human responses to nanomaterials exposure.” Eight appropriate subcategories were identified (Figure 5). In connection with this research need, only six FY 2006 projects were identified. Although the NNI states that all six directly address the need, examination of their content suggests that only three directly address one or more of the subtopics (B3-1, B3-5, and B3-6 in Appendix A). The other three projects (B3-2, B3-3, and B3-4) may generate relevant information but do not explicitly address any of the subtopics in a way that would be useful for environmental or occupational risk assessment. The NNI acknowledges that the gap analysis is flawed, but it offers no recommendations on how to address this critical limitation. “While there is a low number of projects in this priority research need, this assessment does not capture applicable research in other areas nor many additional research efforts on testing schemes that were not captured by the gap analysis, so a determination of future priorities based on this analysis may be misleading” (p. 22). Indeed, the “Summary of Balance-Assessment” for the section does not mention the paucity of research addressing predictive toxicology for nanomaterials (development and validation of in vitro assays that predict in vivo toxicity). It is difficult to fathom how two federally funded projects in FY 2006 (B3-1 and B3-5) that directly address the development of in vitro and in vivo assays and models to predict human response to nanomaterials would be considered a sufficient research effort.

The focus of the research on therapeutics means that the data needs for risk assessment are not being supported. The gap analysis does not accurately or adequately represent research gaps related to nanomaterials that might pose health and safety risks to consumers, researchers, and workers. The committee considers the apparent lack of a sizable number of research projects that directly address the immediate research needs related to potential occupational and consumer risks posed by nanomaterials to be a substantial data gap. Revision of the table (NEHI 2008, p. 20) to separate studies focused on therapeutics from studies that emphasize materials important to these other communities (workers, consumers, and the public) would facilitate a transparent and unbiased assessment of data gaps that will help to spur the needed research.

The small number of projects addressing the research needs in the nanomaterials and human health section and their bias toward therapeutic applications rather than materials relevant to the environmental, occupational, and consumer exposure settings constituted sufficient evidence that the funded research will not support risk-assessment and risk-management needs for these classes of nanomaterials, generate the information needed to support EHS risk assessment and risk management, or provide critical data for regulatory agencies.

Conclusions

There is a need for broad coordination in the parallel pursuit of research needs in the nanomaterial and human health category and across research categories. Research projects in nanomaterials and human health would



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