A RESEARCH STRATEGY FOR ENVIRONMENTAL, HEALTH,
AND SAFETY ASPECTS OF
ENGINEERED
NANOMATERIALS

Committee to Develop a Research Strategy for Environmental,
Health, and Safety Aspects of Engineered Nanomaterials

Board on Environmental Studies and Toxicology

Board on Chemical Sciences and Technology

Division on Earth and Life Studies

National Materials and Manufacturing Board

Division on Engineering and Physical Sciences

NATIONAL RESEARCH COUNCIL
                   OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials Board on Environmental Studies and Toxicology Board on Chemical Sciences and Technology Division on Earth and Life Studies National Materials and Manufacturing Board Division on Engineering and Physical Sciences

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Insti- tute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by Contract EP-C-09-003 between the National Academy of Sciences and the U.S. Environmental Protection Agency. Any opinions, findings, conclu- sions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-25328-4 International Standard Book Number-10: 0-309-25328-4 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334- 3313; http://www.nap.edu/. Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the re- sponsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the Na- tional Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE TO DEVELOP A RESEARCH STRATEGY FOR ENVIRONMENTAL, HEALTH, AND SAFETY ASPECTS OF ENGINEERED NANOMATERIALS Members JONATHAN M. SAMET (Chair), University of Southern California, Los Angeles TINA BAHADORI, American Chemistry Council, Washington, DC (until May 2012) JURRON BRADLEY, BASF, Florham Park, NJ SETH COE-SULLIVAN, QD Vision, Inc., Lexington, MA VICKI L. COLVIN, Rice University, Houston, TX EDWARD D. CRANDALL, University of Southern California, Los Angeles RICHARD A. DENISON, Environmental Defense Fund, Washington, DC WILLIAM H. FARLAND, Colorado State University, Fort Collins MARTIN FRITTS, SAIC-Frederick, Frederick, MD PHILIP HOPKE, Clarkson University, Potsdam, NY JAMES E. HUTCHISON, University of Oregon, Eugene REBECCA D. KLAPER, University of Wisconsin, Milwaukee GREGORY V. LOWRY, Carnegie Mellon University, Pittsburgh, PA ANDREW MAYNARD, University of Michigan School of Public Health, Ann Arbor GUNTER OBERDORSTER, University of Rochester School of Medicine and Dentistry, Rochester, NY KATHLEEN M. REST, Union of Concerned Scientists, Cambridge, MA MARK J. UTELL, University of Rochester School of Medicine and Dentistry, Rochester, NY DAVID B. WARHEIT, DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE MARK R. WIESNER, Duke University, Durham, NC Staff EILEEN ABT, Project Director TINA MASCIANGIOLI, Senior Program Officer ERIK SVEDBERG, Senior Program Officer KEEGAN SAWYER, Associate Program Officer (until August 2011) KERI SCHAFFER, Research Associate NORMAN GROSSBLATT, Senior Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects TAMARA DAWSON, Program Associate ORIN LUKE, Senior Program Assistant (until June 2011) Sponsor U.S. ENVIRONMENTAL PROTECTION AGENCY v

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BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members ROGENE F. HENDERSON (Chair), Lovelace Respiratory Research Institute, Albuquerque, NM PRAVEEN AMAR, Clean Air Task Force, Boston, MA MICHAEL J. BRADLEY, M.J. Bradley & Associates, Concord, MA JONATHAN Z. CANNON, University of Virginia, Charlottesville GAIL CHARNLEY, HealthRisk Strategies, Washington, DC FRANK W. DAVIS, University of California, Santa Barbara RICHARD A. DENISON, Environmental Defense Fund, Washington, DC CHARLES T. DRISCOLL, JR., Syracuse University, New York H. CHRISTOPHER FREY, North Carolina State University, Raleigh RICHARD M. GOLD, Holland & Knight, LLP, Washington, DC LYNN R. GOLDMAN, George Washington University, Washington, DC LINDA E. GREER, Natural Resources Defense Council, Washington, DC WILLIAM E. HALPERIN, University of Medicine and Dentistry of New Jersey, Newark PHILIP K. HOPKE, Clarkson University, Potsdam, NY HOWARD HU, University of Michigan, Ann Arbor SAMUEL KACEW, University of Ottawa, Ontario ROGER E. KASPERSON, Clark University, Worcester, MA THOMAS E. MCKONE, University of California, Berkeley TERRY L. MEDLEY, E.I. du Pont de Nemours & Company, Wilmington, DE JANA MILFORD, University of Colorado at Boulder, Boulder FRANK O’DONNELL, Clean Air Watch, Washington, DC RICHARD L. POIROT, Vermont Department of Environmental Conservation, Waterbury KATHRYN G. SESSIONS, Health and Environmental Funders Network, Bethesda, MD JOYCE S. TSUJI, Exponent Environmental Group, Bellevue, WA Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Scholar RAYMOND A. WASSEL, Senior Program Officer for Environmental Studies ELLEN K. MANTUS, Senior Program Officer for Risk Analysis SUSAN N.J. MARTEL, Senior Program Officer for Toxicology EILEEN N. ABT, Senior Program Officer MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects 1 This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology. vi

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OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Macondo Well–Deepwater Horizon Blowout: Lessons for Improving Offshore Drilling Safety (2012) Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops (2011) Improving Health in the United States: The Role of Health Impact Assessment (2011) A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) Review of the Environmental Protection Agency’s Draft IRIS Assessment of Formaldehyde (2011) Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change (2010) The Use of Title 42 Authority at the U.S. Environmental Protection Agency (2010) Review of the Environmental Protection Agency’s Draft IRIS Assessment of Tetrachloroethylene (2010) Hidden Costs of Energy: Unpriced Consequences of Energy Production and Use (2009) Contaminated Water Supplies at Camp Lejeune—Assessing Potential Health Effects (2009) Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (2009) Science and Decisions: Advancing Risk Assessment (2009) Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2008) Estimating Mortality Risk Reduction and Economic Benefits from Controlling Ozone Air Pollution (2008) Respiratory Diseases Research at NIOSH (2008) Evaluating Research Efficiency in the U.S. Environmental Protection Agency (2008) Hydrology, Ecology, and Fishes of the Klamath River Basin (2008) Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment (2007) Models in Environmental Regulatory Decision Making (2007) Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007) Sediment Dredging at Superfund Megasites: Assessing the Effectiveness (2007) Environmental Impacts of Wind-Energy Projects (2007) Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006) New Source Review for Stationary Sources of Air Pollution (2006) Human Biomonitoring for Environmental Chemicals (2006) Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006) Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006) State and Federal Standards for Mobile-Source Emissions (2006) vii

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Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005) Health Implications of Perchlorate Ingestion (2005) Air Quality Management in the United States (2004) Endangered and Threatened Species of the Platte River (2004) Atlantic Salmon in Maine (2004) Endangered and Threatened Fishes in the Klamath River Basin (2004) Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003) Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002) Biosolids Applied to Land: Advancing Standards and Practices (2002) The Airliner Cabin Environment and Health of Passengers and Crew (2002) Arsenic in Drinking Water: 2001 Update (2001) Evaluating Vehicle Emissions Inspection and Maintenance Programs (2001) Compensating for Wetland Losses Under the Clean Water Act (2001) A Risk-Management Strategy for PCB-Contaminated Sediments (2001) Acute Exposure Guideline Levels for Selected Airborne Chemicals (twelve volumes, 2000-2012) Toxicological Effects of Methylmercury (2000) Strengthening Science at the U.S. Environmental Protection Agency (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (2000) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter (four volumes, 1998-2004) The National Research Council’s Committee on Toxicology: The First 50 Years (1997) Carcinogens and Anticarcinogens in the Human Diet (1996) Upstream: Salmon and Society in the Pacific Northwest (1996) Science and the Endangered Species Act (1995) Wetlands: Characteristics and Boundaries (1995) Biologic Markers (five volumes, 1989-1995) Science and Judgment in Risk Assessment (1994) Pesticides in the Diets of Infants and Children (1993) Dolphins and the Tuna Industry (1992) Science and the National Parks (1992) Human Exposure Assessment for Airborne Pollutants (1991) Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991) Decline of the Sea Turtles (1990) Copies of these reports may be ordered from the National Academies Press (800) 624-6242 or (202) 334-3313 www.nap.edu viii

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BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY Members RYAN R. DIRKX (Co-Chair), Arkema Inc., Bristol, PA C. DALE POULTER (Co-Chair), University of Utah, Salt Lake City, ZHENAN BAO, Stanford University, Palo Alto, CA ROBERT G. BERGMAN, University of California, Berkeley HENRY E. BRYNDZA, E. I. du Pont de Nemours & Company, Wilmington, DE EMILY A. CARTER, Princeton University, Princeton, NJ PABLO G. DEBENEDETTI, Princeton University, Princeton, NJ CAROL J. HENRY, The George Washington University, Washington, DC CHARLES E. KOLB, JR., Aerodyne Research, Inc., Billerica, MA JOSEF MICHL, University of Colorado, Boulder C. DALE POULTER, University of Utah, Salt Lake City MARK A. RATNER, Northwestern University, Evanston, IL ROBERT E. ROBERTS, Institute for Defense Analyses, Alexandria, VA DARLENE J.S. SOLOMON, Agilent Laboratories, Santa Clara, CA ERIK J. SORENSEN, Princeton University, Princeton, NJ WILLIAM C. TROGLER, University of California, San Diego Senior Staff DOROTHY ZOLANDZ, Director TINA MASCIANGIOLI, Senior Program Officer DOUGLAS FRIEDMAN, Program Officer KATHRYN HUGHES, Program Officer ix

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OTHER REPORTS OF THE BOARD ON CHEMICAL SCIENCES AND TECHNOLOGY Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards, Revised Edition (2011) Promoting Chemical Laboratory Safety and Security in Developing Countries (2010) Research at the Intersection of the Physical and Life Sciences (2010) BioWatch and Public Health Surveillance: Evaluating Systems for the Early Detection of Biological Threats: Abbreviated Version (2010) Strengthening High School Chemistry Education Through Teacher Outreach Programs: A Workshop Summary to the Chemical Sciences Roundtable (2009) Catalysis for Energy: Fundamental Science and Long-Term Impacts of the U.S. Department of Energy Basic Energy Science Catalysis Science Program (2009) Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System: Interim Report (2009) A Framework for Assessing the Health Hazard Posed by Bioaerosols (2008) Disrupting Improvised Explosive Device Terror Campaigns: Basic Research Opportunities: A Workshop Report (2008) Test and Evaluation of Biological Standoff Detection Systems: Abbreviated Version (2008) x

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NATIONAL MATERIALS AND MANUFACTURING BOARD Members ROBERT H. LATIFF (Chair), R. Latiff Associates, Alexandria, VA DENISE F. SWINK (Vice-Chair), Independent Consultant, Germantown, MD PETER R. BRIDENBAUGH, NAE, Retired, ALCOA, Boca Raton, FL VALERIE M. BROWNING, ValTech Solutions, LLC, Port Tobacco, MD YET-MING CHIANG, NAE, Massachusetts Institute of Technology, Cambridge, MA PAUL CITRON, NAE, Retired, Medtronic, Inc., Minnetonka, MN GEORGE T. (RUSTY) GRAY, II, Los Alamos National Laboratories, Los Alamos, NM CAROL A. HANDWERKER, Purdue University, West Lafayette, IN THOMAS S. HARTWICK, Independent Consultant, Snohomish, WA SUNDARESAN JAYARAMAN, Georgia Institute of Technology, Atlanta, GA DAVID W. JOHNSON, JR., NAE, Stevens Institute of Technology, Bedminster, NJ THOMAS KING, Oak Ridge National Laboratories, Oak Ridge, TN MICHAEL F. MCGRATH, Analytic Services Inc., Arlington, VA NABIL NASR, Golisano Institute for Sustainability, Rochester, NY PAUL S. PEERCY, NAE, University of Wisconsin-Madison, Madison, WI ROBERT C. PFAHL, JR., International Electronics Manufacturing Initiative, Herndon, VA VINCENT J. RUSSO, Aerospace Technologies Associates, LLC, Dayton, OH ROBERT E. SCHAFRIK, GE Aviation, Cincinnati, OH KENNETH H. SANDHAGE, Georgia Institute of Technology, Atlanta, GA HAYDN WADLEY, University of Virginia, Charlottesville, VA STEVEN WAX, Independent Consultant, Reston, VA Staff DENNIS CHAMOT, Acting Director ERIK B. SVEDBERG, Senior Program Officer RICKY D. WASHINGTON, Executive Assistant HEATHER LOZOWSKI, Financial Associate LAURA TOTH, Program Assistant xi

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OTHER REPORTS OF THE NATIONAL MATERIALS AND MANUFACTURING BOARD Opportunities in Protection Materials Science and Technology for Future Army Applications (2011) Materials Needs and R&D Strategy for Future Military Aerospace Propulsion Systems (2011) Research Opportunities in Corrosion Science and Engineering (2010) Assessment of Corrosion Education (2009) Proceedings of a Workshop on Materials State Awareness (2008) Integrated Computational Materials Engineering: A Transformational Discipline for Improved Competitiveness and National Security (2008) Managing Materials for a Twenty-first Century Military (2008) A Path to the Next Generation of U.S. Bank Notes: Keeping Them Real (2007) Assessment of Millimeter-Wave and Terahertz Technology for Detection and Identification of Concealed Explosives and Weapons (2007) Fusion of Security System Data to Improve Airport Security (2007) Proceedings of the Materials Forum 2007: Corrosion Education for the 21st Century (2007) Managing Materials for a 21st Century Military (2007) A Matter of Size: Triennial Review of the National Nanotechnology Initiative (2006) Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies (2006) Defending the U.S. Air Transportation System Against Chemical and Biological Threats (2006) Globalization of Materials R&D: Time for a National Strategy (2005) Going to Extremes: Meeting the Emerging Demand for Durable Polymer Matrix Composites (2005) High-Performance Structural Fibers for Advanced Polymer Matrix Composites (2005) Nanotechnology for the Intelligence Community (2005) xii

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Preface Over the last decade, government agencies, academic institutions, indus- try, and others have conducted many assessments of the environmental, health, and safety (EHS) aspects of nanotechnology. The results of those efforts have helped to direct research on the EHS aspects of engineered nanomaterials (ENMs). However, despite the progress in assessing research needs and despite the research that has been funded and conducted, developers, regulators, and consumers of nanotechnology-enabled products remain uncertain about the types and quantities of nanomaterials in commerce or in development, their pos- sible applications, and their associated risks. To address those uncertainties, the Environmental Protection Agency asked the National Research Council to per- form an independent study to develop and monitor the implementation of an integrated research strategy to address the EHS aspects of ENMs. In this report, the Committee to Develop a Research Strategy for Envi- ronmental, Health, and Safety Aspects of Engineered Nanomaterials presents a conceptual framework for the proposed research strategy and identifies critical research gaps and tools needed to address them. The committee identifies high- priority research that needs to be undertaken in the short and long term and the resources needed. The report concludes with a discussion of mechanisms to en- sure effective implementation of the committee’s research strategy. In a subse- quent report, the committee will evaluate research progress. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures ap- proved by the National Research Council Report Review Committee. The pur- pose of the independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manu- script remain confidential to protect the integrity of the deliberative process. We thank the following for their review of this report: Nathan Baker, Pacific North- west National Laboratory; Michael Ellenbecker, University of Massachusetts Lowell; Richard Flagan, California Institute of Technology; Robert Hurt, Brown University; Jacqueline Isaacs, Northeastern University; Jennifer Kuzma, Univer- xiii

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xiv Preface sity of Minnesota; Terry Medley, E.I. duPont de Nemours & Co.; James Mur- day, University of Southern California; Andre Nel, University of California, Los Angeles; Joanne Shatkin, CLF Ventures, Inc.; Robert Tanguay, Oregon State University; David Tirrell, California Institute of Technology; Jason Unrine, University of Kentucky; Paul Westerhoff, Arizona State University; and Yannis Yortsos, University of Southern California. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by the review coordinator, Richard B. Schlesinger, Pace University, and the review monitor, Julia M. Phillips, Sandia National Laboratories. Appointed by the National Research Council, they were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the committee and the institution. The committee gratefully acknowledges the following for making presen- tations to the committee: Lynn Bergeson, Bergeson & Campbell, P.C.; P. Lee Ferguson, Duke University; Richard Judson, Jeffrey Morris, and James Willis, U.S. Environmental Protection Agency; Subhas Malghan, U.S. Food and Drug Administration; Scott McNeil, Science Applications International Corporation; Giovanni Parmigiani, Harvard University; Paul Schulte, National Institute for Occupational Safety and Health; Justin Teeguarden, Pacific Northwest National Laboratory; Alan Tessier, National Science Foundation; Sally Tinkle, National Nanotechnology Coordination Office, and formerly with the National Institute of Environmental Health Sciences; and Jason Unrine, University of Kentucky. The committee is also grateful for the assistance of National Research Council staff in preparing this report. Staff members who contributed to the ef- fort are Eileen Abt, project director; James Reisa, director of the Board on Envi- ronmental Studies and Toxicology; Tina Masciangioli and Erik Svedberg, senior program officers; Keegan Sawyer, associate program officer; Keri Schaffer, re- search associate; Norman Grossblatt, senior editor; Mirsada Karalic-Loncarevic, manager, Technical Information Center; Radiah Rose, manager, editorial pro- jects; Orin Luke, senior program assistant; and Tamara Dawson, program asso- ciate. I would especially like to thank the members of the committee for their ef- forts throughout the development of this report. Jonathan M. Samet, Chair Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials

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Contents SUMMARY ...............................................................................................................3 1 BACKGROUND ..............................................................................................18 Overview, 18 Opportunities and Challenges, 19 Commercialization of Engineered Nanomaterials, 20 Present State of Strategic Nanotechnology Environmental, Health, and Safety Research, 25 History of Nanotechnology Environmental, Health, and Safety Research Assessments, 26 Why Another Strategy Is Needed, 30 Scope of this Report, 32 Elements of a Nanotechnology Environmental, Health, and Safety Research Strategy, 33 Prior Approaches to Setting Research Agendas on Other Topics, 36 Goals of this Strategy, 37 References, 39 2 A CONCEPTUAL FRAMEWORK FOR CONSIDERING ENVIRONMENTAL, HEALTH, AND SAFETY RISKS OF NANOMATERIALS .......................................................................................48 The Nature of the Challenge, 48 Developing a Strategy and a Conceptual Framework, 49 Risk-Assessment Considerations Regarding Nanomaterials, 51 A Conceptual Framework Linked To Risk Assessment, 54 A Life-Cycle and Value-Chain Perspective Leads within the Conceptual Framework, 56 Principles for Identifying and Setting Priorities for Research Needs in the Context of the Conceptual Framework, 61 References, 67 xv

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xvi Contents 3 CRITICAL QUESTIONS FOR UNDERSTANDING HUMAN AND ENVIRONMENTAL EFFECTS OF ENGINEERED NANOMATERIALS .......................................................................................70 Introduction, 70 Prior Research-Gap Analysis—An Overview, 72 Research-Gap Analysis and Identification of Critical Research Questions, 74 References, 99 4 NEW TOOLS AND APPROACHES FOR INDENTIFYING PROPERTIES OF ENGINEERED NANOMATERIALS THAT INDICATE RISKS ............................................................................107 Characterized Nanomaterials for Nanotechnology-Related Environmental, Health, and Safety Research, 107 Tools, Standardized Characterization Methods, and Nomenclature of Engineered Nanomaterials, 110 Standardized Experimental Protocols for Nanotechnology-Related Environmental, Health, and Safety Research, 115 Exposure Modeling, 119 Models for Predicting Human Health, Organismal, and Ecologic Effects, 123 Exposure to Dose Models, 124 Informatics, 126 References, 137 5 RESEARCH PRIORITIES AND RESOURCE NEEDS ............................143 Overview, 143 Adaptive Research and Knowledge Infrastructure for Accelerating Research Progress and Providing Rapid Feedback to Advance Research, 145 Characterizing and Quantifying the Origins of Nanomaterial Releases, 147 Processes Affecting both Exposure and Hazard, 149 Nanomaterial Interactions in Complex Systems Ranging from Subcellular Systems to Ecosystems, 151 Resources for Addressing Research Priorities, 154 References, 159 6 IMPLEMENTING THE RESEARCH STRATEGY AND EVALUATING PROGRESS ........................................................................162 Introduction, 162 Infrastructure for Implementation and Accountability, 163 Evaluating and Assessing Progress for Revising the Strategy, 178 Resources, 187 Key Audiences Needed to Implement the Strategy, 188 Concluding Remarks, 189 References, 189

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xvii Contents APPENDIXES A BIOGRAPHIC INFORMATION ON THE COMMITTEE TO DEVELOP A RESEARCH STRATEGY FOR ENVIRONMENTAL, HEALTH, AND SAFETY ASPECTS OF ENGINEERED NANOMATERIALS .....................................................................................193 B IMPLEMENTATION SCENARIOS: INFORMATICS AND INFORMATION-SHARING ........................................................................202 BOXES, FIGURES, AND TABLES BOXES 1-1 Elements of a Research Strategy, 33 2-1 Incorporating Green-Chemistry Principles into Nanomaterial Development and Application, 52 2-2 Life-Cycle Assessment, Life-Cycle Inventory, and Data Needs, 62 6-1 National Science Foundation Data-Management Plan, 178 6-2 Research-Progress Indicators, 181 6-3 Indicators of Progress in Implementation, 183 FIGURES S-1 Conceptual framework for informing the committee’s research strategy, 8 1-1 A general framework for integrating particulate-matter research, 37 2-1 Conceptual framework for informing the committee’s research agenda, 55 2-2 Potential human and ecosystem exposure through the value chain and life cycle of nanomaterial production, use, and disposal, 57 3-1 Central topics for EHS research on ENMs, 71 3-2 The number of peer-reviewed publications relating to exposure and hazard, 73 3-3 The number of peer-reviewed publications relating to environmental issues, 74 3-4 Projection of the size of the nanotechnology market, 75 3-5 Extrapolation of dosimetry of inhaled particles from rats to humans, 87 3-6 Concept of ENM toxicity testing for human health risk assessment, 92 3-7 Ecologic hazard end points for making predictions of the environmental effects of nanomaterials, 94 TABLES 1-1 Key Reports That Assess or Provide Information on Research Needs and Strategies for Addressing the Environmental, Health, and Safety Implications of Engineered Nanomaterials, 21 2-1 Risk-Related Concerns from NRC (2009) as Applied to Nanomaterials, 53 2-2 Illustration of Potential Releases of and Exposures to Carbon Nanotubes across the Value Chain and Lifecycle of a Textile Application, 58

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xviii Contents 3-1 Summary of Critical Research Questions, 98 3-2 Examples of Common Nanoscale Materials and Their Applications, 76 4-1 Summary of Research Needs Identified in Chapter as Mapped to the Tools, 135 5-1 National Nanotechnology Initiative EHS Research Funding, FY 2006-2012, 156