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)

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

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)

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 (...) class='Hi'>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)

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)

In this paper we will argue that the categories of physical individuals and chemical stuff are not sufficient to face the chemical ontology if nanomaterials are taken into account. From a perspective that considers ontological questions and wonders which the items involved in science are, we will argue that the domain of nanoscience must be considered as populated by entities that are neither individuals, as those of physics, nor stuff, as those items of macro-chemistry. This discussion, in virtue of (...) the analysis of the nature of nanomaterials, leads to propose a proper ontological category for nanoparticles: nanoindividuals. Nanomaterials are sorts of individuals, but they are different from physical individuals and from chemical stuff. We will also claim to contribute to the growing field of the philosophy of chemistry, especially regarding discussions that manifest not only epistemological but also ontological issues. In this scenario, the field on nanoscience is particularly challenging. (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)

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 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 (...) class='Hi'>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)

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)

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)

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 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)

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)

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)

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)

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)

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)

Computer aided modeling and simulation of nanomaterials can describe the correlation between the material’s microstructure and its macroscopic properties quantitatively. In this paper, we propose an integrated modeling, simulation, and visualization approach for designing nanomaterials. Firstly, a fast parametric modeling method for important nanomaterials such as graphene, nanotubes, and MOFs is proposed; secondly, the material model could be edited adaptively without affecting the validity of the model on the physical level; thirdly a preliminary calculation for nanomaterials’ (...) energy is implemented based on the theory of surface fitting; finally, an integrated framework of nanomaterials modeling, simulation, and visualization is designed and implemented. Experimental results show that the proposed approach is feasible and effective. (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)

Scientific writings and policy documents define the terms nanomaterial and nanoparticle in various ways. This variation is considered problematic because the absence of a shared definition is understood as potentially hindering nanomaterial knowledge production and regulation. Another view is that the existence of a shared definition may itself cause problems, as rigid definitions arguably exclude important aspects of the studied phenomena. The aim of this paper is to inform this state of disagreement by providing analytical concepts for a systematic understanding (...) of how, and even whether, nanomaterial and nanoparticle could and should be defined. To do this, we review definitions of nanomaterial and nanoparticle presented in research articles and policy documents. Definitions were identified by first conducting a Scopus search and then tracing cited definitions back to their sources. In total, 36 definitions were identified. Theories of definition from philosophy and linguistics provide analytical guidance for structuring and categorizing the identified definitions, and the main analytical dimensions of the definitions are then identified and discussed. Finally, we propose a framework for understanding the process of defining nanomaterial and nanoparticle. This framework considers both the generality needed for a shared understanding and the level of precision required for different purposes. (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)

While nanosciences and nanotechnologies appear as new concepts developed at the end of the twentieth century, we show that metallic nanoparticles have already been used since ancient times, in particular as colorant in the glass and ceramic industries. Moreover, a lot of natural nanomaterials are also present in the mineral, vegetal and animal worlds. Nevertheless, the breakthrough of nanotechnology has been permitted in the past few decades by the advent of apparatus allowing the manipulation and observation of the nanoworld. (...) Indeed, nowadays, nanomaterials and nanoparticles are used for many applications in our daily life, such as in the fields of electronics, catalysis, optics, biology, and medicine. This article presents an overview about nanotechnologies, with applications from ancient times till the present. (shrink)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA policy, we argue, does (...) not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (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)

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 chapter contains sections titled: Using Nanomaterials Nanotechnology Computing and Robotics Predicting the Future of Technology.

Nanomaterials have attracted much interest in the medical field and related applications as their distinct properties in the nanorange enable new and improved diagnosis and therapies. Owing to these properties and their potential interactions with the human body and the environment, the impact of nanomaterials on humans and their potential toxicity have been regarded a very significant issue. Consequently, nanomaterials are the subject of a wide range of cutting-edge research efforts in the medical and related fields to (...) thoroughly probe their potential beneficial utilizations and their more negative effects. We posit that the lack of standardization in the field is a serious shortcoming as it has led to the establishment of methods and results that do not ensure sufficient consistency and thus in our view can possibly result in research outputs that are not as robust as they should be. The main aim of this article is to present how NanoDiaRA, a large FP7 European multidisciplinary project that seeks to investigate and develop nanotechnology-based diagnostic systems, has developed and implemented robust, standardized methods to support research practices involving the engineering and manipulation of nanomaterials. First, to contextualize this research, an overview of the measures defined by different regulatory bodies concerning nanosafety is presented. Although these authorities have been very active in the past several years, many questions remain unanswered in our view. Second, a number of national and international projects that attempted to ensure more reliable exchanges of methods and results are discussed. However, the frequent lack of publication of procedures and protocols in research can often be a hindrance for sharing those good practices. Subsequently, the efforts made through NanoDiaRA to introduce standardized methods and techniques to support the development and utilization of nanomaterials are discussed in depth. A series of semi-structured interviews were conducted with the partners of this project, and the interviews were analyzed thematically to highlight the determined efforts of the researchers to standardize their methods. Finally, some recommendations are made toward the setting up of well-defined methods to support the high-quality work of collaborative nanoparticle-based research and development projects and to enhance standardization processes. (shrink)

Nanomaterials have the promise of revolutionizing current treatment and diagnosis of diseases, which has led to 33 nanotherapeutics drugs currently on the market and many more in various stages of clinical trials. With an increasing number of products available and in development, along with the unique, emergent properties of the nanoparticle therapeutics themselves, regulatory agencies are now faced with decisions regarding the regulation of such novel technologies. Regulatory guidance, particularly in pre-clinical stages, has the potential to facilitate quick and (...) safe development of these novel materials, but new regulation beyond what is currently in place must be justified in a clear and distinctive toxic response. Herein, we examine literature that compares and correlates in vivo and in vitro nanotoxicity studies to gain a deeper understanding of the modes of nanoparticle toxicity. Additionally, this comparison aims to identify clear and unique toxicity responses caused by nanoparticles, which informs our perspective on pre-clinical nanotherapeutic oversight. (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)

ABSTRACT I propose a division of the literature on natural kinds into metaphysical worries, semantic worries, and methodological worries. I argue that the latter set of worries, which concern how classification influences scientific practices, should occupy centre stage in philosophy of science discussions about natural kinds. I apply this methodological framework to the problems of classifying chemical species and nanomaterials. I show that classification in nanoscience differs from classification in chemistry because the latter relies heavily on compositional identity, whereas (...) the former must consider additional properties, namely, size, shape, and surface chemistry. I use this difference to argue for a scale-dependent theory of scientific classification. _1_ Introduction _2_ The Methodological Problem of Kinds _3_ Chemical Kindhood: Reactivity, Microstructure, and the Structure–Property Paradigm _4_ Scale-Dependence and Nanoscale Kinds _5_ Conclusion. (shrink)

The environment can elicit biological responses such as oxidative stress (OS) and inflammation as a consequence of chemical, physical, or psychological changes. As population studies are essential for establishing these environment-organism interactions, biomarkers of OS or inflammation are critical in formulating mechanistic hypotheses. By using examples of stress induced by various mechanisms, we focus on the biomarkers that have been used to assess OS and inflammation in these conditions. We discuss the difference between biomarkers that are the result of a (...) chemical reaction (such as lipid peroxides or oxidized proteins that are a result of the reaction of molecules with reactive oxygen species) and those that represent the biological response to stress, such as the transcription factor NRF2 or inflammation and inflammatory cytokines. The high-throughput and holistic approaches to biomarker discovery used extensively in large-scale molecular epidemiological exposome are also discussed in the context of human exposure to environmental stressors. We propose to consider the role of biomarkers as signs and to distinguish between signs that are just indicators of biological processes and proxies that one can interact with and modify the disease process. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (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)

This volume launches a new series of contemporary conversations about scientific classification. Most philosophical conversations about kinds have focused centrally or solely on natural kinds, that is, kinds whose existence is not dependent on the scientific process of synthesis. This volume refocuses conversations about classification on unnatural, or synthetic, kinds via extensive study of three paradigm cases of unnatural kinds: nanomaterials, stem cells, and synthetic biology.

The idea of conducting “upstream public engagement,” using nanotechnology as a test case, has been subject to criticism for its lack of any link to the political system. Drawing on the theoretical tools provided by Habermas, this article seeks to explore such a “link”, focusing specifically on the capacity of civil society organizations to distil, raise and transmit societal concerns in an amplified form to the public spheres at the European Union level. Based on content analysis and semi-structured interviews with (...) relevant actors, this article examines the evolution of CSO approaches towards nanotechnology over the past decade and investigates whether and how upstream public engagement could contribute to more vibrant public spheres and facilitate the formation of communicative power. The answer to these questions is twofold: on the one hand, moving public engagement “upstream” enables CSOs to be better informed and to become part of the debates more quickly. A “green alliance” is taking shape, which calls for more stringent regulation on nanomaterials. On the other hand, upstream public engagement has turned out to be unsuccessful in generating substantial and sustained interest. A number of CSOs have quit this field in frustration at the tokenistic engagement and out of fatigue after the intense lobbying battle for Registration, Evaluation, Authorisation and Restriction of Chemicals. (shrink)

A number of scholars have recently drawn attention to the importance of iteration in scientific research. This paper builds on these previous discussions by drawing a distinction between epistemic and methodological forms of iteration and by clarifying the relationships between them. As defined here, epistemic iteration involves progressive alterations to scientific knowledge claims, whereas methodological iteration refers to an interplay between different modes of research practice. While distinct, these two forms of iteration are related in important ways. Contemporary research on (...) the biological effects of nanomaterials illustrates that methodological iteration can help to “initiate,” “equip,” and “stimulate” epistemic iteration. (shrink)

In order to make scientific results relevant to practical decision making, it is often necessary to transfer a result obtained in one set of circumstances—an animal model, a computer simulation, an economic experiment—to another that may differ in relevant respects—for example, to humans, the global climate, or an auction. Such inferences, which we can call extrapolations, are a type of argument by analogy. This essay sketches a new approach to analogical inference that utilizes chain graphs, which resemble directed acyclic graphs (...) (DAGs) except in allowing that nodes may be connected by lines as well as arrows. This chain graph approach generalizes the account of extrapolation I provided in my (2008) book and leads to new insights that integrate the contributions of the other participants of this symposium. More specifically, this approach explicates the role of “fingerprints,” or distinctive markers, as a strategy for avoiding an underdetermination problem having to do with spurious analogies. Moreover, it shows how the extrapolator’s circle, one of the central challenges for extrapolation highlighted in my book, is closely tied to distinctive markers and the Markov condition as it applies to chain graphs. Finally, the approach suggests additional ways in which investigations of a model can provide information about a target that are illustrated by examples concerning nanomaterials in sunscreens and Wendy Parker’s discussion of fingerprints in climate science. (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)

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)

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)

Policymakers, legislators, scientists, thinkers, military strategists, academics, and all those interested in understanding the future want to know how twenty-first century scientific advance should be regulated in war and peace. This book tries to provide some of the answers. Part I summarises some important elements of the relevant law. In Part II, individual chapters are devoted to cyber capabilities, highly automated and autonomous systems, human enhancement technologies, human degradation techniques, the regulation of nanomaterials, novel naval technologies, outer space, synthetic (...) brain technologies beyond artificial intelligence, and biometrics. The final part of the book notes important synergies that emerge between the different technologies and legal provisions, existing and proposed, assesses notions of convergence and of composition in international law, and provides some concluding remarks. The new technologies, their uses, and their regulation in war and peace are presented to the reader who is invited to draw conclusions. (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)

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)

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.

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)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA policy, we argue, does (...) not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

Continuing advances in human ability to manipulate matter at the atomic and molecular levels (i.e. nanoscale science and engineering) offer many previously unimagined possibilities for scientific discovery and technological development. Paralleling these advances in the various science and engineering subdisciplines is the increasing realization that a number of associated social, ethical, environmental, economic and legal dimensions also need to be explored. An important component of such exploration entails the identification and analysis of the ways in which current and prospective researchers (...) in these fields conceptualize these dimensions of their work. Within the context of a National Science Foundation funded Research Experiences for Undergraduates (REU) program in nanomaterials processing and characterization at the University of Central Florida (2002–2004), here I present for discussion (i) details of a “nanotechnology ethics” seminar series developed specifically for students participating in the program, and (ii) an analysis of students’ and participating research faculty’s perspectives concerning social and ethical issues associated with nanotechnology research. I conclude with a brief discussion of implications presented by these issues for general scientific literacy and public science education policy. (shrink)