Nano Today
Volume 9, Issue 5, October 2014, Pages 546-549
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A unified framework for nanosafety is needed

https://doi.org/10.1016/j.nantod.2014.07.001Get rights and content

Highlights

  • A research framework that allows the fastest safety assessment across materials.

  • A stepping-stone based research framework allowing stakeholders to identify position.

  • Focus on establishing links between physicochemical, exposure and hazard identifiers.

  • Highlighting cross-cutting key issues dose metrics, high throughput and modelling.

  • Resulting in a coherent and continuously updatable framework supporting regulation.

Summary

There is an urgent need for sufficient knowledge to allow reliable assessment of the risks associated with nanomaterials. The formulation of an intelligent testing strategy (ITS) that allows safety assessment across materials is required to overcome the current need of testing each nanomaterial on a case-by-case basis. By taking into consideration the research landscape, the available tools and the stakeholders involved, the ITS-NANO consortium developed a stepping-stone based research framework which can, when implemented, deliver the information required for flexible and broadly acceptable ITS and risk assessment (RA) protocols. It was identified that in order to derive this knowledge, there needs to be research emphasis on linking physicochemical identifiers to exposure and hazard identifiers, and attention should be given to a number of key cross-cutting issues have been identified which, among other things, include development of standards, dose metrics, high throughput techniques, modelling and integration into regulatory frameworks. Finally, the developed approach must be coherent and continuously updatable, supporting the unified framework required to ensure that we acquire sufficient, rigorously validated knowledge formulation of a robust reliable ITS and RA as quickly as possible.

Section snippets

Acknowledgements

The content of the full ITS-NANO report was supported by stakeholders from across Europe and the USA, including academia, industry, regulators, foundering bodies, and NGO's. A full list of contributors can be found at http://www.nano.hw.ac.uk/research-projects/itsnano.html. The activities leading to the following results have received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 290589 (ITS-NANO).

Janeck J. Scott-Fordsmand, PhD, has 20 years of experience in ecotoxicology research and on advising EPAs in several countries, the Nordic Council, EU and OECD regarding test guidelines and guidance documents on intelligent testing strategies and risk assessment of chemicals. He is presently co-leading leader in various nano activities in European projects, European Nanosafety Cluster, and Communities of Research activities.

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Janeck J. Scott-Fordsmand, PhD, has 20 years of experience in ecotoxicology research and on advising EPAs in several countries, the Nordic Council, EU and OECD regarding test guidelines and guidance documents on intelligent testing strategies and risk assessment of chemicals. He is presently co-leading leader in various nano activities in European projects, European Nanosafety Cluster, and Communities of Research activities.

Stefano Pozzi Mucelli, PhD, is currently EU Thematic Lead for ICT and Engineering at Queen's University Belfast. Before this position, he managed for six years the activities of the Risk Assessment Technology Unit within Veneto Nanotech, focussing on the areas of policy making in nanosafety and sustainable technology transfer of engineered nanomaterials.

Prof Lang Tran is Director of Quantitative Toxicology of the IOM, an active researcher in the field of particle toxicity. He is the co-editor of the books Nanotoxicology: Characterization, Dosing and Health Effects (2007), and Nanotoxicology: Progress Towards Nanomedicine (2014). He is also the editor of the Journal Nanotoxicology and Particle and Fiber Toxicology.

Karin Aschberger is a scientific project officer at the Nanobiosciences Unit, Joint Research Centre (Ispra) of the European Commission. She has a background in Nutrition, Biochemistry and Toxicology from the University of Vienna (Austria). She has been working as a regulatory toxicologist for > 15 years, dealing with the human health risk assessment of chemicals and nanomaterials.

Stefania Sabella has a broad range of experimental experience in fields such as analytical chemistry and nano-biotechnology. In the last years, her main research interests were focused on understanding the mechanisms governing nanoparticle-cell interactions and the relationship of the NP physical-chemical properties to the induced biological effects. She has published about 30 articles, 2 book chapters and is the inventor of 5 patents.

Ulla Vogel, professor and head of Danish Centre for Nanosafety, National Research Centre for the Working Environment. Professor at National Food Institute, Technical University of Denmark 2008-2010, professor at NRCWE 2010-, adjunct professor at DTU Nanotech, Technical University of Denmark 2011-. She has worked with nanotoxicology since 2005 and has published more than 240 papers.

Dr Craig Poland is Senior Research Toxicologist within the SAFENANO section at the IOM and has a BSc (Hon), MSc, and a PhD in Nanotoxicology. His principle areas of expertise are particle and fibre toxicology, experimental in vitro and in vivo assessment of particle toxicity and integration of hazard data into risk evaluation.

Dominique Balharry, PhD, is a Research Toxicologist at the IOM, with expertise in human toxicology using in vitro techniques. Dominique's research started in the field of pulmonary toxicogenomics, and has since focused on toxicology and its application to hazard and risk assessment, in particular, nanotoxicology, in vitro alternatives, identification of hazard biomarkers, mechanisms of toxicity, and high level gap analysis.

Teresa F Fernandes is Prof of Environmental Science at Heriot-Watt University, Edinburgh, UK, where she teaches and investigates the impacts of a variety of chemicals and human activities on natural communities and the environment. She has 20 years of experience in academia and has published over 80 refereed publications.

Dr. Stefania Gottardo, Ph.D. in Environmental Sciences, Ca’ Foscari University Venice, Italy. She is an expert on environmental risk assessment of chemicals, including nanomaterials. She has contributed to several EU projects (MARINA, ITS-NANO, ENPRA, and MODELKEY) and policy initiatives (e.g. NANO-SUPPORT). Her research interests are in application of non-conventional tools such as Multi Criteria Decision Analysis.

Steve Hankin is Head of the SAFENANO unit at the Institute of Occupational Medicine (IOM) and a Senior Consultant in Risk Assessment. He is a Chartered Scientist with a BSc and PhD in Chemistry and diplomas in Medical Toxicology and Epidemiology. He provides expertise in nanotechnology risk to industry, academia, regulators and policy makers.

Mark G.J. Hartl is Associate Professor in Marine Biology at Heriot-Watt University. His main research interests are focused on the impact of pollution in the marine environment and the development of biomarkers of exposure in marine organisms, in particular for engineered nanomaterials, microplastics and associated contaminants.

Nanna B. Hartmann (MSc Eng, PhD) has previously worked at the Institute of Health and Consumer Protection at the Joint Research Centre of the European Commission. She is currently a postdoctoral researcher at the Department of Environmental Engineering, Technical University of Denmark. She is a specialist in environmental risk assessment of nanomaterials with focus on ecotoxicological testing.

Danail Hristozov, Senior Scientist, Department of Environmental Sciences, Informatics and Statistics of University Ca’ Foscari Venice in Italy. He is performing integrative research across the fields of risk assessment and governance of nanomaterials. Prior to this he worked at Malsch Techno Valuation, the Netherlands, specializing in Technological Assessment of emerging technologies.

Dr. Kerstin Hund-Rinke is ecotoxicologist and is working at the Fraunhofer Institute for Molecular Biology and Applied Ecology, Germany. She deals with nanomaterials, chemicals, pesticides, biocides and their bioavailability as well as with the evaluation of soil quality. She is involved in various national and international projects/joint projects.

Helinor J works in the Nano-Safety Group at Heriot-Watt University (Edinburgh) and specialises in the assessment of nanomaterial toxicity to human health and the environment. HJ was previously employed in the Chemicals and Nanotechnologies division, UK Department for Environment, Food and Rural Affairs (Defra) as a scientific advisor. Her PhD investigated the hepatic toxicity of nanomaterials (Edinburgh, Napier University).

Prof. Antonio Marcomini is leader of the Environmental chemistry and risk assessment unit and director of the Department of Environmental Sciences, Informatics and Statistics, University Ca’ Foscari Venice. Author/co-author of over 200 papers, H-index 38; more on http://www.unive.it/nqcontent.cfm?a_id=138224.

Oliver Panzer has a diploma in physics from the University of Münster, where he worked five years as graduate researcher before being seconded to the European Commission as National Expert. Here he was responsible for topics related to nano-biology, nano-medicine, and nano-analytics. Since 2007 he is director of a consultancy for international research projects, the European Research Services GmbH.

Dr. Davide Roncato, graduated in Materials Science at Turin University with thesis on “Hydrogen storage in intermetallic compound”. In CRF he's working on different activities about innovative polymers, innovative composites materials and hybrid structures metal/plastic. He is also involved in materials characterization and validation activities. He works also on public founding projects. He is author of two scientific papers.

Anne Thoustrup Saber (Ph. D. health sciences, 2006) is senior researcher at the National Research Centre for the Working Environment. She has worked in the field of particle- and nanotoxicology since 2000 and with inhalation toxicology since 2002. The main focus of her research is to investigate the toxicological effects of adding nanomaterials to composites.

Håkan Wallin is a professor in Occupational Toxicology at National Research Centre, and at the Institute of Public Health, Copenhagen University. He received his PhD from Lund University, Sweden and has been researcher at Columbia University, Institute of Cancer Research (1985-86), the Norwegian Institute of Public Health (1986-1990), and the Danish Cancer Society (1990-1995). He is chief editor of the journal Nanotoxicology.

Vicki Stone is a Professor of Toxicology at Heriot-Watt University, Edinburgh, UK, where she is director of the NanoSafety Research Group and Deputy Director of the School of Life Sciences. Vicki coordinated the EU project ITS-NANO and participates in the projects SUN, Quality Nano, Nanomicex and Nanochop.

1

Current affiliation: Technical University of Denmark, Denmark.

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