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NanoSafetyCluster - Compendium 2012 4 Application of validated methods to risk (RA) and life cycle assessment (LCA) 5 Development of reference methods and certified reference materials 6 Case studies to assess the feasibility of validated methods 7 Dissemination, exploitation, training, networking and clustering 8 Scientific coordination 5 Status of the project Work package 4 (WP4) will evaluate the potential of the methods selected under WP3 to perform hazard and risk assessment (HA and RA) and life cycle analyses (LCA) for the ENMs selected and characterized under WP2. This includes the refinement of test strategies for HA, RA and LCA with regard to ENP, as the respective procedures are developed for chemicals and may need modification/adaptation to deliver meaningful results for ENPs. From the results of HA, RA and LCA, feedback is given to WP5 regarding potential hazards and risks of ENPs as well as to WP6 regarding applicability of test methods validated and selected under WP3. Work package 5 (WP5) will provide reference methods and materials (Certified Reference Materials, CRM) for toxicological testing, ENP exposure assessment, assessment of the ENP impact on human and environmental health in order to underpin hazard and risk assessment related to new and known ENPs. Methods identified under WP2 and validated under WP3 will be evaluated for their potential to be developed as reference methods for a special task. Reference methods developed under WP5 will be specifically characterized by uncertainty considerations and traceability. Traceability for measurands will be established through certified reference materials (CRM) when possible. For those measurands where no CRM is available and for method-defined measurements (which are often in use in the toxicology community), comparability will be established by method specific convention parameters. Agreed convention parameters will be obtained through inter-laboratory comparisons. The goal is to “deliver” these reference methods, which will provide reproducible and comparable data, for use under WP4 and WP6 activities. Finally WP5 results will directly underpin standardization activities under WP7. Work package 6 (WP6) will perform case studies to assess the feasibility of validated methods by applying a battery of test systems and modelling tools to assess the safety of nanomaterials in real and simulated working environments. Tests will be either on-site or will use collected materials to be tested in participating laboratories. The case studies will also include accident simulations to develop proper risk management systems. They will allow making of specific recommendations for managing risks deriving from engineered nanoparticles. These recommendations will be set down in the form of reports, good practice documents and guidelines. Work package 7 (WP7) will provide the project results in a suitable format for the wider community to access and use; through regular news and information streams, reports, new standardized protocols, training events, and networking opportunities. It will also afford the wider community (industry, academia, regulatory agencies, relevant NGOs) the opportunity to interact with the consortium and influence the development of the consortium’s work. Work package 8 (WP8) will use measures to ensure a high performance quality of the tasks and methodology, equipment and required expertise, to reach scientific objectives by the methods described and developed in WP2-6 (see below) according to the work programme and within the time schedule. The scientific coordinator will produce a quarterly update report on the scientific-technical work in close cooperation with the responsible Work Package Leaders, review and evaluate achievements, and make them immediately available to all project partners by means of short protocols summarizing main results, progress and problems. NanoValid has started on 1 November 2011 and was launched by a kick-off meeting in Rome, Italy, on 16-17 November 2011. This first meeting was coordinated with the kick-off meeting of the EU FP7 MARINA project. Both NanoValid and MARINA discussed during a joint meeting on 18 November 2012 a common strategy to coordinate and synchronize the planned R&D activities, and agreed upon a common action plan to effectively use existing synergies, share data and test materials, and to organize common dissemination events. Currently (January 2012), an intensive discussion is going on among NanoValid partners, and with MARINA, on the selection and fabrication of a first group of test materials, in accordance with Annex I of the Grant Agreement (Description of Work). The next regular project meeting is planned on 8-9 May 2012 at the National Research Centre for the Working Environment (NRCWE) in Copenhagen, Denmark, followed by a joint session with the EU FP7 NanoSustain project (www.nanosustain.eu), as about half of the members of the NanoSustain consortium (including the hosting partner NRCWE) are also involved in NanoValid and as 210 Compendium of Projects in the European NanoSafety Cluster
oth projects are managed by the same coordinator (Rudolf Reuther NOMI). A half-day common meeting is planned between these two EU FP7 projects in the afternoon of 9 May 2012, to share experiences, exchange data and expertise, and discuss possible ways to cooperate. 6 Expected impact The project aims to compare and validate current test methods, and if necessary modify and adapt these methods, and/or develop new methods for reliable measurement and testing to improve exposure and risk assessment as well as life cycle analysis of nanoscale materials, with the ultimate goal of establishing reference methods and materials. To achieve these objectives, the project will implement a comprehensive inter-laboratory, intercomparison and intercalibration campaign between all participating laboratories and a set of case studies to assess the feasibility of the established methods. It is a first step in the generation of reliable quantitative data on the toxicology and ecotoxicology of nanomaterials and the development of accurate methods required to generate the data. The validated methods and new knowledge developed will trigger a step change in the early scientific assessment of potential health, safety and environmental risks associated with nanotechnology-based materials and associated products. It will help to meet existing regulatory requirements and/or develop new legal requirements for safe, responsible and sustainable development. As a major outcome, the project will provide a set of reliable (prestandardization) protocols and reference methods that are applicable to a wide range of NPs for early hazard identification, risk assessment and the design of sustainable solutions for safe production, use and disposal of ENMs. NanoValid will generate a comprehensive knowledge and database on the intrinsic properties of particular ENMs and associated ENPs and will contribute to a better mechanistic understanding of their behaviour in various test media, physiological solutions and environmental matrices. The generation of scientifically sound and well-defined reference tools will support standardization efforts to characterize ENPs and their potential effects and hence improve current test schemes for risk management, reduction and monitoring. Providing reliable methods for RA and LCA of ENPs, including new in vitro cell panels and other models to assess their bioaccumulation, persistence and bioavailability will help to identify problematic materials early on, which in turn will stimulate the development of safe production processes, novel properties and innovative sustainable products („green nanotechnology“). The proposed toxicological work will address critical issues, such as the validation of current standardized in vitro tests, the follow up of biodistribution, persistence and bioaccumulation of NPs, tracing of NP excretion or immune effects as well as possible genotoxicity and effects on sensory organs or neural tissue. Results from NP testing will contribute to new conceptual and experimental standards for toxicity testing by in vitro test systems, which in turn helps to reduce animal testing. New knowledge on the toxicity of ENMs to particle-ingesting organisms and to those not internalizing NPs, and on mechanisms that control particle solubility and bioavailability, will help to improve the applicability of current RA and LCA systems to NPs. The detection and evaluation of a wide range of different ENMs NanoSafetyCluster - Compendium 2012 under various laboratory and field conditions by various measurement and testing methods will enhance and extend our current understanding of the true nature of the solution, dispersion and agglomeration/aggregation behaviour, persistence and fate of ENMs. NanoValid will develop standardized procedures for labelling and dispersing nanoparticles prior to toxicological testing, which will allow accurate tracing and the conversion of test materials that have been developed and fabricated into standardized stable nanoparticle suspensions. The development of reference methods and materials will support pre and co-normative activities, such as those required for the implementation of REACH and other relevant EU legislation. It will assist current policy and future decision making, to meet increasing regulative requirements in nanotechnology and the need of relevant stakeholders, such as public authorities, industry, researchers and citizens. Finally, a more reliable measurement, characterization and toxicological assessment of ENMs will support good governance in research and industry and contribute to the future definition of appropriate measures and guidelines in line with the precautionary principle. 7 Dissemination and exploitation strategy The NanoValid work programme has the aim of developing a number of new collecting, characterizing, and testing methodologies. A number of these have clear commercialization opportunities. Through the participation of industrial partners and partners that have an established background in the commercialization of new devices, it is expected that project results will lead to: standardized test materials that can be used by different industries to validate the physicochemical properties of ENMs they manufacture or purchase; novel ENP samplers, e.g. for hot gases; novel real-time collection and assessment devices which collect airborne ENPs and assay them on an integrated biomodule, thus addressing issues of bioactivity and transport, and ensuing loss or change of reactivity and physical properties; a multi-compartment cell barrier model to mimic physiological systems and provide a more realistic evaluation of ENP fate and effect in living organisms; novel environmental models to determine the fate and effect of ENMs to post consumer, that can be employed by different manufacturers to comply with new regulations. NanoValid is presently establishing (January 2012) a dedicated project website (www.nanovalid.eu) and database, through which project results will be available, and the wider community can be engaged (through feedback and discussion fora). In addition, it will target stakeholders through newsletters and press-releases, and actively engage with individuals through a series of physical and online events. To ensure all relevant stakeholders are reached, the consortium will leverage its own substantial networks and individual membership of international committees and associations. This takes advantage of the range represented in the consortium: academic organizations, industrial SMEs and large- Compendium of Projects in the European NanoSafety Cluster 211
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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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