IMPLICATIONS OF NANOTECHNOLOGY FOR ENVIRONMENTAL HEALTH RESEARCH

Lynn Goldman and Christine Coussens, Editors

Roundtable on Environmental Health Sciences, Research, and Medicine

Board on Health Sciences Policy

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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Implications of Nanotechnology for Environmental Health Research IMPLICATIONS OF NANOTECHNOLOGY FOR ENVIRONMENTAL HEALTH RESEARCH Lynn Goldman and Christine Coussens, Editors Roundtable on Environmental Health Sciences, Research, and Medicine Board on Health Sciences Policy INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Implications of Nanotechnology for Environmental Health Research THE NATIONAL ACADEMIES PRESS 500 FIFTH STREET, N.W. 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 Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the National Institute of Environmental Health Sciences, National Institute of Health (Contract No. N01-OD-4-2139, Task#43); National Center for Environmental Health and Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention (Contract No. 200-2000-00629, TO#7); National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention (Contract No. 0000166930); National Health and Environment Effects Research Laboratory and National Center for Environmental Research, Environmental Protection Agency (Contract No. 282-99-0045, TO#5); American Chemistry Council (unnumbered grant); and Exxon-Mobil Corporation (unnumbered grant). The views presented in this book are those of the individual presenters and are not necessarily those of the funding agencies or the Institute of Medicine. This summary is based on the proceedings of a workshop that was sponsored by the Roundtable on Environmental Health Sciences, Research, and Medicine. It is prepared in the form of a workshop summary by and in the names of the editors, with the assistance of staff and consultants, as an individually authored document. International Standard Book Number 0-309-09577-8 (Book) International Standard Book Number 0-309-54835-1 (PDF) Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Nanotube on cover © Alfred Pasieka/Science Photo Library. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Implications of Nanotechnology for Environmental Health Research “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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Implications of Nanotechnology for Environmental Health Research THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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. Bruce M. Alberts 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. Wm. A. Wulf 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 responsibility 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 National 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Implications of Nanotechnology for Environmental Health Research ROUNDTABLE ON ENVIRONMENTAL HEALTH SCIENCES, RESEARCH, AND MEDICINE Paul Grant Rogers (Chair), Partner, Hogan & Hartson, Washington, DC Lynn Goldman (Vice Chair), Professor, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD Jacqueline Agnew, Professor, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD Jack Azar, Vice President, Environment, Health and Safety, Xerox Corporation, Webster, NY Roger Bulger, President and CEO, Association of Academic Health Centers, Washington, DC Yank D. Coble, Immediate Past President, American Medical Association, Neptune Beach, FL Henry Falk, Assistant Administrator, Agency for Toxic Substance and Disease Registry, Atlanta, GA Baruch Fischhoff, Professor, Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA John Froines, Professor and Director, Center for Occupational and Environmental Health, Southern California Particle Center and Supersite, University of California, Los Angeles, CA Howard Frumkin, Professor and Chair of the Department of Environmentaland Occupational Medicine, Rollins School of Public Health, Emory University, Atlanta, GA Michael Gallo, Professor of Environmental and Community Medicine, University of Medicine and Dentistry, New Jersey–Robert Wood Johnson Medical School, Piscataway, NJ Paul Glover, Director General, Safe Environments Programme, Health Canada, Ottawa, Ontario, Canada Bernard Goldstein, Dean, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA Charles Groat, Director, U.S. Geological Survey, Reston, VA Myron Harrison, Senior Health Advisor, Exxon-Mobil, Inc., Irving, TX Carol Henry, Vice President for Science and Research, American Chemistry Council, Arlington, VA John Howard, Director, National Institute Occupational Safety and Health, Centers for Disease Control and Prevention, Washington, DC Richard Jackson, Senior Advisor to the Director, Centers for Disease Control and Prevention, Atlanta, GA Lovell Jones, Director, Center for Research on Minority Health; Professor, Gynecologic Oncology, University of Texas, M.D. Anderson Cancer Center, Houston, TX

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Implications of Nanotechnology for Environmental Health Research Alexis Karolides, Senior Research Associate, Rocky Mountain Institute, Snowmass, CO Fred Krupp, Executive Director, Environmental Defense, New York, NY Donald Mattison, Senior Advisor to the Directors of National Institute of Child Health and Human Development and Center for Research for Mothers and Children, National Institutes of Health, HHS, Bethesda, MD Michael McGinnis, Senior Vice President and Director of the Health Group, Robert Wood Johnson Foundation, Princeton, NJ James Melius, Administrator, New York State Laborers’ Health and Safety Fund, Albany, NY James Merchant, Professor and Dean, College of Public Health, Iowa University, Iowa City, IA Sanford Miller, Senior Fellow, Center for Food and Nutrition Policy, Virginia Polytechnic Institute and State University, Alexandria, VA Alan R. Nelson, Special Advisor to the Chief Executive Officer, American College of Physicians–American Society of Internal Medicine, Fairfax, VA Kenneth Olden, Director, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC John Porretto, Chief Business Officer, Health Science Center, University of Texas, Houston, TX Peter Preuss, Director, National Center for Environmental Research, U.S. Environmental Protection Agency, Washington, DC Lawrence Reiter, Director, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC Carlos Santos-Burgoa, General Director, Equity and Health, Secretaria de Salud de México, México D.F., México Michael Shannon, Chair of the Committee of Environmental Health, Associate Professor of Pediatrics, Children’s Hospital, Boston, MA Samuel Wilson, Deputy Director, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC IOM Health Sciences Policy Board Liaisons Lynn R. Goldman, Professor, Department of Environmental Health, Johns Hopkins University, Baltimore, MD Bernard D. Goldstein, Dean of the University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA

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Implications of Nanotechnology for Environmental Health Research Study Staff Christine M. Coussens, Study Director Ricardo Molins, Senior Program Officer Dalia Gilbert, Research Associate Erin McCarville, Senior Program Assistant Victoria Blaho, Intern (Summer 2004) LaTeya Foxx, Intern (Summer 2004) Division Staff Andrew Pope, Division Director Amy Haas, Administrative Assistant Carlos Gabriel, Financial Associate

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Implications of Nanotechnology for Environmental Health Research REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this 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 for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Janet Carter, Senior Scientist, Procter & Gamble, Cincinnati, OH Marcia Lawson, Director of Communications, American Chemistry Council, Annandale, VA Kyle May, Constella Health Sciences, Silver Spring MD Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Melvin Worth, Scholar-in-Residence, Institute of Medicine, who was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Implications of Nanotechnology for Environmental Health Research Preface The Institute of Medicine’s Roundtable on Environmental Health Sciences, Research, and Medicine was established in 1988 as a mechanism for bringing the various stakeholders together to discuss environmental health issues in a neutral setting. The members of the Roundtable on Environmental Health Sciences, Research, and Medicine come from academia, industry, and government. Their perspectives range widely and represent the diverse viewpoints of researchers, federal officials, and consumers. They meet, discuss environmental health issues that are of mutual interest (though sometimes very sensitive), and bring others together to discuss these issues as well in a neutral setting. The purpose is to foster dialogue and discussion across sectors and institutions, and to illuminate issues, not resolve them. To allow full and candid participation by all members, the Roundtable identifies approaches, but does not make recommendations or endorse courses of action. The Roundtable’s twelfth meeting examined the environmental health issues surrounding the emergence of nanotechnology. This discussion continued the theme established by previous Roundtable workshops, looking at rebuilding the unity of health and the environment. This workshop summary captures the discussions and presentations by the speakers and participants, who identified the areas in which additional research was needed, the processes by which changes could occur, and the gaps in our knowledge. The views expressed here do not necessarily reflect the views of the Institute of Medicine, the Roundtable, or its sponsors. The timing of this meeting is important as society prepares for nanotechnology. Presently, we have a number of nanotechnology products that are on the market. Others are close to market or still in development. What this means is that, in the next decade, we will have an onslaught of products that hold great promise for revolutionizing how we manufacture products, communicate with each other, and treat disease. With this new technology come a number of uncertainties. At the beginning of this year, there were a few reports from a number of organizations that questioned the safety of some of these products for health and

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Implications of Nanotechnology for Environmental Health Research the environment. These reports did not call for a moratorium on nanotechnology, but they did suggest that the field of environmental health must now take a critical look at this emerging technology and develop a research agenda for addressing critical issues related to the impact of nanotechnology on health and the environment. The role of the environmental health scientist is not to question whether a technology should be developed, but rather to create a framework so that, as these technologies come to market, scientists and policy makers will be in a better position to put policies in place to safeguard environmental health and inform the public of any risks involved. Why now, when there is little evidence that nanotechnology will have toxic effects? With previous emerging technologies, such as genetically engineered foods and genomics, there have been uncertainty and concern about health risks. Scientists and policy makers point to the misstep that occurred when genetically engineered foods were introduced to the market. The public questioned their safety, and the technology stumbled as environmental health research was put in place to better answer the questions. Even today, the Institute of Medicine is involved in looking at some of the issues surrounding genetically engineered foods and will likely continue to do so for the foreseeable future. The field of nanotechnology may be at risk in a number of ways, and speakers during the workshop considered scenarios where nanotechnology could be a liability or an asset depending on how the various products enter the marketplace and the extent of unintended consequences. During the meeting, the need for open communication was discussed in greater detail as some speakers and participants suggested that trust is very important. Enforcement of regulations and solid research planning are crucial if scientists and policy makers are going to have the answers about the implications of nanotechnology. At the moment, the funding for research and development of the science is outpacing the research on related environmental health issues. With the resources available, the field needs to examine the technology so that the science is in a better position to answer basic questions. A research agenda will need to be developed to ensure that the right questions are being asked and that the research effort is coordinated. There needs to be flexibility in the program to respond to emerging challenges as they occur. Complicating the research is the lack of a nomenclature for the field. Currently, the science is based on the size of nanoparticles, but doesn’t take into account the basic chemical structure, such as titanium or carbon, or the surface coating of the nanoparticles. It remains to be determined whether these particles are new chemicals or not. The discussion at this meeting could not begin to answer the questions, but certainly pointed to a need for a research agenda for the field. As we reflect on the meeting, we are reminded that the public is an important part of the process. Nanotechnology holds great promise for the health and environment, but we need to ensure that our knowledge of any risks develop at a

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Implications of Nanotechnology for Environmental Health Research similar rate as our knowledge of the technology. By knowing about the risks and how to address them, environmental health scientists will be better able to serve the public. Paul G. Rogers, Chair Lynn Goldman Vice Chair

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Implications of Nanotechnology for Environmental Health Research Contents     SUMMARY   1      Benefits and Potential Negative Impact of Nanotechnology,   2      U.S. Governmental Involvement in Ensuring Safety,   3      Canadian Perspective,   4      The Right Time to Plan for Nanotechnology,   5 1   PREPARING FOR NANOTECHNOLOGY: HEALTH, POLICY, AND EMERGING ISSUES   6      Issues in Nanotechnology Involving Environmental Health Safety,   7      Nanotechnology: Policy Implications,   8 2   THE PROMISE OF NANOTECHNOLOGY   11      Products of Today,   11      Environmental Applications for Nanotechnology,   12      Nanotechnology, Human Health, and Medicine,   17 3   NANOTECHNOLOGY: EXPANDING SCIENTIFIC UNDERSTANDING   23      Size Isn’t Everything,   24      Interactions with Biological Systems,   24      Environmental Influence of Toxicology of Nanomaterials,   24      Routes of Administration and Potential Health Effects,   25      Oxidative Stress,   27      Nanotechnology, Inhalation, and Cytotoxicity,   28      What Can We Learn from Diesel Particles?,   30      Nanotechnology and Strategies to Ensure Occupational Health,   31      An Open Process,   33

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Implications of Nanotechnology for Environmental Health Research 4   NANOTECHNOLOGY: GOVERNMENT INVOLVEMENT   38      Approaches from the Canadian Government,   38      Technologies for Improved Risk Stratification and Disease Prevention: U.S. Government Involvement,   39 5   NEXT STEPS   42      Nomenclature,   42      Risk–Benefit Analysis,   43      Need for Framework and Leadership,   44     REFERENCES   45     APPENDIXES     A   Workshop Agenda   47 B   Speakers and Panelists   50 C   Workshop Participants   52