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In Support of the Inclusion of Data on Nanomaterials Transformations and Environmental Interactions into Existing Regulatory Frameworks

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Managing Risk in Nanotechnology

Part of the book series: Innovation, Technology, and Knowledge Management ((ITKM))

Abstract

Research traditionally outstrips regulation leading to a lag between scientific advances and regulatory frameworks. This is nowhere more apparent than in the arena of nanomaterials (NMs) safety testing. Here, regulatory focus has been on assessing the suitability of existing regulatory regimes and standardised assays for use with NMs. Meanwhile scientific focus has moved towards an acceptance of the fact that as-made or so-called pristine NMs do not exist in real products or the environments as a result of physical, chemical, biological and binding-related transformations which drive the NMs towards lower surface energy states. Thus, in parallel with the move towards alternative test methods, there is a need to support regulatory authorities in understanding the relevant species to test in the case of NMs risk assessment and how to best incorporate such new knowledge into regulation. This chapter appraises some of the steps that could support such a transition, including looking for precedent in contiguous regulatory models for assessing transformed variants (e.g. pesticide metabolites), considering grouping and read-across strategies for likely NMs transformations, and validating standard tests for NMs ageing. Finally, it will consider the legal issues surrounding manufacturer’s responsibility for providing safety data for materials that are no longer the as-produced materials. As there is an essentially infinite array of uses/formulations for NMs, all of which can transform the NM from its original form and composition; where does and should a manufacturer’s responsibilities end?

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Notes

  1. 1.

    http://ec.europa.eu/enterprise/sectors/chemicals/reach/nanomaterials/

  2. 2.

    http://www.hsa.ie/eng/Your_Industry/Chemicals/REACH/

  3. 3.

    NMs will be considered as “phase-in” if they or their base substance are listed on the European Inventory of Existing Commercial Chemical Substances (EINECS) are considered as No-Longer Polymers or have been manufactured in the EU but not placed on the market between 1st of June 1992 and 1st of June 2007.

  4. 4.

    Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the regions in accordance with Article 117(4) of REACH and Article 46(2) of CLP, and a review of certain elements of REACH in line with Articles 75(2), 138(2), 138(3) and 138(6) of REACH {COM(2013)0049}. Available: http://www.ipex.eu/IPEXL-WEB/dossier/document/COM20130049.do.

  5. 5.

    http://echa.europa.eu/support/grouping-of-substances-and-read-across

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Acknowledgement

This chapter is based on concepts developed within EU FP7 Marie Curie Career Integration grant EcofriendlyNano (PCIG14-GA-2013-631612).

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Authors and Affiliations

  1. School of Geography, Earth and Environmental Sciences, University of Birmingham, Edgbaston, B15 2TT, UK

    Iseult Lynch

  2. Birmingham Law School, University of Birmingham, Edgbaston, B15 2TT, UK

    Robert Gregory Lee

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Correspondence to Iseult Lynch .

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Editors and Affiliations

  1. Dept. of Accounting and Finance, University of Limerick, Limerick, Ireland

    Finbarr Murphy

  2. University of Limerick, Limerick, Ireland

    Eamonn M. McAlea

  3. Dept. of Accounting and Finance, University of Limerick, Limerick, Ireland

    Martin Mullins

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Lynch, I., Lee, R.G. (2016). In Support of the Inclusion of Data on Nanomaterials Transformations and Environmental Interactions into Existing Regulatory Frameworks. In: Murphy, F., McAlea, E., Mullins, M. (eds) Managing Risk in Nanotechnology. Innovation, Technology, and Knowledge Management. Springer, Cham. https://doi.org/10.1007/978-3-319-32392-3_9

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