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NanoSafetyCluster - Compendium 2012 28 Technical University of Denmark (DTU) Denmark University 29 ACCIONA (ACC) Spain Industry 30 Venice Research Consortium (CVR) Italy Research Organisation 31 The REACH Centre Ltd (TRC) United Kingdom SME 32 Karolinska Institute (KTH) Sweden University 33 National Center for Nanoscience and Technology, Chinese Academy of Sciences (NCNT) China Research Organisation 34 Institute of Biochemistry, Russian Academy of Sciences (INBI) Russia University 35 University of Parma (UP) Italy University 36 Tor Vergata University Roma 2 (TVUR) Italy University 37 Edinburgh Napier University (Napier) United Kingdom University 38 Ludwig-Maximilians-Universität München (LMU) Germany University 39 University of Plymouth (UoP) United Kingdom University 40 The Food and Environment Research Agency (FERA) United Kingdom Research Organisation 41 University of Birmingham (BHAM) United Kingdom University 42 University of Tübingen Germany University 43 Nofer Institute of Occupational Medicine (NIOM) Poland Research Organisation 44 Institut universitaire romand de Santé au Travail (IST) Switzerland Research Organisation 45 NANOCYL sa (Ncyl) Belgium SME 46 National Institute for Materials Science (NIMS) Japan Research Organisation 47 Heriot Watt University (HWU) UK University Contents 1 Concept ....................................................................................... 66 2 Objectives ................................................................................... 67 3 The MARINA approach .............................................................. 67 4 Progress beyond the state-of-the-art ........................................ 68 4.1 The state-of-the-art ................................................................. 68 1 Concept Nanotechnology is recognised as one of the most important new technologies of the 21 st century. The global investment in nanotechnology from all public sources for 2008 exceeds $7 billion 1 . The market size for nanotechnology is expected to grow to over $3 trillion by 2015 2 and nanotechnology promises new materials for industrial applications by having new or enhanced physicochemical properties that are different in comparison to their micron-sized counterparts. However, as in all industrial applications, the potential exposure of humans and the 4.2 Beyond the state-of-the-art .................................................... 69 5 Impact .......................................................................................... 71 6 References .................................................................................. 73 7 Copyright .................................................................................... 74 environment to these materials is inevitable. As these new materials go through their life-cycle – from development, to manufacture, to consumer usage, to final disposal – different human groups (workers, bystanders, users) environmental compartments, (air, soil, sediment, water), and species (e.g. worm, fish or human through secondary exposure), will be exposed to them. Emerging data show a range of toxic (hazardous) effects from engineered nanoparticles, suggesting that any exposure will result in a risk to human health or the environment, risk being the product of exposure and hazard... While standard methods exist 66 Compendium of Projects in the European NanoSafety Cluster
for risk analysis, these tools need to be applied, modified and verified for nanomaterials. Previously used standard approaches to risk management, control and reduction need to be proven for the novel paradigm presented by nanomaterials. Thus, the development of nanotechnology-based products needs to be complemented with appropriate validated methods to assess, monitor and reduce the potential risks of engineered nanomaterials (ENM) to human health and the environment. Public mistrust of any new technology is often high, and demonstrating ‘safe’ products of nanotechnology will enhance the confidence of consumers, workers and other stakeholders. Furthermore, these measures must be validated and integrated in an overarching, coherent strategy for regulators and industry to adapt them. Thus, a safe and environmentally responsible nanotechnology will safeguard current and future global investments and will be the key to the sustainability of this industry. While there are standard procedures for product life cycle analysis, exposure, hazard, and risk assessment for traditional chemicals, is not yet clear how these procedures need to be modified to address all the novel properties of nanomaterials. There is a need to develop specific reference methods for all the main steps in managing the potential risk of ENM. The aim of MARINA is to develop such methods. MARINA will address the four central themes in the risk management paradigm for ENM: Materials, Exposure, Hazard and Risk. The methods developed by MARINA will be (i) based on beyond-state-of-the-art understanding of the properties, interaction and fate of ENM in relation to human health and the quality of the environment and will either (ii) be newly developed or adapted from existing ones but ultimately, they will be compared/validated and harmonised/standardised as reference methods for managing the risk of ENM. MARINA will also develop a strategy for Risk Management including monitoring systems and measures for minimising massive exposure via explosion or environmental spillage 2 Objectives The specific objectives of MARINA are: 1. For Materials, to obtain reference nanomaterials for testing; to develop validated methods for characterising the physicochemical properties of ENM as pristine materials, in biological matrices, in environmental samples and field detection; to isotope-label ENM for their use in bio-distribution studies 2. For Exposure, to conduct exposure assessment in the workplace throughout the life-cycle of a ENM, developing different exposure scenarios. To assess the fate and behaviour of ENM in soil/sediment/water. To characterize the actually released ENM (aged ENM) and compare them to the pristine ENM. To evaluate, as part of a performance assessment, different approaches to conduct exposure assessment for use in the MARINA integrated risk assessment. 3. For Hazard, to address the knowledge gap, especially in areas of non-genomic toxic mechanisms, toxicogenomics, proteomics NanoSafetyCluster - Compendium 2012 and metabolomics by developing new test systems; to develop reference methods for in vitro toxicology tests (including and fully incorporating those developed in other FP projects) by means of a scientific validation strategy; to implement in vivo dose-response models of healthy and susceptible subjects exposed through repeated dosing to ENM via inhalation, ingestion, intravenous injection and dermal exposure; to develop and scientifically validate in vitro and in vivo tests for soil/sediment/aquatic toxicity and secondary poisoning. 4. For Risk, to combine phase (1), (2) and (3) in developing reference methods for assessing the health and environmental risk posed by ENM; to develop a strategy for Risk Management including onitoring systems and measures for minimising massive exposure via explosion or environmental spillage. MARINA is to achieve the objectives described above in 48 months. 3 The MARINA approach The European Commission, to date, has funded some 15 projects relevant to health and safety issues regarding ENM. This commitment is set to continue in the future. At the national level, there are other similar efforts 3,4 . However, to date, the valuable results generated from these projects have in the main been unabled to generate concepts, methodology and data which have been practically used for risk assessment and management.. Thus, there is clearly a need to use the most up-to-date date available information and methodology for guidance on health and safety risk management to industry and regulators. To respond to this need, in MARINA, we have created a consortium consisting of first class scientists and organisations with a track records for research in Health and Safety Issues of ENM. Most importantly, • we have representatives from more than ten FP projects 1 . Our aim is to take the beyond the state-of-the-art results from these projects and use them for creating validated reference tools for Risk Assessment and Management • we recognise the relevance of our results to industry therefore we have involved the direct participation of the Nanotech Industries Association 2 and industrial key partners such as BASF and Nanocyl. • we also recognised the geopolitical and economical 1 The FP projects are: FP6 PARTICLE_RISK, NANOSH, NANOINTERACT, NANOSAFE2, FP7 NANOMMUNE, NANOTEST, ENPRA, NEURONANO, NANODEVICE, NANOLYSE, NANOIMPACTNET, NANEX, ENNSATOX, NANOFATE, NANOHOUSE and ObservatoryNANO. 2 NIA is also involved in another proposal on the same call (NMP.2010.1.3-1: NanoREFORM); this involvement allows the establishment of added-value components to both projects and benefits the nanotechnology research and industries community:. Compendium of Projects in the European NanoSafety Cluster 67
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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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