A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2012) / Chapter Skim
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Pages 18-47
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With our understanding of the role that nanoscale science and engineering can play in the development of innovative materials, processes, and products has also come the knowledge that nanotechnology may lead to new mechanisms by which people and the environment may be harmed. In today's complex, interconnected, and resource-constrained world, it is important that products resulting from novel and emerging technologies that have uncertain risks, such as nanotechnology, be developed responsibly; that all stakeholders have an active role in socially responsible development; and that potential risks are identified and avoided as early as possible during research, innovation, and commercialization.
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. Consequently, there is uncertainty about the potential human health and environmental effects of products emerging from nanotechnology and recognition that the safe and successful development of nanotechnology depends on early, strategic action to address potential risks.
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have helped to direct where EHS research should be focused if ENMs are to be developed and used safely. Yet despite progress in the development of research needs and in the amount of research that is funded and conducted, developers, regulators, and consumers of nanotechnology-enabled products remain uncertain about the types and quantity of nanomaterials in commerce or in development, their possible applications, and the potential risks associated with them.
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2005 A Proposal to Increase Federal Funding of Nanotechnology Risk Research to at least Denison 2005 Identifies strategic-research gaps $100 Million Annually 2005 Joint NNI-ChI CBAN and SRC CWG5 Nanotechnology Research Needs Recommendations Vision 2020/SRC 2005 Identifies strategic-research gaps 2005 Small Sizes that Matter: Opportunities and Risks of Nanotechnologies Allianz/OECD 2005 Provides contextual information on strategic risk research 2006 Opinion on the Appropriateness of Existing Methodologies to Assess the Potential Risks SCENIHR 2006 Provides contextual information Associated with Engineered and Adventitious Products of Nanotechnologies on strategic risk research 2006 Nanotechnology: A Research Strategy for Addressing Risk Maynard 2006 Outlines a research strategy 2006 Safe handling of nanotechnology Maynard et al. 2006 Identifies strategic-research gaps 2006 Characterizing the Environmental, Health and Safety Implications of Nanotechnology: ICFI 2006 Provides contextual information Where Should the Federal Government Go From Here?
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2007 Meeting Report: Hazard Assessment for Nanoparticles -- Report from an Interdisciplinary Balbus et al. 2007 Identifies strategic-research gaps Workshop 2008 Proceedings of the Workshop on Research Projects on the Safety of Nanomaterials: Höck 2008 Identifies strategic-research gaps Reviewing the Knowledge Gaps 2008 Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale Council of Canadian Identifies strategic-research gaps Academies 2008 2008 Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges Schierow 2008 Provides contextual information on strategic risk research 2008 Nanotechnology: Better Guidance is Needed to Ensure Accurate Reporting of Federal GAO 2008 Provides contextual information Research Focused on Environmental, Health and Safety Risks on strategic risk research 2008 Responsible Production and Use of Nanomaterials VCI 2008 Identifies strategic-research gaps 2008 Towards Predicting Nano-Biointeractions: An International Assessment of Nanotechnology ICON 2008 Identifies strategic-research gaps Environment, Health, and Safety Research Needs 2008 Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge NIOSH 2008 Outlines a research strategy Gaps.
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2010 Identifies strategic-research gaps 2010 Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges GAO 2010 Provides contextual information in Regulating Risk on strategic risk research 2010 Nanotechnologies and Food UKHL 2010 Identifies strategic-research gaps 2010 UK Nanotechnologies Strategy: Small Technologies, Great Opportunities HM Government 2010 Outlines a research strategy 2010 Report to the President and Congress on the Third Assessment of the National PCAST 2010 Provides contextual information Nanotechnology Initiative on strategic risk research 2010 Nanotechnology Research Directions for Societal Needs in 2020: Retrospective and Nel et al. 2010 Outlines a research strategy Outlook, Chapter 4 2010 National Nanotechnology Initiative NEHI 2010 Outlines a research strategy 2011 Environmental, Health, and Safety Strategyb a Reports are classified as either providing contextual information on strategic-risk research, identifying strategic-research gaps, or outlining a research strategy.
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that either contain ENMs or have been constructed from other materials to possess nanoscale features and that comprise the second stage; and secondary products, finished goods that incorporate ENMs or intermediate products -- the third stage. In 2009, developers generated $1 billion from the sale of nanomaterials, which constitute the initial stage of the nanotechnology value chain (Lux Research in Wray 2010)
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PRESENT STATE OF STRATEGIC NANOTECHNOLOGY ENVIRONMENTAL, HEALTH, AND SAFETY RESEARCH Despite extensive investment in nanotechnology and increasing commercialization over the last 10 years, uncertainties about the EHS effects of nanomaterials and nanomaterial-based products remain. There continues to be a lack of clarity about the safety, regulatory, and governance challenges that need to be addressed if materials, processes, and products based on nanotechnology are to be developed responsibly.
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However, there remains the task of combining the emerging framework with a strategically responsive research strategy that facilitates the generation and application of timely and relevant data and that extends beyond the borders of federal agencies to include engagement with stakeholders and the international community. HISTORY OF NANOTECHNOLOGY ENVIRONMENTAL, HEALTH, AND SAFETY RESEARCH ASSESSMENTS In the early 2000s, a number of reports from diverse sources began to question the safety of nanotechnology-enabled products and emerging ENMs.
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Those activities were complemented by the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) publication of a comprehensive review of "engineered and adventitious products of nanotechnologies," which is one of the most comprehensive reviews of the potential health risks associated with ENMs (SCENIHR 2006)
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, it expanded on the 25 research priorities identified in 2007 and indicated the changing emphasis that they should receive in the near, middle, and long terms in a research strategy. The document also developed a broad framework to guide strategic risk research and identified lead agencies for addressing research needs.
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However, the document does not describe a strategy for nano-risk research. It lacks input from a diverse stakeholder group, and it lacks essential elements, such as a vision and a clear set of objectives, a comprehensive assessment of the state of the science, a plan or road map that describes how research progress will be measured, and the estimated resources required to conduct such re search.
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. The agency-specific strategies have been complemented by a growing number of reviews and reports that identify nanotechnology EHS research needs, place nanotechnology EHS research within a broader context, and flesh out research strategies (see Table 1-1 for an illustrative list)
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In 2010, highthroughput screening and predictive modeling were central themes in a forward-looking evaluation of nanomaterial EHS challenges by Nel et al.
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established the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The committee was charged with developing and monitoring the implementation of an integrated research strategy to address the EHS aspects of ENMs.
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What criteria should be used to evaluate research progress? ELEMENTS OF A NANOTECHNOLOGY ENVIRONMENTAL, HEALTH, AND SAFETY RESEARCH STRATEGY In addressing its charge, the committee considered the key elements of a successful research strategy, as articulated in the Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (NRC 2009)
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A strategy to address EHS issues would be a guide for scientists and decision-makers who need to set priorities for the use of limited resources while addressing the key risk-related questions. Goals Goals for the EHS risk-research strategy, articulated at the end of this chapter, are intended to guide the responsible development of novel nanomaterials and the management of existing nanomaterials and products to prevent and minimize their potential risks.
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It is beyond the scope of this effort to propose how such resources will be obtained or leveraged, but the magnitude of the resources should be considered if the nature of the problem is to be addressed. Mechanisms Optimal approaches and mechanisms for accomplishing exploratory and targeted research in the context of the strategy need to be discussed.
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The Human Genome Project was implemented in 1991 with interrelated goals involving mapping of the human genome, the creation of a complete sequence of human DNA and the DNA of other organisms, and development of capabilities and technologies (for example, through the National Human Genome Research Institute)
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GOALS OF THIS STRATEGY Despite the progress made to date, it remains imperative that we generate timely and relevant knowledge that will underpin the responsible development of technologies based on manipulating matter at the nanoscale. Nanoscale science and engineering are leading to remarkable new discoveries that have the potential to address major societal challenges while providing for substantial
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As it does, society cannot afford to remain entangled in confusion as the challenges and opportunities presented by nanotechnology are addressed. Although they were invaluable in their own right, previous attempts to identify research needs and develop research strategies have not brought needed clarity to nanotechnology EHS research needs, nor provided a relevant and actionable research strategy.
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2009. EMERGNANO: A Review of Completed and Near Completed Environment, Health and Safety Research on Nanomaterials and Nanotechnology.
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2007. Characterising the Potential Risks Posed by Engineered Nanoparticles: A Second UK Government Research Report.
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2008. Nanotechnology: Better Guidance is Needed to Ensure Accurate Reporting of Federal Research Focused on Envi ronmental, Health and Safety Risks.
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2010b. Advancing the Eco Responsible Design and Disposal of Engineered Nanomaterials: An International Workshop.
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National Nanotechnology Initiative. Nanotechnology Environmental Health Impli cations Working Group, Subcommittee on Nanoscale Science, Engineering, and Technology, Committee on Technology, National Science and Technology Coun cil.
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. NNI-ChI CBAN ESH Working Group (National Nanotechnology Initiative-Chemical Industry Consultative Board for Advancing Nanotechnology, Environmental Safety and Health Working Group)
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Scientific Community on Emerging and Newly Identified Health Risks, Health & Consumer Protection Directorate-General, Euro pean Commission. June 2007 [online]
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, Ed inburg, UK, the Technical University of Denmark (DTU) , the Institute for Health and Consumer Protection of the European Commission's Joint Research Centre (JRC)
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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 47 Wray, P
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