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Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria

Tutkimustuotosvertaisarvioitu

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Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria. / Franken, Remy; Heringa, Minne B.; Oosterwijk, Thies; Dal Maso, Miikka; Fransman, Wouter; Kanerva, Tomi; Liguori, Biase; Poikkimäki, Mikko; Rodriguez-Llopis, Isabel; Säämänen, Arto; Stockmann-Juvala, Helene; Suarez-Merino, Blanca; Alstrup Jensen, Keld; Stierum, Rob.

julkaisussa: NanoImpact, Vuosikerta 17, 100191, 2020.

Tutkimustuotosvertaisarvioitu

Harvard

Franken, R, Heringa, MB, Oosterwijk, T, Dal Maso, M, Fransman, W, Kanerva, T, Liguori, B, Poikkimäki, M, Rodriguez-Llopis, I, Säämänen, A, Stockmann-Juvala, H, Suarez-Merino, B, Alstrup Jensen, K & Stierum, R 2020, 'Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria', NanoImpact, Vuosikerta. 17, 100191. https://doi.org/10.1016/j.impact.2019.100191

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Author

Franken, Remy ; Heringa, Minne B. ; Oosterwijk, Thies ; Dal Maso, Miikka ; Fransman, Wouter ; Kanerva, Tomi ; Liguori, Biase ; Poikkimäki, Mikko ; Rodriguez-Llopis, Isabel ; Säämänen, Arto ; Stockmann-Juvala, Helene ; Suarez-Merino, Blanca ; Alstrup Jensen, Keld ; Stierum, Rob. / Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria. Julkaisussa: NanoImpact. 2020 ; Vuosikerta 17.

Bibtex - Lataa

@article{588da89d48f3435d9056c47a3f07975d,
title = "Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria",
abstract = "The current work describes the interaction with various stakeholder groups to establish consensus on stage-gate specific criteria that human risk assessment (HRA) models for manufactured nanomaterials (MN) need to comply with. During the decisive steps in the innovation process, which can be described in a simplified way as stage-gates, it is decided that an innovation makes it either to launch, or is cancelled during one of these stages. However, at present, it is unknown which current HRA models for MN, can assist in this decision making process and to which extent refinements of these models are needed. To accomplish these goals, several steps were performed: (1) the development of criteria for risk assessment along stage-gates; (2) the active involvement of stakeholders and possible end-users to assign values to these criteria; (3) the inventory, selection and assessment of HRA models according to the developed criteria; (4) the matching of the HRA models to the criteria, assessed by the stakeholders, in order to propose a ranking of existing models and (5) exploration of the model mismatches with stage-gate specific criteria and discussion of current model limitations. The assessment led to a ranking of the models for each of the stage-gates. Two HRA models appeared to be predominantly applicable for all stage-gates, namely the NanoSafer CB and the GUIDEnano tool, where NanoSafer CB scored highest for stage 2 and 3 (scoping and business case) and GUIDEnano tool for stage 4–7 (R&D, testing and validation, launch and monitoring). NanoSafer CB only covers occupational human health. LICARA nanoSCAN scored high for the earlier stages (stage 2, 3 and 4) and scored less for the later stages. RiskofDerm was listed for all stages except stage 3 and 7. ECETOC TRA was represented in stages 3–7, and Stoffenmanager (nano), EGRET2 and ART were applicable for one or two stages. Based on these results, it was possible to prioritize Nanosafer CB, GUIDEnano, RiskofDerm, LICARA nanoSCAN and Stoffenmanager Nano. Of these five models, limitations consisted of e.g. expertise required to use the model, interpretation of the data, quality assessment of the input parameters, consideration of different endpoints and populations (such as children, workers, consumers). Practically, this work provides a prioritization for end users of useful models, among the plethora of different models available, towards HRA of MN. Further, it identifies suggestions for future model improvements, enabling the ultimate practical application in the decision making process during the development of MN or MN containing products.",
keywords = "Human risk assessment models, manufactured nanomaterials, ranking of models, stakeholder assessment, stakeholder criteria",
author = "Remy Franken and Heringa, {Minne B.} and Thies Oosterwijk and {Dal Maso}, Miikka and Wouter Fransman and Tomi Kanerva and Biase Liguori and Mikko Poikkim{\"a}ki and Isabel Rodriguez-Llopis and Arto S{\"a}{\"a}m{\"a}nen and Helene Stockmann-Juvala and Blanca Suarez-Merino and {Alstrup Jensen}, Keld and Rob Stierum",
note = "EXT={"}Kanerva, Tomi{"} EXT={"}S{\"a}{\"a}m{\"a}nen, Arto{"}",
year = "2020",
doi = "10.1016/j.impact.2019.100191",
language = "English",
volume = "17",
journal = "NanoImpact",
issn = "2452-0748",
publisher = "Elsevier BV",

}

RIS (suitable for import to EndNote) - Lataa

TY - JOUR

T1 - Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria

AU - Franken, Remy

AU - Heringa, Minne B.

AU - Oosterwijk, Thies

AU - Dal Maso, Miikka

AU - Fransman, Wouter

AU - Kanerva, Tomi

AU - Liguori, Biase

AU - Poikkimäki, Mikko

AU - Rodriguez-Llopis, Isabel

AU - Säämänen, Arto

AU - Stockmann-Juvala, Helene

AU - Suarez-Merino, Blanca

AU - Alstrup Jensen, Keld

AU - Stierum, Rob

N1 - EXT="Kanerva, Tomi" EXT="Säämänen, Arto"

PY - 2020

Y1 - 2020

N2 - The current work describes the interaction with various stakeholder groups to establish consensus on stage-gate specific criteria that human risk assessment (HRA) models for manufactured nanomaterials (MN) need to comply with. During the decisive steps in the innovation process, which can be described in a simplified way as stage-gates, it is decided that an innovation makes it either to launch, or is cancelled during one of these stages. However, at present, it is unknown which current HRA models for MN, can assist in this decision making process and to which extent refinements of these models are needed. To accomplish these goals, several steps were performed: (1) the development of criteria for risk assessment along stage-gates; (2) the active involvement of stakeholders and possible end-users to assign values to these criteria; (3) the inventory, selection and assessment of HRA models according to the developed criteria; (4) the matching of the HRA models to the criteria, assessed by the stakeholders, in order to propose a ranking of existing models and (5) exploration of the model mismatches with stage-gate specific criteria and discussion of current model limitations. The assessment led to a ranking of the models for each of the stage-gates. Two HRA models appeared to be predominantly applicable for all stage-gates, namely the NanoSafer CB and the GUIDEnano tool, where NanoSafer CB scored highest for stage 2 and 3 (scoping and business case) and GUIDEnano tool for stage 4–7 (R&D, testing and validation, launch and monitoring). NanoSafer CB only covers occupational human health. LICARA nanoSCAN scored high for the earlier stages (stage 2, 3 and 4) and scored less for the later stages. RiskofDerm was listed for all stages except stage 3 and 7. ECETOC TRA was represented in stages 3–7, and Stoffenmanager (nano), EGRET2 and ART were applicable for one or two stages. Based on these results, it was possible to prioritize Nanosafer CB, GUIDEnano, RiskofDerm, LICARA nanoSCAN and Stoffenmanager Nano. Of these five models, limitations consisted of e.g. expertise required to use the model, interpretation of the data, quality assessment of the input parameters, consideration of different endpoints and populations (such as children, workers, consumers). Practically, this work provides a prioritization for end users of useful models, among the plethora of different models available, towards HRA of MN. Further, it identifies suggestions for future model improvements, enabling the ultimate practical application in the decision making process during the development of MN or MN containing products.

AB - The current work describes the interaction with various stakeholder groups to establish consensus on stage-gate specific criteria that human risk assessment (HRA) models for manufactured nanomaterials (MN) need to comply with. During the decisive steps in the innovation process, which can be described in a simplified way as stage-gates, it is decided that an innovation makes it either to launch, or is cancelled during one of these stages. However, at present, it is unknown which current HRA models for MN, can assist in this decision making process and to which extent refinements of these models are needed. To accomplish these goals, several steps were performed: (1) the development of criteria for risk assessment along stage-gates; (2) the active involvement of stakeholders and possible end-users to assign values to these criteria; (3) the inventory, selection and assessment of HRA models according to the developed criteria; (4) the matching of the HRA models to the criteria, assessed by the stakeholders, in order to propose a ranking of existing models and (5) exploration of the model mismatches with stage-gate specific criteria and discussion of current model limitations. The assessment led to a ranking of the models for each of the stage-gates. Two HRA models appeared to be predominantly applicable for all stage-gates, namely the NanoSafer CB and the GUIDEnano tool, where NanoSafer CB scored highest for stage 2 and 3 (scoping and business case) and GUIDEnano tool for stage 4–7 (R&D, testing and validation, launch and monitoring). NanoSafer CB only covers occupational human health. LICARA nanoSCAN scored high for the earlier stages (stage 2, 3 and 4) and scored less for the later stages. RiskofDerm was listed for all stages except stage 3 and 7. ECETOC TRA was represented in stages 3–7, and Stoffenmanager (nano), EGRET2 and ART were applicable for one or two stages. Based on these results, it was possible to prioritize Nanosafer CB, GUIDEnano, RiskofDerm, LICARA nanoSCAN and Stoffenmanager Nano. Of these five models, limitations consisted of e.g. expertise required to use the model, interpretation of the data, quality assessment of the input parameters, consideration of different endpoints and populations (such as children, workers, consumers). Practically, this work provides a prioritization for end users of useful models, among the plethora of different models available, towards HRA of MN. Further, it identifies suggestions for future model improvements, enabling the ultimate practical application in the decision making process during the development of MN or MN containing products.

KW - Human risk assessment models

KW - manufactured nanomaterials

KW - ranking of models

KW - stakeholder assessment

KW - stakeholder criteria

U2 - 10.1016/j.impact.2019.100191

DO - 10.1016/j.impact.2019.100191

M3 - Article

VL - 17

JO - NanoImpact

JF - NanoImpact

SN - 2452-0748

M1 - 100191

ER -