Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2013) / Chapter Skim
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3 Assessment of Progress
3 Assessment of Progress
Pages 41-82
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nanotechnology reviews and planning efforts have occurred within the same period as its own work, including publication of the National Nanotechnology Initiative (NNI) EHS research strategy, other government assessments, international initiatives, and continuing research efforts in general (see Chapter 2)
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The following text identifies the indicators, discusses progress, and presents the rationale for selection of a particular assessment. BOX 3-1 Status of Indicators of Research Progress1 Adaptive Research and Knowledge for Accelerating Research Progress and Providing Rapid Feedback to Advance the Research Extent of development of libraries of well-characterized nanomaterials, including those prevalent in commerce and reference and standard materials Development of methods for detecting, characterizing, tracking, and monitoring nanomaterials and their transformations in simple, well-characterized media Development of methods to quantify effects of nanomaterials in experimental systems Extent of joining of existing databases, including development of common informatics ontologies Advancement of systems for sharing the results of research and fostering development of predictive models of nanomaterial behaviors Quantifying and Characterizing the Origins of Nanomaterial Releases Developing inventories of current and near-term production of nanomaterials Developing inventories of intended uses of nanomaterials and value-chain transfers Identifying critical release points along the value chain Identifying critical populations or systems exposed Characterizing released materials in complex environments Modeling nanomaterial releases along the value chain (Continued)
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and reference materials for use in studies and measurement tools and methods to estimate exposure and dose in complex systems INDICATORS OF RESEARCH PROGRESS Adaptive Research and Knowledge for Accelerating Research Progress and Providing Rapid Feedback to Advance the Research In the committee's 2012 report (NRC 2012) , the first set of research priorities involved establishing an adaptive infrastructure for research and knowledge generation to accelerate and advance EHS nanotechnology research.
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183) Enhancing Interagency Coordination Progress toward establishing a mechanism to ensure sufficient management and budgetary authority to develop and implement an EHS research strategy among NNI agencies Extent to which the NNCO is annually identifying funding needs for interagency collaboration on critical high-priority research Providing for Stakeholder Engagement in the Research Strategy Progress toward actively engaging diverse stakeholders in a continuing manner in all aspects of strategy development, implementation, and revision Conducting and Communicating the Results of Research Funded Through Public–Private Partnerships Progress toward establishment of effective public-private partnerships, as measured by such steps as completion of partnership agreements, issuance of requests for proposal, and establishment of a sound governance structure Managing Potential Conflicts of Interest Progress toward achieving a clear separation in management and budgetary authority and accountability between the functions of developing and promoting applications of nanotechnology and understanding and assessing its potential health and environmental implications Continued separate tracking and reporting of EHS research activities and funding distinct from those for other, more basic or application-oriented research
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For the last few years, it has been recognized that nanomaterials for EHS research need to be well characterized in the media in which they are used (Richman and Hutchison 2009; von der Kammer et al. 2012; Pettit and Lead 2013)
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Not surprisingly, the structural diversity of the materials that have been produced does not yet support the needed breadth of nanotechnology EHS studies. Thus, although there has been some progress in producing and characterizing new nanomaterials to support EHS research, there are large gaps, and progress toward this goal is categorized as yellow.
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More toxicity information on a greater variety of nanomaterials is needed so that different ENM properties and different end points can be examined. Standardization of assays and development of reference materials for positive and negative controls are also needed to ensure that the data gathered for toxicity assays are comparable and useful.
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The committee considered that there was some research progress in this category, but the progress was marked yellow because of the lack of identification of a set of methods to determine effects. More information on the variety of potential mechanisms and research that elucidates these mechanisms will move this indicator toward green.
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The foregoing examples show the need for libraries of nanomaterials; for improved reporting on nanomaterial production processes and sample-preparation techniques; for new methods for characterizing, tracking, and monitoring nanomaterials and their transformations; for methods for quantifying the effects of nanomaterials; and for systems for sharing research results and the development of predictive models for nanomaterial behaviors. Core systems, services, and applications are not yet available or have been insufficiently adopted, and this gap impedes research and the translation of research findings into products.
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For example, high-throughput methods are increasingly used in nanotechnology-EHS research, and applications from EPA–NSF funded centers (Thomas et al. 2011; Mandrell et al.
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so that these data can be used to develop predictive models of ENM behavior. The goals of advancing systems for sharing and developing models of behavior are intimately related in that the models and data structures are both influenced by the specific questions related to exposure to ENMs and the resulting effects that need to be addressed.
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Therefore, inventories3 are needed that describe what ENMs are being produced, how they are being used, and what their forms are along the value chain. However, the creation of inventories of nanomaterials is based on the notion that there is agreement as to what constitutes a nanomaterial.
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Developing inventories of current and near-term production of nanomaterials The committee identified efforts in academic and government laboratories to quantify and characterize the origins of nanomaterial releases and privatesector efforts focused on market reports. Production quantities, estimates of trends in production quantities, and the associated descriptions of what is being produced are components of what is referred to as inventories of nanomaterial production.
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Identifying critical release points along the value chain As discussed in the first report, "each nanomaterial or product containing nanomaterials along the steps of the value chain has an associated life cycle of production, distribution, use, and end-of-life releases that may affect human health and the environment" (p.
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Because a more comprehensive and comparative view of where nanomaterials may be released along the value chain is needed to identify where to mitigate risks, the indicator is yellow. Identifying critical populations or systems exposed In its first report, the committee noted the importance of characterizing not only the quantity and nature of ENMs to which humans and ecosystems are exposed but possible changes in exposed populations and systems that occur during ENM releases throughout the life cycle and value chain.
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Given the challenge of effectively measuring ENM exposures along the value chain and some, but limited progress in identifying both human populations and ecosystems exposed, the committee has labeled this indicator yellow. Characterizing released materials in complex environments5 Characterization of materials that are released into the environment remains a challenge because released materials are present at low concentrations, are often transformed during release, and must be analyzed within structurally and compositionally heterogeneous matrices (von der Kammer et al.
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Those are examples of methods that rely on separation of nanomaterials from or within a matrix followed by analysis, but concern that the separation process itself can transform the materials remains (von der Kammer et al.
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Steps taken toward development of a knowledge infrastructure able to describe the diversity and dynamics of nanomaterials and their transformations in complex biologic and environmental media In its first report, the committee indicated the need to develop a knowledge infrastructure to measure and describe nanomaterial behaviors, including transformations that affect exposure and hazard. The types and nature of the transformations that affect both exposure and toxicity studies (for example, aggregation,
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Little progress has been made in this indicator despite its importance and the recognition that such measurements are crucial for accelerating nanotechnology EHS research. Several sections in this chapter describe how analytic techniques are being adapted and used in combination to gain information about the composition and structure of ENMs in simple well-characterized media.
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2010) , the committee identified a major gap in understanding of the effects, particularly in vivo effects, of the types and amounts of adsorbed lipids and proteins.
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Another is the absence of a central structured database for consistent documentation of research results that permits datasets to be compared and used in models. Some efforts are under way in EPA–NSF funded centers to develop models for predicting nanomaterial behavior in complex biologic and environmental systems, but they are disjointed.
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Therefore, a first step is to identify relevant exposure sources, concentrations, and cellular and ecologic targets so that potential effects on complex systems can be addressed. Research progress indicators for this category ranged from yellow to red; no indicators were denoted as green.
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In the aggregate, those integrated components are necessary for developing science-based in vivo predictability and extrapolation. With regard to acute-hazard ranking, HTS assays can be powerful, but present approaches for short-term and long-term hazard assessments and corresponding risk characterization have serious limitations.
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The committee therefore determined that this indicator is yellow. Development of a set of screening tools that reflect important characteristics or toxicity pathways of the complex systems described above8 As noted in the committee's first report, hazard-identification studies of a variety of ENMs have used both in vivo and in vitro methods.
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Laboratories are pursuing such research, and important insights into mechanisms of toxicity are being generated, but these efforts are not sufficient to provide the information necessary for adequate un 9 U19 is part the National Institute of Environmental Health Sciences Centers for Nanotechnology Health Implications Research. It is an interdisciplinary program that comprises five U19 and three cooperative centers and other grantees and is intended to increase understanding of how the properties of ENMs influence their interactions with biologic systems and potential health risks.
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. 11 The committee differentiates between benchmark materials and reference materials.
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169) and continues to believe that accountability for implementation of the NNI EHS research strategy is limited and hampered by the absence of an entity that has sufficient management and budgetary authority to direct implementation throughout NNI agencies and to ensure its integration with EHS research being undertaken in the private sector, the academic community, and international organizations.
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Progress toward establishing a mechanism to ensure sufficient management and budgetary authority to develop and implement an EHS research strategy among NNI agencies The committee reviewed the NNI's 2011 research strategy and its 2013 budget supplement, which show considerable progress in coordination among NNI agencies on EHS research. Favorable developments include the addition of FDA and CPSC research programs to the NNI's EHS budget "crosscut", an increased focus by the Nanotechnology Environmental Health Implications working group on identifying opportunities for cross-agency collaborations, joint solicitations and funding of research by multiple NNI agencies, and clearer tracking of research against the NNI's broad goals and designated program component areas.
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The committee remains concerned about the absence of a clear, central convening authority in the NNI structure and considers it a serious gap in the NNI's ability to implement an effective EHS research strategy. Extent to which the NNCO is annually identifying funding needs for interagency collaboration on critical high-priority research The NNI and its member agencies have made considerable progress toward increased collaboration in EHS research, including issuance of its 2011 EHS research strategy.
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Because of the limited progress made in addressing this indicator, the committee denotes it yellow. Providing for Stakeholder Engagement in the Research Strategy Progress toward actively engaging diverse stakeholders in a continuing manner in all aspects of strategy development, implementation, and revision This indicator represents a very high but achievable bar for stakeholder engagement, seeking broad engagement both in a continuing manner and in all aspects of the strategy.
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actively involved in the research. For example, data on reference materials, nanomaterial product inventories, and the release of nanomaterials through the value chain are critical inputs into the research; one good way to provide such information accurately is to establish formal partnerships between government agencies, manufacturers, and other key stakeholders -- such as academe -- that are involved in implementing the research strategy.
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In its first report, the committee noted possible models and mechanisms that could be used to separate accountability for the NNI's dual functions, for example, elevating oversight of the EHS research portfolio in OSTP (NRC 2012; pp.
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also provides narrative information on agency-specific EHS research activities and projects. Despite the impressive progress, the tracking of EHS research progress and performance between and within NNI agencies remains challenging.
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2012. Incorporating bi ological, chemical, and toxicological knowledge into predictive models of toxicity.
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2013a. Nano Release Consumer Products [online]
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2009. Efficacy of simple short-term in vitro assays for predicting the potential of metal oxide nanoparticles to cause pulmonary inflammation.
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2012. NIEHS Centers for Nanotechnology Health Implications Research (NCNHIR)
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2011. Envi ronmental Health and Safety Research Strategy.
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von der Kammer, and T Hofmann.
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von der Kammer, M Dusinska, R
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:12-21. von der Kammer, F., P.L.
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ACS Nano.
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