A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2012) / Chapter Skim
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6 Implementing the Research Strategy and Evaluating Progress
6 Implementing the Research Strategy and Evaluating Progress
Pages 162-192
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as necessary for implementing an effective research strategy: Infrastructure for implementation and accountability: Two distinct types of new or expanded infrastructure are needed for implementing the strategy: expansion of institutional arrangements, including interagency coordination, stakeholder engagement, public-private partnerships, and management of potential conflicts of interest; and mechanisms for integrating informatics and information-sharing into the research structure. Evaluation of research progress and revision of the strategy: A critical element of an effective research strategy is the inclusion of processes for evalua 162
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INFRASTRUCTURE FOR IMPLEMENTATION AND ACCOUNTABILITY Mechanisms for effective implementation of an EHS research strategy are just as essential to its success as is the substance of the identified research, a key finding in NRC (2009)
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working group (NEHI 2010) also calls on NNI agencies to explore and exploit new media and networking opportunities to improve interagency communication and stakeholder interaction, to develop new mechanisms for NNI agencies to partner with industry, to facilitate "development of joint programs among NNI agencies to fund EHS research of mutual interest and avoid unproductive redundancy" (p.
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." Those "bottom-up" functions -- interagency coordination, information exchange, facilitation, and communication -- clearly are important and necessary. However, they are insufficient to ensure the degree of accountability needed to develop and execute a national EHS research strategy (NRC 2009, pp.
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ensuring that a research plan for the EHS research activities required under subsection (b) is developed, updated, and implemented .
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estimate the funding required for each major objective of the plan and the source of funding by agency for the following 3 fiscal years." The plan was required to be made public and updated annually. A public database was to be established and maintained with all EHS research projects funded under the plan by NNI agencies, "including a description of each project, its source of funding by agency, and its funding history, .
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It provides a formal mechanism for interagency coordination relevant to environment, natural resources, and sustainability policy and R&D issues nationwide and globally. The model has been effectively used in coordinating research on particulate matter (PM)
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Conclusion: While recognizing the important coordinating role of NNI, the committee concludes that to implement its strategy effectively an entity with sufficient management and budgetary authority is needed to direct development and implementation of a federal EHS research strategy throughout NNI agencies and to ensure its integration with EHS research undertaken in the private sector, the academic community, and international organizations. Progress in implementation of the strategy will be severely limited in the absence of such an entity.
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. The NNI has established several industry partnerships called Consultative Boards for Advancing Nanotechnology (CBANs)
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Conclusions: To implement its strategy effectively, the committee concludes that several elements are needed to enhance stakeholder engagement: Establishing a standing means to receive input and actively engage stakeholders at all stages of strategy development, implementation, and revision. Establishing stakeholder groups representing or with interest in EHS implications relevant to specific sectors of application of nanotechnology and nanomaterials.
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. Others have cited limitations of the model for nanotechnology-related EHS research, including a much broader scope of research than that under the HEI, challenges associated with conducting research on proprietary materials, and research that occurs in many different agencies and industry sectors (Teague 2007)
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The debate over the adequacy of the portion of the total NNI budget devoted to addressing EHS concerns is one manifestation. An equally contentious disagreement is that over NNI's classification of research projects with respect to their "EHS relevance" and its tendency to "overcount" the dollars spent on EHS research (NRC 2009)
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A historical precedent and model for addressing perceived and actual conflicts between the federal government's interest in developing and its interest in managing the risks posed by new technologies was the establishment of the Nuclear Regulatory Commission (U.S.
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. Informatics and Information-Sharing Just as institutional arrangements are critical to the implementation of the nanotechnology-related EHS research strategy, so is the development and use of informatics for information collection, analysis, and sharing.
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The discussion below provides examples of means by which collaboration may be fostered to support an informatics infrastructure to aid nanotechnology-related EHS research. One means of facilitating coordination of informatics projects is the Semantic Web, which is a set of practices and standards designed to enable individuals to structure their data so that they are compatible with Web-based exchange.
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One model of collaboration that relies on the Semantic Web is NCI's cancer Biomedical Informatics Grid (caBIG)
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. However, to address the high-priority research needs outlined in Chapter 5, mechanisms are needed to facilitate nanotechnology-related EHS research in the larger community of researchers and decisionmakers beyond NNI.
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2-3) : Given the dynamic nature of research in this area, the NNI incorporated adaptive management into its first NNI EHS research strategy, the 2008 NNI Strategy for Nanotechnology-Related EHS Research to allow for modification of the strategy based on research progress, new findings, and product development.
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For examining initiation of research, the committee will simply ask whether the specific research-progress indicators are being addressed; little or no evaluation will be possible. With respect to the strategy-implementation issues, the committee will be particularly attentive to progress in establishing institutional arrangements and mechanisms that foster interagency interaction, collaboration, and accountability; developing and implementing mechanisms for stakeholder engagement; efforts to advance integration among sectors and institutions involved in EHS research, including public-private partnerships; structural changes that address conflicts of interest; and informatics and information-sharing.
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Developing inventories of intended use of nanomaterials and value chain transfers. Identifying critical release points along the value chain.
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: Scientific value: Does the research fill critical knowledge and data gaps? Decision-making value: Does the research reduce uncertainties and inform decision-making by key stakeholders, for example, decisions about risk assessment and risk management?
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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 as sessing its potential health and environmental implications. Continued separate tracking and reporting of EHS research activi ties and funding distinct from those for other, more basic or application oriented research.
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As noted in Chapter 5, such scientific knowledge will fill important data gaps and provide information on what the committee believes are the most critical elements and interactions for understanding EHS effects and determining whether a material is harmful. This includes knowledge about pathways and the likelihood of exposure through the life cycle and value chain, exposure of relevant targets, activation of pathways of disease and organism effects, and resulting effects on the health of humans and ecosystems.
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That includes information about the nanomaterials and products being produced, planned, or envisioned; identification of populations potentially exposed and at risk; prevention and control measures and practices in place or needed for protection and precaution in the face of uncertainty; identification of nanomaterial-enabled consumer products and information on consumer use; and information about disposal practices. Specific progress indicators include The extent to which the research has generated knowledge or information useful for decision-makers and other stakeholders.
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Public participation in implementing the research strategy. Integration Given the agency-based government appropriations process, the different mandates and structures in and among government agencies, and the capacities and resources of private organizations, it is challenging to integrate the planning, budgeting, management, and monitoring of EHS research.
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That timeframe should be sufficient to observe progress and identify any needed changes in research directions and additional steps to maintain momentum toward addressing the identified high-priority research. RESOURCES There have been repeated expressions of concern that the federal funding devoted to EHS research on nanomaterials is insufficient (GAO 2008; Maynard
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gap over a specified time frame." In Chapter 5 of this report, the committee calls for maintenance of core EHS research funding at about $120 million per year over the next 5 years, as well as a strategic realignment of the federal resources being devoted to nanotechnology-related EHS research. The committee also recommends that modest additional resources from the private and public sectors, both nationally and internationally, augment the infrastructure needed to support an effective research program.
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Denison, Senior Scientist, Environmental Defense, before the House of Representatives Committee on Science At Hearing on Research on Environmental and Safety Impacts of Nanotechnology: Current Status Planning and Implementation under the National Nanotechnology Initiative, October 31, 2007 [online]
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House of Representatives: The National Nanotechnology Initiative Amendments Act of
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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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Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission [online]
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