[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?
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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
U.S. GOVERNMENT PRINTING OFFICE
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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?
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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.
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\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
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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.
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\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
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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.
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\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.
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\6\ Clayton Teague Testimony, November 17, 2005, House Science
Committee, p. 3.
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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.
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\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.
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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.
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\8\ Lux Research, ``Taking Action,'' 2006.
\9\ Lux Research, ``A Prudent Approach to Nanotech Environmental,
Health and Safety Risks.'' May, 2005.
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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.
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\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.
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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.
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\11\ This analysis was performed on the inventory as of November
23, 2005.
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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.
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\12\ Wilson Center, Project on Emerging Nanotechnologies,
``Nanotechnology: A Research Strategy for Addressing Risk,'' July,
2006.
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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.
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\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
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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.
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\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
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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\
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\15\ Small Wonders, Endless Frontiers: A Review of the National
Nanotechnology Initiative, National Research Council/National Academy
of Sciences, 2002.
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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.
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\16\ Id.
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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\
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\17\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October
2004.
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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.''
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\18\ Lux Research, ``A Prudent Approach to Nanotech Environmental,
Health and Safety Risks.'' May 2005
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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.
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\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.
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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.
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\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.
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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,
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\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
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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\
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\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.
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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\
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\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.
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\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.
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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.
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\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
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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.
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\1\ U.S. Congress (2003). 21st Century Nanotechnology Research and
Development Act (Public Law 108-153), S.189 Washington DC, 108th
Congress, 1st session.
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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.
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\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.
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\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.
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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.
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\4\ Nanotechnology Health and Environmental Implications: An
Inventory of Current Research. www.nanotechproject.org/18 Accessed
September 12th 2006.
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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.
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\5\ A Nanotechnology Consumer Products Inventory.
www.nanotechproject.org/consumerproducts Accessed September 12th 2006.
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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.
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\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).
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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.
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\8\ Interagency Working Group on Nanotechnology Environmental and
Health Implications (NEHI WG): www.nano.gov/html/society/NEHI.htm
Accessed September 12th 2006.
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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.
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\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.
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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.
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\11\ Health Effects Institute (HEI) Website. ``What is the Health
Effects Institute.'' Available at www.healtheffects.org/about accessed
July 27th 2006.
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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\
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\12\ HEI Annual Report 2005, p. 6.
\13\ HEI Annual Report 2005, p. 6.
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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\
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\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.
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\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\
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\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\
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\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.
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\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.
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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.
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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\
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\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.
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\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
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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.
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\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