6


Implementing the Research Strategy and Evaluating Progress

INTRODUCTION

This report has articulated the rationale for an environmental, health, and safety (EHS) risk-research strategy related to engineered nanomaterials (ENMs) (Chapter 1) and proposed a conceptual framework for addressing EHS risks (Figure 2-1). Chapter 3 summarized the current state of the science and high-priority data gaps on the potential EHS risks posed by ENMs. Chapter 4 described the fundamental tools and approaches needed to pursue an EHS risk research strategy. Chapter 5 presented the committee’s proposed research agenda, short-term and long-term research priorities, and estimates of needed resources.

This chapter focuses on implementation of the research strategy and evaluation of its progress, elements that the committee considered integral to its charge. It envisions a strategy that is fully integrated and coordinated, that addresses short-term and long-term needs, and that evolves as information is gleaned and progress is made. It places the discussion of Chapters 3-5 into the context of this broader vision. The present chapter also addresses the following core components that reflect elements identified in the 2009 National Research Council report (NRC 2009) 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-



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6 Implementing the Research Strategy and Evaluating Progress INTRODUCTION This report has articulated the rationale for an environmental, health, and safety (EHS) risk-research strategy related to engineered nanomaterials (ENMs) (Chapter 1) and proposed a conceptual framework for addressing EHS risks (Figure 2-1). Chapter 3 summarized the current state of the science and high- priority data gaps on the potential EHS risks posed by ENMs. Chapter 4 de- scribed the fundamental tools and approaches needed to pursue an EHS risk research strategy. Chapter 5 presented the committee’s proposed research agenda, short-term and long-term research priorities, and estimates of needed resources. This chapter focuses on implementation of the research strategy and evaluation of its progress, elements that the committee considered integral to its charge. It envisions a strategy that is fully integrated and coordinated, that ad- dresses short-term and long-term needs, and that evolves as information is gleaned and progress is made. It places the discussion of Chapters 3-5 into the context of this broader vision. The present chapter also addresses the following core components that reflect elements identified in the 2009 National Research Council report (NRC 2009) 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 poten- tial conflicts of interest; and mechanisms for integrating informatics and infor- mation-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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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 163 tion of progress in relation to the goals of the strategy and for refinement and adaptation of the strategy as the information base evolves and drives the need for change. Resources needed to conduct research and implement the strategy: An in- tegral part of an effective strategy is a means for continuing assessment of re- sources for conducting the research and for implementing the strategy. That in- cludes assessing the adequacy of current resources, how they are to be deployed, and how additional resources would best be acquired and used. Key audiences for implementing the strategy: The strategy should effec- tively consider and integrate the needs of and appropriate roles for the full array of stakeholders involved in implementing the strategy or concerned with its out- comes. These stakeholders include the National Nanotechnology Initiative (NNI) and the federal agencies within its structure; the private sector, including nanomaterial developers and users; consumers; and the broader scientific com- munity, including academic researchers and non-governmental organizations. Many of the questions posed in formulating a strategy for research on nanomaterials are equally applicable to strategies that might be developed for other emerging technologies. Lack of knowledge and high degrees of uncer- tainty, with a rapidly changing landscape of perceived risks and benefits, are inherent in the rollout of any new technology. As with nanomaterial research, there are likely to be challenges in developing common protocols for a commu- nity of researchers that turns its attention to the evaluation of the environmental and health implications of any new technology and seeks to compare the results of research among laboratories. For those reasons, the proposed research strat- egy can be considered a model approach for developing a strategy that examines the risks produced by other emerging technologies. 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). Questions that must be grappled with include the fol- lowing: What are the most effective approaches to achieving the stated goals? How will research efforts be coordinated to ensure a coherent approach to achieving the stated goals? What mechanisms and approaches are in place or could be created to enable interdisciplinary research that crosses established funding and agency boundaries and to foster effective coordination and partner- ships? As noted in Chapter 1, the committee acknowledges the contribution that the NNI has made toward implementation (NEHI 20101, Chapter 8). Most nota- 1 A final version of the strategy was published in October 2011 (NEHI 2011a). Because the committee’s report had already gone to peer review, NEHI (2011a) was not reviewed by this committee.

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164 Implementing the Research Strategy and Evaluating Progress bly, through the naming of the National Nanotechnology Coordination Office (NNCO) Coordinator for EHS, the Office of Science and Technology Policy (OSTP) has vested leadership and a measure of accountability for EHS research. This NNCO EHS coordinator is charged with leading efforts to integrate nanotechnology EHS research, to identify and leverage domestic and interna- tional collaborations, and to serve as the NNI point of contact for stakeholders on nanotechnology EHS issues (NEHI 2010). The Nanotechnology Environ- mental Health Implications (NEHI) 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 “devel- opment of joint programs among NNI agencies to fund EHS research of mutual interest and avoid unproductive redundancy” (p. 78), to expand work in data storage and management, and to “develop and maintain data communication infrastructures and organization” (p.79). The committee lays out below implementation needs of two major kinds: institutional arrangements and informatics and information-sharing. The discus- sion includes models and means to address the key needs and provide account- ability to the broader community of stakeholders. Institutional Arrangements As noted earlier, to ensure successful implementation of a research strat- egy, accountability must be integral to the strategy’s development and execu- tion. There are numerous dimensions of accountability:  Ensuring and assigning ownership of the overall strategy.  Establishing appropriate means of governance among parties imple- menting the strategy.  Establishing and applying mechanisms for accomplishing exploratory, translational, and targeted research in the context of the strategy, including an appropriate balance between government and private-sector funding and facili- tating needed or desired interdisciplinary research.  Assigning responsibility for executing elements of the strategy.  Ensuring that stakeholders are involved in and have substantive input into formulating and reviewing the strategy.  Monitoring progress in comparison with elaborated research goals and timelines to ensure that the strategy is conducted effectively and efficiently and to ensure that responsible parties are held accountable for the extent of research progress.  Coordinating periodic review and revisions to the strategy.  Ensuring that sufficient resources are devoted to conducting the needed research and to implementing the overall strategy and allocating and managing the resources.

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 165  Managing potential or perceived conflicts of interest resulting from the dual missions of the federal government in nanotechnology—investment in the development and commercialization of nanotechnology and in ensuring its safety.  Ensuring wide dissemination of research results to decision-makers and other stakeholders. This section discusses the needs for and approaches to providing account- ability in implementing the strategy in four categories: enhancing interagency coordination, providing for stakeholder engagement in the research strategy and its revision, conducting and communicating the results of research funded through public-private partnerships, and managing potential conflicts of interest. The committee’s conclusions in the four areas also are presented. Enhancing Interagency Coordination A shortcoming identified in the 2009 National Research Council report was the inadequacy of mechanisms in the NNI structure to ensure accountability for implementation of the research strategy. This problem reflects the largely coordinating and information-sharing roles of the NNI and of the primary body in the NNI that addresses environmental health and safety issues, the Nanoscale Science, Engineering and Technology (NSET) Subcommittee’s NEHI. NEHI’s mission includes (NEHI 2011b)  “Providing for information exchange among Federal agencies that support nanotechnology research . . .;  “Facilitating the identification, prioritization, and implementation of research and other activities required for the responsible research necessary to develop, use, and oversee nanotechnology;  “Promoting communication of information related to research on envi- ronmental, health, and safety implications of nanotechnology;  “Adaptively managing (i.e., coordinating, reviewing, and revising) the interagency EHS research strategy . . .;  “Assisting in developing information and strategies as a basis for draft- ing guidance in the safe handling and use of nanomaterials and products;  “With input from NSET and other interagency groups, supporting the development of tools and methods to identify, prioritize, and manage strategies for specific research to enable risk analysis and regulatory decision-making for nanomaterials and products incorporating nanomaterials [emphasis added].” Those “bottom-up” functions—interagency coordination, information ex- change, 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. 47-49).

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166 Implementing the Research Strategy and Evaluating Progress NEHI’s function needs to be supplemented with a “top-down” authority to direct and oversee the EHS research budgets and associated activities within and among NNI agencies and between government and the private sector (Denison 2007a, p. 4). As discussed previously, OSTP’s naming of an NNCO EHS coordinator is a step in this direction. However, as the title of the position suggests, the role of the coordinator stops short of the needed “top-down” authority inasmuch as the role is to “ensure effective communication and coordination of the NNI . . . and of agency EHS R&D efforts and integration of these efforts with the NNI Strat- egy for Nanotechnology-Related EHS Research (Nanowerk News 2010).” Hence, it appears that the new position principally formalizes and raises the role and function already served by NEHI rather than creating an entity with addi- tional budget and oversight authority. Various models have been proposed and others might be considered to provide greater authority. One model envisioned under the proposed “NNI Amendments Act of 2010” (Section 103 of Subtitle A of H.R. 5116, the Amer- ica COMPETES Reauthorization Act of 2010)2 was for an associate director of OSTP to be appointed and made responsible for “oversight of the coordination, planning, and budget prioritization” of EHS research-related activities. The act further delineated those responsibilities: “(1) ensuring that a research plan for the EHS research activities required under subsection (b) is developed, updated, and implemented . . ., “(2) encouraging and monitoring the efforts of the agencies participating in the Program to allocate the level of resources and management attention necessary to ensure that the . . . environmental . . . concerns related to nanotechnology, including human health concerns, are addressed under the Program, including the implementation of the research plan described in subsection (b); and “(3) encouraging the agencies required to develop the research plan under subsection (b) to identify, assess, and implement suitable mechanisms for the establishment of public-private partnerships for support of EHS re- search.” Under the proposed legislation, the OSTP associate director would chair a panel that comprised senior officials of the federal agencies funding relevant research “to develop, periodically update, and coordinate the implementation of a research plan.” In carrying out that activity, the associate director would be 2 This passed the U.S. House of Representatives on May 29, 2010. S. 3605, the Sen- ate bill of the same name, was reported out of the Committee on Commerce, Science, and Transportation, but it did not include the provisions related to nanotechnology that were in the House bill. It was the Senate version of the America COMPETES Reauthorization Act that ultimately was enacted in the 111th Congress and signed by President Obama on January 4, 2011.

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 167 required to solicit and take into account the recommendations of a newly estab- lished EHS subpanel of the external advisory panel established pursuant to the original legislation that established the NNI (the 21st Century Nanotechnology Research and Development Act of 2003, Section 4). The research plan called for under the proposed legislation would have been required to: “(A) specify near-term research objectives and long-term research objec- tives; “(B) specify milestones associated with each near-term objective and the estimated time and resources required to reach each milestone; “(C) with respect to subparagraphs (A) and (B), describe the role of each agency carrying out or sponsoring research in order to meet the objectives specified under subparagraph (A) and to achieve the milestones specified under subparagraph (B); “(D) specify the funding allocated to each major objective of the plan and the source of funding by agency for the current fiscal year; and “(E) 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, . . . grouped by major objective as defined by the research plan.” (See Section 102 of Subtitle A of H.R. 5116, the America COMPETES Reauthorization Act of 2010.) Most of the previously identified elements to ensure accountability would be addressed through the provisions of the 2010 proposed legislation. The pro- posed legislation was passed by the House of Representatives but not by the Senate in the 111th Congress; at the time of this writing, it has not been reintro- duced in the 112th Congress. Another approach that might be housed in the existing NNI and NEHI structure would be to designate a person (Maynard 2007), a small group of sen- ior health and environmental officials (Denison 2007b), or an agency with lead responsibility and to provide this entity with the budgetary and management authority needed to direct the EHS research. The officials might be drawn prin- cipally from NNI agencies whose missions are to protect human health and the environment and have related research capabilities. Whether situated in or out- side the current NNI structure, such an entity would need to have decision- making authority that is independent of the parts of NNI charged with advancing nanotechnology development (Denison 2007a, p. 4). (See section below, “Man- aging Potential Conflicts of Interest.”) An example that may serve as a model for interagency coordination and sharing of research roles is the agreement that was reached between the Envi- ronmental Protection Agency (EPA) and the Department of Energy (DOE) con-

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168 Implementing the Research Strategy and Evaluating Progress cerning radon research (EPA 1987, 1989). In the middle 1980s, extremely high concentrations of radon were found in homes in Pennsylvania and led to intense public interest and Congressional attention to issues related to indoor radon. In a reauthorization of the Superfund Amendments and Reauthorization Act, Con- gress designated EPA as the lead agency for addressing radon and other indoor pollutants. However, DOE had a long history of research in radiation biology, anthropogenic sources of radiation exposure, and energy efficiency and building science. Each agency had its supporters, and the tension between them created considerable turmoil. To address the problems, a memorandum of understanding was signed in September 1987 that defined primary responsibilities for each agency (EPA 1987, 1989). EPA’s role was applied research, particularly that related to moni- toring and mitigation techniques and to operational indoor-radon programs. DOE was responsible for basic research in methods for reducing overall expo- sure to radiation, for investigation of health and environmental effects of radon exposure, and for issues related to the further development of energy efficiency in buildings. Within a few years, EPA clearly led with action programs and pub- lic outreach regarding radon exposures, and DOE had a substantial basic- research and applied-research program that fostered understanding of exposure issues, radiation biology, and basic science. Another model of coordination among federal agencies originates in OSTP: the Committee on Environment, Natural Resources, and Sustainability (CENRS) established by the National Science and Technology Council (OSTP 2011). CENRS is cochaired by OSTP, the National Oceanic and Atmospheric Administration, and EPA. It provides a formal mechanism for interagency coor- dination 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) funded by multiple federal agencies. In the early 1990’s, PM research was largely uncoordinated and frag- mented. Following the promulgation of a new PM standard by EPA in 1997, there was a call for a research agenda. A report by the NRC Committee on Re- search Priorities for Airborne Particulate Matter published in 1998 laid the groundwork for an integrated research and management program. This commit- tee was charged with monitoring progress and did so over a six-year period. Within a few years, coordination among funding agencies, investigators, and regulators benefited from an interagency working group chaired by EPA but with representation of all the key participants (CENR 2011). The oversight ef- fort identified research gaps and collectively supported the research to address them. The oversight program also fostered collaborative efforts among investi- gators when this approach was perceived as the optimal means of solving prob- lems. The coordination of the PM research agenda clearly has enhanced research productivity and utility in public-policy decisions. CENRS also is using the model to coordinate climate issues in the federal government, including up- grades of meteorology and air-quality models and how the improved models should be optimized for global and regional issues.

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 169 NEHI (2010) acknowledges the need for stronger agency coordination and describes some new initiatives, including more active involvement by the Con- sumer Product Safety Commission and the Food and Drug Administration, the naming of the new NNCO EHS coordinator, the development of an interagency Web site, and a new charge to NEHI to clarify research priorities and identify cross-agency collaboration opportunities. Conclusion: While recognizing the important coordinating role of NNI, the commit- tee concludes that to implement its strategy effectively an entity with sufficient management and budgetary authority is needed to direct development and im- plementation 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 implementa- tion of the strategy will be severely limited in the absence of such an entity. It would be helpful for NNCO to identify funding needs and mechanisms for inter- agency collaboration on high-priority research annually. Providing for Stakeholder Engagement in the Research Strategy NRC (2009) concluded that the federal nanotechnology-related EHS re- search strategy did not adequately seek and incorporate the inputs and perspec- tives of various stakeholders. Input into the strategy was limited to that from the NNI agencies and was constrained by their experience, expertise, and resources. The review concluded that such an insular approach results in an insular re- search strategy (NRC 2009, p. 49): The reason is that federal agencies have a vested interest in justifying the applicability of current efforts rather than critically assessing what is not being done and how deficiencies might be addressed. For example, when agencies are developing their own research strategies, they tend to ask, What research can we do within our existing capabilities?, rather than the more appropriate, What research should we be doing? Other relevant questions need to be addressed, such as, Are resources adequate? Are ade- quate mechanisms and organizational structures in place to achieve the de- sired goals? As a result, the federal strategy becomes a justification for current activities based on a retrospective examination that demonstrates success rather than the development of a prospective strategy that ques- tions current practices with an eye to future research needs. Only by actively soliciting from the outset and integrating the needs of those who have a stake in the outcomes of the strategy can it be responsive and ensure that the right questions are being asked and answered.

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170 Implementing the Research Strategy and Evaluating Progress Progress has been made in engaging stakeholders in the development of NEHI (2010). NNI held four public workshops focused on various aspects of nanotechnology-related EHS that solicited reaction to the 2008 strategy (NEHI 2008, 2010): “Human and Environmental Exposure Assessment”, “Nanomateri- als and the Environment and Instrumentation, Metrology, and Analytical Meth- ods”, “Nanomaterials and Human Health and Instrumentation, Metrology, and Analytical Methods”, and “Risk Management and Ethical, Legal, and Societal Implications of Nanotechnology.” Participants were asked to review and update the state of the science and to identify critical research gaps and barriers to con- ducting needed research. NNI also published a request for information in the Federal Register and established an online portal to receive input on its 2011 draft strategy during a designated comment period (NEHI 2010). The NNI has established several industry partnerships called Consultative Boards for Advancing Nanotechnology (CBANs) that are limited to industry and, as the name suggests, are aimed primarily at developing nanotechnology. Nonetheless, they do provide a potential means of obtaining input from industry stakeholders. NRC (2009) cited one model for stakeholder input drawn from the prac- tice of an existing NNI agency, the National Institute for Occupational Safety and Health (NIOSH) (NORA 2008): The National Occupational Research Agenda (NORA) is a partnership program to stimulate innovative research and improved workplace prac- tices. Unveiled in 1996, NORA has become a research framework for NIOSH and the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing these needs. NORA has several appealing features that go beyond NNI’s efforts to date and that could be considered as a model for stakeholder engagement. NORA provides means by which the needs of stakeholders—“from universities, large and small businesses, professional societies, government agencies, and worker organizations”—inform the research questions and by which stakeholders are directly involved in the development of the research strategy designed to meet those needs. Various means of involvement are provided, recognizing the differ- ential capacity of individuals and stakeholder groups. In contrast with the process used by NNI, the NORA process of stake- holder engagement is continuing, rather than one-time or occasional, with input solicited and considered at all stages of strategy development and execution. Finally, national and sector-specific research agendas are produced and main- tained in addition to an overall national strategy. NORA identifies the diversity of stakeholders that it engages as key to its success. Going well beyond submitting comments on draft documents or attend- ing meetings, stakeholders actively participate in standing “councils.” For ex-

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 171 ample, the Manufacturing Sector Council has representatives of state agencies, hospitals, insurance companies, universities, consulting firms, federal agencies, manufacturers, and labor unions. In addition to producing its sector research agenda, the council prepared and released a dozen fact sheets summarizing the state of information for different occupational health and safety problems in the manufacturing sector. Leaders of each sector council participate in a cross-sector council, the goal being “to enhance the effectiveness of the NORA Sector Coun- cils through coordination of their activities, sharing information, and seeking efficiencies in dealing with issues that are common in two or more sectors” (NORA 2011). The standing nature of the NORA stakeholder venues, the variety of in- terim and final products, the sector-specific strategies to supplement the national strategy, and the diversity of stakeholders engaged are all features that could be incorporated into a stakeholder-engagement effort focused on nanotechnology research needs and strategy development. NORA holds biennial symposia to discuss research findings, their implications, and future needs. Although NORA serves the needs of NIOSH in soliciting stakeholder en- gagement, NNI’s purview is far broader and involves multiple agencies and de- partments with differing agendas, cultures, processes, and practices. The NORA model would need considerable adaptation to ensure meaningful stakeholder engagement in this more complex setting. Nonetheless, some of NORA’s fea- tures—opportunities to provide input, the provision for substantive stakeholder leadership roles, and the success in involving a broad array of stakeholders— would be desirable features of stakeholder engagement needed to develop and implement the current research strategy. Conclusions: To implement its strategy effectively, the committee concludes that sev- eral 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.  Ensuring that diverse stakeholders are provided with a means of play- ing leadership roles in strategy development, implementation, and revision. The committee notes that these conclusions go beyond stakeholder en- gagement opportunities provided under the NNI, and provide a framework for engagement of a broader cross-section of stakeholders. For example, standing councils and stakeholder groups need not and should not be limited to “inside- the-beltway” participants. The process for selecting their membership should be

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172 Implementing the Research Strategy and Evaluating Progress designed to be as inclusive as possible and invite nominations through broadly disseminated channels. Conducting and Communicating the Results of Research Funded Through Public-Private Partnerships NEHI (2010) briefly acknowledges the need to develop and leverage pub- lic-private partnerships. It notes the continuing use of the Small Business Inno- vation Research program and the Small Business Technology Transfer program. It notes that “new programs could support industry-public partners-agency col- laborations on EHS research,” but it provides or proposes none. NEHI (2010) has an equally short and nonspecific section on the related topic of knowledge dissemination. As noted earlier, the NNI has established several industry partnerships called Consultative Boards for Advancing Nanotechnology (CBANs), though these are, as the name suggests, aimed primarily at developing nanotechnology. Another example of a partnership is the Industry Consortium for Envi- ronmental Measurement of Nanomaterials (ICEMN) that involves stakeholders from industry and academia who are working to provide the California Depart- ment of Toxic Substances Control (DTSC) or other regulatory bodies with in- formation that could be used to measure nanomaterials in air, surface water, and soil and to assess if these methodologies can be adapted to quantify or to charac- terize environmental concentrations of these nanomaterials. The consortium was established in response to a “data call-in” by DTSC for information on analytic test methods, and on fate and transport in the environment from manufacturers or importers of certain nanomaterials (DTSC/ICEMN 2011; NIA 2011). Various models have been recommended by stakeholders to facilitate ef- fective, reliable public-private partnerships to conduct nanomaterial EHS re- search. One such model is the Health Effects Institute (HEI) (HEI 2011). HEI is a nonpartisan, nonprofit research institute, jointly funded by the automotive in- dustry and EPA that focuses on the health effects of air pollution. Strengths of the HEI model include its ability to solicit and fund targeted, policy-relevant research, its quality control and independent governance and peer-review proce- dures, and its operational transparency and commitment to release all research results (Denison 2007a; Maynard 2007). 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). Other models that have been considered germane to the conduct and communication of nanotechnology-related EHS research through public-private partnerships include the Foundation for the National Institutes of Health (FNIH 2011) and the National Cancer Institute (NCI) Nanotechnology Characterization Laboratory (NCI 2011a).

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182 Implementing the Research Strategy and Evaluating Progress BOX 6-2 Continued Nanomaterial interactions in complex systems ranging from subcellular systems to ecosystems  Extent of initiation of studies that address heretofore underrepre- sented fields of research, such as those seeking to relate in vitro to in vivo observations, to predict ecosystem effects, or to examine effects on the en- docrine or developmental systems.  Steps toward development of models for exposure and potential ef- fects along the ecologic food chain.  Extent of refinement of a set of screening tools that reflect important characteristics or toxicity pathways of the complex systems described above.  Extent of adaptation of existing system-level tools (such as individ- ual species tests, microcosms, and organ-system models) to support stud- ies of nanomaterials in such systems.  Identification of benchmark or reference materials, both positive and negative, for use in such studies and measurement tools and methods to estimate exposure and dose in those complex systems. The Longer Term As discussed in Chapter 1, the National Research Council Committee on Research Priorities for Airborne Particulate Matter was charged with developing and monitoring progress in implementing a similar risk-research strategy. That committee developed six criteria that it used to evaluate progress in conducting the high-priority research and in implementing the strategy (NRC 1998, 1999):  Scientific value: Does the research fill critical knowledge and data gaps?  Decision-making value: Does the research reduce uncertainties and in- form decision-making by key stakeholders, for example, decisions about risk assessment and risk management?  Feasibility and timing: Is the research technically and economically feasible, and can it be done in a timeframe responsive to stakeholder and deci- sion-maker needs?  Interaction and collaboration: How well does the research agenda foster the collaboration and interaction needed among scientific disciplines, agencies, academe, and private sector, especially in addressing cross-cutting issues? Are the scientific expertise, capacity, and resources appropriately used to enhance scientific creativity, quality, and productivity?

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 183 BOX 6-3 Indicators of Progress in Implementation 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 NNCO is annually identifying funding needs for in- teragency collaboration on critical high-priority research. Providing for stakeholder engagement in the research strategy  Progress toward actively engaging diverse stakeholders in a con- tinuing 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 partner- ships, as measured by such steps as completion of partnership agree- ments, 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 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.  Integration: How well is the research agenda coordinated and inte- grated with respect to planning, budgeting, and management, including between government and private organizations?  Accessibility: How well is information about research plans, budgets, progress, and results made accessible to agencies, research organizations, and interested stakeholders? The present committee believes that the same criteria should be used to evaluate the extent of longer-term progress in implementing the research agenda proposed in this report. The criteria should be applied in evaluating research progress periodically. The committee notes that the NNI has already made sub- stantial progress in addressing the latter three criteria (NEHI 2008, 2010).

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184 Implementing the Research Strategy and Evaluating Progress As previously stated, the planning, management, and implementation of the research strategy are just as critical as the identification of the research pri- orities themselves. Without careful attention to those processes, any research agenda will fall short of expectations, no matter how compelling and well rea- soned it may be. To evaluate research progress later, the committee suggests applying spe- cific longer-term progress indicators that correspond to the criteria presented in NRC (1998, 1999). Scientific Value The scientific value of the information generated can be assessed in terms of its overall contribution to enhancing understanding of the EHS effects of ENMs and reducing the uncertainty faced by stakeholders who must make deci- sions about nanotechnology and managing its potential risks. As noted in Chap- ter 5, such scientific knowledge will fill important data gaps and provide infor- mation 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 expo- sure through the life cycle and value chain, exposure of relevant targets, activa- tion of pathways of disease and organism effects, and resulting effects on the health of humans and ecosystems. Specific progress indicators include  Number, distribution, and adequacy of research projects that address priorities, gaps, and critical interactions in each part of the research agenda, in- cluding the number of research-agenda priorities planned and initiated, even if not completed, and the number of strategy-related research project applications received and funded.  Distribution and adequacy of research through the life cycle and value chain of ENMs.  Usefulness of study results for forming hypotheses for future research.  Usefulness of research in building new research capacity, skills, and tools for future research.  Extent to which uncertainty about human health and environmental risks is reduced. Decision-Making Value The decision-making value of the knowledge generated can be assessed in terms of its usefulness to the stakeholders who must make decisions about the development, production, and life-cycle use of ENMs. They include government agencies charged with protecting human and ecosystem health; developers, pro- ducers, suppliers, and purchasers of ENMs who must make economic and risk-

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 185 management decisions in the face of scientific and regulatory uncertainty about EHS effects; and consumers of nanomaterial-enabled products. In addition to providing scientific information that reduces uncertainty about key decisions for stakeholders, the agenda should generate and make accessible basic information about the materials and products themselves—information critical for the re- search enterprise and important to many stakeholders. That includes information about the nanomaterials and products being produced, planned, or envisioned; identification of populations potentially exposed and at risk; prevention and con- trol measures and practices in place or needed for protection and precaution in the face of uncertainty; identification of nanomaterial-enabled consumer prod- ucts and information on consumer use; and information about disposal practices. Specific progress indicators include  The extent to which the research has generated knowledge or informa- tion useful for decision-makers and other stakeholders. To what extent has it identified (and, ideally, reduced) the magnitude of uncertainty about EHS effects of ENMs? For example, to what extent has the new knowledge been integrated into risk-assessment decisions or regulatory processes? To what extent has it influenced private-sector research, investment, or production decisions related to nanomaterials?  The extent to which the research has informed risk-management deci- sions—by government, industry, workers, and the public.  The extent to which basic information about nanomaterials has become available and accessible to researchers, decision-makers, and the public—for example, information on nanomaterials and products containing nanomaterials currently produced and in use, data on exposure and exposure pathways, identi- fication of populations at risk, preventive measures or practices in place or needed in the face of uncertainty, disposal practices, and consumer use.  The usefulness of results in defining adverse effects on human health and ecosystems.  The usefulness of results in identifying susceptible populations. Timing and Feasibility This indicator is related to the operational, technical, and economic feasi- bility of the research. Can it realistically be done in a timeframe responsive to decision-makers’ needs? Specific progress indicators include  Whether the technical tools and approaches to conduct the research are available or under development.  Whether the research capacity and expertise for conducting the research are adequate and whether they are in the government, private sector, or aca- deme.

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186 Implementing the Research Strategy and Evaluating Progress  Whether the research is appropriately sequenced. Has a timeframe been articulated for each component of the research?  Whether funding for the task is available and adequate. Interaction and Collaboration The scientific expertise, research capacity, and decision-making authori- ties needed to ensure the safety of ENMs are varied. They are found in a host of government, private-sector, and nonprofit organizations and are embedded in multiple disciplines from chemistry, biology, toxicology, medicine, and public health to engineering, computer modeling, and informatics. The committee be- lieves that multidisciplinary interactions and collaborations both domestically and internationally are essential for progress in understanding and addressing the EHS dimensions of ENMs. Specific progress indicators include  Specification of disciplines, expertise, and skills needed to achieve spe- cific research objectives.  Cooperative use of resources, including mutually funded or conducted research.  Multidisciplinary collaboration in research projects.  Joint workshops and conferences, and presentations and publications across disciplinary boundaries.  Public-private research partnerships on specific elements of the EHS- research strategy.  Sharing of databases and information among agencies and disciplines.  Consistent use of terminology and measures among disciplines.  Stakeholder engagement and participation in all aspects of the research agenda.  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. But it is the very plethora of institutions, resources, and capacities that warrants efforts to inte- grate and optimize the use of federal resources, talent, and infrastructure in pur- suit of the research agenda. Specific progress indicators include  Collaborative or coordinated planning, monitoring, and evaluation of research both domestically and internationally, including multistakeholder en- gagement.

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 187  Formal processes for exchanging and integrating knowledge, experi- ence, and expertise of the EHS research communities in the implementation, monitoring, and evaluation of the research agenda.  Appropriate balance and differentiation of kinds and loci of research activities, for example, applied vs basic, health vs ecosystem risk, intramural vs extramural, and public vs private.  Use of a full spectrum of funding mechanisms.  Mutually funded or conducted research.  Data-sharing and model-sharing among investigators in and outside the federal government. Accessibility The ultimate outcome of EHS research is the prevention of harm or effec- tive management of risks associated with ENMs. Thus, the knowledge and in- formation generated must be accessible to and shared with scientists, research sponsors, decision-makers, the public, and others interested or with a role in risk prevention and management. Specific progress indicators include  An accessible, searchable central database of research plans, studies, progress, funding, and results open to the research community, key stakeholders, and other interested parties.  An “evergreen” database of nanomaterials, products, applications, and uses, and information on effective exposure-control technologies and practices.  Outreach and provision of information to target, at-risk populations about EHS exposures, risks, risk prevention, and risk management.  Periodic reports that summarize the status of research activities, synthe- size research results and accomplishments, and identify remaining knowledge gaps. Because the lifetime of the present committee is too short to provide for an assessment of research progress in understanding the EHS aspects of nanotech- nology, the committee recommends that a rigorous and critical evaluation of the progress made in implementing and conducting research in keeping with its strategy be conducted within 5 years after completion of the committee’s second report. That timeframe should be sufficient to observe progress and identify any needed changes in research directions and additional steps to maintain momen- tum 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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188 Implementing the Research Strategy and Evaluating Progress 2008). That concern was echoed in the NRC (2009) review of the federal strat- egy (NEHI 2008). NRC (2009) also expressed concern that the federal strategy did not identify resources necessary to address questions concerning nanotech- nology-related EHS-research needs. Specifically, there was no assessment of whether the aggregate level of spending by the federal agencies was adequate to address EHS-research needs or whether the resource expenditures by the agen- cies were appropriate to address EHS-research needs based on their own mis- sions (p. 30). NRC (2009) recommended development of a strategy that in- cluded the “estimated resources that would be needed to address the [research] 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. The committee acknowledges, but has not attempted to esti- mate the resources (in addition to those required to conduct the research), needed for effective implementation of this strategy. KEY AUDIENCES NEEDED TO IMPLEMENT THE STRATEGY Implementation of the EHS-research strategy will require the coordinated participation of numerous entities—government, private sector, academic, and nongovernment organizations. Government organizations have multiple roles related to understanding the potential implications of ENMs. They include conducting and supporting EHS research; ensuring coordination with ongoing research activities occurring inter- nationally; responsibility for protecting workers, consumers, the general public, and the environment from adverse effects that may arise from exposure to nanomaterials in the workplace, products, and the general environment; and providing access to and assessing EHS-relevant information. Private-sector nanomaterial developers and suppliers are core drivers and holders of nanotechnology-related EHS information. Manufacturers, nanomate- rial suppliers, and their customers are the primary producers and handlers of the materials, so their input and knowledge are essential to the research agenda. For example, carbon nanotube (CNT) producer Bayer MaterialScience (BMS) con- ducts much of its toxicologic studies internally through Bayer Health Care. However, BMS is also involved in publicly supported studies through the pro- ject Nanotechnology Capacity Building NGOs, a European program to increase the understanding of nanomaterial-related EHS risks. And BMS—with other European CNT suppliers, such as Arkema and Nanocyl—is conducting work- place-exposure studies with the Producers Association of Carbon nanoTubes in Europe (PACTE) (Lux Research 2009).

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 189 Academic and research institutions also play a crucial role, especially in the fundamental research relevant to understanding EHS implications of nanotechnol- ogy. Academic researchers publish a large share of peer-reviewed articles on nanotechnology-related EHS research and provide expertise relevant to develop- ment, implementation, and evaluation of an effective research strategy. Nongovernment and consumer organizations provide an additional per- spective and expertise, a voice for the general public, and a valuable means of monitoring the overall efforts and progress of a research agenda. For example, they have highlighted the need for an accessible repository of EHS data to in- form the public about the uses of and risks posed by nanomaterials (Lux Re- search 2009). CONCLUDING REMARKS The committee was charged with developing an integrated research strat- egy for addressing EHS aspects of ENMs. The committee recognizes that the success and impact of the proposed strategy depend on the institutional ar- rangements for its implementation and maintenance. This chapter has addressed critical issues related to coordination, collaboration, and leadership. The com- mittee urges that these issues receive high priority because their resolution is integral to the success of the proposed research strategy. REFERENCES Callan, L.J. 1998. Organizational Conflict of Interest Regarding Department of Energy Laboratories. Memorandum to the Commissioners, from L. Joseph Callan, Execu- tive Director for Operations, U.S. Nuclear Regulatory Commission. SECY-98-003. January 6, 1998 [online]. Available: http://www.nrc.gov/reading-rm/doc-collect ions/commission/secys/1998/secy1998-003/1998-003scy.html [accessed Mar. 17, 2011]. CENR (Committee on Environment and Natural Resources). 2011. Air Quality Research Subcommittee [online]. Available: http://www.esrl.noaa.gov/csd/aqrs/ [accessed May 16, 2011]. Denison, R. 2007a. Questions for the record to Dr. Richard A. Denison, U.S. House of Representatives: Research on Environmental and Safety Impacts of Nanotechnol- ogy: Current Status of Planning and Implementation under the National Nanotech- nology Initiative, October 31, 2007 [online]. Available: http://www.edf.org/docu ments/7347_DenisonQFRresponsesFINAL.pdf [accessed Mar. 15, 2011]. Denison, R. 2007b. Statement of Richard D. 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]. Available: http://www.edf.org/documents/7287_Deni sonTestimony_10312007.pdf [accessed Mar. 15. 2011]. Dingbaum, S.D. 2002. Audit of NRC Oversight of ITS Federally Funded Research and Development Center (OIG-02-A-11). Memorandum Report to William D. Travers,

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