cluding the NNI), academic institutions, and industry (see Table 1-1). Those efforts have helped to translate and communicate information on the potential EHS effects of nanotechnology among researchers who are generating the scientific evidence, the businesses that use nanotechnology, the consumers who are using products with ENMs, and the various regulators who are overseeing ENMs. In the United States, the NNI has coordinated the efforts of regulatory and research agencies in identifying and addressing cross-agency research needs. The NNI guidance is complemented by agency-specific research strategies. In addition, the 2009 National Research Council review of the federal strategy highlighted the coordinating functions of the NNI and identified elements that are integral to a research strategy, including input from various stakeholders and mechanisms to ensure that the research strategy will be supported and funded. The 2009 report also identified limitations of the NNI approach. The NNI’s 2011 Draft EHS Strategy addresses some of the limitations and further develops a framework for coordination among federal agencies and mechanisms to support the implementation of the strategy.4
Despite some progress in assessing research needs and in funding and conducting research, developers, regulators, and consumers of nanotechnology-enabled products remain uncertain about the variety and quantity of nanomaterials in commerce or in development, their possible applications, and any potential risks. There is insufficient connection and integration between generation of data and analyses on emergent risks and strategies for preventing and managing the risks.
Based on the committee’s review of the current state of research and its relation to the needs of developers, regulators, and users of ENMs, three particular gaps are evident. First, little research progress has been made on some key topics, such as the effects of ingested ENMs on human health. Second, there is little research on the potential health and environmental effects of the more complex ENMs that are expected to enter commerce over the next decade. Third, system-integrative approaches are needed that can address all forms of ENMs based on their properties and an understanding of the underlying biologic interactions that determine exposure and risk. In spite of the need to provide more certain information on potential EHS risks, the gaps in understanding identified in many scientific workshops over the last decade have not been aggressively addressed with needed research. Common themes identified in workshops include the need for standardized materials, standardized methods to evaluate exposures, both in the workplace and in the environment, and harmonized methods for in vitro to in vivo validation in hazard assessments. In addition, rapidly evolving research approaches reflect an increasing emphasis on high-throughput screening and predictive modeling, both essential for managing the complexity of ENMs.
4The final version of the strategy was released in October 2011. However, because this report had already gone through peer review, the final version of the NNI EHS strategy was not reviewed or commented on by the committee.