Abstract: Expectations in the form of promises and concerns contribute to the sense-making and valuation of emerging nanotechnologies. They add up to what we call ‘de facto assessments’ of novel socio-technical options. We explore how de facto assessments of nanotechnologies differ in the application domains of water and food by examining promises and concerns, and their relations in scientific discourse. We suggest that domain characteristics such as prior experiences with emerging technologies, specific discursive repertoires and user-producer relationships, play a key role in framing expectations of nanotechnology-enabled options. The article concludes by suggesting that domain-specific discourses may lead to undesirable lock-ins into specific de facto assessments pre-structuring anticipatory strategies of actors

Abstract: The Technology Assessment (TA) Program established in 2003 as part of the Dutch R&D consortium NanoNed is interesting for what it did, but also as an indication that there are changes in how new science and technology are pursued: the nanotechnologists felt it necessary to spend part of their funding on social aspects of nanotechnology. We retrace the history of the TA program, and present the innovative work that was done on Constructive TA of emerging nanotechnology developments and on aspects of embedding of nanotechnology in society. One achievement is the provision of tools and approaches to help make the co-evolution of technology and society more reflexive. We briefly look forward by outlining its successor program, TA NanoNextNL, in place since 2011

Abstract: 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.

Abstract: During the last few decades we have witnessed a proliferation of exercises dealing with the public participation of citizens in various different dimensions of their societies, including issues of science and technology. On the one hand, these mechanisms provide more robust forms of public engagement with matters that were traditionally dealt with by experts; on the other hand, they raise concerns relating to their design, efficiency or potential for the empowerment of citizens. As part of the EC-funded project DEEPEN (Deepening Ethical Engagement and Participation in Emerging Nanotechnologies) a research team in Coimbra, Portugal, was put in charge of identifying the ethical and social “impacts” of emerging nanotechnologies, transforming the traditional focus groups through the incorporation of two methodological innovations: the Pedagogy of the Oppressed and the Theatre of the Oppressed. This article reflects on the outcomes and complexities of the introduction of these two methodologies. Since the participants had little or no information on nanotechnologies, we reflect on the politics of these focus groups by exploring how issues of intervention, subjectivity, representation and agency were interconnected during this exercise of public participation in Science and Technology, analyzing the role of social sciences in developing nanoethics.

Abstract: 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.

Abstract: 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.

Abstract: In this paper I focus on the question of whether nanotechnology is giving rise to new ethical problems rather than merely to new instances of old ethical problems. Firstly, I demonstrate how important it is to make a general distinction between new ethical problems and new instances of old problems. Secondly, I propose one possible way of interpreting the distinction and offer a definition of a “new ethical problem”. Thirdly, I examine whether there is good reason to claim that nanotechnology is giving or will give rise to new ethical problems. My conclusion is that there are no new ethical problems in nanotechnology but merely new occurrences of certain well-known types of ethical problems. Fourthly, I consider three arguments by van de Poel (NanoEthics 2:25–28, 2008) which contradict my conclusion. I argue that my negative conclusion is consistent with the claim that certain ethical issues arising in nanotechnology may require new normative standards or new analytical tools. I conclude that it is likely that a number of ethical issues arising in nanotechnology will have a considerable impact on our ethical theories and values – and that ethical reflection on nanotechnology will be one of the mother lodes of future ethical research – in spite of the fact that no ethical problem in nanoethics will actually be “new”.

Abstract: 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

Abstract: The nanotechnologies and nanomaterials sector is a huge and growing industry. The amount of legislation already in place and still to be produced in order to regulate it will be very substantial. What process is used to produce such regulation? The answer is that very diverse regulatory approaches are and will be used. The approach taken by the European Commission diverges from the one taken by the European Parliament. Moreover, at national level, Member States add their own contribution to the process. This article attempts to describe the landscape and various regulatory actions that have been undertaken by all these actors in the European Union. It first describes the role played by the European Commission and Parliament. It then looks at specific regulatory initiatives from a more sectoral perspective: Cosmetics, Food information, Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, Waste Electrical and Electronic Equipment and Biocides. The third part of the paper describes some major national initiatives, in particular those concerning the establishment of reporting systems for nanomaterials, mixtures, articles and consumer products containing them, as an example of how to improve the current governance in the EU and to prevent the risks to human health and the environment. The fourth part gives the perspective of the European Trade Union Confederation. Finally it presents some conclusions and policy recommendations, taking into consideration the diversity of regulatory approaches.

Abstract: At workplaces where nanomaterials are produced or used, risk assessment and risk management are extremely difficult tasks since there is still limited evidence about the risks of nanomaterials. Measurement methods for nanoparticles are contested and safety standards have not yet been developed properly. To support compliance with the legal obligation of the employer to care for safe workplaces a large number of ‘soft’ regulatory tools have been proposed (e.g. codes of conduct, benchmarks, standards). However, it is not clear whether and under which conditions soft regulation is complied with. This article discusses the potential advantages and drawbacks of soft regulation. It explores compliance issues when exposure measurement devices and other technology-related factors are involved. The exploration of three examples of soft regulation on occupational health and safety (a ministerial recommendation on preliminary exposure benchmarks, a nano-specific guidance of a chemical company and a public–private OHS guideline) shows that the capacity of the regulated parties to comply depends on the availability of appropriate technological devices and methods, technical expertise and other resources. When technological prerequisites are met, compliance is likely to increase

Abstract: The presence of nanotechnologies grew and spread throughout Latin America during the first decade of the 21st century. Science and Technology policies have played an important role in the performance of these new technologies. Various international institutions, such as the World Bank, the Organization for Economic Co-operation and Development, and the Organization of American States promoted similar Science and Technology policies, and included nanotechnology as a priority area. This article shows the role of these Science and Technology policies in the promotion of specific objectives and the gap that was left due to the failure to incorporate an examination of the potential risks to health and environment, not to mention other labor-related effects. The omission of matters relevant to workers and consumers by these institutions led to a distancing from organized civil society.

Abstract: Soft regulatory measures are often promoted as an alternative for existing regulatory regimes for nanotechnologies. The call for new regulatory approaches stems from several challenges that traditional approaches have difficulties dealing with. These challenges relate to general problems of governability, tensions between public interests, but also (and maybe particularly) to almost complete lack of certainty about the implications of nanotechnologies. At the same time, the field of nanotechnology can be characterized by a high level of diversity. In this paper, we discuss and compare two models for framing public policy in relation to technology regulation: the first is a deliberative model based on foresight knowledge and the second the wide reflective equilibrium model, developed by political philosopher John Rawls. In both models, the aim is to find consensus on (a framework for) policy measures and regulation. On the basis of a critical discussion of the strengths and weaknesses of both models, some tentative conclusions are drawn for effective policy making and implementation based on soft law.

Abstract: 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.

Abstract: This article contributes to the debate on governance of emerging technologies, focusing in particular on the international level and taking into account the fact that these technologies are developed through a common effort of different stakeholders including governments, research communities, industry and civil society actors. These issues are explored from the perspective of communitarian ethical criticism of liberal social contract thinking, in order to enhance visibility of the influence collective non-state actors exercise on the development of these technologies. In particular, the effect of different values in the discussion on emerging technologies on the perceived governance options is explored. A paradigm shift from defensive values such as security, risk and human rights to more optimistic values like peace, justice and integrity of creation is proposed and discussed.

Abstract: Nanotechnology has been facing multiple obstacles related to the applicability of patentability criteria. In this article, the authors addressed the novelty requirement in nanotechnology inventions in Iraqi and Malaysian patent acts. First, novelty was discussed to determine its applicability in the field of nanotechnology. Then, problems on nanotechnology patent application were presented along with some suggested solutions. The problems encountered in the patentability of nanotechnology inventions were summarized in two categories. First, the multidisciplinary nature of nanotechnology casts its shadow on the examination process in patent offices. To overcome this problem, the United States Patent and Trademark Office and the European Patent Office created new divisions to examine nanotechnology inventions; thus, this step must be followed by developing countries. In addition, with the existence of larger scaled materials and devices in prior art, three potentials have been introduced to overcome this issue. First, novel properties in nanoinventions can be demonstrated to reach the point of novelty. Second, nanoinventions can be patentable if they are carried out despite scientific problems occurring when materials are shaped in nanoscale. Third, the process of creating nanomaterials can be patentable as the bottom-up approach, which is not used in larger scaled materials. Finally, pre-disclosure must be considered as an enabling disclosure, which enables a skilled man in the art to put the nanoinvention in practice.

Abstract: To what extent do nanotechnology researchers discern specific work-related ethical responsibilities that are incumbent upon them? A questionnaire was designed and administered to answer this question. Analysis of responses to 11 ethical responsibility statements (ERSs) by 213 researchers at the Stanford Nanofabrication Facility revealed widespread agreement about a number of work-related ethical responsibilities and substantial divergence in the views about several others. Explanations of this divergence are proposed. A new variable is defined that gauges the respondent’s overall level of discernment of the ethical responsibilities referenced in the ERSs. The mean discernment level score for respondents who had taken a course that included discussion of ethical issues closely related to science, technology, or engineering was significantly higher than for those who had not. Further, among respondents who had taken such a course, the mean discernment level score for those who had taken an ethics course devoted to exploration of ethical issues closely related to science, technology, or engineering was significantly higher than for those who had taken a technical science or engineering course that typically pays only fleeting attention to such issues. Implications of these findings are discussed.

Abstract: “In this article we sketch out the landscape for this Special Issue on anticipating and embedding the societal challenge of nanotechnologies. Tools that actors may choose to employ for these processes are articulated, and further explored through the introduction of the seven articles which comprise this Issue. Taken together, these articles create a cogent narrative on the societal challenges posed by nanotechnologies. They are drawn together by three distinct themes, each of which is briefly considered within this context of this Introductory article”.

Abstract: The aim was to learn about responsible management in private sector nano enterprises by telephone conversations with lead technologists and managers in companies in the US Midwest. The conversations took place between January and March of 2011. The marked increase starting in 2008 of prescriptive documents such as guidelines, codes of responsibility, and best practices in NanoEthicsBank offered an entry point for initiating the conversations. Had respondents noticed these documents and did they find them useful? Follow-up questions asked about the full life cycle of their products. The responses from 22 of the 25 organizations selected are categorized in 5 groups according to how they described their nano materials/business. A conception of responsible management in organizations is provided to underpin the analysis of the responses. This conception features virtues of concern, care, and foresight implied by a fundamental moral obligation. In the analysis, definitions from the Organization for Economic Cooperation and Development (OECD) and the International Standards Organization (ISO) are used as a basis of comparison in assessing respondents’ claims. Two important gaps are identified. One gap is between actual practices and the prescriptive use of the conception of responsible management in organizations. The other gap is between the actual use of nano terminology and OECD definitions.

Abstract: There is interest in more and better interaction between civil society and actors developing nanotechnologies, nano-materials and nano-enabled products: government agencies but also branch organizations in the chemical sector position civil society organizations (CSOs) as ‘voices of civil society’, and invite CSOs to participate in multistakeholder events. In such events, CSOs are expected to articulate societal needs, issues and values so that these can be taken up by actors with institutional roles and mandates to develop and embed newly emerging nanosciences and nanotechnologies (NEST). This article argues that such a division of moral labor between CSOs and nanotechnology actors is not productive to address NEST and its emerging societal issues. There is an assumption that societal issues are ‘out there’ and can be recognized by CSOs, while in fact, societal issues might co-evolve with new development trajectories and thus have to be discovered and articulated. More productive deliberation requires, ideally, overcoming the traditional division of moral labor between these two groups of actors: technology developers should also inquire into and articulate emerging societal issues, and CSOs should inquire into and reflect on actual development trajectories. In order to explore issues and repercussions that arise in such a repositioning, this article will discuss a bottom up experiment of such an interaction between a nanotechnology developer (DuPont) and a CSO (Environmental Defense Fund). Based on the empirical analysis of this bottom up experiment, tentative requirements will be developed for how joint inquiries between technology developers and CSOs can be realized on a larger scale in our society.