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Alternative test methods for (nano)materials hazards assessment: Challenges and recommendations for regulatory preparedness

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisReviewForskningpeer review

The outstanding work performed by standardization organizations for guidelines to assess hazards, e.g., OECD (Organisation for Economic Co-operation and Development), is clearly visible by the currently available number and broad coverage, from aquatic to terrestrial organisms dealing with environmental relevant issues. Nevertheless, novel materials challenge the adequateness and fit-for-purpose of such standards, as the standards were developed to assess hazards of “conventional” chemical substances and not advanced materials (e.g. materials that may deliberately change behaviour). While standardization is a well-known process that requires extended time before reaching implementation stage, there is strong support from regulatory bodies for the development of New Approach Methodologies (NAMs) (e.g., updating of current guidelines, development of novel omics-, in vitro-, and in silico- tests including modelling and read-across) that meet regulatory preparedness (i.e. have considered issues important for regulatory testing). There are currently several NAMs available, complying with high quality standards and relevancy, which should be adopted. In the current review, we collected the available literature on NAMs to assess hazards of Nanomaterials (NMs), focusing on the terrestrial environment, and critically discuss the advantages, challenges and gaps. Tests were grouped into 1) Standard tests (OECD/ISO), 2) Standard tests (OECD/ISO) extensions: time course or prolonged exposures and/or multigenerational, and 3) Alternative tests, beyond current OECD/ISO: omics, biomarkers, in vitro, in silico and modelling. The goal is to provide guidance on the best practices and test designs focusing on the specificities of testing NMs, outlining recommendations and way forward.

OriginalsprogEngelsk
Artikelnummer101242
TidsskriftNano Today
Vol/bind40
ISSN1748-0132
DOI
StatusUdgivet - okt. 2021

Bibliografisk note

Funding Information:
This study received funding from the European Commission within NANORIGO (H2020-NMBP-13-2018, GA No. 814530), NanoInformaTIX (H2020-NMBP-14-2018, No. 814426) and BIORIMA (H2020-NMBP-12-2017, No. 760928) projects and also to FCT (Funda??o para a Ci?ncia e Tecnologia) / MCTES (Minist?rio da Ci?ncia e Tecnologia do Ensino Superior) for the financial support to CESAM (UIDP/50017/2020+UIDB/50017/2020). Also, S.I.L. Gomes is funded by national funds (OE), through FCT ? Funda??o para a Ci?ncia e a Tecnologia, I.P. in the scope of the framework contract foreseen in the numbers 4, 5 and 6 of the article 23, of the Decree-Law 57/2016, of August 29, changed by Law 57/2017, of July 19.

Funding Information:
The scientific (and regulatory) community is well aware of the challenges and has contributed to identify some of these as well as ways forward [1] including adaptations of current OECD guidelines to NMs [2,3] . Some TGs have been updated and other are being developed [4] . The importance of this is also clear for regulatory agencies, e.g., the later EU funds allocated to regulatory aspects after the standardization of methods (e.g., FP7: MARINA, SUN, H2020: BIORIMA). Obviously, not all needs are tackled and there are concurrent initiatives, e.g. the Malta initiative (2017) ( https://www.nanosafetycluster.eu/international-cooperation/the-malta-initiative/ ), where several European countries, including Directorate-General of the European Commission, the European Chemicals Agency (ECHA), authorities, research institutions, NGOs, universities and industry, aim to mitigate and fill the many gaps towards legislation. In relation to this initiative are projects such as NanoHarmony (EU) and NANOMET (OECD), which further promotes this development of guidelines. On a broader level, the overall governance of NMs, as funded by the EU call NMBP13, is being widely discussed and considered under 3 collaborative projects (H2020 NANORIGO, GOV4NANO, RISKGONE). One of the frameworks’ needs [besides data], are fit-for-purpose tools to assess the hazards, and hence the role of standardized tools is a key asset to have consolidated and harmonised between countries. The standardization process is well-known to require extended time before reaching implementation stage. While this is part of a continuous ongoing effort, there is strong support from regulatory bodies for the development of New Approach Methodologies (NAMs) to establish “Alternative Tests” both in EU [5] , USA, Canada and Australia (as well as elsewhere e.g., Japan, South Korea) [6] . NAMs usually refer to alternative methods, such as in silico and in vitro, modelling, read-across and omics, etc. There are currently several NAM tests and methods available, complying with high quality standards and relevancy (e.g. [7,8] ).

Funding Information:
This study received funding from the European Commission within NANORIGO ( H2020-NMBP-13-2018 , GA No. 814530 ), NanoInformaTIX ( H2020-NMBP-14-2018 , No. 814426 ) and BIORIMA ( H2020-NMBP-12-2017 , No. 760928 ) projects and also to FCT (Fundação para a Ciência e Tecnologia) / MCTES (Ministério da Ciência e Tecnologia do Ensino Superior) for the financial support to CESAM ( UIDP/50017/2020+UIDB/50017/2020 ). Also, S.I.L. Gomes is funded by national funds (OE), through FCT – Fundação para a Ciência e a Tecnologia, I.P., in the scope of the framework contract foreseen in the numbers 4, 5 and 6 of the article 23, of the Decree-Law 57/2016, of August 29, changed by Law 57/2017, of July 19.

Publisher Copyright:
© 2021 The Author(s)

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