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NanoSafetyCluster ‐ Compendium 2012 Contents 1 Summary ................................................................................... 242 2 Background .............................................................................. 242 3 Project Description and Organisation ..................................... 243 4 Key Challenges being addressed by QNano ............................ 244 5 QNano activities ....................................................................... 246 6 Next steps and how to get involved in QNano ....................... 250 7 References ................................................................................. 251 8 Directory .................................................................................... 251 9 Copyright ...................................................................................253 1 Summary Nanoscale objects interact with living organisms in a fundamentally new manner, ensuring that a fruitful marriage of nanotechnology and biology will long outlast short term imperatives. Therefore, investment in an infrastructure to drive scientific knowledge of the highest quality will have both immediate benefits of supporting the safety assessment of legacy nanomaterials, as well as pointing towards future (safe) applications with the lasting benefits to society. There are immediate priorities, for few doubt that serious damage to confidence in nanotechnology, unless averted, could result in missed opportunities to benefit society for a generation, or more. QNano, as an infrastructure for analysis of nanomaterials for biological safety assessment, will materially affect the 2 Background Nanoscience constitutes a new scientific frontier in which we can, for the first time, engineer materials on the length scale of some millionths of a millimetre. The potential applications of nanotechnology for the benefit of mankind range from information technology, energy storage and harvesting, to radically new medical technologies. The projected market for nanotechnology incorporated in manufactured goods may be worth US$ 1.6 Trillion in the forecast period (2009‐2013). 1 The scientific issues are fundamental, and durable. Much of the internal processing, passing of signals, and other key functions of living organisms use endogenous processes operating on the nanometer scale. Engineered nanoscale objects (nanomaterials) therefore can interact with organisms in a fundamentally new way (compared to micron scale materials of identical composition), ensuring that the fruitful marriage of nanotechnology and biology will long outlast short term imperatives. 2 As such, our ability to generate fundamental scientific knowledge of the highest quality to support the safety assessment of nanomaterials for humans and for the environment will be an investment in the infrastructure, and the future, with lasting positive impact. All steps must therefore be taken, as quickly as possible, to ensure that the field is guided towards success, with responsibility. Few doubt that serious damage to confidence in the technology could result in missed opportunities to benefit society for a generation, or more. outcome, at this pivotal moment of nanotechnology implementation. The overall vision of the QNano Research Infrastructure for nanosafety assessment is the creation of a ‘neutral’ scientific & technical space in which all stakeholder groups can engage, develop, and share scientific best practice in the field. Initially it will harness resources from across Europe and develop efficient, transparent and effective processes. Thereby it will enable provision of services to its Users, and the broader community, all in the context of a best‐practice ethos. This will encourage evidence‐ based dialogue to prosper between all stakeholders. However, QNano will also pro‐actively seek to drive, develop and promote the highest quality research and practices via its Joint Research Activities (JRA), Networking Activities (NA) and provision of Transnational Access (TA) functions, with a global perspective and mode of implementation. QNano will also look to the future, beyond the current issues, and promote the growth and development of the science of nanoscale interactions with living organisms. By working with new and emerging scientific research communities from medicine, biology, energy, materials and others, it will seek to forge new directions leading to new (safe, responsible, economically viable) technologies for the benefit of European society. The QNano project commenced on 1 st February 2011 and will run for 48 months. Despite significant R&D investment over the last 10 years, 3 several critical road‐blocks to rapid implementation and commercialisation in a safe and responsible manner, acknowledged by all stakeholders, were not fully foreseen. The real (and perceived) unknown hazards and risks of nanomaterials, allied to concerns about the reliability of current testing approaches have been highlighted in all dimensions from science, media, and even to the highest levels of government. 4 Furthermore, discussions between stakeholders have not always been easy and to some degree the discussion has become polarised, based on opinions, and some erosion of trust has occurred. 5 Additional complicating issues have arisen because manufacturing standards, and workplace practices, of nanomaterials are not uniform across market sectors, and in different parts of the world. It is clear that, in the absence of an understanding of what constitutes (useful) standards, the reputation of nanotechnology could be affected by the weakest players. Serious issues have already arisen, for example, from issues of impurities, unconventionally sequestered in nanomaterials. The political sensitivity of these issues in a global market, and the need to address them via infrastructural developments such as we propose here, is universally acknowledged. Compounding this, very significant variability of reported biological and toxicity outcomes on nominally identical materials has caused controversy in science, and the media, and could, if not urgently 242 Compendium of Projects in the European NanoSafety Cluster
eversed, lead to a loss of confidence in science that single force capable of unifying societal views on this topic. Solid, disciplined, evidence based dialogue is urgently required to resolve these issues. The need for scientific opinion, whether academic research, regulatory or industrial, to converge on basic results within a QNano will: 3 Project Description and Organisation The vision of QNano is the creation of a ‘neutral’ scientific and technical space in which scientists from all stakeholder groups can engage, develop, and share the scientific best practices in the field. It is understood that such an organization cannot resolve all of the challenges, nor even address all the important areas of the science, especially at the beginning. In the early days its aspiration must be limited to the creation of an ethos, development of processes, and harnessing of the resources, to allow evidence based dialogue in critical areas to flower. The program will not engage in controversy, nor promote opinions, for in doing so it will lose the trust of one or more stakeholders. Uniquely important in the current situation, the infrastructure will need to patiently display ethical standards in actions and processes if the current uncertain atmosphere is to yield to clarity and unity of purpose. By processes (for example, blind round robins) it will determine (and provide the support to determine) facts, and report them to the scientific community, and stakeholders. Its greatest strength is that these factual results (from well defined studies) even if their implications remain open to interpretation will be trusted by all. The infrastructure will be global in perspective, and implementation. As noted above, some of the challenges do not lie in Europe alone, nor can they be resolved there. Existing warm relations in the United States, Asia and Latin America (and beyond) will be further developed within the framework. Many issues need to be addressed, short term, and longer term. A scientific culture must be built, and full acceptance of the challenges and difficulties of working in scientific excellence in such a new arena must be argued, and won, step by step. At this period in history, resolving even simple issues, such as the creation and provision of (nanoparticulate) biological end‐point positive (and negative) controls, will have profound effects on the way that the User community performs its’ work. NanoSafetyCluster ‐ Compendium 2012 cohesive framework of structured research (in part based on blind round robin tests) is now critical. Indeed, there are few more urgent or compelling cases to be made than the need for infrastructure now to transform and drive the transition required. 1. Create a neutral ethos of excellence where all nanotechnology stakeholders can focus on concrete science‐based outcomes; 2. Establish a core infrastructure to address the critical issues currently hampering the industrial deployment of nanotechnologies across a range of industry sectors; 3. Provide Users with a full range of services from standard nanomaterials, tuition in best practice, laboratory support and training, and a suite of protocols for all aspects of nanomaterials processing and characterisation in a biological context; 4. Push beyond the state of the art in nanomaterials processing, labelling and identification and characterisation in situ; 5. Develop novel analytical approaches and tools where most urgently needed to enhance understanding of health and safety issues in nanotechnology; 6. Create a hub to drive the development and implementation of standards across all aspects of nanosafety evaluation and to link with other EU actions (RTD, ERANET, Nanosafety Cluster, OECD, ISO ) and international stakeholders; 7. Look to the future ‐ framed with new scientific communities, and new industry sectors, forging new (safe and responsible) applications of nanoscience and implementations of nanotechnology. QNano will qualitatively change the outcome and potential for successful commercialisation of nano‐enabled products at this critical period of nano‐implementation. QNano is founded on a belief in the potential of nanoscience and nanotechnology. It will therefore look to the future, beyond the legacy of the current debates, and find creative approaches to organising and thinking, implementing new ways to deliver the promise nanotechnology to benefit mankind ‐ safely. The union of nanoscience and living organisms is indissoluble. They have a long way to travel together in the future, as outlined in the vision statement of the European Technology Platform for nanomedicine. Well‐conceived infrastructures to support that journey will give lasting value to European society, and far beyond. Practically speaking, QNano will be an accessible integrated European resource for research, regulatory, and industry (both small and large) developers in nanoscience and nanotechnology. It will harness and integrate existing research expertise and facilities from across the EU member states into a cohesive interdisciplinary entity strongly focussed on scientific excellence and quality of execution in all aspects of nanomaterials processing and characterisation for assessment of their biological and environmental impacts. It has consulted with, and will build in alliance with OECD, ISO, the International Alliance for NanoEHS Harmonisation (www.nanoehsalliance.org), the EU FP7 CSA NanoImpactNet (www.nanoimpactnet.eu), and numerous other national platforms. It will offer a distributed set of transnationally accessible facilities, centrally managed, as with any infrastructure program, but also offer a range of added‐value services to users and stakeholders. These will include high quality (‘approved’) Nanomaterials, Training (and certification) in advanced characterisation methodologies and round robin validated protocols for biological assays, as well as Industry‐oriented support, using flexibly configured distributed ‘hubs’ via which different constituencies can interact. Crucially, these hubs will embed existing (and emerging) core constituencies Compendium of Projects in the European NanoSafety Cluster 243
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Compendium of Projects in the Europ
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EDITED BY Michael Riediker, PD Dr.s
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CONTENTS NanoSafetyCluster - Compen
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Project Acronym ENNSATOX ENPRA EURO
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Foreword NanoSafetyCluster - Compen
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ENNSATOX ENgineered Nanoparticle Im
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The biological membrane and its dep
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distinguishes between the interacti
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Figure 10. Schematic representation
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WP5: • Permeability of NPs in hyd
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NanoSafetyCluster - Compendium 2012
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ENPRA RISK ASSESSMENT OF ENGINEERED
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vitro findings with in vivo models;
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protocols with real biological samp
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and it was organised in the frame o
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First Name Last Name Affiliation Ad
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EURO-NanoTox European Center for Na
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silver nanoparticles, iron nanopart
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The core functions of the Center, h
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8 Directory Table 1 Directory of pe
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HINAMOX Health Impact of Engineered
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High Resolution Electron Microscopy
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integrated risk assessment. Integra
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powders: What is the difference in
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InLiveTox Intestinal, Liver and End
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- to develop and validate a novel m
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environments, IEEE Industrial Elect
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INSTANT Innovative Sensor for the f
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complementary research which will l
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7 Copyright NanoSafetyCluster - Com
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ITS-NANO Intelligent testing strate
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approach to conveying the appropria
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in the discussion. The integration
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MARINA MANAGING RISKS of NANOMATERI
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for risk analysis, these tools need
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environmental ENM toxicity, but tox
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propose it as a Method Validation F
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and SiO2-NM200 and NM203, and a SiO
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ModNanoTox Modelling nanoparticle t
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3) To model environmental exposure
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Nanodetector European Network on th
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measurement interval. Measurements
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5 Directory Table 1 Directory of pe
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NANODEVICE Novel Concepts, Methods,
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ENP in order to be sure of their sa
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4.3 Exploring the association betwe
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NanoFATE Nanoparticle Fate Assessme
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or proteins associated with particu
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sludge. Information on rates of slu
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The exposures to be conducted will
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NanoFATE progression beyond the “
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Timing, hosts and locations of (grouped) events of NanoImpactNet

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