Discussions about the appropriate way of assessing and managing new or emerging technologies—like nanomaterials—expose the problematic relationship between scientific knowledge production and regulatory decision-making. On one hand, there is a strong demand for scientific expertise to support decisions, especially by analyzing risks and hazards when uncertainties are prevalent and society’s stakes are high. On the other hand, science is criticized for its authoritative claim to objectivity and for keeping the inherent uncertainty, ambiguity, and selectivity of scientific observation latent. Requests (...) for more transparency in science can lead to revealing, to risk managers and the public, the indeterminacy in knowledge production processes. This has consequences for the prevalence of scientific knowledge in decision-making, because it increases uncertainty on both sides of the breach between science and decisions: scientists lose confidence regarding the scientifically tested knowledge which they pass on, and risk managers lose confidence regarding their decisions based on this knowledge. Nonetheless, the concept of “probabilistic risk assessment” remains an important heuristic for dealing with potential future events. This paper addresses questions of the function of scientific risk assessment in organized risk management. The main argument in this paper is that knowledge alone no longer functions as a mechanism for absorbing uncertainty. Accordingly, the interaction between science and decisions must enable a temporarily stable commitment to manage new threats like products and applications coming from the field of nanoscience and nanomaterials. (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)

There is a growing literature on how scientific experts understand risk of technology related to their disciplinary field. Previous research shows that experts have different understandings and perspectives depending on disciplinary culture, organizational affiliation, and how they more broadly look upon their role in society. From a practice-based perspective on risk management as a bottom-up activity embedded in work place routines and everyday interactions, we look, through an ethnographic lens, at the laboratory life of nanoscientists. In the USA and Sweden, (...) two categories of nanoscientists have been studied: upstream scientists who are mainly electrical and physical engineers and downstream scientists who are toxicologists, often with a more multidisciplinary background, including physics, chemistry, biology, and engineering. The results show that although the two groups of scientists share the same norms of appropriate laboratory conduct to promote safety and good science practice, they have very different perspectives on risk with nanomaterials. Upstream scientists downplay risk; they emphasize the innovative potential of the new materials to which they express an affectionate and personalized stance. The downstream scientists, instead, focus on the uncertainties and unpredictability of nanomaterials and they see some materials as potentially highly dangerous. The results highlight the ambiguous and complex role of scientific experts in policy processes about the risk and regulation of nanotechnology. (shrink)

Risk assessment is an evidence-based analytical framework used to evaluate research findings related to environmental and public health decision-making. Different routines have been adopted for assessing the potential risks posed by substances and products to human health. In general, the traditional paradigm is a hazard-driven approach, based on a monocausal toxicological perspective. Questions have been raised about the applicability of the general chemical risk assessment approach in the specific case of nanomaterials. Most scientists and stakeholders assume that the current (...) standard methods are in principle suitable, but point out that experimental aspects and practical guidelines need specific adaptations. Beyond this laboratory level, risk assessment of nanomaterials also faces a number of substantive and procedural limitations, which are intrinsically attributed to the general orthodoxy of the risk assessment concept. Moreover, the developed formalism used to organize scientific knowledge is closely interlinked with the underlying governance design and the mode of interaction between the two spheres of ‘science’ and ‘decisions’. This contribution will provide a closer look at the evolution of different institutional settings for risk assessment in the context of decision-making. Improved risk governance frameworks with different narratives, process designs and procedural elements will be compared. The question of a general principle of enhanced organization of risk assessment will be discussed taking account of the barriers of substantive and procedural limitations in the special case of nanomaterials. (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)

Nanoscience has enabled the understanding of organisation of the atomic and molecular world. Due to the unique chemical, electronic and magnetic properties nanomaterials have wide applications in the chemical, manufacturing, medical sector etc., Single walled carbon nanotubes, buckyballs, ZnSe quantum dots, TiO 2 nanoparticle based products are nearing commercialisation. Research is on-going worldwide on suitable delivery systems for nanomaterial based drugs. Nanomaterials are highly reactive in biological systems due to the large surface area. While the benefits of nanomaterials are (...) evident there are studies which indicate the potential risk to biological systems. Substances known to be harmless in bulk can be potentially toxic in certain fibrous and nanoparticle form. Risk assessment studies with nanomaterials largely focus on mouse models. There are very few studies on their effects on aquatic species and plants which form the largest in the productivity chain with respect to the ecological pyramid. This study reviews the research done worldwide in the area of risk assessment of nanomaterials, particularly the effects on aquatic and plant systems. Risk assessment is the foundation for regulatory decision making. A general comparison of the regulatory regime in nanotechnology is performed to understand the extent of development. (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)

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. (shrink)

Research and business investment in emerging nanotechnologies is leading to a diverse range of new substances and products. As workers are faced with handling new materials, often with novel properties, the robustness of current workplace health and safety regulatory frameworks is being brought into question. Here, 12 characteristics of the U.S. occupational safety regulatory framework identified by Choi and Ramachandran are considered in the context of emerging nanotechnologies. The assessment suggests that, as the number of new materials entering the workplace (...) continues to increase, OSHA will need to develop flexible approaches to identifying and reducing potential risks. Relying on conventional approaches in the face of unconventional challenges will increase the probability of otherwise avoidable heath impacts. If the potential for engineered nanomaterials to cause harm is to be understood and managed, the agency will need to look at new approaches to generating, sharing, and using information. (shrink)

The Safe by Design conceptual initiative being developed for nanomaterials offers a template for a new sustainable innovation approach for advanced materials with four important sustainability characteristics. Firstly, it requires potential toxicity risks to be evaluated earlier in the innovation cycle simultaneously with its chemical functionality and possible commercial applications. Secondly, it offers future options for reducing animal laboratory testing by early assessment using in silico predictive toxicological approaches, minimizing the number that reaches in vitro and in vivo trials. (...) Thirdly, it promotes a culture of shared responsibility for ethical and sustainable outcomes in the innovation process by promoting early dialogue between groups with vested interests. Finally, it offers the prospect of a more democratized innovation process by including civil society actors in decisions on product safety, commercial applications, and social utility. Collectively, these four characteristics offer the prospect for a new social contract between science, technology, and society for the societal alignment and sustainable innovation of advanced materials. (shrink)

This paper evaluates the proposed amendments to New Zealand’s Cosmetic Group Standard that relate to nanomaterials in cosmetics. Manufactured nanomaterials are being increasingly used in cosmetic products. There are concerns that some nanomaterials present potential human and environmental health and safety risks. The proposed amendments are unique in New Zealand not only because they make specific mention of nanomaterials, but also because they propose introducing labelling requirements. Few jurisdictions have adopted mandatory labelling for products containing nanomaterials. The use of (...) nanomaterials in consumer products provides another opportunity to explore the efficacy of labelling as a regulatory tool. The challenges are heightened for products containing nanomaterials due to the difficulties in defining the term “nano.”. (shrink)

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. (shrink)

The risks of materials containing nanoscale components are in the public debate discussed as if a manufactured nanomaterial will remain invariant with time and environmental exposure, and as if we can identify its risks by the risks of its nanoscale components. Additionally, the debate on mitigation of specific nanorisks by new legislation implicitly assumes that we can have full and accurate knowledge of the distribution and composition of nanomaterials in a product or the environment. In this (...) discussion note, I argue that physical laws intrinsic to the behavior of nanoparticles both lead to limits on the risks to which we are likely exposed and on our technological ability to verify compliance with new regulations. My conclusion is that governmental actors should be careful not to overreact in their response to a technological revolution that only in few areas is likely to lead to increased public exposure, and in doing so using legal measures for which compliance cannot be monitored. (shrink)

Nanomaterials are handled in global value chains for many different products, albeit not always recognisable as nanoproducts. The global market for nanomaterials faces an uncertain future, as the international dialogue on regulating nanomaterials is still ongoing and risk assessment data are being collected. At the same time, regulators and civil society organisations complain about a lack of transparency about the presence of nanomaterials on the market. In the project on Sustainable Nanotechnologies, a Decision Support System has been developed, primarily for (...) confidential use by risk and sustainability managers inside a company or consortium. In this article, we formulate a scenario concerning a potential role for an open access decision support system in negotiations on international agreements regulating trade in nanomaterials. The scenario includes design rules for decision support systems as well as procedures for use of such a system in stakeholder dialogue and policy-making on governance of these and other emerging technologies. This article incorporates analysis of results of stakeholder engagement on nanomaterials as well as literature and internet sources suggested by these stakeholders. (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)

Graphene is a nanomaterial with many promising and innovative applications, yet early studies indicate that graphene may pose risks to humans and the environment. According to ideas of responsible research and innovation, all relevant actors should strive to reduce risks related to technological innovations. Through semi-structured interviews, we investigated the idea of graphene as a risk held by two types of key actors: graphene researchers and innovation advisors at universities, where the latter are facilitating the movement of (...) graphene from the laboratory to the marketplace. The most common idea found is that graphene is not a risk due to, e.g., low toxicity, low amounts produced/used, and its similarity to harmless materials. However, some researchers and advisors also say that graphene is a risk, e.g., under certain conditions or due to a lack of risk-related information. We explain the co-existence of these seemingly contradictory ideas through the semantic ambiguity of the word risk and a risk/no-risk rhetoric, where risks are mentioned rhetorically only to be disregarded as manageable or negligible. We suggest that some of the ideas held by the researchers and innovation advisors constitute a challenge to responsible research and innovation regarding graphene. At the same time, we acknowledge the dilemma that the discourse of responsible innovation creates for the actors: denying graphene risks makes them irresponsible due to a lack of risk awareness, while affirming graphene risks makes them irresponsible due to their everyday engagement in graphene development. We therefore recommend more research into what researchers and innovation advisors should do in practice in order to qualify as responsible. (shrink)

Public and experts’ perceptions of benefits and risks of nanotechnology constitute an important element of nanoethics studies. On the one hand, compared with traditional ethics, nanoethics is a future-oriented ethics. The construction of ethical norms requires public participation. On the other hand, nanotechnology is characterized by uncertainty. Our previous research showed the Chinese public’s support for nanotechnology was associated more with beliefs, including views of technology and the weighing of benefits and risks of nanotechnology, and less with knowledge (...) about nanotechnology; the support was high but might change over time. Meanwhile, Chinese researchers have been actively conducting studies on nanotechnology while being highly aware of nanosafety issues. In this context, we further examined in the present study Chinese nanoresearchers’ perceptions of specific benefits and risks of nanotechnology, compared them with those of the Chinese public, and examined the Chinese nanoresearchers’ perceptions of risks of specific nanoapplications. Initial cross-regional comparisons were made with results from equivalent US and European surveys. Results showed Chinese nanoresearchers perceived a higher level of overall nanobenefits than the public and an almost equal level of overall nanorisks with the public. Four nanorisks were perceived by a higher proportion of experts than public; the experts likely relied on technical expertise while the public, possessing little knowledge about nanotechnology, might have exercised caution based on experiences and observations of other technologies. Of 23 nanoapplications, Chinese nanoresearchers regarded food using nanomaterials as the most risky and displays using nanomaterials as the least risky. Similarities and differences were observed in comparisons of Chinese with US and European survey results. In our age of technology and economic globalization, this research is of significance both for China’s formulation of nanotechnology development strategies and for the further study on nanoethics and good governance of emerging technologies such as nanotechnology worldwide. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered (...) nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

There has been relatively little empirical research into the causes of research misconduct. To begin to address this void, the authors collected data from closed case files of the Office of Research Integrity (ORI). These data were in the form of statements extracted from ORI file documents including transcripts, investigative reports, witness statements, and correspondence. Researchers assigned these statements to 44 different concepts. These concepts were then analyzed using multidimensional scaling and cluster analysis. The authors chose a solution consisting of (...) seven clusters: (1) personal and professional stressors, (2) organizational climate, (3) job insecurities, (4) rationalizations A, (5) personal inhibitions, (6) rationalizations B and, (7) personality factors. The authors discuss the implications of their findings for policy and for future research. (shrink)

The risks of novel technologies, such as nano(bio)technology cannot be fully assessed due to the existing uncertainties surrounding their introduction into society. Consequently, the introduction of innovative technologies can be conceptualised as a societal experiment, which is a helpful approach to evaluate moral acceptability. This approach is illustrated with the marketing of sunscreens containing nano-sized titanium dioxide (TiO2) particles. We argue that the marketing of this TiO2 nanomaterial in UV protective cosmetics is ethically undesirable, since it violates four (...) reasonable moral conditions for societal experimentation (absence of alternatives, controllability, limited informed consent, and continuing evaluation). To remedy the current way nano-sized TiO2 containing sunscreens are utilised, we suggest five complementing actions (closing the gap, setup monitoring tools, continuing review, designing for safety, and regulative improvements) so that its marketing can become more acceptable. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered (...) nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (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)

While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because (...) they differ so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized. (shrink)

The biomedical literature and popular media are full of upbeat reports about the health benefits we can expect from medical innovations using nanotechnology. Some particularly enthusiastic reports portray nanotechnology as one of the innovations that will lead to a significantly extended human life span. Extreme enthusiasts predict that nanotechnology “will ultimately enable us to redesign and rebuild, molecule by molecule, our bodies and brains….”Nanomaterials have special characteristics that could contribute to improved patient care. But the same characteristics that make nanotechnology (...) promising also present risks to humans exposed to nanomaterials. A failure to appreciate these risks could jeopardize the research effort. As others have pointed out, if nanomedical interventions produce unexpected human harm, a loss of public and government support for nanomedicine is likely to follow.Like other forms of medical innovation, novel nanomedical interventions require human testing to evaluate their safety and effectiveness. (shrink)

First concerns about the use of nanosilver were raised almost a decade ago, but assessing the risks has been extremely challenging scientifically, and regulation to protect environmental and human health remains controversial. In order to understand the known risks and issues associated with the use of nanosilver, we carried out a DPSIR analysis and analysed drivers, pressures, state, impacts and potential policy responses. We found that most concerns relate to the potential development of multi-resistant bacteria and the environmental (...) impacts of nanosilver. From the DPSIR analysis, we found that new legislation for nanomaterials in general and nanosilver-specific changes in the current European chemical, biocide and medical legislation were the optimal policy responses, along with limiting the overall use of nanosilver. In order to qualify the identified potential policy responses, we carried out a stakeholder analysis, in order to explore possibilities for reaching consensus amongst stakeholders. Through the stakeholder analysis, the interests, views, power and influence of the identified stakeholders were mapped. Overall, the policy options identified in the DPSIR analysis were deemed not to be implementable, as industry and NGOs seem to have fundamentally conflicting views and interests. The use of the combination of DPSIR and stakeholder analysis proved valuable for use in cases of complexity, as they compensate for each other’s limitations and open up for a discussion what can be done to reduce risks. (shrink)

Scientists’ sense of social responsibility is particularly relevant for emerging technologies. Since a regulatory vacuum can sometimes occur in the early stages of these technologies, individual scientists’ social responsibility might be one of the most significant checks on the risks and negative consequences of this scientific research. In this article, we analyze data from a 2011 mail survey of leading U.S. nanoscientists to explore their perceptions the regarding social and ethical responsibilities for their nanotechnology research. Our analyses show that (...) leading U.S. nanoscientists express a moderate level of social responsibility about their research. Yet, they have a strong sense of ethical obligation to protect laboratory workers from unhealthy exposure to nanomaterials. We also find that there are significant differences in scientists’ sense of social and ethical responsibility depending on their demographic characteristics, job affiliation, attention to media content, risk perceptions and benefit perceptions. We conclude with some implications for future research. (shrink)

Textual representation of graphene in Sweden’s most circulated newspapers is analyzed in 229 articles from 2004 to 2018. What is and is not said about graphene is explored through systematically identifying the lexical and grammatical patterns of sentences using the word “graphene.” Graphene is said to be a super material with certain properties, to be an object of research, commercialization, and application, and to have societal significance. Given frequent classifications of graphene as a nanomaterial in scientific discourse, there is (...) notably limited reference to graphene as “nano” in the newspapers and only marginal reference to risk. This paper discusses the findings regarding this Swedish newspaper discourse on graphene in relation to its intertextuality, i.e., how texts draw upon and recontextualize other texts: the Swedish newspaper discourse on graphene echoes discourses of promise formulated elsewhere in society; it is not very diversified in terms of themes; it is dominated by positive and neutral representations rather than by risk; and it makes limited reference to the nano-discourse, even though, according to most definitions, graphene is a nanomaterial. (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)

The article focuses on issues relating to occupational exposures of researchers and lab workers, and exposures of bystanders such as health care workers and family members during HSR using nanomaterials. Such third-party exposures give rise to unique challenges relating to oversight as well as exposures to worker groups not previously studied. Given the current state of knowledge regarding health risks from such exposures, a more precautionary approach to oversight seems advisable.

Ethicists and policy makers have spent a good deal of effort considering how to make societal decisions in response to emerging public- and environmental-health risks like those posed by nanomaterials. This paper explores how these sorts of ethical and societal value judgments about responding to nanotechnology’s environmental health and safety risks arise not only in the public-policy domain but also “upstream,” in the performance of scientific research. It focuses especially on the notion that particular forms of research can (...) be more “precautionary” than others, in the sense that they tend to facilitate the identification and prevention of environmental or public health threats to a greater extent than other approaches. This is illustrated in a specific case study of recent research in nanotoxicology, which shows how ethical and societal values could influence at least four aspects of research: the nanomaterials studied; the biological models used to investigate them; the effects examined; and the standards of evidence required for drawing conclusions. The paper concludes by proposing some mechanisms for integrating more careful ethical reflection into these “upstream,” value-laden decisions that pervade research on nanotechnology as well as other policy-relevant areas of science. (shrink)

Much of the focus of the published 2011 symposium that inspired this work focused on the question, “When have you reduced risk enough to move from bench/animal studies to ‘first in-human’ studies?” Building applied research ethics related to nanotherapeutics requires bench and clinical scientists to have a clear vision about how to test nanotherapeutic safety, and it is clear that there is still much to be considered at the steps before “in-human” assessment. Herein, the perspective of the bench scientist is (...) brought to bear on using in vivo and in vitro models to assess the safety of nanotherapeutics. Much of this work falls under the purview of the field of nanotoxicology that aims to understand the toxicological impact of engineered nanoscale materials. Engineered nanomaterials include a wide variety of materials that are manipulated and controlled on the nanoscale level where, typically, the nanoparticle or nanomaterial has some dimension that is less than 100 nm. (shrink)

Based on fieldwork, this article highlights the unexpected effects of controversies about nanotechnology in France. These controversies stem in particular from a strong challenge to the field by civil society protests and criticism concerning environmental and health risks. One reason for this challenge is the specific difficulties in assessing the toxicity and ecotoxicity of nanomaterials. Civil society organizations have pushed for strictly controlling or stopping academic, industrial, or even basic research. They were not successful in this regard but their (...) activities prompted researchers to think about “safe by design” solutions and this led to new interdisciplinary cooperation. Furthermore, the uncertainty about the risks assessment resulted in a reconfiguration of the relationship between academic research and industrial companies. Researchers have become essential to the shaping of safe products. The risks of nanomaterials have thus been a driving force for new research and innovation practices. (shrink)

This work presents a blueprint or set of guidelines for the planning and development of sustainable national centers dealing with the safety of nanomaterials and nanotechnologies toward public health and environment. The blueprint was developed following a methodological approach of EU-wide online survey and workshop with several stakeholders. The purpose was to identify the key elements and challenges in the development and sustainability of a national nanosafety center. The responses were received from representatives of 16 national nanosafety centers across Europe (...) and 44 people from 18 EU member states who represented the stakeholder groups of researchers, academics, industry, regulators, civil society, and consultants. By providing an overview of the organizational design of existing national nanosafety centers across EU and converging demands in the field of nanosafety, the blueprint principally benefits those EU member states who do not have a national nanosafety center, but intend to develop an entity to manage the human health, environmental, ethical, and social concerns/risks toward the growing nationwide activities on engineered nanomaterials, e.g., their production, use or disposal, at national level. (shrink)

The article analyses European regulations concerning the health protection at work with nanomaterials in the context of the Christian vision of human work. The increasingly widespread presence of nanotechnology in workplaces requires serious reflection on the adequacy of employers’ measures to protect workers’ health from the risks in the workplace. The lack of clear guidance in European legislation directly concerning work with nanoparticles is problematic. Moreover, the health consequences for workers using nanomaterials in the work process are not fully (...) explored in science. It is therefore essential to consider what values should accompany employers in shaping working conditions and what values should be legislated when creating occupational health and safety law. First of all, how should the employers deal with the unknown? Should they abandon nanomaterials for which they do not have adequate information at all until the consequences for workers’ health have been established? Should such action be limited to situations where studies indicate the toxicity of the nanomaterials present in the working environment? In this context, the article analyses values and objectives indicated by the teaching of the Catholic Church. The publication presents a Christian vision on the protection of workers’ health and their place in the work process. Europe has been under the influence of Christianity for many centuries now. The Catholic Church’s view of human labour continues to be present in public debates in Europe. The Christian view of human labour is focused on the working man and his dignity. Irrespective of other concepts of labour, Christianity assumes the priority of a human being over capital. The Catholic Church analyses the working man as going beyond the Earthly context, which is not typical for such doctrines as liberalism or Marxism. The author’s article is an attempt in answering the question about how up to date the Catholic Church’s views on human labour are in the light of nanotechnology development in the workplace. (shrink)

Nanotechnology-enabled cosmetic products have been accessible in the market for the last 30 years. More than 250 products have been commercialized in the global market potentially exposing two billion people. These products are present in all formulations including creams, powders, lotions, and sprays. These involve contact with all body especially skin and mucosae; other tissues like airways and gastrointestinal tract can be reached by accidental exposure. Due to the size, NCPs exhibit an increased surface area volume ratio and biodistribution that (...) potentially augments their reactivity compared with bulk materials, which raises concerns for consumer’s safety. Consumers are attracted by the novel properties and functions of nano-enabled products but expose to technologies where no legal frameworks have been implemented to prevent potential side effects. Here, we review the current gaps between the commercialization process of NCPs and the regulatory frameworks to assess these products in USA, Europe, Japan, and Latin America prior and after commercialization. We identify the requirements for a proper assessment of the potential hazard of nanomaterials in cosmetics considering the nanomaterial properties. (shrink)

This chapter contains sections titled: Formation of Materials Carbon Nanomaterials Inorganic Nanomaterials.

The purpose of this work is to discuss which relation can be established between molecular chemistry, on the one hand, and macrochemistry and nanochemistry, on the other hand. In order to do this, we will consider molecular chemistry as an underlying level, and macrochemistry and nanochemistry as emergent levels. Emergence is characterized in very different ways in the philosophical literature; we will not discuss those differences. We will address a distinction between inter-domain emergence and intra-domain emergence. It is our purpose (...) to argue that, from a basal micro-molecular level, macrochemistry and nanochemistry emerge in parallel. The emergence of macrochemistry is an inter-domain emergence, while the emergence of the nanolevel is an intra-domain one. If this is the case, therefore macrochemistry and nanochemistry are not “successive” levels, but parallel ones. This discussion will be held from an ontological point of view, instead of the classical characterization in terms of scale. (shrink)

Preface -- Which risk society, and for whom? -- The sociology of risk and the ineliminability of realism -- Risk society and systematic social theory -- Thinking with Bourdieu, Marx, and Weber to analyse contemporary inequalities and class -- Risk society and the distribution of bads -- Risk illusion and organized irresponsibility in contemporary finance -- Conclusion: beyond the quiet politics of risk.

International regulation of autonomous weapon systems (AWS) is increasingly conceived as an exercise in risk management. This requires a shared approach for assessing the risks of AWS. This paper presents a structured approach to risk assessment and regulation for AWS, adapting a qualitative framework inspired by the Intergovernmental Panel on Climate Change (IPCC). It examines the interactions among key risk factors—determinants, drivers, and types—to evaluate the risk magnitude of AWS and establish risk tolerance thresholds through a risk matrix informed (...) by background knowledge of event likelihood and severity. Further, it proposes a methodology to assess community risk appetite, emphasizing that such assessments and resulting tolerance levels should be determined through deliberation in a multistakeholder forum. The paper highlights the complexities of applying risk-based regulations to AWS internationally, particularly the challenge of defining a global community for risk assessment and regulatory legitimization. (shrink)