[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]


 
                     RESEARCH ON ENVIRONMENTAL AND
                   SAFETY IMPACTS OF NANOTECHNOLOGY:
                  WHAT ARE THE FEDERAL AGENCIES DOING?

=======================================================================

                                HEARING

                               BEFORE THE

                          COMMITTEE ON SCIENCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 21, 2006

                               __________

                           Serial No. 109-63

                               __________

            Printed for the use of the Committee on Science


     Available via the World Wide Web: http://www.house.gov/science



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                                 ______

                          COMMITTEE ON SCIENCE

             HON. SHERWOOD L. BOEHLERT, New York, Chairman
RALPH M. HALL, Texas                 BART GORDON, Tennessee
LAMAR S. SMITH, Texas                JERRY F. COSTELLO, Illinois
CURT WELDON, Pennsylvania            EDDIE BERNICE JOHNSON, Texas
DANA ROHRABACHER, California         LYNN C. WOOLSEY, California
KEN CALVERT, California              DARLENE HOOLEY, Oregon
ROSCOE G. BARTLETT, Maryland         MARK UDALL, Colorado
VERNON J. EHLERS, Michigan           DAVID WU, Oregon
GIL GUTKNECHT, Minnesota             MICHAEL M. HONDA, California
FRANK D. LUCAS, Oklahoma             BRAD MILLER, North Carolina
JUDY BIGGERT, Illinois               LINCOLN DAVIS, Tennessee
WAYNE T. GILCHREST, Maryland         DANIEL LIPINSKI, Illinois
W. TODD AKIN, Missouri               SHEILA JACKSON LEE, Texas
TIMOTHY V. JOHNSON, Illinois         BRAD SHERMAN, California
J. RANDY FORBES, Virginia            BRIAN BAIRD, Washington
JO BONNER, Alabama                   JIM MATHESON, Utah
TOM FEENEY, Florida                  JIM COSTA, California
RANDY NEUGEBAUER, Texas              AL GREEN, Texas
BOB INGLIS, South Carolina           CHARLIE MELANCON, Louisiana
DAVE G. REICHERT, Washington         DENNIS MOORE, Kansas
MICHAEL E. SODREL, Indiana           DORIS MATSUI, California
JOHN J.H. ``JOE'' SCHWARZ, Michigan
MICHAEL T. MCCAUL, Texas
MARIO DIAZ-BALART, Florida


                            C O N T E N T S

                           September 21, 2006

                                                                   Page
Witness List.....................................................     2

Hearing Charter..................................................     3

                           Opening Statements

Statement by Representative Sherwood L. Boehlert, Chairman, 
  Committee on Science, U.S. House of Representatives............    22
    Written Statement............................................    23

Statement by Representative Bart Gordon, Minority Ranking Member, 
  Committee on Science, U.S. House of Representatives............    24
    Written Statement............................................    25

Prepared Statement by Representative Jerry F. Costello, Member, 
  Committee on Science, U.S. House of Representatives............    26

Prepared Statement by Representative Daniel Lipinski, Member, 
  Committee on Science, U.S. House of Representatives............    26

                               Witnesses:

Dr. Norris E. Alderson, Chair, Nanotechnology, Environmental, and 
  Health Implications Working Group; Associate Commissioner for 
  Science, Food and Drug Administration
    Oral Statement...............................................    28
    Written Statement............................................    30
    Biography....................................................    32

Dr. Arden L. Bement, Jr., Director, National Science Foundation
    Oral Statement...............................................    32
    Written Statement............................................    34
    Biography....................................................    39

Dr. William H. Farland, Deputy Assistant Administrator for 
  Science, Office of Research and Development, U.S. Environmental 
  Protection Agency
    Oral Statement...............................................    40
    Written Statement............................................    42

Dr. Altaf H. (Tof) Carim, Program Manager, Nanoscale Science and 
  Electron Scattering Center, U.S. Department of Energy
    Oral Statement...............................................    45
    Written Statement............................................    46
    Biography....................................................    49

Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging 
  Nanotechnologies, Woodrow Wilson International Center for 
  Scholars
    Oral Statement...............................................    50
    Written Statement............................................    51
    Biography....................................................    63
    Financial Disclosure.........................................    64

Mr. Matthew M. Nordan, President, Director of Research, Lux 
  Research, Inc.
    Oral Statement...............................................    65
    Written Statement............................................    67
    Biography....................................................    73

Discussion
  Coordinating Federal Environmental, Health, and Safety 
    Nanotechnology Research Programs.............................    74
  Regulatory Structure for University and Industry Nanomaterial 
    Research.....................................................    79
  Is the Marketplace Outrunning Research?........................    80
  Setting Priorities.............................................    81
  Public Awareness of Nanotechnology.............................    82

             Appendix 1: Answers to Post-Hearing Questions

Dr. Norris E. Alderson, Chair, Nanotechnology, Environmental, and 
  Health Implications Working Group; Associate Commissioner for 
  Science, Food and Drug Administration..........................    86

Dr. Arden L. Bement, Jr., Director, National Science Foundation..    93

Dr. William H. Farland, Deputy Assistant Administrator for 
  Science, Office of Research and Development, U.S. Environmental 
  Protection Agency..............................................    99

Dr. Altaf H. (Tof) Carim, Program Manager, Nanoscale Science and 
  Electron Scattering Center, U.S. Department of Energy..........   102

Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging 
  Nanotechnologies, Woodrow Wilson International Center for 
  Scholars.......................................................   105

             Appendix 2: Additional Material for the Record

Environmental, Health, and Safety Research Needs for Engineered 
  Nanoscale Materials, Nanoscale Science, Engineering, and 
  Technology Subcommittee, Committee on Technology, National 
  Science and Technology Council, September 2006.................   112


 RESEARCH ON ENVIRONMENTAL AND SAFETY IMPACTS OF NANOTECHNOLOGY: WHAT 
                    ARE THE FEDERAL AGENCIES DOING?

                              ----------                              


                      THURSDAY, SEPTEMBER 21, 2006

                  House of Representatives,
                                      Committee on Science,
                                                    Washington, DC.

    The Committee met, pursuant to call, at 10:05 a.m., in Room 
2318 of the Rayburn House Office Building, Hon. Sherwood L. 
Boehlert [Chairman of the Committee] presiding.


                            hearing charter

                          COMMITTEE ON SCIENCE

                     U.S. HOUSE OF REPRESENTATIVES

                     Research on Environmental and

                   Safety Impacts of Nanotechnology:

                  What Are the Federal Agencies Doing?

                      thursday, september 21, 2006
                         10:00 a.m.-12:00 p.m.
                   2318 rayburn house office building

1. Purpose

    On Thursday, September 21, 2006, the Committee on Science of the 
House of Representatives will hold a hearing to examine whether the 
Federal Government is adequately funding, prioritizing, and 
coordinating research on the environmental and safety impacts of 
nanotechnology.

2. Witnesses

Dr. Norris E. Alderson is the Chair of the interagency Nanotechnology 
Environmental and Health Implications Working Group and the Associate 
Commissioner for Science at the Food and Drug Administration (FDA).

Dr. Arden L. Bement, Jr. is the Director of the National Science 
Foundation (NSF).

Dr. William Farland is the Deputy Assistant Administrator for Science 
in the Office of Research and Development at the Environmental 
Protection Agency (EPA).

Dr. Altaf H. (Tof) Carim is a Program Manager in the Nanoscale Science 
and Electron Scattering Center at the Office of Basic Energy Sciences 
in the Department of Energy (DOE).

Dr. Andrew Maynard is the Chief Science Advisor for the Project on 
Emerging Nanotechnologies at the Woodrow Wilson International Center 
for Scholars.

Mr. Matthew M. Nordan is the President and Director of Research at Lux 
Research Inc., a nanotechnology research and advisory firm.

3. Overarching Questions

          How much is the Federal Government spending on 
        research on environmental and safety impacts of nanotechnology? 
        How are funding levels determined? Are current federal research 
        efforts adequate to address concerns about environmental and 
        safety ramifications of nanotechnology?

          What are the priorities for federally-supported 
        research on the environmental and safety impacts of 
        nanotechnology? How are these priorities determined, and are 
        the current priorities appropriate?

          What impacts are environmental and safety concerns 
        having on the development of nanotechnology-related products 
        and their entry into the marketplace? What impact might these 
        concerns have in the future?

          Are additional steps needed to improve management and 
        coordination of federal research in this area?

4. Brief Overview

          Nanotechnology, the science of materials and devices 
        of the scale of atoms and molecules, has entered the consumer 
        marketplace. Today, there are over 300\1\ products on the 
        market claiming to contain nanomaterials (materials engineered 
        using nanotechnology or containing nano-sized particles), 
        generating an estimated $32 billion in revenue.\2\ By 2014, 
        according to Lux Research,\3\ a private research firm that 
        focuses on nanotechnology, there could be $2.6 trillion worth 
        of products in the global marketplace which have incorporated 
        nanotechnology.
---------------------------------------------------------------------------
    \1\ Wilson Center, Project on Emerging Nanotechnologies, 
``Nanotechnology: A Research Strategy for Addressing Risk,'' July, 
2006. p. 4.
    \2\ Lux Research, ``Taking Action on Nanotech Environmental, 
Health, and Safety Risks,'' Advisory, May 2006 (NTS-R-06-003) 
(hereafter cited as ``Taking Action'').
    \3\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October, 
2004.

          There is significant concern in industry that the 
        projected economic growth of nanotechnology could be undermined 
        by either real environmental and safety risks of nanotechnology 
        or the public's perception that such risks exist. Recently, 
        some reports have indicated that these concerns are causing 
        some companies to shy away from nanotechnology-related products 
        and downplay nanotechnology when they talk about or advertise 
        their products. There is an unusual level of agreement among 
        researchers, and business and environmental organizations that 
        the basic scientific information needed to assess and protect 
---------------------------------------------------------------------------
        against potential risks does not yet exist.

          The President's fiscal year 2007 (FY07) budget 
        requests $1.3 billion for the National Nanotechnology 
        Initiative (NNI), the interagency nanotechnology research and 
        development (R&D) program. Of this amount, the budget proposes 
        $44.1 million (3.5 percent of the overall program) for research 
        on environmental and safety implications of nanotechnology. 
        This is $6.6 million above the FY06 funding level. Nearly 60 
        percent of this funding would go to NSF.

          In October 2003, the White House National Science and 
        Technology Council organized an interagency Nanotechnology 
        Environmental and Health Implications (NEHI) Working Group, 
        composed of agencies with research and regulatory 
        responsibilities for nanotechnology, to coordinate 
        environmental and safety research. The NEHI Working Group is 
        charged with ``facilitate[ing] the identification, 
        prioritization, and implementation of research. . .required for 
        the responsible'' development and use of nanotechnology.\4\ The 
        Food and Drug Administration serves as the current Chair of the 
        NEHI Working Group.
---------------------------------------------------------------------------
    \4\ Terms of Reference, Nanotechnology Environmental and Health 
Implications Working Group Nanoscale Science, Engineering, and 
Technology Subcommittee Committee on Technology; March, 2005.

          One of the NEHI Working Group's initial tasks was 
        developing a report describing research needs for assessing and 
        managing the potential environmental and safety risks of 
        nanotechnology. In March 2006, the Administration informed the 
        Science Committee that this report would be completed that 
---------------------------------------------------------------------------
        spring, but the document has not yet been released.

          In July 2006, the Wilson Center's Project on Emerging 
        Nanotechnologies released a report proposing a research 
        strategy for ``systematically exploring the potential risks of 
        nanotechnology.'' The report highlights critical federal 
        research that urgently needs to be carried out in the next two 
        years and recommends that a non-governmental organization, such 
        as the National Academy of Sciences, develop and regularly 
        review a long-term research strategy. The report also finds 
        that current federal coordination does not yet have an 
        effective mechanism to set research priorities, distribute 
        tasks among the agencies, and ensure that adequate resources 
        are provided for the most urgent research.

5. Previous Science Committee Hearing

    The Science Committee held a previous hearing on this topic, 
Environmental and Safety Impacts of Nanotechnology: What Research is 
Needed?, on November 17, 2005. The charter for that hearing is attached 
(Appendix). At that hearing, witnesses from the Federal Government, 
industry, and environmental organization agreed that relatively little 
is understood about the environmental and safety implications of 
nanotechnology. The non-governmental witnesses emphasized that, for the 
emerging field of nanotechnology to reach its full economic potential, 
the Federal Government must significantly increase funding for research 
in this area.

6. Developments Since November 2005

Fiscal Year 2007 Budget
    In July 2006, the Administration released its nanotechnology 
supplement to the President's FY07 budget request.\5\ This document 
includes information about the overall funding levels for research on 
environment and safety impacts of nanotechnology at each of the federal 
agencies participating in the NNI (see Table 1). The budget supplement 
also provides brief descriptions of some of the activities underway in 
this area, and highlights FY07 initiatives such as the expansion of a 
joint grant program among EPA, NSF, the National Institute for 
Occupational Safety and Health (NIOSH) and the National Institute of 
Environmental Health Sciences (NIEHS), but it does not provide funding 
levels for specific research activities. (NIOSH is part of the 
Department of Health and Human Services (DHHS), and NIEHS is part of 
the National Institutes of Health (NIH), also part of DHHS.) To help 
the agencies determine how to estimate the funding levels reported in 
Table 1, the National Nanotechnology Coordinating Office provides a 
definition of ``Environment Health, and Safety Implications Research 
and Development (R&D),'' but the agencies' application of the 
definition to their programs can vary.
---------------------------------------------------------------------------
    \5\ The National Nanotechnology Initiative: ``Research and 
Development Leading to a Revolution in Technology and Industry, 
Supplement to the President's FY 2007 Budget.'' http://www.ostp.gov/
nstc/html/NNI%2007%20Budget%20Supplement%20July%202007.pdf



Report on Federal Priorities for Research on Environmental and Safety 
        Implications of Nanotechnology Is Not Completed
    At the Science Committee's November 17, 2005 hearing on 
nanotechnology, Dr. Clayton Teague, Director of the National 
Nanotechnology Coordination Office, testified that the NEHI Working 
Group was ``preparing a document that identifies and prioritizes 
information and research needs in this area. The document will serve as 
a guide to the NNI agencies as they develop budgets and programs and 
will inform individual investigators as they consider their research 
directions.'' \6\ In his responses to questions for the record, Dr. 
Teague said the report was expected to be completed by ``Spring 2006'' 
and ``is intended to be sufficiently detailed to guide investigators 
and managers in making project-level decisions, yet broad enough to 
provide a framework for the next five to ten years.'' The report has 
not yet been completed and no drafts have been released for public 
comment.
---------------------------------------------------------------------------
    \6\ Clayton Teague Testimony, November 17, 2005, House Science 
Committee, p. 3.
---------------------------------------------------------------------------
    For the final document to provide useful guidance to agencies, 
Congress, industry academic researchers, environmental groups, and the 
public, it will need to define the scale and scope of the needed 
research, set priorities for research areas, provide information that 
can affect agency-directed spending decisions, and be specific enough 
to serve as overall research strategy for federal and non-federal 
research efforts. In the absence of such a document, each agency can 
only set its priorities and funding levels based on its individual 
mission rather than in the context of other agencies' needs or 
activities.
Recent Reports
    In the past year, five new reports have been published that 
characterize how the private sector is coping with environmental and 
safety implications of nanotechnology and how the Federal Government is 
funding and should be prioritizing its research in this area. Three of 
the most significant new reports are summarized below.\7\ In addition, 
this week the Wilson Center released the results of a national poll 
indicating that the majority of the public still has heard little to 
nothing about nanotechnology. The poll also finds that the public looks 
to the Federal Government and independent parties to monitor 
nanotechnology research and products. These findings bolster earlier 
calls by Congress, businesses, and environmental groups for the Federal 
Government to prioritize and provide more support for critical research 
on understanding the risks associated with nanotechnology so as to 
inform the public and enable the responsible development of 
nanotechnology.
---------------------------------------------------------------------------
    \7\ In addition to the three reports described in detail in this 
charter, Guy Carpenter & Company, Inc., a leading risk and reinsurance 
specialist and a part of the Marsh & McLennan Companies, Inc., 
published a report in August 2006 titled, ``Nanotechnolgy: The Plastics 
of the 21st Century.'' The report provides businesses and risk managers 
with an overview of the field and some of the environmental issues that 
can be expected to arise relating to insurance and government 
regulation. In another important report issued just before the Science 
Committee's Nov. 2005 hearing, Innovest, an investment research firm 
that rates companies on their environmental management and performance, 
issued a report titled, `` Nanotechnology'' (October 2005), in which it 
introduced an investment index for investors. The report discusses the 
market viability of nano-products and materials in light of 
environmental and safety issues that could play a role in 
commercialization and in company performance. It also provides an 
overview of company best practices. The report distills a list of 300 
public and private companies found in NanoInvestornews.com down to an 
index of 15 companies, and a watch list of an additional eight 
companies. Innovest is tracking the indexed companies and updates its 
findings for clients.
---------------------------------------------------------------------------
            Lux Research Report
    In May 2006, Lux Research, a business research and advisory firm 
specializing in nanotechnology, released a report\8\ updating its May 
2005 assessment\9\ of the environment and safety landscape for 
businesses involved with nanotechnology. According to Lux, the debate 
about the environmental and safety implications of nanotechnology has 
``intensified,'' while the continuing lack of data, tools, and 
protocols for answering key safety questions is creating significant 
challenges for companies interested in developing nanotechnology-
related products and their potential investors.
---------------------------------------------------------------------------
    \8\ Lux Research, ``Taking Action,'' 2006.
    \9\ Lux Research, ``A Prudent Approach to Nanotech Environmental, 
Health and Safety Risks.'' May, 2005.
---------------------------------------------------------------------------
    Some large companies are shying away from nanotechnology-related 
products because they fear potential liabilities or the costs of 
extensive toxicity testing. Smaller, nanotechnology-focused companies, 
on the other hand, cannot leave the field, but are unable to afford to 
provide the data on the safety of their products increasingly requested 
by their customers. There are some signs that companies unsure of how 
to deal with potential risks may be trying to sidestep the issue by 
simply not using the term ``nanotechnology'' in their product 
descriptions.
    The Lux report notes that many environmental groups have advocated 
for increased funding for research on the environmental and safety 
implications of nanotechnology and several have called for temporary or 
permanent moratoria on nanotechnology products. The report also 
suggests that regulation by agencies such as EPA, FDA, the Occupational 
Safety and Health Administration, and the Consumer Product Safety 
Commission, is in the offing, but notes that the timing and substance 
of regulatory action remain uncertain. Many companies have been 
pressing these agencies to provide information about their plans in 
this area and to take actions that will reduce the uncertainty 
surrounding regulation of nanotechnology.
    Due to the uncertainty of the current research and regulatory 
environments, the Lux report recommends that companies develop their 
own plans to address potential real and perceived risks of 
nanomaterials and products. The Lux report does not include any 
recommendations for the research or regulatory agencies of the Federal 
Government.
            Wilson Center Inventory of Research on the Environmental 
                    and Safety Impacts of Nanotechnology
    As was discussed at the Science Committee's last hearing on this 
topic, in 2005 the Wilson Center began assembling an inventory of 
ongoing research into the environmental and safety impacts of 
nanotechnology; the analysis of this inventory was released just after 
the hearing in November 2005.\10\ The inventory catalogs research 
funded by governments around the world as well as some research funded 
by industry and foundations. The primary purpose of the inventory is to 
facilitate strategic, coordinated and integrated research among the 
public and private sectors on research in this area. While the 
inventory is not complete, it includes all the available public 
information on federally-sponsored research.
---------------------------------------------------------------------------
    \10\ The Wilson Center inventory continues to be updated; the most 
current version is available online at http://www.nanotechproject.org/
18. Information from the inventory was included in the November 17, 
2005 hearing record.
---------------------------------------------------------------------------
    The Wilson Center's initial analysis\11\ of the inventory 
highlights two main points. The first is that significant gaps exist in 
the current portfolio of federally supported research projects. For 
example, the Wilson Center found few projects focused on controlling or 
preventing exposure to engineered nanomaterials and their release into 
the environment, as well as little research into the diseases and 
environmental impacts that may result from exposure. While there were 
many research projects studying the hazards of exposure to 
nanoparticles, most research focused on the lungs, with no projects 
focusing on the gastrointestinal tract. The Wilson Center's research 
needs report, described in the next section, suggests that these gaps 
in the research portfolio may reflect the absence of an overall federal 
strategy for conducting research on the environmental and safety 
impacts of nanotechnology.
---------------------------------------------------------------------------
    \11\ This analysis was performed on the inventory as of November 
23, 2005.
---------------------------------------------------------------------------
    The second main finding of the analysis is the inconsistency 
between the Wilson Center inventory and the federal budget supplement. 
The Wilson Center found $31 million worth of research projects funded 
by the U.S. Government in 2005 that had some relevance to the potential 
environmental and safety risks of nanotechnology. However, only $11 
million of the $31 million was going to projects that specifically 
focused on the environmental or safety implications of nanotechnology. 
In contrast, the FY07 NNI budget supplement states that, in FY05, the 
federal agencies in NNI spent $35 million on research for which the 
primary purpose was understanding and addressing potential 
environmental and safety risks of nanotechnology. The Wilson Center 
inventory includes the available public information on federally 
sponsored research, and since the NNI has not developed its own 
detailed inventory of projects in this area, it is not currently 
possible to determine why these accountings differ.



            Wilson Center, ``Nanotechnology: A Research Strategy for 
                    Addressing Risk"
    In July 2006, Dr. Andrew Maynard, the Wilson Center's Chief 
Scientist, and a former NIOSH scientist, proposed a research strategy 
for ``systematically exploring the potential risks of nanotechnology.'' 
\12\ Based on the significant knowledge gaps identified in a variety of 
research needs reports from federal agencies, private groups, and 
international bodies; the Wilson Center's inventory of research in this 
area; his own experience in interagency activities while at NIOSH; and 
a risk-based framework that he developed, the report outlines the 
highest priority areas of research in which investment is needed 
between 2007 and 2009 to ensure the safety of technologies in use or 
close to commercialization and lay the groundwork for future research 
needs. The highest short-term priorities include identifying and 
measuring exposure and environmental releases, assessing toxicity, 
controlling releases, and developing best practices for worker safety, 
while longer-term needs include investment in areas such as predictive 
toxicology, the ability to predict the toxicological effects of 
nanomaterials.
---------------------------------------------------------------------------
    \12\ Wilson Center, Project on Emerging Nanotechnologies, 
``Nanotechnology: A Research Strategy for Addressing Risk,'' July, 
2006.
---------------------------------------------------------------------------
    The report also makes recommendations for changes in federal 
nanotechnology programs to ensure that the appropriate investments are 
made and the programs are carried out effectively. First, the report 
calls for the Federal Government to shift funding for research on 
environmental and safety impacts of nanotechnology to those federal 
agencies with clear mandates and expertise in risk-related research, 
including EPA, NIOSH, NIEHS, and NIST, and the analysis in the report 
suggests that these agencies will require a minimum of $100 million 
over the next two years to carry out the needed research. The report 
also expresses concern that the current interagency process is 
insufficient and that gaps in the research portfolio are resulting from 
a bottom-up approach in which each agency develops its own research 
priorities. The report therefore recommends the establishment of a new 
interagency oversight group with the ``authority to set and implement a 
strategic research agenda'' and to assure adequate resources for those 
agencies carrying out the highest priority research.
    The report also recommends that the Federal Government work closely 
with outside groups in executing research in this area. It says that 
mechanisms are needed to facilitate government-industry research 
partnerships and to enable international collaboration and information 
sharing. It cites the Health Effects Institute, an organization that 
has effectively addressed controversial air pollution research through 
joint government and private sector funding, as an excellent model for 
what is needed.\13\ It also calls for international cooperation to 
share research costs and exchange information.
---------------------------------------------------------------------------
    \13\ The Health Effects Institute (HEI) is as an independent, non-
profit research organization, chartered in 1980, to provide high-
quality, impartial, and relevant science on the health effects of air 
pollution. Typically, HEI receives half of its core funds from the EPA 
and half from the worldwide motor vehicle industry. http://
www.healtheffects.org
---------------------------------------------------------------------------
    The report also calls for a long-term research strategy to be 
developed and reviewed regularly by an organization such as the 
National Academies. This recommendation is consistent with the 
recommendation made by Dr. Richard Denison, of the environmental 
organization Environmental Defense, in his testimony before the 
committee at the November 17, 2005 hearing.

7. Witness Questions

Questions for Dr. Norris Alderson, Food and Drug Administration
    In your testimony, please briefly describe the responsibilities and 
activities of the National Nanotechnology Environmental and Health 
Implications (NEHI) Working Group and address the following questions:

          What are the overall priorities for federally-
        supported research on the environmental and safety impacts of 
        nanotechnology and how are these priorities determined? To what 
        extent is the NEHI Working Group involved in setting or 
        recommending funding levels for research in these areas? How 
        are research roles allocated among the different agencies? How 
        are ongoing research activities coordinated?

          When will the federal report that describes research 
        needs for assessing and managing the potential risks of 
        nanotechnology be completed and released? How is the NEHI 
        Working Group incorporating information about risk and about 
        the research needs of federal regulatory activities into the 
        research needs document? How is input from groups outside of 
        government, including industry, incorporated?

          What topics will the report cover and what issues 
        will remain to be addressed in the future? What will be the 
        responsibilities and activities of the NEHI Working Group once 
        the report is complete?

Questions for Dr. Arden Bement, National Science Foundation
    In your testimony, please briefly describe NSF's current and 
proposed fiscal year 2007 programs and funding for research on possible 
environmental and safety risks associated with nanotechnology, and 
address the following questions:

          What are your agency's research priorities for 
        studies of environmental and safety impacts of nanotechnology? 
        How were these priorities determined, and what would cause them 
        to change? To what extent is your research agenda specifically 
        designed to inform potential regulation? How have you decided 
        what portion of your nanotechnology funding to allocate to 
        research in this area?

          In what specific ways has your agency's research 
        agenda been shaped by interagency coordination? Are there areas 
        of research you are conducting because they have not been taken 
        up by other agencies or areas that you are forgoing because 
        other agencies are taking on that research? Is there research 
        being done because of the specific needs of regulatory 
        agencies?

Questions for Dr. William Farland, Environmental Protection Agency
    In your testimony, please briefly describe EPA's current and 
proposed fiscal year 2007 programs and funding for research on possible 
environmental and safety risks associated with nanotechnology and 
address the following questions:

          What are your agency's research priorities for 
        studies of environmental and safety impacts of nanotechnology? 
        How were these priorities determined, and what would cause them 
        to change? To what extent is your research agenda specifically 
        designed to inform potential regulation? How have you decided 
        what portion of your research funding to allocate to 
        nanotechnology-related projects?

          In what specific ways has your agency's research 
        agenda been shaped by interagency coordination? Are there areas 
        of research you are conducting because they have not been taken 
        up by other agencies or areas that you are forgoing because 
        other agencies are taking on that research? Is there research 
        being done because of the specific needs of regulatory 
        agencies?

Questions for Dr. Altaf (Tof) Carim, Department of Energy
    In your testimony, please briefly describe the Department of 
Energy's current and proposed Fiscal Year 2007 (FY07) programs and 
funding for research on possible environmental and safety risks 
associated with nanotechnology and address the following questions:

          What are your agency's research priorities for 
        studies of environmental and safety impacts of nanotechnology? 
        How were these priorities determined, and what would cause them 
        to change? To what extent is your research agenda specifically 
        designed to inform potential regulation? How have you decided 
        what portion of your nanotechnology funding to allocate to 
        research in this area?

          In what specific ways has your agency's research 
        agenda been shaped by interagency coordination? Are there areas 
        of research you are conducting because they have not been taken 
        up by other agencies or areas that you are forgoing because 
        other agencies are taking on that research? Is there research 
        being done because of the specific needs of regulatory 
        agencies?

Questions for Dr. Andrew Maynard, Project on Emerging Nanotechnologies, 
        Woodrow Wilson Center
    In your testimony, please briefly describe the results of the 
Wilson Center's inventory of federal research on the environmental and 
safety impacts of nanotechnology and the report, ``Nanotechnology: A 
Research Strategy for Addressing Risk?'', and address the following 
questions:

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? Are there gaps in the portfolio of 
        federal research currently underway; if so, in what areas?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? How should 
        the responsibility for funding and conducting this research be 
        divided among the federal agencies, industry, and universities?

          What elements should the forthcoming report on 
        research needs produced by the National Nanotechnology 
        Environmental and Health Implications Working Group contain to 
        adequately guide federal research investment in this area? What 
        additional steps are needed to improve management and 
        coordination of federal research on the environmental and 
        safety impacts of nanotechnology?

Questions for Mr. Matthew Nordan, Lux Research
    Please address the following questions in your testimony:

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? How should 
        the responsibility for funding and conducting this research be 
        divided among the federal agencies, industry, and universities?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? Are there gaps in the portfolio of 
        federal research currently underway; if so, in what areas?

          What additional steps are needed to improve 
        management and coordination of the Federal Government's 
        research enterprise?

Appendix: Hearing Charter from November 17, 2005 Hearing on 
                    Environmental and Safety Impacts of Nanotechnology: 
                    What Research is Needed?

                            hearing charter

                          COMMITTEE ON SCIENCE

                     U.S. HOUSE OF REPRESENTATIVES

                        Environmental and Safety

                       Impacts of Nanotechnology:

                        What Research Is Needed?

                      thursday, november 17, 2005
                         10:00 a.m.-12:00 p.m.
                   2318 rayburn house office building

1. Purpose

    On Thursday, November 17, 2005, the Committee on Science of the 
House of Representatives will hold a hearing to examine current 
concerns about environmental and safety impacts of nanotechnology and 
the status and adequacy of related research programs and plans. The 
Federal Government, industry and environmental groups all agree that 
relatively little is understood about the environmental and safety 
implications of nanotechnology and that greater knowledge is needed to 
enable a nanotechnology industry to develop and to protect the public. 
The hearing is designed to assess the current state of knowledge of, 
and the current research plans on the environmental and safety 
implications of nanotechnology.

2. Witnesses

Dr. Clayton Teague is the Director of the National Nanotechnology 
Coordination Office, the office that coordinates federal nanotechnology 
programs. The office is the staff arm of the Nanoscale Science, 
Engineering, and Technology Subcommittee of the National Science and 
Technology Council (NSTC). NSTC includes all federal research and 
development (R&D) agencies and is the primary coordination group for 
federal R&D policy.

Mr. Matthew M. Nordan is the Vice President of Research at Lux Research 
Inc., a nanotechnology research and advisory firm.

Dr. Krishna C. Doraiswamy is the Research Planning Manager at DuPont 
Central Research and Development, and is responsible for coordinating 
DuPont's nanotechnology efforts across the company's business units.

Mr. David Rejeski is the Director of the Project on Emerging 
Nanotechnologies at the Woodrow Wilson International Center for 
Scholars.

Dr. Richard Denison is a Senior Scientist at Environmental Defense.

3. Overarching Questions

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

4. Brief Overview

          Nanotechnology is expected to become a major engine 
        of economic growth in the coming years. According to Lux 
        Research,\14\ a private research firm that focuses on 
        nanotechnology, in 2014 there could be $2.6 trillion worth of 
        products in the global marketplace which have incorporated 
        nanotechnology--15 percent of manufacturing output. Lux also 
        predicts that in 2014, 10 million manufacturing jobs 
        worldwide--11 percent of total manufacturing jobs--will involve 
        manufacturing these nanotechnology-enabled products.
---------------------------------------------------------------------------
    \14\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October 
2004.

          There is a growing concern in industry that the 
        projected economic growth of nanotechnology could be undermined 
        by real environmental and safety risks of nanotechnology or the 
---------------------------------------------------------------------------
        public's perception that such risks exist.

          The small size, large surface area and unique 
        behavioral characteristics of nanoparticles present distinctive 
        challenges for those trying to assess whether these particles 
        pose potential environmental risks. For example, nanoscale 
        materials such as buckyballs, nano-sized clusters of carbon 
        atoms, behave very differently than their chemically-equivalent 
        cousin, pencil lead. There is an unusual level of agreement 
        among researchers, and business and environmental organizations 
        that basic scientific information needed to assess and protect 
        against potential risks does not yet exist.

          In December 2003, the President signed the 21st 
        Century National Nanotechnology Research and Development Act 
        (P.L. 108-153), which originated in the Science Committee. This 
        Act provided a statutory framework for the interagency National 
        Nanotechnology Initiative (NNI). Among other activities, the 
        Act called for the NNI to ensure that research on environmental 
        concerns is integrated with broader federal nanotechnology 
        research and development (R&D) activities.

          Federal funding for the NNI has grown from $464 
        million in fiscal year 2001 (FY01) to a requested $1.1 billion 
        in FY06. Of the requested FY06 level, the President's budget 
        proposes that $38.5 million (four percent of the overall 
        program) be directed to research on environmental and safety 
        implications of nanotechnology.

5. Background

    The National Academy of Sciences describes nanotechnology as the 
``ability to manipulate and characterize matter at the level of single 
atoms and small groups of atoms.'' An Academy report describes how 
``small numbers of atoms or molecules. . .often have properties (such 
as strength, electrical resistivity, electrical conductivity, and 
optical absorption) that are significantly different from the 
properties of the same matter at either the single-molecule scale or 
the bulk scale.'' \15\
---------------------------------------------------------------------------
    \15\ Small Wonders, Endless Frontiers: A Review of the National 
Nanotechnology Initiative, National Research Council/National Academy 
of Sciences, 2002.
---------------------------------------------------------------------------
    Nanotechnology is an enabling technology that will lead to 
``materials and systems with dramatic new properties relevant to 
virtually every sector of the economy, such as medicine, 
telecommunications, and computers, and to areas of national interest 
such as homeland security.'' \16\ As an enabling technology, it is 
expected to be incorporated into existing products, resulting in new 
and improved versions of these products. Some nanotechnology-enabled 
products are already on the market, including stain-resistant, wrinkle-
free pants, ultraviolet-light blocking sun screens, and scratch-free 
coatings for eyeglasses and windows. In the longer run, nanotechnology 
may produce revolutionary advances in a variety of industries, such as 
faster computers, lighter and stronger materials for aircraft, more 
effective and less invasive ways to find and treat cancer, and more 
efficient ways to store and transport electricity.
---------------------------------------------------------------------------
    \16\ Id.
---------------------------------------------------------------------------
    The projected economic growth of nanotechnology is staggering. In 
October 2004, Lux Research, a private research firm, released its most 
recent evaluation of the potential impact of nanotechnology. The 
analysis found that, in 2004, $13 billion worth of products in the 
global marketplace incorporated nanotechnology. The report projected 
that, by 2014, this figure will rise to $2.6 trillion--15 percent of 
manufacturing output in that year. The report also predicts that in 
2014, ten million manufacturing jobs worldwide--11 percent of total 
manufacturing jobs--will involve manufacturing these nanotechnology-
enabled products.\17\
---------------------------------------------------------------------------
    \17\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October 
2004.
---------------------------------------------------------------------------

6.  How Might Environmental and Safety Risks Affect the 
                    Commercialization of Nanotechnology?

Lux Research Report on Environmental and Safety Risks of Nanotechnology
    In May, 2005, Lux Research published a comprehensive analysis of 
how environmental and safety risks could affect the commercialization 
of nanotechnology.\18\ While a limited number of studies have been done 
on specific environmental impacts, the report concludes that the few 
that have been done raise sufficient cause for concern. This leads to 
what the report calls a fundamental paradox facing companies developing 
nanotechnology: ``They must plan for risks without knowing precisely 
what they are.'' The report then identifies two classes of risk that 
are expected to effect commercialization: ``real risks that 
nanoparticles may be hazardous and perceptual risks that they pose a 
threat regardless of whether or not it is real.'' The report calculates 
that at least 25 percent of the $8 trillion in total projected revenue 
from products incorporating nanotechnology between 2004 and 2014 could 
be affected by real risks and 38 percent could be affected by perceived 
risk.''
---------------------------------------------------------------------------
    \18\ Lux Research, ``A Prudent Approach to Nanotech Environmental, 
Health and Safety Risks.'' May 2005
---------------------------------------------------------------------------
    The report describes that varying levels of risk are suspected for 
different types of nanomaterials and products and for different phases 
of a product's life cycle. For example, some nanoclay particles raise 
little initial concern because they would be locked up in composites to 
be used in automotive bodies. On the other hand, cadmium-selenide 
quantum dots that could be injected into the body for medical imaging 
tests are highly worrisome due to the toxicity of cadmium-selenide and 
the fact that they would be used within the human body.
    Another factor that contributes to the potential risk of different 
nanotechnology-related products is the expected exposure of people and 
the environment over the product's life cycle.
    The manufacturing phase is the first area of concern because 
workers potentially face repeated exposure to large amounts of 
nanomaterials.\19\ During product use, the actual risk will vary 
depending in part on whether the nanoparticles have been fixed 
permanently in a product, like within a memory chip in a computer, or 
are more bio-available, like in a sun screen where exposure may be more 
direct or may continue over a long period of time. Finally, the 
greatest uncertainties exist about the risks associated with the end of 
a product's life because it is difficult to predict what method of 
disposal, such as incineration or land disposal, will be used for a 
given material, and there has been little research on, for example, 
what will happen to nanomaterials within products stored in a landfill 
over 100 years.
---------------------------------------------------------------------------
    \19\ Lux Research's findings on worker exposure are consistent with 
the concerns expressed in the recent report on the NNI by the 
President's Council of Advisors on Science and Technology. The report, 
National Nanotechnology Initiative at Five Years: Assessment and 
Recommendations of the National Nanotechnology Advisory Panel, is 
available online at http://www.nano.gov/
FINAL-PCAST-NANO-REPORT.pdf.
---------------------------------------------------------------------------
    The Lux Research report finds that nanotechnology also faces 
significant perceived risks. These risks are driven by people's general 
concerns about new technologies that they may be exposed to without 
being aware of it. However, public perceptions of nanotechnology are 
still up in the air and may be influenced by the press and non-
governmental organizations. The report argues that, with a concerted 
effort to emphasize the benefits of nanotechnology, communicate honest 
assessments of toxicological effects, and engage all interested 
stakeholders from the outset, the public could be made comfortable with 
this new technology.
Woodrow Wilson International Center Study on Public Perceptions
    A more in-depth survey of public perception of nanotechnology was 
recently completed by Woodrow Wilson Center's Project on Emerging 
Technologies.\20\ The study found that the public currently has little 
knowledge about nanotechnology or about how risks from nanotechnology 
will be managed. This lack of information can lead to mistrust and 
suspicion. However, the study shows that when people learned more about 
nanotechnology and its promised benefits, approximately 80 percent were 
supportive or neutral about it. Once informed, people also expressed a 
strong preference for having more information made available to the 
public, having more testing done before products were introduced, and 
having an effective regulatory system. They do not trust voluntary 
approaches and tend to be suspicious of industry. The lesson, according 
to the report, is that there is still time to shape public perception 
and to ensure that nanotechnology is developed in a way that provides 
the public with information it wants and establishes a reasonable 
regulatory framework.
---------------------------------------------------------------------------
    \20\ Informed Public Perception of Nanotechnology and Trust in 
Government, Project on Emerging Nanotechnologies, Woodrow Wilson 
International Center for Scholars is available online at http://
www.pewtrusts.com/pdf/Nanotech-0905.pdf.
---------------------------------------------------------------------------

7. Emerging Environmental and Safety Concerns

    Initial research on the environmental impacts of nanotechnology has 
raised concerns. For example, early research on buckyballs (nano-sized 
clusters of 60 carbon atoms) suggests that they may accumulate in fish 
tissue. Although it may turn out that many, if not most, nanomaterials 
will be proven safe in and of themselves and within a wide variety of 
products, more research is needed before scientists can determine how 
they will interact with people and the environment in a variety of 
situations.
    Nanotechnology's potential to affect many industries stem from that 
fact that many nanoscale materials behave differently than their 
macroscale counterparts. For example, nano-sized quantities of some 
electrical insulating materials become conductive, insoluble substances 
may become soluble, some metals become explosive, and materials may 
change color or become transparent. These novel features create 
tremendous opportunities for new and exciting applications, but also 
enable potentially troubling new ways for known materials to interact 
with the human body or be transported through the environment. It is 
difficult and would be misleading to extrapolate from current 
scientific knowledge on how materials behave in their macro-form to how 
they will behave in nano-form, and new techniques to assess toxicity, 
exposure, and ultimately public and environmental risks from these 
materials may be needed.
Widely Recognized Research and Development Needs
    Businesses, non-governmental organizations, academic researchers, 
federal agencies, and voluntary standards organizations all have 
efforts underway to address concerns about the environmental and safety 
implications of nanotechnology. However, a number of organizations, 
including business associations and environmental groups, worry that 
environmental R&D is not keeping pace with the rapid commercialization 
and development of new nanotechnology-related products. There is 
widespread agreement on the following research and standards needs:

          Nanotechnology needs an accepted nomenclature. For 
        example, ``buckyballs'' is the equivalent of a trade name; it 
        does not convey critical information about the content, 
        structure, or behavior of nanoparticles as traditional chemical 
        nomenclature does for traditional chemicals. The lack of 
        nomenclature creates a variety of problems. For example, it is 
        difficult for researchers to know whether the nanomaterial they 
        are working with is the same as that presented in other 
        research papers. Similarly, it is difficult for a company to 
        know whether it is buying the same nanomaterial from one 
        company that it previously bought from another.

          Nanotechnology needs an agreed upon method for 
        characterizing particles. Nanoparticles unique size enables 
        unusual behavior. At these small sizes, particles can have 
        different optical and electrical properties than larger 
        particles of the same material. In addition, the large surface 
        area of nanoparticles relative to their mass makes 
        nanoparticles more reactive with their surroundings. Further 
        complicating efforts to characterize nanomaterials is that 
        small changes to some nanoparticles, such as altering the 
        coatings of buckyballs, significantly modify the physical 
        properties (and hence the potential toxicity) of the particles.

          A great deal more information is needed on the 
        mechanisms of nanoparticle toxicity. Early studies suggest that 
        a variety of nanoparticles damage cells through oxidative 
        stress. (Oxidation is believed to be a common source of many 
        diseases such as cancer.) A better understanding of the 
        chemical reactions that nanoparticles provoke or take part in 
        within living organisms will enable researchers to more 
        effectively predict which nanomaterials are most likely to 
        cause problems.

          Basic information on how nanomaterials enter and move 
        through the human body are needed. Early studies point to wide 
        variations in the toxicity of nanomaterials depending on the 
        how exposure occurred--through the mouth, skin contact, 
        inhalation, or intravenously. Particles in the range of 1-100 
        nanometers are small enough to pass through cell walls and 
        through the blood-brain barrier, making them particularly 
        mobile once they enter the body. There is also concern that 
        some nanoparticles could lodge in the lungs and might be so 
        small as to be overlooked by the body's defense mechanisms that 
        would normally remove these invaders from the body.

          More research is needed on how and why some 
        nanoparticles appear to behave one way as individual particles, 
        but behave differently when they accumulate or agglomerate. One 
        study of buckyballs, for example, found that while individual 
        buckyballs are relatively insoluble, they have a tendency to 
        aggregate, which makes them highly soluble and reactive with 
        bacteria, raising concerns about their transport in watersheds 
        and their impact on ecosystems.

    According to a variety of experts, many of whom are familiar with 
the development of the largely mature databases available on the 
behavior and toxicity of various chemicals, development of a parallel 
collection of information on nanotechnology-related materials may take 
as long as 10-15 years.
Call for a Governmental Program on Environmental and Safety 
        Implications of Nanotechnology
    Recently, the American Chemistry Council and the environmental 
organization, Environmental Defense, agreed on a Joint Statement of 
Principles that should guide a governmental program for addressing the 
potential risks of nanoscale materials.\21\ They call for, among other 
things,
---------------------------------------------------------------------------
    \21\ Environmental Defense and American Chemistry Council 
Nanotechnology Panel, Joint Statement of Principles, Comments on EPA's 
Notice of Public Meeting on Nanoscale Materials, June 23, 2005. The 
full statement is available online at http://
www.environmentaldefense.org/documents/4857-ACC-
ED-nanotech.pdf.

          ``a significant increase in government investment in 
        research on the health and environmental implications of 
---------------------------------------------------------------------------
        nanotechnology,''

          ``the timely and responsible development of 
        regulation of nanomaterials in an open and transparent 
        process,''

          ``an international effort to standardize test 
        protocols, hazard and exposure assessment approaches and 
        nomenclature and terminology,''

          ``appropriate protective measures while more is 
        learned about potential human health or environmental 
        hazards,'' and

          a government assessment of ``the appropriateness of 
        or need for modification of existing regulatory frameworks.''

8. Federal Government Activities

    The National Nanotechnology Initiative (NNI) is a multi-agency 
research and development (R&D) program begun in 2001 and formally 
authorized by Congress in 2003.\22\ Currently, 11 federal agencies have 
ongoing programs in nanotechnology R&D, while another 11 agencies 
participate in the coordination and planning work associated with the 
NNI. The primary goals of the NNI are to foster the development of 
nanotechnology and coordinate federal R&D activities.\23\
---------------------------------------------------------------------------
    \22\ In 2003, the Science Committee wrote and held hearings on the 
21st Century National Nanotechnology Research and Development Act, 
which was signed into law on December 3, 2003. The Act authorizes $3.7 
billion over four years (FY05 to FY08) for five agencies (the National 
Science Foundation, the Department of Energy, the National Institute of 
Standards and Technology, the National Aeronautics and Space 
Administration, and the Environmental Protection Agency). The Act also: 
adds oversight mechanisms--an interagency committee, annual reports to 
congress, an advisory committee, and external reviews--to provide for 
planning, management, and coordination of the program; encourages 
partnerships between academia and industry; encourages expanded 
nanotechnology research and education and training programs; and 
emphasizes the importance of research into societal concerns related to 
nanotechnology to understand the impact of new products on health and 
the environment.
    \23\ The goals of the NNI are to maintain a world-class research 
and development program; to facilitate technology transfer; to develop 
educational resources, a skilled workforce, and the infrastructure and 
tools to support the advancement of nanotechnology; and to support 
responsible development of nanotechnology.
---------------------------------------------------------------------------
    Federal funding for the NNI has grown from $464 million in FY01 to 
a requested $1.1 billion in FY06. Of the requested FY06 level, the 
President's budget proposes that $38.5 million (four percent of the 
overall program) be directed to research on environmental, health, and 
safety implications of nanotechnology (see Table 1).\24\
---------------------------------------------------------------------------
    \24\ There is of course additional federal funding being spent on 
fundamental nanotechnology R&D that has the potential to inform future 
studies on environmental and safety impacts, so the $38.5 million may 
be a low estimate of the relevant research underway.



    To coordinate environmental and safety research on nanotechnology, 
the National Science and Technology Council organized in October 2003 
the interagency Nanotechnology Environmental and Health Implications 
Working Group (NEHI WG), composed of agencies that support 
nanotechnology research as well as those with responsibilities for 
regulating nanotechnology-based products. NEHI WG is in the process of 
developing a framework for environmental R&D for nanotechnology that it 
expects to release in January 2006. To provide useful guidance to 
agencies, Congress, academic researchers, industry, environmental 
groups, and the public, the research framework will need to define the 
scale and scope of the needed research, set priorities for research 
areas, provide information that can affect agency-directed spending 
decisions, and be specific enough to serve as overall research strategy 
for federal and non-federal research efforts.
    Currently, over 60 percent of the environmental research funding is 
provided by the National Science Foundation (NSF). In FY05 and FY06, 
NSF is putting a small amount of funding (approximately $1 million each 
year) into a joint solicitation on investigating environmental and 
human health effects of manufactured nanomaterials with the 
Environmental Protection Agency, the National Institute for 
Occupational Safety and Health (NIOSH), and National Institute of 
Environmental Health Sciences (NIEHS). However, the majority of the 
NSF's funding in this area is distributed to projects proposed in 
response to general calls for nanotechnology-related research; projects 
are selected based on the quality and potential impact of the proposed 
research. It is not distributed based on the research needs of 
regulatory agencies such as EPA, OSHA or FDA. Currently NSF and the 
research community base their understanding of priorities in 
environmental research on a 2003 workshop ``Nanotechnology Grand 
Challenge in the Environment,'' \25\ but the federal framework being 
developed by the NEHI WG should provide helpful, updated guidance for 
future research solicitations and proposals.
---------------------------------------------------------------------------
    \25\ ``Nanotechnology Grand Challenge in the Environment: Research 
Planning Workshop Report,'' from the workshop held May 8-9, 2003, is 
available online at http://es.epa.gov/ncer/publications/nano/
nanotechnology4-20-04.pdf.
---------------------------------------------------------------------------
    EPA's Office of Research and Development is the second largest 
sponsor of research on the environmental implications of 
nanotechnology, providing approximately 10 percent ($4 million) of the 
federal investment. At the beginning of the NNI, EPA focused its 
research program on the development of innovative applications of 
nanotechnology designed to improve the environment, but in FY03, EPA 
began to shift its focus to research on the environmental implications 
of nanotechnology. In FY04 and FY05, EPA has increasingly tailored its 
competitive solicitations to attract research proposals in areas that 
will inform decisions to be made by the agency's regulatory programs. 
In January 2006, EPA is planning to release an agency-wide 
nanotechnology framework that will describe both the potential 
regulatory issues facing the agency and the research needed to support 
decisions on those issues.
    NIOSH sponsors eight percent ($3 million) of research on 
environmental and safety implications of nanotechnology, and its 
activities are driven by the fact that minimal information is currently 
available on dominant exposure routes, potential exposure levels and 
material toxicity. NIOSH is attempting fill those gaps by building on 
its established research programs on ultra-fine particles (typically 
defined as particles smaller than 100 nanometers). The National 
Toxicology Program, an interagency collaboration between NIOSH and 
NIEHS, also supports a portfolio of projects studying the toxicity of 
several common nanomaterials, including quantum dots, buckyballs, and 
the titanium dioxide particles that have been used in cosmetics. NIOSH 
published a draft research strategy in late September 2005.
Private Sector Research
    There is little information about how much individual companies are 
investing in research on the environmental and safety implications of 
nanotechnology. There are, however, a variety of activities underway in 
industry associations emphasizing the importance of research in this 
area. Members of the American Chemistry Council's ChemStar panel, for 
example, have committed to ensuring that the commercialization of 
nanomaterials proceeds in ways that protect workers, the public and the 
environment. Other elements of the chemical and semiconductor 
industries have formed the Consultive Boards for Advancing 
Nanotechnology, which has developed a list of key research and 
evaluation, identifying toxicity testing, measurement, and worker 
protection.
Potential Regulatory and Policy Issues.
    Some companies, especially large firms that operate in many 
industry sectors, have significant experience dealing with 
environmental issues and risk management plans, are comfortable dealing 
with potential environmental and safety implications arising from 
nanotechnology. However, many companies that are involved with 
nanotechnology-related products are small, start-up companies or small 
laboratories with less experience in this area. According to the Lux 
Research report described above, some of these small enterprises do not 
carry out testing because they lack the resources to do so, while 
others do not do so because of fear they might learn something that 
could create legal liability or create barriers to commercializing 
their product.
    At EPA, the regulatory program offices are trying to determine 
whether and to what degree existing regulatory programs can and should 
be applied to nanotechnology. For example, EPA is considering how the 
Toxic Substances Control Act (TSCA) will apply to nanotechnology, 
having recently approved the first nanotechnology under that statute. 
(See Appendix A for a recent Washington Post article discussing the 
issue). Enacted in 1976, TSCA authorizes EPA to regulate new and 
existing chemicals and provides EPA with an array of tools to require 
companies to test chemicals and adopt other safeguards. Decisions on 
conventional chemicals under TSCA are driven by a chemical's name, test 
data, and models of toxicity and exposure. Because much of this 
information does not yet exist for nanotechnology, EPA is having a 
difficult time deciding how best to proceed. The lack of information 
led to EPA's recent proposal to create a voluntary program under which 
companies would submit information that would help the agency learn 
about nanotechnology more quickly. EPA is now evaluating all of its 
water, air and land regulatory responsibilities to determine whether 
and how EPA should handle nanotechnology in these areas.
    Other federal agencies with regulatory responsibilities, such as 
the Food and Drug Administration and the Occupational Safety and Heath 
Administration, are also trying to determine how they will address 
environmental and safety concerns related to nanotechnology.
    A number of observers, including the United Kingdom's Royal 
Society,\26\ have suggested a precautionary approach to nanotechnology 
until more research has been completed. They urge caution especially 
regarding applications in which nanoparticles will be purposely 
released into environment. Examples of these so-called dispersive uses 
are nanomaterials used to clean contaminated groundwater or those that 
when discarded enter the sewer system and thereby the Nation's 
waterways.
---------------------------------------------------------------------------
    \26\ The United Kingdom's Royal Society and Royal Academy of 
Engineering's report ``Nanoscience and Nanotechnologies: Opportunities 
and Uncertainties'' was published in July 2004 and is available online 
at http://www.nanotec.org.uk/finalReport.htm
---------------------------------------------------------------------------

9. Witness Questions

    The witnesses were asked to address the following questions in 
their testimony:
Questions for Dr. Clayton Teague
    In your testimony, please briefly describe current federal efforts 
to address possible environmental and safety risks associated with 
nanotechnology and address the following questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          How much is the Federal Government spending for 
        research on environmental and safety implications of 
        nanotechnology? Which agencies have the lead? What additional 
        steps are needed?

Questions for Mr. Matthew Nordan
    In your testimony, please briefly describe the major findings of 
the Lux Research report on environmental and safety issues associated 
with nanotechnology and address the following questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Questions for Dr. Krishna Doraiswamy
    In your testimony, please briefly describe what DuPont is doing to 
address possible environmental and safety risks associated with 
nanotechnology and answer the following questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Questions for Mr. David Rejeski
    In your testimony, please briefly describe the major findings of 
the Wilson Center's recent study on public perceptions about 
nanotechnology and answer the following four questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Questions for Dr. Richard Denison

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Appendix A

                 Nanotechnology's Big Question: Safety

 Some Say Micromaterials Are Coming to Market Without Adequate Controls

                          The Washington Post
                       October 23, 2005, page A11
            By Juliet Eilperin, Washington Post Staff Writer

    With little fanfare, the Environmental Protection Agency has for 
the first time ruled on a manufacturer's application to make a product 
composed of nanomaterials, the new and invisibly small particles that 
could transform the Nation's engineering, industrial and medical 
sectors.
    The agency's decision to approve the company's plan comes amid an 
ongoing debate among government officials, industry representatives, 
academics and environmental advocates over how best to screen the 
potentially toxic materials. Just last week, a group of academics, 
industry scientists and federal researchers, working under the auspices 
of the nonprofit International Life Sciences Institute, outlined a set 
of principles for determining the human health effects of nanomaterial 
exposures.
    By year-end, the EPA plans to release a proposal on how companies 
should report nanomaterial toxicity data to the government.
    ``Toxicity studies are meaningless unless you know what you're 
working with,'' said Andrew Maynard, who helped write the institute's 
report and serves as chief science adviser to the Project on Emerging 
Nanotechnologies at the Woodrow Wilson International Center for 
Scholars, a Washington-based think tank.
    Because of their tiny size, nanomaterials have special properties 
that make them ideal for a range of commercial and medical uses, but 
researchers are still trying to determine how they might affect humans 
and animals. Gold, for example, may behave differently when introduced 
at nanoscale into the human body, where it is chemically inert in 
traditional applications.
    The institute's report urged manufacturers and regulators to 
evaluate the properties of nanomaterials in laboratory tests, adding: 
``There is a strong likelihood that the biological activity of 
nanoparticles will depend on physiochemical parameters not routinely 
considered in toxicology studies.''
    The EPA decided last month to approve the ``pre-manufacture'' of 
carbon nanotubes, which are hollow tubes made of carbon atoms and 
potentially can be used in flat-screen televisions, clear coatings and 
fuel cells. The tubes, like other nanomaterials, are only a few ten-
thousandths the diameter of a human hair.
    Jim Willis, who directs the EPA's chemical control division in the 
Office of Pollution Prevention and Toxics, said he could not reveal the 
name of the company that received approval for the new technology or 
describe how that technology might be marketed. He added, however, that 
the EPA reserved the right to review the product again if the company 
ultimately decides to bring it to market.
    Nanomaterials are already on the market in cosmetics, clothing and 
other products, but these items do not fall under the EPA's regulatory 
domain. EPA officials judge applications subject to the Toxic 
Substances Control Act (TOSCA), a law dating from the mid-1970s that 
applies to chemicals.
    In a Wilson Center symposium last Thursday, Willis said ``it is a 
challenge'' to judge nanotechnology under existing federal rules.
    ``Clearly, [TOSCA] was not designed explicitly for nanoscale 
materials,'' he said, but he added that chemicals ``have quite a number 
of parallels for nanoscale materials'' and that ``in the short-term, we 
are going to learn by doing.''
    Scientific studies also suggest nanoparticles can cause health 
problems and damage aquatic life. For instance, they lodge in the lungs 
and respiratory tract and cause inflammation, possibly at an even 
greater rate than asbestos and soot do.
    ``Nanoparticles are like the roach motel. The nanoparticles check 
in but they don't check out,'' said John Balbus, health program 
director for the advocacy group Environmental Defense. ``Part of this 
is a societal balancing act. Are these things going to provide such 
incredible benefits that we're willing to take some of these risks?''
    Nanomaterials have possible environmental advantages as well. For 
instance, they can absorb pollutants in water and break down some 
harmful chemicals much more quickly than other methods.
    ``Just because something's nano doesn't mean it's necessarily 
dangerous,'' said Kevin Ausman, Executive Director of Rice University's 
Center for Biological and Environmental Nanotechnology. He added that 
when it comes to nanotechnology's toxic effects, ``we're trying to get 
that data before there's a known problem, and not after there's a known 
problem.''
    Companies such as DuPont are pushing to establish nanotechnology 
safety standards as well, in part because they have seen how 
uncertainties surrounding innovations--such as genetically modified 
foods--have sparked a backlash among some consumers.
    ``The time is right for this kind of collaboration,'' said Terry 
Medley, DuPont's Global Director of corporate regulatory affairs. 
``There's a general interest on everyone's part to come together to 
decide what's appropriate for this technology.''
    Chairman Boehlert. I want to welcome everyone to this 
important hearing on a subject that has been a matter of 
continuing concern to this committee.
    As our hearing last fall on this subject brought home, a 
great deal is at stake in setting a research agenda on the 
environmental and safety consequences of nanotechnology. I am 
still out of breath. The nanotechnology industry, which has 
enormous economic potential, will be stymied if the risks of 
nanotechnology are not clearly understood and addressed. And, 
of course, the potential danger to human beings and the 
environment is literally incalculable if we don't understand 
how nanotechnology can interact with our bodies and our world. 
That is why there is unusual agreement among every sector--
business, government, environmental advocacy groups--that we 
need to get a handle on this issue. Our witnesses will 
underscore these basic points again today.
    There is also broad agreement, I think, about what the 
government has to do to protect both the public and business. 
The government needs to establish and implement a clear, 
prioritized research agenda and fund it adequately. The problem 
is that we still haven't done that, and ``time is a wasting.''
    The federal agencies have made some steps in the direction 
of setting an agenda, which, admittedly, is a difficult 
process. I am pleased that the long-delayed interagency report 
on research needs is finally being released at, and dare I say, 
because of, our hearing today. But as that document itself 
states, it is only a first step, and it doesn't fully set 
priorities, never mind assign them. So we are on the right path 
to dealing with the problem, but we are sauntering down it at a 
time when a sense of urgency is required.
    The second problem, of course, is that environmental 
research on nanotechnology is grossly under-funded. 
Conservative estimates of what is needed are more than twice as 
much as we are spending today. This is ``penny wise and pound 
foolish,'' to put it mildly, given what nanotechnology could 
contribute to our economy and what health problems from 
nanotechnology could detract from it.
    So I hope that our discussion today can infuse everyone 
here, including the media and the public, with a sense of 
urgency about this problem. We need to come up with a mechanism 
in which priorities will be set for, assigned to, and actually 
carried out by the responsible federal agencies. Current 
coordinating mechanisms clearly are inadequate, and I hope we 
can have a good discussion today of what to do to replace that 
current mechanism.
    I know that diversity is a source of strength in our 
research establishment, and I am not one who believes that 
duplication is always a bad thing. But we have to bring some 
order to this process or we are going to squander our chance to 
understand nanotechnology on a schedule that will help business 
and protect the public.
    So I look forward to hearing from our witnesses today, and 
I can assure them we will be following up on this. At the very 
least, until the day I leave this chair in this institution 
Dec. 31, and hopefully long past that.
    Let me just address a couple of protocol matters before I 
turn to Mr. Gordon.
    First, I am going to try to keep witnesses and Members to 
their five minutes, because we have a huge panel and votes may 
occur as early as 11:30. Second, let me say that normally, we 
would have Dr. Bement testify first, as the highest-ranking 
official on the panel, but we wanted to hear first from the 
official who is chairing the interagency effort to get some 
perspective. Finally, I understand that Mr. Farland has 
announced his retirement, and I want to thank him for his years 
of helping this committee and for serving the public. That is 
something we both have announced: our retirement. We will go 
forth together.
    With that, let me turn to Mr. Gordon.
    [The prepared statement of Chairman Boehlert follows:]
          Prepared Statement of Chairman Sherwood L. Boehlert
    I want to welcome everyone to this important hearing on a subject 
that has been a matter of continuing concern to this committee.
    As our hearing last fall on this subject brought home, a great deal 
is at stake in setting a research agenda on the environmental and 
safety consequences of nanotechnology. The nanotechnology industry, 
which has enormous economic potential, will be stymied if the risks of 
nanotechnology are not clearly understood and addressed. And, of 
course, the potential danger to human beings and the environment is 
literally incalculable if we don't understand how nanotechnology can 
interact with our bodies and our world. That's why there's unusual 
agreement among every sector--business, government, environmental 
advocacy groups--that we need to get a handle on this issue. Our 
witnesses will underscore these basic points again today.
    There's also broad agreement, I think, about what the government 
has to do to protect both the public and business. The government needs 
to establish and implement a clear, prioritized research agenda and 
fund it adequately. The problem is that we still haven't done that, and 
``time's a wasting.''
    The federal agencies have made some steps in the direction of 
setting an agenda, which, admittedly, is a difficult process. I'm 
pleased that the long-delayed interagency report on research needs is 
finally being released at--and dare I say, because of--our hearing 
today. But as that document itself states, it's only a first step, and 
it doesn't fully set priorities, never mind assign them. So we're on 
the right path to dealing with the problem, but we're sauntering down 
it at a time when a sense of urgency is required.
    The second problem, of course, is that environmental research on 
nanotechnology is grossly underfunded. Conservative estimates of what's 
needed are more than twice as much as we're spending today. This is 
``penny wise and pound foolish,'' to put it mildly, given what 
nanotechnology could contribute to our economy and what health problems 
from nanotechnology could detract from it.
    So I hope that our discussion today can infuse everyone here--
including the media and the public--with a sense of urgency about this 
problem. We need to come up with a mechanism in which priorities will 
be set for, assigned to, and actually carried out by the responsible 
federal agencies. Current coordinating mechanisms clearly are 
inadequate, and I hope we can have a good discussion today of what to 
do instead.
    I know that diversity is a source of strength in our research 
establishment, and I am not one who believes that duplication is always 
a bad thing. But we have to bring some order to this process or we're 
going to squander our chance to understand nanotechnology on a schedule 
that will help business and protect the public.
    So I look forward to hearing from our witnesses today, and I assure 
them we will be following up on this at the very least until the day I 
leave office on Dec. 31, and hopefully long past that.
    Let me just address a couple of protocol matters before I turn to 
Mr. Gordon. First, I'm going to try to keep witnesses and Members to 
their five minutes because we have a large panel and votes may occur as 
early as 11:30. Second, let me say that normally, we would have Dr. 
Bement testify first as the highest ranking official on the panel, but 
we wanted to hear first from the official who is chairing the 
interagency effort to get some perspective. Finally, I understand that 
Mr. Farland has announced his retirement, and I want to thank him for 
his years of helping this committee and serving the public.
    Mr. Gordon.

    Mr. Gordon. Thank you, Mr. Chairman.
    As usual, I concur with your remarks, and let me assure you 
that that oversight will go beyond December 31 to honor you as 
well as to do our job here.
    Let me recap.
    This morning's hearing is a follow-up on our hearing of 
last November that addressed the health and environmental risks 
that may arise from applications of nanotechnology. That 
hearing clarified several important points and raised new 
issues. All the previous witnesses who represented government, 
industry, and non-government organizations stressed that 
nanotechnology will advance faster and receive public support 
if the environmental health and safety implications of the 
technology are understood.
    To that end, all witnesses stressed the need for the 
interagency National Nanotechnology Initiative to include a 
prioritization and adequately funded component focused on 
environmental health and safety issues. The outside witnesses 
either recommended that NII--or rather NNI--increase funding 
for the EHS research or expressed frustration that they were 
unable to determine exactly what EHS research was being 
supported by NNI.
    And finally, the Administration witness at the hearing told 
us an Interagency Working Group was developing a coordinated 
approach to nanotechnology research on EHS. This process would 
identify and prioritize research needs to assess the risks 
associated with engineering nanotechnology materials and be 
sufficiently detailed to guide researchers and research 
managers in making project-level decisions. That sounded like a 
good idea.
    We were told the research plan would be available by the 
spring of 2006, but it has only just appeared, as a matter of 
fact, last night, I think, at six o'clock. And unfortunately, 
it is not the prioritized research plan we expected to see. 
This is the product that came last night at six o'clock, 
although we were promised it this spring, and I am very 
disappointed--I think it is a very juvenile piece of work, 
given the time that you have had to work on this. You did not 
get the job done. And in the back of it, it says, ``Next 
steps.'' Well ``next steps'' seems to me like first steps. Next 
steps says ``further prioritize research needs among those 
identified in this report.'' Well, this report is just an 
accumulation of things that need to be done. There is no 
prioritization. That is what you were supposed to be doing in 
this one: evaluate in greater detail the current NNI EHS 
research portfolios. You don't know what those portfolios are 
yet? I mean, what have you been doing since 2003? I mean, it 
seems to me there is just a lack of urgency. Materials are out 
on the market now. You know, it is just really hard to 
understand.
    Mr. Chairman, I, frankly, do not understand the inability 
of the responsible agencies to produce their research plan with 
well defined priorities and resources requirements. It is the 
first step for developing proposed research programs in 
associated budgets for fiscal year 2008. It is now late in the 
budget planning cycle for fiscal year 2008. So what then will 
the agencies use to guide their selection of EHS research 
projects and determine their budget requirements?
    In the absence of a prioritized EHS research plan, I see no 
way to initiate a carefully crafted set of research programs 
that are relevant to the needs of the companies that will be 
developing and using nanomaterials and to the needs of the 
agencies charged with oversight of EHS aspects of 
nanotechnology.
    As we learned from the previous hearings, applications of 
nanomaterials are rapidly advancing. Consumer products 
employing nanomaterials are already on the market. The Wilson 
Center's Nanotechnology Project has identified at least 200 
such products, many of which are actually designed to be 
ingested. Prudence suggests the need for urgency in having the 
science of health and environmental implications catch up to, 
or, even better, surpass the pace of commercialization.
    But here we are today, nearly a year after our initial 
nanotechnology hearing on health and environmental risks, with 
little sign of forward progress in focusing the interagency 
research effort. I want to hear from our witnesses why progress 
has been so slow. Or if you are satisfied with this process and 
you think it is hunky-dory and we are just where we should be, 
I would like for you to tell us that. But if you are not 
satisfied, I would like for you to tell us why, and what we 
need to do from now.
    We need to consider whether the interagency process under 
the NNI can be made to function to meet environmental health 
and safety needs. And if not, we must look for an alternative 
approach without further delay.
    So, Mr. Chairman, this is a very important hearing, and I 
thank you for bringing us together for this.
    [The prepared statement of Mr. Gordon follows:]

            Prepared Statement of Representative Bart Gordon

    This morning's hearing is a follow-on to our hearing of last 
November that addressed the health and environmental risks that may 
arise from applications of nanotechnology. That hearing clarified 
several important points and raised new issues.
    All the previous witnesses, who represented government, industry, 
and non-government organizations, stressed that nanotechnology will 
advance faster and receive public support if the environmental, health, 
and safety implications of the technology are understood.
    To that end, all witnesses stressed the need for the interagency 
National Nanotechnology Initiative (NNI) to include a prioritized and 
adequately funded component focused on environmental, health, and 
safety issues.
    The outside witnesses either recommended that the NNI increase 
funding for EHS research or expressed frustration that they were unable 
to determine exactly what EHS research was being supported by the NNI.
    And finally, the Administration witness at the hearing told us an 
interagency working group was developing a coordinated approach to 
nanotechnology research on EHS. This process would identify and 
prioritize research needs to assess the risks associated with 
engineered nanomaterials and be sufficiently detailed to guide 
researchers and research managers in making project-level decisions.
    We were told the research plan would be available by the spring of 
2006, but it has only just appeared. And, unfortunately it is not the 
prioritized research plan we expected to see.
    Mr. Chairman, I frankly do not understand the inability of the 
responsible agencies to produce a research plan with well defined 
priorities and resource requirements. It is the first step for 
developing proposed research programs and associated budgets for FY 
2008.
    It is now late in the budget planning cycle for FY 2008. What then 
will the agencies use to guide their selection of EHS research projects 
and to determine their budget requirements? In the absence of a 
prioritized EHS research plan, I see no way to initiate a carefully 
crafted set of research programs that are relevant to the needs of the 
companies that will be developing and using nanomaterials and to the 
needs of the agencies charged with oversight of EHS aspects of 
nanotechnology.
    As we learned from the previous hearing, applications of 
nanomaterials are rapidly advancing. Consumer products employing 
nanomaterials are now on the market. The Wilson Center's Nanotechnology 
Project has identified at least 200 such products, many of which are 
actually designed to be ingested.
    Prudence suggests the need for urgency in having the science of 
health and environmental implications catch up to, or even better 
surpass, the pace of commercialization. But here we are today, nearly a 
year after our initial nanotechnology hearing on health and 
environmental risks with little sign of forward progress in focusing 
the interagency research effort. I want to hear from our witnesses why 
progress has been so slow.
    We need to consider whether the interagency process under the NNI 
can be made to function to meet environmental, health and safety needs. 
And if not, we must look for an alternative approach without further 
delay.
    Mr. Chairman, I believe that is the key issue the Committee should 
address relative to EHS research, and I look forward to the discussion 
today.

    Chairman Boehlert. And I thank you for your opening 
statement.
    Some of the sentiments you have expressed I share. I am not 
sure I--maybe it depends upon where you sit on how you would 
express it, but at least we are started, and we have got to get 
going. We have got to accelerate the pace. We have got to do a 
better job. I am not happy. You are not happy. And we have had 
good conversation, as is usual on this committee. This is a 
committee where we operate, I think, the way Congress should 
operate, and a lot of other committees. Guess what? We actually 
talk to each other. He has got a ``D'' after his name. I have 
got an ``R'' after my name. We know what is going to happen on 
November 7. It is going to be a big election. But we don't 
concentrate on politics. We concentrate on policy. And we are 
here collectively on this committee to try to encourage the 
best possible policy for the Nation, and we want to encourage 
all those present to work with us to accelerate the pace and do 
something quicker, better.
    [The prepared statement of Mr. Costello follows:]

         Prepared Statement of Representative Jerry F. Costello

    Good morning. I want to thank the witnesses for appearing before 
our committee to examine current concerns about environmental and 
safety impacts of nanotechnology and the status and adequacy of related 
research programs and plans.
    Relatively little is understood about the environmental and safety 
implications of nanotechnology. The lack of knowledge about the effects 
of nanoparticles and the absence of established methods to assess their 
impacts on the environment and human health is troubling since 
nanomaterials are already on the market in cosmetics, clothing and 
other products. Further, there are no established scientific protocols 
for either safety or environmental compatibility testing for 
nanomaterials.
    I am pleased we are having this hearing today because greater 
knowledge is needed to enable a nanotechnology industry to develop and 
to protect the public. Regulation for certain types or applications of 
nanomaterials could eventually be needed and Congress needs more 
information on the environmental and safety impacts of nanotechnology 
to better protect the public.
    I look forward to hearing from the panel of witnesses.

    [The prepared statement of Mr. Lipinski follows:]

          Prepared Statement of Representative Daniel Lipinski

    Thank you, Mr. Chairman. I am pleased to be here today for this 
hearing on nanotechnology. Nanotechnology is one of the most promising 
technologies of our time and could revolutionize industries ranging 
from transportation to medicine, as well as have a huge impact on 
improving our national security.
    Many universities and businesses are becoming invested in 
nanotechnology efforts in my home state of Illinois, which is one of 
the strongest states in nanotechnology research according to the Small 
Times Magazine. For example, Northwestern University, my alma mater, 
houses the Institute for Nanotechnology, which supports efforts in 
nanotechnology and facilitates collaboration in solving major problems 
in the field of nanotechnology. It includes the Center for 
Nanofabrication and Molecular Self-Assembly, a multi-million dollar 
research facility and one of the first federally funded centers of its 
kind. The Institute helps foster partnership to encourage researchers 
and entrepreneurs to become involved in this cutting edge technology, 
creating jobs and the potential for entirely new industries. In these 
times of increasing economic competitiveness, this new technology is 
extremely critical.
    I would also like to recognize Jack Lavin, Director of the Illinois 
Department of Commerce and Economic Opportunity, for the work that he 
and the DCEO have done to make nanotechnology a strong presence in 
Illinois. They have worked to attract federal and private funds to the 
state to encourage the expansion of nanotechnology research and 
development and fully realize the vast economic benefits that our state 
will receive from current investment.
    Yet there are numerous challenges still facing the development of 
nanotechnology, particularly regarding environmental and health safety. 
There is simply so much that we do not know about the ways that 
nanoparticles behave and how they interact with each other and other 
particles. The properties and behaviors can change dramatically when 
substances are reduced to such a small size. We need to at least better 
understand these changes. And this need is even more pressing 
considering that nanotechnology is already on the market in many 
products, from sun screen to stain resistant pants.
    The Federal Government must promote research and education about 
the impacts of these emerging technologies, both to ensure that 
negative effects are minimized and to facilitate public acceptance of 
nanotechnology. Development of nanotechnology is surging ahead, with 
America as a leader in the international community, and I am pleased to 
see that. But we must make sure that proper health and environmental 
safeguards are in place, and government regulation may be necessary to 
ensure this safety.
    On this note, I am disappointed with the just-released prioritized 
environmental, health, and safety research plan from the National 
Nanotechnology Initiative, six months late and lacking a clearly 
prioritized set of research objectives with specific agency 
responsibilities and costs. I look forward to receiving more 
information from the Administration on the ``next steps'' listed in 
this plan.
    There is so much potential for our economy with nanotechnology that 
we must find a safe and comprehensive way to resolve these issues. Our 
economic future may depend on it.
    Thank you, Mr. Chairman.

    Chairman Boehlert. With that, let me introduce this panel.
    Dr. Norris Alderson, Chair of Nanotechnology, Environmental 
Health Implications Working Group, Associate Commissioner for 
Science for Food and Drug Administration.
    Dr. Arden Bement, Director, National Science Foundation.
    Dr. William Farland, Deputy Assistant Administrator for 
Science, Office of Research and Development, U.S. Environmental 
Protection Agency. Thank you for your good work and your 
distinguished career.
    Dr. Altaf Carim, Program Manager, Nanoscale Science and 
Electron Scattering Center, U.S. Department of Energy. Doctor.
    Dr. Andrew Maynard, Chief Science Advisor, Project on 
Emerging Nanotechnologies, Woodrow Wilson International Center 
for Scholars. Dr. Maynard.
    And Mr. Matthew Nordan, President, Director of Research, 
Lux Research, Inc. Mr. Nordan, thank you very much.
    And thank all of you for being resources for this 
committee, for helping provide a tutorial for us, because you 
know a hell of a lot more about this than we do. We are trying 
to learn, but we want to work together, and I always appreciate 
it and I am very gratified when I look down at the list of 
witnesses and see people of your caliber, your experience, your 
commitment.
    So with that, let us go.
    Dr. Alderson, you are first up.

  STATEMENT OF DR. NORRIS E. ALDERSON, CHAIR, NANOTECHNOLOGY, 
ENVIRONMENTAL, AND HEALTH IMPLICATIONS WORKING GROUP; ASSOCIATE 
     COMMISSIONER FOR SCIENCE, FOOD AND DRUG ADMINISTRATION

    Dr. Alderson. Good morning, Mr. Chairman, and Members of 
the Committee. Thank you for the opportunity to speak with you 
today about nanotechnology programs and the work of the 
Nanotechnology Environmental and Health Implications Working 
Group, or the NEHI Working Group.
    I am Dr. Norris Alderson, Associate Commissioner for 
Science, at the Food and Drug Administration. As FDA's 
Associate Commissioner for Science, I am responsible for the 
management of the Office of Women's Health, the Office of 
Orphan Products Development and the Good Clinical Practices 
Staff. I am also responsible for coordination of science issues 
across the Agency, the oversight of FDA-sponsored clinical 
trials and standards coordination.
    In addition to serving as Associate Commissioner for 
Science at FDA, I am also chair of the NEHI Working Group.
    I have been with the NEHI Working Group since it was 
established by the Nanoscale Science, Engineering, and 
Technology, NSET, Subcommittee in 2003.
    The purpose of the NEHI Working Group is to provide for the 
exchange of information among agencies that support 
nanotechnology research and those responsible for regulation 
and guidelines related to nanoproducts, products that contain 
engineered nanoscale materials to facilitate the 
identification, prioritization, and implementation of research 
and other activities required for the responsible research and 
development, utilization, and oversight of nanotechnology, 
including our research methods of life cycle analysis, and 
promote communication of information related to research on 
environmental and health implications of nanotechnology to 
other government agencies and non-government organizations.
    One of the key objectives of the NEHI Working Group is to 
exchange information on the issues raised within the 
participating regulatory agencies by advances in 
nanotechnology. The NEHI Working Group assists in the 
development of information and strategies as a basis for the 
drafting by the regulatory agencies of guidance toward safe 
handling and use of nanoproducts by researchers, workers, and 
consumers. Further, the group is working to support development 
of nanotechnology standards, including nomenclature and 
terminology, by consensus-based standards organizations.
    In pursuit of these aforementioned objectives, activities 
of the NEHI Working Group over the past two years include, and 
I just want to mention a few because of the time:

    First, communication by participating regulatory agencies 
concerning their respective statutory authorities for 
regulating nanoproducts, and their approaches for carrying out 
these authorities. We encouraged all of the participating 
regulatory agencies to develop a position statement of how they 
are addressing nanotechnology. This resulted in all of the 
agencies developing a website on their positions. We developed 
a preliminary ``risk assessment influence diagram'' that was 
ultimately published as a peer-reviewed publication. We have 
had discussions with various relevant standards bodies 
regarding nomenclature and terminology. And we have compiled 
the inputs from participating agencies on their perceived needs 
for EHS research and information and development of a draft 
document drawn from this compilation and inputs from industry. 
This draft document is now a final document, and it is a 
product of these activities that is in a report entitled 
``Environmental Health and Safety Research Needs for Engineered 
Nanoscale Materials.'' I have the report, Mr. Chairman, and 
would like to submit a copy for the record. (See Appendix 2: 
Additional Materials for the Record.)
    Chairman Boehlert. Without objection, so ordered.
    Dr. Alderson. The primary purpose of this document is to 
identify for the Federal Government the EHS research and 
information needs related to understanding and management of 
potential risks of engineered nanoscale materials that may be 
used in commercial or consumer products, medical treatments, 
environmental applications, research, or elsewhere. In 
addition, industry producers and users of engineered nanoscale 
materials may use this document to inform their own research, 
risk assessment, and risk management activities.
    The report is the first step in addressing the research 
needed to support informed risk assessment and risk management 
of nanomaterials. The document represents over a year of 
intensive work by the participating agencies.
    In addition to gathering input from its members for the 
purposes of this report, the NEHI Working Group has considered 
a number of public documents, and those are included in the 
report. These are both domestic and international documents. 
These ideas were then grouped into five categories, which you 
will see in the report.
    Research on nanoscale materials is supported by each agency 
respectively, based on its primary scientific mission. For 
example, the NIH supports a broad spectrum of biological 
nanoscale research ranging from basic science to clinical and 
translational investigations and clinical trials. The National 
Science Foundation supports basic research on engineered 
nanoscale materials and cells.
    Chairman Boehlert. Excuse me, Mr. Alderson, could you 
somewhat wrap up? We are going to try to stick to the--here is 
what----
    Dr. Alderson. Right.
    Chairman Boehlert.--we are going to do. We are going to try 
to stick to the five minutes for everybody else. We are giving 
you a little leeway, because you are the Chair of the panel. 
But from my experience, I know when Administration witnesses 
come up, they tell us what they are doing right. We understand 
what you are doing right, but there are a lot of things that we 
are not happy with. And we know what the charge is, but we are 
not pleased with the implementation plan. So if you could, wrap 
it up, and then we could get to the other witnesses. And I am 
going to try to keep the other witnesses to the five minutes so 
we really can engage.
    Dr. Alderson. Will do.
    Chairman Boehlert. Thank you, sir.
    Dr. Alderson. With the completion of the report released 
today, issues that remain to be addressed in the future include 
a step-wise process of determining priorities. Under the 
guidance of NSET, I expect the NEHI Working Group to play an 
active role in all of the ``next steps'' mentioned above, 
although the Working Group will serve only in an advisory 
capacity with respect to assisting agencies in setting their 
respective research priorities.
    Thank you again for the opportunity to testify, Mr. 
Chairman. I appreciate the Committee's continued interest in 
nanotechnology, and I would be happy to answer any questions 
you may have.
    [The prepared statement of Dr. Alderson follows:]
                Prepared Statement of Norris E. Alderson

INTRODUCTION

    Mr. Chairman and Members of the Committee, thank you for the 
opportunity to speak with you today about nanotechnology programs and 
the work of the Nanotechnology Environmental and Health Implications 
(NEHI) Working Group. I am Dr. Norris Alderson, Associate Commissioner 
for Science, at the Food and Drug Administration (FDA or the Agency). 
As FDA's Associate Commissioner for Science, I am responsible for the 
management of the Office of Women's Health, the Office of Orphan 
Products Development, the Good Clinical Practices Staff, coordination 
of science issues across the Agency, and oversight of FDA-sponsored 
clinical studies and standards coordination.

OVERVIEW

    Nanotechnology is expected to contribute to scientific advances in 
medicine, energy, electronics, materials, and other areas. Many of the 
benefits of nanotechnology arise from the fact that nanomaterials 
exhibit properties and behavior different from those of materials at 
larger scales. These unique properties that enable new benefits, 
however, also could lead to nanomaterial-specific human health and 
environmental risks.
    That a new technology could offer both benefits and, at the same 
time, potential risk, is not unique to nanotechnology. Other common 
examples are electricity, household cleaning supplies, gasoline, and 
medical X-rays. Learning more about risks of technologies provides 
information for their successful management and the realization of 
their benefits.

NANOTECHNOLOGY ENVIRONMENTAL AND HEALTH IMPLICATIONS (NEHI) WORKING 
                    GROUP

    I have been involved in the Nanotechnology Environmental and Health 
Implications (NEHI) Working Group since its inception. The Nanoscale 
Science, Engineering, and Technology (NSET) Subcommittee established 
the Working Group informally in late 2003 and formally chartered it in 
2005.
    The purpose of the NEHI Working Group is to provide for exchange of 
information among agencies that support nanotechnology research and 
those responsible for regulation and guidelines related to nanoproducts 
(containing engineered nanoscale materials); facilitate the 
identification, prioritization, and implementation of research and 
other activities required for the responsible research and development, 
utilization, and oversight of nanotechnology, including research 
methods of life-cycle analysis; and promote communication of 
information related to research on environmental and health 
implications of nanotechnology to other government agencies and non-
government organizations.
    One of the key objectives of the NEHI Working Group is to exchange 
information on the issues raised within the participating regulatory 
agencies by advances in nanotechnology. The NEHI Working Group assists 
in the development of information and strategies as a basis for the 
drafting by the regulatory agencies of guidance toward safe handling 
and use of nanoproducts by researchers, workers, and consumers. 
Further, the group is working to support development of nanotechnology 
standards, including nomenclature and terminology, by consensus-based 
standards organizations.
    In pursuit of these aforementioned objectives, activities of the 
NEHI Working Group over the past two years include:

          communication by participating regulatory agencies 
        concerning their respective statutory authorities for 
        regulating nanoproducts, and their approaches for carrying out 
        those authorities;

          encouraging all the participating regulatory agencies 
        to develop a position statement on how they are addressing 
        nanotechnology (an effort that has resulted in the 
        establishment of a nanotechnology web site at most of the 
        participating regulatory agencies);

          development of a preliminary ``risk assessment 
        influence diagram'' to help guide the NEHI Working Group's 
        approach to thinking about potential risks from nanoproducts 
        and services (this effort led to a peer-reviewed scientific 
        publication);

          discussion with various relevant standards bodies 
        regarding nomenclature and standards development for 
        nanotechnology that will affect both regulators and 
        researchers; and

          compiling the inputs from participating agencies on 
        their perceived needs for Environmental, Health, and Safety 
        (EHS) research and information and development of a draft 
        document drawn from this compilation and inputs from industry 
        and other similar documents from other countries and 
        organizations.

    A product of these activities is a report titled Environmental, 
Health, and Safety Research Needs for Engineered Nanoscale Materials.

THE NEHI WORKING GROUP REPORT

    The primary purpose of this document is to identify for the Federal 
Government the EHS research and information needs related to 
understanding and management of potential risks of engineered nanoscale 
materials that may be used in commercial or consumer products, medical 
treatments, environmental applications, research, or elsewhere. In 
addition, industry producers and users of engineered nanoscale 
materials may use this document to inform their own research, risk 
assessment, and risk management activities.
    The report is the first step in addressing the research needed to 
support informed risk assessment and risk management of nanomaterials. 
The document represents over a year of intensive work by the 
participating agencies.
    In addition to gathering input from its members for the purposes of 
this report, the NEHI Working Group has considered a number of public 
documents on the subject of EHS research while drafting this report. 
Included were documents from the chemical industry, the Environmental 
Protection Agency (EPA), the National Institute for Occupational Safety 
and Health (NIOSH), the Royal Society/Royal Academy of Engineering in 
the United Kingdom, and the Scientific Committee on Emerging and New 
Identified Health Risks/European Commission.
    Once the research needs were identified, they were grouped into 
five areas:

        1.  Instrumentation, metrology, and analytical methods

        2.  Nanomaterials and human health

        3.  Nanomaterials and the environment

        4.  Health and environmental surveillance

        5.  Risk management methods

    Research on nanoscale materials is supported by each agency, 
respectively, based on its primary scientific mission. The National 
Institutes of Health (NIH) supports a broad spectrum of biological 
nanoscale research ranging from basic science to clinical and 
translational investigations and clinical trials; the National Science 
Foundation (NSF) supports basic research on interactions between 
engineered nanoscale materials and cells. The EPA looks at broader 
implications for both human health and the environment including how 
nanomaterials will potentially affect whole ecosystems containing many 
different organisms. In some cases, such as the EPA-NSF-NIOSH-National 
Institute of Environmental Health Sciences joint interagency 
solicitation on environmental implications of nanotechnology, agencies 
conduct joint review of proposals, and then allocate the top rated 
proposals among themselves according to their respective missions and 
program emphases.
    The NEHI Working Group Report supports NSET's mandate to coordinate 
federal nanoscale research activities. The document will serve as a 
uniform guide for all federal agencies in developing their plans to 
support environmental, health, and safety research on the implications 
of nanoscale materials.

NEXT STEPS

    With the completion of the report released today, issues that 
remain to be addressed in the future include:

          Further prioritize research needs. Priorities will be 
        evaluated based primarily on the principles outlined in the 
        document. Other factors that will be considered include the 
        time frame for developing the information--because certain 
        studies are inherently lengthy--and the availability of 
        research tools.

          Evaluate in greater detail the current National 
        Nanotechnology Initiative (NNI) EHS research portfolio.

          Perform a ``gap analysis'' of the NNI EHS research 
        compared to the prioritized needs.

          Coordinate and facilitate among the NNI agencies 
        research programs to address priorities. Agencies will work 
        individually and jointly, where possible, to address research 
        needs.

          Establish a process for periodically reviewing 
        progress and for updating the research needs and priorities. 
        Such a review must take into consideration advances made by 
        entities other than U.S. Government-funded bodies, such as 
        advances by the private sector and foreign governments.

CONCLUSION

    I expect the NEHI Working Group to play an active role in all of 
the ``next steps'' mentioned above; although, the Working Group will 
serve only in an advisory capacity with respect to assisting agencies 
in setting their respective research priorities. Thank you again for 
the opportunity to testify today, Mr. Chairman. I appreciate the 
Committee's continued interest in nanotechnology, and I am happy to 
answer any questions you may have.

                    Biography for Norris E. Alderson

    Associate Commissioner for Science, U.S. Food and Drug 
Administration (FDA). Dr. Alderson began his career in FDA in 1971 
following a BS degree from the University of Tennessee and MS and Ph.D. 
degrees and post-doctoral work at the University of Kentucky. The 
majority of his FDA career has been in the Center for Veterinary 
Medicine, holding a number of management positions, culminating in the 
position of Director, Office of Research. In 2001, he became Acting 
Senior Advisor for Science, and Acting Director, Office of Science 
Coordination and Communication. In 2002, he was appointed Senior 
Associate Commissioner for Science, and Director, Office of Science and 
Health Coordination. The title was later changed to Associate 
Commissioner for Science. In his current position, he is responsible 
for coordination of science issues across the agency, the Office of 
Women's Health, Office of Orphan Products Development, the Good 
Clinical Practices Staff, oversight of FDA sponsored clinical studies, 
and standards coordination.

    Chairman Boehlert. Thanks very much. And incidentally, this 
committee has been privileged to have--to be familiar with all 
of you, because you have been before us. So--and I can say this 
without any fear of contradiction, that we know you 
individually and your careers, and we have high regard for you. 
And--but we are frustrated. I know how difficult it is to get 
interagency panels to act, and I know every single one of you 
have very demanding schedules. And this isn't the only item on 
your agenda. But I hope you take from this hearing the feeling 
that both of us, all of us on this committee, would like it to 
be a little bit higher on your respective agendas, a little bit 
higher priority so that we can get beyond the preliminary 
stages. And I am being kind when I say, ``Well, this is an 
important first step,'' but we should be a couple of steps 
ahead.
    Dr. Bement.

   STATEMENT OF DR. ARDEN L. BEMENT, JR., DIRECTOR, NATIONAL 
                       SCIENCE FOUNDATION

    Dr. Bement. Chairman Boehlert, Ranking Member Gordon, and 
distinguished Members of the Committee, I am pleased to be with 
you once again to speak on behalf of the National Science 
Foundation.
    However, before I begin my formal remarks today, Mr. 
Chairman, I want to extend a very warm personal note of 
appreciation for your support of NSF. Throughout the years, 
your leadership has been of immeasurable value to the science 
and engineering community. I know the work that you have done 
here will continue to strengthen this nation for years to come.
    Chairman Boehlert. Thank you very much, sir.
    Dr. Bement. Nowhere is that impact more evident than in the 
emerging field of nanotechnology. The amazing advances we have 
seen in this new frontier are, in no small part, due to your 
leadership in Congress on this issue. Your tremendous help in 
pushing the Administration's American Competitiveness 
Initiative will provide even more opportunities for discovery.
    Mr. Chairman, with your help, NSF not only provides 
leadership for the National Nanotechnology Initiative, we also 
provide the lion's share, 72 percent, of the NNI's $82 million 
research investments into the societal dimensions of 
nanotechnology. NSF also provides nearly 60 percent of the 
total NNI Environmental Health and Safety funding. These 
investments are critical, because we cannot effectively and 
safely exploit nanotechnology's fast potential without also 
understanding its societal implications.
    NSF research in this area is categorized into three main 
groups: environmental health and safety; education; and 
ethical, legal, and social issues.
    Of our investment, nearly half goes to fundamental research 
on the environmental health and safety aspects of 
nanomaterials. This also includes studying risk assessment. 
This research covers all the possible sources of nanoparticles: 
those created through manufacturing, those produced as a 
byproduct of other processes, and those existing naturally in 
the environment.
    NSF research also investigates how nanoparticles behave in 
a variety of settings: in the laboratory, in water, in the air, 
and in the workplace. We also study their non-clinical 
biological implications, such as the development of new 
instrumentation to measure toxicity.
    Funding a research agenda for these important areas is 
challenging, but managed in a variety of coordinated 
activities. NSF contributes and coordinates its NNI research 
and education activities through the Nanoscale Science, 
Engineering, and Technology Subcommittee, or NSET, of the 
National Science and Technology Council. Our activities are 
well integrated in the NSTC through periodic meetings, 
strategic and annual planning processes, co-sponsoring and co-
funding events of program solicitations, all in the framework 
of NSET and the National Nanotechnology Coordination Office.
    NSF is also part of NSET's subcommittees, namely 
Nanotechnology Environmental and Health Implications Working 
Group, or NEHI. This group provides regular interactions with 
other agencies that support research in regulatory activities.
    In the recent past, we have coordinated grantees meetings 
with the Environmental Protection Agency, the National 
Institute of Environmental and Health Sciences, the National 
Institute for Occupational Safety and Health, and other 
agencies. These meetings help ensure open lines of 
communication, cross-fertilization of ideas, funding of 
complementary projects, and leveraging.
    NSF also sets internal annual priorities for its nanoscale 
science and engineering research. Input for these priorities 
come from the NSF's Nanoscale Science and Engineering Working 
Group, the NNI Strategic Plan, the National Academies, other 
national, international, and industry perspectives as well as 
from grass roots sources, such as the general public and your 
grantees meetings, and other non-governmental sources.
    The NSF, according to its mission, conducts fundamental 
environmental health and safety research. This fundamental 
research complements the more directed approach of regulatory 
agencies in improving our understanding of the behavior of 
nanoparticles in the environment and their implications for 
human health and the ecology.
    NSF's fundamental research also complements the toxicity 
studies conducted by the National Institutes of Health and 
regulatory activities of the EPA, the Food and Drug 
Administration, and NIOSH.
    Mr. Chairman, NSF works closely with the regulatory 
agencies by offering our unique expertise and strength in 
fundamental research. This research will add to the overall 
body of knowledge on nanotechnology, provide the future 
workforce, and will prove essential to the regulatory mission 
agencies' abilities to develop science-based standards.
    Mr. Chairman, I hope that this brief overview conveys to 
you NSF's continued commitment to advance science and 
technology in the national interest. I appreciate you and your 
Committee's longstanding support of NSF, and I will be pleased 
to answer any questions you may have.
    [The prepared statement of Dr. Bement follows:]

               Prepared Statement of Arden L. Bement, Jr.

Fundamental Nanotechnology Research: The Key to Finding the Promise and 
                    Minimizing the Peril

    Chairman Boehlert, Ranking Member Gordon, and distinguished Members 
of the Committee, I am delighted to be with you once again to speak on 
behalf of the National Science Foundation. NSF is an extraordinary 
agency, with an equally extraordinary mission of enabling discovery, 
supporting education, and driving innovation--all in service to society 
and the Nation.
    The past several months have been particularly exciting for the NSF 
and the U.S. research community. As you are well aware, the National 
Science Foundation is an integral part of the President's American 
Competitiveness Initiative (ACI). The President's request for an eight 
percent increase at NSF this year represents the first step in the 
Administration's commitment to doubling the budgets of the ACI research 
agencies over the next 10 years.
    The ACI encompasses investments across NSF's research and education 
portfolio. NSF's investments in discovery, learning, and innovation 
have a longstanding and proven track record of boosting the Nation's 
economic vitality and competitive strength. This level of commitment is 
recognition of the urgent and ongoing need to invest in our nation's 
future through fundamental research and innovation.
    Frontier research is NSF's unique task in pursuing the 
Administration's research priorities within the larger federal research 
and development effort. Over the years, NSF has advanced the frontier 
with support for pioneering research that has spawned new concepts and 
even new disciplines. NSF provides strong support in fundamental 
research for activities coordinated by the National Science and 
Technology Council (NSTC), including our role as a lead federal agency 
in the multi-agency National Nanotechnology Initiative (NNI).
    But before I begin, let me thank this committee for its historic 
and ongoing support of NSF. I also want to extend special thanks--on 
behalf of everyone associated with the National Science Foundation--to 
Representative Boehlert for his many years of leadership as Chairman of 
the House Science Committee. The science and engineering community 
appreciates all that you have done as a champion for our nation's quest 
for knowledge.

Nanotechnology--First Steps and Demand for Fundamental Principles

    Ten years ago, predicting the state of nanotechnology research 
today would have been a fruitless gesture. In the 1990s, NSF and other 
research entities around the globe were just beginning to apply 
nanoscale concepts to the frontiers of science and engineering.
    Though some visionary researchers certainly recognized the vast 
potential of skillful atomic and molecular manipulation, no one could 
have predicted the enormous impact of these early steps into a new 
realm of discovery. One reason for this lack of prescience is our 
limited understanding of the physical principles that come into play on 
the nanoscale.
    The research community's first vision for nanotechnology was based 
on our understanding of the macro world, where the same laws and 
physical properties of our everyday experience hold sway, regardless of 
size or scale. We now know that this simplistic view was woefully 
inaccurate. The world of nanotechnology--it turns out--is an often 
topsy-turvy world where familiar physical properties disappear and new 
capabilities emerge.
    Consider something with which we are all familiar--ordinary gold. 
Whether in a ring, shielding sensitive electronics in space, or kept as 
a trusted investment for a rainy day, gold behaves in the same 
predictable ways. It has a certain color, luster, hardness, and melting 
point. This is true for an ounce or a metric ton. But something 
remarkable happens when we study the vanishingly small bits of gold 
called nanodots. On the nanoscale, gold no longer behaves the same as 
it does in our day-to-day lives. Its color changes to a striking red 
(as ancient stained-glass artists learned), and it's no longer the 
inert metal used in home and biological appliances. Rather, under 
certain circumstances, gold nanoparticles may be very reactive, may 
penetrate the blood/brain barrier, or may enter into cells.
    So we have to ask ourselves: as the NSF funds fundamental nanoscale 
research, how should we address the societal issues associated with the 
development and use of nanotechnology, and in particular engineered 
nanoscale materials.

Societal Dimensions

    We typically refer to the impact of nanotechnology on the 
environment, humans, cultures, and societal relationships as the 
``societal dimensions'' of nanotechnology. NSF characterizes research 
in this area into three main groups:

          Environment, Health, and Safety

          Education, and

          Ethical, Legal, and other Social Issues.

    Each pillar of this triumvirate is indispensable, and removing one 
would weaken the stability of our efforts to effectively and safely 
exploit nanotechnology's vast potential, which is why NSF's support of 
fundamental research is so critical. Of the total 2007 NSF Request 
within the National Nanotechnology Initiative of $373.2 million, $59 
million--or 16 percent--is directed toward societal dimensions.\1\ This 
is a $7.5 million (15 percent) increase over the FY 2006 estimated 
funding of $51.5 million.
---------------------------------------------------------------------------
    \1\ NSTC/NSET, July 2006

* FY 2001-2004 data retrospectively collected based upon FY 2005 OMB 
guidance.



    Because of NSF's critical impact on building a fundamental body of 
knowledge, specialized facilities, and qualified people, NSF funds a 
large fraction of the overall National Nanotechnology Initiative (NNI) 
investment in Societal Dimensions: $59 million of $82.1 million in the 
FY 2007 Request, and $51.5 million of $71.7 million in the FY 2006 
estimate.
    NSF dedicates about seven percent of its NNI budget to projects 
that focus primarily on fundamental aspects of environmental, health, 
and safety implications and applications of nanomaterials, and basic 
research that assesses the risk of these implications. This comes to 
$25.7 million or 6.9 percent of the total FY 2007 NNI/NSF Request, or 
$3.6 million over the FY 2006 estimate.

Setting a Research Agenda

    NSF sets annual priorities for nanoscale science and engineering 
research. Input for these priorities comes from the NSF's Nanoscale 
Science and Engineering Working Group; the NNI strategic plan; other 
national, international, and industry perspectives; as well as from 
grassroots sources such as the general public, annual grantees 
meetings, and other non-governmental sources.
    Another important input in developing the NSF's NNI-related 
research and education activities is through participation in the 
Nanoscale Science, Engineering and Technology Subcommittee (NSET) of 
the National Science and Technology Council (NSTC) Committee on 
Technology. NSF participates in all NNI workshops, research directions 
and planning meetings, and is coordinating its programs with the work 
done by other agencies in the general context of R&D, infrastructure, 
and education needs. NSF is also part of the NSET Subcommittee's 
Nanotechnology Environmental and Health Implications Working Group 
(NEHI), through which it has systematic interactions with other 
agencies supporting research and regulatory activities. NSF also has 
co-organized grantees meetings with the Environmental Protection Agency 
(EPA), the National Institute for Occupational Safety and Health 
(NIOSH), and other agencies to ensure open lines of communication, 
cross-fertilization of ideas, funding of complementary projects, and 
leveraging. Since FY 2001, the results from these meetings, and 
nanoscale science and engineering awards and solicitations, have been 
placed on NSF's dedicated nanotechnology web site: www.nsf.gov/nano.
    NSF also receives input from industry on the impact of this 
research agenda, ensuring that it is both deep and broad, and one that 
will serve the fundamental research needs of the entire community.

NSF Focus on Environmental, Health, and Safety Research

    As stated earlier, NSF--through its proven system of merit review--
seeks to advance the central body of knowledge on nanotechnology and 
corresponding infrastructure by support for fundamental research, not 
including clinical testing, and other activities that address broad 
societal dimensions. We do not fund product development or late-stage 
innovation: the research necessary to move a product into a commercial 
market.
    NSF research addresses a variety of nanoparticles and 
nanostructured materials in different environmental settings (air, 
water, soil, biosystems, and working environment), as well as the non-
clinical biological implications. These topics are supported through 
programs in all the NSF research directorates.
    There are several priority areas for environmental, health, and 
safety research at NSF. These key EHS priority research areas are:

          new measurement methods and instrumentation for 
        nanoparticle characterization and nanotoxicity,

          transport phenomena of nanoscale aerosols and 
        colloids, interaction of nanomaterials with cells and living 
        tissues,

          safety in nanomanufacturing, physico-chemical-
        biological processes of nanostructures dispersed in the 
        environment,

          separation of nanoparticles from fluids,

          development of user facilities, and

          educational programs supporting EHS issues.

    For example, the NSF is funding research on the safety of 
manufacturing nanoparticles through four Nanoscale Science and 
Engineering Centers (NSECs) and one Network:

          The NSEC at Rice University in Houston is 
        investigating the evolution of manufacturing nanoparticles in 
        the wet environment;

          The NSEC at Northeastern University in Boston is 
        looking into occupational safety during nanomanufacturing;

          The University of Pennsylvania's NSEC is exploring 
        the complex behavior and interactions between nanomaterials and 
        cells; and,

          The NSEC at University of Wisconsin, Madison, is 
        looking broadly at the effects of nanostructured polymers on 
        Environmental Health and Safety.

          The National Nanotechnology Infrastructure Network is 
        also exploring societal dimensions through nanoparticle 
        characterization centers at the University of Minnesota and 
        Arizona State University.

    Additionally, about twenty interdisciplinary research teams (NIRTs) 
were funded in the EHS area since FY 2001.\2\ Research through these 
teams has covered such diverse topics as:
---------------------------------------------------------------------------
    \2\ NSF 2001-2006

          Theoretical and experimental methods of describing 
        the formation and transformation of carbon nanoparticles in the 
---------------------------------------------------------------------------
        atmosphere.

          The effect on human cells of exposure to single-wall 
        carbon nanotubes. Research at the Houston Advanced Research 
        Center has indicated that these nanotubes have less toxicity 
        than carbon black and silica. However, research results on 
        toxicity depend on many factors and more knowledge is needed 
        before a final conclusion can be reached.

          NSF also is looking into the robust large-scale 
        manufacturing of nanoparticles and their toxicology. This 
        project will involve an academic-government-industrial 
        partnership, encompassing chemistry, chemical and mechanical 
        engineering, and medicine. Extensive tests will be performed on 
        toxicology. Mechanisms of particle/cell interactions will also 
        be evaluated, and the potential adverse and beneficial effects 
        will be determined.

          An NSF-supported Nanoscale Interdisciplinary Research 
        team is investigating ceramic membranes for filtration of 
        nanoparticles, which is relevant in control technology for 
        manufacturing processes involving aqueous nanoparticles.

          An NSF-supported Nanoscale Interdisciplinary Research 
        team is developing solvent-free techniques, using supercritical 
        carbon dioxide, for the de-agglomeration of nanoparticles. This 
        will enable environmentally benign manufacturing of high-
        surface-area nanostructured composites.

    In addition to the Center and NIRT awards, single investigator and 
small group awards provides creative ideas and innovation across all 
directorates in NSF. Several examples are:

          Several NSF awardees are developing instrumentation 
        for monitoring nanoparticles which could be useful for ensuring 
        the proper operation of control technology in factories. 
        Examples include instrumentation for:

                --  in-situ, real-time, high-resolution measurements of 
                nanoparticle size distributions

                --  chemical composition of nanoscale aerosols

                --  size-resolved measurements of surface tension, 
                critical supersaturation, and chemical composition of 
                nanoscale cloud condensation nuclei, which will help 
                elucidate the role of organic materials in environment

          Laser Doppler Velocimetry (LDV) in synchronous AC 
        electric and acoustic fields, to determine the size and charge 
        of nanoparticles. These technologies could also be used to 
        monitor nanoparticle emissions in the environment, providing 
        critical information for the design and implementation of 
        mitigation strategies where needed.

          An NSF Nanoscale Exploratory Research project is 
        developing risk scenarios for the full life-cycles of three 
        types of nanoparticles currently manufactured in multi-ton 
        quantities: endohedral metallo-fullerenes, titania 
        nanoparticles, and carbon nanotubes. The project's broad 
        interdisciplinary approach, including toxicity studies, life-
        cycle analysis, hierarchical holographic modeling, and 
        assessment of the existing regulatory framework, will serve as 
        a model for to identifying environmental impacts and risks of 
        nanomaterials.

    Since FY 2002, NSF has had a Nanotechnology Undergraduate Education 
program. The program is currently sponsoring an effort to introduce 
research-based environmental nanotechnology experiences into the 
undergraduate curricula. Research-based hands-on laboratory modules 
will introduce students to the effects of nanomaterials on the 
environment and the potential use of nanomaterials for removal of 
environmental pollutants.
    We also support fundamental research on decision making, risk, and 
uncertainty as part of our Human and Social Dynamics portfolio. This 
research will yield insight into decision-making processes, loss and 
mitigation models, and risk perception that are widely applicable to 
managing the risks and general governance associated with emerging 
technologies including nanotechnology.
    NSF has also released a number of solicitations that deal directly 
with the societal impacts of nanotechnology. These include an NSF-wide 
solicitation in FY 2001 to FY 2005 that had two major research and 
education themes: nanoscale processes in the environment, and societal 
implications of nanotechnology. There also was a solicitation in FY 
2006 and FY 2007 on active nanostructures and nano-devices.

Research to Enable Risk Assessment and Risk Management

    What sort of research is necessary to enable sound risk assessment 
and risk management of nanotechnology? And what is the role of NSF in 
supporting that research? NSF's unique expertise and strength of its 
human and administrative resources is in fundamental research. This 
research will add to the overall body of knowledge on nanotechnology, 
will prove essential to the regulatory mission agencies' abilities to 
develop science-based standards, and complements the more applied 
approach of EPA, toxicity studies by the National Institutes of Health, 
and regulatory activities by the Food and Drug Administration and 
NIOSH.
    By creating the strong foundation of fundamental research, NSF 
catalyses the development of trained researchers, the future workforce, 
and the laboratory infrastructure that is needed for the mission 
specific research and development in the regulatory agencies.
    As with any new technology, the benefits and risks of 
nanotechnology need to be evaluated from the beginning; nanotechnology 
has been exemplary in this regard. But research to understand the 
benefits and risks cannot advance without the combination of 
fundamental research, domain specific research, and technology and 
product specific research. This is where a balanced approach ensures 
the best results. Without these three components, the successful long-
term commercialization of new products is at risk.
    This foundation for commercialization is of great concern to 
industry, and NSF activity integrates their input and concerns into its 
research agenda. NSF receives input from industry through the 
Collaborative Boards for Advancing Nanotechnology, which was 
established by NNI with the electronic industry, the chemical industry, 
and other businesses and organizations.
    NSF, therefore, does have an important role to play in enabling the 
acceptance of nanotechnology-based goods in the marketplace. Primarily, 
this is through fundamental research and the development of the 
necessary infrastructure--education, physical infrastructure for 
nanomaterials research, and more comprehensive topics such as 
nomenclature, metrology, and patent-evaluation framework. NSF also 
develops the institutional capability for R&D, production, information 
dissemination, safe use and regulations, and commercialization of 
nanotechnology. Above all, NSF supports the long-term R&D for new 
generations of nanoproducts. NSF research is most effective when 
targeted at long-term results and broad impacts that cut across the 
entire research landscape.

The Public and Nanotechnology

    NSF supports a host of education-related activities to communicate 
the state and future direction of nanotechnology research. This 
includes developing materials for schools, curriculum development for 
nanoscience and engineering, development of new teaching tools, and K-
12 and public outreach. Three networks for nanotechnology education and 
societal dimensions with national outreach have been established:

          The Nanotechnology Center for Learning and Teaching, 
        with the main node at the Northwestern University, will reach 
        one million students in high school and undergraduate education 
        in all 50 states in the next five years;

          The Nanoscale Informal Science Education, focused at 
        the Museum of Science in Boston will address innovative science 
        learning approaches, supplement K-12 education, and engage 
        adult audiences; and

          The Network for Nanotechnology in Society will 
        address both short-term and long-term societal implications of 
        nanotechnology, as well as public engagement.

    The success of these efforts, however, hinges on a firm foundation 
of research across all areas and considering all implications. That 
outcome can only be achieved with the fundamental, broad-based research 
supported by NSF.

Conclusion

    For many years, NSF has used the slogan ``Where Discoveries Begin'' 
to welcome people to our web site. That phrase, however, did not come 
from a focus group or a marketing guru: it came from our mission--our 
mission of research and discovery. The same is true for nanotechnology. 
NSF is where the discoveries begin.
    Mr. Chairman, I hope that this brief overview conveys to you NSF's 
continued commitment to advance science and technology in the national 
interest. If there is one thing that I would want to leave you with is 
that the vital, critical, and highly visible regulatory decisions that 
will need to be made will be based on the equally vital, critical, 
yet--by and large--unseen fundamental research that is NSF's hallmark.
    I appreciate your--and your committee's--longstanding support of 
NSF. I would be pleased to answer any questions that you may have.
    Thank you.

                   Biography for Arden L. Bement, Jr.

    Arden L. Bement, Jr., became Director of the National Science 
Foundation on November 24, 2004. He had been Acting Director since 
February 22, 2004.
    He joined NSF from the National Institute of Standards and 
Technology, where he had been director since Dec. 7, 2001. Prior to his 
appointment as NIST director, Bement served as the David A. Ross 
Distinguished Professor of Nuclear Engineering and head of the School 
of Nuclear Engineering at Purdue University. He has held appointments 
at Purdue University in the schools of Nuclear Engineering, Materials 
Engineering, and Electrical and Computer Engineering, as well as a 
courtesy appointment in the Krannert School of Management. He was 
director of the Midwest Superconductivity Consortium and the Consortium 
for the Intelligent Management of the Electrical Power Grid.
    Bement served as a member of the U.S. National Science Board from 
1989 to 1995. The board guides NSF activities and also serves as a 
policy advisory body to the President and Congress. As NSF director, 
Bement will now serve as an ex officio member of the NSB.
    He also chaired the Commission for Engineering and Technical 
Studies and the National Materials Advisory Board of the National 
Research Council; was a member of the Space Station Utilization 
Advisory Subcommittee and the Commercialization and Technology Advisory 
Committee for NASA; and consulted for the Department of Energy's 
Argonne National Laboratory and the Idaho National Engineering and 
Environmental Laboratory.
    Bement joined the Purdue faculty in 1992 after a 39-year career in 
industry, government, and academia. These positions included: Vice 
President of Technical Resources and of Science and Technology for TRW 
Inc. (1980-1992); Deputy Under Secretary of Defense for Research and 
Engineering (1979-1980); Director, Office of Materials Science, DARPA 
(1976-1979); Professor of nuclear materials, MIT (1970-1976); Manager, 
Fuels and Materials Department and the Metallurgy Research Department, 
Battelle Northwest Laboratories (1965-1970); and Senior Research 
Associate, General Electric Co. (1954-1965).
    He has been a director of Keithley Instruments Inc. and the Lord 
Corp. and was a member of the Science and Technology Advisory Committee 
for the Howmet Corp. (a division of ALCOA).
    Bement holds an Engineer of Metallurgy degree from the Colorado 
School of Mines, a Master's degree in metallurgical engineering from 
the University of Idaho, a doctorate degree in metallurgical 
engineering from the University of Michigan, an honorary doctorate 
degree in engineering from Cleveland State University, and an honorary 
doctorate degree in science from Case Western Reserve University. He is 
a member of the U.S. National Academy of Engineering.

    Chairman Boehlert. Thank you very much, Dr. Bement.
    You know, you are only 20 seconds over, but since you had 
that nice preamble, I allowed that.
    Dr. Farland.
    And incidentally, I apologize to no one. I am an unabashed 
cheerleader for the National Science Foundation. It does 
marvelous work.
    Thank you.

     STATEMENT OF DR. WILLIAM H. FARLAND, DEPUTY ASSISTANT 
ADMINISTRATOR FOR SCIENCE, OFFICE OF RESEARCH AND DEVELOPMENT, 
              U.S. ENVIRONMENTAL PROTECTION AGENCY

    Dr. Farland. Thank you, Mr. Chairman and Members of the 
Committee, for the invitation to appear here today and provide 
testimony on behalf of the Environmental Protection Agency. Mr. 
Chairman, thank you for your kind words regarding my career.
    I am Dr. William Farland, Deputy Assistant Administrator 
for Science for the Office of Research and Development. EPA has 
been and will continue to be a leader in promoting development 
of environmental applications. EPA understands the potential 
implications of nanotechnology and vigorously pursues 
collaborations with United States and international scientists 
and policy makers. My submitted testimony describes our 
research needs in this area and how EPA is going about meeting 
these needs.
    EPA recognizes that nanotechnology has the potential to 
improve the environment, both through direct applications to 
detect, prevent, and remove pollutants as well as through 
design of cleaner industrial processes and creation of 
environmentally-friendly products.
    However, some of the same unique properties that make 
manufactured nanoparticles beneficial also raise questions 
about the impacts of nanoparticles on human health and the 
environment. The evaluation of potential nanoparticle toxicity 
is complex, possibly being regulated by a variety of physical 
chemical properties, such as size and shape, as well as surface 
properties, such as charge area reactivity, coating type, and 
others.
    As products made from nanoparticles become more numerous, 
the potential for release of nano-sized particles into the 
environment may also increase. The EPA, under its various 
statutes, has an obligation to ensure that potential 
environmental risks are adequately understood and managed. 
Potential environmental risks are dealt with as we review 
information on nanomaterials to assess and understand these 
risks and take control measures, as needed. For example, EPA is 
reviewing pre-manufacture notifications on nanomaterials that 
have been received under Section 5 of the Toxic Substances 
Control Act. It is important that throughout our evaluation of 
nanotechnology, decision making be informed by the best 
available scientific information.
    I mentioned that EPA has been a leader in research on the 
application and implications of nanotechnology in the 
environment. EPA began funding research on nanotechnology under 
its Science To Achieve Results, or STAR program, in 2001. Some 
36 grants totaling nearly $12 million have been funded since 
that time to identify beneficial environmental applications, 
addressing prevention, sensors, treatment, and remediation.
    In addition, through its Small Business Innovation 
Research, or SBIR program, EPA has supported projects 
addressing nanotechnology applications. Beginning in 2003, EPA 
turned its focus to the potential environmental implications of 
nanotechnology and has now funded an additional 30 implications 
projects totaling approximately $10.4 million under the STAR 
program. This research is addressing exposure, fate and 
transport of nanomaterials in the environment, and potential 
human and environmental toxicity. We partnered with the 
National Science Foundation, National Institute of 
Environmental Health Sciences, NIOSH, and have funded 
additional projects under these solicitations with their help. 
Currently EPA and the three partner agencies are reviewing the 
proposals from the latest joint solicitation to make new 
funding decisions.
    While some EPA research needs are shared by other federal 
agencies, EPA has particular needs to support its statutory 
mandates. To that end, EPA has set research priorities that 
reflect these program needs. EPA plans to issue the final 
version of its nanotechnology white paper in the near future. 
This paper was released in December of 2005 as the review draft 
that describes EPA nanotechnology research needs. The needed 
research is in the following broad areas: chemical 
identification and characterization, environmental fate, 
environmental detection and analysis, potential releases to the 
environment and human exposures, and human health effects, as 
well as ecological effects.
    Based on the President's fiscal year 2000 budget request, 
$8.6 million will go toward nanotechnology research. The EPA is 
developing a nanotechnology research framework for fiscal years 
2007 through 2012 that is problem-driven, focusing on 
addressing the agency's programmatic needs. EPA will conduct 
research to understand whether nanoparticles in particular, and 
those with the greatest potential to be released into the 
environment or trigger a hazard concern, pose significant risks 
to human health or ecosystems by looking at the life cycle of 
nanoparticles. We are also working with our federal partners to 
conduct research to identify approaches for detecting and 
measuring nanoparticles in the environment and looking at 
pollution prevention and enhancing manufacturing processes.
    Based on these kinds of recommendations, we will be able to 
continue our collaborative efforts in these research areas into 
the near future, and we look forward to these types of 
activities. As members of the National Science and Technology 
Council's Nanoscale Science, Engineering, and Technology 
Subcommittee, which manages the NNI, EPA plays a leadership 
role in the coordination of federal activities concerning 
nanotechnology and the environment, and we look forward to 
continuing these kinds of efforts as we move toward the future.
    Chairman Boehlert. Thank you, Doctor.
    Dr. Farland. Thank you, Mr. Chairman.
    [The prepared statement of Dr. Farland follows:]

                Prepared Statement of William H. Farland

Introduction

    Thank you, Mr. Chairman and Members of the Committee for the 
invitation to appear here today and provide testimony on nanotechnology 
research at the Environmental Protection Agency (EPA). I am William 
Farland, Deputy Assistant Administrator for Science for the Office of 
Research and Development. EPA is a leader in promoting research to 
develop environmental applications and understand potential 
implications of nanotechnology, and vigorously pursues collaborations 
with U.S. and international scientists and policy-makers. My purpose 
today is to describe our research needs in this area, and how EPA is 
going about meeting these needs.
    EPA recognizes that nanotechnology has the potential to improve the 
environment, both through direct applications to detect, prevent, and 
remove pollutants, as well as by using nanotechnology to design cleaner 
industrial processes and create environmentally friendly products. 
However, some of the same unique properties that make manufactured 
nanoparticles (which in the remainder of this testimony I refer to 
simply as ``nanoparticles,'' recognizing that our focus is on particles 
intentionally manufactured at the nanoscale) beneficial also raise 
questions about the impacts of nanoparticles on human health and the 
environment. The evaluation of potential nanoparticle toxicity is 
complex, possibly being regulated by a variety of physicochemical 
properties such as size and shape, as well as surface properties such 
as charge, area, reactivity, and coating type on the particle. As 
products made from nanoparticles become more numerous, the potential 
for release of nano-size particles into the environment may also 
increase. The EPA, under its various statutes, has an obligation to 
ensure that potential environmental risks are adequately understood and 
managed. Certain EPA programs are already reviewing information on 
nanomaterials to assess and understand risks and take control measures 
as needed. For example, EPA is reviewing pre-manufacture notifications 
on nanomaterials that have been received under Section 5 of the Toxic 
Substances Control Act. It is important that throughout our evaluation 
of nanotechnology, decision-making be informed by the best available 
scientific information.
    EPA began funding research on nanotechnology under its Science to 
Achieve Results (STAR) program in 2001. Some 36 grants totaling nearly 
$12 million have been funded since that time to identify beneficial 
environmental applications, addressing prevention, sensors, treatment, 
and remediation of conventional pollutants using nanotechnology. In 
addition, through its Small Business Innovation Research program EPA 
has supported projects addressing nanotechnology applications.
    Beginning in 2003, EPA turned its focus to the potential 
environmental implications of nanotechnology and has now funded an 
additional 30 implications projects totaling approximately $10.4 
million under the STAR program. This research is addressing potential 
human and environmental toxicity, exposure, and fate and transport of 
nanoparticles in the environment. EPA has partnered with the National 
Science Foundation, National Institute for Environmental Health 
Sciences (NIEHS), and National Institute for Occupational Safety and 
Health (NIOSH), which have funded additional projects under these 
solicitations. Currently, EPA and the three partner agencies are 
reviewing the proposals from the latest joint solicitation to make new 
funding decisions.

Research Needs

    While some of EPA's research needs are shared by other federal 
agencies, EPA has particular needs to support its statutory mandates. 
To that end, EPA must set research priorities that reflect these 
program needs. EPA plans to issue its Nanotechnology White Paper, 
released in December 2005 as a review draft that describes EPA's 
nanotechnology research needs. This research is in the following broad 
areas: chemical identification and characterization, environmental 
fate, environmental detection and analysis, potential releases to the 
environment and human exposures, human health effects assessment, 
ecological effects assessment, and environmental applications.

Chemical Identification and Characterization

    A number of properties will need to be considered in order to 
characterize nanoparticles for the purposes of evaluating hazard and 
assessing risk. Terminology and nomenclature also need to be 
standardized. EPA is participating in deliberations with the American 
National Standards Institute, the American Society for Testing and 
Materials, and the International Organization for Standardization 
regarding the development of terminology and chemical nomenclature for 
nano-sized substances, and will also continue with its own nomenclature 
discussions with the Chemical Abstracts Service.

Potential Releases and Human Exposures

    Workers may be exposed to particles during the production and use 
of materials made from nanoparticles, and the general population may be 
exposed to releases to the environment during these materials' 
production or use in the workplace, during the use of commercially 
available products containing nanoparticles, and during disposal and 
recycling stages. Workers who manufacture materials made from 
nanoparticles may be exposed to higher levels of nanoparticles than the 
general population, and therefore may need additional personal 
protective equipment. Research is needed to better understand these 
exposures.

Environmental Detection and Analysis

    The challenge in detecting nanoparticles in the environment is not 
only their extremely small size but also because the metric of 
importance is unknown. Consequently we are currently unsure of what to 
measure and detect. The chemical properties of particles at the 
nanometer size may require new analytical and detection techniques. To 
that end, we need to assess available detection methods and 
technologies for nanoparticles in environmental media, and to develop a 
set of standard methods for the sampling and analysis of nanoparticles 
of interest in various environmental media.

Environmental Fate

    As more products are developed using nanoparticles, there is 
increased potential for releases of nanoparticles into the environment. 
Particles may be released to the environment during their manufacture 
and processing, or as they break down during use, disposal, or 
recycling. We need to understand what happens to these particles as 
they are released into and move through the air, soil, and water.

Human Health Effects

    Very little data exist on the toxicity, hazardous properties, 
translocation, and ultimate fate of nanoparticles in humans. We need to 
understand whether adverse health effects may result from exposure to 
nanoparticles or their byproducts, by local toxic effects at the site 
of initial deposition as well as by systemic toxic responses. 
Toxicological assessment of manufactured nanoparticles will require 
information on the routes (inhalation, oral, dermal) that carry the 
greatest potential for exposure to nanoparticles.

Ecological Effects

    Research is needed on the potential exposure and effects of 
nanoparticles on invertebrates, fish, and wildlife. Furthermore, 
dispersion of nanoparticles in the environment may result in novel 
byproducts or degradates that also may pose hazards. We need to 
understand the behavior of nanomaterials in aquatic and terrestrial 
environments, and nanoparticles' potential acute and chronic toxic 
effects. To do this, we need to develop and validate analytical 
methodologies for measuring nanoscale substances (both parent materials 
and metabolites/complexes) in the environment.

Environmental Applications

    Nanotechnology can help create materials and products that will not 
only directly advance our ability to detect, monitor, and clean-up 
environmental contaminants, but also help us avoid creating pollution 
in the first place. By using less materials and energy throughout a 
product's lifecycle--such as by using highly reactive nanoparticles as 
more-efficient catalysts--nanotechnolgoy may contribute to reducing 
pollution and energy consumption. Research is needed to advance the use 
of nanotechnology to enhance environmental protection.

EPA Research

    Based on the fiscal year 2007 President's budget request of $8.6 
million, EPA is developing a nanotechnology research framework for 
fiscal years 2007-2012 that is problem-driven, focusing on addressing 
the Agency's programmatic needs. EPA will conduct research to 
understand whether nanoparticles, in particular those with the greatest 
potential to be released into the environment and/or trigger a hazard 
concern, pose significant risks to human health or ecosystems, by 
looking at the life cycle of nanoparticles. Also, EPA will conduct 
research to identify approaches for detecting and measuring 
nanoparticles in the environment, and for using nanotechnology for 
pollution prevention and enhancing manufacturing processes, as well as 
to facilitate the development of nanotechnology-based materials in an 
environmentally benign manner.
    This research program will be based on the recommendations from the 
EPA Nanotechnology White Paper, which was developed by a cross-agency 
committee working under the auspices of our Science Policy Council. Our 
research will be guided by the information needed to conduct 
assessments of risk to humans and the environment. We are uniquely 
positioned to lead in the ecosystem and exposure areas, due to our 
existing expertise in these areas. Also, because of expertise in areas 
such as fine particulate toxicology, we plan to engage in a limited 
amount of human health effects research. However, we also will look to 
partnerships and collaboration with other agencies to fill our research 
needs. For example, we are currently working with NIEHS to ensure that 
human toxicity research is conducted that is relevant and timely for 
environmental decision-making.
    Because the President's budget request proposes to significantly 
increase EPA's nanotechnology research budget in 2007, I believe the 
Agency is well positioned to examine the potential human health and 
ecological risks from nanoparticles.

Collaboration

    To meet the research needs outlined here, we need a collaborative 
approach that will energize the research community, public and private. 
EPA scientists are leaders in explaining how we can use nanotechnology 
to improve our environment and how we can improve our understanding of 
any potential adverse effects resulting from the production, use, 
disposal and recycling of materials that contain nanoparticles. We 
intend to continue these efforts and to increase direct collaborations 
on the research discussed above.
    As a member of the National Science and Technology Council's 
Nanoscale Science, Engineering and Technology Subcommittee, which 
manages the National Nanotechnology Initiative, EPA plays a leadership 
role in the coordination of federal activities concerning 
nanotechnology and the environment. The Agency is also a pivotal member 
of the Subcommittee's Nanotechnology Environmental and Health 
Implications (NEHI) working group, whose membership includes, among 
others, EPA, Food and Drug Administration, Consumer Products Safety 
Commission, NIOSH, Department of Defense, Department of Energy, and 
NIH. The NEHI has prepared a research needs document, in the 
development of which EPA has played a central role, that complements 
our white paper.
    EPA is also engaged in international collaboration. For example, 
EPA is part of the Organization for Economic Cooperation and 
Development effort to address the topic of the implications of 
manufactured nanomaterials among its members under the auspices of the 
Joint Meeting of the Chemicals Committee and Working Party on 
Chemicals, Pesticides and Biotechnology.

Conclusion

    EPA recognizes the potential of nanotechnology to clean up the 
environment, prevent pollution, and contribute to the sustainable use 
of resources. EPA is also committed to improving our understanding of 
the properties of nanoparticles, the behavior of nanoparticles in the 
environment, and the potential for unintended consequences for humans 
and the environment from exposure to nanoparticles. The Agency will 
continue to play a domestic and international leadership role to better 
understand the environmental issues surrounding this and other emerging 
technologies. Mr. Chairman, I would like to thank you and the Committee 
for inviting EPA to participate in this hearing and for giving us this 
opportunity to describe our nanotechnology research program. I would be 
happy to answer any questions that you may have.

    Chairman Boehlert. Thank you, Dr. Farland.
    Dr. Carim.

    STATEMENT OF DR. ALTAF H. (TOF) CARIM, PROGRAM MANAGER, 
    NANOSCALE SCIENCE AND ELECTRON SCATTERING CENTER, U.S. 
                      DEPARTMENT OF ENERGY

    Dr. Carim. I am sorry. I thought it was on already.
    Mr. Chairman and Members of the Committee, good morning, 
and thank you for the opportunity to speak with you today about 
nanotechnology programs at the Department of Energy. My name is 
Altaf Carim, and I manage major nanoscience user facilities and 
coordinate nanoscience activities in the Office of Science at 
DOE. The longstanding support of this committee for scientific 
research and development, including that carried out within the 
Office of Science, is deeply appreciated and Mr. Chairman, I 
also want to add thanks for your longstanding leadership in 
this area.
    Nanoscale science and technology is, of course, a key area 
among those encompassed by the American Competitiveness 
Initiative. Collectively, these efforts do constitute vital 
investments that are essential to maintaining the U.S. 
leadership in innovation and its associated economic benefits.
    The mission of DOE's Office of Science is ``to deliver the 
remarkable discoveries and scientific tools that transform our 
understanding of energy and matter and advance the national, 
economic, and energy security of the U.S.'' To address this 
mission, the Office of Science includes key portfolio 
components in two types of activities: fundamental research in 
support of long-term energy security and discovery science that 
enables the DOE missions, and forefront scientific user 
facilities for the Nation which provide the infrastructure for 
world leadership in science. Accordingly, our nanotechnology 
activities include both support of basic research at 
universities and National Laboratories, and the development and 
operation of major facilities for nanoscale research.
    Nanotechnology research programs at DOE are part of the 
broad portfolio of programs in the Office of Science, and are 
supported through submissions to our core research program, the 
equivalent of a broad agency announcement, as well as through a 
variety of other occasional solicitations. Only a few such 
solicitations have concentrated specifically on nanotechnology. 
The Office of Science also has a small program that supports 
research on the ethical, legal, and societal issues in two 
primary areas: biotechnology and nanotechnology. Broadly, 
decisions on research programs are made through peer review and 
merit evaluation and through program managers' judgments on 
portfolio balance. The determination of priorities for 
solicitations and funding is also informed by DOE workshops, 
advisory groups, federal budget priorities, independent 
reports, and interagency discussions and documents, including 
the Strategic Plan and workshop reports of the National 
Nanotechnology Initiative, or NNI.
    With respect to major facilities, the development and 
operation by DOE of five Nanoscale Science Research Centers 
represents by far the largest component of the NNI investment 
in scientific infrastructure. Each of these centers serves as a 
resource to the entire scientific community, including 
researchers from other federal agencies such as the 
Environmental Protection Agency, and provides researchers 
access based on the scientific merit of their proposals. These 
centers are collocated with other major capabilities such as x-
ray synchrotrons, neutron scattering facilities, electron 
microscopy centers, and advanced computing facilities to 
maximize the advantage of those tools for nanoscience research.
    While not their primarily research mission, these user 
facilities will enable work, possible nowhere else in the 
United States, in environmental, health, and safety issues by 
providing widely-accessible capabilities for advanced 
synthesis, characterization, and properties measurement. Four 
of the NSRCs have completed construction of their specially-
designed buildings and are now in operation and the fifth is 
still under construction.
    Furthermore, DOE fully expects the Nanoscale Science 
Research Centers themselves to be ``best in class'' with 
respect to their own environmental, health, and safety 
practices. Just over a year ago, in September 2005, the 
Secretary of Energy issued a formal Secretarial Policy 
Statement on Nanoscale Safety, which I would ask to have 
included in the record, and it is attached to my testimony.
    National Laboratory staff with environmental, health, and 
safety responsibilities at the Nanoscale Science Research 
Centers also constitute a working group which meets and 
teleconferences on a regular basis to share information and 
best practices.
    Interagency coordination has provided very valuable input 
in defining DOE's nanotechnology activities. The Department of 
Energy has participated in the NSET Subcommittee since the 
subcommittee's genesis in 2000, and prior to that was a member 
of the precursor Interagency Working Group of the same name. 
And in fact, DOE was one of the six initial agencies involved. 
The development of plans for the Nanoscale Science Research 
Centers, in particular, was in part a response to the need 
identified by the interagency group for such major facilities
    I hope this testimony provides a fuller awareness of DOE's 
many activities in the field of nanoscience, including our 
attention to the environmental, health, and safety aspects
    I appreciate your time and would be glad to address any 
questions you may have.
    [The prepared statement of Dr. Carim follows:]

                  Prepared Statement of Altaf H. Carim

    Mr. Chairman, and Members of the Committee, good morning and thank 
you for the opportunity to speak with you today about nanotechnology 
programs at the Department of Energy. My name is Altaf Carim, and I 
manage major nanoscience user facilities and coordinate nanoscience 
activities in the Office of Science at DOE. The longstanding support of 
this committee for scientific research and development, including that 
carried out within the Office of Science, is deeply appreciated. 
Nanoscale science and technology is a key area among those encompassed 
by the American Competitiveness Initiative. Collectively, these efforts 
constitute vital investments essential to maintaining U.S. leadership 
in innovation and its associated economic benefits.
    The mission of DOE's Office of Science is ``. . .to deliver the 
remarkable discoveries and scientific tools that transform our 
understanding of energy and matter and advance the national, economic, 
and energy security of the U.S.'' To address this mission, the Office 
of Science includes key portfolio components in two types of 
activities: fundamental research in support of long-term energy 
security and discovery science that enables the DOE missions, and 
forefront scientific user facilities for the Nation which provide the 
infrastructure for world leadership in science. Accordingly, our 
nanotechnology activities include both support of basic research at 
universities and National Laboratories, and the development and 
operation of major facilities for nanoscale research.
    Nanotechnology research programs at DOE are part of the broad 
portfolio of programs in the Office of Science, and are supported 
through submissions to our core research program (the equivalent of a 
broad agency announcement) as well as through a variety of other 
occasional solicitations. Only a few such solicitations have 
concentrated specifically on nanotechnology. The Office of Science also 
has a small program that supports research on the ethical, legal, and 
societal issues in two primary areas: biotechnology and nanotechnology. 
Broadly, decisions on research programs are made through peer review 
and merit evaluation and through program managers' judgments on 
portfolio balance. The determination of priorities for solicitations 
and funding is also informed by DOE workshops, advisory groups, federal 
budget priorities, independent reports, and interagency discussions and 
documents, including the Strategic Plan and workshop reports of the 
National Nanotechnology Initiative (NNI).
    Procedures and criteria in the solicitation selection process are 
consistent with the Code of Federal Regulations at 10 CFR Part 605, 
with selection and evaluation based on the following criteria which are 
listed in descending order of importance:

        (1)  Scientific and/or technical merit or the educational 
        benefits of the project;

        (2)  Appropriateness of the proposed method or approach;

        (3)  Competency of applicant's personnel and adequacy of 
        proposed resources;

        (4)  Reasonableness and appropriateness of the proposed budget; 
        and

        (5)  Other appropriate factors, established and set forth in a 
        notice of availability or in a specific solicitation.

    With respect to major facilities, the development and operation by 
DOE of five Nanoscale Science Research Centers represents by far the 
largest component of the NNI investment in scientific infrastructure. 
Each of these centers serves as a resource to the entire scientific 
community (including researchers from other federal agencies such as 
the Environmental Protection Agency) and provides researchers access 
based on the scientific merit of their proposals. The Nanoscale Science 
Research Centers are collocated with other major capabilities such as 
x-ray synchrotrons, neutron scattering facilities, electron microscopy 
centers, and advanced computing facilities to maximize the advantage of 
these tools for nanoscience research.
    While not their primarily research mission, these user facilities 
will enable work--possible nowhere else in the United States--in 
environmental, health, and safety issues by providing widely-accessible 
capabilities for advanced synthesis, characterization, and properties 
measurement. Four of the NSRCs have completed construction of their 
specially-designed buildings and are now in operation at Argonne 
National Laboratory, Lawrence Berkeley National Laboratory, Oak Ridge 
National Laboratory, and jointly at Sandia and Los Alamos National 
Laboratories. The fifth, at Brookhaven National Laboratory, is still 
under construction.
    Further, DOE fully expects the Nanoscale Science Research Centers 
to be ``best-in-class'' with respect to their own environmental, 
health, and safety practices. Just over a year ago, in September 2005, 
the Secretary of Energy issued a formal Secretarial Policy Statement on 
Nanoscale Safety, which I would ask to have included in the record (DOE 
P 456.1, attached). National Laboratory staff with environmental, 
health, and safety responsibilities at the NSRCs also constitute a 
working group which meets and teleconferences on a regular basis to 
share information and best practices.
    Interagency coordination has provided very valuable input in 
defining DOE's nanotechnology activities. The Department of Energy has 
participated in the Nanoscale Science, Engineering, and Technology 
(NSET) Subcommittee of the National Science and Technology Council from 
the subcommittee's genesis in 2000, and prior to that was a member of 
the precursor Interagency Working Group of the same name--in fact, DOE 
was one of the six initial agencies involved in NSET and the NNI, which 
has now grown to encompass 25 entities. The development of plans for 
the Nanoscale Science Research Centers was in part a response to the 
need identified by the interagency group for such major facilities. DOE 
is actively involved in the NSET subcommittee itself, on which I 
currently serve as Co-Chair, and its various working groups, including 
that on Nanotechnology Environmental and Health Implications. DOE and 
national laboratory staff also participate in related activities such 
as development of standards necessary for effective understanding of 
environmental, safety, and health implications through organizations 
like the American National Standards Institute.
    I hope this testimony provides a fuller awareness of DOE's many 
activities in the field of nanoscience, including our attention to the 
environmental, health, and safety aspects of this vital area of 
science. I appreciate your time and would be glad to address any 
questions you may have.




                   Biography for Altaf H. (Tof) Carim

Education

S.B. in Materials Science and Engineering, Massachusetts Institute of 
        Technology, 1982

M.S. in Materials Science and Engineering, Stanford University, 1984

Ph.D. in Materials Science and Engineering, Stanford University, 1989

Experience

    Tof Carim joined the Office of Basic Energy Sciences at DOE in 
September 2001 as a Program Manager with primary responsibility for 
activities in the structure and composition of materials. His present 
duties include serving as the DOE program manager for five Nanoscale 
Science Research Center user facilities, representing DOE on and co-
chairing the interagency Nanoscale Science, Engineering, and Technology 
subcommittee of the National Science and Technology Council, and 
overseeing operations of three electron beam micro-characterization 
user facilities.
    Prior to joining DOE, Dr. Carim was at Pennsylvania State 
University (Penn State), where he was on the faculty for eleven years, 
most recently as Chair of the Electronic and Photonic Materials 
Program. He previously held summer positions at Bell Laboratories and 
the Xerox Palo Alto Research Center, did graduate work under support 
from Philips Research Laboratories Sunnyvale, held a post-doc at the 
Philips Natuurkundig Laboratorium in The Netherlands, and for two years 
was a faculty member at the University of New Mexico. He also was a 
visiting investigator at the Carnegie Institution of Washington on a 
sabbatical leave.
    Dr. Carim's primary expertise is in microstructural and 
microchemical characterization of materials, with research 
contributions in a variety of areas including semiconductor interfaces, 
superconducting and ferroelectric oxide thin films and ceramics, 
crystal structure determination, crystalline defects, joining of 
ceramics and composites, development of anisotropic microstructures, 
electron holography, and morphology of nanoparticles and nanowires. He 
has authored or co-authored over 85 research publications in these 
areas, including two book chapters, has edited two volumes, and has 
given more than 70 conference, seminar, and other presentations. He has 
been active in numerous professional societies, has organized a number 
of technical meetings and symposia, and has held editorial roles with 
several journals. His awards and honors include recognition as an 
Office of Naval Research Young Investigator and receipt of an AIST 
Foreign Researcher Invitation to lecture in Japan.

    Chairman Boehlert. Thank you.
    Dr. Maynard.

  STATEMENT OF DR. ANDREW D. MAYNARD, CHIEF SCIENCE ADVISOR, 
     PROJECT ON EMERGING NANOTECHNOLOGIES, WOODROW WILSON 
               INTERNATIONAL CENTER FOR SCHOLARS

    Dr. Maynard. Thank you, Chairman Boehlert, Ranking Member 
Gordon, and Members of the Committee for holding this hearing 
and for inviting me to speak. My name is Andrew Maynard. I am 
the chief science advisor for the Project on Emerging 
Nanotechnologies at the Woodrow Wilson International Center for 
Scholars, and this is also a partnership with the Pew 
Charitable Trusts. But obviously, my comments here are my own 
personal opinions.
    I have had over 15 years research experience looking at 
nanoscale materials. I have also spent some time in the Federal 
Government, and I have had the great pleasure of co-chairing 
the NEHI Working Group at its inception with my colleague, Dr. 
Alderson, who is sitting here.
    I would like to begin my testimony by telling you a story.
    Imagine a successful businessman who decides to build a new 
mansion. He gathers together 20 of the best builders in America 
and tells them to construct his dream home. Sure enough, the 
details within the mansion are impeccable: Italian marble 
countertops, vaulted ceilings, exotic hardwood floors. Yet, 
without the direction of an architect or master plan, the 
overall building is an incoherent mess.
    The point, I think, is obvious: you can't embark on a 
complex project unless you know where you are going and have at 
least some idea of how to get there. Yet, this seems to be 
where we are with research aimed at ensuring the safety of 
emerging nanotechnologies.
    Without a doubt, the Federal Government is funding 
innovative and ground-breaking research in this area. As my 
colleagues on this panel have just alluded to, you have heard 
some excellent examples of what they are doing. But these 
programs arise from the vision of individual scientists and 
research leaders within the agencies, and only coincidentally 
give the fleeting illusion of coherence.
    Nanotechnology, as has already been said, is no longer a 
scientific curiosity. It is already in the workplace, the 
environment, and the home. If we are to realize the benefits, 
we need a master plan for identifying and reducing potential 
risks. This plan should include a top-down research strategy, 
sufficient funding to do the job, and mechanisms to ensure 
resources are used as effectively as possible.
    Let me address each of those points in turn.
    Nanotechnology, as my colleague from EPA has said, is 
complex. In fact, it is far too complex for disjointed, bottom-
up research agendas to answer critical questions on safety. The 
only viable alternative is a top-down, strategic research 
framework. This should identify what needs to be done and when 
in order to provide regulators, industry, and others with the 
knowledge they need to ensure safe nanotechnologies.
    Without the high-level perspective embodied in a top-down 
strategy, the emergence of safe nanotechnologies will be 
coincidental rather than intentional. But a strategy without 
sufficient resources will be ineffective. In my estimation, the 
Federal Government needs to invest a minimum of $100 million in 
targeted research over the next two years in order to lay a 
strong science-based foundation for safe nanotechnology. This 
is largely in addition to current research funding, which, from 
my analysis, is closer to $11 million per year rather than the 
National Nanotechnology Initiative's stated $37 million to $44 
million per year.
    Targeted research will address specific problems involving 
the potential impact of nanotechnology, but it also must be 
complemented by more basic exploratory research that develops 
the scientific knowledge needed to identify and address future 
risks.
    And finally, mechanisms. Mechanisms are needed to support 
and enable the right research. These must ensure targeted 
research is led by agencies charged with protecting human 
health and the environment and supported by those agencies with 
the resources and the ability to do the job. But they must also 
support partnerships that provide innovative solutions to new 
challenges. In particular, government and industry need to work 
together to address specific issues, and on this point, I am 
recommending that a jointly funded nanotechnology and health 
impact research initiative is established within the Health 
Effects Initiative--Institute. Sorry.
    So in closing, I come back to the fundamental question 
driving this hearing: ``Do federal agencies have a coherent, 
adequately resourced research strategy, which will answer the 
questions industry needs to develop nanotechnology safely and 
which will ensure the public that nanotechnology is being 
managed wisely?''
    If the report that we just had released this morning from 
the NEHI Working Group is anything to go by, I must conclude 
that there is still a long, long way to go. Lists of research 
needs are useful, and I don't want to detract from the 
expertise represented in this report. I think it is a very 
useful report. But a list is not a research strategy, and 
without a strategy, it becomes very, very hard, indeed, to 
differentiate truly relevant research from that which, in all 
honesty, isn't relevant at all.
    In the meantime, people are asking, ``What do I do to 
ensure the safety of nanotech products?'' To answer them, the 
government needs a master plan, and it needs it soon.
    Thank you.
    [The prepared statement of Dr. Maynard follows:]

                Prepared Statement of Andrew D. Maynard

    I would like to thank Chairman Sherwood Boehlert, Ranking Member 
Bart Gordon, and the Members of the House Committee on Science for 
holding this hearing on ``Research on Environmental and Safety Impacts 
of Nanotechnology: What Are the Federal Agencies Doing?''
    My name is Dr. Andrew Maynard. I am the Chief Science Advisor to 
the Project on Emerging Nanotechnologies at the Woodrow Wilson 
International Center for Scholars. I am an experienced researcher in 
the field of nanomaterials and their environmental and health impacts, 
and have contributed substantially in the past fifteen years to the 
scientific understanding of how these materials might lead to new or 
different environmental and health risks. I was responsible for 
stimulating government research programs into the occupational health 
impact of nanomaterials in Britain towards the end of the 1990's and 
have spent five of the past six years developing and coordinating 
research programs at the Centers for Disease Control and Prevention 
(CDC) National Institute for Occupational Safety and Health (NIOSH) 
that address the safety of nanotechnologies in the workplace. While at 
NIOSH, I represented the agency on the Nanoscale Science, Engineering 
and Technology (NSET) Subcommittee of the National Science and 
Technology Council (NSTC), and was co-chair of the Nanotechnology 
Environmental and Health Implications (NEHI) Working Group from its 
inception.
    The Project on Emerging Nanotechnologies is an initiative launched 
by the Woodrow Wilson International Center for Scholars and The Pew 
Charitable Trusts in 2005. It is dedicated to helping business, 
government and the public anticipate and manage the possible health and 
environmental implications of nanotechnology. As part of the Wilson 
Center, the Project on Emerging Nanotechnologies is a non-partisan, 
non-advocacy organization that collaborates with researchers, 
government, industry, non-governmental organizations (NGOs), and others 
concerned with the safe applications and utilization of nanotechnology.
    Our goal is to take a long-term look at nanotechnologies; to 
identify gaps in the nanotechnology information, data, and oversight 
processes; and to develop practical strategies and approaches for 
closing those gaps and ensuring that the benefits of nanotechnologies 
will be realized. We aim to provide independent, objective information 
and analysis that can help inform critical decisions affecting the 
development, use, and commercialization of responsible nanotechnologies 
around the globe.
    In short, both the Wilson Center and The Pew Charitable Trusts 
believe there is a tremendous opportunity with nanotechnology to ``get 
it right.'' Societies have missed this chance with other new 
technologies and, by doing so, have made costly mistakes.
    As a scientist, I am awed by the vast potential of nanotechnology. 
I also understand the thrill of making new discoveries and turning them 
into societal or economic gain. But through my work in occupational 
health, I also understand the very real dangers of proceeding without 
due caution. Make no mistake, nanotechnology is different, and there 
will be some materials and products developed under this banner that 
have the potential to cause harm. The challenge we face is how to 
recognize and manage this possibility ahead of time and deal with it. 
The stakes are high: not only are human health and the environment 
potentially at risk, but so is the ``health'' of nano-commerce. If 
investors and consumers reject nanotechnology through fear and 
uncertainty, missed opportunities in areas like medical treatment and 
energy production could deal a severe blow to the quality of life and 
the future economic well-being of this country.

Are current federal and private research efforts adequate to address 
concerns about environmental and safety impacts of nanotechnology? Are 
there gaps in the portfolio of federal research currently underway; if 
so, in what areas?

    The long-term solution must be to reduce uncertainty about the 
possible health and environmental impacts of nanotechnology through 
systematic scientific research. Perhaps uniquely in regards to an 
emerging technology the Federal Government and industry have moved to 
understand the potential risks of nanotechnology at an early stage. The 
21st Century Nanotechnology Research and Development Act\1\ and the 
NEHI Working Group within NSET are testaments to the attempts of this 
government to act early to minimize potential risks. Yet these good 
intentions do not seem to have translated into hard information 
regarding how to avoid risks and develop safe nanotechnologies. The 
fact is that nanotechnology is a reality now--in workplaces and in the 
marketplace: Every day, people are asking questions like ``how safe is 
this product?'', ``how do I protect myself?'', and ``what happens to 
this material in the environment?'' These are questions that we do not 
yet have answers for, and for which we do not yet have a clear pathway 
to finding answers anytime soon. Our inability to provide clear and 
timely answers can ultimately jeopardize the ability of government and 
industry to reap the economic and social benefits of billions of 
dollars of R&D investments.
---------------------------------------------------------------------------
    \1\ U.S. Congress (2003). 21st Century Nanotechnology Research and 
Development Act (Public Law 108-153), S.189 Washington DC, 108th 
Congress, 1st session.
---------------------------------------------------------------------------
    Part of the problem is that nanotechnology is complex--no single 
agency, research group or even scientific discipline is able to grapple 
with the challenges it presents without collaborating and working with 
others. This is not a problem we can solve piecemeal--effective 
solutions will require top-down direction and coordination if we are to 
remove the uncertainty surrounding nanotechnology and potential risk.
    In a recent study, Nanotechnology: A Research Strategy for 
Addressing Risk, I considered what needs to happen if critical research 
questions are to be addressed.\2\ Drawing on previously published 
papers from government, industry, academia and NGOs, the report--which 
is included with this testimony--identifies and prioritizes critical 
research needs and makes specific recommendations on how to develop an 
effective strategic research framework. In assessing the current risk 
research situation, it became very clear that current federal 
coordination of nanotechnology research is not sufficient to ensure 
that timely and relevant information on minimizing and managing 
nanotechnology's risks is being developed.
---------------------------------------------------------------------------
    \2\ Maynard, A.D. (2006). Nanotechnology: A Research Strategy for 
Addressing Risk, PEN 03 Washington DC, Project on Emerging 
Nanotechnologies, Woodrow Wilson International Center for Scholars. 
Available at www.nanotechproject.org.
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    In particular, the relevant agencies are under pressure, because 
they are under-resourced and struggling without adequate leadership or 
broad strategic direction. I see no evidence of foresight; of the 
government looking longer-term to identify emerging risks that may 
appear as nanotechnology becomes more complex and converges with 
biotechnology. Without better foresight, there is little hope that the 
government will be positioned to underpin regulation with good science, 
or provide solid answers to questions that the public will inevitably 
raise about the risks of nanotechnologies. Individual agencies such as 
NIOSH, the Environmental Protection Agency (EPA), the National 
Institutes of Health (NIH) and the National Science Foundation (NSF) 
are doing their best to develop research programs from the bottom-up--
in some cases with very limited resources. But these disconnected 
research programs will not make a significant difference in ensuring 
safe nanotechnologies without sweeping changes to the way 
nanotechnology risk research is directed and supported at the federal 
level.
    The current approach leads to some perplexing oddities. For 
example, it is widely accepted that research into assessing and 
preventing health risks in the workplace is critical to the success of 
nanotechnologies. However, the anticipated increase in risk-related 
research funding for the National Science Foundation between 2006 and 
2007 (an increase of $3.6 million, from $22.1 million to $25.7 
million), far exceeds the total requested nanotechnology risk research 
budget for the National Institute for Occupational Safety and Health in 
2007 ($3 million).\3\ If these figures accurately reflect the Federal 
Government's current priorities, then it is clear that ensuring safe 
nanotechnology workplaces is not high on the list--particularly since 
the mandate of NSF is basic research and not mission-driven 
environmental and human-health studies.
---------------------------------------------------------------------------
    \3\ NSET (2006). The National Nanotechnology Initiative: Research 
and Development Leading to a Revolution in Technology and Industry 
Supplement to the President's FY 2007 Budget, Washington, DC, 
Subcommittee on Nanoscale Science, Engineering and Technology, 
Committee on Technology, National Science and Technology Council.
---------------------------------------------------------------------------
    Of course, numbers alone can be misleading: What is important is 
the research that those numbers represent. It is obvious that without 
knowing where you are, you cannot plan how to get where you want to be. 
If federal research addressing the potential risks of nanotechnology is 
to be strategic, transparent and relevant, we need to know what is 
being done and what is being missed. Unfortunately, information as to 
what risk-related research is currently being carried out is not 
readily available from or even within the Federal Government. National 
Nanotechnology Initiative (NNI) representatives have noted that it is 
hard to tease out risk-related projects from the general mix of the 
government's nanotechnology research portfolio. However, without a more 
precise understanding of what U.S. Government funded investigators are 
studying, the reported figures tell us nothing about whether the right 
questions are being asked--and answered--in order to ensure 
nanotechnology's safe management. It is important to emphasize that 
this research by the government is being supported by public funds and 
it is ultimately the public--as workers or consumers, for instance--
that may bear many of the potential risks related to nanotechnology. 
Project-by-project data on what the government is funding to understand 
and mitigate risks should be placed in the public realm now.

What should be the priority areas of research on environmental and 
safety impacts of nanotechnology? How should the responsibility for 
funding and conducting this research be divided among the federal 
agencies, industry, and universities?

    Recognizing this information gap, last year the Project on Emerging 
Nanotechnologies compiled and published an inventory of current 
nanotechnology risk-related research.\4\ The inventory is publicly 
accessible on-line, fully searchable, and classifies research to allow 
a clear picture of what is currently being done. The inventory first 
and foremost confirms that a substantial body of research is being 
funded to try and understand the potential impacts of nanotechnology on 
human health and the environment. In 2005, we estimate that the annual 
U.S. Federal Government in research with some relevance to 
nanotechnology risks was over $30 million. However, it is unclear how 
relevant this research is to reducing the current uncertainty over 
nanotechnology's health and environmental impacts, providing guidance 
for emerging oversight regimes at agencies such as EPA and FDA, or 
answering increasing numbers of public questions and concerns over the 
safety of nanotech-related products and applications.
---------------------------------------------------------------------------
    \4\ Nanotechnology Health and Environmental Implications: An 
Inventory of Current Research. www.nanotechproject.org/18 Accessed 
September 12th 2006.
---------------------------------------------------------------------------
    Two examples serve to highlight an apparent disconnect between the 
Federal Government's research agenda and what is needed to illuminate 
any hazards related to nanotechnology. The first example draws on the 
Project on Emerging Nanotechnologies' inventory of nanotechnology-based 
consumer products,\5\ and compares the prevalence of nanomaterials in 
these products to research into their potential impacts. In Figure 1, I 
compare research into the impact of six nanomaterials--carbon, silver, 
silica, titanium, zinc and cerium--to the number of consumer products 
known to be using these materials.
---------------------------------------------------------------------------
    \5\ A Nanotechnology Consumer Products Inventory. 
www.nanotechproject.org/consumerproducts Accessed September 12th 2006.
---------------------------------------------------------------------------
    Although this is a very subjective exercise, it shows the vast 
majority of the material-specific risk research is focused--
disproportionately it would seem--on carbon-based nanomaterials. At the 
time of the analysis, carbon-based nanomaterials accounted for just 34 
percent of listed consumer products, while silver accounted for 30 
percent of listed products, and silica and metal oxides such as silica, 
titanium dioxide, zinc oxide and cerium oxide accounted for 36 percent 
of listed products. In other words, risk research does not appear to be 
in step with current market realities.




    The second example considers the number of research projects that 
are probing the potential effects of nanomaterials on different parts 
of the body--the lungs, the skin, the central nervous system, the 
cardiovascular system and the gastrointestinal tract. Figure 2 
indicates that current human hazard research appears to focus heavily 
on nanomaterials in the lungs (24 projects), while no projects are 
specifically addressing the potential effects of nanomaterials in the 
gastrointestinal tract. Given the large number of current and future 
nano-products that are intended to be eaten--such as food and 
nutritional supplements--this is a curious and serious omission.




    These examples indicate that current federally funded research is 
not addressing the general range of risks that may already be present 
in the market and that risk research is not guided by a careful 
consideration of needs--today or tomorrow. Why is there so little 
research on nanomaterials in use now? Is the emphasis on lung impacts 
due to careful consideration of relative risks, or because pulmonary 
toxicologists are more active in this field?
    Having cataloged information on current risk-research, the Project 
on Emerging Nanotechnologies (PEN) was able to go back and check the 
validity of published government funding figures. Comparing estimates 
of federal spending on nanotechnology risk research from our research 
inventory to figures published by NSET tells an interesting story. 
Table 1 compares the NSET figures with PEN-estimated annual funding for 
research which is highly relevant to understanding risk and research 
which has some degree of relevance.




    Highly-relevant research covers projects with the specific aim of 
understanding the potential risks of nanotechnology, and includes areas 
such as using a life-cycle approach to evaluate the impact of future 
nanotechnologies (EPA), and evaluating assessment methods for 
nanoparticles in the workplace (NIOSH). On the other hand, research 
with some degree of relevance includes projects that are not focused on 
nanotechnology risk, but nevertheless have the potential to shed some 
light on our understanding of risk. Examples include studying the 
formation of nano-droplets (NSF), developing biosensors for metals 
(EPA) and controlling exposure to welding fumes (NIOSH).
    There is close agreement between the NSET estimate for highly-
relevant risk research and the Project on Emerging Nanotechnologies 
estimate of research with some degree of relevance. When the Project on 
Emerging Nanotechnologies estimate of research that is highly relevant 
to engineered nanomaterials is compared to the NSET estimate, the gap 
widens considerably. Based on all available information, we estimate 
that only $11 million per year is being spent on research that is 
highly relevant to nanotechnology risks, compared to NSET's estimate of 
$38.5 million per year. That gap is too large to be explained by the 
different reporting periods or a lack of agency disclosure.

What elements should the forthcoming report on research needs produced 
by the National Nanotechnology Environmental and Health Implications 
Working Group contain to adequately guide federal research investment 
in this area? What additional steps are needed to improve management 
and coordination of federal research on the environmental and safety 
impacts of nanotechnology?

    The evidence before us strongly suggests that current federal 
research efforts are not adequate to address concerns arising about the 
environmental, health and safety impacts of nanotechnology. There are 
clear gaps in the research portfolio in determining potential hazard, 
evaluating exposure, controlling releases of nanomaterials, determining 
potential impact and managing risk. But I am more concerned over the 
lack of an apparent top-down strategy that couples risk research to 
real information needs. Without such a strategy, it is next to 
impossible to identify clearly where the gaps are and how best to 
address them. Implicit in a strategy is the setting of hard priorities, 
the linking of these priorities to actual multi-year funding levels, 
and the development of metrics to measure results over time. There is a 
large difference between a strategy and a list of research needs.
    A government strategy must also consider and integrate industry 
issues and, ultimately, enable collaborative funding. Much less 
information is available on industry-based risk research and testing 
programs. Some initiatives shine out, such as the research consortium 
led by DuPont to develop measurement methods and research supported by 
the International Council On Nanotechnology (ICON) into good workplace 
practices. But these are the exception--most nanotechnology industries 
are looking to the government for guidance on what should be done and 
are coming up against a brick wall. This means that we not only lack a 
coherent government strategy, but we lack a coherent public-private 
sector strategy, and we certainly have no international strategy to 
address risks in a timely manner.
    With the right leadership from the Federal Government, effective 
research programs and partnerships can be developed that will lead to 
safe nanotechnologies. In the attached report, I make a number of 
recommendations on what needs to be done in the next two years. Here, I 
would like to focus on three specific recommendations for developing a 
strong federal research agenda that simultaneously reduces uncertainty 
as fast as possible and serves the needs of regulators, industry and 
other stakeholders:

          Develop a top-down strategic risk-research framework 
        within the Federal Government;

          Adequately fund strategic risk-focused research, with 
        an investment of #at least $100 million, over the next two 
        years; and

          Support a joint government-industry funded 
        cooperative science organization, with a five-year plan to 
        systematically address the human health impacts of engineered 
        nanomaterials through independent, targeted research.

    Although not comprehensive, I believe making advances in each of 
these three areas, as I will explain in more detail, will lead to 
effective research programs that serve the needs of various end-users.

Develop a top-down strategic risk-research framework within the Federal 
Government.

    Nanotechnology is no longer confined to the laboratory; it is a 
commercial reality now.\7\ As our ability to make new materials, 
devices and products through nanoscale engineering becomes increasingly 
sophisticated, researchers, workers and the public are raising real 
concerns over what the possible impacts to their health and the 
environment will be. These are concerns that can only be addressed 
through systematic, targeted and coordinated research.
---------------------------------------------------------------------------
    \7\ An on-line Project on Emerging Nanotechnologies inventory 
identifies nearly 300 nanotechnology-based consumer products 
(www.nanotechproject.org/consumerproducts). These represent the tip of 
the commercial nanoproduct iceberg. Lux Research estimates that $32 
billion worth of nanotechnology-enabled products were sold in 2005 
(www.luxresearchinc.com/press/RELEASE-TNR4.pdf).
---------------------------------------------------------------------------
    Bottom-up, or investigator and agency-driven research, is highly 
effective at generating new knowledge. However, it will never have the 
context and perspective to holistically address issues arising from 
technology development and implementation. Instead, a top-down approach 
is essential, one that maps out necessary areas of research, 
prioritizes critical needs and provides support and direction for 
research agencies. In effect, a top-level framework is needed that 
enables scientists and research agencies to do their job as effectively 
as possible, to the best of their ability.
    Where resources are limited, a top-down approach is the only way of 
ensuring that the necessary research is done within budgetary 
constraints and in a timely manner. The danger of not coordinating 
direction and resources from the highest levels is that research 
becomes unfocused and untargeted--and ultimately ineffective. It is 
irresponsible to spend millions of dollars on building a better 
microscope in the name of risk research when we cannot tell workers how 
effective their respirators are when working with nanomaterials!
    An effective top-down strategic framework must identify and 
prioritize critical research needs within the context of oversight and 
regulation. But it must also have teeth--it must have the authority to 
ensure that research priorities can be met through the provision of 
sufficient resources, the support of key agencies and the use of 
effective and relevant research and development mechanisms. It also 
must enable collaboration and partnerships between researchers, 
agencies and other organizations. As I have mentioned previously: 
nanotechnology is complex, and progress will only be made by working 
together.
    While the NEHI Working Group has been effective in getting research 
agencies talking about risk, it has shown little evidence of leadership 
in setting and implementing a strategic research agenda. Although the 
NEHI Terms of Reference focus on supportive roles of information 
sharing and communication,\8\ the Working Group has no clear authority 
to direct research from the top down. To be truly effective in removing 
uncertainty surrounding the potential impacts of nanotechnologies, a 
new interagency oversight group should be established with authority to 
set, implement and review a strategic risk research framework. This 
group would be responsible for developing a top-level strategic 
framework that would serve as a guide for the coordination and conduct 
of risk-related research in relevant agencies. It would have the 
authority to set and implement a strategic research agenda and assure 
that agencies are provided with appropriate resources to carry out 
their work. The group would direct efforts to provide a strong 
scientific basis for regulatory decisions, thus bridging the existing 
gap between the need for oversight and our poor technical understanding 
of nanotechnology risks. It would also ensure that the results of risk-
relevant research are put to practical uses, including education and 
outreach programs. In addition, the group would ensure that risk-
related research is coordinated between industry and government and 
between the U.S., other countries and international organizations.
---------------------------------------------------------------------------
    \8\ Interagency Working Group on Nanotechnology Environmental and 
Health Implications (NEHI WG): www.nano.gov/html/society/NEHI.htm 
Accessed September 12th 2006.
---------------------------------------------------------------------------
    In order to establish a long-term research agenda, the group must 
draw on the expertise of stakeholders, as well as government and non-
government experts. I would strongly recommend that the National 
Academies are commissioned to conduct an independent, rolling review of 
research needs and priorities, which informs the strategic risk 
research framework.

Adequately fund strategic risk-focused research, with an investment of 
at least $100 million, over the next two years.

    Once a research strategy is in place, it must be funded at 
realistic levels if it is to be successful. In my analysis of short-
term strategic needs, I estimated the minimum level of funding needed 
to address critical questions by estimating the cost of the most 
important immediate research areas. From this analysis, a minimum of 
$100 million should be invested in targeted, highly relevant 
nanotechnology risk research over the next two years if significant 
progress is to be made. This is a substantial increase in the estimated 
$11 million per year currently being spent on risk-specific 
research.\9\ Funding should be tied to a top-level strategic risk 
research framework, and it should support agencies with missions and 
competencies to assess and reduce harm to people and the environment, 
such as NIOSH, EPA and the National Institute of Environmental and 
Health Sciences (NIEHS). But, it should also leverage the research 
expertise and facilities of agencies such as the Department of Energy 
(DOE) and NSF.
---------------------------------------------------------------------------
    \9\ Maynard, A.D. (2006). Nanotechnology: A Research Strategy for 
Addressing Risk, PEN 03 Washington, DC, Project on Emerging 
Nanotechnologies, Woodrow Wilson International Center for Scholars. 
Based on data published in the Project on Emerging Nanotechnologies 
inventory of nanotechnology EH&S research (www.nanotechproject.org/18). 
This figure does not include recent increased EPA investment in 
nanotechnology risk research.
---------------------------------------------------------------------------
    Critical research is needed that addresses risk assessment, 
environmental impact, human health impact and hazard prediction. In 
Table 2, I outline the highest research priorities--based upon my 
previously published analyses of research needs--and identify agencies 
that are ideally placed to lead these research efforts.




Support the formation of a joint government-industry funded cooperative 
science organization, with a five-year plan to systematically address 
the human health impact of engineered nanomaterials through 
independent, targeted research.

    The success of a strategic risk research framework for 
nanotechnology will depend critically on the mechanisms used to 
implement research. Federally-funded research must be systematic and 
targeted, if it is to answer questions being asked by industry and the 
public. But progress will also depend on collaborating and partnering 
with other stakeholders--particularly industry.
    Industries investing in nanotechnology have a financial stake in 
preventing harm, manufacturing safe products and avoiding long-term 
liabilities. Yet, with a few exceptions, most of the questions that 
need answering are too general to be dealt with easily by industry 
alone. Perhaps more significantly, the credibility of industry-driven 
risk research is often brought into question by the public and NGOs as 
not being sufficiently independent and transparent. It seems that the 
current state of knowledge is sufficient to cast doubt on the safety of 
some nano-industries and products, but current information lacks the 
credibility for industry to plan a clear course of action on how to 
mitigate potential risks. Getting out of this ``information trap'' is a 
dilemma facing large and small nanotechnology industries alike.
    One way out of the ``trap'' is to establish a cooperative science 
organization, tasked with generating independent, credible data that 
will support nanotechnology oversight and product stewardship. The 
organization would leverage federal and industry funding to support 
targeted research into assessing and managing potential nanotechnology 
risks. The success of such an organization would depend on four key 
attributes:

         Independence. The selection, direction and evaluation of 
        funded research must be science-based and must be fully 
        independent of the business and views of partners in the 
        organization.

         Transparency. The research, reviews and the operations of the 
        organization must be fully open to public scrutiny.

         Review. Research supported by the organization must be 
        independently and transparently reviewed.

         Communication. Research results must be made publicly 
        accessible and fully and effectively communicated to all 
        relevant parties.

    A number of research organizations have been established over the 
years that comply with some of these criteria. Yet, perhaps the 
organization most successful and relevant to nanotechnology is the 
Health Effects Institute (HEI).
    HEI was established in 1980 as a non-profit research institution 
focused on providing ``high-quality, impartial, and relevant science'' 
around the issue of air pollution and its health impacts.\11\ The 
Institute is committed to supporting risk-relevant research through 
anticipating the needs of policy-makers and scientists and by 
identifying the underlying questions propping up policy arguments and 
research priorities. Additionally, the production of timely scientific 
evidence is crucial to allow for decisions to be made within 
appropriate product development cycles.
---------------------------------------------------------------------------
    \11\ Health Effects Institute (HEI) Website. ``What is the Health 
Effects Institute.'' Available at www.healtheffects.org/about accessed 
July 27th 2006.
---------------------------------------------------------------------------
    The HEI research model is unique in a number of ways. New research 
projects are chosen based on a competitive proposal process. This 
project selection process is similar to those employed by NSF and NIH, 
but it includes added attention to the policy relevance of scientific 
research. Once projects are selected for support, HEI issues 
contracts--not grants--to investigators. This is a unique component of 
the HEI process, and it allows the organization to benefit from the 
most creative proposals from the science community but still have much 
greater control over the scope of work and the final products to ensure 
their relevance to decisions. Close control over research enables HEI 
to aggressively manage investigations by monitoring progress and 
terminating projects that are not meeting established standards.
    Once projects are funded, strict quality control is followed. Both 
HEI staff and independent investigators audit and review project 
quality. HEI's strict adherence to their quality control guidelines and 
rigorous peer reviews serves as potent defense against possible 
detractors. While this quality control does come at the cost of 
burdening investigators with more numerous reviews, it also serves to 
strengthen the validity of the data when applied in the policy realm 
and has raised HEI to a place among the most respected research 
organizations in the world.
    Finally, supported research undergoes independent peer review and 
policy relevance critique. This process allows for thorough review 
prior to publication of a comprehensive report by HEI. The findings of 
any dissenting critiques are published along with final reports. In 
turn, all results are openly published in HEI's reports, both positive 
and negative, so that industry professionals and policy-makers can 
better understand how the investigators reached their conclusions.\12\ 
Since these results are presented in a highly transparent manner and 
are available at varying levels of detail, they are accessible to a 
wide variety of audiences. In addition, after reports are released, HEI 
monitors their use and strives to ensure that the full range of 
conclusions is considered by decision-makers in order to maintain their 
scientific integrity.\13\
---------------------------------------------------------------------------
    \12\ HEI Annual Report 2005, p. 6.
    \13\ HEI Annual Report 2005, p. 6.
---------------------------------------------------------------------------
    HEI has funded over 250 studies in North America, Europe and Asia 
on a variety of topics, including carbon monoxide, air toxics, nitrogen 
oxides, diesel exhaust, ozone and particulate matter. The organization 
credits its success to five key factors: effective governance, joint 
industry-government funding, quality science, no advocacy and 
communication. Members constituting the HEI Board of Directors are 
chosen based upon their independence of any interests that could 
constitute bias, and this level of independence is extended down 
through the committees and staff. Individuals selected to the board are 
dually approved by stakeholders on both sides. The board of directors 
is charged with screening for potential conflicts of interest, 
overseeing staff, appointments to panels and the selection of 
researchers.
    The HEI model is ideally suited to generating the credible and 
relevant information necessary to develop safe nanotechnologies. 
Developing a program using such a model would complement federal 
research into the potential risks of nanotechnology and would provide 
industry and regulatory agencies with needed information on managing 
possible health and environmental impacts. HEI could well be used as a 
template for establishing a separate ``Nanotechnology Effects 
Institute.'' But it would be more expedient to develop a nanotechnology 
risk research program within HEI. For this to occur, four conditions 
would need to be met:

          Commitment by HEI to develop a nanotechnology risk 
        research program.

           Informal discussions with HEI have indicated a willingness 
        to consider extending the Institute's research portfolio to 
        addressing nanotechnology and potential risks. Successful 
        development of such a research program will depend on long-term 
        funding commitments from government and industry and a 
        targeted, relevant research agenda.

          Commitment from the Federal Government to jointly 
        fund research.

           A successful program will depend on matched federal-industry 
        funding, over a minimum of five years. Federal funding levels 
        of at least $10 million over that time frame will be needed to 
        ensure a coherent, relevant and influential research program 
        and to attract industry funding. Currently, most government 
        funding for HEI comes from EPA, with one half from the research 
        arm and one half from the program/regulatory side. This allows 
        for a tight link between research and regulation and the 
        provision of a solid scientific underpinning for oversight. 
        This approach can be followed for nanotechnology but should be 
        expanded to consider research needs of agencies beyond EPA, 
        such as FDA.

          Commitment from industry to jointly fund research.

           Likewise, establishing a successful research program will 
        depend on a matching financial commitment from industry of at 
        least $10 million over the next five years. Provisions should 
        be made to integrate research issues from small business and 
        start-up firms.

          A relevant and robust strategic research agenda.

           The success of a HEI-based nanotechnology risk research 
        program will depend on identifying research areas that 
        complement federal research, while responding directly to 
        industry needs. Based on my analysis of critical research 
        needs, I would propose that the initial emphasis of such a 
        research agenda should focus on understanding and reducing the 
        potential toxicity of engineered nanomaterials in humans. Table 
        3 lists a suite of research projects, along with estimated 
        funding levels, which could form the backbone of a credible 
        five-year research program. Of course, an expert oversight 
        committee convened by an organization like HEI could--with 
        broad input from the science and regulatory communities--review 
        these priorities rapidly and finalize a set of targeted 
        priorities to be sought in a first Request for Applications.

    It must be emphasized that this proposed program would complement, 
and not replace, either federal or industry research programs and that 
the estimated $20 million over five years is in addition to funding 
levels recommended for government-specific research.




Conclusions

    Nanotechnology is a reality now, and our ability to produce ever-
more sophisticated materials, processes and products by engineering at 
the nanoscale will only increase over the coming years. Yet our 
understanding of the potential environmental, safety and health impacts 
of these emerging technologies is rudimentary at best.
    Government and industry have been commendably astute in recognizing 
the possibility of new risks arising from emerging nanotechnologies at 
an early stage. But over a decade after the first indicators of 
nanostructured material-specific hazards were published, risk-based 
research remains poorly focused and under funded. Current federal 
research programs are unlikely to provide answers where they are most 
needed, and needed they are--especially since a proper understanding of 
risks is the only way to assure the emergence of economically viable 
technologies that do not harm people or the environment.
    In this testimony, I have examined where current research 
strategies are lacking, and what can be done to ensure that future 
research is effective in reducing uncertainty surrounding the safety of 
nanotechnologies. In particular, I highlighted the need to develop a 
top-down strategic risk-research framework within the next six months 
and the need to adequately fund risk research--with an investment of at 
least $100 million over the next two years. I also proposed 
establishing a five-year, $20 million joint government-industry risk 
research partnership through the Health Effects Institute that will 
complement federal research initiatives.
    As the recommendations presented above begin to be implemented, it 
is clear that a host of questions remain to be addressed, including:

          How are federal agencies ensuring that nanotechnology 
        risk research information is being made widely available to the 
        public, researchers, and small businesses?

          How can the risk-related research needs of small 
        nanotechnology businesses and start-ups be integrated into a 
        comprehensive government-industry strategy?

          How is the Federal Government translating risk-based 
        research into effective guidance on working with and using 
        nanotechnology-based products as safely as possible?

          What plans does the Federal Government have to 
        closely coordinate risk research at a global level?

          What processes are in place that will allow the 
        government to better anticipate and address future risks, 
        especially as nanotechnology becomes more complex and converges 
        with biotechnology?

          How much is the Federal Government spending to design 
        and engineer risks out of nanotechnology processes and products 
        (rather than just addressing them after the fact)?

    In closing, let me say that I have tremendous respect for the 
researchers who are working to understand the potential impacts of 
nanotechnology on human health and the environment. It is through their 
efforts that we now know many of the key issues that need to be 
addressed in order to make nanotechnology safe. However, for these 
researchers and research directors to be effective, they must be better 
supported with the necessary financial, human and strategic resources 
that they need. By taking action now, we have the opportunity to 
realize the full potential nanotechnology has to offer, without 
creating a legacy of harm to human health and the environment.

                    Biography for Andrew D. Maynard

    Dr. Andrew Maynard serves as the Science Advisor to the Project on 
Emerging Nanotechnologies. He is internationally recognized as a 
research leader and lecturer in the fields of aerosol characterization 
and the implications of nanotechnology to occupational health. He 
trained as a physicist at Birmingham University (UK), and after 
completing a Ph.D. in ultra-fine aerosol analysis at the Cavendish 
Laboratory, Cambridge University (UK) joined the Aerosols Research 
Group of the UK Health and Safety Executive.
    In 2000, Dr. Maynard joined the National Institute for Occupational 
Safety and Health (NIOSH), part of the U.S. Centers for Disease Control 
and Prevention (CDC). At NIOSH, he established a groundbreaking 
research program in ultra-fine aerosol analysis, and was instrumental 
in developing NIOSH's nanotechnology research program. This research 
was at the forefront of international scientific efforts to better 
understand the occupational health implications of nanomaterials, and 
to develop guidance on workplace exposures in this burgeoning industry. 
While at NIOSH, Dr. Maynard was a member of the Nanomaterial Science, 
Engineering and Technology subcommittee of the National Science and 
Technology Council (NSET). He also co-chaired the Nanotechnology Health 
and Environment Implications (NEHI) working group of NSET. Both are a 
part of the National Nanotechnology Initiative (NNI), the federal 
research and development program established to coordinate the U.S. 
Government's annual $1 billion investment in nanoscale science, 
engineering, and technology.
    Dr. Maynard was Co-Chair of the first two international conferences 
on nanotechnology and occupational health, and is affiliated with many 
organizations and initiatives exploring the responsible and sustainable 
development of nanotechnology. He is a member of the Executive 
Committee of the International Council On Nanotechnology (ICON), and 
until recently, chaired the International Standards Organization 
Working Group on size selective sampling in the workplace. He holds an 
Associate Professorship at the University of Cincinnati (OH), and is an 
Honorary Senior Lecturer at the University of Aberdeen (UK). His 
expertise covers many facets of scientific research and policy, from 
occupational aerosol sampler design to recommendations on strategic 
nanotechnology research, as reflected in over 70 professional 
publications. Dr. Maynard is a regular international speaker on 
nanotechnology, and frequently appears in print and on radio and 
television.



    Chairman Boehlert. Thank you very much, Dr. Maynard.
    Mr. Nordan.

  STATEMENT OF MR. MATTHEW M. NORDAN, PRESIDENT, DIRECTOR OF 
                  RESEARCH, LUX RESEARCH, INC.

    Mr. Nordan. Good morning, Chairman Boehlert, Ranking Member 
Gordon, and Members of the Committee, and thank you for 
inviting me to speak today.
    My company, Lux Research, conducts hundreds of interviews 
and advisory sessions each year with companies that are 
commercializing nanotechnology. In this testimony, I will 
attempt to synthesize their views.
    Ten months ago, this committee held its first hearing on 
nanotech EHS risks, and since then, commercialization has shot 
forward, and academic research on nanoparticle toxicity has 
broadened. However, when it comes to coordinate government 
action to address risk, very little has changed, and the status 
quo remains inadequate.
    From the perspective of industry, nanotechnology EHS 
concerns fall into three categories: real risks, perceptual 
risks, and regulatory risks. Real risks represent the 
possibility that nanoparticles may harm workers or consumers or 
the environment. Although new publications in the last year 
have somewhat revised judgments about real risks, research is 
still extremely thin on the ground. Only about one-half of one 
percent of the 81,000 journal articles on toxicology since 2000 
so much as mention nanomaterials.
    The second concern, perceptual risks, is the threat that 
even if nanoparticles were shown to be entirely benign, public 
skepticism could still make their commercial use untenable. In 
the United States, consumer perceptions of nanotech remain 
unchanged. Citizens remain uninformed but favorably 
predisposed. What has changed is the aggressiveness of non-
governmental organizations that are hostile to nanotech, 
particularly outside the United States. When the French 
government's Ninetech nanotechnology research center opened in 
May, protesters stormed conference rooms and accosted 
scientists on the street.
    The final concern seen by industry is regulatory risks, 
worry that the playing field will shift underneath them. Now 
this concern isn't what you might expect. Corporate EHS 
officers consistently want to see regulation that will help 
them plan, yet regulatory ambiguity persists. While companies 
are pleased about how the EPA, in particular, has communicated 
with them, they are also frustrated by how slow the EPA has 
been to set specific guidance, namely its long-proposed 
voluntary stewardship program for nanomaterials.
    These three concerns, real risks, perceptual risks, and 
regulatory ambiguity, are adversely impacting nanotech 
commercialization in the United States. A few large 
corporations are halting nanotech activities entirely. One 
Fortune 500 R&D head told us that, ``Our CEO decided to 
postpone new investments in nanotechnology until the FDA 
decides how it will be handled.''
    Venture capitalists are beginning to shrink from funding 
start-ups that face nanotech EHS risks, as prominent nanotech 
investor Steve Gervitson recently stated. Firms are 
increasingly banning references to the word ``nanotechnology'' 
because of perceptual risks, even as they pursue nanotech R&D, 
a dangerous approach that risks a backlash. Estee Lauder, for 
example, reportedly held a special meeting earlier this year, 
instructing employees never to use the ``nana'' prefix.
    Finally, start-ups even struggle to obtain business 
services. We have heard direct reports of one U.S. insurer 
cancelling coverage of small companies once it learned that 
they were involved with nanotech.
    This committee has asked what the priority areas of 
research should be. We don't see identification of priority 
areas as being the key roadblock to progress. Multiple well 
developed needs lists have already been produced by 
organizations ranging from the EPA to the Wilson Center and, 
most recently, NEHI. They all prioritize the development of 
test methods, hazard screening, and exposure route 
investigation.
    What is missing is not this ingredients list, but two 
things: a specific game plan for accomplishing the research, 
and adequate funding to execute it.
    The biggest issue is the absence of a game plan. 
Nanotechnology EHS research in government agencies, academic 
institutions, and industrial facilities is being performed in 
an ad hoc fashion, according to individual priorities. The NEHI 
Working Group has not yet established a research strategy, one 
that makes tough decisions about prioritizing specific research 
tasks, apportioning them to public and private sector entities, 
and measuring progress.
    Now this is not surprising, because NEHI has no authority 
to mandate such priorities, and it can't allocate funding. A 
new interagency body with such authority is required to break 
the deadlock. We believe the effort to establish one and 
formalize a clear, short-term research plan should be led by 
the National Academy's Board of Environmental Studies in 
Toxicology and the National Institute of Environmental and 
Health Sciences.
    The second issue is funding. We continue to believe that 
the appropriate funding level for these risks is likely between 
$100 million and $200 million annually, or two to four times 
today's spending. This is not an arbitrary figure. It 
represents a consensus widely held in industry and among non-
governmental organizations formed by bottom-up calculation, 
analogy to other materials, and calculations that figure the 
costs as an insurance premium for nanotech.
    Nanotech continues to move forward rapidly in the United 
States. Just in the last three months, free scale 
semiconductors shipped pioneering nano-enabled memory chips. 
Becton-Dickinson partnered to create new nano-enabled 
diagnostics that will revolutionize disease testing.
    The United States has faced new EHS issues from previous 
broad technology waves, like semiconductors and polymers, in 
the past and addressed them effectively. The same can be done 
in nanotech.
    Thank you for inviting me to speak, and I am pleased to 
answer any questions.
    [The prepared statement of Mr. Nordan follows:]

                Prepared Statement of Matthew M. Nordan

    Global sales of products incorporating nanotechnology are more than 
doubling annually, but environmental, health, and safety (EHS) risks 
threaten to stall commercialization. Industry sees three key concerns: 
Real risks, perceptual risks, and regulatory risks. Awareness among the 
scientific community is already in place and multiple, well-developed 
lists of research needs are already built. Now, the Federal Government 
must establish a game plan for basic research--which will require a new 
interagency body with the authority to implement that plan--and supply 
adequate funding to carry it out. These actions will enable companies 
to carry out their own research on specific applications, and help 
address perceptual and regulatory risks in the bargain.

Nanotech EHS Issues Still Confront Industry

    Since the House Committee on Science last held hearings about the 
environmental, health, and safety (EHS) risks of nanotechnology in 
November 2005, the debate about whether and how nanoparticles might 
injure workers, harm consumers, or damage the environment has 
intensified.\1\ Nanotech's growing commercial success--$32 billion in 
products incorporating nanotech were sold in 2005--has meant increased 
scrutiny of EHS issues from advocacy groups and regulators, and 
increased urgency among companies developing products that incorporate 
nanoparticles (see Figure 1).\2\ Lux Research studies the 
commercialization of nanotechnology and advises companies about how 
they should approach nanotech opportunities, and when it comes to EHS 
issues, we see three key concerns faced by industry (see Figure 2):\3\
---------------------------------------------------------------------------
    \1\ See the May 2005 Lux Research report ``A Prudent Approach to 
Nanotech Environmental, Health, and Safety Risks,'' the November 17, 
2005 Lux Research written congressional testimony ``Nanotech 
Environmental, Health, and Safety Risks: Action Needed,'' and the May 
2006 Lux Research report ``Taking Action on Nanotech Environmental, 
Health, and Safety Risks.''
    \2\ For more information on the value of products sold 
incorporating emerging nanotechnology, see the February 2006 Lux 
Research report ``How Industry Leaders Organize for Nanotech 
Innovation.''
    \3\ This testimony focuses on a specific class of nanomaterials, 
namely nanoparticles--purposefully engineered bits of matter size-
dependent properties and sub-100 nm dimensions. They may either be 
miniature chunks of established materials (like Nanophase's nanoscale 
zinc oxide, used in sunscreens), or highly ordered structures that only 
form at the nanoscale (like CarboLex's single-walled carbon nanotubes, 
which may be soon used in flat-panel displays). We specifically do not 
address bulk materials with nanostructured features (like Apollo 
Diamond's nanostructured synthetic diamond) or nanoporous materials 
that have nano-sized holes (like Argonide's nanoporous ceramic water 
filtration media) because these materials appear unlikely on current 
evidence to pose novel EHS risks. We also do not address ``incidental 
nanoparticles'' which have nanoscale dimensions but have not been 
purposefully engineered, like the ultra-fine carbon particles emitted 
in diesel exhaust. It's important to note that ``nanotechnology does 
not equal nanoparticles'' and that many nanotech applications, like a 
wide variety of next-generation semiconductor technologies, do not 
involve the use of any nanoparticles at all.

          Real risks of nanoparticles. Companies working with 
        nanoparticles--like metal nanopowders, carbon nanotubes, and 
        quantum dots--need to ensure that their materials and 
        applications won't harm people or the environment. But 
        considerable uncertainty surrounds real risk because the 
        hazards of most nanoparticles are not well understood, exposure 
        can be difficult to predict and measure, and even solid 
        scientific studies arrive at contradictory results. For 
        example, researchers at Rice University's Center for Biological 
        and Environmental Nanotechnology found that even at low 
        concentrations, fullerenes are toxic to bacteria and human 
        cells in water; however, others at the Universite Paris XI 
        found the same particles not only safe but beneficial, 
        protecting lab rats' livers from damage caused by other 
        chemicals.\4\ While scientists debate, companies like General 
        Electric must forge ahead now with decisions about how to 
        invest in nanotech R&D, partnerships, and products.
---------------------------------------------------------------------------
    \4\ ``[60]Fullerene is a Powerful Antioxidant in Vivo with No Acute 
or Subacute Toxicity.'' Gharbi, N.; Pressac, M.; Hadchouel, M.; Szwarc, 
H; Wilson, S.R.; Moussa, F. Nano Letters 2005, 5, 2578-85, and ``The 
Differential Cytotoxicity of Water-Soluble Fullerenes.'' Sayes, C.M. ; 
Fortner, J.D.; Guo, W.; Lyon, D.; Boyd, A.M.; Ausman, K.D.; Tao, Y.J.; 
Sitharaman, B.; Wilson, L.J.; Hughes, J.B.; West, J.L.; Colvin, V.L. 
Nano Letters 2004, 4, 1881-1887.

          Perceptual risks when real dangers are unknown or 
        misunderstood. Regardless of the real risks presented by any 
        given nanoparticle or application, firms developing products 
        using nanoparticles could find commercial feasibility blocked 
        by the perception that the materials are dangerous--even if 
        they are proven safe. Public perception of nanotechnology in 
        the U.S. remains largely undetermined to date, with public 
        opinion surveys continuing to show low awareness of 
        nanotechnology and high optimism. A 2005 U.S. study found that 
        just 16 percent of respondents rated themselves ``at least 
        somewhat informed'' about nanotech, but in the same study 66 
        percent agreed with positive statements about the field.\5\
---------------------------------------------------------------------------
    \5\ ``The public and nanotechnology: How citizens make sense of 
emerging technologies.'' Scheufele, D.A., Lewenstein, B.V. J. 
Nanoparticle Res. 2005, 7, 659-667.

             However, many non-governmental organizations opposed to 
        nanotech development--particularly those overseas--have grown 
        more forceful in their protests. In May 2006, the environmental 
        group Friends of the Earth issued a fiery report on the use of 
        nanoparticles in cosmetics and sunscreens, condemning companies 
        for ``treating their customers like guinea pigs'' and calling 
        for a ban on the use of nanomaterials in these products. When 
        the French government's Minatec nanotechnology research center 
        opened in May 2006, protestors stormed conference rooms and 
        accosted scientists on the street. Such reactions make firms 
        like Johnson & Johnson look at the decades-long public 
        relations and legal battles over supposedly dangerous products, 
        from silicone breast implants to red M&Ms, and wonder whether 
        even the safest nanoparticles could become a liability.
        
        

          Regulations--or lack thereof. U.S. companies will 
        also have to abide by regulations of nano-enabled products and 
        processes, ranging from workplace guidelines under the 
        Occupational Health and Safety Administration to restrictions 
        on the release of materials by the Environmental Protection 
        Agency (EPA)--as well as regulations in the other countries 
        where they do business.

             The EPA held a public meeting in June 2005 to solicit 
        comments on a proposed voluntary pilot program that would 
        collect data on nanomaterials. In December it issued a 
        regulatory decision on carbon nanotubes, the first nanoparticle 
        submitted to it under the Toxic Substances Control Act, 
        approving the material for manufacturing under a low release 
        and exposure exemption; the EPA also issued a broad draft white 
        paper on nanotechnology in the same month. Meanwhile, the Food 
        and Drug Administration (FDA), National Institute for 
        Occupational Safety and Health, and Consumer Product Safety 
        Commission have all issued position papers on nanotechnology. 
        The FDA has also gone further, announcing the formation of an 
        internal task force and calling public meetings on nanotech.

             Despite all the action, regulatory ambiguity persists--
        it's still often not clear how current regulations apply to 
        nanoparticles or whether and when agencies will issue new 
        ones--leaving firms that work with nanoparticles confused about 
        how to plan for regulatory rulings. While companies are 
        generally pleased about how the EPA, for example, has 
        communicated with them so far, they're also frustrated by how 
        slow those agencies have been to set specific guidance, like 
        the EPA's long-proposed voluntary Stewardship Program for 
        nanoparticles.

    With nanotech continuing to shift more and more from ``R'' to ``D'' 
and into products--$150 billion worth of nano-enabled products will be 
sold by 2008--sound policy to help firms manage these risks effectively 
is more urgent than ever.

EHS Risks Are a Gating Factor for U.S. Nanotechnology Leadership

    Our firm conducts hundreds of interviews, site visits, and advisory 
sessions each year with executives and scientists responsible for 
nanotech at large corporations, as well as leaders of startups 
specializing in nanotech. Our conversations with them rarely fail to 
touch on EHS issues. We hear that even as many U.S. corporations and 
start-ups drive nanotech commercialization forward, others are 
canceling their efforts or failing to find funding and support for them 
due to EHS risks.

          The sheer cost of real risk dissuades companies from 
        worthy endeavors. Without the data, tools, and frameworks 
        needed to manage the real risks of nanoparticles, large 
        corporations retrench rather than expose themselves to undue 
        liability or sink millions into toxicity tests. Meanwhile, 
        nanotech start-ups face an even tougher situation--they have 
        little hope of funding such research on their own, yet their 
        customers expect them, like any other supplier, to come 
        equipped with data on health effects. Interviewees consistently 
        cite nanoparticle EHS concerns as a major topic of discussion, 
        and even a bargaining chip, in partnership negotiations.

           ``We've stopped development where costs were too high to 
        ensure no exposure or risk across the life cycle, or where we 
        couldn't clearly judge hazard potential due to the lack of 
        accepted methods. It's quite complicated; we can't set decision 
        points today.'' (Corporation)

           ``The BASFs, Degussas, and DuPonts of the world come in with 
        their act together, but start-ups typically say, `Oh, we didn't 
        bring the EHS guy with us.' We've canceled several projects 
        because of a lack of EHS information from the supplier. We 
        could generate the information ourselves, but it's just not 
        worth it.'' (Corporation)

          Perceptual risks threaten to drive ``nano'' 
        underground. Companies are universally concerned about 
        perceptual risks but don't know how to handle them, and many 
        try to duck the issue by simply forbidding the term 
        ``nanotechnology''--a dangerous strategy that risks a backlash. 
        Executives at Estee Lauder reportedly held a special meeting in 
        early 2006 to instruct employees, brand managers, and customer 
        relations people to cease any use of or reference to the term. 
        Solar-cell maker Konarka takes pains never to mention the 
        fullerenes it uses in its flexible photovoltaics, lest EHS 
        fears about fullerenes damage the ``clean and green'' message 
        it emphasizes to investors and the public. Even companies that 
        are comfortable with the real risks of their materials don't 
        trust their buyers to make informed decisions about them:

           ``We promote the benefits better products bring without 
        talking about technology. With nanotech, it's no different: You 
        won't hear us talking about nanotech or advertising it in any 
        way. That's our strategy for dealing with potential negative 
        publicity.'' (Corporation)

           ``Our strategy is pretty clear. Focus on features and 
        benefits; give the products names associated with benefit of 
        product; don't put `nano' in the name of the product.'' (Start-
        up)

          Corporations are eager for regulation; among start-
        ups, paranoia reigns. Contrary to what one might expect, large 
        corporations consistently want to see clear regulatory guidance 
        on nanoparticles, which they feel will ensure a level playing 
        field and tell them what to plan for. These firms are 
        enthusiastic about the EPA's approach--which lets them 
        participate in its deliberations and gain insight into its 
        thought processes--but frustrated by agencies like the FDA that 
        have communicated less on key issues. With start-ups, on the 
        other hand, we frequently hear the plea for ``rational'' and 
        ``science-based'' regulations--subtext for fears that 
        regulators will overreach and impose sweeping and onerous rules 
        that could kill their businesses.

           ``Our CEO decided it was too early to make any more 
        investments in nanotech until the FDA makes some decisions on 
        how it will be handled. We're all very disappointed about this, 
        since we have already dedicated significant resources.'' 
        (Corporation)

           ``For some of our product categories, a full battery of 
        tests might cost $40 million. But if it's a reformulation of an 
        existing compound, it could be only a few hundred thousand. 
        Right now with nano we have no idea which it will 
        be.''(Corporation)

           ``We're working very hard to make sure regulations are in 
        place. Everyone benefits from strong, robust regulations--not 
        only to protect consumers, but to level the playing field for 
        companies, so that everyone puts the right amount of thought 
        into protecting health and assessing safety.'' (Corporation)

           ``I'm concerned about the regulatory environment. We need 
        (real risk data), or we'll get regulated to levels that don't 
        make sense in terms of facts. Our concern is that regulations 
        will change not based on fact, but based on hysteria. . 
        .hopefully the regulators won't do something silly.'' (Start-
        up)

           ``I have no idea how (regulation) is going to evolve. It 
        could be very factual and science-based, or it could be very 
        politicized. We'd like to influence it and have it be 
        rational.'' (Start-up)

    The combination of the struggles firms face around all three 
factors is leading to adverse consequences for industry and the U.S. 
economy, as promising innovations get de-prioritized in corporate R&D 
budgets for reasons unrelated to performance, price, and market demand. 
The results can be particularly dire for the small firms that our 
technologically-driven economy relies on to develop crucial 
innovations. Venture capitalists are beginning to shrink from funding 
start-ups that face nanotech EHS risks, as prominent U.S. nanotech 
investor Steve Jurvetson stated in a recent Nature article.\6\ Start-
ups even struggle to obtain business services: At least one U.S. 
insurer has canceled coverage of small companies once it learned they 
were involved with nanotech.
---------------------------------------------------------------------------
    \6\ ``Nanotech's big issue,'' Gewin, V., Nature 2006, 443, 137.
    
    

Government Support for Basic Research Will Help Address Real Risks

    Clearly the first and most important responsibility of any company 
developing nanoparticle applications is to ensure that they won't 
present hazard to workers, consumers, or the environment. As we have 
described previously, conventional risk management paradigms--
identifying hazard, characterizing hazard, assessing exposure, and 
characterizing risk--can be applied to nanoparticles, and only 
applications where both hazard and exposure are present constitute 
serious risks.\7\ However, many aspects of nanoparticles make them 
uniquely challenging to address (see Figure 3). These challenges boil 
down to two key categories of research needs:
---------------------------------------------------------------------------
    \7\ See the May 2005 Lux Research report ``A Prudent Approach to 
Nanotech Environmental, Health, and Safety Risks'' and the November 17, 
2005 Lux Research written congressional testimony ``Nanotech 
Environmental, Health, and Safety Risks: Action Needed.''

        1)  Lack of specific data. Simply put, the health and 
        environmental effects of nanoparticles haven't been studied 
        well enough for EHS professionals to assess them confidently. 
        While a vast literature on conventional materials exists for 
        these researchers to draw on, the literature on nanoparticles 
        still lags behind by a wide margin. A scientist working with an 
        organic chemical can very likely turn to the literature and 
        find several papers addressing the health effects the compound 
        she is studying, or at least very similar ones; scientists 
        working with nanoparticles have no such luxury. Of 81,334 peer-
        reviewed journal articles on toxicology from January 2000 
        through May 2006, just 0.6 percent make any mention of 
        nanoparticles--compared with 12 percent for polymers, a much 
        better-known class of materials.\8\ More specifically, we 
        identified just 316 articles specifically focused on the EHS 
        risks of engineered nanoparticles (through May 2006) from a 
        review of over 1,500 documents drawn from databases of 
        published research like that maintained by the International 
        Council on Nanotechnology (ICON) at Rice University, literature 
        searches using Science Citation Index; and review articles like 
        the report from the International Life Sciences Institute 
        Nanomaterial Toxicity Screening Working Group.\9\
---------------------------------------------------------------------------
    \8\ Science Citation Index as of May 21, 2005; search terms 
``(toxici* OR toxico*) AND (X)'', where X = (quantum dot OR nanopartic* 
OR nanotub* OR fulleren* OR nanomaterial* OR nanofib* OR nanotech* OR 
nanocryst* OR nanocomposit* OR dendrimer*) or X = (poly* OR copoly* 
ANDNOT polychlorinated).
    \9\ The ICON database can be found at http://icon.rice.edu/
centersandinst/icon/resources.cfm?doc-id=8597. The ILSI 
report was published as ``Principles for characterizing the potential 
human health effects from exposure to nanomaterials: elements of a 
screening strategy'' Oberdorster, G.; et al. Particle and Fibre 
Toxicology 2005, 2:8. Other review article used were: (a) 
``Nanotoxicology: An Emerging Discipline Evolving from Studies of 
Ultra-fine Particles.'' Oberdorster, G.; Oberdorster, E.; Oberdorster, 
J.; Env. Health Perspect. 2005, 113, 823-839. (b) ``Airborne 
nanostructured particles and occupational health.'' Maynard, A.D.; 
Kuempel, E.D. J. Nanoparticle Res. 2005, 7, 587-614. (c) ``Industrial 
application of nanomaterials--chances and risks.'' Luther, W., ed. 
Future Technologies Division, VDI Technologiezentrum (sponsored by the 
EC Nanosafe program). With over 1300 records in the ICON database, 
readers may be surprised that so few are used in our analysis. ICON's 
database includes many articles on incidentally-produced nanoparticles 
(such as those found in diesel exhaust or generated by welding), as 
well as articles on environmental or health applications of 
nanomaterials, such as the use of iron nanoparticles in wastewater 
remediation or polymer nanoparticles in drug delivery. Such studies can 
contain helpful information on hazard or exposure, but are of less 
direct use for trying to understand the risks of their own materials 
than those that squarely address EHS questions.

        2)  Lack of well-developed frameworks for understanding real 
        risks. For more familiar classes of chemicals and materials, 
        long experience has given scientists a good understanding of 
        what characteristics make a substance harmful, so they can make 
        reasonable judgments even when they lack specific toxicity 
        data. In the case of nanoparticles, however, these frameworks 
        (often referred to as ``structure-activity relationships'') are 
        only beginning to be developed, and current results often 
        contradict each other. For instance, while Gunter Oberdorster 
        at Rochester University found that smaller particles of 
        titanium dioxide (TiO2) are more harmful that large 
        ones, David Warheit at DuPont found no relationship between 
        size and toxicity; he also found that nanoparticles of silica 
        (SiO2) and zinc oxide (ZnO) are less harmful than 
        larger ones.\10\
---------------------------------------------------------------------------
    \10\ Oberdorster, G; Ferin, J; Lehnert, B.E. Environ. Health 
Perspect. 1994, 102, Supplement 5, 173-179; ``Pulmonary Instillation 
Studies with Nanoscale TiO2 Rods and Dots in Rats: Toxicity 
Is Not Dependent upon Particle Size and Surface Area.'' Warheit, D.B.; 
Webb, T.R.; Sayes, C.M.,; Colvin, V.L.; Reed, K.L. Toxicol. Sci. 2006, 
91, 227-236; Warheit, D.B., personal communication.

    Nanotech's critics rightly point out that companies themselves must 
take responsibility for generating data on the specific materials they 
work with and applications they put the materials to, and shouldn't 
depend on the government to do it for them. This important point 
addresses the first category of research need above.\11\ However, the 
key role for government lies in the second category of research need: 
Supporting the basic research needed to develop frameworks that 
companies and researchers can put to use in evaluating their own 
materials. Just as wise government funding produced the fundamental 
scientific breakthroughs that lead to the successful nanotech 
commercialization we're seeing today, similar investment in 
understanding the basic science of nanoparticle EHS factors will 
underlie safe nanotech developments.
---------------------------------------------------------------------------
    \11\ A key exception to this rule lies with start-up companies. As 
we have previously stated to the House Committee on Science, start-ups 
are both generally the earliest commercial developers of new 
nanoparticles and also the parties least likely to be able to afford 
expensive toxicology studies. As long as these dynamics hold, there 
will be a market failure that only government can correct. We continue 
to believe that a market-based mechanism, which would require companies 
receiving government funding for products that incorporate 
nanoparticles to submit their materials for anonymous testing as a 
condition of the grant, is the most efficient way to ensure that scarce 
government research funds are allocated efficiently to materials of 
greatest commercial interest. Such a mechanism would place a new 
requirement on small businesses receiving Small Business Innovation 
Research and/or Small Business Technology Transfer grants, but because 
the only requirement is the submission of a small amount of material 
for anonymous testing with no financial or onerous documentation 
requirements, it does not seem to our layman's eyes to represent an 
undue burden.
---------------------------------------------------------------------------

Research Priorities Are Well-Understood; What's Needed Is a Game Plan 
                    and Money

    In terms of specific research needs, we do not see identification 
of priority areas of research as being the key roadblock to progress. 
Multiple well-developed needs lists have already been produced by 
organizations ranging from the EPA to the Wilson Center, and they all 
prioritize the development of test methods, hazard screening, and 
exposure route investigation (see Figure 4). What is missing is not 
this ``ingredients list,'' but two things: A specific game plan for 
accomplishing the research and adequate funding to execute it.

          A new interagency body must form a nanotech EHS game 
        plan--with authority to execute. The biggest issue is the 
        absence of a game plan; nanotechnology EHS research in 
        government agencies, academic institutions, and industrial 
        facilities is expanding, but it is being performed in an ad hoc 
        fashion according to individual priorities that both risk 
        costly duplication of effort and raise the specter of key 
        issues remaining unaddressed. The National Science and 
        Technology Council's Nanotechnology Environmental and Health 
        Implications working group (NEHI), the body nominally in charge 
        of nanotech EHS issues as part of the National Nanotechnology 
        Initiative (NNI), has not yet established a research strategy--
        one that makes the tough decisions about prioritizing specific 
        research tasks, apportioning them to public and private sector 
        entities, and measuring progress. This is not surprising, 
        because NEHI has no authority to mandate such priorities and 
        cannot allocate funding. A new, interagency body with such 
        authority is required to break the deadlock. The effort to 
        establish such an authority and formalize a clear, short-term 
        research plan could be led by NEHI, but also the National 
        Academies' Board on Environmental Studies and Toxicology or the 
        National Institute of Environmental Health Sciences.

          Funding must grow. We continue to believe that the 
        appropriate funding level for addressing nanotech EHS research 
        needs is likely between $100 and $200 million annually, or two 
        to four times today's spending under the NNI. This figure is 
        not an arbitrary number, but represents a consensus widely held 
        in industry and among non-governmental organizations formed by 
        bottom-up calculations, analogy to other materials, and 
        calculations that figure the costs as an ``insurance premium'' 
        for nanotech development.
        
        

    Towards these ends, Lux Research has joined with a broad consortium 
of nanotech stakeholders, including leading corporations active in 
nanotech (like Air Products & Chemicals, BASF, Degussa, and DuPont), 
non-governmental organizations (like Environmental Defense, the Natural 
Resources Defense Council, and the Union of Concerned Scientists), 
prominent nanotech start-ups (like Altair Nanotechnologies and Carbon 
Nanotechnologies Inc.), and business associations (like the 
NanoBusiness Alliance). This coalition has petitioned the Senate 
Committee on Appropriations both to increase funding for nanotech EHS 
research, and to allocate $1 million to the National Institute of 
Environmental Health Sciences and the National Academy of Sciences to 
develop a specific game plan for the U.S. Government's approach to 
nanotech EHS research. We encourage Committee members to support these 
efforts.

Better Research on Real Risks Will Help Address Perceptual and 
                    Regulatory Ones

    There is less that Congress can do to aid with perceptual risks, 
and while regulation clearly falls into the Federal Government's remit, 
key decisions need to be made at regulatory agencies. However, 
successfully addressing the basic research needs around real risks will 
help make significant progress on these challenges as well. Consider 
that:

          Better understanding will drive regulation. 
        Regulatory transparency is important for nanotech's commercial 
        development, but agencies are hesitant to issue specific 
        guidance, even on general principles, without a better 
        scientific understanding of the issues involved. While we still 
        think agencies can do more to communicate their thinking to 
        industry and to set specific regulatory expectations in a 
        timely fashion, the basic research spurred by additional 
        investments and research prioritization alone will help them 
        set firm plans.

          Lack of knowledge--and of regulations--are major 
        drivers of perceptual risks. One of the most significant 
        ``fright factors'' identified for new technologies is ``poor 
        understanding by science or responsible agencies,'' which 
        certainly describes nanotech today.\12\ Moreover, arguments 
        that nanotech is unregulated are widely used by groups calling 
        for restrictions on development. By addressing this lack of 
        understanding and abetting regulatory efforts, Congress can 
        help promote informed public understanding of nanotechnology's 
        benefits and risks.
---------------------------------------------------------------------------
    \12\ Bennett, P.; Calman, K. Risk Communication and Public Health. 
Oxford University Press, Oxford, 1999.
---------------------------------------------------------------------------

Addressing Nanotech EHS Risks Has a Big Economic Payoff

    Nanotechnology continues to move forward rapidly in the U.S.--just 
in the last three months, Freescale Semiconductor has shipped 
pioneering nano-enabled memory chips, and Becton Dickinson has 
partnered to develop new nano-enabled medical diagnostics that could 
revolutionize disease testing. While we calculate that $32 billion in 
nano-enabled products were sold in 2005 and project that $150 billion 
will be in 2008, and that by the middle of the next decade this value 
will figure in the trillions of dollars globally. The U.S. has faced 
new EHS issues from previous broad technology waves, like 
semiconductors and polymers, in the past, and addressed them 
effectively; it's important that we do so for nanotechnology as well--
since the challenges facings our country in achieving energy 
independence, finding curing for debilitating diseases, securing the 
homeland, and creating new jobs and economic growth all benefit from 
nanoscale science and engineering.

                    Biography for Matthew M. Nordan

    Matthew Nordan is the President of Lux Research and heads the 
company's research organization. Under Matthew's leadership, the Lux 
Research analyst team has become a globally recognized authority on the 
business and economic impact of nanotechnology. Lux Research serves as 
an indispensable advisor to corporations, start-ups, financial 
institutions, and governments seeking to exploit emerging technologies 
for competitive advantage.
    Matthew has counseled decision-makers on new technologies for a 
decade. Prior to Lux Research, Matthew held a variety of senior 
management positions at emerging technology advisor Forrester Research, 
where he most recently headed the firm's North American consulting line 
of business. Earlier, Matthew lived for four years in the Netherlands 
growing Forrester's operations in Europe, where he launched and led 
research practices in retail, mobile commerce, and telecommunications.
    Matthew has been invited by news outlets including CNN and CNBC to 
comment on emerging technology markets and has been widely cited in 
publications such as The Wall Street Journal and The Economist. He has 
delivered advice to clients and been an invited speaker at conferences 
in North America, Europe, Southeast Asia, Japan, Australia, and South 
Africa. Beyond the corporate sphere, Matthew has testified before the 
U.S. Congress twice on nanotechnology issues, advised the Committee to 
Review the National Nanotechnology Initiative of the National 
Academies, and spoken on nanotechnology at universities including 
Harvard, MIT, and Columbia. Matthew has also participated in developing 
public-sector technology strategy for organizations including the World 
Economic Forum, the European IT Observatory, and the Dutch 
transportation ministry.
    Matthew is a summa cum laude graduate of Yale University, where he 
conducted cognitive neuroscience research on the neural pathways 
mediating emotion and memory.

                               Discussion

        Coordinating Federal Environmental, Health, and Safety 
                    Nanotechnology Research Programs

    Chairman Boehlert. Thank you very much, Mr. Nordan.
    I would point out to the government witnesses that both you 
and Dr. Maynard have pretty clearly and convincingly laid out 
the deficiencies in the current federal program. And quite 
honestly, if I sense things up here from this side of the 
witness table, I think Mr. Gordon, in his opening statement, 
which was very emphatic and very eloquent, he has got the mood 
of the Committee on both sides of the dais.
    So here is what I would like to do. I would like to ask 
each of our witnesses what they think needs to be done to have 
a truly coordinated, targeted, prioritized federal program. And 
while you are giving some thought to that, let me point out 
that what--you have been at this for more than a year, and 
what, essentially, we have is a basic inventory. We don't have 
any priorities. We tell that is the ``next step.'' I mean, I 
think we should be a lot farther ahead now than we are. I was a 
little--tried to finesse it a little bit in my opening 
statement, but Mr. Gordon got right to it. And I have to say, 
``Amen.''
    So let us go. You are the----
    Mr. Gordon. Mr. Chairman, if I could, I think you have hit 
the heart of the question, and I would like to share my time 
with you, if these folks need the time to address, again, the 
fundamental question for us today.
    Chairman Boehlert. Yeah. And so let me just repeat it.
    What do you think needs to be done to have a truly 
coordinated, targeted, prioritized federal program?
    Dr. Alderson.
    Dr. Alderson. Thank you, Mr. Chairman.
    Obviously, this is a very important question to the NEHI 
group and NSET as well.
    My response to your question is, and I think I am speaking 
for all the members of the NEHI committee, we believe we are on 
the track to get to that point. The issue is how long will it 
take us to get there. All of the 19 agencies that are 
represented on NEHI represent the best scientists, expertise, I 
think, the Federal Government has to offer on this issue. 
Bringing them together in this environment, I believe, is the 
best approach to get there.
    How to speed that up is another issue.
    As you mentioned earlier, all of us have other jobs. This 
is something else we are all doing. So it is a matter of how 
much time do you want us to spend on this, how much does our 
respective agencies want us to spend on this to make this 
happen. But I really, honestly believe this group is the body 
to do that.
    Chairman Boehlert. Dr. Bement, look, you are right. Just 
let me point out that once again, as I said before, we have a 
high regard for each one of you. You are dedicated, very able 
federal employees. I don't know how many various interagency 
panels you are on, Dr. Alderson, for example, and Dr. Bement. I 
mean, it is probably as long as--the list is as long as your 
arm. Some--we would be comforted if we had some indication that 
you are giving some priority attention to this. And I 
understand all of your other demands in your schedule, but 
there is no evidence of that thus far. I would suggest that the 
one reason we have this report today is we sort of forced it, 
because we have scheduled this hearing, and your staff probably 
said, ``We have got to get ready for those guys. They are going 
to ask some questions. You better show some movement.'' So this 
is what you came up with. And if this hearing hadn't been 
scheduled, we probably wouldn't have anything yet.
    So I am not trying to be argumentative or confrontational. 
I just want you to sense from here that we feel very strongly 
about this on both sides, and we know you have the wherewithal, 
the commitment, and all of that. Let us hope you get some time 
and attention to it.
    Dr. Bement.
    Dr. Bement. Well, I will address your question from my 
perspective.
    Chairman Boehlert. Yeah. And well, while you are at it, I 
wanted to ask, is there someone that you think should be 
directed to have his sole job as being chair of this 
coordinating agency?
    Dr. Bement. Well, I will come to that question in a moment.
    The first point I would like to make is that characterizing 
the current situation as a ``bottom-up approach'' is 
overstating it. It is true that it is bottom up as far as 
science input and the various agencies' input into the budget 
formulation process. But it is also lateral. There is a lot of 
interagency cooperation. We solicit inputs from the regulatory 
agencies in identifying those scientific questions that we need 
to address. And it is also top-down through the budget----
    Chairman Boehlert. Well, that is very important. You know. 
And the top-down--what I am asking is should we get someone 
solely committed to coordinating this thing, or do we say to 
Dr. Alderson----
    Dr. Bement. Well----
    Chairman Boehlert.--this is the 27th item on your agenda. 
You have got to chair this interagency----
    Dr. Bement. Okay. I have been in government a long time, 
and almost in every new program of this type, everyone wants 
this on top, but I have to tell you that this area is so 
complex that I don't know of any person or a small group of 
people who would be smart enough to be able to identify all of 
the risks, set the priorities, and lay out a so-called game 
plan. That has to be very organic, and it is organic. It--the 
situation changes day by day. And so there has to be more of a 
soccer approach to this rather than an American football 
approach, if I can put it in that metaphor.
    Chairman Boehlert. Dr. Maynard is nodding yes.
    Mr. Gordon. The Chairman graciously--we are sharing time 
and sharing this. We are not asking that there be somebody 
smart enough that knows it all. We are asking that there is 
somebody that is able to coordinate it all. I think there is a 
difference.
    Dr. Bement. Yeah. Well, I didn't say the last thing I 
wanted to say, and that is how it is top-down managed. It is 
top-down managed through the budget--the formulation of the 
budget review and the budget approval process in putting 
together the Administration's budget to the Congress. That is a 
matter of policy. It is policy formulation. And that is a very 
well coordinated process through OMB and OSTP. So you do have 
two very high government offices that do provide this 
coordination, and it is top-down.
    Mr. Gordon. So you are satisfied that we have got the best 
plan now or the best----
    Dr. Bement. No, I am not satisfied. I came up through 
nuclear technology, and I know what happened to that industry 
because it wasn't visible enough. It didn't have adequate 
dialogue with the public at large. And they weren't forward 
with--they weren't as forthright as the industry needed to be 
about risks. We have to avoid that, and we have to be 
anticipatory. We have got to be proactive, and we need to turn 
up the gain. I have no arguments with any of that.
    Chairman Boehlert. Yeah, but you are not satisfied with the 
present arrangement. I mean, won't you concede to us? I mean, I 
am not trying to put you in a spot, but you can't be happy with 
where we are right now, given the magnitude of the problem and 
the magnitude of the challenge.
    But I--once again, Doctor, I can imagine what your schedule 
is like every single day, each one of you in the government. 
You have got more things to do than you have got time to do 
them. But we are suggesting that maybe someone should be, not a 
Czar, but at least a coordinator and have more time to devote 
to coordinating. I mean, how do your various departments decide 
how much to allocate to nanoresearch? Does OMB tell you how 
much you allocate? I mean, he doesn't know diddley about 
nanoresearch. Is it just an exercise in numbers?
    Dr. Bement. Well, I think each agency has a process for 
developing priorities and also developing their request. And 
that has to be discussed, and it has to be prioritized. And 
that is, again, OMB and OSTP.
    Chairman Boehlert. Well, let us get Dr. Farland a chance to 
answer the question.
    Dr. Farland. Thank you, Mr. Chairman.
    Chairman Boehlert. And keep in mind you have already 
announced that you are already retiring, so you can be a little 
bolder if you want to.
    Dr. Farland. Well, I am just going to start my remarks by 
suggesting that both society and government really have 
multiple needs in understanding these health and environmental 
issues. And so I think to suggest that there could be a single 
approach that was really going to get to this without 
addressing those multiple needs may be a bit naive. So I think 
we have to look at this from the standpoint of the complexity 
of the problem that we are facing.
    Chairman Boehlert. But, Dr. Farland, let me just say, first 
of all, I am not a scientist, and Mr. Gordon is not a 
scientist. We have got some scientists, a couple of physicists 
on the panel, and Ralph Hall knows everything about everything. 
But--so we are not suggesting that it is easy. What we are 
saying in every way that we know how is that we think it should 
be given a higher priority. There should be better 
coordination. We think we should be farther ahead than we are 
now after a more than a year invested, the time and talent of 
several able, dedicated public officials. And what we have now 
is just sort of a basic inventory that was sort of forced out, 
you know, pulled out, extracted because the hearing was 
scheduled. So----
    Dr. Farland. Well, let me try to address a few of those 
points, because I think that, first of all, from an agency 
perspective, we benefit tremendously by the kind of interagency 
dialogue that has gone on in the NNI and in the NEHI 
particularly. We play a large role in that. We share the 
feelings we have about the priorities. We take from others what 
they can do and what their priorities are.
    We also take that back, and we don't wait for those 
priorities in terms of making decisions.
    Mr. Gordon. Okay. If I could--are you satisfied with the 
structure, as Dr. Alderson said, to get us--he used the word 
``there.'' I would like to know more what ``there'' is. But are 
you satisfied that we have an adequate structure to get us 
``there''?
    Dr. Farland. I think we have a structure that is working 
very well right now. It has a way to go. I agree with that. I 
agree that we have----
    Mr. Gordon. Okay. So how do we--you know, so what else do 
we need to do? To me, that is the fundamental question here we 
are trying to determine is whether or not we have a structure 
that is going to allow us to get, as Dr. Alderson said, you 
know, ``there.'' And we can talk about ``there'' other--I mean, 
but do we have that structure? And if not, how do we need to--
it is not a criticism to anyone. You know.
    Dr. Farland. Dr. Bement talked about the idea of turning up 
the game. And I think that is happening. It is happening as we 
work through these kinds of issues. It is happening as we have 
our dialogue, our workshops with our----
    Mr. Gordon. So we have an adequate structure? There just 
needs to be more intensity within that structure? Is that----
    Dr. Farland. That is the way I see it.
    Mr. Gordon.--what you are--okay. All right. Thank you.
    Chairman Boehlert. Dr. Carim.
    Dr. Carim. Yes. Thank you.
    With respect to the report, honestly, we have done our best 
to produce a report that tries to address these issues in a way 
that is coordinated across the Federal Government, the federal 
agencies, and that is of high quality, that really produces a 
science-based approach to risk assessment and to what the 
research needs are in this area. And that takes time. It has 
been an ongoing effort, and I think the level of effort has 
been quite high. And I won't deny the fact that certainly the 
presence of the upcoming hearing and the activities----
    Mr. Gordon. And so are you satisfied with the----
    Dr. Carim.--have added some----
    Mr. Gordon.--structure that we have?
    Dr. Carim. Yes, I am.
    Mr. Gordon. Okay.
    Dr. Carim. I think----
    Mr. Gordon. All right. That is fine.
    Dr. Carim. I think that having these other activities 
certainly added some urgency to agency responses and to agency 
approvals, and that is a good thing.
    I would agree with the comments of my colleagues, and I do 
think that, with respect to a more top-down organization, you 
have heard some things about the top-down aspects that are 
already in place, but I share the Chairman's sentiment that 
diversity is a source of strength in the research programs of 
the United States. And this is already one of the most highly 
coordinated activities across agencies, and I am afraid that 
taking too much of a top-down approach will cause us to miss 
things. That is one of my largest concerns is that if we feel 
that we have identified the priority areas and addressing 
those----
    Mr. Gordon. Could they help us be more efficient with what 
seems to be terribly limited funds?
    Dr. Carim. I am sorry?
    Mr. Gordon. Could it help us to be more efficient with what 
seems to be terribly limited funds?
    Dr. Carim. Increases in efficiency are always valuable. The 
question is how to do that. And I think it is all of the 
agencies.
    Mr. Gordon. Okay. But we wouldn't have as much duplication, 
potentially, if we had more leadership?
    Dr. Carim. I don't believe that we have much duplication.
    Mr. Gordon. Okay.
    Dr. Carim. I believe that the----
    Mr. Gordon. All right.
    Dr. Carim.--interagency coordination process is very 
effective in informing each agency as--of what the others are 
doing.
    Chairman Boehlert. Thank you, Doctor.
    I am anxious to get to other members of the panel. We 
shared this opening time, and I hope this is instructive to all 
of you that there is a high level of intensity in terms of our 
feeling on this. And before I call on Dr. Schwarz, I don't 
know--Dr. Maynard and Mr. Nordan are the ones that outlined the 
problem, so we needed the government agency to--I mean, they 
agree with you and with us, essentially.
    It is unfortunate that somewhere someone mentioned the word 
``czar,'' because then we--it connotes a dictator is going to 
say, ``This is what you are going to do.'' And that is not what 
we are talking about. We are talking--when we talk about 
someone at the top, just devotes more time and more effort to 
do a better job of coordinating the diverse elements coming in 
and helping to get what Dr. Maynard and Mr. Nordan are pleading 
for, some priorities and some emphasis. So we are not talking 
about a dictator that we want to install someplace in 
Washington, DC, but we are saying that we want--and I hope it 
is instructed for all of you, we want something more than what 
we have now. We are not satisfied. We are not pointing fingers 
at any one individual saying, ``You are not doing your job.'' 
We are just saying the present mechanism doesn't seem to be 
working in a way that would satisfy us that we are giving a 
sense of sufficient urgency to the issue.
    With that, let me call on Dr. Schwarz.

     Regulatory Structure for University and Industry Nanomaterial 
                                Research

    Mr. Schwarz. Thank you, Mr. Chairman.
    I am randomly asking, so anyone jump in that chooses to do 
so.
    I am a cutting doctor and not a research doctor. However, I 
am on the board of the Life Science Institute at the University 
of Michigan, which meets tomorrow, in fact, on the board of the 
Cardiovascular Center at the University of Michigan, on the 
Deans Advisory Committee for the school at that university, 
which supervises those activities, and I am the President of 
the Alumni Association of the University of Michigan, which I 
think all of you would say is one of the foremost research 
universities in the country. So I have an interest in this.
    Very, very briefly, many of the new therapies, the 21st 
century therapies, putting an anti-cancer substance right on 
the tumor cells right in the affected organ, putting the 
material right at the correct spot in the correct coronary 
artery, et cetera. That is not Buck Rogers stuff anymore. That 
is stuff that can be done in the lab with nanomaterials. Yet 
there seems to be no regulatory structure right now that a 
place like my university or other universities--a structure 
that they can look to to say, ``This is what we can do and this 
is what we can't do.'' But my question is this: what do you 
foresee and when do you foresee a structure, an office, an 
organization at the federal level, or certainly overseen by the 
Federal Government, that a University of Michigan or a Harvard 
or a Yale or a Stanford or a Cal or a Kansas or a Nebraska can 
look to when they do this research and say, ``This has been 
vetted. This is okay. We can go ahead with animal research. We 
can even go ahead with, perhaps, clinical trials on humans.''? 
Who is going to be the referee here, and when is that referee 
going to be up and ready to make his or her calls?
    Dr. Alderson. Thank you, Mr. Schwarz, for that question, 
and I think it is an excellent one, because it brings into the 
forefront a very significant potential use of nanomaterials. 
And what you are talking about is a delivery mechanism to bring 
therapy to cancer patients, i.e. bringing that pharmaceutical 
directly to that tumor or that cancer site. We are, within FDA, 
having frequent conversations with companies and academic 
institutions on this particular issue. We believe we have the 
structure in place today to be able to communicate with those 
companies that are developing these products. We have a very 
structured process of determining the safety, particularly--as 
a major concern, particularly for the nanomaterials if it is 
something that is normally--that is foreign to our body. But we 
have--I think we have that structure in place today to talk to 
a company who is manufacturing that and guide them through the 
type of information we want to see along the process from the 
basic pharmaceutical information to laboratory information to 
determining whether it is safe enough to go to clinical trials. 
I think----
    Mr. Schwarz. You----
    Dr. Alderson. I think that we have that.
    Mr. Schwarz. Dr. Alderson, you feel that you have 
guidelines in place that are reliable that legitimate 
researchers can pick up the phone, travel to Washington, you 
can have someone travel to their lab, and you have got 
standards in place that are reliable standards where a lab, 
whether it is in a university or in a private organization, can 
actually come to you and say, ``Is this good? Is this bad? Can 
I do this? Can I not do this?''
    Dr. Alderson. We have guidances in place for that type of 
product, and we are regularly talking with companies along 
those same lines you are talking about. Now we may--down the 
road, we may find that something we are asking for presents an 
issue that we haven't seen before, and we will have to work 
with the company in a manner to overcome that particular issue.
    Mr. Schwarz. I am happy to hear that, because I--in my 
mind, I had assumed, always a dangerous thing, but I had 
assumed that there was--that the structure was a work-in-
progress and there wasn't a good identifiable, reliable 
structure in place. You are telling me that there is?
    Dr. Alderson. I think we are prepared to talk with any 
company who wants to talk to us about a product like that.
    Mr. Schwarz. And any university as well?
    Dr. Alderson. Anyone.
    Mr. Schwarz. Thank you.
    Chairman Boehlert. The gentleman's time has expired.
    Here is the deal. There is a series of votes in the House, 
and we are not going to keep you here while we go over and play 
legislators. There will be a series of written questions that 
we will submit to all of you, and we would ask for timely 
responses.
    In the time we have remaining, we are going to give a 
couple of minutes each, and we will run the clock down, to Mr. 
Green, and then is it Mr. Hall, Mr. Rohrabacher, and Mr. Honda. 
All right. Let us go.
    Mr. Green.

                Is the Marketplace Outrunning Research?

    Mr. Green. Yes, sir. Thank you, Mr. Chairman, and thank you 
and the Ranking Member for placing policy above politics. I 
will be as pithy and concise as possible.
    It is my understanding, of course, that because something 
is nano doesn't mean that it is dangerous, per se. 
Nanomaterials can absorb pollutants in water. However, with 
hundreds of products on the market, $32 billion in revenue, by 
one estimate, an estimate that by 2014 we may have $2.6 
trillion in revenues, and given that we are currently using--
utilizing nanomaterials in clothing and cosmetics, the question 
has to become, first of all, is time on our side, given the way 
the marketplace is responding to this technology? And it has 
been said by someone that nanoparticles are like the roach 
motel: they check in, but they don't check out. So we have to 
ask ourselves about time and are we using our time as 
efficaciously as possible.
    So to this end, I am curious as to whether we have any 
products right now that contain any kind of warning with 
reference to the use of nanoparticles?
    Yes, sir, if you would. And be as quickly as you can, 
because I have another question.
    Dr. Maynard. I will just briefly answer that.
    I--you are exactly right. Not every nanomaterial is going 
to be safe. Not every nanomaterial is going to be harmful. We 
have got to find out what is the truth here. We have got to 
have sound science.
    Now if you look at what is on the marketplace at the 
moment, again, you are right: time is not on our side. We are 
having a flood of nano-based materials on the market, and I am 
not aware of any product which has any warnings or any 
identification of what any of the potential risks might be.
    And while I am speaking, let me also say, going back to my 
statement, apparently I inadvertently credited the government 
with only spending $1 million a year on risk-based research. I 
apologize for that. The figure should have been $11 million a 
year.
    Mr. Green. Quickly, one final question, if I may, Mr. 
Chairman.
    We talked about warnings. Now what about notification? Is 
there a codified methodology by which notification can be 
perfected in the event we have some--well, some failure that we 
need to call to the public's attention in a massive way?
    Mr. Nordan. My understanding is that there is no such 
facility today. And I think if you look at the rare cases where 
there have been products that have incorporated nanoparticles 
or have been thought to incorporate nanoparticles where there 
have been health effects, it is a good demonstration. The best 
case study for this is a product by a company called Kleinmann 
in Germany called ``Magic Nano,'' which was a spray that was 
used as an adhesive in bathrooms that caused about 100 people 
to have respiratory problems and to check into hospitals. It 
was actually later found that the product contained no 
nanoparticles at all. But if you imagine, particularly from the 
perspective of someone like the----
    Mr. Green. Thank you, Mr. Chairman.
    Chairman Boehlert. Mr. Honda.
    And incidentally, we are trying to be mindful of your 
schedules. You know. You don't want to sit around and wait for 
us. And you are busy. We want you to go back to work on this in 
urgency.
    Mr. Honda.

                           Setting Priorities

    Mr. Honda. Thank you. Thank you, Mr. Chair.
    And I just--what I have surmised is that we have folks who 
say, ``This is adequate.'' And then we have this that tells us 
what is not adequate in this, and it sets up a timeline.
    My question is have you read this document as of yet, Mr. 
Alderson--Dr. Alderson? The question is have you read this as 
of yet?
    Dr. Alderson. Yes, sir, I have.
    Mr. Honda. And how do you see this fitting in this report?
    Dr. Alderson. They are both very consistent in terms of a 
focus of the research programs. Neither are that detailed in 
specific studies that I think we ultimately want to get to in 
terms of programs. The report you have in your hand there does 
give some areas in what should come first. And that may be 
correct. But I think the government, a little, has not done an 
assessment of that where it would either concur or not concur.
    Mr. Honda. How long would it take you to decide whether you 
need to take the first step or not?
    Dr. Alderson. I could not give you an estimate of that, 
sir.
    Mr. Honda. Could you take a week and get back to me on 
this?
    Dr. Alderson. Yes, sir.
    Mr. Honda. Thank you.
    Chairman Boehlert. All set?
    Mr. Lipinski.

                   Public Awareness of Nanotechnology

    Mr. Lipinski. Thank you, Mr. Chairman.
    A lot of things to talk about here, but I will keep it very 
short. I would also want to make clear that I believe we need 
to move forward. We are not moving forward quickly enough.
    And now moving forward to reading this report, I have not 
had a chance to read it yet, but it is critical, in this new 
technology, that we set the--what we need to let the people 
know, people have confidence in it, those in the general public 
and also those who are involved in nanotechnology know where we 
are going.
    At another time, I would like to talk to Dr. Bement about 
what NSF is doing. I know NSF is doing a lot of funding of 
research in nanotech. At my alma mater, we have the center for 
nanofabrication and molecular self-assembly. I would like to 
talk to him at some other time if he thinks everything is going 
well with NSF funding for nanotech.
    But what my question boils down to is does anyone on the 
panel have any opinions on a sense among the general public 
about--do you have any clue what nanotech is and the impact 
that it may have on them? And someone had raised earlier, when 
I was watching this, that the public needs to be comfortable 
with nanotech. Is this a problem that we have seen yet?
    Dr. Maynard.
    Dr. Maynard. Very briefly, earlier this week, we released 
the results of a poll of public opinions. This was a telephone 
poll of over 1,000 people across America, and we found some 
very interesting things. We found that there is still a low 
level of awareness of nanotechnology. Overall, it was about 30 
percent of the people polled that heard something about it, 
although this figure is up from the previous poll two years ago 
by about twice the number of people. So people are beginning to 
get aware of this.
    People are also beginning to become aware of the debate 
over the benefits versus the risks. One of the messages not 
only in that but in also talking to people, we are finding that 
people want information of what is happening with this 
technology. They want to know where it is going to impact on 
their lives, what the benefits are, what the risks might be so 
that they can plan accordingly. At the moment, people are 
pretty ambivalent about whether it is good or bad. They want 
information.
    Mr. Lipinski. Dr. Bement, do you have something you want to 
add?
    Chairman Boehlert. And you will have the final word.
    Dr. Bement. I will have the final word.
    NSF is one of the promoters of nanotechnology. Also 
recognize at the very beginning of the National Nanotechnology 
Initiative, that it was critically important not only to look 
at the environmental and health safety aspects but also public 
outreach and education. And so we have a balanced program in 
that regard. But we started out with a huge agenda in this 
area. First of all, we had to do the basic research, and if I 
can take a little bit out of Dr. Maynard's written testimony, 
he calls for systematic scientific research to recognize 
potential risks at an early stage. He recognizes that 
nanotechnology is complex. And we have to look longer-term to 
identify emerging risks.
    But in addition to that, we had to put an infrastructure in 
place. We even had to develop characterization tools so that 
you could even look at nanoparticles and understand it in terms 
of their size, their shape, their surface charge, their 
physical and chemical characteristics of nanoparticles, and not 
all of those tools are yet developed.
    Furthermore, and finally, we had to develop a workforce, a 
science and engineering workforce that not only could do the 
research but could also look at toxicology, could look at 
interaction with cells, could look at the various transport 
modes, and that workforce is now migrating into academia, in 
the National Laboratories, and also in the federal 
laboratories.
    Chairman Boehlert. Thank you, Doctor.
    That is it.
    We have got less than five minutes to report, and we are 
considerate of your time, and so we could say we recess, but we 
are going to adjourn and--with this request: we will submit 
questions in writing, and we would appreciate a timely 
response. A timely response. And I would indicate that you get 
back before Dr. Farland and I go off into the sunset. The last 
time we submitted written questions, it took four and one-half 
months for the Administration to get the okay to get us 
answers. That is not ``timely response.'' So I am anxious to 
pursue this before I leave.
    And secondly, Mr. Gordon rightfully points out that at the 
conclusion of the report, you talk about the ``next steps.'' 
Dr. Alderson, do you have sort of a timetable in mind for the 
``next steps''? And keep in mind----
    Dr. Alderson. Well, I think--Mr. Chairman, I think your 
message is loud and clear.
    Chairman Boehlert. Thank you.
    All right. With that, adjourned.
    [Whereupon, at 11:30 a.m., the Committee was adjourned.]

                              Appendix 1:

                              ----------                              


                   Answers to Post-Hearing Questions

Responses by Norris E. Alderson, Chair, Nanotechnology, Environmental, 
        and Health Implications Working Group; Associate Commissioner 
        for Science, Food and Drug Administration

Questions submitted by Chairman Sherwood L. Boehlert

Q1.  The Nanotechnology Environment and Health Implications (NEHI) 
working group report released on September 21, 2006 says that NEHI's 
next steps include assessing the existing portfolio of research on 
environmental and safety impacts of nanotechnology, identifying gaps, 
and setting research priorities. When will these activities begin and 
when do you expect them to be completed?

A1. The Nanotechnology Environmental and Health Implications Working 
Group (NEHI) will begin work immediately to address the ``next steps'' 
identified in the ``Environmental, Health, and Safety Research Needs 
for Engineered Nanoscale Materials'' (EHS) report. NEHI is comprised of 
representatives from the sixteen Federal Government agencies that are 
the most experienced and scientifically qualified in the U.S. 
Government to consider nanotechnology issues. They all recognize the 
importance of completing this effort as part of the United States' 
commitment to realizing the benefits of nanotechnology in a manner that 
is responsible and that protects health and the environment.
    An important next step is development of a more detailed inventory 
of the research currently being conducted by the National 
Nanotechnology Initiative (NNI) funded agencies. This will involve 
working through the Office of Management and Budget (OMB) to get 
information so that we can make assessments as to the extent that 
current research is addressing the priority work of the five research 
areas identified in the research needs report.
    As for a completion date, NEHI will be in a better position to 
define this following our receipt and assessment of the information on 
the current research programs funded under the NNI. We see ourselves 
moving expeditiously to address the issues and produce a report that is 
credible and endorsed by all the U.S. Government's agencies represented 
in NEHI. In the meantime, research related to all five research areas 
is continuing to be supported in increasing amounts by NNI agencies, 
including the Environmental Protection Agency (EPA), the National 
Science Foundation (NSF), the National Institute for Occupational 
Safety and Health (NIOSH), the National Institutes of Health (NIH), the 
Department of Defense (DOD), and the Department of Energy (DOE).
    We understand the importance of this issue to the Committee and to 
the United States maintaining its dominance in the development of 
nanotechnology that is safe for both the U.S. consumer and the 
environment. We believe that the process we are following will enable 
achievement of these goals.

Q2.  In your written testimony, you say that the NEHI working group 
``will only serve in an advisory capacity'' with respect to setting 
priorities for research on environmental and safety impacts of 
nanotechnology. In the Q&A during the hearing, Dr. Bement said that the 
role of setting budget priorities is for the Office of Science and 
Technology Policy and the Office of Management and Budget. Does the 
NEHI have any role in the budget setting process of individual agencies 
or the White House Office's of Science and Technology Policy or 
Management and Budget? If so, how? If not, should it?

A2. NEHI plays a valuable role in the budget-setting process of those 
agencies that fund nanotechnology Research and Development (R&D). 
Through the interagency process, reports like the research needs 
document represent the consensus of all NEHI member agencies, including 
those that do not have nanotechnology R&D budgets, and both the Office 
of Science and Technology Policy (OSTP) and OMB. The work of NEHI 
provides input to the NNI agencies that fund nanotechnology R&D and 
through the development of these documents, informs and provides 
guidance to the respective budget formulation processes for each 
agency. It is through this process that the NNI agencies that do not 
have nanotechnology R&D funding, yet that have a mission interest, have 
an impact on those agencies that have nanotechnology R&D funding. In 
addition, the NEHI process provides for the development of mutual 
decisions on the direction of EHS funding in the budget setting process 
involving the individual agencies and OMB.

Q3.  In Dr. Maynard's testimony, he reported that the Federal 
Government is spending less on research on environmental and safety 
issues than the Federal Government claims it is spending. Why do his 
estimates differ so greatly from the figures reported by the 
Administration? What do you need to do to reconcile your figures with 
his? Are detailed accountings of the each agency's spending estimates 
available? If so, would you please provide them to the Committee?

A3. The funding amounts reported in the NNI Supplement to the 
President's 2006 and 2007 Budgets for spending on the environmental 
health and safety (EHS) research to understand the implications of 
engineered nanoscale materials were obtained from the Office of 
Management and Budget. Considerable care was exercised by OMB to obtain 
the best funding numbers from those agencies funding research on this 
topic. The intentionally restrictive definition developed by the 
involved agencies and used by OMB was chosen to aid program managers in 
making clear decisions about which projects and efforts to include in 
their funding estimates. The definition used by OMB in their request to 
the agencies was:

         Research and development on the environmental, health, and 
        safety (EHS) implications of nanotechnology includes efforts 
        whose primary purpose is to understand and address potential 
        risks to health and to the environment posed by this 
        technology. Potential risks encompass those resulting from 
        human, animal, or environmental exposure to nanoproducts--here 
        defined as engineered nanoscale materials, nanostructured 
        materials, or nanotechnology-based devices, and their 
        byproducts.

    With such a restrictive definition, it is doubtful that the Federal 
Government estimates of funding for this research topic are 
overestimates. In fact, the research topics being proposed by other 
countries for inclusion under EHS research on nanotechnology include 
several types of research not included in the definition given above. A 
key example is research to develop instrumentation and metrology for 
characterizing the properties of engineered nanoscale materials. Most 
researchers in this field now recognize that knowledge of the purity of 
materials used in EHS studies is key to obtaining reproducible results 
among research studies.
    Dr. Maynard's estimates for the Federal Government's spending on 
EHS R&D likely differ from the Federal Government's estimates because 
he did not have full access to funding data from all the agencies 
involved in this research, and he apparently does not agree with the 
definition used by the Federal Government.
    A detailed breakdown--beyond the agency-by-agency data provided in 
the NNI Supplements to the President's Budgets--of the estimated 
funding for EHS R&D is not available at this time. As indicated in the 
``Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale materials'' document, development of a more detailed 
breakdown of each agency's spending estimates is part of the next steps 
to be taken by the Federal Government as we move forward with our 
assessment of the research needs in this R&D area.

Q4.  In his testimony at the hearing on September 21, Dr. Andrew 
Maynard from the Wilson Center recommended that the government should 
ask the Board on Environmental Studies and Toxicology of the National 
Academies of Science to help develop a long-term research agenda and 
conduct rolling reviews for nanotechnology environmental and safety 
research. Dr. Maynard also recommended that the government should 
contract with the Health Effects Institute to manage and/or perform 
some of the highest priority research. What is your view of Dr. 
Maynard's recommendations?

A4. The National Academies of Science (NAS) is already tasked to 
provide a rolling review of the NNI. It would be appropriate to ask the 
NAS to include the other NAS Boards in the triennial review of NNI. As 
for the involvement of a third party organization such as Health 
Effects Institute to conduct nanotechnology health and environment 
research, this can be an effective means to address specific needs when 
there is a commitment by both industry and government to provide 
sustained funding. Without this commitment, it can become unproductive. 
We are not aware of a nanotechnology industry group that can provide 
the sustained funding necessary to support this research.

Questions submitted by Representative Bart Gordon

Q1.  The EMS research needs report released at the hearing includes 
several ``next steps'' (page 10 of the report) for the NEHI working 
group. What is the estimated timeframe or developing the specific EMS 
research priorities, evaluating in detail the current federal EMS 
research portfolio, and performing a gap analysis of current EHS 
research compared to prioritized needs?

A1. The NEHI will begin work immediately to address the ``next steps'' 
identified in the ``Environmental, Health, and Safety Research Needs 
for Engineered nanoscale Materials'' EHS report. The representatives of 
the sixteen U.S. Government agencies are the most experienced and 
scientifically qualified in the U.S. Government to consider 
nanotechnology issues. They all recognize the importance of completing 
this effort as part of the United States' commitment to realizing the 
benefits of nanotechnology in a manner that is responsible and that 
protects health and the environment.
    An important next step is development of a more detailed inventory 
of the research currently being conducted by the NNI funded agencies. 
This will involve working through the OMB to get information so that we 
can make assessments as to the extent that current research is 
addressing the priority work of the five research areas identified in 
the research needs report.
    As for a completion date, we will be in a better position to define 
this following our receipt and assessment of the information on the 
current research programs funded under the NNI. We see ourselves moving 
expeditiously to address the issues and produce a report that is 
credible and endorsed by all the U.S. Government's agencies represented 
in NEHI. In the meantime, research related to all five research areas 
is continuing to be supported in increasing amounts by NNI agencies, 
including EPA, NSF, NIOSH, NIH, DOD, and DOE.
    We understand the importance of this issue to the Committee and to 
the United States maintaining its dominance in the development of 
nanotechnology that is safe for both the U.S. consumer and the 
environment. We believe that the process we are following will enable 
achievement of these goals.

Q2.  In responses to questions at the hearing, the agency witnesses 
seemed to be saying the current planning/coordinating mechanism for EHS 
research based on the NEHI working group will be able to produce an EHS 
research plan or roadmap, consisting of a cross-agency set of specific 
research priorities, timelines, and associated funding targets broken 
out by agency. What adjustments are needed to the way NEHI functions or 
to the way it is staffed to achieve this goal in a timely way?

A2. Adjustments are not needed at this time in order for the NEHI to 
perform a gap analysis and to address any areas that such an analysis 
might suggest are not being adequately investigated. NEHI members 
represent sixteen agencies, plus OMB and OSTP. NEHI is supported by the 
full-time staff of the National Nanotechnology Coordinating Office. The 
sixteen agencies include agencies that have nanotechnology R&D budgets, 
as well as those that do not, but that have a mission interest in the 
subject.
    The NEHI process is significant in terms of the credibility of the 
products produced. It is not a top-down process. The NEHI process is a 
collaborative approach to very complex, scientific issues. The 
collaboration brings to bear the collective expertise of the many 
agencies involved and provides for their ongoing buy-in-this would not 
be achieved with a top-down approach. NEHI members also recognize the 
importance of public input in this process and will develop the means 
to achieve this objective. We also recognize that the process of 
obtaining public input adds to the time required.
    NEHI does not produce funding targets for the NNI funded agencies. 
The NEHI report serves to inform and guide the funding agencies in 
their respective funding processes, which involve OMB.
    All the NEHI agencies endorse the continuation of the process 
followed in the development of the NEHI EHS Report. This collaborative 
process takes time, but the process is sound and in the best interest 
of the United States in maintaining its dominance in the development of 
nano-engineered products that are safe to both the U.S. consumer and 
the environment.

Q3.  How frequently does the NEHI working group meet (include the 
schedule of meetings during the past 12 months), and do most members 
attend meetings (provide the list of current members)?

A3. The NEHI Working Group has met on an approximately monthly schedule 
starting in March 2004. As requested, the meeting schedule for the past 
12 months is provided in Enclosure 1. This schedule omits many 
meetings, both face-to-face and teleconference meetings, by several 
drafting groups during the six months prior to the publication of the 
research needs document. Over 75 percent of the NEHI Working Group 
members normally participate in the meetings. A roster of current 
members of the NEHI Working Group is provided in Enclosure 2.

Q4.  Does the NEHI working group attempt to develop a funding target 
for the overall EHS research effort under the NNI, as well as funding 
requirements to achieve specific research goals? What was the role of 
the NEHI working group in developing the funding estimate for EHS 
research shown in the FY 2007 NNI budget supplement report?

A4. The NEHI does not incorporate any funding considerations for EHS 
research under NNI in any of its report development. NEHI was not 
involved, as a body, in developing funding estimates for the fiscal 
year 2007 NNI budget supplement report. Individually, NEHI members, 
representing their respective agencies on the Nanoscale Science, 
Engineering and Technology (NSET) Subcommittee, were involved.
    NEHI's process provides for the development of collaborative 
reports for which there is buy-in during the development process by all 
the agencies involved. This process also involves OMB, a significant 
collaborator in the development of the required agency budgets.

Q5.  Do you believe the NEHI working group's charter prevents or 
impedes it from developing budget requirements for achieving EHS 
research objectives?

A5. According to the NEHI charter, one purpose of the working group is 
to ``facilitate the identification, prioritization, and implementation 
of research and other activities required for the responsible research, 
development, utilization, and oversight of nanotechnology, including 
research on methods of life-cycle analysis.'' Agency budgets must be 
developed within the larger context of agency missions and priorities. 
By developing a consensus among NEHI members regarding priorities in 
the area of EHS research related to nanomaterials, NEHI enables the 
agencies that fund research related to engineered nanoscale materials 
to better assess and justify programs in this area within their own 
organization and to OMB.

Q6.  By what means do industry and other interested non government 
entities have their views considered by the NEHI working group? Does 
NEHI hold any open meetings with non-government attendees?

A6. In the development of the NEHI EHS Report, other reports were used 
as information sources. Specifically, a report developed by the 
chemical and semiconductor industries was used. We also reviewed 
reports from the Royal Society/Royal Academy of Engineering in the 
United Kingdom and a report funded by the European commission.
    In past meetings of NEHI, we have had presentations from non-
government organizations including the Chemical Abstract Service, March 
2004; Intel, Cooperative Boards for Advancing Nanotechnology-EHS, on 
the group's suggested research targets, October, 2005; and National 
Research Council's Board on Environmental Studies and Toxicology, 
March, 2005. We will continue to take advantage of these opportunities 
as we continue our work.
    All members of NEHI are committed to a more formal process that 
involves the industry and other interested non-government experts, 
especially in identifying priority areas. The development of this 
process will be a priority for NEHI as we address the next steps 
identified in the first NEHI document on environment, health, and 
safety of engineered nanoscale materials.

Q7.  Has the NEHI working group attempted to coordinate EHS research 
funded under the NNI with related research being carried out abroad?

A7. In furtherance of the efforts of the NSET Subcommittee and NEHI to 
address the significant issues of nanotechnology standards development, 
NSET and NEHI members are working in a collaborative manner with 
representatives from this industry and academia, and with our non-U.S. 
counterparts. This activity includes participation by NSET and NEHI 
members on the American National Standards Institute Technical Advisory 
Group to the International Organization for Standards Technical 
Committee on Nanotechnologies, ASTM International E56 Committee, and 
the Institute of Electrical and Electronics Engineers Committees on 
Nanotechnology. Additionally, members are collaborating with the U.S. 
National Committee Technical Advisory Group for the newly formed 
International Electrotechnical Commissions' technical committee (TC) 
113, on Nanotechnology Standardization for Electrical and Electronic 
Products and Systems.
    In addition, the nanotechnology funded agencies, through their 
normal activities with their foreign counterparts, will collaborate, 
where appropriate. This would not be an activity of the NEHI, but 
relevant information would be reported to NEHI.
    Recently, the Global Issues in Nanotechnology Working Group (GIN) 
was chartered as a formal working group under the NSET. Chaired by the 
State Department, it has representation from the offices of the NNI 
participating agencies that handle international science and technology 
issues. The GIN provides review, input, and feedback on documents and 
other materials for international activities that relate to 
nanotechnology.
    Just getting underway is an international activity within the 
Organization for Economic Cooperation and Development. A new working 
party on manufactured nanomaterials is meeting for the first time this 
month in London. The main objective will be to address issues related 
to environmental, health, and safety implications of manufactured (or 
engineered) nanomaterials, including sharing information on research 
efforts underway and identifying opportunities for cooperation. The NNI 
participation in this effort will be coordinated through both the NEHI 
and the GIN.

Q8.  In his testimony at the hearing, Dr. Maynard suggested a mechanism 
for government to partner with industry to fund EHS research that would 
support the needs of government in formulating a regulatory framework 
for nanomaterials and the needs of industry on how to develop 
nanotechnology safely. The idea is to use the Health Effects Institute 
model, which studies the health effects of air pollution. What are your 
views on this suggestion: would this be a workable approach for 
instituting a government/industry partnership for support of EHS 
research related to nanotechnology?

A8. The involvement of a third party organization such as Health 
Effects Institute to conduct nanotechnology health and environment 
research can be an effective means to address specific needs when there 
is a commitment by both industry and government to provide sustained 
funding. Without this commitment, it can become unproductive. We are 
not aware of a nanotechnology industry organization that can provide 
the sustained funding necessary to support this research.



                   Answers to Post-Hearing Questions
Responses by Arden L. Bement, Jr., Director, National Science 
        Foundation

Questions submitted by Chairman Sherwood L. Boehlert

Q1.  In his testimony at the hearing on September 21, Dr. Andrew 
Maynard from the Wilson Center recommended that the government should 
ask the Board on Environmental Studies and Toxicology of the National 
Academies of Science to help develop a long-term research agenda and 
conduct rolling reviews for nanotechnology environmental and safety 
research. Dr. Maynard also recommended that the government should 
contract with the Health Effects Institute to manage and/or perform 
some of the highest priority research. What is your view of Dr. 
Maynard's recommendations?

A1. The National Research Council (NRC) completed its report on the 
National Nanotechnology Initiative (NNI) with a special section on 
Environmental, Health and Safety (EHS) in October 2006. The report was 
requested by Congress and was sponsored by NNI participating agencies. 
The report evaluated the status of EHS research and provides general 
guidance for future work. A subsequent NRC study will begin in 2007, 
and EHS issues will be addressed. The NRC will conduct rolling reviews 
for nanotechnology, including EHS. The NRC panel may be asked to 
address additional issues, and include the Board on Environmental 
Studies and Toxicity in the evaluation. However, another parallel study 
would be duplicative.
    Regarding the issue of management and performance of highest 
priority research, the mission-oriented agencies are best equipped to 
address various aspects of the EHS issues. The problems are too complex 
and diverse to be addressed by a single group in a single institute. A 
coordinated approach among existing federal agencies is appropriate. A 
single institute may not have the expertise in all areas, and may not 
be able to respond effectively in a fast evolving field. In addition, 
we believe that basic research funding should be accomplished through a 
competitive, merit-based process.

Q2.  Does the National Science Foundation (NSF) issue targeted 
solicitations for research focused on specific potential environmental 
or safety risks associated with nanotechnology? If not, please explain 
how NSF addresses the highest priorities in nanotechnology 
environmental and safety research? Are there are additional ways to 
target NSF's solicitations to specific risk-based questions, while 
still preserving the strengths of NSF's investigator-driven model of 
research?

A2. The annual NSF program solicitation ``Nanoscale Science and 
Engineering'' in the interval FY 2001-2005 included one theme related 
to nanoscale processes in the environment and another theme on societal 
implications. The NSF program solicitation ``Active Nanodevices and 
Nanosystems'' in FY 2006-2007 has a major theme on societal dimensions 
of nanotechnology. In the last two years (FYs 2006-2007) NSF has 
partnered with the Environmental Protection Agency (EPA), National 
Institute for Occupational Safety and Health (NIOSH) and the National 
Institute of Environmental Health Sciences (NIEHS) for a separate 
program solicitation on toxicity. All themes are aligned with the NSF 
mission of creating fundamental knowledge, establishing the 
infrastructure including human resources, and supporting nanotechnology 
education. NSF plans to continue to emphasize the EHS and Ethical, 
Legal, and Societal Implications (ELSI) areas. We will include 
environmental aspects in program descriptions, and support workshops to 
stimulate proposals in the field.
    NSF co-sponsored the first (2000) and second (2003) workshops on 
Societal Implications of Nanoscience and Nanotechnology in order to 
highlight the key research topics. NSF co-sponsored with EPA and the 
Nanoscale Science, Engineering, and Technology (NSET) Subcommittee the 
grand challenge workshop on the environment; the report on those 
proceedings is expected to be published in November 2006. Also, NSF 
organized other topical workshops on the environment to identify the 
research trends and stimulate interest in the community.

Q3.  How has NSF decided how much money to allocate to nanotechnology 
environmental and safety research? Why is the funding level proposed in 
NSF's fiscal year 2007 budget request so low compared to what is 
recommended by the Wilson Center and by Lux Research?

A3. NSF identifies key knowledge gaps and the level of funding needed 
to address the issues through the process described in the following 
paragraph. Because of NSF's critical impact on building a fundamental 
body of knowledge, specialized facilities and qualified people, NSF 
funds a large fraction of the overall NNI investment in Societal 
Dimensions: $59 million (72 percent) of the $82.1 million total in the 
FY 2007 Request, and $51.5 million (72 percent) of $71.7 million in the 
FY 2006 estimation (see The NNI--Supplement FY 2007 Budget, page 36-
37). Of the total NSF contribution to NNI ($373 million), about 16 
percent is for societal dimensions of which seven percent is 
specifically for EHS. These percentages are in the range of those 
recommended on average for all of NNI by the Woodrow Wilson Center 
(WWC) and Lux Research (about four percent for EHS recommended by WWC 
and about nine percent recommended by Lux Research on average for all 
agencies).
    The NSF funding level is established following an annual evaluation 
process where input is sought from the research community, industry, 
and other organizations. All NSF proposals under NNI are evaluated by 
merit review. Also, NSF has an annual process of establishing overall 
priorities for nanoscale science and engineering research, including:

        (a)  NSET Subcommittee: Results from periodic workshops and 
        meetings with the communities are synthesized by program 
        directors and discussed in the NSET Subcommittee and its 
        working groups;

        (b)  National context: NSF contributes to and coordinates its 
        NNI research and education activities through the Nanoscale 
        Science, Engineering and Technology Subcommittee (NSET) of the 
        National Science and Technology Council (NSTC), as a cross-
        cutting priority reported to the Office of Management and 
        Budget (OMB), and a national priority of the Administration. 
        NSF participates in all NNI workshops, research directions and 
        planning meetings and is coordinating its program with the work 
        done by other agencies in the general context of R&D, 
        infrastructure and education needs;

        (c)  International context: NSF organized the first 
        ``International Dialogue on Responsible Nanotechnology'' 
        conference which included 25 countries and the European Union 
        (EU) and was held in the U.S. in June 2004, and contributed to 
        the second in July 2006 in Japan. Other international 
        interactions have been developed with the Organization for 
        Economic Cooperation and Development (OECD), international 
        standards and other international organizations. NSF organized 
        bilateral meetings with the European Commission, Japan, Korea, 
        Switzerland, India, China, Ireland, and others in order to 
        identify research directions and develop collaborations. NSF 
        has recently funded an international project on identifying EHS 
        research needs, and has interactions with the EU and Japan on 
        future joint research funding activities in societal 
        dimensions;

        (d)  Industry perspective: A joint NNI-industry working group 
        on EHS with the electronic and chemical industries has resulted 
        in a report on EHS Research Needs (2005) and periodically 
        provides input to NSF staff;

        (e)  Public and Non-Governmental Organizations (NGOs): NSF 
        receives feedback through surveys and periodical interactions. 
        For example, NSF has supported surveys that are used as a 
        reference in setting up the new Network for Nanotechnology in 
        Society. All Nanoscale Science and Engineering Centers (NSEC) 
        and nanotechnology networks supported by NSF are encouraged to 
        have public outreach activities, and two networks have a well-
        defined task in this area, the Network for Nanotechnology in 
        Society and the Network for Informal Science Education;

        (f)  Annual Grantees Meetings and other evaluation activities: 
        NSF's Committees Of Visitors (COVs), NSF's Directorate Advisory 
        Committees, OMB's Program Assessment Rating Tool (PART), 
        Presidential Council of Advisors for Science and Technology 
        (PCAST) review);

        (g)  Interagency Coordination via NSTC/NSET and its three 
        working groups: Nanomaterials Environmental and Health Issues 
        (NEHI), Nanotechnology Innovation and Liaison to Industry 
        (NILI), Global Issues in Nanotechnology (GNI), and 
        Nanotechnology Public Engagement Group (NPEG).

Q4.  In your testimony on September 21, you laid out some specific 
priorities for nanotechnology environmental and safety research. To 
what extent do these priorities overlap with the research that other 
federal agencies are sponsoring? To what extent do these priorities 
fill research gaps identified in the Wilson Center report? Of the 
research priorities that the Wilson Center identified, are there some 
priorities that NSF does not plan to investigate?

A4. There is very little, if any, overlap. The topics covered by NSF 
align with the agency's mission and cover some of the top 
recommendations made by both WWC and Lux Research for fundamental 
understanding, infrastructure, and education in the field of 
nanotechnology. The mission-oriented goals for testing the toxicity of 
specific nanomaterials and exposure to the digestive system are best 
covered by the respective mission oriented agencies.

Q5.  Please explain the degree to which, and how, NSF's agenda for 
nanotechnology environmental and safety research is shaped by 
interagency coordination, and how it is shaped by the need to inform 
potential regulation.

A5. NSF coordinates closely with other agencies in planning to 
eliminate duplication of effort and ensure effective knowledge 
transfer. NSF's agenda in this area is defined by the fundamental 
knowledge gaps, infrastructure and education needs.
    NSF develops its strategic and annual planning, and its 
collaboration with other participating agencies in NSET and NSET's 
Nanomaterials Environmental and Health Issues (NEHI) Working Group. NSF 
conducts fundamental research in EHS according to its mission, which 
complements the more practical approach of EPA, toxicity studies by the 
National Institutes of Health (NIH), and regulatory activities by the 
Food and Drug Administration (FDA) and NIOSH. This research provides a 
broad-based foundation of knowledge, trained people and suitable 
laboratory infrastructure for the mission-specific applied R&D done by 
the regulatory agencies. NSF-sponsored research and education results 
have long-term, broad impact and may be used by multiple agencies. All 
NSF awards are listed on the web site and searchable by programs, 
authors, and keywords. In addition, NSF has communicated its results at 
periodic interagency meetings and workshops, including grantees 
workshops.

Questions submitted by Representative Bart Gordon

Q1.  NSF funds well over half of all EHS research under the NNI. How 
specific are NSF's announcements to the research community regarding 
funding opportunities in this area? That is, does NSF direct the 
attention of potential grant awardees to research questions of high 
relevance to the regulatory agencies responsible for dealing with the 
human health and environmental risks of nanomaterials, and what 
percentage of the EHS funding available from NSF would fall into this 
category of directed basic research?

A1. NSF has allocated a high percentage of its investment in 
nanotechnology in the EHS area in order to define the key science and 
engineering issues, prepare the scientific foundation for environmental 
implications, develop the research infrastructure and train suitable 
workers in the field. NSF conducts fundamental research in EHS 
according to its mission, which complements the more practical approach 
of EPA, toxicity studies by NIH, and regulatory activities by FDA and 
NIOSH. NSF has encouraged research in the fundamental aspects of EHS 
partially by its program solicitations and several core program 
descriptions, as well as workshops and conferences on these topics.

Q2.  In his testimony at the hearing, Dr. Maynard suggested a mechanism 
for government to partner with industry to fund EHS research that would 
support the needs of government in formulating a regulatory framework 
for nanomaterials and the needs of industry on how to develop 
nanotechnology safely. The idea is to use the Health Effects Institute 
model, which studies the health effects of air pollution. What are your 
views on this suggestion? Would this be a workable approach for 
instituting a government/industry partnership for support of EHS 
research related to nanotechnology?

A2. We believe that fundamental research on nanotechnology EHS issues 
will be advanced most effectively by supporting researchers at academic 
institutions using merit review. The role of government is in creating 
the knowledge foundation for industry to apply knowledge, general 
principles and reference data to various applications. It is not clear 
that placing all resources in one place for a complex problem with 
multiple stakeholders (government, various industries with proprietary 
claims, public, NGOs) would lead to superior results.

Q3.  In responses to questions at the hearing, the agency witnesses 
seemed to be saying the current planning/coordinating mechanism for EHS 
research based on the NEHI working group will be able to produce an EHS 
research plan or roadmap, consisting of a cross-agency set of specific 
research priorities, timelines, and associated funding targets broken 
out by agency. What adjustments are needed to the way NEHI functions or 
to the way it is staffed to achieve this goal in a timely way?

A3. NEHI is a working group that provides coordination in the field of 
EHS and reports to NSET. NEHI plays an advisory role to agencies. The 
Office of Science and Technology Policy (OSTP) and OMB coordinate the 
research and development plans, set priorities with input from 
agencies, and approve budgets for NNI each year, including for EHS 
efforts. Accordingly, only agencies with financial responsibility and 
under guidance from OMB and OSTP can set priorities and allocate 
funding. No changes are needed in the NEHI function and staffing.

Questions submitted by Representative Brad Sherman

    This hearing focuses on the safety impacts of nanotechnology. I 
have concerns about the implications of nanotechnology that have not 
yet been adequately addressed and are often incorrectly dismissed as 
``science fiction.'' It is said that computer engineering can be 
referred to as ``dry nanotechnology,'' that generic engineering can be 
referred to as ``wet nanotechnology,'' and that the implantation of 
computer chips and similar devices into a human or other biological 
organism is ``damp nanotechnology.'' Thus, the term nanotechnology 
encompasses the most interesting cutting-edge scientific research. It 
seems the science that will affect our lives in the biggest way is 
mighty small, in fact, nano-small. All three types of nanotechnology 
could well lead to what I call ``engineered intelligence,'' i.e., the 
creation of self-aware entities with intellectual capacities for 
exceeding the brightest human. Computer engineering (dry 
nanotechnology) is likely to create artificial intelligence exceeding 
humans within 25-30 years, according to the consensus of experts who 
testified before our committee on April 9, 2003. The time will come 
when genetic engineers will be able to create a 1,000 pound mammal with 
two fifty pound brains capable of a perfect score on the LSAT. And 
perhaps the first entities with superhuman intelligence will be humans 
with substantial computer chip implants capable of thinking in ways no 
ordinary human has. In any case, I refer to all three of these 
nanotechnologies (dry, wet and damp) when I use the term engineered 
intelligence.
    Dr. Bement, in your written testimony you mention the three main 
categories of what the National Science Foundation (NSF) characterizes 
as the ``societal dimensions'' of nanotechnology and you also go on to 
say that each of these categories is indispensable. My concern falls 
within the category of ``ethical, legal and other social issues.'' The 
ethical and societal repercussions of engineered intelligence should be 
studied.

Q1.  Please describe in detail the projects that are funded by the 
National Science Foundation, which address the ethical and societal 
concerns accompanying the development of nanotechnology. Which of these 
focus on engineered intelligence in general or artificial intelligence 
in particular? If there are no such projects, what is the NSF's plan to 
promote studies addressing these concerns?

A1. The National Science Foundation is investing $4.8 million in FY 
2006 and is seeking $5.4 million in the FY 2007 Request to Congress for 
ethical, legal, and social issues research and education. The NSF is 
funding several projects addressing ethical and social concerns of 
nanotechnology including: two major centers devoted to the examination 
of nanotechnology in society at the University of California Santa 
Barbara (UCSB) and Arizona State University (ASU); two nanotechnology 
in society research groups, one at Harvard/UCLA and the other at the 
University of South Carolina; two grants for Nanotechnology 
Interdisciplinary Research Teams (NIRTs) at the University of 
Minnesota, and Northeastern; several Nanotechnology Exploratory 
Research (NERs) grants; two Ethics Education in Science and Engineering 
(EESE) grants that involve ethical issues associated with 
nanotechnology; and several standard research grants funded through NSF 
programs. In addition, the National Nanotechnology Infrastructure 
Network (NNIN) includes activities related to societal and ethical 
issues, and a number of Nanoscale Science and Engineering Centers 
(NSECs) include research components on societal and ethical issues. 
Most of these projects address a range of mid- and long-range ethical 
and societal issues including personal privacy, security, identity, 
human enhancement, regulatory capacity, public perceptions and 
acceptance, and media coverage.
    Although none of the above projects specifically addresses the 
ethical and societal issues of engineered intelligence or artificial 
intelligence, three projects directly engage ethical issues associated 
with nanotechnology and human enhancement. The Center for 
Nanotechnology in Society at ASU has a research focus on human 
identity, enhancement and biology. The NSEC for Molecular Function at 
the Nano/Bio Interface at the University of Pennsylvania has an ethics 
component. A recently awarded standard research grant to scholars at 
Dartmouth and Western Michigan University will examine ethical issues 
associated with human enhancement and nanotechnology, particularly 
those that may be made possible with nanomaterials and nanoelectronics, 
e.g., nanotechnologically-augmented vision.

Q2.  It is widely recognized that information about the risks of 
nanotechnology, to be useful, needs to be communicated to the potential 
users of that information in an effective way. Information that is not 
the product of an ongoing dialogue with various stakeholders, such as 
public health officials, theologians, philosophers, representatives of 
non-profit organizations, the private sector, and the general public, 
is not likely to be seen as credible by such stakeholders. Dr. Bement, 
please describe for me the NSF's plan for ensuring an ongoing dialogue 
with the public about nanotechnology issues so that the results of 
ethical and societal studies are valuable and usable for stakeholders. 
Please particularly focus on the ethical and societal research 
regarding the impacts of nanotechnology's potential creation of 
engineered intelligence in each of the three forms I have outlined 
above.

A2. NSF has activities in formal and informal education for 
nanotechnology, as well as public surveys and public participation. For 
nanotechnology education and outreach alone, NSF has allocated $24.5 
million in FY 2006 and $28.0 million in the FY 2007 Request to 
Congress.
    We have several projects that specifically address the need to 
ensure an ongoing dialogue with the public on nanotechnology.

          Nanotechnology: The Convergence of Science and 
        Society (ESI-0452371, Oregon Public Broadcasting, Needham) is 
        producing three one-hour television programs for national 
        broadcast on the social, ethical, legal, and environmental 
        implications of nanotechnology based on the Fred Friendly 
        Seminar format, accompanied by community-based outreach efforts 
        and a web site.

          The Nanoscale Informal Science Education Network 
        (ESI-0532537, Museum of Science, Bell), which is creating 
        exhibits and media to educate the public about nanoscience and 
        technology, includes development and implementation of public 
        forums in science museums designed to engage adults in 
        discussing potential societal impact.

          Other projects, such as Earth & Sky Nanoscale Science 
        and Engineering Radio Shows (ESI-0426417, EarthTalk Inc., 
        Britton) that will increase general public awareness of 
        nanotechnology and its role in our lives.

    There are numerous other activities associated with the projects 
outlined in the answer above that are designed to foster an ongoing and 
informed dialogue with various stakeholders including the public. For 
example, Science Cafes, at which nano-scientists talk about their 
research and afford members of the public an opportunity to raise 
questions and concerns, are being held on a regular basis at the 
University of Wisconsin and ASU. The University of South Carolina has 
organized several Citizens' Schools of Nanotechnology where members of 
the public read and discuss nanotechnology and related societal issues 
over a several-week period. The Harvard/UCLA research project is 
developing a pilot NanoEthicsBank providing an online database of 
articles, journals, reports, and meeting minutes related to 
nanotechnology and ethics; the NanoEthicsBank is accessible to the 
public and other stakeholders. Several projects, including those at 
ASU, UCSB, and North Carolina State, have public deliberation 
activities related to nanotechnology and society. Finally public 
opinion surveys, as well as scientist surveys, associated with various 
aspects of nanotechnology and society are being conducted as part of a 
number of these projects. In all these instances, the local media are 
utilized to inform the public about the activities.
    In addition to the activities focusing on public knowledge, 
understanding and concerns, several workshops on nanotechnology and 
society issues have been held in conjunction with NSF funded projects. 
At these, representatives from academia, non-profits, government and 
industry have participated. For example, Michigan State held a workshop 
on what nanotechnology can learn from the experiences of biotechnology. 
A workshop on ethical issues and nanotechnology is being planned and 
will be held at ASU.

Q3.  Roughly two percent of the National Science Foundation's FY 2007 
request for the National Nanotechnology Initiative goes to ``ethical, 
legal, and social issues,'' while about eight percent is directed 
toward environmental, health and safety research. Dr. Bement, you state 
in your submitted testimony that ``ethical, legal, and social issues'' 
are an important dimension of the study of nanotechnology's societal 
issues. Then, why is so little of the funding for the National 
Nanotechnology Initiative (NNI) directed towards the ``ethical, legal, 
and social issues'' category?

A3. The support for ``ethical, legal, and social issues'' was 
determined by the need for funding the relevant and meritorious social 
sciences projects, the level of current developments in the field and 
formation of a multi-disciplinary community, and the funding needs of 
competing areas such as Environmental, Health and Safety (EHS). The 
current investment is beginning to create a community with critical 
mass for advancing research and understanding of the ethical, legal and 
social issues associated with nanotechnology.
    Now, leaving the issue of engineered intelligence, I have some 
general questions about the NNI which are frankly less important to me 
than the previous questions, but I hope you will answer them at your 
convenience.

Q4.  Is your agency involved in a systematic assessment of emerging 
products of nanoscale science and engineering so that you can identify 
possible new sources of risk at the earliest possible stage?

A4. NSF co-organized a grand challenge workshop on the environment, 
supports four centers for partial support of this topic, and initiated 
the industry-government working groups on EHS in 2003. NSF does not 
directly evaluate products, as that is a role that is more pertinent to 
other agencies and industry.

Q5.  Is your agency involving researchers in the process of identifying 
and prioritizing research problems, to ensure that research agendas are 
responsive to stakeholder concerns? What societal research are you 
supporting to help identify the various ways that nanotechnology risk 
is being framed by researchers? If you are not engaged in such work, 
why are you confident that the research you are funding will be 
valuable for stakeholders?

A5. NSF provides opportunities for stakeholder input through its 
process of establishing priorities, including workshops with various 
communities, joint working groups, direct interactions, grantees 
meetings, and interagency exchanges. For example, NSF supports projects 
on safety in manufacturing, occupational health issues, implications 
for food and agriculture, as well as for long-term societal 
implications.
    NSF is supporting research on different approaches to risk 
assessment and risk perception for nanotechnology. For example, the 
University of Wisconsin is studying the effect of nanotechnology on 
food production and risk perception. NSF is funding research and 
education activities to assess risk for the current and future 
generations of nanoproducts. All projects are subject to peer review 
where stakeholders are invited to participate.

Q6.  According to a Congressional Research Services document, the 
Administration's FY 2007 request for the National Nanotechnology 
Initiative is a four percent decline in real dollars than what was 
enacted in FY 2006. Why would we decrease the funding, given the 
importance of the research?

A6. The Request for NNI investment has increased each year including in 
FY 2007 ($1,278 million) as compared to the FY 2006 Request ($1,054 
million).
                   Answers to Post-Hearing Questions
Responses by William H. Farland, Deputy Assistant Administrator for 
        Science, Office of Research and Development, U.S. Environmental 
        Protection Agency

Questions submitted by Chairman Sherwood L. Boehlert

Q1.  In his testimony at the hearing on September 21, Dr. Andrew 
Maynard from the Wilson Center recommended that the government should 
ask the Board on Environmental Studies and Toxicology of the National 
Academies of Science to help develop a long-term research agenda and 
conduct rolling reviews for nanotechnology environmental and safety 
research. Dr. Maynard also recommended that the government should 
contract with the Health Effects Institute to manage and/or perform 
some of the highest priority research. What is your view of Dr. 
Maynard's recommendations?

A1. The National Academies of Science (NAS) provides periodic reviews 
of the government activities under the National Nanotechnology 
Initiative (NNI) as required by the 21st Century Nanotechnology 
Research and Development Act of 2003. The NNI is managed within the 
framework of the National Science and Technology Council (NSTC), the 
Cabinet-level council by which the President coordinates science, 
space, and technology policies across the Federal Government. The 
Nanoscale Science Engineering and Technology (NSET) Subcommittee of the 
NSTC coordinates planning, budgeting, program implementation and review 
to ensure a balanced and comprehensive initiative. The NSET 
Subcommittee is composed of representatives from agencies participating 
in the NNI.
    The NSET Subcommittee members value its relationship with NAS and 
hope to use it in the future to receive input and feedback from the 
Board on Environmental Studies and Toxicology (BEST) and other NAS 
Boards on research directions and priorities related to environmental, 
health and safety. However, the agencies that participate in NSET and 
its Nanotechnology Environmental and Health Implications Working Group 
(NEHI) have already made significant progress toward a long-term 
research agenda with the publication in September of the report 
``Environmental, Health and Safety Research Needs for Engineered 
Nanoscale Materials,'' and are committed to taking steps immediately to 
establish priorities for their research needs Given this progress, it 
seems most effective to utilize BEST and other NAS bodies to review, 
rather than to establish, an additional long-term research agenda. EPA 
believes that the current NAS role provides timely and appropriate 
input to the government's research agenda.
    EPA supports collaboration with the private sector and other 
stakeholders. While EPA has a positive relationship with the Health 
Effects Institute on air pollution research, we believe it is too early 
to conclude that the same model is appropriate for nanotechnology 
environmental and safety research. On October 18, EPA announced its 
intent to develop a stewardship program that would provide a valuable 
collaboration with industry and other stakeholders, and which we expect 
to result in significant new information being made available on 
nanomaterials. EPA is inviting the public, industry, environmental 
groups, other federal agencies and other stakeholders to participate in 
the design, development and implementation of this program. A 
successful stewardship program will complement the Agency's new and 
existing chemical programs under the Toxic Substances Control Act and 
can help provide a scientific foundation for regulatory decisions by 
encouraging the development of key scientific information and 
appropriate risk management practices.

Q2.  How has the Environmental Protection Agency (EPA) decided how much 
money to allocate to nanotechnology environmental and safety research? 
What impact will the report from the Nanotechnology Environmental and 
Health Implications Working Group have on EPA's nanotechnology research 
programs? What impact will it have on EPA's fiscal year 2008 budget 
request?

A2. Determinations of research budget priorities are made in the 
context of the Agency's overall priorities and budget needs in concert 
with the Agency program offices. EPA also has allocated resources to 
new, emerging issues, such as nanotechnology, through its Science to 
Achieve Results (STAR) exploratory grants. Initial results from this 
STAR nanotechnology research and research by others helped clarify 
research gaps and opportunities that were considered as EPA increased 
its nanotechnology budget request from FY06 to FY07. The EPA's FY08 
budget process has been guided in part by the development of the 
Nanotechnology White Paper, which was released as a draft report in 
December 2005 for public comment. Over the past year, the process of 
developing the NEHI research needs document has provided additional 
insight into EPA's research needs. EPA has developed a nanotechnology 
research strategy framework which, along with the White paper should 
advance the NEHI efforts to develop an overall federal prioritized 
research strategy in this area.

Q3.  In your testimony on September 21, you laid out some specific 
priorities for nanotechnology environmental and safety research. To 
what extent do these priorities overlap with the research that other 
federal agencies are sponsoring? To what extent do these priorities 
fill research gaps identified in the Wilson Center report? Of the 
research priorities that the Wilson Center identified, are there some 
priorities that EPA does not plan to investigate?

A3. Our testimony on September 21 stated that EPA will conduct research 
to understand whether nanoparticles, in particular those with the 
greatest potential to be released into the environment and/or trigger a 
hazard concern, pose significant risks to human health or ecosystems. 
We stated that we are uniquely positioned to lead in the ecosystem and 
exposure areas. A research framework included in the White Paper 
identifies specific near-term priority research areas as fate, 
transport, transformation, exposure and monitoring, and detection 
technologies. The Agency has taken steps to ensure that the priority 
research areas will not overlap either with current research sponsored 
by other agencies or with their research priorities. EPA communicates 
regularly with other federal agencies concerning priorities through the 
NEHI and NSET and collaborates with other agencies on research 
solicitations to ensure that environmental and health issues are 
undertaken in a coordinated manner. For example, EPA has issued joint 
solicitations over the past two years with National Science Foundation, 
National Institute of Occupational Safety and Health and the National 
Institute of Environmental Health Sciences.
    EPA's priorities are also consistent with those suggested in the 
Woodrow Wilson Center research document, which suggests the Agency give 
priority to the areas of exposure and monitoring/detection technologies 
with subsequent focus on ecotoxicity and life cycle approaches (found 
on pp. 34-36 of the report, http://www.nanotechproject.org/67/7-19-06-
nanotechnology-a-research-strategy-for-addressing-risk). All of these 
areas are contained within the priorities identified in the recent 
testimony and the draft White Paper. While the Wilson Center report 
does not mention fate, transport and transformation explicitly, these 
areas are critical to understanding both exposure and toxicity--whether 
ecological or human--as well as life cycle considerations.

Q4.  EPA released a draft white paper on its research needs for the 
environmental and safety impacts of nanotechnology for public comment 
last year. Your written testimony said that it complements the report 
released today. In what way are they complementary? When will the white 
paper be finalized? Will you be revising it based on today's report? 
Will the final version identify short-, medium- and long-term 
priorities?

A4. The Nanotechnology White Paper was recently approved by the 
Agency's Science Policy Council, so EPA anticipates that the final 
version will be released to the public soon.
    The draft White Paper provides an extensive review of research 
needs for both environmental applications and implications of 
nanotechnology. To help EPA focus on priorities for the near-term, the 
draft concludes with recommendations on the next steps for addressing 
science policy issues and research needs. In addition, it includes in 
Appendix C, a description of EPA's framework for nanotechnology 
research, which outlines how EPA will strategically focus its own 
research program (as outlined in the September testimony) to provide 
key information on potential environmental impacts from human or 
ecological exposure to nanomaterials in a manner that complements 
federal, academic, and private-sector research activities. 
Collaboration with other researchers is a major focus of the draft 
paper.
    EPA was represented on the committee that developed the NEHI 
report, and played a key role in identifying research needs. As such, 
there is no need to modify the white paper since the two reports 
complement one other. The NEHI report was designed to give an overview 
of environmental, health and safety research needs for all federal 
agencies. The research needs identified in EPA's draft White Paper were 
included in the NEHI report. As the NEHI prioritizes needs, those areas 
that fall within the mission and expertise of the EPA will be addressed 
in the context of the Agency's overall research priorities and budget.

Questions submitted by Representative Bart Gordon

Q1.  In his testimony at the hearing, Dr. Maynard suggested a mechanism 
for government to partner with industry to fund EHS research that would 
support the needs of government in formulating a regulatory framework 
for nanomaterials and the needs of industry on how to develop 
nanotechnology safely. The idea is to use the Health Effects Institute 
model, which studies the health effects of air pollution. What are your 
views on this suggestion: would this be a workable approach for 
instituting a government/industry partnership for support of EHS 
research related to nanotechnology?

A1. EPA supports collaboration with the private sector and other 
stakeholders, and EPA has a positive relationship with the Heath 
Effects Institute on air pollution research. However, we believe it is 
too early to conclude that the same model is appropriate for 
nanotechnology environmental and safety research. On October 18, EPA 
announced its intent to develop a stewardship program that would 
provide a valuable collaboration that could result in significant new 
information that will help the Agency better understand the potential 
risks and benefits of nanotechnology. EPA is inviting the public, 
industry, environmental groups, other federal agencies and other 
stakeholders to participate in the design, development and 
implementation of this program. A successful stewardship program will 
complement the Agency's new and existing chemical programs under the 
Toxic Substances Control Act and can help provide a scientific 
foundation for regulatory decisions by encouraging the development of 
key scientific information and appropriate risk management practices.

Q2.  In responses to questions at the hearing, the agency witnesses 
seemed to be saying the current planning/coordinating mechanism for EHS 
research based on the NEHI working group will be able to produce an EHS 
research plan or roadmap, consisting of a cross-agency set of specific 
research priorities, timelines, and associated funding targets broken 
out by agency. What adjustments are needed to the way NEHI functions or 
to the way it is staffed to achieve this goal in a timely way?

A2. The Agency does not believe any alterations nor changes in the NEHI 
staffing or functionality are required to prioritize the research needs 
that are identified in the NEHI report. As indicated above, EPA has 
already developed its own prioritized research strategy, and will work 
with other agencies through the NEHI to develop a coordinated cross-
agency set of research priorities in a timely manner.
                   Answers to Post-Hearing Questions
Responses by Altaf H. (Tof) Carim, Program Manager, Nanoscale Science 
        and Electron Scattering Center, U.S. Department of Energy

Questions submitted by Chairman Sherwood L. Boehlert

Q1.  In his testimony at the hearing on September 21, Dr. Andrew 
Maynard from the Wilson Center recommended that the government should 
ask the Board on Environmental Studies and Toxicology of the National 
Academies of Science to help develop a long-term research agenda and 
conduct rolling reviews for nanotechnology environmental and safety 
research. Dr. Maynard also recommended that the government should 
contract with the Health Effects Institute to manage and/or perform 
some of the highest priority research. What is your view of Dr. 
Maynard's recommendations?

A1. Periodic reviews of the National Nanotechnology Initiative, 
specifically including environmental and safety aspects, are already 
required from both the National Academies and the President's Council 
of Advisors on Science and Technology (serving as the National 
Nanotechnology Advisory Panel) under P.L. 108-153. Initial reports from 
both groups have been issued (the Academies' review report, A Matter of 
Size: Triennial Review of the National Nanotechnology Initiative, was 
released in pre-publication form shortly after the hearing, on 
September 25th, 2006, and the PCAST report, The National Nanotechnology 
Initiative at Five Years: Assessment and Recommendations of the 
National Nanotechnology Advisory Panel, was issued in May 2006). Both 
reports discussed environmental, health, and safety aspects of the 
initiative and it is anticipated that this topic area will 
appropriately receive attention in subsequent reviews by these groups.
    Development of a long-term agenda for environmental and safety 
research is already underway via the interagency Nanoscale Science, 
Engineering, and Technology (NSET) subcommittee of the National Science 
and Technology Council and its subsidiary Nanotechnology Environmental 
and Health Implications (NEHI) working group. These activities are in 
the context of the missions, resources, and expertise of the 
participating agencies, and represent comprehensive coordination of 
federal efforts. The document prepared by NEHI and released on the date 
of the hearing, Environmental, Health, and Safety Research Needs for 
Engineered Nanoscale Materials, represents an initial step in the 
ongoing process of defining and evaluating these activities. Given the 
existing mandate for the National Academies to review these aspects of 
the National Nanotechnology Initiative and the time required from 
commissioning to final publication of a National Academies report, an 
additional review requirement by the National Academies in this area 
would not appear to be warranted or fruitful.
    The Department of Energy is not involved with the existing work of 
the Health Effects Institute (HEI) and defers to other agencies with 
more expertise in this subject area. HEI appears to be focused on 
particular classes of problems, with roughly half of its core funding 
coming from ``the worldwide motor vehicle industry'' (as per its 
homepage, at http://www.healtheffects.org/about.htm). Government 
partnerships with, or support of, private parties can be appropriate 
and effective, though a preferable approach might be to define the 
needs and then consider competitive proposals to achieve the desired 
ends, rather than pre-selecting a specific party to manage and/or 
perform such work. This is best pursued in the context of agency 
missions, resources, expertise, and past experience.

Q2.  In your testimony on September 21, you stated that the Department 
of Energy (DOE) supports research on potential environmental and safety 
risks associated with nanotechnology by providing uniquely capable 
synthesis and characterization tools, but you suggested that DOE does 
not sponsor or conduct targeted nanotechnology environmental and safety 
research. Given DOE's significant contribution to the National 
Nanotechnology Initiative (NNI), shouldn't DOE's contribute more 
directly to NNI's targeted environmental and safety research 
priorities?

A2. As is the case for all the agencies involved in the NNI, DOE 
contributes to NNI goals and priorities in the ways which align most 
closely with the Department's mission, resources, and expertise. The 
distinct nature of each agency's nanotechnology programs reflects the 
ongoing interagency coordination and the corresponding efforts to avoid 
duplication and most effectively pursue such work. DOE solicitations 
have not focused specifically on nanomaterials environmental and safety 
research, though a limited amount of work with the primary purpose of 
understanding transport and ultimate disposition of nanoscale particles 
in the environment has been supported via competitive merit review as 
part of our geosciences research program. Other activities with 
important relevance to environmental and safety concerns include the 
operation of user facilities that provide capabilities for obtaining 
comparable, reproducible data; work on measurement and characterization 
techniques, including novel instrumentation; and development of 
standards and nomenclature. These activities include some which are 
critical and involve DOE and/or contractor staff but little or no 
direct funding, such as internal working group discussions of best 
practices among DOE-supported laboratories and participation in groups 
such as the American National Standards Institute and the International 
Organization for Standardization. Nevertheless, the Department intends 
to reassess its direct support of environmental and safety research as 
it relates to nanotechnology applications in DOE mission areas.

Q3.  Please explain the degree to which, and how, DOE's investments in 
advanced nanotechnology facilities are shaped by nanotechnology 
environmental and safety research priorities, and how those investments 
are shaped by the need to inform potential regulation related to 
possible environmental and safety risks.

A3. The DOE Nanoscale Science Research Center user facilities 
investments have been shaped by a variety of factors including initial 
interagency discussions at the start of the National Nanotechnology 
Initiative, a series of planning workshops that attracted nearly 2,000 
participants, definition of nanoscience research needs to address 
energy issues, and efforts to optimize the utility and accessibility of 
other major BES facilities for nanoscience. While the instrument suites 
and infrastructure investments over the past five years have not 
directly reflected recently-developed environmental and safety research 
priorities or regulatory needs, DOE representatives have made members 
of those communities aware of the resources that will be made available 
to them through the NSRCs via presentations to and meetings with 
program managers and grantees from EPA, USDA, NIH, NSF, and the NSET 
interagency group as a whole.
    The NSRCs are part of the scientific infrastructure of the Nation. 
They support the specific research missions of other agencies by 
providing access to unique capabilities and collections of instruments 
and expertise that are unavailable elsewhere or impractical for many 
individual organizations to obtain and support. The NSRCs also provide 
opportunities for collaboration. The methods and practices developed 
and used at the NSRCs allow the collection of comparable, I 
reproducible data across material types and across multiple research 
groups through the use of standardized platforms and procedures; such 
consistency in measurement and characterization is critical to 
understanding research issues.

Q4.  How are priorities for nanotechnology environmental and safety 
research considered in DOE's budget and planning processes for 
nanotechnology research and development?

A4. The NSET-NEHI report and other external documents on nanotechnology 
environmental and safety research needs provide guidance; agencies then 
make their plans for activities in this area within the framework of 
the NSET report(s) and based on the input and directions identified by 
the interagency process, third parties, the community through workshops 
and discussions, and a variety of other means. In the case of DOE, the 
budget and planning processes for nanoscience and related activities 
center on the mission of the Office of Science, involving fundamental 
research in support of long-term energy security and discovery science, 
and forefront scientific user facilities for the Nation. The planning 
for nanoscience centers rests on the principles of broad access and of 
facilitating leading-edge research in all areas by providing a 
comprehensive suite of tools and expertise.

Questions submitted by Representative Bart Gordon

Q1.  In his testimony at the hearing, Dr. Maynard suggested a mechanism 
for government to partner with industry to fund EHS research that would 
support the needs of government in formulating a regulatory framework 
for nanomaterials and the needs of industry on how to develop 
nanotechnology safely. The idea is to use the Health Effects Institute 
model, which studies the health effects of air pollution. What are your 
views on this suggestion: would this be a workable approach for 
instituting a government/industry partnership for support of EHS 
research related to nanotechnology?

A1. (As answered as part of the response to Question #1 from Chairman 
Boehlert and repeated here.) The Department of Energy is not involved 
with the existing work of the Health Effects Institute (HEI) and defers 
to other agencies with more expertise in this subject area. HEI appears 
to be focused on particular classes of problems, with roughly half of 
its core funding coming from ``the worldwide motor vehicle industry'' 
(as per its homepage, at http://www.healtheffects.org/about.htm). 
Government partnerships with, or support of, private parties can be 
appropriate and effective, though a preferable approach might be to 
define the needs and then consider competitive proposals to achieve the 
desired ends, rather than pre-selecting a specific party to manage and/
or perform such work. This is best pursued in the context of agency 
missions, resources, expertise, and past experience.

Q2.  In responses to questions at the hearing, the agency witnesses 
seemed to be saying the current planning/coordinating mechanism for EHS 
research based on the NEHI working group will be able to produce an EHS 
research plan or roadmap, consisting of a cross-agency set of specific 
research priorities, timelines, and associated funding targets broken 
out by agency. What adjustments are needed to the way NEHI functions or 
to the way it is staffed to achieve this goal in a timely way?

A2. The very aspect of the NEHI working group that causes the process 
to be at times lengthy is also its strength: it synthesizes and 
reconciles input from the many agencies involved, and thus provides a 
coordinated and consensus output that is reflective of the overall U.S. 
federal position. We believe that the current NSET and NEHI structure 
is the best approach to engaging the needed expertise from the member 
agencies to do credible, effective, and implementable planning.

                   Answers to Post-Hearing Questions

Responses by Andrew D. Maynard, Chief Science Advisor, Project on 
        Emerging Nanotechnologies, Woodrow Wilson International Center 
        for Scholars

Questions submitted by Chairman Sherwood L. Boehlert

Q1.  In your testimony you indicated that the interagency working group 
is not able to carry out the important tasks identified in the 
Nanotechnology R&D Act, including assessing research gaps, setting 
priorities, and reviewing and directing agency budgets? How would you 
make NEHI more effective?

A1. First, I would suggest that the NEHI working group's position under 
the National Science and Technology Council Committee on Technology 
places it at an immediate disadvantage in ensuring that targeted 
research informs regulation and other forms of oversight. I will expand 
on my reasoning behind this statement below. If NEHI does continue to 
be the interagency group primarily responsible for ensuring effective 
nanotechnology risk-research across the Federal Government, then I 
would propose that three changes are essential if the group is to be 
effective in implementing relevant parts of the 21st Century 
Nanotechnology Research and Development Act:

        1.  The charter of the NEHI working group must be modified to 
        increase the group's charge and authority to establish and 
        implement a strategic nano-risk research framework, which 
        underpins nanotechnology oversight.

        2.  The NEHI working group must have the authority to ensure 
        that appropriate agencies have the resources they need to 
        conduct relevant, effective and coordinated risk research.

        3.  A full-time director, with appropriate staffing, must 
        oversee the activities of the NEHI working group, with 
        responsibility for developing and implementing a cross-agency 
        strategic risk-research plan. The Director must be seen as an 
        ``honest broker'' with no immediate ties to any government 
        agency. The Director must also have direct access to key 
        decision makers in both the White House and the Office of 
        Management and Budget (OMB).

    These changes will provide the tools NEHI needs to develop and 
implement an effective top-down strategic research framework across 
federal agencies, a framework that enables each agency to operate to 
maximum effect within its mission and competencies. However, by 
themselves, these changes will not guarantee success. Implementation of 
the recommended changes will require the support and commitment of all 
participating agencies, the Office of Science and Technology Policy 
(OSTP) and OMB. NEHI will also need new funding to cover critical 
research and support a full-time director. I have previously estimated 
that a minimum of $100 million over the next two years needs to be 
spent on targeted risk-related research, with additional funding for 
basic and applications-focused research with some relevance to 
understanding risk. I would suggest that mechanisms are needed whereby 
additional research funds can be allocated to agencies via the NEHI 
group to supplement current resource-starved programs--possibly through 
new funds being appropriated by a relatively neutral agency, and 
allocated out through interagency agreements. Effective resource 
allocation will depend on developing a strategic research agenda within 
NEHI, identifying the roles of research agencies within this agenda, 
and enabling cross-agency collaborations.
    I also recommended in my testimony to the House Committee on 
Science that an external organization be used to allow public and 
private sector co-funding of strategic environmental, health and safety 
research. One model explored was the Health Effects Institute, which 
receives funding from the Environmental Protection Agency (EPA) (both 
the Office of Research and Development and the Air Office) along with 
industry to conduct targeted research on the health effects of air 
pollution.

Is NEHI the most appropriate cross-agency group to assess research 
                    gaps, set priorities, and review and direct agency 
                    budgets?

    I would suggest that the NEHI working group's position under the 
National Science and Technology Council Committee on Technology places 
it at an immediate disadvantage in implementing risk-related aspects of 
the 21st Century Nanotechnology R&D Act, and in particular in ensuring 
that targeted research informs regulation and other forms of oversight. 
The paradigms and mechanisms that drive research for effective risk 
assessment and management differ significantly from those that drive 
basic science. There is a significant overlap between these two areas--
applied risk-research will always build on basic science. But if 
applied research aimed at assessing and managing risk is approached in 
the same way as exploratory research, there is a danger that resulting 
research programs will not be responsive to the needs of regulators, 
industry and the public. The National Nanotechnology Initiative (NNI) 
has been extremely successful in stimulating exploratory research 
across many areas of science, which will underpin new applications and 
new ways of managing risk. Yet, there are indications that approaches 
to applied risk-research within the NNI are clouded by following an 
exploratory research-paradigm. I would highlight just three examples 
that support this observation:

          The current NEHI Terms of Reference focus on 
        facilitating and supporting bottom-up research programs and 
        strategies--an approach that is ideal for fostering 
        collaborative investigator-driven exploratory research, but is 
        not responsive to assessing research gaps, setting priorities, 
        and reviewing and directing agency budgets.

          Current investment in risk-based research is 
        purportedly dominated by the National Science Foundation 
        (NSF)--despite a widely recognized need for targeted risk 
        research beyond the directive of this agency. As nanotechnology 
        moves off the lab bench and into the marketplace, one would 
        expect to see a significant shift in risk-related research 
        funding to mission-driven agencies such as the EPA, the U.S. 
        Department of Agriculture (USDA), and the Food and Drug 
        Administration (FDA), which have direct oversight 
        responsibilities. This is not happening.

          The recent NSET research needs document\1\ refers to 
        current research, which, while conceivably enhancing our 
        understanding of risk in the distant future, has little 
        practical relevance at present. Take, for instance, the cited 
        development of Transmission Electron Aberration-corrected 
        Microscope (TEAM) project within the Department of Energy 
        (DOE).\2\ From my own research, I can confidently state that, 
        while this is a vital area of research for nano-applications, 
        it is of only secondary importance to increasing our 
        understanding of nano-implications.\3\
---------------------------------------------------------------------------
    \1\ NSET. 2006. Environmental, Health, and Safety Research Needs 
for Engineered Nanoscale Materials. Nanoscale Science, Engineering, and 
Technology Subcommittee, Committee on Technology, National Science and 
Technology Council. September.
    \2\ Ibid, p. 15.
    \3\ Maynard, A.D. 1995. ``The application of electron energy-loss 
spectroscopy to the analysis of ultra-fine aerosol particles.'' J. 
Aerosol Sci. 26(5): 757-777; Maynard, A.D. and L.M. Brown. 2000. 
``Overview of methods for analysing single ultra-fine particles.'' 
358(1775): Philosophical Transactions of the Royal Society of London 
Series a-Mathematical Physical and Engineering Sciences. 2593-2609; 
Maynard, A.D., Y. Ito, et al. 2004. ``Examining elemental surface 
enrichment in ultra-fine aerosol particles using analytical Scanning 
Transmission Electron Microscopy,'' Aerosol Sci. Tech. 38: 365-381.

    With the best will in the world, an effective strategic risk-
research framework is unlikely to be developed and implemented if those 
responsible are working within the wrong paradigm, in an inappropriate 
framework. This is why, in my report on strategic risk research 
published earlier this year,\4\ I recommend that a separate interagency 
group be established that can address these issues within ,an 
appropriate framework.
---------------------------------------------------------------------------
    \4\ Maynard, A.D. 2006. Nanotechnology: A Research Strategy for 
Addressing Risk. Washington, DC: Project on Emerging Nanotechnologies, 
Woodrow Wilson International Center for Scholars, July. Available at: 
http://www.nanotechproject.org/reports.

Q2.  In your testimony you reported that the Federal Government is 
spending less on research on environmental and safety issues than the 
Federal Government claims it is spending. Why do your estimates differ 
so greatly with the figures reported by the Administration? What do you 
---------------------------------------------------------------------------
need to reconcile your figures with the government's accounting?

A2. Based on the considerations outlined below, it is my opinion that 
the discrepancy between the NSET and the Project on Emerging 
Nanotechnologies (PEN) figures reflects a rather broad interpretation 
within NSET of research that is highly relevant to understanding the 
potential risks of engineered nanomaterials. Because federal agencies 
within the NNI remain unable to provide information on risk research at 
the project level, it is not possible to identify the sources of the 
discrepancy with any certainty.
    Funding figures without access to the underlying data are largely 
meaningless. Understanding the potential risks of nanotechnology is 
complex, and identifying research that might provide insight is more 
than an accounting exercise. Because of this, the PEN inventory of 
health and environmental implications research\5\ categorizes 
information in a way that captures the complexity of current research, 
and provides a resource for anyone interested in planning relevant, 
coordinated and strategic research. Open-access to the inventory also 
allows anyone to challenge or validate conclusions drawn from the 
information it contains. I would encourage the Federal Government to 
take a similar approach, and indeed would consider this essential for 
developing strategic research plans that identify and address critical 
research needs. To achieve this, information must be collated, 
categorized and made available at the project level. An open accounting 
of the federal research portfolio would also make it easier for 
industry to determine where and how it could partner with government to 
fund risk research, as well as supporting effective international 
cooperation on strategic research.
---------------------------------------------------------------------------
    \5\ PEN. 2005. Nanotechnology Health and Environmental 
Implications: An Inventory of Current Research. Washington, DC: Project 
on Emerging Nanotechnologies, Woodrow Wilson International Center for 
Scholars. Available at: http://www.nanotechproject.org/18/esh-
inventory.

Examining the differences between PEN and NSET risk research estimates

    The NSET annual spending figure purportedly reflects research 
investment where the primary purpose is to understand and address 
potential risks to health and the environment. Research is either 
included in or excluded from the reported figures--there is no gray 
area of research that might have some relevance, but does not have a 
primary purpose of understanding risk. It must be assumed that 
interpretation of what constitutes relevant research is undertaken at 
the agency level and may be based on subjective judgments. 
Unfortunately, without information on which projects NSET does and does 
not account for, it is not possible to comment in depth on how this 
definition has been applied.
    In contrast, the PEN inventory categorizes research according to 
its relevance to understanding risk (high, substantial, some or 
marginal), allowing an inherently more sophisticated assessment of 
current activity. In this scheme, highly relevant research is directly 
focused on addressing risk, while research having lesser relevance 
might be focused on applications of nanotechnology, general 
characterization methods or non-engineered nanomaterials. In addition, 
research into incidental nanomaterials (such as vehicle emissions and 
naturally occurring nanoparticles) is classified separately from 
research specifically focused on engineered nanomaterials. This 
distinction is important--research into the impact of incidental 
nanomaterials can help inform our understanding of nanotechnology 
risks, but it is misleading to account for it as being directly 
relevant to nanotechnology.
    From the PEN inventory, it is estimated that the Federal Government 
invested $11 million on research, which is highly relevant to 
engineered nanomaterials in 2005 (Table 1). This added sophistication 
in accounting might explain some of the $28.7 million difference 
between PEN and NSET estimates. For instance, research on welding fume 
in the workplace--an incidental nanomaterial--has been included in the 
PEN inventory as it is useful for understanding purposely made 
nanomaterials. Yet this research has not been included in the estimated 
$11 million--precisely because it is not specifically focused on 
engineered nanomaterials. There is no way of telling at present whether 
the NSET has included this, and similar research projects, in spending 
estimates.




    The DOE, Department of Commerce (DOC), USDA and Department of 
Justice (DOJ) together account for a $3.4 million difference between 
the PEN and NSET figures. Information on what research DOJ is funding 
on nanotechnology risk research is not directly available, and is thus 
not included in the PEN inventory. For the other three agencies, it is 
likely that research accounted for by NSET as primarily addressing 
nano-risk was not considered highly relevant in the PEN inventory. For 
instance, a DOE project led by Dr. Kaufmann on controlling the shape, 
size and reactivity of metal oxide nanoparticles is categorized as 
having substantial, but not high relevance to risk in the PEN 
inventory. Likewise, a NIST project on developing microsphere-based 
spectroscopic instruments is categorized as having marginal relevance 
to risk in the PEN inventory. It is unclear whether NSET included these 
projects in its accounting.
    The EPA and the National Institute for Occupational Safety and 
Health (NIOSH)--two federal agencies charged with supporting research 
to understand and reduce adverse health and environmental impacts--
account for a $2.9 million difference between PEN and NSET figures. 
Discrepancies associated with EPA may well be due to differences in 
accounting--the NSET--reported figure for EPA includes a research 
investment in nanotoxicology grants for the period of fiscal year 
2006`fiscal year 2009, while the PEN figure reports mean annual EPA 
spending on risk-relevant research. Differences in the NIOSH estimates 
result from the lack of project-specific information being directly 
available from the agency. In the absence of further information, the 
reported $3 million per year investment was factored by the number of 
NIOSH projects in the PEN inventory that are highly relevant to 
understanding the potential risks of engineered nanomaterials.
    By far the largest discrepancy is with estimated NSF funding--with 
a difference of $21.5 million per year between NSET and PEN. This is 
likely due to different interpretations of relevant research. Once 
again, I can only speculate on why the figures are so different, 
without NSET providing information at the project level. However, as an 
agency charged with funding basic research, it is surprising to see NSF 
purportedly accounting for over 60 percent of research where the 
primary purpose is to understand and address potential risks to health 
and the environment--over three times the NSET-reported investment 
within NIOSH and EPA. This in itself is cause to question the figures.
    The PEN inventory classifies many of the NSF projects as relevant 
to understanding risk, but not highly relevant. For instance, the NSF-
funded Center for Biological and Environmental Nanotechnology (CBEN) at 
Rice University was considered substantially relevant to understanding 
risk, but the center's focus on applications as well as implications of 
nanotechnology precluded the research being categorized as highly 
relevant. Similarly, research into biologically compatible engineered 
nanoparticles to prevent UV-radiation induced damage was considered to 
have some relevance to risk, but not to be highly relevant.

Questions submitted by Representative Bart Gordon

Q1.  In responses to questions at the hearing, the agency witnesses 
seemed to be saying the current planning/coordinating mechanism for EHS 
research based on the NEHI working group will be able to produce an EHS 
research plan or roadmap, consisting of a cross-agency set of specific 
research priorities, timelines, and associated funding targets broken 
out by agency. Do you believe that there are adjustments that could be 
made to the way NEHI functions or to the way it is staffed that would 
allow it to achieve this goal in a timely way?

A1. From my experience as co-chair of NEHI, my knowledge of the terms 
of reference of the working group and my observations of the group's 
activity over the past year, I can only conclude that NEHI will not be 
able to produce an EHS research plan consisting of a cross-agency set 
of specific research priorities, timelines, and associated funding 
targets broken out by agency, within an acceptable time frame. Let me 
qualify this by stating that the current members of NEHI are extremely 
well qualified to identify and assess what research needs to be done 
and by whom if the Federal Government's investment in nanotechnology 
research is to translate into responsible industries and products. The 
recent NSET report on research needs attests to this. Yet, NEHI lacks 
the terms of reference, authority and resources to achieve what is 
necessary, and members of the group are often juggling many other 
conflicting commitments to spend the necessary time on ensuring the 
group functions effectively. There is, as Chairman Boehlert observed 
during the hearing, a sense of urgency in this task as more nano-based 
products pour into the marketplace. It is not enough to ask the right 
questions, they must be asked early enough so that we have time to 
generate practical answers. Our ability to reap the long-term benefits 
of our investments in nanotechnology will depend heavily on how we 
address any emerging risks.
    In my response to the first question from Chairman Boehlert 
(above), I consider three changes that I consider essential, if NEHI is 
to be effective in ensuring assessing research gaps are assessed, 
priorities are set, and agency budgets are reviewed and directed. Let 
me reiterate these changes here:

        1.  The charter of the NEHI working group must be modified to 
        increase the group's charge and authority to establish and 
        implement a strategic nano-risk research framework, which 
        underpins nanotechnology oversight.

        2.  The NEHI working group must have the authority to ensure 
        that appropriate agencies have the resources they need to 
        conduct relevant, effective and coordinated risk research.

        3.  A full-time director, with appropriate staffing, must 
        oversee the activities of the NEHI working group, with 
        responsibility for developing and implementing a cross-agency 
        strategic risk-research plan. The Director must be seen as an 
        ``honest broker'' with no immediate ties to any government 
        agency. The Director must also have direct access to key 
        decision makers in both the White House and the Office of 
        Management and Budget.

    In my opinion, these changes will also enable NEHI to develop a 
strategic risk research framework, consisting of a cross-agency set of 
specific research priorities, timelines, and associated funding targets 
broken out by agency. Without significant changes to the way the group 
operates, I am extremely pessimistic that we will see an effective 
strategic research framework emerge that enables federal agencies to 
operate to the best of their ability when addressing the complex 
challenges that nanotechnology is raising.

                              Appendix 2:

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                   Additional Material for the Record



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