title: The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials.
abstract: An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720 BA, The Netherlands. Peter.Bos@rivm.nl.
authors.forename: Peter M J
authors.initials: PM
authors.lastname: Bos
authors.affiliation: European Commission, Joint Research Centre, Via E. Fermi 2749, Ispra (VA) 21027, Italy. Stefania.GOTTARDO@ec.europa.eu.
authors.forename: Stefania
authors.initials: S
authors.lastname: Gottardo
authors.affiliation: Department of Bioscience, Aarhus University, Vejlsøvej 25, PO Box 314, Silkeborg 8600, Denmark. jsf@bios.au.dk.
authors.forename: Janeck J
authors.initials: JJ
authors.lastname: Scott-Fordsmand
authors.affiliation: Institute of Occupational Medicine, Centre for Human Exposure Science (CHES), Research Avenue North, Riccarton, Edinburgh EH14 4AP, UK. Martie.VanTongeren@iom-world.org.
authors.forename: Martie
authors.initials: M
authors.lastname: van Tongeren
authors.affiliation: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, c/o VEGApark, Via delle Industrie 21/8, Marghera (VE) 30175, Italy. Semenzin@unive.it.
authors.forename: Elena
authors.initials: E
authors.lastname: Semenzin
authors.affiliation: School of Life Sciences, Heriot-Watt University, Edinburgh EH14 4AS, UK. T.Fernandes@hw.ac.uk.
authors.forename: Teresa F
authors.initials: TF
authors.lastname: Fernandes
authors.affiliation: Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, c/o VEGApark, Via delle Industrie 21/8, Marghera (VE) 30175, Italy. Danail.Hristozov@unive.it.
authors.forename: Danail
authors.initials: D
authors.lastname: Hristozov
authors.affiliation: Fraunhofer Institute for Molecular Biology and Applied Ecology, Auf dem Aberg 1, Schmallenberg 57392, Germany. Kerstin.Hund-Rinke@ime.fraunhofer.de.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Hund-Rinke
authors.affiliation: The REACH Centre, Gordon Manley Building, Lancaster Environment Centre, Lancaster University, Lancaster LA1 4YQ, UK. N.Hunt@thereachcentre.com.
authors.forename: Neil
authors.initials: N
authors.lastname: Hunt
authors.affiliation: Experimental Toxicology and Ecology, BASF SE, GB/TB-Z470, Ludwigshafen 67056, Germany. muhammad-adeel.irfan@basf.com.
authors.forename: Muhammad-Adeel
authors.initials: MA
authors.lastname: Irfan
authors.affiliation: Experimental Toxicology and Ecology, BASF SE, GB/TB-Z470, Ludwigshafen 67056, Germany. robert.landsiedel@basf.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Landsiedel
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720 BA, The Netherlands. Willie.Peijnenburg@rivm.nl.|Centre for Environmental Sciences, University Leiden, PO Box 9518, 2300 RA Leiden, The Netherlands. Willie.Peijnenburg@rivm.nl.
authors.forename: Willie J G M
authors.initials: WJ
authors.lastname: Peijnenburg
authors.affiliation: Institute of Occupational Medicine, Centre for Human Exposure Science (CHES), Research Avenue North, Riccarton, Edinburgh EH14 4AP, UK. Araceli.Sanchez@iom-world.org.
authors.forename: Araceli
authors.initials: A
authors.lastname: Sánchez Jiménez
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720 BA, The Netherlands. peijnenburg@cml.leidenuniv.nl.
authors.forename: Petra C E
authors.initials: PC
authors.lastname: van Kesteren
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, Bilthoven 3720 BA, The Netherlands. Petra.van.Kesteren@rivm.nl.
authors.forename: Agnes G
authors.initials: AG
authors.lastname: Oomen
mesh_terms: D003625:Data Collection; D004781:Environmental Exposure / Q000009:adverse effects*; D006801:Humans; D008962:Models, Theoretical; D053758:Nanoparticles / Q000009:adverse effects*; D049329:Nanostructures / Q000009:adverse effects*; D018570:Risk Assessment / Q000379:methods*; D012308:Risk Management / Q000379:methods*
keywords: exposure-driven; nanomaterials; problem framing; risk assessment strategy