Rooted in different disciplines such as ethics, ecology, law, social and political sciences, this volume explore the normative approaches, societal practices, and legal mechanisms which have emerged in the nano-field over the last two decades.

This article reviews the public health and environmental regulations applicable to nanotechnology using a life cycle model from basic research through end-of-life for products. Given nanotechnology's immense promise and public investment, regulations are important, balancing risk with the public good. Trading zones and earth systems engineering management assist in explaining potential solutions to gaps in an otherwise complex, overlapping regulatory system.

Productive work on societal implications needs to be engaged with the research from the start. Ethicists need to go into the lab to understand what's possible. Scientists and engineers need to engage with humanists to start thinking about this aspect of their work. Only thus, working together in dialog, will we make genuine progress on the societal and ethical issues that nanotechnology poses.Davis Baird, in testimony before the Senate Committee on Commerce, Science and Transportation, May 1, 2003Federal funding of (...) the National Nanotechnology Initiative has averaged roughly $1 billion annually for the last three years, from 2004 to 2006. Society is poised to see more realistic nano-scale devices enter the marketplace, along with futuristic depictions of nanotechnology. For this reason, serious thought must be given to the societal impact of nanotechnology. (shrink)

Based on the experiences of two high profile voluntary data collection programs for engineered nanomaterials, this article considers the merit of an international online registry for scientific data on engineered nanomaterials and environmental, health and safety (EHS) data. Drawing on the earlier experiences from the pharmaceutical industry, the article considers whether a registry of nanomaterials at the international level is practical or indeed desirable, and if so, whether such an initiative—based on the current state of play—should be voluntary or mandatory. (...) The article commences with an examination of the success and failures of voluntary reporting schemes in the UK and the US, as well as the International Council of Nanotechnology’s EHS Database and the OECD’s Working Party on Manufactured Nanomaterials. The article then examines the history of clinical trials registries, including the key motivations behind their creation, the role of self-regulation, and the perceived benefits thereof. Key lessons of the rise of clinical trials registration are highlighted, as are crucial considerations that must be addressed by policy makers should a multi-lateral public registry for data on nanoscale materials and EHS research be perceived to be a desirable option. The article concludes by arguing that while the creation of a registry to record information generated on nanomaterials is not straightforward, this reason alone should not deter industry from taking a proactive approach to the dissemination of fundamental data and research findings. (shrink)

Current nanotechnology regulation is focussed on risks. On the other hand, technical guidelines and other soft law tools are increasingly replacing hard law. This risk reduction approach does not seem to be fully aligned with open principles like sustainable nanotechnology. Indeed, risk optimization tends to be rather a continuous process than a way to settle ultimate lists of risks. There is therefore a need for a more dynamic view: Life cycle assessment contributes to add momentum and context (...) to the models. However, a complementary perspective is here suggested, based on information technologies: nanotechnology platforms. Platforms for nanotechnology governance are supposed to complement and enhance the nano-regulation, adding risk assessment and management. These platforms are mainly offering information, coordination, and context or situational awareness. More recently, some informal platforms appear to play a, certainly limited but still clear, co-regulatory role. Can these informal platforms play a relevant role in nanotechnology governance? In the context of the EU Better Regulation strategy, why not envision some of these informal platforms as future co-regulation tools? The main goal of this paper is to start a discussion on the requirements these informal co-regulatory platforms should fulfill before their hypothetical inclusion in a future better regulation toolbox. (shrink)

Nanotechnology has been established as a priority research and policy focus, cutting across several R&D fields from pharmaceutics, food and electronics. The raise of nanotechnologies has been accompanied by an enduring uncertainty characterising the developments of the scientific knowledge related to this field, as well as the social trajectories of technological applications. Such a condition inevitably affects regulatory responses to such technologies, their development and their uses. This special issue addresses this junction between uncertainty and regulation. With no (...) ambition of providing a comprehensive assessment of such a complex issue, this collection of articles examines three relevant dimensions for understanding uncertainty in nanotechnology regulation, which can be useful entry points for further reflection and discussion: scientific uncertainty, regulatory fragmentation, social actors’ opinions about and attitudes to nanotechnology and regulation. (shrink)

This contribution discusses the United Kingdom (UK) government’s regulatory activities related to nanotechnological development. The central question is what other prudent public regulation can learn from the UK government’s regulatory strategy, its regulatory attitude and its large variety of regulatory measures. Other public regulators can learn from the interactive and integrative UK regulatory approach. They can also draw lessons from the critique on the UK government’s regulatory attitude and its problems to cope with specific nanotechnological challenges. These lessons are (...) based on an evaluation of the UK government’s regulatory activities from the viewpoint of prudent regulation. The notion of responsive regulation, which provides basic ideas for the evaluation methodology, refers to a view on prudence that focuses on moral constitutional values. Interestingly, a similar view on prudence has been discussed in nanoethics. (shrink)

Media reports of the health hazards posed by nano-sized particles have turned a white hot spotlight on the risks of nanotechnology. Worried about the risks posed to workers producing nano-materials, the Washington Post has labeled nanotechnology a “seat-of-the-pants occupational health experiment.” This article examines our emerging knowledge base about the hazards of two types of exposure: inhalation of NSPs and topical application of products containing NSPs. It argues that a clear-eyed evaluation of the benefits and risks of (...) class='Hi'>nanotechnology is made extremely difficult by the marriage of a complex science with a venture capitalist-like hype. It then suggests that, absent additional statutory authority, governmental regulators cannot readily address the risks posed by these products. This regulatory inaction leaves a significant role for the private insurance market, a role that regulators should support in tangible ways outlined in the article. (shrink)

Nanotechnology is a subject about which we know less than we should, but probably more than we think we do at first glance. Like Defense Secretary Donald Rumsfeld's “known unknowns,” we have learned enough to know what we should be concerned with. Glimmers of risk cropped up recently when German authorities recalled a bathroom cleansing product, “MagicNano,” that purported to contain nanosized particles and was on the market for only three days. More than one hundred people suffered severe respiratory (...) problems – six of whom were hospitalized with pulmonary edema. Although a subsequent analysis of MagicNano found that the nanoliquid ingredient morphed in the production into “supersized” particles, the recall nonetheless turned a white hot spotlight on the risk of NSPs. Latching onto the risks posed to workers producing materials using nanotechnology, the Washington Post has labeled nanotechnology a “seat-of-thepants occupational health experiment.”. (shrink)

This chapter contains sections titled: The Stricter‐Law Argument Learning from History Objections to the Stricter‐Law Argument An Interim Solution? Putting the Pieces Together.

This paper focuses on the contribution of meta-regulation in responding to the regulatory needs of a field beset by significant uncertainties concerning risks, benefits and development trajectories and characterised by fast development. Meta-regulation allows regulators to address problems when they lack the resources or information needed to develop sound “discretion-limiting rules”; meta-regulators exploit the information advantages of those actors to be regulated by leveraging them into the task of regulating itself. The contribution of meta-regulation to the governance (...) of nanotechnologies is assessed in terms of responsibilisation. Responsibilisation is regarded as a pre -requisite for regulatory actors to internalise social values (such as consumer safety and occupational health) and to ensure that these values are built into regulatory practice. In order to explore the potential of responsibilisation, the Code of Conduct for Responsible Nanosciences and Nanotechnologies Research launched by the European Commission in 2008 is evaluated. The Code is a good case of meta-regulation that aims to steer the self-regulation of nanotechnological business and research organisations. The paper concludes that, while efforts were made on the part of meta-regulators and self-regulators to contribute to responsibilisation, important opportunities for responsibilisation such as dissemination and promotion of the Code, trust-building activities, and failure to provide rewards, incentives and stakeholder guidance were not taken up. In order to foster responsibilisation within the meta-regulatory instrument of the EC Code, a number of crucial activities to be undertaken by meta-regulators are recommended. (shrink)

Expectations play a central role in understanding scientific and technological changes. Future-oriented representations are also central with regard to nanotechnologies as they can guide policy activities, provide structures and legitimation, attract different interests, focus policy-makers’ attention and foster investments for research. However, the emphasis on future scenarios tends to underrate the complexity of the challenges of the present market of nanotechnologies by flattening them under the needs and promises of scientific research. This is particularly apparent if we consider the viewpoint (...) of the regulator who faces two different ranges of problems with regard to the market and research and is expected, simultaneously, to manage two different types of regulatory instruments, pursuing at the same time the same goals. Instead, by favoring only the future scenarios, the regulator runs the risk of abruptly shifting from more flexible and elastic tools to forms of hard legislation, wasting, thus, the resources of the soft-regulation, in particular those of self-regulation. By referring primarily to the European context, human rights, also thanks to their normative structure of principles, can help in strengthening both the legislation needed for regulating the present market and the soft instruments needed for steering research and for fostering the stakeholders’ participation without sacrificing the coherence of the regulatory response. (shrink)

In continuing news, there is a growing debate on whether current laws and regulations, both in the US and abroad, need to be strengthened as they relate to nanotechnology. On one side, experts argue that nanomaterials, which are making their way into the marketplace today, are possibly harmful to consumers and the environment, so stronger and new laws are needed to ensure they are safe. On the other side, different experts argue that more regulation will slow down the (...) pace of business and innovation in nanotechnology, or that self-regulation is the answer, or other opposing positions. This paper will draw out the core issues behind the debate and explain that there is more at stake than merely environmental, health and safety worries or business interests, as it first appears. We will also suggest an alternative solution to stricter laws, since stricter laws would face formidable practical challenges, even if they are warranted. (shrink)

The governance of nanotechnology seeks to limit its risks, without constraining opportunities. The literature on the effectiveness of approaches to governance has neglected approaches that impact directly on the behavior of a researcher. We analyze the effectiveness of legal regulations versus regulation via self-commitment. Then, we refine this model by analyzing competition and autonomy as key contingency factors. In the first step, qualitative interviews with nanotechnology researchers are conducted to reflect this model. In the second step, its (...) empirical relevance is tested using a survey of 90 nanotech researchers. The results indicate that legal regulations, as well as self-commitment to an informal CoC reduce the scope of behavior. Finally, that competition and autonomy affect the relative strength of these governance factors. (shrink)

Like all technologies, nanotechnology will inevitably present risks, whether they result from unintentional effects of otherwise beneficial applications, or from the malevolent misuse of technology. Increasingly, risks from new and emerging technologies are being regulated at the international level, although governments and private experts are only beginning to consider the appropriate international responses to nanotechnology. In this paper, we explore both the potential risks posed by nanotechnology and potential regulatory frameworks that law may impose. In so doing, (...) we also explore the various rationales for international regulation including the potential for cross-boundary harms, sharing of regulatory expertise and resources, controlling protectionism and trade conflicts, avoiding a “race to the bottom” in which governments seek economic advantage through lax regulation, and limiting the “nano divide” between North and South. Finally, we examine some models for international regulation and offer tentative thoughts on the prospects for each. (shrink)

Legal regulation has a substantial impact on the development of technologies. Depending on its scope, structure, and effectiveness, regulation can essentially shape the research, development, production, commercialization, and consumption of emerging technologies in various ways. The lack of regulation, or of corresponding enforcement, can lead to the infringement of rights, harm to workers, consumers, and the environment, and to the neglect of the public interest. On the other hand, too strict regulations, based on incomplete information or excessive (...) caution, may equally cause harm by omitting the potential benefits or by distorting and delaying the technological development. At the current stage, nanotechnologies affect many areas of law: occupational health and safety, environ-. (shrink)

There is much we do not know about nanotechnology. Despite its tremendous promise, nanotechnology today is mostly forecast and fervent hope. Predictions that spending on nanotechnology will increase from current levels of $13 billion to more than $1 trillion by 2015 are no more than that – simply predictions. Hopes that nanotechnology will be an essential part of solving the globe's energy, food, and water problems should be tempered by recalling a century of revolutionary technologies that (...) failed to live up to their early promise such as nuclear energy, supersonic airplanes, or gene therapy. Many other questions continue to nip at nanotechnology's heels, not the least of which are debates about what is and is not technically feasible. Despite these uncertainties, we can have complete confidence in one aspect of nanotechnology's future – it will be subject to a host of regulations. (shrink)

Good governance for nanotechnology and nanomaterials is predicated on principles of general good governance. This paper discusses on what lessons we can learn from the oversight of past emerging technologies in formulating these principles. Nanotechnology provides us a valuable opportunity to apply these lessons and a duty to avoid repeating past mistakes. To do that will require mandatory regulation, grounded in precaution, that takes into account the uniqueness of nanomaterials. Moreover, this policy dialogue is not taking place (...) in a vacuum. In applying the lessons of the past, nanotechnology provides a window to renegotiate our public's social contract on chemicals, health, the environment, and risks. Emerging technologies illuminate structural weaknesses, providing a crucial chance to ameliorate lingering regulatory inadequacies and provide much needed updates of existing laws. (shrink)

Historically, market regulation has played an important role in shaping the trajectory of scientific and technological innovation in food and agriculture. However, regulators’ traditional focus on safety and efficacy may be insufficient to address more complex ethical, legal, and social implications of novel products, such as the use of nanotechnology and nanomaterials in food and agriculture. One solution might be to implement the principles of responsible innovation to challenge innovators and policymakers to better anticipate risks further upstream and (...) be responsive to societal desires and concerns, although substantial barriers to implementation persist. This paper presents stakeholder views on the relationship between regulation and RI in nano-agrifoods based on a broader U.S. stakeholder engagement study conducted in the fall of 2020. We found that participants raised key issues that incorporated all 4 pillars of RI. We also found that participants’ attitudes about the relationship between regulation and innovation informed their recommendations about the relationship between regulation and RI. These attitudes are represented in a spectrum of views, ranging from “regulation as barrier” to “regulation as driver” of innovation. We further identified implications for how each attitude might be used to operationalize RI in regulatory systems. Overall, these results suggest that just as regulation drove key innovations in the twentieth century, regulation may still have a role to play in helping to promote RI of nano-agrifoods in the twenty-first. (shrink)

How should we oversee new and emerging technologies and their products? What lessons can we discern from existing regulatory examples and from past mistakes? How do these lessons learned translate into informed recommendations for adequate oversight for nanotechnology to avoid repeating the mistakes of the past? The investigators of this interdisciplinary project undertook this endeavor intending to answer these questions among others.In parallel with the project team putting together this symposium, another, very different process on the oversight of (...) class='Hi'>nanotechnology took place. An international coalition of non-governmental organizations formed to address the nanotech policy dialogue. The first goal of this NGO group was to agree upon and draft fundamental principles of oversight, which it completed in 2007-08. These principles close with a call for their adoption and/or internalization by all relevant actors and bodies. In effect, they serve a function in the policy dialogue similar to that of this project’s forthcoming recommendations. (shrink)

This interdisciplinary, social scientific analysis of the regulatory discourse on nanotechnology in the three German-speaking countries of Germany, Austria and Switzerland and in the EU between 2000 and 2013 has shown three distinct phases, characterised by shifts in the configuration of actors and in the thematic scope from nanotechnology to nano-materials. Compared to modes of governance based on traditional statutory law, modes of governance based on less binding forms of soft law and self-regulation (like codes of conduct, (...) guidelines and certification systems) and new modes of governance (like assessment studies, risk management frameworks as well as participatory and cooperative forms of communication and negotiation) have gained importance. Despite some similarities, two different cultures in governing nanotechnology can be distinguished: a product-oriented culture in statutory regulations (when speaking about products, the article is also referring to substances) and a risk-based culture in applying soft law based on new modes of governance. In addition, the different regulatory cultures have led to four strategic approaches: modes of governance mainly based on hard law and soft law at the EU level, modes of governance mainly based on cooperative and self-regulatory approaches in Germany, cooperative governance approaches in Austria and modes of governance mainly based on self-regulatory and soft law approaches in Switzerland. (shrink)

Soft regulation has increased its importance in science and technology governance. Despite such indisputable significance, the literature on technology policy and regulation so far seems to have dedicated only a limited attention to a systematic understanding of the factors affecting compliance with these soft rules. This article addresses this limitation. By way of a literature scoping exercise, we propose a taxonomy of the mechanisms affecting compliance with soft regulation. We subsequently apply the taxonomy as a guide to (...) examine the opinions of a small group of scientists and company managers in the Italian nanotechnology sector. The case study does not assess compliance in a direct way, i.e., observing how organizations comply with regulation, but it explores the opinions on what the factors affecting compliance are. (shrink)

Nanotechnology (henceforth NT) is a rapidly advancing field with the potential of revolutionizing diverse areas such as electronics, healthcare, transport and energy production. NT products and applications come with (potential) benefits and (potential) harms. The presence of potential harms calls for regulation. Both under- and overregulation – I argue – are morally undesirable. In the case of underregulation, stakeholders fall victim to the harmful effects of the technology. In the case of overregulation, stakeholders are deprived of the benefits (...) of the technology. In this chapter, I identify the biases and factors that lead to under- and overregulation and offer solutions in response. More precisely, I argue that a lack of specific regulation, the presence of conflicts of interest and short-term economic incentives could lead to the underregulation of NT products and applications. Conversely, I argue that a negativity bias, harm aversion, the fear of opening ‘Pandora’s box’ and the intuition that what is natural is good and what is artificial (human-made) is bad could lead to overregulation. To avoid these pitfalls and the woes of under- and overregulation following in their wake, we need to set up a process – which I describe – in which policymakers and independent scientists closely collaborate. (shrink)

In recent years, the development and the use of engineered nanomaterials have generated many debates on whether these materials should be part of the new or existing regulatory frameworks. The uncertainty, lack of scientific knowledge and rapid expansion of products containing nanomaterials have added even more to the regulatory dilemma with policy makers and public/private actors contenting periods of both under and over regulation. Responding to these regulatory challenges, as well as to the global reach of nanotechnology research (...) and industrial needs, governance arrangements beyond the state have addressed the challenge head-on. This article focuses on the governance arrangements of the International Organization for Standardization (ISO), which has led to the development of numerous “horizontal anticipatory standards” with an important role in setting the foundation for science, technology and market development. During the course of its operation ISO has broadened its scope to address not only technical issues related to the concept and the size of nanomaterials but also broader aspects of the technology, including health, environment and safety issues. The increasing relevance of the ISO to regulate economic relations and achieve certain public policy goals has given rise to many concerns about its legitimacy. The important questions are whether these governance arrangements may be deemed as being legitimate and where this legitimacy is derived from? What are the main sources of legitimacy at the transnational level and how we can apply them to analyse nanotechnology standardization? This article provides concise answers to these questions. It focuses at the normative concepts of democratic and scientific legitimacy and explores the institutional structures and processes by which nanotechnology standards are established. (shrink)

Food is a big business in the EU and nanofood products are beginning to be placed on the market. It is still unclear whether the absence of minimum regulation at a global level promotes or prevents the growth of a market in nanofood. However, the development of an adequate risk management policy in relation to food safety is a key concern for consumers. Importantly, the European Parliament in its 2009 Resolution on “Legal aspects on nanomaterials” called for more in-depth (...) scientific research on the toxicity of compounds in nanomaterials, and for the adoption of an EU definition of nanomaterials for regulatory purposes. Unfortunately, in 2011, nanotechnology led to inconclusive debates in the context of the revision of Novel Food Regulation. General Food Law applies to nanofood in terms of safety requirements, and specific rules also apply to food contact materials containing nanoparticles as well as to to additives, vitamins and minerals. The EU legislator also introduced mandatory labelling in respect of products derived from nanotechnologies. The legal framework is evolving according to the so-called “incremental approach”, a governance model that creates the risk of fragmentation. But the main problem is the inconsistent definition of the terms “nanotechnology” and “nanomaterials” when looking at the enforcement of regulations and the provision of a wide range of specific tools for different nanofoods: for example the use of positive lists of authorised substances applying only to food contact materials, additives and supplements. This contribution aims to review the regulations in force in respect to nanofood and novel foods and to highlight the problems that are still unresolved. (shrink)

This article explores a unique opportunity for shaping public health law and policy to reflect a greater balance between public and private goods in two areas of primary concern to human well-being: medicine and human biosecurity. This opportunity is presented both by the rapid changes likely to occur in these areas as a result of nanotechnology and the fact that multinational corporate actors have not yet had the opportunity to use their well-honed techniques of governance influence to modify public (...) health policy and law in this area to their own narrowly focused advantage. Such a rare opportunity to rethink some fundamental assumptions about a regulatory framework for globally important health issues in advance is one reason why issues concerning nanotechnology regulation in medicine and human biosecurity should have considerable interest to health law and policy scholars. (shrink)

ABSTRACT Nanotechnologies are an expression of the human ability to control and manipulate matter on a very small scale. Their use will enable an even and constant monitoring of human organisms, in a new and perhaps less invasive way. Debates at all levels – national, European and international – have pointed out the common difficulty of giving a complete, clear definition of nanotechnologies. This is primarily due to the variety of their components, to the fact that there is not just (...) one technology but several. The most significant medical applications of nanotechnologies are in the diagnostic and the therapeutic fields, eg biosensors and molecular imaging, providing diagnosis and drug delivery with no invasive methods involved. Like any other emerging field, such technologies imply new possibilities for improving health but, on the other hand, they are still at an experimental stage and therefore should be implemented under rigorous safety testing before going on general release. For this purpose, the ethical, legal and social implications (ELSI) of nanotechnologies have been elaborated by study groups, in order to develop solutions before the results of the tests are diffused into medical practice. The aim of this paper is to define some of the ethical issues concerning biomedical applications and to evaluate whether there is a need for new or additional guidelines and regulations. (shrink)

The European Union is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance (...) to develop special regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as “Responsible Research and Innovation”, widely claim that a diversity of considerations and issues are integrated into R&D processes. Even so, the possibility of more radically alternative constitutions of socio-technical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy. (shrink)

The emergence of nanotechnology, with all its promises of economic, social, and medical benefits, along with dire predictions of environmental, health, and safety threats, has occasioned an active debate in the Science and Technology Studies field, in which we have seen five distinct conversations that frame the discussion. The topical threads include ethics, regulation, opportunities and threats including utopian/dystopian visions of the future, public perception, public participation. These conversational distinctions are not absolutes with firm borders as they clearly (...) overlap at many points. Nonetheless, common to all is a strong sense that control and consequence are significant problems that have yet to be addressed adequately by the promoters of nanotechnology. A final section addresses articles on nanotechnology that exemplify the social construction theory of technology. We include herein a selective summary of this recent body of science, technology, and society (STS) journal literature focused on the social and ethical interactions of nanotechnology (SEIN) that has emerged in the last few years. The intent is not to be encyclopedic in coverage, but rather to seek to understand, in a general way, the key issues and concepts STS scholars are discussing. It is clear that STS-oriented scholars are well poised to grapple explicitly with the cultural, socio-political, and ethical dimensions of nanotechnology. Drawing on understandings of earlier socio-technical areas of interest and concern—nuclear power, genetically modified organisms, the human genome—such scholars have moved well beyond the questions of whether and where nanotechnology intersects society. More important is their effort to seek an understanding in depth of exactly how they are socio-politically, culturally, and ethically interconnected. In doing so, SEIN studies have at the same time become increasingly diverse and more sophisticated and mature over the course of the past decade. Scholars have quite rightly recognized the inadequacies of blanket ideas of moratoria versus non-regulatory environments, utopian versus dystopian futures, and whether or not the public has a role to play in nanotechnology decision making. Rather, a more sophisticated, often case specific, flexible understanding of the societal context of a given issue or concern is called for. (shrink)

Although some regulatory frameworks for the occupational health and safety of nanotechnology workers have been developed, worker safety and health issues in these laboratory environments have received less attention than many other areas of nanotechnology regulation. In addition, workers in nanotechnology labs are likely to face unknown risks and hazards because few of the guidelines and rules for worker safety are mandatory. In this article, we provide an overview of the current health and safety guidelines for (...) nanotechnology laboratory workers by exploring guidelines from different organizations, including the Department of Energy Nanoscale Science Research Centers, Massachusetts Institute of Technology, the National Institutes of Health, the National Institute for Occupational Safety and Health, the Occupational Safety and Health Administration, Texas A&M University, and University of Massachusetts-Lowell. After discussing these current guidelines, we apply an ethical framework to each set of guidelines to explore any gaps that might exist in them. By conducting this gap analysis, we are able to highlight some of the weaknesses that might be important for future policy development in this area. We conclude by outlining how future guidelines might address some of these gaps, specifically the issue of workers’ participation in the process of establishing safety measures and the development and enforcement of more unified guidelines. (shrink)

Risk management of nanotechnology is challenged by the enormous uncertainties about the risks, benefits, properties, and future direction of nanotechnology applications. Because of these uncertainties, traditional risk management principles such as acceptable risk, cost–benefit analysis, and feasibility are unworkable, as is the newest risk management principle, the precautionary principle. Yet, simply waiting for these uncertainties to be resolved before undertaking risk management efforts would not be prudent, in part because of the growing public concerns about nanotechnology driven (...) by risk perception heuristics such as affect and availability. A more reflexive, incremental, and cooperative risk management approach is required, which not only will help manage emerging risks from nanotechnology applications, but will also create a new risk management model for managing future emerging technologies. (shrink)

Using Canada as a case study, this article argues that regulating biotechnology and nanotechnology is made unnecessarily complex and inherently unstable because of a failure to consult the public early and of-ten enough. Furthermore, it is argued that future regulators (and promoters) of nanotechnology may learn valuable lessons from the mistakes made in regulating biotechnology.

Nanotechnology will allegedly have a revolutionary impact in a wide range of fields, but has also created novel concerns about health, safety and the environment (HSE). Nanotechnology regulation has nevertheless lagged behind nanotechnology development. In 2004 the International Organization for Standardization established a technical committee for producing nanotechnology standards for terminology, measurements, HSE issues and product specifications. These standards are meant to play a role in nanotechnology development, as well as in national and international (...) nanotechnology regulation, and will therefore have consequences for consumers, workers and the environment. This paper gives an overview of the work in the technical committee on nanotechnology and discusses some challenges with regard to legitimacy in such work. The paper focuses particularly on stakeholder involvement and the potential problems of scientific robustness when standardising in such early stages of the scientific development. The intention of the paper is to raise some important issues rather than to draw strong conclusions. However, the paper will be concluded with some suggestions for improving legitimacy in the TC 229 and a call for increased public awareness about standardisation in the field of nanotechnology. (shrink)

This book defines 'nanowares' as the ideas and products arising out of nanotechnology. Koepsell argues that these rapidly developing new technologies demand a new approach to scientific discovery and innovation in our society. He takes established ideas from social philosophy and applies them to the nanoparticle world. In doing so he breaks down the subject into its elemental form and from there we are better able to understand how these elements fit into the construction of a more complex system (...) of products, rules and regulations about these products. (shrink)

Nanotechnologies are enabling technologies which rely on the manipulation of matter on the scale of billionths of a metre. It has been argued that scientific uncertainties surrounding nanotechnologies and the inability of regulatory agencies to keep up with industry developments mean that voluntary regulation will play a part in the development of nanotechnologies. The development of technological applications based on nanoscale science is now increasingly seen as a potential test case for new models of regulation based on future-oriented (...) responsibility, lifecycle risk management, and upstream public engagement. This article outlines findings from a project undertaken in 2008–2009 for the UK Government’s Department of Environment, Food and Rural Affairs (DEFRA) by BRASS at Cardiff University, involving an in-depth survey both of current corporate social responsibility (CSR) reporting in the UK nanotechnologies industry, and of attitudes to particular stakeholder issues within the industry. The article analyses the results to give an account of the nature of corporate social performance (CSP) within the industry, together with the particular model of CSR operating therein (‘do no harm’ versus ‘positive social force’). It is argued that the nature of emerging technologies requires businesses to adopt particular visions of CSR in order to address stakeholder issues, and that the nanotechnologies industry presents specific obstacles and opportunities in this regard. (shrink)

Nanotechnology presents significant challenges in terms of developing a regulatory framework. This is due to a lack of scientific knowledge about the behaviour of the technology in its interactions with biological and ecological processes, the environment and other technologies. Crucially, there is a great deal of uncertainty surrounding the potential environmental and human health and safety impacts of NT. Consequently, the development of NT is a potential test case for framing new models of ‘soft law’ voluntary governance as a (...) substitute for traditional command and control type regulation. Driven by ‘new science governance,’ an approach based on a combination of ideas in anticipatory ethics, future-oriented responsibility, upstream public engagement and deliberation and theories of justice may offer a solution. The uniqueness of the approach can be found in the incorporation of anticipatory approaches via public participation and deliberation as the input into procedural justice approaches with distributional justice as the output. The overarching objective of this work is to contribute to the discussion in relation to the internalisation of responsibility and the building of intellectual and societal capacity to anticipate negative consequences before they arise in the hope that such an approach could be the antithesis of the retrospective imposition of responsibility and liability after the harm is done, which is the outcome of traditional regulatory and ethical approaches. Ultimately, the purpose is to contribute to the long-term sustainability of NT. (shrink)

The following article offers a brief overview of current nanotechnology policy, regulation and ethics in Europe and The People’s Republic of China with the intent of noting (dis)similarities in approach, before focusing on the involvement of the public in science and technology policy (i.e. participatory Technology Assessment). The conclusions of this article are, that (a) in terms of nanosafety as expressed through policy and regulation, China PR and the EU have similar approaches towards, and concerns about, nanotoxicity—the (...) official debate on benefits and risks is not markedly different in the two regions; (b) that there is a similar economic drive behind both regions’ approach to nanodevelopment, the difference being the degree of public concern admitted; and (c) participation in decision-making is fundamentally different in the two regions. Thus in China PR, the focus is on the responsibility of the scientist; in the EU, it is about government accountability to the public. The formulation of a Code of Conduct for scientists in both regions (China PR’s predicted for 2012) reveals both similarity and difference in approach to nanotechnology development. This may change, since individual responsibility alone cannot guide S&T development, and as public participation is increasingly seen globally as integral to governmental decision-making. (shrink)

Nanotechnology shows great promise in a variety of applications with attractive economic and societal benefits. However, societal issues associated with nanotechnology are still a concern to the general public. While numerous technological advancements in nanotechnology have been achieved over the past decade, research into the broader societal issues of nanotechnology is still in its early phases. Based on the data from the Web of Science database, we applied the main path analysis, cluster analysis and text mining (...) tools to explore the main research fronts and hierarchical structure of these societal issues. We found that the research studies fell into four categories: "General Toxicity and EHS (Environment, Health and Safety)," "Medicine and Cytotoxicity," "Assessment and Regulation," and "Environment and Ecotoxicity." These research studies have disclosed much information about the potential effect of nanotechnology on public health and the environment. Relatively speaking, the studies on the assessment, regulation, preventive solutions, and environmental protection are just emerging. This finding indicates that an abundance of effort should be conducted on these emerging themes to maximize the benefits of nanotechnology while minimizing its potential harm. The implications for various parties in this domain are also presented. (shrink)

The genetically manipulated organism crisis demonstrated that technological development based solely on the law of the marketplace and State protection against serious risks to health and safety is no longer a warrant of ethical acceptability. In the first part of our paper, we critique the implicitly individualist social-acceptance model for State regulation of technology and recommend an interdisciplinary approach for comprehensive analysis of the impacts and ethical acceptability of technologies. In the second part, we present a framework for the (...) analysis of impacts and acceptability, devised—with the goal of supporting the development of specific nanotechnological applications—by a team of researchers from various disciplines. At the conceptual level, this analytic framework is intended to make explicit those various operations required in preparing a judgement about the acceptability of technologies that have been implicit in the classical analysis of toxicological risk. On a practical level, we present a reflective tool that makes it possible to take into account all the dimensions involved and understand the reasons invoked in determining impacts, assessing them, and arriving at a judgement about acceptability. (shrink)

Nanotechnologies and nanoscience have generated an unprecedented global research and development race involving dozens of countries. The understanding of associated environmental, ethical, and societal implications lags far behind the science and technology. Consequently, it is critical to consider both what is known and what is unknown to offer a kernel that future work can be added to. The challenges presented by nanotechnologies are discussed. Some initial solutions such as self-regulation and borrowing techniques and tools from other fields are accompanied (...) by a call for further research. (shrink)

Nanotechnology has revolutionized various industries and has become a notable catalyst for economic growth. The emerging issues of human health and safety associated with nanotechnology development have raised regulatory concerns worldwide. In occupational settings, the same novel characteristics of nanomaterials that are utilized for innovation may also be the source of toxins with adverse health effects for workers. The existing regulatory framework may function effectively to regulate chemical substances in their conventional forms but may not be adequate with (...) regard to the specific issues of nanoform substances. A foundation of knowledge concerning properties of nanomaterials, and risk management approaches for these materials have been established, but conclusive results remain elusive. It is difficult for lawmakers to regulate nanotechnology-related activities effectively if conventional regulatory mechanisms are applied. The present article analyses in a country study the adequacy of existing Malaysian occupational safety and health law with regard to the specific issues presented by nanotechnology. The applicable regulatory approaches are examined to justify the adoption of soft law instruments as regulatory mechanisms for nanotechnology. A number of soft law best practices are briefly discussed as a basis to recommend practical solutions to close the existing regulatory gap. (shrink)

This paper analyses rhetorics of scientific and corporate enthusiasm surrounding nanotechnology. I argue that enthusiasts for nanotechnologies often try to have it both ways on questions concerning the nature and possible impact of these technologies, and the inevitability of their development and use. In arguments about their nature and impact we are simultaneously informed that these are revolutionary technologies with the potential to profoundly change the world and that they merely represent the extension of existing technologies. They are revolutionary (...) and familiar. In debates surrounding possible regulation of these technologies it is claimed both that their development is inevitable, so that regulation would be fruitless, and that increased research funding and legislative changes are necessary in order that we can enjoy their benefits. That is, they are inevitable and precarious. An increased awareness of these rhetorical contradictions may allow us better to assess the likely impact and future of nanotechnology. (shrink)

Examining those risk and benefit perceptions utilised in the formation of attitudes and opinions about emerging technologies such as nanotechnology can be useful for both industry and policy makers involved in their development, implementation and regulation. A broad range of different socio-psychological and affective factors may influence consumer responses to different applications of nanotechnology, including ethical concerns. A useful approach to identifying relevant consumer concerns and innovation priorities is to develop predictive constructs which can be used to (...) differentiate applications of nanotechnology in a way which is meaningful to consumers. This requires elicitation of attitudinal constructs from consumers, rather than measuring attitudes assumed to be important by the researcher. Psychological factors influencing societal responses to 15 applications of nanotechnology drawn from different application areas were identified using repertory grid method in conjunction with generalised Procrustes analysis. The results suggested that people differentiate nanotechnology applications based on the extent to which they perceive them to be beneficial, useful, necessary and important. The benefits may be offset by perceived risks focusing on fear and ethical concerns. Compared to an earlier expert study on societal acceptance of nanotechnology, consumers emphasised ethical issues compared to experts but had less concern regarding potential physical contact with the product and time to market introduction. Consumers envisaged fewer issues with several applications compared to experts, in particular food applications. (shrink)

Despite their growing usage in commercial and industrial applications, nanomaterials have yet to be been thoroughly researched as to their potential health, safety, and environmental risk to human life after incorporation into new product improvement, development, design, and manufacturing processes. Identifying the appropriate governance framework for effective risk assessment analysis of toxicological risk to human beings—specifically manufacturing employees and consumers—and other living organisms, resulting from the development and application of these nanotechnology-based products, has yet to be scientifically determined. With (...) major regulatory gaps in the public regulation framework at national and international levels of governance, a proposed private governance framework is needed to assist the existing public regulatory framework with the proliferation of products and manufacturing processes utilizing nanomaterials. There are three distinct (yet complimentary) approaches available to develop a private governance framework to complement existing national public regulatory frameworks: responsible innovation, risk management, and voluntary guidelines/industry standards. The case for supporting a hybrid governance framework, combining public and private governance mechanisms, for nanotechnology is reflective of the current public policy environment that has emerged to best address health, safety, and environmental risk assessment issues concerning nanotechnology and nanomaterials. (shrink)

Nanoethics seeks to examine the potential risks and rewards of applications of nanotechnology. This up-to-date anthology gives the reader an introduction to and basic foundation in nanotechnology and nanoethics, and then delves into near-, mid-, and far-term issues. Comprehensive and authoritative, it: -/- - Goes beyond the usual environmental, health, and safety (EHS) concerns to explore such topics as privacy, nanomedicine, human enhancement, global regulation, military, humanitarianism, education, artificial intelligence, space exploration, life extension, and more -/- -Features (...) contributions from forty preeminent experts from academia and industry worldwide, reflecting diverse perspectives -/- -Includes seminal works that influence nanoethics today -/- -Encourages an informed, proactive approach to nanoethics and advocates addressing new and emerging controversies before they impede progress or impact our welfare -/- This resource is designed to promote further investigations and a broad and balanced dialogue in nanoethics, dealing with critical issues that will affect the industry as well as society. While this will be a definitive reference for students, scientists in academia and industry, policymakers, and regulators, it's also a valuable resource for anyone who wants to understand the challenges, principles, and potential of nanotechnology. (shrink)

Looking at our knowledge of the risks associated with nanotechnology, one wonders to what degree should its products and applications be regulated? Do we need any governing body to regulate nanotechnology research and development? Do individuals have a right to know to make informed decisions through labelling mechanism? The question of regulation and responsibility in the interaction between science, technology and society is one of the most pressing issues. Risks and regulations regarding nanoscience and nanotechnology are (...) mostly debated amongst policy-makers and not amongst the nanoscientists, who actually produce the new science. Thus, the paper makes an attempt to contribute significantly to an increased body of knowledge regarding how scientists think and talk about science. Little has been documented about perceptions of nanotechnology regulation and responsibility in developing countries. Given the importance of perceptions in the genetically-modified foods debate, the way nanotechnology is perceived holds serious repercussions for the framing of its ethical, legal and social implications. Through a field-survey that records the opinions of leading Indian nanoscientists, the paper examines scientists' perceptions about nanotech-regulation. Such discussion is imperative to address technological risks and uncertainties. The paper further explores whether scientists have different views on what responsibility amounts to and under what conditions one is responsible. Though the study has considered Indian nanoscientists due to access issues, the research questions raised and addressed in this study are universal in nature. (shrink)

There are increasing calls internationally for the development of regulation and policies related to the rapidly growing nanotechnologies sector. As part of the process of policy formation, it is widely accepted that deliberative community engagement processes should be included, enabling publics to have a say about nanotechnologies, expressing their hopes and fears, issues and concerns, and that these will be considered as part of the policy process. The Australian Federal and State governments have demonstrated a commitment to these ideals, (...) undertaking a number of public engagement activities in recent years. However, despite promises that these community engagement activities will enable policy makers to identify complex and contested community attitudes, and that these will be included as part of the policy making process, a closer look at Australia’s engagement activities reveals something quite different. Through an analysis of a number of Australia’s nano-engagement activities, this paper demonstrates the limits of public engagement related to the development of nanotechnology related policies and regulation in Australia. Our analysis reveals the extent to which industry interests have captured policy makers and regulators, dissenting voices have been excluded from engagement processes, and engagement processes have not connected with actual policy making activities. Reflecting on these limits, this paper concludes with recommendations for improving public engagement processes related to nanotechnologies in Australia. (shrink)

Risk analysis as a regulatory driver has now become firmly entrenched in public health and environmental protection. Risk analysis at any level essentially has to accommodate two gut feelings of the constituency: whether society should be risk-prone or risk averse, and whether government and its institutions can be trusted to make the necessary decisions with a high or a low degree of discretion. The precautionary principle (or rejection thereof) arguably is the ultimate reflection of the promotion of risk to a (...) societal value. There is no doubt that especially amongst the representatives of the Member States (as opposed to the officials at the European Commission), public (pre)caution with respect to the long-term environmental and public health implications of gene technology influenced the reluctance to allow marketing of GM foods and feeds until a strict regulatory regime had been rolled out. Industry would argue that the delay in regulation, as well as the eventual regime was of such a nature as to stifle the technology. This contribution reviews a number of features of standard EU risk analysis decisions, so as to assess its current propensity towards smothering rather than smoothing the introduction of new technology. The current development of a regulatory framework for nanotechnology serves as a case study. (shrink)

Commentators continue to weigh in on whether there are ethical, social, and policy issues unique to nanotechnology, whether new regulatory schemes should be devised, and if so, how. Many of these commentaries fail to take into account the historical and political environment for nanotechnologies. That context affects regulatory and oversight systems as much as any new metrics to measure the effects of nanoscale materials, or organizational changes put in place to facilitate data analysis. What comes to count as a (...) technical or social “problem” says much about the sociotechnical and political-historical networks in which technologies exist. This symposium's case studies provide insight into procedural successes and failures in the regulation of novel products, and ethical or social analyses that have attended to implications of novel, disruptive technologies. Yet what may be needed is a more fundamental consideration of forms of governance that may not just handle individual products or product types more effectively, but may also be flexible enough to respond to radically new technological systems. Nanotechnology presents an opportunity to think in transdisciplinary terms about both scientific and social concerns, rethink “knowns” about risk and how best to ameliorate or manage it, and consider how to incorporate ethical, social, and legal analyses in the conceptualization, planning, and execution of innovations. (shrink)

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles are prominent (...) in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)