Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2013) / Chapter Skim
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4 Getting to Green
4 Getting to Green
Pages 83-114
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From page 83... ...
The success of research in this domain, as in others, depends on identifying -- through stakeholder engagement -- the most critical questions that need to be addressed; networking in the United States and internationally among investigators in government, academe, and industry; developing standards for analyses and reference materials; using uniform terminology and data descriptions; capturing data in an accessible, quality-assured database; and continuing to refine research methods. Figure 4-1 represents the committee's construct for a successful research enterprise in the potential environmental, health, and safety (EHS)
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From page 84... ...
The research is supported by the availability of materials (reference materials, materials from inventories developed with industry input, and materials released and modified through their value chain and life
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From page 85... ...
Leadership in its development and stewardship of its maintenance are also essential. In the discussion below, the committee analyzes the findings of Chapter 3 in the context of the flow of activities in the nanotechnology EHS research enterprise (Figure 4-1)
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From page 86... ...
. Information generated from process-based research influences how ENMs are produced, including considerations of life-cycle risks and relevant reference materials for conducting studies.
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From page 87... ...
NANOMATERIAL SOURCES AND DEVELOPMENT OF REFERENCE MATERIALS The committee's nanotechnology EHS research strategy is driven by the need to assess potential risks associated with the accelerating production of new ENMs and materials that are present in an increasing number of products. As shown in Figure 4-1, ENMs are the central element of nanotechnology-related research studies in the knowledge commons, the laboratory world (mechanismdriven research)
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From page 88... ...
Appropriate ENMs are needed to carry out research that will generate data needed to populate the knowledge commons, to develop new methods and instruments, to conduct mechanistic studies, and to perform investigations in complex media. Research to characterize ENM production and releases along the value chain was generally considered to show moderate progress (yellow)
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From page 89... ...
Developing precisely defined and characterized reference materials is expensive and time-consuming. Sustainable approaches are needed to set priorities among materials for development and distribution to researchers.
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From page 90... ...
Steps to Ensure Progress Toward Characterizing Commercial Sources of Nanomaterials Greater investment in research at the interface between the physical sciences, social sciences, and business. A full understanding of potential risks along the value chain requires broad and multidisciplinary expertise that will bridge physical and social sciences and engage the commercial sector.
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From page 91... ...
. As described in Chapter 3, several indicators of research progress involve successful model development.
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From page 92... ...
Toxicity testing and other screening assays are discussed later in this chapter. Not surprisingly, the need for characterization and detection methods is apparent in the four primary cross-cutting research categories identified in the committee's first report: adaptive research and knowledge for accelerating research progress and providing rapid feedback, quantifying and characterizing the origins of nanomaterial releases, processes affecting hazard and exposure, and nanomaterial interactions in complex systems.
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From page 93... ...
The inability to isolate single-particles also constrains our ability to determine mechanistically how ENM properties affect their behavior. Steps to Improve Progress in Methods and Instrumentation Development Advancing research requires methods and instrumentation for measuring key properties of ENMs, particularly in complex media.
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From page 94... ...
It is an extremely challenging task, especially in complex media, and will probably require new instrumentation with spatial resolution adequate for focusing on single particles and initial development in well-characterized systems before application in more complex media. Another important component of this research is the ability to determine critical release points along the value chain and to identify exposed populations.
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From page 95... ...
The underlying strength of the knowledge commons would be in linking these existing capabilities and others in a new environment focused on providing quantitative, reliable estimates of uncertainty for risk estimation and method validation and for establishing a vital missing link between the reductionist and integrative branches of research on the EHS aspects of nanotechnology. New programs, such as NanoRelease (ILSI 2013a)
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From page 96... ...
However, the goals and structure of the knowledge commons are sufficiently broad to accommodate the integration of data, methods, and models used by stakeholders in these related fields. First, the evaluation of both EHS risk and product-design risk involves uncertainty propagation and the documentation and sharing of errors, uncertainties, sensitivities, and expert opinion through the knowledge commons and the informatics systems (see NRC 2012, pp.175-178 and Appendix B)
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From page 97... ...
The use of virtual collaborative environments would also be key for methods development, creating a single focus for a method -- its documentation and range of validity, accompanying video for adding detail or providing training, current instrumentation and later improvements, links to data obtained from the method and links to data and models derived from the data, annotation on the method and datasets, information on sample preparation and controls for different ENMs, and metadata and information regarding method curation and provenance. The primary advantages of the collaborative environments for analytic methods would be a common focus for all aspects of method development, robustness testing and capture of sensitivity data, interlaboratory testing and data capture, use of reference materials for calibration, suggestions for improvements and extensions, method revision and retesting, and provenance concerning all uses of the data.
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From page 98... ...
In addition, informed decisions concerning the structure or distribution of structures of particular ENM samples would be possible, and structural models of the samples could be deposited in a repository, such as the Collaboratory for Structural Nanobiology, for use in developing detailed predictive models of ENM effects in different environments. Collaboration spaces would also support aggregation of data on ENMs from different lots or from similar materials.
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From page 99... ...
. To provide more useful information, studies need to focus on more complex experimental design issues -- such as relevant dose and dosimetry; dose response and time course characteristics; appropriate target cells, tissues, and organisms; and examination of more biologic pathways -- concomitantly with better characterization of ENM test substances and incorporation of standardized reference materials as controls.
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From page 100... ...
. There is an absence of validated screening tools that are needed to apply data gained from experiments to challenging risk-related questions in humans and ecosystems (that is, transitioning from the laboratory world to the real world)
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From page 101... ...
The successful establishment of adequate in vivo models should be followed sequentially by corresponding and validated in vitro toxicity tools; only then can the development of high-throughput toxicity screens informed by in situ and in vitro data represent a realistic approach. ANALYSIS OF PROGRESS TOWARD ADDRESSING IMPLEMENTATION NEEDS Indicators of Progress in Implementation and Their Link to the Nanotechnology Environmental, Health, and Safety Research Enterprise The committee identified mechanisms to ensure implementation of the EHS research strategy, including enhancing interagency coordination, providing for stakeholder engagement in the research strategy, conducting and communicating results of research funded through public–private partnerships, and managing potential conflicts of interest (NRC 2012, p.
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From page 102... ...
The role of public–private partnerships in the research portfolio for EHS aspects of ENMs has proved more difficult to define and implement. Funding and policy issues limit formation of such partnerships in that federal agencies involved in nanotechnology EHS research may have expended their allocated research budget and industry may have only modest interest in joint funding because of competitive business concerns.
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From page 103... ...
The discussion below addresses steps needed to "get to green" in the implementation indicators. Steps to Ensure Progress Toward Enhancing Interagency Coordination In Chapter 3, the committee recognizes the progress that the NNI has made in coordination of EHS research among federal agencies but reiterates the need for accountability for implementation of the NNI's EHS research strategy and the need for the strategy's integration with research undertaken by other entities, both domestically and internationally.
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From page 104... ...
The NNI has identified a number of activities aimed at improving interagency coordination and stakeholder engagement, both in its 2011 EHS research strategy (NEHI 2011) and in its 2013 budget supplement (NSET 2012b)
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From page 105... ...
coordinate development by the NNI member agencies of performance measures, targets, and time frames for nanotechnology EHS research that align with the research needs of the NNI, consistent with the agencies' respective statutory authorities, and include this information in publicly available reports" (p.
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From page 106... ...
Similar forums should be created, perhaps aligned with the EHS categories of worker–consumer–environment or value chain (raw materials–intermediates–final products)
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From page 107... ...
EPA and representatives from the motor-vehicle industry -- Ford Motor Company, General Motors Corporation, and Chrysler LLC -- fund the organization, each with about a 50% share. In addition to NIOSH's nanotechnology-focused public–private partnerships discussed in Chapter 3, a nanotechnology EHS–focused public–private partnership that could serve as a model was the Europe-based Nanotechnology Capacity Building NGOs (NanoCap)
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From page 108... ...
Public–private partnership agreements should take into account the confidentiality concerns of industrial partners. It is understood that the organization of an effective and well-run public–private partnership takes time, but NNI agencies should increase their efforts to initiate partnership programs because they are critical for the implementation of the research strategy; without them, research progress will be slower and more limited.
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From page 109... ...
It is clear that applications R&D takes priority over EHS risk research, so it is understandable that some stakeholders may question or have concerns about the NNI's ability to pursue research on EHS implications with vigor and integrity. The tension between the dual roles of NNI is exacerbated in that the results of EHS research may inform regulatory decisions and affect the developers and users of nanotechnology applications.
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From page 110... ...
Even within its current remit, greater transparency can help to address concerns about possible conflicts of interest and real or perceived bias within the NNI research community.4 The NNI has already made some progress in enhancing transparency for its EHS research, for example, by improving the tracking and reporting of EHS research activities and funding and by providing narrative information on agency-specific EHS research activities and projects in the NNI supplement to the president's FY 2013 budget. Further efforts to enhance the timeliness, specificity, and accessibility of information about EHS research projects are needed, including development of clearer guidance on how agencies should differentiate between research directly relevant to EHS risk and applications-oriented research with EHS implications.
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From page 111... ...
2013. Biological accumulation of engineered nanomaterials: A review of current knowledge.
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From page 112... ...
Nanotechnology Environmental Health Implications Working Group, Subcommittee on Nanoscale Science, Engineering, and Technology, Committee on Technology, National Science and Technology Council [online]
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From page 113... ...
2012. A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials.
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From page 114... ...
A Materials Genome Initiative Workshop, May15-15, 2012, Washington, DC.
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