A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2012) / Chapter Skim
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Pages 3-17
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From page 3... ...
Lack of capabilities to monitor rapid changes in current, emerging, and potential ENM applications and to identify and address the potential consequences for EHS risks. Lack of standard test materials and adequate models for investigating EHS risks, leading to great uncertainty in describing and quantifying nanomaterial hazards and exposures.
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From page 4... ...
The committee was charged to create a conceptual framework for EHSrelated research, to develop a research plan with short-term and long-term research priorities, and to estimate resources needed to implement the research plan2. In a subsequent report, the committee will evaluate research progress.
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From page 5... ...
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.
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From page 6... ...
, the committee considered properties that might be identified in a new nanomaterial that could pose a new, enhanced, or ill-defined risk. There is a need for an approach that promotes scientifically sound investigations of emerging risks and provides timely results relevant to the rapidly developing nanomaterial industry without relying on case-by-case evaluations of the nanomaterials.
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The application of three principles that help guide our understanding of ENMs and research gaps when addressing ENM risks. The three principles address the emergent nature of ENM risks, the plausibility or likelihood of significant risks, and the potential severity of an effect.6 Figure S-1, which is not intended to show a linear process, depicts sources of nanomaterials originating throughout their value chains and life cycles and considers the environmental or physiologic context of these materials and the processes that they affect.
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. CRITICAL RESEARCH GAPS Despite the substantial research already done on potential EHS risks posed by ENMs, critical gaps remain.
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Exposure assessment should include evaluation of modifications of ENMs across their lifecycle, as materials may undergo both subtle and extreme changes as they move through biologic and environmental systems that affect their size, surface chemistry, and reactivity. Human exposures potentially occur through inhalation, oral, and dermal routes.
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Research is needed to guide identification of appropriate ecologic receptors, to develop appropriate ENM assays, and to conduct model ecosystem studies that address potential effects on a larger scale, such as a population, a community, or an ecosystem. Although numerous standard screening-level toxicity tests for specific aquatic and terrestrial organisms have been proposed for evaluating effects of ENMs, data are needed to assess whether standard tests can predict ecosystem effects of ENMs.
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This will require standardized and validated in vitro methods (for example, standardized cell types and exposure protocols) that represent specific
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Developing models for predicting releases of ENMs into the environment throughout their life cycle and value chain will require information on the types of materials being produced and used, types of applications, and intended uses. To understand the transport of the ENMs into the environment, existing exposure models need to be modified to include processes most relevant to ENM distribution in the environment and human exposure.
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RESEARCH PRIORITIES AND RESOURCE NEEDS Having considered the research gaps and the needed tools, the committee identified four broad, cross-cutting high-priority categories that form the backbone of its recommended research strategy. Because of the diversity of nanomaterials and the breadth of their potential applications, the committee considered that a prescriptive approach to addressing the EHS aspects of nanomaterials would be short-sighted and would probably fail to anticipate the rapid evolution of this field and its potential effects.
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From page 14... ...
Processes that affect both potential hazards and exposure. Research topics in this necessarily broad category would include the role of nanoparticlemacromolecular interactions in regulating and modifying nanoparticle behavior on scales ranging from genes to ecosystems; the effects of particle-surface modification on aggregation and nanoparticle bioavailability, reactivity, and toxicity potential; processes that affect nanomaterial transport across biologic or synthetic membranes; and the development of relationships between the structure of nanomaterials and their transport, fate, and effects.
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From page 15... ...
Cross-cutting activities are encompassed in the high-priority research categories and will need to be supported by greater coordinated investment in five areas: nanotechnology-related EHS informatics; investment in translating advanced nanomaterial measurement and characterization approaches to EHS-relevant applications; investment in developing and providing benchmark nanomaterials; investment in identifying and characterizing nanomaterial sources throughout the value chain and life cycle of products; and investment in developing and maintaining research networks that provide human infrastructure for collaborative research, information-sharing, and translation of knowledge to effective use. Without budgetary increases in each of these areas, the committee anticipates that the federal government's ability to derive strategic value from investments in nanotechnology-related EHS research will remain insufficient.
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The committee considers that the current structure of the NNI, which serves primarily coordinating and information-sharing roles, hinders its accountability for effective implementation of the research strategy. Because the NNI has only coordinating functions, it has no "top-down" budgetary or management authority to direct nanotechnology-related EHS research.
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From page 17... ...
Progress in addressing those foundational elements will go a long way toward ensuring effective support and management of the research needed to provide information for identifying, assessing, and managing the potential EHS consequences of ENMs. CONCLUDING REMARKS Despite the promise of nanotechnology, without strategic research into emergent risks associated with it -- and a clear understanding of how to manage and avoid potential risks -- the future of safe and sustainable nanotechnologybased materials, products, and processes is uncertain.
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