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Performance testing, calibration and implementation of a next generation system-of-systems Risk Governance Framework for nanomaterials


D.3.3 Report on improvements of environmental risk assessment models and user guidance

This report will contain the results from the model refinement for the environmental risk assessment methods identified in D3.2 so that they are suitable for the needs of decision holders and practical guidance to a.o. stakeholders on the use of (refined/improved) existing hazard/risk models along the stage gate Cooper innovation chain.

Results from the demonstration of the Risk Governance framework

The entire SoS Nano-Risk Framework will be demonstrated using comprehensive case studies collated in WP6.

Document on quality criteria for data

This deliverable will describe quality criteria for data. The data requirements defined in D 5.1 will form the basis of the methodology of quality labelling.

Results of gap analysis

This deliverable is a document containing a) a list of the available information collected from task 5.2, b) a list of the information needed for calibration of the selected risk assessment models (input from WP2-4), and c) a description of the gaps that exist and need to be filled.

caLIBRAte summary report of annual dissemination and communication activities

Annual updates foreseen. Each year, the project will compile an overview of all outreach activities conducted under the auspices of caLIBRAte. This will ensure the project is continuing to meet the dissemination objectives outlined at its commencement. In addition, it will provide the consortium with a clear view of what activities must still be conducted in the following years in order to meet project obligations.

Inventory of existing value-chain case-studies

This deliverable will map/catalogue existing cases studies for NM and NM-enabled products, their production, downstream use and waste handling, focusing on those where exposure/release is considered a possibility. Information will be collated from finished and ongoing EU projects and also from literature. Value-chain case studies will be categorized in different levels in line with the rest of the project (e.g., sector covered, environmental compartments affected, applicable existing Tools).

Report addressing the compilation of omics data sets, network inference and benchmarks for gap identification

This report will give the results of the evaluation of the evaluation of data sets and the applicability of innovative hazard methods in the hazard and risks assessment methods in each of the stages.

Comprehensive analysis of available tools and methodologies for Horizon Scanning

The deliverable is the outcome of the Task 1.2, and it will report a catalogue and mapping of available tools for horizon scanning together with a comprehensive analysis identifying gaps and overlaps of the past’s efforts.

Plan for dissemination, implementation and exploitation

Two versions of the plan will be produced. The first will be internal and will provide guidance to the partners on protection and exploitation of IPR and the project’s data management plan. The second will be external and will be used to communicate the measures of success or the project. The plan will be updated with dissemination activities and outcomes. Annual updates foreseen.

Complete list of requirements for a nano-specific risk governance framework

This deliverable will report the outcomes of the Task 8.1, and it will list the outcomes of surveys, literature reviews, and workshops for identifying key requirements and functionalities of the SoS Risk Governance approach.

Integrated HRA models, in the format of a suite of computational models and written guidance documentation

This deliverable builds further upon D2.3 and D2.4. It extents the practical guidance drafted under deliverable D2.3 with possible improvements by inclusion of more innovative approaches. In addition, this deliverable may also consist of practical computational models, that are specific to certain stage-gates This deliverable is the ultimate product delivered by WP2, near the end of the project and involves the integration of existing and possibly novel innovative hazard, exposure and risk assessment approaches, as well as the practical guidance for use along the stage-gate model.

caLIBRAte decision support tools

The decision support tool (DSS) is the core of this deliverable and is further developed based on results from the SUN project. It will enable the end-user to make decisions based on the existing input of different stakeholders and enhance communication through the applicability to experts and non-experts alike.

Review article with completed evaluation and guidance on prioritisation of innovative hazard exposure and risk assessment models towards applications in the stage-gate model

This deliverable consists of a scientific review in which novel approaches (that are e.g. not contained in existing methods listed under D2.2 for which practical guidance is provided in D2.3) are described, discussed and prioritized towards (future) application in the stage-gate model.

caLIBRAte logo and website

This deliverable will provide branded resources for use by the project and its partners. The website will be used as a tool to provide information to interested stakeholders and to build engagement with them. The website will eb delivered by month 6.

Project webinars on project website and social media

Update foreseen month 36. The project webinars will be delivered under Task 9.4 and used as a means of disseminating the project outcomes through social media. The webinars will be especially useful for non-experts. They will feature experts drawn from within the project partners to highlight and show the work that they are delivering.


INfORM: Inference of NetwOrk Response Modules

Author(s): Veer Singh Marwah, Pia Anneli Sofia Kinaret, Angela Serra, Giovanni Scala, Antti Lauerma, Vittorio Fortino, Dario Greco
Published in: Bioinformatics, 2018, ISSN 1367-4803
Publisher: Oxford University Press
DOI: 10.1093/bioinformatics/bty063

Directions in QPPR development to complement the predictive models used in risk assessment of nanomaterials

Author(s): Joris T.K. Quik, Martine Bakker, Dik van de Meent, Mikko Poikkimäki, Miikka Dal Maso, Willie Peijnenburg
Published in: NanoImpact, Issue 11, 2018, Page(s) 58-66, ISSN 2452-0748
Publisher: Elsevier
DOI: 10.1016/j.impact.2018.02.003

Toxic and Genomic Influences of Inhaled Nanomaterials as a Basis for Predicting Adverse Outcome

Author(s): Penny Nymark, Pekka Kohonen, Vesa Hongisto, Roland C. Grafström
Published in: Annals of the American Thoracic Society, Issue 15/Supplement_2, 2018, Page(s) S91-S97, ISSN 2325-6621
Publisher: American Thoracic Society
DOI: 10.1513/AnnalsATS.201706-478MG

Network Analysis Reveals Similar Transcriptomic Responses to Intrinsic Properties of Carbon Nanomaterials in Vitro and in Vivo

Author(s): Pia Kinaret, Veer Marwah, Vittorio Fortino, Marit Ilves, Henrik Wolff, Lasse Ruokolainen, Petri Auvinen, Kai Savolainen, Harri Alenius, Dario Greco
Published in: ACS Nano, Issue 11/4, 2017, Page(s) 3786-3796, ISSN 1936-0851
Publisher: American Chemical Society
DOI: 10.1021/acsnano.6b08650

Dip coating of air purifier ceramic honeycombs with photocatalytic TiO 2 nanoparticles: A case study for occupational exposure

Author(s): Antti Joonas Koivisto, Kirsten Inga Kling, Ana Sofia Fonseca, Anders Brostrøm Bluhme, Marcel Moreman, Mingzhou Yu, Anna Luisa Costa, Baldi Giovanni, Simona Ortelli, Wouter Fransman, Ulla Vogel, Keld Alstrup Jensen
Published in: Science of The Total Environment, Issue 630, 2018, Page(s) 1283-1291, ISSN 0048-9697
Publisher: Elsevier BV
DOI: 10.1016/j.scitotenv.2018.02.316

Testing the performance of one and two box models as tools for risk assessment of particle exposure during packing of inorganic fertilizer

Author(s): Carla Ribalta, Antti J. Koivisto, Ana López-Lilao, Sara Estupiñá, María C. Minguillón, Eliseo Monfort, Mar Viana
Published in: Science of The Total Environment, Issue 650, 2019, Page(s) 2423-2436, ISSN 0048-9697
Publisher: Elsevier BV
DOI: 10.1016/j.scitotenv.2018.09.379

Material-specific properties applied to an environmental risk assessment of engineered nanomaterials – implications on grouping and read-across concepts

Author(s): Henning Wigger, Bernd Nowack
Published in: Nanotoxicology, Issue 10, 2019, Page(s) 1-21, ISSN 1743-5390
Publisher: Informa Healthcare
DOI: 10.1080/17435390.2019.1568604

Value of information analysis for assessing risks and benefits of nanotechnology innovation

Author(s): Alex Zabeo, Jeffrey M. Keisler, Danail Hristozov, Antonio Marcomini, Igor Linkov
Published in: Environmental Sciences Europe, Issue 31/1, 2019, Page(s) 11, ISSN 2190-4707
Publisher: Springer Verlag
DOI: 10.1186/s12302-019-0194-0

Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process

Author(s): Sara Nørgaard Sørensen, Anders Baun, Michael Burkard, Miikka Dal Maso, Steffen Foss Hansen, Samuel Harrison, Rune Hjorth, Stephen Lofts, Marianne Matzke, Bernd Nowack, Willie Peijnenburg, Mikko Poikkimäki, Joris T. K. Quik, Kristin Schirmer, Anja Verschoor, Henning Wigger, David J. Spurgeon
Published in: Environmental Science: Nano, Issue 6/2, 2019, Page(s) 505-518, ISSN 2051-8153
Publisher: Royal Society of Chemistry
DOI: 10.1039/c8en00933c

Risk associated with engineered nanomaterials: Different tools for different ways to govern

Author(s): Benjamin D. Trump, Danail Hristozov, Timothy Malloy, Igor Linkov
Published in: Nano Today, Issue 21, 2018, Page(s) 9-13, ISSN 1748-0132
Publisher: Elsevier BV
DOI: 10.1016/j.nantod.2018.03.002

A transcriptomics data-driven gene space accurately predicts liver cytopathology and drug-induced liver injury

Author(s): Pekka Kohonen, Juuso A. Parkkinen, Egon L. Willighagen, Rebecca Ceder, Krister Wennerberg, Samuel Kaski, Roland C. Grafström
Published in: Nature Communications, Issue 8, 2017, Page(s) 15932, ISSN 2041-1723
Publisher: Nature Publishing Group
DOI: 10.1038/ncomms15932

Health risk assessment from exposure to particles during packing in working environments

Author(s): C. Ribalta, A. López-Lilao, S. Estupiñá, A.S. Fonseca, A. Tobías, A. García-Cobos, M.C. Minguillón, E. Monfort, M. Viana
Published in: Science of The Total Environment, Issue 671, 2019, Page(s) 474-487, ISSN 0048-9697
Publisher: Elsevier BV
DOI: 10.1016/j.scitotenv.2019.03.347

Risk Governance of Nanomaterials: Review of Criteria and Tools for Risk Communication, Evaluation, and Mitigation

Author(s): Panagiotis Isigonis, Danail Hristozov, Christina Benighaus, Elisa Giubilato, Khara Grieger, Lisa Pizzol, Elena Semenzin, Igor Linkov, Alex Zabeo, Antonio Marcomini
Published in: Nanomaterials, Issue 9/5, 2019, Page(s) 696, ISSN 2079-4991
Publisher: MDPI AG
DOI: 10.3390/nano9050696

Redefining environmental nanomaterial flows: consequences of the regulatory nanomaterial definition on the results of environmental exposure models

Author(s): Henning Wigger, Wendel Wohlleben, Bernd Nowack
Published in: Environmental Science: Nano, Issue 5/6, 2018, Page(s) 1372-1385, ISSN 2051-8153
Publisher: Royal Society of Chemistry
DOI: 10.1039/c8en00137e

Systematic consideration of parameter uncertainty and variability in probabilistic species sensitivity distributions

Author(s): Henning Wigger, Delphine Kawecki, Bernd Nowack, Véronique Adam
Published in: Integrated Environmental Assessment and Management, 2019, ISSN 1551-3777
Publisher: Society of Environmental Toxicology and Chemistry
DOI: 10.1002/ieam.4214

Powder Intrinsic Properties as Dustiness Predictor for an Efficient Exposure Assessment?

Author(s): Neeraj Shandilya, Eelco Kuijpers, Ilse Tuinman, Wouter Fransman
Published in: Annals of Work Exposures and Health, Issue 63/9, 2019, Page(s) 1029-1045, ISSN 2398-7308
Publisher: Oxford University Press
DOI: 10.1093/annweh/wxz065

Identifying ecotoxicological descriptors to enable predictive hazard assessments of nano-TiO2 from a meta-analysis of ecotoxicological data

Author(s): Yaping Cai, Bernd Nowack, Henning Wigger
Published in: NanoImpact, Issue 15, 2019, Page(s) 100180, ISSN 2452-0748
Publisher: Elsevier
DOI: 10.1016/j.impact.2019.100180

From risk perception to risk governance in nanotechnology: a multi-stakeholder study

Author(s): Andrea Porcari, Elisabetta Borsella, Christina Benighaus, Khara Grieger, Panagiotis Isigonis, Somik Chakravarty, Pete Kines & Keld Alstrup Jensen
Published in: Journal of Nanoparticle Research, Issue 2019, 21: 245, 2019, ISSN 1388-0764
Publisher: Kluwer Academic Publishers

Best practices from nano-risk analysis relevant for other emerging technologies

Author(s): Khara Grieger, Jacob L. Jones, Steffen Foss Hansen, Christine Ogilvie Hendren, Keld Alstrup Jensen, Jennifer Kuzma, Anders Baun
Published in: Nature Nanotechnology, Issue 14/11, 2019, Page(s) 998-1001, ISSN 1748-3387
Publisher: Nature Publishing Group
DOI: 10.1038/s41565-019-0572-1

Common gene expression patterns in environmental model organisms exposed to engineered nanomaterials: a meta-analysis

Author(s): Michael Burkard, Alexander Betz, Kristin Schirmer, Anze Zupanic
Published in: Environmental Science & Technology, 2019, ISSN 0013-936X
Publisher: American Chemical Society
DOI: 10.1021/acs.est.9b05170

A Data Fusion Pipeline for Generating and Enriching Adverse Outcome Pathway Descriptions

Author(s): Penny Nymark, Linda Rieswijk, Friederike Ehrhart, Nina Jeliazkova, Georgia Tsiliki, Haralambos Sarimveis, Chris T Evelo, Vesa Hongisto, Pekka Kohonen, Egon Willighagen, Roland C Grafström
Published in: Toxicological Sciences, Issue 162/1, 2017, Page(s) 264-275, ISSN 1096-6080
Publisher: Oxford University Press
DOI: 10.1093/toxsci/kfx252

Particle release and control of worker exposure during laboratory-scale synthesis, handling and simulated spills of manufactured nanomaterials in fume hoods

Author(s): Ana S. Fonseca, Eelco Kuijpers, Kirsten I. Kling, Marcus Levin, Antti J. Koivisto, Signe H. Nielsen, W. Fransman, Yijri Fedutik, Keld A. Jensen, Ismo K. Koponen
Published in: Journal of Nanoparticle Research, Issue 20/2, 2018, ISSN 1388-0764
Publisher: Kluwer Academic Publishers
DOI: 10.1007/s11051-018-4136-3

Introducing WikiPathways as a Data-Source to Support Adverse Outcome Pathways for Regulatory Risk Assessment of Chemicals and Nanomaterials

Author(s): Marvin Martens, Tim Verbruggen, Penny Nymark, Roland Grafström, Lyle D. Burgoon, Hristo Aladjov, Fernando Torres Andón, Chris T. Evelo, Egon L. Willighagen
Published in: Frontiers in Genetics, Issue 9, 2018, ISSN 1664-8021
Publisher: Frontiers Media
DOI: 10.3389/fgene.2018.00661

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