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Review of Recent Reports and National Research Council Committee Workshop

INTRODUCTION

For its second report, the committee was charged with evaluating research progress since release of its first report and with assessing the extent to which progress has been consistent with its recommendations. Since release of the committee’s report in January 2012, a number of national and international efforts have focused on environmental, health, and safety (EHS) aspects of nanotechnology. In the United States, reports have commented on continuing efforts and needs with regard to EHS nanotechnology research, including The National Nanotechnology Initiative—Supplement to the President’s FY 2013 Budget (NSET 2012) (released in February 2012), Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative (PCAST 2012) (released in April 2012), and the Government Accountability Office (GAO) report Nanotechnology: Improved Performance Information Needed for Environmental, Health, and Safety Research (released May 2012). In addition, international research efforts directed at EHS aspects of engineered nanomaterials (ENMs) have advanced, particularly in the European Commission (EC) Seventh Framework Program (FP71)2.

In this chapter, the committee reviews findings from key recent reports and assessments and comments on the committee’s workshop held in November 2012 (see Appendix C). The chapter is intended to provide insights into the

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1 Funding programs created by the European Union to support research. The specific objectives vary depending on the funding period.

2 The committee recognizes that there are other international research efforts, but this analysis is not intended to be a comprehensive review. Rather it focuses on a few major reports from the US federal government and from the European Union.



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2 Review of Recent Reports and National Research Council Committee Workshop INTRODUCTION For its second report, the committee was charged with evaluating research progress since release of its first report and with assessing the extent to which progress has been consistent with its recommendations. Since release of the committee’s report in January 2012, a number of national and international ef- forts have focused on environmental, health, and safety (EHS) aspects of nano- technology. In the United States, reports have commented on continuing efforts and needs with regard to EHS nanotechnology research, including The National Nanotechnology Initiative—Supplement to the President’s FY 2013 Budget (NSET 2012) (released in February 2012), Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative (PCAST 2012) (released in April 2012), and the Government Accountability Office (GAO) report Nanotechnology: Improved Performance Information Needed for Environmental, Health, and Safety Research (released May 2012). In addition, international research efforts directed at EHS aspects of engineered nanomateri- als (ENMs) have advanced, particularly in the European Commission (EC) Sev- enth Framework Program (FP71)2. In this chapter, the committee reviews findings from key recent reports and assessments and comments on the committee’s workshop held in November 2012 (see Appendix C). The chapter is intended to provide insights into the 1 Funding programs created by the European Union to support research. The specific objectives vary depending on the funding period. 2 The committee recognizes that there are other international research efforts, but this analysis is not intended to be a comprehensive review. Rather it focuses on a few major reports from the US federal government and from the European Union. 28

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Review of Recent Reports & National Research Council Committee Workshop 29 broader “systems” of research on EHS aspects of ENMs and to set out a back- ground for Chapters 4 and 5, where the committee offers recommendations for building a more cohesive research enterprise on ENMs and human health and ecosystems. The findings of the recent reports of the US agencies complement the committee’s review, and the research efforts in Europe are an important component of the global research enterprise. THE NATIONAL NANOTECHNOLOGY INITIATIVE SUPPLEMENT TO THE PRESIDENT’S FY 2013 BUDGET The National Nanotechnology Initiative: Supplement to the President’s FY 2013 Budget (NSET 2012) serves as the annual report on the National Nano- technology Initiative (NNI) and summarizes NNI activities for 2011 and 2012 and plans for 2013. It first examines changes in the balance of investment by program component area (PCA)3 and then progress toward achieving NNI goals. The focus of this committee is on PCA 7 (EHS) and Goal 4, “Supporting re- sponsible development of nanotechnology”. The report details a large number of agency contributions and coordination activities among the federal agencies and international partners that support the EHS research enterprise.4 A few are high- lighted here. The Consumer Product Safety Commission (CPSC) and the Food and Drug Administration joined the NNI budgeting process in 2011. CPSC has been collaborating with other federal agencies—such as the National Science Founda- tion and the Environmental Protection Agency (EPA)—to support the develop- ment of exposure and risk assessments of nanomaterials and to allow for updates to flag reports of incidents that involve nanotechnology and consumer products (NSET 2012, p. 14). EPA’s nanotechnology resources were expected to increase by $1.9 million from 2011 to 2013, with increased efforts focused on nano- materials that are more environmentally sustainable. EPA proposed to investi- gate how nanomaterial physicochemical properties influence fate and effects and to couple this research with that on sustainable chemistry and life-cycle assess- ment. It recently released two requests for applications on sustainable molecular design and synthesis and characterization of chemical life cycle. NIOSH antici- pated increasing its investment on three topics in 2013: applying prevention through design principles in its work, developing and sharing containment and control strategies to support responsible development of nanomaterial-based products, and expanding data on worker exposure and health issues in high- volume nanomaterial industries and applications (for example, carbon nano- tubes, titanium dioxide, and nanosilver). The National Institute of Standards and 3 Program component area is one of the means by which NNI research and major ac- tivities are grouped. 4 At the time of this writing, the FY 2013 federal budget has not been finalized, and federal agencies are operating under a continuing resolution that will probably affect expected programmatic changes for NNI-funded EHS research.

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30 Research Progress on EHS Aspects of Engineered Nanomaterials Technology (NIST) 2013 budget was expected to triple from 2011 levels with increased support for development of measurement methods and standards for detecting and characterizing ENMs and for development of standard reference materials, measurement protocols, and predictive models. NIST released the first reference material for single-walled carbon nanotube soot and plans to release additional nanoscale reference materials (carbon nanotubes, titanium dioxide, silver nanoparticles, and nanoporous glass). The National Institute of Environ- mental Health Sciences intends to continue investments in its Centers for Nano- technology Health Implications Research Consortium and is evaluating potential research opportunities in susceptibility factors, including underlying disease, genetic factors, and age. With regard to EHS research coordination-related activities, CPSC signed an interagency agreement with EPA in 2011 to support research with agencies in the United Kingdom to study potential human exposures to ENMs from con- sumer products and some environmental sources. In another effort, under the leadership of the International Life Sciences Institute Research Foundation’s Nanorelease Project, agencies of the NNI are working with nonprofit groups, industry, and international organizations to develop methods for measuring the release of ENMs from consumer materials (ILSI 2012). EPA researchers and regulators are continuing their collaboration with other federal agencies and na- tions in the international testing program on nanomaterials under the auspices of the Organisation for Economic Co-operation and Development (OECD) Work- ing Party on Manufactured Nanomaterials. EPA is also partnering with other federal agencies of the NNI in the United States-European Union (EU) collabo- ration to develop communities of EHS nanotechnology research. The NNI’s progress in responding to recommendations from the Presi- dent’s Council of Advisors on Science and Technology (PCAST 2010) is also detailed, and issues relevant to the work of the present committee are discussed in Chapter 3. With regard to the committee’s first report, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council’s Committee on Technology (NSET 2012) states that the “NNI agencies are just beginning to assess the first [National Research Council committee] report and consider how its recommendations may be ap- plied to the NNI EHS research program” (p. 61). THE REPORT TO THE PRESIDENT AND CONGRESS ON THE FOURTH ASSESSMENT OF THE NATIONAL NANOTECHNOLOGY INITIATIVE The Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative (PCAST 2012) is the fourth review of the NNI by PCAST. Although focused on the whole of the NNI, the report provides some key recommendations regarding EHS research. The report follows up on the recommendations that PCAST made to the NNI in 2010. PCAST acknowl-

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Review of Recent Reports & National Research Council Committee Workshop 31 edges that the NSET Subcommittee responded to its 2010 recommendations (PCAST 2010) by creating an EHS research strategy and establishing the posi- tion of NNI EHS coordinator as a central facilitator among the NNI agencies and international partners. However, it expressed concern regarding the lack of integration between nanotechnology-related EHS research funded through the NNI and information needed by policy-makers to manage potential risks posed by ENMs (PCAST 2012, p. vi). To address that concern, PCAST recommended that “the NSET should establish high-level, cross-agency authoritative and ac- countable governance of Federal nanotechnology-related EHS research so that the knowledge created as a result of Federal investments can better inform poli- cy makers” (PCAST 2012, p. viii). PCAST also called for an “increase [in] in- vestment in cross-cutting areas of EHS [research] that promote knowledge trans- fer such as informatics, partnerships, and instrumentation development” (p. viii). The latter recommendation comes from the present committee’s 2012 conclu- sion that an additional $20–25 million was needed for this cross-cutting research that would not undercut other fields of research. PCAST acknowledged the pro- gress made in multistakeholder and interagency collaborations but called for additional coordination particularly in occupational safety and health. Other subjects that PCAST commented on that are pertinent to EHS in- clude recognition of the “significant hurdles to an optimal structure and man- agement” of the NNI (p. 17). Specifically, the hurdles include “the level of au- thority that representatives appointed to NSET have within their home agencies to influence the budget allocations needed to meet NNI objectives, the inade- quacy of mechanisms to solicit and act upon advice from outside of government, and the level of funding and capacity of the NNCO [National Nanotechnology Coordination Office] leadership to support the agencies in implementing pro- grams that align with the NNI strategic plan” (p. 17). PCAST also commented on the lack of metrics for assessing the effects of federal investment in nano- technology and stated that “the NNCO should track the development of metrics for quantifying the Federal nanotechnology portfolio and implement them to assess NNI outputs” (p. 21). Many of the PCAST recommendations are con- sistent with those found in the present committee’s first report (NRC 2012). GOVERNMENT ACCOUNTABILITY OFFICE REPORT, NANOTECHNOLOGY: IMPROVED PERFORMANCE INFORMATION NEEDED FOR ENVIRONMENTAL, HEALTH, AND SAFETY RESEARCH In May 2012, GAO issued its most recent report to the chairman of the US Senate Committee on Environment and Public Works. The report, Nanotechnol- ogy: Improved Performance Information Needed for Environmental, Health, and Safety Research, responds to a request to review federal nanotechnology EHS research and examines changes in federal funding for such research, nano- materials that NNI member agencies focused on in their EHS research in FY

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32 Research Progress on EHS Aspects of Engineered Nanomaterials 2012, collaboration of NNI member agencies with stakeholders, and the extent to which NNI strategy documents address desirable characteristics of national strategies (GAO 2012, p. 1). In preparing the report, GAO found substantial increases in funding by NNI agencies for nanotechnology EHS research. In the five fiscal years begin- ning in 2006, funding for EHS research more than doubled, according to agency reports. Nonetheless, GAO found it difficult to confirm that all the reported pro- jects were focused on EHS research and struggled with the nonuniform report- ing approaches used by NNI agencies. Regarding the former issue, GAO report- ed that “of the 236 projects that the seven agencies reported to us as EHS research for fiscal year 2010, we determined that, for 43 projects (18 percent), it was not clear that the projects met the definition for PCA 7—research primarily directed at the EHS impacts of nanotechnology development and corresponding risk assessment, risk management, and methods for risk mitigation” (p. 18). Those projects accounted for more than $15 million in reported EHS funding or 18% of the total projects. The latter issue identified in the report, nonuniformity of reporting approaches, had been raised by GAO in 2008 and was the subject of one of its recommendations for improvement.5 In addition, GAO noted that agencies were focusing on limited categories of nanomaterials (primarily carbon nanotubes, nanosilver, and nanoscale titanium dioxide). The report noted that the 2011 NNI EHS research strategy provides an approach to setting priorities among nanomaterials for EHS research, although it commented that it was too early to determine the influence of the approach on the agencies’ research. The 2012 GAO report states that “NNI agencies have collaborated exten- sively on EHS research and strategies” and have initiated numerous formal col- laborative EHS research projects. GAO further reported that “nonfederal stake- holders who responded to GAO’s Web-based questionnaire on nanotechnology EHS research” said “that they benefited from collaboration with the NNI mem- ber agencies” (GAO 2012, p. 1). Three types of collaborations were identified as the most frequent: “joint data gathering and sharing, joint research solicitations or funding of research consortia, and competitive grants” (p. 34). The question- naire also identified a “lack of funding and limited awareness” of opportunities for collaboration for some NNI agencies as continuing challenges (p. 1). GAO (2012) comments that despite those challenges, “most respondents rated the 2011 NNI EHS research strategy as somewhat or very effective at addressing nanotechnology EHS research needs” (GAO 2012, p. 1). Focusing on the 2011 NNI strategic plan (NSET 2011), the 2011 NNI EHS research strategy (NEHI 2011), and the NNI supplement to the president’s 2012 budget (NSET 2012), GAO (2012) found that the NNI’s EHS program had ad- 5 GAO (2008) recommended “that the Director, OSTP, in consultation with the Direc- tor, NNCO, and the Director, OMB [Office of Management and Budget], provide better guidance to agencies regarding how to report [nanotechnology EHS] research” (p. 30). However, GAO (2012) states that “as of February 2012, updated guidance had not been issued” (p. 20).

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Review of Recent Reports & National Research Council Committee Workshop 33 dressed or partially addressed all six characteristics of what GAO identified as desirable characteristics of a national strategy. The GAO was particularly positive about how the three strategy documents address the first two criteria: purpose, scope, and methodology and problem definition and risk assessment. For desirable characteristic 3 (goals, subordinate objectives, activities, and performance measures), GAO suggests that additional work is needed to articulate priorities, milestones, or outcome-related performance measures that can be used to measure the effectiveness of implementation of an EHS strategy. The 2012 GAO report comments that “independent reviews of the prior NNI strategy documents also noted an absence of performance information” (p. 46). (This finding is also re- flected in PCAST 2012 [noted above], regarding the lack of metrics for assessing the effects of federal investments in nanotechnology.) With respect to the fourth and fifth characteristics, GAO’s assessment was that the strategy documents had partially addressed resources, investments, and risk management and organiza- tional roles, responsibilities, and coordination (p. 47). However, concerns were raised, because, although “the 2011 NNI EHS research strategy identifies research goals, . . . it is up to the agencies to determine how their funding should be spent” (p. 48). Consequently, there is a perceived lack of oversight of agency roles and little discussion of how agencies will be held accountable for the goals and re- search needs of the NNI strategy documents. GAO (2012) suggests that “the NNI strategy documents . . . partially address the sixth characteristic describing integra- tion and implementation” (p. 48). This concern arises because the strategy docu- ments do not discuss agency-level EHS research strategies and efforts to map agency strategies to the NNI-level documents are not publically available. The 2012 GAO report made two recommendations to the director of the Office of Science and Technology Policy (OSTP). It has recommended that “the Director of OSTP coordinate development by the NNI member agencies of per- formance measures, targets, and time frames for nanotechnology EHS research that align with the research needs of the NNI, consistent with the agencies’ re- spective statutory authorities, and include this information in publicly available reports” (p. 51). In addition, it recommends that “to the extent possible, the Di- rector of OSTP coordinate the development by the NNI member agencies of estimates of the costs and types of resources necessary to meet the EHS research needs” (p. 52). In summary, as illustrated above with examples from several recent re- ports, a number of consistent themes have emerged. They include the need for rigor in identifying the most critical questions to be addressed by federal funding through cooperative efforts and with stakeholder engagement. Increased net- working among all sectors of the scientific community should be sought. Stand- ards for analysis and reference materials will be critical for this effort; the use of uniform terminology, data descriptions, and approaches to data capture will un- derpin this broader engagement. Production of not just data but knowledge that can be applied in the construction of decision-support tools and risk assessments will be needed to inform decision-making around EHS issues as we move to- ward the future. In Chapter 4 of this report, the committee presents a diagram for

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34 Research Progress on EHS Aspects of Engineered Nanomaterials the EHS nanotechnology research enterprise that builds on those characteristics. It describes the interrelated and interdependent aspects of the enterprise. Alt- hough aspirational and relatively simple, it is founded on the key principles for a successful EHS research program that are articulated in the three reports de- scribed above and the first report of the present committee. EUROPEAN UNION EFFORTS Research on nanotechnology funded through the EC—including EHS re- search—has been guided since 2004 by a broad strategy. Published in 2004, the Communication from the Commission: Towards a European Strategy for Nano- technology (EC 2004, pp. 21-22) outlined key elements of research investment related to commercial and societal progress. Actions toward identifying and ad- dressing potential human and environmental risks included  Identifying and addressing safety concerns at the earliest possible stage.  Reinforcing support for the integration of health, environmental, risk, and other related aspects into research and development (R&D) activities.  Supporting the generation of toxicology and ecotoxicology data (in- cluding dose–response information) and the evaluation of potential human and environmental exposure.  Adjustment, if necessary, of risk-assessment procedures to account for issues associated with nanotechnology applications.  Application of risk assessment to consumers, workers, and the envi- ronment at all stages of the life cycle of ENMs (including design, R&D, manu- facturing, distribution, use, and disposal). The strategy was influential in guiding ENM safety projects funded under the current and previous research framework programs (FP6 and FP7). The first implementation report on the strategy, published in 2007 (EC 2007), highlighted a number of steps toward addressing potential risks of nano- technologies. The steps included expanding the pan-European research program, work by the European Joint Research Center on harmonized methods of charac- terizing and evaluating the toxicity of ENMs, scientific reviews of research needs and opportunities by the Scientific Committee on Emerging and Newly Identified Risks, and a focus on regulatory review. A number of international collaboration initiatives with the OECD Working Party on Manufactured Na- nomaterials, the International Organization for Standardization (ISO), and spe- cific US federal agencies were also highlighted. The second implementation report on the strategic plan (EC 2009) also emphasizes those themes. Specifically, the EC concluded that from a regulatory perspective there was an urgent need for more action on increasing and consoli- dating risk-related research funding to keep pace with the development and marketing of new applications; adjusting, validating, and harmonizing available

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Review of Recent Reports & National Research Council Committee Workshop 35 methods for risk assessment for ENMs to ensure the generation of relevant data; improving, developing, and validating methods for characterization, exposure assessment, hazard identification, life-cycle assessment, and simulation, includ- ing research on fundamental interactions of ENMs with living organisms; devel- oping suitable reference ENMs for methods development, validation, and quali- ty assurance; developing public databases to serve in the safety assessment of ENMs; and increasing the development of test guidelines and standards within OECD, ISO, and the Comité Européen de Normalisation. The EC also has published two regulatory reviews on nanosciences and nanotechnologies—the first in 2008 (EC 2008) and the second in 2012 (EC 2012). On the basis of a number of pan-European reviews and analyses of the state of the science and its relevance to regulation, the review concluded that (EC 2012, p. 11) In the light of current knowledge and opinions of the EU Scientific and Advisory Committees and independent risk assessors, nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not. Possible risks are related to specific nanomaterials and spe- cific uses. Therefore, nanomaterials require a risk assessment, which should be performed on a case-by-case basis, using pertinent information. Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required. The definition of nanomaterials will be integrated in EU legislation, where appropriate. The Commission is currently working on detection, meas- urement and monitoring methods for nanomaterials and their validation to ensure the proper implementation of the definition. Important challenges relate primarily to establishing validated methods and instrumentation for detection, characterization, and analysis, complet- ing information on hazards of nanomaterials and developing methods to assess exposure to nanomaterials. In 2004, an EC project was funded to coordinate activities between re- searchers working on the responsible development of ENMs. NanoImpactNet (NanoImpactNet 2013) ran from 2004 to 2012 and was highly influential in achieving coordination among research groups working on FP6 and FP7 projects across Europe. The key aims of NanoImpactNet were to facilitate collaborations among research projects, communicate results to stakeholders and communicate their needs back to researchers, and help to implement the EC’s action plan for nanotechnology. Following in part from NanoImpactNet, all EC research pro- jects addressing the potential risks associated with ENMs are coordinated through the EC NanoSafety Cluster (NanoSafety Cluster 2013), an EC initiative aimed at ensuring strong strategic synergy in the field of EHS nanotechnology research.

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36 Research Progress on EHS Aspects of Engineered Nanomaterials The EC NanoSafety Cluster is designed “to maximise the synergies be- tween the existing FP6 and FP7 projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure assessment, mechanisms of inter- action, risk assessment and standardisation” (NanoSafety Cluster 2013). The objectives “are to facilitate the formation of a consensus on nanotoxicology in Europe; to provide a single voice for discussions with external bodies; to avoid duplicating work and improve efficiency; to improve the coherence of nanotoxi- cology studies and harmonize methods; to provide a forum for discussion, prob- lem-solving, and planning of R&D activities in Europe; and to provide industrial stakeholders and the general public with appropriate knowledge on the risks to human health and the environment posed by ENMs” (Nanosafety Cluster 2013). Current or completed projects in the cluster represent an R&D investment of about €137 million (about $180 million). In association with the NanoSafety Cluster, a US–EU discussion on ENM safety research (Finnish Institute of Occupational Health 2012) was formalized in 2011, and there continue to be regular meetings of researchers from both sides of the Atlantic. Through that mechanism, communities of research (CoRs) are being established between the US and the EU. The CoRs are addressing expo- sure through the life cycle, ecotoxicity testing and predictive models, predictive modeling for human health, databases and ontology, risk assessment, and risk management measures. In summary, European research on the EHS implications of ENMs has de- veloped into a highly integrated program over the last 8 years. An emphasis on interdisciplinary and interstate collaboration, public–private partnerships, re- search networks, and integrated programs has contributed to supporting research that is problem-driven and solution-focused. The advantages of that approach are seen in a close integration between research and practice among multiple constituencies. In contrast, the US model of investigator-driven research funded by individual agencies with limited strategic oversight has led to rapid progress in specific fields but less overall coherence than observed in Europe. Both models have advantages and disadvantages, and there are undoubtedly lessons to be learned on both sides of the Atlantic. As discussed above and as il- lustrated in Chapter 4, a systematic and networked approach to knowledge crea- tion for improved decision-making would have value around the world. There is considerable opportunity for high-value coordination and integration that can lev- erage the strengths of both the European and the US efforts to ensure a global stra- tegic research program. This is already beginning to occur through informal and formal collaborations between the US and the EU, but more can be done to ensure efficient and responsive research programs.

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Review of Recent Reports & National Research Council Committee Workshop 37 NATIONAL RESEARCH COUNCIL COMMITTEE WORKSHOP On November 7, 2012, the committee held a workshop to obtain input on research progress since release of its first report, A Research Strategy for Envi- ronmental, Health, and Safety Aspects of Engineered Nanomaterials. An addi- tional focus was on other efforts that were under way to address the scientific uncertainties and research-infrastructure needs for a robust research approach to EHS issues related to ENMs. The information gathered informs the present re- port. The workshop featured presentations by federal agency and foreign offi- cials, academic researchers, and representatives of nongovernment organizations and industry on the scientific and regulatory framework for EHS research, on recent research progress, and on the applications of the research results to risk management. Panel discussions provided opportunities for expanded dialogue of many of the issues raised during the workshop presentations. A summary of the workshop is provided as Appendix C of this report. CONCLUSION Recent reports provide an opportunity to gauge progress on EHS research related to ENMs and on the development of infrastructure for such research. The NNI’s supplement to the President’s 2013 budget offers an opportunity to re- view intended enhancements of the NNI program that were developed coinci- dentally with the publication of the committee’s first report. The NNI’s supple- ment to the president’s budget does not meet the requirement of completed and published research, but it does provide an opportunity to review the trajectory of NNI work in the context of the progress indicators identified in the committee’s first report. Both PCAST (2012) and GAO (2012) provide opportunities to as- sess the influence of the committee’s 2012 report (NRC 2012) on federal over- sight groups: PCAST and GAO reinforced many of the committee’s recommen- dations, including the need for clear accountability for NNI spending, particularly on EHS research, for “top-down” strategic direction, and for addi- tional, targeted research funding. The EC research model aligns more closely with calls for accountability and top-down strategic direction and has been highly successful in stimulating effective research partnerships and integrated approaches to complex challenges. Although there are limitations to that approach, lessons from the EU FP7 pro- gram in particular may be usefully applied in the United States. FP7 has been successful in leading to multidisciplinary research programs that are driven by specific safety challenges (for example, the MARINA6 research program is ex- plicitly focused on developing reference methods that support risk management of engineered nanomaterials), programs that facilitate public–private partner- 6 http://www.marina-fp7.eu/.

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38 Research Progress on EHS Aspects of Engineered Nanomaterials ships (for example, NANODEVICE7 brings together researchers and instrument manufacturers to develop new measurement tools), and programs that enable deep cross-disciplinary collaboration and coordination (for example, NanoIm- pactNet (2013) provides a unique research community–driven forum for infor- mation-sharing). In the committee’s November 2012 workshop, it heard from the NNI agencies and the stakeholder communities regarding the progress made in EHS research. The perspective gained there helped the committee in assessing re- search and implementation progress in Chapter 3 and informed the construction of Figure 4-1. Although the committee recognizes the short timeframe for evalu- ating research progress, it strongly endorses the concepts of coordinated, trans- parent efforts and of retrospective impact analysis for assessing progress in ad- vancing knowledge in the EHS nanotechnology research enterprise. REFERENCES EC (European Commission). 2004. Communication from the Commission: Towards a European Strategy for Nanotechnology. COM (2004) 338 final. Commission of the European Communities, Brussels. December 5, 2004 [online]. Available: http://ec. europa.eu/nanotechnology/pdf/nano_com_en.pdf [accessed Feb. 27, 2013]. EC (European Commission). 2007. Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee- Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. First Implementa- tion Report 2005-2007. COM(2007) 505 final. Commission of the European Communities, Brussels. September 6, 2007 [online]. Available: http://eur-lex.eu ropa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0505:FIN:EN:PDF [accessed Feb. 27, 2013]. EC (European Commission). 2008. Communication from the Commission to the Europe- an Parliament, the Council and the Economic and Social Committee: Regulatory Aspects of Nanomaterials. COM(2008) 366 final. Commission of the European Communities, Brussels. June 17, 2008 [online]. Available: http://ec.europa.eu/ nanotechnology/pdf/comm_2008_0366_en.pdf [accessed Feb. 27, 2013]. EC (European Commission). 2009. Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee- Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implemen- tation Report 2007-2009. COM(2009)607 final. Commission of the European Communities, Brussels. October 29, 2009 [online]. Available: http://eur-lex.eu ropa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0607:FIN:EN:PDF [accessed Feb. 27, 2013]. EC (European Commission). 2012. Communication from the Commission to the Europe- an Parliament, the Council and the Economic and Social Committee: Second Reg- ulatory Review on Nanomaterials. COM(2012) 572 final. Commission of the Eu- ropean Communities, Brussels. October 3, 2012 [online]. Available: http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0572:FIN:en:PDF [ac- cessed Feb. 27, 2013]. 7 http://www.ttl.fi/partner/nanodevice/Pages/default.aspx.

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