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

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

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Nanomaterial risk governance requires models to estimate the material flow, fate and transport as well as uptake/bioavailability, hazard and risk in the environment. This study assesses the fit of such available models to different stages during the innovation of nano-enabled products. Through stakeholder consultations, criteria were identified for each innovation stage from idea conception to market launch and monitoring. In total, 38 models were scored against 41 criteria concerning model features, applicability, resource demands and outcome parameters. A scoring scheme was developed to determine how the models fit the criteria of each innovation stage. For each model, the individual criteria scores were added, yielding an overall fit score to each innovation stage. Three criteria were critical to stakeholders and incorporated as multipliers in the scoring scheme; the required time/costs and level of expertise needed to use the model, and for risk assessment models only, the option to compare PEC and PNEC. Regulatory compliance was also identified as critical, but could not be incorporated, as a nanomaterial risk assessment framework has yet to be developed and adopted by legislators. In conclusion, the scoring approach underlined similar scoring profiles across stages within model categories. As most models are research tools designed for use by experts, their score generally increased for later stages where most resources and expertise are committed. In contrast, stakeholders need relatively simple models to identify potential hazards and risk management measures at early product development stages to ensure safe use of nanomaterials without costs and resource needs hindering innovation.
Original languageEnglish
JournalEnvironmental Science: Nano
Volume6
Issue number2
Pages (from-to)505-518
ISSN2051-8153
DOIs
Publication statusPublished - 2019

Cite this

Sørensen, Sara Nørgaard ; Baun, Anders ; Burkard, Michael ; Dal Maso, Miikka ; Hansen, Steffen Foss ; Harrison, Samuel ; Hjorth, Rune ; Lofts, Stephen ; Matzke, Marianne ; Nowack, Bernd ; Peijnenburg, Willie ; Poikkimäki, Mikko ; Quik, Joris T. K. ; Schirmer, Kristin ; Verschoor, Anja ; Wigger, Henning ; Spurgeon, David J. / Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process. In: Environmental Science: Nano. 2019 ; Vol. 6, No. 2. pp. 505-518.
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title = "Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process",
abstract = "Nanomaterial risk governance requires models to estimate the material flow, fate and transport as well as uptake/bioavailability, hazard and risk in the environment. This study assesses the fit of such available models to different stages during the innovation of nano-enabled products. Through stakeholder consultations, criteria were identified for each innovation stage from idea conception to market launch and monitoring. In total, 38 models were scored against 41 criteria concerning model features, applicability, resource demands and outcome parameters. A scoring scheme was developed to determine how the models fit the criteria of each innovation stage. For each model, the individual criteria scores were added, yielding an overall fit score to each innovation stage. Three criteria were critical to stakeholders and incorporated as multipliers in the scoring scheme; the required time/costs and level of expertise needed to use the model, and for risk assessment models only, the option to compare PEC and PNEC. Regulatory compliance was also identified as critical, but could not be incorporated, as a nanomaterial risk assessment framework has yet to be developed and adopted by legislators. In conclusion, the scoring approach underlined similar scoring profiles across stages within model categories. As most models are research tools designed for use by experts, their score generally increased for later stages where most resources and expertise are committed. In contrast, stakeholders need relatively simple models to identify potential hazards and risk management measures at early product development stages to ensure safe use of nanomaterials without costs and resource needs hindering innovation.",
author = "S{\o}rensen, {Sara N{\o}rgaard} and Anders Baun and Michael Burkard and {Dal Maso}, Miikka and Hansen, {Steffen Foss} and Samuel Harrison and Rune Hjorth and Stephen Lofts and Marianne Matzke and Bernd Nowack and Willie Peijnenburg and Mikko Poikkim{\"a}ki and Quik, {Joris T. K.} and Kristin Schirmer and Anja Verschoor and Henning Wigger and Spurgeon, {David J.}",
year = "2019",
doi = "10.1039/C8EN00933C",
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Sørensen, SN, Baun, A, Burkard, M, Dal Maso, M, Hansen, SF, Harrison, S, Hjorth, R, Lofts, S, Matzke, M, Nowack, B, Peijnenburg, W, Poikkimäki, M, Quik, JTK, Schirmer, K, Verschoor, A, Wigger, H & Spurgeon, DJ 2019, 'Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process', Environmental Science: Nano, vol. 6, no. 2, pp. 505-518. https://doi.org/10.1039/C8EN00933C

Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process. / Sørensen, Sara Nørgaard; Baun, Anders; Burkard, Michael; Dal Maso, Miikka; Hansen, Steffen Foss; Harrison, Samuel; Hjorth, Rune; Lofts, Stephen; Matzke, Marianne; Nowack, Bernd; Peijnenburg, Willie; Poikkimäki, Mikko; Quik, Joris T. K.; Schirmer, Kristin; Verschoor, Anja; Wigger, Henning; Spurgeon, David J.

In: Environmental Science: Nano, Vol. 6, No. 2, 2019, p. 505-518.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process

AU - Sørensen, Sara Nørgaard

AU - Baun, Anders

AU - Burkard, Michael

AU - Dal Maso, Miikka

AU - Hansen, Steffen Foss

AU - Harrison, Samuel

AU - Hjorth, Rune

AU - Lofts, Stephen

AU - Matzke, Marianne

AU - Nowack, Bernd

AU - Peijnenburg, Willie

AU - Poikkimäki, Mikko

AU - Quik, Joris T. K.

AU - Schirmer, Kristin

AU - Verschoor, Anja

AU - Wigger, Henning

AU - Spurgeon, David J.

PY - 2019

Y1 - 2019

N2 - Nanomaterial risk governance requires models to estimate the material flow, fate and transport as well as uptake/bioavailability, hazard and risk in the environment. This study assesses the fit of such available models to different stages during the innovation of nano-enabled products. Through stakeholder consultations, criteria were identified for each innovation stage from idea conception to market launch and monitoring. In total, 38 models were scored against 41 criteria concerning model features, applicability, resource demands and outcome parameters. A scoring scheme was developed to determine how the models fit the criteria of each innovation stage. For each model, the individual criteria scores were added, yielding an overall fit score to each innovation stage. Three criteria were critical to stakeholders and incorporated as multipliers in the scoring scheme; the required time/costs and level of expertise needed to use the model, and for risk assessment models only, the option to compare PEC and PNEC. Regulatory compliance was also identified as critical, but could not be incorporated, as a nanomaterial risk assessment framework has yet to be developed and adopted by legislators. In conclusion, the scoring approach underlined similar scoring profiles across stages within model categories. As most models are research tools designed for use by experts, their score generally increased for later stages where most resources and expertise are committed. In contrast, stakeholders need relatively simple models to identify potential hazards and risk management measures at early product development stages to ensure safe use of nanomaterials without costs and resource needs hindering innovation.

AB - Nanomaterial risk governance requires models to estimate the material flow, fate and transport as well as uptake/bioavailability, hazard and risk in the environment. This study assesses the fit of such available models to different stages during the innovation of nano-enabled products. Through stakeholder consultations, criteria were identified for each innovation stage from idea conception to market launch and monitoring. In total, 38 models were scored against 41 criteria concerning model features, applicability, resource demands and outcome parameters. A scoring scheme was developed to determine how the models fit the criteria of each innovation stage. For each model, the individual criteria scores were added, yielding an overall fit score to each innovation stage. Three criteria were critical to stakeholders and incorporated as multipliers in the scoring scheme; the required time/costs and level of expertise needed to use the model, and for risk assessment models only, the option to compare PEC and PNEC. Regulatory compliance was also identified as critical, but could not be incorporated, as a nanomaterial risk assessment framework has yet to be developed and adopted by legislators. In conclusion, the scoring approach underlined similar scoring profiles across stages within model categories. As most models are research tools designed for use by experts, their score generally increased for later stages where most resources and expertise are committed. In contrast, stakeholders need relatively simple models to identify potential hazards and risk management measures at early product development stages to ensure safe use of nanomaterials without costs and resource needs hindering innovation.

U2 - 10.1039/C8EN00933C

DO - 10.1039/C8EN00933C

M3 - Journal article

VL - 6

SP - 505

EP - 518

JO - Environmental Science: Nano

JF - Environmental Science: Nano

SN - 2051-8153

IS - 2

ER -