Appendix C


Workshop Summary: Research Progress on Environmental, Health, and Safety Aspects of Nanotechnology

On November 7, 2012, the National Research Council Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials held a workshop to obtain input on research progress since release of the committee’s first report, A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (NRC 2012) and to learn of other efforts that were under way to address scientific uncertainties and infrastructure needed for a robust approach to research on EHS issues related to ENMs. The workshop featured presentations by federal agency and foreign officials, academic researchers, and representatives of nongovernment organizations and industry on the scientific and regulatory framework for EHS research, on recent research progress, and on applications of the results of research to risk management. Panel discussions provided opportunities for expanded discussion of many of the issues raised during the presentations. The information gathered in the workshop informs the committee’s present report.

Setting the Stage—Emerging Issues and Emerging Materials

In response to questions regarding the possible EHS risks posed by ENMs, the workshop documented increased efforts by government agencies—in particular the NNI, academic institutions, and industry—to investigate, translate, and communicate information on the environmental and health aspects of nanotechnology. This workshop was part of the committee’s information-gathering effort to improve understanding of the evolving research landscape as it developed its report. In opening remarks to the workshop participants, Jonathan Samet, of the



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Appendix C Workshop Summary: Research Progress on Environmental, Health, and Safety Aspects of Nanotechnology On November 7, 2012, the National Research Council Committee to Devel- op a Research Strategy for Environmental, Health, and Safety Aspects of Engi- neered Nanomaterials held a workshop to obtain input on research progress since release of the committee’s first report, A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (NRC 2012) and to learn of other efforts that were under way to address scientific uncertainties and infra- structure needed for a robust approach to research on EHS issues related to ENMs. The workshop featured presentations by federal agency and foreign officials, aca- demic researchers, and representatives of nongovernment organizations and indus- try on the scientific and regulatory framework for EHS research, on recent re- search progress, and on applications of the results of research to risk management. Panel discussions provided opportunities for expanded discussion of many of the issues raised during the presentations. The information gathered in the workshop informs the committee’s present report. Setting the Stage—Emerging Issues and Emerging Materials In response to questions regarding the possible EHS risks posed by ENMs, the workshop documented increased efforts by government agencies—in partic- ular the NNI, academic institutions, and industry—to investigate, translate, and communicate information on the environmental and health aspects of nanotech- nology. This workshop was part of the committee’s information-gathering effort to improve understanding of the evolving research landscape as it developed its report. In opening remarks to the workshop participants, Jonathan Samet, of the 137

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138 Research Progress on EHS Aspects of Engineered Nanomaterials University of Southern California, chair of the committee, reviewed the charge to the committee and key messages from the committee’s first report, which was released in January 2012. Maxine Savitz, a member of the President’s Council of Advisors on Science and Technology, described the NNI’s investment in nanotechnology and specifi- cally in EHS research. She commented on recommendations in the Report to the President and Congress on the Fourth Assessment of the National Nanotechnolo- gy Initiative (PCAST 2012). Specifically, Dr. Savitz highlighted needs for a high- er-level authority that is accountable for EHS research to ensure that better policy is made; for an increase in the EHS nanotechnology research budget to about $25 million in cross-cutting fields, including informatics and instrumentation devel- opment (a recommendation originally made in the present committee’s first re- port); for an emphasis on partnerships and interagency collaborations; for greater attention to worker safety by industry; and for individual agencies to have imple- mentation plans that result from the federal strategic plan. Michael Holman, of Lux Research, described trends in nanotechnology commercialization. The nanotechnology industry is no longer focused on manu- facture of novel nanomaterials but is interested in integrating the materials into intermediate products. For example, he commented that most of the industry’s effort will focus not on novel material classes but on successful integration (and novel uses) of known nanomaterials—carbon nanotubes, metal nanoparticles, ceramic nanoparticles (silicon dioxide and aluminum and zinc oxides), quantum dots, nanostructured metals and ceramics, and nanoporous materials. Dr. Hol- man also described movement away from improvement of existing products to enabling new ones. The shift is evident in the solar and nanomedicine fields. In addition, small and large companies are shifting from emphasizing “nano per se” to emphasizing how nanotechnology innovations solve problems. For example, in 2002-2007, many large companies had central nanotechnology initiatives; now, nanotechnology activities are typically incorporated into the business (functional) teams. Startups are less likely to term themselves nanotech compa- nies and more likely to define themselves by the applications of their products. Jim Alwood, of the US Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics, reported that under the Toxics Substances Control Act more than 140 new chemical notices for ENMs have been received since 2005 (30 related to carbon nanotubes or fibers). However, Mr. Alwood, a regulator, commented that there is not much information on existing uses of ENMs and on what materials are being manufactured. He acknowledged that materials cannot be regulated case by case, but stated that categories of nano- materials need to be developed, as happens in EPA’s chemical program, and data on nanomaterials need to be integrated into risk assessments to identify those that are of concern for risk management. Mr. Alwood commented that the most important data needs are for characterization of ENMs and for understand- ing exposures. Georgios Katalagarianakis, of the European Commission (EC), discussed initiatives in the European Union (EU), including the Communities of Research

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Appendix C 139 (CoR) launched in a joint EU-US effort by the EC and the National Nanotech- nology Coordination Office (NNCO), to address EHS questions about ENMs and to advance the field collaboratively. Institutional Needs to Support the Research Enterprise In its first report (NRC 2012), the committee identified institutional ar- rangements and mechanisms that need to be addressed better to support implemen- tation of the research enterprise, including fostering interagency interaction, col- laboration, and accountability; developing and implementing mechanisms for stakeholder engagement; advancing integration among sectors and institutions involved in EHS research, including public–private partnerships; and implement- ing structural changes aimed at conflicts of interest. Representatives of federal organizations—including Sally Tinkle, NNCO; Tina Bahadori, EPA; Christopher Weis, National Institute of Environmental Health Sciences (NIEHS); Charles Geraci, National Institute for Occupational Safety and Health (NIOSH); Mike Roco, National Science Foundation (NSF); Teresa Croce, US Food and Drug Ad- ministration (FDA); and Scott McNeil, National Cancer Institute (NCI)— addressed a number of those themes and provided examples of recent efforts. Dr. Tinkle reviewed efforts to map the NNI’s EHS research-strategy goals to its strategic plan; further mapping will occur in the NNI’s supplement to the president’s 2014 budget. The NNI is trying to establish a process for tracking re- search progress. Dr. Tinkle commented that the NNI is considering requesting an Office of Management and Budget data call-in every 3 years, as was conducted in 2006 and 2009, to obtain EHS nanotechnology project-by-project data from all the federal agencies’ NNI projects. She stated that a much higher-level review would occur during the intervening years. Dr. Weis described coordination efforts within NIEHS and with other feder- al agencies, including FDA, NIOSH, and EPA. He commented on the successful coordination involved in the development of the NIEHS strategic plan, which is now being implemented, and emphasized that quality assurance and careful char- acterization of ENMs are needed for communication and exchange of data and findings. Dr. Geraci discussed how NIOSH’s work is closely aligned with that of oth- er agencies’ goals and how NIOSH coordinates with the NNI and external partners in the private, academic, government, and international sectors. He described ef- forts aimed at stakeholder engagement, including direct engagement with the na- nomaterial industry through the site-visit program for nanomaterial manufacture and use and through evaluation of materials and processes that are under devel- opment. Dr. Geraci also described efforts to communicate results from NIOSH public–private partnerships, including publication of research results from NIOSH and development of memoranda of understanding at key research and develop- ment centers; he stated that further development of public–private interactions is needed.

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140 Research Progress on EHS Aspects of Engineered Nanomaterials Dr. McNeil reported that NCI–Frederick (now called the Frederick National Laboratory for Cancer Research or the Frederick National Lab [Reynolds 2012]) recently became a national laboratory and is able to conduct research through pub- lic–private partnerships and with other agencies. It offers a niche where material scientists, toxicologists, and others can, for example, examine specific questions regarding interactions between nanomaterials and biologic systems. Dr. McNeil provided several examples of the laboratory’s work with NIEHS and FDA on na- nomaterials and an industry partnership to assess toxicity of nanocrystalline cellu- lose. Perspectives of Researchers Several researchers discussed directions and initiatives that they considered to have the highest priority for addressing uncertainties about EHS aspects of ENMs. Martin Philbert, of the University of Michigan School of Public Health, discussed the need to learn lessons from nanomedicine, emphasizing that drug development takes longer than it used to and that public–private partnerships are needed. He suggested the need to consider the “rule of six” for nanotechnology EHS research that was originally developed to move clinical drug development forward by identifying a simple set of physicochemical parameter ranges that the compounds needed to meet for design and selection (see Keller et al. 2006). He emphasized that there are few chronic safety studies on ENMs and that we need to move beyond classical toxicology to less expensive, higher-throughput analyses. Robert Tanguay, of Oregon State University, noted that ENM behavior depends completely on a material’s inherent properties and that the goal of EHS research is to develop methods for predicting behaviors from the inherent prop- erties. He described progress toward filling research gaps: distribution of some reference materials and their use in cross-evaluation of models, wider ac- ceptance of minimum characterization standards (although perhaps not yet suffi- cient), greater understanding of the dynamic behavior of ENMs, greater under- standing of the need for precision engineering to support structure–response relationship studies, and application of Tox211 principles to in vitro and in vivo studies (for example, in zebrafish). However, the focus remains on simple mate- rials with a heavy emphasis on silver ENMs and metal oxides. Apart from that progress, Dr. Tanguay commented that the key toxicologic question remains: What are the unique properties that influence toxicity? Dr. Tanguay described research that is needed to explore the unique properties of ENMs systematically and to understand how these properties influence molecular interactions and biocompatibility. The needs include further development of characterization 1 Tox21 is a collaboration among EPA, NIEHS, the National Human Genome Research Institute, the National Institutes of Health Chemical Genomics Center, and the Food and Drug Administration that was established to leverage resources to advance the recommen- dations in the 2007 National Research Council report Toxicity Testing in the 21st Century: A Vision and a Strategy.

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Appendix C 141 methods for understanding the principles that drive the dynamic behavior of materials, identification of a minimum set of testing platforms for comparative ENM bioactivity assessments, development and distribution of standard materi- als for calibrating assays, identification of more diverse sets of materials for comparative testing, more aggressive data-sharing strategies, and implementa- tion of an informatics platform for data-mining. Mark Wiesner, of Duke University and a member of the committee, dis- cussed work of the Center for the Environmental Implications of Nanotechnolo- gy (funded by EPA and NSF) and the need to elucidate principles that determine environmental behavior of nanomaterials and to translate data on the environ- mental behavior of ENMs into risk. Dr. Wiesner asked, What nanomaterial properties and environmental conditions control the spatial and temporal distri- butions of nanomaterials in the environment? He emphasized the need to look at next-generation nanotechnologies, in that much of the EHS community is still focused on first-generation materials. Development of Tools Speakers talked about progress and innovations in the development of tools—standard test and reference materials, methods to measure ENMs in complex media, exposure and effects models, and informatics—to address the research priorities. Vincent Hackley, of the National Institute of Standards and Technology, described progress in detecting and measuring ENMs. He noted the challenge posed by the lack of adequate characterization of materials in the pub- lished toxicologic literature. That problem frustrates efforts to link ENM proper- ties with biologic responses. There was discussion of how the research commu- nity can meet the needs for reference materials better in light of the fact that there is a gray area between traditional reference materials and “study” materials that are sufficiently homogeneous, widely available, and well characterized. Jamie Lead, of the University of South Carolina, described integration of experimental data and their use in informing environmental-exposure models. Exposure, aggregation, bioavailability, and toxicity models are available. Dr. Lead commented that the models are more conceptual than quantitative and do not treat complex media and systems accurately. There is a need to obtain better data (coordinated with these models) so that values can be assigned to parame- ters and models can be validated. Nathan Baker, of the Pacific Northwest National Laboratory, commented on the increasing number of informatics tools available for EHS nanotechnology research. A number of communities have been established to facilitate develop- ment and use of the tools, including the US-EU CoR for Databases/Ontology and Modeling, the National Cancer Informatics Program Nanotechnology work- ing group, and the National Nanomanufacturing Network Nanoinformatics meetings. There are efforts to collect and archive metadata for data-mining and meta-analyses, such as the Nanomaterial Registry, the Nano-Bio Interactions

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142 Research Progress on EHS Aspects of Engineered Nanomaterials Knowledgebase, and the caNanoLab. However, data-mining is complicated by several factors, including the sparseness of datasets collected on different mate- rials with different conditions and the lack of systematic variation in collected data. More incentives are needed for data-sharing and for integration of the vari- ous informatics tools. During the discussion, the role of journal editors in help- ing to tackle some of the issues was addressed. Dr. Baker commented that in the future it will be essential to provide a standard format for sharing data but that at this point it is important to engage the communities in the discussion. Perspectives of Federal Agency Technical-Program Managers Technical-program managers in EPA, NIEHS, NSF, and NIOSH discussed current and planned research efforts to address high-priority research needs, in- cluding how agency research projects and extramural funding efforts are being shaped by emerging data. Dr. Bahadori described some of the current EHS nanotechnology research efforts in EPA, including projects in fundamental material characterization, fate and transport of materials, ecosystem health, and human health. Dr. Bahadori commented that the committee’s first report will not have an immediate impact on inhouse research, but it does provide an opportunity to influence emerging fields of research through requests for application. Barbara Karn, NSF, described efforts to move the EHS nanotechnology research program toward more complex generations of materials. Dr. Karn dis- cussed program directions, including detailed material characterization; preven- tion of adverse effects; development of instrumentation, sensors, methods, and standards; a systems approach; and research to support sustainability. She de- scribed the partnership of NSF and the Consumer Products Safety Commission that was established in 2012 and expressed a hope that other research agree- ments can be established. Sri Nadadur, NIEHS, discussed research funding, including the NIEHS Centers for Nanotechnology Health Implications Research (an interdisciplinary program that comprises five U192 and three cooperative centers and other grant- ees and is intended to learn how the “properties of ENMs influence their interac- tions with biologic systems and potential health risks) and the Nano Grand Op- portunity Consortium (whose major goals are to develop reliable and reproducible assays, methods, and models that can be used to predict exposure and biologic response to ENMs in different systems and laboratories)” (NIEHS 2012). He also described the National Toxicology Program (NTP) EHS nano- 2 U19 is part the National Institute of Environmental Health Sciences Centers for Nan- otechnology Health Implications Research. It is an interdisciplinary program that com- prises five U19 and three cooperative centers and other grantees and is intended to in- crease understanding of how the properties of ENMs influence their interactions with biologic systems and potential health risks.

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Appendix C 143 technology research efforts. Dr. Nadadur related how the Chemical Effects in Biological Systems database is being used to integrate and share EHS nanotech- nology data generated by the NIEHS and NTP research programs. Paul Schulte, NIOSH, commented that workers are the first people to be ex- posed to nanomaterials. He described a recently released report, Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace (NIOSH 2012), that documents research progress. Dr. Schulte discussed how the research priorities outlined in the committee’s first report align with NIOSH initiatives. For example, regarding the quantification and characterization of the origins of nanomaterial releases, Dr. Schulte commented that NIOSH is conducting field assessments for a variety of scenarios, including where materials are manufactured. Committee members discussed NIOSH’s focus on more typical materials (for example, na- nosilver), and Dr. Schulte said that the agency is trying to be more aggressive in investigating them. There was some discussion regarding the generation of large quantities of data resulting from various federal research efforts and how to integrate the data. Committee members questioned whether there is a cross-agency effort to syn- thesize EHS nanotechnology data. Dr. Tinkle responded that there are efforts to coordinate planning but no collective effort in interpretation of data, which is left to the academic community. Another member rephrased the question in terms of the committee’s desire to understand outcomes of federally funded re- search, and Dr. Tinkle responded that the NNI is looking at metrics for assessing funding programs but does not have the answers yet. Perspectives of Stakeholders In this session, representatives of academe, industry, labor, and environ- mental groups provided their perspectives on the extent of research progress and the effectiveness of stakeholder engagement in developing and implementing needed research. Consumers do not know which products that they use contain nanomaterials, and workers do not know that they may be exposed to nano- materials in the workplace. Those comments were expressed by Carolyn Cairns, Consumers Union, and Anna Fendley, United Steel Workers, when addressing the needs of the stakeholders with whom they work. Ms. Cairns emphasized the need for linkages between research and policy. Similarly, Ms. Fendley discussed the need for better sharing of information with workers and the need to dissemi- nate and apply information in research strategies among those who are potential- ly exposed. Robert (Skip) Rung, Oregon Nanoscience and Microtechnologies Institute (an economic-development organization), echoed the need for more attention to workers, given that they receive the greatest exposures. Mr. Rung expressed concern about continued regulatory uncertainty and stated that an op- tion for companies would be to move their operations outside the United States. Seth Coe-Sullivan, a member of the committee and founder and chief technolo- gy officer of QD Vision, pointed out the need for an approach to determine what

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144 Research Progress on EHS Aspects of Engineered Nanomaterials tools are needed to inform stakeholders better and to move development of the technologies forward. Dr. Coe-Sullivan, picking up on comments by Mr. Al- wood, recognized that a case-by-case approach for regulating nanomaterials is not sustainable and that we need to look at categories. He stated that the research strategies are good enough but that implementation of the strategies is the prob- lem. REFERENCES Keller, T.H., A. Pichota, and Z. Yin. 2006. A practical view of ‘druggability’. Curr. Opin. Chem. Biol. 10(4):357-361. NIEHS (National Institute of Environmental Health Sciences). 2012. Nanotechnology Con- sortiums [online]. Available: http://www.niehs.nih.gov/research/supported/dert/cos pb/programs/nanotech/index.cfm [accessed Nov. 30, 2012]. NIOSH (National Institute for Occupational Safety and Health). 2012. Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace. A Progress Report from the NIOSH Nanotechnology Research Center: 2004-2011. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Na- tional Institute for Occupational Safety and Health [online]. Available: http:// www.cdc.gov/niosh/docs/2013-101/pdfs/2013-101.pdf [accessed Nov. 28, 2012]. NRC (National Research Council). 2012. A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. Washington, DC: National Acad- emies Press. PCAST (President’s Council of Advisors on Science and Technology). 2012. Report to the President and Congress on the Fourth Assessment of the National Nanotech- nology Initiative. April 2012 [online]. Available: http://nano.gov/sites/default/files/ pub_resource/pcast_2012_nanotechnology_final.pdf [accessed Apr. 18, 2013]. Reynolds, C.W. 2012. Letter to Frederick National Laboratory Staff, from Craig W. Reynolds, NCI Associate Director, Frederick National Laboratory for Cancer Re- search [online]. Available: http://ncifrederick.cancer.gov/News/Spotlight/Frede rickNationalLab.aspx [accessed Nov. 27, 2012].