title: Frameworks and tools for risk assessment of manufactured nanomaterials.
abstract: Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainties, it is necessary to generate sound scientific data on hazard and exposure by means of relevant frameworks and tools. The development of such approaches to facilitate the risk assessment (RA) of MNs has become a dynamic area of research. The aim of this paper was to review and critically analyse these approaches against a set of relevant criteria. The analysis concluded that none of the reviewed frameworks were able to fulfill all evaluation criteria. Many of the existing modelling tools are designed to provide screening-level assessments rather than to support regulatory RA and risk management. Nevertheless, there is a tendency towards developing more quantitative, higher-tier models, capable of incorporating uncertainty into their analyses. There is also a trend towards developing validated experimental protocols for material identification and hazard testing, reproducible across laboratories. These tools could enable a shift from a costly case-by-case RA of MNs towards a targeted, flexible and efficient process, based on grouping and read-across strategies and compliant with the 3R (Replacement, Reduction, Refinement) principles. In order to facilitate this process, it is important to transform the current efforts on developing databases and computational models into creating an integrated data and tools infrastructure to support the risk assessment and management of MNs.
authors: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, c/o PST Vega di Venezia - Via della Libertà 12, 30175 Marghera (VE), Italy. Electronic address: danail.hristozov@unive.it.
authors: Danail
authors: D
authors: Hristozov
authors: European Commission's Joint Research Centre, Via E. Fermi 2749, 21027 Ispra, Italy. Electronic address: Stefania.GOTTARDO@ec.europa.eu.
authors: Stefania
authors: S
authors: Gottardo
authors: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, c/o PST Vega di Venezia - Via della Libertà 12, 30175 Marghera (VE), Italy. Electronic address: semenzin@unive.it.
authors: Elena
authors: E
authors: Semenzin
authors: National Institute of Public Health & the Environment (RIVM), P.O. Box 1, 3720, BA, Bilthoven, The Netherlands. Electronic address: agnes.oomen@rivm.nl.
authors: Agnes
authors: A
authors: Oomen
authors: National Institute of Public Health & the Environment (RIVM), P.O. Box 1, 3720, BA, Bilthoven, The Netherlands. Electronic address: peter.bos@rivm.nl.
authors: Peter
authors: P
authors: Bos
authors: National Institute of Public Health & the Environment (RIVM), P.O. Box 1, 3720, BA, Bilthoven, The Netherlands. Electronic address: willie.peijnenburg@rivm.nl.
authors: Willie
authors: W
authors: Peijnenburg
authors: Centre for Human Exposure Science, Institute of Occupational Medicine, Research Avenue, North, Riccarton, Edinburgh, EH14 4AP, Scotland. Electronic address: Martie.VanTongeren@iom-world.org.
authors: Martie
authors: M
authors: van Tongeren
authors: EMPA-Swiss Federal Laboratories for Materials Science and Technology, Technology and Society Laboratory, CH-9014 St. Gallen, Switzerland. Electronic address: nowack@empa.ch.
authors: Bernd
authors: B
authors: Nowack
authors: The REACH Centre, Lancaster Environment Centre, Lancaster University, Lancaster, Lancashire, LA1 4YQ, United Kingdom. Electronic address: n.hunt@thereachcentre.com.
authors: Neil
authors: N
authors: Hunt
authors: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, c/o PST Vega di Venezia - Via della Libertà 12, 30175 Marghera (VE), Italy. Electronic address: andrea.brunelli@unive.it.
authors: Andrea
authors: A
authors: Brunelli
authors: Department of Bioscience-Terrestrial Ecology, Aarhus University, Vejlsøvej 25, 8600 Silkeborg, Denmark. Electronic address: jsf@bios.au.dk.
authors: Janeck J
authors: JJ
authors: Scott-Fordsmand
authors: Centre for Human Exposure Science, Institute of Occupational Medicine, Research Avenue, North, Riccarton, Edinburgh, EH14 4AP, Scotland. Electronic address: lang.tran@iom-world.org.
authors: Lang
authors: L
authors: Tran
authors: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, c/o PST Vega di Venezia - Via della Libertà 12, 30175 Marghera (VE), Italy. Electronic address: marcom@unive.it.
authors: Antonio
authors: A
authors: Marcomini
mesh_terms: D003198:Computer Simulation; D004777:Environment; D004782:Environmental Health; D006801:Humans; D049329:Nanostructures / Q000009:adverse effects*; D036103:Nanotechnology; D018570:Risk Assessment / Q000379:methods*; D012308:Risk Management
keywords: Frameworks; Nanomaterials; Risk assessment; Tools