Nanotechnological medical devices and nanopharmaceuticals: the European regulatory framework and research needs

The European regulatory framework is examined in relation to nanotechnology based medical devices and medicinal products. Medical applications of nanotechnology will have to comply with the requirement for a high level of public health, safety, consumer, and environmental protection. An evaluation of the possible health or environmental risks of nanoparticles must therefore be carried out and it is important to ensure that particle size and chemistry are taken into account when investigating possible adverse effects. Further research is needed on the toxicological and ecotoxicological properties of nanoparticles, their uptake in the body, accumulation in tissues and organs, transport characteristics, exposure and dose-response data, and their distribution and persistence in the environment. The existing regulations appear adequate to manage the risks of nanotechnology at its current stage of development but continuous review of the regulatory regime will be needed to determine whether it is sufficient to protect human health and the environment. Modification of the legislation may prove necessary as new scientific evidence emerges regarding the effects of nanoparticles on living organisms and in the ecosystems.     

Nanotechnology and the environment: A European perspective

The potential positive and negative effects of nanotechnology on the environment are discussed. Advances in nanotechnology may be able to provide more sensitive detection systems for air and water quality monitoring, allowing the simultaneous measurement of multiple parameters and real time response capability. Metal oxide nanocatalysts are being developed for the prevention of pollution due to industrial emissions and the photocatalytic properties of titanium dioxide nanoparticles can be exploited to create self-cleaning surfaces that reduce existing pollution. However, while nanotechnology might provide solutions for certain environmental problems, relatively little is known at present about the environmental impact of nanoparticles, though in some cases chemical composition, size and shape have been shown to contribute to toxicological effects. Nanotechnology can assist resource saving through the use of lightweight, high strength materials based on carbon nanotubes and metal oxide frameworks as hydrogen storage materials. Other energy related applications include nanostructured electrode materials for improving the performance of lithium ion batteries and nanoporous silicon and titanium dioxide in advanced photovoltaic cells. It is important to develop an efficient strategy for the recycling and recovery of nanomaterials and methods are needed to assess whether the potential benefits of nanotechnology outweigh the risks. Life cycle analysis will be a useful tool for assessing the true environmental impacts.     

How strategic environmental assessment can inform lenders about potential environmental risks

In this paper, we explore the potential for strategic environmental assessment (SEA) to be a useful tool for banks to manage environmental risks and inform lending decisions. SEA is an environmental assessment tool that was developed to assist strategic-level decision-makers, such as policy-makers, planners, government authorities and environmental practitioners in improving developmental outcomes, aiming to facilitate the transition to sustainable development. We propose that SEA may also be a valuable tool for banks because it has the capacity to provide information about environmental risks at a time when it can be used as an input to bank lending decisions, which can assist banks in making lending decisions with better environmental outcomes. For these reasons, we argue that in some circumstances, and particularly for project finance transactions, SEA may be a more useful environmental assessment tool for lenders than environmental impact assessment, which many banks are currently relying on to help assess and mitigate environmental risks. Furthermore, we suggest that the use of SEA by banks would contribute to the sustainability goals of SEA.     

Nanotechnology and nanomaterials: toxicology, risk assessment, and regulations

Nanomaterials have very unique chemical and physical properties that suggest potential health hazards, but limited health and safety information exists for engineered nanomaterials. This review identifies a need for expanding efforts for addressing health and safety concerns in nanotechnology development and in nanotoxicology of engineered nanomaterials. The efforts include research to generate data for safety evaluation, toxicologic evaluation of potential human health effects, risk assessment to support risk-management decision-making, and regulations development to protect human health and the environment. The federal government's current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications. On the other hand, the present review identifies weaknesses in the current research efforts and inadequacies in existing regulations. A collaborative effort involving multidisciplinary groups is a key element to address the related needs and issues. While federal agencies with regulatory responsibilities are looked upon to develop and implement sound policies and regulations to protect public health and the environment, state agencies may be required to initiate policies which rapidly incorporate new innovations and address public concerns. To address current and futures need related to nanotechnology, the responsible state agencies need to fill the information gaps and address the health and environmental issues. In California, activities have been initiated, but legislative authority and resources are required to provide risk assessment and health protection in an efficient and timely manner.     

A decision-directed approach for prioritizing research into the impact of nanomaterials on the environment and human health

The emergence of nanotechnology has coincided with an increased recognition of the need for new approaches to understand and manage the impact of emerging technologies on the environment and human health. Important elements in these new approaches include life-cycle thinking, public participation and adaptive management of the risks associated with emerging technologies and new materials. However, there is a clear need to develop a framework for linking research on the risks associated with nanotechnology to the decision-making needs of manufacturers, regulators, consumers and other stakeholder groups. Given the very high uncertainties associated with nanomaterials and their impact on the environment and human health, research resources should be directed towards creating the knowledge that is most meaningful to these groups. Here, we present a model (based on multi-criteria decision analysis and a value of information approach) for prioritizing research strategies in a way that is responsive to the recommendations of recent reports on the management of the risk and impact of nanomaterials on the environment and human health.     

What drives public acceptance of nanotechnology?

How do the risks and benefits of nanotechnology, as viewed by the public, compare with those associated with other technologies such as genetically modified organisms, stem cells, biotechnology and nuclear power? And when deciding to use a specific nanotechnology product, will consumers consider the risks, the benefits, or both? We report the first large-scale empirical analyses of these questions.     

Entropy-based model for the ripple effect: managing environmental risks in supply chains

Due to increasing diversity and growing size of modern industrial supply chains, today problems of identification, assessment and mitigation of disruption risks become challenging goals of the supply chain risk management. In this paper, we focus on environmental (ecological) risks in supply chains which represent threats of adverse effects on living organisms, facilities and environment by effluents, emissions, wastes, resource depletion, etc. arising due to supply chain’s activities. Harmful environmental disruptions may ripple through the supply chain components like a wave. The paper presents the entropy-based optimisation model for reducing the supply chain model size and assessing the economic loss caused by the environmental risks subject to the ripple effect. A main advantage of the suggested entropy-based approach is that it permits to essentially simplify the hierarchical tree-like model of the supply chain, at the same time retaining the basic knowledge about main risk sources.     

纳米产品生命周期评估发展现状分析

纳米制备过程存在能耗大、生产率低、环境污染大等问题。文章在综合论述纳米安全风险评估发展的基础上，分析了纳米生命周期评估在纳米科技和纳米毒理学中的地位，探讨了国内外政策和项目导向，阐述了纳米生命周期评估的现状、存在问题及今后需要开展的研究方向。     

Public benefit and risk perceptions of nanotechnology development: Psychological and sociological aspects

Nanotechnology enables the development of new and improved products. However, the public is also concerned about uncertain risks associated with nanotechnology-enabled products. To address this concern, the study aims to expand the understanding about public benefit and risk perceptions as a basis for the effective formulation of policy that addresses public interests. The study investigates public benefit and risk perceptions of nanotechnology development from the psychological and sociological aspects through a questionnaire survey conducted on Klang Valley, Malaysia. Analysis of variance (ANOVA) illustrates that demographics indeed influences public benefit and risk perceptions of nanotechnology development. However, public knowledge about nanotechnology exerts no effect on public benefit and risk perceptions of nanotechnology development based on independent t-tests. Simple linear regression reveals that the lack of public trust in government increases risk perception. Public attitude perceives nanotechnology to be more beneficial than risky, thus influencing benefit perception rather than risk perception. Public lifestyle, such as culture, religious beliefs and social group influence benefit perception but not risk perception. Result is expected to deliver better communication of benefit and risk of nanotechnology to the public as well as ensure an ethical policy regarding nanotechnology development.     

Green synthesised iron and iron‐based nanoparticle in environmental and biomedical application: – a review

Owing to the development of nanotechnology and its influence in various fields, the development of efficient and environmental friendly technique for the synthesis of nanomaterials is important. Among the various traditional and conventional methods available for the synthesis, plant‐mediated synthesis seems to be a very attractive and environmental friendly method, attributing to its simple methodology and eco‐friendly approach. The synthesis rate and stability of the nanoparticle synthesised are good when compared to the other methods of synthesis and it is proved to be efficient in various fields of application. Hence, the present review article deals with furnishing information about the plant sources used so far and details about the environmental and biomedical applications of the synthesised nanoparticles.Inspec keywords: nanoparticles, reviews, nanomedicine, nanofabrication, antibacterial activity, ironOther keywords: environmental application, biomedical application, iron‐based nanoparticle, environmental friendly technique, traditional methods, plant‐mediated synthesis, environmental friendly method, simple methodology, eco‐friendly approach, synthesis rate, nanoparticle stability, green synthesis, nanotechnology, nanomaterials, conventional methods, Fe     

Challenges in using probabilistic climate change information for impact assessments: an example from the water sector

Climate change impacts and adaptation assessments have traditionally adopted a scenario-based approach, which precludes an assessment of the relative risks of particular adaptation options. Probabilistic impact assessments, especially if based on a thorough analysis of the uncertainty in an impact forecast system, enable adoption of a risk-based assessment framework. However, probabilistic impacts information is conditional and will change over time. We explore the implications of a probabilistic end-to-end risk-based framework for climate impacts assessment, using the example of water resources in the Thames River, UK. We show that a probabilistic approach provides more informative results that enable the potential risk of impacts to be quantified, but that details of the risks are dependent on the approach used in the analysis.     

Investigating the prospects of bacterial biosurfactants for metal nanoparticle synthesis – a comprehensive review

Establishing biological synthesis of nanoparticles is increasing nowadays in the field of nanotechnology. The search for an optimal source with durability, stability, capacity to withstand higher environmental conditions with excellent characteristics is yet to meet. Consequently, there is need to create an eco‐friendly strategy for metal nanoparticle synthesis. One approach investigated in this review is the use of biosurfactants to enhance the synthesis biologically. In comparison with the other technologies, biosurfactants are less toxic and exhibit higher properties. This method is different from the conventional practice like physical and chemical methods. Several research studies represented that the biosurfactant influences the production of nanoparticles about 2–50 nm. In this manner, the research towards the biosurfactant has raised. This review also addressed the feasibility of biosurfactant and their benefits in the synthesis of metallic nanoparticles. The findings from this review can recommend a conceivable use of biosurfactant as a source for metal nanoparticle synthesis.Inspec keywords: nanoparticles, microorganisms, nanotechnology, biotechnology, nanofabrication, durability, surfactants, reviewsOther keywords: biological synthesis, bacterial biosurfactants, environmental conditions, metallic nanoparticles synthesis, nanotechnology, durability, review, stability, size 2.0 nm to 50.0 nm     

Implementation of Interdisciplinary Group Learning and Peer Assessment in a Nanotechnology Engineering Course

Nanotechnology is an inherently interdisciplinary field that has generated significant scientific and engineering interest in recent years. In an effort to convey the excitement and opportunities surrounding this discipline to senior undergraduate students and junior graduate students, a nanotechnology engineering course has been developed in the Department of Materials Science and Engineering at Northwestern University over the past two years. This paper examines the unique challenges facing educators in this dynamic, emerging field and describes an approach for the design of a nanotechnology engineering course employing the non‐traditional pedagogical practices of collaborative group learning, interdisciplinary learning, problem‐based learning, and peer assessment. Utilizing the same nanotechnology course given the year before as a historical control, analysis of the difference between measures of student performance and student experience over the two years indicates that these practices are successful and provide an educationally informed template for other newly developed engineering courses.     

Internationalization and evolution of application areas of an emerging technology: The case of nanotechnology

Nanotechnology patenting has grown rapidly in recent years as an increasing number of countries are getting into the global nanotechnology race. Using a refined methodology to identify and classify nanotechnology patents, this paper analyses the changing pattern of internationalization of nanotechnology patenting activities from 1976–2004. We show that the dominance of the G5 countries have declined in recent years, not only in terms of quantity, but also in terms of quality as measured by citation indicators. In addition, using a new approach to classifying the intended areas of commercial applications, we show that nanotechnology patenting initially emphasized instrumentation, but exhibited greater diversification to other application areas in recent years. Significant differences in application area specialization are also found among major nanotechnology nations. Moreover, universities are found to play a significant and increasing role in patenting, particularly in US, UK and Canada.     

Environmental,health and safety aspects of nanotechnology—implications for the R&D in (small) companies

The growth of nanotechnology has led to an unprecedented research and development effort in both the public and the private sectors; world wide, an increasing number of laboratories, fabrication and manufacturing plants develop or apply novel nanometre-sized materials for applications ranging from large-scale industrial materials, to electronic components and healthcare and medical products; an increasing number of start-ups have been launched to establish their nanotechnology-based products in a trillion-dollar market.

Very little, however, is known about the interaction of man-made nanostructured materials and living organisms, as studies of nanotoxicology are gaining increasing interest, but are still in their infancy. Despite the formation of many focus and lobbying groups, proper legislation of the environmental, health and safety aspects of nanotechnology will take years to be implemented. In the mean time, it is of utmost importance that companies working with nanometre-sized matter take appropriate precautions to protect their staff, the environment and the customer. Toxicology tests and agency approval of new nanometre-sized materials are prohibitively expensive, but, even if working on a tight budget, nanotechnology companies can achieve an ethical and safe business conduct via a number of possible routes.     

Trophic transfer of nanoparticles in a simplified invertebrate food web

The unique chemical and physical properties of engineered nanomaterials that make them attractive for numerous applications also contribute to their unexpected behaviour in the environment and biological systems. The potential environmental risks, including their impact on aquatic organisms, have been a central argument for regulating the growth of the nanotechnology sector. Here we show in a simplified food web that carboxylated and biotinylated quantum dots can be transferred to higher trophic organisms (rotifers) through dietary uptake of ciliated protozoans. Quantum dot accumulation from the surrounding environment (bioconcentration) was limited in the ciliates and no quantum dot enrichment (biomagnification) was observed in the rotifers. Our findings indicate that dietary uptake of nanomaterials should be considered for higher trophic aquatic organisms. However, limited bioconcentration and lack of biomagnification may impede the detection of nanomaterials in invertebrate species.     

Nanocharacterization,Materials Modeling,and Research Integrity as Enablers of Sound Risk Assessment: Designing Responsible Nanotechnology

Nanotechnology, as a mature enabling technology, has great potential to boost societal welfare. However, nanomaterials' current and foreseen applications raise serious concerns about their impact on human health and the environment. These concerns emerge because a reliable risk assessment in nanotechnology is yet to be achieved. The reasons for such a shortcoming are the inherent difficulties in characterizing nanomaterials properties. The interaction of characterization with modeling is an open issue and, due to overarching concerns about the reliability of research results, usually framed within the context of research integrity. This essay explores the connection between these different, but deeply intertwined concerns and the way they enable the production of responsible nanotechnology, i.e., nanotechnology devoted to societal welfare.     

Nanotechnology – Markets & Trends. Nanotechnologie – Märkte und Trends

The world of nanotechnology is gaining more and more interest from the scientific point of view as well as for industrial applications. Promising product and process innovations that are based on nanotechnology have stimulated the involvement of industry and the financial community. Rather than an evolutionary oriented top‐down approach pushing critical dimensions from microns down into the nanometre range, the real potential of nanotechnology lies in the creation of novel functional structures of superior performance by controlling structures on a scale between 1 and 100 nanometres with completely changed properties. Making use of these novel properties of known materials is highly attractive for applications in a variety of fields, underlining that nanotechnology is regarded as key technology of the 21st century a promising product and process innovations that are based on nanotechnology have stimulated the involvement of scientific community and the industry, because nanotechnology is not only scientific artwork but is currently used in a considerable number of products in a multibillion‐dollar marketplace.     

Dealing with uncertainty and pursuing superior technology options in risk management--the inherency risk analysis

Current regulatory systems focus on the state of scientific evidence as the predominant factor for how to handle risks to human health and the environment. However, production and assessment of risk information are costly and time-consuming, and firms have an intrinsic disincentive to produce and distribute information about risks of their products as this could endanger their production opportunities and sales. An emphasis on more or better science may result in insufficient thought and attention going into the exploration of technology alternatives, and that risk management policies miss out on the possible achievement of a more favorable set of consequences. In this article, a method is proposed that combines risk assessment with the search for alternative technological options as a part of the risk management procedure. The method proposed is the inherency risk analysis where the first stage focuses on the original agent subject to investigation, the second stage focuses on identifying technological options whereas the third stage reviews the different alternatives, searching for the most attractive tradeoffs between costs and inherent safety. This is then used as a fundament for deciding which technology option to pursue. This method aims at providing a solution-focused, systematic technology-based approach for addressing and setting priorities for environmental problems. By combining risk assessment with a structured approach to identify superior technology options within a risk management system, the result could very well be a win-win situation for both company and the environment.     

Regional development and interregional collaboration in the growth of nanotechnology research in China

China is becoming a leading nation in terms of its share of the world??s publications in the emerging nanotechnology domain. This paper demonstrates that the international rise of China??s position in nanotechnology has been underwritten by the emergence of a series of regional hubs of nanotechnology R&D activity within the country. We develop a unique database of Chinese nanotechnology articles covering the period 1990 to mid-2006 to identify the regional distribution of nanotechnology research in China. To build this database, a new approach was developed to clean and standardize the geographical allocation of Chinese publication records. We then analyze the data to understand the regional development of nanotechnology research in China over our study period and to map interregional and international research collaboration linkages. We find that the geographical distribution of China??s domestic nanotechnology research is characterized by regional imbalance, with most of the leading regions located in eastern China, including not only Beijing and Shanghai but also a series of other new regional hubs. There is much less development of nanotechnology research in central and western China. Beijing, Shanghai, and Hong Kong are among the leading Chinese regions for international nanotechnology research collaboration. Other Chinese nanotechnology regions are less focused on international collaboration, although they have developed domestic interregional collaborations. Although new regional research hubs have emerged in the nanotechnology domain, the paper notes that their concentration in eastern China reinforces existing imbalances in science and technology capabilities in China, and in turn this may further reinforce the dominant position of eastern China in the commercialization of new technologies such as nanotechnology.