Nanotechnology

Regulation and Public Discourse

Iris Eisenberger, Angela Kallhoff, Claudia Schwarz-Plaschg

• Publisher: Rowman & Littlefield International
• Year: 2019
• ISBN:
  9781786608949
• Edition: 1
• Topic: Philosophy
• Subtopic: Ethics & Moral Philosophy

Over the last decades, nanoscience and nanotechnology has been ascribed the potential to contribute beneficial applications in fields such as medicine, cosmetics, or environmental remediation. At the same time it is still contested whether engineered nanomaterials might be not one-sidedly “good” but may also entail negative side-effects for human health and the environment. To address this uncertainty, academic and political initiatives have sought to establish norms and practices to assess and govern nanomaterials. Rooted in different disciplines such as ethics, ecology, law, social and political sciences, the chapters in this edited volume explore the normative approaches, societal practices, and legal mechanisms which have emerged in the nano-field over the last two decades. The chapters also present a broad variety of evaluative approaches that may assist societal actors in their attempts to actively shape and contribute to the debate about nanomaterials.

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 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 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 socio-political 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, 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 non-nanoform). 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 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 nano-compounds 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 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-by-design 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 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 mus...

Table of contents

• Cover
• Half-Title
• Series
• Title
• Copyright
• Contents
• List of Figures, Tables, and Boxes
• Preface
• 1 Rethinking Ethical, Legal and Societal Frameworks for Assessing and Governing Nanomaterials
• PART I: Evaluation and Standardisation
• PART II: Norms and Regulation
• PART III: Politics and Publics
• References
• Index
• About the Contributors