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HARN - Nanotech Regulatory Document Archive

HARN - Nanotech Regulatory Document Archive

Task Topic Lead Partner

Task Topic Lead Partner 3.1.1 Asbestos & Industrial Fibre Characterisation IOM 3.1.2 Asbestos & Industrial Fibre Health Effects in Humans IOM 3.1.3 Asbestos & Industrial Fibre Mechanisms of Toxicity KD 3.1.4 HARN Characterisation NPL 3.1.5 HARN Mechanisms of Toxicity Napier Table 1 Tasks for the critical review For each Task, our approach for the critical review is: • To organise and collate the information obtained in 3.1 into each Task in Table 1 • To review, extract the important data and summarise the findings for each Task. • To synthesise the findings across all the Tasks for the purpose of comparison. Table 2 illustrates the theoretical framework constructed for the comparison between asbestos and HARN. • To summarise the findings of the comparison as input for the planned Research Strategy (Section 3.3). The critical reviews have delivered information on the state-of-the-art of the potential hazard of HARN in comparison to asbestos hazard and the knowledge gap in HARN potential hazard. Asbestos CNT Nanorod Nanowire Characterisation Health effects in Humans ? ? ? Mechanisms of Toxicity ? Table 2 Scheme for the comparison of Asbestos and HARN potential toxicity based on similarities and differences (tick marks are for illustration purpose only) 3.3 Develop a research strategy to investigate potential hazard of HARN (Lead Partner: IOM) The results from the critical review are used to formulate a research strategy to investigate the potential hazard of HARN. • The rationale of this strategy is based on information on the similarities and differences between HARN and asbestos hazard. • The objective of the strategy is to reduce the knowledge gap in order to better ascertain the HARN hazard. We will design: • Specific toxicology experiments (in vitro and in vivo) to address the questions highlighted in the critical reviews. We will also take into account: o the necessary scientific issues (e.g. validation of in vitro results by in vivo experiments); o regulatory implications (e.g. safe level of exposure). The research strategy has layout a plan for in vitro, in vivo, mathematical modelling studies to reduce the knowledge gap and ascertain whether the concern for the health effects of HARN is justified. Page 4

3.3 Workshop (Lead Partner: IOM) A draft final report was prepared, discussed with Defra/HPA, and used as prior information for the workshop. The project team, jointly with Defra/HPA, has selected the stakeholders to be invited for the workshop. Stakeholders include key members of the toxicology, regulatory and other appropriate communities. We invited a limited number of participants from the US and EU to reflect the international dimension of this activity. The workshop was informed by the state of the arts reviews which was provided to all participants prior to the workshop. The workshop was structured as follows: • Facilitator introduced the workshop aims, objectives and protocol; • Overview of the key components of the study; • Chaired round table discussion, with break out groups as required; • Consensus on recommendations / comments to finalise the report. The workshop was held at the Central Science Laboratories (CSL) in York. IOM undertook to record the discussion to inform the final stages of the study. Based on the discussion and outcomes of the workshop, the draft report was updated and finalised prior to submission to Defra/HPA at the conclusion of the project. The workshop informed an audience of relevant toxicologists, regulators on the findings of the review process and invited their comments which were incorporated in the final report. Page 5

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