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

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?