials in Europe and in other parts of the world is neither comprehensive nor consistent (Eisenberger 2016). One of the most intricate issues is the very definition of “nanomaterials.” Throughout this volume, the well-established classifications of nanomaterials are applied. Yet, as a common denominator of the contributions, we identify the claim that current classifications of nanomaterials can be improved and shortcomings of existing regulatory instruments need to be addressed. In the Recommendation of the European Commission (EC 2011) a definition is proposed that focusses on the size of particles and the relative quantity of particles occurring in a specific material. The following wording has attracted broad attention: “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where,

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for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm–100 nm. (EC 2011)

The stipulated size range refers to the International Organization for Standardization’s (ISO) term “nanoscale,” which determines the range between 1 and 100 nm.3 Considering the relative quantity of 50 percent of the particles, the recommendation acknowledges that in specific cases, materials that do not exceed this threshold may also have certain undesirable properties for human or animal health or for the environment. Nevertheless, it is concluded that a pragmatic stance toward a conceptualisation of nanomaterials would support this condition while leaving open different assessments in specific cases. Based on a recent study of stakeholders’ opinions on the definition, the Institute for Health and Consumer Protection of the Joint Re-search Centre argues for a refinement (EC 2015b). The recommendation mainly concerns adjustments of the thresholds. Because of the aim to serve regulatory purposes, the institute’s findings indicate little support for deviating from the exclusive focus on size and quantity. Primarily, it is considered to expand the thresholds without accounting in more detail for the specific characteristics of the material. In more specific EU regulations of products that include material produced with nanotechnological procedures, a further condition is identified: In contrast to the mere occurrence of nanomaterials by coincidence, the intention to include these materials is seen as a necessary component. In this vein, the EU cosmetics regulation4 highlights the producer’s intent to apply the material. Furthermore, the regulation acknowledges some specific properties, such as bio-persistence, insolvability, and external dimensions. The EU regulation of novel foods5 defines engineered nanomaterials. Thus, it distinguishes these materials from natural particles. The formulation provides an account to determine nanomaterials by their characteristic properties, such as surface reactivity or chemical properties only applying to nano-sized particles (which differ significantly from those of the same material when occurring in nonnanoform). The EU’s biocidal regulation6 does not uphold the distinction between natural and manufactured materials. Still, the intention of applying a certain material in a biocidal product is seen as a necessary condition for the declaration of the product as including nanomaterial. Furthermore, the regulation sets the focus on activity of the materials and their external dimensions. For regulatory purposes, in general, two aspects of a definition of nanomaterials are added beyond size and quantity. First, the producers need to have the intention to include the material in the product. Second, certain characteristic properties of these materials, which deviate from the properties of the same material at a larger scale, are defined. Reflecting on a definition of nanomaterials, we would give some recommendations regarding which

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additional aspects ought to be taken into account. For ethical, legal, and societal considerations the definition needs to address not only technical concepts but also properties that enable a normative assessment of how to handle the development, application, production, and supply of nanomaterials. On the one hand, reactivity and relational toxicity need to be accounted for. Toxicity of nanomaterials is dependent on their surface reactivity, which depends on the core material, the coating compounds, its functionalisation, and the absorbing material. When released into other materials that do not support cohesion or produce toxicity in other ways, the release of nanomaterials may have undesirable effects. On the other hand, the fact that a product consists of certain nanocompounds is not as important for a normative assessment as the possibility that during its life cycle the product releases nanomaterial into the environment. Due to difficulties of re-detecting nanomaterials in the natural environment, the irreversibility of the act of release cannot be overstated. Some nanomaterials may contribute to significant changes in the biotic or the abiotic environment, particularly when becoming “agents” themselves (this concept will be outlined below). 2. REGULATORY INSTRUMENTS: BETWEEN LEGAL AND MARKET REGULATION By now, the regulatory debate has moved past the more general question of whether nanotechnology should be regulated to the question of how effective specific regulatory instruments are for dealing with specific nanomaterials (Bowman 2017; Eisenberger 2016). In the EU context, labelling of nanomaterials in specific product groups (cosmetics, food, biocides) has emerged as an important regulatory instrument. A label can have various purposes, such as providing consumer information, hazard prevention information, or risk management information. Even though limited in its scope, it enhances consumers’ decision procedures. The third function, risk management, became part of the European Union’s legal framework in the legislation on genetic engineering that has been adopted for nanotechnology. Applying labelling as an instrument implies that consumers have to decide individually whether they consider nanomaterials in certain products to be risky or not risky. Consumers thereby perform a task that is traditionally subject to the state and governing bodies. Without adequate information that allows for a rational and informed choice, such a shifting of responsibility onto the consumer is problematic. Assigning consumers with risk assessment and management competences is only fair in a context in which this assessment and management can actually be performed on sufficient epistemic grounds. At the moment, these

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grounds are not provided with the current practice of labelling (Shelley-Egan and Bowman 2015; Eisenberger 2016; Schwarz-Plaschg, chapter 10 in this volume). Although very important in the area of nanotechnology, law is just one means of regulating nanomaterials. The alternatives are mechanisms such as industrial codes of conduct or co-regulation between CSOs and the industry that yields voluntary reporting schemes. The co-regulation of the industry, as proposed in BASF’s “Code of Conduct” (2014, 2015), however, can also be seen critically because it tends to attach too much weight to the interests of industry and commerce. It might also end up shifting decision-making procedures to markets. Insurance companies provide an example in the United States. They represent a central actor, because, by insuring against adverse effects, firms (if they are held liable) may distribute the financial risk on numerous other developers. This clearly supports developments by lowering potential costs. However, insurance companies may also exclude certain technologies from coverage if they cannot properly estimate the risk at stake (Wilson 2006, 710). Therefore, the risk assessment of insurance companies has a great impact on the decision-making of developers. Academic engagement from a variety of disciplines (e.g., ethics, social sciences, legal studies) will be needed to address and critically discuss the impact of responsibility-shifting mechanisms on individuals and markets and their role in a democratic society facing more and more “risky” technologies. Regulating new technologies such as nanotechnology might need to move beyond legal and market regulation. Smart regulation combines scientific expertise with ethical, legal, and social science expertise, such as safer-bydesign concepts (Schwarz-Plaschg, Kallhoff, and Eisenberger 2017), deep ethical assessments (Kallhoff and Moser, chapter 2 in this volume), or experimental regulation (Eisenberger and Bereuter, chapter 8 in this volume). 3. INTEGRATING SOCIETAL PERSPECTIVES AND SELF-REFLECTION OF ELSA RESEARCHERS In recent years, we have witnessed a need to integrate the opinions and perspectives of citizens and civil society actors into the development and regulation of nanomaterials and nanoproducts. In particular, the assessment of environmental impact has gained importance. Policy makers feel increasingly obliged to foster nanotechnological innovation that potentially benefits society and the environment. In order to achieve these objectives, we need to assess the previous ways of integrating the voice of society into research and policy decision-making and offer suggestions on how to improve feedback mechanisms. Researchers exploring ELSA in nanotechnology have played an

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integral part in bringing actors from science, policy, and civil society closer together. We want to highlight that it is time to reflect on the past and future roles of ELSA researchers as well as to gauge the ways in which they may continue to shape the debate on nanotechnology and its assessments. A central concern addressed in this volume are the ascribed and actual roles of publics and CSOs in debates on possibilities, implications, and regulations of nanomaterials. Even though CSOs play an important role in representing the public, it is important not to equate CSOs with the general public. Authors in this volume hold the view that CSOs cannot represent civil society at large, nor should they be invited into co-regulatory processes only to accomplish societal acceptance. A representational model of CSO engagement is suspected to falsely assume that societal issues are either known or can be easily identified. In fact, these issues only appear when concrete choices have to be made (Krabbenborg and Mulder 2015). Arguably, the public voice is only raised when people are affected by a specific issue or a problematic situation. From such a perspective, controversy is not something to be avoided, but rather becomes a resource for social learning. In contrast to current public engagement initiatives at the EU level that are primarily focused on gaining acceptance for nanotechnological developments, this implies fostering critical debate instead of compliance. Regarding the involvement of the public, there exists a dilemma between the intention to include publics “upstream” (i.e., when, practically, there is still an opportunity to influence developments) and the problem that members of the public often find it difficult to relate new technologies to their everyday lives. In order to allow for early engagement, authors have proposed that designers and facilitators of engagement processes develop and use creative methods to stimulate imagination (Felt et al. 2014; Felt, Schumann, and Schwarz-Plaschg 2017). Furthermore, Coenen recommends addressing the political economy of techno-science, which includes the ways in which capitalism and techno-science are entangled (Coenen 2016). Although it appears to be important to inform publics about nanotechnology and to raise attention, such activities are sometimes based on problematic assumptions on public opinions and their emergence, such as imputations of a knowledge or opinion deficit, or even general technophobia in citizenry (Schwarz-Plaschg 2018a). Despite the “nano hype” in science and policy and concomitant attempts to make it a topic of broad public debate, nanotechnology remains a marginal issue in public discourse. Thus, the field of nanotechnology also provides a perfect case for a revision of the models and myths held among actors in the science policy field. Such a revision must account for the ways in which and the reasons why publics or counter-publics evolve around novel techno-scientific developments in specific cultural contexts. Because public attention is a scarce good in an age

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of information overload, many issues only come to public attention through catastrophic events or scandals rather than through orchestrated top-down efforts. In this vein, this volume deviates in some respects from a far too naïve model that either ELSA researchers, marketing of nanotechnologies, or government-sponsored public engagement can incite broader public attention for the issue or that they are even capable of producing public opinions in any predefined way. Nevertheless, beyond being mere observers, ELSA researchers can be reflexively aware of their agency in configuring the regulatory and societal debate around nanotechnology. For instance, they have played a central role in shaping the “deliberative turn” in nanotechnology governance, which has led to the growing involvement of public voices and CSOs. Understanding the role of ELSA researchers as the advocates and catalysts of policy allows deliberative experimentation. This focus also entails critical reflection on the so-called folk theories and narratives that are constructed and repeated in ELSA circles to influence policy actors in specific ways—for example, the analogy between genetically modified organisms (GMOs) and “nano” (Schwarz-Plaschg 2018b). Additionally, ELSA researchers need to critically reflect on and address their dependency on external funding (Coenen 2016). Thus, we also need to reimagine the conditions under which researchers can work continuously on topics and explore these in inter- and transdisciplinary settings, instead of moving from one field of research to the next. 4. AN ETHICAL FRAMEWORK FOR ASSESSING PRODUCTION AND RELEASE OF NANOMATERIALS Critical to the interpretation of nanomaterials and to the assessment of possible risks are not only empirical studies on how nanomaterials interact with the environment but also theoretical accounts of the conceptualisation of the status of nanomaterials. According to Bensaude-Vincent (2010, 2013), nano-objects raise the question of their ontological properties. In particular, nano-objects blur the boundary between nature and artefacts, life and inert matter, matter and mind (when embedded in smart materials), and structural and operational units. A promising approach to conceptually grasping nanomaterials is to look at them as “relational objects.” Nanoparticles cannot be conceived of as independent objects since they are blended in associated milieus: They exist in combination and interaction with materials of which they become an integral part (Bensaude-Vincent 2013, 316–317). As such, nanomaterials become “co-agents” and it is difficult to fully control their behaviour and to predict how they will develop in the future. Hence, we must learn to assess these new materials in relation to their respective environmental contexts during their life cycle.

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Thus, ethics should no longer exclusively stick to assessing consequences and effects in terms of “risks,” but rather be based on a new normative approach that focuses on concepts of coexistence and coevolution. This includes paying attention to the interactions of nanomaterials with the environment and with living beings (other than humans). This also demands empathy and respect for life, apart from human life, as well as an awareness of the essential services that natural ecosystems provide. Instead of relying on metaphors of domination, control, and risk prevention, such a reevaluation needs to include biocentric and eco-centric approaches (Kallhoff 2017b). An eco-centric approach pays tribute to the affordances of living and non-living beings in a shared world and interprets human life as one incident of evolution that proceeds in long-term phases and that for the sake of human life should pay tribute to the affordances resulting from natural integrity (Kallhoff 2017b). This ontological-ethical framework can be applied in three ways. First, the results of studies in the field of nano-(eco)-toxicology depend upon many variables, such as test equipment, particle coatings, or interactions with dispersants. Undoubtedly, these variables affect the outcome of tests. In other words, the way in which toxicity tests are designed has an influence on whether nanoparticles are labelled as either “toxic” or “non-toxic” (Wickson and Forsberg, chapter 3 in this volume). As a consequence, a critical exploration of current testing models and conditions—and tacit assumptions about what “toxicity” means—is needed. This is important because toxicological studies are central to informing risk regulation of the application of nanotechnologies. Moreover, we need to account for the relational nature of nanomaterials. They should be classified by their interaction with surrounding material and their behaviour in the environment and not simply by their size or their relative quantity (Bensaude-Vincent 2013). The effect of the release of nanoobjects on the environment ought to be evaluated in relation to their product life cycle (Filser, chapter 7 in this volume). Even though this is particularly demanding, a study of interactions with the natural environment is necessary in order to really understand toxicity and the trajectories of material in living surroundings. Second, new technologies are peculiar with regard to the significant increase in the pace of innovations. The dynamics of new technologies are rapid. In this respect, the slow adjustment of assessment processes has to be considered. In some specific scenarios and within constitutional boundaries, moratoria (e.g., European Environment Agency 2013) might also be considered as preliminary legal instruments to govern new and emerging technologies. Practically, this means restraining developments that could have negative effects on either the environment or human health in order to allow time for researchers to provide an in-depth assessment. At a minimum, the normative case of precaution should include that worst-case scenarios (e.g., McKee and Filser 2016) be taken seriously.

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Yet, it also should be noted that the hypothetical scenarios of extremely hazardous developments have played a central role in shaping the early public debate on nanotechnology. While the public debate, to some extent, has overstated possible threats, dystopian visions have triggered research on the potential negative effects of nanoparticles on human health, animal health, and the environment. Today, risk research is guided by a more balanced approach that neither praises nanotechnology as undisputedly good nor condemns it as profoundly bad. Instead, a fine-grained approach to a variety of ethical methods of assessment has to be developed (Kallhoff and Moser, chapter 2 in this volume). Nonetheless, scientifically inspired worst-case scenarios are still relevant for any assessment of nanomaterials. Third, it is also important to note that certain ideas, such as the conviction that technological developments are fully controllable or the hope that all major risks can be prevented, are not realistic with regard to new technologies. If we conceive of nanomaterials as agents, there is no full control. In contrast, we promote conceptions such as “precaution”, which are more open to a variety of possible outcomes. Some clarifications are needed in case of the latter. When the effect of a new substance on nature cannot be anticipated, it might seem reasonable to shift the “burden of proof” onto inventors, developers, or companies applying these new materials by holding them responsible to show that the product has no hazardous effect on human health, animals, or the environment. It is generally acknowledged that the so-called precautionary principle (PP) effectuates such a shift of the onus of proof (Martuzzi and Tickner 2005). The principle demands that with regard to potential risks, certain remedies should be taken to avoid them. In our opinion, it is reasonable to apply PP in situations where potential risks can (to some degree) be measured and anticipated. Yet there are also many reasons why this could be problematic in the case of nanomaterials. Given that nanotechnology is a risk technology and risk information is essentially lacking, shifting the burden of proof onto inventors, developers, or companies would equal a ban (Kallhoff and Moser, chapter 2 in this volume). Banning nanotechnology would, however, be a disproportionate interference with fundamental rights (for safer-by-design practices, see Kallhoff 2017a). Even if appropriate assessment tools were available, these assessment procedures would be very cost-intensive. High costs for assessment procedures favour big companies over start-ups and small and medium-sized enterprises (SMEs), but pushing start-ups and SMEs out of the nanotechnology market or other emerging technologies’ markets should in the end be a deliberate and democratic decision (for a similar argument with regard to gene editing, see Stelzer und Eisenberger 2019). Beyond legal and pragmatic arguments, ethical accounts have developed a range of procedures in order to anticipate not only risks, but also beneficial

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developments. In order not to overstate risk, authors engage in evaluative practices that support cooperation in favour of a shared vision of a natural good (Kallhoff 2017b). An alternative ethical principle that is also used to assess the eligibility of nanomaterial is the so-called beneficiary-first principle. It states that in order to be permitted, the application of a specific material should not only be anticipated to be beneficial, but should objectively be proven to be beneficial. But standards for the “goodness” of developments and materials should not be reduced to utilitarian or economic values. What should matter are the effects not only on human health and animal health, but also on the natural environment (i.e., the shared world of humans and other living beings). 5. CONTENT OF THIS VOLUME In this volume, we propose the mentioned normative recommendations as potential starting points for rethinking and reforming existing ethical, legal, and societal frameworks for assessing and governing nanomaterials. We consider them equally relevant for academics and other stakeholders such as regulators, policy makers, CSOs, and industry. The three parts of this edited volume provide a discussion of these issues from the viewpoints of various disciplinary and interdisciplinary approaches. The first part, titled “Evaluation and Standardisation,” is edited by Angela Kallhoff and Elias Moser. It encompasses four chapters that present and engage with evaluation and standardisation practices of ethical, legal, and economic backgrounds. In chapter 2, Angela Kallhoff and Elias Moser outline different ethical approaches of relevance for a normative assessment of nano-release. They elaborate on traditional risk assessment and the well-known notion of PP in order to demonstrate that these accounts need to be complemented to provide ethical guidance with regard to environmental influence of emerging technologies. They conclude that it is obligatory to engage in what they call an “eco-centric evaluation” of nano-release. In chapter 3, Fern Wickson and Ellen-Marie Forsberg draw attention to an implicit aspect of current discussions on RRI, which has a highly significant impact on scientific research, innovation, and policy—namely, the interstitial space of international standardisation. They argue 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 to prove successful in their aims. Chapter 4 explores the effects of patenting in nanotechnology on innovation and competition. Some of these effects may be seen as positive in terms of

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stimulating investments in innovation and also enabling interoperability and comparability. Yet, some effects run counter to the aims of protection and standardisation—namely, where “bottlenecks” are created for competition in downstream markets or when patenting leads to obstacles for follow-on innovation. Thomas Jaeger seeks to pinpoint the positive and negative effects of standardisation and patenting in the nanotech field and assesses tools for better balancing and avoiding overprotection. Chapter 5 focusses on standardisation. Henk de Vries’s contribution proposes voluntary standardisation as an instrument to mitigate risks while enabling innovation rather than hindering it. He describes the current efforts of developing international standards for terminology, measurements, health, safety and environment, and material specifications. Additionally, he discusses how legislation and standardisation can also be used in combination, thus avoiding the danger of legislation obstructing innovation. The second part of this volume, edited by Iris Eisenberger, focusses on “Norms and Regulation.” It assembles chapters that analyse and assess existing regulatory frameworks in different national contexts. In chapter 6, Diana Bowman and Lucille Tournas explore the question of who is in charge of regulating nanomaterials and adopt a more comprehensive account of thinking about regulation, drawing upon Black’s notion that regulation “produce[s] changes in behaviour” (Black 2001, 108). Bowman and Tournas argue that all sectors of society are currently “regulating” nanotechnologies, with insurance and reinsurance markets as well as consumers playing a significant regulatory role. They conclude that nanotechnology serves as a powerful illustration of how emerging technologies may be regulated in the future. In their opinion, the multifaceted regulatory framework captures the complexity of the technology. Juliane Filser, in her very critical examination, observes that, historically, risk assessment procedures have been developed for conventional chemicals and they do not account for the fact that nanoparticles (because of their size) behave and react differently in the natural environment. In chapter 7, she suggests that current regulatory practices for nanomaterials do not sufficiently protect the environment and that they significantly differ from one country to another. Furthermore, Filser argues that standardised guidelines for environmental hazard assessment underestimate the potential risks of engineered nanomaterials by not accounting for biotic interactions. In chapter 8, Iris Eisenberger and Franziska Bereuter analyse nanotechnology research as a phenomenon with dual-use potential—it can be used for good and for bad. The conflict between promises of beneficial innovation, on the one hand, and concerns about possible harmful consequences, on the other hand, makes nanotechnology research an object of regulation. Its twofold character, however, makes this difficult. Regulation of nanotechnology research needs to balance freedom of research with the right to life or physical integrity.

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Thus, fundamental rights both limit and oblige the legislator in the context of dual-use research. According to Eisenberger and Bereuter, regulation is best placed between law and science, where tools such as “safety by design” combine legal and scientific strategies. The contribution of Emad Yaghmaei, Andrea Porcari, Elivio Mantovani, and Steven Flipse describes and discusses a possible method to quantitatively assess the value of RRI strategies in innovation departments in the commercial industry. In chapter 9, they outline their experience within the EU-funded project PRISMA,7 which aims to help industries implement RRI strategies in their innovation processes as part of their corporate social responsibility (CSR) policy. Moreover, they attempt to provide evidence on how the RRI approach and its explicit attention to the gender dimension can improve the innovation process and its outcomes. The third and final part of the volume, titled “Politics and Publics,” is edited by Claudia Schwarz-Plaschg. It comprises contributions that investigate the role of political actors, institutions, publics, and civil society in the ongoing societal debate about nanomaterials. In chapter 10, Schwarz-Plaschg scrutinises whether nano-labelling and the concomitant shifting of decisionmaking responsibility onto consumers represents an adequate governance mechanism under uncertain epistemic conditions. In order to provide an answer, she explores the current state of nano-labelling regulation in Europe and contrasts this with members of the Austrian public’s ideal nano-labelling scenarios. Based on a detailed discourse analysis, she diagnoses that nanolabels are often not very meaningful and sometimes even produce a dilemma for consumer-citizens. To counter-steer such confusion, she calls for an epistemic transparency—in combination with the material transparency that a nano-label purports to provide—that openly communicates the limits of existing (scientific) knowledge and institutional processes for establishing certainty and safety with regard to the application of nanomaterials in consumer products. In chapter 11, Lotte Krabbenborg studies the important role of CSOs in the evaluation processes surrounding emerging technologies. She argues that two problems arise when CSOs are positioned as “voices of civil society.” First, these organisations do not always see themselves as representatives of civil society. Second, such positioning underestimates the socio-technical complexity involved when emerging technologies become a topic for deliberation and negotiation. Building upon the work of philosopher John Dewey, Krabbenborg shows that in order to attain the societal evaluation of emerging technologies, the challenge is not to involve more CSOs (even though they could play a valuable role), but rather how to investigate the indeterminate situations that arise, both on a small and large scale. Franz Seifert begins chapter 12 with the observation that there is general hype around nanotechnology, which not only promotes discourse and rhetorical hyperbole, but also carries substantial financial, scientific, and innovative

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influence. He provides some explanation for the structure of public discourse on nanotechnology and then explores the discussion on nanotechnology in EU technology policy from a critical viewpoint. Finally, he proposes certain lessons that we may learn from the nanotechnology field in terms of emerging technologies and their accompanying social science research. All contributions share the presumption that nanomaterials withstand a clear categorisation as being either beneficial or harmful. Existing research does not yet provide definitive evidence on their (eco)toxicological effects. Despite this ambiguity, we have witnessed a growing number of academic and political initiatives that establish norms and practices to govern emerging nanotechnologies over the last two decades. In bringing together approaches from ethics, ecology, economics, law, science, and technology studies, as well as other social and political sciences, we wish to combine these disciplinary perspectives to address existing challenges and provide a forward-looking normative frame that also offers space for public debate. We hope that the recommendations and the arguments developed in the individual chapters can stimulate further debate among ELSA and RRI scholars, nano-scientists, (eco)toxicologists, policy makers, regulators, industries, CSOs, and other stakeholders in the nano-field, and also inspire them to question widespread and well-established assumptions, definitions, and structures. NOTES 1. CORDIS, “FP2-Framework 2C—Framework Program for Community Activities in the Field of Research and Technological Development, 1987–1991,” available at https​://co​rdis.​europ​a.eu/​progr​amme/​rcn/2​4_en.​html.​ 2. Public Law 108–153, 21st Century Nanotechnology Research and Development Act (2003). 3. ISO 8000–1:2015, 2.1. 4. Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, 22 December 2009, O.J. (L342) 59–209 (2009). 5. Regulation (EU) 2015/2283 481 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No. 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No. 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No. 1852/2001, recital 10, 11 December 2015, O.J. (L327) 1–22 (2015). 6. Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, 27 June 2012, O.J. (L167) 1–123 (2012). 7. Piloting RRI in Industry: A Roadmap for tranSforMAtive Technologies, 2016– 2019. https​://co​rdis.​europ​a.eu/​proje​ct/rc​n/203​531/f​actsh​eet/e​n.

Part I

EVALUATION AND STANDARDISATION

Chapter 2

Ecocentric Evaluation of Nano-Release Risk, Precaution and Imagination Angela Kallhoff and Elias Moser

1. INTRODUCTION Nanotechnology is one of the most rapidly emerging new technologies of our time. Applications of nanotechnologies have contributed to the mass production of nanoparticles, which also entails an inevitable release into the natural environment. Neither the effects of nanoparticles in living beings nor the effects of the release of nanoparticles into the abiotic environment can be fully anticipated at present (cf. Filser, chapter 7 in this volume). Critical voices emphasise the incalculable risks of nanotechnologies. Nanoparticles differ significantly from other materials; some authors even speak of a new generation of chemicals (Bensaude-Vincent 2009, 610). Simultaneously, the expectations regarding the positive effects of nano-materials on the environment are high. Nanoparticles can be used to clean up water more effectively than former sewage treatment devices (e.g., Gangadharan et al. 2010; Hillie and Hlophe 2007; Jones 2007); in agriculture nano-materials may serve as highly effective carriers for nutrients and chemicals (e.g., Bradley, Castle, and Chaudhry 2011; Chaudhry and Castle 2011; Chun 2009; Fang and Bhandari 2010; Fathi, Mozafari, and Mohebbi 2012; Miller 2010); and nanomaterials have low weight, so that energy for transport—for example, in aviation—might be reduced significantly with the help of less weighty equipment and devices (Bundesamt für Umwelt 2010; Steinfeldt 2010; Greßler and Nentwich 2014). Even though the release and application of nano-materials in nature has divergent effects, it is not easy to tell whether the positive outweigh the negative outcomes. Instead, nano-ethics draws a far more complex picture. On the one hand, risk assessment is a multifaceted approach to a variety of problems. Moreover, the material qualities of nano-materials cannot be foreseen in 17

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detail. As chemicals, nanoparticles behave irregularly—their fate in the environment and their trajectories in natural environments are difficult to describe (Klaine et al. 2012; von der Kammer et al. 2012; Kah, Beulke, Tiede, and Hofmann 2013). On the other hand, the positive effects of nanoparticles cannot easily be assessed either. As always, much of the scenario-based foresight considering new emerging technologies is still a very opaque view into the future (Nordmann 2007; Nordmann and Rip 2009; Grunwald 2010; Lucivero, Swierstra, and Boenink 2011). In this chapter we elaborate on this particularly complex picture, focussing on the interface between “nano” and “nature.” We start with a distinct normative claim: In order to evaluate that interface in a fair and future-oriented way, it is obligatory to engage in what we call an “eco-centric evaluation” of nano-release. “Eco-centrism” is a broad term that covers a range of normative claims regarding the relation between human activities and nature. Its meaning will be outlined by investigating some of its facets. Nature is a web of interrelated living entities, which together build up ecosystems. An eco-centric evaluation makes a judgement about effects on nature that result from human activities (the anthropogenic effects) with respect to effects on the well-being of living beings and the integrity of ecosystems. Whether or not nature is endowed with value, and whether or not the well-being of living beings deserves respect, is part of an ongoing debate in environmental ethics (Jamieson 2001). Whereas many different proposals have been made in order to justify respect to nature, this chapter relies on a rather broad interpretation of these claims. Today, many authors in different camps agree that it is right not to destroy nature’s web arbitrarily and intentionally. Instead, nature should be protected from major harm, in particular when materials are released into nature whose effects cannot fully be anticipated. We proceed in four steps. In section 2 we give a brief review of current research on normative approaches to the effects of nanotechnology on nature. Several research projects have focussed on how nano-materials influence the natural environment and how nano-materials can be used in order to enhance functioning of biological systems and to increase well-being of living beings. Section 3 starts with an assessment of future scenarios. We elaborate on the traditional view that future scenarios need to be evaluated in the context of risk analysis. Also, we examine the so-called precautionary principle (PP), which is one of the most prominent principles in environmental ethics that provides reasons for avoiding risks. Furthermore, we argue that risk assessment is not a comprehensive answer to challenges posed by nanotechnology. In sections 4 and 5 we therefore discuss alternatives. In section 4 we explain a more comprehensive assessment of risk that has been developed in the context of social and environmental risk analysis. It takes the claim seriously that risk assessment needs to pay tribute to democratic procedures. In particular,

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we investigate how a concept of integrated risk analysis that has been put forward in the context of nuclear materials can be applied to nanotechnologies. In section 5 we attempt an assessment in the context of possible future socio-technological imaginaries—a concept developed by Paul Thompson (2011, 2017, 2018). 2. ETHICS AT THE INTERFACE OF NANO AND NATURE The development of nanotechnological applications to products has raised questions about ethical issues. The academic and public debate has primarily focussed on questions about the safety, responsibility, and overall desirability of recent developments (Ach 2006; Allhoff and Lin 2008). Recently, authors have claimed that the release of nanoparticles into the environment also needs an ethical investigation and that the application of nanotechnologies for environmental cleaning and for treatment of natural goods needs ethical debate (Hongladarom 2012; Myhr and Myskja 2011; Bruce 2006; Faunce 2012; Kulve et al. 2013). Yet research in these areas has only just started to develop. So far, three concerns have dominated the debate: issues of safety, societal effects of nanotechnology, and the PP. Concerning safety, questions have been raised about the responsibility of researchers (McGinn 2010) and methods for assessing expectations in the field of nano-development (Lucivero, Swierstra, and Boenink 2011). Nanoparticles behave in unusual ways: Toxicity is not positively correlated with mass, but instead more mass might contribute to less toxicity (Reimhult 2017). Due to the specific characteristics of nanoparticles, and due to the challenges resulting from research at the intersection of natural systems and technological options, it is argued that an evaluative assessment of research needs to go beyond classical schemes of evaluating new emerging technologies (e.g., Bruce 2006). It is an academic novelty to discuss whether or not responsibilities in the development of nanotechnologies differ from ethical toolboxes for researchers in comparable fields—for instance, in biotechnology (McGinn 2010). Nevertheless, an encompassing nano-specific ethics of safe release has not been elaborated yet. Three ethical issues have been identified so far. First, for societal effects, research on nanotechnology includes proposals for enhanced safety and proposals for risk assessment (Bachmann 2006, 76–91; Robison 2011). Second, there is a legitimate question of how a fair distribution of gains from nanotechnology can be achieved (Bachmann 2006, 92–101). The term “nano-divide” refers to an unwelcome scenario in which new nanotechnologies intensify the gulf between economically developed countries and countries that cannot invest in new technologies due to poverty

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and a poor economic performance. Third, the discussion about precautionary measures has distinguished two different approaches of technological development—either “Nano2Bio” or “Bio2Nano.” Both investigate an immediate effect of nano-materials on living entities. The former field of research addresses applications of nanotechnology in the life sciences, including approaches that attempt to manipulate biological systems by means of new technologies. The latter approach contributes to applications of nanotechnology in order to enhance certain properties of living beings (Bachmann 2006, 37–42). Even though both research areas raise important questions about possible risks, they focus entirely on organisms. So far, the core concern has been about interrelations of “nano-bio-technology” as a treatment of plants and living beings (Hongladarom 2012). However, among the most pressing issues in terms of environmental conservation is the effect on water and the soil. In general, the debate on a normative assessment of nano-release is still in its infancy. One reason for this unsatisfactory situation is that evaluation of the effects of the release of nanoparticles into the environment is almost entirely done in a risk assessment framework. Moreover, evaluation usually focusses on societal concerns, disregarding the natural environment and healthy living conditions. In the remainder of this chapter, we wish to challenge this limitation and argue in favour of an eco-centric evaluation of nano-release. We start with an interpretation of eco-centrism as a normative approach and then explore the dimensions of an eco-centric evaluation in more detail. 3. RISK ASSESSMENT Probably the most relevant aspect of an assessment of nano-release is the actual or potential risk it bears for living beings and future generations, but also for the environment. In this section we focus on three particular aspects of risk assessment of nano-release. First, we focus on the normative implications of risk in general. What sort of action does the instance of a certain risk give a reason for and why? Second, we will briefly outline different accounts of risk management and confront them with criticism. The elucidation of this rather traditional debate in technology assessment will help to clarify some of the pitfalls of reducing ethics of nanotechnology to mere risk assessment. We then turn to an analysis of the concept of PP as a specific sort of ethical principle for risk governance. We will outline the problem of a proper definition before we turn to more pluralist ethical accounts in section 4. In a highly abstract way, risk can be expressed as expectation value. The probability of a certain negative outcome is multiplied by its disvalue. Thus conceived, a risk is high if the negative consequence occurs with a high

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probability, or if the disvalue of the negative outcome is exceptionally high. Identified risks of nano-release can be put into three different categories (cf. Gammel 2007, 22): • scientifically proven hazardous effects • hypothetical effects • meta-risk mainly associated with the creation of artificial microorganisms Two dimensions of risk assessment need to be distinguished (Bachmann 2006, 68). First, there is the empirical task of identifying certain effects and estimating probabilities of certain outcomes in order to define a specific risk (e.g., Organisation for Economic Co-operation and Development [OECD] 2003). An example of this interpretation has already been given. Second, the ascription of “risk” in itself also includes a value statement about the state of affairs when the unwelcome scenario comes true. The evaluation of an outcome justifies normative judgements on how to handle the given risk (cf. Kermish 2012).1 It is the basis for argumentation about duties and permissions. The ethics of risk of nano-release, as we comprehend it here, are exclusively concerned with this second dimension. When drawing normative conclusions about risks of nanotechnologies, one needs to keep in mind that possible negative consequences of the development of a new technology and its industrial and commercial application are not intended. Developers, designers, companies, or regulators who are presumed to be responsible for a certain risk are only taking some probable negative consequences into account. They do not willingly bring about that state of affairs. Nevertheless, they are responsible for them. When talking about normative implications of risks, we therefore focus almost exclusively on negligence: risks are presumed to be a negative by-product of nano-release and not its intended consequence. While some authors exclude mere risk evaluation from ethics and locate it in (presumed) neutral technology assessment (Renn and Roco 2006b), we regard it as an ethical issue. However, evaluation of the development and application of nanotechnology products based on a risk assessment can be seen as nano-ethics in a narrower sense. Whereas a wider perspective of ethical issues involves issues such as principles of equity (the problem of “nano-divide”), autonomy (transhumanist scenarios of human enhancement through nanotechnology), and privacy and data protection (see Allhoff 2009), the main concern of risk assessment is with threats to health, security, and the environment. A risk is generally perceived to be a disvalue—something worthy of being avoided. However, taking a closer look at possible normative implications following from the incidence of risks presents a more intricate ethical picture.

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There is a reason to avoid a risk, which is grounded in a principle of nonmaleficence (Ebbeson, Andersen, and Besenbacher 2006), which states that in general no harm should be caused and, if possible, harm should be avoided. Many authors in nano-ethics rely on that principle as a basic pillar for the justification of normative evaluation.2 This principle justifies a prima facie duty to avoid risk. The term “prima facie” is used to describe obligations that hold as long as there are no contrary reasons outweighing them. Therefore, a duty to avoid risk does not include that it should categorically be avoided. To claim a categorical duty would not be defendable. Individual, social, and political actions inevitably imply certain risks. Thus, an obligation is generally included in the incidence of a risk, but it can be weighed against competing reasons. On the one hand, riskbenefit analysis consists of an assessment of reasons for and against a certain practice and can, therefore, provide overweighing reasons. On the other hand, there may be other values and principles besides the disvalue of the badness of an outcome—for example, basic rights and liberties of action—that may be more fundamental. So, the identification of a certain risk provides a reason for action or regulation. Nevertheless, it is not sufficient for the justification of a duty to avoid it. The ethical responsibility (besides the legal or political responsibility) to avoid risks of nano-release applies to scientists, designers, developers, and regulators. It is based on a moral duty not to negligently harm people, future generations, living beings, or the environment. In traditional risk management there are three different approaches to derive normative guidance based on the incidence of potential threats (Marchant, Sylvester, and Abbott 2008). First, the so-called acceptable risk approach defines a threshold beyond which humans, living beings, or the environment should not be exposed to potential harm. Considering nanotechnology, this account not only takes the evaluative stance on certain potential harm to be unacceptable, but it also lacks specific evidential basis for determining these thresholds. Second, if a certain risk is evaluated in the context of potential benefits, risk assessment is equivalent to risk-benefit analysis. Normative statements about proper risk handling on this account are mainly consequentialist— harms can be outweighed by gains. Similar to the acceptable risk approach, this account relies on data that is not available for nanotechnological applications (Marchant, Sylvester, and Abbott 2008, 44). Third, one account that avoids the problem of evidence is the best available technology account (Shapiro and McGarity 1991; cf. also Sunstein 1991). This account can also be justified on the basis of a strong precautionary principle (see further below). It basically states that for a certain risk, the current best technical means should be applied to avoid that risk. Considering the release of artificial nanoparticles, the account demands that they should

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be reduced to a minimum in order to avoid toxic interaction with humans, animals, and nature. This pragmatic account on handling threats is in some sense conservative. Without reference to evidence, it pleads for caution about emission of nanoparticles. There is a risk of overregulation. Also, in not providing reasons for the reduction of nano-release, it lacks a justificatory basis (Marchant, Sylvester, and Abbott 2008, 44–45). Besides their theoretical difficulties, the proposed accounts of traditional risk management all seem to provide normative guidance for an appropriate application and regulation of emerging technologies if there is a recognised threat or a potentially bad future outcome. However, they seem to presuppose sufficient knowledge about future scenarios. One central feature of the ethics of risk that is specific to considerations on emerging technologies is the fact that at an early stage of development, potential harm induced by the production and application of a new technology can only be anticipated.3 The lack of knowledge about potentially negative outcomes calls for a moral principle (to avoid risk) that is not exclusively action-based but also includes duties of ex ante acquisition of information about possible hazardous outcomes (Weckert and Moor 2006).4 Usually for a person, a group of people, a company, or an institution to be responsible for their actions implies that they know about possible negative side effects. This implication is called the knowledge condition of responsibility. However, this condition does not seem to hold when it comes to a proper allocation of moral responsibilities in nano-ethics (Robison 2011, 9). We therefore encounter a different sort of responsibility when it comes to new and emerging technologies, especially with nanotechnology. A candidate for an ethical imperative that does not suffer from the shortfalls of risk analysis as portrayed in this section is often seen in PP that traces back to the so-called Vorsorgeprinzip in German environmental law (O’Riordan, Jordan, and Cameron 2001, 11). We will briefly examine it and its application to nanotechnology below. The common basis that calls for precautionary remedies is the assumption of a threat induced by the development of a new technology and the uncertainty about the causal impact (cf., for example, Raffensperger and Tickner 1999, 1; Sandin 1999, 890–91; Gardiner 2006, 36). From this we can infer that a precautionary principle demands mandatory action—either omission of risks or regulation—justified only by the uncertainty about a potential threat. The fact that the threat is to some extent unknown implies that there is a duty to acquire knowledge. Arguably, this principle is very abstract and therefore in need of further refinement and explanation in order to be applicable for regulatory or policy advice (Bodansky 1991, 5). The academic discourse focusses on a proper definition of normative implications of PP. A distinction is commonly drawn between strong versions of PP and weak versions (Soule 2000; Foster, Vecchia, and Repacholi 2000). The former versions are

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endorsed (e.g., by the ETC Group [2005, 16]), whereas the latter are defended (e.g., by the Royal Society [2004] and SwissRe [2007]). Strong versions of PP demand that as long as a certain action—the development of a technology, its application, production, and distribution—involves a certain threat to health, security, or environment, it should be omitted or restricted. The burden of proof lies on those who promote the introduction of the technology. If there is a scenario of a bad outcome, it should be given more weight than possible positive effects of the technology. As long as the possibility of that bad outcome cannot be excluded, the technology should not be developed, or its development should be restricted. Weak versions state that an action—the development of a technology, its application, production, and distribution—is permitted as long as it cannot be scientifically proved that it causes a threat. Scenarios of bad outcomes can be assessed in relation to possible positive effects. The burden of proof lies on the shoulders of opponents to the new technology. One can immediately see that both of these versions of a precautionary principle are deficient. On the one hand, strong versions of PP are overly conservative or even “irrational” (Hourdequin 2007, 344). They seem to attach an unjustifiably high moral weight to a yet unknown bad outcome, while disregarding potentially good outcomes. Also, they set the threshold for the legitimacy of a certain technology too high. Empirically, the nonexistence of an object or an event—the nonexistence of a potential threat—cannot be proven. Thus construed, the principle seems to withhold legitimacy for all technologies. As we have outlined above, the incidence of a risk is not sufficient for inferring a duty to avoid it. This seems all the more true for risks which are unknown or yet unquantifiable. A strong version of the precautionary principle, therefore, cannot be endorsed. On the other hand, the weak versions do not represent an appropriate alternative to derive normative conclusions. Without attaching more weight to the potentially bad outcome of the development of a technology than to potentially good outcomes, the normative conclusions from the principle are congruent to those of riskbenefit assessment. Thus construed, the principle is “empty” (Hourdequin 2007, 344). Beyond mere risk-benefit analysis the principle does not demand any precaution. A meaningful version of PP, therefore, needs to be conceptualised as a “weaker” type of the strong formulation. Usually, the idea behind the principle can be expressed by the phrase “better safe than sorry.” From an ethical perspective this norm certainly has some appeal. The problem is that when it comes to precise formulations in order to derive normative conclusions for scientists, developers, designers, or regulators, PP does not seem to give guidance without further explanation of its meaning. First, it is unclear where to draw the line between justified and unjustified precaution. Second, the

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conceptual problem remains that the principle itself does not provide justification to “overweigh” unknown threats. However, with regard to the risks of nanotechnology, there needs to be an ethical principle that goes beyond the evaluation of costs and benefits and that states a case for precaution. When there is a possible threat, normative accounts on technology need to account for that, even if it is uncertain. As for the application to nano-release in the environment, the evaluation of the PP might follow different lines. If we assume the effects of nano-release on natural beings are—even though not fully known—probably particularly harmful, and if we further assume that there is no practical chance to ever recover nano-materials that have been released into the natural environment, the fact that effects are still unknown needs to be weighed against the gravity and the irreversibility of the effects on nature. We know that nanoparticles once released into nature might have negative and disturbing effects that also cannot be healed afterward. An eco-centric interpretation of the PP contributes to the view that “better safe than sorry” makes sense, even though an exclusive application of PP is not possible. In particular, “safe” does not necessarily relate to human health. In an eco-centric framework, the imperative to be safe includes a demand for respect for the safety and health of natural living beings. In order to develop the content of that principle, future scenarios are necessary for outlining what “safety” means. A risk assessment framework may be supplemented by a sort of eco-centric forecasting. We shall further discuss this in section 5. Nonetheless, it has to be assumed that traditional risk assessment and the PP are insufficient normative guidelines for addressing the ethical challenges of nano-release. Before elaborating an eco-centric framework for an assessment, we will examine an ethical account that attempts to combine a range of different evaluative standards related to moral issues of nanotechnology. 4. AN INTEGRATED NORMATIVE MODEL Recently, environmental ethicists highlighted the role of fair procedures in making decisions about environmental risk (Thompson 2011). They also considered the social role of risks and the broad variety of the meaning of risks to people living in various places. Even though we think that it is particularly important to get citizens involved in decisions on risky technologies, we also claim that this is only part of a much broader and deeper normative procedure. In particular, coping with risk is only one element, even though it is a particularly important one, in an evaluative practice that should also include a range of normative dimensions. As we have seen in the discussion on a traditional risk assessment framework, the above outlined accounts only

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have limited meaning with respect to ethical challenges of nanotechnology. One further point of criticism, however, has not been fully established: Risk assessment schemes have a tendency for consequentialist evaluation, and they tend to disregard so-called wider ethical aspects. The principle of non-maleficence, that is the basis for normative judgements about handling risks, is logically included in the utilitarian claim that overall beneficence should be promoted. Utilitarians consider risk in relation to possible positive effects of an event or action on happiness, well-being, or utility. However, to avoid maleficence does not necessarily include the promotion of overall well-being, utility, or happiness. In contrast to utilitarian theories, deontological theories claim that for some risks, there is a duty to avoid the risk which holds, regardless of positive outcomes which could be achieved by taking it. Furthermore, the disvalue of a risk’s potentially bad outcome does not have to entail the derogation of citizens’ utility (Kuzma and Besley 2008). It may also include an infringement of citizens’ rights or the causation of injustice. Therefore, risk assessment need not always be set in a utilitarian framework. Nevertheless, the principle has a consequentialist orientation. It evaluates actions on the basis of their outcomes. Deborah Oughton criticises risk assessment’s consequentialist foundation as too narrow to be applicable to the specific ethical dimensions in question. As one of only a few scholars in the field of environmental risks, she attempts to establish an encompassing approach to ethical issues of environmental protection (Oughton 2003), of taking appropriate measures to ensure health, safety, and sustainability (Oughton, Bay-Larsen, and Voigt 2009; Oughton 2013), and of restoration of contaminated areas (Oughton et al. 2004), with a focus on radioactive contamination. According to Oughton, a merely consequentialist perspective has some major deficiencies when it comes to a normative assessment on the causal impact of emerging technologies (Oughton 2003, 6). On the one hand, there is the conceptual problem that values cannot be empirically determined. Furthermore, there is the difficulty of weighing benefits or harms and of making them comparable, which could also be called the “problem of incommensurability” of different harms (Chang 1997): A potentially bad outcome may, for example, consist of a threat to health, or also a threat to social justice. When it comes to comparing these bad outcomes—both undesirable in their own right—it seems to be impossible to put them into a quantifiable relation. On the other hand, consequentialist risk assessment has what Oughton calls “intrinsic” deficiencies (Oughton 2003). The criticism can be made that assessments of future scenarios are mainly conceptualised on instrumental grounds. The question is in what way certain events or actions may negatively affect some predefined values, such as economic well-being, health, safety,

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etc. Oughton claims that some things are not merely instrumentally valuable (as a means to promote welfare or utility). There are other values that have a significance in their own right and that do not depend on other values. In philosophical jargon these independent values are called intrinsic values. Oughton’s account proposes an irreducible set of ethical ideas based on a range of different values. She identifies four distinct areas of ethical evaluation (Oughton, BayLarsen, and Voigt 2009, 439; cf. also Shrader-Frechette and Persson 1997). Relevant ethical issues include: • equitable distribution of cost and benefits • consent of affected individuals • involvement of affected individuals in decision-making • threats to the environment Since it helps to differentiate the ethical dimensions at stake with nano-release, we are confident that such an integrated approach is helpful when applied to the ethics of nanotechnology. While, according to Oughton, ethicists may not provide ultimate answers to entrepreneurial, political, or legal questions on what is right or wrong, they may inform about the ethical reasons behind normative convictions in the light of more fundamental principles (Oughton 2003, 9; Oughton et al. 2004, 77–78). The aforementioned ethical dimensions are presumed to represent the candidates for a (nonexclusive) list of the most important moral principles involved. As becomes evident when considering these ethical dimensions, strong emphasis is put on the attitudes of individuals toward the effects of certain practices or policies. When it comes to regulation of a certain practice, it is relevant how indirectly and directly affected people evaluate different options and outcomes. This concerns not only measures to avoid pollution of the environment but also remedies to cope with environmental pollution. The question is: Do people agree to the proposed political and legal solutions? Of specific importance is the consent of affected parties, which can only be obtained by involving them in the decision-making process. With regard to the resettlement of families living in contaminated areas adjacent to Chernobyl, for example, Oughton et al. (2004) ask whether people, if included in decision-making, would rather have stayed in these areas than leave their homes. An integrated approach accounts for this in promoting a broad inclusion of different parties and democratic ways of finding solutions. According to Oughton, special emphasis should also be put on intrinsic values of species, plants, animals, or entire biospheres and biodiversity (Oughton 2003, 9). In our common moral understanding, these things seem to have a value in their own right that does not depend on their usefulness

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for achieving other goals. Both consequentialist and deontological ethical theories provide support for the normative claim that the environment should not be damaged unnecessarily. The reasons for that support, however, differ greatly depending on basic assumptions about values. Whereas anthropocentric accounts plead for protection of the environment solely on an instrumental basis, bio-centric or eco-centric theories reason for protection of the environment based on the assumption of intrinsic values. For example, Oughton (2003, 9) addresses the question of ethical imperatives to protect the environment from ionising radiation. The duty to avoid contamination and to take remedies to reduce exposure of biotic and abiotic nature to radioactive material is defended on both anthropocentric and ecocentric grounds. She identifies the lowest common denominator of both accounts in the justifiability of obligations to protect certain populations of living organisms (animals and plants) and abiotic nature (soil, groundwater, etc.). In both accounts there are reasons for preservation. Whereas eco-centric approaches identify an intrinsic value in species and natural environments, anthropocentric theories also have legitimate grounds to claim that we should not endanger or destroy them (Oughton 2003, 12). The latter argue that there are essential human interests in preserving biospheres and landscapes. For example, a case for biodiversity can be defended with regard to a human interest to perform research on natural substances to use for economic applications. But most importantly, functioning biological systems in many cases are a precondition for human economic activity. As Oughton’s example shows, an integrated approach attempts to reconcile deviating ethical accounts in common principles. Considering ethical obligations to protect the environment from toxic nanoparticles an integrated approach could provide a promising account for a broad justification. In the following section we will attempt to flesh out this eco-centric dimension of moral judgements on nanotechnological developments. The idea is to frame certain convictions about the value of the environment in a theoretical conception of eco-centric evaluation. 5. ECO-CENTRIC EVALUATION OF FUTURE SCENARIOS Even though environmental ethics has recently gained momentum, its application to concrete scenarios is still insufficient. In this section we shall present some recently defended accounts that help to evaluate nano-release against the backdrop of environmental concern. Obviously, nanotechnology aims at generating nanoparticles, which in turn are ingredients in materials and products or are used as transport media. As a consequence, the particles are

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released into the environment. In sunscreen, in cosmetics, as ingredients in food (e.g., in tomato sauce), but also as integrated parts of surfaces and wall paint, nanoparticles are released into the environment. Sometimes nanoparticles are also intentionally used to change the behaviour of certain materials (e.g., they are used as catalysts in water treatment procedures) (Moon et al. 2013; Jiao et al. 2015). In order to assess the effects of nanoparticles on natural entities, much more would have to be known about their fate and their behaviour in natural surroundings. As already argued in section 3, an assessment of risks is particularly difficult in a situation in which studies exploring the trajectories of nanoparticles in nature are rare. Considering studies in the laboratory, the problem—to really observe the behaviour of particularly tiny materials— cannot be overstated. In addition, nano-materials might also be particularly helpful in supporting processes of environmental cleaning. Despite this two-sided picture, one lesson of environmental ethics needs to be taken seriously. Some authors now defend the view that a new era has begun. We live in times in which the “Anthropocene” is reality (Crutzen 2002). In other words, planet earth is in the midst of deep modification, including change of its basic geophysical mechanisms and systems. And according to widespread conviction, this process is irreversible. Therefore, humankind needs to react to it in a constructive manner in order to prevent really dreadful scenarios, perhaps even climate catastrophes and water shortages. We do not want to paint a particularly dark picture here. But it needs to be emphasised that eco-centrism is no longer a luxury of some environmental philosophers. It is a timely approach whose lesson needs to be learned. Instead of providing theoretical advice that focuses on “planet–people–profit,” it is time to develop a new order, changing the sequence to “planet–people–prospect.” As for the assessment of nano-release, this speaks in favour of strengthening precautions. It also speaks in favour of research on technologies that support environmental cleaning (e.g., exploring nano-materials as catalysts in sewing factories) and that work in favour of eco-efficiency, such as providing smart and lightweight materials. Yet the eco-centric assessment will apply not only to nano-release, but also to nanotechnologies as important technologies in the transformation of plant life and in the agricultural sector. One proposal to evaluate technologies at an early stage of development has been elaborated by Paul Thompson (Thompson 2018). His proposal is particularly helpful for the assessment of technologies in agriculture. In particular, he departs from a unilateral focus on risk. Instead, he regards emerging technologies (e.g., the genetic modification of organisms) as a form of progress that produces harm as well as benefits (Thompson 2011, 137–177). In addition, he discusses alternatives to the technologies—for instance, so-called organic breading (Thompson 2011, 178–198). Besides this fair

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balance, what really is new and of particular interest for an ethical assessment are his insights into the underlying normative assumptions behind choosing one specific technology instead of another. Overall, he rejects what he calls “naïve economic utilitarianism” (Thompson 2017, 5) as a normative framework for assessing benefits and harms accordingly. In contrast, he argues that real decisions about the choice of technologies are not the outcome of a rational calculus. According to his account, choices are guided by normative assumptions and what he calls an “ethos” of the groups of people who favour one technology over another (Thompson 2017, 4–5). This ethos provides the backdrop of the evaluation of technologies by groups of practitioners. In order to give a systematic overview of the choices that can be made in evaluating an emerging technology, Thompson correlates the deep embeddedness of the assessment of technologies in the ethos of practitioners with theoretical insights of philosophers of technology. In particular, he argues with Sheila Jasanoff about whether the future development of technologies can be crystallised along lines of “imaginaries” (Jasanoff and Kim 2015). In contrast to dreams about possible future lines of development, sociotechnical imaginaries are shaped by material and institutional conditions. An imaginary is a way to characterise how innovators and developers “envision the transformation of existing realities into a future shaped by the realisation of mere possibilities” (Thompson 2018, 187). For agricultural development, he offers four socio-technical imaginaries as competing visions (Thompson 2018, 187). Even though he focusses on agro-technologies, these four imaginaries can serve as paradigms for the imagination of future developments of technologies; in particular, they can provide a baseline for understanding the dreams and expectations of technicians that in the end guide collective decisions. The first socio-technical imaginary is named “technological modernisation” (Thompson 2018, 188). It envisions the future of a technology that is still in its infancy through processes of industrialisation that open the door to a consumer-oriented industry. Becoming a sector of the existing economy is a goal of modernisation. The second imaginary is termed “sustainable intensification” (Thompson 2018, 188–189). It is driven by one overarching value commitment concerning the agricultural sector: the commitment to “feed the world” and thus to increase production by means of efficient techniques of land use. Thompson argues that intensification is not possible without additional use of technologies such as genetic engineering. Yet the objective is to ameliorate the current procedures and not to replace agriculture as it is practised today. The third imaginary is called “extensification” (Thompson 2018, 189–190). This imaginary envisions alternative social institutions. In the food market, for example, institutions could be built and sustained that support food sovereignty. The fourth imaginary is “urban agriculture” (Thompson

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2018, 190). It places emphasis on the social relations surrounding a technology. In particular, it also relates to initiatives that wish to realise not only technological change, but also social change. At first glance, the proposal to adopt the technique of “socio-technological imaginaries” for the evaluation of nano-materials in an eco-centric framework might look far-fetched. However, a second look reveals some interesting possibilities for application. The assessment of new technologies is usually based on the notions of risk, precaution, and perhaps also shared values that are either supported by or put at risk through the invention and application of new technologies. Also, the calculation of costs and benefits might follow simple economic principles. However, this is only one aspect of the deliberative process and choices that people make. As for the agriculture sector, these choices include the opposition between a “productionist paradigm” (Thompson 2017, 66–92) and the opposite, which is the ideal of the “good farmer” in terms of “agricultural stewardship” (Thompson 2017, 93–112). Both relate to completely different visions not only of possible future developments, but also of goals that are worth pursuing. Whereas the productionist paradigm is basically oriented toward an ever more efficient economic performance, the ideal of stewardship takes responsibility not only for the urgent needs of human beings, but also for goals of sustainability. Certainly, to assess new technologies by scrutinising the underlying imaginaries and ethical commitments is not a particularly hard technique compared to the calculation of risks. It allows one to derive a bottom line, which is needed for real evaluation not only of benefit and harm, but also of the possible gains from a technology that should ultimately serve goals that are more important than goals of risk prevention or profit-seeking behaviour. In particular, this is also a technique that can be used to become aware of the underlying wishes and values that guide the further development of technologies. 6. CONCLUSION In this chapter, we have chosen a rarely discussed, yet ever more pressing perspective on nanotechnologies. We have highlighted several options to assess the effects of nano-materials in the context of natural environments. Even though it is obviously the first goal of regulators and a major function of public discourse to emphasise the dangers for human health, it is equally important to get a clear picture of the immediate and long-term effects of nano-materials on the natural environment. Some of the established techniques of risk assessment in the context of the ethics of risk can be applied to this specific concern. In section 3 we described ways to get a clearer picture of the existing risk management account for

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nano-materials. Risk assessment is difficult yet possible, but it includes theoretical assumptions about normative dimensions of the incidence of risks. We have argued that risk assessment rests on ethical decisions that need to be taken seriously. They not only include an estimation of the value of outcomes in scenarios with uncertainty, but also include a duty to be as well informed as possible. This proves not only important for regulators, but also for policy makers. In particular, the funding for research is one of the ways to live up to the duty to get informed. We have further argued that the limits of this approach must be considered. It is not helpful to put too much weight on an ethical procedure that has only limited applicability in a specific scenario. As a supplement to risk assessment, we have discussed one of the most important principles in environmental law, at least in Europe, which is the PP. Its normative demands include a severe shift of the burdens of proof: The principle favours a “better safe” perspective. Furthermore, it also needs to be complemented by a clear-cut assessment of the boundaries and meanings of safety. In particular, it needs to relate to an interpretation of goods in nature that can be argued to be eminently worthy for the human population. Before discussing this facet of eco-centrism, we provided an introductory interpretation of a model of “integrated value management,” as proposed by Oughton. Even though Oughton’s focus lies much more on dangerous nuclear materials, we think that lessons from her approach can also be learned regarding nano-release. She argues, among other things, that the final assessment of risks needs to be performed by persons who suffer from risks or from harmful incidents. Risk assessment has a subjective and a cultural side. And sometimes people are willing to take risks, even though it might seem irrational from an external perspective. In particular, a normative framework needs to integrate elements that have been described in theories of democracy. Our final section was dedicated to an evaluation of future scenarios in the context of an eco-centric assessment. Even though nobody is in a position to foresee the future, the framing of possible trajectories of developments by choosing and analysing various socio-technological imaginaries is helpful. In particular, this account suggests that the shaping of our institutional and material surroundings is not a matter of necessity, nor is it just something that happens. Instead, groups of people and decision makers choose future developments by means of shared value commitments. It is helpful to be aware of these commitments. Thompson’s proposals to distinguish various paradigmatic imaginaries is just a beginning for an evaluative enterprise that is also needed for nanotechnologies. In times of ecological crisis, the future of our planet is at stake. Even though nobody knows what impact nanotechnologies will finally have in supporting environmental cleaning and enhancing

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eco-efficiency, highlighting these goals in an imaginary of guardianship is the first important step. Overall, in this chapter we have pursued two major objectives. First, we wish to highlight the need for an eco-centric debate when it comes to ethical principles concerning the application of new emerging technologies. “Nature first” is a normative demand to be taken seriously in this context. Second, we think that regulators as well as public discourse need to be informed by ethics. In particular, ethics need to apply a rich diversity of practices of evaluation to concrete scenarios in order to support regulators in developing fair and helpful normative guidelines. NOTES 1. The distinction between the empirical side of risk assessment and the normative conclusions that derive from it are often described as the division between “risk assessment” and “risk management” (cf. Jahnel 2015a, 2015b). 2. Scholars in the field of nano-ethics sometimes refer to parallels in the ethics of biotechnology and the crucial ethical framework provided by Beauchamp and Childress (2001) and Kemp and Rendtorff (2000) (e.g., Ebbesen et al. 2006, 453). 3. The problem of knowledge about potentially bad outcomes becomes more apparent given the so-called Collingridge dilemma: The later the stage of development of a new technology, the more knowledge that exists about potentially negative impacts. Also, however, the later the stage of development, the fewer the measures that can be taken to alter production procedures or designs in order to avoid negative impacts (Collingridge 1980). 4. For simplicity, by “lack of knowledge” we refer to both the “ignorance” of possible outcomes and the “uncertainty” about the probability that certain outcomes will occur (cf. European Environment Agency 2001, 170).

Chapter 3

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

1. 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 Development [WCED] 1987; Beder 1996). This overarching concept was to influence technological advances, shape socioeconomic structures, and guide political decision-making toward a brighter future. At the turn of the new millennium, however, as the interpretive flexibility of this concept and its operationalisation became increasingly apparent (e.g., see Giddings, Hopwood, and O’Brien 2002; Hopwood, Mellor, and O’Brien 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 (EC) 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  Reprinted with permission from Fern Wickson and Ellen-Marie Forsberg, “Standardizing Responsibility? The Significance of Interstitial Spaces,” Science and Engineering Ethics 22, no. 5 (2015): 1159–1180.

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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 harmonisation (Jacob and van den Hoeven 2013; Stilgoe, Owen, and Macnaghten 2013). Indeed, a new international effort to consolidate RRI definitions, approaches, and best practices has now begun with the establishment of the Virtual Institute for Responsible Innovation (VIRI).1 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 chapter 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 intermediary space of international standardisation, we will specifically present examples of how international standards are entangled in the development of RRI, yet the process of international standardisation and its dominant organisations largely fail to embody the norms proposed as characterising 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 of responsible innovation. New governance mechanisms are necessary as the existence of a master narrative in which innovation is inherently desirable and indispensable for solving societal ills (Felt and Wynne 2007), as arguably represented in the Europe 2020 strategy and its vision of an “Innovation Union” (see EC 2013b), collides with a “risk society” (Beck 1986) in which there exists a high level of awareness and sensitivity to the fact that technologies also come with downsides and the potential for unintended negative consequences. For nanoscale sciences and technologies, the desire to have innovation and its commercialisation 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

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improved risk identification and management (DuPont and Environmental Defense 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 a 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 standardisation, have tended to fall between the cracks. International standards play a significant role in shaping: (a) scientific research (e.g., by defining agreed-upon 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 and van den Hoeven 2013), to date no significant attention has been paid to the process of standardisation 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 standardisation 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 chapter, our contribution is targeted toward understanding the emerging notion of RRI, specifically to understanding how it is operating within the context of standardisation. 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 characteristic principles of RRI apply to the processes and practices of standardisation as they influence the innovation process. This arguably represents a novel perspective and focus, both within the RRI discourse and the standardisation discourse. In this chapter, 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.

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This then leads to 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 standardisation. Finally, in querying why the practise 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 sociotechnical nature. We then conclude by outlining some of the areas at this intersection between RRI and standardisation that we think deserve further attention and research in the future. The aim of this chapter is therefore not to answer a specific and predefined 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 the intermediary space of standardisation is essential if a truly responsible approach to research and innovation is to be advanced. 2. RESPONSIBLE INNOVATION The concept of Responsible Innovation (RI) or Responsible Research and Innovation (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, Owen, and Macnaghten (2013) as observable through the development of practices such as technology assessment in its various forms (e.g., see Rip, Misa, and Schot 1995; Guston and Sarewitz 2002); the increasing institutionalisation of upstream public engagement (Wilsdon and Willis 2004; Delgado, Kjølberg, and Wickson 2011); the embedding of research on ethical, legal, and social aspects (ELSA) into large technology development initiatives (Zwart and Nelis 2009; Stegmaier 2009); and the enhanced use of ethical or socio-technical integration in laboratories (van der Burg and Swierstra 2013) and midstream modulation (Schuurbiers and Fisher 2009; Fisher, M ­ ahajan, and Mitcham 2006). Despite a sense that RRI is an amalgamation or a culmination of all of these efforts in recent decades, a universally accepted definition of RRI has yet to fully sediment. Various actors and initiatives

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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 EC, has chosen to define RRI as follows (von Schomberg 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) who 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, have defined it with colleagues from the United States (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 EC released a kind of position statement titled “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 emphasised, 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 EC released its report on “Options for Strengthening Responsible Research and Innovation” (Jacob and van den Hoeven 2013). This group was chaired by Dutch moral philosopher Jeroen van den Hoven and had Linda Nielsen, Francoise Roure,

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Laima Rudze, and Jack Stilgoe as members; Knut Blind, Anna-Lena Guske, and Carlos Martinez Riera as contributors; and Klaus Jacob as rapporteur. The definition this expert group provided is as follows: 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 these definitions differ in the terminology they use, the orientation they adopt, the depth of description they provide, and the placement of their emphasis, the characteristics they share can be identified as central to the emerging concept of RRI, including: 1. a specific focus on addressing significant societal needs and challenges; 2. a research and development process that actively engages and responds to a range of stakeholders; 3. a concerted effort to anticipate potential problems, identify alternatives, and reflect on underlying values; and 4. 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 toward 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 (NST). 3. RESPONSIBLE INNOVATION AND NANOSCALE SCIENCES AND TECHNOLOGIES The language of responsibility is threaded throughout European policy documents on NST. From its first communication, “Towards a European Strategy for Nanotechnology” (EC 2004b), the EC emphasised the importance of nanotechnology developing in a “responsible” manner, which was described

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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 2004b). This sentiment was echoed and strengthened through the “Action Plan” that followed, in which the overarching strategy for nanotechnology was characterised as safe, integrated, and responsible (EC 2004a). 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 accountability (EC 2008c). While the support for and uptake of this specific code of conduct has certainly varied among 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 the one developed 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. In 2006 the Organisation for Economic Cooperation and Development (OECD) developed a working party on manufactured nanomaterials that was focused on developing international cooperation and harmonisation on human health and environmental safety testing. It then established a broader working party on nanotechnology in 2007, with the explicit intent to provide “advice upon emerging policy issues of science, technology and innovation related to the responsible development of nanotechnology” (OECD 2008). The International Organization for Standardization (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

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good practices in their production, use, and disposal (ISO/TC 2012). In 2004 CEN also established a technical committee on nanotechnologies (TC 352), which has expressed a specific commitment to liaising 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 called “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 present a more detailed discussion of this initiative later in the chapter. 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 within these international bodies also have significant capacity to influence science, technology, and innovation, in more or less responsible directions. 4. INTERNATIONAL STANDARDS In a recent work, Lawrence Busch referred to standards as forming our “recipes for reality” (Busch 2011), 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 chapter we focus on international standards being developed by bodies like the OECD, the ISO, and CEN that have the capacity to shape, influence, and impact research and innovation. We will concentrate on processes occurring in organisations dedicated to standardisation, 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

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can often be assumed that standards developed for scientific research and/ or technology development have been primarily agreed upon on the basis of scientific criteria alone, it is important to understand that social, economic, and political factors will almost always play an equally influential role in the negotiation process. Furthermore, as Busch (2011) notes, standards are not only technical but are 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 2012), and while it is 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 developing shared technical specifications to enable internationally interlinked innovation, production, and distribution chains, international standardisation 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 work not only to shape innovation and research but also to become crucial factors influencing regulation and legislation. Within ISO TC 229’s “Business Plan” (ISO/TC 2012), it has been argued that international standardisation 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 characterise nanoscale materials and devices • developing protocols for bio- and ecotoxicity testing • developing protocols for whole life cycle assessment of nanoscale materials, devices, and products

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• 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 harmonisation but also for understanding and regulating impacts on human health and environmental safety (practices that then inter alia influence innovation). The practice of developing international standards, despite their scope for significant influence, has typically remained black-boxed and backgrounded in the emerging discourse of responsible research and innovation. 5. STANDARDS AND RESPONSIBLE RESEARCH AND INNOVATION: PRODUCTS AND PROCESS International standards have been presented as a possible device through which RRI may be articulated and facilitated in a harmonised manner (e.g., see Jacob and van den Hoeven 2013). In the European context, it has been proposed that this could first be pursued through an initial initiative within CEN that could then later be translated into ISO (Jacob and van den Hoeven 2013). As indicated above, in the field of nanoscale sciences and technologies, such an initiative has in fact already begun with the new work item “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 socioeconomic and political dimensions of science and technology to bear on the process. We have also specifically explored the possibility of bringing this initiative into a closer dialogue with the emerging ideas of RRI in academic literature.

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Although the work on this new work item remains ongoing, in the spirit of the exploratory agenda-setting nature of this chapter, 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 of the French National Organisation for Standardisation (AFNOR, Fr: Association Française de Normalisation), 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 nanoproducts 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 2012). 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 2012). Following an open call for the nomination of expert delegates to this initiative, in February 2012 twenty-nine 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 organisation AFNOR (2), the EC (1), consultancy firms (1), a consumer organisation (1), and an unknown affiliation (1). At the time of this writing, five meetings had been held in the working group, through which the themes and topics of discussion listed in table 3.1 had emerged and been pursued.

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Table 3.1  Themes and topics of discussion Theme

Topics of Discussion

Scope and aims

• the appropriate target audience for the technical specification (TS) • the relevant terminology and definitions for nanomaterials and -objects • whether natural, incidental, and engineered nanomaterials were all included within the scope • whether materials in use for many years but newly labelled nanotechnology would fall within the scope • whether the TS aims toward 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 time frame from three to five years) • whether the role of participants was primarily envisaged as one of co-producers of the TS or only a group providing critical feedback • the importance of developing a transparent standardisation 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 costbenefit analysis • the relationship to the Responsible NanoCode (providing guidance on process) and the Nanokommission (guidance on risk-benefit assessment) • the relationship to the EC Code of Conduct for Responsible Research in Nanoscience and Nanotechnology, and the Responsible Care initiative of the chemical industry (Continued)

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Table 3.1  (Continued) Theme Meaning and operationalisation of terms

Topics of Discussion • 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 gono-go options • the relevant timescale for assessments

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 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 recognised that handling uncertainties would be an important component of any integrated risk-benefit assessment, upon facing 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, Gillund, and Myhr 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 suggestions from one of the institutional actors involved in that work who 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

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on responsible development as presented at the start of this chapter, 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? (What kinds of companies along the value chain are relevant? Does the size of the company matter? Are commercial companies the only relevant actors?) What counts as nano? (Are incidental nanoparticles in a product sufficient to bring it into the scope? Are well-­established products recently relabelled as nano part of the scope?) Should the guidelines lead to a publicly transparent accreditation system or not? None of these issues are solely technical in nature, nor is there any requirement for 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 be “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 2012), 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 broad range of stakeholders that the norms of RRI seem to require. 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 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 gatekeeping function that allows both innovators and regulators to decide what can be commercialised. 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

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technologies is being conducted within the OECD, ISO, and more recently, in a 7th Framework Programme (FP7) large-scale coordinating project called NANoREG (a large coordinating project with over sixty partners from sixteen 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 realise 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 2000, 5–6). When the ethical dimension of such choices is recognised, 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 standardisation 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 have 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 organisations. Like the World Trade Organisation (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-labelling, water privatisation, 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.2

6. RESPONSIBILITY AND LEGITIMACY IN THE PROCESS OF STANDARDISATION The EC states in its new approach to regulation (see, for example, EC 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 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 or the validity of the specific process used to generate them (Forsberg 2012, 725). Rather, such standards seem to possess

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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, 1) defines legitimacy as “the aspect of governance that validates institutional decisions as emanating from right process.” Van den Berghe adds, “In secularised, 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” (van den Berghe 1999, 6). Without possessing the authority of elected representatives, organisations like the CEN, ISO, and OECD often argue for the legitimacy of their process by emphasising 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 standardisation 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) performed a similar analysis of the legitimacy of TC 229 and compared it with the OECD working party on manufactured nanomaterials. Both studies draw attention to the significant problem of limited participation and transparency in standardisation 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 standardisation processes requires significant resources. This includes the time necessary to keep up with a constant stream of draft documents and technical discussions, not to mention attending 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 six to ten 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 standardisation 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 organisations 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 standardisation processes therefore tend to come from industry (with the possible exception of the OECD, within

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which negotiations are more typically dominated by governmental representatives). In the nanotechnology field, Forsberg (2011) and Kica and Bowman (2012) both point to low participation of stakeholders such as NGOs and consumer organisations in the standardisation process. This has been echoed by Blind and Gauch (2009), who report problems with recruiting nonindustrial researchers to nanotechnology standardisation in Germany (and, indirectly, also to ISO). Werle and Iversen (2006) and Jakobs (2006) report similar problems in ICT standardisation, indicating that this is not a problem specific to TC 229, but rather a structural problem connected to ISO. A further open question relates to the impact that individuals representing such organisations have on the discussions and decisions in the process. In addition to participation, transparency has also been identified by ­Forsberg (2011) 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 standardisation scholars have pointed out (Jakobs 2010; Lee 2009), standardisation is as much about negotiation as about rational discussion; however, the content of the actual negotiations is 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 standardisation negotiations, access to information about who the participants are, their backgrounds and affiliations, and the content of discussions and points of contention is near impossible to attain. Scientific robustness is affected by the constitution of 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 toward industryoriented researchers, to the potential exclusion of a wider range of scientific perspectives. Or as highlighted by Kica and Bowman (2012), 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 (without an option to abstain) even if there is a lack of expertise to evaluate the content. Scientific robustness therefore cannot be assumed even if a standard is produced by these well-recognised 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 given the authority to set standards for health, safety, and environmental testing despite extensive scientific uncertainty and widespread ambiguity in the available knowledge base. The tendency for such a select group of interested

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actors to then also circulate among the different bodies and spaces involved in science/technology/policy development and standardisation (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 is hard fought and won over 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 standardisation 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 toward 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 appear to be no systematic frameworks to anticipate potential problems, anticipate alternatives, or reflect on underlying values within these standardisation 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 use 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, as well as New Work Item proposals (work that one of the current authors has been involved in), it has not yet been implemented in the technical committee. Finally, some stakeholders claim that even if they participate in the standardisation process, they have little impact on the results of standardisation (Forsberg 2010, 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 26000 appears to be the standardisation 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 standardisation processes, it may be seen as a standard that is typically directed outward toward other organisations and businesses rather than reflexively applied back onto standard organisations themselves.

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The procedural challenges to legitimacy, participation, transparency, scientific robustness, and responsiveness in processes of international standardisation indicate that if research and innovation really are to be “responsible” (as this is coming to be defined within the European policy discourse on RRI), these important components of the innovation system also need to be actively engaged and mobilised. Creating responsible standardisation 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 standardised 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 make it necessary to have a broad-based and inclusive process, capable of anticipating potential futures, imagining alternatives, and reflecting on underlying 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 mobilise RRI characteristics in the to-date neglected interstitial spaces. 7. 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 standardisation 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 to 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

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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 the way 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 do a better job of taking into account innovation systems in all their complexity. Focusing only on specific categories of actors, such as research funders, industrial innovators, citizens, and legislators/regulators (e.g., see Jacob and van den Hoeven 2013), fails to acknowledge and account for the kinds of interstitial space that standardisation represents. Standardisation can be thought of as a kind of interstitial space because it effectively occupies a location somewhere between what are currently recognised as key domains (e.g., those of science, policy, civil society, and industry). At the same time, however, standardisation 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 are currently identified as apparently separate core spheres of action, but which effectively function 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 what we wish to describe as an interstitial space. 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 recognise 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 seek 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 processbased 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 to the types of interstitial spaces that standardisation arguably represents, there appears to be potential value for the emerging RRI discourse to more fully integrate work and scholars from innovation studies (Zwart, Landeweerd, and Rooij 2014) and to specifically draw on and

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relate to the corpus of existing work on system-oriented innovation research, with its concepts such as sectoral (Malerba 2005) 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 the path 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 standardisation to more clearly come to the fore. Further research should therefore be directed toward 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 way that is too generic. 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 toward different types of technologies, sectors, and/or applications. Third, such systems-based approaches to innovation highlight the complex relationships between institutions and their members. Malerba (2005) points out that in some systems, individual innovators may be the most crucial agents, while in others, the institutional level will be more important. In the case of standardisation of nanoscale sciences and technologies, the working procedures and informal processes in the organisations (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). From a practical perspective in this case, then, this means that if one wants to induce change, one needs to target standardisation principles and practices both at the ISO level and at the TC level, as well as working with the individuals engaged in the institutions.

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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 standardisation. Furthermore, comparative studies looking across the institutional actors, practices, and cultures of different standardisation organisations (e.g., the ISO vs. CEN vs. OECD) and/ or the work of different national delegations involved in such organisations would be useful. 8. 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 standardising 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 standardisation itself and have received little commentary from standardisation scholars to date. The backgrounded interstitial political space of international standardisation 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 standardisation 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 chapter have a scholarly interest in the emerging notion of RRI and have directly taken part in standardisation activities, actively seeking to influence these activities in the direction of enhanced RRI. This chapter is a kind of meta-reflection on such work. We have explicitly adopted the perspective of RRI to observe, analyse, and engage in standardisation practices. Our main intention in this chapter has been to raise awareness of standardisation as an important interstitial space between research, innovation, and policy; to explore the interface between RRI and international standardisation 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. In this chapter 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

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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 toward 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 standardisation representing, RRI seems destined to constitute little more than window dressing used to sell business as usual. NOTES 1. See the Virtual Institute for Responsible Innovation website at http://cns.asu. edu/viri. 2. International NGO Network on ISO, “Why ISO?” Available at http://www2. pacinst.org/inni/index.htm.

Chapter 4

Standardisation and Patenting in Nanotechnology Better Balancing for a Necessary Nuisance Thomas Jaeger

1. STANDARDS AND NANOTECHNOLOGY Most problems in life can be approached and solved in different ways: Glasses of different shapes all contain water, vehicles with different types of motors and combustion all move forward, wall sockets in different regions of the world all provide electricity, regardless of their very different looks. However, unless the sockets in one geographical area all have the same shape, it will not be possible to plug all electrical devices into them. Therefore, in spite of the availability of a range of possible ways to approach the technical problem, some uniformity is necessary in order to ensure interoperability. Standards bring about that uniformity. A technical standard is a norm that establishes one technical solution from among a range of possible technical solutions as the single relevant method for engineering a product, a component, or a process. The use of standards by market actors is usually voluntary. It may become compulsory where statutory law so declares (e.g., for safety or health concerns). In particular, the designation of a single uniform technical solution ensures interoperability, matching, and comparability of items, components, and performances. Standardisation interoperability and matching also carries a number of unintended but positive consequences. For example, it helps with harmonising the language, definitions, and units of measurement, as well as the means for conducting measurements. It also aids in the harmonisation of instrument or product performance (e.g., quality, safety, etc.), unification of reference materials (e.g., nationally used physical units), and the creation

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of benchmarks for products and services (i.e., creating recognisable standards for industry and consumers [Appl 2012, 48]). Standards may simply evolve de facto. This is the case when a given technical solution dominates the market (Hilty and Slowinski 2015, 783). Examples of de facto standards are the internet protocol HTML (developed by the WorldWideWeb Consortium), MS Windows (by Microsoft Corp.), or, in the analogue world, common screw-cap barrels (by the German Verband der Chemischen Industrie). However, most standards develop through specific standard-setting organisations (usually composed of private and public stakeholders). Famous examples of such organisations are, in particular, the International Organization for Standardization (ISO), the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC), the European Telecommunications Standards Institute (ETSI), and the Institute for Reference Materials and Measurements (IRMM). It is important to point out that standards change with production cycles and not with innovation cycles. Therefore, standards need not necessarily incorporate the best or newest technical solution available at a given point in time. Yet they inform the public of the most commonly used state of the art. The field of nanotechnology also utilises standard-setting. The ISO and CEN have both established specialised committees on nanotechnologies (ISO Technical Committee no. 229, CEN Technical Committee no. 352). At the time this chapter was written in late 2017, 55 standards elaborated by ISO’s nanotech committee alone had been published and 229 more were under development. Nanotech standards were developed in regard to a variety of tests. For example, nanotech standards were necessary in testing the mesoscopic shape factors of multiwall carbon nanotubes, the characteristics and measurement of nanoscale titanium dioxide in powder form, and the characteristics and measurement of nanoscale calcium carbonate in powder form. Standards were also created through the endotoxin test on nanomaterial samples for in vitro systems, the compilation and description of toxicological screening methods for manufactured nanomaterials, the development of representative test materials consisting of nano-objects in dry powder form, and the surface characterisation of gold nanoparticles for nanomaterial specific toxicity screening (FT-IR method).1 2. PATENTS AND NANOTECHNOLOGY Intellectual property rights (IPRs), particularly patenting, are of equal significance for nanotechnology as standards. Patents are granted for inventions in all fields of technology on the precondition (so-called requirements for

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protection) that they are new, involve an inventive step, and are capable of industrial application.2 The term “invention” refers to solutions (teachings) for previously unsolved technical problems. Mere discoveries, scientific theories, mathematical or mental practices, or aesthetic creations and the like are thus not inventions in the sense of patent law, unless they incorporate a technical component (e.g., extraction of biological material from a plant by technical means) (Gupta 2014, 1023). 2.1 Top-Down and Bottom-Up Nanotech Inventions To date, nanotechnology has two main applications: From a top-down approach, structures can be made smaller and smaller until they reach nanometric scale. The majority of known uses today lie here (e.g., in electronics). Yet there is also a bottom-up approach where elements at nanoscale are chosen and assembled to form a new material or mechanism. A lot of dynamic research is conducted in this area, but there are not many actual applications yet. Nanotech patent applications (IPC-Class B82) at the European (EPO) and US (USPTO) patent offices, respectively, rose from 7 (7) in 1990 to 59 (103) in 2000 to 159 (1,833) in 2010 (Sabellek 2014, 26).3 However, some claim that existing nanotech patents do not sufficiently emphasise the innovation occurring in the field because nanotechnology is difficult to copy (e.g., by reverse engineering) and, thus, much of it is being kept secret (Zekos 2006a, 316). Universities are the predominant holders of existing nanotech patents (Allison et al. 2004, 465). Examples (Igami and Okazaki 2007, 20) of potentially patentable nanotech uses come, for instance, from the field of health technology, where diagnostic tools penetrating (and remaining in) cells or therapeutic micro-tools directly treating ill cells from the inside are under development (Schellekens and Vantsiouri 2013, 190). They also come from electronics, where development of powerful miniaturised electronic components seems possible. Likewise, in material engineering, more robust, lighter, and thinner materials (e.g., for aircraft and space technology, construction, or clothing) might be developed with nanotechnology. In the area of environmental protection and energy generation, to state a final example, more efficient and powerful use of alternative energy sources (e.g., solar energy panels) might rely on nanotech inventions (RS-RAE 2004, viii). 2.2 Challenges to Nanotech Patentability Patentability problems for nanotech developments arise on three levels (for further references see World Intellectual Property Organisation [WIPO] 2017). First, there is the problem of distinguishing nanotech innovation from

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mere discovery. Second, problems arise because all three of the requirements for protection need to be met: “novelty,” “inventive step,” and “commercial applicability” (Zekos 2006a, 317). In addition, nanotech patents may face exceptions to patentability. Finally, though not discussed in this chapter, the question of classification of nanotech patents or of apparatus patents may pose patentability problems (as was discussed for so-called nanocars, for example) (Uhrich and Zech 2008, 769 et seq.). 2.2.1 Discovery or Invention? First, a distinction must be made between invention and mere discovery: As a rule, patents are not granted for materials or results that are indistinguishable from what occur in nature. The term “discovery,” which is excluded from patentability, thus refers to preexisting materials of natural origin. To make a discovery means unveiling a preexisting but unknown object or property. “Invention,” by contrast, refers to the creation of a new object or process with preexisting knowledge. Does a mere reassembly of preexisting materials (e.g., atoms of carbon or silicon) at an atomic scale (bottom-up approach) represent a mere discovery, or is the applied method sufficiently technical for the notion of invention to capture it? The distinction between mere (natural, nontechnical, non-patentable) discoveries and (nonnatural, technical, patentable) inventions is obviously particularly relevant in the field of biotechnology, where preexisting biological materials form the basis for potentially patentable inventions. This is the case with nanotechnology, which equally relies on preexisting natural materials (atoms). How is the distinction to be drawn? Art. 52 (3) EPC sets the baseline by stipulating that discoveries are only non-patentable when the patent is applied for the discovery “as such.” Where, however, the preexisting natural matter is paired with a technological (inventive) component in an inseparable manner, that composite may form the subject of a patent (Zech 2009, 149). Further guidance on this distinction can be drawn from the EU’s Biotech Directive,4 which clarifies patentability requirements in relation to biotechnological inventions. While there is no comparable specific legislation for the nanotech area, the Biotech Directive’s principles and logic are also applicable to nanotech. In fact, biotechnology and nanotechnology are closely related. These disciplines converge, for example, in the field of synthetic biology, which combines approaches from various disciplines, such as biotechnology, nanotechnology, chemistry, computing, and engineering (Rai and Boyle 2007, 389; Rutz 2009, 15). Art. 3 (2) Biotech Directive requires the combination of biological materials with a technical process as a precondition for patentability. According to this norm, “biological material which is isolated from its natural environment

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or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.” An example of this distinction is the patenting of DNA or gene sequences. It is specifically dealt with in Art. 5 Biotech Directive. According to this norm, while “the human body (. . .) and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions . . . an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.” As a result, a gene or sequence of a gene is patentable if all of the following features are present: It is technically isolated or technically produced (technicality, novelty), the functioning of the technique is revealed (sufficient disclosure, inventive step), its structure and function are specified in a precise and credible manner (disclosure and formulation of claims), and its industrial application can be disclosed (industrial applicability). It is non-patentable if, by contrast, the gene or sequences “as such” are merely discovered, if their function is uncertain or speculative, if the function is already known or obvious, if it cannot be sufficiently explained (disclosed) how the specific function can be obtained, or if the industrial applicability of the gene or sequence cannot be substantiated (Feuerlein 2001, 563). Thus, for nanotechnology too, technicality is an issue: Nano structures that form naturally or spontaneously without the need for interference by (or separation through) a technical process will not qualify as inventions (but constitute mere discoveries) if based on natural materials (like carbon or silicon). Yet even if the formation of the nano structure is technically induced, patentability still faces similar hurdles as biotech inventions or patents on genes. The applicant for a nanotech patent will thus have to demonstrate in a sufficiently clear manner: first, how the building or separation process for a given nano structure works; second, what its features and functions are in a precise and credible manner; and third, what its potential industrial uses are. 2.2.2 Novelty and Inventive Step in Nanotech Second, the requirements of novelty and inventive step may be questionable. The reproduction of a known product at atomic scale in application of the top-down approach either may not be novel at all, or alternatively, may be novel but not sufficiently innovative to be patentable (Huebner 2007, 839; Schauwecker 2009, 29). In the latter regard, the patentability requirement of an inventive step stipulates that the novel technical solution must be at least so far beyond the state of the art that it could not have been seen or easily developed by an expert

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versed in the field (so-called nonobviousness). Using the bottom-up approach in nanotechnology in particular, one may encounter problems of overcoming the nonobviousness criterion insofar as it amounts to a mere reassembly of atomic structures to build a certain mechanism. 2.2.3 Commercial Applicability of Nanotech Inventions Lastly, the commercialisation and commercial applicability of nanotech inventions may pose an obstacle to patentability. In order to fulfil this requirement of protection, patent applicants must demonstrate in a sufficiently credible manner that the invention has potential industrial uses. To do so, the applicant must, to put it bluntly, know what his nanotech product is good for. This may not always be easy. Today, nanotech products still experience rather modest commercialisation, although their commercialisation is predicted to strongly rise in the foreseeable future. 2.3 Exceptions to Nanotech Patentability Certain types of inventions are specifically excluded from patentability for reasons of public concern, although they otherwise fulfil all patenting requirements. Article 27 (2) TRIPS Agreement states that patents may be refused for inventions, the commercial exploitation of which would be contrary to ordre public or morality. Reasons may include the protection of human, animal, or plant life or health or serious damage to the environment.5 The ordre public exception seeks to provide leeway for matters that threaten the structure of civil society in a broad sense (i.e., including health, the environment, etc.), whereas the exception of morality refers to the inconformity of an invention to moral principles. These exceptions are therefore flexible in scope and make room for an influx of sociocultural and other values in patent law. One obvious area for the application of ordre public and morality concerns is biotechnology. Another likely area is nanotechnology, given its relative novelty and uncertainty about the impact of its uses on health and the environment (Macnaghten, Kearnes, and Wynne 2005, 268; RS-RAE 2004, 35). Regarding biotechnology, Art. 6 (2) Biotech Directive contains a number of unpatentable biotech inventions for reasons of morality and ordre public. These include processes for cloning or modifying the germ line genetic identity of human beings, uses of human embryos for industrial or commercial purposes, and processes for modifying the genetic identity of animals that are likely to cause them suffering without any substantial medical benefit to man or animal, as well as patents on animals resulting from such processes. In turn, therefore, uses of embryos for other (e.g., research) purposes remain

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just as patentable as uses of other types of human cells that do not possess the ability to develop into human beings. Equally patentable are, on the same line, genetic modifications of animals (or plants) for medical purposes. Examples of the application of these exceptions include various cases decided by the European Court of Justice (ECJ) in the area of medical use of embryos or embryo-like cells.6 At the same time, there are also a number of patent applications dealt with at the European Patent Office (EPO) involving uses of embryos, genetically modified plants (Opposition Division of the European Patent Office 1993, 618), and animals. In relation to embryos, both the ECJ and the EPO held that patenting was excluded for products (derived from embryos) that could be prepared exclusively by a method necessarily involving the destruction of those embryos.7 In one case, the ECJ clarified that for cells that were not capable of developing into human beings, and which thus did not qualify as embryos in the sense of the Biotech Directive, even consumptive research was allowed.8 With regard to animal research, an example of an early case where the exclusion was argued in relation to transgenetic animals was the so-called Onco-Mouse, a mouse genetically modified to carry a specific gene in order to make it more vulnerable to cancer. The aim was to use this mouse in cancer research. The EPO’s Board of Appeals eventually confirmed that such a mouse, and indeed the whole mouse, could be patented if the medical benefit and the degree of suffering caused to the animal were proportionate.9 This approach was subsequently confirmed.10 Suffice it to say in the present context that both the ECJ and the EPO take a limited approach to applying ordre public and morality exceptions in biopatenting. Therefore, they do not forestall any morally controversial research or deal with research in which the consequences cannot be predicted with full certainty. Instead, some absolute limits apply to such research (e.g., consumptive uses of embryos), whereas most cases are decided on a balancing approach that weighs the benefits of the activity against moral or safety concerns. In principle, the approach is therefore friendly to biotech research even in controversial areas. It is to be presumed that the same approach will be applied in controversial or borderline cases of nanotech research (e.g., when implications of a nanoscale invention for health or environment are in doubt) (Nogueira de Sousa Branquinho and Nordberg 2009, 74). 3. BOTTLENECKS AND OVERPROTECTION Standardisation comes with boons and pitfalls. On the one hand, it serves the aforementioned functions of providing information, interoperability, and comparability. On the other hand, standards may impede essential activities

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of third parties: If the standard is only accessible to some market actors, industrial production and competition are hampered and consumer choice is limited. Equally, access to the standard may be relevant for follow-on innovation, research, or creativity. In this sense, standardisation may, as expressed in the chapter subtitle, be termed a necessary nuisance. 3.1 Mutually Reinforcing Effects of Standards and IPRs Standards are not per se a problem for competition and innovation. They only become a problem where they create or aggravate so-called bottlenecks. A bottleneck arises when all demand for a given technology is locked in with a specific provider to which there is no alternative. When ownership or control of the standardised technology lies in the hands of a single provider, a bottleneck is created for third parties. All parties demanding that technology must thus arrange the terms of use with that one provider or owner of the technology. In order to access a given market or engage in a given activity, third parties depend on know-how exclusively controlled by someone else. Without that person’s or undertaking’s consent, they are barred from using it. As long as a given technology incorporated in the standard is freely available, no bottleneck and no detrimental effects for competition and innovation arise: Any sufficiently capable market actor may use that technology in the manufacture of products. Standards will only create bottlenecks when they are backed up by IPRs. IPRs granted for a given invention or creation, particularly patents, utility models, copyright, or design rights, confer their owners exclusive control over market-relevant know-how. Where, by contrast, know-how underlying a standard is not IPR protected or where that know-how was developed under an open license (e.g., creative commons), there is no exclusive control and thus no bottleneck effect for third parties. Standardisation and IPR protection are thus two intrinsically linked phenomena, which together set the frame for competition in know-how and innovation-driven markets. Standards and IPRs are also mutually reinforcing in this regard. If IP-protected know-how is selected to be the single uniform technical solution to be used for a given product (a so-called standardessential patent), there is no way around it for any participant of the relevant market. That technological solution becomes the rule. Standard-setting thus has the effect of excluding the use of potential alternatives, either de facto or even—where the standard is also made compulsory by law—de lege. As a consequence, standard-essential patents and other standard-relevant IPRs will form bottlenecks for competition on the downstream market.

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3.2 Incentive to Abuse Because of the bottleneck effect, ownership of standard-essential IPRs creates an incentive for potentially abusive and anticompetitive behaviour. In particular, right-holders may be inclined to exploit licensees through unfair licensing terms and fees (Malaga 2014, 637). Likewise, right-holders who are also active on the relevant product market may try to use their control over the standard-essential know-how as a lever to conquer the downstream market for products relying on the relevant standard (the so-called leveraging-effect). The leveraging problem and its anticompetitive effects are illustrated by the recent Huawei case, decided by the European Court of Justice (ECJ) in 2015.11 Huawei Technologies, a multinational company active in the telecommunications sector, was the owner of a patent for a synchronisation signal. That patent was notified by Huawei to the relevant standard-setting organisation ETSI as being essential for the Long-Term Evolution (LTE) communication standard: Anyone using the LTE standard would inevitably have to use the teaching of that patent. Huawei declared that it would grant licenses for use of that standard to third parties on fair, reasonable, and nondiscriminatory terms (so-called FRAND terms). However, when Zhongxing Telecommunication Equipment Corp. (ZTE), a company belonging to a multinational group active in the telecommunications sector and marketing products equipped with software linked to the LTE standard, approached Huawei for a FRAND license, the negotiations remained fruitless. Since ZTE had to rely on the standard, it started using it without Huawei’s consent and was, in return, sued for infringement and damages by Huawei. The substance of the case subsequently centred on the question of whether and under which conditions such an infringement action by Huawei constituted an abuse of the dominant position conferred by the standard-essential patent.12 The ECJ found that the refusal to license a standard-essential patent and subsequent infringement actions may indeed fall foul of EU competition law unless, prior to bringing the action, the owner had warned the third party about the infringement and extended a written offer for a license on FRAND terms, to which it did not receive a diligent and fair response by the alleged infringer.13 3.3 Functions of IP Protection and Overprotection The decision to grant IP protection follows a choice by the lawmaker. Modern IP theory does not regard IPRs and IP protection as being commanded by natural law (i.e., as fruit of the mind that requires equal protection to, and treatment with, fruit of the soil). Rather, IP protection is the result of a compromise that seeks, on the one hand, to provide sufficient incentives for investments in innovation, while on the other hand ensuring the dissemination

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and widespread use of those innovations and know-how within the society (thereby ensuring follow-on innovation). IP law thus protects the investment from free-riders (i.e., copying, marketing, and other uses without consent) by way of conferral of a limited monopoly. The monopoly rights consist in moral as well as commercial rights. The former is, in particular, the right to be named as inventor or author. The latter is mainly the right to exclusively exploit the innovation (i.e., sale, licensing, use as a security). Evidence for the effort of balancing the limited monopoly against its benefits to society can be found throughout IP law, especially in patent law. Like other IPRs, patent protection is subject to conditions, exceptions, and limitations far beyond what general civil law stipulates in relation to the protection of physical property. These conditions, exceptions, and limitations tailor the type and scope of protection to the fulfilment of the essential function of IP protection (i.e., the stimulation of innovation investments that at the same time benefit society). For example, patent law’s dissemination function finds expression in the obligations to sufficiently disclose the invention in the patent application and to make that application and the invention claimed therein available to the general public.14 Likewise, IP law tolerates the stifling effects of the monopoly right for a limited period of time only (i.e., the period of protection).15 After its expiry, the knowledge or creation falls to the general public (i.e., the actual use of the invention is disseminated or mediatised). In addition, IP rights, and patents in particular, are subject to an open system of revocation of the right to second- and triple-check, in particular, whether the decision to grant the patent was correct (e.g., via third-party opposition in the granting procedure or via post-grant court actions for invalidity).16 Therefore, know-how that was not worth patenting in the first place is handed over to the general domain at any point in time where this is the case. Another illustration of the balancing exercise is the basic fact that IP does not protect the results of any activity, only results of a certain quality. The relevant threshold is set by the so-called requirements for protection.17 Patents in particular are only granted for innovations (i.e., not for copies of preexisting knowledge, merely banal furthering of that knowledge, or mere discoveries of what preexists in nature). Therefore, the grant of a patent requires novelty, sufficiently inventive teaching, and demonstrated industrial applicability of the technical teaching submitted in the patent application. It is also important to note that the monopoly effects are not tolerated without preconditions and limits. IP law is governed by limitations for the enjoyment and exercise of rights, which go far beyond what is common for tangible property under civil law. Examples are private use or experimental

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use of an invention, but also compulsory licensing.18 However, the availability of limitations is not the same in all jurisdictions. This is also a problem for the nanotech area that will be revisited further below. As a final example of balancing, patent protection is always subject to exceptions: No protection is granted for activities not beneficial to society, even if the invention was otherwise patentable.19 Examples are the cloning of human beings, modifications of the genetic identity of human beings, uses of human embryos for industrial or commercial purposes, and the like. The aforementioned Huawei case highlights a scenario where the trade-off between the protection granted and the dissemination of knowledge to the public doesn’t work. It illustrates a problem of potential overprotection of the owner of an IPR and the aggravation of that problem through standardisation. Whereas in the Huawei setting, the right-holder is in a position to use the IPR as a lever to weaken competition on a downstream market, the exclusive rights enjoyed under the IPR must be trimmed down to a level where such behaviour is no longer possible. 4. OVERPROTECTION AND REMEDIES IN NANOTECHNOLOGY The problem of potential overprotection is also present with the patenting of nanotech inventions. If a patented technology is, in addition to being patented, also turned into a standard, the problem is, as shown above, aggravated due to the mutually reinforcing negative cross-effects between IPRs and standardisation. Standardisation, however, is key to the market success of nanotech applications (Blind and Gauch 2009, 340). Any of the aforementioned standards developed by the ISO and CEN technical committees in the nanotech area are prima facie potentially capable of creating a bottleneck. If IP-protected nanotechnologies are standardised, they become especially difficult to substitute with more readily available, non-patented technologies. This is especially true with nanotech, because technologies related to a component of products or processes become standards, and market actors are de facto required to rely on them, thereby creating bottlenecks. 4.1 An Illustration of Problems Yet even where nanotech is not subject to standardisation on top of an IP right, patent law in itself may pose an obstacle to innovation and third-party use of nanotechnology. This is so in part because of intrinsic deficits of patent law—particularly regarding exceptions and limitations—but in part also because of the peculiarities of nanotech innovations.

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4.1.1 Indiscriminate Nanotech Claims Nanotech is a relatively novel area of research, with its full innovation potential only just unfolding. As a consequence, there usually isn’t much prior art (i.e., preexisting nanotech solutions relevant to a specific patentable application of nanotech) available. Relatively few nanotech inventions are patented in comparison to other traditional areas of patenting (mechanics, electronics, etc.). Also, nanotech is only in the process of developing a common language: Along with the relative novelty of the science goes the need to agree on uniform terminology. To date, the terminology used in patent applications and patent claims does not pinpoint the intended technicality (Sabellek 2014, 41). The consequence of these two peculiarities is that nanotech patent applications as well as the claims for subsequently granted nanotech patents tend to be overly broad. Because there is so little prior art, patent applicants can delineate the boundaries of their own inventions rather generously. And because there is no uniform terminology, claims are at risk of being interpreted broadly, thereby deterring potential third parties and creating legal and commercial insecurity as to what part of nanotech is protected and what may be used freely. Three concrete challenges arise from this. The first challenge consists in safeguarding the need to keep nanotech knowledge free for the common sphere. Where claims cover huge areas of nanotechnology, considerable parts of nanotech knowledge are “locked up” in those patents and withheld from third-party use without the patentee’s consent (Lemley 2005, 618). A second challenge consists in the gradual emergence of nano patent thickets.20 Where patent claims are broad and the language is ambiguous, patent protection in the nanotech field is intransparent and there is a risk that nanotech patents could overlap with one another. Unless such patents are crosslicensed, the respective patentees block each other (Gurgula 2017, 389). A third challenge consists in so-called nano-trolling behaviour. As a result of the potentially indiscriminate and intransparent scope of nano patents, topdown nano inventions may come into conflict with patents for regular products, which are granted without specification of size. Such nano patents, the essence of which is the replication of an existing product at nano size, might be used to extort license fees from the manufacturers of the corresponding full-size product (i.e., to “troll” or to harass those regular manufacturers).21 In this sense, an incentive for research in top-down nano applications might exist, even if their actual marketing prospects and uses might be otherwise limited. It is clear, however, that such inventions—or at least their patenting—are neither in the general interest from the perspective of stimulating innovation nor from the perspective of competition.

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4.1.2 Insufficiency of Limitations Patent law, as it stands, does not seem fit to answer to the specific characteristics and to meet the needs of nanotechnology in order to forestall overprotection and bottleneck effects. Overprotection impeding innovation processes may, in particular, result from insufficient limitations of patent protection as laid down in patent law. Limitations in particular safeguard the aforementioned need to keep nanotech know-how free for follow-on innovation, particularly for use in further research. One illustration of this problem is offered by the example of so-called building blocks (i.e., methods for assembling atoms in new ways that can be used in the building of novel materials, structures, or applications) (Sabellek 2014, 39). A ready example of building blocks are so-called buckyballs (soccer ball–like clumps of molecules; buckminsterfullerene) and nanotubes or nanowires (i.e., tubes or wires at nanoscale dimensions; so-called buckytubes). Buckyballs are naturally occurring products and as such are unpatentable, but large numbers of patents on implementations of these molecules have been issued in both the United States and Europe (Zekos 2006a, 315). Buckyballs and buckytubes come in different varieties of materials (typically carbon, but variants also include silicon or boron nitride) and shapes (hollow spheres, ellipsoids, tubes, etc.). Buckyballs and buckytubes are particularly relevant for biomedicine (e.g., in the development of contrast agents or in new forms of drug and gene delivery). At the same time, they are equally important as gatekeepers for follow-on research, exploring both new ways of assembling these materials as well as new ways to apply them. However, where building blocks are IP protected, the protected blocks may not be used without the consent of the patentee in follow-on research. Buckyballs, for example, were covered by patent protection granted in 1991.22 Although that patent expired (in 2011, after twenty years of protection), its broad scope, combined with insufficient limitations in the law, caused a number of much-discussed problems for the use of buckyballs in follow-on research while the patent was still in force (Sabellek 2014, 39). The claims of the buckyball patent were devised in a particularly generous manner. They included, for example, any “amorphous or crystalline particulate matter comprised of C60 or C70,” any “free flowing particulate comprised of C60 or C70,” but also “substantially pure C60 or C70,” and even “C60 or C70” as such in solid form, as well as “the vapor of C60 and C70.”23 The effects of this generous wording were that any manufacture, offering, placing on the market, use, importation, or possession (for those purposes) of C60 and C70 carbon was fully prohibited to anyone without patent-holder consent. The deterrent effect of such an overly broad monopoly for research in, or research relying on, buckyballs is prevalent. First of all, such a patent

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monopolises the subject or substance of protection. Second, and even worse, it also monopolises the theory or teaching underlying that innovation, because the building block itself is needed to falsify the theory or its implications by way of follow-on research (Zekos 2006b, 120). Another case for insufficient limitations with the same effects relates to so-called research tools in biotechnology (i.e., tangible or informational input required in the process of follow-on discovery) (Derzko 2004, 347). Examples are patented genes or gene fragments, cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools like polymerase chain reaction, methods, laboratory equipment and machines, and databases and computer software. All of these are essential for follow-on research. 4.2 Existing Limitations in National Laws and in the New Unitary Patent System The current limitations existing in patent law are arguably insufficient to answer to the problems of monopolisation of nanotech inventions and even of the theories underlying them. Although some national patent acts of the EU member states include limitations for research and experimental use of inventions, those limitations are not designed to provide sufficient legal certainty for researchers or actual incentives for follow-on research.24 First of all, not all member states have explicit general research privileges as limitations in national patent law. Austria is an example of such a member state. Arguably, certain secondary EU laws prescribe research privileges, but their applicability is limited to the specific context of the legislation (i.e., de facto research in medicines, the so-called Bolar exemption) (Kupecz et al. 2015, 712).25 Also, there are some hints in Austrian jurisprudence26 of an implicit recognition of a research privilege, but its applicability and scope are not certain (Österreichisches Monitoring Komitee 2006, 45). Second, even in the member states that foresee an explicit general research privilege (e.g., Germany,27 Switzerland,28 or the proposed new Unitary Patent29 system), it is typically not sufficiently broad in scope. In Germany, for example, a limitation of patent protection applies in relation to experiments on the “subject-matter of the patented invention.” This allows only for research on the research tool itself, but not on its application to other areas or items. Also, the German limitation only covers certain commercial purposes of an experiment (essentially where there are scientific aims behind the experiment and not solely commercial or revenue interests) (Jaenichen and Pitz 2015, 4). In addition, experiments may not exceed a certain scale defined by jurisprudence, beyond which they are no longer deemed to be justified by experimental purposes and thus fall outside the research privilege.30 Other

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examples, which are unclear under German law, include the possibility of outsourcing experimental research while still relying on the privilege or its coverage of preparatory and supplying acts necessary for conducting a privileged experiment. Limited wording of the research exception in national patent laws is supported by the patent law framework laid down in the TRIPS Agreement. Article 30 of TRIPS, which stipulates the possibility of exceptions to the rights conferred by a patent (the so-called three-step test), authorises TRIPS parties to provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. (Geiger et al. 2008)

The TRIPS Agreement does therefore authorise, but not require, more generous exceptions and limitations to patent protection vis-à-vis research and experiments. Commonly, the leeway provided for in Article 30 of the TRIPS Agreement is exercised in the German manner (i.e., to exclude private use and experiments on the subject matter of the invention, but not commercial or fundamental research in general). Article 27 of the Unified Patent Court Agreement (UPCA), setting up the litigation branch for the Unitary Patent, stipulates the following limitations to patent protection: The rights conferred by a patent shall not extend to (. . .) (a) acts done privately and for non-commercial purposes; (b) acts done for experimental purposes relating to the subject-matter of the patented invention; (c) the use of biological material for the purpose of breeding, or discovering and developing other plant varieties; (d) [tests for obtaining marketing permission for medications]; (e) the (. . .) preparation by a pharmacy, for individual cases, of a medicine in accordance with a medical prescription (. . .); (f) the use of the patented invention on board vessels [to repair them].

Other provisions limiting the patentee’s rights are contained in Articles 28 (prior use of the invention) and 29 (exhaustion) of the UPCA. The UPCA thus lays down a number of limitations, some of which may also play a role in the nanotech field. The most important of these for nanotech, however—the research privilege foreseen in the new system—will not have a scope beyond what most EU member states currently have laid down. As is common, the UPCA will permit only experiments relating to the subject matter of the invention, thereby excluding experiments for application

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to other areas or items. Beyond this, the scope of the privilege (e.g., scale, commercial purposes, outsourcing, preparatory acts, etc.) will depend on the (more or less patentee friendly) line of jurisprudence developed by the new Unified Patent Court. In sum, therefore, the existing limitations for the third-party and research use of nanotech inventions are insufficient both in the national laws of EU member states and under the coming transnational Unitary Patent system. Protection may go beyond what is necessary to safeguard the incentive effect. Examples are the indiscriminate duration of protection and its indiscriminate scope, but also insufficient exceptions and limitations. Regarding the latter in particular, typical national patent laws and the Unitary Patent system do not contain specific limitations in favour of research tools or building blocks. Likewise, there is no safe harbour for research in the sense of a generous and sufficiently reliable research privilege. Instead, the research exemption is interpreted differently throughout EU member states, and therefore it neither appears sufficient in scope, nor can it provide sufficient legal certainty to stimulate research. This is so in spite of the fact that more specific and more comprehensive limitations, better catering to the needs of nanotechnology in particular, would be possible under the TRIPS Agreement’s three-step test. Ideally, the legislature would test the law against a functionality benchmark: Is there market failure if protection is denied (i.e., would the respective product not be offered or would an activity not be pursued)? If there is no threat of market failure, the need to keep innovation results and processes free for the common sphere should, as a rule, be given preference. 4.3 Compulsory Licensing and Competition Law Remedies Where patent law’s intrinsic mechanisms (exceptions, limitations, and licensing obligations) do not suffice to correct negative effects of overprotection from the patenting and standardisation of nanotechnologies for innovation and competition, remedies may also be sought in neighbouring fields of law. In fact, IP law (patent, trademark, design, copyright protection, etc.) overlaps with, and is closely related to, competition law both in the narrower sense (i.e., antitrust proper, cartels, anti-abuse, merger law)31 and in the wider sense (i.e., unfair competition law), but also with the internal market stipulations for free movement of goods and services.32 All those neighbouring regimes offer tools to fine-tune the scope of IP protection, sometimes expanding that scope (e.g., in the overlap of IP and unfair competition, where the latter may be employed to stop free-riding on IP, confusion and misleading information, breach of trade secrets, etc.), sometimes limiting it (e.g., in the overlap of IP and free movement provisions, where

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the exhaustion doctrine was developed to balance IP against obstacles to free movement).33 An alternative to denying (exceptions) or limiting (limitations) the scope of IP protection to avoid situations of bottlenecking or overprotection is compulsory licensing: Under certain circumstances, the IPR holder is required by law to allow third-party use in return for (in particular) adequate remuneration. Both IP law and neighbouring areas of law know compulsory licensing provisions. However, as shown here, only the latter are effective in practice. 4.3.1 TRIPS Framework The general framework for (patent-intrinsic as well as competition law– based) compulsory licenses for private parties or governments is set by Article 31 of the TRIPS Agreement. The possibility of allowing third-party use without any authorisation of the right-holder is optional for TRIPS parties. The conditions of Article 31 need to be followed only if compulsory licenses are foreseen. While most national patent laws implement compulsory licensing provisions,34 the coming Unitary Patent system,35 as a prominent example, does not. Equally, the type of authority deciding over compulsory licensing applications (court or administration) is not specified in TRIPS. In the Austrian system, for example, the patent office decides on patent law–based compulsory licenses, while in Germany, compulsory licenses are enforced by way of actions before the patent court. For jurisdictions where the option is implemented, Article 31 stipulates a tight set of requirements to be followed in national laws. In particular, authorisation of such use shall be considered on its individual merits; general authorisations (e.g., for certain categories of patents or products) are prohibited. In addition, the interested third party must unsuccessfully have made efforts to obtain authorisation from the right-holder on reasonable commercial terms and conditions (i.e., the aforementioned FRAND terms). If granted, the scope and duration of use are to correspond to the purpose, and authorisations must be nonexclusive, non-assignable, and predominantly for the supply of the domestic market. If the circumstances for authorisation cease to exist, such use must end. Finally, TRIPS requires that the right-holder be paid adequate remuneration for any third-party use. As stated earlier, these conditions are in principle the same for patentintrinsic and competition law–based compulsory licenses. However, Article 31 contains some peculiarities that only apply to one or the other regime. Compulsory licenses for dependent inventions, which are by definition patent-intrinsic mechanisms, are subject to alternative conditions (elaborated immediately below).36 By contrast, in a situation where third-party use

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constitutes the remedy for an anticompetitive practice, it becomes the case that it is neither mandatory for a third party to obtain a license, nor must authorisation be limited to the domestic market.37 Also, remuneration for use of the patent may be determined with the need to correct the anticompetitive practice in mind. Where the practice is likely to recur, the authorisation need not end with any change in the conditions that led to the authorisation. 4.3.2 Patent-Intrinsic Compulsory Licensing Patent-intrinsic compulsory licensing in national laws38 is essentially limited to two situations. The first possibility to obtain a compulsory license is where the private interest overlaps with a public interest in obtaining the license. Where the private party has unsuccessfully tried to obtain a license and the grant of such a license would be in the public interest, it may be granted against the will of the right-holder.39 While this first possibility is relatively flexibly and openly worded, its requirements are actually quite demanding. Instances where the private commercial interest and an essential public interest overlap will be rare, which limits the scope of application of these provisions. An example of a situation of overlap of interests might be the production of essential medicines for a given market.40 The second possibility is the use of a patent to exploit a so-called dependent innovation. This possibility is explicitly accounted for in Article 36 (l) of the TRIPS Agreement and is essentially implemented in national laws in the same way.41 The provision stipulates that use may be authorised to permit the exploitation of a (second) patent that cannot be used without infringing the (first) patent, for which a license is sought. In this case, the general conditions of Article 31 of TRIPS do not apply. Instead, a compulsory license only lies where the invention claimed in the second patent constitutes an important technical advance of considerable economic significance in relation to the invention claimed in the first patent. In addition, the owner of the first patent is entitled to a cross-license on reasonable terms to use the invention claimed in the second patent. Finally, TRIPS requires that the use authorised in respect to the first patent shall be non-assignable except with the assignment of the second patent. Again, these conditions are rather tight. They seek to address situations of bottlenecking to the detriment of innovation and consumers. However, the scales that are required (innovation must be technically and economically considerable) indicate that only exceptional situations will, again, fall under this provision. In sum, therefore, owing to tight requirements, both of the patent-intrinsic compulsory licensing tools are hardly ever used in European practice (Wilhelmi 2017; Böttger 2008, 885). In addition to tight requirements, the current system of cross-border jurisdiction and recognition of judgements only

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covers civil and commercial litigation and thus does not include compulsory licensing applications, which are deemed to belong to public litigation (Jaeger 2013, 520). Therefore, since procedures cannot be joined, patent-based compulsory licenses currently have to be obtained state by state. If the license for a certain jurisdiction remains missing, this jeopardises the value and usability of licenses for all other jurisdictions, as the product cannot be promoted throughout the internal market without risk. The considerable procedural shortcomings of the current system for patentbased cross-border compulsory licenses are, as mentioned, not remedied by the new Unitary Patent system. The absence of a compulsory licensing provision for the new system in fact endows patent holders with a strategic advantage in facilitating strategic patenting (switching between patent systems). Key technologies may be brought into the new system to shield them from the threat of patent-based compulsory licenses authorised in favour of owners of patented dependent innovations. 4.3.3 Antitrust-Based Compulsory Licensing Given the shortcomings of patent-based compulsory licenses, the most important fine-tuning instrument to trim down potential overprotection from bottlenecks and lock-ins in practice comes from the antitrust area. There, denial of access to a so-called essential facility may, under given circumstances, constitute an abuse of a dominant market position in the sense of Article 102 of the Treaty on the Functioning of the European Union (TFEU). Article 102 prohibits practices exploiting customers or excluding competitors. The latter category is by far the more relevant. Action under Article 102 yields a number of manifest advantages compared to patent-based actions under national laws. Since the antitrust regime is laid down in European law, it benefits from the characteristics of EU law. Those particularly include (1) the uniformity of conditions throughout all jurisdictions; (2) the primacy of the EU law-based prohibition vis-à-vis potentially conflicting national laws or measures (of courts or authorities); (3) the centralised one-stop-shop enforcement by either the European Commission (EC) or national competition authorities acting cross-border under the antitrust enforcement Regulation 1/2003; and (4) minimum standards for remedies (based, in part, on secondary EU law42 and, in part, on the EU law principles of equivalence and effectiveness43 of national measures for the enforcement). Refusal to deal and essential facilities The decisive question is: At what point might the creation of a monopoly as a reward (incentive) for investments in innovation and the exercise of

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the conferred rights turn into an abuse of those rights (i.e., of the dominant market position afforded by the key nature of the innovation)? From a patent perspective, any such abuse is a sign of the presence of overprotection and calls for limiting measures in the form of compulsory licensing. The competition law–based compulsory licensing doctrine seeks to strike a balance between the prohibition of abuse of a dominant market position in the sense of Article 102, on the one hand, and the right to property, as enshrined in Article 345 of TFEU and Article 17 of CFR, on the other. Article 345 states that EU law does not prejudice member states’ rules governing the system of property ownership. Article 17 guarantees the fundamental right to own and lawfully use acquired possessions, limits the possibility to be deprived of that right to instances of public interest, and grants fair compensation. The European courts have long confirmed that the prohibition of abuse of a dominant position constitutes a valid public interest for the restriction of the right to property in the sense of Article 17 of CFR: Although the right to property forms part of the general principles of [EU] law, (. . .) its exercise may be restricted, provided that those restrictions in fact correspond to objectives of general interest pursued by the [EU] and do not constitute a disproportionate and intolerable interference, impairing the very substance of the rights guaranteed. . . . [The] application of [Art. 102 TFEU] constitutes one of the aspects of public interest.44

The classic constellation behind an abuse based on refusal of access (refusal to deal with a competitor) is illustrated by the landmark judgement in Commercial Solvents, decided in 1974, long before the nano era.45 In the case, Commercial Solvents Corp. dealt with raw materials for the production of a tuberculosis drug. As the main producer of that raw material, Commercial Solvents supplied only its own subsidiary drug manufacturer, Imperial Chemical Industries ICI, and refused to deal with competing producers (e.g., a company named Zoja, the plaintiff at hand). In doing so, Commercial Solvents was able to transfer its market power in the market on raw materials onto the downstream market of those materials (so-called leveraging).46 The Court of Justice held that exclusionary practices of dominant undertakings are not only caught by Article 102, where they are directed against horizontal competitors, but also in vertical relationships, meaning downstream markets. Commercial Solvents’ refusal to deal in order to leverage market power was to be seen as an abuse of the producer’s dominant position, if the company’s actions were capable of “eliminating all competition”47 on the downstream market. The freedom to conduct business and property rights in such a constellation thus yields to the interest in protecting undistorted competition.

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The case of Commercial Solvents was about dominance in the production of a raw material and the refusal to supply downstream competitors. Subsequent jurisprudence applied the concept to other instances of market dominance created through similar control over resources and the ensuing ability to control downstream markets. In particular, any control over a facility that is essential for competition in the sense that undertakings must rely on it for goods or services can be tested against the Commercial Solvents standard and its newer variants. If successful (i.e., if the refusal to deal [grant access] is found to be abusive), the facility must be opened up (i.e., the dominant undertaking is forced to enter into a contract allowing use). This essential facilities doctrine is just a further development of the Commercial Solvents’ logic and thus a sub-form of the refusal to deal. The quest is to find the appropriate balance between the right of the dominant company to freely choose trading partners and at the same time to ensure that the downstream market is not distorted to the detriment of consumers. In its straightforward sense, “facility” means a physical infrastructure, like ports, airports, rail or telecom networks, pipelines, and so on.48 The undertaking that owns the infrastructure is in control (i.e., dominant) regarding the conditions of use. Where access is denied, competition on markets downstream of the facility is distorted (e.g., cargo handling in a port, choice of supplier in a gas pipe network, etc.). Essential facilities in nanotech The concept of essential facilities, however, is broader than physical infrastructure. It also includes control over indispensable nonphysical resources, like nonphysical networks (e.g., computer reservation systems, encrypted TV signals, newspaper delivery networks, etc.),49 as well as control over IPRs, know-how, and data—currently the most important field of application of the essential facilities doctrine.50 This is where competition law’s essential facilities doctrine and the problem of IPR protection, standardisation, and nanotechnology close ends. Accordingly, the solutions developed under competition law for access to IPRs, know-how, and data can also be applied to bottlenecks, lock-ins, and exclusionary practices relating to protected nano innovations. In the case of IPR-protected and standardised nanotech inventions, exclusive control over the technology allows the IPR holder to act independently of the restraints of competition on a downstream market. Since the patented nanotechnology is by definition unique (patents are only granted for novel and sufficiently innovative inventions), there is no horizontal competition on the level of the technology.

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An incentive not to license nanotechnology arises where, just as in the old Commercial Solvents setting, there is competition for products in downstream markets relying on nanotechnology, where the facility owner or a subsidiary is also active. In that case, control over nanotechnology is a lever to business expansion on the relevant downstream market. Thus the rightholder is in a position not only to control competition in products relying on that nanotechnology, but also to control research and innovation processes requiring use of that technology, through a simple refusal of access to (refusal to license) the IPR-protected nanotechnology. Criteria for access to nanotech bottlenecks Criteria for access to physical and nonphysical essential facilities, with the latter being relevant for access to bottlenecks created by IPR-protected nanotechnology, have been established by the European courts in a long line of case law.51 That case law retraces the evolution of the essential facilities doctrine from infrastructure to IPR protection on the one hand, and from analogous markets to digital and innovation-driven markets on the other. It can now be found summarised in the EC’s 2009 guidance notice on exclusionary conduct (EC 2009, § 75–90). While the criteria for access to physical essential facilities and to essential facilities in the form of IPRs (nonphysical essential facilities) largely overlap, access to IPRs meets some additional requirements. The following criteria are cumulative. • First, the undertaking must indeed be dominant regarding the facility on the preceding (upstream) market. Control over the facility (e.g., a patent) usually confers dominance regarding the conditions of access. The crucial question is whether the patent entails so-called lock-ins, which presuppose that there is no substitution for the standard on the downstream market. The patent holder will thus usually be dominant where a ready emergence of alternative standards is unlikely (Eckel 2017, 409). • Second, the facility must be indispensable for the competitor. The facility (e.g., an IPR) is essential if it creates a bottleneck that competitors must pass through in order to be active on the (downstream) market. We explained earlier that standards aggravate the bottleneck problem by way of an elimination of de facto technically viable alternatives. IP-protected standards therefore always create indispensable facilities in the sense of Article 102. This is especially so where activities on the downstream market are subject to licensing (Eckel 2017, 410). By contrast, there is no bottleneck where alternatives are available or where the facility or know-how can be duplicated using economically reasonable means (e.g., in the case of standards based on freely available know-how).

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In the 2004 Bronner judgement, for example, the court held that a home-delivery system for newspapers might be dispensable, because newspapers could also be sold in kiosks and shops, or sent through the mail.52 In addition, there were no technical, legal, or economic obstacles to prevent the duplication of the home-delivery system in question. • Third, the refusal to deal must be capable of limiting effective competition on the downstream market. This third criterion is where the assessment criteria for physical infrastructure diverge from those of IPRs, networks, and knowhow. For the latter, the European Court of Justice developed the additional criterion that the refusal to deal hinders the emergence of a new product on the downstream market for which there is a demonstrated consumer demand.53 This criterion seeks to distinguish jurisprudence on access to IPRs from preceding, more restrictive (i.e., right-holder-friendly) case law concerning IPRs in regular (nonessential) licensing settings. For example, the refusal to grant licenses for the production of spare parts for cars was deemed justified and non-abusive, as the licensing decision of the right-holder was seen as forming part of the “very subject-matter”54 of IP protection. In the case of a bottleneck, the court needed an additional explanation as to why access should be granted in spite of the older, more lenient, case law. The explanation was found in the new product offered by the undertaking seeking access, which would otherwise not emerge, and the ensuing consumer harm due to a denial of access. More recently, the court seems to have softened (Drexl 2009, 447; Jaeger 2015, 155) the criterion for the emergence of a new product as a precondition for access to an IPR by stating that access might already be justified where there would otherwise be a substantial restriction of technical development and innovation capacity.55 This softened standard might account for the particular requirements of lock-ins in innovation-driven markets (e.g., operating software or social platforms). While the criterion of a substantial restriction of technical development and innovation has not been applied explicitly in a number of cases where there was no comparable lock-in,56 jurisprudence for Article 102 in general seems to be gradually becoming more innovation-sensitive. For example, the court recently confirmed in another context (for a rebate system falling foul of Article 102) that dominant undertakings cannot engage in practices that lead to the market exit of competitors who are equally efficient in terms of, inter alia, innovation.57 Innovation capacity of the smaller undertaking is, in other words, a criterion to be taken into account in the context of the so-called as-efficient-competitor test (relevant for the assessment of pricing practices of dominant undertakings). • Fourth and last, the refusal to grant access will not be caught by Article 102 if it can be objectively explained. Possible explanations are, for example,

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capacity restraints. Also, where the party seeking access has undermined the relationship of trust in the context of other contractual relationships, or where it is obviously not able to fulfil the FRAND requirements, refusal might be justified (Eckel 2017, 441). Under these criteria, access to IPR-protected bottlenecks of nanotechnology is certainly to be granted if the competitor seeking access emerges with a new product on the downstream market that relies on that nanotechnology. Access, however, might also be granted where the competitor merely offers a product similar to that of the dominant undertaking, but where access is essential to uphold its innovation capacity in order to be able to stay on the market (Jaeger 2015, 155). The innovation dimension of refusal of access for competitors not (yet) offering substantially novel products compared to what is already on the market seems particularly suitable to open up research on IP-protected nanotech know-how in situations where the existing limitations of patent law (particularly a research privilege, where it exists) are too narrowly construed. Legal consequences and enforcement of access to nanotechnology As mentioned at the outset, the legal consequences of a successful qualification of IP-protected nanotech as an essential facility are significantly more attractive for undertakings than what patent law has to offer. If access to an essential facility is denied, that denial constitutes an abuse of a dominant position under Article 102. The initial consequence for a finding of abuse is that access must be granted.58 As Article 17 CFR warrants, the facility (IPR) owner must be compensated for use by the third party. Compensation and the other terms of use should correspond to the aforementioned FRAND standard. The basis for access, laying out the terms for access in detail, is ideally a contract concluded with the facility owner (IPR holder). Where the IPR holder is not ready to enter into a contract, the court judgement finding the abuse may substitute the consent of the right-holder and specify the terms of access.59 Likewise, a commission decision finding the abuse might specify the terms for access of third parties in the form of behavioural remedies (i.e., as an obligation to change market behaviour in the future).60 In innovation-driven markets like nanotechnology, however, where innovation and product cycles are typically short, a court judgement (or commission decision) might come too late to preserve the market opportunities of downstream market undertakings. This is why European jurisprudence more recently adopted an alternative, noncontractual approach for granting

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temporary access before a court judgement is handed down.61 A third party that believes the denial of access constitutes an abuse in the sense of Article 102 may start using a given technology right away and defend itself against infringement claims by the right-holder with an Article 102–based objection. In principle, this is the relatively more attractive option, but it comes at some risk for the downstream market undertaking, which must self-assess both the legal (presence of an abuse) and economic (value of access) circumstances correctly in order to avoid damages and other negative consequences. The court held that the owner of a standardised IPR is, by virtue of Article 102, prohibited from bringing infringement or damages proceedings before a national court against a third party using the IPR without a license, where that IPR constitutes an essential facility and the third party has unsuccessfully tried to obtain a license at FRAND terms before starting use.62 Such use is thus intended to be a means of last resort to overcome blockages after fruitless access negotiations. However, the third party will have to self-assess what the FRAND terms are in the given setting and, in particular, what the appropriate royalty is (Henningsson 2016, 449). It would then likely also have to start paying the royalty from the first use onward—if necessary—to a trustee account.63 If the third party gets that assessment wrong, the use remains illegal. Where the specific patented innovation is part of a technical standard, and the standard-setting institution had, prior to declaring the technology a standard, required the patent holder to issue a licensing commitment (i.e., promise that licenses would be granted to everybody seeking one) (CEN-CLC Declaration Form 2011), the conditions are even tighter on the part of the rightholder. Against the background of standardisation and the initial declaration that licenses would be granted, the right-holder must even extend a hand to the alleged infringer. Before being allowed to bring an infringement action, the right-holder must (1) alert the infringer to the potential infringement; (2) invite them to conclude a licensing agreement; (3) specify in writing the terms of the license and, in particular, the appropriate royalty; and finally (4) wait for the infringer’s response.64 Only in the absence of such a response, or where the response is apparently aimed at delaying negotiations, may the IPR holder bring an infringement action. Licensing commitments are, in fact, part of the regular requirements many standardisation bodies set before accepting certain patented know-how as a standard. However, the commitments themselves do not suffice in practice, as the individual terms for the license must still be negotiated in every single case. This might take a long time or even ultimately be unsuccessful. By contrast, very few right-holders are willing to issue open license declarations (i.e., open licensing offers at fixed terms for everybody). In sum, therefore, the Article 102–based objection is attractive in innovation-driven markets like nanotechnology because it allows interested parties

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to use patented know-how without having to wait for the outcome of a court case. In nanotech-based markets, this approach safeguards third-party market opportunities. The Article 102–based objection is in fact particularly attractive if the patented nanotechnology is at the same time part of a standard for which the right-holder has committed to grant licenses in principle. In such a case, the right-holder is under an obligation to reach out to the third party by notifying it of the alleged infringement and by making an offer for a licensing contract on FRAND terms. These additional obligations on the part of the right-holder alleviate one major downside of the plain Article 102–based objection (i.e., outside the contexts of standardisation and licensing commitments), which is the need for self-assessment of the FRAND terms by the third party. If the right-holder is under an obligation to specify its understanding of FRAND in a given setting, assessing that offer and responding to it is relatively easier than doing otherwise (Neven and Régibeau 2017, 464). As stated earlier, an Article 102–based objection to gain access to nanotechnology may not just lie where a competitor on a downstream market offers a noticeably new product, but may also safeguard an “as-efficient” downstream undertaking’s innovation abilities. In this generous understanding, the Article 102–based objection might allow third parties to use nanotech know-how immediately for their research and innovation activities, without having to wait for a licensing agreement or court judgement in order to bring out new or (even just) additional products next to those of the dominant undertaking, thereby expanding their range of action beyond what the currently inflexible limitations in patent law (particularly a narrowly constructed research privilege) afford. 5. CONCLUSION This chapter’s subtitle calls standardisation and patenting a necessary nuisance in nanotechnology. Patents are necessary to uphold incentives for investment in innovation, as they protect those investments from free-riders by conferring monopolies for use. Standards are necessary to allow, in particular, for the better interoperability of products and the comparability and homogeneous quality of product performance. At the same time, standards and patents are a nuisance insofar as they necessarily create anti-innovative and anticompetitive monopolies and, in that regard, have mutually reinforcing effects in terms of creating bottlenecks for downstream markets and follow-on research and innovation. In the interest of innovation and undistorted competition, legal systems must thus seek to strike a balance between the positive and the negative

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effects of standardisation and patenting. Where balance is missing and negative effects prevail, the scope of protection derived from a patent underlying a standard must be adjusted accordingly. Patenting for nanotech is in principle subject to an innovation-friendly approach, similar to what can be observed in biotechnology today. As a result, patentability requirements in both areas are handled inclusively, with a view to bringing more innovations under the roof of patent protection. At the same time, patent-intrinsic post-grant limitations to protection remain few and narrowly construed. The current patent-intrinsic instruments for keeping a balance between protection and accessibility of patented and standardised nanotechnology are thus insufficient. With regard to patents in the nanotech field, several possible tools for adjustment come to mind. They range from the requirements of protection via the field of patent-intrinsic limitations to patent-extrinsic compulsory licensing based on Article 102 of TFEU. Regarding the requirements of protection, the assessment of the element of technicality for distinguishing mere discoveries from patentable inventions could be clarified in order to unambiguously exclude from patent protection natural nano structures that form spontaneously without any or only insignificant human (technical) interference. Likewise, the criteria of novelty and inventive step could be tightened, so that nanotech innovations of lesser quality vis-à-vis the state of the art no longer benefit from patent protection. A tighter approach here might free up some parts of nanotech activities for the common sphere, particularly regarding bottom-up nano innovations. Regarding patent-intrinsic limitations, there is particular need for a more generous construction of the research privilege. Currently, the availability and scope of that privilege varies among EU member states, with the scope being typically narrow and sometimes ambiguous. Frequently, research on the application of a nanotech invention to other areas or items, research for commercial or revenue interests, experiments exceeding a certain scale, outsourcing of research and experiments, and supply and preparatory acts relying on the nanotech invention are not clearly included in the privilege. These exclusions and ambiguities stifle follow-on innovation in nanotech, limit consumer choice of nanotech-based products, and keep prices at a higher level than in an environment of lively innovation-driven competition. A more generous approach by member states to limitations in general, and to research privilege in particular, is encouraged by the TRIPS Agreement’s three-step test,65 which affords some leeway in that regard (Geiger et al. 2008). Patent-intrinsic compulsory licensing provisions, which afford mandatory third-party access to patented technologies in return for adequate remuneration to the patentee, encounter high thresholds and are therefore hardly ever used in practice. However, compulsory licenses for patented and standardised

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nanotechnology can also be obtained on the basis of EU competition law, namely Article 102 of TFEU. This option is relatively more attractive and effective and is thus frequently employed in practice to force patent holders into license agreements. The Article 102–based approach is not entirely without shortcomings. Apart from the need to carefully delineate the market for which a given nanotech invention is relevant as a precondition for the application of Article 102, proof of the innovation’s indispensability for activities on a downstream market may turn out to be just as tricky as the subsequent assessment or agreement of the terms of use for the patent at FRAND principles. Here, again, the overlap between patents and standards becomes significant. While on the one hand the overlap aggravates bottleneck effects, on the other hand it also helps with the employment of remedies for access. First, proof of the indispensable character of the patent is not a problem where the patent is standardised and thereby turned into the single uniform option available. Second, the standardisation context also facilitates agreement on the licensing terms. In such a situation, European courts have held the patent holder responsible for reaching out to a potential patent infringer by making a FRAND-conform licensing offer. If no such offer is made, or where its terms are not appropriate, courts have disallowed infringement and damage claims on the part of the patentee. The recent recognition by European jurisprudence of the possibility for third parties to access and use patented inventions without having to wait for the patentee to enter into a licensing contract or for a court to substitute the patentee’s consent by judgement constitutes a significant advance toward a readjustment of the balance between patent protection and innovation and competition concerns. Especially in innovation-driven markets like those for nanotech-based products, this possibility is crucial to safeguard first-mover advantages, market opportunities, and innovation capacities for competing undertakings. It is also helpful considering the fact that European jurisprudence is arguably becoming more innovation-sensitive (i.e., it takes increasing account of the effects of abusive behaviour in the sense of Article 102 for the innovation potential of downstream market undertakings that are as efficient, but not as powerful, as the patentee’s). A lot is yet unknown regarding the uses, effects, and implications of nanotechnology (Huber 2017, 13; Forsberg 2012, 720). This uncertainty includes the legal sphere’s regulatory aspects in general (Mandel 2009, 10) and the patenting and competition aspects dealt with here in particular. The numbers of both nanotech standards and nanotech patents are relatively low compared to other areas of technology, but both are constantly increasing. This increase in number will on the one hand aggravate the competition and innovation effects of nanotech standardisation and patenting as more know-how is

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monopolised, but on the other hand it may also resolve current uncertainties as more cases will be decided by patent offices and courts. The primary addressees of calls for clarification and adjustment of the requirements for, and limitations of, patent protection are the EU, national legislators, and patent offices handling applications. However, standard-setting organisations could support these efforts by contributing to the development of a common vocabulary for nanotechnology. Furthermore, standard-setting organisations could back up the effectiveness of compulsory licensing tools by beefing up their requirements for licensing commitments as a precondition for declaring patented inventions standard-relevant. Patent holders should not only be required to commit to subsequent licensing, with the terms of such licenses remaining up for individual negotiation,66 but they should also be required to obtain fully fledged license declarations, modelled after what many patent offices offer in return for rebates on fees.67 These declarations would have to be sufficiently detailed, albeit perhaps with several alternatives to choose from, to the degree that third parties seeking licenses could simply opt in and thereby conclude a license contract at fixed terms without the need for individual negotiations. Despite the low numbers for nanotech patent cases at present, some guidance regarding the problems and potential solutions for patenting and standardisation in nanotech can be derived from the closely related field of biotech patenting. The implications of that field of technology for society and ethics, as well as for competition and innovation, have only slowly unfolded and are continuing to unfold. Biotechnology illustrates the difficulties of balancing all involved interests at the various levels of patent law while demonstrating where imbalances currently lie. An overhaul of patent law to better adjust the requirements of protection and limitations would thus benefit both biotechnology and nanotechnology, and it would help society take full advantage of the great innovation potential vested therein. NOTES 1. ISO/TS 14101:2012. 2. See, for example, Art. 52 EPC. 3. The first number refers to applications to the European Patent Office, while the number in brackets refers to applications to the US Patent Office. 4. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions [1998] OJ L 213/13. 5. Equally Art. 53 EPC. 6. See, for example, Case C-34/10, Brüstle, ECLI:EU:C:2011:669.

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7. See EPO Decision No. G 0002/06, Use of embryos / WARF, ECLI:EP:BA:2008:1 G000206.20081125, paras. 32 et seq.; Case C-34/10, Brüstle, ECLI:EU:C:2011:669, para. 52. 8. Case C364/13, International Stem Cell, ECLI:EU:C:2014:2451, para. 38. 9. See EPO Decision No. T 0019/90, Onco-Mouse, ECLI:EP:BA:1990:1 T001990.19901003, paras. 4 et seq. 10. See, for example, EPO Decision T 0315/03, Transgenic animals / HARVARD, ECLI:EP:BA:2004:T031503.20040706, paras. 12.2 et seq. 11. Case C-170/13, Huawei, ECLI:EU:C:2015:477, paras. 21 et seq. 12. See the prohibition of abuse of a dominant market position in Art. 102 TFEU. 13. Case C-170/13, Huawei, ECLI:EU:C:2015:477, para. 71. 14. See Art. 83 and 93 EPC. 15. For example, Art. 63 EPC. 16. See, for example, Art. 99 EPC; § 48 Austrian Patent Statute. 17. See Section 2; 2.2. E.g. Art. 52 European Patent Convention (EPC). 18. For example, Art. 31 TRIPS; Art. 102 TFEU; § 36 Austrian Patent Statute. 19. For example, Art. 53 EPC. 20. For an in-depth analysis of the general problem, see Shapiro (2001, 119 et seq.). 21. Regarding patent trolling in a wider context, see Malaga (2014, 637 et seq.). 22. See EP 0500914 (1991/98), New form of carbon. 23. EP 0500914 (1991/98), New form of carbon, claims 11, 17, 18, 21, and 22. 24. For a different view, see Jaenichen and Pitz (2015), 1 et seq. 25. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, [2001] OJ L 311/1; Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, [2001] OJ L 311/67. 26. See OGH judgement of 22 May 1973, 4 Ob 315/73. 27. See § 11 (2) German Patent Act. 28. See § 9 (1) (b) Swiss Patent Act. 29. See Art. 27 (b) Unified Patent Court Agreement. 30. BGH judgement of 17 April 1997, X ZR 68/94. 1997. “Patentrechtliches Versuchsprivileg– Klinische Versuche II.” NJW 46: 3093. 31. See Art. 101 and 102 TFEU. 32. See Art. 34 and 56 TFEU. 33. See, for example (for patents), Case 15/74, Centrafarm, ECLI:EU:C:1974:114, para. 9. 34. For example, § 36 Austrian Patent Act; § 24 German Patent Act. 35. See Art. 27 (b) Unified Patent Court Agreement. 36. See Art. 31 (l) TRIPS Agreement. 37. See Art. 31 (k) TRIPS Agreement. 38. See note 33. 39. For example, § 36 (5) Austrian Patent Act; § 24 (1) German Patent Act. 40. See BPatG judgement of 31 August 2016, 3 LiQ 1/16 (EP). 2017. “Zwangslizenz für Herstellung eines HIV-Medikaments–Isentress.” GRUR 4: 377 et seq.

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41. For example, § 36 (1) Austrian Patent Act; § 24 (2) German Patent Act. 42. Directive 2014/104/EU of the European Parliament and of the Council of 26 November 2014 on certain rules governing actions for damages under national law for infringements of the competition law provisions of the Member States and of the European Union, [2014] OJ L 349/1. 43. For example, Case C-271/91, Marshall, ECLI:EU:C:1993:335, paras. 27 et seq. 44. Case T-65/98, Van den Bergh Foods, ECLI:EU:T:2003:281, para. 170. 45. Joined Cases 6/73 and 7/73, Commercial Solvents, ECLI:EU:C:1974:18. 46. Cf. Section 3.2 above. 47. Joined Cases 6/73 and 7/73, Commercial Solvents, ECLI:EU:C:1974:18, para. 25. 48. See, for example, ports (Commission Decision of 21 December 1993, IV/34.689, Sea Containers/Stena Sealink; Commission Decision of 21 December 1993, 94/119/EC, Port of Rødby), airports (Commission Decision of 14 January 1998, IV/34.801, FAG—Flughafen Frankfurt/Main), rail networks (Commission Decision of 27 August 2003, COMP/37.685, GVG/FS), gas pipelines (Commission Decision of 14 November 2006, COMP/M.4180, Gaz de France/Suez; Commission Decision of 4 May 2010, COMP/39.317, E.ON Gas), telecom infrastructure (notice on the application of the competition rules to access agreements in the telecommunications sector, [1998] OJ C 265/2), and airplanes (Commission Decision of 26 February 1992, IV/33.544, British Midland/Aer Lingus). 49. For example, airline reservation systems (Commission Decision of 4 November 1988, IV/32.318, Sabena), decoder boxes (Commission Decision of 21 March 2000, COMP/JV.37, BSkyB/KirchPayTV), banking services (T-301/04, Clearstream, ECLI:EU:T:2009:317), newspaper home delivery (Case C-7/97, Oscar Bronner, ECLI:EU:C:1998:569). 50. For example, copyrighted information (joined Cases C-241/91 P and C-242/91 P, Magill, ECLI:EU:C:1995:98; C-418/01, IMS Health., ECLI:EU:C:2004:257), interoperability data (Case T-201/04, Microsoft, ECLI:EU:T:2007:289; COMP/ AT.40099, Google Android [ongoing]), platform access (COMP/AT. 39740, Google Search [ongoing]), standard-essential patents (Commission Decision of 29 April 2014, COMP/AT.39985, Motorola; Commission Decision of 29 April 2014, COMP/ AT.39939, Samsung). 51. See particularly joined Cases C-241/91 P and C-242/91 P, Magill, ECLI:EU:C:1995:98 (copyright in analogous market), Case C-7/97, Oscar Bronner, ECLI:EU:C:1998:569 (analogous network), C-418/01, IMS Health., ECLI:EU:C:2004:257 (copyright in the digital market), Case T-201/04, Microsoft, ECLI:EU:T:2007:289 (know-how in digital market lock-in). 52. See Case C-7/97, Oscar Bronner, ECLI:EU:C:1998:569, paras. 43 et seq. 53. See joined Cases C-241/91 P and C-242/91 P, Magill, ECLI:EU:C:1995:98, para. 54. 54. See Case C-53/87, Renault, para. 11; C-238/87, Volvo/Veng, para. 8. 55. See Case T-201/04, Microsoft, ECLI:EU:T:2007:289, paras. 643 et seq., 688 et seq.

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56. For example, concerning patent renewal in pharmaceuticals: C-40/09, Astra Zeneca, ECLI:EU:C:2010:450; concerning banking services: T-301/04, Clearstream, ECLI:EU:T:2009:317. 57. See Case C-413/14 P, Intel, ECLI:EU:C:2017:632, para. 134; Case C‑209/10, Post Danmark, ECLI:EU:C:2012:172, para. 22. 58. See already joined Cases 6/73 and 7/73, Commercial Solvents, ECLI: EU:C:1974:18, para. 46. 59. See, for example, joined Cases C-241/91 P and C-242/91 P, Magill, ECLI: EU:C:1995:98. 60. See, for example, COMP/AT. 39740, Google Search (ongoing); Press release 27 June 2017, IP/17/1784 and Fact Sheet 27 June 2017, MEMO/17/1785. 61. See Case C-170/13, Huawei, ECLI:EU:C:2015:477, paras. 40 et seq. 62. See Case C-170/13, Huawei, ECLI:EU:C:2015:477, para. 71. 63. In that sense, BGH judgement of 6 Jun 2009, KZR 39/06-Orange-BookStandard. 2009. “Einwand der Zwangslizenz im Patentverletzungsverfahren um Industriestandard.” GRUR 7: 694. 64. See Case C-170/13, Huawei, ECLI:EU:C:2015:477, para. 71. 65. Art. 30 TRIPS Agreement. 66. Cf. note 63. 67. For example, Art. 8 Unitary Patent Regulation 1257/2012, [2012] OJ L 361/1; § 23 German Patent Act.

Chapter 5

Standardisation Enabler for Nanotechnology Innovation Henk J. de Vries

Nanotechnology is an amazing field of innovation—in terms of both the materials used and the products made. However, the technology carries many risks and uncertainties: It may pose harm to people, nature, and the environment. Is an assessment of the potentially adverse impacts of nanomaterials and nanoproducts necessary before they can be brought onto the market? Many researchers see a need for legislation, but could setting standards be an alternative, either alone or in combination with legislation? This chapter will argue that standards can enable innovation while also addressing the broader societal impact of nanotechnology. The chapter will first introduce the relation between standardisation and innovation in general. Next, it will describe and discuss current activities of the International Organization for Standardization (ISO) in this field. Section 3 will address the possible harm, the precautionary principle (PP), and the possible role of legislation and standards. This chapter is based on lessons from literature combined with the author’s own practical experience in other fields of standardisation and innovation. 1. STANDARDISATION TO SUPPORT INNOVATION The combination of standardisation and innovation is not self-evident. At first glance the two concepts ironically seem to exclude each other. Standardisation is the activity of establishing, with regard to actual or potential matching problems, provisions for common and repeated use, aimed at the achievement of the optimum degree of order in a given context (de Vries 1997). In order to establish order, standardisation “freezes” a provision for a certain period of time. Innovation, on the other hand, involves the creation of something new. 91

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In Schumpeter’s classic definition (1934), innovation is the commercialisation of all new combinations based upon the application of new materials and components, the introduction of new processes, the opening of new markets, and/or the introduction of new organisational forms. The core of nanotechnology is in new materials, but the technology’s development also leads to the creation of new products and requires innovation in the other categories in a manner consistent with Schumpeter’s definition. If standards “freeze” a solution, that solution cannot be changed anymore until the standard is withdrawn or revised, so in that sense it indeed hinders innovation. However, this stability is needed for interoperability: Standard interfaces remain stable, providing a basis for the interconnected modules’ further innovation (Lee 2010). In addition to interoperability, the economic functions of standards also include (minimum) quality and safety, variety reduction, and information (Blind 2016). Blind and Gauch (2009) relate standards to phases in the innovation process and argue that the nanotechnology field needs these standards. Semantic standards are needed in the transition from pure basic research to oriented basic research, measurement and testing standards are needed to prepare for applied research, interface standards are needed for experimental development, and interoperability standards, quality standards, and varietyreducing standards are all needed to prepare for market entry. In nanotechnology, interoperability standards are necessary only if the technology is used in systems consisting of several interlinked components. Standards for health, safety, and the environment are needed to mitigate any potential risks of nanotechnology products. For an up-to-date overview of the current insights on the relation between standardisation and innovation, consult the Handbook of Innovation and Standards (Hawkins, Blind, and Page 2017). 2. ISO/TC 229 NANOTECHNOLOGIES 2.1 Introduction Meanwhile, the development of standards for nanotechnology is already underway. ISO initiated the development of international standards in 2005 by establishing Technical Committee (TC) 229 Nanotechnologies. The main topics covered by this TC are terminology and nomenclature, measurement and “characterisation,” health, safety, and the environment, and material specifications. These will be discussed in the subsequent sections of this chapter. 2.2 Terminology Scientists working in nanotechnology come from different disciplines, backgrounds, and industries and lack common terminology (Delemarle 2017).

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The development of terms, definitions, units of measurement and codes, if any, is a core element in the development of any scientific field (Kuhn 1962). Whether nanotechnology is a separate field of science or a subfield of materials science remains open for debate. Regardless of this debate, terminology is still needed to facilitate communication, reduce transaction cost, and avoid misunderstandings and any potential resulting mistakes. Terminology standardisation for nanotechnology is a basis for research itself, but also for other standards and regulation, and it may also benefit practitioners in the field. Finally, sound terminology is a good basis for communicating about nanotechnology in languages other than English (Teichmann 2010). The importance of standardising the terminology we use when discussing nanotechnology is often underestimated. Therefore, it can be difficult to find experts for standardisation committees who are willing to invest money and, more importantly, time in this important work. Moreover, the specialised nature of the topic makes the involvement of nanotechnology experts, along with experts with an affinity for linguistics, a prerequisite. Even if standards are available, stakeholders may be unaware of their existence, may lack financial resources to purchase them, may lack the time to become familiar with the terminology, or may even have difficulty interpreting the standard terminology (de Vries et al. 2009). 2.3 Measurements The properties of technologies and prototypes of products made out of nanotechnology materials need to be assessed throughout the research and development (R&D) process. While different chemical, physical, electronic, and structural properties of nanomaterials create new opportunities for products, the very innovative nature of the technology entails that existing test methods for both materials and products are insufficient and new ones need to be developed in parallel to this advancing technology. Research institutes or companies may do this themselves, but establishing standards for common test methods is preferable for increased reliability and impartiality. Laying down the test methods in standards can facilitate agreement for actors across the field. Especially if such tests based on a common standard are carried out by independent third-party certification bodies with sophisticated knowledge, they make the market more transparent, and the knowledge about current characteristics may further challenge innovators to develop even better technologies and products. 2.4 Health, Safety, and the Environment Nanomaterials are potentially risky for both people and the environment. ISO/ TC 229 (2011) sees assessment of the risks posed by nanotechnology-based

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products throughout their life cycle as an important priority. The development of test methods for use at nanoscale is needed in order to accomplish this. Test methods are also needed to detect and identify nanoparticles, and to characterise nanoscale materials and devices. The TC develops protocols for such assessments. Standards provide two types of legitimacy: input legitimacy originating from stakeholder involvement in the process of standard formation, and output legitimacy resulting from the effectiveness and coordinative capacity of standardisation (Botzem and Dobusch 2012). 2.5 Standardisation of Material Specifications Nanotechnology enables the creation and use of new materials with superior performance for many applications. Standardisation of material specifications helps to define these and to create a database of materials with their known characteristics, which may also include negative side effects. Designers of products can use such a database to make use of the materials that are best fit for their purposes. A company like Philips used to have such a database internally to speed up the process of product development and to reap the benefits of better product quality while lowering the cost of purchasing, storage, and testing. At the European level, the REACH database of chemicals yields an example.1 The REACH information covers the intrinsic properties of around 15,000 chemical substances and their impact on human health and the environment. In 2017 it included 21 nanomaterials, whereas the TSCA Chemical Substance Inventory of the United States Environmental Protection Agency (EPA) listed approximately 160 approved nanomaterials (Sayre, Steinhäuser, and van Teunenbroek 2017). At company level, standards for materials provide a basis for communication between designers, engineers, and purchase and sales people within the company. Standards also allow for easier communication between companies. Standards provide an important basis for trade between sellers and buyers, which may constitute an entire chain, from the production of raw materials via companies processing these materials and companies making semi-finished products to the manufacturers of final products and, at the end of the chain, the customers. Using standards, the customer can specify what he or she wants. This can be an exact specification of the material, but it may also be a specification of the functional or manufacturing requirements for the material. In the latter case there is more choice and room for innovation. Of course, such specifications might be agreed upon within one company or between a supplier and its customer. However, companies increasingly do business with many partners worldwide, and therefore there is a need for international standards for materials (van Mourik, van der Hoek, and de Vries 2012).

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3. MITIGATING RISKS 3.1 Precautionary Principle ISO/TC 229 develops standards for nanotechnology, including standards related to the risks for health, safety, and the environment, but it remains to be determined if having such voluntary standards is sufficient to mitigate risks. Is it acceptable to bring a new technology onto the market if there is no evidence that it does not harm people, wildlife, or the environment? This ethical question relates to the precautionary principle (PP). Stewart (2002, 76) distinguishes four versions of this precautionary principle. 1. PP1: Scientific uncertainty should not automatically preclude regulation of activities that pose a potential risk of significant harm (Non-Preclusion PP); 2. PP2: Regulatory controls should incorporate a margin of safety; activities should be limited below the level at which no adverse effect has been observed or predicted (Margin of Safety PP); 3. PP3: Activities that present an uncertain potential for significant harm should be subject to best technology available requirements to minimise the risk of harm unless the proponent of the activity shows that they pre­ sent no appreciable risk of harm (BAT PP); 4. PP4: Activities that present an uncertain potential for significant harm should be prohibited unless the proponent of the activity shows that it presents no appreciable risk of harm (Prohibitory PP). PP1 and PP2 are weak versions of precautionary approaches. Unlike the strong versions, PP3 and PP4, they do not mandate regulatory action and do not make uncertainty regarding risks an affirmative justification for such regulation. (Stewart 2002)

The question of which version of PP is adequate is an ethical one, which needs to be reflected in light of a societal debate. Existing legislation may also make one of them prevail. 3.2 Legislation Stewart (2002) defined the four versions of the precautionary principle in terms of regulation. However, governments that want to develop legislation for the field of nanotechnology face some problems. 1. They may lack the knowledge to formulate proper legislation, so they will have to rely on technical experts.

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2. Developing regulation takes time, and this hinders the development of the technology by extending the pay-back period of investment. Even worse, because of this delay, commercial application of the technology becomes uncertain. 3. Regulation may be too rigid and as a consequence may hinder innovation. 4. The regulation, once finished, may be already outdated, which also hinders innovation. Given these disadvantages of legislation, standards in combination with conformity assessment have to be considered as an alternative. 3.3 Standards and Conformity Assessment Assessments of the risks of nanomaterials allow market actors to make informed decisions. Such assessments require the ability to accurately and reproducibly measure the physical and chemical characteristics of these materials (Gao and Lowry 2018). Therefore, standardised testing is essential for risk assessment of nanomaterials (Oomen et al. 2018). Sayre, Steinhäuser, and van Teunenbroek (2017) argue that new methods are needed for testing material characterisation, hazard, exposure, fate, and risk assessment of nanomaterials. Determining environmental exposure requires modelling flows of nanomaterials over their entire life cycle (Nowack 2017). So, the risks that are inherent to nanotechnology create a need for agreed-upon methods of performing impact analysis. The challenge is to develop such test methods in parallel to the technology itself. This is even more difficult than developing methods for testing intended effects, because possible unintended effects need to be anticipated. Measurement standards may help to assess impacts in an objective way, as far as objectivity is achievable in such a developing field. Different risk assessment frameworks for nanomaterials have been developed. These differ in terms of scope, advantages, and disadvantages. Most of them lack decision criteria (Oomen et al. 2018). They also point to the need for assuring quality of data. Thus, a system of conformity assessment is needed (de Vries et al. 2010). Gao and Lowry (2018) provide an incomplete overview of projects and organisations active in preparing standards but also conclude that while some methods are becoming standardised and even automated, the full range of factors influencing the reliability and reproducibility of those measurements has not yet been well documented. 3.4 Combining Legislation and Voluntary Standards The question is to what extent stakeholders will take responsibility to make and apply rules for the nanotechnology field themselves. Companies in many

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other fields have done an insufficient job of this, at least in the perception of governments and societal stakeholders such as NGOs. Therefore, governments entered those fields by imposing regulations in areas like health, safety, and the environment (de Vries, Nagtegaal, and Veenstra 2017). However, as we have seen, this tends to hinder innovation in several ways. Actually, such technical regulation is the “Old Approach” to product safety in the EU, used several decades ago, though it is still common practice in China and also partly in the United States (de Vries, Nagtegaal, and Veenstra 2017). Meanwhile, the EU has had positive experiences with the so-called New Approach (EC 2016; Hanson 2005; Hesser and Gautama 2010). In this approach, European directives set essential requirements, mostly related to product safety. These directives need to be implemented in the legal systems of the member states. They refer to European voluntary standards that provide guidance to companies in how they can meet the European directives in the case of specific product groups, as well as test methods to measure conformity to the essential requirements. Meeting such European standards provides a presumption of conformity to the essential requirements. Companies can declare this conformity themselves. In the case of products for which safety is a core issue, a certification body should get involved to provide an independent assessment. If the company has a very innovative product for which the standards do not apply, they may demonstrate conformity to the essential requirement in another way than by meeting the standard. Because neither the regulation nor the standards prescribe a specific solution, companies can improvise. In the United States this is often different—more requirements are established through legislation and compulsory standards, and both may prescribe certain solutions. This hinders companies from finding better safety solutions and may thus be detrimental to innovation (de Vries, Nagtegaal, and Veenstra 2017). The question is if this New Approach to product safety could also be used for the field of nanotechnology. Is it possible to formulate general performance requirements for nanotechnology? 3.5 Need for Balanced Stakeholder Involvement in Standardisation In a longitudinal (1996–2015) case study about energy performance standards for houses in the Netherlands, de Vries and Verhagen (2016) show that a combination of a (national) governmental performance standard and a voluntary committee-based measurement standard could lead to a win-win situation in the sense of stimulating innovation and addressing the societal issue of climate change. The involvement of many stakeholders in this committee (forty-six stakeholder groups were represented) ensured the methods were realistic, up to date, and acceptable for most stakeholders. Government lacks

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stakeholder participation, but companies may have influence via lobbying. The case shows that lobbying hindered timely tightening of the energy performance requirements in periods when the ministry had a weaker minister. Such tightening would have been beneficial not only for energy savings and reduction of CO2 emissions, but also for innovation and economic strength within the sector. Following this line of reasoning, regulation in combination with standardisation may form a realistic and up-to-date package of requirements that stimulate the nanotechnology field to innovate in a responsible way, but the risk of strong influence by certain stakeholders remains. Gottlieb, Verheul, and de Vries (2003) conducted a case study that clearly illustrates the risk of the influence of stakeholders who stand to gain from inaccurate health and environmental safety test results. They examined a scenario involving the standard for measuring the release rate of biocides in antifouling paint. The measurement method laid down in the standard turned out to be inaccurate, allowing the paint industry to continue production of paint with a small fraction of the forbidden substance. This outcome of the standardisation process may be related to the one-sided composition of the ISO working group that developed this standard—most of its participants were employed by big paint producers. The Dieselgate case provides a more recent example of standards that are influenced by commercial interests (Skeete 2017): The standards for measuring car emissions afforded automakers the opportunity to legally sidestep strict performance standards laid out in the law and resulted in a significant performance gap in real world driving emissions. This may be an issue in the nanotechnology field as well. Apart from possible manipulations, there is the more general problem that perceptions differ between experts. Beaudrie et al. (2014) notice important differences in risk perceptions: Nanoscientists and engineers at the upstream end of the nanomaterial life cycle perceived the lowest level of risk, whereas those who are responsible for assessing and regulating risks at the downstream end perceived the greatest risks. So, in order to make standardisation an acceptable instrument for legislators, balanced stakeholder representation is needed, taking foreseeable differences in perceptions and interests into account. To achieve an accurate and unbiased picture, participation of stakeholders involved in the different subsequent stages of the nanomaterial life cycle is necessary. 4. CONCLUSION The field of nanotechnology needs standards developed in parallel to both fundamental and applied research. Fundamental research is necessary for developing technologies, while applied research is necessary for discovering

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their use in all kinds of products. These standards include terminology; specifications of materials; harmful impacts of these materials on health, safety, and the environment; and testing methods. Fundamental and applied research both should be used in combination with forms of conformity assessment. Because of the innovative character of the field, government regulation may hinder development. A combination of rules with voluntary standardisation is the better way to involve stakeholders and to stimulate them to take responsibility. Therefore, balanced stakeholder representation is needed, with participation of experts involved at different stages of the nanomaterial life cycle. Because of nanotechnology’s innovative character and its promising applications, governments may stimulate further development of this new field by supporting both fundamental and applied research. As standards are important from the earliest stages of the R&D process, before granting subsidies governments should require researchers to develop standards in parallel to their investigations. This would be beneficial not only for the field, but also for the country—if these standards get accepted on an international level, it gives the country’s stakeholders a competitive advantage, because for them the standards are perfectly fit for use and they know all of their ins and outs from the outset. Health, safety, and environmental risks may arise from the use of nanotechnology. Standards can ensure that technologies and products made from them do not cause harm. Societal debate may be more informed if such evidence is required before products based on nanotechnology are permitted to enter the market. Eventually, a publicly available database may show accepted technologies. Standards bodies should ensure balanced stakeholder representation to avoid biases in testing methods. NOTE 1. Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/ EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and 2000/21/ EC.

Part II

NORMS AND REGULATION

Chapter 6

Science, Democracy, Industry Who Is in Charge of Regulating Nanomaterials? Diana M. Bowman and Lucille M. Tournas

1. INTRODUCTION Interest in nanotechnologies, and the products and processes associated with the technology, is not new (see Eigler 1999; Smaglik 2000; Roco 2005). Nor are the questions regarding whether nanotechnologies are good, whether the technology is bad—or, in other words, what the potential risks posed by the technology are—and whether or not the technology, and products containing nanomaterials, are regulated (see Fiedler and Reynolds 1993; Reynolds 2003; RS-RAE 2004). These questions have been debated for well over a decade, alongside the increasing production of nanoscale materials and the entry into the market of products containing these materials (RS-RAE 2004; Maynard et al. 2006; Renn and Roco 2006a; Bowman and Hodge 2006). Despite this global discourse and the increasing body of scientific data relating potential risks to human and environmental health and safety (see, for example, Schulte et al. 2014; Maynard and Aitken 2016; Foss Hansen et al. 2017), questions still remain over the efficacy of current regulatory frameworks for minimising potential nano-related risks, and the need for new, nano-specific, regulatory tools and instruments (Hull and Bowman 2018). Such questions and concerns are not new, nor are they unique to nanotechnologies. Commentators and academics alike have long lamented the challenges that new technologies pose to regulatory frameworks and legal instruments, and the inability of these tools to keep pace with the emergence of new technologies and their by-products (Marchant, Allenby, and Herkert 2011; Bennett Moses 2011; Wallach 2015). In relation to nanotechnologies, Ludlow, Bowman, and Kirk (2009) have suggested that this so-called pacing 103

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problem has the potential to lead to periods of both over and under regulation of the technology that can make it difficult to assess the efficacy of the regulatory framework at any given moment in time. Moreover, they argue that an individual’s perception of efficacy and/or adequacy is likely to be influenced by, for example, their background, culture, risk perception, and level of risk tolerance. In this chapter we explore the question of who is in charge of regulating nanomaterials. While such a question may, at face value, seem simplistic (i.e., the regulator), we adopt a more comprehensive lens for thinking about regulation, drawing upon Julia Black’s notion that regulation “produce[s] changes in behaviour” (Black 2001, 108). Accordingly, we argue in this chapter that all sectors of society are currently “regulating” nanotechnologies—albeit to varying degrees—with insurance and reinsurance markets and consumers each having significant regulatory roles. Moreover, this chapter explores the mechanisms through which these various actors play regulating roles with regard to nanomaterials. Furthermore, nanotechnologies serves as a powerful illustration of how future emerging technology may be regulated. The multifaceted regulatory framework captures the complexity of the technology while highlighting limits of hard law, the complicated nature of the geopolitics at play, the shifting power of market forces, and the dilemma of constructing regulatory guidance alongside technological development. In section 2 of this chapter, we begin to unpack the question of who regulates nanomaterials by placing them into their historical context. In sections 3 and 4, we explore the roles that the insurance sector and industry play in regulating nanotechnologies. The role of the state in regulating nanotechnologies and nanomaterials is examined in section 5; here we set out seven broad regulatory principles that are being employed, albeit to varying degrees, in response to the entry of nanotechnology into the market. Section 6 looks at the market and the powers that the market can flex in response to new technologies and/or products. This chapter concludes by arguing that good governance of any new technologies requires the active engagement and participation of all sectors due to the unique regulatory capacities and tools that each brings to the table. 2. WHO REGULATES NANOMATERIALS? PUTTING THE REGULATORY QUESTION INTO CONTEXT The emergence of nanotechnologies into the global market was surrounded by great hype as well as hyperbole (Toumey 2004; Berube 2006; McGrail 2010). During its nascent stage, proponents of the technology claimed that it

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would signal, among other things, a “new industrial revolution” and would be the “economic driver” for the twenty-first century (see, for example, White House Office of the Press Secretary 2000; National Nanotechnology Initiative 2001; Roco 2001). Given such claims, it is arguably not surprising— especially given its emergence so soon after the backlash against genetically modified organisms within the EU—that the technology quickly became subject to widespread scrutiny and intense debates. Uncertainty regarding the developmental trajectory of the technology, significant scientific uncertainty regarding the potential risks of certain nanomaterials, and dual—and often conflicting—roles being played by governments as promoters and regulators of the technology appeared to only fuel these discussions (see Renn and Roco 2006a; Foss Hansen et al. 2008; Hodge, Maynard, and Bowman 2014). The landmark report by the Royal Society and Royal Academy of Engineers (RS-RAE 2004) sought to articulate the breadth of potential applications as well as document issues relating to risk and risk assessment, and an array of ethical, legal, and societal issues. While a comprehensive review of the report is beyond the scope of this chapter (see instead, Bowman 2017), the report acted as a catalyst for debate on the adequacy of existing legal frameworks to effectively regulate nanotechnologies and nano-based products (see Chaudhry, Castle, and Watkins 2017; Ludlow, Bowman, and Hodge 2007; FDA 2007; EPA 2007; EC 2008a, 2008b; Falkner and Jaspers 2012). This included, for example, a number of nongovernmental organisations, including Friends of the Earth and the ETC Group, calling for a moratorium on the use of nanotechnologies in several market sectors and the implementation of nano-specific regulatory arrangements (see ETC Group 2005; Miller and Senjen 2008). Following the release of the RS-RAE’s (2004) report, a number of governments and government agencies undertook their own in-house and/or commissioned independent reviews of their regulatory arrangements for nanotechnologies (see Chaudhry, Castle, and Watkins 2017; FDA 2007; EPA 2007; Ludlow, Bowman, and Hodge 2007; EC 2008a, 2008b, 2012; Gavaghan and Moore 2011). These reviews focused exclusively on reviewing the adequacy of existing hard law instruments (i.e., legislation, regulations, and rules) and their operation. Each review illustrated the ways in which nanoproducts would be “captured” by the existing instruments in the same way that their conventional counterparts would be—a phenomenon that Stokes (2012) coined a “regulatory inheritance”—while also illuminating potential weaknesses. These included, for example, the inability of traditional chemical regulatory regimes to differentiate between approved conventional chemical substances and their nano-counterparts displaying unique ­ physico-chemical characteristics (Chaudhry, Castle, and Watkins

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2017; Ludlow, Bowman, and Hodge 2007; Gavaghan and Moore 2011). The European Commission (EC), in their report, also sought to highlight the challenges associated with implementation and enforcement (2008a, 2008b). It is important to note, however, that these latter challenges are not unique to nanotechnologies, nor is the issue of regulator capacity. Against this backdrop of regulation by default rather than by design, Marchant and Sylvester anticipated that “purposeful regulation” would be forthcoming (2006, 714). They were correct. For regulatory scholars LeviFaur and Comaneshter (2007), the early push for nano-specific regulations was unique. As they observed, “probably for the first time ever, the attempt to develop a regulatory framework for a new technology is emerging on the public agenda hand in hand with the development of the technology itself” (2007, 150). Within two years of this statement being made, the EU became the first jurisdiction in the world to enact legislation that contained nano-specific provisions with the passage of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (“Consumer Products Regulation”). Importantly, while the recast of the regulatory framework for cosmetics was not initiated as a result of the increasing use of nanomaterials in cosmetic products (Bowman, van Calster, and Friedrichs 2010), the significance of a regulatory definition for a “nanomaterial,” and the subsequent (additional) regulatory requirement created by Regulation (EC) No. 1223/2009 on nano-cosmetics entering the EU market, should not be understated. Regulation (EC) No. 1223/2009 sought to enhance transparency in the market through the creation of a number of initiatives, including additional reporting requirements for the commission (Article 16[3]), a publicly available registry (Article 16[10]), and consumer labelling requirements for products containing nanomaterials—(nano) (Article 19[1][g]). It can be argued that these requirements allow for, or at least provide some of the necessary elements for, consumers to make informed decisions about their cosmetics. This interplay between the regulator and the market highlights the complex and interrelated matrix that exists in relation to regulation and the various roles that are played by different communities. In the following sections, we illustrate the ways in which different actors—as illustrated by figure 6.1— regulate nanotechnologies, and nanomaterials more specifically. We argue that each of these actors have an important role to play in regulating nanotechnologies, and that by working collectively, the benefits of the technology are more likely to be realised in a shorter time frame. In the following sections, we look at each of the sectors in turn.

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Figure 6.1  Key constituents in the regulation of nanotechnologies

3. INSURANCE AND REINSURANCE The insurance and reinsurance sectors can be viewed as powerful actors who shape the trajectory of R&D activities, as well as the entry of products onto the market. This is especially true in the field of nanotechnologies and nanomaterials, where there still remains a high degree of uncertainty over the potential risks of some nanomaterials in certain circumstances (Lloyd’s 2007; Hett 2004; see also Chatterjee 2009)—including questions of latency— and limited government intervention in the way of nano-specific rules and/ or regulations. Taken together, these circumstances suggest that there is a significant role for the private insurance sector to shape and address potential risks of nanotechnology early in the innovation cycle. 3.1 Industry Perspective Nanotechnologies offer a unique complication for the insurance sector, as risk is an important variable that actuaries must use in order to calculate policies. The more data that is available to the actuary, the more reliable the risk calculations are likely to be for premium pricing (at least in theory). Balancing benefits and risks is central to these calculations. In 2002, Munich Re Group issued one of the earliest reports by an insurance company looking at the benefits and risks of the technology. Munich Re

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highlighted the role of the insurance sector in helping to facilitate the positive impact of emerging technologies while minimising the negative impacts through the active management of risks (Munich Re 2002). The insurer sought to highlight the potential significance of nanomaterials in advancing a myriad of products across all industrial sectors. Their report was not without caution; Munich Re acknowledged that their major concerns with the technology were those of latent risk and the risk of general liability coverage and mass tort litigation. Swiss Re echoed the opinion that the presence of nanomaterials cannot be interpreted as de facto dangerous to people and the environment (Hett 2004). In their 2004 report, they emphasise the importance of finding actual harm before making these determinations. With nanomaterials, there are many questions to be answered and, in answering these questions, Swiss Re stressed the need for a precautionary approach to the technology (Hett 2004). In 2007, Lloyd’s of London issued their own guidance report on nanomaterials (Lloyd’s 2007). Specifically, they acknowledged that nanomaterials can create significant advancement across many products and industries. Additionally, they stressed the importance of distinguishing between real and perceived risks. In acknowledging a number of (potential) risks, the insurer went on to state that it is critical to think of nanotechnologies and nanomaterials as not one homogenous technology or material, but rather as a collection of different types of applications and materials. As such, there is no one singular risk profile or set of concerns that apply universally across the technology. The ability to differentiate between different applications and materials will be critical for risk assessment and risk management (Lloyd’s 2007). Lloyd’s stressed the importance of anticipating real risk but went on to suggest that this must be balanced with innovation. This agenda, they suggested, should be driven by industry and governments in order to leverage the different strengths of the partners (Lloyd’s 2007). Collectively, these reports served to highlight the very real concerns of the insurance sector and their push for governments and industry to take a precautionary approach to nanotech R&D activities. Despite these concerns, it is important to note that as of May 2018, there had been no reported harm to human health, nor any mass tort litigation involving nanomaterials. That being said, the absence of acute harm has done little to relieve the concerns of some stakeholders in relation to latent harm potentially posed by some nanomaterials (see, for example, Gwinn and Vallyathan 2006; Pacurari, ­Castranova, and Vallyathan 2010; Mullins and Gatof 2014). The increasing body of risk data on nanomaterials has, we would argue, addressed some of the concerns expressed by the insurance sector early in the technology’s development. However, the increasing production volume of nanomaterials, including non-biodegradable, metal oxide nanomaterials, still

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does raise myriad concerns for potential human and/or environmental health risks. These include risks relating to worker exposure to certain types of nanomaterials during the manufacturing process (RS-RAE 2004; Gwinn and ­Vallyathan 2006), which has increased significantly over the last two decades (Gottschalk and Nowack 2011; Hendren et al. 2011). 3.2 Coverage It is not surprising that there are comparisons between nanotechnology and asbestos, with the potential for future mass tort litigation (Poland et al. 2008; Mullins and Gatof 2014). This section will briefly explore different policies, the exclusion of carbon nanofilters from coverage by one firm, the challenges of calculating premiums, and anticipating longer-term liability. While cursory in nature, this section of the chapter highlights the power that the insurance sector has in shaping the ways in which companies engage with nanotechnologies, including in relation to R&D activities. To date, insurance companies have, for the most part, covered nanotechnologies through their existing liability policies and instruments, which do not refer specifically to nanotechnologies or nanomaterials. These policies would—in the same way existing regulatory instruments cover nanotechnologies by default—seem to implicitly cover processes and products (Blaunstein and Linkov 2010; Mullins et al. 2013; McAlea et al. 2016). The exception is Continental Western, a US-based firm, which began to exclude coverage to companies processing or manufacturing carbon nanotubes in September 2008. This move by Continental Western was somewhat controversial at the time (Chatterjee 2009), with a number of stakeholders criticising the insurance company (see, generally, Monica and Monica 2008). It is arguably not surprising, therefore, that Continental Western’s seemingly aggressive approach to managing nanotech-related risks has not become pervasive. Rather than exclude nanotechnologies from their risk portfolio, Lexington Insurance has, instead, introduced a NanoShield policy, which offers insurance products and risk management services that are designed for companies whose principal business is manufacturing nanoparticles or nanomaterials, or using them in their processes (Chartis 2010). These policies include liability coverage that offers protection for general liability, product liability, and first-party product recall coverage if a product containing nanoparticles or nanomaterials is recalled from the market for safety concerns (Chartis 2010). It is noteworthy that while there have not been significant claims linked to adverse outcomes and nanotechnologies as yet, the unknown risks of certain nanomaterials, under certain circumstances, has given rise to a number of liability concerns. Should we see litigation occurring, the initial claims are

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likely to come from employees of manufacturing firms that produced raw, non-biodegradable, metal oxide nanomaterials (RS-RAE 2004). To be successful in such a suit, the plaintiff(s) will need to demonstrate causation; this is likely to be difficult for some employees/plaintiffs to prove if they have worked in a number of manufacturing facilities. However, a jury could find a suit very persuasive if there are catastrophic compensation claims from many employees connected to a single employer. One can assume that once harm has been established in relation to employees, third-party claims from consumers who have used and/or consumed products manufactured by the company/employer are likely to follow. A number of specific concerns have been raised by members of the scientific community and others in relation to the similarities exhibited between carbon nanotubes and asbestos fibres (Poland et al. 2008; Donaldson et al. 2010, 2013). While the full complexity of asbestos-induced carcinogenesis is not fully understood, it is understood that some of the physical characteristics of asbestos are factors. Specifically, high biopersistence as well as its needlelike structure have been identified; both characteristics are also displayed in carbon nanotubes (Donaldson et al. 2010, 2013). As with asbestos, it has been suggested that carbon nanotubes may easily enter the pulmonary system and have a similarly long latency period before damage is discovered. These concerns are highlighted in a study that showed that under certain circumstances, certain types of carbon nanotubes may produce mesothelioma-like symptoms when installed into the abdominal cavity of rats. Currently, however, there is no evidence of harm to humans relating to carbon nanotube exposure. In countering the Poland et al. (2008) study, Monica and Monica (2008) argue that the authors improperly infer that the injection of fibres into the peritoneal cavity of mice will mimic the inhalation of fibres by humans and thus result in mesothelioma. They also note that the study would fail the Daubert standard of admissibility and therefore would not be admissible in a US court of law (Monica and Monica 2008). Nonetheless, these concerns highlight the difficulty in anticipating long-term liability issues that may arise. To date, we are not aware of any claims that have been made in relation to nanotechnology-related harms. As such, the frequency and severity of potential insurance losses is still conjecture, with liability risks associated with nanotechnologies still outside typical insurance practices. Traditionally, insurance underwriters depend on the ability to calculate insurance risk based on the extent of damage, and probability of its occurrence must be accessible. Therefore, calculating premiums in the short term would appear to be extremely difficult. That being said, we would argue that insurance and reinsurance companies wield significant power in shaping and influencing the trajectory of the technology as it is being developed and brought into the market. The current

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status of implied coverage allows companies to develop quickly and without fear of immediate financial risk. Conversely, if this presumption of coverage is challenged, and insurance companies do not want to cover nanotechnology, it could disrupt and halt entire industry sectors. Therefore, insurance companies can move the direction of development of an emerging technology like never before. 4. INDUSTRY It is widely accepted that regulatory responses lag behind the new and emerging technologies, tools, and products that they govern (Marchant, Allenby, and Herkert 2011; Brownsword and Yeung 2008). Importantly, while this may mean that the regulatory framework is not the most effective for regulating a given technology at the time of its entry into the market, it does not mean that the technology and its products are “unregulated.” As eloquently framed by Stokes (2012), existing regulatory frameworks will capture new products in the same way that they capture their conventional counterparts. The lag that this gives rise to, which can be seen as a period of potential “under regulation” (Ludlow, Bowman, and Kirk 2009), can be said to provide industry with opportunities to innovate within the research and development space, as well as in the ways they govern their own activities within the innovation space. The emergence of nanotechnologies provides myriad examples in which industry actors sought to go beyond the requirements set down by the state, employing different forms of “governance” approaches or non-legislativebased activities as part of their approach to business (Brownsword 2010; Bowman and Hodge 2008). While traditionally associated with the activities of government (Stoker 1998), the term “governance” now refers to the development of governing styles in which boundaries between and within public and private sectors have become blurred. The essence of governance is its focus on governing mechanisms which do not rest on recourse to the authority and sanctions of government. (Stoker 1998, 17)

In this way, each approach developed by industry—voluntary codes of conduct, risk management frameworks, industry codes, and/or private standards—can be seen as a case study in what does or does not work for promoting human and/or environmental health and safety. These forms of governance are less resource intensive to develop and administer and have the ability to evolve and respond to the changing environment quicker than state-based regulation (Braithwaite 1982, 1993; Sinclair 1997). Moreover,

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these soft approaches can provide breathing space for innovation and creativity to occur. It is important to recognise, however, that industry’s interest in soft law preceded the emergence of nanotechnologies products and processes. Early examples include the chemical industry’s Responsible Care Program (see Rees 1997; King and Lenox 2000), which has been widely adopted by the industry (International Council of Chemical Associations 2018). While not perfect (Gunningham 1995), the Responsible Care Program is more robust than many other voluntary programmes. As such, its legitimacy within industry, combined with the perceived benefits of self-regulation to industry, is arguably a key factor in the proliferation of voluntary codes of conduct and risk management frameworks designed specifically in response to nanotechnologies. Early examples of these initiatives include BASF’s “Code of Conduct,” DuPont and Environmental Defense’s “Nano Risk Framework,” the European Commission’s “Responsible NanoCode,” NanoSafe’s “Five-Point Program,” and NanoAction’s “Principles for the Oversight of Nanotechnologies and Nanomaterials” (Royal Society et al. 2007; European Commission 2009; Hull 2010; DuPont and Environmental Defense 2007; NanoAction 2007; BASF 2015). An analysis of the effectiveness and impact of these initiatives is beyond the scope of this chapter, in part because of the great variation between the programmes, including their stated goals and the tools they employ to help achieve them, and the difficulties more generally of evaluating them from a quantitative basis (see instead Meili and Widmer 2010; Weidl, Klein, and Zollner 2010; Shelley-Egan and Bowman 2018). What we can say, however, is that many of these programmes draw upon and incorporate, albeit to varying degrees, traditional risk management principles, including “(a) acceptable risk, (b) cost-benefit analysis, and (c) feasibility (or best available technology)” (Marchant, Sylvester, and Abbott 2008, 44). Shelley-Egan and Bowman (2018) suggest a number of these initiatives have also been subsumed under the broader Responsible Research and Innovation (RRI) agenda that evolved largely in response to the emergence of nanotechnologies in the mid- to late 2000s (see also von Schomberg 2011; Rip 2014, 2016; Shelley-Egan, Bowman, and Robinson 2017). These initiatives, in all of their various forms, are a form of regulation. While they may be lacking in teeth and claws—in the form of sanctions traditionally associated with legislation (Sinclair 1997; Gunningham and Rees 1997; Bowman and Hodge 2008)—it is important to acknowledge that this is arguably not their intent. Rather, these industry-driven programmes and initiatives operate in addition to their formal regulatory obligations. They operate by incorporating a precautionary approach to the manufacturing of nanoscale materials, by implementing innovative processes and state-of-the-art scientific

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knowledge in current practices, as well as by gathering data through processes that can then be used to develop risk-appropriate management practices for nanomaterials. They are, in sum, one part of the broader governance matrix shaping R&D activities and the entry of nanotechnologies onto the market. 5. GOVERNMENT AND REGULATORY AGENCIES Safety regulators act as gatekeepers for new technologies, applications, and/or products making their way into the market. They play a critical role in managing and mitigating risk and protecting human and/or environmental safety. But, as evidenced by a number of recent regulatory failures—including, for example, Vioxx and Celebrex (Horton 2004; Epstein 2005; Couzin 2005)— regulatory agencies are not infallible and today are subject to close scrutiny and oversight from many different actors and sectors. This has been especially true, we would argue, in relation to their handling of nanotechnologies and nanomaterial within jurisdictions such as Australia, Canada, the EU, New Zealand, and the United States. This scrutiny has promoted a range of responses from health and safety agencies, including a number of regulatory reviews (see section 2), white papers, guidance materials, and policy documents (see Health and Safety Executive 2006; Chaudhry, Castle, and Watkins 2017; Royal Commission on Environmental Pollution 2008; EC 2008a, 2008b, 2012; Bowman 2017). The ability of a regulator to effectively regulate nanotechnologies is, as noted by Chaudhry et al. (2006) and Ludlow, Bowman, and Hodge (2007),1 governed by powers vested in the regulatory agency by the legislature. In short, if the enabling piece of legislation only provides the regulator with the power to assess human health risks, then the regulator is bound to only consider human health risks; it is outside their scope to consider, for example, environmental risks. Moreover, safety regulators, such as the European Medicines Agency, Singapore’s National Environment Agency, and the US EPA, are vested with powers that only allow them to assess human and/or environmental health risks and not broader societal issues such as ethical and societal issues. The inability of regulators to consider issues such as equity, access, and broader societal risks posed by nanotechnologies has been a contentious issue for a number of stakeholders (see, for example, Miller and Scrinis 2010; Wehling 2012; Miller and Wickson 2015; Petersen and Bowman 2012; Lyons and Smith 2018). While arguably frustrating for some, without enabling legislation that provides them with the ability to consider questions beyond narrow human and/or environmental risk-related issues, the regulator is unable to act. This does, however, provide policy makers more generally with an ability to engage with all stakeholders on issues beyond a narrow risk-related framing.

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Such concerns have gone hand in hand with what some stakeholders, such as Friends of the Earth and the ETC Group, see as limited, if not tokenistic, forms of public engagement in the regulatory decision-making progress (see Miller and Scrinis 2010; Miller and Wickson 2015). Their concerns are not without merit. It took, for example, the US Food and Drug Administration (FDA) six years to respond to the International Center for Technology Assessment (ICTA) et al.’s citizen’s petition on the use of nanomaterials in FDA-regulated products, including sunscreens (ICTA 2006; FDA 2012). Such delays, in our view, have the potential to undermine the legitimacy of the engagement process and create unnecessary barriers to productive engagement between key stakeholder groups. But how are nano-based products being regulated today? With a number of in-depth regulatory reviews having been undertaken over the last fourteen years on this question (see, generally, Bowman 2017), this chapter instead seeks to show how two jurisdictions—the EU and the United States—have diverged on the regulation of nanomaterials in their market. Our focus on these two jurisdictions can be easily explained: they represent two of the largest markets for nano-based products in the world, they have both made significant investments in nano R&D activities, and they have been significant actors in shaping the nano-agenda. We have also seen significant divergence in their approach to nanotechnologies over the last ten years. Table 6.1 sets out seven regulatory principles that we consider important to the EU and the US governments’ approach to the entry of nanomaterials into the market. Precautionary principle. First detailed in Article 191 of the Treaty on the Functioning of the European Union, the PP has increasingly been a feature of EU law and policy, especially those relating to consumer and environmental protections. The wholesale recasts of the regulatory frameworks for chemical substances and cosmetics, for example, saw the EU expressly incorporate the PP into the regulations. Article 1(3) of the Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH, or Table 6.1  Regulatory principles being deployed for nanotechnologies Regulatory Principle

EU

US

Precautionary Principle Product-Based Regulation Process-Based Regulation Nano-Specific Regulations Use of Existing Rules to “Capture” Nano Nano-Labelling Requirements Mandatory Disclosure Requirements

✓ ✓ ✓ ✓ ✓ ✓ ✓

✗ ✓ ✗ ✗ ✓ ✗ ✗

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REACH Regulation [EC] 1907/2006) states, for example, that “its provisions are underpinned by the precautionary principle.”2 Similarly, the preamble to the Cosmetics Regulation (Regulation [EC] No. 1223/2009) states that “action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle” (Preamble, 36). In order to ensure a high level of consumer protection, the council and the Parliament have expressly incorporated the principle into their regulatory frameworks. This, in sum, provides the EU with significant latitude when dealing with scientific uncertainties posed by, for example, nanotechnology and nanomaterials. In contrast, while key legislative instruments in the United States—including, for example, the Toxic Substances Control Act and the Federal Food, Drug, and Cosmetic Act—are underpinned by a precautionary approach, they do not expressly refer to the precautionary principle. This stance is echoed by the White House in “Principles for Regulation and Oversight of Emerging Technologies,” which states, for example, that “regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatising new technologies, or creating trade barriers” (Holdren, Sunstein, and Siddiqui 2011b, 1), and that “where possible, regulatory approaches should be performancebased and provide predictability and flexibility in the face of fresh evidence and evolving information” (Holdren, Sunstein, and Siddiqui 2011a, 3). Product-based regulation. A product-based scheme bases regulatory action on the final product entering the market. In regard to nanotechnology, this has been the default system for the United States, as explained by Holdren, Sunstein, and Siddiqui (2011a) in the White House’s memo, “Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials.” This memo acknowledges that the government’s approach is to regulate products, not processes, and that a case-by-case assessment can be taken where warranted (Holdren, Sunstein, and Siddiqui 2011a; see also FDA 2007). The majority of EU regulatory systems—including those for drugs, medical devices, and cosmetics—are also product-based; however, there is some deviation in this. The product-based system, utilised in both the United States and the EU—as well as most other jurisdictions—fosters innovation by lessening the costs associated with early regulatory hurdles (Marchant and Stevens 2015; FDA 2007). Moreover, a product-based approach promotes innovation by balancing benefits (i.e., promoting safety) with potential risks (i.e., by not assuming the materials are de facto dangerous) (Marchant and Stevens 2015; Abbott, Marchant, and Corley 2012). Process-based regulation. The EU has implemented several frameworks that aim to regulate the process and/or technology by which a product is made rather than the final product. This process-based approach originated in

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response to the scientific uncertainties and public response to biotechnology. While GM foods were originally regulated in the same way as their conventional food equivalents, there was public backlash, which the EU responded to in 2003 by adopting regulations specifically for GM foods, feeds, and crops (EU Parliament and Council 2003). These regulations integrate definitions from EU Directive 2001/18/EC, which subjected products that involve recombinant DNA to pre-market risk assessment, approval, labelling, and traceability requirements (Marchant and Stevens 2015). The sui generis regulatory regime gave rise to more rigorous requirements for foods made with GM ingredients (Marchant and Stevens 2015). While the EU has not created a sui generis regulatory regime for nanotechnologies per se, the inclusion of nano-specific requirements in, for example, Regulation (EC) No. 1223/2009, Regulation (EU) No. 1169/2011, and Regulation (EU) 2017/2470, does single out the technology and treat it somewhat differently from other earlier technologies. While the United States has taken a product-based approach to regulating products containing nanomaterials (i.e., products containing nanomaterials are regulated in the same way as their conventional counterparts), it should be noted that the regulatory scheme for biotechnology has morphed from a product-based approach to a hybrid approach. Specifically, the US Department of Agriculture (USDA) requires more information for GM crops, the US EPA oversight now incorporates the genetic material in plants that are engineered to produce a pesticide prior to production, and the US FDA has recommended that GM producers “volunteer” for “informal consultation” with the FDA prior to marketing new GM foods (Marchant and Stevens 2015). Nano-specific regulations. As noted above, the EU has incorporated a number of nano-specific provisions into recast legislative instruments, including Regulation (EC) No. 1223/2009, Regulation (EU) No. 1169/2011, and Regulation (EU) 2017/2470. Importantly, the recast of these instruments was part of a larger package of reforms and was not a direct response to the emergence of nanotechnologies and nanomaterials into the market. Each regulation defines what is meant by “nanomaterials” for the purposes of the regulation and establishes a number of specific obligations for products (i.e., cosmetics, foodstuffs, or novel foods) produced by nanotechnologies or containing nanomaterials. These obligations are in addition to those established for their conventional counterparts. As set out in Article 16 of Regulation (EC) No. 1223/2009, the basis for the inclusion of nano-specific provisions is to ensure “a high level of protection of human health.” This sentiment is echoed in the other regulations. In line with its stance that US federal regulatory agencies regulate products and not processes, no nano-specific provisions have been incorporated into federal regulatory instruments. Products are, instead, regulated on a caseby-case basis (FDA 2007). Agencies such as the US FDA have, however,

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produced a number of guidance documents for nanotechnologies in order to clarify key issues and promote the safe entry of nanotechnologies into the market (FDA 2014a, 2014b, 2014c, 2015, 2017). The US EPA also has existing tools, such as the Significant New Use Rule (SNUR) under §5 of the Toxic Substances Control Act, to require industry to provide the regulator with additional information on certain nanomaterials, including, for example, multiwalled carbon nanotubes (EPA 2017a). The EPA has also employed its rule-making power under §8(a) of the Toxic Substances Control Act to require industry to provide certain information to the agency about the manufacturing, importation, or use of nanomaterials in the US market (EPA 2017b). The use of existing, softer instruments has allowed the agencies to tailor their activities toward nanotechnologies. Mandatory labelling. The passage of Regulation (EC) No. 1223/2009 through the European Parliament and Council in 2009 provided the EU with the power to require the mandatory labelling of nanomaterials in cosmetic products for the first time. In doing so, Regulation (EC) No. 1223/2009 became the first piece of national or supranational legislation to include nanospecific provisions, including those relating to labelling. Pursuant to Article 2(1)(k) of Regulation (EC) No. 1223/2009, a “nanomaterial” is defined, for the purposes of the regulation, as “an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”3 Pursuant to Article 19(1)(g), cosmetics containing nanomaterials must indicate the presence of the nanomaterial(s) in the list of ingredients by using the word “nano” following the listing. These labelling guidelines also apply to the labelling of foods containing nanomaterials and to novel foods produced using nanotechnologies (although the definition of a nanomaterial differs for these regulations when compared to Regulation [EC] No. 1223/2009). The United States, however, has not instituted mandatory labelling for consumer products containing nanomaterials. US regulators tend to view labels as a form of risk identification (FDA 2007). In this way, requiring nanomaterial labelling implies a hazard. To that point, in 2007, the FDA addressed the issue of labelling products containing nanomaterials in its Task Force Report. In rejecting the need for nano-specific labelling rules, the FDA noted that the consumer may not always understand nanotechnology; specifically, the consumer may not understand if nanotechnology affects the safety or efficacy of the product (FDA 2007). In the FDA’s view, products containing nanomaterials under the purview of the administration do not raise any new safety concerns; thus, there is no legislative basis for mandatory labelling (FDA 2007). This should, instead, be addressed on a case-by-case basis. Moreover, pursuant to the Federal Food, Drug, and Cosmetic Act, product labels must be

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truthful and not misleading. On this basis, the FDA (2007) went on to suggest that if the disclosure of the use of nanoscale materials in the product is not essential to safety, then it is not required. Mandatory disclosure. In addition to the labelling requirements established by Regulation (EC) No. 1223/2009, the Cosmetic Regulation also established mandatory reporting requirements for industry. Pursuant to Article 16(3), responsible parties must disclose to the commission information relating to cosmetics containing nanomaterials. Parties must, for example, provide the commission with information on the identity of the nanomaterial, including its chemical name; specifications and chemical properties; quantity of nanomaterial in annual production; toxicological profile; safety information; and reasonably foreseeable exposure considerations.4 The Cosmetic Regulation also created disclosure requirements for the commission. Pursuant to Article 16(10), the commission is required to provide a public catalogue documenting all nano-based cosmetics available on the European market5 and furnish the Parliament and council with an annual report on the status of nano-based cosmetics in the European market.6 Despite setting out milestones for the publication of this information, the commission has not been able to meet its requirements, resulting in the EU ombudsman reprimanding the commission for its delays (ClientEarth 2018). US federal regulators do not, at present, have powers similar to those of the commission in relation to nano-cosmetics. The EPA has, however, used existing tools to garnish information regarding the manufacturing, importation, and/or use of nanomaterials in commerce. This included a voluntary data call on nanomaterials in 2008, the results of which have been described by some stakeholders as underwhelming. In critiquing the programme, Environmental Defense Fund senior scientist Richard Denison noted the following: Fewer than 10%—123 out of the more than 1,600 unique nanomaterials EPA estimates are already commercially available—were addressed in the basic program submissions. The submissions encompass only one-seventh (28 of 200) of the unique chemical structures on which nanomaterials in use or development are based. (Denison 2009)

The limited data gathered through the voluntary programme is similar to that observed in relation to the UK’s and Australia’s voluntary data call-ins (Bowman 2017). In January 2017 the EPA also exercised its reporting rule powers under §8(a) of the Toxic Substances Control Act. The rule “established final reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale” (82 Fed. Reg. 3641). These include, for example, “chemical identity, production volume, methods

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of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects” (8 Fed. Reg. 3641). The rule, which came into effect in May 2017, provides only for the provision of information by industry to the regulator; it does not provide for public reporting of data. 6. MARKET As seen in other areas of emerging technology, the market can arise as the ultimate regulator. This is arguably best illustrated by the so-called failure of GM crops in the EU market, where a large segment of the European public rejected GM foods (see Bauer, Gaskell, and Durant 2002; Bonny 2003). While new technologies often struggle from fears based on public perception, the experience of GM foods in the EU highlights the powerful voice of the public when it comes to risk perception and the way that perceived dangers— real or imagined—can influence purchasing decisions. There are many lessons that can be learned by focusing on the food industry when thinking about how the market can act as a powerful regulator for any new or emerging technologies and the products they give rise to. The food industry has historically been an area for rapid innovation, with small to multinational companies competing for an increasing share of the market in an area with traditionally low profit margins (Galizzi and Venturini 2012). Companies are often aggressive in their R&D activities, looking to new and emerging technologies to give them the competitive edge (see Chaudhry et al. 2008; Rollin, Kennedy, and Wills 2011; Neethirajan and Jayas 2011). Food is also personal in nature for many of us, with Bowman and Ludlow (2017, 175) arguing that it is “inextricably linked to custom and culture, rituals and religion, and family and friends.” As such, adverse views from just a few— especially influential—individuals or stakeholder groups can dramatically influence market receptiveness, consumer purchasing behaviour, and, in turn, business practices. A case in point in relation to the use of nanotechnologies in food was the very public case of America’s beloved Dunkin’ Donuts using nanoscale titanium dioxide as a whitening agent in the sugar coating of their donuts in 2013 (Biello 2013; Gergely, Bowman, and Chaudhry 2017). Newspaper headlines were for many consumers their first introduction to the use of nanomaterials in their food. In July 2014 an article appeared in the Guardian with the title “Activists Take Aim at Nanomaterials in Dunkin’ Donuts: The Donut Giant—along with Kraft and McDonald’s—Faces Challenges over Microscopic Materials in Its Food Chain. Is This the Next GMO Crisis?” (Shemkus 2014).

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The use of titanium dioxide in food is not new. As noted by Gergely, Bowman, and Chaudhry (2017), for example, the FDA approved “food grade TiO2 as a colour additive under Title 21 of the Code of Federal Regulations,” with its use believed to be widespread in commercially available food products (Illuminato 2014). Despite this, public outrage concerning its use in products, and the potential backlash to share prices, led Dunkin’ Donuts to remove the ingredient. When announcing the decision, the company noted that titanium dioxide used in their products “does not meet the definition of ‘nanomaterial’ as outlined under FDA guidance” (Westervelt 2015). Despite this incident, which played out against a backdrop of broader concerns in relation to the use of nanomaterials in food (see EFSA 2009; Bouwmeester et al. 2009; Cushen et al. 2012; Chaudhry, Castle, and Watkins 2017), there has been no (reported) sustained backlash to the use of nanomaterials in commercially available products such as foods and personal care products. One could argue, of course, that it is difficult for the public to reject a technology and its application if they do not know that they are buying a nano-based product. This is a powerful point in relation to nanotechnologies, with—as noted above—only a few regulatory instruments, such as the EU’s “Regulation (EC) N° 1223/2009 on cosmetic products and Regulation (EU) 2015/2283 on novel foods” (EC 2013c) requiring industry to label nanobased products captured by the regulations as such. Figure 6.2 provides an illustration of the “nano” label required under Regulation (EC) No. 1223/2009. Of note, the cosmetic product, which is in compliance with EU law, is manufactured by an Australian company and was purchased in the US market. In this way it provides an example of how the requirements of EU law have diffused across jurisdictional boundaries.

Figure 6.2  Example of a “nano” label compliant with Regulation (EC) No. 1223/2009

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The use of the “nano” ingredient label can be viewed as a tool that allows consumers to exercise greater control of the types of products they purchase, whether in a positive way (i.e., by actively seeking products containing nanomaterials) or a negative way (i.e., by purposely avoiding products containing nanomaterials) (Caswell 1998; Bowman, van Calster, and Friedrichs 2010; Stokes 2011). In regard to the latter, we have seen a number of companies actively embrace the use of the “non-nano” label in an attempt to differentiate their product from that of the competition (Gruère 2011; Amenta et al. 2015). This approach is reminiscent of the anti-GM movement in the EU, as illustrated by figures 6.3a and 6.3b. Whether or not labelling for nanomaterials has had an impact on consumer behaviour remains to be seen; to date there is very limited data on how EU consumers have responded to the introduction of mandatory “nano” labels for cosmetics and food products in the EU market. We have yet to witness any sustained public backlash to such products since the introduction of the labelling regimes. However, the efficacy of any labelling regime is dependent on at least two elements: consumer behaviour and knowledge. By this we mean that consumers must engage with the information on the label in a meaningful way and have adequate knowledge about ingredients, such as nano, in order to make the information consequential to their actions. This presents a number of challenges given that public awareness of what nano means remains, for the most part, low (Sheetz et al. 2005; Handford et al. 2015; Hallman and Nucci 2015), and we would argue that consumer engagement with product labels is

Figure 6.3  Examples of negative labelling for GMOs. Source: Pictures by bauhaus1000, https​://ww​w.ist​ockph​oto.c​om/at​/foto​/nich​t-gvo​-seeb​%C3%A​4r-au​f-ein​em-ap​ple-g​m5360​ 57407​-5771​2658,​ and VladSt, https​://ww​w.ist​ockph​oto.c​om/at​/vekt​or/le​bensm​ittel​etike​ttgu​mmi-b​riefm​arken​-gvo-​nat%C​3%BCr​liche​-bio-​speis​en-gm​52722​2474-​92737​043.

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generally low. The label itself, we would argue, is therefore not enough on its own to promote informed purchasing practices. Other tools are needed to support and empower consumers. Shelley-Egan and Bowman (2015) have suggested that tools such as (nano-)labelling also operate in such a way as to shift responsibility from industry and the regulator to the consumer. The authors argue that without the provision of meaningful information about what the “(nano)” means, including any scientific uncertainties, consumers are unfairly placed in a situation where they must make a purchasing decision in the absence of knowledge. To address the shift in responsibilities, they argue that “accessible campaigns should complement the disclosure tools found in the Cosmetic Regulation, and seek to enhance the overall information exchange associated with its implementation” (Shelley-Egan and Bowman 2015, 9). As such, while the market can be a powerful regulating force—and, indeed, it should be—its effectiveness is dependent on many other factors. These are both intrinsic to the individual as well as extrinsic, and they are consistently in a state of flux. What we do know, though, is that readily accessible information is key to enabling the market to operate in the most effective way. 7. WHAT THE FUTURE MAY HOLD This chapter examined the ways in which nanotechnologies—in particular, products containing nanomaterials—are being regulated. By adopting Black’s widely accepted definition of regulation, the chapter illustrated the different ways in which four key sectors are engaging in regulatory activities—purposefully, as is the case in industry and/or the state, or incidentally, as is often the case with consumers. The tools and instruments being adopted by key actors are often complementary in nature, with each adding to the overall governance framework. Each, therefore, should be considered an important element overall, contributing to—rather than displacing—the effectiveness of other tools and approaches. By examining the question of who is regulating nanotechnologies, this chapter has also sought to highlight the fact that there is no one “right way” to regulate emerging technologies and their products and processes. In periods of uncertainty, we would argue, regulatory homogeneity can be problematic; stakeholders should, instead, be encouraged to experiment with a range of different regulatory tools and approaches so as to ensure that the best practices and approaches are developed and refined alongside the development itself. In this way, innovation can be promoted not just in relation to the technology, but also in the development of the overarching governance framework. This, we argue, is the best way of ensuring that consumers are able to benefit from a

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promising technology such as nanotechnology while minimising the potential risks associated with its products and applications. NOTES 1. In the context of their reviews of the regulatory regimes in the UK and Australia, respectively. 2. Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and 2000/21/EC. 3. Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products (Recast). 4. Art. 16(3)(a)–(f). 5. Art. 16(10)(a). 6. Art. 16(10)(b).

Chapter 7

Pros and Cons of Nano-Regulation and Ways toward a Sustainable Use* Juliane Filser

In recent years, engineered nanomaterials (ENM) have increasingly conquered the market, not only in industrial and specialised high-tech applications, but also in manifold consumer products. Accordingly, the number of nanomaterials entering the environment during their life cycle (production, transport, use, and disposal) is constantly rising. Therefore, it is all the more important to avoid undesired side effects of these materials on the environment. However, despite a lot of research and discussion in international boards, our knowledge on the potential risks of nanomaterials in the environment is still insufficient (Syberg and Foss 2016, 784), and there is hardly any nano-specific regulation. Perhaps even more important, existing procedures of hazard assessment have been developed for conventional chemicals, yet these procedures do not account for the fact that nanoparticles, due to their small size, behave and react differently. In what follows, I will illustrate this problem using mainly—but not only—examples from research performed in our group, General and Theoretical Ecology, University of Bremen, over the past decade. Based on the central hypothesis that the current practices for regulating nanomaterials do not sufficiently protect the environment, I draw a number of conclusions. First, regulation differs widely between countries and between guidelines within the EU. Second, nanomaterial toxicity does not follow the dose-response pattern on which the authorisation of chemicals is based. Third, standardised guidelines for environmental hazard assessment underestimate potential risks of engineered nanomaterials, mainly because of short  I am grateful to all my collaborators and cooperating colleagues whose research over the past ten years fundamentally contributed to this short chapter. In particular, I thank Maria Engelke, Stephan Hackmann, Jan Köser, Moira McKee, and Yvonne Sakka—plus all of the bachelor’s and master’s students who helped pave the way in this field of research.

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duration, and do not take into account biotic interactions. Finally, I sketch the societal context of nanomaterials and propose to increase transparency, information, and risk literacy within society. 1. HOW MUCH “NANO” DO WE NEED? Undoubtedly, nanotechnology has been a great step forward in technological development. Discovering and making use of the unusual properties of such ultrafine structures has catalysed a fascinating array of applications, from medical products to mobile devices, catalysts for fuels, and even energy-efficient tires. Still, many products raise questions as to whether their development was driven by economic interest or by a desire to achieve true improvement (e.g., technical properties, reduced environmental impact)— particularly when potential hazards are unknown or insufficiently studied. Perhaps the most prominent example is silver. Historically, market prices for silver peaked in 1980, followed by a dramatic decline (due to the increasing replacement of black-and-white film, which relied on silver, by colour and digital photography) until the beginning of the second millennium. With the rise of nanotechnology, the prices of silver experienced an even steeper increase (Macrotrends 2018). However, do we really need engineered nanoparticles as food additives, in cosmetics, clothing, toys, and even in pacifiers? To what extent have ethical concerns been considered in military applications of nanotechnology, in particular when it comes to “human enhancement”? And what was the idea behind suggesting nanotechnology as a new application for the use of atrazine (University of Vienna 2015, presentation 17166), an herbicide forbidden decades ago in the EU (EC 2013a) due to problems with its persistency and products that caused toxic degradation? 1.1 Precaution and Legislation Apparently, economic interest has strong prevalence. As is often the case, risk assessment and—even worse—the necessary action to prevent harm lag behind instead of following the precautionary principle (EEA 2013, 9–11). So, if harm does occur, who will take responsibility? According to the European REACH guideline, the producer should take responsibility, but the vast majority of ENM is being produced in the United States and Asia (Patil et al. 2016, 12). For several of these producing countries, the concern is justified as to whether their current governments act in a manner that takes human and environmental health into account with sufficient farsightedness. Moreover, such legislation is as diverse as the countries themselves (Wang et al. 2013, 59). Even within the EU, there is no common framework for

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ENM regulations, most of which are being treated under the same REACH guidelines as any other chemical (Baumung et al. 2016, 6). Nano-specific labelling is required for food, feed, cosmetics, and biocides, but interestingly not for medical products—and the definition of ENM varies with the respective guidelines (Baumung et al. 2016, 5–12). However, labelling alone does not help much, as there are still major technical problems with measuring particles: “Thus, with regard to the numbers-based European Commission definition, nearly all measurement techniques probably fall short of the required accuracy and inter-laboratory comparability at the present time” (Stamm, Gibson, and Anklam 2012, 1179). Syberg and Foss (2016, 784–794) have pointed out general problems in the risk assessment of chemicals, using engineered nanomaterials as one prominent case study. Some of the nano-specific points they identified are concentration-dependent agglomeration, surface area reactivity, and different uptake and elimination kinetics, all of which prevent the derivation of typical dose-response curves. The latter rely on the well-known assumption that toxicity increases with dose, and they are the basis of any risk assessment: Action must be taken soon, as the expected environmental concentration1 exceeds the toxic threshold. However, not all ENM behave in such a dosedependent manner. Several studies have shown that the toxicity of nanomaterials does not necessarily increase with the dose (e.g., McKee et al. 2017, 6; Sakka, Völkel, and Filser 2016, 5; Simonin et al. 2017, 251), and even inverse patterns have been found (Filser et al. 2013, 1041). 1.2 Practical Problems Working with ENM is quite a challenge. This begins with the proper characterisation of raw material (which already requires expensive equipment and a lot of time and experience) and gets increasingly complicated when the core material is chemically modified, coated, or functionalised—peaking in finding and characterising ENM in aquatic media (Köser et al. 2017, 1480; Stamm, Gibson, and Anklam 2012, 1178–1179). Yet characterising the material in the solution is only the starting point, as most colloidal solutions are not stable. Over time part of the nanoparticles dissolve, sorb to the surface of the test vessel (Sakka, Koeser, and Filser 2017, 2498–2499), agglomerate (Baumann et al. 2014, 178), or react with ions in the solution and precipitate (Köser et al. 2017, 1477). Therefore, compared to other chemicals, a much greater effort with analytics is required if we are to understand their toxic mode of action (see Kookana et al. 2014, 4234, for an example with nanopesticides). Even the size (Baumann, Sakka, Bertrand, Köser, & Filser, 2014, 2209) and the material of the vessel in which the study is conducted (Sakka et al. 2017, 2499) influence how much of the material is adsorbed and how

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much remains reactive and thus toxic. Retrieving ENM in more complex matrices such as sediments and soils was impossible until very recently, and the published method is time-consuming and requires extremely expensive equipment (Praetorius et al. 2017, 312–313). This is not yet the end of the story, for thus far we have only considered the abiotic environment. As soon as organisms come into play—and this is what we want to protect—they also interfere with the fate of ENM (Navarro et al. 2008a, 8963; Navarro et al. 2008b, 375–378). Moreover, even if the core material appears to be nontoxic, the coating of the particles can be decisive for their toxicity (e.g., by clogging the antennae of water fleas) (Baumann, Köser, et al. 2014, 182), as can the dispersant in the solution or the formulation of the product (Engelke et al., 2018, 14; McKee 2018, 41). 1.3 Testing Guidelines Often Not Protective The hazard potential of a chemical is assessed using standardised testing procedures with species from different environmental compartments and various trophic levels. Examples of species on which acute tests are performed include water fleas and soil- and sediment-living bacteria. Reproduction tests are also conducted with algae, earthworms, or springtails (OECD 2018). Reproduction tests are conducted over longer periods and are usually more sensitive than acute tests. Which of these tests is chosen as part of the hazard assessment—acute versus reproduction—is highly relevant as their sensitivity within a single compartment varies by several orders of magnitude (Engelke et al. 2013, 194). Next to the general problems with the hazard assessment of ENM summarised by Syberg and Foss (2016, 784–794), we have to remember that standardised testing procedures should represent worst-case scenarios. This is true when it comes to exposure conditions of soluble chemicals (solid substances like nanoparticles behave very differently) and due to the fact that historically the most sensitive species have been selected as test organisms. Yet—irrespective of whether we consider air, water, sediments, or soils—the choice has always been limited due to the very small set of organisms that can be cultivated easily. Typically, these are fastreproducing, small species living in warm and nutrient-rich conditions such as compost heaps or coastal waters in the tropics. Due to their fast growth and reproduction, over the long term these species can more quickly adapt to unfavourable conditions than others, meaning they certainly do not represent the most vulnerable species. At this point we encounter the next problem, namely the short duration of the majority of standard tests. An extreme example is the sediment contact test with the bacterium Arthrobacter globiformis, lasting only thirty minutes. Using this test, Engelke et al. (2014, 1145–1146) showed that the toxicity of

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silver nanoparticles (AgNP) depended on their primary particle size and the amount of dissolved silver ions. Very small silver nanoparticles at the surface of titanium dioxide nanoparticles, amounting to 5 percent silver in the combined compound, were as toxic as the corresponding salt (silver nitrate), while larger particles were one order of magnitude less toxic. Using the same sediment contact test, with large AgNP and silver nitrate, and extending the test duration over up to eight hours, Lesnikov (2010, 75–81) revealed that AgNP became ever more toxic over time, ultimately even exceeding the toxicity of the salt. With the same substances, similar results were obtained in a more realistic scenario: Soil had been treated with sewage sludge containing the substances and aged for 32, 60, 100, and 140 days. At each time interval, a Collembola reproduction test (each lasting twenty-eight days) was performed. Differences from the untreated control were only found from day sixty onward, and once again AgNP were or tended to be more toxic than AgNO3 (McKee et al. 2017, 6). The reason for such patterns is quite trivial: Salts dissolve readily in solution, while small-sized particles take a longer time to dissolve into ions, which are the main cause of toxic action. Part of the ions reacts with the organisms, while another part sorbs or precipitates. When comparing salts with particles in the solution, this is comparable to acute and chronic pollution. Over time, more toxic ingredients are taken up by the organisms in the chronic scenario, as illustrated for nanopesticides by Kookana et al. (2014, 4233). The previous examples all represented standard tests with single species, which ignore the countless interactions with other species in natural ecosystems (Syberg and Foss 2016, 789). The relevance of food availability was studied by Sakka and colleagues: In a chronic toxicity test with AgNP and water fleas, three levels (50 percent, 75 percent, and 100 percent) of food algae were provided. Food reduction drastically increased AgNP-induced mortality and had distinct but less pronounced negative effects on the number of clutches and the onset of reproduction (Sakka, Völkel, and Filser 2016, 1–5). Still, other interaction partners may have much stronger effects than food. In several experiments with model communities, the presence of both competitors and predators increased the toxicity of AgNP to Collembola (Hackmann, unpublished data). An extensive literature review on the impact of metal-based ENM on soil communities (McKee and Filser 2016, 507–533) gave detailed information on the manifold factors affecting bioavailability and toxicity of these ENM. In a worst-case scenario, they also offered explanations as to why singlespecies tests may dramatically underestimate their toxicity. Box 7.1 summarises the most important interactions in this scenario. Note that any decline described will have cascading negative effects on the subsequent food chain; for instance, when bacteria are reduced due to ENM, their predators (mainly

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nematodes and protozoa) will decline as well, and so will predators such as predatory mites. Most alarming is the potential catalytic effect due to ENM production by metal-tolerant microorganisms. BOX 7.1 SUMMARY OF THE MAIN COMMUNITY INTERACTIONS AND RESULTING TROPHIC CASCADES THAT POTENTIALLY LEAD TO UNDERESTIMATING THE TOXICITY OF METAL-BASED NANOPARTICLES (NP) IN SOIL • ENM accumulation takes place at the plant rhizosphere. • The majority of rhizosphere bacteria is particularly sensitive to NP, resulting in their decline. • Direct and transgenerational effects have been described for soil nematodes. • Nematodes contribute a large extent to the remineralisation of ammonia, and this will negatively affect plant growth and the associated carbon input into the rhizosphere—the main food source of associated bacteria. • Overall reduction of bacteria leads to a competitive advantage for fungi, including pathogens. • An overall reduced microbial biomass will negatively affect all subsequent invertebrate consumers, including, for instance, earthworms and all associated ecosystem services, such as improving plant nutrition, soil drainage, and erosion resistance. • On the other hand, many fungal and some bacterial species are metal-tolerant. However, this tolerance is accompanied by energetic costs, leading to increased respiration (loss of carbon dioxide into the atmosphere). • Some of these tolerant microorganisms may even form new NP, so the cycle starts anew, eventually leading to a catalytic effect. Note that this is highly simplified, by no means representing the true complexity of a natural soil food web. Adapted from McKee and Filser (2016, 527–529) where the underlying published evidence can be found.

Overall, the facts listed in box 7.1 point out the crucial relevance of biotic interactions for assessing the risks of metal-based nanomaterials in soils. As the registration and authorisation of chemicals is—with very few exceptions—based on tests with single species, at this point a clear gap opens in the current regulatory practice. This gap is not only true for nanomaterials but for all chemicals, as recently demonstrated by Schäffer et al. (2018, 28–29).

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2. SYNOPSIS: PRESSURE GROUPS AND FUTURE PERSPECTIVES This short exemplary overview should provide enough evidence that the regulation of ENM, in particular the underlying hazard assessment, is far from protecting our environment from undesired harm by ENM, a view supported by many scientists (e.g., EEA 2013, 32; Syberg and Foss 2016, 792), including OECD experts (Kühnel and Nickel 2014, 352). There are many reasons for this unsatisfactory situation. First, both chemical analytics and toxicity tests are time-consuming and expensive, and for financial reasons it is impossible to include all interactions shown in figure 7.1 in standard hazard assessment procedures for every single type of ENM. Second, the economic potential of nanotechnology is huge, and the benefits of manifold applications must of course be considered as well. Costs and benefits must be carefully weighed against each other—and here we have to consider the large variety of opinions and interests among pressure groups involved in nanotechnology (see figure 7.1). Not shown in figure 7.1, however, are the powerful forces acting below the surface—namely lobbyism, corruption, and, perhaps most important nowadays, media and its potential manipulation, which has become increasingly relevant with the emergence of social media. So, how do we proceed? Next to the obstacles addressed, luckily there are plenty of promising and feasible options for influencing the future development of ENM without compromising the environment. Many of these options have been applied in several large interdisciplinary research projects on nanotechnology (see acknowledgements). First of all, “green synthesis” is possible for many ENM (e.g., Iravani 2011, 2638–2650; Patil et al. 2016, 16–18). Both UMSICHT, assessing the entire life cycle of silver nanoparticles in textiles (Köser et al. 2014), and DENANA, dealing with design criteria based on properties and effects of silver, cerium dioxide, and silicium dioxide nanoparticles (Engelke et al. 2018), involved industry partners, science, and

Figure 7.1 

Pressure groups associated with nanotechnology

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environmental regulation, fostering not only (sometimes fierce) discussions between these three fields but also the development of products that we do not consider harmful for the environment. A precondition for this was also environmental fate modelling addressing the full product life cycle, an approach that was also pursued within nanoToxCom, a graduate school assessing toxic combination effects with an emphasis of iron oxide nanoparticles (Filser et al. 2013, 1042–1043; Juliane Filser and Warrelmann 2016b; Wigger et al. 2015, 160–171). In a scenario where the environmental conditions are known, speciation modelling can successfully replace expensive chemical analytics (Köser et al. 2017, 1476). For any ENM with a highly toxic core material, but also for ENM that will enter the environment in large quantities, a realistic long-term hazard assessment is indispensable. This was clearly shown by McKee et al. (2017, 6); studies by other authors were reviewed by McKee and Filser (2016, 507–533). The societal aspect must be accounted for on several levels. These include (1) open communication between all stakeholders; (2) transparency—which, unfortunately, is impossible in most cases where industry is involved; and (3) information made accessible to the public. To achieve the latter, scientists have to massively invest in frequent and easily understandable communication such as public lectures or online videos (certainly built on their foundation of robust scientific knowledge). Yet another approach is increasing the “risk literacy” of the public, especially of schoolkids, something that we are establishing within the graduate school nanoCompetence (Filser and Warrelmann 2016a). Unlike the previous initiatives, this ongoing project is not purely based on science and technology but also involves education and the humanities. Referring to their data on fate and effects of copper and cerium dioxide nanoparticles in brain cells, freshwater microcosms and soils, the graduates also work on improved education and public information as well as on ethical questions related to nanotechnology. We are convinced that such highly interdisciplinary approaches are necessary to move nanotechnology into a sustainable and environmentally friendly direction in the future. ACKNOWLEDGMENTS I would like to thank my collaborators and all institutions who have supported our research in the past decade. The Federal Ministry of Education and Research funded two large projects, UMSICHT (BMBF 03X0091, 2010– 2013) and DENANA (BMBF 03X0152, 2014–2017). Two graduate schools were financed by the Hans Böckler Stiftung, nanoToxCom (2008–2013) and nanoCompetence (PK 041, since 2015). Both of these were further supported by the VCI (Association of the Chemical Industry) and the University of

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Bremen; nanoToxCom additionally by the closely linked project “Environmental Competence Nanomaterials,” funded by the “Senator für Umwelt, Bau, Verkehr und Europa” in Bremen (Programme “Applied Environmental Research”) via the EFRE (European Fonds for Regional Development). Last not least, thanks to Angela Kallhoff and Claudia Schwarz-Plaschg for inviting me to the Conference “Good Nano – Bad Nano: Who Decides?” in Vienna with its inspiring discussions and for all their support. NOTE 1. Divided by a safety factor depending on the available information, usually between ten and one thousand.

Chapter 8

Nanotechnology and Fundamental Rights* Regulating Dual-Use Research Iris Eisenberger and Franziska Bereuter 1. INTRODUCTION Research on modified nanoparticles—particles that, for instance, could cross the blood-brain barrier1—has created both positive expectations, such as the prospect of developing therapies for brain diseases, and concerns, such as the potential threat of modified nanoparticles being misused for destructive nanoscale weaponry (Eggleson 2013). Research like this can be used for both good and bad (Fiedler and Reynolds 1993; Reynolds 2003; RS-RAE 2004), which has been referred to as the so-called dual-use dilemma (Selgelid 2009). Research with dual-use potential promises beneficial innovation, on the one hand, and raises concerns about possible harmful consequences for humans, society, animals, and the environment, on the other (Atlas and Dando 2006). This twofold character of nanotechnology research (Allhoff, Lin, and Moore 2010) is further intensified with developments in the life and material sciences, cognitive sciences, or information sciences (Roco and Bainbridge 2003). The convergence of these diverse scientific disciplines opens up unexplored ways of modifying materials and organisms, ways that could again be both beneficial and harmful (Eggleson 2013). These circumstances make nanotechnology research not only representative of dual-use research, but also an object of regulatory interest ­(Eisenberger 2016; Bowman and Tournas in this volume). Its potentials and risks challenge science and society as much as the legal system itself (Bowman and Tournas, this volume), a system that is sometimes ill-equipped or unwilling to regulate

 The authors would like to extend their gratitude to Thomas Buocz and Michael Holohan, for their quick and thorough proofreading of this article.

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emergent technologies such as modified nanoparticles (Eisenberger 2016; Schwarz-Plaschg, Kallhoff, and Eisenberger 2017). From a legal, especially constitutional, point of view, regulating nanotechnology research might entail balancing opposing rights. In the case of dual-use (nano) research, there is freedom of research on one side and the right to life and physical integrity on the other. These fundamental rights both limit and oblige the legislator (Vöneky 2015) in the context of dual-use (nano) research. Against this background, we will look at the legal boundaries and obligations that fundamental rights impose on dual-use (nano) regulation. These boundaries and obligations will be looked at from a European and specifically Austrian point of view (section 2). Subsequently, we will present different approaches and tools for regulating dual-use (nano) research (section 3). On this basis, we will analyse the concept of safer by design as one strategy for regulating emerging technologies in general and dual-use (nano) research in particular (section 4). The chapter concludes by arguing that combining scientific, legal, and self-regulation strategies could be a way forward in regulating dual-use (nano) research in circumstances where opposing fundamental rights and rights to non-interference and obligations to protect collide (section 5). 2. DUAL-USE (NANO) RESEARCH BETWEEN RIGHTS TO NON-INTERFERENCE AND OBLIGATIONS TO PROTECT Most European constitutions grant researchers freedom of research. For example, Article 5, paragraph 3 of the German Basic Law stipulates that “arts and sciences, research and teaching shall be free” (Vöneky 2015). In Austria, Article 17 of the Basic Law on the General Rights of Nationals2 rules that “knowledge and its teaching are free.” Article 13 of the Charter of Fundamental Rights of the European Union3 regulates that “the arts and scientific research shall be free of constraint” and “academic freedom shall be respected.” Additionally, Article 10 of the European Convention on Human Rights (ECHR)4 protects freedom of expression. According to the European Court of Human Rights (ECtHR), this also includes the freedom of science.5 The scope of protection usually covers basic and applied research and protects the planned investigation of new scientific knowledge.6 In each of these jurisdictions, state interference in the freedom of research is only allowed under specific circumstances. In Germany, for example, freedom of research can only be restricted for legitimate aims and in a proportionate way (Vöneky 2015). In Austria, intentional infringements of science violate the freedom of science (Stelzer 1991). Article 52, paragraph 1

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of the European Charter of Fundamental Rights allows for limitations of the freedom of science if they pursue any legitimate aim and are proportionate (Eisenberger 2016). Article 10, paragraph 2 of the European Convention on Human Rights only provides for restrictions that are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or rights of others, for preventing the disclosure of information received in confidence, or for maintaining the authority and impartiality of the judiciary.

The exact boundaries of these rights and their legitimate limitations are contested among legal scholars (e.g., Ermacora 1963; Binder 1973; Rebhahn 1982; Wielinger 1992; Potacs 1986; Blankenagel 2000; Bernsdorff and Borowsky 2002; Ruffert 2006, 2016; Schulte 2006; Schulze-Fielitz 2009; Kopetzki 2011; Wilholt 2012; Bernsdorff 2014; Kröll 2014; Moser 2014; Augsburg 2016; Eisenberger 2016; Hammer 2016; Jarass 2016; Pöschl 2017). Regardless of where one might draw these legal boundaries, laws prohibiting or broadly restricting dual-use (nano) research will quickly violate the freedom of science if the basis of their bans or restrictions lacks profound knowledge of the hazards or risks involved. In all the above-mentioned jurisdictions, fundamental rights entitle human beings and oblige first and foremost the state (Stelzer 2011; Mayer, Kucsko-Stadlmayer, and Stöger 2015; Öhlinger and Eberhard 2016; Berka 2018). The state has to abstain from interfering with fundamental rights, and if the state interferes in an unjustified manner, the infringement can be subject to judicial review (Stelzer 2011). This classical function of fundamental rights, the so-called defensive function (Stelzer 2011) or right to non-interference, is supplemented by state obligations to actively protect fundamental rights (Holoubek 1997). These state obligations to protect should enable human beings to effectively exercise their fundamental rights (Stelzer 2011). It is prevailing doctrine that, for instance, in the jurisdiction of the European Convention on Human Rights, the enshrined fundamental rights mandate state obligations to protect (Grabenwarter and Pabel 2016). The right to life in Article 2 of the ECHR (Kneihs 2006) and the right to physical integrity in accordance with Article 8 of the ECHR (Wiederin 2002, 2014) are two fundamental rights where such state obligations to protect have been extensively discussed, both in the literature and in court decisions (Holoubek 1997; Grabenwarter and Pabel 2016). In one of these cases, the European Court of Human Rights decided that the right to respect private and family life7 obliges the state to actively take environmental measures.8 Because dual-use (nano) research can endanger human beings,

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states might be obliged to take measures to protect life and physical integrity (Vöneky 2015). With regard to the concrete measures taken, the European Court of Human Rights leaves states with a wide margin of appreciation. Possible measures include, for example, obligatory assessments, evaluations of risks, and obligatory consultations with an ethics board prior to conducting dual-use research (Vöneky 2015; Eisenberger 2016). However, duties to protect are, again, limited by other fundamental rights. In the case of dualuse (nano) research, they are especially limited by the right to freedom of research. Any regulatory strategy must be developed within these legal boundaries and ought to be guided by the principles laid down in fundamental rights (Ruggiu 2013). 3. REGULATORY OPTIONS FOR DUAL-USE (NANO) RESEARCH The debate over whether and how to regulate dual-use research intensified in 2011 (Suk, Vogel, and Ozin 2015) when Ron Fouchier and Yoshihiro Kawaoka were about to publish their research on the influenza virus H5N1 in Science and Nature (Koblentz 2014). The fact that the virus could be transmitted to humans led to fierce discussions about whether the research results should be published (Patrone, Resnik, and Chin 2012; Casadevall et al. 2013; Thurnherr 2014). Suggestions ranged from publishing all the results to removing selected parts of the article to not publishing the results at all. Both articles were published eventually (Herfst et al. 2012; Imai et al. 2012). Nevertheless, dual-use research and its regulation gained considerable public attention as a result of the preceding debate (Vöneky 2015). 3.1 Legal Regulation The regulation of dual-use research is both constrained and made possible by fundamental rights. Whereas freedom of research enables dual-use research, the right to life and physical integrity might limit it (Vöneky 2015). Within these boundaries, several regulatory options for dual-use research in general, and dual-use nano research in particular, are conceivable. On the spectrum of possible legal regulatory options, hard law marks one end and soft law the other. With regard to the marketing of nano products and substances, there is a substantial body of relevant European Union legislation9 (Eisenberger 2016; Bowman and Tournas, this volume)—for instance, legislation concerning cosmetics,10 food,11 biocides,12 or medical devices.13 These legislative acts contain provisions such as definitions of nanoparticles,14 labelling requirements15

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(Schwarz-Plaschg, this volume), reporting schemes,16 or publicly available registries.17 However, legal bans, restrictions, and obligatory requirements in the area of nanotechnology research are restricted by the narrow boundaries of the freedom of research (Eisenberger 2016). Not least because of this, mechanisms with softer legal effects have been adopted in order to regulate (dual-use) nano research. One of these mechanisms is the European Commission’s nonbinding recommendation for a code of conduct for responsible nanosciences and nanotechnologies research.18 Although it is nonbinding and very limited in its practical impact, this code of conduct was the first nano-specific EU legislative act (Eisenberger 2014, 2016). The code of conduct already advocated for an ethical review of dualuse nano research.19 3.2 Scientific Self-Regulation Parallel to these top-down binding or nonbinding legislative efforts, there is an ongoing discourse within the scientific community that aims to foster responsible dual-use research (Edwards and Kelle 2012). The resulting bottom-up approaches try to raise awareness about dual-use research and identify, analyse, and reduce risks (Tucker 2012). Furthermore, they advocate for transparent documentation throughout the research planning process, the research itself, and the communication around it (German Ethics Council 2014; Max Planck Society 2017). A central element of such efforts are codes of conduct or guidelines for dual-use research. They usually contain some of the following recommendations for researchers, research institutions, and funding agencies (National Science Advisory Board for Biosecurity 2007; World Health Organization 2010; Deutsche Forschungsgemeinschaft and Leopoldina 2014): • Researchers: First, researchers are advised to familiarise themselves with the safety-relevant issues of their research. They should do so by participating in voluntary training activities. Second, once aware of dual-use research, they ought to identify research that poses risks for humans, society, animals, and the environment and if there is potential for abuse by third parties. This must be done through the entire research process, from planning to researching to communicating. When researchers conduct thirdparty-funded research, they need to inform themselves about the contract parties and their respective interests. Third, once the risks are identified, they should be assessed, and risks and benefits should be balanced against each other. Negative effects of not realizing certain research projects will always be taken into account. Fourth, the identified and evaluated risks must be minimised. Possible measures could include access restrictions,

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obtaining expert knowledge, adapting the research design, or voluntary research limitations. Examples of voluntary research limitations are nonpublication, editing publications, or restricting communication to within the scientific community only. A voluntary research moratorium, however, is the last resort. Finally, all these measures will be documented and handed over to institutionally established advisors. • Research institutions: Within the respective political and legal framework, research institutions provide for appropriate research conditions. Responsible research requires adequate freedom, information, and training. Students should be trained in dual-use awareness early in their studies through specialised lectures. Moreover, dual-use advisory boards ought to be established. They will help not only in assessing dual-use research and in implementing risk reduction measures, but also in actively providing information. Furthermore, institutional and financial resources for the necessary technical and organisational measures will be provided. Finally, specific guiding principles should be developed for the different research disciplines. • Funding agencies: Apart from researchers and research institutions, funding agencies play an important role in accomplishing responsible dual-use research. Like researchers and students, their staff has to be informed about the specifics of dual-use research through training measures. Having a concept for handling risk-related issues should be a condition for the funding of dual-use research. Finally, funding agencies shall be encouraged to fund projects that engage with questions on how to manage and regulate dualuse research. Fundamental rights enable researchers to conduct dual-use (nano) research. On the other hand, certain fundamental rights oblige the state to limit hazardous research. Since binding legal restrictions on research can easily infringe freedom of research, regulating dual-use (nano) research should rely on soft mechanisms such as awareness-raising activities or voluntary incentives. 4. SAFER BY DESIGN AS A REGULATORY SOLUTION BETWEEN LAW AND SCIENCE? In addition to legal strategies and scientific strategies, a third option for regulating dual-use nano research is being discussed (Schwarz-Plaschg, Kallhoff, and Eisenberger 2017): the concept of safer by design as a regulatory solution between law and science. This concept is gaining more attention as nanotechnology advances together with the life and material sciences, cognitive sciences, and big data sciences (Institute of Medicine and National Research Council [U.S.] 2006).

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The concept of safer by design, also “safe by design” or “safety by design” (Schwarz-Plaschg, Kallhoff, and Eisenberger 2017), tries to use scientific instruments in order to reduce risks. The concept’s aim is to design materials, organisms, substances, or products that are inherently safe (Reimhult 2017; Schwarz-Plaschg, Kallhoff, and Eisenberger 2017; van de Poel and Robaey 2017; Kraegeloh et al. 2018). In this context, “safe” means that unintended consequences, such as Eric Drexler’s dystopian scenario of a grey goo, where self-replicating nanobots destroy the biosphere (Drexler 1986), are avoided in the first place. Scenarios of self-replicating entities in the area of nanotechnology are becoming more realistic as synthetic biology further complicates the idea of designing safety (Imperiale and Casadevall 2018). Design as a way of reducing risks is not new. Similar approaches can be found in concepts such as “benign by design,” “prevention through design,” “inherent safety,” “green chemistry,” “privacy by design,” or “security by design” (Schwarz-Plaschg, Kallhoff, and Eisenberger 2017). Although safety by design has been on the research agenda in the area of nanotechnology since at least 2004 (Schwarz-Plaschg, Kallhoff, and Eisenberger 2017), safer by design strategies have been criticised, since appropriate techniques for identifying the risks of nanomaterials are not yet available (Reimhult 2017). Examples of strategies for minimising risks through safety by design are isolation or labelling strategies, which are becoming more important as different scientific areas converge: • Isolation strategies: Although organisms are physically isolated in closed systems, carelessness and accidents might lead to their escape (Wright, Stan, and Ellis 2013; Giese and von Gleich 2015). Strategies that biologically isolate these organisms are built on the idea of constructing living biological systems with increasing artificiality in a way that leaves them with low chances of survival outside of laboratory conditions (Benner, Yang, and Chen 2011). In this regard, safety by design would mean, for instance, that organisms would depend on nutrients that are not found in nature. As a consequence, these organisms would die as soon as they were (intentionally or unintentionally) released into the environment. • Labelling strategies: Nanomaterials could be labelled, for example, with barcodes (Duong et al. 2014; Dahlman et al. 2017). This strategy has already been used successfully with synthetic DNA. Synthetic DNA makes it possible to keep apart artificial and natural DNA. Labelling nanomaterials in such ways would enable researchers to keep track of their engineered materials. One drawback is that these strategies make it possible to monitor entities once they are released, but they do not make the materials safer per se. However, these or similar strategies could help protect humans, society, animals, and the environment from the risks that dual-use (nano) research poses.

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Combining these scientific strategies with legal strategies would be an interesting option for regulating dual-use (nano) research, especially once the research leaves the lab and enters the market.20 The idea of combining technical or scientific methods with legal mechanisms to safeguard legally protected goods is not new. Privacy or security by design is a well-known regulatory tool within digital and online environments (Hildebrandt 2017). It secures privacy or security where other mechanisms fail. Article 25 of the European Union General Data Protection Regulation,21 for instance, stipulates data protection by design. The provision specifies that appropriate technical measures have to be implemented in order to protect each data subject’s rights. Technical tools like pseudonymisation provide for the protection of legal interests such as privacy and data protection. Similar to the privacy or security by design concept, the aforementioned safer-by-design strategies could be combined with legal obligations in order to protect human beings’ rights to life or physical integrity. This could help in fulfilling existing legal obligations that stem from fundamental rights obligations. One way to combine scientific methods and legal mechanisms to make dual-use (nano) research safer could be legal obligations that require researchers to make organisms incapable of surviving outside the laboratory environment if the organisms have dual-use potential. As discussed above, freedom of research would, however, limit such restrictions or obligations. Another way to implement such design strategies could be through academic incentives to voluntarily adapt these strategies. In this vein, European Union funding policy has integrated safer by design concepts into their 7th Framework Programme (FP7) and Horizon 2020 funding schemes (Schwarz-Plaschg, Kallhoff, and Eisenberger 2017; Kraegeloh et al. 2018). If technically feasible, labelling engineered nanomaterials with barcodes or watermarks during the research process could be an addition to EU nano legislation. Some of the nano-relevant provisions differentiate between engineered or manufactured nanomaterials on the one hand and natural nanomaterials on the other,22 even though they lack the analytical methods for distinguishing between these different types of nanomaterials (Reimhult 2017). Combining scientific and legal mechanisms can be an interesting way forward when trying to regulate dual-use (nano) research, especially when fundamental rights such as the right to life and physical integrity oblige the state to act. However, where freedom of research puts limits on hard law mechanisms due to a lack of knowledge about risks, a more promising approach could lie in combining design or engineering mechanisms by employing soft law or self-regulation mechanisms.

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5. CONCLUSION Fundamental rights both enable and limit dual-use (nano) research and its regulation. Freedom of research and the right to non-interference provide a space for widely unrestricted research. What limits this freedom, however, are the rights of others and the state’s duty to protect. In the case of dual-use (nano) research, these duties to act stem from the right to life and the right to physical integrity. The measures the state must take are not only contested in each jurisdiction but are also subject to a wide margin of appreciation. If the state takes regulatory measures in order to deal with dual-use (nano) research, the boundaries of possible actions are yet again to be found in freedom of research and its defensive function. Within this frame, different regulatory approaches for dual-use (nano) research have already been applied, yet others are conceivable and possible. They range from legally binding and nonbinding top-down mechanisms to self-regulatory bottom-up mechanisms, as well as forms combining elements of both. The specific characteristics of dual-use (nano) research, however, make other regulatory concepts worth considering. One such regulatory concept could be the combination of law, selfregulation, and science. Despite reasonable criticisms of such efforts (Schwarz-Plaschg, Kallhoff, and ­Eisenberger 2017), the combination of legal enforcement, voluntary incentives, and design elements is one way forward in conceptualising the regulation of dual-use (nano) research—research that is characterised as being both good and bad for as many legal interests one can think of (e.g., human beings, society, animals, or the environment). Whichever regulatory path one might take, the legal sources and limits of any regulatory effort are to be found in fundamental rights, specifically in the freedom of research, the right to life, and the right to physical integrity. NOTES 1. The blood-brain barrier is defined as “a physiological mechanism that alters the permeability of brain capillaries, so that some substances, such as certain drugs, are prevented from entering brain tissue, while other substances are allowed to enter freely” (American Heritage Medical Dictionary 2007). 2. Basic Law of 21 December 1867 on the General Rights of Nationals in the Kingdoms and Länder represented in the Council of the Realm—StGG, Federal Law Gazette No. 142/1867 as amended by Federal Law Gazette No. 684/1988. 3. Charter of Fundamental Rights of the European Union, Official Journal of the European Union C 326/391, 26.10.2012.

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4. Convention for the Protection of Human Rights and Fundamental Freedoms, Rome 4.XI.1950; https​://ww​w.ech​r.coe​.int/​Docum​ents/​Conve​ntion​_ENG.​pdf. 5. For example, Wille v. Liechtenstein: 28 Oct. 1999, ECtHR 28396/95; Lombardi Vallauri v. Italy: 8 August 2011, ECtHR 39128/05. 6. For example, Compendium of Judgements and Most Important Decisions of the Austrian Constitutional Court 3191/1957; 15.617/1999; 18.559/2008; 18.763/2009. 7. Article 8, European Convention on Human Rights. 8. López Ostra v. Spain: 9 December 1990, ECtHR 16798/90. 9. For example, Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives; Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (“Cosmetics Products Regulation”); Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 on food information to consumer (“Food Information Regulation”); Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 on biocidal products (“Biocidal Products Regulation”); Regulation (EU) No. 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods (“Novel Food Regulation”); Regulation (EU) 2017/745 of the European Parliament and of the Council of April 2017 on medical devices (“Medical Devices Regulation”); Commission Recommendation (EU) No. 2011/696 of 18 October 2011 on the definition of nanomaterial (“Nanomaterial Definition Recommendation”). 10. Cosmetics Products Regulation. 11. For example, Novel Food Regulation. 12. Biocidal Products Regulation. 13. Medical Devices Regulation. 14. For example, Article 2, para. 1k, Cosmetics Products Regulation; Article 3, para. 2f, Novel Food Regulation; Recommendation No. 2, Nanomaterial Definition Recommendation. 15. For example, Article 19, Cosmetics Products Regulation. 16. For example, Article 16, para. 3, Cosmetics Products Regulation; Article 65, para. 3d, Biocidal Products Regulation. 17. For example, Article 16, para. 10, Cosmetics Products Regulation. 18. Commission Recommendation (EC) No. 2008/424 of 7 February 2008 on a code of conduct for responsible nanosciences and nanotechnologies research (“EU Code of Conduct”). 19. Recommendation No. 8 of the EU Code of Conduct: That this Recommendation also be used as an instrument to encourage dialogue at all governance levels among policy makers, researchers, industry, ethics committees, civil society organisations and society at large with a view to increasing understanding and involvement by the general public in the development of new technologies. (emphasis added)

20. For further considerations in the field of Synthetic Biology, see Franziska Bereuter’s doctoral thesis “Regulation of Biosecurity-Related Research” (upcoming).

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21. Regulation (EU) 2016/697 of the European Parliament and of the Council of 27 April 2016 on general data protection. 22. For example, Article 3, para. 1z of the Biocidal Products Regulation: “‘Nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1–100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials” (emphasis added); Recommendation No. 2 of the Nanomaterial Definition Recommendation: “‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm–100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%” (emphasis added).

Chapter 9

Monitoring the Value of Responsible Research and Innovation in Industrial Nanotechnology Innovation Projects* Emad Yaghmaei, Andrea Porcari, Elivio Mantovani and Steven M. Flipse 1. INTRODUCTION 1.1 Responsible Research and Innovation in Industry Since the start of initiatives to practically implement Responsible Research and Innovation (RRI), mostly related to calls within EU framework programmes and a few specific national initiatives (e.g., the UK Engineering and Physical Sciences Research Council [EPSRC] framework for RRI), a variety of approaches have emerged that can help scientists and engineers participate in RRI activities. As examples, we consider the RRI Toolkit1 and the PRISMA Toolkit2 with its specific search engine that allows one to select specific approaches for academic and/or industrial researchers and developers. These approaches include testimonials, best practices, projects, and tools for specific RRI aspects. The activities range from frameworks to implement RRI in specific technological development trajectories, to reflection tools to help scientists and engineers think about the socio-ethical context of their work, to co-development and co-construction methods that allow for shared, multi-stakeholder innovation development. Some approaches remain on a theoretical level, but some researchers have carried out specific field tests to demonstrate the approaches’ functionality in practice. If we consider these approaches from the perspective of Stilgoe, Owen, and Macnaghten’s (2013)  This project has received funding from the EU’s Horizon 2020 research and innovation programme under grant agreement No. 710059. The opinions expressed in this chapter reflect only the authors’ views and in no way reflect the European Commission’s (EC) opinions. The EC is not responsible for any use that may be made of the information it contains. An earlier version of this chapter was presented at the International Conference on Responsible Research and Innovation in Science, Innovation and Society, in Rome, Italy, on September 25–26, 2017. Also, a short version of this chapter was published in the ETHICOMP conference proceedings.

*

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framework for RRI, such activities seemingly can cover all RRI dimensions: anticipation of future effects, reflection on socio-ethical and socioeconomic context, inclusion of relevant actors/stakeholders in development, and being responsive toward societal values, needs, and desires. We write this chapter from the perspective of the EU Research and Innovation programme “Horizon 2020” (H2020)–funded PRISMA (Piloting RRI in Industry: A Roadmap for TranSforMAtive Technologies) project, which runs between 2016 and 2019. The PRISMA project aims for integration of RRI in eight pilot companies, exploring RRI tools and methods in specific research and innovation (R&I) projects on transformative technologies, including in particular biotechnologies, nanotechnologies, the Internet of Things, and autonomous vehicles. Activities are complemented by comparison of and reflection on experiences of RRI with respect to the usual social responsibility practices and policies of these organisations. We intend to provide evidence on how the RRI approach can improve the innovation process and its outcomes. Based on this experience, we develop a “roadmap” that helps industries implement RRI in their innovation processes in order to deal with uncertain and sometimes partly unknown risks (anticipate), inform product development through dialogue with stakeholders (inclusion and reflection), and address public and ethical concerns of transformative technologies (responsiveness). PRISMA’s ambition is to achieve a broad uptake of this roadmap by companies through networking with industry and branch associations, corporate social responsibility (CSR) and certification organisations, and governments and civil society organisations. In our quest for relevant methods to support the integration of RRI in decision-making processes at company level, we tried to design methods that both fit with actual ongoing R&D and innovation activities and match the vision and objectives of the other functions of the company (e.g., management, R&D, legal, and CSR). As acknowledged by previous studies ­(Chatfield et al. 2017), these methods are essential for fostering a “culture of RRI” in the company. 1.2 Assessing Responsible Research and Innovation in Industry We aim to take this approach one step further. We also wish to find evidence of how RRI can help improve the innovation process and its outcomes, showcasing the benefits of RRI actions for the company. We found in the literature that such evidence is still largely lacking, which begs the question: What is the value of RRI from the perspective of industrial innovation? Researchers from the social sciences and humanities have proposed that RRI can help innovation processes have more socially robust outcomes, and

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possibly to be more financially rewarding in a socially responsible way. This may or may not be the case, but it still begs the question of what the value of RRI practices is in the “midstream” (Fisher, Mahajan, and Mitcham 2006) of industrial innovation: on the R&D working floor. In our project approach, we aim to find such evidence (or a lack thereof) through a mixed approach, combining both a qualitative and a quantitative assessment. Regarding the qualitative assessment, we have been conducting (and continue to conduct) interviews, field observations, and dialogue with companies in order to support them in finding practical approaches to implementing RRI, and as well to show them that our RRI projects indeed perform differently from “other” company projects without specific attention to RRI. This chapter includes a focus on the quantitative approach, the setup of our approach, and how we perceive its possible functionality, as well as a preliminary meta-analysis of the results of both the qualitative and quantitative approaches. However, before we highlight the way in which we developed the tool and envision it to work, we first wish to share some considerations with regard to its development. We acknowledge that the term “improve” is somewhat problematic from the perspective of RRI. (Improvement from the perspective of which actor or stakeholder?) From a societal perspective, benefits to the company might not always correspond with aspired user and market benefits. From a corporate perspective, there is one lesson that decades of marketing research have taught us—namely that it is impossible to sell a product to everyone: There will always be “laggards” who will never buy the innovation developed, possibly for financial and/or other value-based reasons. This probably holds true for both the business-to-business context and the business-to-consumer context. Notwithstanding this fact, our PRISMA project considers transformative technologies, and its developers (i.e., the companies involved in our project) do not always sell their products to consumers directly. Often, they provide technology that is useful in a business-to-business context. In this respect, we may also wonder what “improvement” on the process level of innovation means and what the potential value of it is. When we consider production, then there may be an obvious link: for example, more responsibly produced (whatever that may mean) products might provide a competitive advantage to the company (e.g., increased market share). However, we argue that the impact (in either a business-to-business or business-to-consumer context) of a product using “responsible innovation processes” could be much broader than market benefits. We could of course consider it might be beneficial if the production process also included the viewpoints, needs, and values of prospective users. This aspect of “user-producer interaction” (see Nahuis, Moors, and Smits 2012) has been known within the innovation management

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community (and possibly beyond) for years and in itself might be considered an RRI dimension if we think of this approach as a method to achieve inclusion of the innovators and their subsequent responsiveness based on this inclusion. Also, the labour conditions of factory workers, or researchers and developers for that matter, might be an issue of concern from the perspective of RRI. However, there may be other RRI aspects for which the direct link with the (potential) competitive advantage provided to the final product is much less evident. Examples include open source or open access production and development, with related issues of data ownership across teams and partners, but also gender distribution of the development team and the reflexive capacities of the research group and related willingness to act responsively toward societal needs and concerns. Including these aspects explicitly may make the innovation process more responsible. Yaghmaei (2015, 2018) also shows successive levels of RRI uptake and argues that companies move from one RRI stage to another and improve themselves on RRI awareness, RRI implementation, and RRI assessment. Another consideration in relation to industrial innovation revolves around the question of how “improvement” and “responsible” are related. From an innovation management point of view, improvement can be considered incremental or radical. Considering first incremental innovations, a slightly better version of a product or a slightly more sustainable production process can of course be more socially or environmentally responsible. But this begs the question of how much is enough. When is good, good enough? Not only from a technological perspective, but also from a responsibility perspective, what level of (financial) resources should be invested to reach this slightly more responsible outcome? Second, from the perspective of radical innovation, history has taught us that radical or disruptive innovations are not necessarily seen as more socially, practically, or even environmentally beneficial. The question could be: Do we need this product at all? Is there a (social/ economic) market at all? And, from another perspective: Is there a social benefit that justifies the investment—and not just commercial investments but possibly also governmental or municipal investments—to facilitate innovation introduction? Also, on another level, maybe the opposite of innovation—that is, “stagnation”—is more socially responsible from a societal perspective. According to de Saille and Medvecky (2016), the concept of responsible stagnation (as opposed to responsible innovation) might also be worth further exploration. In any case, when considering RRI-relevant aspects of innovation practices on the actual, ongoing R&D by innovators working on transformative technologies, we feel we have to start from the perspective of those who actually carry out the work on the laboratory working floor (Schuurbiers and Fisher, 2009). That is where our methodological approach starts.

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2. THE RESPONSIBLE RESEARCH AND INNOVATION MONITORING TOOL Our overall methodology to monitor the value of RRI over the course of the PRISMA project consists of six steps that are carried out over the course of the project. Currently, we are working on steps five and six of the process. The preliminary results from step 6a are presented in this chapter. Table 9.1 provides an overview of our methodological steps. Note that though the methodology is being applied to all eight pilots of the PRISMA project, the data reported in this chapter, unless indicated differently, refer only to the specific case of the two pilots dealing with nanotechnologies. Step 1: Literature Review To include both obvious and less obvious RRI dimensions on the product and process levels, we first wanted to find out which indicators could theoretically and practically contribute to making such a process “responsible,” and then we assessed the value of scoring/assessing these aspects (from whichever perspective). To find such indicators, we explored literature in the field of both innovation management and responsible innovation. Within the field of innovation management, we found literature explicitly highlighting quality performance indicators for ongoing R&D processes, from a management/organisational perspective, from a practical/working floor perspective, and from the perspective of the outcomes of such processes, all from different fields of innovation, also including literature reviews (see Maidique and Zirger 1984; Cooper and Kleinschmidt 1995; van der Panne, van Beers, and Kleinknecht 2003; Tepic, Fortuin, and Omta 2013; Flipse et al. 2013). Within the field of RRI, quality performance criteria are much less frequently found in peer-reviewed, academic literature. We therefore resorted to reports of EU-funded projects and policy makers (see Ravn, Nielsen, and Mejlgaard 2015; Spaapen et al. 2015; Schollten et al. 2016). From these papers and reports we distilled roughly 250 indicators. We reduced this number to a list of ninety-two indicators by removing redundancies and irrelevant indicators (examples can be found in the results section below and the complete list in Appendix A). We then reformulated all these indicators into statements about R&D processes, which people might agree or disagree with to a certain extent, in preparation for the later “scoring” of these elements on a seven-point Likert scale. These remaining indicators we subsequently clustered collaboratively with the authors and external advisers of the project into themes, relating to organisational R&D aspects and specific RRI criteria, both on the product and on the process level of innovation practice. In preparation for the following workshop with companies, we used a visual approach based

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Table 9.1  Methodological steps to monitor the value of RRI in companies and R&I projects Step

Description

  1  1a

Literature review Review academic literature from innovation management (Academic) reports on RRI criteria

 1b

Use Find R&D-relevant innovation performance criteria Find RRI criteria to add to innovation performance criteria Integrate literature findings to compose general indicators list

 1c

Identify, select, and further develop RRI performance criteria (indicators)

  2  2a

Workshop with individual companies Companies categorise relevant Determine which RRI and indicators (yes, maybe, no) innovation indicators are relevant Combining indicators into clusters Determine broader themes (clusters) that matter to the companies Scoring of relevance of individual Determine priorities within clusters items (materiality analysis)

 2b  2c   3  3a  3b

  4  4a  4b

Tool development and first analysis Integrate selected indicators (and clusters of indicators) in the digital tool (online environment) Initial academic analysis of workshop results

On-field observation and auditing (Desk) analysis of RRI aspects related to the pilot company and R&I project (PRISMA partner) Continuous interaction with pilot companies (interviews and meetings of PRISMA partners)

Enable companies to enter data in a personalised and easy-to-use digital tool Determine which elements were always/never selected, identify cluster relations between companies Preliminary identification of RRI dimensions relevant for the company Reflection on RRI dimensions relevant for the company

  5   Apply the RRI monitoring tool in pilot organisations (the eight pilot organisations) – (in parallel with step 4) T-0 measurement: starting situation  5a First measurement of RRI-Key for companies Performance Indicator (KPI) on selected R&I projects (one project for each pilot)  5b Midterm review(s) T-1-n measurement: finding out how projects developed  5c Final measurement T-n measurement: assess how projects developed in the end (Continued)

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Table 9.1  (Continued) Step

Description

Use

  6    Meta-analysis (step 6a in parallel with steps 4 and 5) Identify way forward, actions,  6a Assessment of ongoing results drivers, and barriers to of monitoring of RRI-KPI implementing RRI within the R&I (quantitative) and on-field project(s) observation  6b Comparison within organisations Determine if RRI projects have (dis) similar development patterns vs. “non”-RRI projects  6c Comparison between organisations Investigate patterns of RRI performance development between organisations

on an “RRI card game” (the ninety-two indicators printed on individual cards, using a business card format). Step 2: Workshop with Individual Companies In April 2017 we hosted a workshop for the companies participating in the PRISMA project. Two of the eight involved organisations were companies active in nanotechnology. The workshop had three parts (see figure 9.1). After steps 2b and 2c we collected the results. Participants provided the input for the subsequent steps. Clustering activities (the card game) were organised in groups, with at least one company representative, assisted by one PRISMA partner and one or two external experts. In the first step of this phase (2a), taking roughly forty-five minutes, representatives of each company were asked to distribute our ninety-two indicators into three categories: absolutely relevant to their ongoing R&D work, absolutely not relevant, and possibly relevant. In the second step (2b), taking roughly thirty minutes, the indicators that were not considered relevant were discarded for each company, while the remaining indicators were clustered into categories by the company representatives. This clustering was different from the clustering we did by ourselves (step 1c), but this guaranteed that the elements were clustered into categories that were relevant for the individual companies. In the third step (2c), taking roughly fifteen minutes, the company representatives were asked to distribute a total of one hundred points over their identified categories, to determine which categories they found to be the most important with regard to their influence on the quality of ongoing R&D work. The groups were free to determine their own approach toward the point distribution process (e.g., each person in a four-person group got twenty-five points, or twenty rounds of five points distribution per person, or any other approach).

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Figure 9.1  Workshop for the companies participating in the PRISMA project. Left: groups categorising the indicators as relevant, not relevant, and possibly relevant. Top right: participants clustering the elements into categories. Bottom right: resulting clusters, ready to be scored for their relative importance.

Step 3: Tool Development and First Analysis The scoring method builds upon an earlier innovation quality monitoring tool called the “success factor based live innovation project scoring and evaluation” (sFLIPSE) tool (Flipse et al. 2015) and expands this tool with specific RRI elements. The tool basically asks for indicators to be entered and clustered into key performance indicators and gives a score that determines the mathematical relative value of each of the clusters in relation to each other (step 2c). The tool can also include relative values of the individual indicators within a cluster, but for the time being we assume that each identified indicator within one cluster contributes to that cluster equally. With regard to our analysis (step 3b), we aim to determine initial similarities and differences between the participating companies. We therefore took our own clustering (step 1c) as a starting point and identified to what extent the participating companies recognised the same individual indicators within these clusters. We also looked at which indicators were always or never chosen and which indicators were found to be unclear or wrongly formulated. We also compared the clusters that the companies identified to see if they recognised the same clusters of indicators.

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Step 4: On-Field Observation and Auditing In their role as “RRI experts and advisers,” PRISMA partners have worked with companies to help them understand, reflect on, and find ways forward with practical implementation of RRI within their organisations. This activity has been performed in parallel with the “quantitative” assessment made in step 5 to lead to the final analysis in step 6. The work with indicators has been used as a basis for reflection with the companies to identify and assess relevant RRI aspects of their activities. In PRISMA this has been a continuous process, lasting almost two years. However, for the purpose of the application of the RRI monitoring tool in other contexts, different—even less cumbersome—ways to perform this step can be envisaged. Step 5: Apply the RRI Monitoring Tool in Pilot Organisations Figures 9.2 and 9.3 indicate how the tool is used in innovation practice at participating organisations. Its functionality requires RRI project participants (and possibly participants in other R&I projects of the company, within specific RRI efforts) to periodically fill in a questionnaire using a seven-point Likert scale to assess the list of identified indicators (provided in the form of questions/ statements). We envision at least three monitoring points—at the beginning, midway, and at the end of a project’s run time—and in PRISMA we are currently in the process of gathering data. The monitoring should be performed on a medium- to long-term frame, to follow evolution of the R&I project. In PRISMA the three measurements have been done over a period of eighteen months. Of course, acquiring the assessments themselves is not considered the primary goal here. We explicitly want our assessments to be “food for thought” and to lead to deliberation within the organisation on questions such as why certain elements are scored higher/lower than others and why different project participants have different ideas about why a certain element is scored high/low. The tool is highly interactive, with multiple elements being selectable and “clickable.” Our aim for the future is to also develop a demonstration version for use online. At least one of the measurements (generally the first one) is made with an external expert (e.g., PRISMA partner) to provide advice and support reflection on the questions proposed by the tool. Step 6a: Meta-Analysis While the projects’ quantitative assessments are taking place, analyses of data and qualitative evaluations with the project teams are also performed.

Figure 9.2  Example of company dashboard comparing four projects on four possible (random) criteria

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Figure 9.3  Example of dashboard for users indicating performance development of a sample innovation project. The projects are compared for levels of success, based on a database of the scores of indicators and clusters from previous projects.

These analyses can also be useful to find out if projects in which specific RRI efforts were deployed differ in performance or performance development from projects without such specific efforts. The results include reflection on reasons why RRI performance progressed the way it did, whether RRI efforts can support the quality of ongoing R&D work, showing drivers and barriers for RRI implementation, and which RRI methodologies fit best with company needs. 3. RESULTS FROM INDUSTRIAL CASES IN THE NANOTECHNOLOGY FIELD In the remainder of this chapter, we describe our experience in using our approach to monitor two of the eight PRISMA pilot studies (i.e., two companies active in the field of nanotechnology). The aim is to provide a critical assessment method for RRI within these two pilots, in the form of a monitoring system that assesses the value and efficiency of RRI in nano innovation projects. We take an approach to the challenge of developing knowledge that is fit for the purpose of promoting RRI and the values of inclusivity, collaboration, and transparency in R&I organisations.

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3.1 Our Cases in the Nanotechnology Context The uncertainties in evaluating and measuring potential scientific and societal impacts are common aspects of emerging technologies such as nanotechnology. The attention generated by the debate on nanotechnologies, together with negative experiences of the past (such as the debate on GMOs) and other parallel debates on emerging technologies (such as synthetic biology and information and communication technologies [ICTs]), have helped to increase the interest in new approaches to addressing the governance issues of nanotechnologies (Porcari and Mantovani 2015). Over the last few years, stakeholders in Europe have acknowledged the importance of a more articulated approach to addressing social and ethical impacts of nanotechnology and the need to develop tools for anticipatory governance and early public engagement to support its development (Fedrigo and Senjen 2010). The debate has now moved to a general debate on responsible research and innovation. The RRI dimension is, in principle, a feature that should guide all research and innovation efforts, but in the case of nano-related products and processes this approach is even more necessary given the peculiar character of nanotechnologies, which may pose unexpected challenges and situations. The lack of knowledge about behaviour and properties of particles and systems on a nanoscale makes it more challenging to anticipate unwanted impacts. Assessing RRI in nanotechnology innovation projects is typically related to so-called environmental, health, and safety (EHS) issues as well as (in some respects potentially overlapping) ethical, legal, and social aspects (ELSA). Regulatory uncertainties, health and safety aspects, the issue of stakeholder engagement, the need to deal with complex and multidisciplinary aspects, issues concerning risk perception of nanotechnologies from stakeholders and the public, and peculiar ethical issues (related to specific applications) are some of the most relevant RRI concerns related to nanotechnology and nano-related products. These aspects have increased the interest in RRI for companies as they attempt to find approaches to dealing with and addressing EHS and ELSA uncertainties. 3.2 Literature Study (Step 1): Which Elements and Clusters Did We Identify? The following section has three parts: the outcome of our literature study, the outcome of our initial workshops with the two nanotechnology companies, and the first analysis of the workshop results. In our study we selected ninetytwo different possible organisational and RRI indicators, related to literature in the field of innovation management and responsible innovation. These were further classified into topics and clusters, and as well indicators of aspects of the R&I process and indicators of characteristics of the final product of the R&I processes (note that this classification does not constitute an evaluation

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Monitoring the Value of Responsible Research and Innovation Table 9.2  Overview of total number of indicators Company

Process indicators

Product indicators

Total

22 26

27 17

49 43

Organisational indicators RRI indicators

of these items). We take into account all six pillars of RRI proposed by the EC under the suggested indicators. Some appear under the “process” category (i.e., relating to the process of innovation and production), and the rest are under “product” (i.e., relating to the result of innovation processes and the further market introduction). Based on the MoRRI project (Metrics and Indicators of RRI) (Ravn, Nielsen, and Mejlgaard 2015) and a report on RRI indicators from the EC (2015a), we decided to include “environmental sustainability” and “social sustainability” categories as RRI indicators. We argue that the indicators (either organisational ones or RRI-relevant) can potentially be adapted during the course of the PRISMA project according to literature and industry stakeholders’ feedback. Table 9.2 shows an overview of the number of aspects, and table 9.3 gives an overview of the individual Table 9.3  Identified organisational and RRI indicators (topics and cluster) from literature study Organisational (topic/ cluster)

# process items/ # product items

Internal Technology Sales/marketing Planning/ management Resources Collaboration/ communication

5/4 2/3 4/1 4/1 2/0

External Market

0/8

Customer/end-user

5/9

Total

22/27

RRI (topic/cluster) Diversity and Inclusion Gender equality Engagement Anticipation and reflection Legislative landscape Assessment

# process items/ # product items

2/1 8/2 2/1 3/3

Public and ethical issues

1/1

Responsiveness and adaptive change

3/0

Openness and Transparency Intellectual property and confidentiality Open access Environmental sustainability Social sustainability Total

2/1 3/2 1/3 1/3 26/17

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identified clusters as well. Appendix A shows our complete overview, also including the formulated statements to further study the indicators in practice. 3.3 Initial Workshop Results (Step 2): Which Elements Are Considered Relevant in Nanotechnology? In our workshop we first asked our two companies dealing with nanotech to identify, from the stack of ninety-two indicators, which indicators they considered “relevant,” “irrelevant,” or “maybe relevant” for their organisations. Out of the ninety-two indicators, seventy-eight functioned as “relevant” and fourteen functioned as “irrelevant” in one or more situations for the two nanotech companies combined. Of the seventy-eight “relevant” indicators, thirty-one emerged as “relevant” for all companies, while eleven functioned as “maybe relevant” for one of the companies. For example, the indicator “This project provides substantial societal benefits, compared to available alternatives (health, safety, solidarity, equity)” (in the “RRI Environmental Sustainability” category) was implied to be “relevant,” whereas the indicator “Within this project we include input of policy-makers in the design and development process” (in the “RRI Diversity and Inclusion” category) was implied to be “irrelevant” for both companies. In all six observed organisations, a total of eighty-nine “relevant” indicators were identified, which illustrates that the nanotechnology companies are considering a relatively low number of “relevant” indicators in their R&I initiatives. In order to help derive our organisational and RRI indicators for nanotechnology companies, it can be noted that the two nanotech pilots identified relevant indicators within their projects from forty-nine organisational and forty-three RRI indicators. Of these, forty-one of the organisational indicators (83 percent) and thirty-seven of the RRI indicators (86 percent) were identified as either “relevant” or “maybe relevant.” However, the two pilots showed extensive variation in their selection of “relevant” indicators under organisational indicators and RRI counterparts. An overview is presented in table 9.4. While Nano Company 1 selected 73 percent of the organisational indicators as relevant for its projects, Nano Company 2 selected 35 percent of the organisational indicators as relevant. The selection of relevant RRI indicators also varied between the two companies. Although the selection of relevant indicators for each company varied in both categories, an average of 60 percent for selection of relevant indicators is seen. Given the fact that these variations probably reflect differences in the stage of implementation of RRI within the two pilots, the result supports our

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Monitoring the Value of Responsible Research and Innovation Table 9.4  Categorised indicators for the two nanotechnology companies Relevant

Irrelevant

Maybe

Relevant %

Nano Company 1

Organisational RRI

36 29

11 14

0 0

73% 67%

Nano Company 2

Organisational RRI

17 27

22 12

7 4

35% 63%

Total

Organisational RRI All

54% 65% 60%

idea on later re-categorising of indicators through an iterative process and having a tailor-made solution for each pilot. We asked the companies to cluster the “relevant” items (table 9.5). The comparison of clusters identified by the two pilots combined demonstrates that there are clearly some common clusters among them—namely, market and economic, social and environmental, and intellectual property rights (IPRs)—although the common clusters’ importance may differ from one company to another. We also asked the two pilots to score the relative importance of the identified clusters compared to one another by distributing one hundred points over their identified clusters (figure 9.4 and table 9.5).

Figure 9.4  Point distribution over clusters of indicators per company. The sum of the scores is one hundred for each company. (Note: Companies were able to change and adapt the name of the clusters, and for this reason there could be different names for similar clusters for the two companies.)

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Table 9.5  Clusters of indicators as identified per company (data also reported in figure 9.4) Nano Company 1 Resources and benefits (economic) Project management Internal organisation Ethics and values Communication with external stakeholders Market IPR Policy Impact on society and environment Gender

Points out of 100 Nano Company 2

Points out of 100

15

Technical

25

15 15 10

Economic Resources Social desirability and acceptance (including health and safety) Inclusive (design/process)

25 15 10

10 10 10 5 5

IPR and confidentiality + open access/sharing Outreach Gender

10 9 3 3

5

3.4 First analysis of the workshop results (Step 3): To what extent do the indicators that we identified ourselves match the nanotechnology companies’ indicators? We checked how the indicators that companies selected related to our own clustering of indicators. Table 9.6 gives an overview. For example, for the “Internal—Technology” aspect, Nano Company 1 scored 4/2, indicating that of the five process items, they identified four as relevant, and of the four product items, they considered two to be relevant. In contrast, both companies acknowledged the value of the customer/end-user (>6/10 items selected). Interestingly, both companies acknowledged all “Assessment” product items as relevant, whereas Nano Company 2 did not see the necessity of the “Assessment” process (one item out of three selected). The aspect of collaboration/communication was not selected to be relevant, even though stakeholder engagement is generally considered to be important on a process level. Also, Nano Company 1 selected all gender indicators as relevant, whereas Nano Company 2 selected less than 50 percent of them (product and process) as relevant. What we learned after steps 2 and 3 is summarised below. • RRI implementation is related to different aspects and functions within a company and along the R&I value chain. Needs and perspectives might also change over time, during product development. • The clustering and selection of indicators with the pilots shows how this process is strongly context- and case-dependent.

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Table 9.6  Comparison of our framework (table 9.3) with the indicators identified by the two nanotechnology companies

Organisational indicators Internal Technology Sales/marketing Planning/management Resources Collaboration/communication External Market Customer/end-user TOTAL

# process items/ # product items (clustering from literature study)

Clustering from Nano Company 1

Clustering from Nano Company 2

5/4 2/3 4/1 4/1 2/0

4/2 2/3 4/1 3/1 0/0

2/1 1/2 0/1 1/0 0/0

0/8 5/10 22/27

0/6 4/6 17/19

0/2 0/7 4/13

2/1 8/2

2/1 4/2

1/0 6/1

2/1 3/3 1/1 3/0

1/1 3/3 0/0 3/0

2/0 3/1 1/0 3/0

2/1

2/0

2/0

3/2 1/3 1/3

2/1 1/3 0/1

1/1 1/1 1/2

26/17

18/12

21/6

RRI indicators Diversity and inclusion Gender equality Engagement Anticipation and reflection Legislative landscape Assessment Public and ethical issues Responsiveness and adaptive change Openness and transparency Intellectual property and confidentiality Open access Environmental sustainability Social sustainability TOTAL

• Therefore, it is quite difficult to find common aspects, or in any case to preselect indicators suitable for different companies, even in the case of companies active in the same technological field. • It is thus mandatory to start the RRI monitoring process with a wide choice of indicators and then work with the companies to select them. This process should be repeated over time to adapt to the development of the R&I project (and other changes in company operations). Step 4: On-field observation and auditing We had several interactions with companies to identify suitable industrial activities within their R&D departments to test the implementation of RRI;

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we also discussed with them the most relevant EHS and ELSA issues relevant to the work of PRISMA. We selected R&I projects related to the application of nano-systems for the targeted and controlled release of active ingredients for health-care and well-being applications. In particular, these projects are about the development of advanced nano-based systems for medical therapies, dermo-cosmetics, and medical devices. The two companies have a leading role in these projects, but other partners, including research organisations, universities, hospitals, and other companies, are also involved. However, all measurements performed were carried out only with personnel of the two pilot companies. In both cases, key RRI aspects include: addressing EHS issues of nanomaterials in research and throughout the product life cycle, product quality, transparency, and communication about use of nanomaterials toward supply chain actors and end-users/consumers. The analysis of RRI aspects, including discussion on results of monitoring indicators, led to a reflection on the reasons for the two companies to engage in RRI, as well as identification of specific actions that could be pursued to further integrate RRI into the companies. In the next sections we present some preliminary results of our work. Steps 5 and 6: The way forward, drivers and barriers for the adoption of RRI A preliminary reflection on the importance of RRI in our pilots is related to the characteristics of the business case of the two R&I projects. One of the companies is engaged in a complex and ambitious R&D project, requiring relevant medium- to long-term investments and a clear vision regarding positioning of future products with respect to health-care stakeholders. There is little chance of success without a broader alignment with the needs and perspectives of the final users, in particular the health-care system, health professionals, and patients. The R&D project of the other company is aiming to introduce use of nanotechnologies in natural and organic cosmetics products, a market segment that in principle is reluctant to use new technologies. Engaging with all actors along the supply chain in the design of the product is essential to ensuring the success of the product. The interaction with PRISMA partners, through the various steps of our approach, allowed us to identify specific RRI actions for integration into the product development of the two pilots, the expected results of these actions, and thus clear reasons for companies to engage in RRI. Examples of the actions identified with the pilots include: • integration of specific risk-management approaches for nanomaterials in production phases;

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• foresight activities to anticipate socioeconomic impacts of future products; • participatory methods for co-design of products with R&I partners, suppliers, and professional users; • establishment of an ethical board to supervise R&I activities; • regular cooperation with authorities and certification bodies to inform about product development; and • creation of “RRI-oriented” communication strategies to ensure transparency toward stakeholders on product properties and features. In the medium to long term, these RRI actions promise to support companies in anticipating potential ethical, legal, and social risks, improving product performance and aligning it with users’ and society’s needs (societal acceptability), and ensuring compliance with existing and future developments in norms and standards. Short-term objectives are also envisaged by these actions, translating into immediate benefits at product level. RRI actions should help to introduce specific procedures for safe use of nanomaterials all along the value chain, thus increasing the safety and quality of the products. Participatory methods could allow the design of specific ethical protocols to deal with biological and predictive health data, the design of new (responsible) models for clinical trials suitable for personalised medicine, the anticipation of socioeconomic impacts of new products, and adjustment of business models accordingly (a business model following an RRI approach, thus ensuring broader and fairer access to treatments). Dialogue activities could also help in addressing normative aspects (e.g., expected future regulatory requests in the nanomedicine areas, fulfilment of certification requirements for natural and organic cosmetics products), alignment with distributors’ requirements for “premium” products, and better understanding of consumers’ expectations. From a strategic point of view, RRI is thus expected to create value for R&D and innovation activities, improve corporate image and reputation, and thus in the long term help companies gain a competitive advantage. PRISMA activities showed that there are also several barriers to companies engaging with RRI, both at strategic and operational levels. An initial barrier is the understanding of the concept and its potential added value for business by the company. This is again closely related to what we called the “RRI maturity stage.” On the one hand, it is the awareness and attitude of the company about social responsibility and ethics issues; on the other hand, companies with relevant social responsibility activities might not see the added value of RRI compared to their usual practices in this area. Another barrier is identifying approaches for RRI that fit the specific company case—and related potential benefits—because they might not be

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evident or straightforward. Interaction between the company and RRI experts and in-depth reflection on company activities and processes is often needed to this end. In all cases, getting the initial interest of a company to cooperate and experiment on RRI is a long process, where awareness raising and building trust between the company and RRI experts is essential. RRI integration requires the company to open up (part of) their processes and foster cooperation with different stakeholders at different levels in the company and also in different phases of the R&D development. This might be in conflict with the usual management procedures of the company and may entail problems of confidentiality and IPR. RRI covers broad aspects of technology development and requires actions in the short, medium, and long terms. A strategy needs to be developed and aligned with the company business strategy. This implies the agreement and commitment of several functions within the company (at least management, R&D, and probably also quality and CSR). Most R&D projects involve close technical cooperation with other partners along the R&I value chain and product supply chain, and some of these partners might lack experience in cooperating and taking part in RRI actions—or the willingness to do so. Specific skills and experiences with RRI aspects might be lacking within the company, and use of external advisers and experts might be required to implement RRI. Resources (human and financial) are needed to implement RRI actions, and the more RRI is embedded in existing processes, the more this could be resource-demanding. The experience with the two PRISMA pilots provides some examples of the complexity of opportunities and challenges related to the integration of RRI aspects in real-life processes at company level. The development of a knowledge base of company experiences of RRI, sustained by qualitative and quantitative key performance indicators at both strategic and operational levels, could be very helpful to show how medium- to long-term benefits could outweigh costs and thus promote the broader application of RRI at industrial level. 4. CONCLUSION Nanotechnology innovation projects include a broad and diversified set of sciences, research, application fields, and technologies. There are a few criteria that might help to structure and focus the analysis of RRI impacts in nanotechnology innovation projects and identify whether and how RRI principles are related to a technology itself, an application, or to a societal challenge. The results show various RRI-relevant elements that play a role for our pilot companies. These include, but are not limited to, having an impact on society

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and the environment; resources and benefits (economic); social desirability and acceptance (including health and safety); IPR and confidentiality, as well as access to novel applications of nanotechnology innovation projects; sustainability; and gender aspects. The analytical work performed on indicators, as described in the previous paragraphs, shows that RRI aspects are deeply connected with a broad spectrum of factors related to company operation and strategies. Integration of RRI could influence the way a company sets up its governance structure and organises internal procedures, the plans and goals of research and product development, communication, dialogue with stakeholders, and the marketing strategy at company and product levels. In principle, most of the company functions could be involved and influenced by the implementation of RRI principles. Drivers and barriers for inclusion of RRI, as emerged in the work with pilot companies, touch upon a variety of issues. They range from strategic factors at company level, which are often difficult to quantify in the short term (e.g., improvement in company reputation), to tangible and short-term aspects related to specific issues around product development (e.g., addressing specific certification requirements related to the use of nanomaterials). The application of transformative technologies, such as nanotechnologies, typically implies a certain degree of uncertainty, from both a technical and societal point of view, and thus is the initial driver for companies to look at RRI approaches. However, the reasons why a company could decide to apply a structural and long-term approach to RRI are much broader and less related to the specific technology concerned. The two pilot cases described in this chapter give some hints about the complexity of reasons and factors influencing the choice of a company to take an RRI pathway. An essential aspect of the two pilot companies that facilitated the cooperation with PRISMA was their attitude toward social responsibility. For both of them, aspects related to sustainability, precaution, business, and research ethics were already part of their usual business practices. Using the RRI maturity levels defined by Yaghmaei (2015, 2018), both companies were valued at an “RRI managerial stage.” However, despite different activities (both formal and informal) that could be linked to RRI, the RRI concept itself was new for both of them. The main motivation for them to practice with RRI was the EHS and ELSA uncertainties related to their R&D projects, in particular the use of nanotechnologies. Within the PRISMA project, one of our aims is to provide evidence of how an RRI approach can improve the innovation process and its outcomes. To obtain this evidence we used the mixed quantitative and qualitative approach we presented in this chapter. We hope that ultimately our scoring system and analysis can demonstrate an increase in performance of projects in time. Yet

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maybe the RRI projects show a different performance development pattern than other projects that can be explained by circumstances that may or may not be related to RRI specifically. At present it is too soon to tell. In addition, in order to make sense of the scoring patterns, it is still very important to collect data in a qualitative manner, using our proposed scoring of projects at the beginning, middle, and end of their run time. Still, to us personally, the specific scoring assessments and related patterns and developments in time are not the most important things to achieve. We hope that the individual assessments can be used within the organisations as a starting point for constructive dialogue about RRI installation in practice, from within the organisation itself. However, such discussions have to be kick-started and moderated by experts. In a broader sense, in these and other PRISMA pilots, RRI integration is in all cases guided by expert advice, and the extent to which this is inevitable or desirable should be discussed later and elsewhere. In addition, the outcomes that are considered important now could become irrelevant in a year or a decade. Therefore, our approach should be repeated over time to see if elements that were missed earlier can still be included, or if items that are no longer relevant can be excluded. We hope to find the best frequency for carrying out the assessment activities described in this chapter. In any case, the assessment method makes us ask the following question: Are we “measuring” the initiative of the company itself or of ourselves (or others)? We acknowledge that, similar to ethnographic methods, we cannot measure without influencing the practice we are studying. Even with this assessment method, the question remains of whether and to what extent companies can organise RRI by themselves and demonstrate that it works in practice. From our current PRISMA experience we have understood that—at least nowadays, in the early stages of integration of RRI at company level— an expert-driven approach is essential to supporting companies in the process. The tool developed could be helpful to supporting and accompanying the (reflection) activity carried out by the company together with the expert on RRI dimensions. Therefore, within our project we can explore the value of our approach to implementing RRI in industrial innovation practice, but it might be difficult to continue making such assessments when our project ends. Future studies could also consider what the value of RRI is without explicitly making it part of projects in industry, what options there are for independent RRI assessments and certifications, and possibly what options there are for integrated reporting on both RRI and annual statements/reports.

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Monitoring the Value of Responsible Research and Innovation Appendix A  Complete set of identified indicators Process

Product

The technology required to carry out this project is totally new to our company Our company is technologically very capable of carrying out this project Our engineering skills and people are more than adequate for this project Our production resources/skills are more than adequate for this project Our project is a very high technology (high-tech) one

The product type is totally new for our company

Our marketing research skills and people are more than adequate for selling this project to the customer Our sales, advertising, and promotion skills are more than adequate for this project

The type of sales-force or distribution system for this project is totally new to our company The probability that this project will have a spin-off effect, such as development of a new generation of products, is very high Marketing and communication of the outcome of this project will emphasise heavily the societal benefits (health, sustainability) of the project

The probability that this project will be completed within the original planning is very high I completely understand the potential problems for the project Our management skills are more than adequate for this project This project makes use of many outsourced activities (consultancies, technical skills, etc.)

We use sufficient risk assessment methods concerning relevant (legal, organisational, public, technical, etc.) aspects

Organisational Internal Technology

This project fulfils all its technical objectives/meets the specifications (is very high) The performance requirements for the project are clear to me The nature of the production process is totally new to our company

Sales/marketing

Sales/marketing

(Continued)

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Appendix A  (Continued) Process

Product

The probability that this project will be completed within the original budget is very high Our financial resources are more than adequate for this project Our sales/distribution resources are more than adequate for this project We have sufficient resources explicitly dedicated to RRI activities

The probability that this project will earn more money for our company than it costs is very high

Resources

Collaboration/communication I have enough communication with my team members to do my work efficiently in an effective way If I doubt the opinion of a team member, I will definitely confront him/her about it External Market Our project’s outcome is highly innovative and totally new to the market Our project will be of higher quality than competing projects (in other companies) There are many competitors in the market for the outcome of the project The market for the outcome of the project is characterised by intense price competition The market for the outcome of this project is growing very quickly This project will contribute to the competitive advantage of our company The competitors we face in the market for this project are totally new to our company The monetary value of the market (existing or potential market) for this project is large (Continued)

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Appendix A  (Continued) Process

Product

Customer/end-user R&D is core to the business of our customer

The (potential) customer for this project is totally new for our company We have good insight into the Our project outcome will be clearly superior to competing interests of the members projects (in other companies) of the project team of our in terms of meeting our customers customer’s needs Compared to competing projects We are well aware which (at other companies), our persons play a role in the project will offer a number of project on our customer’s unique features or attributes to side our customer Our project will allow our The project manager of the customer to do a job it cannot customer has much to gain presently do with what is personally (on a social level) available from this project (social status, promotion, image) The probability that this project Within the R&D culture of will directly benefit the endour customer, externally user, either through increasing executed R&D projects are efficiency or effectiveness, is very well appreciated very high Potential customers have a great need for this type of product The customer will definitely use the (outcome of the) project Our customer’s clients (endusers) will definitely use the (outcome of the) project This project will contribute to the competitive advantage of our customer The project is of high strategic importance to our customer (Continued)

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Appendix A  (Continued) Process

Product

RRI Diversity and Inclusion Gender equality The integration of gender Within the project we have dimensions is actively equal participation of integrated in research and women and men in both innovation outcomes research and project management We have organisational arrangements to progressively eliminate barriers impeding women’s advancement to top positions and factors inducing women to drop out of science Engagement Within our project we use tools and mechanisms for organising dialogue with stakeholders on appraisal/ ethical acceptability Within this project we use a systematic approach (specified how, when, and why) from the beginning to include various stakeholder viewpoints on a wide set of values (technical, social, ethical, legal, etc.) Within this project we include input of end-users/ customers in the design and development process Within this project we include input of possible non-users/ indirect stakeholders in the design and development process Within this project we include input of suppliers (materials and/or knowledge) in the design and development process

The outcome of this project is assessed actively using user experience tools We organise science communication/education activities aimed at educating citizens and generating awareness of aspects/issues of the innovations we are working on

(Continued)

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Appendix A  (Continued) Process Product Within this project we include input of funders/investors in the design and development process Within this project we include input of civil society groups/ NGOs in the design and development process Within this project we include input of policy makers in the design and development process Anticipation and reflection Legislative landscape Current regulation and the legislative landscape for this type of project presents no problems to our project

For the outcome of this project to become widely adopted, the project requires lobbying activities in the domain of decision-making and policy development

We have an official code of conduct/ethical review board that safeguards that this project can be carried out without issues Assessment We have conducted analysis on We use ongoing, continuous (or have monitored) the impact monitoring of ethical aspects of the products/services of this in this project project We continuously consult other Societal acceptance is not a major risk for this project researchers and research projects to signal new and future technological trends The outcomes of this project may Within our project team we have large macroeconomic regularly organise group effects deliberation (employee engagement, training, discussions, etc.) on societal/ social/public/policy aspects Public and ethical issues We document best practices about ethical acceptability for this type of project during its development

There has, historically, been little public resistance against the use of the outcome of this project (Continued)

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Appendix A  (Continued) Process

Product

Responsiveness and adaptive change Within this project we actively and continuously include values and normative principles (health, safety, security, privacy, accountability, etc.) in research and technological design. Within this project we apply risk identification and risk management strategies to adjust the course of the project. Within this project we adopt a learning approach to adapt the research programme according to the viewpoints and ideas of other stakeholders. Openness and transparency Intellectual property and confidentiality Within this project, IP in the form of patent applications (from our side) or acquiring licences (from others) does not play a large role Confidentiality of methods and results is not an issue within this research and development project

Personal data and privacy issues do not play a major role in this project once its outcomes are used

Open access Our project makes use of virtual This project uses institutional mechanisms for promoting the platforms for data exchange results of our R&D activities for use inside the company publicly after these activities (e.g., laboratory notebooks, are finished meeting minutes, etc.) This project uses institutional Our project makes use of mechanisms for promoting the virtual platforms for data results of our R&D activities to exchange (sharing) with involved stakeholder groups clients after these activities are finished Research results are actively communicated within the research network (stakeholders) during the project (Continued)

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Appendix A  (Continued) Process

Product

Environmental sustainability Environmental values are actively included in the innovation process

This project provides substantial environmental benefits to society compared to available alternatives This project leads to improved resource use efficiency (water, materials, energy, pollution, waste) This project does not influence the ecosystem or environment in a harmful way

Social sustainability Societal values (privacy, safety, health, security, data ownership, etc.) are actively included in the design process of this project

This project provides substantial societal benefits compared to available alternatives (health, safety, solidarity, equity) The implementation of the outcomes of this project in society is not hampered by issues of trust The implementation of the outcomes of this project in society is not dependent on societal support

NOTES 1. See the RRI Toolkit website at https://www.rri-tools.eu/. 2. See the PRISMA website at http://www.rri-prisma.eu/toolkit/.

Part III

POLITICS AND PUBLICS

Chapter 10

The Politics and Public Imagination of Nano-Labelling in Europe Claudia Schwarz-Plaschg

1. INTRODUCTION Nanoparticles and nanomaterials (in the following, “nano” for short) are already applied to a variety of consumer products to enhance their functions. They are used to make textiles water-repellent, to make sunscreens more effective and less visible on the skin, and to enrich foods with nano-coated nutrients. At the same time, it is still largely uncertain whether nanoparticles might have negative environmental, health, and safety implications, which is why political and regulatory actors are confronted with the challenge of how to govern and regulate such nano-enabled products. In the absence of clear scientific evidence (Miller and Wickson 2015), the labelling of nanoparticles in consumer products (nano-labelling) is considered a viable approach to inform the public and enable consumer choice, at least in the European context (see Bowman and Tournas, this volume). The following closing sentence of a media article about nano-related regulatory developments, published on the widely read website of the Austrian Broadcasting Corporation, is representative of the hopes ascribed to nano-labelling: “Then responsible consumers can decide for themselves how much ‘nano’ they’ll permit on their skin in the future.”1 In this envisioned future, the discourse of consumer empowerment is intertwined with the figure of “responsible consumers” who are expected to fulfil their civic duty by participating in the risk management of nanoproducts via their buying decisions (Eisenberger, Greßler, and Nentwich 2012). This conception of nano-labelling and its societal embedding relies on a shifting of responsibility toward consumers (Shelley-Egan and Bowman 2015); however, it remains an open question whether this represents the ideal governance approach for all involved stakeholders, especially those who 179

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are often referred to as “consumer-citizens,”2 thus pointing to the increasing entanglement of consumerism and citizenship (Mol 2009; Michael 1998). To tackle this question, this chapter explores the current state of nanolabelling regulation in Europe and considers whether it matches the public imagination of nano-labelling in a specific national context inside the ­European Union (EU), namely Austria. I enquire into the following two more specific questions: How do members of the Austrian public imagine the (ideal) labelling of nano-enabled consumer products and the meaning of a nano-label? In what ways does the public’s imagination correspond to or diverge from the existing EU labelling regime? For this purpose, I first examine the role(s) of product labels in general and present a theoretical approach for how to conceptualise these roles from a Science and Technology Studies (STS) perspective. Next, I sketch the European nano-regulation with regard to the labelling of nano-enhanced consumer products and the politics inscribed in this specific nano-labelling regime. Afterwards, I present the methodological approach used for generating the empirical material. In the main part of the chapter, I then trace empirically how members of the Austrian public discussed the issue of nano-labelling in three discussion groups on nanotechnology applied in different fields: food, information and communication technology, and consumer products more generally. As part of this analysis I identify what I term the “nano-labelling dilemma” and show how participants in the discussion groups sought to resolve it. In a final step, I discuss how the identified public imagination of an ideal nano-labelling approach relates to the regulatory reality in the EU, based on which I draw some conclusions for the governance of nanotechnology and the application of labelling instruments more generally. 2. WHAT IS (IN) A LABEL? Since this chapter revolves around the issue of product labelling, it is useful to first conceptualise how a product label can be understood and what meaning(s) might be ascribed to labels more broadly. In a very basic sense, a label placed on a product can be read as a sign conveying a—more or less clear—meaning (de Saussure 1916). In this structural linguistic framework, a label is understood as encoded with specific information, and the reader is assumed to possess or not possess the required decoding capacity to extract the inscribed information from it. Such unilateral understanding is, however, reductionist because not only may the label not signify an unambiguous message, but also, to ensure the desired information transfer, it assumes that the sender and receiver share the same knowledge base. An interactional model—underpinned by insights from a critical public understanding of

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science perspective (Wynne 1995; Irwin and Wynne 1996)—represents a better, alternative framework that accounts for the fact that a label acquires its situated meaning through negotiation processes, thus allowing different interpretations. By following this model, we acknowledge that readers of a label actively participate in its construction and meaning-making rather than being mere receivers of a predefined package of information (Eden 2011). Similarly, in the framework of actor network theory (ANT), technologies— as well as product labels—are conceived of as incorporating prescribed uses, a feature captured with the metaphor of a script: “Like a film script, technical objects define a framework of action together with the actors and the space in which they are supposed to act” (Akrich 1992, 208). ANT provides concepts such as subscription, de-inscription, and antiprogram that allow us to understand activities ranging from underwriting to renegotiating or rejecting the script or encoded “message” of a label (Akrich and Latour 1992). We can thus conceptualise labels on consumer products as prescribing a certain script—and in our case, attributing specific meanings to “nano”—which can be accepted, contested, or countered. Thus, although labels configure the roles and relations of consumer-citizens and other actors,3 people may bring with them their antiprograms that work against prescribed meanings and uses. ANT also highlights that not every inscribed meaning of a label might be equally plausible or decodable in different cultural or national contexts. That is, some meanings simply suggest themselves more directly in a specific context—for instance, if an analogous mode of labelling was employed with other technologies in the past. Hence, labels on consumer products are designed for a particular communicative purpose and may be intended to influence people’s actions in certain ways, but experiences with and knowledge of similarly designed labels and their existing cultural connotations also shape the range of possible descriptions. Yet this theoretical understanding of the function of and engagement with product labels does not correspond to the rationale behind attempts to establish labelling as a governance mechanism. In current regulatory contexts, mandatory product labelling is still largely applied as an information instrument to facilitate consumers’ buying decisions and protect them from deceptive information (Eisenberger, Greßler, and Nentwich 2012). Framing labelling as mere information transfer to enable choice is itself a very powerful script because it builds on the principles of freedom of choice and transparency, which are highly valued in Western societies. As many consumer-citizens may subscribe to these principles, they may see the label as acting in their interests. As part of this script, mandatory product labelling also seeks to promote innovation and product development as well as build public trust by strengthening the credibility and authority of regulators (Blewett et al. 2011). Thus, also in this respect, labels are not neutral agents

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of information but have norms, values, and power structures inscribed into them. Without falling back on the unilateral model, it is equally necessary to account for the fact that the way in which a nano-label is designed may affect how publics will understand nanotechnology to some extent. Although multiple meanings will always be ascribed to a specific label, we need not lose sight of the (culturally) hegemonic meanings that will be most easily evoked. For instance, if a nano-label were modelled on an already existing label, the culturally dominant meaning attached to this template might rub off on the nano-label. This is not only an issue of design or wording, as some consumers could interpret even the mere existence of a mandatory nano-label as a warning sign. The framing power of labelling was demonstrated in an experimental study (Siegrist and Keller 2011) in which test persons who received nano-labelled sunscreens and additional information perceived these sunscreens as more risky than non-labelled ones. Labels are obviously powerful agents in constructing the public image of nano-enabled consumer products, which is why regulators, industry, and nongovernmental organisations suspiciously oversee their emergence, design, and use. Against this background, it is relevant to look into the implicit politics of the current nano-labelling regime in Europe. 3. THE POLITICS OF NANO-LABELLING IN EUROPE In 2018, nano-labelling existed in three versions in the EU. First, as voluntary labelling by companies that market their products as “nano,” thus promising additional consumer benefits. Well-known early examples of such nanomarketing are the lotus effect of nano-coated surfaces or the iPod nano; the latter actually does not include nanotechnology but uses the term “nano” merely to highlight its small size. While this voluntary labelling was common when nanotechnology first began to move into the public eye, it has decreased in recent years—mainly because the term has also been associated with potential risks for consumers (Eisenberger, Greßler, and Nentwich 2012). Second, a more recent version of nano-labelling is mandatory back labelling of nanoparticles in certain product groups, to which the EU has committed itself gradually over the past ten years. The EU has notably been the first jurisdiction to apply labelling in its regulatory framework toward nanotechnology, while others, such as the United States (FDA 2007), have not embraced this approach because they consider nano-labels a risk signifier (see Bowman and Tournas, in chapter 6 of this volume, for a more detailed comparison between the US and EU regulatory regimes). Nano-specific labelling requirements have since come into effect in the areas of cosmetics,4 novel foods,5 and biocides.6 These legislative instruments focus on specific

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product areas and not on nano as such. For the purpose of this chapter it is important to note that these regulations rely on different definitions of nanomaterials, while they also share certain commonalities. For one, they state that the word “nano” has to be put in brackets after the respective material in the list of ingredients—that is, on the back label of most products. Producers of such nano-enabled products are not required to inform consumers about potential nano-related risks—with biocides being the exception. Thus, what is specific about nano-labelling of cosmetics and food products is that the label neither informs about risks nor communicates safety information to consumers: It solely informs consumers that nanoparticles are in a product but does not explain what this information might mean. The regulations, however, also entail nano-specific reporting requirements for industry, which should include toxicological and safety information. A public catalogue documenting all nano-enabled cosmetics available on the European market— prescribed by the cosmetics regulation—has not been made public yet. The third version of nano-labelling is the absence of nano-labelling in all product groups that fall outside the above-mentioned categories. Thus, no mandatory labelling requirement for nanotechnology is applied in products such as electronics, textiles, surface coatings, or sports equipment, to mention just a few. Hence, European consumers are currently confronted with a diversity of labelling approaches, which might complicate their assessment of nanoenabled products. The politics of this European nano-labelling regime can be summarised as follows. It prescribes a diverging assessment of different application fields (i.e., that nano should matter more to consumer-citizens in certain product groups, such as cosmetics and food, than others). Nano-labelling in cosmetics and food seemingly provides information, but rather than inform, it forms a whole host of relationships and transforms consumers into consumer-citizens who are expected to actively participate in the governance process. It thus co-creates “responsible consumers” who have to decide whether or not to buy nano-enabled products. As mentioned, this ties to the discourse of consumer empowerment that leaves the assessment of risks and benefits to consumers (Throne-Holst and Rip 2011), which can be criticised as a problematic shifting of responsibility (Shelley-Egan and Bowman 2015). Since the current labelling regime does not provide any relevant information or guidance with regard to what the label means in terms of the risks, safety, or properties of a particular product, this insufficient information infrastructure (Stokes 2011) might inhibit rather than foster fully informed consumer choice. These criticisms point toward the need to explore how consumer-citizens actually interpret and make use of such labelling instruments in the area of nanotechnology and how they envision a future in which labelling serves their interests. To address this issue, this chapter empirically investigates the public imagination

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of nano-labelling in Europe. To achieve empirical feasibility, I focus specifically on the Austrian context, to which the EU labelling regime applies, but which also has a unique history with regard to rejecting and labelling the application of new technologies such as green biotechnology (Felt 2015), thus making it an interesting national case study. 4. EMPIRICAL MATERIAL AND METHODOLOGICAL APPROACH In order to explore how members of the Austrian public (i.e., laypeople, or nonexperts, with regard to nanotechnology) imagine and assess nanolabelling, I analyse talk-in-interaction from three public engagement events on nanotechnology that were organised in Vienna in 2009/2010. These four-hour discussion groups were conducted as part of a larger project on the coproduction of nanotechnology and society in the Austrian context.7 In each of these discussion groups, six different participants discussed a specific nano-application field, covering the areas of food, information and communication technologies (ICTs), and consumer products (a fourth group focusing on nanomedicine has not been considered in this chapter because the issue of labelling was not much debated in it). To stimulate reflection and deliberation on the then (and still) not widely known topic of nanotechnology, the project team developed a card-based discussion method—IMAGINE (Felt et al. 2014; Felt, Schumann, and Schwarz-Plaschg 2017). The method makes use of four types of cards (story, application, issue, and future cards) that are uncovered in four respective, consecutive stages. Each participant gets their own stack of cards and is invited to choose between one and three cards in each stage based on their own rationale of choice. The issue of labelling appeared on several cards, as the cards were designed to present relevant topics and questions that were already part of or could be imagined to become relevant in the scientific, policy, or public discourse about nanotechnology. It is important to note that the text on these cards was phrased as statements, open questions, and descriptions of tentative future developments rather than presented as readymade nano-labels, which is the usual approach in studies on labelling (see, for example, Siegrist and Keller 2011; Eden 2011). However, it was mentioned that labelling regulations were not yet in place at the time, thus making nanotechnology a matter of voluntary labelling by producers. This methodological approach animated the participants to develop their own visions for nano-labelling. In other words, the discussants could act like designers who would envision and critically discuss different modes of labelling and their broader socio-political embedding as well as implications. Yet, as discussed

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elsewhere, more than just sense-making and imagining takes place in these settings; a detailed analysis of the unfolding discourse demonstrates that what the participants imagine is already imbued with specific interests and hence incorporates a rhetorical dimension (Schwarz-Plaschg 2018a, 2018b). Although the card methodology was primarily employed to stimulate debate, it also allowed the moderator and researchers to keep track of the cards and topics that were most relevant for the participants. In the three groups, the labelling cards were among the most frequently chosen ones, which already highlights the key role ascribed to this regulatory instrument. In what follows, I will trace how the issue of labelling emerged and was negotiated in the discussion groups. I employ a finely grained discourse analytic approach that is interested not only in what is being said but also in how discourse emerges, the functions that speech acts embody, and what utterances can tell us about the relationship between interlocutors and other absent actors (for more on the methodological basis of this approach, see Schwarz-Plaschg 2018a; Schwarz-Plaschg 2014). While studies of public opinions on nanotechnology have shown that publics throughout the world (Siegrist and Keller 2011; Brown and Kuzma 2013; Throne-Holst and Rip 2011)8 are in favour of labelling, only a few have analysed in detail how publics talk about these issues and debate various labelling approaches. The following empirical sections start with material from the ICT group and then move to incorporate data from the other two groups to slowly reveal the way in which labelling was discussed and how the application fields mattered for shaping the debate. 5. LABELLING TO ENABLE GOVERNANCE VIA CONSUMPTION In the ICT group, the issue of labelling emerged in the context of a larger argument for more democratic modes of governing new technologies. One participant—we will call him Ben (all participants’ names have been changed to ensure anonymity)—tentatively proposes a referendum as a democratic instrument to enable “the people” to vote on whether they want to allow or prohibit nanotechnology in Austria. In response, Daniel suggests an alternative governance-via-consumption scenario in which people’s purchasing decisions would gradually determine the fate of technological innovations, which is closer to the existing governance approach than the referendum idea. Ben, however, challenges the feasibility of Daniel’s governance model by arguing that consumers are generally not aware of whether a product includes nano without a label noting the presence of nano. At this point, Agnes mentions the labelling of genetically modified organisms (GMOs) as a case from

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which a lesson might be drawn as to how Daniel’s model might work for nano; we see this in the first turn of excerpt 1. Excerpt 1 1 Agnes: Yes, that’s interesting. So, this genetic engineering prohibition, or– or– say quasi quality label “without GM,” how– how did it develop? I think it also developed because of the people. Well, this pressure that you don’t, that you abstain from GM products actually came from the people. 2 Daniel: Yes, the people demanded it, that’s why it came. 3 Ben: And because somewhere organic farmers started with it, with “no GM.” The issue didn’t come from nothing. And it’s also interesting that we’re now talking about nanotechnology, because that’s also showing that a discussion is starting. 4 Agnes: Like, without nanotechnology (laughs). (ICT, 2440–2453)9

Agnes recalls the GM food case as an example of how “the people” fostered a “without GMO” label to make genetically modified ingredients visible on food products. Labelling here rehabilitates Daniel’s governancevia-consumption model, which is also expressed in his affirmative response (2). Ben (3) no longer challenges this idea but adds that organic farmers likewise contributed to the development of the “without GMO” label by first using it voluntarily. He concludes that “the issue” has to be generated by someone, and he takes the fact that the discussion group revolves around nano as an indicator that a similar public debate on nano is already forming. Agnes then draws a GMO-nano labelling analogy, which was only implicit in the previous turns. Collectively remembering the GMO labelling approach thus facilitates the emergence of the idea of a “without nano” label. But there exists no evidence that the group is fully committed to or actively advocating this labelling solution at this point. Most importantly, the excerpt demonstrates that the GMO-nano labelling analogy coincided with the group starting to imagine itself as representative of “the people.” As we see in the next excerpt, once fully actualised, this analogy has a huge influence on the continued discussion. Excerpt 2 1 Daniel: Well, . . . labelling, I think it was in Germany, no, in England it was, I think, there more and more German products came on the market and I think it was during the Second World War, or before, they always came to England and they were bought. And that was enough for the English, they wanted their– their import thing to start, that’s why

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they pushed through the label “German labour.” And then there was the problem that exactly the opposite happened. Now all people just bought German labour (laughs). The English wanted to prevent the people from buying it, and what the people say is: ah, this is German labour, okay, then I’ll take it. Then it’s just, I guess then automatically the experience– the people decide if it’s accepted or not accepted. 2 Mod: But was the point you wanted to make with the GMO comparison that it should be labelled? That labelling– that labels should be made that say: this product, electronic product, includes nano components. (Several lines omitted, in which the moderator makes a joke and Agnes laughs.) 3 Ben: Yes. In the break I was looking at this apple juice and there it says stupidly: it includes sugar or it doesn’t include sugar. I mean that’s really something trivial actually, if you think about it and it’s mentioned nevertheless. And now we’re talking about genetic engineering and nanotechnology. Why shouldn’t it be labelled? To put it simply: does anything speak against it? Creating transparency is certainly nothing bad. 4 Daniel: Well, they’ve already started this– this nano there, like the iPod nano. So, everyone buys that now, because it’s labelled nano, because it’s a small iPod. (ICT, 2455–2488)

In the first turn, Daniel gives an account of a historical case from another national context, in which “the people” resisted state-prescribed meanings of labels. The subtext of his story is that a label is open to different interpretations and that labelling hence is bound to fail as a means of steering public opinion if (a majority of) the public attributes a different—here positive— meaning to a specific label such as “German labour.” Daniel’s narrative provides historical evidence for the argument that emerged in the preceding excerpt, namely that a socially robust label needs to develop in a bottomup fashion from “the people” if one does not want the scenario evoked in the story to repeat itself with nano. In the second turn, the moderator asks whether Agnes tried to make an argument for labelling or a specific labelling approach. In the omitted lines, the moderator and Agnes switch into a playful mode of joking, which allows Agnes to escape from having to give a clear answer to the moderator’s question. This playfulness continues until Ben moves back into work mode by formulating a well-argued, earnest response to the moderator’s question (3). First, he uses the apple juice package right in front of him as an example of how nutritional labels include detailed descriptions of sugar amounts. He argues that one could thus also expect that GMOs or nano—both of which he distinguishes from the “trivial” sugar as more important—would be indicated on products. Referring to a visible fact right in front of everyone assists in presenting labelling as a well-entrenched practice in the given cultural context. Second, Ben uses the phrase “creating

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transparency” to further corroborate his claim. “Transparency” here relates to nano’s non-transparent state since mandatory labelling of nanoproducts did not exist at the time. In addition, the widespread use of “transparency” in political rhetoric has contributed to making it a largely undisputed value in Western democratic cultures (Brown and Michael 2010). Ben equates labelling with the practice of establishing transparency, and hence labelling is framed as a culturally indisputable value. In short, Ben has built a convincing argument as to why nano-labelling appears to be a logical thing to do in the given cultural context. The persuasiveness of this account is also revealed in the next turn (4), where Daniel mentions that nano-labelling has already begun because certain small electronic products are called “nano.” In contrast to the GMO-nano analogy, which points toward resistance to technologically enhanced products, the nano-labelled iPod becomes more, instead of less, attractive for buyers. Daniel and Ben talk at cross-purposes here: Ben refers to labelling in the form of regulation (of food products), while Daniel talks about a nanolabel used for marketing purposes (on ICTs). These two different interpretations of a label point to the diverging public assessment of nano in different application fields: In food, nano is to be avoided, but in ICTs it works as a buying incentive. This indicates that the varying assessments of nanotechnological application fields complicate the debate about nano-labelling. We will explore this complexity in more detail in the following sections. What has become clear already is that the ICT group has shown that a GMO-analogous, bottom-up emerging nano-label would be in line with a well-established governance-via-consumption model and previous experiences with GMOs. 6. (DE)CONSTRUCTING GMO-ANALOGOUS NANO-LABELLING SCENARIOS The GMO case was also used extensively as a resource to support calls for nano-labelling foods. In the following excerpt, Emil develops a strong argument for nano-labelling in food products. Excerpt 3 1 Emil: 2 Ernst: 3 Emil:

Well, to me labelling would be an absolute prerequisite. The economy, that is, the industry, refuses it. But now we are back to the first card, right, what– what kind of faith do you put in consumers, do you say: you don’t get what it means anyway. Like it says on the card: why should it be labelled, someone will just incite you to be against it. Or do you say, okay: let’s have freedom of choice. We live in a democracy, everyone can choose what

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he wants, what she doesn’t want, everyone has the possibility to gather information, some of which you understand, some of which you don’t so much. But when you start with not declaring nano, well then that’s not acceptable for me. This already starts with genetic engineering. There you can be of this or that opinion, but if it’s not labelled anymore and consumers were just told: yes, take it, it’s good for you, that would be crossing a line. (Food, 390–403)

Emil states his clear preference for nano-labelling and formulates a long argument (only briefly interrupted by Ernst) in which he mobilises various resources to underline why non-labelling is unacceptable. First, by referring back to a card depicting a scientist’s position, which he criticises for its “scientific arrogance,” Emil builds a counter-position against which he takes a stand. More particularly, he argues against experts who paternalistically deny consumer-citizens their right to make their own choices—which he associates with non-labelling. “Freedom of choice” and “democracy” are mobilised as cultural resources—similar to Ben’s call for “transparency”—to strengthen the argument for individual choice and to counter a deficit model of the public (“you don’t get what it means anyway”). Not labelling nanoproducts is thus equated with an expert-lay relation in which experts frame consumers as either ignorant or susceptible. Ben constructs a specific figure of consumercitizens by integrating consumerism into a democratic framework. This allows him to sidestep epistemic questions regarding whether people possess an adequate knowledge base on which to make decisions about nanofood, since citizens are entitled to partake in democratic decision-making regardless of their understanding of information. Here, the label is conceptualised as a conveyor of important information; consequently, unlabelled nanoproducts imply a lack of information that deprives consumers of their right to choose (“freedom of choice”). This represents an unacceptable situation to Emil. In the discussion after excerpt 3, Emil links the debate about nanofood with GMOs, presenting GMOs as a predecessor to and potential role model for nano. In his account, GMO labelling enables diverging opinions to peacefully coexist in society—labelling is again understood as a democratic tool, because it allows for a diversity of opinion. In a last move, Emil imagines a counterfactual scenario of nonlabelled GM food modelled after the current state of nanofood, which would affect him in the same way as the nonlabelling of nano currently does. In sum, Emil employs the GM case in different ways to argue that a desirable future scenario for nano should avoid societal conflict—a scenario in which labelling plays a key role as a governance mechanism. By threatening to protest, he rhetorically performs the conflict predicted to arise without labelling. The GMO-nano analogy, references to paternalistic experts, and the evocation of democracy are the main resources used to construct a convincing argument for labelling nano in food products.

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To Emil, GMO-like labelling clearly represents a positive horizon for nano because it would counterbalance a scenario in which nano invisibly— that is, without a label, unnoticed—“creeps into” (his words) society and consumer-citizens are deprived of a decision-making opportunity. At this point in the debate, the GMO-nano analogy was not contested, presumably because the group was not yet familiar with the many consumer benefits nanofood promises, which were only introduced in the next stage with the application cards. In the early period of the discussion, Emil could still argue convincingly that nano—like GM—brings consumer-citizens no significant benefits: “Genetic engineering only benefits certain enterprises, that you know, and it simply causes damage, but we won’t talk about genetic engineering now, but with nanotechnology it’s similar . . . because to say that for the ketchup to flow better and faster out of the bottle, for this we should take these risks?” (Food, 495–502). Later in the debate, it was not just the promised benefits of nanofood that made the group doubt the appropriateness of a GMO-nano analogy. The GM labelling success story also began to erode and consequently lost its attractiveness as a template for nano-labelling. This was mainly due to the fact that the GM labelling approach was revealed to have flaws, notably because specific food products were allowed to contain a certain amount of genetically modified ingredients without being labelled as such. 7. MARKETING NANOFOOD LIKE LIGHT PRODUCTS AND PROBIOTICS Constructing a direct GMO-nano analogy in the food domain is not only complicated by GMO-labelling “bolt-holes” but also because nanofood appears to be distinct from GM foods due to the consumer benefits it promises, such as making foods lighter while retaining the original taste, or enriching foods with vitamins and healthy oils (note, however, that similar claims have also been made with regard to GM food applications such as “golden rice”). Several application cards (see box 10.1) introduced promises that portrayed existing or envisioned nano-enhanced foods. As excerpt 4 demonstrates, nanofoods that had health claims on their application cards were associated with existing functional food products—that is, “products created just so that they can be marketed using health claims” (Nestle 2002, 316). Excerpt 4 Doris:

It’s similar to . . . I’m still with functional food, there’s this advertisement, these small bottles against cholesterol. My hair stands on end every time because I think that can’t work and people buy it,

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because it’s advertised and it definitely doesn’t work. That maybe also belongs in this category of the added vitamins, probiotics, and such things. (Food, 568–574)

Doris draws an analogy between future visions of vitamin-enriched nanofood products (see application card 1 in box 10.1) and functional foods such as probiotic drinks. Since she describes functional foods as delivering empty promises, the promises of nanofood are also called into question. Doris uses an idiom (“hair stands on end”) to emphasise the physical terror she experiences when hearing such false promises. Although she strongly opposes these health claims, she also acknowledges that other people buy these products. She continues her critique when another application vision is discussed (application card 2 in box 10.1), which inspires the emergence of a “nano light” marketing label in the group. BOX 10.1 NANOCAPSULES AS TRANSPORTERS OF HEALTHY NUTRIENTS, REDUCING CALORIES WITH NANOPARTICLES Application card 1

Application card 2

Nanocapsules as transporters of healthy nutrients

Reducing calories with nanoparticles

Nutritional supplements such as vitamins or pharmaceuticals can be packed into minuscule capsules and thus added to all kinds of foods. In Australia, certain brands of bread are enriched with fish oil, which is good for your heart. The omega-3 fatty acids are encapsulated, which avoids the unpleasant smell and fishy taste. Once inside the body, these additives impart their full effects.

In conventional mayonnaise small oil drops create the distinctive taste and creamy texture. Nano-mayo, however, replaces oil drops with water drops encased in a thin oil slick. This mayo promises less fat with full taste. In a similar way, low-calorie milkshakes use nano-sized silicon crystals coated with chocolate. Silicon has no calories, which reduces the number of calories in the shake.

Excerpt 5 1 Doris:

Well, card 2, I didn’t choose it but I just wanted to remark that it says that the innovation promises less fat but with full flavour. I mean, today, many people are actually overweight because they lack fat. And the body needs fat to lose weight and if I look at the card, that instead of fat then this nano comes and there’s even less fat than now, which is already not enough, well, somehow I think, people won’t get healthier.

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2 Franca: These are mere marketing strategies, it seems to me, so, everywhere less fat. 3 Armin: Light, nano light . . . 4 Bertha: It sounds great, but it doesn’t taste great . . . all that low-fat stuff, I don’t like the taste of it. 5 Mod: Yes, but the promise is that nanotechnology will solve the problem that it doesn’t taste good. . . . 6 Doris: Well, people will certainly buy that just as they were buying the other stuff. 7 Emil: If it’s advertised accordingly, then yes, you only have to look at Actimel . . . it’s crazy how the people—well, you see how the shelves are full of it. The commercial was just ingenious and very intense. (Food, 897–942)

In turn 1, Doris challenges assumptions about the role of fat in dieting that are built into low-fat products. She speaks from the subject position of a diet consultant (her professional identity) who is entitled to remark on a misconception on the card and question the underlying scientific theory behind the nanofood vision. Doris’s expertise and assessment are accepted, since Franca agrees with her that the promise of fat reduction is a mere selling strategy (2). Armin (3), then, transfers the marketing of light products onto nano by coming up with the idea of a “nano light” label. In contrast to Doris and Franca, Bertha (4) does not question the epistemic grounds on which light products are marketed; she merely claims to be put off by their taste. This prompts the moderator to clarify that applying nano in such products precisely promises to rectify this gustatory shortcoming (5). A few lines later in the transcript, Doris predicts (6) that “people” will again succumb to these promises of nanofood, thus depicting them as ignorant or easily susceptible. Emil agrees with Doris and supports her assessment that food marketing successfully persuades consumers by pointing to the huge number of probiotic products available (here epitomised by the brand Actimel) (7). The reference to Actimel implies that nano-enhanced functional food products can also be expected to sell, since similar marketing strategies are used. In this context, the acceptance of functional nanofood—in the sense that these products will manage to enter the food market and will also be bought—appears more likely in the future. In short, nano’s similarities with functional and light foods are foregrounded by focusing on the marketing strategies with which nanofood is promoted. Evidently, the group here is talking about voluntary labelling in the form of marketing rather than regulation. 8. COUNTERING ACCEPTANCE SCENARIOS Although certain nanofood visions are imagined to be analogous to functional foods, others such as “interactive food” (see box 10.2) are not readily connected

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with existing food products. The vision of food changing its taste or colour merely by changing the wattage on the microwave thanks to nanotechnology appears strange to some participants. By definition, if something is strange or uncanny, it is not completely familiar but familiar enough to irritate. In the case of interactive food, both pizza and microwave are familiar objects, but their combination with the word “interactive” and the attendant functional visions point to an unfamiliar—and thus strange—usage and combination of these elements. Participants use references to this “strangeness” to justify their refusal of the interactive food vision, which also shows that “strangeness” is an acceptable argument for the individual rejection of a new technology. In the following excerpt, the moderator asks if the participants anticipate that interactive foods will be widely rejected in society. The discussants’ reactions also include various other argumentative resources besides “strangeness” that are drawn upon to make a rejection scenario appear plausible. BOX 10.2 INTERACTIVE FOOD Application card 3 Interactive food In the future, food whose taste and colour can be shaped individually could become reality. Tiny nanoparticles in drinks or foodstuffs will enclose certain substances and, depending on the wattage of the microwave, give off different flavours, colours, or nutrients. Pizza Diazole or Pizza Quattro Formaggi: Consumers can decide individually and spontaneously how they want their product to taste and what it will look like.

Excerpt 6 1 Mod: Don’t you think that people wouldn’t buy such a thing? 2 Franca: Honestly, I can’t imagine that it will be a total boom. I don’t know, because I think, I’m a bit sceptical of– I don’t think that people are that stupid. Okay, I mean low-fat sounds good but I think that in the meantime people have realised that these whole light and low-fat products are not the real deal. . . . Now we have a countermovement and when I hear about things like that, then I’m disconcerted, and I’m actually very generous towards new technologies. And if people think about it even a little bit, I can’t imagine that it will really be a raving success. At least not in the next few years, maybe in a few decades, if the world has developed completely differently. . . . 3 Emil: If it were labelled as it is now with genetic engineering, well, genetic engineering is not accepted, looking at it from our perspective here in Austria at the moment. It isn’t accepted because the consumers

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simply don’t want it and it has to be labelled. And the supermarkets brag about it, that they don’t have GM products in their product line. And if it had to be declared, I think then the atmosphere would turn to– that people would say: no, I think, that’s too uncanny for me, I don’t really need it, that’s too technical . . . and I think everyone has some kind of a desire for the most natural, it doesn’t matter whether they do it or not, but essentially everybody wants to eat as naturally as possible and is suffering that he or she is not, because of no time, no money, or whatever. (Food, 975–1002)

In turn 2, Franca constructs a plausible nonacceptance scenario in accord with her own, previously expressed sceptical reaction to interactive nanofood. In her scenario, people realise over time that the promises of light products do not deliver. Imagining people as knowledgeable and actively resisting marketing allows Franca to envision a future where interactive nanofood is not fully embraced by society as a whole. In a sense, Doris and Emil already (per)formed such a countermovement in excerpt 5. Hence, Franca takes the group dynamic as an indicator of a wider societal movement, and she uses this to underpin her scenario. After speaking of the countermovement, Franca comes to the interactive food vision that alienates her (“I’m disconcerted”). By highlighting that she is generally very positively inclined toward new technologies, she tries to strengthen her claim, and by again ascribing “thinking” to the people, she anticipates that interactive nanofood will not become widely accepted under current sociocultural conditions. In turn 3, Emil joins forces with Franca by making use of the GMOnano labelling analogy. If nano were labelled like GM food, Emil predicts, it could turn out like GM foods (i.e., get rejected). Furthermore, he claims that supermarkets make use of non-GMO labels for marketing purposes, which suggests that voluntary abstention from nanofood might work as a better marketing strategy. Then, Emil shifts from labelling conceptualised as marketing to labelling as regulation (“if it had to be declared”), which he expects would negatively impact nano’s public image. In this way, he ascribes to labelling the power to frame the debate about nanofood. He also follows up the GMO-nano analogy with several other arguments for the societal rejection of nanofood. First, the word “uncanny” works in the same way as the “strangeness” argument. The second argument, then, is one of having either no use for such products or of voluntary abstinence. Here, the advertised consumer benefits of nanofood are silenced most explicitly. Third, Emil mobilises the dichotomy of technologised versus natural foods and attributes to everybody a “desire” for superior “natural” food (for a detailed analysis of the use of “nature” and “natural” in these discussion groups, see Felt, Schumann, and Schwarz-Plaschg 2015; Schumann and Schwarz-Plaschg 2015). All

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these arguments seem familiar from the debate over GM foods, which Emil transposes onto nanofood to make its societal rejection appear plausible in the future. The mobilisation of these arguments can best be understood as an attempt to counter the acceptance scenarios based on the analogies with functional and light foods that were constructed before by the very same interlocutors. Excerpt 7 indicates how the GM case was further explored as a potential template for nano in the same group. Excerpt 7 1 Emil:

When nano arrives as something new, it will be about the image, the marketing. Well, genetic engineering, they didn’t manage it in time, the mood shifted, that’s my impression . . . in Austria certainly 80 percent of the general public doesn’t want it in their food . . . With nano it’s still undetermined . . . if nano develops like GMOs, that people think it’s yucky, then it will have lost. If it becomes fashionable– it’s probably a question of whether the marketing strategists for nano– 2 Franca: Yes, but isn’t it that nano is exactly– that GMOs are bad precisely because somehow, I don’t know, it’s like something alien, because it’s something unnatural and nanotechnology insofar, it seems to me, is actually the same in that respect . . . I can’t imagine that it’ll become chic, if GMOs didn’t become chic, well. The same scepticism will be there too. 3 Emil: No, this can– for me yes, but I think for the big impact externally a lot of marketing is also required. Well, there are other things that are also not much better, but that have become chic, because things took a different course, but I don’t know. (Food, 1076–1099)

Emil starts by anticipating two diverging futures for nanofood, depending on its image. He recounts the public perception of GM foods as a story of belated marketing that failed to counteract GMOs’ emerging negative image in the food sector. Emphasising that a huge majority of the Austrian population rejects GM foods, Emil says he believes that if nano were to develop like GM foods it would be similarly viewed in a negative light (“yucky”). Note that Emil does not predict such a future as more plausible than another—he also imagines the possibility of a different scenario in which nano becomes “fashionable” due to the effective work of marketing strategists. Constructing such a bifurcated future works as a call for action here. Conceptualising public perceptions as malleable allows him to highlight the work needed to create a negative image of nanofood to oppose otherwise effective marketing strategies. This is underlined by Emil’s refusal to predict that nano will turn out like GM food, which would undermine his emphasis on the work needed

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to make this future possible. Constructing a convincing GM-nano analogy is one step toward achieving this goal. The overall communicative message of Emil’s turn is that those opposing nanofood still have a chance to influence its public perception—and thus should act. By presenting strangeness (“alien”) and unnaturalness as inherent to both food technologies, Franca (2), in contrast to Emil, constructs the GM-nano analogy as a fact based on a shared ontology. This ontological similarity serves as proof that nanofood likewise will not manage to become “chic” in the future—it creates certainty. Emil claims to share this ontological perspective (3), thereby admitting his personal interest in making nano turn out like GM food, but he also repeats his theory (and the call for action it entails) that marketing will be powerful in shaping nano’s image. The analysis so far has shown how analogies pointing toward nanotechnology’s societal acceptance and rejection (Schwarz-Plaschg 2018a) were constructed and negotiated. The acceptance analogies emerged from the application cards and their promises of functional and light nanofood, making clear that nano at present is not a straightforward candidate for a second GM food scenario, because nanofood also seems to resemble existing light and enriched food products that have managed to become an accepted part of Austrian food culture. This, in turn, raised awareness among those participants who rejected nanofood most vehemently that (argumentative) work is needed to counter marketing efforts and thus prevent an acceptance scenario from becoming reality. Drawing GM-nano analogies—based on the shared “strangeness” and “unnaturalness” of GM and nanofood products—is a crucial element of the participants’ arguments for a future in which the public will reject nanofood. Although not explicitly debated, labelling appears in the participants’ talk as a central agent determining nanofood’s future. While voluntary labelling in the form of positive product marketing (e.g., “nano light”) is expected to be powerful in getting people to buy nanofood, labelling in the form of mandatory regulation—like a “without GM” label—is expected to affect nanofood’s public image negatively. The debate about nanofood thus also illustrates the tension between these two meanings of labelling and the different power that is attributed to them in shaping the future of nanotechnology in society. 9. THE NANO-LABELLING DILEMMA We now move on to how labelling was debated in the group exploring nanotechnology in consumer products more generally. The discussed nanoenhanced products ranged from textiles, energy applications, cleaning agents, cosmetics, and sports equipment to surface coatings and refrigerators; thus, food and ICT applications were not the focus here. In this group, the

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nano-labelling dilemma emerged more fully than in the others. The following excerpt introduces this dilemma. Excerpt 8 1 Albert: Well, I’ve got the solution for you . . . there should simply be a sticker, like “nanotechnology-free,” right? [Denise: Yes, that’s– ] If that existed, I mean, if somebody starts it, a “nano-free” sunscreen, then everyone will think: oops, that’s nano-free, the others are nano, well, then I’d better not take these, right? They won’t use that sunscreen probably. 2 Barbara: Yes, but then I’d need to know whether nano is good or bad. That’s something we don’t know yet for the most part. 3 Albert: Well, when it says “free” that automatically implies that whenever it’s not “free” it’s bad. 4 Barbara: Well, why? There will be people who’ll say: okay, I’ll buy only that one with nano, because I think it’s so great. 5 Albert: I think like that too when it comes to medicine or technologies, for instance, but I don’t want to apply it on my body, I don’t want it in my food. Yes, well, if it was labelled “nano-free” then I’d buy it. (Con Pro, 1707–1734)

Here, Albert (particularly in turns 1 and 3) proposes a “nano-free” front label as a “solution,” because he imagines it to indicate that products without this label (i.e., nano-enhanced products) are worse than those with the nano-free label. A nano-free label is thus conceptualised as an agent that would affect nanotechnology’s image negatively, similar to the role it would play in the food group. Albert anticipates that consumers would avoid nanoproducts in this scenario, which in turn would ultimately prompt sunscreen producers to voluntarily abstain from applying nanoparticles to their products. Barbara, however, reacts sceptically to this scenario and contests its plausibility. She argues that it is still undetermined whether nano is perceived as good or bad (2). Then (4), she challenges Albert’s assumption that nano-free always implies that a product is better, arguing that some consumers might consider nano to be beneficial in consumer products. In turn 5, Albert distinguishes between different nanotechnological application fields (a “nano is not like nano” move [Schwarz-Plaschg 2018a]), which allows him to argue that nano should be welcomed in certain application areas (medicine, electronic products) but avoided in others (cosmetics, food). The application area thus becomes the main factor, based on which nanoproducts are categorised as desirable or undesirable. Whereas for Barbara the time for a nano-label has not yet come, because it would signal certainty when nano’s riskiness is still contested,

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Albert is already committed to a normative judgement as to whether to reject or accept nano, based on a distinction of application fields. Albert’s argument is similar to Emil’s in the way he also proposes a GM-analogous labelling approach, even though Albert does not mention GM explicitly as a template. Barbara’s turns, by contrast, are an expression of the nano-labelling dilemma; that is, to her it is not settled whether nano is good or bad, and thus decoding a potential nano-label becomes an impossible or, at best, random task. The labelling dilemma co-emerges with the understanding of a label as conveying clear, prescribed information delivered by an authority. Consumer-citizens here are framed as mere decoders of information, without any meaningmaking capacity of their own. Similar to the alternative model I proposed in the section “What Is (In) a Label?” Albert’s solution to the dilemma is to conceptualise the meaning-making of labels not as unidirectional but as an interactive process where his personal assessment plays the leading role. In this framework, the dilemma disappears and consumer-citizens become capable of acting. A little later, the moderator asks whether the participants would prefer a label indicating that a product contains nano (e.g., “with nano”) or is made without nano (e.g., “nano-free”), which conforms to the labelling approach Albert proposed. As the following excerpt indicates, these two modes are expected to have already inscribed an assessment of the labelled product in the specific cultural context. Excerpt 9 1  Mod:

Do we want a label that says: without nanotechnology? That would be one mode of labelling. Another mode of labelling is: contains nanotechnology. 2  Denise: Well, I would prefer it if it said: contains nano. 3  Carl: Yes. 4  Denise: So, I would know it and then I would know as well if there’s no label, then it doesn’t contain it, in reverse. 5  Carl: The question is always whether you consider it a good or bad thing, isn’t it? 6  Barbara: Right. 7  Denise: I would read it as a warning sign first. 8  Carl: If it’s something bad, like fat, yes, fat, then it’s without fat, right? 9  Albert: Yes, but in principle fat isn’t bad, is it? Too much fat is the problem. 10 Carl: It’s marketed like that. 11 Barbara: And which kind of fat (laughs). (Con Pro, 1982–2007)

In reaction to the moderator’s question, Denise articulates a preference for a label indicating that a product contains nano (2, 4). Although Carl agrees at

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first (3), he then argues that the applied labelling mode might depend on the general normative judgement of the labelled product (5). Next, Denise discloses that she would interpret a “with nano” label as a warning sign, making people aware of dangerous substances. The idea of inventing a nano warning sign was also propagated by the Canadian anti-nanotechnology-oriented ETC Group, which called for designs of “nano hazard symbols” in 2006.10 The selected designs were clearly evocative of existing warning signs and hence were not merely means to “raise public awareness,” as the ETC Group itself stated, but rather sought to fix nano’s still ambivalent meaning by associating it with danger, which would allow them to argue for its regulation. The way Denise reads the “with nano” label corresponds with this framing. Carl, in turn 8, brings up a counterexample: the case of fat in food products, which entails a shift of frame from labelling understood as regulation to labelling understood as marketing. We already encountered fat in the food group, and here it is similarly used to point out that the absence of “bad” ingredients such as fat is generally advertised using “free from” labels in food products. But, as in the food group, the consumer products group also challenges the marketing claim that fat in general is “bad” by arguing that the quantity (9) and quality of fat (11) should also make a difference in how fat is assessed. The discourse about fat-free (or fat-reduced) products demonstrates the group’s attempt to explore how nano should be labelled by drawing on an example from the food area. The discourse is still ambiguous because the fat case does not exemplify Denise’s preference for a label as a warning sign (regulation) but foregrounds the use of labelling as a marketing instrument. After this exchange, the discussion further revolves around the marketing of certain nano-enabled consumer products, but by switching to the application field of textiles. In the course of this debate, Albert argues that nano-socks will be more expensive than others, thereby attributing to them a special quality for which consumers will be willing to pay more, although he claims that he would not buy them himself. The next excerpt details how this discussion continued. Excerpt 10 1  Albert:

If I know that it doesn’t contain nano, then I’m on the safe side. [Carl: Well] Then I don’t have to deal with whether it’s good or bad, I simply don’t have it. And that’s that! [Several lines omitted in which Albert, Carl, and Barbara agree that a substance that was once marketed as having great effects might be considered a health risk after some decades.] But as I already said, I’m of the opinion that if one producer starts assessing it as nano-free, which automatically implies, if it’s not “free” it’s bad. . . .

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2  Mod: How are other foodstuffs labelled? Have you thought about that? 3  Albert: GM-free. 4  Barbara: Yes, it always says free there. I’ve never read that somebody uses genetic engineering, right? 5  Albert: Or organic. 6  Denise: CFC-free was also used frequently for a time. 7  Barbara: Yes. 8  Albert: Yes, the law prescribed that everything had to be CFC-free, I think, didn’t it? 9  Carl: Well, if it’s regulated then it’s always something bad, a bad material is being kept out. 10 Barbara: Right. 11 Carl: Well that– that defines, OK, this is a bad substance, it’s dangerous for some reason, it’s staying out. Here, the authorities provide security to consumers; if it’s labelled, you are assured that it’s not in it. (Con Pro, 2032–2087)

In this excerpt, the group continues to struggle to find a suitable labelling approach for nano. Albert (1) again suggests a nano-free label and offers two reasons for this approach. First, this would allow him to be on the “safe side” by simply avoiding nano, which implies again that he considers nano to be potentially risky. In the omitted lines, several participants highlight that nano’s riskiness cannot be known at present, and any assessment could also be subject to change since they see the possibility that certain nanomaterials might turn out to be “carcinogenic,” as one discussant put it. Therefore, they stress that nobody can ever claim with absolute certainty that a new type of material will always be categorised as “good.” Albert, then, repeats his solution of a voluntary nano-free label (marketing) as the best alternative, because he assumes this would affect nano’s reputation negatively and thus lead to its general non-use. Next, the moderator (2) encourages the participants to think of labelling practices known from the food area. This can be interpreted as an attempt to help the participants by means of focusing the debate on one application field, since the group switched continuously from food to textile products, each of which entails different assessments of nano. In the following turns, the participants come up with several examples of “free-from” labelling, and they do so in a collaborative manner by building on rather than challenging each other (see the many affirmatives, including “yes” and “right”). Based on the examples of “GM-free” and “CFC-free” labelling,11 they agree that the usual (regulatory) labelling practice is the “free-from” approach. In order to reach this conclusion, the example of “organic” (5), where this reasoning does not apply, is ignored. In turns 9 and 11, Carl draws a further conclusion from the brainstorming the group

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engages in, namely that labelling as regulation has the function to “keep the bad out” and protect consumers. Although this might seem to echo Albert’s “free-from” suggestion, the debate has not returned to the beginning because the “free-from” labelling approach is now discussed as a regulatory rather than a marketing tool. To summarise, the excerpts in this section demonstrate how the participants in the group discussing consumer products tried to find a labelling rationale that would guarantee the safety of consumer products. As stated by Carl, the regulatory labelling approach is seen to presuppose a negative assessment of nano, but the majority of the participants (Albert being the exception) are still caught in the nano-labelling dilemma, which means they feel unable to commit to an assessment. 10. SEALS OF QUALITY AND CLEAR-CUT FUTURES SOLVE THE DILEMMA Since the participants in the consumer products group are hesitant to commit to a normative assessment of nano, which is co-shaped by the broad application spectrum discussed in this group, they come to imagine an alternative labelling approach as a way to solve the labelling dilemma. The approach is based on their knowledge of existing seals of quality in the food area. This solution was already implicit in the previous excerpt in the reference to “organic” and was further elaborated upon in the ensuing discussion. Excerpt 11 1 Carl:

2 Barbara: 3 Carl: 4 Barbara: 5 Carl:

Or just “controlled.” There are a variety of seals. With meat there’s the AMA seal of quality and the like. This you trust, there’s a regulatory authority that inspects it regularly and properly, when they’ve inspected it, then it’s OK. . . . Well, nano can also be very positive. It doesn’t mean automatically that it’s bad, right? [Simultaneous talk and laughter.] But, how shall I decide then, even if it’s labelled as free or not free? [laughs] If a harmlessness symbol, well, a certificate, would exist, then it would be certified. Yes, but this requires that it’s inspected. And at the moment that’s not the case. Yes, that’s the point. Yes, it’s not done now, yes. So, that would assure me, OK, that is certified, it’s harmless. And then it wouldn’t matter what’s in it or not. (Con Pro, 2087–2120)

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Carl (1) puts forward an alternative to a nano-specific label with the idea of a seal of quality, here exemplified by the AMA (Agrarmarkt Austria) seal, which conveys to consumers that the meat has been produced in Austria, is high quality, and has been strictly monitored in all marketing stages. The seal is used as a positive model for how food products should ideally be inspected and controlled. Carl also stresses that this quality seal approach is based on trust in the work of regulatory authorities. The seal is talked about as a regulatory instrument, obscuring the fact that it could likewise be seen as a marketing instrument of the Agrarmarkt Austria Marketing GesmbH. Since Carl’s solution remains more implicit at first, Barbara reiterates the dilemma (2). This prompts Carl to further explain how the seal solves the dilemma by focusing solely on the harmlessness of (food) products rather than focusing on nano (4). The debate thus has shifted away from nano to the issue of product quality or safety as the more general concern underlying the participants’ discussion about nano-labelling. As Carl points out (5), this reframing makes it possible to sidestep categorisations of nano as either good or bad, because with seals of quality it no longer matters to consumers whether nano is in a product or not. In this ideal labelling scenario, nano remains invisible and a nonissue to consumers. The area of food therefore provides an alternative perspective and a positive template for how nano-enabled products could (or should) be controlled and labelled, making it possible to avoid the nanolabelling dilemma. In fact, the quality label solution already came up earlier when Carl demanded that for consumer products in general “there should be a certification authority. Like with organic farming, there exists a certification . . . that is able to assess consequences and makes tests before licencing” (Con Pro, 1282–1286). As exemplified here, organic food labels were the second template from which an alternative labelling approach was imagined for nano, and this was particularly the case in the food group, where organic labels served the same function as the AMA seal. Participants who presented themselves as open advocates of organic food argued that “organic” should be understood as a safe alternative to the uncertainty nano creates. It has to be added here, though, that “organic” labelling in Austria does not officially promise safety of any kind but merely denotes a specific form of production. Many participants also expressed their shattered trust in labels and seals of quality, which they saw as becoming less strict and as misused for marketing purposes. Instances in which seals of quality were revealed not to “hold water” threaten to destabilise the trust-based network of human actors that these labels are supposed to maintain from a consumer-citizen perspective. Thus, participants stressed the need for clear information on and about labels in order to avoid improper use by industry. The debate about alternative labelling via seals of quality shows that a nano-specific labelling approach would enable consumer sovereignty in

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risk management (for those who feel equipped to engage in it), but it would also involve the difficult task of having to categorise nano as either good or bad—in other words, it would entail consumer-citizens’ individual managing of the labelling dilemma. By contrast, seals of quality are seen to remove the necessity for consumer-citizens to perform such an assessment. The participants’ preference for seals of quality thus indicates that they would like to hand over responsibility to other trustworthy and capable actors. Accordingly, some discussants argued that it is the function of scientists and “public authorities or agencies to free us from these tasks” (Carl, Con Pro, 1701). The labelling dilemma was also managed by a second strategy—namely, by imagining clear-cut futures in which nano turns out to be unambiguously good or bad. By analysing how participants imagined these futures, we thus obtain a different perspective on the dilemma they face in the present. Excerpt 12 1 Flora:

2 Denise:

3 Barbara:

Well, for me the near future or present is characterised by a lack of transparency. . . yes, it will eventually become public, I think, on the one hand there will be scandals, to push it in the media, and on the other hand there will also be a labelling requirement, I think. And then in the distant future, in certain areas there will be abuse . . . in the even more distant future, I think, perhaps there will be a horror scenario, catastrophes, but also maybe revolutionary changes. . . . Well, I have chosen future cards 14 and 15,12 because I think that the topic will definitely crop up one day, yes, then suddenly, everything, wow, nanotechnology, and we didn’t know anything about it, and back and forth. Then there will be a labelling period, a labelling requirement, and then the whole thing will wane, and then things will simply contain nano, right? Then it’ll be like preservatives. They are also in our food; there you can decide for or against them. But they’re not anything revolutionary anymore because you’ve become used to them. It’s not that you will say: wow, there’s nanotechnology in it, but, okay, that’s just a t-shirt with nanotechnology. It will become completely normal, I think . . . all jackets will be nano because it will be totally normal. . . . Well, it will be like with calories. Calories are also written on everything. If nothing serious happens. That we don’t know. It could also be that there’s a total scandal and nano in general gets demonised. . . . But it could also be like with preservatives, right? For some time, they weren’t declared, then products were labelled if they contained them, and now everywhere the labels say: no preservatives. [laughs] (Con Pro, 2916–2971)

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These three accounts provide two main kinds of scenarios for nanotechnology’s future in society: on the one hand, scenarios in which nano becomes normalised, and on the other hand, scenarios in which nano becomes problematic (note that the second scenario is also imagined as a precursor to the first). Both scenario types, however, imply certain regulatory measures. In turn 1, Flora envisions the second type, motivated by her wish for nano to become publicly visible (transparent) via labelling. In order to make nano a public issue, Flora imagines rather dystopian scenarios in which nano appears unambiguously in a negative light due to “scandals,” “horror scenarios,” or “catastrophes.” Only after having imagined these nano-futures does she add a more positive vision that nano might likewise induce “revolutionary changes.” Denise (2) starts out with a similar scenario in which nano suddenly becomes a public issue entailing mandatory labelling, but she then begins to construct a future belonging to the other scenario type, in which nano undergoes a process of normalisation analogous to that of preservatives.13 While nano may at first be considered revolutionary or special (“wow” signals enthusiasm), the analogy with preservatives makes her envision nano becoming widely applied in clothing. At first this is imagined to permit a choice for or against nano, but it ends in a future world in which nano has become “normal,” ubiquitous, and unavoidable (all jackets are nano). In this scenario, time will tell whether nanotechnology turns out to be good or bad, which is in contrast to Flora’s vision that nano may be clearly categorised as “good.” In turn 3, Barbara anticipates that nano could turn out like calories. The analogies with preservatives and calories both correspond to nano-labelling in the list of ingredients, which is how nano-labelling is currently enacted with regard to food, cosmetic, and biocidal products in the EU. In this scenario, nano is no longer a potential threat but has become normalised and regulated. Barbara also envisions a counter-scenario in which a scandal damages nano’s image (“demonise”), thereby acknowledging that Flora’s vision could also be plausible. In a final move, Barbara integrates Denise’s preservatives analogy with Flora’s more negative vision by pointing out that nano could also turn out like preservatives. But her story differs from Denise’s in that it does not end with preservatives/nano being normalised. In her recollection of the preservatives case, after a phase of non-labelling, regulation prescribed the labelling of preservatives on food products and hence led producers to advertise their absence. Her narrative highlights once more that emerging consumer preferences might be exploited by marketing. Excerpt 11 reveals that participants seek to imagine nano turning out as either “good” (unproblematic) or “bad” (problematic), because both scenarios would remove the present labelling dilemma and promote regulation. In order to achieve this, nano has to move from its current

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ambiguous state into a state in which its meaning has become collectively stabilised, and a nano-label hence conveys a clear, unambiguous message. Analogies play a central role in this imaginative process because previous trajectories in other areas provide evidence for what could be plausible avenues for nano’s further development and governance (Schwarz-Plaschg 2018b, 2018a). Since there is no sign of contestation in the discussion, the diverging analogy-based scenarios are all considered equally plausible, presumably because they all serve to resolve the dilemma. Another relevant observation concerns the fact that the direction of the future scenarios changes with regard to application field: While Denise envisions an acceptance scenario for clothes, the scenarios deriving from food examples generally suggest more indirect and complex acceptance scenarios. 11. CONCLUSION This chapter sought to explore how the public imagination of ideal nanolabelling scenarios corresponds to or diverges from the existing nanolabelling regime in the EU. For this purpose, I analysed how members of the Austrian public talked about the issue of nano-labelling in three discussion groups on nanotechnology. I will now discuss the main points of the detailed analysis and map the public imagination against the current regulatory regime in order to identify whether a gap between them exists. The first two empirical sections examined the ways in which participants in the ICT and food group responded to being informed that nano is already applied in consumer products without being labelled as such, because the groups were held before the EU’s labelling regulations came into effect. Participants employed various arguments to stress the unacceptability of this situation and the necessity of labelling to enact choice. The ICT group concluded that the public should play a prominent role in defining the meaning of a nano-label. In the food group, the GM case served as a central template for how nano-labelling should be handled, and it was in particular used by nanofood opponents to envision a similar negative public image and scenario for nanofood. In both the ICT and food group, the complexity of labelling crystallised when nano-labelling in the form of marketing—in contrast to labelling as regulation—was considered. This was the case, for instance, when discussants became aware of the fact that the promises of nanofood resemble those of existing functional and light foods that have managed to successfully enter the market. This resemblance suggested future scenarios in which nanofood might also become (at least partly) accepted in society. To counter these scenarios, participants tried to undermine visions of “attractive” nanofood by establishing a GMO-nano analogy based on the argument that

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both technologies are characterised by “strangeness” and “unnaturalness” when applied to foods. With this move, the collective rejection of nanofood became again a plausible future. Labelling, more generally, was treated as a culturally well-established regulatory mechanism to close down disputes over new technologies and materials (see Lezaun and Schneider 2012). Based on knowledge of previous labelling approaches from their cultural sphere, the participants highlighted that normative assessments have become inextricably linked to specific modes of labelling and hence would become transferred onto nano, if nanolabelling followed their example. For instance, a voluntary “without nano” label was expected to negatively affect nano’s public image and imply that nano should be avoided. Labels were thus treated as powerful devices moving a technology from a state of interpretative flexibility to stability. Ideally, this process of reaching closure or stability over nano’s meaning is imagined as the outcome of a public debate, as has been the case with GMOs in Austria, which led to a referendum and subsequent regulation and labelling (Felt 2015). While we have witnessed a broad variety of top-down-induced, nanofocused public engagement initiatives in Europe over the past fifteen years— the outcomes of which may have informed regulatory decision-making—a broader public debate did not take place in Austria and other European countries. In this context, those members of the public who were not part of the “mini-publics” (Goodin and Dryzek 2006) of engagement events are left with the labelling dilemma and the need to ascribe meaning to nano individually if they happen to read about nano-sized ingredients on the back label of specific products. Thus, while public engagement may be useful for informing policy making and getting a small portion of the population to deliberate about new technologies, it does not represent a substitute for a broader public debate enacted via mass media, and may thus only constitute a limited version of a public sphere (see chapter 11 in this volume). A main governance-relevant finding of the analysis was the nanolabelling dilemma. Some participants in the consumer products group found themselves in this dilemmatic situation because they could not decide whether to categorise nano as “good” or “bad,” and hence they felt unable to engage meaningfully with a nano-label. By contrast, participants who had already made up their mind as to how to assess nano in specific application fields claimed to be able to make use of a nano-label and thus act on their assessment. In order to solve the labelling dilemma, participants envisioned various future scenarios. First, seals of quality were envisioned as a better alternative to a nano-label, allowing consumer-citizens to avoid the issue of nano as a whole. Such labels were expected to indicate non-riskiness and the existence of safety tests, thus releasing consumer-citizens from the need to perform the difficult task of individual risk assessment. A second strategy

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was to imagine futures in which nano turns out clearly “good” or “bad.” The current EU nano-labelling approach has normalised nano (i.e., made it appear unproblematic) in certain products in the sense that nano now—as imagined in one group—resembles unproblematic preservatives or calories rather than GMOs. One could take this and the fact that there has not been a real outcry about labelling regulation as a sign that nano is not considered to be as risky as GMOs. But matters are more complicated, and the question remains of whether the nano-labelling dilemma has really disappeared. It is important to note that the nano-labelling dilemma is not an ethical dilemma in which a choice has to be made between different courses of action that are in conflict with each other; it may entail positive as well as negative implications. Seeing the nano-labelling dilemma as a mere decision-making situation would attribute responsibility to consumer-citizens as “responsible consumers.” In fact, the nano-labelling dilemma stems from a deeper ideological dilemma—a concept that refers to “moral and ideological complexities” (Billig et al. 1988, 12) that arise out of conflicting or contradictory socioculturally entrenched values, principles, or practices. Culture does not provide “its people” with clear instructions on how to think or act but leaves them with a struggle between arguments and ideals pulling in different directions. This is what we see at work with the nano-labelling dilemma: The practice of labelling indicates that it is important to make nano visible for decision-making purposes, but the basis and logic for this decision-making simultaneously remains uncertain and highly individualistic. Consumer-citizens are expected to cobble together their own rationale as to how to formulate their individual preferences, and it is here where conflicting values and discourses, such as the rather incompatible models of consumerism and citizenship, clash. Since labelling entangles consumerism and citizenship in a governance-via-consumption model, it co-creates consumer-citizens who have to deal with the fact that they are not able to fulfil their civic duties and make use of their rights through their “informed” buying decisions. This dilemma could potentially arise with any kind of product labelling, but with nano it becomes particularly salient, as neither the scientific debate about nanoparticles’ potential riskiness is settled (as with preservatives), nor has there been a broad public debate that would lead to a broadly shared negative cultural assessment (as with GMOs). Yet the solution to the dilemma would not be to force a societal debate about nano, which cannot be forced anyway; a much better option would be to acknowledge that the governance-viaconsumption model—and, with it, the labelling instrument—is at best not very meaningful and at worst dilemma-producing for consumer-citizens. In addition to the material transparency that labels provide, they also call for an epistemic transparency among techno-regulatory actors that openly communicates the limits of (scientific) knowledge and institutional processes

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for creating certainty and safety. Only through such honest information politics in combination with an interactional understanding of meaningmaking of labels will consumer-citizens be freed from the illusory task of having to make “fully informed” decisions. This, then, would also imply dropping responsibility-shifting notions such as “responsible consumers” and simple information-transfer models of product labelling, which obscure the fact that consumers are not responsible for conducting risk assessment with regard to new technologies and that labels never just provide clear-cut information about whether a product or substance is “good” or “bad.” Based on the above, we could argue that there exists a gap between public imagination and regulatory reality with regard to nano-labelling in Europe for three main reasons. First, consumer-citizens seem to orient toward front labels, not back labels, in their everyday practices, which renders the existing labelling approach practically invisible. Second, the current labelling regime shifts the responsibility of risk assessment onto consumer-citizens who may not feel capable of performing this task. Thus, the “right to know and choose” argument that some actors—including members of the public—use backfires for those consumer-citizens who still experience the nano-labelling dilemma. Third, the gap exists because in an ideal scenario, nano would be labelled in all product groups, as the use of nano in currently non-regulated applications such as textiles is also considered “risky” in some cases (Felt, Schumann, and Schwarz-Plaschg 2015). However, at least three arguments speak against the existence of a gap. First, labelling regulation now covers the most sensitive application areas from a consumer-citizen perspective, which is definitely better than absolute non-labelling; second, as a back label, nano remains invisible for most consumer-citizens, thus making it a nonissue and releasing those who do not (want to) notice it from the need for assessment; third, the nonexistence of a nano front label reflects the nonexistence of a broader public debate and the ambiguity still surrounding the scientific and socio-political evaluation of nano, because a front label is imagined as the outcome of a public debate and a collectively shared evaluation (see “GM-free” label)— thus the current labelling approach is at least “transparent” in this sense. Considering the above points together, the current nano-labelling regime in Europe thus represents a middle way between providing the labelling the public demands and not providing it in an extensive, effective, and very meaningful manner. The presented analysis has one main limitation: its limited scope, because it focuses on just one European member state—Austria. As argued above, national differences matter for the construction of labelling models and their interpretations—and this holds for a supranational economic union that seeks to construct a shared identity and overarching regulatory regime.

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If we thus see Europe as an assemblage of different technopolitical cultures (Felt, Fochler, and Winkler 2010), each with its own specific national publics and labelling histories, the ways in which nano-labelling is envisioned and interpreted may indeed be nation-dependent. With regard to the analysis, this means that the results cannot be extrapolated to Europe as a whole without caveats. To complicate matters further, the analysis indicates that even within one nation-state, a diversity of opinions and interests toward nano-labelling exists. This points to the already well-established notion that it is better to speak of a variety of publics, not just at the European level, but also the national level. However, despite these differences, there might also exist a variety of shared elements in how publics imagine ideal nanolabelling throughout Europe that go beyond simply preferring nano-labelling to non-labelling. Moreover, as Bowman and Tournas state in chapter 6 of this volume, we do not know much about how EU consumers have responded to the introduction of mandatory nano-labels for cosmetics and food products. Hence, exploring national public responses to and actual engagement with these labels—now that these regulations have come into effect—would be an important area for future study. NOTES 1. “Neue EU-Verordnung in Juli,” 17 June 2013, http:​//www​.orf.​at/st​ories​/2181​ 758/2​18061​1/ (translation mine). 2. I use the term “consumer-citizens” here to point out that the figures of the consumer and citizen are not mutually exclusive, as people cannot be easily categorised into one or the other category and may embody both roles at the same time. A main difference between the terms is that “consumers” refers to people with respect to their capacity and role in making buying decisions, whereas “citizens” denotes that people living in a certain area have certain (democratic) duties as well as rights. Please note that I do not use the notion of consumer-citizen to imply that consumerism should be seen as the preferred means for political participation. 3. Consumer-citizens are not the only potential users of labels, as labelling regulations also address producers of consumer products, regulators, lawmakers, and other actors who engage with these labels as part of their specific professional life worlds—and who are, of course, simultaneously consumers and citizens themselves. 4. Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products (Recast). 5. Regulation (EU) 2015/2283 481 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No. 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No. 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No. 1852/2001, recital 10, Dec. 11, 2015 O.J. (L327) 1–22 (2015).

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6. Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 Concerning the Making Available on the Market and Use of Biocidal Products. 7. This material stems from the research project “Making Futures Present: On the Co-Production of Nano and Society in the Austrian Context” (2008–2012, Principal Investigator: Ulrike Felt), conducted at the Department of Science and Technology Studies, University of Vienna. I gratefully acknowledge all my project collaborators—especially Ulrike Felt—for their work and stimulating ideas. The analysis is based on a chapter from my dissertation (Schwarz-Plaschg 2014). 8. For Europe, see, for instance, the results of the public survey carried out in the NanOpinion project (2014): NanOpinion, “Nanotechnologies: A Subject for Public Debate,” https​://ww​w.zsi​.at/o​bject​/publ​icati​on/35​02/at​tach/​nanOp​inion​_book​let.p​df (accessed 24 May 2018). 9. These numbers refer to lines in the respective transcript. The words “ICT,” “Food,” and “Con Pro” after each excerpt denote the respective discussion group from which the excerpt is taken (information and communication technology; food; consumer products). 10. ETC Group, “ETC Group Announces International Graphic Design Competition,” http:​//www​.etcg​roup.​org/c​onten​t/etc​-grou​p-ann​ounce​s-int​ernat​ional​-grap​hic-d​ esign​-comp​etiti​on (accessed 13 March 2018). 11. CFCs (chlorofluorocarbons) are compounds of chlorine, fluorine, and carbon that demonstrably reduce the ozone layer and have thus also been connected with an increase in skin cancer. CFCs were widely used in consumer products such as refrigerators or sprays, but they have been heavily regulated since the 1970s. At present, sprays may still display “CFC-free” labels, but even sprays without such labels may be free of CFCs, as they have been practically replaced with other, less problematic propellants in consumer products. 12. “Future card 14”: Labelling and personal choice. In the future, labelling will make transparent whether a product contains nanoparticles. Therefore, every consumer will get the chance to decide if she or he wants to buy nanoproducts. “Future card 15”: Getting accustomed to the new. We already live with nanoproducts today. Without noticing it, they will become more and more part of our everyday lives and we will get accustomed to them. It has always been this way with new things. 13. Preservatives are a subcategory of food additives; each preservative is given an E number by the EU, which has to be listed on products containing them. Preservatives are only approved in foods if they have been scientifically proven not to involve health risks, if they are technologically necessary, and if they do not deceive consumers.

Chapter 11

Emerging Technologies and the Problem of Representation* Lotte Krabbenborg

The development of nanotechnology, just like other newly emerging sciences and technologies (NEST), such as synthetic biology and geoengineering, is surrounded by attempts at anticipatory governance. Rather than waiting for societal impacts to become evident, government agencies and some technology developers now try to anticipate potential concerns and needs, with the aim of making better-informed decisions about the further development of emerging technologies in the present. The early, or upstream, involvement of civil society actors in the form of individual citizens and civil society organisations, like NGOs, patient organisations, trade unions, or faith-based organisations, is one of the forms anticipatory governance has taken. Concrete experiments are now being undertaken in this respect, ranging from one-day events in which nanoscientists and citizens meet, to focus groups where citizens can develop and voice their concerns. An example of these types of experiments in civic engagement can be found in recent EU projects Nano2all and GoNano, as well as large-scale national dialogue events, like those organised in the Netherlands (Krabbenborg and Mulder 2015) and France (Laurent 2016). A further step in creating anticipatory governance is the recent policy initiative to create “Responsible Research and Innovation” (RRI). With RRI, not only is civil society expected to become involved and actively participate, but the policy-making world also explicitly encourages technology developers to become more responsive to societal issues and needs by engaging in early-stage interactions with civil society and by taking up the issues that are  For more details on the case-study presented in this chapter, see Krabbenborg 2013a; for more details on the analysis of Dewey in relation to emerging technologies as presented in this chapter, see Krabbenborg 2013b, 2013c, and 2016.

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articulated in their decision-making processes. Phrases such as “voices of civil society must be heard” and “nanotechnology developers should engage with civil society” testify to this. There is a tension in referring to civil society as distinct from scientists and industrialists. The notion of civil society, in principle, suggests that it encompasses every citizen, including the scientists, industrialists, and policy makers who are supposed to be interacting with civil society. I will not solve this conundrum in this chapter, and I actually follow the usage of the notion of civil society that is now visible in anticipatory governance attempts: civil society as a collective in its own right, distinct from actors who see themselves as responsible for the development and embedding of new technologies such as nanotechnology. Nevertheless, what I do want to problematise in this chapter is the division of labour that accompanies interactions between technology developers and civil society, particularly between civil society organisations (CSOs). While there is no clear-cut definition of what counts as a civil society organisation, a widely quoted and applied definition of CSOs from the World Bank (Mandell et al. 2005) is useful in this respect: Civil society organizations refer to a broad array of organizations: community groups, non-governmental organizations (NGOs), labor unions, indigenous people, charitable organizations, faith-based organizations, professional associations and foundations. (Laasonen 2012, 38)

A shared characteristic of these organisations is that they do not operate in the economic marketplace and are (except for labour unions) not part of traditional governance arrangements. Additionally, though not visible in the World Bank definition, CSOs can also be temporary organisations—like a neighbourhood group—which disband when they have done their job. Developers and promotors of nanotechnology now even invite civil society organisations to be new dialogue partners. The European Commission (EC), for instance, positions CSOs as “new and knowledgeable dialogue partners” in participatory policy-making processes and research and innovation trajectories (EC 2001). CSOs are seen as knowledgeable in giving voice to the concerns, issues, and needs of citizens (Commission of the European Communities 2001, 14). Also, in the words of the EC: CSOs . . . as potential sources of knowledge, know-how and innovation . . . can contribute together with industry, science and policy, to a European knowledgebased society, one that is responsive to societal needs and concerns. (EC 2005)

This type of positioning of civil society organisations evokes at least two problems. First, in general, the positioning of CSOs as voices of needs and

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issues of civil society evokes problems of representation (Hess 2010; Houtzager and Gurza Lavalle 2010), because whose issues are actually represented? Moreover, in practice, CSOs do not always position themselves as voices of civil society because, for example, they have no regular consultations with their constituency and they also develop their own (longer-term) agendas. Secondly—and this is the problem I want to zoom in on in this chapter—a positioning of civil society organisations as representing societal needs and issues underestimates the socio-technical complexity that is involved when discussing newly emerging sciences and technologies. There is the assumption that societal issues or concerns are already a given, and that civil society can recognise and articulate them. However, as already stated by Rip, Misa, and Schot (1995) as well as Boenink, Swierstra, and Stemerding (2010), societal issues co-evolve with the development of newly emerging technologies like nanotechnology. What kind of new roles, responsibilities, human behaviour, and values emerge depends on considerations and actions made by actors— such as scientists, industrialists, and policy makers—who are active in and able to steer innovation processes. As already noted (Krabbenborg 2016), choices made by government agencies or funding agencies for instance with regard to sponsoring certain science and technology developments, influences which promises can be further developed by scientists in R&D laboratories. In turn, the actions that scientists or industrialists carry out, for example to develop certain functionalities to materials or medical devices, influence the actions that users, e.g. patients, can or cannot take.

So, innovation trajectories involve multiple stakeholders, who, in some cases, also push and pull new science and technology developments in different directions. However, their activities are entangled in one way or another, as illustrated above, and these activities set enabling and constraining conditions for how new technologies become materialised in society. Thus, when the aim is to anticipate societal implications of emerging technologies by involving civil society organisations, a problem shift is necessary. The question is not whether civil society organisations ought to be involved, but rather how their involvement can improve the discovery and articulation of emerging societal issues occasioned by the development of NEST (see also Krabbenborg 2013a). The aim of this chapter is to evaluate to what extent we can use John Dewey’s (1859–1952) notions on public involvement to cultivate pointers for a new division of labour between technology developers and civil society organisations. My reason to turn to Dewey is that there is, as I will demonstrate, an affinity between Dewey’s philosophy and the development and governance of nanotechnology (and other emerging technologies). Uncertainty, unpredictability, unknowns, and heterogeneous groups of actors pushing and

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pulling in different directions are central points in both Dewey’s philosophy and the development of emerging technologies. 1. JOHN DEWEY Dewey belongs to the pragmatist tradition. For Dewey—in contrast to, for instance, Plato or Kant—philosophy grows out of and is intrinsically connected with human affairs (Dewey 1920). An important aim for Dewey’s pragmatist philosophy was to cultivate and expand the capacity of human beings to intelligently navigate a world in flux and to solve actual problems as they are experienced in everyday life. In developing his philosophy, Dewey was concerned with the question of how to improve the relation between the interpretative frameworks of human beings—that is, their perspectives, values, institutions, and beliefs—as they exist within a continually changing environment. As such, Dewey was strongly influenced by the circumstances in which he found himself. He lived in a period of rapid social, economic, demographic, political, and technological change—part of the rise of urbanindustrial society in the United States, or, as Dewey called it, the rise of the “machine age” (Dewey 1927). As noted in Krabbenborg (2013b and 2013c), Dewey saw how new scientific and technological developments, such as public transport, the daily press, and the radio, destabilised existing ways of living and associating, while citizens were unable to interpret, value, and judge these new developments adequately because they inherited values, norms, routines, habits, and institutions that stemmed from an earlier era. For example, with the further development of the telephone, it became possible for people to maintain relations at a distance without actually meeting each other. However, in everyday interpretative frameworks, small-scale communities and face-to-face contact remained the main point of reference for people. As a consequence, “uneasy equilibriums,” as Dewey called them, emerged between the new daily realities of the urban-industrial era and the interpretative frameworks of human beings (Dewey 1920). Novelties made existing norms, values, and routines less adequate, but new ones could not be developed because people did not have the right “equipment”—in the sense of perspectives, values, norms, and theories—to think and handle change, contingency, and unpredictability. Specifically, Dewey argued, traditional philosophy and ethics (such as Plato’s “quest for certainty” and the deontological ethics of Kant) were not adequate to serve as a guide for people living in the new industrial era to understand and assess the world around them. The challenge for Dewey was to reconstruct philosophy—which he saw as a “as set of beliefs and attitudes”—in such a way that it was able to handle change, contingency, heterogeneity, and unpredictability. To realise this

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reconstruction, Dewey turned to the scientific-empirical methodology of observation, deliberation, hypothesising, and experimenting (Dewey 1920, xxxiii). In the late nineteenth century, it became accepted in science to see theories as fallible and thus always provisional. Dewey argued that this could also be the case with regard to interpretative frameworks, with human beings also perceiving their perspectives, values, beliefs, and societal institutions as provisional, temporary, and sometimes in need of revision. In order to cultivate the capacity of human beings to make such revisions and to solve actual problems, Dewey developed his joint inquiry approach. For Dewey, the existential experience of indeterminacy, referring to a situation in which it is not clear what is at stake, for whom, and how to move forward, is an occasion to start a joint inquiry, which subsequently should lead to problem articulation and problem solving (Dewey 1920). Rather than attempting to mould a problem into an already fixed pattern, one should enquire into the indeterminate situation and discover what the exact nature of the problem is: What are the issues? Who is involved? What is at stake? (Keulartz et al. 2004). What is important to notice, and what is already distinct from the division of labour currently visible in the governance of emerging technologies, is that Dewey emphasises that acquiring insight into societal implications of new technologies is neither something that can occur in isolation, nor is it the responsibility of one particular group of actors, such as civil society actors in our era. Instead, explicit understanding is acquired through dedicated interaction and collaboration with others who also experience indeterminacy. Dewey’s philosophy calls this type of dedicated interaction joint inquiry or dramatic rehearsal. See box 11.1 for the four successive phases of a joint inquiry. BOX 11.1 INTERACTIVE PROCESS OF DRAMATIC REHEARSAL After the existential experience and recognition of an indeterminate situation, the first phase is to transform an indeterminate situation into a problematic situation by means of an inquiry into and articulation of problems. Problems can be articulated by participants sharing experiences, doubts, and difficulties of how consequences of an act affect their daily lives and activities. Dewey emphasises that problems do not exist prior to an inquiry. In judging that something is a problem, we judge how it is, we define it (Hildebrand 2008). In the second phase, participants should formulate hypotheses about possible solutions to deal with a problem. Interactions take the form of forecasting, backcasting, and imagining the possible

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consequences of taking a particular line of action. The third phase consists of an actual rehearsal, in interaction, of how new lines of action could work out in practice. In this phase, an estimate of possible consequences is made for those who are involved. The final phase of a joint inquiry is the experimental testing or piloting (in real life) of the hypothesis that participants pointed out as the preferred solution. Dewey stresses that a solution should address as many issues as possible that were discovered during the inquiry process (Dewey, 1957). Furthermore, he emphasises that a reflective inquiry should take the form of interaction and participation in the light of the unknown. What to value, how to act, and which ends to pursue emerge through sharing experiences and questioning each other. Source: Krabbenborg 2013c.

As such, a joint inquiry functions as a space for interaction that allows people to enquire into the new and develop—by sharing experiences, needs, and doubts—new or adapted interpretative frameworks through which an understanding of the new can be acquired. Thus, a joint inquiry urges participants to perceive their values, norms, and ideas as contingent and provisional. The product of a joint inquiry is situated and time-bound knowledge. Its value can be measured by whether it is able to solve actual problems—that is, whether it can “effect a working connection between old habits, customs, institutions, beliefs and new conditions” (Dewey 2008a, 137). Dewey introduced the notion of publics in relation to the emergence of indeterminate situations. In contrast to current governance situations around emerging technologies, Dewey does not assume the existence of a particular group of citizens that can be involved as such. Instead, a public emerges in relation to indeterminate situations and disappears when their business—that is, joint inquiry—is concluded (Dewey 2008b, 10:23). Or, to phrase it differently, consequences of actions (like the development of new science and technology) call particular publics into being, and there can be many publics at the same time in society, dealing with different consequences. In contrast to existing notions of civil society or the general public, which are seen as distinct from scientists and technology developers, a Deweyan public does not have a prior social, geographical, or institutional status. Members of a Deweyan public are related because they are all affected by the consequences of particular actions, albeit in different ways, as people are situated and related to the world in different ways and thus experience—in our case, newly emerging technologies—in different ways. Extrapolating Dewey’s notion of publics to the current governance situation around emerging technologies would imply that both developers

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and civil society actors are, in principle, part of the same public, as both groups of actors are affected by indeterminate situations occasioned by the development of emerging technologies like nanotechnology, albeit in different ways and with different roles and mandates (see also Krabbenborg 2016). Engaging in a joint inquiry would then imply an alternative, more symmetrical, division of labour in which technology developers are also responsible for enquiring into and articulating societal needs and concerns, in close collaboration with civil society actors. In turn, civil society actors should enquire into and reflect how actual development trajectories challenge, contradict, or contribute to their stakes, needs, and dilemmas. As already noted: It is important to note that symmetry in this case does not refer to equality: institutional roles and mandates of technology developers and civil society actors remain different, but it refers to a situation where both technology developers and civil society actors, during the early stages of a new technology development, share and discuss their activities, and inquire how these are entangled in order to discover and anticipate emerging societal issues occasioned by the development of nanotechnology. (Krabbenborg 2013a, 47)

2. DEWEY FOR THE TWENTY-FIRST CENTURY Dewey developed his work in an era that is different from ours. In order to maintain the core of his ideas on joint inquiry and public involvement as a way to develop pointers for an alternative division of labour between technology developers and civil society organisations, we have to deviate from some of his assumptions and develop requirements that fit better with the socio-technical dynamics of the twenty-first century. First, Dewey made certain assumptions about the functioning of societies that do not apply to the present situation. Marres (2005) pointed out that “Dewey assumed that there was, or should be, one state that would address the issues. However, we have the multiplicity of states to deal with” (11). Newly emerging science and technology is international and not limited in scope by nation-states, even if these play an important role. A simple example is the potential toxicity of engineered nanoparticles in products that are produced, distributed, and used worldwide. Currently, guidelines for risk assessment and risk management of engineered nanoparticles are being developed at the national as well as at EU and international levels. Second, Dewey developed his thinking in relation to existing technologies— such as railways and automobiles—that were already part of a common world, and, as such, were a lived experience in people’s daily lives. Newly

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emerging nanosciences and nanotechnologies, or synthetic biology and geoengineering for that matter, are mainly hopeful promises and expectations, and they do not yet exist as concrete products and systems embedded in a common world where society at large experiences concrete dilemmas and faces other issues. Thus, it may well be that for newly emerging technologies to become a topic for joint inquiry, additional efforts will be required. Third, science and technology have far-reaching consequences that in principle call many publics into being. But, as Dewey states in The Public and Its Problems (1927), at the same time, science and technology developments also increase complexity. Acts and their consequences become entangled in such a way that citizens cannot gain an overview of what affects them and thus cannot organise themselves effectively to engage in a joint inquiry as a way to articulate problems and develop solutions. Dewey’s diagnosis is even more applicable at present, with newly emerging science and technology where diffuse promises abound and can only be met with diffuse concerns. Dewey scholar Marres (2005) emphasises a related point—that in our era, a Deweyan public consists of a community of strangers. Those who are affected by new science and technology developments do not necessarily belong to the same social world, which makes it difficult for them to organise themselves and become aware of the fact that they are implicated in an emerging indeterminate situation (Marres 2005, 10). The development and societal embedding of nanotechnology is a global challenge, transcending national boundaries. This implies that those who might become affected by the consequences of nanotechnology (and thus, in principle, are part of a Deweyan public) cannot solely be found within a national border, or in Western Europe. Additionally, in our differentiated society, actors involved in innovation processes—such as scientists, industrialists, funding bodies, policy makers, insurance companies, and civil society actors—operate in relatively separate worlds, which makes it difficult for them to assemble and interact so as to take one another’s activities, perspectives, and values into account. Dewey saw a role for what he called “officials” to bring together all those involved to start a joint inquiry. In a sense, officials would act as representatives of public issues, as civil society organisations in our era claim to do and are expected to do, but in a more ad hoc manner. When the issue has been addressed, the “official” will step back, unless another issue requires representation. In Dewey’s philosophy, representatives of public issues have a double role (see Brown 2009). The authority of a representative of public issues rests on their capacity to identify what Dewey scholar Brown describes as “passive protopublics” (and thus representatives in Dewey’s sense have to recognise and articulate indeterminate situations). At the same time, the task of a representative is to ensure that identified issues are taken care of:

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“Representatives partially construct the public they represent. They cannot simply mirror a pre-existing public will, because representation involves organising and articulating the public itself” (Brown 2009, 142). In addition, in order to address public issues, representatives must seek to promote—through agenda setting and other means—those issues that publics articulate and prioritise via joint inquiries. This process enables the state or other authoritative bodies to address them. As soon as issues are dealt with, these representatives disappear. Thus, Dewey had a bottom-up politics in mind, characterised by flexibility and temporal agreements. Assemblages of publics play an important role in Dewey’s idea of bottom-up politics, and what is an appropriate configuration of and between publics in one context, or for one problematic situation, might not be appropriate for another. It is not quite clear from Dewey’s philosophy how his idea of representatives works out in practice, but if we extrapolate his thought to the current governance situation around emerging technologies, one can see that the projected role of civil society organisations as “voices of civil society” locates them as Deweyan “officials” (i.e., as professional “spokespersons” for public issues). See, for example, how CSOs are positioned by the EC as “knowledgeable in giving voice to the concerns, issues and needs of citizens” (EC 2001, 14). However, there is also a difference between civil society organisations in our era and Deweyan “officials.” CSOs that are active in the domain of emerging technologies, such as Friends of the Earth, the ETC Group, and Greenpeace, are professional organisations that want to survive and need financial resources to do so; they also need symbolic resources, such as being recognised as “voices of civil society.” Thus, they must work with a business model that enables them to survive. However, it is not just a matter of surviving. In accumulating experiences and insights, they also become better able to identify and address the relevant issues, and they do a better job than individual citizens could do themselves. The other side of the coin is that their contribution might be shaped by their interests and avowed concerns rather than the specifics of the issue. For example, in the UK, organisers of a public debate under the title “GM Nation” had concerns about the predictability of the contribution of CSOs and therefore excluded them from the debate, looking instead for citizens with no predetermined views (Lezaun and Soneryd 2007). Another entry point for dealing with the question of representation of societal issues in our era, as noted in Krabbenborg (2013b), is to recognise that in the domain of emerging technologies, technology assessment (TA) scholars, social scientists, and ethicists can play, and actually do play, a role as Deweyan officials. They organise dedicated spaces for assembly to bridge the relatively “separated” worlds of technology developers and civil society actors based on a diagnosis of the present indeterminate situation (see Robinson 2010; Parandian 2012; Krabbenborg 2013c). Their role as “Deweyan

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official” is not simply claimed but is based on insights derived from their moving about in the various relevant worlds of technology development, policy making, and future users, asking questions and analysing what is happening. As such, a TA scholar, social scientist, or ethicist can see things and point out emerging indeterminacies that are more difficult to see for other actors, such as scientists or policy makers, as they are operating in a particular domain and focused on realising their daily tasks and mandates properly. Fourth, Dewey assumed that if people acted as a public, every indeterminate situation would be dealt with, so no orphan issues would remain. However, research into governance of emerging technologies has already shown that in our society, there is a cultural repertoire that both enables and constrains NEST as a topic for deliberation between technology developers and civil society actors (Swierstra and Rip 2007; Krabbenborg and Mulder 2015). A repertoire functions as a toolkit and provides actors with a historically transmitted and publicly available system of symbols, myths, worldviews, and stereotypes from which actors can draw certain elements to make sense of new situations and shape their actions (Swidler 1986). As Swierstra and Rip (2007) argue, in our Western societies, risk and privacy issues related to new science and technology can become a topic for deliberation between different actors relatively easily; this is because, by now, there is a cultural repertoire available for these issues that actors can draw on (selectively) in developing their arguments and claims. There are examples, stories, and analogies from earlier technologies that can be mobilised to make sense of the new situation (see also SchwarzPlaschg 2018b). For other societal issues, such as the way technology shapes how we relate to the world and to each other, and how it might change the way we value certain behaviours and norms (Boenink, Swierstra, and Stemerding 2010), there is much less of a repertoire available for actors to use as a toolkit. Finally, as Marres (2007) argues, Dewey does not really address the question of who decides—or who has the agency or authority to decide— when a problem is solved. In our era, however, there is a difference in agency between nanotechnology developers and civil society actors. Civil society actors come in at a later stage, with little information (Rip and Robinson 2013) and with little agency to steer innovation trajectories compared to technology developers. Also, technology developers can decide whether or not to take up the concerns, values, and wishes of civil society in their decision-making processes. Moreover, there is a further asymmetry. Compared with Dewey’s emphasis on lived experience as a means to enquire into indeterminacies, nanotechnologies are still under construction, so there are few if any lived experiences. The best one can do is to anticipate possible experiences, building on information about current developments. This, then, introduces another issue: Who provides such information, and from what perspective? Thus, while we have to deviate from some of Dewey’s assumptions since he lived in a different era and was responding to his contemporary situation,

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his perspective on joint inquiry and publics is valuable because it undermines the assumed legitimacy of the existing distribution of roles and responsibilities between technology developers and civil society actors visible in current governance arrangements around emerging technologies. In the domain of nanotechnology, there are some cases in which technology developers and civil society actors experimented with a new division of labour and where, at least partially, both nanotechnology developers and civil society actors shared their views and concerns. In these cases, both parties jointly enquired into an indeterminate situation and articulated problems and possible solutions. I will zoom in on one such novel space for deliberation, namely the threeyear partnership between chemical company DuPont and the nongovernmental organisation Environmental Defense Fund (EDF) in order to see what we can learn about the conditions and proceedings of a joint inquiry between a company and a CSO in the twenty-first century. The empirical data on the interaction processes between DuPont and EDF were acquired after the partnership was formally terminated. I conducted a telephone interview with one of the project leaders of EDF, Gwen Ruta (vice president of corporate partnerships), in 2009, as well as a face-to-face interview with the project leader of DuPont, Terry Medley, and a face-toface group interview with DuPont project members in the United States. To complement the interview data, I studied a video conference that had been launched about the partnership in June 2007. To more deeply understand enabling and constraining conditions with regard to engaging in a joint inquiry, I studied position papers of CSOs and codes of conduct produced by the chemical industry. In addition, I held interviews with three chemical companies, and I participated in two international CSO meetings in which CSOs articulated roles and responsibilities in relation to the development and embedding of nanotechnology.1 This case description is part of a larger study on the involvement of civil society actors in emerging technologies (Krabbenborg 2013a, 2013b). The larger study provides a more detailed description of the case as well as more details about joint inquiry processes around emerging technologies in the twenty-first century. 3. JOINT INQUIRY PROCESSES BETWEEN DUPONT AND EDF In 2004, EDF had approached DuPont with the invitation to work together to develop a risk-management methodology to address an indeterminate situation: the potential health and safety hazards of engineered nanoscale materials. While developing such a risk framework was a common concern for both

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groups of actors, the stakes for both parties were different. For DuPont, as a manufacturer, the stake emanated from their interest in the continuation of production processes of nanoscale materials. The goal of the Environmental Defense Fund was to realise particular environmental endpoints, like cleaner energy production.2 According to their perspective, nanomaterials, in principle, can contribute to these environmental endpoints, but potential risks have to be addressed first. So, although the stakes between the two parties were different, DuPont and EDF had a common concern in conducting an inquiry into the indeterminate situation to uncover how engineered nanoscale materials might pose health and environmental problems to society at large. To do this, they decided to cooperate, leading to an actual partnership between 2006 and 2009. Both DuPont and EDF positioned the challenges of engineered nanoscale materials as a novel situation, in need of new or adapted regulations: Current regulations, designed for a world before nanotechnology, should be reassessed and changed as needed to account for the novel properties of nanomaterials. Business and government may need new approaches to make sure workers, consumers, the public and the environment are adequately protected. (Krupp and Holliday 2005)

In order to respond productively to this new situation, they designed a space for deliberation and negotiation that allowed for joint inquiry into actual innovation processes. DuPont’s production processes of nanoscale materials were taken as a starting point for joint inquiry and articulation of what could be at stake with regard to health and environmental safety issues. As the DuPont project leader explained, “The aim of using information from actual production processes was that ‘we had to have some real things to build on; otherwise it would become too abstract’” (interview by author, 2010). To gain access to the production processes, though, EDF had to sign a nondisclosure agreement, implying that everything said and done during the collaboration would be kept between the two parties. As noted in Krabbenborg (2013a), to stimulate an inquiry into the actual development process of nanoscale materials, small project groups were established in which members of both DuPont and EDF participated. The aim of the different project groups was to reach a consensus about what was at stake—for example, with regard to ecological concerns, workplace safety, and what should be included in the risk framework. There were face-to-face deliberations as well as deliberations via email and conference calls. Once in a while, project members of DuPont and EDF made a trip to a farm, owned by DuPont, “to work and play together.” The idea behind these trips was that an informal setting could contribute to both teams getting to know each other’s positions, views, and values better. The fact that DuPont

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and EDF had agreed to come together to write a risk framework stimulated interactivity, as they had to come to agreements about the content. DuPont members and the project leader of EDF pointed out that there were differences of opinion on some issues, but in these circumstances, as a DuPont member recalled, “We had a 360° look . . . we kept spinning around and everybody would look at it from their perspective” (interview by author, 2010). For DuPont, the collaboration with EDF was more than just a symbolic exercise. The nano risk framework became part of their “mandatory product stewardship process.” Based on a pilot-test during the partnership, DuPont decided to wait for the further development of a particular nanoscale material.3 While interactions between DuPont and EDF took place in a dedicated space, protected by a nondisclosure agreement, the outcomes of their inquiry became public via multiple outlets—websites, a video conference on YouTube, and presentations—enabling other actors, who were not present in the protected space, to respond. When the framework became public though, the framework as well as the partnership attracted praise but also critique, and even rejection. As stated in Krabbenborg (2013a), the chemical sector in general welcomed the partnership. The International Organization for Standardization (ISO), for instance, built on the risk framework to develop its own guidelines (ISO/TR31321) for nanotechnology-nanomaterials risk evaluation. In addition, the risk framework fit well with the Responsible Care Program of the chemical industry.4 At the collective level of CSOs, however, the risk framework, as a form of soft governance, as well as the partnership between a chemical company and an environmental NGO, were criticised and rejected. In response to the launch of the risk framework, an international coalition of more than twenty CSOs (e.g., Friends of the Earth, Greenpeace, ETC Group) developed a position paper that was addressed to the “international nanotechnology community at large” (Civil Society-Labor Coalition, 2007).5 In this paper, the coalition condemns the partnership and the risk framework as “fundamentally flawed.” They perceive soft governance proposals as “weak regulations” that are often used as a tactic to delay or weaken rigorous regulation. According to the international coalition, what is needed is a “meaningful and open discussion on societal impacts, and urgent worldwide oversight priorities for nanotechnology.” 4. CONCLUSION So, what can we learn from this specific case, and Dewey’s thoughts on joint inquiry and publics more generally? Inspired by Dewey, I have tried to show that an alternative incentive to involving civil society organisations can be

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the need to address indeterminacies rather than merely involving civil society organisations as a new dialogue partner because they a priori represent societal issues and needs. We saw that the involvement of EDF in the co-construction project with DuPont was not based on the fact that they could a priori represent issues and concerns of civil society. Instead, their involvement was based on their content- and issue-specific contributions. We also saw that having a common concern stimulated interactive inquiry processes between DuPont and EDF as they had to come to agreements and needed each other’s knowledgeability to move forward with the subject matter. So, a more “symmetrical” division of labour in which both technology developers and CSOs enquire into emerging societal implications could, in this case, be established in a protected space. Is it also possible to realise this type of interaction on a larger scale in our society? If we look at how the coalition of CSOs responded to the partnership and the framework, we can already conclude that joint inquiry processes between technology developers and CSOs are not a matter of course in the wider world. However, what we also saw is that the launch of the framework pushed the chemical industry and the international coalition of CSOs into articulation processes about what they saw as a legitimate way to proceed with the governance of nanotechnology and nanoscale materials in particular. So, because the outcome of this partnership (the framework) became public, articulation processes were not limited to the protected space DuPont and EDF had created. And as Dewey argued, it is exactly these types of articulation processes that we need in society as a way to enquire into indeterminacies occasioned by the development and embedding of new technologies. Rip (1986) also noted that friction and tension among actors involved in the development of new technologies could lead to articulation processes, on both a small and large scale. For example, activities of CSOs, such as protest, web-based petitions, and occasional direct action, lead to responses and positioning, not just in terms of what should or should not be done, but also about the legitimacy of CSOs and their own actions. Therefore, instead of avoiding possible controversies surrounding emerging technologies, one can also try to learn from controversies. Controversies are a resource for learning through the articulation and investigation of who is implied in the indeterminate situation, what is actually at stake, and for whom. My insistence on addressing indeterminacy and considering articulation processes has implications for who is to engage or be engaged, and how. One point is the need to enquire into indeterminacies and those who might be affected, and how this requires more than the organisation of focus groups with citizens and public outreach activities (i.e., accessing as many citizens

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as possible). “Third persons,” like social scientists, TA scholars, and ethicists acting as Deweyan officials in innovation processes, can play a role in developing a diagnosis of indeterminacy and in bringing together those who are involved (see Lindblom 1990). Moreover, of course, in our society there are professional spokespersons and official representatives for particular issues—such as dedicated NGOs— but there are also other types of CSOs who are seen as representatives of “societal needs and issues.” They can play a role in deliberation processes with science and industry, but, building upon Dewey, having NGOs or CSOs as new dialogue partners in innovation trajectories should not mean that the search for those who are affected comes to an end. Within current governance arrangements around emerging technologies, it is easy to invite dedicated NGOs and CSOs like Friends of the Earth or the ETC Group to interaction events because of their visibility and their standing on particular issues. This is, as it were, an engagement-supply push. My argument, as noted in Krabbenborg (2016), and building upon the work of Marres (2005, 2007), is that a particular indeterminate or problematic situation must be the starting point for technology developers and civil society actors to engage in dedicated interaction processes. This might well identify certain NGOs or CSOs as relevant participants, but it also implies that those who are or might be affected by the development of new technologies might not be immediately visible. As such, “Deweyan publics” must be discovered and articulated, time and again, during the course of new science and technology trajectories, as indeterminate situations emerge throughout the innovation process. The topic of this chapter, namely developing a more productive division of labour between technology developers and CSOs to address indeterminacies occasioned by the development of emerging technologies, touches upon foundational issues such as the question of how to (re)arrange existing governance structures. While there are no easy answers, the ongoing efforts to stimulate public involvement and the possibility of Responsible Research and Innovation, or, what EU commissioner Carlos Moedas has called more recently “Open Science, Open Innovation,” provide opportunities to shape our governance structures around emerging technologies more reflexively. NOTES 1. In 2008, I joined a meeting, organised by the Netherlands Society for Nature and the Environment (www.snm.nl), in which (international) environmental organisations discussed roles and responsibilities in relation to nanotechnology. In the same year, I also joined an international CSO meeting in Bonn, in which one of the topics was

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the positioning of CSOs in relation to emerging technologies such as nanotechnology, genetic modification, and synthetic biology. 2. See the Environmental Defense Fund’s website at www.edf.org. 3. See Nano Risk Framework, “Case Studies,” http://www.nanoriskframework. org/13-2/. 4. See European Chemical Industry Council, “Responsible Care: The Chemical Industry’s Commitment to Sustainability,” www.cefic.org/Responsible-Care. 5. Environmental Research Foundation, “An Open Letter to the International Nanotechnology Community,” http://www.rachel.org/?q=es/node/90.

Chapter 12

Nanotechnology* Democratising a Hyped-Up Technology? Franz Seifert

1. INTRODUCTION Since the turn of the millennium, nanotechnology has become a policy priority in most countries in the Organisation for Economic Cooperation and Development (OECD) and beyond. Following the example of the multibillion-dollar US National Nanotechnology Initiative (NNI), all major hightech nations in the EU embarked on powerful nanotech funding campaigns.1 While such international waves of innovation policy are not unusual and can easily be explained as the outcomes of an international high-tech race, in the field of nanotechnology two characteristics stand out. The first one is the key role of the international “hype” about nanotechnology in the policy process.2 The term “hype” refers to the specific character of nanotechnology’s discursive construction, which, most obviously, depicts nanotechnology in the most promising terms as a unique and revolutionary technology of “the next industrial revolution” that calls for extensive funding. While the hype conveys excessive, sometimes utopian future promises, there is a flip side, too, with speculation about threats ranging from environmental and health risks of nanoparticles to transhumanist dystopias. It should be noted that the hype around any new technology is far from a fleeting, inconsequential fashion. As I point out in this chapter, hype not only promotes discourse and rhetorical hyperbole, but it also carries substantial financial, scientific, and innovative influence. According to widespread understanding, hype follows a typical curve shape.3 In its initial phases it mobilises a multitude of actors in policy, research, innovation, and the media. Soon, enthusiasm  Writing and research for this chapter was supported by the Austrian Science Fund (P 29114-G16). For a corresponding German version of this chapter, see Seifert (2018).

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is met with an equally speculative discourse of environmental and ethical concern that calls risk assessment and social expertise into action. More realistic, sobering assessments of the technology and its regulation usher in the downswing of the hype. In the case of nanotechnology, the hype’s downturn is already behind us, which offers the opportunity to gain an overview of the entire process.4 Second, the nanotechnology policy field highlights the strong presence of ethics, social science, and public engagement and participation. The political rhetoric surrounding nanotechnology abounds with democratic buzzwords such as “public engagement,” “dialogue,” “upstream engagement,” and “citizien participation.” The literature even talks about a “deliberative turn” in the nanotechnology field. This trend calls for explanation. One could hypothesise that if nanotechnology had been the subject of public controversy, this might explain such a shift toward ethics and deliberation. But this has not been the case. Nanotechnology has hardly ever provoked controversy and has generally maintained a low public profile in the media and in opinion surveys. So, why has this “deliberative turn” in nanotechnology policy come to pass? And why has it been observed as an international trend (i.e., taking place simultaneously in different countries)? I contend that there is a link between these two particular features of the nanotechnology field—the hype over nanotechnology and the hype over public engagement—which it sets out to explore in seeking to shed light on the conditions of potentially opening up scientific-technological decision-making to citizen participation. The demand for more democratic participation in an inaccessible field such as nanotechnology arises, on the one hand, from the massive spending of public funds on this technology and, on the other hand, from the supposed profound social and physical consequences of this technology. Both justify the demand for democratic handling of this technology. There are two approaches from the literature on nanotechnology that lend themselves to explaining this issue. First, the trend is often interpreted as occurring in response to epistemic and institutional crises of trust in the wake of increasingly frequent technological controversies. Second, the observable trend toward more deliberative participation appears to take place in particular policy fields that are characterised by actual or assumed physical, social, and ethical uncertainties. As for the other aspect of this deliberative turn, its more or less simultaneous unfolding across nations, I suggest two possible explanations. First, it can be shown that the trend toward deliberative participation follows transboundary diffusion dynamics. More specifically, a key element of this dynamic are programmatic developments of the EU’s research and innovation policy bringing about incentives to expand participatory deliberation practices in the member states. Second, the international hype surrounding

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nanotechnology is of key importance. Nanotechnology discourse, which, in an important respect, circulates through transnational, technology-political publics, conveys not only hyperbolic promises but also warnings, such as the threat of public controversy surrounding nanotechnology. The latter supports the demand for participatory procedures in technology policy. Another aspect of concern I aim to examine is the particular role of the social sciences in the nanotechnology field. The social sciences are involved in nanotechnology through accompanying research in, for example, foresight, technology assessment (TA), or ethical studies. I argue that, to the social sciences and humanities, the nanotechnology field presented itself as an opportunity for research and intervention. In retrospect, the resulting extraordinary involvement of the social sciences creates an opportunity for reflection on their practical significance in the democratisation of research and innovation policy. The structure of this chapter is as follows. In the next section, I define the practices of public deliberation that are at stake and explain their emergence in certain policy areas. Subsequently, I outline the international evolution of the nanotechnology field, entailing the beginnings of nanotechnology funding policies in the United States and the international discourse over nanotechnology that circulates in transnational expert publics and supranational institutions. Brief case studies in three major nanotechnology nations—the United Kingdom, Germany, and France—illustrate how national settings bear on the general trend toward deliberative participation. In the concluding section, I resume the explanation of the convergent trend toward dialogue and participation against the background of the nanotechnology hype, drawing attention to the special discussion on nanotechnology in EU technology policy and lessons to be drawn from the nanotechnology field for other technologies and accompanying social science research. Sources for my argument include extensive social science literature, materials from the media, and interviews conducted in Germany, the United Kingdom, and the United States in the course of an ongoing research project. 2. PUBLIC DELIBERATION AND ITS INTERNATIONAL CAREER Two questions have to be answered. What is public deliberation and how can its international rise in technology policy be explained? As for the first question, it is emphasised that, while public deliberation has become a routine practice in domains such as environmental and infrastructure decision-making, the diversity entailed in the term renders a uniform definition difficult.5 At any rate, public deliberation is to be distinguished from public information

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campaigns. Deliberation means dialogue, the exchange of arguments that are taken seriously by both sides, rather than top-down education of the public. The call for dialogue specifically applies to science. While science contributes vitally to public debate about nanotechnology as a supplier of information, science is now expected to act as humble partner in a dialogue with the public rather than as benevolent educator or impartial arbitrator in public debate. It is common to distinguish public deliberation from stakeholder processes. While the latter bring representatives of interest groups together, most consider public deliberation to be a wider, more inclusive process that involves citizens from an unspecific, disinterested public. Yet, stakeholder participation and public deliberation have a key quality in common. Both create “mini publics”—that is, a relatively small number of participants (say about ten to twenty) who engage in dialogue.6 The small group of participants, preferably meeting face-to-face without tight time constraints, is an essential condition for the very possibility of dialogue, which obviously cannot take place in large settings or in a state of conflict (Goodin and Dryzek 2006). What is generally understood as public deliberation therefore corresponds to models of citizen engagement such as consensus conferences, planning cells, and citizen juries. In these models a small number of “disinterested” citizens who do not have a stake in the issue are invited to engage in debate and deliver recommendations. Due to its outstanding features—direct citizen involvement and intense, transparent dialogue—public deliberation became equated with “democracy” (Thorpe and Gregory 2010). However, this is a superficial understanding. While public deliberation is becoming a standard practice in research funding and policy making, division and dissatisfaction in the analytical literature is also on the rise. Hardly any aspect of public deliberation is spared from theoretical dissent, but the main lines of critique refer to the limits of public deliberation and to its integration into decision-making and the wider social discourse. With regard to the latter point, the most common critique addresses the fact that public deliberation rarely has a direct effect on the content of technology policy making. Goodin and Dryzek (2006), for example, note that “it is not hard to identify limits and failures when it comes to mini-publics; this is hardly surprising given their novelty and the challenge they often present to political power constituted in more conventional terms. Sometimes the mini-publics’ deliberations pass almost unnoticed, getting little attention from the press, the public, or the politicians” (237–238). While this disappointing state of affairs mirrors the lack of meaningful integration of public deliberation into both formal and informal decisionmaking practices in liberal-representative democracy, seen from a larger perspective, less tangible impacts of public deliberation on public debates—such as informing these debates, building public confidence, market-testing, or

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legitimation of policies—can be plausibly demonstrated. Two questions outline the problem with the limits of public deliberation. First, what is the subject of dialogue and what is not? Second, who takes part in dialogue and who does not? In the scholarly debate, both issues are far removed from a consensus. A frequent critique of public deliberation denounces the fact that the way in which deliberations are typically organised and framed precludes the participants from scrutinising the assumptions, values, and visions that drive research and innovation. However, any meaningful dialogue has to have closure at some point. This also holds for the question of who is to participate in public deliberation exercises. While a handful of uninvolved citizens are certainly able to engage in meaningful dialogue and arrive at general consensual recommendations, these small random samples clearly cannot claim to represent the general public. So, public deliberation beyond the stakeholder model at best serves as a simulation of democratic dialogue, which might or—much more likely—might not have a wider effect on public debate or policy. In this context, the distinction between “invited” and “uninvited” publics is important (Wynne 2007). Public deliberation is a planned, managed process. Organisers commissioned by political or corporate decision makers who finance the dialogue events invite participants. Occasionally, civil society or protest groups who engage in technology debates of their own accord turn up as “uninvited” guests at these events or—more frequently—in social debate in general. Such “uninvited publics” constitute a problem from the perspective of deliberative participation for two reasons. First, social movements engage in public communication aimed at influencing public opinion, which poses an obstacle to dialogue oriented toward mutual understanding, as protest and polemics tend to dominate public communication. Second, uninvited publics cause technological backlash, as was the case with civil nuclear power and food biotechnology in specific nations. For technology advocates in science, industry, and public administration, who typically act as funders of public deliberation events, uninvited publics constitute a potential threat. However, critics argue that instead of promoting deliberative debates that predefine dialogue and rule out questioning the values and motives that drive technological development, uninvited publics and protest groups bring their own problem definitions that radically differ from those of decision-making elites in a way that might actually force change on innovation pathways (Wynne 2007; Wehling 2012). Which explanations for the trend toward deliberative participation in the nanotechnology field does the literature offer? The most general explanation understands the rise of public deliberation in policy fields such as environment or infrastructure as a response to a crisis of representative democracy as it shows itself in the public’s growing alienation toward political elites and mistrust of state institutions (Rayner 2003; Kearnes 2010). Procedures

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of deliberative participation are seen as a remedy. Public engagement, citizen dialogue, and participation are thought to return a sense of authenticity to public debate. Hence, the crisis of liberal-representative democracy appears as an opportunity for the deliberative “democratisation of democracy.” A more specific variant of this explanation interprets the rise of public deliberation in certain policy fields related to science and technology as a response to the failure of conventional public communication strategies in technology controversies and the resulting erosion of public trust in state institutions and state-sponsored expertise. For example, Kurath and Gisler (2009) demonstrate how experiences from the nuclear controversy influenced public communication strategies regarding biotechnology, and how experiences with the biotechnology controversy influenced communication strategies regarding nanotechnology. A third approach adopts both explanations but puts the focus on the specificities of certain policy fields. Gottweis (2008) argues that, in the course of the 1990s, in policies related to new biotechnologies and life sciences, a characteristic “New Governance” emerged. In this New Governance mode, funding programmes that promote certain technologies integrate a mix of measures aimed at assessing and managing these technologies’ ethical and social consequences, thus notably expanding research into technology’s controversial drawbacks, which previously was limited to assessing risks to human health and the environment. Besides academic ethics, media research, technology assessment, and science outreach activities, this mix also includes measures fostering public deliberation (see also Irwin 2006; Kearnes 2010). According to Gottweis, aside from the aforementioned erosion of trust in state and scientific authorities, this change is partly due to the specific ethical and cultural ambivalence raised by the life sciences, including the multitude of options they create and the threats they pose to a (culturally constructed) natural order. Resulting public controversy has “triggered” the New Governance mode. The trend toward New Governance initially manifested itself in the context of the US-led Human Genome Project, which reserved about five percent of its budget for research on ethical, legal, and social issues (referred to as ELSI) related to genome research. ELSI practices spread rapidly throughout the OECD area. In 1994, the EU also established an analogous strand of research in the 4th Framework Programme (Zwart, Landeweerd, and Rooij 2014).7 As a result of these priorities and the rise of related “funding arenas” (Zwart, Landeweerd, and Rooij 2014) for this type of research in the social sciences and humanities, a research landscape emerged addressing potentially “problematic” technologies through a range of activities, such as opinion polling, ethics discussions, technology assessment, and public dialogues. The following decades saw the expansion and differentiation of a research

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community specialised in these forms of what Marris calls ELSI work (Marris 2014, 2–3).8 The academic actors in this field mostly come from academic philosophy, the humanities, and social sciences, particularly Science and Technology Studies (STS) and Technology Assessment (TA), which has a firm institutional base in some EU member states. The suggested explanation now argues that New Governance also became the operational mode in the nanotechnology field. This explanation has the advantage of also accounting for the fact that the nanotechnology field shows the entire range of ELSI work, not just efforts to promote public deliberation. There are two features, however, that seem not to fit smoothly into this explanation. First, nanotechnology is not primarily a life science; therefore, it is not necessarily expected to raise the same type of socio-ethical challenges that promoted the institutionalisation of ELSI work. Second, nanotechnology has hardly ever raised public controversy.9 Instead, research on public opinion and media reporting about nanotechnology draws a general picture of scant information, minimal public interest, and no particular sense of threat (Berube 2006, 337–338). By no means can nanotechnology be regarded as a subject of public controversy or a crisis of trust that might “trigger” the New Governance mode. So why does the nanotechnology field nonetheless exhibit these characteristics? The following section sheds light on this question by tracing the origins and history of the international discourse on nanotechnology. 3. THE TRANSNATIONAL DISCOURSE ABOUT NANOTECHNOLOGY Key to understanding nanotechnology is the way in which mass media and research policy discursively present it as a future technology. The expectations thus staked out by its discursive construction guide the behaviour of the actors involved in nanotechnology in a variety of fields: in politics and administration, the media, as well as nanotechnology research and innovation or the social sciences and humanities (Kehrt 2016, 39). So, how did the discourse about nanotechnology unfold? Although only an outline can be given here, some justice has to be done to the complexity of the discourse. Therefore, a preliminary remark: Discourses and narratives have an instrumental dimension—that is, they are strategically shaped, propagated, and reproduced by social groups and actors in ways that suit their collective or individual interest. This has to be taken into account in discourse analysis. With respect to public discourse I distinguish two types of publics for analytic purposes: mass publics and policy publics. Discourse in mass publics is produced by the mass media and supplied to mass audiences. Mass publics,

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for example, in the form of “public opinion” or aggregate voting preferences, are of considerable importance to policy makers. Policy publics convey policy-relevant communication, are produced via specialised transnational media—journals, conferences, reports, etc.—and address a decision-oriented audience in science, administration, industry, politics, and civil society. Transnational policy diffusion essentially takes place via policy publics. Let us now turn to the history of the discourse about nanotechnology. This discourse is generally believed to have started in 1959, with Richard Feynman’s presentation “There Is Plenty of Room at the Bottom” in which the Nobel laureate in physics laid out a highly optimistic vision of the yet unexplored potential of nanoscale research. This origin, however, is a myth—more precisely, a foundation myth (Kehrt 2016, 42–46). Feynman’s lecture was quickly forgotten, as it did not receive much attention at the time, not even from Feynman himself. However, in later years nanotechnologists routinely quoted the Feynman lecture as nanotechnology’s birth, thus propagating and reproducing a narrative about a charismatic Nobel laureate’s inspirational speech. The actual starting point of the public discourse on nanotechnology, however, was in the 1980s with technology visionary Eric Drexler’s book Engines of Creation: The Coming Era of Nanotechnology (1986), which outlined the vision of a technology-driven civilisational leap based on self-organising, self-replicating nanotechnology systems. Although he was later derided as a dreamer and banned from policy debate, Drexler’s contribution was key for the early popularisation of nanotechnology, not least by introducing the term into general usage.10 The proof of nanotechnology’s viability came with the arrival of the scanning tunnelling microscope in the 1980s11 and the demonstration that it can be used to manipulate objects at the atomic level.12 At about the same time, the discovery of fullerenes promised unimagined possibilities in the field of new materials.13 From the early 1990s, the prefix “nano” mushroomed in scientific literature. The nanotechnology research field took shape. It should be noted, however, that this research, which has now come to be labelled “nanotechnology,” combined a number of already established research traditions and research strands that had previously been referred to differently.14 Often, the prefix “nano” simply replaced “micro.” Hence, alongside some spectacular discoveries and instrument innovations, the emergence of nanotechnology is largely owed to the rhetorical relabelling of already existing research, making it more attractive in marketing terms (Bennett and Sarewitz 2006, 311; Kehrt 2016, 118). Much of the research and development known as nanotechnology and funded under this label does not fit into an exact or narrow definition that, for example, is based on the use of specific physical properties of nanoscale objects and processes. Instead, the “nano” prefix creates an umbrella term that denotes an

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eclectic variety of approaches in research and innovation. Funding practice semantically benefits from the indefiniteness and flexible interpretability of such an open definition of nanotechnology (Decker, Fiedeler, and Fleischer 2004, 45).15 However, the breakthrough of the international nanotechnology discourse came as a result of a political decision. On January 21, 2000, in a speech at the California Institute of Technology, US president Bill Clinton announced the launch of the NNI.16 Quoting the enthusiastic metaphor of a “new industrial revolution,” the US government seized on the hitherto largely intra-­science hype about nanotechnology and transferred it to the sphere of the mass public. From the year 2000, use of the term exponentially rose in the mass media, just as (mostly dystopian) science fiction scenarios dealing with nanotechnology amassed in popular culture (Berube 2006, 20; Bennett and Sarewitz 2006, 313–314; Schummer 2010, 103). With a remarkably short delay of about one to two years, a wave of national nanotechnology programmes in many developed and emerging economies followed the US NNI. Regarding the process and imitative rationale of opinion formation in the transnational policy public that underlay this fast-paced dynamic, philosopher of science Joachim Schummer notes: The speed at which many of these programs were launched suggests that policy makers hardly considered whether nanotechnology was useful for their own country, whether it suited state-specific technology needs or national strengths in research. Instead, the fact that the Americans already had such a program appears to have provided sufficient legitimacy for their own initiatives. This inclination to imitate, which often reflects right down to the detail in the wording of national programs, testifies to a fundamental insecurity of science policy in all the countries concerned. In such a situation, it seems politically more legitimate to follow given trends, even if they turn out to be a global error, than taking risks and responsibility for one’s own decisions. (Schummer 2010, 26–27 [author’s translation from German])

In these early years of hype, the wave of nanotechnology programmes that swept through science and innovation policies around the world enjoyed undivided support. Unsurprisingly, science and technology enthusiastically embraced the new funding cornucopia. The number of scientific articles that now assigned themselves to the new funding arena through the use of the nano prefix skyrocketed. The close link between research activity and the availability of financial resources becomes apparent from the fact that temporal fluctuations in NNI budgets correlate closely with the frequency of articles classified as nanotechnology (Schummer 2010, 30; Bennett and­ Sarewitz 2006, 311).

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Meanwhile, the policy discourse about nanotechnology began to differentiate. The White House statement on the NNI already noted the need to integrate ethical and social aspects into funding programmes (Schummer 2010, 101). Later that year, the US National Science Foundation hosted a two-day workshop called the “Societal Implications of Nanoscience and Nanotechnology,” bringing together experts in politics, science, and the humanities to deliberate about nanotechnology’s ELSI dimension at the earliest possible stage in its development (Roco and Bainbridge 2001). In short, the rapidly expanding nanotechnology field had embarked on the New Governance path. It should be noted that this early step was not a response to external influences such as a sceptical climate of opinion or even an emerging protest movement against nanotechnology. None of this was in sight. Instead, it constituted a policy choice in favour of the mix of ELSI measures that had already been established in the Human Genome Project and other New Governance fields (Bennett and Sarewitz 2006, 316). The choice of this “ethical” approach was made in the inner circle of NNI supporters and organisers.17 It was not due to impulses from civil society, nor did it follow suggestions from the humanities and social sciences; rather, it was decided in a top-down manner (Bennett and Sarewitz 2006, 316). In fact, ELSI/STS/TA research did not show recognisable interest in nanotechnology before 2000. This changed only with the emergence of the NNI funding arenas. After a hesitant first few years, starting in 2003, considerable project funds for accompanying “ethical” research began to flow. From 2004 onward, a notable amount of ELSI/STS/TA literature on nanotechnology was published (Bennett and Sarewitz 2006, 317–318; Grunwald 2011, 45). By 2009, it had grown to more than one hundred journal articles, more than ten monographs and anthologies, the creation of the specialist journal NanoEthics, and several international collaborative projects (Nordmann and Rip 2009, 273).18 In the United States, two academic Centers for Nanotechnology in Society—one at Arizona State University (CNS-ASU) and one at the University of California, Santa Barbara (CNS-UCSB)—were established as part of NNI. The funding-induced boom in nanotechnology was briefly followed by one of ELSI/STS/TA research. It should be noted that this development also took place internationally, mediated through a transnational policy public.19 As early as 2003, with the launch of the German nanotechnology campaign, the Office for Technology Assessment at the German Bundestag (TAB) published a comprehensive report on the status and perspectives of nanotechnology (Paschen et al. 2004). In the UK this was followed by the internationally acclaimed report of the Royal Society and the Royal Academy of Engineering (RS-RAE 2004), which gave special emphasis to ELSI and, in particular, the need for public dialogue (RS-RAE 2004, 51–58, 59–68). The EU played

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a key role in the diffusion of ELSI practices in Europe. For example, the sixth research framework programme (2002–2006), which for the first time focused on promoting nanotechnology, also funded ELSI/STS/TA projects. In its European Strategy for Nanotechnology, the EU Commission emphasised the need to integrate social aspects into the innovation process (EC 2004b, 17–19).20 The fact that these emerging funding arenas for New Governance practices constituted a special opportunity for ELSI/STS/TA research has been addressed by ELSI/STS/TA research itself, typically in discussions about its appropriate role in technology policy (Macnaghten, Kearnes, and Wynne 2005; Grunwald 2011). In this programmatic literature the demand to influence the research and innovation process at an early stage in order to steer nanotechnology trajectories effectively in socially desired directions emerged as a general topic (Barben et al. 2008).21 This was also reflected in the ELSI/STS/TA discussion on deliberative participation, in which the notion of “upstream engagement” began to circulate, requiring discussion and social coproduction of science and innovation to set in as far as possible “upstream”—that is early, in the innovation chain (Kearnes 2010). One of the main reasons for the enormous political demand for ELSI expertise lay in a characteristic facet of the discourse on nanotechnology: the fear, articulated early on, that nanotechnology was in danger of being targeted by public protests similar to the backlash against biotechnology. According to Rip (2006), this discourse of warning and threat, widespread among nanotechnology promoters and stakeholders in industry, government, and science, is a “folk theory,” a popular, unproven interpretation of social reality from which general policy recommendations are derived. In this case, the story goes that one must learn from the mistakes that were made with biotechnology. According to the folk theory, these mistakes had been made in dealing with the public. New ways to prevent the fiasco from recurring had to be found. Against this background, there emerged a demand for ELSI, STS, and TA to move away from one-sided science communication in favour of a dialogue and true involvement through, for example, forms of deliberative participation. This urge was met with open ears among policy elites. Rip notes that fears of a looming backlash against nanotechnology were based on concerns of technology elites rather than empirical evidence. Empirical evidence almost consistently painted a picture of indifference toward, if not a general approval of, nanotechnology. In fact, during the years that these concerns emerged, technology elites seemed to be driven by a veritable “nanotechnology-phobia-phobia”—a fear of the presumed public fears of nanotechnology—which gave the folk theory a life of its own. Lastly, it was technology elites’ particular sensitivity toward a potentially resistant public

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that gave particular significance to the rare appearance of nanotechnology’s critics, or potential critics, in the early 2000s. In 2000, a single warning voice was to be heard—the prominent US software developer Bill Joy published the article “Why the Future Does Not Need Us” in Wired. In the article, he argued that the rapid rise of robotics, biotechnology, and nanotechnology would eventually bring humanity to the brink of extinction. Joy’s article received some attention in technology circles and among the broader public (probably thanks to his prominence), but it did not trigger a more far-reaching wave of technology critique (Berube 2006, 73–76). The Canadian environmental and social justice NGO ETC received much more attention, at least in the policy community, when it called for a moratorium on nanotechnology in 2002 until its environmental and health impacts had been assessed (Seifert and Plows 2014).22 ETC was dreaded. The small but highly influential group had contributed significantly to preventing the use of “terminator genes” in the conflict over genetically modified organisms (GMOs).23 In later years, ETC became highly visible in the international policy public with a series of reports on nanotechnology’s socio-environmental impact. Later on, the environmental NGO Friends of the Earth—especially its US, Australian, British, and German chapters—also dealt with the topic of nanotechnology, with a focus on its environmental and health risks. All in all, however, no more than a handful of professional or semi-professional NGOs have critically dealt with nanotechnology. While most of these actors have also been critically engaged against GMOs, which might appear to add credibility to the folk theory about a similar public controversy threatening nanotechnology, no comparable wave of protest ever came about. Without receiving much resonance in the public, organised criticism remained rudimentary. Nevertheless, the policy public adhering to its folk theory met any criticism with particular sensitivity. Critical or even just potentially critical NGOs received special attention in the social science literature and the transnational policy public. These NGOs were invited as early as possible to take part in “upstream” dialogues and stakeholder arrangements. How did the notion of deliberative participation circulating in transnational policy discourse translate into concrete practice in national contexts? The following section presents developments in three EU countries—the United Kingdom, Germany, and France—in order to illustrate the use of deliberative participation both in rhetoric and practice and thus to shed light on the significance of the national context for shaping these processes. These three countries have been chosen for comparison as they hold top positions in terms of European industrial power and innovator capacity. They also run major nanotechnology policies,24 which, in each case, entail measures tackling ELSI and the perceived need for public engagement.

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3.1 United Kingdom: Upstream Engagement In the early 2000s, the United Kingdom went through an intensive discussion regarding the relationship between science and the public. The background was the BSE (Bovine Spongiform Encephalopathy) crisis and the GMO controversy, both of which had been particularly acrimonious in the United Kingdom. The political think tank Demos and STS academics were the most prominent critics of state authorities’ and authoritative experts’ instrumental and narrow approach toward the public. Throughout the 1990s, these actors had persistently questioned the hitherto prevailing understanding of science communication that blamed an allegedly ignorant public for resistance to technological projects and loss of trust in authorities and government-related science (Irwin 2006; Wynne 2007). What was required instead, according to this position, was the radical opening of decision-making processes in science and technology policy for forms of deliberative participation to the extent that the invisible motives and objectives of these policies could be questioned too. From the turn of the millennium, political rhetoric in the UK signalled increasing support for a more dialogue-oriented relationship between science and the public. Participation and dialogue became the buzzwords of the technology debate.25 Against this backdrop, a vibrant scene of often privatesector dialogue organisers, facilitators, and commentators emerged. These exchanges were characterised by fragmentation, competition, and increasing professionalism (Chilvers 2010). The breakthrough in the nanotechnology debate came in 2004 with the report of the Royal Society that gave particular emphasis to public dialogue. In 2004, as nanotechnology was proclaimed a funding priority in the UK, funding panel decision makers began to call for measures fostering “public engagement” (Thorpe and Gregory 2010, 274–275). Demos took centre stage. The think tank organised, for example, the two-year “Nanodialogues” (Stilgoe 2007) and crucially contributed to the popularisation of the upstream engagement concept (Wilsdon and Willis 2004), which resonated not only in the UK, but also, due to the high visibility of academic literature in the English language, in the international ELSI/STS/ TA discussion. 3.2 Germany: Orchestrated Inclusion Germany, home of half of Europe’s nanotech companies and holding the third position in patents after the United States and Japan (NanoKommission 2008, 13), holds a leading position in nanotechnology. This is largely due to massive funding programmes since 2002. In order to foster cooperation between the sciences and the economy, a number of additional instruments have been employed, including network projects, strategic research co-operations,

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alliances for innovation, and technology clusters. From early on, great effort was made to orchestrate this campaign to develop a comprehensive innovation strategy. The “Nano-Initiative” coordinated by seven departments placed special emphasis on TA and ELSI work, and on the inclusion of all stakeholder groups for participation in a comprehensive public dialogue (Seifert 2013, 74–75). From 2004 to 2008, a total of seventy dialogical events took place at both the federal and state level, with the majority occurring in 2006 (NanoKommission 2011, 20–30). The heart of this dialogical policy component was the “NanoKommission” that was launched by the Federal Ministry of the Environment and composed of experts and representatives from the following sectors: public administration, science, industry, civic organisations, and NGOs. From 2006 to 2011, the NanoKommission delivered recommendations for nanotechnology’s responsible management. The commission’s special effort to invite critical and potentially critical actors is noteworthy. The most important of these critical actors was BUND (Bund für Umwelt und Naturschutz: Federation for Environmental Conservation and Natural Protection), Germany’s largest environmental organisation, a partner organisation of the Friends of the Earth network, and one of the key players in the German anti-biotechnology movement (Seifert and Plows 2014, 83–84). In critically engaging with nanotechnology, the NanoKommission is the major arena in which the BUND invested considerable resources and personnel. It is noteworthy, however, that other important NGOs, such as the World Wide Fund for Nature (WWF) and Greenpeace Germany, declined the offer to participate. The reason was sheer disinterest. None of the groups made nanotechnology a campaign topic. Beyond this, the German movement sector, which is mainly involved in antinuclear initiatives, global justice, and climate change, displayed little interest in the matter. While activist groups in the UK had shown at least some interest in the issue (Seifert and Plows 2014, 81–83), in Germany the folk theory about the looming anti-nano protest wave proved utterly illusionary. 3.3 France: Top-Down Debate—Radical Obstruction Just like the entire OECD area after the turn of the century, France gave funding priority to nanotechnology. As part of its national funding program, France has focused on strengthening regional innovation clusters. A major development in this respect is the cluster pôle d’innovation en micro et nanotechnologies in the Grenoble region. Despite its notoriously technocratic political culture, France also followed the international trend to foster deliberative participation in nanotechnology (Laurent 2017, 151–178; Seifert 2013, 75–78). From 2005 to 2009, nine public dialogues took place (BayaLaffite and Joly 2008). In this chapter I focus on those events that have had

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the most impact on the public, albeit inadvertently. Although a widespread protest mobilisation against nanotechnology has not occurred in France, the protest group Pieces et Main d’Oeuvre (PMO), engaging in radical, mediasavvy, and highly effective activism, stands out in this field.26 PMO is an activist group located in Grenoble committed to the radical critique of industrial society and high technology, which they consider an inherent part of totalitarian power. PMO combines a theoretical critique of technology, which it understands as a hidden form of domination, with research and a variety of activist methods, ranging from spiteful satire to disruptive action. After several protests in Grenoble that already sabotaged dialogue events, PMO activists achieved their biggest success at national scale in 2009 and 2010. The group chose to target the Débat publique (a nationwide public debate) on nanotechnology. The debate, which had been called for by the Grenelle Environment, was commissioned by eight state departments and was planned and organised by the Commission nationale du débat publique (CNDP).27 The CNDP, established in 1995, is a formally independent administrative authority whose function is to spread information and ensure public debate on infrastructure projects of national significance and with potential repercussions for communities. The nationwide debate on nanotechnology, under the title Je m’informe, je m’exprime,28 was scheduled from 15 October 2009 to 23 February 2010, in the form of internet-supported panel discussions in seventeen French cities.29 For the CNDP, such a large-scale dialogue event was a novelty. This novelty, however, does not explain its ultimate failure. First, participation was rather low. On average, the events were attended by only half of the expected audience. More importantly, however, the deliberative campaign failed due to the obstructionist techniques used by the activists. From the first event onward, discussion was rendered impossible by endless oral contributions, chanting, heckling, use of stink bombs, and so forth. Out of seventeen events, nine were aborted partway through, three ended in chaos, nine required the interference of security personnel, one had to be conducted in an isolated, online environment, and the last two were cancelled in advance. Since the “public dialogue” was merely a measure designed to promote acceptance for PMO, it was only logical that no dialogue be allowed. For the same reason, any participation of potential critics or ELSI/STS academics in these events was denounced as complicity. The activists’ disruptive actions frequently provoked the involvement of security personnel, which served to illustrate PMO’s claim regarding the totalitarian nature of nanotech policy. CNDP, in turn, accused PMO of irrational and antidemocratic agitation. In the end, the failure of the national Débat publique was hard to deny. ­Particularly disappointing was the campaign’s modest sphere of influence:

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Ten thousand participants had been expected; fewer than three thousand attended. The attendees’ low level of familiarity with the subject also suggested that a preparatory information campaign would have been required for a meaningful dialogue to take place. The major fiasco, however, was that massive protests were raised against the dialogue campaign, which, paradoxically, had the desired effect of raising nanotechnology’s media coverage, albeit in an uninvited manner. 4. CONCLUSION The presented cases do not even claim to approximate a complete picture of the manifold forms of deliberative participation in nanotechnology. Rather, they illustrate the fact that, while the trend toward more deliberative participation is global, concrete deliberative processes take place within local or national contexts in which they unfold depending on institutional and circumstantial factors, political cultures and path dependencies that, in turn, affect other processes. In the United Kingdom, for example, the public controversies of the previous decade played an important role in popularising the idea of deliberative participation. The provision of funding money rapidly created a free market for dialogue events, while the academic discussion in the United Kingdom developed widely acclaimed programmatic innovations. In Germany, on the other hand, the government succeeded in integrating stakeholders, including potentially critical interest groups, into a permanent dialogue within the framework of a national innovation strategy while the broader public took little notice. Conversely, a small group of protesters in France thwarted the state-mandated national dialogue, launching a radical critique which itself escaped any criticism or dialogue due to its hermetic character. Ironically, all this had the paradoxical effect of bringing nanotechnology to the attention of a mass media public. However, in addition to these country-specific developments, the rise of public deliberation is a transnational phenomenon too. By tracing the transnational discourse on “hyped-up” nanotechnology, I have illustrated how this process has taken place in the nanotechnology field and delivered ample evidence for confirming the proposed explanatory concepts. At a very early stage, nanotechnology policy took a New Governance path. This path began initially in the United States, which became a global role model for countries that followed suit in the EU. Public deliberation constitutes one among many elements of this New Governance mode, including TA, technology foresight, ethical reflection, media and opinion research, and traditional science communication. It is noteworthy that the New Governance mode constitutes a “package” of practices. It is not only the idea of nanotechnology promotion

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programs and their associated discourses and hype that are being imported, but also the ELSI/STS/TA research and practices that are part of the “package.” Transnational policy publics in which policy-relevant problems, discussions, and solution models circulate in specialist journals, conferences, and reports play a major role in this diffusion process. This also holds true for the involved supranational institutions, especially the EU, which impacts national research policies and policy discourses through research framework programmes and programmatic rhetoric. Hype generates attention, exaggeration, and myths. In the case of nanotechnology, the central myth is that of the “next industrial revolution.” As this revolution is without alternative, states have to massively invest in its promotion if they do not want to be left behind. However, the hype about nanotechnology also generates a multitude of other myths. One of these myths is the folk theory about the imminent threat of a public backlash against nanotechnology circulating in policy publics. This myth provided the grounds for a new, rhetorical, and financial commitment to deliberative participation among policy elites. That this is a myth is evidenced by the fact that there have been no significant protests against nanotechnology except in France. And in this case, ironically, it was the state-mandated dialogue that became the focal point of effective protests from a small anti-technology group. The New Governance mode chosen by the US technology elite was adopted internationally, along with the folk theory of the looming public backlash, which benefited the ELSI/STS/TA research field. ELSI/STS/TA research quickly seized the opportunity that emerged with the incoming funding and engaged in innovative ELSI work. For example, programmatic calls for forward-looking, “upstream,” and anticipatory forms of public engagement and governance emerged. Ironically, ELSI/STS/TA research itself did not initially play a forward-looking role with respect to nanotechnology. ELSI/STS/TA research in the area of nanotechnology did not appear before the pertinent funding arenas had opened up. Later, with the downswing of the hype curve and the shift of funding arenas into new New Governance fields, ELSI/STS/TA research also moved on, as did the next wave of public dialogue practices. Ultimately, this type of research follows the same hype as the types of policy, technology, and science it criticises. This seems to happen for obvious and, to some extent, very material reasons. It is up to the reader and perhaps future “reflexive” studies to examine and evaluate this interpretation. At any rate, democracy in general and public deliberation in particular will remain key topics of academic debate within ELSI/STS/TA research, which, in turn, will remain critical of and dissatisfied with increasingly common practices of public deliberation. The reasons are that, first, criticism is the recognised function of this research, which itself acts as analyst, commentator, and critic of public deliberation rather than as its organiser or facilitator;

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and second, because the notion of deliberative democracy will remain an unattainable ideal in the context of established forms of decision-making and interest representation within “actually existing democracy.” What does the trend toward deliberative participation tell us about the democratisation of nanotechnology? Any simple or straightforward answer is ruled out by the many ways in which this trend manifested itself—from its inconclusive, divergent, and ongoing theorisation in the literature, to its diffuse, discursively coproduced nature, which leaves open the question of what actually should be debated and decided in public deliberation. If one compares the outlined developments in the United Kingdom, Germany, and France, it is hardly possible (and possibly futile) to judge which countries have gained or perhaps lost how much or which aspect of democracy due to deliberative experimentation. In current political language, public deliberation is typically equated with a gain in democracy. At closer inspection, however, this turns out to be an inadmissible generalisation. It most probably can be ruled out that dialogue events fundamentally impact the trajectories of technology policy and technological innovation, both of which are driven by rationales of global military or economic competition. At the same time, it can equally be ruled out that public deliberation only has legitimate or cosmetic effects on policy making and debates in the media. What remains is the diagnosis of an experimental approach to democracy in a technology field that is, though hyped up, without a doubt important for the future. NOTES 1. I use a broad definition of the term “nanotechnology” (from ancient Greek nános, “dwarf”) as a collective term for all branches of research and techniques that operate within a size range of 0.1 to 100 nm (1 nm = 10−9 m) and make use of physical qualities of surfaces and materials specifically occurring within this size range. This is a tentative definition, however. As will be argued, to date, no uniform definition is in common use (see Decker, Fiedeler, and Fleischer 2004). 2. The term “hype” derives from the linguistic term “hyperbole” that stands for the rhetorical figure of exaggeration and originates from Greek hyperballein, “overshooting the mark” (see also Rip 2006, 352–357). 3. The popular, but untested, heuristic of the “hype cycle” for information and communication technologies has been introduced by the US consulting company Gartner Group (Rip 2006, 352–354). 4. In 2011, Armin Grunwald talks of a “normalisation” of the nanotechnology discourse (Grunwald 2011, 53). 5. Rowe and Frewer (2005) give an international overview. 6. Deliberative mini-publics are frequently combined with wider-reaching public debates—for example, via online forums and social networks or, as part of coordinated “national debates,” in combination with the mass media.

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7. In Europe ELSI is called ELSA. The letter A stands for “aspects,” but ELSI and ELSA refer to similar research practices in fields of technology. 8. The term “Responsible Research and Innovation” (RRI) recently appeared in the official EU terminology on technology issues and largely replaced ELSI/ELSA research in the context of EU promotional campaigns. While the concrete meaning of RRI in practice, in particular the way in which it differs from ELSI/ELSA, is still unclear, Zwart et al. assume that both terms overlap to a large extent and that the ELSI/ELSA research scene will largely merge into the newly formed RRI label (2014, 17). 9. I present the only notable case of public protest below. 10. In fact, the term “nanotechnology” was used for the first time in 1974 by the Japanese precision machine engineer Norio Taniguchi but remained largely unnoticed. 11. For this achievement the Nobel Prize in physics went to Gerd Binnig and Heinrich Rohrer. 12. In 1989, Don Eigler, with the aid of the scanning tunnelling microscope, managed to arrange thirty-five Xenon atoms to the letters IBM. The photo made it to the cover page of Nature and became one of nanotechnology’s icons. 13. Fullerenes are hollow molecular carbon structures of pentagonal or hexagonal shape. For the discovery of fullerenes, in 1996, the Nobel Prize for Chemistry went to Robert F. Curl, Sir Harold W. Kroto, and Richard E. Smalley. 14. It was referred to as surface and material science, molecular biology, or solidstate physics, just to name a few. 15. According to Kehrt (2016), these semantic manoeuvres signal a change in the social role of science that is conceptualised in the notion of “strategic science.” Strategic science implies that, today, actors in science strategically and discursively position themselves in fields of research that are associated with major societal and political expectations such as nanotechnology. In so doing, these actors claim to be in command of the needed problem-solving capacity, and they earn legitimacy and attract resources while in fact continuing their previously pursued research paths. 16. Initially, the budget for nanotechnology more than doubled from $270 million in the year 2000 to $495 million in 2001. Subsequently, US president George W. Bush budgeted $3.63 billion for the following fiscal years. Since then, funding in billions of US dollars kept flowing until 2018 (http://www.nano.gov/about-nni/, 14/05/2018). For the events leading up to the NNI, see Berube 2006 (125–129). 17. One of the organisers of the workshop, the renowned and influential physicist Mihail Roco, was also one of the leading minds of the NNI (Berube 2006, 87–89). 18. For example, S.NET (Society for the Studies of New and Emerging Technologies), http://www.thesnet.net, accessed 18 March 2018. 19. A transatlantic ELSI scene meeting at conferences quickly developed. As early as January 2002, for example, the US-EU joint conference “Nanotechnology: Revolutionary Opportunities & Societal Implications” took place in Lecce, Italy. One of the two organisers was Mihail Roco. 20. It is noteworthy that even supranational organisations such as the OECD made considerable efforts to propagate and standardise ELSI practices such as deliberative participation (Laurent 2016).

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21. The intellectual achievements of the rich corpus of ELSI/STS/TA literature on nanotechnology cannot be addressed here. However, a characteristic part of it should be mentioned, notably the literature that critically deals with the unrealistic, exaggerated, often fantastic expectations—visions, promises, warnings—typical for the hyperbolic nanotechnology discourse. 22. ETC stands for Action Group on Erosion, Technology and Concentration. Until 2001, the group called itself RAFI—Rural Advancement Foundation International. ETC’s political strategy relies on conducting in-depth research and analysis criticising the downsides of (bio)technological modernisation in rural areas of developing countries. 23. Terminator genes are transgenes that block seed germination, thus technically protecting proprietary claims. 24. According to a global survey, Germany, France, and the UK possess the fifth, eighth, and ninth rank worldwide in nanotechnology-related publications and are thus also the highest-ranking EU countries (http://statnano.com/news/57105, 14/05/2018). 25. As buzzwords they reached beyond technology debates. Thorpe and Gregory (2010) point to the distinctive role of the dialogue and participation theme in Tony Blair’s “third way” government rhetoric. 26. Pieces et Main d’Oeuvre is part of the typical formula on product guaranties “for parts and technical support.” 27. The term “Grenelle Environment” derives from Paris’s rue de Grenelle, where, in May 1968, decisive negotiations between unions and industry associations took place. In summer 2007, this same location was used to host deliberations between all relevant social stakeholders regarding ecology and sustainability. 28. “I inform myself, I express myself.” 29. In chronological sequence: Strasbourg, Toulouse, Orleans, Bordeaux, Clermont-Ferrand, Lille, Besancon, Grenoble, Caen, Metz, Rennes, Lyon, Marseille, Orsay, Montpellier, Nantes, and Paris.

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Index

Actor-network Theory (ANT), 181 agriculture, 17, 29–31; urban, 30; US Department of (USDA). See United States Anthropocene, 29 anthropocentrism, 28 asbestos, 109–10 Asia, 126 Australia, 113, 118, 120, 191, 238 Austria, 13, 72, 75, 136, 185; Austrian Broadcasting Corporation, 179; labelling in, 180, 184, 193–96, 202–8 autonomy, 21 balancing: in patent and IP law, 68–69, 87; risk and benefits, 65, 107, 115; rights, 136 BASF. See chemical industry biocides, 5, 98, 127, 138, 182–69 biology, synthetic, 62, 141, 144n20, 158, 211, 218 biotechnology, 19–20, 72, 116, 148, 184; controversy, 231–38, 240; patenting of, 55, 62–65, 85, 87.

See also European Union: Biotech Directive biotic: and abiotic, 17, 28, 128; interactions, 126, 130; pro-, 190–92 bottleneck effect, 55, 65–69, 71–77, 79–86 cancer, 65, 110, 200, 210n11 carbon, in nano, 60–63, 71, 109–10, 117, 145n22, 210n11, 245n13 chemical industry: BASF, 37, 112; DuPont, 36–37, 112, 221–24; Imperial Chemical Industries (ICI), 78; Responsible Care Program, 46, 112, 223 chemicals, 17–18, 125–130. See also European Union: REACH Regulation China, 97 citizen: consumer-, 13, 180–83, 189– 90, 198, 202–3, 206–8, 209nn2–3; involvement, 25, 54, 114, 172, 211– 19, 224, 228–231

285

286

Index

civil society, 54, 64, 216, 234, 236; organisations (CSOs) and actors, 42, 114n19, 148, 173, 211–31 cleaning: environmental, 19, 29, 32; agents, 196 climate: change, 97, 240; risks, 29, 35 Clinton, William Jefferson “Bill”, 235 cloning, 64, 69, 72 code of conduct, 111–12, 139, 173, 221. See also chemical industry: BASF; European Union: Responsible NanoCode co-development, 147 commercial applicability, 62–64, 68, 72 communication: public, 139, 181, 231–34; science, 44, 132, 139–40, 172, 237, 239, 242; between stakeholders, 94, 132, 159, 162–69, 170, 172. See also information and telecommunication technologies (ICTs; standards: telecommunication compensation, 78, 82, 110 competition, 66–67, 69–70, 74, 77–81, 84–87, 121, 170, 239, 244; advantage, 99, 119, 130, 149–50, 165, 170–71; anti-, 67, 76, 84. See also law: competition Consumer: behaviour, 5, 81, 119, 121, 149, 165, 199, 204; choice, 66, 85, 106, 179–183, 189; detriment to, 76, 79, 81, 110; engagement, 104, 121–22, 179; information, 45, 52, 60, 119, 164, 182–83, 185, 189–94, 197, 200, 202; protection, 114–117, 201; responsible, 179, 183, 207–8. See also citizen: consumer-; product

corporate social responsibility (CSR), 46, 49, 148, 166 cosmetics, 29, 106, 114–18, 121, 126– 27, 138, 164–65, 182–83, 196–97, 209. See also European Union: Cosmetics Regulation culture: context, cultural, 32, 104, 119, 181– 82, 187–89, 198, 206–7, 209, 220, 235, 240, 242; food, 196; institutional, 55–56, 171 data: big, 140; health, 103, 165; ownership, 150, 174–75; protection, 21, 142 decision-making, 6, 25, 27, 30, 32, 35, 49–50, 114–15, 148, 173, 189–90, 206–8, 212, 220, 228–31, 235, 239, 244 deliberation, 8, 31, 39, 54, 155, 173, 184, 215, 220–22, 225, 228–33, 237–44 democracy, 6, 10, 27, 32, 50, 103, 137, 185, 188–89, 228–32, 241, 243–44 Dewey, John, 211, 213–20, 223–25 Dieselgate, 98 disclosure, 41, 63, 122, 137; mandatory, 114, 118; non-, agreement, 222–23 discussion groups, 180, 184–86, 194, 205 division of labour, 212–17, 221, 224–25 DNA (Deoxyribonucleic acid), 63, 72, 116, 141 dual-use, 135–43 Dunkin’ Donuts, 119–20 dystopia, 10, 141, 204, 235; transhumanist, 21, 227 eco-centrism, 9, 18, 20, 25, 28–29, 31–33

Index

embryos, 64–65, 69 environment, health, and safety (EHS), 25–26, 41–44, 48, 51, 92–99, 103, 111, 113, 158, 162–67, 174–75, 179, 221–22 equity, 21, 113, 160, 175 essential facilities, 77–80 ethical, legal, and social issues/aspects (ELSI/ELSA), 2–8, 11, 14, 38, 105, 158, 164–67, 172, 232–43 ethics: board, 138, 165; consequentialist, 22, 26–28; deontological, 26, 28, 214; environmental, 18, 25, 28–29; nano-, 17, 21–23; of risk, 21, 23, 31; utilitarian, 11, 26, 30 European Committee for: Electrotechnical Standardisation (CENELEC), 60; Standardisation (CEN), 38, 42–52, 56, 60, 69, 83 European Convention on Human Rights (ECHR), 136–37 European Court of Justice (ECJ), 65, 67; Bronner case, 81; Commercial Solvents Corp. case, 78–80; Huawei case, 67, 69 European Patent Office (EPO), 61, 65 European Telecommunications Standards Institute (ETSI), 60, 67 European Union (EU), 72, 97, 105–6, 113–21, 125–26, 139, 142, 147– 48, 151, 180, 182, 184, 204–5, 207, 209, 211, 217, 225, 227–29, 232–38, 242–43; Biotech Directive, 62–65; Consumer Products Regulation, 106; Cosmetics Regulation, 4, 115, 118, 183; Europe 2020, 36; European Commission, 3, 35, 39–41, 45, 49, 77, 80, 106, 115, 127, 139, 159, 212, 219, 225, 237;

287

European Environment Agency (EEA), 9, 126, 131; European Medicines Agency, 113; Horizon 2020, 3, 35, 142, 148; internal market, 49, 74, 77, 118, 183; labelling regime, 180, 184; member states, 41, 72–74, 78, 85, 97, 115, 228; REACH Regulation, 94, 115, 126–27; Responsible NanoCode, 112; Strategy for Nanotechnology, 40–41, 237; Treaty on the Functioning of the (TFEU), 77–78, 85–86 experts, 45, 93, 95, 98–99, 131, 153–55, 166, 168, 184, 189, 236, 239–40 fair, reasonable and non-discriminatory (FRAND) terms, 67, 75, 82–86 Feynman, Richard, 234 focus groups, 211, 224 folk theory, 237–38, 240, 243 food: biotechnology, 231; genetically modified (GM), 105, 116, 119, 186, 189–90, 194–96; nano-, 179, 188–96, 205–6 France, 45, 211, 229, 238, 240–44; Association Française de Normalisation (AFNOR), 45; Commission nationale du débat publique (CNDP), 241; Grenelle Environment, 241; Pôle d´innovation en micro et nanotechnologies, 240 freedom: of choice, 181, 188–89; to conduct business, 78, of research. See rights: fundamental future scenarios, 23, 25–26, 28–32, 189, 205–6 gatekeepers, 48, 71, 113 gender, 13, 39, 150, 159, 162–63, 167, 172

288

Index

gene: -tic engineering, 5, 30, 186–90, 193–95, 200; -tically modified organisms (GMOs), 8, 119, 121, 158, 185–90, 194–95, 205–7, 238–39 geo-: engineering, 211, 218 politics, 104 Germany, 45, 51, 72, 75, 136, 186, 229, 238–40, 242, 244; Nano-Initiative, 240; Office for Technological Assessment at the German Bundestag (TAB), 236 governance, 1–3, 8, 20, 36–44, 50, 54, 104, 111–13, 122, 158, 167, 179–89, 205–7, 211–25; anticipatory, 158, 211–12; via consumption, 185–88, 207; New, 232–37, 242–43 government, 8, 42, 49–51, 75, 95–99, 105, 107–15, 126, 148, 222, 235–42; agencies, 45, 211, 213 health, 1, 25–26, 31, 41, 44, 61, 108, 115–16, 137, 164, 190–91, 199; See also data: health; environment, health, and safety (EHS) human enhancement, 21, 126. See also dystopia: transhumanist Human Genome Project (HGP), 2, 232, 236 imaginaries, socio-technological, 30–32 indeterminacy, 215–25 industrial application, 21, 61–64, 68, 125 information and communication technologies (ICTs), 51, 158, 184–85, 188, 196 information transfer, 180–81, 208 innovation. See Responsible Research and Innovation (RRI)

Institute for Reference Materials and Measurements (IRMM), 60 insurance sector, 6, 104, 107–11, 218; International Organization for Standardization (ISO), 4, 41–44, 49–56, 60, 69, 91–98, 223 interoperability, 59, 65, 84, 92 interpretative frameworks, 206, 214–16 Jasanoff, Sheila, 30 Kant, Immanuel, 214 Kuhn, Thomas Samuel, 93 labelling, 5–6, 49, 106, 114, 116–18, 121–22, 127, 138, 141–42, 179–209. See also European Union (EU): labelling regime law: competition, 67, 74–75, 78–79, 86; environmental, 23, 32; hard, 104–105, 138, 142; intellectual property (IP), 60–61, 68, 74–75, 159, 161, 163, 174; liability, 108–10; litigation, 73, 77, 108–9; patent, 61, 64, 68–87; soft, 36, 112, 138, 142, Trade-Related Aspects of Intellectual Property Rights, Agreement on (TRIPS), 64, 73–76, 85. See also ethical, legal, and social issues/aspects (ELSI/ELSA); rights legislation, 43, 54, 62, 72, 74, 87, 91, 95–98, 106, 112–17, 126, 136–39, 142 legitimacy, 24, 48–50, 53, 94, 112, 114, 221, 224, 235 licensing, 67–69, 74–87 lobbying, 98, 131, 173 maleficence, principle of non-, 22, 26 marketing, 149, 167, 169, 182, 188, 190–205

Index

media, 68, 179, 203, 206, 227–29, 232– 35, 241–44; social, 131 medicine, 71–73, 113, 138, 165, 184, 197 military, 126, 135, 244 monopoly, 68, 70, 77 nano-divide, 19–21 negligence, 21–22 newly emerging sciences and technologies (NEST), 211–13, 220 non-governmental organisations (NGOs), 51, 54, 97, 173, 211–12, 223, 225, 238, 240; Action Group on Erosion, Technology and Concentration (ETC Group), 24, 105, 114, 199, 219, 223–25, 238; Bund für Umwelt und Naturschutz (BUND), 240; Environmental Defense Fund (EDF), 221–24; Friends of the Earth, 105, 114, 219, 223–25, 238, 240; Greenpeace, 219, 223, 240; network on ISO, 49; Pièces et Main d'Oeuvre (PMO), 241; World Wide Fund for Nature (WWF), 240. See also civil society nuclear, 19, 32, 231–32, 240; Chernobyl, 27; radioactive contamination, 26, 28 Omega 3, 191 open access, 39, 150, 159, 162–63, 174 open source, 150 ordre public, 64–65 Organisation for Economic Cooperation and Development (OECD), 21, 41–42, 49–50, 56, 131, 227, 232, 240

289

participatory methods, 39, 165, 212, 228–29 paternalism, 189 pesticides, 116, 127, 129 Plato, 214 policy-makers, 32, 144, 151, 160, 173, 206, 211–13, 218, 220, 230, 234–35, 244 precautionary principle (PP), 10, 18–24, 47, 91, 95, 108, 114–15, 126 privacy, 21, 141–42, 174–75, 220 product, 30, 196, 201, 205–6; nano-enabled, 179–84, 199, 202; life cycle, 5, 8, 43, 94, 96, 99, 125, 132, 164; safety, 97 public: Deweyan (see Dewey, John). See also civil society referendum, 185, 206 regulation: by default / by design, 106, 136, 140–41; process-based, 54, 114, 115; self-, 112, 136, 139, 142–43. See also law; legislation reporting, 6, 106, 118–19, 139, 168, 183, 233 research and development (R&D), 93, 99, 107–9, 113–14, 119, 148–53, 157, 163–67, 171, 174, 213 responsible research and innovation (RRI), 35–40, 44, 48, 52–57, 112, 147–72, 211 rhetoric, 41, 185, 188, 227–28, 234, 238–39, 243 rights: fundamental, 78, 136–38, 140, 142–43; citizen, 26. See also law risk: acceptable, 22, 112;

290

Index

assessment, 18–26, 31–33, 44, 46– 47, 96, 105, 108, 116, 126, 127, 169, 206, 208, 217, 228, 232; as expectation value, 20; management, 20, 22–23, 31, 108–9, 111–12, 164, 174, 179, 217, 221; mitigation, 92, 95; perception, 96, 104, 119, 158; society, 36 Schumpeter, Joseph, 92 Science and Technology Studies (STS), 180, 233, 236–37, 239, 241, 243, 246n21 sciences: cognitive, 135, 140; life, 20, 135, 140, 232; nanoscale, 36–37, 40–44, 48, 51, 55–56, 139; social, 148, 228–29, 232–33, 236, 238. See also newly emerging sciences and technologies (NEST) seal, of quality, 201–3, 206 silicon, 62–63, 71, 191 silver nanoparticles, 126, 129, 131 Singapore, National Environment Agency, 113 skin, 179, 210n11 stakeholders, 54, 60, 93, 108–109, 118, 122, 158–59, 162, 237, 242, 246n27; engagement of, 40–41, 46–48, 51– 52, 96–99, 113–14, 148, 164–67, 172, 174, 179, 213. See also communication: between standard: Commercial Solvents, 79; international, 36–38, 41–44, 48–49, 52–56, 94; telecommunication, 60, 67; technical, 49, 59, 83; testing, 128; voluntary, 97 standardisation, 37–38, 42, 46, 49–56, 59–87, 91–99;

legitimacy of, 94. See also International Organization for Standardization (ISO) subsidies, 99 sunscreen, 29, 114, 179, 182, 197 sustainability, 26, 31, 39, 52, 54, 132, 150, 167, 169; environmental and social, 159, 160, 163, 175; development, sustainable, 35, 41 Switzerland, 45, 72 synthetic. See biology, synthetic technology assessment (TA), 20–21, 38, 219, 229, 232–33; International Center for, 114. See also Germany: Office for Technological Assessment at the German Bundestag (TAB) textiles, 131, 179, 183, 196, 199, 200, 208 toxicity, 19, 43, 60, 125, 127–31, 217 toxicology, 49, 52, 60, 118, 183 toys, 126 traceability, 45, 116 Trade-Related Aspects of Intellectual Property Rights, Agreement on (TRIPS). See law transparency, 39, 41, 45–51, 53, 57, 70, 93, 106, 126, 132, 139, 157, 159, 163, 164–65, 174, 181, 187–89, 203, 207 transport, 17, 125, 214 United Kingdom (UK), 36, 45, 47, 118, 219, 229, 239–40, 242; Demos (think tank), 239; Engineering and Physical Sciences Research Council, 39, 147; Royal Academy of Engineering, 105, 236; Royal Society, 24, 41, 105, 112, 236, 239 United States of America (USA), 39, 71, 97, 113–17, 126, 214, 221, 229, 239, 242;

Index

Centres for Nanotechnology in Society, 236; court of law, 110, Department of Agriculture (USDA), 116; Environmental Protection Agency (EPA), 94, 113, 116–18; Federal Food, Drug, and Cosmetic Act, 115, 117; Food and Drug Administration (FDA), 114–20, 182; National Nanotechnology Initiative (NNI), 105, 227, 235–36, 245n17;

291

Toxic Substances Control Act, 115, 117–18; TSCA Chemical Substance Inventory, 94; Patent and Trademark Office (USPTO), 61; White House, 105, 115, 236 unpredictability, 213–14 Virtual Institute of Responsible Innovation (VIRI), 36

About the Contributors

Franziska Bereuter is currently clerking for the Court of the 2nd District of Vienna and finalising her PhD thesis on the regulation of biosecurity-related research, with a focus on synthetic biology, at the University of Natural Resources and Life Sciences, Vienna (BOKU). She graduated from law school in 2016 and completed her bachelor’s degree in Social and Cultural Anthropology in 2014, both at the University of Vienna. Her research interests include biotechnology law, medical law, and the intersection of innovation and technology law. Diana M. Bowman has been an Andrew Carnegie Fellow since 2018. She is an Associate Professor in the Sandra Day O’Connor College of Law and the School for the Future of Innovation in Society at Arizona State University. She is also a visiting international scholar in the Faculty of Law at KU Leuven. Bowman earned her PhD in law in 2007 from Monash University. Her research has primarily focused on the legal and policy issues associated with emerging technologies and public health law. Henk J. de Vries is an Associate Professor of Standardisation at the Rotterdam School of Management, Erasmus University, and Guest Researcher at Delft University of Technology, Faculty of Technology, Policy and Management. He finished his studies in Geodesy at Delft University of Technology in 1982 and obtained his PhD at the Erasmus University Rotterdam in 1999. His research and teaching focus on standardisation from a business point of view. Henk is the President of the European Academy for Standardisation (EURAS). He is the coauthor of more than 350 publications in the field of standardisation. 293

294

About the Contributors

Iris Eisenberger has been Professor of Law and Head of the Institute of Law at the University of Natural Resources and Life Sciences, Vienna (BOKU), since 2016. She is also a Visiting Professor at the Technical University of Munich and was an Erwin Schrödinger Fellow at the Program on Science, Technology & Society at Harvard University. She earned her PhD in Law from the University of Graz and a master’s degree in Political Theory from the London School of Economics and Political Science. Her research focuses on the intersection of law and innovation, technology and research law, and human rights. Juliane Filser has been a Professor of General and Theoretical Ecology since 2000 and Vice Director of the UFT Centre for Environmental Research and Sustainable Technology since 2008 at the University of Bremen. She obtained her PhD in 1992 and her habilitation in 2000 at the Ludwig Maximilians University of Munich. She worked at the Institute of Soil Ecology at the GSF Research Centre for Environment and Health between 1988 and 2000, and she was managing director of the FAM Research Network on Agroecosystems between 1995 and 1997. Steven M. Flipse is an Assistant Professor in Science Communication at the Delft University of Technology, where he acquired his PhD in 2013 at the Faculty of Applied Sciences. His research focuses on the design and testing of communication-based methods that help scientists and engineers communicate and collaborate more effectively. These practical methods enable Responsible Research and Innovation (RRI) in science and engineering practice, in both industrial and academic contexts. Ellen-Marie Forsberg is a Research Professor and former Head of Research at the Work Research Institute at Oslo Metropolitan University. She also leads the Oslo Research Group on Responsible Innovation. She coordinates the European Commission (EC) Science-with-and-for-Society project RRI in Practice. She also leads a project on responsible development of assisted living technologies, funded by the Research Council of Norway. Forsberg earned her PhD in Applied Ethics in 2007 at the University of Oslo. Her research interests include RRI in general, ethics and governance of emerging technologies, agricultural and food ethics, and research ethics. Thomas Jaeger is a Professor for European Law at the University of Vienna. He studied law in Vienna and Paris and acquired his LL.M. at K.U. Leuven in 2003. Subsequently, he worked as an Assistant for European Law at S ­ alzburg University, and was later Senior Research Fellow at the Max-­ PlanckInstitute for Innovation and Competition in Munich. From 2013 to 2016, he substituted Chairs in Civil Law at the Universities of Hanover and Munich.

About the Contributors

295

His research focuses on issues of European economic law and integration, particularly the internal market and competition. He is the author and editor of a vast number of publications in those fields, including Austria’s leading EU law commentary. Angela Kallhoff has been a Professor of Ethics with special emphasis on Applied Ethics at the University of Vienna since 2011. She received a Feodor-Lynen research grant of the Humboldt-Foundation and was Visiting Scholar at Columbia University and the University of Chicago. She also served as a Practicing Professor at the University of Cologne and the University of Muenster, Germany, where she earned her PhD in Philosophy in 2001. Her main research areas are ethics, political philosophy, and environmental ethics. Lotte Krabbenborg is an Assistant Professor at the Institute for Science, Innovation and Society at Radboud University Nijmegen. She has a background in the humanities, with specialization in political philosophy. In her 2013 PhD thesis, Krabbenborg studied these topics within the field of nanotechnology. Her thesis was part of the TA program of the Dutch Research and Development (R&D) consortium NanoNed. Her research focuses on the role of civil society actors in the governance of emerging technologies. She is particularly interested in examining how the present public sphere can be extended to effectively include emerging technologies as a topic for deliberation and negotiation. Elivio Mantovani has been a Scientific Director of Airi/Nanotec IT, the Committee for Nanotechnology and Key Enabling Technologies of the Italian Association for Industrial Research, since 2003. He earned his PhD in Chemistry at the University of Rome La Sapienza and is Member of the Royal Society of Chemistry. He has worked both in academia and in industry, first as senior scientist, and then in a senior managerial position for research and development strategies and planning. His present activities cover technology assessment and forecasting of transformative technologies, as well as technology transfer, with particular attention to responsible growth. Elias Moser is a postdoctoral researcher on the project Nano-Norms-Nature at the University of Vienna. He is also a Visiting Fellow at the Institute for Legal Philosophy in Vienna. From 2013 to 2017, he worked for the Institute of Criminal Law at the University of Berne and earned his PhD at the Faculty of Philosophic-Historical Studies in 2017. His research focuses on legal philosophy, applied ethics, and ethics of technology.

296

About the Contributors

Andrea Porcari is a Project Manager at Airi, Italian Association for Industrial Research. He achieved his degree in Physics at University of Milano in 1998. Porcari has several years of experience working in the semiconductor industry. His current interests include technology assessment and policy analysis, risk governance, Responsible Research and Innovation (RRI), technology transfer, and multi-stakeholder dialogues on emerging and enabling technologies. Claudia Schwarz-Plaschg is currently a Visiting Research Fellow at the Program on Science, Technology & Society at the Harvard Kennedy School, and she is a postdoctoral researcher at the Department of Science and Technology Studies (STS) at the University of Vienna. She studied media and communication science, English and American studies, and sociology with a specialization in STS at the University of Vienna. Prior to coming to Harvard, Claudia worked as a Postdoctoral Assistant at the interdisciplinary research platform Nano-Norms-Nature at the University of Vienna. In her PhD thesis in 2012, she analysed the role of analogies in public engagement with nanotechnology. Franz Seifert studied biology, anthropology, and political science in Vienna. He acquired his PhD at the University of Salzburg in 2001. His research focuses on social movements and public controversies, as well as the governance of new and emerging technologies in a globalising world. Lucille M. Tournas is a Research Fellow in the School for the Future of Innovation in Society at Arizona State University. Tournas earned her JD in 2018 from Arizona State and her BA in Philosophy in 2004 from Pepperdine University. Her current research interests include the regulation of emerging technologies, and more specifically, the role of artificial intelligence in health care as well as genetic editing. Fern Wickson is a Senior Scientist and Research Leader at GenØk Centre for Biosafety in Tromsø, Norway, where she coordinates the transdisciplinary collaborative for Responsible and Sustainable Biotechnoscience (RootS). She completed an interdisciplinary PhD across the Arts and Science faculties at the University of Wollongong in 2006. She also has a BA/BSc degree from the Australian National University and an honours degree in Environmental Politics from the University of Tasmania. Her current research projects are on subjects such as feminist ethics and epistemology for environmental governance, systems-based thinking for the regulation of new and emerging technologies, agricultural biodiversity conservation, and RRI.

About the Contributors

297

Emad Yaghmaei is a Research Fellow in Ethics and Technology at Delft University of Technology. He is also an advisor and evaluator for the European Commission’s Science-with-and-for-Society programme. Yaghmaei earned his PhD degree at the University of Southern Denmark in 2017. His main research interests concern the role of RRI in industry. As a response to integrating RRI principles in industry, he has been working on monitoring and assessing the strategic value of responsible innovation, where he studies different assessment strategies, namely ethics assessment, risk assessment, impact assessment, and technology assessment.