Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials.
nanomaterials
nanosafety
regulation
risk governance council
risk governance framework
Journal
Small (Weinheim an der Bergstrasse, Germany)
ISSN: 1613-6829
Titre abrégé: Small
Pays: Germany
ID NLM: 101235338
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
28
05
2020
pubmed:
24
7
2020
medline:
18
5
2021
entrez:
24
7
2020
Statut:
ppublish
Résumé
Nanotechnologies have reached maturity and market penetration that require nano-specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)-by-Design (SbD) concepts. This paper provides an overview of the state-of-the-art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re-thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science-based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally.
Identifiants
pubmed: 32700469
doi: 10.1002/smll.202003303
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2003303Informations de copyright
© 2020 The Authors. Published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Références
M. Baalousha, W. How, E. Valsami-Jones, J. R. Lead, Nanoscience and the Environment (Eds J. R. Lead, E. Valsami-Jones), Elsevier, Amsterdam 2014, pp. 1-54.
I. Malsch, V. Subramanian, E. Semenzin, A. Zabeo, D. Hristozov, M. Mullins, F. Murphy, I. Linkov, A. Marcomini, Environ. Syst. Decis. 2017, 37, 465.
A. Porcari, E. Borsella, C. Benighaus, K. Grieger, P. Isigonis, S. Chakravarty, P. Kines, K. A. Jensen, J. Nanopart. Res. 2019, 21, 245.
G. Correia Carreira, A. Epp, M. Lohmann, G.-F. Böl, J.-P. Ferdinand, M. Gossen, G. Scholl, B. Holzhauer, Nanoview-Influencing Factors on the Perception of Nanotechnology and Target Group-Specific Risk Communication Strategies, Bundesinstitut für Risikobewertung, Berlin 2016.
I. A. Joubert, M. Geppert, S. Ess, R. Nestelbacher, G. Gadermaier, A. Duschl, A. C. Bathke, M. Himly, NanoImpact 2020, 17, 100201.
O. Renn, M. C. Roco, J. Nanopart. Res. 2006, 8, 153.
P. Laux, J. Tentschert, C. Riebeling, A. Braeuning, O. Creutzenberg, A. Epp, V. Fessard, K.-H. Haas, A. Haase, K. Hund-Rinke, N. Jakubowski, P. Kearns, A. Lampen, H. Rauscher, R. Schoonjans, A. Störmer, A. Thielmann, U. Mühle, A. Luch, Archives of Toxicology, Springer Verlag, Berlin.
EU and ECHA, European Union Observatory for Nanomaterials [Online], https://euon.echa.europa.eu/ (accessed: May 2020).
USA, National Nanotechnology Initiative [Online], https://www.nano.gov/ (accessed: May 2020).
J. Ahtiainen, E. Väänänen, Regulatory Safety Assessment of Nanomaterials : Are We Facing the Same Challenges as the Regulation of Endocrine Disrupting Chemicals?, Nordic Council of Ministers, Copenhagen 2012.
I. Linkov, F. K. Satterstrom, J. C. J. Monica, S. Foss, Nanotechnol. Law Bus. 2009, 6, 203.
G. E. Marchant, B. Atkinson, D. Banko, J. Bromley, E. Cseke, E. Feldstein, D. Garcia, J. M. Grant, C. Hubach, M. Silva, R. L. Swinford, S. Willman, Jurimetrics, American Bar Association, IL Vol. 52, 2012, pp. 243.
T. Van Teunenbroek, J. Baker, A. Dijkzeul, Part. Fibre Toxicol. 2017, 14, 54.
J. J. Scott-Fordsmand, et al., We need governance of Nanotechnology now: developing a sustainable system for European society, unpublished.
K. Van Kersbergen, F. Van Waarden, Eur. J. Pol. Res. 2004, 43, 143.
J. Jordana, D. Levi-Faur, The Politics of Regulation : Institutions and Regulatory Reforms for the Age of Governance, E. Elgar Publishing, Cheltenham, UK 2004.
I. Linkov, B. D. Trump, E. Anklam, D. Berube, P. Boisseasu, C. Cummings, S. Ferson, M.-V. Florin, B. Goldstein, D. Hristozov, K. A. Jensen, G. Katalagarianakis, J. Kuzma, J. H. Lambert, T. Malloy, I. Malsch, A. Marcomini, M. Merad, J. Palma-Oliveira, E. Perkins, O. Renn, T. Seager, V. Stone, D. Vallero, T. Vermeire, Environ. Syst. Decis. 2018, 38, 170.
J. Chataway, J. Tait, D. Wield, Technol. Anal. Strategic Manage. 2006, 18, 169.
V. P. Nanda, Ann. Am. Acad. Pol. Soc. Sci. 2006, 603, 269.
T. G. Weiss, in Thinking about Global Governance. Why People and Ideas Matter, 1st ed. (Ed: T. G. Weiss) Routledge, Abingdon, UK 2012, pp. 179-200.
O. Renn, P. Graham, Risk Governance - Towards an Integrative Approach, 2005.
T. Malloy, B. D. Trump, I. Linkov, Environ. Sci. Technol. 2016, 50, 6822.
Commodification is the hoped-for endpoint of any technology - either for the private sector, or for public good. Risk governance is fundamentally centered upon governing uncertain commodities (either as materials or as composite products).
IRGC, Nanotechnology Risk Governance, Geneva, 2007.
M. Roco, O. Renn, A. Jäger, Nanotechnology Risk Governance, Springer, Dordrecht 2008, pp. 301-327.
Gov4NANO H2020 Project [Online], http://www.gov4nano.eu (accessed: May 2020).
NANORIGO H2020 Project [Online], http://www.nanorigo.eu (accessed: May 2020).
RiskGONE H2020 Project [Online], http://www.riskgone.eu/ (accessed: May 2020).
M. B. Kearnes, P. M. Macnaghten, J. Wilsdon, Governing at the Nanoscale : People, Policies and Emerging Technologies, Demos, London 2006.
E. Casals, M. F. Gusta, J. Piella, G. Casals, W. Jiménez, V. Puntes, Front. Immunol. 2017, 8, 970.
I. Lynch, C. Weiss, E. Valsami-Jones, Nano Today 2014, 9, 266.
I. Lynch, A. Ahluwalia, D. Boraschi, H. J. Byrne, B. Fadeel, P. Gehr, A. C. Gutleb, M. Kendall, M. G. Papadopoulos, BioNanomaterials 2013, 14, 195.
T. A. Börzel, T. Risse, Regul. Governance 2010, 4, 113.
A. D. Maynard, Ann. Occup. Hyg. 2006, 51, 1.
G. Miller, F. Wickson, Rev. Policy Res. 2015, 32, 485.
T. A. J. Kuhlbusch, S. W. P. Wijnhoven, A. Haase, NanoImpact 2015, 10, 11.
T. Rycroft, B. Trump, K. Poinsatte-Jones, I. Linkov, J. Nanopart. Res. 2018, 20, 52.
OECD, No. 57 - Guidance Manual towards the Integration of Risk Assessment into Life Cycle Assessment of Nano-Enabled Applications, 2015.
OECD, No 25 - Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme: First Revision, Paris, 2010.
OECD, No. 85 - Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials, 2018.
Malta Initiative [Online], https://www.nanosafetycluster.eu/international-cooperation/the-malta-initiative/ (accessed: May 2020).
A. Rip, De facto Governance of Nanotechnologies, Springer VS, Wiesbaden 2018, pp. 75-96.
R. Justo-Hanani, T. Dayan, Res. Policy 2015, 44, 1527.
D. Rotolo, D. Hicks, B. R. Martin, Res. Policy 2015, 44, 1827.
B. Reidy, A. Haase, A. Luch, K. A. Dawson, I. Lynch, Materials. 2013, 6, 2295.
M. R. Wiesner, J. Y. Bottero, C. R. Phys. 2011, 12, 659.
M. Dent, R. T. Amaral, P. A. D. Silva, J. Ansell, F. Boisleve, M. Hatao, A. Hirose, Y. Kasai, P. Kern, R. Kreiling, S. Milstein, B. Montemayor, J. Oliveira, A. Richarz, R. Taalman, E. Vaillancourt, R. Verma, N. V. O'Reilly CabralPosada, C. Weiss, H. Kojima, Comput. Toxicol. 2018, 7, 20.
A. P. Worth, Comput. Toxicol. 2019, 10, 60.
V. Rogiers, E. Benfenati, U. Bernauer, L. Bodin, P. Carmichael, Q. Chaudhry, P. J. Coenraads, M. T. D. Cronin, M. Dent, M. Dusinska, C. Ellison, J. Ezendam, E. Gaffet, C. L. Galli, C. Goebel, B. Granum, H. M. Hollnagel, P. S. Kern, K. Kosemund-Meynen, G. Ouédraogo, E. Panteri, C. Rousselle, M. Stepnik, T. Vanhaecke, N. Goetz, A. Worth, Toxicology 2019, 436, 152421.
EU, Commission Regulation 2018/1881, 2018.
ECHA, Appendix 4:Recommendations for nanomaterials applicable to the Guidance on Registration, 2017.
ECHA, Appendix for nanoforms applicable to the Guidance on Registrationand Substance Identification, 2019.
P. A. Schulte, C. L. Geraci, E. D. Kuempel, Occup. Environ. Med. 2018, 75, A11.3.
P. A. Schulte, V. Leso, M. Niang, I. Iavicoli, Scand. J. Work, Environ. Health 2019, 45, 217.
O. Renn, K. Walker, Global Risk Governance, Vol. 1, Springer, Dordrecht, Netherlands 2008.
M. Cobaleda-Siles, A. P. Guillamon, C. Delpivo, S. Vázquez-Campos, V. F. Puntes, J. Phys.: Conf. Ser. 2017, 838, 012016.
A. Kraegeloh, B. Suarez-Merino, T. Sluijters, C. Micheletti, Nanomaterials 2018, 8, 239.
C. O. Hendren, G. V. Lowry, J. M. Unrine, M. R. Wiesner, Sci. Total Environ. 2015, 536, 1029.
M. Markiewicz, J. Kumirska, I. Lynch, M. Matzke, J. Köser, S. Bemowsky, D. Docter, R. Stauber, D. Westmeier, S. Stolte, Green Chem. 2018, 20, 4133.
SCCS, The SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision, 2018.
SCCS, Guidance on the safety assessment of nanomaterials in cosmetics, 2019.
D. Hristozov, S. Gottardo, E. Semenzin, A. Oomen, P. Bos, W. Peijnenburg, M. van Tongeren, B. Nowack, N. Hunt, A. Brunelli, J. J. Scott-Fordsmand, L. Tran, A. Marcomini, Environ. Int. 2016, 95, 36.
E. Lombi, E. Donner, M. Dusinska, F. Wickson, Nat. Nanotechnol. 2019, 14, 523.
K. Grieger, N. Bossa, J. W. Levis, K. J. F. von Borries, P. Strader, M. Cuchiara, C. O. Hendren, S. F. Hansen, J. L. Jones, Environ. Sci.: Nano 2018, 5, 1844.
V. Subramanian, E. Semenzin, A. Zabeo, D. Hristozov, I. Malsch, P. Saling, T. Van Harmelen, T. Ligthart, A. Marcomini, Integrating the Social Impacts into Risk Governance of Nanotechnology, Springer, Cham 2016, pp. 51-70.
P. Isigonis, D. Hristozov, C. Benighaus, E. Giubilato, K. Grieger, L. Pizzol, E. Semenzin, I. Linkov, A. Zabeo, A. Marcomini, Nanomaterials 2019, 9, 696.
B. D. Trump, D. Hristozov, T. Malloy, I. Linkov, Nano Today 2018, 21, 9.
S. N. Sørensen, A. Baun, M. Burkard, M. Dal Maso, S. Foss Hansen, S. Harrison, R. Hjorth, S. Lofts, M. Matzke, B. Nowack, W. Peijnenburg, M. Poikkimäki, J. T. K. Quik, K. Schirmer, A. Verschoor, H. Wigger, D. J. Spurgeon, Environ. Sci.: Nano 2019, 6, 505.
Nano Risk Framework, Environmental Defense Fund and DuPont, Washington 2007.
ISO organisation and R. M. ISO/TC 262, ISO 31000:2018, Risk management - Guidelines, 2018.
IRGC, Introduction to the IRGC Risk Governance Framework, revised version, https://doi.org/10.5075/EPFL-IRGC-233739 (accessed: December 2019).
O. Renn, A. Klinke, M. van Asselt, Ambio 2011, 40, 231.
A. Jovanovic, et al., Managing Emerging Technology-Related Risks, No. CWA 16649, 2013.
NanoTEST FP7 Project [Online], http://www.nanotest-fp7.eu/ (accessed: May 2020).
MARINA FP7 Project [Online], https://cordis.europa.eu/project/id/263215 (accessed: May 2020).
SUN FP7 Project [Online], http://www.sun-fp7.eu/ (accessed: May 2020).
NANoREG FP7 Project [Online], http://www.nanoreg.eu/ (accessed: May 2020).
NANoREG2 H2020 Project [Online], http://www.nanoreg2.eu/ (accessed: May 2020).
caLIBRAte H2020 Project [Online], http://www.nanocalibrate.eu (accessed: May 2020).
NanoMILE FP7 Project [Online], http://www.nanomile.eu-vri.eu (accessed: May 2020).
E. Semenzin, E. Giubilato, E. Badetti, M. Picone, A. Volpi Ghirardini, D. Hristozov, A. Brunelli, A. Marcomini, Environ. Sci. Pollut. Res. 2019, 26, 26146.
A. Sips, C. Noorlander, H. Lehmann, K. Höhener, NANoREG Safe-by-Design (SbD) Concept to be used for the first ProSafe Call and EU US CoR, 2015.
R. Hjorth, L. van Hove, F. Wickson, Nanotoxicology 2017, 11, 305.
K. Savolainen, et al., Nanosafety in Europe 2015-2025: Towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations, Finnish Institute of Occupational Health, Helsinki 2013.
C. W. Babbitt, E. A. Moore, Nat. Nanotechnol. 2018, 13, 621.
A. D. Maynard, R. J. Aitken, Nat. Nanotechnol. 2016, 11, 998.
NanoCommons H2020 Project [Online], http://www.nanocommons.eu/ (accessed: May 2020).
NanoInformaTIX H2020 Project, [Online], http://www.nanoinformatix.eu/ (accessed: May 2020).
NanoSolveIT H2020 Project, [Online], http://www.nanosolveit.eu/ (accessed: May 2020).
D. D. Varsou, A. Afantitis, A. Tsoumanis, G. Melagraki, H. Sarimveis, E. Valsami-Jones, I. Lynch, Nanoscale Adv. 2019, 1, 706.
EU, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, 2000.
EU, Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives, 2008.
A. Hardy, et al., Guidance on Risk Assessment of the Application of Nanoscience and Nanotechnologies in the Food and Feed Chain: Part 1, Human and Animal Health, Wiley-Blackwell Publishing Ltd, NJ 2018.
I. Malsch, P. Isigonis, M. Dusinska, Embedding Ethical Impact Assessment in Nanosafety Decision Support, Malsch TechnoValuation, The Netherlands 2019.
M. D. Wilkinson, M. Dumontier, I. J. Aalbersberg, G. Appleton, M. Axton, A. Baak, N. Blomberg, J.-W. Boiten, L. B. da Silva Santos, P. E. Bourne, J. Bouwman, A. J. Brookes, T. Clark, M. Crosas, I. Dillo, O. Dumon, S. Edmunds, C. T. Evelo, R. Finkers, A. Gonzalez-Beltran, A. J. G. Gray, P. Groth, C. Goble, J. S. Grethe, J. Heringa, P. A. C‘t Hoen, R. Hooft, T. Kuhn, R. Kok, J. Kok, et al., Sci. Data 2016, 3, 160018.
Afantitis et al., Comp. Stru. Bio. J. 2020, 18, 583, https://doi.org/10.1016/j.csbj.2020.02.023.
R. Owen, P. Macnaghten, J. Stilgoe, Sci. Pub. Policy 2012, 39, 751.
A. Grunwald, Responsibity in Nanotechnology Development, Springer, Dordrecht, Netherlands 2014, pp. 191-205.
I. Mahapatra, J. R. A. Clark, P. J. Dobson, R. Owen, I. Lynch, J. R. Lead, Environ. Sci.: Nano 2018, 5, 1873.
J. Stilgoe, R. Owen, P. Macnaghten, Res. Policy 2013, 42, 1568.
T. Gebel, H. Foth, G. Damm, A. Freyberger, P. J. Kramer, W. Lilienblum, C. Röhl, T. Schupp, C. Weiss, K. M. Wollin, J. G. Hengstler, Arch. Toxicol. 2014, 88, 2191.
K. Donaldson, C. A. Poland, Curr. Opin. Biotechnol. 2013, 24, 724.
A. E. Nel, W. J. Parak, W. C. W. Chan, T. Xia, M. C. Hersam, C. J. Brinker, J. I. Zink, K. E. Pinkerton, D. R. Baer, P. S. Weiss, ACS Nano 2015, 9, 5627.
M. Riediker, D. Zink, W. Kreyling, G. Oberdörster, A. Elder, U. Graham, I. Lynch, A. Duschl, G. Ichihara, S. Ichihara, T. Kobayashi, N. Hisanaga, M. Umezawa, T. J. Cheng, R. Handy, M. Gulumian, S. Tinkle, F. Cassee, Part. Fibre Toxicol. 2019, 16, 19.
B. C. Steimle, J. L. Fenton, R. E. Schaak, Science 2020, 367, 418.
L.-J. A. Ellis, E. Valsami-Jones, I. Lynch, Environ. Sci.: Nano 2020, 7, 1136.
L. Armand, A. Tarantini, D. Beal, M. Biola-Clier, L. Bobyk, S. Sorieul, K. Pernet-Gallay, C. Marie-Desvergne, I. Lynch, N. Herlin-Boime, M. Carriere, Nanotoxicology 2016, 10, 913.