[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
RESEARCH ON ENVIRONMENTAL AND
SAFETY IMPACTS OF NANOTECHNOLOGY:
CURRENT STATUS OF PLANNING AND
IMPLEMENTATION UNDER THE NATIONAL
NANOTECHNOLOGY INITIATIVE
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HEARING
BEFORE THE
SUBCOMMITTEE ON RESEARCH AND SCIENCE EDUCATION
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
OCTOBER 31, 2007
__________
Serial No. 110-69
__________
Printed for the use of the Committee on Science and Technology
Available via the World Wide Web: http://www.house.gov/science
______
U.S. GOVERNMENT PRINTING OFFICE
38-534 PDF WASHINGTON DC: 2008
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COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
MARK UDALL, Colorado LAMAR S. SMITH, Texas
DAVID WU, Oregon DANA ROHRABACHER, California
BRIAN BAIRD, Washington ROSCOE G. BARTLETT, Maryland
BRAD MILLER, North Carolina VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois FRANK D. LUCAS, Oklahoma
NICK LAMPSON, Texas JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona W. TODD AKIN, Missouri
JERRY MCNERNEY, California JO BONNER, Alabama
LAURA RICHARDSON, California TOM FEENEY, Florida
PAUL KANJORSKI, Pennsylvania RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington
JIM MATHESON, Utah MICHAEL T. MCCAUL, Texas
MIKE ROSS, Arkansas MARIO DIAZ-BALART, Florida
BEN CHANDLER, Kentucky PHIL GINGREY, Georgia
RUSS CARNAHAN, Missouri BRIAN P. BILBRAY, California
CHARLIE MELANCON, Louisiana ADRIAN SMITH, Nebraska
BARON P. HILL, Indiana PAUL C. BROUN, Georgia
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
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Subcommittee on Research and Science Education
HON. BRIAN BAIRD, Washington, Chairman
EDDIE BERNICE JOHNSON, Texas VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois ROSCOE G. BARTLETT, Maryland
JERRY MCNERNEY, California RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon DAVID G. REICHERT, Washington
RUSS CARNAHAN, Missouri BRIAN P. BILBRAY, California
BARON P. HILL, Indiana
BART GORDON, Tennessee RALPH M. HALL, Texas
JIM WILSON Subcommittee Staff Director
DAHLIA SOKOLOV Democratic Professional Staff Member
MELE WILLIAMS Republican Professional Staff Member
MEGHAN HOUSEWRIGHT Research Assistant
C O N T E N T S
October 31, 2007
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Brian Baird, Chairman, Subcommittee
on Research and Science Education, Committee on Science and
Technology, U.S. House of Representatives...................... 8
Written Statement............................................ 9
Statement by Representative Vernon J. Ehlers, Ranking Minority
Member, Subcommittee on Research and Science Education,
Committee on Science and Technology, U.S. House of
Representatives................................................ 10
Written Statement............................................ 11
Prepared Statement by Representative Daniel Lipinski, Member,
Subcommittee on Research and Science Education, Committee on
Science and Technology, U.S. House of Representatives.......... 12
Witnesses:
Dr. E. Clayton Teague, Director, National Nanotechnology
Coordination Office (NNCO)
Oral Statement............................................... 12
Written Statement............................................ 14
Biography.................................................... 24
Mr. E. Floyd Kvamme, Co-Chair, President's Council of Advisors on
Science and Technology
Oral Statement............................................... 25
Written Statement............................................ 27
Biography.................................................... 28
Dr. Vicki L. Colvin, Professor of Chemistry and Chemical
Engineering; Executive Director, International Council on
Nanotechnology; Director, Center for Biological and
Environmental Nanotechnology, Rice University
Oral Statement............................................... 29
Written Statement............................................ 31
Biography.................................................... 35
Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for
Scholars, Washington, D.C.
Oral Statement............................................... 36
Written Statement............................................ 37
Biography.................................................... 57
Dr. Richard A. Denison, Senior Scientist, Environmental Defense
Oral Statement............................................... 57
Written Statement............................................ 59
Biography.................................................... 66
Mr. Paul D. Ziegler, Chairman, American Chemistry Council
Nanotechnology Panel
Oral Statement............................................... 71
Written Statement............................................ 73
Biography.................................................... 77
Discussion....................................................... 78
Appendix: Answers to Post-Hearing Questions
Dr. E. Clayton Teague, Director, National Nanotechnology
Coordination Office (NNCO)..................................... 96
Mr. E. Floyd Kvamme, Co-Chair, President's Council of Advisors on
Science and Technology......................................... 104
Dr. Vicki L. Colvin, Professor of Chemistry and Chemical
Engineering; Executive Director, International Council on
Nanotechnology; Director, Center for Biological and
Environmental Nanotechnology, Rice University.................. 108
Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for
Scholars, Washington, D.C...................................... 110
Dr. Richard A. Denison, Senior Scientist, Environmental Defense.. 117
Mr. Paul D. Ziegler, Chairman, American Chemistry Council
Nanotechnology Panel........................................... 136
RESEARCH ON ENVIRONMENTAL AND SAFETY IMPACTS OF NANOTECHNOLOGY: CURRENT
STATUS OF PLANNING AND IMPLEMENTATION UNDER THE NATIONAL NANOTECHNOLOGY
INITIATIVE
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WEDNESDAY, OCTOBER 31, 2007
House of Representatives,
Subcommittee on Research and Science Education,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:00 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Brian
Baird [Chairman of the Subcommittee] presiding.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
hearing charter
SUBCOMMITTEE ON RESEARCH AND SCIENCE EDUCATION
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
Research on Environmental and
Safety Impacts of Nanotechnology:
Current Status of Planning and
Implementation Under the National
Nanotechnology Initiative
wednesday, october 31, 2007
10:00 a.m.-12:00 p.m.
2318 rayburn house office building
1. Purpose
On Wednesday, October 31, 2007, the Subcommittee on Research and
Science Education of the Committee on Science and Technology will hold
a hearing to review the need and motivation for research on the
environmental, health and safety (EHS) aspects of nanotechnology,
determine the current state of planning and implementation of EHS
research under the National Nanotechnology Initiative (NNI), and
explore whether changes are needed to the current mechanisms for
planning and implementing EHS research. This hearing is one in a series
the Committee will hold to review the administration and content of the
NNI as part of the process for developing legislation to reauthorize
the 21st Century Nanotechnology Research and Development Act of 2003
(P.L. 108-153) during the next session of Congress.
2. Witnesses
Dr. Clayton Teague, Director of the National Nanotechnology
Coordination Office (NNCO). The NNCO serves as the focal point for and
provides staff support to the Nanoscale Science, Engineering, and
Technology (NSET) Subcommittee of the National Science and Technology
Council. The NSET Subcommittee is responsible for the planning and
coordination of the interagency NNI.
Mr. Floyd Kvamme, Co-Chair of the President's Council of Advisors on
Science and Technology (PCAST). PCAST was designated by the President
to act as the National Nanotechnology Advisory Panel (NNAP) in
accordance with the 21st Century Nanotechnology Research and
Development Act of 2003 (P.L. 108-153).
Dr. Vicki L. Colvin, Executive Director, International Council on
Nanotechnology and Professor of Chemistry and Chemical Engineering,
Rice University.
Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for Scholars.
Dr. Richard Denison, Senior Scientist, Environmental Defense.
Mr. Paul D. Ziegler, Chairman of the Nanotechnology Panel, American
Chemistry Council, and Global Director, PPG Industries, Inc.
3. Overarching Questions
How important for the advancement of nanotechnology
is developing greater understanding of potential risks that the
technology may introduce to the environment and human health?
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 current federal research efforts adequate to
address concerns about environmental and safety ramifications
of nanotechnology? Is the EHS research funding properly aligned
with the agencies' roles and responsibilities for environmental
and safety matters; is the overall level of funding adequate;
have the most important research priorities been identified;
and is the funding aligned satisfactorily to address those
research priorities?
What is the status of the development of a
prioritized, detailed implementation plan for EHS research
under the NNI? Will the plan now under development provide
specific goals and timelines for achieving those goals; will it
have a description of the roles and responsibilities of the
participating agencies; and will it specify funding, by agency,
required to reach the goals? Are the research priorities in the
interim planning document appropriate?
How can the current planning, coordination and
implementation of EHS research under NNI be improved? Are
alternative mechanisms needed to ensure EHS research is carried
out expeditiously and on topics that will support the research
needs of the agencies charged with environmental and safety
regulation?
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.\4\ There is an unusual level of agreement among
researchers, and business and environmental organizations that
the basic scientific information needed to assess and protect
against potential risks does not yet exist.
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\4\ Matthew Nordan testimony, Science Committee hearing, September
21, 2006, Serial No. 109-63.
The President's fiscal year 2008 (FY08) budget
requests $1.4 billion for the NNI, the interagency
nanotechnology research and development program. Of this
amount, the budget proposes $58.6 million (4.1 percent of the
overall program) for research on EHS research. This is $10.8
million above the FY07 funding level. Nearly 50 percent of this
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funding would go to NSF.
In October 2003, the NSET organized an interagency
Nanotechnology Environmental and Health Implications (NEHI)
Working Group to coordinate environmental and safety research
carried out under the NNI. 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.\5\
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\5\ 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 prioritized plan for EHS research under the NNI.
In March 2006, the Administration informed the Science
Committee that this report would be completed that spring, but
the document that was finally released in September 2006 was a
non-prioritized list of EHS research areas. At a Science
Committee hearing organized at the time of the report's
release, the Chairman and Ranking Member stressed the urgency
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of developing the prioritized research plan.
The latest iteration of the EHS research plan, which
was released for public comment in August 2007, presents a
rationale for the process of defining EHS research priorities
and provides a reduced set of priorities based on the previous
report. It also indicates that the ``next steps'' (with no
indication of timing) include NEHI evaluating the NNI EHS
research portfolio to carry out a gap analysis to compare
current work to the priorities list and then develop ``a
strategy to address EHS research priorities'', which is
essentially what was promised in the plan expected in the
spring of 2006.
5. Previous Hearings
The Committee held a hearing on this topic, Environmental and
Safety Impacts of Nanotechnology: What Research Is Needed? [Serial No.
109-34], on November 17, 2005. At that hearing, witnesses from the
Federal Government, industry, and environmental organizations 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. The hearing also raised
questions about the effectiveness of the coordination and
prioritization of EHS research being carried out under the NNI, as well
as whether the key agencies having responsibilities for regulating
exposure of people and the environment to nanomaterials were fully
engaged in setting the priorities and funding appropriate activities.
A second, related hearing was held by the Committee on September
21, 2006, Research on Environmental and Safety Impacts of
Nanotechnology: What Are the Federal Agencies Doing? [Serial No. 109-
63]. The witnesses were from the agencies sponsoring EHS research and
participants in the NEHI Working Group, along with representatives from
an industry association and an NGO. The hearing was intended to review
the NEHI EHS research plan that the Committee had expected to receive
earlier that year (see following section). The agency witnesses were
unable to explain why the prioritized research plan had not been
completed. The non-government witnesses reiterated the urgency of
developing and implementing such a plan without further delay and
indicated that there were deficiencies in the scale and content of the
current EHS research portfolio. The hearing also raised, but did not
resolve, the issue of whether the current process for planning and
carrying out EHS research under NNI is viable.
6. National Nanotechnology Initiative
Fiscal Year 2008 Budget
The National Nanotechnology Initiative (NNI) is a multi-agency
research and development (R&D) program authorized by the 21st Century
Nanotechnology Research and Development Act (P.L. 108-153). Currently,
13 federal agencies participate in the coordination, planning, and
implementation of the research and development activities carried out
under the NNI. The primary goals of the NNI are to foster the
development of nanotechnology and coordinate federal R&D activities.
The total NNI funding for FY 2007 is $1.35 billion and the FY 2008
request is $1.44 billion. More information on agency roles and
activities under the NNI is available at http://www.nano.gov/.
The following table provides the FY 2008 funding proposal for each
participating agency and the amount the agency has identified as
supporting EHS activities:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Research Plan for Environmental and Safety Implications of
Nanotechnology
At the Science Committee's November 17, 2005 hearing on EHS
research related to 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 was finally released at the time of the September 21, 2006
Committee hearing, but it was merely a listing of research topics, not
a prioritized research plan with agency roles and funding levels
delineated.
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\6\ Clayton Teague testimony, Science Committee hearing, November
17, 2005, Serial No. 109-34.
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In August 2007, a new report was released, ``Prioritization of
Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials: An Interim Document for Public Comment.'' \7\ This
report, once again, is not the prioritized research plan originally
anticipated for release in the Spring of 2006. It is a refined list of
research priorities along with a description of a process for updating
the priorities list. The document includes a ``next steps'' section
that indicates NEHI will evaluate the NNI EHS research portfolio to
carry out a gap analysis to compare current work to the priorities list
and then develop ``a strategy to address EHS research priorities.'' No
estimate is given for a date for completion of this EHS research
program assessment and strategy document.
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\7\ http://www.nano.gov/
Prioritization-EHS-Research-Needs-
Engineered-Nanoscale-Materials.pdf
7. Witness Questions
Dr. Teague was asked to provide an overview of the current scope of
EHS research being conducted under the NNI, including how it relates to
international and private sector EHS research efforts, and to provide
an update on the development of a detailed implementation plan for EHS
research. He was asked to include in his testimony:
a description of the process that is underway to
develop the EHS research plan;
a description of the tenor of the responses received
during the period the NEHI Working Group report referenced
above was open for public comment; and
recommendations for ways to improve the planning,
prioritization, and implementation of EHS research under the
NNI.
Mr. Kvamme was asked to provide the views of the NNAP on the
effectiveness, scope, and content of the current EHS research efforts
under the NNI and any recommendations the NNAP may have on ways to
improve the process for planning, prioritization, and implementation of
EHS research under NNI. He was asked to answer the following questions:
Has the NNAP reviewed the recent report of the
Nanotechnology Environmental and Health Implications Working
Group, ``Prioritization of Environmental, Health, and Safety
Research Needs for Engineered Nanoscale Materials''? If so, are
the priorities listed in the report the right ones, and will
carrying out the ``next steps'' described in the report result
in a satisfactory detailed implementation plan for EHS
research?
Has the NNI assigned a sufficiently high priority to
EHS research and are there gaps in the portfolio of NNI
research now underway? What level of funding over what time
period is needed to make acceptable progress in understanding
the potential environmental and health risks associated with
the development of nanotechnology?
What are the optimum roles for the agencies in
sponsoring or conducting EHS research? Are responsibilities and
available resources currently in balance?
Does the NNAP believe the current process is working
for developing an EHS research plan under the NNI, and if not,
what changes are needed?
The other witnesses were asked to provide their views on the
effectiveness, scope, and content of the current EHS research efforts
under the NNI and recommendations on ways to improve the process for
planning, prioritization, and implementation of EHS research under NNI.
They were asked to answer the following questions:
What is your reaction to the recent report of the
Nanotechnology Environmental and Health Implications Working
Group, ``Prioritization of Environmental, Health, and Safety
Research Needs for Engineered Nanoscale Materials''? Do outside
groups have a way to influence this planning process? Are the
priorities listed in the report the right ones, and do you
believe that carrying out the ``next steps'' described in the
report will achieve the detailed implementation plan for EHS
research that is needed?
Has the NNI assigned a sufficiently high priority to
EHS research and are there gaps in the portfolio of NNI
research now underway? What level of funding over what time
period is needed to make acceptable progress in understanding
the potential environmental and health risks associated with
the development of nanotechnology?
What are the optimum roles for the agencies in
sponsoring or conducting EHS research? Are responsibilities and
available resources currently in balance?
Can the current process for developing the EHS
research plan under the NNI be made to work, and if so, what
changes are needed? If not, do you have recommendations for a
different approach for developing and implementing a
prioritized, appropriately funded EHS research plan with well
defined goals, agency roles, and milestones?
Chairman Baird. This morning's hearing is the third one in
three years the Science Committee has held on federally
sponsored research on the health and environmental risks that
may arise from applications of nanotechnology. The Committee's
attention to the issue reflects our view of its importance to
the development of nanotechnology and to capturing the enormous
promise of this technology.
The previous hearings have shown that there is wide
agreement on two main points: first, nanotechnology will
advance faster and receive public support if environmental,
health, and safety implications of the technology are fully
understood. Secondly, the interagency National Nanotechnology
Initiative must include a prioritized and adequately funded
research component focused on environmental, health, and safety
issues, or as they are sometimes known, EHS issues.
So the question before us today is not whether EHS research
is important nor whether the NNI should fund research on
environment and health risks. The question is how effectively
is the NNI carrying out the planning and implementation of the
EHS research component of the interagency program.
With regard to the adequacy of the funding, the outside
witnesses at the previous hearings either recommended that the
NNI substantially increase funding for EHS research or they
expressed frustration that they were unable to determine
exactly what EHS research was being supported by the NNI. The
basic position of most outside observers from industry and non-
governmental organizations is that the funding level should be
on the order of 10 percent of the total funding, rather than
the current four percent.
More important than funding level is the concern that the
EHS research component has not been well-planned and executed.
At the Committee's November 2005 hearing, the Administration's
witness indicated that an interagency working group was
developing a coordinated approach to nanotech research on EHS
that included input from industry and other non-governmental
entities. That was back in '05 I should emphasize.
We were told that the working group was in process of
producing a document that would identify and prioritize
research needs to assess the risks associated with engineered
nanomaterials and would be sufficiently detailed to guide
researchers and research managers in making project-level
decisions.
The estimated completion date for the document back in '05
was Spring of 2006. The fact that I have alluded to Halloween
in 2007 suggests we have missed that date. Unfortunately, we
are still waiting for that detailed implementation plan for
EHS.
At the Committee's hearing last September, then-Chairman
Boehlert and Ranking Member Gordon both expressed frustration
at the slow pace in developing this research plan. But they
were assured that the agencies were hard at work and that the
plan would soon be forthcoming.
Nearly a year later, this past August, an interim report
was released for public comment. Although the report makes some
progress in defining research goals, once again it is not a
research plan laying out goals and timelines, funding levels,
and defined agency roles and responsibilities for achieving
these goals. The report suggests this is all coming in the
``next steps,'' although it does not provide a target date for
completion of those next steps.
Meanwhile, more and more engineered nanoparticles continue
to enter the marketplace. The number of such products has
doubled to 500 over the past year according to surveys by the
Wilson Center's Project on Engineering Nanotechnologies. Simple
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.
The bottom line is that this is simply not an acceptable
situation. We are basically still waiting for the EHS research
strategy and detailed implementation plan that we were told
would be available 18 months ago.
I am genuinely puzzled why more progress has not been made,
hence today's hearing, to develop this research strategy and
plan that everyone believes is necessary for the successful
development of nanotech.
Today, I want to determine how the mechanisms in place for
planning and implementing the interagency EHS research
component of the NNI can be made to work better and what steps
are needed to accomplish that outcome.
On the other hand, if the process is flawed or is
intrinsically unable to function satisfactorily, I would invite
our witnesses to suggest alternative approaches and mechanisms.
I am looking for concrete suggestions that the Committee can
use as it develops legislation to reauthorize NNI over the next
few months. I will just interject as we look towards that
reauthorization, I will keep in mind closely whether or not we
have actually been able to meet some of the goals that we are
now 16 months past achieving. For me it seems difficult to
promote reauthorizing the program when fundamental elements of
environmental health and human safety are not being well-
addressed.
So I want to thank our witnesses for their attendance at
today's hearing, and I look forward to our discussion of this
important set of issues.
I now recognize the Ranking Member, Mr. Ehlers for an
opening comment.
[The prepared statement of Chairman Baird follows:]
Prepared Statement of Chairman Brian Baird
This morning's hearing is the third one in three years the Science
Committee has held on federally sponsored research on the health and
environmental risks that may arise from applications of nanotechnology.
The Committee's attention to this issue reflects our view of its
importance to the development of nanotechnology and to capturing the
enormous promise of this technology.
The previous hearings have shown that there is wide agreement on
two main points:
First, nanotechnology will advance faster and receive
public support if the environmental, health, and safety
implications of the technology are understood.
Secondly, the interagency National Nanotechnology
Initiative must include a prioritized and adequately funded
research component focused on environmental, health, and safety
issues--or EHS issues.
So the question before us today is not whether EHS research is
important nor whether the NNI should fund research on environmental and
health risks. The question is how effectively is the NNI carrying out
the planning and implementation of the EHS research component of the
interagency program.
With regard to the adequacy of funding, the outside witnesses at
the previous hearings either recommended that the NNI substantially
increase funding for EHS research or expressed frustration that they
were unable to determine exactly what EHS research was being supported
by the NNI. The basic position of most outside observers from industry
and non-governmental organizations is that the funding level should be
on the order of 10 percent of the initiative's total funding, rather
than the current four percent.
More important than funding level is the concern that the EHS
research component has not been well planned and executed. At the
Committee's November 2005 hearing, the Administration's witness
indicated that an interagency working group was developing a
coordinated approach to nanotechnology research on EHS that included
input from industry and other non-governmental entities.
We were told the working group was in process of producing a
document that 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.
The estimated completion date for the document was the spring of
2006. Unfortunately, we are still waiting for that detailed
implementation plan for EHS research.
At the Committee's hearing last September, then Chairman Boehlert
and Ranking Member Gordon both expressed frustration at the slow pace
in developing this research plan. But they were assured that the
agencies were hard at work and that the plan would soon be forthcoming.
Nearly a year later--this past August--an ``interim report'' was
released for public comment. Although this report makes some progress
in defining research goals, once again it is not a research plan laying
out goals and timelines, funding levels, and defined agency roles and
responsibilities for achieving those goals. The report suggests this is
all coming in the ``next steps,'' although it does not provide a target
date for completion of these next steps.
Meanwhile, more and more products containing engineered
nanoparticles continue to enter the marketplace--the number of such
products has doubled to 500 over the past year according to surveys by
the Wilson Center's Project on Emerging Nanotechnologies. Simple
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.
The bottom line is that this is simply not an acceptable situation.
We are basically still waiting for the EHS research strategy and
detailed implementation plan that we were told would be available 18
months ago.
I am genuinely puzzled why more progress has not been made to
develop this research strategy and plan that everyone believes is
necessary for the successful development of nanotechnology.
Today, I want to determine how the mechanisms in place for planning
and implementing the interagency EHS research component of the NNI can
be made to work better, and what steps are needed to accomplish that
outcome.
On the other hand, if the process is flawed or is intrinsically
unable to function satisfactorily, I invite our witnesses to suggest
alternative approaches and mechanisms. I am looking for concrete
suggestions that the Committee can use as it develops legislation to
reauthorize the NNI over the next few months.
I want to thank our witnesses for their attendance at today's
hearing, and I look forward to our discussion of this important set of
issues.
I now recognize the Ranking Member for an opening statement.
Mr. Ehlers. Thank you, Mr. Chairman. I am pleased the
Committee is holding this important hearing today, but I also
hope that the scary reputation of this day doesn't somehow
impinge on the seriousness of the topic we're engaged in.
The promises of technology often compete for media
attention with coverage of the unknown pitfalls nanotechnology
products may have on human health and the environment. The
nanoscale is so unexplored that we know very little about the
short- and long-term environmental effects of nanomaterials in
our ecosystem, and having lived through some periods of life
where we did the wrong thing, for example, with pesticides and
DDT and so forth, I can certainly understand the concern and
perhaps even paranoia of society. At the same time, I am not
sure very many people appreciate the difficulty of the work
that has to be done. It is quite easy when you conduct a human-
scale, large-scale experiment such as using pesticides
throughout the entire world and now observe the effects. It is
quite a different matter to take an unknown effect and a
relatively new scientific development and try to project what
the problems might be. And I think very few people realize how
difficult the work is and trying to identify the environmental
effects of nanomaterials. The calm prevailing force here, of
course, is the incredible benefits of nanoscale. I just read a
fascinating article last week, and I am a would-be pilot and so
I read a lot of aviation literature. And I found this
fascinating article about nanotubes used in composite airplane
construction. If you put a wire grid in, you also have the
great advantage of using the nanotubes to detect cracks; but at
the same time, by applying heat through the grid, you have a
self-healing composite. This is a marvelous development for
aviation and many other areas.
What are the bad effects? We do not yet know, but as our
country invests in innovative research in nanotechnology, we
must ensure that accurate risk assessments are conducted and
communicated to all stakeholders. An atmosphere of trust
between the nanotechnology industry and the public is necessary
to allow benign products to benefit our nation and to ensure
that dangerous products and byproducts never enter the market
or ecosystem, a very demanding agenda.
Congress must continually assess whether nanotechnology
research priorities to address unintended public health
consequences of nanotechnology have been established and are
being effectively implemented. As this committee prepares to
reauthorize the National Nanotechnology Initiative, today's
witnesses will provide valuable insights on both conducting
research and sharing its results with the public.
I look forward to hearing an update from our witnesses on
this most important topic, and thank you all very much for
taking the time to be here.
I yield back.
[The prepared statement of Mr. Ehlers follows:]
Prepared Statement of Representative Vernon J. Ehlers
Thank you Chairman Baird. I am pleased that the Committee is
holding this important hearing today, but I also hope that the
``scary'' reputation of today is not in any way linked with the topic
at hand.
Nonetheless, the promises of nanotechnology often compete for media
attention with coverage of the unknown pitfalls nanotechnology products
may have on human health and the environment. The nanoscale is so
under-explored that we know very little about the short- and long-term
environmental effects of nanomaterials in our ecosystem.
As our country invests in innovative research in nanotechnology, we
must ensure that accurate risk assessments are conducted and
communicated to all stakeholders. An atmosphere of trust between the
nanotechnology industry and the public is necessary to allow benign
products to benefit our nation, and to ensure that dangerous products
and byproducts never enter the market or ecosystem. Congress must
continually assess whether nanotechnology research priorities to
address unintended public health consequences of nanotechnology have
been established and are being effectively implemented. As this
committee prepares to reauthorize the National Nanotechnology
Initiative, today's witnesses will provide valuable insights on both
conducting research and sharing its results with the public.
I look forward to hearing an update from our witnesses on this
important topic.
Chairman Baird. Thank you, Dr. Ehlers. We also are joined
today by Mr. Rothman from New Jersey, and Dr. McNerney from
California; and others will be joining us. As you know, we
often have multiple hearings at the same time.
[The prepared statement of Mr. Lipinski follows:]
Prepared Statement of Representative Daniel Lipinski
Thank you, Mr. Chairman.
I am proud to note that the State of Illinois was ranked 8th in the
Nation this year by Small Times magazine of leading nanotechnology
states. However, with success comes responsibility and nanotechnology
certainly is no different as we examine potential environmental, health
and safety implications.
This week's copy of BusinessWeek contains an article about how new
nanotechnologies are helping to save vast amounts of energy simply by
reducing the amount of friction in pipes throughout our economy.
Innovative thin coatings and ball bearings in pipelines, as well as
nanotech additives to motor oils, are helping to reduce friction by 50
percent and promote much more efficient processes. Every day, new
products such as these are being introduced into the marketplace. As
nanotechnology moves from a multi-billion to a multi-trillion dollar
industry in just the next few years, now more than ever we must take
action to identify, assess and manage potential environmental, health
and safety risks.
Chairman Baird. In the interest of hearing what you all
have to say, I will be very brief in the introductions and then
we will have the panel have five minutes to speak. Dr. Ehlers
and I have agreed that there are buttons we press when people
go about five and one-half minutes. The chairs drop out from
underneath you and you disappear into an oblivion that we will
try to rescue you from at some future date.
Dr. Clayton Teague is Director of the National
Nanotechnology Coordination Office. Mr. Floyd Kvamme is Co-
Chair of the President's Council of Advisors on Science and
Technology; Dr. Vicki Colvin, Executive Director of the
International Council on Nanotechnology and Professor of
Chemistry and Chemical Engineering at Rice University; Dr.
Andrew Maynard, Chief Science Advisor for the Project on
Emerging Nanotechnologies, Woodrow Wilson International Center
for Scholars; Dr. Richard Denison, Senior Scientist,
Environmental Defense; and Mr. Paul D. Ziegler, Chairman,
Nanotechnology Panel, American Chemistry Council.
So a very, very distinguished and accomplished panel of
experts. We look forward to your comments, and with that we
will begin our testimony with Dr. Teague.
STATEMENT OF DR. E. CLAYTON TEAGUE, DIRECTOR, NATIONAL
NANOTECHNOLOGY COORDINATION OFFICE (NNCO)
Dr. Teague. Good morning, and thank you, Mr. Chairman, and
other Members of the Subcommittee. Thank you for inviting me to
testify at this hearing. I am pleased to have the opportunity
to update the Subcommittee on the extensive efforts of the NNI
to address the needs for research on the environmental, health,
and safety, or EHS, aspects of nanotechnology.
Since its inception, the NNI has supported research along
two paths: research toward beneficial uses of nanotechnology
for society and research to protect public health and the
environment. By integrating results from these two paths of
research, the NNI aims to maximize the benefits of this new
technology at the same time it is developing an understanding
of any potential risk and means to manage such risk.
EHS research is and has been a top priority of the
Administration and the NNI. During fiscal years 2005 through
2008, the NNI agencies will have invested nearly $180 million
in what we call primary purpose EHS research. This U.S.
investment in such research leads all other countries by a wide
margin. For 2008, the NNI agency request totaled about $59
million, an increase of 55 percent over that that was invested
in 2006. We expect this trend to continue as increased
knowledge informs our path forward.
Our strategic approach to prioritizing and addressing
nanotechnology-related EHS research consists of four major
elements: successful coordination, comprehensive planning and
guidance, leveraging forefront science and collaboration, and
periodic review. This four-element strategy for nanotechnology
EHS research enables the NNI to identify new research needs and
to pursue paths to meet those needs. By continuing to iterate
these elements over the long-term, the NNI will accelerate the
pace at which EHS information is developed and made available
to government regulators and to industry; helping to ensure
that nanotechnology enabled products are brought to the market
responsibly.
The NNI is effectively coordinating government-funded
research and the agency's multi-disciplinary expertise on the
EHS aspects of nanotechnology. NNI agencies have expressed
strong satisfaction with the coordination and collaboration
opportunities stimulated by their participation in the
Nanotechnology Environmental and Health Implications Working
Group, or NEHI, as shown in some exemplary endorsements of the
NEHI by the NNI agencies that I have provided in my written
testimony. This group's outputs are developed by consensus, a
process which is time consuming but ensures that the results
receive strong support from all the member agencies. To provide
guidance for investments in nanotechnology EHS research, we
started by identifying the breadth of research necessary to
support the risk assessment and risk management decision-making
to inform the safe use and commercialization of nanomaterials.
We narrowed the list to a set of high priority needs. We
obtained a snapshot of the government portfolio of
nanotechnology EHS research in 2006, and we are now comparing
this list of research projects to the priority research needs
in order to determine what research topics may need increased
emphasis.
The important outcome of this process will be the creation
of a science-based nanotechnology EHS research strategy
document that provides comprehensive guidance for the planning,
management, and coordination of nanotechnology-related EHS
research. We hope this document's recommendations will inform
and influence you in Congress, the Administration, and the
agencies as they develop their annual budgets and make
decisions on funding and program support. Publication of our
EHS research strategy document will complete the first cycle of
a long-term process. Ongoing evaluation of research needs will
continue and priorities may change as new materials become
candidates for use in products or as funded research yields
important new results.
NNI's growing portfolio of EHS research is leveraged
through collaborations among multi-disciplinary research
groups, with industries, NGO's, and other governments
worldwide. Significant inputs to our research strategy document
have come from consultations, national and international
workshops, hearings, and subsequent highly constructive public
comment periods. Some 100 experts within the NNI agencies
contributed to this planning process. I am confident that the
EHS strategy document will facilitate the research necessary to
generate the knowledge for the risk assessment, risk
management, and regulatory decision-making.
Extraordinary level of multiagency coordination occurring
within the NNI with respect to nanotechnology is rare, and in
my own experience, unique. The NNI approach has been endorsed
by reviews by the National Research Council and the President's
Council of Advisors on Science and Technology. Let me assure
you that we at the NNI share the importance that you, the
Members of Congress, the Administration, and the research
community place on nanotechnology-related EHS research. We
share that view and will continue to make responsible
development of nanotechnology a top priority of our research
efforts.
Thank you for the attention and I am sure the extra time.
[The prepared statement of Dr. Teague follows:]
Prepared Statement of E. Clayton Teague
Introduction
Mr. Chairman and Members of the Subcommittee, thank you for
inviting me to testify at this hearing. My name is Clayton Teague and I
am the Director of the National Nanotechnology Coordination Office
(NNCO). The NNCO supports the efforts of the multi-agency National
Nanotechnology Initiative (NNI). I am pleased to have the opportunity
to update this subcommittee on the extensive efforts underway in the
NNI to address the needs for research on the environmental, health and
safety (EHS) aspects of nanotechnology.
Since its inception, the NNI has supported research along two
fundamental paths: research toward promising, highly beneficial uses of
nanotechnology for our society and our nation's economic growth and
research to protect public health and the environment. By integrating
the results and new knowledge from these two paths of research, the NNI
can expedite progress toward maximizing the benefit-to-risk ratio in
the development of nanotechnology.
Further, EHS research is and has been a top priority of the
Administration and the NNI. The Directors of the Office of Science and
Technology Policy (OSTP) and Office of Management and Budget (OMB) have
highlighted EHS research in each of the annual Research and Development
Budget Priorities memoranda issued since 2004. During fiscal years 2005
through 2008, it is estimated that NNI agencies will have invested
nearly $180 million in research whose primary purpose is to address the
EHS implications of nanomaterials. With these investments, the United
States leads all other countries in the world by a wide margin in
support for such research. The 2008 request for this area is $58.6
million, an increase of 55 percent over 2006,\1\ the last year for
which we have estimates of actual funding. This growth reflects
intentional and systematic program development by the NNI for
nanotechnology-related EHS research.
---------------------------------------------------------------------------
\1\ See Table 6 in the NNI Supplement to the President's FY 2008
Budget, http://www.nano.gov/NNI-08Budget.pdf, p. 11, which
shows an estimated actual R&D investment for FY 2006 of $37.7 million
and the amount stated for the FY 2008 request in the PCA for research
whose primary purpose was EHS implications of nanotechnology.
---------------------------------------------------------------------------
I have been asked to describe the NNI's approach to prioritizing
and addressing EHS research related to nanotechnology. Our approach--
our strategy--consists of four major elements. 1) Successful
coordination: The NNI is effectively coordinating Government-funded
research and the multi-disciplinary expertise of participating agencies
on the EHS aspects of nanotechnology; 2) Comprehensive planning and
guidance: Through ongoing analysis of available research results by
government subject matter experts, along with inputs from program
managers, funding decision-makers, and the public, the NNI has
published and is drafting further planning documents to provide
guidance for agencies, industry, and academia on EHS research needs; 3)
Leveraging forefront science through collaboration: The NNI is
supporting a growing portfolio of EHS research and is leveraging its
investment through collaborations among multi-disciplinary research
groups, with industry, and with other governments worldwide; 4)
Periodic review: The NNI plans to conduct periodic reviews of the state
of EHS research to determine new developments or discoveries that would
require changes in emphases or directions of research.
This four-element strategy for planning and implementing
nanotechnology EHS research enables the NNI to adapt to the dynamic
aspects of research and to pursue appropriate paths that address
identified research needs. Equally, practicing these elements in an
iterative long-range fashion accelerates progress toward producing the
information necessary to assess safety of nanomaterials and to
responsibly develop products enabled by nanotechnology.
Successful Coordination
The Nanoscale Science, Engineering, and Technology (NSET)
Subcommittee's Nanotechnology Environmental Health Implications (NEHI)
Working Group serves centrally and effectively to coordinate the
planning and implementation of the U.S. Government's EHS
nanotechnology-related research and activities. This interagency
approach aligns the agencies' mandates, missions, authorities, and
resident expertise with EHS research planning and implementation.
Twenty of the 26 NNI agencies participate in the NEHI Working
Group. Thirteen of the agencies fund safety-related research in the
field and/or have regulatory authorities to guide the safe use of
nanomaterials.
The NEHI Working Group is co-chaired by Dr. Norris Alderson,
Associate Commissioner for Science in the U.S. Food and Drug
Administration, and Dr. George Gray, Assistant Administrator for the
Office of Research and Development in the Environmental Protection
Agency. Under their combined leadership, NEHI creates the framework
that supports a robust, proactive process for identifying and
addressing EHS research related to nanotechnology.
Starting with initial, informal meetings beginning in 2003 and
formally established by the NSET Subcommittee in 2005, the NEHI Working
Group has the following objectives:
provide for the exchange of information among
agencies and non-government parties that support nanotechnology
research and those responsible for regulation and guidelines
related to nanoproducts
facilitate the identification, prioritization, and
implementation of research and other activities required for
the responsible research, development, utilization, and
oversight of nanotechnology
promote communication of information related to
research on environmental and health implications of
nanotechnology to other government agencies and non-government
parties.
The NEHI Working Group operates on a consensus basis, thereby
leading to reports and other documents that have broad approval from
all member agencies. Moreover, representatives to the working group
involve appropriate experts within their agencies in the development
and review of any working group product. Such involvement can be time
consuming, however the result is strong awareness of and support for
the ultimate output. Consensus-building among key decision makers
produces agency commitments to carry out their parts in generating
needed information through research activity.
With this support, the NNI, through its multi-agency participation
and access to the wide range of subject matter expertise, is
successfully coordinating EHS research among the NNI agencies, with
industry and academia, and with other nations. Doing so enables us to
leverage all available resources and to accelerate the pace of progress
toward generating safety-related information.
The NEHI Working Group is the most active working group of the NNI
and has been described by agency representatives as the most effective
interagency collaboration they have witnessed or in which they have
participated. This is a clear indication of the NEHI Working Group's
success.
NNI agencies have expressed strong satisfaction with the
coordination and collaboration opportunities stimulated by their
participation in the NNI. Some example endorsements are presented in
Appendix A: How the Interagency Process Helps Individual Agencies. The
Administration through its Budget Priorities memoranda and Congress
through the 21st Century Nanotechnology Research and Development Act
also have emphasized coordination of EHS research.
Nonetheless, some have called for a centralized office with
budgetary authority to oversee the NNI's EHS research program. It is
the consensus of NEHI Working Group members that such an approach would
have significant detrimental effects:
No one agency or centralized organization would have
the breadth of scientific expertise and knowledge of regulatory
authorities and needs currently represented by the 20 agencies
participating in the NEHI Working Group.
Creation of a new central authority would undermine
the existing successful interagency coordination.
Moving the management of all nanotechnology EHS
research into a single office would likely decouple such
research from related efforts within NNI agencies and from the
knowledge base in the agencies that is currently networked into
the NNI's EHS research effort.
Creating a separate office would, on the one hand,
give mission agencies a disincentive for doing nanotechnology-
related EHS research. They would reasonably assume that another
agency is responsible, and they therefore could redirect their
limited resources to address other priorities. A likely result
could be that the level of research would actually decrease.
Conversely, creating a separate office could lead to
duplicative work being funded, thereby wasting tax dollars and
not optimizing progress.
Comprehensive Planning and Guidance
The NNI strategy for addressing EHS research needs for engineered
nanoscale materials consist of five steps.
Step one--Identify research needs: In September 2006, the NNI published
its assessment of the research needed to support risk assessment and
risk management decision-making. This guidance was contained in the
document, Environmental, Health, and Safety Research Needs for
Engineered Nanoscale Materials,\2\ henceforth referred to as the
Research Needs document. Comments submitted during the public comment
period acknowledged the comprehensiveness of the document to guide the
breadth of research needed to inform safety assessment. The research
needs are organized into five categories: instrumentation, metrology,
and analytical methods; nanomaterials and human health; nanomaterials
and the environment; health and environmental exposure assessment; and
risk management methods.
---------------------------------------------------------------------------
\2\ http://www.nano.gov/
NNI-EHS-research-needs.pdf
Step two--Prioritize research needs: In August 2007, the NNI published
a prioritization of the identified research needs on the NNI website
www.nano.gov as an interim document for public comment. These priority
needs were identified following extensive dialogue among the subject
matter experts and careful analysis based on principles outlined in the
Research Needs document and public comments received.
It is important to underscore that EHS-research planning and
implementation have been taking place simultaneously for several years.
The processes, like those of the research itself, are not linear. The
NNI agencies have been funding basic research at increasingly higher
levels and through this research have been producing information
critical to this field.
Step three--Obtain a snapshot of the government portfolio of EHS
research in categories identified in Step one: In order to enable a
more detailed assessment of funded research in this area, OMB collected
data from the NNI research agencies on all FY 2006 spending for
research related to the five categories outlined in the Research Needs
document. Note that this call captures research reported in several
Program Component Areas (PCAs) as reported in the NNI Supplement to the
President's 2006 Budget. For example, some research in the PCA for
Instrumentation Research, Metrology, and Standards was found to be
highly relevant.
Step four--Analyze data from OMB on EHS research portfolio: The NEHI
Working Group is analyzing the responses to the OMB data call to
perform a systematic evaluation of the NNI's EHS research portfolio.
NEHI experts have retrospectively categorized research funded by NNI
agencies in FY 2006 according to the priority research needs.
Preliminary results from the NEHI analysis are summarized in the
following table.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
NEHI's preliminary analysis indicates strong alignment of ongoing
research and the priority needs. NEHI members are continuing to analyze
those data as they complete this step toward drafting the NNI EHS
research strategy document. While this step is not yet completed, the
initial analysis indicates that many of the areas identified by experts
are already receiving significant support. An initial analysis of OMB's
call for data on research in the five categories of the NNI Research
Needs Document is provided in Appendix B.
Step five--Provide research strategy document as guidance:
The single most important outcome of this process is the creation
of a science-based EHS research strategy document that the NNI
recommends to individual agencies, the Administration, and Congress for
use as guidance in their decisions for funding and program support.
Within the NNI EHS research strategy document, the management of
R&D programs, as with all other NNI research and funding activities,
will remain within the agencies that have the appropriate jurisdiction,
expert staff, and expertise to manage day-to-day research activities
and funding decisions.
Agencies whose missions are reflected in a research category of the
Research Needs document will be noted in the NNI EHS research strategy
document to be published shortly.
Agencies will use the NNI EHS research strategy document to:
Understand where their mission-related research fits
into the overall strategy
Identify opportunities for collaboration or
cooperation
Identify critical needs within their missions which
have not gotten sufficient attention
Understand their relationship to other agencies and
their research.
We understand that some would like to have seen the initial NNI EHS
research strategy document published yesterday. However, the NNI has
undertaken thorough, time-consuming activities such as highly specific
data collection, and the solicitation and synthesis of expert and
public input to ensure that the strategy would have scientific
integrity and would reflect real data and information needs and thus
have the credibility to guide agencies in decisions concerning their
research funding and activities. And as noted earlier, the lack of a
published strategy has not delayed getting started on high priority
research.
To provide some insight into the complexity of this process, it is
helpful to note the range of expertise sought through consultations, a
public hearing, and two highly constructive public-comment periods.
World-renowned scientists from academia, industry, NGOs, and government
all have provided input. Within the government alone, some 100 subject
matter experts across agencies reviewed and contributed to this
comprehensive document. Among those who informed the development of
this strategy were experts in:
quantum mechanical properties of engineered nanoscale
materials
characterization of the physical and biological
properties of these nanoscale materials through transmission
electron microscopy, dynamic light scattering, and in vitro and
in vivo toxicology
absorption, distribution, metabolism, and elimination
of materials in mammalian systems
environmental toxicology and pharmacokinetic models
of toxicity
interactions of materials with the body at the
molecular, cellular, and tissue levels
metrics for measuring exposure, fate and transport of
materials in the environment
occupational health and exposures; and risk
assessment and management practices.
The road to effectively safeguarding public health is dynamic and
requires attention to alternative paths for obtaining the necessary
knowledge and understanding. An ongoing evaluation of the materials
being considered for use in products and new research findings must
continue to inform and guide our ongoing strategic planning efforts. In
the coming six months, for instance, we anticipate the publication of a
large number of highly informative research papers in the field,
reflecting the fruits of some of the NNI's earliest investments. These
research findings could possibly provide information that calls for a
stronger emphasis on current areas of research or that calls for a
redirection of resources to another area of inquiry. Science is not
stagnant and planning for research activity cannot be either.
The NNI strategic planning process will give the agencies ongoing
guidance for funding research, and it will continue to inform industry
of the most important safety issues--something that industry has asked
us to provide.
We expect industry-created research plans will address in greater
detail important industry needs--especially with regard to product-
safety testing. Many of the plans already underway are complementary to
the Federal Government strategy; indeed, they were input to the
formulation of the federal strategy. This underscores the fact that
multiple parties will play significant roles in gaining scientific
knowledge in this field. But only the NNI process addresses the breadth
of information needs of the federal agencies and includes the
deliberations necessary for interagency cooperation. Federal agency
responsibilities for safeguarding public health cannot be delegated to
any other agency or group, nor can planning for how those
responsibilities will be met.
Leveraging Forefront Science Through Collaboration
The evaluation of research needs through the NNI strategic planning
process has been guiding agency research efforts since the NNI was
formed. Implementation of identified research activities also has been
underway as has the development of partnerships to facilitate research
collaborations among agencies and with partners from industry, academia
and non-government organizations (NGOs).
The 2006 data provide a snapshot of EHS research investments and
have already helped inform and direct future government research
funding. Below are a few of the research activities and collaborations
in priority areas:
NNI agencies have issued three joint solicitations
for research on potential EHS implications of nanotechnology:
One led by EPA that is now in its third year focuses
on investigating fate, transport, transformation, and
exposure of engineered nanomaterials (DOE is joining
EPA and NSF in 2008).
A second solicitation starting in 2007 is focused on
human health implications. It is led by NIH's National
Institute of Environmental and Health Sciences and
includes participation by five other NIH institutes as
well as EPA and NIOSH.
Recently NSF and EPA issued a third joint
solicitation for proposals to create a national Center
for the Environmental Implications of Nanotechnology
(CEIN) to conduct fundamental research and education on
the implications of nanotechnology on the environment
and living systems at all scales. The center will
address interactions of naturally derived, incidental
and engineered nanoparticles and nanostructured
materials, devices and systems with the living world.
The award is slated to be up to $5 million annually for
up to five years, pending the availability of funds and
successful review.
NIH, FDA, and NIST are collaborating on work at the
Nanotechnology Characterization Lab (NCL) of the National
Cancer Institute (NCI), where a battery of characterization
tests are being developed for pre-clinical evaluation of
nanomaterials intended for cancer therapeutics.
NIH, FDA, and NIOSH are supporting the National
Toxicology Program (led by NIEHS) as it develops and carries
out research and testing programs addressing health and safety
issues. Collaborations are underway with NIOSH, the FDA
National Center for Toxicological Research, and the NCI
Nanotechnology Characterization Lab.
NSF and EPA have issued a joint solicitation for
proposals to create a national Center for the Environmental
Implications of Nanotechnology (CEIN) to conduct fundamental
research and education on the implications of nanotechnology on
the environment and living systems at all scales. The center
will address interactions of naturally derived, incidental and
engineered nanoparticles and nanostructured materials, devices
and systems with the living world. The award is slated to be up
to $5 million annually for up to five years, pending the
availability of funds and successful review.
Identification of detailed research needs within the broader
strategic framework also is taking place through various other
activities and partnerships. In January 2007, NSF and NIH supported a
meeting on International Nanomaterial Environmental Health and Safety
Research Needs Assessment at the NIH Campus in Bethesda, Maryland. This
meeting, organized and sponsored by the International Council on
Nanotechnology (ICON), focused on a piece of the research framework,
bringing detail to the materials in need of study. NSF supported
another ICON meeting last summer that focused on research needed to
inform predictive modeling of biological interactions. In addition to
providing funds, government agencies sent representatives to plan and
participate in each of these workshops.
NIST held a workshop in September 2007 to develop approaches for
identifying standard materials for critical risk assessment and risk
management and priority reference materials, among other things.
Two years ago, NIOSH released its Approaches to Safe
Nanotechnology, a document that offers guidelines for working with
nanomaterials, consistent with the best scientific knowledge. That
document recently has been updated and NIOSH's work has been used as a
basis in international forums toward drafting international
recommendations for working with nanomaterials. Furthermore, EPA and
FDA have developed policy papers guiding their mission-related research
and information needs. These agencies and NIH each have established
intra-agency nanotechnology task forces that coordinate across each
agency and with the other NNI agencies.
International Coordination and Collaboration
Although the United States is leading the world in the level of
effort aimed at EHS research, it cannot--and should not--go it alone.
The U.S. Government conducts many of its planning and implementation
activities in coordination with other nations and international
organizations. The NEHI Working Group, with assistance from another
body of the NSET Subcommittee, the Global Issues in Nanotechnology
Working Group, coordinates the U.S. position and participation in
international activities related to environmental, health, and safety
implications of nanotechnology. For example, NNI representatives are
leading national and international collaborations that ensure
coordination of the U.S. strategic priorities with those of the
International Organization for Standardization (ISO) and the
Organization for Economic Co-operation and Development (OECD).
Standards are imperative for accurate and reliable measurement and
characterization of nanomaterials, which in turn is vital for assessing
exposure and its effects. NSET Subcommittee members are active
participants in the ISO Technical Committee on Nanotechnologies (ISO
TC229). The NSET Subcommittee has provided initial financial support to
the American National Standards Institute (ANSI) accredited Technical
Advisory Group (TAG) that represents the United States on the ISO
TC229. The NNCO Director chairs the TAG and heads the U.S. delegation
to ISO TC229. The United States holds the convener position for the ISO
TC229 working group whose charter is the development of science-based
standards in the areas of health, safety, and environmental aspects of
nanotechnologies. The U.S. TAG also is participating actively in the
working group on terminology and nomenclature and the working group on
metrology and characterization.
The U.S. Government was instrumental in the formation of two
nanotechnology-related working parties at the OECD, and U.S. Government
representatives currently chair the bureaus of each working party. This
work is not limited to the 30 OECD member countries. Non-OECD countries
and regions including the European Commission, Argentina, Brazil,
China, India, Israel, Russia, and Thailand are active participants, as
well as the nanotechnology and chemicals industries, ISO, and NGOs.
International efforts to better understand the potential health,
environmental, and safety implications of manufactured nanomaterials
are being developed by the Working Party on Manufactured Nanomaterials
(WPMN) under OECD's Chemicals Committee. Its objective is to promote
international cooperation in health and environmental safety aspects of
manufactured nanomaterials, in order to assist in their safe
development. This will help ensure that approaches to assessment of
hazard, exposure, and risk are of a high, science-based standard. The
United States is heavily involved in all the current WPMN activities,
which include:
International coordination to assess ongoing EHS
research and identify mechanisms to address future research
needs
Testing a representative set of manufactured
nanomaterials in collaboration with industrial partners, in
order to develop a foundation data set of their physical and
chemical properties as well as their fate, safety, and health
and environmental effects
Developing guidelines for EHS-related testing of
nanomaterials, building upon already developed methods where
possible
Exchanging information on risk assessment approaches
for manufactured nanomaterials and making recommendations to
fill gaps in current approaches
Sharing information on voluntary data collection and
regulatory activities.
The second OECD body is the Working Party on Nanotechnology (WPN)
under the Committee for Scientific and Technological Policy. The
objective of the WPN is to promote international cooperation that
facilitates research, development, and responsible commercialization of
nanotechnology in member countries and in non-member economies. WPN
activities relevant to EHS matters include evaluating the regulatory
concerns of businesses utilizing nanotechnology, and public
communication issues.
Conclusion
In closing, the NNI effectively coordinates EHS research planning
and multi-disciplinary expertise across the 26 participating federal
agencies. This ensures systematic and comprehensive planning across the
broad spectrum of research programs needed to support risk assessment
and risk management and to inform decision-makers.
The NNI agencies support forefront research, and leverage this
research through collaborations. These research programs have generated
and will continue to generate research that informs decision-makers. I
am highly confident that the forthcoming NNI EHS Research Strategy will
provide the needed framework for the development and support of
research programs that provide new knowledge as needed for risk
assessment and risk management regarding the use of nanomaterials.
Previous reviews of the NNI by the National Research Council (NRC)
and the President's Council of Advisors on Science and Technology
(PCAST) in its capacity as the National Nanotechnology Advisory Panel
called for by the 21st Century Nanotechnology Research and Development
Act, confirm the effectiveness of our coordinated, collaborative
approach. The 2006 NRC review of the NNI\3\ was complimentary of the
NNI's coordinated interagency approach in addressing EHS research and
regulatory issues. PCAST is in the process of performing its second
review of the NNI later this year. The NRC will take a comprehensive
look at the NNI EHS research strategic process upon its completion.
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\3\ ``A Matter of Size: Triennial Review of the National
Nanotechnology Initiative,'' http://books.nap.edu/
openbook.php?record-id=11752&page=92
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We will of course welcome any recommendations these outside
reviewers have as to how to make our strategy even more effective.
Thank you for the opportunity to speak with you on this important
subject today.
Appendix A
How the Interagency Process Helps Individual Agencies
The effectiveness of the NNI for the participating agencies has
been described by individual agencies as follows:
The Consumer Product Safety Commission (CPSC): While CPSC does not have
the resources for research at this point in time, we have benefited
greatly from the ability to make our research needs known to other
agencies who have research funding and who share similar needs for
toxicity and exposure data, etc. The concept of ensuring collaboration/
communication across federal agencies to leverage limited research
dollars is an important one.
U.S. Food and Drug Administration: The NNI collaboration has provided
FDA the opportunity to discuss, review, and influence the priority of
federally funded research organizations in their research programs.
This has been particularly true in the areas of EHS needs. It is clear
that the current activities of NCI/NCL, with NIST and FDA as partners,
has benefited from the collaborative activities under NEHI. As a
regulatory agency, FDA's research program provides the science support
for current regulatory issues. Through the activities of NEHI, FDA has
had the opportunity to assist in developing a research focus for issues
that are a primary concern for nano-engineered materials as components
of FDA regulated products. Through NEHI, FDA can leverage the resources
of the funded research organizations to address those areas of concern
that are shared with other regulatory agencies.
Department of Energy (DOE): DOE has included funding for new efforts in
understanding the fate and transport of nanoscale materials in the
environment in the FY 2008 budget request, and has joined with EPA and
NSF in issuing a call for proposals in these areas. This interagency
solicitation has been made possible by the interactions between DOE and
the other participating agencies in the NSET and NEHI venues.
U.S. Environmental Protection Agency: The EPA is leveraging its
research and development strengths by partnering with other federal
agencies such as NIH, NCI, NIEHS, NIOSH, NSF, DOE, and NIST. The NEHI
Working Group provides the agency with the forum and opportunity to
engage in fruitful collaborative ventures. Many of our collaborative
efforts have been enabled through dialogues and cooperation afforded by
the NEHI Working Group and the NSET Subcommittee member meetings. The
NEHI venue is especially advantageous for three critical reasons:
1. Direct communication of agency-to-agency information on
engineered nanomaterial EHS issues is enabled.
2. Ways to enhance the understanding of agency-specific EHS
issues are discussed.
3. Input on complex EHS issues from different agency
viewpoints is provided that results in more rapid and tenable
solutions.
U.S. Geological Survey: The USGS is in the planning phase of its
activities with respect to nanotechnology, but has participated in the
coordination activities of the NEHI Working Group and NSET
Subcommittee. This involvement has given the USGS the opportunity to
see where our scientific strengths will be best utilized within the set
of research priorities, and to avoid duplication of effort. The
involvement has also enabled us to get to know nanotechnology
scientists and science leaders in other agencies in order to develop
collaborative scientific projects that play to our strengths. The
structure of the interagency interaction fostered by the NNCO provides
forums for agencies to discuss research facilities that can be shared,
thus increasing the value of the limited research dollars by enabling
agencies like USGS to avoid duplicating expensive facilities.
The Nanotechnology Characterization Laboratory (NCL): The NCL at
Frederick is an example of interagency coordination fostered by the
NEHI Working Group. The laboratory is the result of a formal
collaboration between three NEHI participating agencies: the National
Cancer Institute (NCI) at the National Institutes of Health, the U.S.
Food and Drug Administration (FDA), and the National Institute of
Standards and Technology (NIST) within the Department of Commerce. The
NCL's charter is to conduct safety testing of nanomaterials intended
for medical applications; it is a resource available to investigators
in academia, industry, and government laboratories toward facilitating
the rapid transition of nanotechnology-based drugs and imaging agents
into commercial products.
In its three years of operation, the NCL has characterized over 100
nanoparticle types, including titanium oxide (TiO2), fullerenes,
dendrimers, gold colloids, polymers, and liposomes. In collaboration
with FDA and NIST, the lab has developed over 20 ``best practice''
protocols for characterizing these particles; several of these are now
being adopted by formal Standards Developing Organizations such as ASTM
and ISO.
Through its association with NEHI Working Group, the NCL also has
recently engaged the National Toxicology Program (NTP); the NTP now has
a seat on NCL's Scientific Oversight Committee and utilizes NCL data to
inform its own nanomaterial characterization strategy and to avoid
duplication of effort.
National Institute for Occupational, Safety and Health (NIOSH): NIOSH
has had a good experience working with the NSET Subcommittee and NEHI
Working Group for sharing information, networking, and identifying
possible collaborations. This interaction also has helped provide
feedback on the NIOSH Nanotechnology Program and review of NIOSH
documents. NIOSH has had a broad range of collaborations with other
agencies that have evolved as a result of being an early entrant into
the field. Involvement with the NSET Subcommittee and the NEHI Working
Group has provided an opportunity to promote and enhance some of those
collaborations, including:
1. An MOU developed with OSHA regarding control banding and
hazard communication
2. A collaborative arrangement with EPA to work on the
Nanoscale Material Stewardship Program
3. Collaborations with DOE, DOE, and NASA to develop site-
specific practices and with NIST to develop reference materials
4. Collaborations with OSHA and EPA on international
conferences
5. Joint Requests for Applications with EPA, NSF, and NIH,
since 2004
6. NIOSH active participation in OECD's Working Party on
Nanotechnology and Working Party on Manufactured Nanomaterials
(WPMN), including leadership of the WPMN's activity on
Cooperation on Exposure Measurement and Exposure Mitigation.
The National Institute of Standards and Technology (NIST): Interactions
with the NNI and NEHI Working Group, in particular, have supported the
establishment of nanotechnology as a research direction for NIST with
direct emphasis on innovation and traceable measurements, not only to
advance the development of a measurement-and-standards infrastructure
for nanotechnology enabled products, but also those standards necessary
to support the EHS aspects of nanomaterials and products that contain
them.
Examples of EHS program developments at NIST as a result of NIST-
NEHI interactions include:
2005 Advanced Technology Program Project: Development
of 2- and 3-Dimensional Analysis Methodology for Determining
the Fate of Nanoparticles in Biological Tissues
2006 Innovative Measurement Science Program:
Metrology for the Fate of Nanoparticles in Biosystems
2008 (if appropriated): Metrology for Nano-EHS
NIST's interactions with the NEHI Working Group member agencies has
facilitated advances needed by NIST to leverage nanotechnology
standards development work among other federal programs, to establish
direct collaborations with other federal agencies, and to work with
representatives from the risk assessment and regulatory communities
representing not only government, but also academia, industry, and the
international community.
National Institutes of Health (NIH): Through the NIH/National Institute
of Environmental Health Sciences, active participation in the NEHI
activities has provided a broad, interagency perspective that has
enhanced its research program. NIH/NIEHS has worked on teams with
representatives from CPSC, OSHA, and FDA, as well as funding agencies
such as NIOSH, EPA and NSF. This interaction enhanced the NIH/NIEHS
understanding of regulatory issues and informed the development of the
NIH/NIEHS NanoHealth Initiative, the trans-NIH research strategy for
environmental health and safety research. Additionally, NEHI was
instrumental in providing the opportunity for NIH/NIEHS to participate
in two interagency RFAs that have addressed the interaction of
engineered nanomaterials with biological systems and in international
dialogue on nanotechnology health and safety issues.
National Science Foundation (NSF): NSF's mission is focused on
fundamental research, education, and infrastructure that support
activities in universities, industry and other agencies. The NNI
coordination helps in adjusting research directions, informing NSF
decisions about funding centers, and developing comprehensive
infrastructure and research and education programs. A few specific
collaborations that have resulted from this coordination are:
Three joint solicitations (2005, 2007, 2008) with
EPA, NIEHS, NIOSH, and DOE, respectively
The NSF-EPA MOU and their joint support for the
establishment of a Center for Environmental Implications of
Nanotechnology.
Appendix B
Initial Analysis of OMB's Call for FY 2006 Data on Research in Five
Categories of NNI Research Needs Document
In 2006, five agencies performed or supported research on the
Instrumentation, Metrology and Analytical Methods. This category was
cited as providing essential tools and methods for several other
categories, for example to support toxicological research. It is the
category with the largest 2006 investment, consistent with this
enabling role. Instruments and methods are being developed to
characterize a large variety of materials in pure form and in complex
media, including biological environments. Additional future emphasis
may be needed on instrumentation specific to the workplace and the
environment. Since 2006, work has begun to develop reference materials
for calibration of instruments, examination of analytical processes to
assess the chemical or physical properties of such materials, and to
assess the quality or comparability of results from tests designed to
determine the toxicity of similar health-benefit or drug-related
materials.
Six agencies funded Nanomaterials and Human Health research. With
the most widespread investment, reported research addresses both
particular nanomaterials and broad classes of materials. Effects of
exposure through the lung, skin, and gastrointestinal tract are under
investigation, as well as intravenous injection. Inhalation is the
exposure route that is the subject of the largest number of projects.
Translocation out of the exposure organ is also under study, most
commonly using rodent models. As expected for a new class of materials,
there is more emphasis on acute exposure than on chronic exposure.
Analysis of ongoing research in this area reiterated the value that
could be realized from a comprehensive database for EHS properties of
nanomaterials, a concept already under development by several agencies
and through our international collaborations.
Five agencies funded research in the category Nanomaterials and the
Environment. Five broad classes of manufactured nanomaterials (metals,
quantum dots, nanoceramics, carbon-based nanoparticles, and organic
nanomaterials) are covered by funded projects. Studies of the effects
of engineered nanomaterials on individuals of a species are underway
for numerous aquatic organisms. Transport and transportation of
nanomaterials in the environment are well covered. Numerous studies of
physical and chemical transformation processes are underway.
Three agencies funded research on Health and Environmental Exposure
Assessment. The investment is, in rough terms, evenly split between two
categories: projects related to collecting general exposure information
for workers in facilities manufacturing and using nanoscale and micro-
scale titanium dioxide particles, and projects which broadly
characterize and analyze factors influencing the evolution of
nanoparticles emitted by production equipment in the workplace
environment and its effect on the exposure potential. In 2006, this
category has the smallest budget which mirrors to some extent the
nascent nature of nanotechnology. Systematic collection of exposure
information is hindered by the lack of standardized methods, reference
materials, protocols, and affordable instrumentation for EHS
measurements. The NNI has already begun to address the need for
additional research in this priority area, with NIOSH directing
additional funding in FY 2007 for field evaluations in partnership with
various enterprises.
Four agencies funded research into Risk Management Methods. About
one-third of the funding addresses risk-management control measures for
airborne particles in the workplace with the rest of the funding
addressing more general assessment of the application of risk
management methods to nanomaterials. Inhalation is likely to be the
most important initial exposure route during development and
manufacture of particles with nanoscale features or dimensions, and is
addressed by NIOSH funding for workplace exposures. Research into risk
management methods for scenarios such as such as environmental
releases, ecological receptors, and consumer or incidental exposures,
was not funded in 2006, but the applicability of general (as opposed to
nanomaterial-specific) risk management methods to these cases has also
not yet been evaluated.
Biography for E. Clayton Teague
Clayton Teague is Director of the federal National Nanotechnology
Coordination Office (NNCO) since April 2003. Established in 2001, the
NNCO is the secretariat to the Nanoscale Science, Engineering and
Technology Subcommittee of the NSTC. As such, the NNCO provides day-to-
day technical and administrative support to the NSET Subcommittee and
assists in the preparation of multi-agency planning, budget and
assessment documents. The NNCO is the point of contact on federal
nanotechnology activities for government organizations, academia,
industry, professional societies, foreign organizations, and others to
exchange technical and programmatic information. In addition, the NNCO
develops and makes available printed and other materials as directed by
the NSET Subcommittee as well as maintains the NNI website.
Dr. Teague was previously Chief of the Manufacturing Metrology
Division in the Manufacturing Engineering Laboratory of the National
Institute of Standards and Technology (NIST).
At NIST since 1972, Dr. Teague has designed, constructed, and used
precision instrumentation for ultra-high accuracy dimensional metrology
of surfaces and micrometer to nanometer-scale features. Beginning with
his metal-vacuum-metal tunneling work in the 1970's, he continued to
work with such precision instrumentation as scanning tunneling
microscopes, atomic force microscopes, displacement and phase-measuring
interferometry, stylus instruments, flexure stages, and light
scattering apparatus. Because the laboratory and building environments
were always factors in the ultimate performance of these instruments,
the subject of this workshop has been an ongoing topic of great
interest.
Dr. Teague is a member of the American Society for Precision
Engineering, has served twice as the Society's President, and is a
fellow of the UK Institute of Physics. He served as Editor-in-Chief of
the international journal Nanotechnology for ten years and is currently
a member of the Editorial Board of the journal. He holds a B.S. and
M.S. in physics from the Georgia Institute of Technology and a Ph.D. in
physics from the University of North Texas. He has authored or co-
authored 70 papers, has presented 50 invited talks in the technical
fields described, and jointly with colleagues, has six patents. Dr.
Teague has received the Gold Medal, Silver Medal, and Allen V. Astin
Measurement Science Award from the Department of Commerce, the Kilby
International Award by the Kilby Awards Foundation, and an IR-100
Industrial Research and Development Award for his work.
Chairman Baird. Mr. Kvamme.
STATEMENT OF MR. E. FLOYD KVAMME, CO-CHAIR, PRESIDENT'S COUNCIL
OF ADVISORS ON SCIENCE AND TECHNOLOGY
Mr. Kvamme. Thank you, Mr. Chairman, and Members of the
Subcommittee. I am pleased to have the opportunity to testify
before you today.
My name is Floyd Kvamme, and I am co-chair of the
President's Council of Advisors on Science and Technology, or
PCAST. PCAST comprises a group from academia, industry, and
other entities with experience in leading successful science
and technology enterprises. My remarks today are my own but
based on my conversations with fellow PCAST members. I am
confident that they feel similarly on the issues under
discussion today.
As part of its second review, PCAST is taking a close look
at the environmental, health, and safety, or EHS, aspects of
the NNI. My Co-Chair for that review is Nancy Dicciani from
Honeywell Corporation, who brings years of experience in the
chemical industry and the responsible development of materials.
The Council has received input from a wide range of
perspectives, including a technical advisory group, or TAG,
made up of more than 60 leading academic and industry experts
including two of my co-witnesses here today.
The main points I want to make today are, one, the NNI
approach for identifying and addressing research needed to
understand and manage the potential risks associated with
nanotechnology appear sound and appropriate. Secondly, research
to understand EHS implications should remain integrated with
the broader portfolio of nanotech R&D.
It is important to note that the terms nanotechnology and
nanomaterial do not refer to a single material or class of
materials. Rather, they refer to a broad spectrum of engineered
materials with unique size-dependent properties. Each
individual nanomaterial will have a benefit-to-risk ratio that
depends on the material's specific characteristics and intended
application.
Federal investment in nanoscale science and engineering
research remains money well spent. PCAST's assessments show
that the U.S. is a leader in nanotechnology research and
innovation. Solar cell technology, improved materials, energy
storage, and medicine are just some of the areas sure to reap
the benefits, economic and societal, from nano advances. To do
so, however, there also needs to be investment in research for
understanding and overcoming, that is, managing or designing
out, the potential risks. As someone said in a recent PCAST
discussion, we need to be cautious, not precautious. My own
experience at the outset of the semiconductor industry taught
me that EHS risks are part of any new technology, but they are
risks that can be addressed.
Our TAG survey shows broad consensus with respect to the
role of the Federal Government in supporting nanotechnology-
related EHS research. The majority of respondents are eager to
see the NNI continue its proactive approach and to grow
research support.
Secondly, the interagency approach is effective. I reviewed
the September 2006 report that outlined EHS research needs, as
well as the more recently released interim document
prioritizing the needs. These documents cast the wide net
necessary to address the array of nanotechnology-related EHS
issues and are good descriptions of the priorities. I believe
the interagency process will lead to a sound research strategy.
Funding increases for EHS research across the federal
agencies are of the right scale and indicate a steady increase
in the capacity to conduct the necessary research. EHS research
also fundamentally depends on advances in non-EHS areas such as
instrumentation development and basic research on
nanomaterials.
Development of nanotechnology in a responsible manner,
especially at the early stages, will be expedited by
integration of EHS research with broader basic and applied
research. Applications-oriented research will lead to
information about EHS. So rather than setting arbitrary funding
levels or percentages of total spending as a guideline for the
EHS budget, NNI agency should focus on addressing the
identified EHS research priorities, while at the same time
investing in world-class applications research. The NNI's
strong interagency coordination approach is essential to
optimize progress in both.
In summary, I am pleased with the extensive coordination
and collaboration among the NNI agencies. Their approach
appears to leverage the expertise and related efforts across
the government. While there is much to be done, the process is
not broken. I expect the current planning and coordination
process will lead to a well-thought-out plan for nanotechnology
EHS research. In fact, the coordination process used by the
NNCO and the similar process used to manage networking and
information technology research and development are so
effective that they could well be considered models for similar
coordination in fields such as K-12 education where hundreds of
programs spread over many agencies without any formal mechanism
whereby the agencies might coordinate and share information.
PCAST is, however, anxious to see the nanotechnology EHS
research strategy document that has been referred to and
strongly encourages the NEHI Working Group to complete its work
as expeditiously as possible, hopefully in time for an
assessment in our upcoming report which we hope to issue in
January. Thank you.
[The prepared statement of Mr. Kvamme follows:]
Prepared Statement of E. Floyd Kvamme
Mr. Chairman and Members of the Subcommittee, I am pleased to have
the opportunity to testify before you today. My name is Floyd Kvamme
and I am the Co-Chair of the President's Council of Advisors on Science
and Technology (or PCAST), which was designated by Executive Order as
the National Nanotechnology Advisory Panel called for by the 21st
Century Nanotechnology Research and Development Act of 2003.
PCAST comprises a group from academia, industry, and other entities
with experience in leading successful science and technology
enterprises. My remarks today are my own, but based on my conversations
with fellow PCAST members, I am confident that they feel similarly on
the issues under discussion today.
As part of its second review, PCAST is taking a close look at the
environmental, health, and safety (EHS) aspects of the National
Nanotechnology Initiative (NMI). I co-chair the PCAST subcommittee
performing that review, along with Nance Dicciani from Honeywell
Corporation, who brings years of experience in the chemical industry
and a personal commitment to the importance of responsible development
of materials. The Council has received input from a wide range of
perspectives, including from a technical advisory group (or TAG) made
up of more than 60 leading academic and industry experts from a broad
cross-section of disciplines related to nanotechnology, including two
of my co-witnesses here today.
Based on PCAST discussions and meetings, input from the TAG, and my
own talks with researchers at universities and in small and large
companies, the main points I want to make in response to the
Subcommittee's questions are:
1. The NMI approach for identifying and addressing research needed to
understand and manage the potential risks associated with engineered
nanomaterials appears sound and appropriate.
2. Research to understand EHS implications should remain integrated
with the broader portfolio of nanotechnology R&D.
It is important to note that the terms ``nanotechnology'' and
``nanomaterial'' do not refer to a single material or even class of
materials. Rather, the terms refer to a broad spectrum of engineered
materials with unique nanoscale-dependent properties. Each individual
nanomaterial will have a benefit-to-risk ratio that depends on the
material's specific characteristics and intended application.
Federal investment in nanoscale science and engineering research
remains money well spent. PCAST's assessments show that the U.S. is a
leader in nanotechnology research and innovation. Solar cell
technology, improved materials, energy storage, and medicine are just
some of the areas sure to reap the benefits--economic and societal--
from nano advances. To do so, there also needs to be investment in
research for understanding and overcoming--that is, managing or
designing out--the potential risks. As someone said in a recent PCAST
discussion, we need to be ``cautious, not precautious.'' My own
experience at the outset of the semiconductor industry in the 1960s and
'70s taught me that EHS risks are part of any new technology. But they
are risks that can be addressed.
Already, research is shedding light on some of the questions being
asked. Specifically, a study at Purdue on the environmental impact of
manufactured nanoparticles on ordinary soil showed no negative effects;
Georgia Tech scientists are doing similar work. Researchers at Dayton
University are working on the health and safety aspects of the use of
nanodiamonds as drug delivery vehicles with encouraging results.
University of Oregon chemists are looking at the use of nanomaterials
to clean up toxic groundwater contaminants that have until now been
difficult to remove. In vivo tests at Rice University have found no
immediate adverse health effects from carbon nanotubes injected
directly into the bloodstream and that the liver seems to collect these
materials effectively for excretion. These and many other studies are
increasing the body of knowledge on EHS implications and
providing,useful information on the responsible use of various
nanomaterials. The collection and dissemination of this research is an
important essential function of the NNI, as noted in our first report.
Our TAG survey shows broad consensus with respect to the role of
the Federal Government in supporting nanotechnology-related EHS
research. The majority of respondents are eager to see the NNI continue
its pro-active approach and expand research support.
The interagency approach is effective. I have reviewed the September
2006 report (EHS Research Needs for Engineered Nanoscale Materials), as
well as the more recently released interim document, prioritizing the
needs. These documents cast the wide net necessary to address the array
of nanotechnology-related EHS issues and are good descriptions of the
broad research needs. Thus, I believe the interagency process will lead
to a sound research strategy. Some have called for there to be a
separate office established to plan and fund EHS research related to
nanotechnology. While this might provide a sense of stronger
management, I do not believe that it is the best way to reduce
uncertainty about potential risks to health or the environment. As I
mentioned earlier, the field of ``nano'' is broad and the risk-benefit
assessment is complex. The best way to address this complexity is by
utilizing all of the expertise of the federal agencies in a coordinated
fashion. The National Nanotechnology Coordination Office and the
interagency NEHI Working Group appear to be the optimal approach at
this time. Creating a separate office would not just add bureaucracy,
it would risk losing the collaborative community of experts from
agencies like EPA, FDA, NIOSH, NIST, and NIH.
Funding increases for EHS research across the federal agencies are of
the right scale and indicate a steady increase in capacity to conduct
the necessary research. Funding increases (from $38M in 2006 to $59M
requested in 2008) are encouraging and indicate a steady increase in
capacity. In general, increasing funding too rapidly does not lead to
equivalent increases in high quality research. It is crucial to note
that EHS research also depends on advances in non-EHS areas, such as
instrumentation development and basic research on nanomaterials.
Development of nanotechnology in a responsible manner, especially at
the early stages, will be expedited by integration of EHS research with
broader basic and applied research. The NNI should continue to fund
cutting-edge research in all areas, including for EHS. Applications-
oriented research may well lead to information about EHS. Rather than
setting arbitrary funding levels or percentages of total spending as a
guideline for the EHS budget, NNI agencies should focus on addressing
the identified EHS research priorities while at the same time investing
in world-class applications research. In addition, the NNI agencies
should continue their efforts to coordinate the entire portfolio of
applications and implications research to leverage and optimize
progress in both.
In summary, at this point in our review, I am pleased with the
amount of coordination taking place among the agencies through the NNI.
Their approach appears to leverage the expertise and related efforts
across the government (e.g., work to assess risks of diesel, exhaust
and other incidental nanomaterials).
I expect the current planning and coordination process will lead to
a well thought out plan for nanotechnology EHS research across NNI
member agencies. While there is much to be done, the process is not
broken. In fact, the coordination process used at the NNCO and the
similar process used to manage Networking and Information Technology
Research and Development are so effective, they could well be
considered models for similar coordination in fields such as K-12
education where spending for hundreds of programs is spread over many
agencies without any formal mechanism whereby the spending agencies
might be informed of activities in their sister government departments.
The Council is eager to see the final nanotechnology EHS research
strategy, and strongly encourages the Nanotechnology Environmental and
Health Implications working group (NEHI) to complete its work as
expeditiously as possible--hopefully in time for an assessment in our
upcoming report.
Biography of E. Floyd Kvamme
Floyd Kvamme is a Partner at Kleiner Perkins Caufield & Byers, a
high technology venture capital firm. He is responsible for the
development of high technology companies from early start-up to
publicly traded phase. Mr. Kvamme currently serves on the boards of
Brio Technology, Gemfire, Harmonic, National Semiconductor, Photon
Dynamics, Power Integrations, and Silicon Genesis. Mr. Kvamme was one
of five members of the team that began at National Semiconductor in
1967, serving as its General Manager of Semiconductor Operations and
building it into a billion-dollar company. He served as President of
the National Advanced Systems subsidiary, which designed, manufactured
and marketed large computer systems. In 1982 he became Executive Vice
President of Sales and Marketing for Apple Computer. While at Apple,
his responsibilities included worldwide sales, marketing, distribution
and support. He holds two degrees in Engineering; a BS in Electrical
Engineering from the University of California at Berkeley and an MSE
specializing in Semiconductor Electronics from Syracuse University.
Chairman Baird. Thank you, Mr. Kvamme. I want to
acknowledge the presence of Ms. Hooley from Oregon who has been
a strong leader in nanotechnology issues. Also welcome back to
our Committee Ms. Johnson from Texas. It is good to have you
back. And also I would like to at this time to ask you now for
unanimous consent to the gentleman from California, Mr. Honda,
to join us without objection.
Thank you. We will return to the witnesses now. Dr. Colvin,
please.
STATEMENT OF DR. VICKI L. COLVIN, PROFESSOR OF CHEMISTRY AND
CHEMICAL ENGINEERING; EXECUTIVE DIRECTOR, INTERNATIONAL COUNCIL
ON NANOTECHNOLOGY; DIRECTOR, CENTER FOR BIOLOGICAL AND
ENVIRONMENTAL NANOTECHNOLOGY, RICE UNIVERSITY
Dr. Colvin. Thank you, Mr. Chairman, and Members of the
Committee for the opportunity to speak today about the
environmental, health, and safety research needs for
nanotechnology. Today I am providing my individual opinions,
but they have been informed by my association with the
International Council on Nanotechnology, or ICON. This
organization based at Rice University is a public-private
partnership founded on the principle that multi-stakeholder,
international collaboration is an essential ingredient for
effective risk management of nanotechnology. As its executive
director, it is my great honor to work with its director,
Kristen Kulinowski, and our many volunteers from around the
world on projects ranging from a free, searchable database of
EHS research papers to a survey of current practices for
nanoparticle handling in the workplace.
ICON's most recent activity has been an EHS research needs
project funded in part by the National Science Foundation. We
have used the global reach of our volunteers to recruit diverse
stakeholders to international workshops where we asked them to
assess the research needs for nano-EHS.
Given this background and my own experience as a practicing
scientist and director of NSF Center for Biological and
Environmental Nanotechnology, I will comment on the latest NNI
document concerning nano-EHS research.
I commend the NEHI Working Group for its prioritization of
the research needs in this area. I know that couldn't have been
an easy process, and the deliberations were necessary. There is
an urgency to nano-EHS research that affects the entire NNI
investment. Innovation in nanotechnology is being threatened by
the uncertainty about its risks. We need this innovation more
than ever right now. Nanotechnologies offer new approaches to
curing cancer and cleaning water and maybe will even enable
energy independence for our country. But fewer of these
transformative technologies will make it into commerce if the
technology transfer pipeline is limited by concerns about
nanoproduct safety. This problem cannot be solved by increasing
the inputs to the pipeline, nor should it be addressed by
relaxing regulatory oversight. The only sure fix is high
quality and intelligently packaged risk-related information. To
create such information, researchers must start work soon and
under the guidance of a federal research strategy that is in
place no later than 2008.
Going from a climate of uncertainty to one of confidence in
managing nanotechnology's risks is a massive undertaking that
will take years to fully develop. It requires careful planning,
coordination among agencies, and international cooperation.
External advisors included as partners in the NNI planning
process could accelerate the pace as well as make the effort
more integrated internationally.
The current NNI document as is clear from its title is not
a strategic plan but a collection of priority research needs.
These needs are grouped by not how they connect to some end
objective but by the relationship to agency missions. The
cross-cutting issues of nano-EHS do not map well onto single
agencies, and this presentation left me uncertain that there
were any shared goals driving the federal investment. I
recommend that specific research priorities be grouped so as to
link them to two, maybe three concrete outcomes which have
clear relevance to developing safe nanotechnology.
One example of such an outcome is the predictive model for
nanotechnology risk. During our ICON workshops, we found this
outcome had broad appeal to everyone, regulators, academics,
and industry alike. This is because the old ways of managing
risk are not easily adapted to nanotechnology. Nanomaterials
can come in millions of different sizes and shapes and surfaces
and chemical types. Faced with such immense variety, we can't
just expect to apply new risk assessment for each new flavor of
nanomaterial. Instead, we have to explore the latest tools of
21st-Century biology to move from observations of nanoparticles
hazards to a paradigm that seeks to predict these hazards
before a material is even created. Such predictive simulations
are a long-term grand challenge for nanotechnology risk
research, but to develop them requires near-term, more
pedestrian activities focused on unifying researchers'
terminology, methods, data structures, and even materials. I
loosely refer to these as harmonization tools, and with the
exception of reference materials, these needs did not make it
into the top 25 list in the latest NNI analysis. At the ICON
workshops, these took center stage in our discussion. Most
participants felt that these tools were a prerequisite for
nano-EHS research and should receive immediate priority.
To understand why this issue is so important, consider the
difference between investing in applications versus risk
research. In the first case, you might find five different
teams to build a better battery, each with its own approach;
but in the end, you help your cause even if only one team
succeeds. In the second case, if you find five teams to help
understand nanotube toxicity, for example, and then get five
different answers, your research investment actually hurts you
because it creates uncertainty rather than combating it. The
bad news is that by my count, we have way over five different
opinions about carbon nanotube toxicity right now. The good
news is that the U.S. Government can, if it is thoughtful about
the mechanisms, help researchers solve this problem and for
relatively low cost.
In conclusion, I look forward to the rapid development of
the NNI's strategic plan for nanotech EHS research. Breaking
down risk research into several concrete outcomes, such as
predictive simulations, will help to rally the scientific
community and create an effective strategy. Perhaps the first
step along the path will be programs that encourage researchers
to adopt a common set of tools for risk research. These
developments would create confidence that we are on a path
towards understanding nanotechnology's risks and spread the
doors open for safe nanotechnology innovation.
Thank you.
[The prepared statement of Dr. Colvin follows:]
Prepared Statement of Vicki L. Colvin
Summary
I am Executive Director of the multi-stakeholder International
Council on Nanotechnology (ICON), and director of a federal research
center in nanotechnology, and these roles have informed my opinions of
the Federal Government's approach to nanotechnology risk research. I
commend the Nanotechnology Environmental and Health Implications (NEHI)
working group for its effort to identify and prioritize the research
needs in this area. The urgency to nano-EHS research affects the entire
NNI investment. This group should provide a full strategic plan within
a year, and engage a broader community in authoring this document. The
apparent agency boundaries that are currently used to classify the
research needs should be removed, and instead these needs should be
grouped and linked to larger unifying objectives--such as the
development of predictive models for nanomaterial's impacts on the
environment. These organizing goals should be described so that it is
clear how they help transition us from a climate of uncertainty with
regards to nanotechnology's risks to one of confidence. Finally, the
NEHI prioritization misses the critical needs related to uniform
methods, data structures and languages for nanotechnology risk
researchers. There should be a clear plan to support the research
harmonization activities so that the policy-makers can extract--within
a few years--consensus answers to key questions in this research area.
These developments would create confidence that we're on a path towards
understanding nanotechnology's risks, and keep the pipeline for
nanotechnology wide open for innovations.
Thank you Mr. Chairman and Members of the Committee for the
opportunity to speak about the environmental, health and safety (EHS)
research needs for nanotechnology. Today, I am providing my individual
opinions, but they have been informed by my association with the
International Council on Nanotechnology (ICON). ICON was established in
2004 by a coalition of academics, non-governmental organizations,
industry and governments. This organization, based at Rice University,
is a public-private partnership founded on the principle that multi-
stakeholder, international collaboration is an essential ingredient for
effective risk management of nanotechnology. As its Executive Director,
it is my great honor to work with its Director, Kristen Kulinowski, and
our many volunteers from around the world on projects ranging from a
free, searchable database of EHS research papers to a survey of current
practices for nanoparticle handling in the workplace.
ICON's most recent effort is an international research needs
assessment project--funded in part by the National Science Foundation
(NSF). We have used the global reach of our volunteers to recruit
diverse stakeholders to international workshops, where we asked them to
assess the research needs for nanotechnology EHS. The first step in
this process is to evaluate known information about these connections
and identify where resources should be directed to address knowledge
gaps. The ultimate goal envisioned by this project is the design of
biocompatible and environmentally benign nanomaterials through the
development of a framework that enables prediction of interactions
based on physicochemical properties of engineered nanoparticles. The
framework contains priorities to enable improved risk assessment over
time as new nanomaterials or applications are developed. Armed with
this knowledge, we can work together to develop safe applications of
nanoscale materials or, in cases where the risks are too great, an
alternative to their use.
Given this background, and my own experiences as a practicing
nanotechnologist and Director of the NSF Center for Biological and
Environmental Nanotechnology, I will comment on the latest National
Nanotechnology Initiative (NNI) document concerning nano-EHS research
needs.
I commend the Nanotechnology Environmental and Health Implications
(NEHI) working group for its effort to identify the research needs in
this area; however, there is an urgency to nano-EHS research that
affects the entire NNI investment. Innovation in nanotechnology is
being threatened by the uncertainty about its risks and how government
will manage them. We need this innovation more than ever right now.
Nanotechnologies offer new approaches to treating cancer and cleaning
water, and may enable energy independence for our country; but fewer of
these transformative technologies will make it into commerce if the
technology transfer pipeline becomes clogged by concerns about
nanoproduct safety. This problem cannot be solved by increasing the
inputs to the pipeline, nor should it be addressed by relaxing
regulatory oversight. The only sure fix is high quality and
intelligently packaged risk-related information.
Going from a climate of uncertainty to one of confidence in
managing nanotechnology risk is a massive undertaking that will take
years to fully develop. It will also take careful planning and
coordination among agencies in this government and abroad. The 2007
NEHI report is an important first step towards creating a coherent and
effective strategy for nanotechnology's EHS research, but by summer of
2008 there should be a full and detailed strategic plan made available.
As it makes clear in its title, this report is not a strategy. The
steps proposed to getting to a strategy are reasonable and
deliberative; however, I would recommend sacrificing some of them (the
gap analysis for example) because of the urgency of this issue.
Break down barriers between agencies
The NEHI working group could greatly improve future documents by
working to break down the apparent agency boundaries that define its
approach to this area. The needs in this area are all cross-agency, and
an effective strategic plan cannot look like it was created by agency
silos. It appears that the various sections of the report were authored
in large part by agencies working separately from one another. Section
2, for example, is clearly related to the NIST mission; section 3 to
the NIH mission and section 4 to the EPA mission; sections 5 and 6 to
NIOSH. Also, it is not clear that each agency should get five
priorities; some agency activities need to be greater in scope in the
beginning and taper towards the end of the program for example.
A missing agency in this discussion is the Department of Energy
(DOE). DOE has a large investment in nanotechnology through its network
of nanotechnology facilities, and is thus an immediate customer for
information about risk management in a research setting. Moreover, the
DOE has enormous capability for particulate and molecular contaminant
transport in air, water and soil, with unparalleled experimental and
computational capacity. In addition, DOE manages existing programs that
seek to understand how nature both produces and uses natural
nanoparticles and this perspective is of great value in risk research.
For all of these reasons DOE should be a more active participant in the
planning process. Like any agency, it should not receive any unfunded
mandates. However, I believe that in the area of environmental exposure
(fate, transport and modeling) of nanoparticles it is a key partner.
Also apparently missing is the role of the National Science
Foundation in nanotechnology risk research. Currently, NSF is the
single largest funder of nano-EHS research among the agencies; while
risk research is not as clearly connected to NSF's mission, I would
argue that this investment is an excellent one for both nanotechnology
and fundamental science. In particular, the challenge of predicting the
interactions of nanomaterials with the environment is one that will
bring together new disciplines in computational biology and
bioinformatics--disciplines nurtured in large part by the NSF.
A strategic plan needs several unifying objectives
The prioritization document provides 20,000 foot agency-specific
views of this problem, but it never brings these together into a 50,000
foot view of exactly how each research need will transition us from a
climate of uncertainty to one of confidence. I believe this disconnect
may exist because of the silo approach to writing this report; this
division is not a general feature of the NNI and risk research, and I
note with great appreciation the productive coordination among EPA,
NSF, NIOSH and NIH already with respect to current funding in the area.
These agencies know how to work together, they just didn't convey that
fact very effectively in this current report. As a result of this, the
overall document left me without a sense of the shared objectives that
will drive the program. The ultimate strategic plan must be structured
by two, maybe three, overarching outcomes that stakeholders agree will
give us more confidence in managing risks.
During our ICON workshops, we structured debate around the shared
objective of predictive models for nanotechnology risk. There was great
enthusiasm for framing the problem this way among scientists with
research and regulatory missions alike. Nanotechnology throws a curve
ball at conventional risk assessment, which is designed to evaluate the
risk of a single substance like DDT. Its basic materials can be created
with millions of possible variations of different sizes, shapes,
surfaces and chemical type. Faced with such variety, we can't just
apply a risk tool over and over again. Instead, we have to predict
based on measurable properties how nanomaterials might move into
organisms, and to then use informatics models to link their presence to
an impact such as toxicity. Such a concrete outcome is the best
starting point for the NNI's planning process.
Engage external stakeholders in developing Grand Challenges for Nano-
EHS Research
The NEHI's work would benefit greatly from a more open process that
engaged external advisors not only as commenters on the document, but
also as authors. This report was made available for public comment for
one month, and comments were restricted to the `principles used for
prioritization,' not the actual priorities. The NEHI would benefit
greatly from convening external advisors for the next stage of the
process; in the least, this engagement could accelerate the drafting of
the full plan. I would point to the NNI grand challenge workshops
(2000-2003) as a model for this activity. These events drew researchers
from all sectors together to draft the language of `grand challenges'
in area of nanotechnology related to information sciences, biology,
materials and manufacturing as well as environment. Reports from these
meetings often included prioritization of issues and in some cases
rather detailed plans about how best to proceed with research in the
area. I think especially for this topic that engagement of multiple
stakeholder groups is essential. The NNI should hold `Grand Challenge
for Nanotechnology Risk Research' workshops and structure them in such
a way as to directly input into their planning--and convey that
structure to the participants. Engaging external advisors as real
partners in the planning process should accelerate the pace of this
activity and ensure the planning document is well integrated with other
global efforts.
Support harmonization of language, methods and materials
Finally, there should be a clear plan to support activities devoted
generally to harmonizing researchers' languages, methods and materials.
These issues were mentioned in 2006, but this year only a need for
reference materials made the cut. At the ICON workshops, it was hard to
get participants to stop complaining about how the lack of standard
terminology, data structures, methods and reference materials made
their research slower and less conclusive. Overwhelmingly, participants
agreed that harmonizing research methods was a critical first step in a
global nano-EHS research effort.
To understand why this issue is so important consider the
difference between funding applications research versus risk research.
In the first case you might fund five teams to build a better battery,
each with its own approach, but in the end you get what you want if
only one team manages to improve the battery. In the second case, if
you fund five teams to help understand nanotube toxicity and they get
five different answers you are actually worse off because your research
creates uncertainty rather than combating it. Unfortunately, such
dissonance in the technical literature is normal for new types of
science and what we are trying to measure (nanotechnology's risks) is
very challenging. We researchers cannot really tackle the problem until
we have a mechanism to deliberate, argue and ultimately agree on what
to call nanomaterials and what protocols to follow in doing the risk
research.
The harmonization that I envision will not mean that there will be
consensus among the technical community on elements of nanotechnology's
hazard and exposure; rather, that we will reach consensus faster
because we will not be arguing through the slow channels of peer-review
about methods and language. The most important features of this
harmonization activity are that it must result in voluntary practices,
designed by the active researchers in nano-EHS through a collaborative
and consensus process. Top-down and mandatory instructions about how
best to collect data, organize it or report would be a disaster. A
great model, mentioned in the NNI's 2006 report on nano-EHS needs, are
the MIAME standards for protein arrays; these are driven by researchers
and NIH had the good sense to fund workshops and a website to keep them
updated. To get this started for nanotechnology would require a good
nano-EHS network of researchers; NSF has examples of network funding
for community building in other areas. This community would convene a
few workshops, use the electronic data-sharing possible via the web,
and perhaps contract the services of a technical writer. Round robin
tests of methods and materials would follow from any uniform practices
that emerge in a Phase 2 of the harmonization program.
It is important to realize that the standardization efforts
underway at ASTM and ISO are not equivalent to what I am referring to a
research harmonization. I chair the ASTM E56 committee on
nanotechnology and over the past few years have developed a good
familiarity with international standardization. I have enormous respect
for these processes, but they are poorly suited for the task I
envision. First, academics are not traditionally represented in these
activities. Indeed, I am one of the few academics actively involved in
nanotechnology standardization and I cannot see that changing. Second,
research harmonization could in principle happen over the span of nine
months and several workshops; even a straightforward ASTM standard
could take two years. Third, there are real issues with international
participation in either ASTM or other standard developing
organizations, including the International Organization for
Standardization (ISO). U.S. scientists can only write standards by
being on ASTM (unless they are nominated to the U.S. technical advisory
group to ISO), and foreign scientists are usually expected to
participate in their national standards activities--to which ASTM is a
competitor. Fourth, international standardization is highly politicized
and any document takes on legal and commercial scrutiny that is out of
place when researchers are discussing the nitty gritty details of
evaluating cell death, for example. Finally--and most problematic--
standards documents from ASTM and ISO are copyrighted and expensive.
The research harmonization documents need to be freely available to
anyone with a computer--they have to be easy to use and access.
It may be that the research harmonization documents could serve as
starting points for more formal standardization in ASTM, ISO or
elsewhere. In this model, research harmonization activities would be a
precursor not a competitor for formal standardization processes; in
this way, they could better serve the immediate needs of the research
community.
Conclusion
In conclusion, I hope that the NNI can quickly, with external
input, develop a detailed strategic plan. Breaking down risk research
into several concrete outcomes--such as predictive simulations--will
help to rally the scientific community and create public confidence in
existing and new nanoproducts. Perhaps the first step will be programs
that catalyze the research community to develop and adopt common
practices for nanotechnology risk research. These developments would
create confidence that we're on a path towards understanding
nanotechnology's risks, and keep the pipeline for nanotechnology
innovation flowing.
International Nano-EHS Research Needs Assessment: A Preview of Reports
from Two Workshops
ICON sponsored two workshops this year to discuss the research
needed to enable prediction of nanomaterial impacts. The first
workshop, held at the National Institutes of Health campus in Bethesda,
MD, in January, tested whether nanomaterial composition was a
reasonable way to begin classifying nanomaterials for predictive
purposes and where in the life cycle of a given class of nanoparticle
there might be high exposure potential. However, the dynamic nature of
nanomaterials throughout their life cycle presents challenges for using
physicochemical properties as predictors of biological behavior.
Workshop participants identified the need for a set of screening tools
to correlate the functional properties of nanomaterials--i.e., how they
behave rather than what they are made of--to determine potential for
bio-interaction. These tools do not exist today.
The second workshop, held at the Centre for Global Dialogue in
Ruschlikon, Switzerland in June, focused on the mechanisms by which
engineered nanomaterials interact with biological organisms--including
oxidative stress, inflammation and immune response, protein misfolding,
apoptosis and necrosis, genotoxicity and mutagenicity, and
developmental effects--and interactions between engineered
nanomaterials and in vitro and in vivo systems at the level of
biological molecules, target cells, tissues and whole animals. Workshop
participants identified a need to understand what happens to a
nanoparticle when it enters a biological organism and becomes coated
with biomolecules in a complex and dynamic manner that is still poorly
understood. Tools for characterizing these coatings, for tracking
certain types of nanoparticles throughout the body, and for correlating
cell-culture studies with impacts in whole organisms are all
outstanding challenges.
Some themes that cut across both workshops were the need for
standard terminology, a robust library of standard reference materials
for use in nano-EHS research, a set of toxicology tools that have been
validated for use with nanomaterials, and a better understanding of how
dose and dose rate impact toxicity for nanomaterials. All these needs
were seen as limiting the research community's ability to develop
predictive models for the interactions of nanomaterials with humans and
the environment.
The workshops were enabled by funding from the National Science
Foundation (BES-0646107) with generous in-kind support from the
National Institutes of Health and the Swiss Reinsurance Company. The
final report is in preparation and will be made available at http://
icon.rice.edu.
Biography for Vicki L. Colvin
Dr. Vicki Colvin received her Bachelor's degree in chemistry and
physics from Stanford University in 1988, and in 1994 obtained her
Ph.D. in chemistry from the University of California, Berkeley, where
she worked under the guidance of Dr. Paul Alivisatos. During her time
at the University of California, Berkeley, Colvin was awarded the
American Chemical Society's Victor K. LaMer Award for her work in
colloid and surface chemistry. Colvin completed her postdoctoral work
at AT&T Bell Labs.
In 1996, Colvin was recruited by Rice University to expand its
nanotechnology program. Today, she serves as Professor of Chemistry and
Chemical & Biomolecular Engineering at Rice University, as well as
Director of its Center for Biological and Environmental Nanotechnology
(CBEN). CBEN was one of the Nation's first Nanoscience and Engineering
Centers funded by the National Science Foundation. One of CBEN's
primary areas of interest is the application of nanotechnology to the
environment.
Colvin has received numerous accolades for her teaching abilities,
including Phi Beta Kappa's Teaching Prize for 1998-1999 and the Camille
Dreyfus Teacher Scholar Award in 2002. In 2002, she was also named one
of Discover Magazine's ``Top 20 Scientists to Watch'' and received an
Alfred P. Sloan Fellowship. Her research in low-field magnetic
separation of nanocrystals was named Top Five (no. 2 of 5) Nanotech
Breakthroughs of 2006 by Forbes/Wolfe Nanotech Report.
Colvin is also a frequent contributor to Science, Advanced
Materials, Physical Review Letters and other peer-reviewed journals,
having authored/ co-authored over 75 articles, and holds patents to
four inventions.
Chairman Baird. We have just now been joined by Dr.
Bartlett. Dr. Bartlett, thank you for being here with us. Dr.
Maynard?
STATEMENT OF DR. ANDREW D. MAYNARD, CHIEF SCIENCE ADVISOR,
PROJECT ON EMERGING NANOTECHNOLOGIES, WOODROW WILSON
INTERNATIONAL CENTER FOR SCHOLARS, WASHINGTON, D.C.
Dr. Maynard. Thank you, Mr. Chairman, Ranking Member
Ehlers, and Members of this committee. My name is Dr. Andrew
Maynard. I'm the Chief Science Advisor to the Project on
Emerging Nanotechnologies which is a partnership between the
Woodrow Wilson International Center for Scholars and the Pew
Charitable Trusts. But of course, the views I express here are
my own.
A few years ago, nanotechnology was little more than the
stuff of scientists' dreams. Yet now it is being used more and
more within the products we use every day, and the
nanomaterials that make up these products are available for
anyone to buy and use.
I want to give you an example of that and very topical
after Vicki's comments. I have here a pouch of single-wall
carbon nanotubes bought over the Internet. You can see they
came in a USPS envelope. Anybody with a credit card can buy
this product, and they can buy it in quantities from a few
grams up to thousands of kilograms.
Now, we live in a society where materials like this are
becoming more and more available, and the question continues to
arise, are we doing enough to ensure the safety of these
materials?
I just want to focus a little bit more on this particular
example, so take these carbon nanotubes. If you look at the
safety information which is provided by the company, the
manufacturer's materials safety data sheet, this material is
graphite, nothing more than the lead in my pencil. And the
listed health precautions are really no more than you would
have for nuisance dust. But under closer examination, these
carbon nanotubes are as similar to pencil lead as the soot on
my grill at home is to diamonds. Let me just read you something
that a group of experts wrote in the journal Nature last year,
and this was an article where Vicki was one of my co-authors. I
am quoting here from this article. ``Although it is not clear
whether fiber-shaped nanoscale particles from carbon
nanomaterials will behave like asbestos or not, some materials
are sufficiently similar to cause concern. Any failure to pick
up asbestos-like behavior as early as possible will be
potentially devastating to the health of exposed people and to
the future of the nanotechnology industry.''
I think you can see, as this particular example eloquently
demonstrates, there is a yawning knowledge gap between
nanomaterials entering commerce now and what we know about
their safety. And this uncertainty over how to develop
nanotechnology safely is hamstringing regulators, paralyzing
nanobusinesses, and confusing consumers.
So how do we bridge this gap? Well, in my written comments,
I consider what we need to do to move forward and how the
government's actions match up to this. But in the interest of
time, let me cut to the chase here and give you the top six
recommendations arising from this assessment.
First of all, we need a top-down research strategy by the
end of this year at the latest, and this must respond to
oversight challenges and it must be backed up with authority
and resources to ensure its implementation. As part of this
strategy, we desperately need a federal advisory committee to
be established to allow transparent input and review from
industry, academia, non-government organizations, and other
stakeholders.
Secondly, new mechanisms are needed to make a strategic
plan work. These must overcome both institutional and
scientific barriers and ensure resources go to where they're
needed to get the job done. They must empower agencies to do
what they do best, and they must prevent resources being
squandered on research which is both ill-conceived and
irrelevant.
Third, 10 percent of the Federal Government's
nanotechnology R&D budget should be dedicated to goal-oriented
nanotechnology EHS research. And looking at this, a minimum of
$50 million per year should go to targeted research that
directly addresses specific strategic challenges. The balance
of funding should support exploratory or basic research that is
conducted within the scope of a strategic research program.
Fourth, a public-private partnership should be established
to address critical research questions. This should enable
goal-driven research in support of government and industry
oversight and a commitment of $10 million per year for the next
five years sought split evenly between government and industry.
Fifth, a targeted program of public engagement on
nanotechnology should be established that ensures two-way
communication between the developers of these technologies and
the users.
And finally, top-level leadership of a single person within
the Federal Government is needed to ensure appropriate action
is taken in addressing these issues.
Members of the National Nanotechnology Initiative have
great intentions to do the right thing, and I think we have
already heard that. But considering what is at stake here, the
quality of our environment, the vitality of the American
economy, and the health of people like you and people like me,
good intentions are simply not enough. It is vital that we take
action now to ensure a world where we cannot only buy
engineered nanomaterials like these carbon nanotubes, but we
can also use them without fear of harm.
Thank you.
[The prepared statement of Dr. Maynard follows:]
Prepared Statement of Andrew D. Maynard
Overview
I would like to thank Chairman Bart Gordon, Ranking Republican
member Ralph Hall, and the Members of the House Committee on Science
for holding this hearing on ``Research on Environmental and Safety
Impacts of Nanotechnology: Current Status of Planning and
Implementation under the National Nanotechnology Initiative.''
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. By way of background, my area of
expertise is nanomaterials and their environmental and health impacts,
and I 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
spent five 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.
In my current role as Chief Science Advisor to the Project on
Emerging Nanotechnologies, I am heavily involved in working with
government, industry and other groups to find science-based solutions
to the challenges of developing nanotechnologies safely and
effectively. The Project on Emerging Nanotechnologies is an initiative
launched by the Woodrow Wilson International Center for Scholars and
The Pew Charitable Trusts in 2005.\1\ 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 is a non-partisan, non-advocacy policy
organization that works with researchers, government, industry, non-
governmental organizations (NGOs), and others to find the best possible
solutions to developing responsible, beneficial and acceptable
nanotechnologies. The opinions expressed in this testimony are my own,
and do not necessarily reflect views of the Wilson Center or The Pew
Charitable Trusts.
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\1\ For further information, see http://www.nanotechproject.org/.
Accessed October 13, 2007.
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In this testimony, I explore why we need to address the
Environmental, Health and Safety (EHS) aspects of nanotechnology, and
what in my perspective are key components of an effective research
strategy. I then look at where current National Nanotechnology
Initiative (NNI) actions and plans align with or diverge from what is
needed, and draw clear recommendations on how we can get back on track
to realizing the promise of nanotechnology. Finally, I draw from this
assessment to address the questions specifically asked by the House
Science Committee.
Executive Summary
Nanotechnology has tremendous potential to create wealth and jobs,
improve standards of living and provide solutions to some of our
greatest technological challenges. But this potential will not be
realized unless strategic action is taken to identify, assess and
manage potential risks before serious harm is caused. Despite a good
start, the Federal Government's current approach to ensuring the
development of responsible and successful nanotechnologies falls short
of the mark. Action in six areas is recommended to get EHS research
back on track, in support of sustainable and safe nanotechnologies:
1. Strategy. A top-level strategic framework should be
established by the end of this year at the latest and updated
every two years, that identifies the goals of nanotechnology
risk research across the Federal Government, and provides a
roadmap for achieving these goals. The strategy should identify
information needed to regulate and otherwise oversee the safe
development and use of nanotechnologies; which agencies will
take a lead in addressing specific research challenges; when
critical information is needed; and how the research will be
funded. It should reflect evolving oversight challenges, and
must be backed up with authority and resources to ensure its
implementation.
2. Mechanisms. Mechanisms are needed to allow a strategic
research framework to be implemented. These must transcend
institutional and scientific barriers, and ensure resources get
to where they are needed to get the job done. They must empower
agencies to do work effectively within their missions, but
within an overarching strategic framework. And they must
prevent resources from being squandered on research that is
ill-conceived and irrelevant. A federal advisory committee
should be established to allow transparent input and review
from industry, academia, non-government organizations and other
stakeholders.
3. Funding. Ten percent of the Federal Government's
nanotechnology research and development budget should be
dedicated to goal-oriented EHS research. A minimum of $50
million per year should go to targeted research directly
addressing clearly-defined strategic challenges. The balance of
funding--an estimated $95 million in fiscal year 2008--should
support exploratory research that is conducted within the scope
of a strategic research program.
4. Public-Private Partnerships. A public-private partnership
should be established to address critical industry and
government-research questions that fall between the gaps. A
partnership model should be developed that enables goal-driven
research in support of government and industry oversight, and a
commitment to $10 million per year for the next five years
sought; split evenly between government and industry sources.
5. Communication. A targeted program of public engagement on
nanotechnology should be established that ensures two-way
communication between the developers and users of these
technologies. This should be supported by approximately $1
million per year in funding. The program should have the
fourfold aims of ensuring transparency, disseminating
information, enabling science-based dialogue between
stakeholders, and supporting informed decision-making by
citizens, businesses, regulators, and other stakeholders.
6. Leadership. Top-level leadership is needed to ensure the
successful development and implementation of a government-wide
strategic research framework addressing nanotechnology EHS
risks. One person should be appointed to oversee nanotechnology
EHS research and regulation within the Federal Government, and
given resources and authority to enable funding allocations and
interagency partnerships that will support the implementation
of a strategic research plan.
We cannot afford to drive blind into the nanotechnology future. Not
only will this prevent us from seeing and navigating around the
inevitable bends associated with possible risks, but it will also give
those economies with the foresight to identify and negotiate the bends
a very real competitive edge. Despite a good start, the U.S. is still
caught up in developing new technologies within an old mindset. If
emerging nanotechnologies are to be built on a sound understanding of
the potential risks--and how to avoid them--new research strategies,
new mechanisms of execution and new funding are all needed. These
should be overseen by clear leadership and an interagency group with
the authority to develop a strategic research framework and ensure its
execution.
What is needed to make nanotechnology work?
Nanotechnology has the potential to turn our world upside down. The
increasing dexterity at the nanoscale it provides gives us the
opportunity to greatly enhance existing technologies, and to develop
innovative new technologies. When you couple this capability with the
unusual and sometimes unique behavior of materials that are engineered
at near-atomic scales, you have the basis for a transformative
technology that has the potential to impact virtually every aspect of
our lives. Some of these emerging technologies will benefit
individuals. Others will help solve pressing societal challenges like
climate change, access to clean water and cancer treatment. Many will
provide companies with the competitive edge they need to succeed. In
all cases, nanotechnology holds within it the potential to improve the
quality of life and economic success of America and the world beyond.
But nanotechnology also is shaking up our understanding of what
makes something harmful and how we deal with that. New engineered
nanomaterials are prized for their unconventional properties. But these
same properties may also lead to new ways of causing harm to people and
the environment.\2\ Research has already demonstrated that some
engineered nanomaterials can reach places in the body and the
environment that are usually inaccessible to conventional materials,
raising the possibility of unanticipated harm arising from unexpected
exposures. And studies have shown that the toxicity of engineered
nanomaterials is not always predictable from conventional knowledge.\3\
For instance, we now know that nanometer sized particles can move along
nerve cells; that the high fraction of atoms on the surface of
nanomaterials can influence their toxicity; and that nanometer-diameter
particles can initiate protein mis-folding, possibly leading to
diseases.
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\2\ Maynard, A.D., Aitken, R.J., Butz, T., Colvin, V., Donaldson,
K., Oberdorster, G., Philbert, M.A., Ryan, J., Seaton, A., Stone, V.,
Tinkle, S.S., Tran, L., Walker, N.J. and Warheit, D.B. (2006). Safe
handling of nanotechnology. Nature 444:267-269.
\3\ Oberdorster, G., Stone, V. and Donaldson, K. (2007). Toxicology
of nanoparticles: A historical perspective. Nanotoxicology 1:2-25.
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Moving towards the nanotechnology future without a clear
understanding of the possible risks, and how to manage them, is like
driving blindfold. The more we are able to see where the bends in the
road occur, the better we will be able to navigate round them to
realize safe, sustainable and successful nanotech applications. But to
see and navigate the bends, requires the foresight provided by sound
science, and the ability to apply science-informed lessons.
Twenty-first century technologies like nanotechnology present new
challenges to identifying and managing risks, and it would be naive to
assume that twentieth century assumptions and approaches are up to the
task of protecting health and the environment in all cases. In the case
of engineered nanomaterials, the importance of physical structure in
addition to chemical composition in determining behavior is making a
mockery of our chemicals-based view of risks and regulation.
Clearly, action is needed to realign how we oversee the safety of
engineered nanomaterials with how these new materials might cause harm.
This is a complex, but not impossible, task. A successful plan for
realizing the benefits of nanotechnology while minimizing the risks
depends on acknowledging the possibility of unconventional behavior,
leadership, a strategic plan, mechanisms to put a research strategy
into practice and sufficient resources to do this. Each of these five
components are discussed below.
1. Acknowledging the possibility of unconventional behavior
Assuming that new technologies will have conventional, predictable
and manageable risks is a recipe for disaster. Materials that are
intentionally engineered to behave in unconventional ways will have the
potential to cause harm in a manner that is not predictable from
conventional understanding alone. And as a consequence, we cannot
assume by default that established ways of evaluating and regulating
risks will prevent these new materials from causing harm.\4\ There
undoubtedly will be new engineered nanomaterials and nanotechnology
applications that do not impact health and the environment in an
unpredictable way. Yet research has already demonstrated the ability of
some engineered nanomaterials to defy convention, by getting to places
inaccessible to larger scale materials, and causing harm that would not
be predicted from a conventional world-view.\5\
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\4\ Davies, J.C. (2006). Managing the effects of nanotechnology.
Woodrow Wilson International Center for Scholars, Project on Emerging
Nanotechnologies, Washington, DC.
\5\ Maynard, A., D. (2007). Nanotechnology: The next big thing, or
much ado about nothing? Ann. Occup. Hyg. 51:1-12.
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Denying the potential for engineered nanomaterials to cause harm in
unconventional ways not only flies in the face of common sense; it also
prevents effective science-based decision-making. Based on the current
state of knowledge, ways in which nanomaterials might demonstrate
unconventional behavior include:
Adverse reactions to exposure that are not
predictable from the material's chemical makeup alone.\6\
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\6\ Oberdorster, G., Gelein, R.M., Ferin, J. and Weiss, B. (1995).
Association of particulate air pollution and acute mortality:
involvement of ultrafine particles? Inhal. Toxicol. 7:111-124.
An ability to penetrate to parts of the body and the
environment that are inaccessible to non-nanomaterials.\7\
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\7\ Elder, A., Gelein, R., Silva, V., Feikert, T., Opanashuk, L.,
Carter, J., Potter, R., Maynard, A., Finkelstein, J. and Oberdorster,
G. (2006). Translocation of inhaled ultrafine manganese oxide particles
to the central nervous system. Environ. Health Perspect. 114:1172-1178.
The emergence of physical and chemical properties
that are not directly predictable from individual atoms, or the
bulk material.\8\
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\8\ Preining, O. (1998). The physical nature of very, very small
particles and its impact on their behavior. J. Aerosol Sci. 29:481-495.
A possible ability to interfere with living systems
including DNA and proteins that are naturally nanoscale.\9\
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\9\ Colvin, V. and Kulinowski, K. (2007). Nanoparticles as
catalysts for protein fibrillation. Proc. Natl. Acad. Sci. U.S.A.
doi:10.1073/pnas.0703194104
An association with diseases not conventionally
associated with exposure to non-nanomaterials.\10\
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\10\ Mills, N.L., Tornqvist, H., Gonzalez, M.C., Vink, E.,
Robinson, S.D., Soderberg, S., Boon, N.A., Donaldson, K., Sandstrom,
T., Blomberg, A. and Newby, D.E. (2007). Ischemic and Thrombotic
Effects of Dilute Diesel-Exhaust Inhalation in Men with Coronary Heart
Disease. New England J. of Med. 357:1075-1082.
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This knowledge needs to be tempered by the likelihood of exposure
(or environmental release) occurring, which could be negligible in the
case of nano-engineered electronics, but might be substantial for a
range of products designed to be eaten, put on the body or dispersed in
the environment.
2. Leadership in nanotechnology EHS research
Without clear leadership, the emergence of safe nanotechnologies
will be a happy accident rather than a foregone conclusion.
In addressing any difficult task or challenge, progress is likely
to be slow to non-existent if no one provides vision, direction,
motivation and encouragement for achieving results, and is not held
accountable for results. And, ensuring the emergence of safe
nanotechnologies, where the risks are uncertain and the science
complex, is a fiendishly difficult challenge when seen from any angle.
Leadership towards the goal of identifying, assessing and managing
nanotechnology-specific risks will present many challenges. The
nanotechnology community includes the Federal Government, State
government, businesses, researchers, non-government organizations and
consumers, as well as all their international counterparts. Each set of
stakeholders brings a different set of issues to the table, and a range
of abilities and skills to address those issues. Effective leadership
will enable these groups to work effectively toward addressing a common
goal of ensuring that emerging nanotechnologies are as safe as
possible.
The Federal Government is an acknowledged leader in promoting
nanotechnology research and development, and is looked to for
leadership in ensuring the emergence of safe nanotechnologies. Yet the
diverse makeup of the Federal Government and the different (and
possibly competing) interests of agencies present real challenges to
developing effective leadership. Communication and collaboration
between agencies is essential if the Federal Government as a whole is
to identify and address critical issues underpinning the development of
safe nanotechnologies. But committees and networks in and of themselves
do not constitute leadership.
Could an internal committee--or working group--provide the
leadership necessary to ensure safe nanotechnologies? Possibly, if it
was empowered to establish research directions and allocate resources.
Yet even working groups are only as good as the person leading them.
And while it is possible for a good committee to direct, encourage and
motivate people toward addressing a common set of goals, this is more
often than not a reflection of the ability of the committee's leader to
direct, encourage and motivate its members. Certainly, a working group
without leadership is a very ineffective device!
In short, there must be one individual within the Federal
Government who is tasked with leading efforts to ensure the safety of
emerging nanotechnologies, and has the resources and authority to get
the job done. A key role of such a person would be to ensure agencies
are able to work within their missions and competencies toward a common
set of established goals. But he or she would also provide leadership
to the broader stakeholder community involved--both national and
international--in developing safe nanotechnologies.
3. An effective strategic framework
We are unlikely to arrive at a future where nanotechnology has been
developed responsibly without a strategic plan for how to get there.
Like all good strategies, this should include a clear idea of where we
want to be, and what needs to be done to get there. And if we are
currently lost, one of the first steps should be to find out where we
are now.
Funding for research and development into nanoscience and
nanotechnologies serves many purposes, including developing knowledge
for its own intrinsic value, providing a platform for job and wealth
creation, and improving quality of life. Research into the potential
impacts of nanotechnologies supports these goals in that they are
unlikely to be met if we blindly develop new technologies that might,
or are perceived to, cause unacceptable harm. Yet strategically, the
goals of risk-related research must be untwined from those driving
nanotechnology discovery in general, if an effective research agenda is
to be developed.
Later in this testimony, I will explore the goals and elements of a
viable strategic framework for addressing nanotechnology EHS issues. In
brief, an overarching goal for federally-funded risk-based
nanotechnology research should be to develop the information necessary
to identify (or predict), assess and manage risks associated with
nanotechnologies. Ultimately, this means research directed towards
effective oversight. A central principle of this goal is science in the
service of safety, and not science for its own sake.
Broad challenges to addressing this goal include:
Providing answers to pressing questions.
Developing new tools and knowledge to identify the
questions not currently being asked.
Translating research results into practice, and in
particular, developing new ways of predicting and managing
risks.
Many of the recommended research needs identified over the past few
years by a wide range of organizations fit within these challenges,
including those published by the NEHI group in 2006\11\ (and the
shorter list released in 2007).\12\ Addressing these challenges within
the context of a strategic plan will lead to progress towards the
overarching goal.
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\11\ NSET (2006). Environmental, health and safety research needs
for engineered nanoscale materials. Subcommittee on Nanoscale Science,
Engineering and Technology, Committee on Technology, National Science
and Technology Council, Washington, DC.
\12\ NEHI (2007). Prioritization of Environmental, Safety and
Health Research Needs for Engineered Nanoscale Materials. An Interim
Document for Public Comment, Nanotechnology Environment and Health
Implications (NEHI) Working Group of the Subcommittee on Nanoscale
Science, Engineering and Technology, Committee on Technology, National
Science and Technology Council, Washington, DC.
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Developing an effective roadmap to addressing these challenges is
not as simple as prioritizing research needs. As I discovered while
developing recommendations on a short-term research strategy in
2006,\13\ it is necessary to work back from what you want to achieve,
and map out the research steps needed to get there. This inevitably
leads to complex and intertwined research threads. Yet if this
complexity is not acknowledged, the result is simplistic research
priorities that look good on paper, but are ineffective at addressing
specific aims. And without a clear sense of context, it is all too easy
to highlight research efforts that appear to be strategically
important, but are in reality only marginal to achieving the desired
goals.
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\13\ Maynard, A.D. (2006). Nanotechnology: A research strategy for
addressing risk. Woodrow Wilson International Center for Scholars,
Project on Emerging Nanotechnologies, Washington, DC.
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In developing the elements of a research strategy in the earlier
2006 paper, and in a commentary published in the journal Nature with
thirteen distinguished colleagues,\14\ it became clear that an
effective research strategy addressing potential nanotechnology risks
will have a number of key elements. These will include:
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\14\ See supra note 2.
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Goal-oriented research,
A balance of targeted and exploratory research,
Interdisciplinary collaboration,
Enabling and empowering researchers and research
organizations, and
Communication and translation of information.
Building a top-down strategic nanotechnology EHS research plan
around these goals, challenges and elements, is essential to providing
a framework for generating the information that regulators, industry,
consumers and others need to develop and use nanotechnologies as safely
as possible.
As an example of what is possible, Australia recently announced the
formation of an AU$36.2 million initiative to develop nanotechnologies
for niche markets--the Niche Manufacturing Flagship.\15\ What sets this
initiative apart is an integrated approach to EHS research from the
start, an approach that will lead to products that have been researched
and designed with safety in mind. And while the Niche Manufacturing
Flagship approach represents just one component of an effective
strategic research framework, in the long run, it is products arising
from programs like this that are most likely to be embraced by
consumers and industry alike.
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\15\ Niche Manufacturing Flagship. http://www.csiro.au/org/
NicheManufacturingFlagshipOverview.html. Accessed October 19, 2007.
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4. Mechanisms to get the job done
A strategic research plan that looks good on paper fails at the
first hurdle if the mechanisms to implement it effectively are not in
place.
Administrative mechanisms necessary to get the job done are largely
covered by the elements of an effective research strategy already
discussed, and include responsiveness to new challenges, leadership,
vision, coordination and communication. But while this list is short,
the challenges to developing administrative approaches that enable a
top-level federal research strategy to be implemented are substantial.
In many ways, it is easier to start by looking at what is not
effective. Relying on individual agency-driven research plans and
individual investigators to get the job done, for instance, is not
effective, as leadership, vision, directed funding, coordination and
communication are lost. Likewise, establishing mechanisms for
communication and coordination alone is not effective, as there is no
vision, no targeted resources and no leadership to apply the resulting
flow of information.
Instead, mechanisms need to be implemented at the highest level
that ensure an environment in which agencies with different but
complementary competencies and missions can operate most effectively.
Ideally, administrative structures are needed that: provide leadership
in addressing research challenges across the Federal Government;
facilitate the strategic sharing and use of information between
agencies; enable interdisciplinary and interagency partnerships that
are goal-oriented rather than mission-driven; simplify resource sharing
between agencies; and allow for new resources to be allocated
strategically across agencies to address key issues.
Mechanisms also are needed that support relevant research that is
not constrained by bureaucratic and organizational barriers. These
mechanisms will enable different approaches to supporting research to
be used in the best possible way to address identified research goals--
including using intramural and extramural research as appropriate, and
balancing applied and exploratory research. It is vital that mechanisms
continue to be developed that actively encourage interdisciplinary
research, and provide frameworks where ill-conceived studies resulting
from inadequate interdisciplinary collaboration are the exception,
rather than the norm.
Where research needs fall between the gap of government and
industry (because of their different goals), public-private research
partnerships provide an important mechanism for bridging the gaps.
Industries investing in nanotechnology have a financial stake in
preventing harm, manufacturing safe products and avoiding long-term
liabilities. Yet many 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. For many nanomaterials and
nanotechnologies, the current state of knowledge is sufficient to cast
doubt on their safety but lacks the certainty and 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 that is tasked with generating independent, credible data
that will support nanotechnology oversight and product stewardship.
Such an organization would leverage federal and industry funding to
support targeted research into assessing and managing potential
nanotechnology risks. Its success would depend on five key attributes:
Independence. The selection, direction and evaluation
of funded research would have to be science-based and fully
independent of the business and views of partners in the
organization.
Transparency. The research, reviews and the
operations of the organization should be fully open to public
scrutiny.
Review. Research supported by the organization should
be independently and transparently reviewed.
Communication. Research results should be made
publicly accessible and fully and effectively communicated to
all relevant parties.
Relevance. Funded research should have broad
relevance to managing the potential risks of nanotechnologies
through regulation, product stewardship and other mechanisms.
As I discussed in my comments to this committee last September,\16\
a number of research organizations have been established over the years
that comply with some of these criteria. One of these is the Health
Effects Institute (HEI),\17\ which has been highly successful in
providing high-quality, impartial, and relevant science around the
issue of air pollution and its health impacts. The Foundation for the
National Institutes of Health\18\ also has been successful in
developing effective public-private partnerships, and the International
Council on Nanotechnology (ICON)\19\ is a third model for bringing
government, industry and other stakeholders to the table to address
common goals. The Wilson Center Project on Emerging Nanotechnologies is
currently exploring these and other models as possible templates for
public-private partnerships addressing nanotechnology risks.
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\16\ United States House of Representatives Committee on Science
and Technology. Hearing on Research on Environmental and Safety Impacts
of Nanotechnology: What are Federal Agencies Doing? Testimony of Andrew
D. Maynard. September 21, 2006.
\17\ For further information, see The Health Effects Institute,
http://www.healtheffects.org. Accessed October 13, 2007.
\18\ For further information, see The Foundation for the National
Institutes of Health, http://www.fnih.org. Accessed October 13, 2007.
\19\ For further information, see the International Council On
Nanotechnology, http://icon.rice.edu/. Accessed October 13, 2007.
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Irrespective of which model is the best suited for nanotechnology,
the need is urgent to develop such partnerships as part of the
government's strategy to address nanotechnology risks. Nanotechnologies
are being commercialized rapidly--going from $50 billion in
manufactured goods in 2006\20\ to a projected $2.6 trillion in
nanotechnology-enabled manufactured goods by 2014--or 15 percent of
total manufactured goods globally.\21\ And knowledge about possible
risks is simply not keeping pace with consumer and industrial
applications.
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\20\ Lux Research (2007). Profiting from International
Nanotechnology, Report Press Release: Top nations see their lead erode.
Lux Research Inc., New York, NY.
\21\ Lux Research (2006). The Nanotech ReportTM: Investment
Overview and Market Research for Nanotechnology. 4th edition, volume 1.
Lux Research Inc., New York, NY.
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5. Sufficient resources to address critical challenges
To be effective, a nanotechnology risk-research strategic framework
needs adequate funding to support proposed research, as well as
sufficient expert personnel to oversee its development and
implementation.
In my testimony to this committee on September 21, 2006,\22\ I made
the case for a minimum of $50 million per year to be spent on relevant
nanotechnology risk research. This was based on an assessment of
critical short-term research needs, and only covered targeted research
to address these needs.\23\ This estimate still stands. However, I must
be clear that such an investment would need to be directed towards
addressing a very specific suite of problems that regulators and
industry need answers to as soon as possible. This is not envisaged as
a general pot of money to be assigned to research that does not address
specific and urgent nanotechnology risk goals. In other words, this is
an investment that needs to be directed towards the right research.
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\22\ See supra note 16.
\23\ See also: supra note 13.
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But beyond the $50 million figure, further investment in
exploratory research is needed to identify the questions we haven't
thought of yet. It isn't possible to place a firm figure on how much
should be spent here, but a useful rule of thumb--and one that others
have advocated--is to ensure that at least 10 percent of the Federal
Government's nanotechnology research and development budget is
dedicated to strategic risk-related research. This would place the
overall estimated EHS research budget for 2008 at $145 million--
allowing for $50 million in targeted research and $95 million dedicated
to exploratory research. Given the nature of exploratory research,
which requires substantial investment to make significant progress,
this does not seem unreasonable.
Targeted research primarily would address specific questions where
answers are urgently needed to make, use and dispose of nanotechnology
products as safely as possible. I would envisage that much of the
necessary research would be funded by or conducted within mission-
driven agencies, such as NIOSH and the Environmental Protection Agency
(EPA). In addition, we must ensure that regulatory agencies, including
the Food and Drug Administration (FDA) and the Consumer Product Safety
Commission (CPSC), either have access to resources to fund regulation-
relevant research or input to research that will inform their decision-
making.
There will also be a role for science-oriented agencies such as the
National Institutes of Health (NIH) and the National Science Foundation
(NSF) in funding targeted research, where the missions of these
agencies coincide with research that informs specific oversight
questions. For example, these two agencies are ideally positioned to
investigate the science behind nanomaterial properties, behavior and
biological interactions in a targeted way, with the aim of predicting
health and environmental impact. But ensuring that targeted research
conducted within these agencies is relevant to addressing risk
identification, assessment and reduction goals will be critical, and
underscores the need for a robust cross-agency risk research strategy
and pool of designated funds.
Exploratory research, on the other hand, primarily would be
investigator-driven (within determined bounds), and so would
preferentially lie within the remit of NSF and NIH. However, in
ensuring effective use of funds, it will be necessary to develop ways
of supporting interdisciplinary research that crosses the boundary
separating these agencies, and combines investigations of basic science
with research into disease endpoints, with the goal of informing
oversight decisions.
Exploratory research should not be confined to these two agencies,
however, as there will be instances where goal-oriented but exploratory
research will fit best within the scope of mission-driven agencies, and
will benefit from research expertise within these agencies. For
example, researchers in NIOSH are currently engaged in exploratory
research that is directly relevant to identifying and reducing
potential nanotechnology risks in the workplace.\24\
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\24\ NIOSH (2007). Progress towards safe nanotechnology in the
workplace, National Institute for Occupational Safety and Health,
Washington, DC.
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At present, there is no pot of ``nanotechnology'' money within the
Federal Government that can be directed to areas of need. Rather, the
NNI simply reports what individual agencies are spending. Yet if
strategic nanotechnology risk research is to be funded appropriately,
mechanisms are required that enable dollars to flow from where they are
plentiful to where they are needed. Extremely overstretched agencies
like NIOSH and EPA cannot be expected to shoulder their burden of
nanotechnology risk research unaided, and regulatory agencies like FDA
and CPSC currently have no listed budget whatsoever for nanotechnology
EHS research. If the Federal Government is to fully utilize expertise
across agencies and enable effective nanotechnology oversight,
resource-sharing across the NNI will be necessary.
In addition to adequate funding, development and implementation of
an effective strategic framework will only be as good as the people who
develop and implement it. And this means ensuring experts within the
Federal Government have the time to commit to getting such a strategy
right. Such a framework is too important to be developed and
implemented at the margins of peoples' responsibilities. My own
experiences in co-chairing the NEHI group would suggest that, even with
some of the best minds in government around the table, little progress
can be made when those involved do not have the time to dedicate to the
issues at hand. And nowhere is this need for time more critical than
with the person charged with leading activities.
How do the Federal Government's actions match up to what is needed?
While I argue later that the Federal Government's actions on
nanotechnology have so far been too little too late, it is important to
recognize that the government has not been deaf to the need to address
nanotechnology EHS issues. Preliminary discussions on the importance of
EHS in the development of nanotechnology are evident in some of the
earliest publications coming out of the NNI. For instance, quoting from
an early NSET subcommittee of the NSTC document published in 2001:
``Although proponents of nanotechnology view it as benign,
there are likely to be some unforeseen, undesirable effects.
Even at the basic research stage, nanotechnology advocates
need to inform the public about the prospects and risks. They
need to engage and involve the public and the groups that
represent them. While this will delay the introduction of new
technologies, in the end it is likely to save time.''\25\
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\25\ NSET (2001). Societal Implications of Nanoscience and
Nanotechnology. NSET Workshop Report, M.C. Roco and W.S. Bainbridge,
eds., National Science and Technology Council Committee on Technology,
Subcommittee on Nanoscale Science, Engineering and Technology,
Washington, DC.
The NEHI working group was established in 2003 as a direct result
of concerns over possible adverse impacts of technologies under
development. This early awareness of the need to understand and manage
risks is reflected in the 21st Century Nanotechnology Research and
Development act published in 2003,\26\ the NNI strategic plan,\27\
annual NNI budget requests and the current efforts within the Federal
Government to develop a strategic research agenda.
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\26\ U.S. Congress (2003). 21st Century Nanotechnology Research and
Development Act (Public Law 108-153), 108th Congress, 1st session,
Washington, DC.
\27\ NSET (2004). The National Nanotechnology Initiative Strategic
Plan, Nanoscale Science Engineering and Technology Subcommittee
Committee on Technology National Science and Technology Council, ed.,
National Science and Technology Council, Washington, DC.
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Yet talking about the issues is no substitute for progress, and in
addressing possible harm to people and the environment, good intentions
are not enough. The Federal Government may have been diligent in
identifying and discussing issues, but is real progress being made
towards addressing the challenges, and ensuring businesses, regulators
and the public have the tools they need to make informed decisions over
nanotechnology applications?
Some of the first indications that nanomaterials may present an
unusual and previously unrecognized health risk came out as far back as
1990.\28\ Fifteen years ago, the first concerns were raised about the
potential health impacts of using carbon nanotubes in commercial
products.\29\ I first wrote about the health and safety challenges
presented by nanotechnology in 1999, in a report for the UK Health and
Safety Executive.\30\ In 2004, the UK Royal Society and Royal Academy
of Engineering stressed the urgency with which action was needed to
identify and assess the risks presented by nanoparticles,\31\ and the
past few years have seen an increasing number of research papers
questioning conventional approaches to understanding health and
environmental risks. At the same time, uncertainty over potential
risks, and what is being done to minimize them, has raised barriers to
businesses hoping to invest in nanotechnology,\32\ and caused consumer
groups to question whether people should be using nano-products.\33\
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\28\ Ferin, J., Oberdorster, G., Penney, D.P., Soderholm, S.C.,
Gelein, R. and Piper, H.C. (1990). Increased Pulmonary Toxicity of
Ultrafine Particles. 1. Particle Clearance, Translocation, Morphology.
J. Aerosol. Sci. 21:381-384.
\29\ Coles, G.V. (1992). Occupational risks. Nature 359:99.
\30\ Maynard, A.D., Brown, R.C., Crook, B., Curran, A. and Swan,
D.J. (1999). A scoping study into ultrafine aerosol research and HSL's
ability to respond to current and future research needs, health and
Safety Laboratory, UK.
\31\ RS/RAE (2004). Nanoscience and nanotechnologies: Opportunities
and uncertainties, The Royal Society and The Royal Academy of
Engineering, London, UK, 113 pp.
\32\ Lux Research (2006). Taking action on nanotech environmental,
health and safety risks, Lux Research Inc., New York, NY.
\33\ Rock, A. (2007). Nanotechnology. Untold promise, unknown risk,
Consumer Reports. July.
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So how does the Federal Government measure up in terms of
understanding what is needed to reduce uncertainty and maximize the
success of nanotechnology?
1. Acknowledging the possibility of unconventional behavior
In general, agencies within the Federal Government have made good
progress in acknowledging the possibility of unconventional behavior in
nanomaterials. The Office for Research and Development in EPA
recognized the potential to use unconventional characteristics of
nanomaterials in remediating environmental pollution some years ago.
More recently, the agency has been supporting research into addressing
unconventional behavior in nanomaterials that might lead to adverse
environment and human health impacts.\34\ NIOSH established a
nanotechnology research program aimed at workplace exposures in 2004 in
recognition of nano-specific challenges, and now has a successful--if
sparsely funded--research portfolio spanning exploratory to applied
studies.\35\ The NSF recognized the need to develop a science-based
understanding of nanomaterial-biological interactions early on, which
led to the establishment of the Center for Biological and Environmental
Nanotechnology at Rice University, and a number of other risk-relevant
research initiatives.\36\ NIH has encouraged an integrated approach to
understanding nano-bio interactions in the development of health-
related applications, and has led in exploring the detailed toxicology
of select nanomaterials through the National Toxicology Program--a
collaboration between the National Institute of Environmental Health
Sciences, NIOSH and FDA.\37\ NIH also is developing an internal
strategy for developing new knowledge on how nanomaterials interact
with humans. FDA has recently published a paper clarifying the agency's
understanding that engineered nanomaterials may take on risk-relevant
properties due to their nanoscale,\38\ and the CPSC and the
Occupational Safety and Health Administration have both stated that
nanotechnology has the potential to present new regulatory challenges.
In addition, the Department of Energy, the Department of Defense and
the National Institute of Standards and Technology all have research
programs related to how engineered nanomaterials represent
unconventional risks--and how to tackle the resulting challenges.
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\34\ EPA (2007). U.S. Environmental Protection Agency
Nanotechnology White Paper, Environmental Protection Agency,
Washington, DC. EPA 100/B-07/001. February.
\35\ See supra note 24.
\36\ For example, see http://www.nsf.gov/crssprgm/nano/. Accessed
October 13, 2007.
\37\ NTP Nanotechnology Safety Initiative. http://
ntp.niehs.nih.gov/files/NanoColor06SRCH.pdf. Accessed October 13, 2007.
\38\ FDA (2007). Nanotechnology. A report of the U.S. Food and Drug
Administration Nanotechnology Task Force, Food and Drug Administration,
Washington, DC.
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The reason for this long (and probably incomplete) litany is to
demonstrate that the relevant agencies within the Federal Government
are clear that engineered nanomaterials have the potential to behave in
unconventional ways. This understanding is reflected in the laundry
list of research needs to address such unconventional behavior
published by the NNI in September 2006, and the rather shorter list
published in 2007.
However, there is not complete accord here. A recent consultation
paper from EPA on how the Toxic Substances Control Act applies to
nanoscale substances did not provide a mechanism for addressing
unconventional behavior in nanoscale materials, but stated that:
``a nanoscale substance that has the same molecular identity
as a substance listed on the Inventory (whether or not reported
to the Agency as being manufactured or processed in nanoscale
form) is considered an existing chemical, i.e., the nanoscale
and non-nanoscale forms are considered the same chemical
substance because they have the same molecular identity
[emphasis added]''\39\
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\39\ EPA (2007). TSCA Inventory Status of Nanoscale Substances--
General Approach, Environmental Protection Agency, Washington DC.
EPA's paper led Barnaby Feder--a leading journalist with the New
York Times--to write an article with the headline ``EPA to Nanotech:
Size Doesn't Matter.'' \40\ Of course, as I have just laid out, size
and novel properties at the nanoscale assuredly do matter when it comes
to potential adverse impacts.
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\40\ Feder, B. (2007). EPA to Nanotech: Size Doesn't Matter. Bits,
New York Times. http://bits.blogs.nytimes.com/2007/07/12/epa-to-
nanotech-size-doesnt-matter/. July 12. Accessed October 13, 2007.
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Overall, the Federal Government has made important strides in
acknowledging the possibility that unconventional behavior in
engineered nanomaterials could lead to EHS risks. However, as the
recent EPA paper demonstrates, there is considerable room for
improvement in linking unconventional behavior to regulatory
approaches.
2. Leadership in nanotechnology EHS research
While it is generally acknowledged that engineered nanomaterials
potentially present new EHS challenges, the Federal Government has not
provided strong leadership in addressing these challenges. Despite a
good start with the formation of NEHI, the overall Federal Government
response to identifying and managing nanotechnology risks can only be
described as slow, badly conceptualized, poorly directed, uncoordinated
and underfunded.
In a world where unregulated and uncontrolled nanotechnology
applications are appearing almost daily; where we know that there are
possibilities in some cases of harm occurring to humans and the
environment; where industry is calling out for greater certainty in
managing the potential risks of nanomaterials; and where there are
concerns that a lack of progress and transparency will undermine public
confidence in emerging nanotechnologies, the Federal Government took
eleven months to reduce a laundry list of seventy five research needs
down to twenty five. To quote Barnaby Feder of the New York Times
again, ``No one can accuse them [the Federal Government] of acting
rashly.'' \41\
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\41\ Feder, B. (2007). No One Can Accuse Them of Acting Rashly.
Bits, New York Times. August 17. http://bits.blogs.nytimes.com/2007/08/
17/no-one-can-accuse-them-of-acting-rashly/. Accessed October 13, 2007.
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And this latest Federal Government report was not even done as part
of an overarching strategy, but as a precursor to developing a research
strategy. By the government's own admission, it does not yet know where
it is when it comes to addressing risk, and has yet to decide where it
is going.\42\ Yet for some time now, other countries and organizations
outside the government have been mapping out what needs to be done and
how.
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\42\ See supra note 12.
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Just as striking is the proliferation of agency-based initiatives
that do not seem to form part of a coordinated interagency strategy.
With one or two exceptions, there are indications that individual
agencies are going their own way because of a lack of direction from
the top. For instance, NIOSH has established an internal nanotechnology
research program to address the needs of workers and industry
independent of a coordinated interagency strategy, relying solely on
internal resources that are not guaranteed to last. The disconnect
between NIOSH's activities and other agencies' was underlined by the
agency commenting publicly on EPA plans to regulate engineered
nanomaterials--rather than rely on internal channels.\43\ A similar
indication of poor or absent leadership across federal agencies was a
public submission from NIH on the recently published NEHI research
priorities document--a document that NIH representatives had
contributed to!\44\ And the recently announced Center for Environmental
Implications of Nanotechnology--a joint venture between EPA and NSF--
does not seem to be part of any coordinated cross-agency plan.\45\
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\43\ NIOSH (2007). Comments of the National Institute for
Occupational Safety and Health on the Environmental Protection Agency
Federal Register Notice Nanoscale Materials Stewardship Program and
Inventory Status of Nanoscale Substances under the Toxic Substances
Control Act; Notice of Availability, EPA-HQ-OPPT-2004-0122. September
7.
\44\ NIH (2007). National Institutes of Health Comments on
Prioritization of Environmental, Health, and Safety Research Needs for
Engineered Nanoscale Materials to the NSET Subcommittee. September 17.
http://nano.gov/html/society/ehs-priorities/comments/.
Accessed October 25, 2007.
\45\ See http://www.nsf.gov/funding/
pgm-summ.jsp?pims-id=503124. Accessed October 25,
2007.
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Current agency-specific initiatives do address key issues and are
making an important contribution to evaluating and addressing potential
nanotechnology risks. I do not want to detract in any way from their
importance, or the leadership being shown by individuals within
agencies to address specific challenges. But the fractured and
uncoordinated approach to addressing nanotechnology risks that is
emerging demonstrates a lack of overall leadership across the Federal
Government, and challenges the notion that critical issues will be
addressed in a strategic and timely manner, while using resources most
effectively.
Such leadership across many agencies is extremely difficult, which
perhaps explains NEHI's tardy response to repeated calls for action
from Congress over the past two years. Yet when economic interests,
people's health and the environment are on the line, to claim ``it's
difficult'' is a poor excuse for inaction. If those responsible for the
NNI have limited ability to lead effectively in ensuring the emergence
of safe nanotechnologies, then this problem must be fixed if we are to
find effective approaches to addressing the challenges of
nanotechnology.
3. An effective strategic framework
By its own admission, the Federal Government is working towards
developing a strategic research framework--and has been doing so since
the House Science Committee hearing on November 17, 2005. The NEHI
working group plans to follow a series of steps toward develop such a
framework, although whether we will have to wait another two years for
the results is unclear.
Since publication of its document EHS Research Needs for Engineered
Nanoscale Materials in September 2006,\46\ the NEHI working group has
been busy countering criticisms aimed at that report and responding to
invited comments. NEHI's subsequent document, Prioritization of
Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials: An Interim Document for Public Comment,\47\
further refines the prioritization principles established in the 2006
report and uses them to identify five research priority areas in each
of the five categories listed in the initial report, for a total of
twenty five research priority areas. Yet it remains unclear how this
report or subsequent planned activities will help to provide the
scientific information that industry, regulators and the public need to
ensure the safe development and use of nanotechnology.
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\46\ See supra note 11.
\47\ See supra note 12.
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With this report, NEHI has begun to set out a systematic process
for guiding agency research efforts. But we must not mistake
methodology for strategy. While the current document focuses on
prioritization, it does so without a clear understanding of context:
what the overarching issues are, what is needed to address them, when
results are needed and how the work will get done. Without this degree
of vision, the document is in danger of being a bureaucratic reaction
to criticism, rather than a proactive statement of purpose.
The stated principles for prioritizing EHS research do provide a
means for sifting the many research ``wants'' into research ``needs.''
But in the absence of a strategic overview, it is hard to see how
application of these principles will result in an effective research
plan. And while the principles appear sound individually, it is hard to
see how as a group they can be used to identify a set of coherent
research priorities.
The twenty-five identified research priorities provide little new
information, but rather reflect many of the recommendations made by
other organizations over the past few years. Comparing them with the
strategic research priorities published by the Project on Emerging
Nanotechnologies in July 2006,\48\ there appears to be substantial
agreement. But the NEHI priorities are open to broad interpretation in
many cases. And so, while they reflect repeatedly articulated concerns,
they present a poor basis for a strategic framework. In contrast, the
Project on Emerging Nanotechnologies' research priorities are more
specific and reflect the need to address clear goals.
---------------------------------------------------------------------------
\48\ See supra note 13.
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In short, it is hard to see how following the NEHI priorities will
provide the information decision-makers need to ensure the safety and
sustainability of emerging nanotechnologies. Indeed, many of the
priorities are so broad that they could be adequately addressed without
any progress being made towards ensuring the safety of
nanotechnologies!
On the basis of current evidence, the Federal Government is out of
touch with reality and seems to be caught in a bureaucratic process
that lacks the responsiveness and vision to address the questions to
which nanotechnology stakeholders need answers. There is no sense of
urgency to address which new research is needed, how it will be funded
or the extent to which the economic success of emerging
nanotechnologies will depend on this research.
4. Mechanisms to get the job done
Three mechanisms currently exist within the Federal Government to
enable EHS research on nanotechnology. Firstly, individual agencies are
able (within their budgetary constraints) to address specific
challenges that are aligned with their own agendas and missions.
Secondly, agencies are encouraged to consider priority research areas
suggested by the Office of Science and Technology Policy (OSTP) and the
NNI. Thirdly, information is shared between agencies within the NEHI
working group. But these are weak mechanisms compared to the tasks at
hand.
Certainly, these mechanisms have led to some progress--agencies are
developing their own research agendas (independently of an overarching
research strategy it would seem), and discussions within NEHI have
undoubtedly led to a useful exchange of information. Yet taken
together, they have thus far been ineffective in ensuring that relevant
and coordinated research is carried out, sufficient resources are
available to support this research, or that research is translated
effectively into practical use by regulators, industry and others.
Clearly, the Federal Government needs a new toolkit if it is to
provide answers to questions surrounding the safety of
nanotechnologies. Comparing current Federal Government activities to
the previously outlined actions needed to support safe and successful
nanotechnologies, the Federal Government is struggling to develop and
use:
Administrative mechanisms that enable federal
agencies to participate in an overarching strategic risk
research framework, break down institutional barriers
preventing collaboration and cooperation and provide leadership
within the government and to stakeholders in the U.S. and the
rest of the world.
Mechanisms that ensure the right research funding
approaches are used for the job, appropriate agencies take the
lead in addressing specific questions and enable effective
interdisciplinary and international research collaborations.
Public-private partnerships that leverage government
and industry funding to provide timely and independent answers
to critical questions.
Funding mechanisms that ensure agencies (and, in
particular, agencies with regulatory missions) have sufficient
funds to participate fully and effectively within an
overarching strategic nanotechnology EHS research framework.
As a result, important research is not being funded because it
falls between the cracks, because it doesn't fit within a particular
agency's mandate, or because adequate funding mechanisms do not exist.
To give one example, research is needed on how atomic-level
variations in structure at the surface of engineered nanomaterials
influences biological interactions and potentially causes or
exacerbates certain diseases. But the necessary interdisciplinary
research that combines an understanding of materials properties,
fundamental biological processes and disease is extremely difficult to
support within the current federal research and development funding
structure. And where cross-disciplinary proposals are considered (or
where agencies attempt to fund research in unfamiliar areas), there is
a danger of applying inappropriate selection criteria.
This may lead to the perception that there is a lack of competent
researchers or good research proposals to address a specific challenge,
whereas the reality is that those judging the proposals do not
understand them, or their relevance.
Some progress has been made to correct these failings. The NSF has
successfully funded a number of interdisciplinary research centers that
are providing extremely valuable information on the potential risks of
nanotechnologies--and how to address them. Yet these centers exist
outside of an overall strategic risk framework, and remain constrained
in their ability to directly relate engineered nanomaterials to
potential diseases, or to inform regulation. Another partial success
story is the EPA Science To Achieve Results (STAR) nanotechnology
research program that has supported many projects addressing the
potential health and environmental impacts of engineered nanomaterials.
Yet funding for individual projects is capped at a level too low for
many researchers evaluating human and ecological toxicology to consider
applying. As a result, while the research portfolio looks good on
paper, in reality it is merely nibbling around the edges of the
questions that need answering.
While I do not want to detract from the efforts of individuals
within agencies to make a difference and develop relevant research
programs, their research programs could be substantially more effective
if they were given the support they need to do the job.
5. Sufficient resources to address critical challenges
The FY 2008 NNI request for nanotechnology health and safety
research funding is $58.6 million\49\--less than the estimated $144
million needed for targeted and exploratory EHS research, but more than
the estimated $50 million for targeted research alone. However, this
figure comes with marginal information on how the money will be spent
and whether it will, in fact, address strategically relevant questions,
or be squandered on marginally relevant research.
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\49\ NSET (2007). The National Nanotechnology Initiative. Research
and Development Leading to a Revolution in Technology and Industry.
Supplement to the President's FY 2008 Budget, Subcommittee on Nanoscale
Science, Engineering and Technology, Committee on Technology, National
Science and Technology Council, Washington, DC.
---------------------------------------------------------------------------
Out of this request, 49 percent is to go to NSF, 20 percent to NIH
and the National Institute of Standards and Technology, 16 percent to
EPA and eight percent to NIOSH. In other words, despite the need for
nanotechnology risk research to inform oversight and regulation, the
vast bulk of the requested funding is associated with agencies that
have no regulatory mission. Is this an appropriate use of funds, or
does it merely reflect the spending power of the respective agencies?
The only way this question can be answered is by understanding how
each agency's research will feed into an overarching strategic
framework that is designed to provide answers that decision-makers need
to oversee the development of safe nanotechnologies.
Unless the Federal Government is able to give a clear account of
what is being invested in nanotechnology risk research, and how that
investment will reduce uncertainty and enable effective risk
management, there is a danger that current funding will be
ineffective--no matter how impressive on paper.
In addition to questions over adequate funding, there is scant
evidence that the Federal Government is investing in people to develop
and implement an effective research strategy. Agency personnel
addressing nanotechnology are frequently doing so at the margins of
their responsibilities. Despite the acknowledged importance of EHS
research, there is no single person dedicated to leading and
coordinating activities across the government.
Conclusions
We cannot afford to drive blindly into the nanotechnology future.
Not only will this prevent us from seeing and navigating around the
inevitable bends associated with possible risks, but it will also give
those economies with the foresight to identify and negotiate the bends
a very real competitive edge. Despite a good start, the U.S. is still
caught up in developing new technologies within an old mindset. If
emerging nanotechnologies are to be built on a sound understanding of
the potential risks--and how to avoid them--new research strategies,
new mechanisms of execution and new funding all are needed. These
should be overseen by clear, strong leadership and an interagency group
with the authority to develop a strategic research framework and ensure
its execution--a NEHI group with teeth.
At the beginning of this testimony, I recommended six areas where
action is needed to get nanotechnology EHS research back on track,
drawing from the assessment above. But the window of opportunity is
fast closing. In the words of Chairman Boehlert at the September 2006
House Science Committee hearing addressing nanotechnology EHS research,
which I believe expressed the sentiment of the entire Committee,
``time's a wasting.'' \50\ The stakes are too high for the Federal
Government not to take appropriate action now.
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\50\ Congressman Sherwood Boehlert (R-NY) opening statement for
nanotechnology hearing. September 21, 2006. http://
gop.science.house.gov/hearings/full06/Sept%2021/sbopening.pdf. Accessed
October 14, 2007.
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Responses to specific questions
What is your reaction to the recent report of the Nanotechnology
Environmental and Health Implications Working Group, ``Prioritization
of Environmental, Health and Safety Research Needs for Engineered
Nanoscale Materials? Do outside groups have a way to influence this
planning process? Are the priorities listed in the report the right
ones, and do you believe that carrying out the ``next steps'' described
in the report will achieve the detailed implementation plan for EHS
research that is needed?
Reaction to the recent NEHI report
With this report, the NEHI working group has begun to set out a
systematic process for guiding agency research efforts. But the working
group is in danger of mistaking methodology for strategy. While the
current document focuses on prioritization, it appears to do so without
a clear understanding of context: what the overarching issues are, what
is needed to address them, when results are needed and how the work
will get done. Without this degree of vision, the resulting document is
a bureaucratic reaction to criticism, rather than a proactive statement
of purpose.
The stated principles for prioritizing EHS research do provide a
means for sifting the many research ``wants'' into research ``needs.''
But in the absence of a strategic overview, it is unclear how
application of these principles will result in an effective research
plan. And while the principles appear sound individually, it is
difficult to understand how they can be applied as a group to identify
a set of coherent research priorities. In particular, the second and
third principles (leveraging research funded by other organizations,
and adaptive management) are critical components of a research
strategy, but do not help to prioritize research in the absence of such
a strategy.
Potential for outside groups to influence the planning process
Public input has been sought on this and the previous NEHI research
needs document. Responses to the most recent public consultation have
yet to be published. However, it appears that the public comments on
the document released in September 2006\51\ led to marginal input to
the following report. In order to develop a robust research strategy
that addresses the needs of multiple stakeholders, more effective
mechanisms are needed for soliciting expert input. Specifically, a
federal advisory committee should be established to allow transparent
input and review to an evolving research strategy from industry,
academia, non-government organizations and other stakeholders.
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\51\ See supra note 11.
Are these the right research priorities?
The research needs listed in the current and previous NEHI
documents closely match those identified by other groups. Comparing the
latest set of twenty-five research priorities with the strategic
research priorities published by the Project on Emerging
Nanotechnologies in July 2006,\52\ (which draw on recommendations from
a number of other groups, including the UK Royal Society and Royal
Academy of Engineering, the American Chemistry Council, and the
Environmental Protection Agency, EPA) there appears to be substantial
overlap. But this is because the NEHI priorities are open to broad
interpretation. While they reflect repeatedly articulated concerns,
they present a poor basis for a strategic framework. Indeed, many of
the priorities are so broad that they could be adequately addressed
without any progress being made towards ensuring the safety of
nanotechnologies!
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\52\ See supra note 13.
Will the ``next steps'' achieve the desired goal
While the process initiated by NEHI looks logical on paper, it is
hard to see how following it will provide the information decision-
makers need to ensure the safety and sustainability of emerging
nanotechnologies. This is a bureaucratic process that is picking at the
edge of a problem from within the system, rather than starting with a
clean slate and asking what needs to be done to achieve a well-defined
end. The current process lacks a clear vision of what is needed to
prevent people being harmed, the environment being damaged and industry
being impacted by real and perceived nanotechnology risks. It lacks a
sense of how research will serve effective science-based decision-
making, and an appreciation for how urgently action is needed.
As an example, anyone with a credit card can purchase carbon
nanotubes in powder form from a company called Cheap Tubes Inc. The
nanotubes come in a sealed bag, and the accompanying safety data
describes them as graphite--the same substance used to form pencil
leads. Yet research has shown carbon nanotubes to be potentially
hazardous in ways we don't fully understand yet if inhaled.\53\ If I
purchased some of these carbon nanotubes today, how long will it take
before someone is able to tell me how to open the package, extract the
material, and use it--safely? Would it be days, months, years or even a
decade? Researchers, businesses and consumers are facing similar
questions every day. Yet the currently outlined ``next steps'' hold no
hope for early answers.
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\53\ Cheap Tubes, Inc. http://www.cheaptubesinc.com/. Accessed
October 19, 2007. Purchased materials are accompanied by detailed--if
currently out-dated--information on published hazard studies. Yet the
supplied manufacturer's safety data sheet continues to list the
material as graphite, in the absence of clear guidance from regulatory
authorities.
Has the NNI assigned a sufficiently high priority to EHS research and
are there gaps in the portfolio of NNI research now underway? What
level of funding over what time period is needed to make acceptable
progress in understanding the potential environmental and health risks
---------------------------------------------------------------------------
associated with the development of nanotechnology?
EHS research priority
A continued lack of an overarching research strategy, ineffective
research mechanisms and inadequate resources suggest that the NNI has
not assigned a sufficiently high priority to EHS research. The NNI is
unable to give a clear picture of the current research portfolio
addressing nanotechnology risk, making it hard to gauge where the
research gaps might be. An independent inventory of publicly available
information on current research indicates that personal research
interests, rather than overarching needs, are driving the
portfolio.\54\ As a result, current research is predominantly focused
on novel materials like carbon nanotubes and existing areas of
expertise such as inhalation toxicology, while exposure routes that
include ingestion and environmental release, and materials like
nanoscale silver, dendrimers and smart nanoparticles are receiving less
attention.
---------------------------------------------------------------------------
\54\ Nanotechnology health and environmental implications. An
inventory of current research. http://www.nanotechproject.org/18
Accessed October 14, 2007.
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Overall, it is possible to find research being carried out within
each of the twenty-five priority areas identified by NEHI. But there
are no indications that this research is sufficiently focused, or
extensive enough, to come close to answering critical questions.
Funding levels
In my testimony to this committee on September 21, 2006,\55\ I made
the case for a minimum of $50 million per year to be spent on relevant
nanotechnology risk research. This was based on an assessment of
critical short-term research needs, and only covered targeted research
to address these needs.\56\ This estimate still stands. However, I must
be clear that such an investment would need to be directed towards
addressing a very specific suite of problems that regulators and
industry need answers to as soon as possible--this is not envisaged as
a general pot of money to be assigned to research that does not address
specific and urgent nanotechnology risk goals. In other words, this is
an investment that needs to be directed towards the right research.
---------------------------------------------------------------------------
\55\ See supra note 16.
\56\ See also: supra note 13.
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But beyond this figure, there is a need for further investment in
exploratory research that will identify the questions we haven't
thought of yet. It isn't possible to place a firm figure on how much
should be spent here, but a useful rule of thumb--and one that others
have advocated--is to ensure that at least 10 percent of the Federal
Government's nanotechnology research and development budget is
dedicated to strategic risk-related research. This would place the
overall estimated EHS research budget for 2008 at $145 million--
allowing for $50 million in targeted research and $95 million dedicated
to exploratory research. Given the nature of exploratory research,
which requires substantial investment to make significant progress,
this does not seem unreasonable.
What are the optimum roles for the agencies in sponsoring or conducting
EHS research? Are responsibilities and available resources currently in
balance?
Agency roles
An effective nanotechnology EHS strategic research framework will
enable and empower agencies to take a lead in addressing issues that
fall within their competences and missions. While top-level direction
will be essential to ensuring success, the most effective model will
not be one of command and control, but of leadership, coordination and
facilitation.
An effective research framework would enable an appropriate balance
between targeted research aimed at addressing specific questions, and
exploratory research that helps to inform relevant questions. Targeted
research would primarily address specific questions where answers are
urgently needed in order to make, use and dispose of nanotechnology
products as safely as possible. Much of this research would be funded
by or conducted within mission-driven agencies such as the National
Institute for Occupational Safety and Health (NIOSH) and EPA. An
effective framework would also ensure that regulatory agencies have the
resources to fund regulation-relevant research, or direct research that
will inform their decision-making--including the Food and Drug
Administration, the Consumer Product Safety Commission and the
Occupational Safety and Health Administration.
Research agencies such as the National Institutes of Health (NIH)
and the National Science Foundation (NSF) would also have a critical
role in funding targeted research, where the missions of these agencies
coincide with research that informs specific oversight questions. For
example, these two agencies are ideally positioned to investigate the
underlying science of nanomaterial properties, behavior and biological
interactions, with the aim of predicting health and environmental
impact.
Exploratory research within an effective strategic research
framework would primarily be investigator-driven (within strategically
determined bounds), and would preferentially lie within the remit of
science-oriented agencies such as NSF and NIH. But if research funds
are to be used effectively, it will be necessary to develop ways of
supporting interdisciplinary research that crosses the boundary
separating these agencies, and combines investigations of basic science
with research into disease endpoints, with the goal of informing
oversight decisions.
Exploratory research should not be confined to these two agencies;
however, there will be instances where goal-oriented but exploratory
research will fit best within the scope of mission-driven agencies and
will benefit from the considerable research expertise within these
agencies. As an example, researchers in NIOSH are currently engaged in
exploratory research that is directly relevant to identifying and
reducing potential nanotechnology risks in the workplace.\57\
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\57\ See supra note 24.
Balancing responsibilities and resources
Responsibilities and available resources are not currently in
balance across federal agencies. Examining the $58.6 million FY 2008
NNI budget request for nanotechnology EHS research, 49 percent is
associated with NSF, 20 percent with NIH and the National Institute of
Standards and Technology, 16 percent with EPA and just eight percent
with NIOSH.\58\ These figures are not supported by clear research
objectives, goals and plans, so it is hard to say whether the funding
will all go to nanotechnology risk-relevant research. An assessment of
the 2005 Federal Government's risk research portfolio could only
identify $11 million associated with highly relevant research into the
potential risks of engineered nanomaterials, compared to a NNI-reported
estimate of $38.5 million--a shortfall of $27.5 million!\59\
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\58\ NSET (2007). The National Nanotechnology Initiative. Research
and Development Leading to a Revolution in Technology and Industry.
Supplement to the President's FY 2008 Budget, Subcommittee on Nanoscale
Science, Engineering and Technology, Committee on Technology, National
Science and Technology Council, Washington, DC.
\59\ See supra note 13.
---------------------------------------------------------------------------
Without clear information from the NNI on how requested funds will
be used, it looks like that the research portfolio will be biased
towards exploratory research, and away from targeted and oversight-
relevant research (as reflected in NSF and NIH requesting twice as much
funding for EHS research as EPA and NIOSH combined). This imbalance
reflects the NNI role of simply reporting individual agency funding
plans, rather than coordinating a strategic response to research needs.
The resulting budget figures reflect strategic thinking only
incidentally, rather than by design--wealthy agencies invest more in a
``hot topic'' area, while poorer agencies struggle to scrape together
precious resources to carry out their mandated duties. The irony in
this situation, of course, is that it is the agencies without the
resources to do the right research that have the clearest perspective
on what needs to be done. In the FY 2008 budget request, the NSF budget
for nanotechnology EHS research increased by $7.8 million from FY 2006
to $34.2 million--an increase of over one and a half times NIOSH's
entire request for FY 2008 ($4.6 million). And this is in spite of most
stakeholders acknowledging that addressing occupational exposure to
engineered nanomaterials is a top priority.
In other words, despite the need for nanotechnology risk research
to inform oversight and regulation, the vast bulk of the requested
funding is associated with agencies having no regulatory mission.
Whether this is an appropriate use of funds, or merely reflects the
spending power of the respective agencies, can only be answered by
understanding how each agency's research will feed into an overarching
strategic framework. But this framework does not yet exist.\60\ Until
it does (and mechanisms are in place to implement it), the Federal
Government is unlikely to achieve a balance between agency resources
and responsibilities in addressing nanotechnology risks.
---------------------------------------------------------------------------
\60\ See supra note 12.
Can the current process for developing the EHS research plan under the
NNI be made to work, and if so, what changes are needed? If not, do you
have recommendations for a different approach for developing and
implementing a prioritized, appropriately funded EHS research plan with
---------------------------------------------------------------------------
well-defined goals, agency roles and milestones?
Earlier in this testimony, I outline what is needed in my opinion
to realize the benefits of nanotechnology while minimizing the risks:
acknowledging the possibility of unconventional behavior; leadership; a
strategic plan; mechanisms to put a research strategy into practice;
and sufficient resources to do this. But overarching these steps is the
goal of nanotechnology risk-related research: to develop the
information necessary to identify (or predict), assess and manage risks
associated with nanotechnologies--in essence to use science in support
of oversight.
If the current process for developing the EHS research plan under
the NNI can be made to achieve this goal--and in a timely manner--then
we are on track to ensuring safe and sustainable nanotechnologies. But
changes will be needed; the analysis above clearly shows that the
current approach falls far short of the mark.
In reality, the NNI is not an ideal organization for addressing
nanotechnology EHS risks. It is based on ideas and concepts more
attuned to stimulating exploratory science and developing technology
applications than providing science in support of oversight. While the
NNI has effectively stimulated new research initiatives across the
Federal Government, it remains primarily a forum for sharing
information and reporting on agency activities. Within these functions,
the NEHI working group has provided a useful forum for agency
representatives to coordinate activities. Yet the NNI lacks the
structure, vision and authority to ensure strategic and coordinated
research in the service of effective oversight.
Nevertheless, the NNI is a useful starting point for developing a
strategic Federal Government EHS research plan, if appropriate
operational changes can be made. To be effective, the NNI's goals--and
the terms under which it operates--will need to shift from a passive,
supportive role to an active leadership role. Currently the role of the
NEHI working group within the NNI is to:
Provide for exchange of information among agencies
that support nanotechnology research and those responsible for
regulation and guidelines related to nanoproducts (defined as
engineered nanoscale materials, nanostructured materials or
nanotechnology-based devices, and their byproducts);
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
parties.\61\
---------------------------------------------------------------------------
\61\ Interagency Working Group on Nanotechnology Environmental and
Health Implications (NEHI WG). http://www.nano.gov/html/society/
NEHI.html. Accessed October 14, 2007.
Yet these roles do not enable the NNI to have the vision to develop
an effective research strategy, or the authority to implement it. In my
testimony above, I make six recommendations on what is needed to ``make
---------------------------------------------------------------------------
nanotechnology work'':
1. A top-level strategic framework that identifies the goals
of nanotechnology risk research across the Federal Government,
and provides a roadmap for achieving these goals;
2. Mechanisms that will enable a strategic research framework
to be implemented;
3. Annual funding for nanotechnology risk-related research
(targeted and exploratory) that is equivalent to approximately
10 percent of the overall Federal Government investment in
nanotechnology R&D, with a minimum of $50 million per year to
be dedicated to targeted research;
4. A public-private partnership between industry and the
Federal Government to address specific common and critical
nanotechnology research needs in a timely, transparent and
credible manner;
5. An overarching communications strategy that has the
fourfold aims of ensuring transparency, disseminating
information, enabling science-based dialogue between
stakeholders, and supporting informed decision-making by
citizens, businesses, regulators, and other stakeholders; and
6. Leadership to ensure the successful development and
implementation of a government-wide strategic research
framework addressing nanotechnology EHS risks.
Implementation and coordination of these recommendations will
require new operating terms for the NNI that allow active leadership
within the Federal Government; provide authority to develop and
implement cross-agency strategies; bring a goal-oriented focus to
research; and facilitate the flow of resources to where they are most
effectively used. In making these recommendations, I am very aware that
developing an interagency group with the authority to develop and
implement a cross-agency strategic plan is an enormously difficult and
contentious task. As I noted earlier, the most effective model will be
of leadership, coordination and facilitation, and not one of command
and control. Yet the reality is that, without active leadership from
the top, strategic research needs will not be met, mission-driven
agencies will not have sufficient funds to do the work that is needed,
and the whole nanotechnology enterprise will be jeopardized.
Annex: Goals and elements of an effective EHS strategic research
framework
Strategic goals
The overarching goal for risk-based nanotechnology research can be
succinctly expressed as developing the information necessary to
identify (or predict), assess and manage risks associated with
nanotechnologies. This is science in the service of safety, and not
science for its own sake.
There are many challenges to achieving this goal, and they
typically fall under three broad headings:
Providing answers to pressing questions. These are
questions that researchers, manufacturers and consumers are
asking now, and include: How can exposure to nanomaterials be
measured and controlled? How can I test my nanomaterial to
determine if it is harmful? What happens if I release my
nanomaterial into the environment? Am I at risk if I use
personal care products containing nanomaterials? How do I
dispose of waste nanomaterial and nanotechnology products that
have come to the end of their life? The answers to many of
these questions will require complex research, but until they
are answered, they present real and immediate barriers to
progress.
Developing new knowledge to identify the questions
not currently being asked. Many aspects of nanotechnology are
so new that we do not yet know what are the right questions to
ask regarding potential risks. This knowledge will not come
easily from targeted research, as it is difficult to set
milestones on discovering the unknown. Rather, it will be
driven from the innovation researchers who are given the
freedom to explore new avenues and follow interesting leads.
Yet for such exploratory research to be effective in addressing
risks, it must be directed within an overall risk-relevant
framework, and mechanisms must be set in place to identify and
follow-up on new risk-relevant information.
Translating research into practice: developing new
ways of predicting and managing risks. While the oversight of
nanotechnology is dogged by uncertainty, it seems relatively
certain that new technologies will always be one step ahead of
our understanding of how they might cause harm. This lag
between technology and regulation is clear as we look over the
innovations of the past one hundred years. Yet as the rate of
technological innovation continues to increase, it is
increasingly hard to justify reactive oversight that is bogged
down in bureaucratic inertia and is slow to take corrective
action. In short, emerging technologies like nanotechnology
challenge us to develop new, responsive and proactive
approaches to identifying and managing possible risks, so that
we might prevent a lasting legacy of harm where old approaches
could not keep up with new developments.
Many of the recommended research needs made over the past few years
by a wide range of organizations fit within these challenges, including
those published by the NEHI group in 2006 (and the shorter list
released in 2007). Yet the challenges themselves are not a strategy--
merely the issues that a research strategy needs to address.
Developing an effective roadmap to addressing these challenges is
not as simple as prioritizing the research. As I discovered while
developing recommendations on a short-term research strategy in 2006,
you have to work back from what you want to achieve, and map out the
research steps needed to get there. This inevitably leads to complex
and intertwined research threads. If this complexity is not
acknowledged, the result is simplistic research priorities that look
good on paper, but are ineffective at addressing specific goals.
Key elements of a strategic framework
In developing the elements of a research strategy in the earlier
2006 paper, and in a commentary published in the journal Nature with
thirteen distinguished colleagues, it was clear that an effective
research strategy addressing potential nanotechnology risks will have a
number of key elements. These include:
Goal-oriented research. Whether research exploring
new areas or research addressing a specific problem, an
underlying principle of an effective research strategy must be
science in the service of safety.
A balance of targeted and exploratory research. An
effective research strategy will combine research targeted to
addressing specific problems, with research exploring new areas
of knowledge. Both are important in the long-term to address
practical issues and develop a sound understanding of what
makes a new material potentially harmful, and how to avoid that
harm.
Interdisciplinary collaboration. Nanotechnology is
inherently interdisciplinary, and effective research addressing
the potential risks will be likewise. For example, early
toxicity studies on nanomaterials were compromised because of a
lack of understanding of the materials being used within the
toxicology community, and would have benefited from stronger
collaborations with materials scientists and characterization
experts. Yet the disciplinary barriers faced are substantial,
and cannot be broken down by researchers without help.
Illustrating the problem, some seventeen years after the first
toxicology studies on nanoparticles, research into nanoparticle
toxicity being published now is frequently hard to interpret
and compare with other studies, because the interdisciplinary
barriers in place a decade and a half ago are still reasonably
intact! This is just one example, but it is indicative of the
need for any research strategy to break these barriers down if
it is to be effective.
Enabling and empowering researchers and research
organizations. The effectiveness of a strategic research
framework will only be as good as its ability to engage the
organizations and individuals responsible for implementing it.
While such a framework will of necessity be at a high level
and, in the case of the Federal Government, overlay all
departments and agencies associated with ensuring the safety of
emerging nanotechnologies, the expertise to make it work will
lie within the participating agencies, and within the broader
research community. Therefore, a fine balance must be struck
between controlling the direction of research and empowering
agencies and researchers to lead research efforts. This balance
is perhaps most important in exploratory research, where the
best-positioned person to see where research is leading and its
significance may be the principle investigator or research
manager. Getting the balance right between providing top-down
direction and enabling a degree of autonomy will be important
in supporting innovative research that can be incorporated into
a responsive strategy.
Communication and translation. Multilateral
communication of research goals, activities and findings, and
translation of research into practical information and actions,
are essential to the operation and implementation of an
effective research strategy. These are the glue that holds an
otherwise well thought-through strategic plan together.
Biography for Andrew D. Maynard
Dr. Andrew Maynard is the Chief Science Advisor to the Project on
Emerging Nanotechnologies--an initiative dedicated to helping business,
government and the public anticipate and manage possible health and
environmental implications of nanotechnology. Dr. Maynard is considered
one of the foremost international experts on addressing possible
nanotechnology risks and developing safe nanotechnologies. As well as
publishing extensively in the scientific literature, Dr. Maynard is a
well-known international speaker on nanotechnology, and frequently
appears in print and on radio and television.
Dr. Maynard trained as a physicist at Birmingham University in the
UK. After completing a Ph.D. in ultrafine aerosol analysis at the
Cavendish Laboratory, Cambridge University (UK), he joined the Aerosols
research group of the UK Health and Safety Executive, where he led
research into aerosol behavior and characterization.
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). Dr. Maynard was instrumental in establishing the
NIOSH nanotechnology research initiative, which continues to lead
efforts to identify, assess and address the potential impacts of
nanotechnology in the workplace. Dr. Maynard also represented NIOSH on
the Nanomaterial Science, Engineering and Technology subcommittee of
the National Science and Technology Council (NSET), and he co-chaired
the Nanotechnology Environmental and Health 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 continues to work closely with many organizations and
initiatives on the responsible and sustainable development of
nanotechnology. He is a member of the Executive Committee of the
International Council On Nanotechnology (ICON), he has chaired the
International Standards Organization Working Group on size selective
sampling in the workplace, and he has been involved in the organization
of many international meetings on nanotechnology. Dr. Maynard has
testified before the U.S. House Committee on Science on nanotechnology
policy, and is a member of the President's Council of Advisors on
Science and Technology, Nanotechnology Technical Advisory Group. Dr.
Maynard holds an Associate Professorship at the University of
Cincinnati, is an Honorary Senior Lecturer at the University of
Aberdeen, UK, and has authored or co-authored over 90 scholarly
publications.
Chairman Baird. Thank you. We have been joined by Mr.
Reichert. Dr. Denison?
STATEMENT OF DR. RICHARD A. DENISON, SENIOR SCIENTIST,
ENVIRONMENTAL DEFENSE
Dr. Denison. Thank you very much for the invitation to
present our views today.
Environmental Defense continues to believe that
nanotechnology promises significant health and environmental
benefits. We also believe that a robust process to address the
risks of this technology is absolutely essential to ensure that
those benefits are realized. We are not alone in this view. A
coalition of stakeholders from large and small businesses, from
academic researchers, think tanks, consumer groups, and
environmental NGO's have banded together over the last two
years to consistently press for a balanced approach, publicly
calling for much more federal money to be spent on risk
research and for a cohesive federal strategy to be developed
and implemented.
Unfortunately, the Federal Government's approach under the
NNI is well out of balance. To be fair, scientists at NNI and
its agencies are talking and writing a great deal about the
need to address the risks of this technology, and they in
particular emphasize how little we know about these materials,
how much work it will take to actually fill these gaps, and how
important filling those gaps is to our ability to assess and to
mitigate any potential risks.
But there is a growing disparity between government
scientists' words and the actions of the NNI. The problem is
three-fold in our view. Too little is being spent on risk
research, too little is known about what those current funds
are being spent on, and the pace at which the Federal
Government is moving to develop the cohesive strategy that
everyone needs is bordering on glacial, although these days
glaciers are moving a bit faster.
Let me address each of these in turn. The Committee and
previous speakers have already detailed how little of the
federal nano R&D budget is going to risk research, on the order
of three to four percent, and that percentage amount has
largely unchanged over the last several years. In contrast, we
and many others have been calling for at least 10 percent
commitment of funds to this task, yet NNI has never publicly
indicated its support for such an increase.
The problem goes beyond, however, just how much is being
spent. There is currently no good way to know how it is being
spent, that is, what research NNI is specifically counting in
its totals; and that is because NNI has never made public a
listing of the projects that it is counting in its total budget
figures. Some analyses suggest NNI may well be overcounting by
including not only direct EHS research but also research on
applications that it deems relevant to understanding risk. NNI
itself has noted it has trouble drawing that line and that
assessing relevance is a subjective exercise.
But much of this confusion and uncertainty could be cleared
up immediately if NNI would simply disclose what specific
projects are being funded. All we really know is that NNI
breaks down its numbers in terms of what agencies and
departments get, and this shows the National Science Foundation
whose mission is funding basic research gets the lion's share
of the money being spent on EHS research. While there is
certainly a role for basic research, in our view, research that
is meant to address health and environmental issues needs to be
primarily funded through and conducted by agencies that have
that as their mission: EPA, NIOSH, National Institutes of
Environmental Health Sciences, and so forth.
As the Committee has noted, NNI has been promising to
deliver a strategy for well over a year. It has yet to
materialize, however, and the incremental process that NNI has
laid out for getting there has actually led a journalist at the
New York Times to recently quip, ``No one can accuse them of
acting rashly.''
Unfortunately, in Environmental Defense's view, there are
two structural impediments that are preventing NNI from moving
faster. First, NNI lacks the overarching budgetary and
oversight authority that is needed to shape and direct a
research strategy undertaken by its member agencies and
departments. NNI functions primarily in a facilitation and
coordination role, and it simply cannot be expected to develop
let alone implement such a strategy.
Second, we have become convinced that a conflict of
interest has risen from the decision to house within NNI the
dual, and some might say dueling, responsibilities to both
develop and promote nanotechnology and at the same time to
aggressively identify and mitigate its potential risks. That
conflict in our view is both slowing down and compromising
current efforts. It manifests itself in the budget disparity,
in the confusion over what NNI is actually spending, and we
think it helps to explain why things are taking so long.
Even some individual agencies such as FDA and EPA are
tasked with not only regulating nanotechnology but actually
promoting it, sometimes even within the same office. All agency
proposals pertaining to address potential risks have now to be
vetted through a White House Nanotechnology Policy Group. These
factors we think help to explain the disconnect between the
words and the actions on the part of both NNI and its agencies.
Can the NNI approach be made to work? We think two changes
are essential. First, either a new entity needs to be created
or an existing entity elevated significantly and given the
responsibility and authority and the resources to develop and
manage the implementation of an overall risk research strategy.
This entity needs to have a core health and environmental
mission, and Congress should request that the National
Academies assist in developing this strategy and in overseeing
its implementation. Second, we believe that a stronger firewall
must be established between the parts of the Federal Government
whose mission is to develop and advance nanotechnology and
those parts that are charged with objectively identifying and
mitigating its potential risks.
To ensure that both of those goals receive comparable
consideration, these responsibilities need to be assigned to
different offices and staff members within those agencies.
In sum, the risk-related activities within the National
Nanotechnology Initiative need to be both substantially
elevated and clearly separated from those that are dedicated to
promoting this technology.
Thank you very much.
[The prepared statement of Dr. Denison follows:]
Prepared Statement of Richard A. Denison
Introduction [1]
Environmental Defense continues to believe that nanotechnology
promises major health and environmental benefits. We also believe that
implementation of a robust process to identify and address the
potential risks of engineered nanomaterials is absolutely essential to
ensuring that these benefits are in fact realized. A concurrent and
balanced approach to addressing both the applications and implications
of nanotechnology is the best hope for achieving the responsible
introduction of this remarkable set of new technologies.
There has been a relatively strong consensus among large and small
industry, academic researchers, think tanks and consumer and
environmental NGOs that this balanced approach is needed.
Unfortunately, however, the Federal Government is pursuing an approach
under the National Nanotechnology Initiative (NNI) that is well out of
balance.
To be sure, NNI and many of its member agencies are talking and
writing a great deal about the need to address nanotechnology's risks
as well as its benefits. One need only look at their websites and
reports, especially those written by their scientists. But there is a
continuing, and in some ways, growing disparity between NNI's words and
actions.
Over the past two years, scientists at several NNI agencies and at
NNI itself have published documents elegantly describing how little we
know about nanomaterials' potential hazards and exposures and how much
work will be needed both to address these gaps and to adequately assess
risks.[2] These documents also repeatedly draw needed attention to
three critical facts:
1) Because nanomaterials have different properties than their
conventional counterparts, existing information on substances'
conventional forms is of limited use in elucidating the
behavior and biological activity of their nano forms.
2) Methods for testing nanomaterials or for measuring their
presence in environmental media or in organisms have largely
yet to be developed.
3) Current approaches to predicting the hazard, exposure
potential or fate of chemicals cannot be applied to
nanomaterials, because they do not account for the physical as
well as chemical properties that determine the latter's
behavior and biological activity.
These critical gaps severely hamper our ability to apply the usual
risk assessment and risk management procedures.
For example, the Nanotechnology Task Force of the U.S. Food and
Drug Administration (FDA) recently released a succinct summary of the
state of the science of nanomaterials falling under its jurisdiction.
Reversing its earlier position that suggested nanomaterials are really
nothing new, FDA now acknowledges the inability to effectively predict
nanomaterials' behavior and the need for direct testing:
``[A]t this scale, properties of a material relevant to the
safety and (as applicable) effectiveness of FDA-regulated
products might change repeatedly as size enters into or varies
within the nanoscale range. . . .Biological interactions
influenced by the particular chemistry and physical
configuration of the nanoscale material might also occur in
ways that are unpredictable without specific test data for the
material.''[3]
Likewise, the thorough Nanotechnology White Paper published by the
U.S. Environmental Protection Agency (EPA) notes the following:
``The diversity and complexity of nanomaterials makes chemical
identification and characterization not only more important but
also more difficult. A broader spectrum of properties will be
needed to sufficiently characterize a given nanomaterial for
the purposes of evaluating hazard and assessing risk. . . .The
limited studies conducted to date indicate that the
toxicological assessment of specific intentionally produced
nanomaterials will be difficult to extrapolate from existing
databases. The toxic effects of nanoscale materials have not
been fully characterized, but it is generally believed that
nanoparticles can have toxicological properties that differ
from their bulk material. . . .The sheer variety of
nanomaterials and nanoproducts adds to the difficulty of
developing research needs. Each stage in their life cycle, from
extraction to manufacturing to use and then to ultimate
disposal, will present separate research challenges.
Nanomaterials also present a particular research challenge over
their macro forms in that we have a very limited understanding
of nanoparticles' physicochemical properties.''[4]
These reports also attach a considerable degree of urgency to the
need to address these large and complex questions. FDA notes that ``the
science and applications are developing at a very rapid pace,'' while
EPA highlights ``the rapid development of nanotechnology and the
increasing production of nanomaterials and nanoproducts,'' noting that
hundreds of nanoproducts are already on the market and that
``nanomaterials are already being used or tested in a wide range of
products such as sunscreens, composites, medical and electronic
devices, and chemical catalysts.''[5]
Recognition of both the complexity of the task at hand and the
urgency to get moving are widely shared beyond government. For over two
years now, a coalition comprised of large and small companies, other
industry groups and NGOs has publicly called for much greater attention
to be paid to risk research, noting in particular the disparity between
federal spending on applications versus implications research:
``While industry, academic, and government scientists continue
to vigorously explore nanotechnology's potential applications
in a wide variety of fields, such as groundwater cleanup and
cancer therapy, research on nanotechnology's potential health
and environmental implications has failed to keep up. Federal
research is essential to providing the underlying methods and
tools critical to developing a fundamental understanding of the
risk potential of nanomaterials and nanotechnologies--methods
and tools that all producers and users can then use to fulfill
their appropriate responsibility to identify potential risks of
their own materials and applications.''[6]
This same coalition has also called for development of a federal
risk research roadmap and strategy.[7]
Unfortunately, the words in the FDA and EPA reports I referenced
earlier have not translated into meaningful and sufficient actions by
the Federal Government, even though they have been bolstered by the
remarkable and unusual consensus among key stakeholders just noted. Too
little is being spent on risk research, too little is known about what
current funds are being spent on, and the pace at which the Federal
Government is moving to produce a coherent risk research strategy
borders on glacial. Let me address each of these concerns in more
detail.
What is being spent
NNI's 2007 budget is estimated at $1.35 billion and its 2008 budget
request is $1.45 billion. NNI reports that the fraction of those totals
to be spent on environmental, health and safety (EHS) research and
development (R&D) are 3.5 percent for 2007 and 4.1 percent for
2008[8]--a trend line that has remained nearly flat for the last
several years in percentage terms and is only a modest increase in
absolute dollars. In contrast, Environmental Defense has called for
much more--at least 10 percent--of the federal nanotechnology R&D
budget to be specifically directed, for the foreseeable future, to
targeted EHS research (exclusive of applications research that may
tangentially shed light on implications questions).[9] For more than
two years, many others have joined us in making this call. In June
2005, the CEO of DuPont and the President of Environmental Defense co-
authored an opinion editorial in the Wall Street Journal calling for an
increase in such funding to at least 10 percent of the federal
nanotechnology R&D budget.[10] Indeed, the coalition of industry and
NGOs to which I just referred has also pressed Congress for a
significant increase in federal appropriations. Yet NNI has never
publicly called for or indicated its support for such an increase.
How current funds are being spent
NNI's budget numbers for EHS research must be considered suspect,
unfortunately. There is currently no way to know what research NNI is
counting when it provides its totals, because NNI has not made public
any listing of the projects it includes. In addition, NNI has itself
noted that it has trouble drawing the line between direct EHS
implications research and applications research that it maintains is
``relevant'' to understanding implications. Last year, the Project on
Emerging Nanotechnologies (PEN) at the Woodrow Wilson International
Center for Scholars used NNI's 2005 budget numbers and its inventory of
ongoing federal risk research to try to answer these questions. Of the
roughly $40 million NNI said it was spending on ``relevant'' EHS
research that year, PEN could identify as ``highly relevant'' only $11
million of research and about $30 million as ``generally
relevant.''[11] While PEN's analysis has not been updated, the lack of
transparency on the part of NNI as to what projects it counts in
tabulating EHS spending creates unnecessary confusion and uncertainty
over how much is actually being spent and on what.
To date, the only detail provided by NNI as to how this money is
being spent is a breakdown by agency or department. From this
breakdown, we know that the National Science Foundation (NSF), which
funds basic research but has no public or occupational health or
environmental mission, continues to receive the lion's share (>50
percent) of federal risk research dollars. While there is certainly a
role for basic research, environmental or public health research should
be conducted primarily by, and ideally directed and overseen by,
federal agencies that have such missions, such as EPA, the National
Institute for Environmental Health Sciences (NIEHS), or the National
Institute for Occupational Safety and Health (NIOSH).
In addition, the great majority of federal risk research dollars is
being spent on extramural research, through grants to academic and
other institutions. Both extramural and intramural research have
important roles to play, but to date too few funds have been devoted to
building the needed intramural research capacity. Federal funding for
both intramural and extramural research can and should reflect research
priorities by more tightly focusing calls for proposals on key
environmental and health research objectives. Increased funding for
intramural research at federal agencies and laboratories is needed to
conduct more applied research and to address specific priorities that
are less likely to be efficiently addressed by academic or
institutional research.
Although such federal research institutions may not have the
capacity now to fully absorb the resources needed for intramural
research, immediate priority should be placed on building that capacity
as rapidly as possible. This capacity-building and research agenda
should be viewed as an investment that will facilitate the responsible
development of emerging nanotechnologies.
Need for a comprehensive federal risk research strategy--and the means
to implement it
While NNI has been promising to deliver a risk research strategy
that is coordinated across its agencies for well over a year, such a
strategy has yet to materialize. Its issuance was just delayed again
and is now projected for release in January 2008.
Based on the process NNI has laid out for developing such a
strategy, it still has a considerable way to go:
Step 1--Identify EHS research needs and priorities.
This step took the form of a report issued in September 2006,
which was subjected to public comment.[12] Environmental
Defense's comments on this document are attached to this
testimony.
Step 2--Further prioritize research needs. This step
came in a report issued in mid-August of this year, nearly a
year after the first one, and was again subjected to public
comment.[13] The eight-page second report was essentially a
boiled-down version of the first, 60-page report.
Four more steps remain to be completed, according to NNI:
Step 3--Evaluate in greater detail the current NNI
EHS research portfolio.
Step 4--Perform a ``gap analysis'' of the NNI EHS
research compared to prioritized needs.
Step 5--Coordinate and facilitate among the NNI
agencies' research programs to address priorities.
Step 6--Establish a process for periodic review of
progress and for updating the research needs and priorities.
It is not clear whether each of these steps is to be taken on
sequentially, with a corresponding pause for public comment. In any
event, as a journalist for the New York Times recently put it: ``No one
can accuse them of acting rashly.''[14]
Key impediments to progress
Unfortunately, in Environmental Defense's view, NNI has core
structural impediments that prevent it from acting expeditiously to
identify and address potential risks and from adopting a more balanced
overall approach. The problems are two-fold. First, NNI lacks any
overarching budgetary and oversight authority to shape and direct the
research activities undertaken by its member agencies and departments.
The part of NNI that is mounting current efforts in this area is the
Nanoscale Science, Engineering and Technology Subcommittee (NSET),
which serves primarily in a facilitation and coordination role and
simply has not been given the necessary authority to devise and
implement a coherent, cross-agency risk research strategy. Additional
authority to oversee and direct federal risk-related research is
essential to ensure two things: a) that the right questions are asked
and answered, and b) that identified risks are comprehensively assessed
and do not fall through the cracks between statutes, departments and
agencies.
Second, we have become convinced that a conflict of interest has
arisen from the decision to house within NNI the dual functions of both
seeking to develop and promote nanotechnology and its applications,
while at the same time aggressively pursuing the actions needed to
identify and mitigate any potential risks that arise from such
applications. That conflict of interest is both slowing and
compromising efforts by NNI and its member agencies and departments to
effectively address nanotechnology's implications. The conflict
manifests itself in the continuing budget disparity I have already
discussed. It is also apparent in NNI's evident inability or
unwillingness to clearly identify research activities devoted
specifically to EHS concerns and sufficiently distinguish them from
applications research that may incidentally yield data relevant to
understanding implications. And it may help explain what's taking so
long.
The conflict also appears to be manifesting itself at the
individual agency level. Some NNI agencies, including FDA and EPA, are
themselves charged with both promoting and regulating nanotechnology
applications, sometimes even within the same office. In addition, all
agency proposals pertaining to addressing nanotechnology's potential
risks must now be vetted through a White House nanotechnology policy
group. These factors may be responsible in part for the growing
disconnect between, on the one hand, the recognition by agencies of the
magnitude of and urgent need to address the risk question, and on the
other hand, the tepid response of those same agencies in terms of
actions to be taken.
For example, the FDA Nanotechnology Task Force's recommendations
are vague and lack critical details on actions needed to close
identified research and regulatory gaps. While there is a call for the
agency to promote and participate in research, there is no mention of
the level of resources needed, the timeframe within which this is--or
needs--to be accomplished, or even an indication that there is any
urgency to advance the collection of data. While the recommendations
call on the agency to issue various forms of guidance for manufacturers
to use on a voluntary basis, they propose that the evaluation of
products continue on a case-by-case basis, which is essentially the
status quo. There is no description of how the agency will or should
address two key points: a) the greater uncertainties it has identified
that are posed by using nanomaterials in products for which the agency
has pre-market authority, or b) the considerable gaps in information
for classes of products, such as cosmetics, for which the agency has no
pre-market authority.
Similarly, we can look at how EPA has responded to growing public
concern over the lack of nanotechnology oversight and its own
scientists' identification of the enormous data gaps that must be
filled if risks are to be effectively identified and addressed. EPA has
taken two recent steps. First, it issued a policy decision that
considers the nano forms of existing chemicals to be no different than
their bulk counterparts, and by so doing effectively eliminates the
only opportunity EPA has to review or require testing of such
nanomaterials prior to their manufacture and use.[15] Second, it issued
a ``concept paper'' that proposes an open-ended, voluntary program to
encourage companies to submit any information they already happen to
possess. EPA proposes what its own advisory committee proposed nearly
two years ago--except it has removed the strict deadlines for the
voluntary program and the simultaneous development of mandatory
reporting rules as a regulatory backstop, which the committee had
included.[16]
Recommendations: Can the NNI approach be made to work?
If NNI is to effectively address the potential risks of
nanotechnology, two changes are essential.
First, a new entity needs to be created, or an existing entity
elevated, and given responsibility, ample authority and resources to do
the following:
Ensure the development of an overall federal research
strategy to identify, assess and address the potential risks of
nanomaterials.
Shape and direct the overall federal risk research
agenda across agencies to ensure all critical needs are being
addressed.
Ensure that individual agencies have sufficient
dedicated staff and resources to conduct or commission the
needed research in their areas, and sufficient authority to
identify, assess and address potential risks.
This entity, whether independent or housed in an existing agency,
should have a core public health and/or environmental mission. Congress
should also request that the National Academies' Board on Environmental
Studies and Toxicology (BEST) take a lead role in developing the needed
strategy, and in overseeing its implementation over a number of years.
BEST has successfully played an analogous role in the formulation and
execution of the U.S. Environmental Protection Agency's research
strategy for assessing the risks of airborne particulate matter.[17]
The second essential step is to establish a firewall between the
parts of the Federal Government whose mission is to help develop and
advance nanotechnology, and those parts charged with ensuring a
thorough and objective examination of its potential risks and taking
the steps needed to mitigate those risks. Ensuring that both goals
receive equal consideration would require, at a minimum, that the
responsibility to address the two distinct goals be assigned to
different offices and senior staff members, who are given parallel and
comparable degrees of authority, and who report directly to the highest
levels within their individual agencies and within NNI. We believe that
a clear division of labor and interests is critical if public
confidence in the ability of the Federal Government to facilitate the
responsible development of nanotechnology is to be restored.
In sum, the activities within NNI devoted to identifying and
mitigating the potential risks of nanotechnology need to be both
substantially elevated in importance and clearly separated from those
dedicated to promoting its development and application.
Thank you for the opportunity to present our views today.
Environmental Defense stands ready to assist the Committee as it
considers what changes are needed in legislation to be developed to
reauthorize NNI.
Endnotes
1. A biography of Dr. Denison is attached.
2. For example, see: U.S. Food and Drug Administration,
Nanotechnology: A Report of the U.S. Food and Drug Administration
Nanotechnology Task Force, July 25, 2007, at www.fda.gov/
nanotechnology/taskforce/report2007.pdf; and U.S. Environmental
Protection Agency, Nanotechnology White Paper, February 2007, at
www.epa.gov/osa/nanotech.htm; National Institute for Occupational
Safety and Health, Strategic Plan for NIOSH Nanotechnology Research:
Filling the Knowledge Gaps, at www.cdc.gov/niosh/topics/nanotech/
strat-planINTRO.html; and National Nanotechnology
Initiative, Environmental, Health, and Safety Research Needs for
Engineered Nanoscale Materials, September 2006, at www.nano.gov/
NNI-EHS-research-needs.pdf.
3. FDA, op. cit., pp. ii, 11.
4. EPA, op. cit., pp. 31, 70, 77.
5. FDA, op. cit., p. 8; EPA, op. cit., pp. 4, 13, 21.
6. Letter signed by 14 companies and organizations sent to Chairs and
Ranking Members of the House and Senate Appropriations Committees,
dated June 7, 2006, at www.environmentaldefense.org/documents/
5067-nano-appropsLetter.pdf Emphasis in original.
7. Letter signed by 19 companies and organizations sent to Chairs and
Ranking Members of the House and Senate Appropriations Committees,
dated February 22, 2007, at www.environmentaldefense.org/documents/
6015-Approps- 2007NASLetter.pdf
8. The National Nanotechnology Initiative: Research and Development
Leading to a Revolution in Technology and Industry, Supplement to the
President's FY 2008 Budget, Tables 2 (p. 7) and 6 (p. 11), at
www.nano.gov/NNI-08Budget.pdf
9. Denison R.A. ``A proposal to increase federal funding of
nanotechnology risk research to at least $100 million annually.''
Environmental Defense, Submitted to the National Academy of Sciences'
Committee to Review the National Nanotechnology Initiative (April
2005), at www.environmentaldefense.org/article.cfm?ContentID=5131
10. See Fred Krupp and Chad Holliday, ``Let's Get Nanotech Right,''
Wall Street Journal, June 14, 2005, p. B2, at
www.environmentaldefense.org/documents/
5177-OpEd-WSJ050614.pdf That same month, the
American Chemistry Council's Panel on Nanotechnology and Environmental
Defense issued a Joint Statement of Principles stating: ``A significant
increase in government investment in research on the health and
environmental implications of nanotechnology is essential.'' At
www.environmentaldefense.org/documents/4857-ACC-
ED- nanotech.pdf And in a 2005 report on nanotechnology,
Innovest, a leading investment research and advisory firm, said: ``We
strongly support calls by others in the investment community for
increased government funding of toxicology research. The NNI's lack of
priority for this issue represents a missed opportunity to minimize
uncertainty.'' See Innovest (2005). Nanotechnology: Non-traditional
Methods for Valuation of Nanotechnology Producers. New York, NY. Page
56. At www.innovestgroup.com/images/pdf/final%20nano%2010-30-06.pdf
11. Maynard, A.D. (2006) Nanotechnology: A Research Strategy for
Addressing Risk, pp. 3, 20, at www.nanotechproject.org/
file-download/77
12. NNI, 2006, op. cit.
13. National Nanotechnology Initiative, Prioritization of
Environmental, Health and Safety Research Needs for Engineered
Nanoscale Materials--An Interim Document for Public Comment, at
www.nano.gov/
Prioritization-EHS-Research-Needs-
Engineered-Nanoscale-Materials.pdf
14. Barnaby J. Feder, ``No one can accuse them of acting rashly,''
August 17, 2007, at bits.blogs.nytimes.com/2007/08/17/no-one-can-
accuse-them-of-acting-rashly/
15. U.S. Environmental Protection Agency, ``TSCA Inventory Status of
Nanoscale Substances--General Approach,'' released for public comment
on July 11, 2007, at www.regulations.gov/fdmspublic/component/
main?main=DocumentDetail&d=EPA-HQ-OPPT-2004-0122-0057
16. U.S. Environmental Protection Agency, ``Concept Paper for the
Nanoscale Materials Stewardship Program under TSCA,'' released for
public comment on July 11, 2007, at www.regulations.gov/fdmspublic/
component/main?main= DocumentDetail&d=EPA-HQ-OPPT-2004-0122-0058 The
2005 proposal made by EPA's National Pollution Prevention & Toxics
Advisory Committee (NPPTAC) is at www.epa.gov/oppt/npptac/pubs/
nanowgover viewdocument20051125.pdf Environmental Defense's comments on
both of EPA's recent proposals are at www.environmentaldefense.org/
documents/7010-ED-WrittenCommentson
EPANanoDocs09072007.pdf
17. Board on Environmental Studies and Toxicology, Research Priorities
for Airborne Particulate Matter: I. Immediate Priorities and a Long-
Range Research Portfolio, Committee on Research Priorities for Airborne
Particulate Matter, National Research Council, 1998; and Research
Priorities for Airborne Particulate Matter: IV. Continuing Research
Progress, 2004, both at: books.nap.edu/catalog/6131.html and
books.nap.edu/catalog/10957.html
Attachment 1
Biography for Richard A. Denison
Dr. Denison is a Senior Scientist in Environmental Defense's
Washington, DC office. With more than 20 years of experience in the
environmental arena, he specializes in chemicals policy, hazard and
risk assessment and management for industrial chemicals, and
responsible development of nanotechnology.
Dr. Denison has managed Environmental Defense's participation in
and oversight of the U.S. High Production Volume (HPV) Chemical
Challenge Program, initiated by Environmental Defense, the U.S.
Environmental Protection Agency and the American Chemistry Council to
provide basic hazard data on the 2,200 chemicals produced in the U.S.
in the largest quantities. He also represents Environmental Defense on
the Chemicals Committee and on the Working Party on Manufactured
Nanomaterials of the Organization for Economic Cooperation and
Development (OECD). Dr. Denison was recently appointed to the Science
Advisory Panel for California's Green Chemistry Initiative. Until
recently, he was a member of the National Pollution Prevention and
Toxics Advisory Committee (NPPTAC), which advises EPA's toxics office.
Dr. Denison is part of Environmental Defense's team that worked jointly
with the DuPont Corporation to develop a framework governing
responsible development, production, use and disposal of nanoscale
materials.
Dr. Denison has authored numerous papers and reports, and he is
active in a variety of activities and forums, pertaining to chemicals
and nanomaterial regulation and policy at the federal and State levels
and internationally. Dr. Denison is the author of a major report,
titled Not That Innocent, that provides a comparative assessment of
existing and emerging industrial chemicals policies in the U.S., Canada
and Europe.
Dr. Denison earned a Ph.D. in Molecular Biophysics and Biochemistry
from Yale University in 1982. He joined Environmental Defense in 1987,
after several years as an analyst and assistant project director at the
Office of Technology Assessment, United States Congress.
Attachment 2
ENVIRONMENTAL DEFENSE COMMENTS\1\ ON:
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\1\ These comments are available online at www.nano.gov/html/
meetings/ehs/uploads/
20070131-0752-ED-comments-on
-NNI-EHS-Research-Needs-
FI NAL.doc
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Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials, released September 15, 2006
January 31, 2007
Federal Register: December 8, 2006 (Volume 71, Number 236) DOC
ID:FR08DE06-135
Introductory Statement
Environmental Defense appreciates this opportunity to submit
comments on the National Nanotechnology Initiative's document
Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials, which was released on September 15, 2006.
Environmental Defense is a leading national environmental nonprofit
organization representing more than 400,000 members. Since 1967, we
have linked science, economics, law, and innovative private-sector
partnerships to create pragmatic solutions to the most serious
environmental problems. Among our other activities related to
nanotechnology, we are currently working with DuPont to develop a
comprehensive, practical and transparent approach to proactively
evaluate and address the risks of nanomaterials across their life
cycle.
The National Nanotechnology Initiative's Nanoscale Science,
Engineering, and Technology (NSET) Subcommittee of the Committee on
Technology, National Science and Technology Council (NSTC) has
requested comment on the research needs and prioritization criteria
that were identified in the NSET Subcommittee document Environmental,
Health, and Safety Research Needs for Engineered Nanoscale Materials.
We commend the NSET Subcommittee on the preparation of this report,
which identifies critical research and information needs for nanoscale
materials. The Subcommittee emphasizes that these research needs were
not presented in any priority research order, and requests feedback on
the development of criteria for establishing priority research.
Almost every research need identified in this report addresses a
critical data gap. To this end we urge the U.S. Government to provide
the necessary funds to implement an aggressive and broad research
strategy. However, we recognize that available funds are limited and it
is necessary to prioritize research needs.
The NNI proposes using a ``value of information strategy'' to
prioritize research needs. This approach is predicated on how to assign
value to different kinds of information. The NNI document identifies
the following factors as indicators of research value:
The extent to which the information will reduce
uncertainty about benefits or risks.
The extent to which information can be expected to
lead to broad knowledge about the property and behavior of
nanomaterials.
The extent of expected use of the nanomaterial.
The exposure potential for workers, consumers, or the
environment.
The potential to leverage relevant existing data.
While we agree that these are useful criteria for evaluating
research priorities, we are concerned about applying some type of
formal ``value of information'' methodology to the prioritization of
nanoscale material toxicity research. At this stage, it is not possible
to apply a typical ``value of information'' methodology to predict what
type of research will optimally reduce uncertainty about risks or lead
to broader knowledge and understanding of nanomaterial behavior without
broadly speculating on potential risks and the types of information
needed to reduce them. Value of information methodologies rely on
quantifying the harms being reduced, which is not possible at this time
for nanomaterial risks. Moreover, in the setting of an emerging
technology such as nanotechnology, the economic consequences of
obtaining or failing to obtain critical information on toxicity are in
reality so unpredictable that formalizing the costs and benefits
through a value of information analysis is artificial and potentially
misleading. While some of the principles of a value of information
approach are valid for prioritizing nanomaterials risks, we recommend
that reference to this formal methodology be removed. In our comments
below, we provide additional recommendations on how to proceed with
prioritization in the face of multiple major knowledge gaps, and on the
relative roles for industry and government research programs.
Based on our assessment of the report Environmental Defense would
like to provide support for the EHS research portfolio, and present
specific comments and recommendations pertaining to the need to
prioritize the EHS research. The summary outline of EHS research needs
is reproduced here, with numbering and lettering added to facilitate
direct references in the text below to the research needs identified in
the NNI document.
1. Instrumentation, Metrology, and Analytical Methods
a) Methods for detection nanomaterials in biological matrices,
the environment, and the workplace
b) Methods for standardizing particle size and size
distribution assessment
c) Methods and standardized tools for assessing shape,
structure, and surface area
d) An inventory of engineered nanomaterials and their uses
2. Nanomaterials and Human Health
a) Understanding the absorption and transport of nanomaterials
throughout the body from different exposure routes--methods
development
b) Understanding the properties of nanomaterials that elicit a
biological response
c) Identification and development of appropriate in vitro and
in vivo bioassays
d) Methods to quantify and characterize exposure to
nanomaterials in biological matrices
3. Nanomaterials and the Environment
a) Evaluation of testing schemes for ecological effects
b) Evaluation of factors affecting fate and transport
c) Understanding the transformation of nanomaterials under
different conditions
4. Health and Environmental Surveillance
a) Understanding exposures in the workplace and factors that
affect them
b) Quantification of exposure from industrial, consumer, and
other sources
c) Establishment of environmental monitoring protocols
5. Risk Management
a) Improve understanding of process design and engineering
controls
b) Develop ``green design'' techniques
c) Determine product life cycles and potential impact on EHS
d) Evaluate current risk communication strategies for known
and anticipated risks
Below we present four overarching criteria that we believe should
be used to prioritize the many research needs identified by NNI. These
criteria are:
Research that will develop the ``enabling
infrastructure.''
Information that will facilitate ``look back''
studies.
Selection of materials should focus on key concerns
related to toxicity and biological response.
Selection of relevant materials and methods.
Criterion 1: Research that will develop the ``enabling
infrastructure.''
We strongly recommend that federal funds be used first and foremost
to acquire fundamental knowledge that is needed to develop the
``enabling infrastructure'' for nanomaterial EHS, which is best
addressed by the Federal Government. This ``enabling infrastructure''
includes developing and standardizing, for routine application, the
methods, tools (e.g., instrumentation) and basic scientific
understanding needed to measure and assess:
Physical-chemical characterization of nanomaterials;
Sampling and analysis;
Detection and monitoring: in workplaces, air/
waterborne releases, humans and other organisms, environmental
media;
Biological and environmental fate and behavior;
Acute and chronic toxicity; and
Hazard, exposure and risk.
Development of the enabling infrastructure will advance industry
research in risk assessment and materials design and testing of
specific materials and products, and will facilitate independent
researchers in pursuit of general and applied nanoscale research.
There are several lines of research discussed in the NNI document
that can be included in this category. For example, we agree there is a
critical need for the development of methods to detect, quantify and
characterize nanomaterials in biological matrices, the environment, and
the workplace (1a, 2d).\2\ The development of these methods will
facilitate a cascade of additional research pertaining to fate and
transport in humans and non-human organisms from different exposure
routes, and fate, transport, and transformation in the environment,
which are also of high priority, and addressed in more detail below.
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\2\ Numbers/letters in parentheses here and in the remainder of the
text refer to items in the research outline provided above, to indicate
the category and subcategory from the NNI document to which they refer.
---------------------------------------------------------------------------
Another critical data need identified by the NNI is the development
of methods for the standardized characterization of nanomaterials:
particle size, size distribution, shape, structure, and surface area
(1b, 1c). This will, in turn, advance government research on risk
assessment, development of quantitative structure-activity
relationships, and ultimately identification of the key properties of
nanomaterials that elicit biological responses.
The Federal Government also needs to plays an important role in the
identification and development of key in vitro and in vivo bioassays
(2c) for acute and chronic toxicity testing, and testing schemes for
ecological effects (3a).
A high priority should be placed on developing methods to identify
nanomaterials that exhibit environmental persistence and/or
bioaccumulation potential. These characteristics are critical
indicators of concern for both environmental and human health, and
nanomaterials exhibiting these properties require additional scrutiny.
With such methods, research agencies could assess a broad array of
materials and subsequently focus other lines of research on those
materials presenting greater potential risk on the basis of their
persistence and accumulation potential.
Testing protocols developed by the government can then be used by
industry to demonstrate the safety of their product or to identify
risks requiring mitigation. They are also the key step required for the
development of robust and health protective risk assessment and risk
management protocols.
The status of available assays for nanomaterials was recently
reviewed in a workshop sponsored by Environmental Defense, the Center
for Biological and Environmental Nanotechnology at Rice University, and
the Woodrow Wilson Center, and attended by scientists from government,
academia, industry, and non-profit organizations. The consensus of the
attendees was the highest priority methods development needs include
physical chemical characterization (structure, concentration, and
surface properties, addressed above), and ADME/Translocation methods,
which is equivalent to understanding the absorption and transport of
nanomaterials throughout the body from different exposure routes (2a),
particularly for in vivo bioassays (e.g., nanoparticles tracking,
aggregation, transformation, solubility and stability, transmembrane
movement, and bioaccumulation/bio persistence). The workshop
proceedings are in preparation, and will be provided to the NNI upon
acceptance for publication.
Although we can and should expect industry to address product-
related research needs, the research listed above will be critical in
generating the means by which industry can most effectively evaluate
its own products. This is not to say that there is no role for industry
prior to the development of the enabling infrastructure, as most
standard apical bioassays will allow for the evaluation of potential
toxicity, even in the absence of tissue quantification methods. For
instance, both inhalation and instillation rodent bioassays have been
very useful for elucidating toxicity for inhaled nanomaterials.
Advancing research methods will require an iterative approach,
measuring the outcome of new bioassays against standard apical
bioassays. There is certainly the potential for government-industry and
other stakeholder involvement in government-led initiatives in
partnerships for methods development, and industry co-funding of such
research should be pursued, as long as the government retains the
ability to manage and direct it.
Other considerations: Primary environmental or public health
research, whether conducted intramurally or extramurally, should be
directed and overseen by federal agencies that have an environmental or
public health mission, such as the Environmental Protection Agency
(EPA), the National Institute for Environmental Health Sciences
(NIEHS), or the National Institute for Occupational Safety and Health
(NIOSH). Currently, the National Science Foundation (NSF) funds and
oversees more than 50 percent of the nanomaterials environmental health
and safety research. NSF, which lacks any public health or
environmental mission, may not be in the best position to identify and
oversee such research.
Both extramural and intramural research have important roles to
play, but to date too few funds have been devoted to building the
needed intramural research capacity. Federal funding for both
intramural and extramural research can and should reflect research
priorities by more tightly focusing calls for proposals on key
environmental and health research objectives. Increased funding for
intramural research at federal agencies and laboratories is needed to
conduct more applied research and to address specific priorities that
are less likely to be efficiently addressed by academic or
institutional research.
Although such federal research institutions may not now have the
capacity to immediately fully absorb the resources needed for
intramural research, immediate priority should be placed on building
that capacity as rapidly as possible. This capacity-building and
research agenda should be viewed as investment that will facilitate the
responsible development of emerging nanotechnologies.
Criterion 2: Information that will facilitate ``look back'' studies.
The prioritization of federal research should be undertaken with
the understanding that we have critical knowledge gaps in the face of
ongoing and growing exposures. In order to lay a foundation for
understanding potential risks that may only manifest themselves well
after exposures start, we need to know what types of nanomaterials are
present in products, who is and has been employed in production, and
who may be coming into contact with nanomaterials now. As we move
forward in research to fill the knowledge gaps in the laboratory, the
Federal Government should also address current and emerging exposures
in the workplace by developing a registry of workers who have worked
with or used nanomaterials for at least four weeks. This will not only
aid in helping to understand ``exposures in the workplace and the
factors that affect them'' (4a), but will also facilitate future
epidemiologic studies of workers, a critical research need that is not
sufficiently emphasized in the report. In addition, EPA, FDA and CPSC
should collaborate in developing nanomaterial and nanomaterial-
containing product registries and inventories, which will also
facilitate additional ``look back'' research to the extent it is needed
in the future. This will help to meet the following research needs
identified in the NNI report: an inventory of engineered nanomaterials
and their uses (1d), and the identification and quantification of
exposure from industrial, consumer, and other sources (4b).
Criterion 3: Selection of materials should focus on key concerns
related to toxicity and biological response.
Companies can and should be expected to concentrate their
environmental health and safety research and testing programs on
nanomaterials used in commercial applications, where they should employ
life cycle approaches to identify all known and reasonably anticipated
exposure scenarios. In contrast, government sponsored research should
focus more on nanomaterials that will best elucidate general principles
of toxicity and biological response (similar to 2b), for example,
seeking to understand mechanisms whereby nanomaterials may readily
translocate across biological interfaces, bioaccumulate, interact with
cells or specific macromolecules (e.g., the stimulation of collagen
formation in fibroblasts noted with carbon nanotubes), or generate
reactive oxygen species. By focusing research on those nanomaterials
that exhibit these and related characteristics of biological relevance
and concern, federal research will advance knowledge of the features
and characteristics most associated with biological responses, and also
may facilitate the development of structure-activity relationships.
Acquisition of these data not only can contribute to the construction
of general principles regarding nanomaterials toxicity, but will also
provide nanomaterial developers with important information that can be
used to design ``green'' nanomaterials that do not exhibit these
properties.
While the costs and characteristics of some nanomaterials make the
conduct of chronic bioassays or multi-generational testing challenging,
in general there is likely much greater potential for nanomaterials to
cause more subtle, chronic effects rather than acute toxicity--effects
that may well be missed by only conducting acute testing. We therefore
recommend that a number of nanomaterials with high potential for
chronic exposure be tested for chronic toxicity to begin to gain
understanding of potential long-term effects.
The government should also pursue and fund research in a manner
that provides not only an in-depth characterization of specific
categories of nanomaterial, but also fully elucidates the effects of
variations (in manufacturing processes, surface modifications, etc.)
among materials within those categories on key biological properties.
The NIEHS has begun this process by testing at least two variations of
each category of nanomaterials it is studying. Only by expanding this
approach will we begin to develop the much needed predictive capability
to interpolate or extrapolate among structurally related materials.
The NNI report indicates that government research efforts at the
National Cancer Institute, National Institute for Environmental Health
Sciences, National Institute for Occupational Safety and Health, the
Food and Drug Administration, and the National Toxicology Program are
focused on metal oxides (particularly TiO2 and ZnO), quantum dots,
fullerenes, and carbon nanotubes. While it can be useful for discussion
purposes to group nanomaterials into broad categories such as metal
oxides, carbon-based materials, etc., the assumption that the members
of such categories possess the same or similar biological properties is
at this stage a hypothesis. For example production by different
processes or surface modifications of the same basic material can
dramatically alter the characteristics and behavior of a nanomaterial.
Considerable empirical test data will be needed to test any ``category
hypotheses,'' i.e., to determine the actual extent of similarity, or
the regularity and predictability of trends, among category members,
with respect to both hazard and exposure characteristics.
Criterion 4: Selection of relevant materials and methods.
Research should also consider the need to test materials and
applications that are now or are projected to be the most relevant,
based on likelihood of release and exposure--examined on a life cycle
basis. As noted in the report, ``. . .the exposure potential for some
nanomaterials will be limited to nonexistent whereas exposure potential
for other materials will exist at one or more stages of their product
life cycle.'' Selection of the most relevant materials should be based
on a systematic assessment of nanomaterials with known or reasonably
anticipated human and environmental exposure potential over the life
cycle of a broad array of materials.
Additional Comments: Need for public database for nanomaterial EHS
data.
The development of a publicly available database containing the
results of environmental health and safety testing data is an urgent
need that can be readily addressed through government funding. There is
precedent to make this information available. One recent example of
such a database is the EPA's High Production Volume Information System
(HPVIS), which is providing access to hazard data on hundreds of
chemicals. Directly relevant to nanoparticles are: 1) the NIOSH
Nanoparticle Information Library (http://www2a.cdc.gov/niosh-nil/
index.asp), which includes physical chemical and toxicological data on
a select number of nanomaterials, and 2) the National Cancer
Institute's Nanotechnology Characterization Laboratory's publication of
the results of the testing of nanomaterials, performed at the request
of private companies (http://ncl.cancer.gov/index.asp). The reports are
issued following a 90-day lag to allow for the management of
confidential business information. These efforts should be consolidated
and expanded to include the results of testing performed by industry
laboratories to facilitate the dissemination of EHS data.
Chairman Baird. Mr. Ziegler.
STATEMENT OF MR. PAUL D. ZIEGLER, CHAIRMAN, AMERICAN CHEMISTRY
COUNCIL NANOTECHNOLOGY PANEL
Mr. Ziegler. I am Paul Ziegler, Chairman of the American
Chemistry Council, Nanotechnology Panel. I appreciate the
invitation to address the House Committee on Science and
Technology on the role of NNI in planning and implementing the
environmental, health, and safety necessary for the responsible
development of nanotechnology.
ACC represents the leading companies that are engaged in
the business of chemistry. In 2005, ACC formed the Nano Panel
consisting of companies that manufacture, distribute, and use
nanotechnology in business interests in products of
nanotechnology. The panel was formed to foster the responsible
application of nanotechnology, to coordinate nanotechnology EHS
initiatives undertaken by member companies and other
organizations, to facilitate the exchange of information among
member companies and other domestic and international
organizations on issues related to all aspects of
nanotechnology.
In discussing federal EHS research priorities, I first
would like to emphasize that improved federal coordination and
support are essential for the responsible development of
nanotechnology and its commercial acceptance. The Federal
Government has a unique and critically important role to play
in coordinating and adequately funding the research on EHS
aspects of nanotechnology. It is clear, however, from the
August 2007 draft report of the Nanotechnology Environmental
Health Implications Working Group, ``Prioritization of
Environmental Health and Safety Research Needs for Engineered
Nanoscale Materials'' that the current priority setting process
is slow and incomplete. We applaud the part of the August
report that focused on EHS priorities from 75 to 25. However,
the criteria for reducing these priorities was not fully
articulated, nor was it clear how the 25 priorities fit
together in a cohesive strategy. Moreover, the draft report
does not articulate the research roles of each participating
federal agency. The panel is disappointed that there is no
correlation of the 25 identified research areas to risk
management or urgently needed research. We encourage NEHI to
complete quickly the prioritization of the identified research
areas, complete the final research strategy, and initiate the
top priority projects. Specific projects need to be identified
with annual funding requirements and realistic deliverables and
timelines. The high-quality, comprehensive, and prioritized EHS
research agenda is still missing and should: one, focus on risk
assessments and the generation and application of information
on the continuum of exposure, dose, and response; two, promote
new interdisciplinary partnerships that bring visionary
thinking to research on nanotechnology; three, support better
understanding of the fundamental properties of nanomaterials
that have an impact in the exposure dose response paradigm;
four, develop processes for establishing validated standard
measurement protocols so that individual or categories of
materials can be studied; five, clearly delineate the
responsibilities, programs, timelines, and anticipated results
of funded projects for each federal agency; six, leverage
planned and ongoing work with the Organization for Economic
Cooperation and Development, OECD, working party on
manufactured nanomaterials, particularly in identifying ongoing
or planned research projects by other companies and
interpreting the results of this research and testing of
representative nanomaterials using standard test methods to
assess potential health or environmental hazards.
ACC has communicated at length with EPA, NIOSH, and other
parties on the information that could assist by EHS research
projects and would be useful in the near term. These issues
include information on handling of nanomaterials in dry form
and potential exposures; information on environmental releases
related to production and use of nanomaterials in air, water,
solid waste potential exposures unique to nanomaterials and
risk management; information on the fate and transport
mechanisms of nanomaterials in the environment; information on
hazards of nanomaterials, basic and acute, supplemented by
appropriate tiered decision-making structure for further
testing; information leading to the development of workplace
practices and guidelines; and finally, information on the
explosion hazard potential that has been alleged with some
nanomaterials.
The panel also urges as an appropriate next step the
funding of an independent review by the National Research
Council Board of Environmental Studies and Toxicology, or BEST,
to establish EHS research priorities for manufactured
nanomaterials and a substantial increase in federal funding.
On February 22, ACC along with 18 organizations requested
that Congress appropriate $1 million for BEST to develop a
roadmap for federal EHS projects. This would have enabled BEST
to develop a roadmap and strategy for the Federal Government
for EHS research needed to support safe use and development of
nanoscale materials and technologies.
Until appropriate measures are developed as part of the
comprehensive research to measure the results of EHS funding, a
specific multi-year timetable for funding is premature. The
research strategy should be sufficiently flexible to take into
account results from completed research, address information
gaps that may arise and be adjusted so that projects are not
continually funded.
ACC and member companies of the Nanotechnology Panel
strongly support EPA's planned Nanomaterials Stewardship
Program. Information gained under this, along with the
occupational exposure information gained by NIOSH, supporting
research of other federal agencies and information from
international bodies such as OECD will assist in prioritizing
the EHS research projects.
In closing, I would like to emphasize the importance of
significant and sustained federal funding for development and
implementing comprehensive nanotechnology research strategy.
ACC urges the prioritization process for EHS research to be
completed expeditiously and at best be funded and complete a
research roadmap and strategy. While a foundation for this
important process has been established, NNI must complete its
task with renewed sense of urgency. The agencies need to
identify what needs to be done, what they will do, put together
a timeline, and do it.
Thank you.
[The prepared statement of Mr. Ziegler follows:]
Prepared Statement of Paul D. Ziegler
Introduction
The American Chemistry Council (ACC) appreciates Chairman Gordon's
invitation to address the House Committee on Science and Technology on
the role of the National Nanotechnology Initiative (NNI) in planning
and implementing the environmental, safety, and health research
necessary for the responsible development of nanotechnology.
ACC represents the leading companies engaged in the business of
chemistry. ACC members apply the science of chemistry to make
innovative products and services that make people's lives better,
healthier and safer. ACC is committed to improved environmental, health
and safety performance through Responsible Care, common sense advocacy
designed to address major public policy issues, and health and
environmental research and product testing. The business of chemistry
is a $635 billion enterprise and a key element of the Nation's economy.
It is one of the Nation's largest exporters, accounting for ten cents
out of every dollar in U.S. exports. Chemistry companies are among the
largest investors in research and development. Safety and security have
always been primary concerns of ACC members, and they have intensified
their efforts, working closely with government agencies to improve
security and to defend against any threat to the Nation's critical
infrastructure.
In 2005, ACC formed its Nanotechnology Panel consisting of domestic
producers that are engaged in the manufacture, distribution, and/or use
of chemicals that have a business interest in the products of
nanotechnology.\1\ The Panel was formed to foster the responsible
application of nanotechnology; to coordinate nanotechnology
environmental, health, and safety research initiatives undertaken by
member companies and other organizations; and to facilitate the
exchange of information among member companies and other domestic and
international organizations on issues related to applications and
products of nanotechnology. The Panel supports nanotechnology products
and applications that are consistent with ACC's Responsible Care
Program, and consistent with the Joint Statement of Principles the
Panel and Environmental Defense issued on June 22, 2005 to help ensure
that the commercialization of nanoscale materials proceeds in a way
that protects workers, the public, and the environment.
---------------------------------------------------------------------------
\1\ Panel member companies include: Air Products and Chemicals,
Inc., Arkema Inc., Arch Chemicals, BASF Corporation, Bayer Material
Sciences Corporation, Cytec Industries, The Dow Chemical Company,
DuPont, Eka Chemicals, Elementis Specialties, Evonik Degussa
Corporation, Honeywell, Oxonica, PPG Industries, Inc., Procter &
Gamble, Rohm and Haas Company, and Sasol North America, Inc.
I. Improved Federal Coordination and Support Are Essential for the
---------------------------------------------------------------------------
Responsible Development of Nanotechnology and Its Commercial Acceptance
The Federal Government has a unique and critically important role
to play in coordinating and adequately funding research on the
environmental, health, and safety (EHS) aspects of nanotechnology. In
this regard, the NNI is tasked with coordinating nanotechnology
research across dozens of federal agencies. This task necessarily
requires a prioritized research strategy that clearly delineates the
roles of the participating federal agencies. It is clear, however, from
the August 2007 draft report of the Nanotechnology Environmental and
Health Implications (NEHI) Working Group, Prioritization of
Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials, that the current priority setting process is slow
and incomplete.
We applaud that part of the August 2007 NEHI Working Group's draft
report that focused the EHS research priorities from 75 to a more
manageable 25. However, the criteria for reducing these priorities were
not fully articulated. Nor is it clear how the 25 priorities fit
together into a cohesive strategy. Moreover, the draft report does not
articulate the research roles of each participating federal agency.
The Panel is disappointed that there is no correlation of the 25
identified research areas to risk management or ``urgently'' needed
research. We encourage NEHI to complete quickly the prioritization of
the identified research areas, complete the final research strategy,
and initiate the top priority projects. Specific projects need to be
identified with annual funding requirements and realistic deliverables.
At the Working Group's present pace, others will be establishing a
coherent research strategy for implementation by the various federal
agencies without the involvement or perspective of all NEHI members.
A high quality, comprehensive and prioritized EHS research agenda
is still missing and should:
Focus on risk assessments, and the generation and
application of information on the continuum of exposure, dose
and response;
Promote new interdisciplinary partnerships that bring
visionary thinking to research on nanotechnology;
Support better understanding of the fundamental
properties of nanomaterials that have an impact in the
exposure-dose-response paradigm including the key properties
of:
1. Size and size distribution;
2. Surface area of the primary particle;
3. Shape of the primary particle;
4. Chemical composition of the material;
5. Agglomeration state in the medium used to treat the
test system;
Develop processes for establishing validated standard
measurement protocols so that individual or categories of
materials can be studied;
Clearly delineate the responsibilities, programs,
timelines, and anticipated results of funded projects for each
federal agency. For example, the National Institute for
Standards and Technology (NIST) should take responsibility for
identifying what reference nanoscale materials should be
developed and manage their development. EPA should be
responsible for developing and evaluating methods to assess
exposure to and potential effects of exposure to nanoscale
materials. The Food and Drug Administration (FDA) and the
National Institute for Occupational Safety and Health (NIOSH)
should focus their research efforts on understanding the
absorption and transport of nanoscale materials in the human
body, and better utilize industry's research experience prior
to making final research priority recommendations. To date,
industry's role has been largely restricted to passive review
of decisions already made. Industry's considerable experience
could be better utilized by being actively engaged earlier in
the process; and
Leverage planned and ongoing work by the Organization
for Economic Cooperation and Development's (OECD) Working Party
on Manufactured Nanomaterials, particularly in identifying on-
going or planned research projects by other countries and
interpreting the results of this research, and the testing of
representative nanomaterials using standard test methods to
assess potential health or environmental hazards.
In addition, the NNI should consider compiling a list of ongoing
and completed EHS research or support activities already under way such
as at the International Council on Nanotechnology (ICON). This list
should be updated regularly and made publicly available to ensure
important research is communicated timely and accurately. The public
would also benefit from the NNI ensuring that databases on consumer
products believed to contain nanomaterials are accurate.
ACC has communicated at length with EPA, NIOSH, and other parties
on information that could be assisted by EHS research projects and
would be useful in the near term. These research issues include the
following items:
Information on the handling of nanomaterials in dry
forms and potential exposures to users incorporating
nanomaterials into product applications;
Information on environmental releases related to the
production or use of nanomaterials--air, water, and solid waste
potential exposures unique to nanomaterials and risk management
methods;
Information on the fate and transport mechanisms for
nanomaterials in the environment;
Information on hazards of nanomaterials--basic and
acute data supplemented as appropriate by a tiered decision-
making structure for further testing;
Information leading to the development of workplace
practice guidelines; and
Information on the explosion hazard potential that
has been alleged with some nanomaterials.
Within the most recent NEHI report, ACC agrees with the 25
identified research areas within the five research categories
identified by the Working Group. Within Category #1, the Panel
specifically believes that Projects 1, 2, and 5 are high priority
research areas. The Panel notes that all the projects in Category #2
were considered by the Working Group to be equal in priority. The Panel
agrees with this assessment since these research areas are likely to be
interrelated.
The Working Group identified five priorities for Category #3--
Nanomaterials and the Environment. In its January, 2007 comments, the
Panel noted the importance of research on environmental transport and
fate of nanomaterials. The Panel recommends that Projects 4 and 5
dealing with transport and fate receive the highest priority. Category
#4 covers health and environmental exposure assessment and includes
research projects currently underway. The Panel encourages the Working
Group to consider the pilot studies underway by NIOSH that are designed
to characterize worker exposure and better understand workplace
processes and factors that determine occupational exposure to
nanomaterials. Risk management methods are addressed in Category #5,
and the Panel notes that the Working Group established priorities for
each of the five identified areas. The Panel believes that all five
areas are important research priorities, but notes that accurately
communicating information on the hazards from and potential exposure to
nanomaterials should remain a top priority.
II. The Panel Urges as an Appropriate Next Step the Funding of An
Independent Review By the National Research Council Board of
Environmental Studies and Toxicology (BEST) to Establish EHS Research
Priorities For Manufactured Nanomaterials and a Substantial Increase in
Federal Funding of EHS Programs For Manufactured Nanomaterials
The Panel believes that the National Academy of Sciences' Board of
Environmental Studies and Toxicology (BEST) has an important role to
play in completing the ``next steps'' articulated in the NEHI Working
Group's report. On February 22, 2007, ACC, along with 18 organizations
requested that Congress appropriate $1 million for BEST to develop a
roadmap for federal EHS research projects and set priorities suitable
for federal funding (letter appended to this statement). This funding
would enable BEST to develop a roadmap and strategy for the Federal
Government for environmental, health, and safety research needed to
help support the safe development and use of nanoscale materials and
nanotechnologies.
At current funding levels, only a small percentage of the NNI funds
have been directed to environmental, health, and safety research.
Moreover, the federal budget at other agencies with a significant
interest in nanotechnology, such as EPA and NIOSH, is inadequate in
light of the enormity of the task at hand. The Panel believes that a
more appropriate balance is needed between the funding of potential
health effects studies and environmental studies. In general, the Panel
believes that approximately 5-10 percent of the overall NNI budget
should be focused on EHS research projects on an annual basis. This
range is consistent with the range of funding private industry devotes
to research and development. Additionally, more funds should be
directed to environmental exposure research.
Until appropriate metrics are developed (as part of a comprehensive
research strategy) to measure the results of the EHS research funding,
a specific multi-year timetable for funding is premature. The research
strategy should be sufficiently flexible to take into account results
from completed research, address information gaps that may arise, and
be adjusted so that projects are not continually funded.
III. Identifying and Minimizing Potential Health and Environmental
Risks Is Consistent With the Responsible Development of Nanotechnology
ACC's Nanotechnology Panel member companies are committed to
support and actively promote the safe manufacture and use of the
products of nanotechnology, consistent with the ACC's Responsible Care
program--a set of ethical principles and management systems, now
nearing its 20th year, designed to improve continuously its member
companies' safety, health and environmental performance. This long-
established program helps guide the Panel members' approach to the
development of nanotechnology, just as it does for more conventional
and better understood industrial chemicals and processes.
ACC and the member companies of its Nanotechnology Panel strongly
support EPA's planned Nanomaterials Stewardship Program (NMSP).
Information gained under the NMSP, along with occupational exposure
information gained by NIOSH, supporting research of other federal
agencies, and information from international bodies such as OECD, will
assist in prioritizing EHS research projects for the foreseeable
future.
IV. Conclusion
In closing, ACC would like to emphasize the importance of
significant and sustained federal support for developing and
implementing a comprehensive nanotechnology research strategy,
particularly in areas of worker safety, human health, and the
environment. Federal Government support for a comprehensive EHS
research agenda is essential to the sustained and responsible
development of nanotechnology.
ACC urges that the prioritization process for EHS research be
completed expeditiously and that BEST be funded to complete a research
roadmap and strategy.
While the foundation for this important process has been
established, NNI must complete its task with a renewed sense of
urgency.
Biography for Paul D. Ziegler
Education
1984--Program for Executives, Carnegie Mellon University
1976--Master of Science in Hygiene, University of Pittsburgh, Graduate
School of Public Health
1973--Master of Public Health in Environmental Health, University of
Pittsburgh, Graduate School of Public Health
1968--Bachelor of Science in Pre-Med (Biology/Chemistry), Lincoln
Memorial University, Harrogate, Tennessee
Professional Experience
April 1, 2007-Present
Retired/Consultant
October 2003-April 1, 2007 (Retired this date)
Global Director Product Compliance Assurance, PPG Industries, Inc.
Report to Global Director EHS, serving all PPG SBU's. Globally this
position is responsible for reviewing and assessing product/process
related risk, of PPG's products and businesses at an SBU and Corporate
level. This includes but is not limited to three major components: 1)
Risk Assessment of PPG products and SBU processes & systems; 2)
Technical management of any product compliance issues, discrete
enforcements events and product-related litigation in conjunction with
the Law Department and outside counsel; 3) Horizon or long-term
assessments relating to globally emerging product regulations and
liability trends. Work closely with all appropriate functions and SBU's
and keep the appropriate levels of management informed.
October 1999-October 2003
Global Director Product Stewardship, PPG Industries, Inc. Report to
Corporate Vice President EHS, serving 16 SBU's on a global basis.
Responsibilities include development and implementation of policies/
programs to ensure products can be developed, produced, distributed,
used and disposed of in a safe and environmentally sound manner and
advise customers on their safe use and handling. EHS concerns will be
integrated into all aspects of our businesses.
As part of the Corporate EHS Leadership Team, have duty to drive
the EHS Process and Management System into the SBU's and manufacturing
facilities, integrating it into each Strategic Business Unit providing
technical assistance/guidance to the SBU, as they develop/tailor their
requirements to meet the EHS management needs of the SBU and facilities
worldwide.
Supervise a group of 32 associates, focusing on HazCom, Regulatory
Compliance, Hazardous Materials Transportation, Toxicology, EHS IT, and
share supervision of European Group. Also responsible for Global
Emergency Response. As part of our Regulatory focus, we must deal with
FDA/USDA/NSF/FIFRA issues, providing assistance to SBU's, utilizing
outside counsel/technical consultants as appropriate, develop GMP/GLP
documents and participate in various inspections.
Member of a number of standing committees--EHS Leadership;
Management Development/Talent Review; Salary Review; Quality Council;
European EHS Council; Acquisition/Divestiture Committee; Customs/NAFTA
Steering Committee.
April 1987-October 1999
Director, Environmental Health Sciences for C&R Group, PPG
Industries, Inc. Report to Director, C&R Manufacturing.
Responsibilities involve the development and implementation of policies
to protect and promote the health and safety of all individuals who
might be affected by the processes, products and/or use of PPG
products. Assure Group compliance with laws, rules, regulations and
Company Policy/procedures for environmental, health and safety issues.
This includes responsibility for personnel, products, testing,
environmental concerns, and facility assets. This also involves Group,
Corporate and regulatory liaisons for worldwide operations. Administer
a comprehensive program covering all product safety, health,
toxicology, environmental and safety issues. Act as a focal point for
conveying information and coordinating health, safety/product safety,
toxicology and medical activities for the C&R Group.
This position is responsible for all of the activities and
responsibilities affecting the health of individuals and must be aware
of safety and environmental issues, both inside and outside the
Company. This covers all activities, processes and products of the C&R
Group, including U.S., Canadian and international operations.
Internationally, the incumbent is responsible for development and
control of the product safety, industrial hygiene and medical
activities of affiliates companies.
Supervised a group of 47 associates in EHS and a European Group of
12 associates.
July 1986-March 1987
Manager, Product Safety, Staff Group, Mobay Corporation (Plastics
and Rubber, Coatings Rhein-Chemie, Fibers). Reported to the Director,
Corporate Industrial Hygiene and Regulatory Compliance and had
responsibility for administering a comprehensive program in the areas
of health, environmental, product safety, regulatory and emergency
response; coordinator for the Mobay Emergency Response Team.
1984-June 1986
Manager, Occupational and Environmental Health and Safety, Group
Level, Mobay Corporation (Plastics/Coatings/Organic and Rubber
Chemical/Corporate Business Development/Deerfield Urethane, Inc./Rhein-
Chemie/Newark Compounding Facility/Wolff Walsrode). Reported to the
Executive Vice President and had the responsibility for administering a
comprehensive program in the areas of health, environmental, product
safety and emergency response for those products handled by the
operating units; coordinator for the Mobay Emergency Response Team.
1976-1984
Manager for the Plastics and Coatings Division of Mobay Chemical
Corporation. Responsible for administering a comprehensive program
covering all product safety and health considerations from research
through actual marketing of the product as necessary to meet the
requirements of the law and the Corporate guidelines for product
safety; coordinator for the Mobay Emergency Response Team.
1974-1975
Product Manager/Noise Pollution Specialist with USC Incorporated,
an environmental/engineering consulting firm in Pittsburgh,
Pennsylvania.
1973-1974
Environmental Protection Specialist with the Department of
Environmental Resources for the State of Pennsylvania in Pittsburgh,
Pennsylvania.
Organizations/Societies
American Industrial Hygiene Association (AIHA), National and Local
Society of Chemical Hazard Communication (SCHC)
National Paint and Coatings Association (NPCA)
American Chemistry Council (ACC)
Discussion
Chairman Baird. Thank you, Mr. Zeigler, and again, thanks
to all of our witnesses. Outstanding information and very
enlightening perspectives.
It is a very difficult task here because, you know, on the
one hand both Dr. Ehlers and I and several other members of the
panel are trained as scientists and you can't ask someone to
prove the negative. It can't be done. But neither is one
justified therefore in assuming the negative, and so the task
before us is how can we try to predict and anticipate what
might happen, while at the same time not hamstringing some
potentially very, very valuable areas of research. And that is
a difficult and tall order. It however is one that probably has
been neglected many times in technologies in the past as Dr.
Ehlers mentioned with certain pesticide applications. But very
often in the history of humankind we have come up with
innovations that we thought to be marvelous and they have had
adverse consequences, and only down the road do we recognize
those.
So I commend all of you for what is actually fairly rare
and extremely difficult matter, which is to try to anticipate
something that we don't know yet what it will be. So the
questions that we will ask are not in any way meant to be
accusatory or condemning. I know the difficulty and the
challenge. But one of the obvious questions would be, so here
is this important report, prioritizing the needs, and it is now
somewhat overdue to say the least. What have the hang-ups been
and when might we expect it. Dr. Teague?
Dr. Teague. I guess I would like to bring up or re-
emphasize a couple of things that I said in my opening comments
that are written in the written testimony. The first one is I
think that there is a sort of a general impression that the
U.S. and the Federal Government is behind what we should be
doing relative to the EHS research. I think it should be really
emphasized that if you look at what the Federal Government has
done over the timeframe that we have been looking at
nanotechnology, that the U.S. has, as I indicated, far and away
invested more money in EHS research than any country in the
world. We have, if you look at the publication of research in
the United States that is funded mainly through the NNI, we
publish far more papers in EHS research than any other country
in the world. We put in place----
Chairman Baird. I am going to interrupt you because I have
somewhat limited time and you pointed all this out in your
testimony, and it is valuable. But what I am hearing from other
folks and the question actually was what is the delay in the
report, and what I am hearing from other folks is one, yes,
there has been a lot of research conducted but it is not clear
exactly what that research is. A second issue is it is not
clear how that was prioritized, and those are both valid
questions. My belief is that the purpose of the report is to
help at least answer the second of those questions, in other
words, how it is prioritized. And to say we spent a lot of
money on research but it is not known exactly what the research
is and it is not known how that was prioritized begs the
question of when will this report be due and why has it been
delayed, notwithstanding the various other things you have
addressed.
Dr. Teague. Okay. I will go directly to your question. This
report has been in the process of developing. We have gone
through the steps that I indicated. Even since the last
hearing, we convened one public hearing based upon the
September report to get public feedback on that. We have
instituted and worked with OMB to get a data call to get a full
look at the government portfolio in EHS-related research. We
have those results. We are now analyzing those results, and we
are comparing those against the priorities that are laid out in
the August document in which we had to prioritize needs.
So we are working toward that. You say why is it taking so
long? There are 20 agencies, 20 organizations involved in this,
and even more particular, experts, program managers, decision-
makers on funding, every aspect that is involved in trying to
build consensus on how we move forward. I hope you agree that
when you have that many groups involved in it, that it can take
time; but we think that the time is well-spent. If we were to,
if anyone were to come forward with a plan which did not have
and was not developed on the basis of consensus of the experts
within the agencies, with our international collaborators--we
are working very intensively with the International
Standardization Organization, we are working intensively with
OECD, we are working with ICON, we are working with those
collaborators as input into our decision-making process.
We expect to have this report out later this year or early
next year, but I assure you that going through this very
deliberative process is essential. It obtains buy-in by the
agencies. They are the ones who will be doing and making
decisions on the funding. Our hope is that this document which
we come forward with will be based upon a consensus input from
the agencies, will have buy-in by the agencies. We want to work
with them and not do anything to them, and to get their full
buy-in you need to have much exchange, and dialogue. And the
analysis of the data call that we got from OMB has been gone
over and is being gone over in great detail. It has been combed
and recombed to ensure that we answer some of the criticisms
that I heard at the table today to make sure that when we do
publish the list of projects, and we will do so, after it has
been vetted with the agencies and after we try to address any
confidentiality issues that might be involved in revealing
projects and associated researchers.
So we think the process is working. We have a huge amount
of buy-in and coordination among the agencies, and as I said,
we share this. We want to do it right. We want to do it right
the first time, and this aim to do well-based, well-thought-out
science that has good buy-in for the agencies we think is
absolutely essential to move forward.
Chairman Baird. I appreciate the clarifications. It is
certainly understandable 20 agencies is perhaps the reason for
the glacial pace. It is the equivalent to the mass of a small
glacier, and I can only imagine how difficult. I think there is
merit to that. However, I will in the later round of
questioning--I will yield to Dr. Ehlers in a second; but I
think there is also legitimacy in exploring some of the
suggestions about in the future whether some alternative
executive structure is needed, or agency. I am not advocating
it, I just want to explore that question with the various
panels.
But for now I will recognize Dr. Ehlers for five minutes.
Mr. Ehlers. Thank you, Mr. Chairman. And I would point out
that Congress was always referred to as moving at a glacial
pace, but I think we are really outstripping work that has been
done on nanotechnology safety. So that is kind of comforting to
us. We at least are moving faster than some.
Dr. Kvamme, I really appreciate your being here and your
testimony and also your work on PCAST. You have done a good job
there. You mentioned that funding increases for EHS,
environment, health, and safety, are appropriate, but to quote
you, you note it is also crucial to note that EHS research also
depends on advances in non-EHS areas, and you gave as examples
instrumentation development and basic research on
nanomaterials. I really appreciate that because all the
nanotechnology hearings we have been going through, it seems to
me everyone is so intrigued with the future of nanotechnology
and they are doing the developmental research; and I am just
not convinced we are doing the basic research that is necessary
to achieve what we really need to know and to proceed on EHS
research. So I just wondered how do you think these advances
could be integrated into a strategic plan, and I will be asking
Dr. Colvin a similar question in a few minutes. You can start
thinking about that.
Mr. Kvamme. Sure. I think the most important thing to
realize is that the interrelationship that I referred to in my
testimony. Let us just take the case of bio-nano. You are
trying to do a good health thing, and so obviously you don't
want to hurt the patient while you are trying to deliver the
therapy. So the inter-relationships of the actual application
and the health and safety aspects are like this, they are tied
right together. And that of course takes other things. It takes
instrumentation, it takes the capability of monitoring the
things. Dr. Colvin mentioned this whole aspect of
predictability. I mean, that is exactly what we are looking for
from, for example, the human genome project. Predictability.
That will take time, but it will also take a lot of
instrumentation, a lot of things of that nature. But using just
that example, and that example applies to numerous other areas
other than bio-nano, you have to be knowing what you are trying
to do as well as its relative safety, and in that case, the
health of the individual is tied into the whole thing.
Mr. Ehlers. Well, I appreciate that insight. One of the
most fascinating articles I have ever read by Gerald Holton of
Harvard who traced the development of high-temperature
conductivity, and it just astounded me reading that, that all
of the ancillary things you think that have no relationships
whatsoever, which turned out to play a crucial role in the
development; and I think that is the situation here, too.
Dr. Colvin, you commented that you thought the U.S.
Government could fix the problem of measuring risk of
nanotechnology quickly and for a relatively low cost. I
appreciate your optimism. Optimism is what makes the world go
'round, what made this nation great. I have also noted it is
entirely appropriate for you to be optimistic because generally
the more youthful people are more optimistic. And so that is a
good spirit to have, but I would like for you to try to be more
specific. How can we do that? I mean, how much is your
optimism----
Dr. Colvin. Well, you took my date, so let me clarify it. I
think that certainly I don't think that you can solve all of
the problems. That particular comment, I regret to inform you,
actually concerned what I consider to be the most immediate
needs for the investments that this government is making in
nano-EHS, and that is to make sure that all of the
investigators funded in these programs from whatever agency
agree on the basic terminology, the basic methods, and the
basic way that we approach doing our science. Right now there
is enormous conflict, different labs don't get the same data
with apparently the same materials; and that sort of disharmony
is really creating a technical literature which is not
conclusive, which is typical for young science. But when that
science impacts decisions, that is a problem.
So unfortunately what I was saying is that to fix that
problem, to get the research community to harmonize and really
come to a rapid agreement on how they are going to do this
research--just the tools--I think can be done fairly quickly
and doesn't involve the kinds of longer-term research
strategies that would be necessary. I think that the academic
research community and the government research community needs
to have, you know, the ability to create standards like the
Miami standards used in approaching ray analysis for the
minimal information needed to interpret quantitative biological
data. There is a model for us to use. And that kind of process
took under two years, was a lot of workshops, the use of the
latest in electronic web communication to help create a kind of
a rules to live by if you are publishing papers in the area.
And that kind of investment, in that case, it was made by the
NIH in their human genome work, really transformed and
accelerated how quickly people could extract information from
that research.
Right now I can't go to an agency and get that, even
little, tiny amounts of money to hold a workshop so we can all
get together and hash out, you know, what is the best way to
measure toxicity for this material. And so that is the need
that I see is so critical, easy to fix, but if we just sort of
let it go and hope it will all work out, it will just take a
lot longer. So I think that is a critical research need, and in
our international workshops, every researcher was just begging
their governments to set, you know, little, small amounts of
money to help them communicate with each other outside the peer
review channels which is what is happening now. And that is
really the piece I talked about. And I am optimistic that we
could do it, yes.
Mr. Ehlers. Well, as John Gardner observed years ago, you
have to be optimistic because if you aren't, you will never
solve the problem.
Dr. Colvin. That is right.
Mr. Ehlers. Thank you very much.
Chairman Baird. Ms. Hooley, the gentlelady from Oregon and
the author of the Nanotechnology in the Schools Act. I am
sorry, Mr. McNerney is ahead of Ms. Hooley. My apologies. Dr.
McNerney from California.
Mr. McNerney. Thank you. You teased my good colleagues, Ms.
Hooley here, but I will accept that anyway.
Dr. Colvin, I spent a lot of my career in the modeling
field, and I was intrigued by your comment about developing--
what did you call it--a predictive simulation tool or tools.
Where are we in that effort? Just elaborate on that a little if
you would.
Dr. Colvin. It is a very exciting concept. So I think that,
you know, maybe 20 years ago the field of biology really
remained descriptive in nature; and what we have seen in the
last decade, even the last five years, is a revolution. You
know, predicting biology is not like predicting the weather
anymore. We have ways of measuring the responses of organisms
that are extremely sensitive. We have amazing computational
tools that are now able to integrate data taken from many
experiments, and there is some very exciting developments in
how you might integrate that data into graphical interfaces. So
you might have a virtual fish or virtual ecosystem that you
could actually put an imaginary nanoparticle into and predict a
response. That is not the stuff of science fiction. That is the
stuff that our Federal Government is currently funding in other
areas, including nanotech.
So I want to see those kinds of capabilities that I think
American science leads in drawn into this problem. So I think
that some of the tools that are out there right now that
weren't there are actually some of the tools of
bioinformatics--the data mining technologies we have to go into
vast amounts of literature and extract correlations and trends,
some of the tools that are happening in predicting complex
systems which are coming from areas as diverse as control
theory and moving in developmental biology. These are really
the cutting-edge areas of science in this country, and they are
perfectly suited to addressing these problems. And I think that
agencies like the National Science Foundation and others
realize that enormous capability. I don't think it is a one-
year program, but I think that you can begin to build these
simulations, begin to have theoreticians as diverse as, you
know, folks who work at the quantum mechanical level talking to
people who might think on the micron level, all the way up to
an ecosystem biologist who thinks about the kilometer world.
And you can make those nanometer-kilometer transitions happen.
And I think that that is actually one of the more exciting
areas.
In our ICON workshops, we held out that vision as something
to organize our theoreticians, our computational biologists,
our toxicologists around it; and I think everybody got really
enthusiastic and was able to also translate that enthusiasm
into a very structured approach to that. So I think that in my
own personal opinion, that is a very exciting area, and it is
one that we could actually do that; and nanoparticles and
nanotechnology are just a really good sort of first problem for
that confluence of informatics biology and materials to come
together.
Mr. McNerney. So as far as today is concerned, there is not
much resources available for that sort of process?
Dr. Colvin. No, unfortunately it is a go-to-the-Moon kind
of project, so it is not something I can sort of throw one
grant in and do. It takes me working with very good modelers. A
lot of good--I mean, it takes a village. So this is why I
suggested it in my written testimony as one example--there are
many others--of a great long-term thing that this government
could actually make happen; but to do so will take a planning
process that I am really hoping that they will be able to
achieve. But I absolutely think it is doable and it is
something that many of us in the field are trying to work
towards in our own ways. But I think the Federal Government and
governments world wide could do a lot to really think through
how could we achieve that.
Mr. McNerney. All right. Thank you. That sounds very
exciting. I would like to see us follow up with that a little
bit.
Dr. Denison, you mentioned the problem of insufficient
oversight on the money that is being spent on EHS and also the
need for single leadership position. Do you think that is
achieved through legislation or through administrative means
going back to the Administration?
Dr. Denison. It is a very good question. I think the NNI,
the National Coordinating Office, and the NEHI itself have
struggled with this issue and have in essence had to go through
a process that was hard to direct from the top, if you will,
because of the nature and the way in which that committee is
structured and the overarching facilitation role that it is
intended to play.
That was part of the original concept of what NNCO was
supposed to be, a coordinating office. So I am not very hopeful
that that kind of more directed and top-down approach that I
think most people think we need, can be accomplished without
some new authority, and that that authority probably does need
to come through a legislative means. So there may be some ways,
and I would be certainly happy to consider other ways of doing
it, but I think it is certainly something that in the
reauthorization process that you are starting should be given
serious attention.
Mr. McNerney. Thank you.
Chairman Baird. The Committee has been joined by Dr.
Gingrey and also Dr. Lipinski. Next, Dr. Bartlett.
Mr. Bartlett. Thank you very much. Nanotechnology is a
relatively new technology, and most I think of our citizens
have little understanding of what it is. They kind of know what
the risks are to using explosives. When you use plastics they
can smother you or mechanical things can cut you or poke you or
compress you. Drugs and chemicals can affect your skin----
Chairman Baird. Is this a Halloween speech, Dr. Bartlett?
Mr. Bartlett. Your brain, your kidney, and so forth.
Radiation, I think they have a general understanding that these
little particles go whizzing through your body and disrupt the
machinery of the cells, so they can cause many and varied
disruptions of the body's physiology and chemistry. What is
there about nanotechnology that is unique? Are there things
about nanotechnology that are different than the various
categories of risk that I went through that we require new
research protocols? I think the average citizen has little
appreciation of the risks that nanotechnology could bring in
addition to those that I have mentioned above for all of these
other risks. Anybody?
Dr. Maynard. If I could take a stab at answering that. I
think it is a very good question because of course we have got
to establish whether there really is anything different and
unique about nanotechnology before we begin to say we need to
do lots of research into the potential risks. I think the
easiest way of demonstrating that is to take an everyday
object. Forget about a nanotechnology for the moment, but take
something like this glass. Pretend that it was made out of
glass rather than plastic, and if I asked you, well, what harm
could you do with that? You would say, well, obviously you can
hit somebody with it, you can throw it, you can smash it. If
you have got a sharp edge, you can cut somebody with it. All of
those risks are associated with the physical nature of it as
well as the chemistry. We all understand that. The physical
form of something is really important.
When we get down to the nanoscale, that holds true exactly
the same it does for something like this. The only difference
is we cannot see the nanoscale materials, so we tend to forget
the physical form is important, and we think we can tell
everything about it just looking at the chemistry. Of course,
if I told you you could tell everything about the risk of a
glass just by looking at what it is made of, which is glass,
you would say, that is ridiculous. I would also say it is
ridiculous to say you can understand everything about risk of a
nanomaterial just by looking at the chemicals it is made up of.
That is the challenge we face, understanding that added
dimension of the physical form of the materials; and we know
from research that has already gone on that physical form that
is important in determining how they harm either the
environment or people.
Mr. Bartlett. Yes, sir?
Dr. Denison. May I make----
Mr. Bartlett. Floyd, you were going to----
Dr. Denison. Let me just add one point to that. I think
Andrew is right about the physical as well as chemical makeup
being essential. Part of the problem with these materials is
that they tend to behave in ways that are different from
ordinary chemicals that we are used to dealing with because of
their physical form. So for example, particles in this nano-
range can get into places that materials that are either
smaller or larger can't necessarily get to. These materials are
also being designed to be highly persistent, very non-able to
be broken down. If those materials, as we know from other
experience, get into the environment or get into people, that
persistence can become a problem.
So there are certain characteristics that are being
designed into these materials for functional reasons,
performance reasons that have a flipside. Now, we cannot over-
generalize and we cannot leap to the conclusion that all of
these materials are necessarily problematic. I personally think
certain applications of certain materials, a fairly narrow set,
are likely to be culprits, but we can't yet identify which ones
are going to be those problems because we don't yet know enough
about how to correlate these properties with their biological
activity.
Mr. Kvamme. I think the important thing to realize here is
that this has been true for every new technology. I had the
pleasure of being at the birth of the semiconductor industry in
1959, '60, '61, in that time. We worked with chemicals that
were also used in San Quentin to put people to death as
diffusants. You had to be very, very careful from a risk point
of view. Yes, they were chemicals, yes, they were larger than
what we're talking about now. But take the biofuel that I
referred to before. The small molecule that goes through the
blood-brain barrier, those have been, you know, researched and
they are very, very difficult to figure out. We were involved
in a company studying the Alzheimer's issues of what was going
on in that particular barrier. So yes, there is differences,
but a lot of the significant ways of looking at the problem
aren't really a whole lot different in my view. However, I
would say it is important to have this integration that I
talked about before of application and safety risk. If you tear
those apart and you create a silo for EHS only and it is not
informed by the application, I will disagree with some of my
fellow panelists here, I think you are making a huge mistake.
You are going against the multi-disciplinary thing that we have
learned in our universities is so valuable, having a cross-link
of capabilities. You have to understand both to get the right
answers in my view, and that is why I speak so strongly to the
point of integration and the way the program is now and not
setting up some czar for EHS. I don't think that will be an
informed approach.
Chairman Baird. The gentleman's time has actually expired,
but I am going to extend it a little bit because I think it is
an outstanding line of questions. So if there are others? Dr.
Teague, please.
Dr. Teague. Yes. I guess you were speaking of
nanotechnology and within the NNI we have discussed at length
the question of what is nanotechnology, and I would say the
general definition that we have adopted involves the ability to
work and control matter at the nanoscale. And it is that
ability to control matter at the nanoscale which we say is
approximately one to 100 nanometers which is very, very small.
I typically say, for me to get an understanding that a sheet of
paper is 100,000 nanometers thick; that helps me get a feel for
how tiny the nanometer is. And I think going to Mr. Kvamme's
point about the need for integration; and the point was made
that at this nanoscale, there is a possibility that matter at
this scale can penetrate cell walls and things of that nature.
It is so important to understand that that has the potential to
be a hazard to cells and to the body, but it also offers an
opportunity to deliver therapies. So it is hard to say, is the
ability of a nanoscaled material to penetrate cell walls and to
go inside cells, is that good or bad? It could be good if you
are trying to get therapy into a particular location in the
body. If it happens to be that it poses a hazard, then we hope,
and I think by this integration again, both trying to seek
application as well as to understand their risk, if you
integrate those, then you can use the control of matter at the
nanoscale. If it is a hazard, we hopefully can control it and
we can make it more benign with that high degree of control
that we have at the nanoscale that is being offered by
nanotechnology.
Mr. Bartlett. Mr. Chairman, it might be worth just a moment
for the layman who is reading this to note what the blood-brain
barrier is. If you are trying to get a chemical, a drug, to the
brain, it does not get there anywhere near as easily as it gets
to other parts of the body. So when you are treating an
infection there, an antibiotic which will treat it effectively
in other parts of the body just doesn't get through this
mysterious blood-brain barrier. I haven't been involved in this
technology for a number of years now. Do we know what it is
now?
Chairman Baird. Mr. Bartlett, I am going to--we are well
over time for you and I want to make sure we get the other
witnesses. I think the analogy we would all understand is
blood-brain barrier is similar to the difficulty getting
information from witnesses into the brains of the Members of
the Committee. Very comparable process.
Ms. Hooley, the author of Nanotechnology in the Schools
Act.
Ms. Hooley. I want to thank all of our witnesses today. I
think nanotechnology holds so much promise, and there is so
much we still don't know about it.
If we think five years ahead, what would be the various
options, if we were determined through implication studies,
that there were unintended consequences to nanotechnology? Any
one of you want to answer? Go ahead.
Dr. Denison. I think we need to always keep in mind the
range and types of applications of these materials that we are
addressing. And there is no question that some applications are
going to be relatively easy to contain or control. They pose
very little risk of exposure because of the nature of the
application. Material that is imbedded in a permanent way
inside of a matrix is going to be much less of a problem than
something that you put into a cosmetic that you apply to your
skin.
So I think one of the things we need to be prepared to do
is to recognize that there may be types of applications for
certain materials that we simply don't know enough about to
advance significantly. And the concern I have is that we are
not applying the brakes in certain places. We already have
nanomaterials of a variety of types in cosmetics, in dispersive
applications that are going to introduce these materials in a
fairly uncontrolled way and exposing the people and the
environment.
So I think what we need to do is go cautiously in those
types of applications, and we have every reason to expect they
are going to be dispersive or directly expose people until we
know more about these materials and their properties and
whether they in fact pose risks. That is the major piece of
advice I would offer.
Ms. Hooley. Anyone else want to tackle that?
Mr. Ziegler. Yes. I certainly agree with what Dr. Denison
just said. You really need to understand along the life cycle
of any chemical where are the potential exposures, and some of
the basic stuff that certainly that I look for at the grass
roots, being a practicing industrial hygienist, is what is the
exposure in production. If I am dealing with a powder, it can
be pretty high. The risk is significant. The potential hazard
is great, but if I can get that into a matrices, into a resin,
or into a solution, that hazard and risk is still there but it
goes way down. And I think that is something that really helps
us understand how we need to control this or approach it. It is
quite common with any chemical that we develop that we have to
understand what the exposure is going to be along the
manufacture, incorporation into products, and then at the end-
use level. That certainly is one of the gaps that I think
exists that we don't have a good way to get an exposure.
Fortunately, most of the manufacturing is closed-system; and we
try to get it into some matrices before it is just put into the
environment so the next level of use has a lot more control of
the exposure.
Ms. Hooley. Cadmium is currently used in a lot of new
nanotechnology applications, but it is a heavy metal, similar
toxicity problems as mercury or lead. In light of the recent
concerns about lead in consumer products, what is to prevent
these nanotechnology applications that use cadmium from being
the next type of consumer product that cause safety concerns?
Dr. Teague. Let me take a shot at that.
Ms. Hooley. All right.
Dr. Teague. I am aware that cadmium is used in some of the
quantum dot products, cadmium selenide and some of the other
ones because of its fluorescent properties. I am not too much
aware of it being used in other products. In general, the view
that we have is that the current regulatory system that is in
place from EPA, from FDA, from CPSC, from OSHA are such that
they are appropriate for handling any of these new materials.
They have each taken special attention to any of the new
nanomaterials. Each one of the agencies that I have mentioned
have formed task forces within their agencies to pay special
attention to nanomaterials and to consider how their regulatory
authorities would apply to such materials. The other aspect of
this issue is that it is the responsibility of the
manufacturers to ensure that any materials, any products which
come on the market, are safe. The regulatory agencies are there
to make sure that that is true, but it is the manufacturers'
responsibility to ensure that products, materials, devices are
safe when they come to the marketplace, and we feel confident,
I feel confident, that that is the case with respect to
nanomaterials.
So in the case of cadmium, that particular one, and I think
those are being sold in relatively small quantities, mostly for
experimental applications, at this particular point. Some of it
is being used as a means of quick diagnosis because they have
the nice fluorescence, better than natural fluorescent
materials.
Ms. Hooley. Anyone else? Dr. Denison.
Dr. Denison. Yes, I think you raise an important point that
I think highlights the importance of designing the materials
from the start to avoid potential problems downstream. Using
materials that we know to be highly toxic like cadmium in
applications where we either don't know or we can expect some
release to happen is not a good principle to start with. So
there is quite a bit of talk about green nanotechnology----
Ms. Hooley. Right.
Dr. Denison.--which one element of that is designing out
the potential toxicity or later risk of these materials from
the beginning. While I think Clayton is right that the current
uses of these are relatively limited, quantum dots including
cadmium-based quantum dots are being looked at for a lot of
other applications and may be much higher in volume and so
forth. And the problem with our current regulatory structure is
that for many of the application areas for nanomaterials they
do not provide a sufficient look at those materials before they
hit the market. They either don't meet the thresholds of
tonnages of materials that trigger an assessment or they go in
applications that are regulated by agencies that only have
post-market authorities, to look at a problem only after it has
arisen, like the Consumer Product Safety Commission, like the
FDA with cosmetics.
So for those uses in particular, we need to be very careful
about using materials that we have any reason to expect are
inherently toxic.
Chairman Baird. May I comment? We are expecting votes at
11:30, and in order to make sure that all Members of the
Committee have the chance to ask questions, I am going to
shorten this.
Ms. Hooley. I just want to--five seconds. I would hope that
we do everything we can. Nanotechnology has such great
importance I think to our future, and I would hope that we
would do everything we can as we see materials being used that
are toxic materials, that we figure out a way to get rid of
them before we even start.
Chairman Baird. The gentleman from Georgia, Dr. Gingrey.
Mr. Gingrey. Mr. Chairman, I thank you. You are on such a
Halloween roll today, I probably ought to yield my time to you,
but I do have one question I want to ask and one statement I
would like to make, too. We have passed through this committee
and thanks to the Chairman and my colleagues on both sides of
the aisle, passed green chemistry legislation. We passed it in
the last Congress as well, and hopefully we will get our
buddies in the other body to help us get that through; and here
Dr. Denison just mentioned green nanotechnology. It is amazing,
but we need to do on the growth scale, if you will, we need to
move forward with that.
I am going to ask my question to Dr. Maynard, but hopefully
there will be enough time some of the others can weigh in as
well. Dr. Maynard, you described the Federal Government's
leadership role in nanotechnology EHS research, I think you
said, as slow, badly conceptualized, poorly directed,
uncoordinated, and underfunded.
Dr. Maynard. Did I really say that?
Mr. Gingrey. Why don't you tell us what you really think?
My question is how would you make NEHI more effective? If you
could address that for us I would appreciate it.
Dr. Maynard. Well, first of all, let me acknowledge that
though I agree with that statement, people in the Federal
Government, Clayton Teague and others, have actually been
working very hard to try to make this work, and I applaud their
efforts. But as I said in my testimony, trying hard is not good
enough.
If you look at NEHI at the moment, it is hamstrung in a
number of ways. It is hamstrung because people just do not have
the time to do the work that needs to be done. Everybody is
very, very thinly stretched in that committee. They need the
time to do the right work. It is also hamstrung because they
have little or no authority. They can coordinate activities but
they really can't get what needs to be done to ensure things
like this are safe, rather than just talking about what needs
to be done. They are hamstrung because they don't have a clear
perspective of what the goals are they are trying to achieve.
And getting back to a point Floyd made earlier about
collaboration between different areas to ensure nanotechnology
succeeds. I applaud that. That is essential that we get the
people developing nanotech applications and working with the
people understanding risks. But if you are going to develop
these things safely, you have got to address specific risk-
based questions. You have got to understand what those
questions are and what you have got to do to address them, and
what we have at the moment is we have an applications-driven
attitude where the people setting the questions really don't
understand how risk science works; and to solve that, you have
got to have somebody in leadership that understands the risk-
based issues, the oversight issues, and the regulatory issues.
If you don't have that, I cannot see progress being made.
Dr. Teague. May I respond to that as well?
Mr. Gingrey. Please.
Dr. Teague. I would say that in general among the NEHI
Working Group, by and large no one believes that a nano-EHS
czar is a good idea. In fact, they think it is a bad idea. And
the reason that I think everyone feels so strongly that it is a
bad idea is that no one agency, I don't think even any
centralized organization, would even come close to having the
breadth and the depth of the expertise represented both in the
applications research as well as in the toxicology and other
fields needed as is present in all of the NNI agencies. The 20
agencies I referred to by and large are not just the research
agencies, they are all the regulatory agencies as well. And one
of the reasons that some of those things come to play as much
as they do is that one needs to do a lot of careful planning
and analysis to do good research. A lot of the research that
was done early on was certainly not coordinated from the
Federal Government. I think that is why some of it did produce
some very premature results and a lot of wrong conclusions were
drawn from it. By the careful planning and by tapping into the
depth of experts within the Federal Government and our
collaboration with others outside, I think that we have by far
the best approach to trying to carry out appropriate research
in a careful, deliberately planned way. If one doesn't do that,
the result is typically bad research and research that leads to
premature and often poor results, poor understanding, and
leading to, I think, a lot of misleading conclusions that have
already been drawn because the research was not planned, not
well-conducted.
Mr. Gingrey. Mr. Chairman, if the other witness can respond
very briefly. I know we are running out of time.
Mr. Kvamme. I would just make the point that I think the
real struggle here is do you do this top-down or bottom-up? The
way we looked at it from a PCAST point of view is there is a
lot of stuff bottoms-up that is happening, and I think it is
very, very good stuff. I invite you to go onto Dr. Colvin's
website. A lot of good stuff is coming up, and we are learning
a lot. And I would only say that is the way the semiconductor
industry got started, and we have been pretty successful at it.
That is the way the Internet industry came in, that is the way
the micro-computer came on. I think if you top-down this too
much at this early stage, you are making a mistake.
Chairman Baird. I thank the gentleman, and Dr. Gingery is
being modest when he referred to this committee passed the
green chemistry bill. It was his bill.
Mr. Honda has been a leader and well at the forefront of
the nanotech issue, introduced House Res. 3235 I believe it
was, and Mr. Honda, thanks for joining the Committee and
welcome.
Mr. Honda. Thank you, Mr. Chairman, and I thank you for
inviting me. Just very quickly, I appreciate this kind of
conversation because that bill does address some of the issues
that our blue-ribbon task force that we formed in Silicon
Valley and some of the questions and directions are being
addressed in some of your conversations; and permeating through
a lot of the recommendations was the issue of ethics, and I
think that that is something that as a schoolteacher I would be
always looking for. But I am assuming that that is part of your
value system anyway.
A couple of quick questions, and if the bell rings, then I
will ask if you could respond in writing; but you were talking
about modeling and terminology on modeling, and I guess the
question I have is that when we get to a certain scale in the
nanoparticle activities, the chemistry and the physics all
change. In the modeling area, how do you become predictive in
an area that is not known and unpredictable? And I guess my
second question would be nanoparticles have always existed. It
is nothing new. As a science teacher, I always wondered, then
how did we handle nanoparticles up to now naturally? What are
the differences between a natural-occurring and manipulated
nanoparticles versus man or human manipulated particles? Those
are the two kinds of questions that have been plaguing me.
Dr. Colvin. Let me quickly do this so I can give my other
panelists a chance to speak. So the predictive models are
possible. We actually are pretty good at predicting, for
example, the changing colors of quantum dots from fundamental
principles of quantum mechanics. So we actually know that part.
How we are going to do it I think in the EHS arenas--you know,
I live in Houston, Texas, and when the hurricanes head to us,
there are all these predictive models. But they don't say one
track; they give us a direction with a range. So I think a lot
of the predictive modeling that is developed is actually
statistical. It is not saying exactly what is going to happen.
It is saying likely to happen and with what confidence. So that
would be one comment on predictive modeling.
Mr. Honda. Almost like human variabilities?
Dr. Colvin. Right, and that is a very important point
because I think humans tend to want certainty, and there will
be ranges. And as we get better, we will narrow up those models
and make them more precise; but that is how we will start.
The second part on the natural nanoparticles, that is a
fascinating question. They are out there. It doesn't mean that
all nanoparticles will be safe. There are plenty of natural
things that are not safe, but it does mean that biological
organisms probably have developed ways of processing them. And
in fact, there is already clear evidence that a lot of in vivo
animal studies of nanoparticle interaction shows that our
immune system is quite capable of addressing particular
oxidative stress that is introduced by particles that you don't
see in organisms that are single cellular, for example. So that
is a really important point, and I would just say there is a
lot we need to do to bring that out.
Dr. Teague. I guess one thing that is very important about
your question, and I think sometimes it is a misconception, and
that misconception is that sometimes at the nanoscale some of
our science is new. As Dr. Colvin just indicated, quantum
mechanics doesn't change at this scale. We have the basic
fundamental science to undergird what we are doing, and with
the new computational power, new particular algorithms that are
being developed, we can actually compute from what scientists
call an ab inito calculation, just direct quantum mechanics,
and can predict many other properties up to reasonable sized
nanostructures. We run out of steam at about 10,000-100,000
atoms--but at this size we can predict the properties quite
well. I would also, going back to something you mentioned
earlier, point out that predictive toxicology is something that
the NNI has focused on some and very happy to hear the subject
of modeling brought up in this discussion. We have worked with
Vicki on some of this. But there is a center that is driving
some of this in EPA at the Research Triangle Institute. There
is a center for predictive toxicology that is focusing on
modeling toxicology--now they are turning their attention
toward the predictive toxicology of nanomaterials. And I would
just endorse what she said about your second question.
Dr. Maynard. Can I just very briefly address that second
question? You are exactly right. As you are sitting there, you
are breathing in at least 10 billion nanoparticles per minute,
and you look reasonably healthy. We have all to deal with
these. There are two but's here. The first but is we know
historically people breathe in nanoparticles; some people die.
They are not safe. The second thing is, we have evolved to deal
with certain types of nanoparticles. If you introduce a brand-
new type of nanoparticle to people, we cannot predict that it
will be as safe as the ones we are breathing all the time.
Chairman Baird. Dr. Denison, one final comment?
Dr. Denison. Yes, very quickly. I would just want to
amplify that one of the reasons that the risk part of
nanotechnology started getting attention is precisely because
we know that small particles in that range that are
incidentally produced, primarily through combustion, diesel
exhaust particles, and the like, do in fact have major health
problems. They cause health concerns in people that are exposed
to them. So that is part of the motivation for recognizing that
there is a potential here for engineered materials to have
similar risks.
Mr. Honda. Thank you. Mr. Chairman, thank you in the name
of Robin Williams, nano-nano.
Chairman Baird. Dr. Lipinski and we have about 10 minutes
left, five minutes and we will have to wrap it up. Dr.
Lipinski.
Mr. Lipinski. Well, I will probably make this less than
five minutes, although I just ran out. I had a resolution in
the Transportation Committee, and by the time I had got there
it had already passed. That teaches me that maybe you are
better off not being there.
If I could only find my questions here. First thing, I
would like to thank the Chairman for holding this hearing, and
I want to emphasize Chairman Baird is the only one that I allow
to call me doctor. But as a former chemical engineer,
especially as someone who is very interested in helping to make
this a more green world, it is good to see this article here in
Business Week about saving energy by fighting friction, about
use of nanotechnology to make anything that has a fluid flow
more efficient through nanotechnology. I think it is very
important that especially since we hear about all these issues
right now with the safety of consumer products, especially for
children's toys, but other things that are not really getting
the attention that they deserve. I believe when they are going
out to the public, I think it is very important that as
nanotechnology really more and more--there are nanotech
products out there, and as the world moves more toward using
more nanotech in our products, I think it is very important
that we look at these issues. I thank the Chairman for holding
this hearing.
One thing I wanted to ask, are we right now looking at
comparatively the new nanotech products? Are we comparing those
to products that may already be out there that they are
replacing because some of the products that they may be
replacing already have, you know, concerns, safety problems
with them. Is that really going on? Is that type of comparison
going on or is it just a comparison to an ideal of something
that we have no problems with it? Because I hate to say that
but there is a trade-off there. Dr. Maynard.
Dr. Maynard. Many of the first generation of products that
are appearing are really just extensions of existing products.
So nanotechnology is what I refer to as nowhich technology. You
take something which you have already got and you make it
better using nanotechnology. And so if you look at Consumer
Products, that is where most people are going to come face to
face with nanotechnology. But of course as you look to the
future, there are going to be brand-new nanotechnology
solutions to challenges, and that I think is where you are
going to see brand-new technologies develop.
So there is a little bit of mix of both. But certainly as
far as the everyday person in the street goes, the things that
we keep coming into contact with now and over the next few
years are just going to be extensions of conventional
technologies and material.
Mr. Ziegler. I would like to make a comment here to your
question. I think in some cases the answer is a resounding yes.
The work that is going on with nanotechnology today is
replacing something that is a problem. For instance, chrome-6,
chrome-3, the chromates. For corrosion resistance, I do know
there is work going on. It is not going on at a rapid pace, but
it is going on and there are going to be some trials and then
there has got to be a lot of testing and probably three or four
years on certain pieces of equipment so that we know that it
will perform; but it is based on nano. It is a much safer
product than having the chromates in the workplace or in
landfills or in the air. So I think it is not just an extension
of products in every case that we are accustomed to today.
Dr. Teague. I would like to add very much the same comment.
I think that quite soon nanotechnology-based products will be
replacing some that are on the market. I think one of the ones
that is probably most imminent, and I am not sure if we are
talking five or 10 years, but in that neighborhood, one could
very well see nanotechnology-based light bulbs; which again are
using the quantum dots that we talked about earlier as
fluorescent agents. Using the nanotechnology-based light bulbs,
one is talking about increasing efficiency by 50 percent above
what the fluorescent lights are so that you could have a huge
impact not only in terms of energy efficiency, it also turns
out if you look at it very carefully; you compare the metals
and the elements that are being used in the nanotechnology
based light bulbs which have been demonstrated in the
laboratory already and in some of them in early products; you
reduce even the mercury which is present in fluorescent light
bubs. So if you look at it in terms of the balance between
products and what impact they might have in terms of long life
cycle analysis, the nanotechnology-based products are typically
more efficient and have a lot less of the toxic elements in
their actual manufacture and in their use.
Mr. Lipinski. Thank you. Thank you, Dr. Chairman.
Chairman Baird. Very interesting and appropriate line of
questioning to finish with, an exciting enterprise but also one
that we want to make sure we do right; and I thank all the
panelists for their efforts. We have about five minutes for my
colleagues on the panel here to make the vote, so with this we
are going to adjourn the hearing but I wanted to express my
deep appreciation for all the Members who offered their
outstanding testimony today; and we will look forward to the
report when it comes out and to further progress in this
important field.
Thank you, and with that the hearing stands adjourned.
[Whereupon, at 11:40 a.m., the Subcommittee was adjourned.]
Appendix:
----------
Answers to Post-Hearing Questions
Answers to Post-Hearing Questions
Responses by E. Clayton Teague, Director, National Nanotechnology
Coordination Office (NNCO)
Questions submitted by Chairman Brian Baird
Q1. Is the environmental, health and safety research (EHS) funded and
planned for funding under the National Nanotechnology Initiative
coordinated with related research being carried out abroad? Are there
formal mechanisms available to help coordinate EHS research
internationally? How does the funding under the NNI in this area
compare to foreign research support levels?
A1. The EHS research funded and planned for funding under the NNI is
coordinated with related research being carried out abroad through
three formal mechanisms: first, participation and leadership on the
Organization for Economic Cooperation and Development (OECD) Working
Party on Manufactured Nanomaterials (WPMN) and OECD's Working Party on
Nanotechnology; second, participation and leadership on the
International Organization for Standardization (ISO) Technical
Committee on Nanotechnologies (TC229) Working Group on Environmental
and Health Aspects of Nanotechnologies; and third, close coordination
between solicitations for EHS research by U.S. research agencies and
their equivalents of the European Union. Additional information
follows.
The Unites States currently chairs the OECD WPMN. The
working party has a number of projects focused on EHS research
including the gathering, sharing, and prioritization of
information on research and research needs among member
countries and regions participating in the working party. Other
projects include cooperation on voluntary schemes and
regulatory programs, co-operation on risk assessment, and
information sharing regarding national strategies and policies
for managing EHS research regarding nanomaterials. One project
has recently selected a set of representative nanomaterials for
extensive testing, while another is evaluating the
applicability of existing international testing protocols to
nanomaterials.
The ISO TC229 has participation by 27 member nations
and offers excellent means for communication among member
nations about EHS research through the introduction, selection,
and formulation of new work items. New work items leading to
international documentary standards for the TC and its Working
Group are based on results of research and needs for
standardization as the research results are moved from the
laboratory into commercial products.
At the agency level, the current U.S. solicitation
supporting investigations of fate, transport, transformation,
and exposure of engineered nanomaterials (jointly funded by
EPA, NSF, and DOE) is closely coordinated with a parallel
solicitation by the European Community. In addition, at the
country-to-country level, U.S. agencies are seeking appropriate
partners for nano-EHS research under bilateral science and
technology agreements.
Even with some reasonably focused efforts to obtain information
about the funding levels for EHS research for nanomaterials by other
countries, we have only limited anecdotal information. The information
we have suggests that the U.S. funding for this research is, by amount
and by percentage of national funding for nanotechnology R&D,
significantly larger than any other country. Most other countries and
regions have only begun funding of EHS research on nanomaterials in the
last year or so, whereas the U.S. began funding of this research at the
NNI's inception in 2001 and since then has been increasing the level of
funding at a high rate.
Q2. Dr. Maynard has suggested a mechanism for the 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. Do you believe this would be a good
model for developing a government/industry research partnership for EHS
research related to nanotechnology?
A2. Government/industry partnerships are already a valuable part of
ensuring the vigor and quality of programs to address nanotechnology
EHS research needs. There are several avenues for supporting such
partnerships, for example, the NIH/NCI Nanotechnology Characterization
Laboratory and Cooperative R&D Agreements between individual companies
and federal agencies. Further, NIH, working with several other
agencies, is exploring how the Foundation for the National Institutes
of Health might be used to support such research with funding being
jointly provided by the Federal Government and by industry. Thus, as
the NNI moves forward in exploring collaborative work with industry,
the Health Effects Institute (HEI) model might offer some additional
insights for developing a government/industry research partnership for
EHS research related to nanotechnology.
In assessing the appropriateness of the HEI model for supporting
EHS nanotechnology research there are several major differences between
the avenues being explored by federal agencies for nanotechnology EHS
research and that of the HEI model that need to considered. First,
research funded through the HEI is for materials which are not
proprietary while at this early stage in nanotechnology's development
engineered nanomaterials typically are proprietary. Second, while the
HEI model is based on joint efforts between one agency and one
industrial sector (EPA--primarily, with some special projects involving
one to two other agencies, and the worldwide motor vehicle industry),
nanotechnology EHS research engages a large number of agencies (over
20) and multiple industry sectors. Third, the HEI model examines health
effects associated predominantly with air pollution originating from
mobile sources and therefore only examines one route of exposure, that
of inhalation. Fourth, challenges associated with nanotechnology EHS
research arise from a number of factors such as the diversity of
classes and types of engineered nanomaterials and their applications in
many areas, e.g., biomedical, consumer products, food, energy, and
environmental sectors. Further, the number of application areas is
continuing to grow at a rapid pace. Therefore, it is not clear that the
HEI model offers advantages over the avenues already being pursued
individually and jointly by the agencies under the NNI.
The NNI operating through the NSET Subcommittee, the NEHI Working
Group, the NNCO, the NNI member agencies, and their formalized
interactions with industrial liaison groups for various industrial
sectors provides a broad-based model for planning and conducting
nanotechnology EHS research in collaboration with industry. This model
enables the required multidisciplinary approach and provides a means by
which the research can be guided by the missions and responsibilities
of federal agencies. Further, this model provides a mechanism to
integrate and leverage the expertise that exists across the Federal
Government and the broad cross section of research efforts underway in
government, academia, and industry. Finally, the model provides federal
programs with information that not only meets their needs in a timely
and cost-effective manner but also addresses private sector needs/
guidance on nanotechnology EHS from a wide range of industries. For
example, the NNI document released in September of 2006,
``Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials'' and the more recently released draft EHS research
priorities document were both based in part on substantial input from
two of the industrial liaison groups that the NNI has been working
with, representing the chemical and electronics/semiconductor
industries, respectively. These two groups collaborated in formulating
a list of recommended EHS research priorities, in close coordination
with the NNI agencies.
Q3. Mr. Ziegler and Dr. Denison recommended that the National Academy
of Sciences be tasked to take a lead role in developing the EHS
research strategy and assessing its implementation over time. What is
your view of this recommendation?
A3. The need for a nanotechnology EHS research strategy was recognized
by the NNI agencies and a completed EHS research strategy document is
imminent. Therefore, tasking the National Academy of Sciences to
develop such a strategy at this time would be duplicative. Assessing
the research strategy and the effectiveness of its implementation over
time is an appropriate role for the National Academy of Sciences. The
NSET Subcommittee already has contracted with the NAS to evaluate the
NNI's EHS research strategy that will be published in the next couple
of months. In general such targeted external review by the NAS can be
considerably more helpful to the NNI agencies than a broad assessment
that attempts to address many diverse aspects. The NNAP provides broad
oversight; the NAS can be most helpful by offering more narrowly
focused reviews.
The NSET members believe that employing agency expertise in
assessing both regulatory and scientific needs for nanotechnology EHS
research has resulted in a rigorous research strategy and has
appropriately integrated agency expertise and responsibilities into the
strategy.
Q4. One of the key aspects of carrying out EHS research is to have
agreed terminology and standards for characterization of nanomaterials;
Q4a. Is this getting sufficient attention under the NNI? What is the
role of NIST in this area?
A4a. Under the NNI, development of an appropriate terminology (and
nomenclature) is receiving a high level of attention. Many of the NNI
member agencies are participating in the ISO Technical Committee on
Nanotechnologies (ISO TC229) Working Group on Terminology and
Nomenclature, and the Director of the NNCO is Chair of the ANSI
Technical Advisory Group (TAG) to ISO TC229. NIST, several branches of
DOD, DOE, EPA, NIOSH, NASA, and the National Cancer Institute are
active members of the ANSI TAG. Some NNI agencies are also engaged in
standards development efforts by ASTM, IEEE, and SEMI. All these
standards development organizations and ISO TC229 are also very active
in developing documentary standards for the measurement and
characterization of nanomaterials and for many aspects of the exposure
and potential hazards of nanomaterials.
With respect to physical reference standards, NIST is in the
process of producing ``standards'' relevant to nanotechnology EHS.
These include:
RM 8011-8013 gold nanoparticles in three mean
particle sizes 10 nm, 30 nm, and 60 nm
RM 8281 single wall carbon nanotubes with long and
short lengths in solution
In addition NIST is currently working with NIOSH, NIEHS, and the
NTP on the development of other standards for nanotechnology EHS needs.
NIST hosted an NNI Workshop on Standards for EHS Research Needs for
Engineered Nanoscale Materials on September 12-13, 2007. The purpose of
the workshop was to develop guidance on what physical and documentary
standards are required to enable sound risk assessment and risk
management of engineered nanomaterials. In the longer-term, the
workshop will facilitate the development of standards needed for
understanding and managing occupational exposure to engineered
nanomaterials; nanomaterial fate and transport in the environment; and
nanomaterial potential impacts on human health and the environment.
Q4b. Is there a role for NNI to provide direct assistance to
nanotechnology companies, particularly small companies, to help them
characterize new nanomaterials, which will thereby assist the companies
in assessing the potential environmental and health risks of the new
materials?
A4b. In general, the Federal Government does not assist companies in
characterizing new chemical substances, whether or not they are
nanoscale materials. Nevertheless, there are definitely roles for the
NNI to provide direct assistance to small and large nanotechnology
companies to assist them in assessing potential EHS risks of new
nanoscale materials. Some examples already underway follow.
The Nanotechnology Characterization Laboratory jointly supported by
NCI, FDA, and NIST offers services to characterize new nanomaterials
and is also developing and publishing recommended protocols for
assessing the potential health risks of new nanomaterials.
The NNI-established user facilities offer small and large
businesses access to state-of-the-art instrumentation and facilities
that can be used for characterizing new nanomaterials and studying
their interactions with biosystems. (A list of these user facilities is
provided in the NNI Supplement to the President's 2008 Budget.)
NIOSH offers ``Programs for Nanotechnology in the Workplace'' to
provide companies with guidance for implementation of engineering
controls, use of personal protective equipment, and management
practices for working with nanomaterials. NIOSH also conducts Health
Hazard Evaluations to find out whether there are health hazards to
employees caused by exposures or conditions in the workplace, including
concerns related to nanotechnology. Finally, NIOSH has an
interdisciplinary field team of researchers that partners with
employers and others in conducting field studies to observe and assess
occupational health and safety practices in facilities where
nanotechnology processes and applications are used.
FDA, EPA and CPSC have all announced that they will work with
businesses to guide them regarding their use of specific nanomaterials
in products.
Questions submitted by Representative Vernon J. Ehlers
Q1. Please tell us more about how the agencies are working together on
nanotechnology in general and specific to EHS issues, especially in
areas where there may be some overlap. How are you making sure that
efforts are not being duplicated?
A1. In general the NNI member agencies work together to coordinate both
their intramural and extramural funding for nanotechnology R&D.
Numerous interagency activities are detailed in the 2004 NNI Strategic
Plan and in the annual NNI Supplements to the President's Budgets. To
support the advancement of this broad and complex field, the NNI
creates a framework for a comprehensive nanotechnology R&D program by
establishing shared goals, priorities, and strategies for agencies to
leverage their expertise and resources. Duplicative work is less likely
at the outset of any program, but with time and growth of R&D efforts
attention needs to be paid, both within and across agencies to ensure
duplication is avoided. However, differences in agency missions
decrease the likelihood that identical research will be funded by more
than one agency.
This NNI framework is implemented for nanotechnology EHS research
primarily through the NEHI Working Group. This working group provides a
forum for the sharing and reviewing project-specific information for
coordination. Such communication and collaboration among agencies also
minimizes the potential for undesirable duplication. Joint
solicitations typically involving two to five agencies are specifically
designed to avoid duplication of efforts among the participating
agencies.
Three statements from the NNI member agencies illustrate the
effectiveness of this approach for nanotechnology EHS research. Others
for more general nanotechnology research are provided in the Appendix
to my written testimony.
From the EPA: The U.S. EPA's, Office of Research and Development
(ORD) and the National Toxicology Program, as well as the National
Institute for Occupational Health and Safety, have initiated
collaborative interactions in their intramural (in-house) and
extramural nanomaterials health effect research efforts. These
interactions have their origins in the development of the NNI, NSET,
``Environmental, Health, Safety Research Needs for Engineered Nanoscale
Materials'' document. These interactions have been further enhanced
through invitations by EPA's ORD to the National Toxicology Program and
the NIOSH nanomaterials health effects lead scientists to visit ORD's
National Health and Environmental Effects Laboratory to present their
research activities and to identify areas where common interests and
complementation could be pursued with minimal duplication of efforts.
These activities have led to the following collaborative interactions
with ORD's intramural nanomaterials health effects research:
NIOSH scientists are collaborating with ORD's
intramural investigators to apply unique cell biology
technology and gene expression profiling at EPA to compare the
molecular pathology of granulomas induced by asbestos fibers or
carbon nanotubes to identify common or different mechanisms of
injury.
EPA, NIOSH, and NIEHS have collaborated in generating
and funding extramural grants addressing nanomaterials health
effects research needs. The results of these activities are
communicated amongst the participating federal agencies in
their annual grantees meeting.
A final example of EPA's work with the National
Toxicology Program is provided in the response to Question 1
from Congressman Lipinski.
From the USDA Forest Service: For the USDA Forest Service, which
has no in-house expertise in nanotechnology EHS but is charged with
advancing new uses for forest-derived nanomaterials and incorporating
nanomaterials developed in other industry sectors into forest products,
the NNI is providing: 1) extremely valuable advice and counsel on the
priority issues for EHS; 2) information and coordination on how
nanomaterials must be categorized and characterized with respect to EHS
risks; 3) leadership with engaging public groups and entities on EHS
issues and concerns; and 4) contact points in other agencies who have
capabilities in EHS who can help identify risks with respect to forest-
derived nanomaterials.
From NIST: Through the efforts of the NEHI Working Group and the
NNCO like the September 2006 ``Environmental, Health, and Safety
Research Needs for Engineered Nanoscale Materials'' document and the
NNI/NIST Workshop mentioned above, as well as others organized by the
various agencies, the agencies interact at multiple levels, which
minimizes overlap and at the same time allows for considerable exchange
and communication between agencies. While there is no one way to
develop a research strategy, we believe that the one developed by the
NNI is the best one for the agencies because--if for no other reason--
the agencies participated in its development and have a commitment to
it. Call it buy-in or ownership, if you will, but it's essential to
creating a research agenda that the agencies themselves will support
and thus fund.
Q2. On the issue of stovepiping EHS research versus integrating it
into all research, do all current NNI grants currently include an EHS
component? If not, should they? Why or why not?
A2. For clarification, the only ``NNI grants'' are through the NNI
member agencies. Agency missions drive the way in which EHS research
may or may not be incorporated into grants for nanomaterial and
nanotechnology research and whether EHS research is an implicit or
explicit component. Of the NNI's 25 participating federal agencies, 13
fund safety-related research and/or have regulatory authority to guide
safe use of nanomaterials.
In some cases, the model better suited to the science is having
scientists with the experience, facilities, and understanding conduct
EHS research, rather than adding an EHS component to all research. But
when the research effort brings interdisciplinary efforts together, EHS
is clearly a part. One model is NIH grants for medical applications and
pharmacological research in which EHS is not a separately funded
component, but by necessity is an integral part of the research. A
different model is DOD sensor work, in which EHS is a component, but
the grant does not directly fund EHS research. For their parts, DOE and
NSF do include an EHS requirement in their grants.
Stepping back a moment, it is important to keep in mind that the
state of scientific understanding of how engineered nanoscale materials
of various compositions interact with biological systems is incomplete.
So government-funded basic and applied research toward understanding
the EHS impacts of nanomaterials broadly falls into three areas: not
only (1) research to develop instrumentation and methods for measuring,
characterizing, and testing nanomaterials and for monitoring exposure
and (2) research contributing to safety assessments of nanomaterials
and nanomaterial-based products, but also (3) research to expand
knowledge and further the understanding of how nanomaterials behave.
The very breadth and multidisciplinary nature of nanotechnology and
the collaborative focus of the Nanotechnology Environmental and Health
Implications (NEHI) working group expands the capabilities of agency
missions.
Although not all grants by NNI member agencies include EHS
components, certainly for some types of research, biomedical
applications research in particular, the government is actively
encouraging researchers to address safety and effectiveness issues as
early as possible in the innovation cycle. Many NIH-funded research
projects include safety testing as a part of routine procedures as the
research progresses. As another example, one of the objectives of FDA's
Critical Path Initiative is to encourage researchers to incorporate
into their research, at the earliest possible stages, procedures that
will help them later in the process of satisfying FDA requirements for
demonstrating safety and effectiveness of the final products that might
eventually emerge as a result of that research.
Questions submitted by Representative Daniel Lipinski
Q1. Much of the EHS research to date has focused on exotic materials
with unrealistic exposure-scenarios. While that is useful in
establishing information on an upper bound of the hazard, the context
is rarely communicated and it creates fear. What is critical is that we
make sure nano-enabled products are as safe or safer than what we use
today.
As I understand it, the hazard of a nanomaterial often depends
upon much more than the size and type of material, but also surface
properties, purity, etc. that relate to how it is made. How is the
toxicology work underway controlling for this? Are researchers using
standardized, well characterized materials? If not, how can we make use
of the research findings?
A1. Much of the EHS research to date has been focused on several of the
engineered nanoscale materials being produced in the largest
quantities, e.g., TiO2, and single- and multiple-walled carbon
nanotubes. The current stage for producing many engineered nanoscale
materials is such that the chemical composition and physical
characteristics of manufactured nanomaterials can vary substantially
between batches and vendors. Because of this variability and general
poor characterization of materials used, research findings from much
early toxicology research on engineered nanomaterials are difficult to
interpret. Many studies are having to be repeated with better-
characterized materials in order to establish a better understanding of
the correlation of a particular biological response to a specific
engineered nanoscale material. Recognizing the importance of the need
for well characterized materials for the conduct of toxicology studies,
the NNI agencies are funding and conducting research to develop a suite
of reference materials and improved instrumentation to analyze and
characterize nanomaterials, both as raw materials and as materials in
biological systems. A suite of reference nanomaterials--stable
materials for which the chemical and physical properties are rigorously
characterized to verify the composition or properties of their
products--are being developed to overcome these problems. Within
workshops and standards committee considerations NNI agencies are
participating in expert discussions on what might comprise a minimum
set of measurements that would enable consistency among materials used
and reported on by researchers and accepted means to specify
nanomaterials for efficient commerce.
Due to the numerous types of reference materials needed for
different groups or classes of nanomaterials, a coordinated,
interagency research effort is required to support the significant and
necessary level of R&D. Pure samples are needed and instruments with
the ability to determine the elemental composition, accurate
dimensions, location, and chemical state of all atoms in nanomaterials
must be developed. The critical and relevant physical parameters (size,
shape, composition) must be identified. Reliable methods for
distributing these standards also must be established. While NIST will
have a major role in developing and validating instrumentation and
methods, multiple NNI agencies will need to be involved. NASA and DOD
will play a key role in identifying materials and processes likely to
be used in the composites industry. Contributions from agencies such as
the EPA and NIOSH will be essential to describing the use of these
materials in environmental and workplace monitoring settings. The
expertise of the NIH and FDA will be critical for identifying the
relevant parameters to be characterized for health and safety research.
The National Toxicology Program (NTP) has provided and shared with
EPA's intramural health and ecological effects investigators well
characterized engineered/manufactured nanomaterials of common interest
to both EPA and NTP in order to examine cellular models of toxicity to
complement NTP's animal toxicology studies in an effort to: 1) identify
alternative test methods and approaches to assess/predict the toxicity
of nanomaterials; 2) develop an enhanced health effects database that
could be integrated and used for health risk assessment of
nanomaterials; and 3) assist or guide subsequent sub-chronic and/or
chronic animal toxicity studies of engineered/manufactured
nanomaterials of interest for both agencies/programs. This format using
and sharing well characterized identical nanomaterials of common
interest will be pursued in future NTP and EPA nanomaterials
toxicological studies.
Q2. It seems that most of the early uses of nanotechnology and
nanomaterials are for existing products and processes, many of which
are far from ideal from a health and environmental safety perspective.
What is being done to systematically compare the risks and benefits of
the nanoscale alternative against the conventional approach in use
today so that we accelerate the substitution of nanomaterials where
they are superior (e.g., when replacing a known toxin)?
A2. The ``green'' potential of nanotechnology--the capacity to reduce
pollution through the redesign of industrial processes and the
replacement of toxic solvents, poisonous metals, and corrosive
chemicals with less hazardous nanomaterials--is widely acknowledged to
be great. NNI agencies funding research in green chemistry include the
National Science Foundation, the Department of Energy, and the
Environmental Protection Agency. EPA's recent Pollution Prevention
through Nanotechnology Conference (held September 25-26, 2007) brought
together representatives from industry, academia, non-governmental
organizations, and government to discuss current practices and
potential research in three major areas where nanotechnology can
contribute to pollution prevention:
a. Products: Less toxic, less polluting, and wear-resistant.
b. Processes: More efficient and waste-reducing.
c. Energy and Resource Efficiency: Processes and products that
use less energy and fewer raw materials because of greater
efficiency.
Inputs from this workshop will provide guidance for both intramural
and extramural funding of nanotechnology research by EPA.
Q3. The discussion around nanomaterials tends to focus on
``engineered'' nanomaterials which are roughly defined as those that
are purposefully created. However, the volume of naturally occurring
and ultrafine particles produced by combustion, as well as those used
as fillers in rubber tires or plastics is many orders of magnitude
greater than the newly engineered nanomaterials. What are we doing to
ensure that we leverage the body of EHS knowledge on these particles?
Are we missing the forest from the trees by emphasizing only
``engineered nanomaterials''? What efforts are there to assess the
comparative hazard posed by engineered nanomaterials against incidental
or naturally occurring nanomaterials?
A3. Existing knowledge about EHS implications of ultrafine particles is
being leveraged to address potential EHS concerns regarding
nanomaterials, both naturally occurring and engineered nanoparticles.
NIOSH and DOE, for example, have drawn upon existing knowledge bases to
provide guidance about workforce safety and engineered nanomaterials.
Other agencies are focusing on understanding the behaviors of
nanomaterials, incidental and engineered, in biological systems and the
environment. Many of the analytical methods being used for
characterization of engineered nanomaterials are ones that have been
developed and applied to ultrafine particles. Examples include electron
microscopy, dynamic light scattering, gas absorption measurements of
surface area, etc. Limited research has been conducted to date that
explores the comparison of effects of incidental or natural nanoscale
particles with those of engineered nanomaterials.
The EPA Nanotechnology White Paper, Feb. 2007, recognized the
paucity of data for engineered nanomaterials health effects relative to
the amount of data available for ultrafine particles from emission
sources. The White Paper also recognized the need to query existing
ultrafine particle toxicity databases in order to determine the extent
to which they could provide insight into the engineered nanomaterials
hazard identification, mechanism(s) of injury, and mode(s) of action
relative to ultrafine particles present in ambient air. These
comparisons are critical to determining whether there are potentially
unique health effects, and to understanding mechanisms of injury,
related to the novel physicochemical properties of engineered
nanomaterials. EPA's Office of Research and Development (ORD)
intramural engineered nanomaterials health effects research, supported
through its Nanotechnology Initiative, has started toxicology studies
comparing the pulmonary and cardiovascular toxicity, hazard
identification, and mechanism of injury of specific combustion
particles and engineered nanomaterials. Proposals to continue the
comparative toxicological assessment of environmental ultrafine
particles and engineered nanomaterials are being considered by ORD for
continued research support within its developing multi-year plans.
In terms of missing the forest from the trees by emphasizing only
``engineered nanomaterials,'' research funded under the NNI has focused
primarily on engineered nanomaterials, their properties, and their
interactions with biosystems. However, if one takes a perspective in
terms of the quantity of the two types of materials to which the
general population is exposed or the quantity introduced into the
environment, engineered nanomaterials are a small part of the forest.
(The quantity of ultrafine particles to which the general population is
and has been exposed is much greater than that for engineered
nanomaterials.)
Much understanding of the implications of ultrafine particles
interactions with biosystems also may be gained from studies using
engineered nanomaterials since they are typically far more uniform
than, for example, PM combustion byproducts in their physical and
chemical properties, e.g., size distribution, chemical composition,
atomic and molecular structure, than are those of ultrafine particles.
These more uniform properties and the degree of control of matter at
the nanoscale offered by nanotechnology are enabling major advances in
our understanding of the interactions of all nanomaterials with
biosystems.
Some specific examples follow of research being conducted and
information being provided about working with engineered nanomaterials,
built on the knowledge of working with ultrafine particles.
EPA's Particulate Matter research program is the lead
federal program examining health and environmental effects
associated with exposure to airborne particulate pollution in
order to support the National Ambient Air Quality Standard for
Particulate Matter. A critical research goal within EPA's
Particulate Matter research program is linking particulate
health effects from ultrafine particles generated from the
combustion of fossil fuels. EPA's Particulate Matter research
will provide potentially important information regarding the
dosimetry/translocation, hazard identification, and health
effects of inadvertently produced ultrafine particles.
NIOSH's experience in researching and defining
characteristics, properties, and effect of ultrafine particles
such as welding fumes and diesel particulates provide a strong
foundation for its current nanotechnology research activities.
Existing studies on human or animal exposure to ultrafine and
other respirable particles provide a basis for generating
hypotheses about the possible adverse health effects from
exposures to similar materials on a nanoscale. The studies of
ultrafine particles may provide useful data to generate
hypotheses for further testing. The studies in cell cultures
provide information about the cytotoxic properties of
nanomaterials that can guide further research and toxicity
testing in whole organisms.
Based on leveraged research and the limited amount of
information about the potential risks from handling
nanomaterials in workplaces and laboratories, NIOSH has issued
its ``Guidance for Handling Nanomaterials and Precautionary
Measures for Employees and Workers Handling Engineered
Nanomaterials'' document, which is in wide circulation and has
been proposed for adoption by ISO TC-229.
Current NIOSH research includes a five-year multi-
disciplinary study into the toxicity and health risks
associated with occupational nanoparticle exposure. Another
study examines ultrafine particle intervention studies in
automotive plants.
Within DOE, preliminary research suggests that some
controls used in conventional laboratory settings will work
effectively as guidance for handling engineered nanoparticles
and nanostructured porous materials. Based on the available
science, DOE has issued an ``Approach to Nanomaterial
Environmental Safety & Health'' document, which compiles
recommended practices for laboratory staff and information
about the safety and health effects related to nanomaterials,
particle measurement, and control effectiveness.
Several of the leading researchers in the toxicology
of ultrafine particles have received major grants to do
nanotechnology-related toxicology research. These grants were
awarded by a variety of agencies, including DOD, NSF and EPA to
support research directed explicitly towards the understanding
of EHS aspects of engineered nanomaterials/nanoparticles.
Nanotechnology--specific EHS work has been done in
the EPA health laboratory in rats and various in vitro systems,
including human cells, and in mice. This research has in one
way or another been predicated on work with basic comparisons
of engineered versus other ultrafine particles.
Q4. To what extent is the toxicity research relevant to ``real world''
situations? To what extent are federally funded efforts using the
routes of exposure or formulations that emulate the nanomaterials being
used in available products?
A4. NNI member agencies are funding toxicity research they consider
highly relevant to ``real world'' situations. For example, research is
being funded to understand better the potential for exposure to
engineered materials during manufacturing processes and during use of
products containing engineered nanomaterials. Research is also underway
aimed at improving our understanding of what happens to engineered
nanomaterials as they may be introduced into the environment throughout
the full life cycle of the materials and products containing these
materials. Potential hazards of these materials are the other half of
the potential risks posed by these materials. Research on potential
hazards due to the introduction of these materials into biosystems--
from the cellular level to the full system level--is also underway.
As the National Academies concluded in their 2006 assessment, it is
not possible to draw general conclusions on engineered nanomaterials
since not all nanomaterials are alike. There is still science to be
done in this area. Research results already indicate that certain
nanomaterials are safe as used in products today, while other
nanomaterials cannot be safely used in living systems in unmodified
form. While there are research questions still to answer, the prospects
for the safe use of many, if not most, nanomaterials are great.
We know that some early research on potential toxicity of
nanomaterials, including some with highly publicized results showing
potential negative health effects, did not reflect ``real world
situations'' with likely exposure dosages, pathways, or even pure
samples of the materials in question. In fact, it has been shown that
initial toxicity observed for carbon nanotubes in one study was due to
metal contaminants in the tested samples (Ni, FE, Co)--materials used
as a catalyst during the production process. In another study the mice
being tested suffocated from the ``instillation'' (injection into the
throat or lungs) of a large quantity of carbon nanotubes--not from
material-specific toxic effects.
Appropriate prioritization of the Federal Government's research on
potential toxicity of nanomaterials is underway through the interagency
process I described in my testimony, which does factor in the need to
conduct such research in a way that is relevant to real-world
conditions and to focus first on the most likely exposure routes.
Q5. The NNI Authorization Act requires that a strategic plan for
program activities be prepared and updated at three-year intervals. The
next update is due in December 2007. Will the updated plan be released
on time?
A5. Yes. Work to update the NNI Strategic Plan has been underway since
early 2007 and delivery of the updated Strategic Plan to Congress as
called for in the NNI Authorization Act is expected to be on or before
December 30, 2007.
Answers to Post-Hearing Questions
Responses by E. Floyd Kvamme, Co-Chair, President's Council of Advisors
on Science and Technology
Questions submitted by Chairman Brian Baird
Q1. Progress in understanding the risks of nanotechnology will require
balance among fundamental research and research that is more directed
and product specific. NSF funds basic environmental, health and safety
(EHS) research, and at present, its research portfolio comprises 50
percent of the total federal effort in EHS research. Has PCAST reviewed
the funding balance among agencies contributing to EHS research and
does PCAST believe the current funding allocation represents the
correct balance?
A1. PCAST's review of the NNI is ongoing, and as part of that process I
met recently with NIST, FDA, NIOSH, EPA and NSF agency representatives
personally to get an updated understanding of the overall approach and
infrastructure for nanotechnology EHS research. The current
nanotechnology EHS funding allocation among federal agencies does
appear to be effectively coordinated via the NNI and naturally balanced
in a manner consistent with individual agency's mission, expertise, and
capacity. Through the NNI, the agencies have undertaken a number of
joint solicitations and other jointly funded activities relevant to
nanotechnology EHS research. The increases in basic and applied EHS
research appear to be matched to the increase in capacity for high
quality research. If there is one area that should receive greater
funding, it is the area of metrology and standards. This area is the
focus of NIST, which plans to direct a portion of its increased funding
under the American Competitiveness Initiative toward nanotechnology
EHS-related research (if the FY 2008 appropriation bill for NIST is
passed).
Q2. PCAST was given the responsibility to serve as the statutorily
created advisory committee for the National Nanotechnology Initiative.
The statute requires the advisory committee to assess all aspects of
the management, coordination, implementation, and content of the NNI
and to report on its findings every two years to the President and
Congress. The last report was released in May of 2005. What is the
status of the next report, which is due this year, and when will it be
made available?
A2. The PCAST anticipates reviewing the findings and recommendations
from its review at its meeting on January 8, 2008. We have
intentionally delayed this report somewhat to allow the council to
include a review of the updated NNI strategic plan, which is to be
completed by the end of the year. In my testimony presenting our first
review of the NNI, I recommended that PCAST's reviews of the NNI be
changed to once every three years, consistent with the period for
updating the strategic plan and for the triennial reviews by the
National Research Council, both of which are to be assessed in the NNAP
review. It was my understanding at that time that the members viewed
this quite favorably and we have, therefore, worked to this timeframe.
In your reauthorization of the NNI, we would suggest that this formal
change in the legislation be made.
Q3. Is PCAST satisfied that the NNI is adequately coordinating EHS
research with related foreign research efforts?
A3. As called for in our last report, the NNI is taking a leadership
role in coordinating EHS activities internationally, particularly
within the Organization for Economic Cooperation and Development (OECD)
and the International Standardization Organization (ISO). The OECD
Working Party on Manufactured Nanomaterials, which is chaired by Jim
Willis of the EPA, is the body that is leading efforts to share EHS
information and coordinate the collaborative development of information
that is needed by governments and industries worldwide. Also, Clayton
Teague chairs the U.S. ANSI-accredited Technical Advisory Group and
heads the U.S. delegation to the ISO technical committee on
nanotechnologies, which is working to develop standards for
instrumentation, reference materials, test methods, and EHS practices.
ISO standards often are adopted widely and PCAST endorses the NNI's
continued participation and leadership in these activities. As a result
of this international work, PCAST is very pleased with the increase in
international coordination that has occurred since our first report.
Q4. Dr. Maynard has 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. Do you believe this would be a good model for
developing a government/industry research partnership for EHS research
related to nanotechnology?
A4. As a general model for government-industry partnership, the Health
Effects Institute is centered primarily on one area (air pollution) and
essentially one industry (automakers). This model does not translate
easily to the much broader area covered by nanomaterials and the
diversity of nanomaterial-related EHS risks and benefits, which cannot
be confined to one industry. Moreover, unlike in the case of the HEI,
the information of interest and use to industry would likely be
considered proprietary. Furthermore, it is not clear who would shoulder
the burden and what incentives may be applied. Nonetheless, PCAST is
pleased that the NNI has been reaching out to the private sector
through consultative advisory boards and has reached agreement with the
semiconductor, chemicals, and forest products industries. These
agreements focus on strengthening government-industry interactions with
respect to nanotechnology development, including the need to understand
potential EHS risks. It is very possible that in our upcoming report,
we will call for extending this type agreement to additional industry
groups.
Q5. Mr. Ziegler and Dr. Denison have recommended that the National
Academy of Sciences be tasked to take a lead role in developing the EHS
research strategy and assessing its implementation over time. What is
your view of this recommendation?
A5. As mentioned above, the NAS is already responsible for assessing
the NNI as a whole on a triennial basis. The PCAST welcomes this review
and is taking NAS recommendations from its first report into
consideration in completing its current updated review of the program.
According to the NNI agencies, an interagency-developed plan for EHS
nanotechnology research is near completion. Therefore, it seems
duplicative to ask the NAS to begin work on such a plan. Rather, it
would be helpful if the Academy were asked to assess the NNI plan and
provide expert review and feedback to ensure it is complete and
scientifically sound. PCAST intends to review the NNI EHS research
strategy when it becomes available. Subsequent review by the NAS of the
strategy would be welcomed.
Q6. One of the key aspects of carrying out EHS research is to have
agreed terminology and standards for characterization of nanomaterials.
Q6a. Is this getting sufficient attention under the NNI? What is the
role of NIST in this area?
Q6b. Is there a role for NNI to provide direct assistance to
nanotechnology companies, particularly small companies, to help them
characterize new nanomaterials, which will thereby assist the companies
in assessing the potential environmental and health risks of the new
materials?
A6a,b. Establishing standards (in terms of materials, methods, minimum
data sets for characterization, etc.) is the right area to focus
attention. NIST is expanding its nanotechnology efforts here (again
largely under the increased funding provided for by the ACI) and is
expanding collaborations with other agencies (e.g., NCI, NCL) and
industry in the process. All the agency representatives I have met have
pointed to the central role of NIST in characterization and standard
setting for nanotechnology. NIST recently hosted a workshop focused on
nanomaterials EHS. Such work will facilitate responsible nanotechnology
development across the board, including in industry and small
companies, and represents some of the best assistance the NNI can
provide to ``raise all boats.'' PCAST may suggest broader roles for the
NNI in future reports in this all important area of standard setting
and characterization for each of the many potential suppliers of
nanotechnology based products.
Questions submitted by Representative Vernon J. Ehlers
Q1. On the issue of stovepiping EHS research versus integrating it
into all research, do all current NNI grants currently include and EHS
component? If not, should they? Why or why not?
A1. Many current NNI grants have components relevant to nanotechnology
EHS, as appropriate or related to the specific research aims. It is
essential that these efforts are not separated from applications
research or institute them artificially, which risks waste and
redundancy in research funding. On the other hand, it would not be
prudent to require that every research grant or project include an EHS
component. Some researchers do not have the capacity to do such work.
Rather, all researchers should have the ability to access and share EHS
information with the nanotechnology research community broadly. As
PCAST completes its next review, we will, undoubtedly discuss this
important area of balance between applications and EHS research and the
interplay between them.
Questions submitted by Representative Daniel Lipinski
Q1. Much of the EHS research to date has focused on exotic materials
with unrealistic exposure scenarios. While that is useful in
establishing information on an ``upper bound'' of the hazard, the
context is rarely communicated and it creates fear. What is critical is
that we make sure nano-enabled products are as safe or safer than what
we use today.
As I understand it, the hazard of a nanomaterial often depends
upon much more than the size and type of material, but also surface
properties, purity, etc. that relate to how it is made. How is the
toxicology work underway controlling for this? Are researchers using
standardized, well characterized materials? If not, how can we make use
of the research findings?
A1. Although some early studies were done using nanomaterials that were
poorly characterized, researchers are increasingly aware of what
constitutes well-characterized samples. Scientists are in the process
of identifying the relevant parameters to include to sufficiently
characterize a specific nanomaterial, including size, aspect ratio,
surface chemistry, and charge, for example. However, nanomaterials are
extremely diverse and controlling parameters will vary for different
materials. This highlights again the importance of NIST in establishing
standard reference materials, methodologies, and tools to help guide
the research and development community as it continues to build a
knowledge base that will inform future research. As I will comment on
below in response to Ranking Member Hall's question, each generation of
tests will improve our knowledge of what input parameters are critical
to understanding outcomes of tests.
Q2. It seems that most of the early uses of nanotechnology and
nanomaterials are for existing products and processes, many of which
are far from ideal from a health and environmental safety perspective.
What is being done to systematically compare the risks and benefits of
the nanoscale alternative against the conventional approach in use
today so that we accelerate the substitution of nanomaterials where
they are superior (e.g., when replacing a known toxin)?
A2. Risk vs. benefit comparisons occur on an application-specific basis
(e.g., sunscreens, nanocrystalline formulations of approved drugs). To
my knowledge, this process doesn't differ from the normal process of
evaluating new and improved approaches for any application, whether
they are nano-enabled or not.
Q3. The discussion around nanomaterials tends to focus on
``engineered'' nanomaterials which are roughly defined as those that
are purposefully created. However, the volume of naturally occurring
and ultra-fine particles produced by combustion, as well as those used
as fillers in rubber tires or plastics is many orders of magnitude
greater than the newly engineered nanomaterials. What are we doing to
ensure that we leverage the body of EHS knowledge on these particles?
Are we missing the forest from the trees by emphasizing only
``engineered nanomaterials''? What efforts are there to assess the
comparative hazard posed by engineered nanomaterials against incidental
or naturally occurring nanomaterials?
A3. The NNI agencies are indeed leveraging experience and knowledge of
the EHS implications from studies of naturally occurring and ultra-fine
particles. This is a prime example why a separate entity to oversee the
entire federal nanotechnology EHS research effort is not advisable, as
it would create a new ``stovepipe'' and inevitably limit input from the
expertise resident in the agencies. Furthermore, a number of structures
already exist and are working along this line. For example, EPA has
extensive experience dealing with particulate matter in its Office of
Air and Radiation.
Q4. To what extent is the toxicity research relevant to ``real world''
situations? To what extent are federally funded efforts using the
routes of exposure or formulations that emulate the nanomaterials being
used in available products?
A4. The relevance of a given work in toxicity research to the real-
world varies by study and the investigators' specific aims, and again,
as mentioned earlier, current research is helping to inform future
research. The National Toxicology Program, which incorporates expertise
from NIEHS, EPA, and FDA, is leading the way in systematically
evaluating a number of classes of nanomaterials in commercially
available products, including carbon nanotubes, gold- and silver-based
particles and metal oxides.
Questions submitted by Representative Ralph M. Hall
Q1. With your semiconductor industry background, you have great
experience in bringing new technologies to market. How is
nanotechnology different from other technologies? How did you deal with
new technology uncertainty when the semiconductor industry was in its
infancy?
A1. Each new technology seems to bring its own set of challenges but,
generally speaking, they are similar in that there are unknowns that
must be understood and which do not tend to be discovered in an ordered
fashion. Specifically, when looking at the early days of the
semiconductor business, we were blessed in that the earliest text on
the mechanisms at work in a semiconductor (Electrons and holes in
semiconductors, with applications to transistor electronics by Dr.
William Shockley--circa 1948) was a very accurate description of
semiconductor phenomena. But knowing which processes would be most
effective and manufacturable took a couple of decades. In the early
days, we worked in germanium, silicon, gallium arsenide, as well as
other materials. Germanium was most common in that it was easiest to
work with. Silicon posed many problems in that its surface
characteristics were difficult to understand. Years of experiments, of
course, paid off in the eventual understanding of the many nuances of
the material. One of the most important lessons learned was that with
each succeeding series of experiments, one needed to do more
characterization of the input materials to assure the accuracy of the
output. Without fail, when early experiments were completed, a desire
to have made additional measurements before the experiment started was
present. But progress was made as each generation of data gathering
used knowledge earned from the previous work. Today, in nanotechnology,
a similar process is taking place. Some are critical of early
experiments were of limited value because certain parameters were not
specified or input materials were poorly characterized. But, if that
early work informs the next set of experiments, progress is made and
knowledge of what parameters and characterizations are needed in future
work is established. The other essential is to share results. Published
papers, conferences and other mechanisms were used in the early
semiconductor days. The International Solid State Circuits Conference
held each year in Philadelphia was a major meeting point. This is
partly why I feel that measuring the number of publications and
conferences is an important part of measuring progress at this early
stage in nanotechnology development.
Answers to Post-Hearing Questions
Submitted to Vicki L. Colvin, Professor of Chemistry and Chemical
Engineering; Executive Director, International Council on
Nanotechnology; Director, Center for Biological and
Environmental Nanotechnology, Rice University
These questions were submitted to the witness, but were not
responded to by the time of publication.
Questions submitted by Chairman Brian Baird
Q1. Dr. Maynard has suggested a mechanism for government to partner
with industry to fund environmental, health and safety (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. Do you
believe this would be a good model for developing a government/industry
research partnership for EHS research related to nanotechnology?
Q2. Is there a satisfactory level of international collaboration and
coordination of EHS research? What is the role here of non-governmental
organizations, such as the International Council on Nanotechnology?
Q3. The President's Council of Advisors on Science and Technology
(PCAST) was assigned by the President to serve as the statutorily
created outside advisory committee for the National Nanotechnology
Initiative. How useful is PCAST as a means for private sector
organizations to provide input to the planning and prioritization
process for EHS research under the NNI? Are there other mechanisms
available for stakeholders to have a voice in this process?
Q4. Mr. Ziegler and Dr. Denison have recommended that the National
Academy of Sciences be tasked to take a lead role in developing the EHS
research strategy and assessing its implementation over time. What is
your view of this recommendation?
Q5. One of the key aspects of carrying out EHS research is to have
agreed terminology and standards for characterization of nanomaterials.
a. Is this getting sufficient attention under the NNI? What is
the role of NIST in this area, and do you have recommendations
for how progress in these standards setting activities can be
accelerated?
b. Is there a role for NNI to provide direct assistance to
nanotechnology companies, particularly small companies, to help
them characterize new nanomaterials, which will thereby assist
the companies in assessing the potential environmental and
health risks of the new materials?
Questions submitted by Representative Vernon J. Ehlers
Q1. With regard to the tools that you say are needed ``to correlate
the functional properties of nanomaterials,'' can you speak to where we
are on our research to develop these tools?
Q2. On the issue of stovepiping EHS research versus integrating it
into all research, do all current NNI grants currently include and EHS
component? If not, should they? Why or why not?
Questions submitted by Representative Daniel Lipinski
Q1. Much of the EHS research to date has focused on exotic materials
with unrealistic exposure scenarios. While that is useful in
establishing information on an ``upper bound'' of the hazard, the
context is rarely communicated and it creates fear. What is critical is
that we make sure nano enabled products are as safe or safer than what
we use today.
As I understand it, the hazard of a nanomaterial often depends
upon much more than the size and type of material, but also surface
properties, purity, etc. that relate to how it is made. How is the
toxicology work underway controlling for this? Are researchers using
standardized, well characterized materials? If not, how can we make use
of the research findings?
Q2. It seems that most of the early uses of nanotechnology and
nanomaterials are for existing products and processes, many of which
are far from ideal from a health and environmental safety perspective.
What is being done to systematically compare the risks and benefits of
the nanoscale alternative against the conventional approach in use
today so that we accelerate the substitution of nanomaterials where
they are superior (e.g., when replacing a known toxin)?
Q3. The discussion around nanomaterials tends to focus on
``engineered'' nanomaterials which are roughly defined as those that
are purposefully created. However, the volume of naturally occurring
and ultrafine particles produced by combustion, as well as those used
as fillers in rubber tires or plastics is many orders of magnitude
greater than the newly engineered nanomaterials. What are we doing to
ensure that we leverage the body of EHS knowledge on these particles?
Are we missing the forest from the trees by emphasizing only
``engineered nanomaterials''? What efforts are there to assess the
comparative hazard posed by engineered nanomaterials against incidental
or naturally occurring nanomaterials?
Q4. To what extent is the toxicity research relevant to ``real world''
situations? To what extent are federally funded efforts using the
routes of exposure or formulations that emulate the nanomaterials being
used in available products?
Questions submitted by Representative Ralph M. Hall
Q1. Please share your thoughts on the idea of establishing a separate
program office to oversee EHS research. Why is such an office needed
for nanomaterials versus other materials? What authorities would such
an office need to have? What are the possible pitfalls of such an
approach? How would you prevent the perception of adding another level
of federal bureaucracy to the mix? As an alternative to creating a new
office, how can we improve the mechanisms we currently have in place to
achieve the same goals?
Answers to Post-Hearing Questions
Responses by Andrew D. Maynard, Chief Science Advisor, Project on
Emerging Nanotechnologies, Woodrow Wilson International Center
for Scholars, Washington, D.C.
Questions submitted by Chairman Brian Baird
Q1. Mr. Ziegler and Dr. Denison have recommended that the National
Academy of Sciences be tasked to take a lead role in developing the
environmental, health and safety (EHS) research strategy and assessing
its implementation over time. What is your view of this recommendation?
A1. Two years ago, I would have strongly recommended such an action, as
long as it included a strong work plan that enabled the development of
a robust multi-stakeholder strategy, with a planned series of reviews
and revisions. However, the U.S. Government has run out of time to
develop such strategies, and needs to start taking action on doing the
relevant risk research as soon as possible.
A number of reports and reviews over the past few years have
identified the short-term research needed to support safe
nanotechnology
development.\1\,\2\,\3\,\4\,
\5\,\6\ With hundreds of commercial and consumer products
making nanotechnology claims currently on the market and nanomaterials
easily available for online purchasing (as I exhibited during my
testimony), there is little excuse for not taking action on these
research needs and questions now.
---------------------------------------------------------------------------
\1\ RS/RAE (2004). Nanoscience and nanotechnologies: Opportunities
and uncertainties, The Royal Society and The Royal Academy of
Engineering, London, UK, 113 pp.
\2\ Denison, R.A. (2005). ``A proposal to increase federal funding
of nanotechnology risk research to at least $100 million annually,''
Environmental Defense, Washington, DC.
\3\ NIOSH (2005). Strategic plan for NIOSH Nanotechnology Research,
National Institute for Occupational Health and Safety. Draft.
\4\ Maynard, A.D. (2006). Nanotechnology: A research strategy for
addressing risk, Project on Emerging Nanotechnologies, Woodrow Wilson
International Center for Scholars, Washington, DC.
\5\ NSET (2006). Environmental, health and safety research needs
for engineered nanoscale materials. Subcommittee on Nanoscale Science,
Engineering and Technology, Committee on Technology, National Science
and Technology Council, Washington, DC.
\6\ EPA (2007). U.S. Environmental Protection Agency Nanotechnology
White Paper, Environmental Protection Agency, Washington, DC. EPA 100/
B-07/001. February.
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However, looking to the future, there is a need for a long-term
plan of action. I would therefore recommend that the government put in
place a strategy for dealing with short-term issues as soon as
possible, and that the National Academy of Sciences (NAS), or a similar
independent body, take a lead role in developing, reviewing and
revising a longer-term research strategy. To be effective, this would
require publication of a strategic plan within 12 months, followed by
periodic reviews over the subsequent five years.
Commitment to a robust review/revision process is essential in
order to respond adequately to the evolving development path of
nanotechnologies, especially as new information on nanomaterial health
and safety becomes available. In addition, any strategic plan must be
accompanied by the will, mechanisms and resources to enact it.
Thus, my recommendation is for parallel tracks of government taking
action on a short-term strategy now, with NAS or a similar organization
taking the lead on longer-term planning, implementation and review of
an EHS research strategy. Both tracks should have multi-stakeholder
involvement, and should facilitate international coordination of
research strategies and actions.
Q2. You suggested in your testimony the need for an individual to be
designated to take a leadership role for EHS research under the NNI.
Could you elaborate on the characteristics and functions of this
leadership role and suggest how to implement the proposal?
A2. First, let me stress that any effective approach to addressing
nanotechnology EHS issues must involve multiple agencies and must
engage key decision-makers in the respective agencies.
However, effective leadership is imperative for this approach to
succeed. A highly capable person with the time, responsibility,
authority and desire to work with agencies across the Federal
Government should fill this leadership role, so as to develop and enact
workable solutions to the EHS nanotechnology challenges. This person
would need a clear understanding of the issues involved in developing a
cross-agency EHS research program, as well as the respect of
researchers and decision-makers within the agencies.
As I envision this much-needed oversight position, the individual
in this leadership role would have the assigned authority to engage and
collaborate with agencies at the levels where decisions are made and to
bring people to the table to find mutual solutions to hard problems.
Such problems may entail identifying ways to share resources across
agencies, to coordinate and integrate research activities, to work in a
collaborative manner to address broad challenges, and to break down
institutional barriers.
To create this proposed leadership role, it is my personal and
professional opinion that Congress could include a provision in the
Twenty First Century Nanotechnology Research and Development Act
reauthorization that either establishes this authority, or requires the
National Nanotechnology Initiative (NNI) to establish this authority. I
recommend that Congress provide sufficient funding for this position on
an annual basis.
Q3. The President's Council of Advisors on Science and Technology
(PCAST) was assigned by the President to serve as the statutorily
created outside advisory committee for the National Nanotechnology
Initiative. How useful is PCAST as a means for private sector
organizations to provide input to the planning and prioritization
process for EHS research under the NNI? Are there other mechanisms
available for stakeholders to have a voice in this process?
A3. PCAST draws on input from a wide range of people, through the
Nanotechnology Technical Advisory Group (NTAG)--on which I serve.
However, NTAG and the process of engagement and input are not
transparent.
While the NTAG provides input to the review of the NNI, it is not a
mechanism that is well-suited for transparent and multi-stakeholder
input to the process of planning and prioritizing EHS research.
Alternative mechanisms currently do not exist to achieve this, beyond
the occasional public meetings and consultations held by NSET. These
public meetings and consultations are not strategically effective in
engaging stakeholders.
A robust review and assessment process--whether undertaken by the
NAS or another organization--would lead to a significant increase in
stakeholder input. But this process is too slow and cumbersome to guide
strategic research and policy decisions on a regular basis. In my
testimony, I propose establishing a federal advisory committee that
would allow transparent input from and review of an evolving research
strategy by industry, academia, non-government organizations and other
stakeholders.
Q4. One of the key aspects of carrying out EHS research is to have
agreed terminology and standards for characterizing nanomaterials.
Is this getting sufficient attention under the NNI?
What is the role of NIST in this area?
Is there a role for NNI to provide direct assistance
to nanotechnology companies, particularly small companies, to
help them characterize new nanomaterials, which will thereby
assist the companies in assessing the potential environmental
and health risks of new materials?
A4. Terminology and characterization standards are essential for
effective EHS research. But there are dangers in standards work
unnecessarily delaying EHS research. In the first instance, it is
incorrect to assume that no research can proceed until global standards
are in place--research is about exploring the unknown and will
frequently set the agenda for standards development, rather than being
subject to it. Secondly, there is a danger in assuming that standards
developed to support the commercial development and use of
nanotechnologies are also suitable for governing EHS research. But
there is not a one-size-fits-all solution here.
In the short-term, good research practices are needed to ensure new
data can be interpreted effectively.
In the long-term, researchers need as much help as they can get in
understanding the characteristics of nanomaterials, in a way that will
allow for the cross-comparison and most effective use of studies.
NIST is the lead U.S. agency in developing characterization methods
and has a critical role in leading in and facilitating the development
of applicable standards. The NNI has supported NIST's role, but further
support is needed. In addition, other agencies with EHS expertise need
to be empowered to participate in the standards process, with staff
time and resources made available to do the job effectively.
A central nanomaterials characterization facility focused on EHS
characterization would strongly support small companies. For such a
facility to be effective it must:
1. be developed within an overarching strategy for EHS
research;
2. complement other approaches to materials characterization,
and provides a service to developers/companies lacking the
resources to do the necessary work; and
3. focus specifically on EHS-relevant characterization
methodologies.
Questions submitted by Representative Vernon J. Ehlers
Q1. To date, there is no evidence of any harm from a product which
uses nanotechnology. Are you worried about nanotechnology in products?
Are we doing a good job of prioritizing our research efforts between
final products and other byproducts of nanoproduction?
A1. The short answer to this question is: yes. I am worried about the
widespread and uncontrolled use of engineered nanomaterials in
products, and I do not believe we are doing a good job prioritizing
research to understand the risks of either these materials, or their
byproducts.
We have a great opportunity here to learn from past mistakes; to
avoid significant harm and halt the development of a legacy of adverse
health and environmental impacts that emerge only years or decades
after consumers (including children) have been using products and
exposed to unknown risks. The reality is that new engineered
nanomaterials are entering the market now, with little understanding of
how they will impact on health and the environment. We are aware of
over 570 manufacturer-identified nanotechnology consumer products,\7\
and these represent just the tip of the engineered nanomaterial
iceberg. If we are to understand how to use these materials safely and
wisely, we need action now.
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\7\ Maynard, A.D. and E. Michelson. (2007). A Nanotechnology
Consumer Products Inventory.'' Project on Emerging Nanotechnologies,
Woodrow Wilson International Center for Scholars, Washington, DC.
Available at: http://nanotechproject.org/consumer (accessed November
14, 2007).
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The current research portfolio is not prioritized to address and
manage the impact of these materials--or their byproducts. As I noted
in my testimony, carbon nanotubes are being sold and used now, with the
assumption that they are as safe as graphite. But the toxicity data--
while inconclusive--suggests the material could be much more harmful.
This is just one example. In the meantime, other materials, including
titanium dioxide, nano silver and other nanomaterials, are being used
with increasing frequency. We are doing a poor job of responding to the
fact that they may present a different risk to what conventional
thinking would tell us. Not all of these materials will be harmful. But
without good information, is this a risk we are willing to take?
In addressing potential risks, a life cycle approach is needed--as
I and a number of colleagues have highlighted in the journal Nature.\8\
This means looking at the byproducts of production and use as well
(whether they are nano or not), and the end-of-life impacts. Such an
approach is fundamental to a strategic research program, and yet it is
not in evidence.
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\8\ Maynard, A.D., R.J. Aitken, et al. (2006). ``Safe handling of
nanotechnology.'' Nature 444(16):267-269.
Q2. On the issue of stovepiping EHS research versus integrating it
into all research, do all current NNI grants currently include an EHS
---------------------------------------------------------------------------
component? If not, should they? Why or why not?
A2. Not all federally funded nanotechnology research includes an EHS
component, although an increasing number of large programs do. Yet I
believe the keys here are collaboration and partnership across
programs, not necessarily integration of EHS research into all aspects
of research. Understanding the potential impacts of engineered
nanomaterials is complex, and progress will only be made through
interdisciplinary collaboration that includes the developers of
materials, as well as those equipped to address potential harm.
Attempts to integrate EHS research into applications-focused
projects can lead to divisive battles for resources between
applications and implications research. This could lead to
inexperienced researchers doing EHS research in a way that does not
progress the state of knowledge. It also runs the danger of addressing
very specific EHS challenges, while leaving other equally important
challenges untouched. Of the majority of instances that I am aware,
integrated research programs have a primary focus on developing
applications, with risk-based research forming a relatively small
component of the research portfolio. This does have the disadvantage of
marginalizing risk research--implying that it is not as important or as
worthy as the applications research. Yet if we want the highest quality
of research into understanding potential adverse impacts, it must be
given the same respect as any other scientific endeavor.
On the other hand, well-executed integrated programs can and do
encourage close collaboration and partnerships between researchers
developing applications and understanding risks. We are seeing this in
some of the National Science Foundation-funded nanotechnology research
centers. The Niche Manufacturing Flagship in Australia is also
following this model,\9\ where applications and implications
researchers are working toward a common goal of developing safe and
successful applications.
---------------------------------------------------------------------------
\9\ Niche Manufacturing Flagship. Available at: http://
www.csiro.au/org/NicheManufacturingFlagshipOverview.html (accessed
October 19, 2007).
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The bottom line is that an integrated approach can work well, but
is not always the best way to address every important EHS issue.
Rather, mechanisms and funding are needed that enable strong
partnerships and collaborations between applications and implications
researchers, either within or outside research programs.
Questions submitted by Representative Daniel Lipinski
Q1. Much of the EHS research to date has focused on exotic materials
with unrealistic exposure scenarios. While that is useful in
establishing information on an ``upper bound'' of the hazard, the
context is rarely communicated and it creates fear. What is critical is
that we make sure nano-enabled products are as safe or safer than what
we use today.
As I understand it, the hazard of a nanomaterial often depends
upon much more than the size and type of material, but also surface
properties, purity, etc., that relate to how it is made. How is the
toxicology work underway controlling for this? Are researchers using
standardized, well characterized materials? If not, how can we make use
of the research findings?
A1. The attributes underlying nanomaterial hazard are complex, and we
are just beginning to learn what is important. As others and I have
noted in previous publications, we need to explore somewhat artificial
(i.e., not necessarily commercially relevant) nanomaterials, to
understand what attributes are important and why. But we also need more
targeted research that addresses materials that are in or will enter
commercial production. Both approaches are complementary.
I do not believe that EHS research that explores how well-defined
(but not necessarily commercially relevant) nanomaterials behave
necessarily creates fear, any more than basic research into how the
world works creates false hope. However, it is possible that people
sometimes miscommunicate or misunderstand such research. In this case,
rather than limiting important research from fear of how people will
react to the findings, there needs to be greater education and
engagement on nanotechnology between policy-makers, industry and the
public, to enable informed decision-making. This is a recommendation I
make in my written testimony.
Regarding the challenges of characterizing materials used in
investigations, it is essential that researchers adequately describe
the materials and study protocols they use, if studies are to be
interpreted and compared effectively. This is not an easy task:
researchers are having to learn new techniques and protocols, and we
are not yet sure how we should be characterizing nanomaterials in
toxicity or exposure studies. A number of groups are currently working
on this, including the International Council On Nanotechnology (ICON)
and the American Chemistry Council nanotechnology panel. But it is
researchers in academia and industry, who are frustrated by the lack of
guidance and progress from the Federal Government on nanomaterial
characterization approaches, who are driving current efforts.
Q2. It seems that most of the early uses of nanotechnology and
nanomaterials are for existing products and processes, many of which
are far from ideal from a health and environmental safety perspective.
What is being done to systematically compare the risks and benefits of
the nanoscale alternative against the conventional approach in use
today so that we accelerate the substitution of nanomaterials where
they are superior (e.g., when replacing a known toxin)?
A2. There is some work underway to compare the risks and benefits of
nanoscale alternatives against conventional materials; however, a clear
systematic approach has not yet been established. Many manufacturers of
new commercial nanoproducts make claims about the benefits of their
products as compared to conventional products; however, it is unclear
the extent to which they are systematically evaluating the risks of the
nanomaterials or nanoproducts they create or use to comparable products
made with larger-scale materials. Yet, in recent years, conferences,
papers, and researchers have encouraged the incorporation of life cycle
assessment (LCA) or life cycle thinking into nanomaterial and product
design and development to create products that are safer and greener
during production, use and at end-of-life.
Green nanotechnology approaches encourage the replacement of
existing products with new nanoproducts that are more environmentally
friendly throughout their life cycles, among other risk mitigation
goals. Ultimately, green nano may help accelerate the substitution of
nanomaterials where they are superior as well as safe.
A number of scientists are engaging in this area as described in
the Project on Emerging Nanotechnologies' Green Nanotechnology
report.\10\ These scientists are applying the lessons from green
chemistry and green engineering to nanotechnology in their laboratories
and incorporating life cycle thinking into the design and production of
new nanomaterials and products. These chemists and engineers seek to
design processes that are as clean and efficient as possible, use both
benign and less toxic material inputs, and prevent waste.
---------------------------------------------------------------------------
\10\ Schmidt, K. (2007). ``Green nanotechnology: It's easier than
you think.'' PEN 08. Washington, DC, Woodrow Wilson International
Center for Scholars, Project on Emerging Nanotechnologies. Available
at: http://www.nanotechproject.org/file-download/187
(accessed November 15, 2007).
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Efforts to develop systematic approaches to evaluating the risks
and benefits of nanomaterials include (a) a recent study by researchers
at the Oregon Nanoscience and Microtechnologies Institute applying the
principles of green chemistry to nanoscience,\11\ and (b) a
nanotechnology life cycle assessment workshop of international experts
convened in October 2006 by the European Commission's Nano & Converging
Science and Technologies Unit, EPA's Office of Research & Development,
and the Project on Emerging Nanotechnologies. This collaboration
resulted in a joint report on nanotechnology and life cycle
assessment.\12\ This report provides recommendations for moving forward
with assessing the life cycle impacts of nanotechnologies without near-
perfect data. EPA is actively studying the positive environmental uses
of nanotechnology, as compared to existing technologies and materials.
The agency's National Center for Environmental Research is funding
grants for research in green nanotechnology.
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\11\ Dahl, J.A., B.L.S. Maddux, and J.E. Hutchison. 2007. ``Toward
Greener Nanosynthesis.'' Chem. Rev. 107(6):2228-2269.
\12\ PEN and EC. (2007). ``Nanotechnology and Life Cycle
Assessment: A Systems Approach to Nanotechnology and the Environment.
Synthesis of results obtained at a workshop in Washington, DC, October
2-3, 2006.'' Project on Emerging Nanotechnologies, Woodrow Wilson
International Center for Scholars, and European Commission. Available
at: http://www.nanotechproject.org/fileG5-download/168 (accessed
November 15, 2007).
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As laudable as these initiatives are, they will be ineffective if
not pursued within the context of a strategic plan. Nanotechnology
cannot be seen in isolation, and the potential impacts of developing
and using specific nanotechnology solutions need to be balanced against
the risks of not pursuing these technologies. Yet this does not give
carte blanche to implementing nanotechnology solutions that look good,
but have not been fully evaluated. The prudent approach is to develop
these technologies with as clear an understanding of the science-based
pros and cons as possible. This will only happen within the context of
a top-down research strategy.
Q3. The discussion around nanomaterials tends to focus on
``engineered'' nanomaterials which are roughly defined as those that
are purposely created. However, the volume of naturally occurring and
ultra-fine particles produced by combustion, as well as those used as
fillers in rubber tires or plastics is many orders of magnitude greater
than the newly engineered nanomaterials. What are we doing to ensure
that we leverage the body of EHS knowledge on these particles? Are we
missing the forest from the trees by emphasizing only ``engineered
nanomaterials''? What efforts are there to assess the comparative
hazard posed by engineered nanomaterials against incidental or
naturally occurring nanomaterials?
A3. In addressing the potential impact of engineered nanomaterials,
there is much we can learn from the impacts of incidental nanomaterials
on human health and the environment. But nanotechnology also provides
the tools to create new nanoscale materials to which our bodies have
not been exposed before, and have not necessarily evolved to deal with.
While it is often useful to discuss incidental and engineered
nanomaterials as separate issues, a strong research strategy should
integrate knowledge on both areas.
EHS research is conducted to protect people and the environment,
irrespective of the type of harmful agent. Thus, having a strategic
research plan that enables a free flow of information from where it
resides to where it is needed--regardless of how the technologies or
the materials are classified--is essential. In developing the Project
on Emerging Nanotechnologies' publicly accessible EHS research
database,\13\ we recognized the importance of having access to
information on all types of nanomaterials. For this reason, we include
and categorize research addressing both incidental and naturally
occurring nanomaterials.
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\13\ PEN (2007). Nanotechnology Environmental and Health
Implications Inventory of Current Research. Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for Scholars,
Washington, DC. Available at: http://nanotechproject.org/18 (accessed
November 14, 2007)
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But the bottom line is that engineered nanomaterials present unique
potential threats to our health and the environment; while we can and
must learn from associated research areas, we need a strategy that
clearly articulates the nanotechnology-specific questions that need
answering, and how they are to be answered.
Q4. To what extent is the toxicity research relevant to ``real world''
situations? To what extent are federally funded efforts using the
routes of exposure or formulation that emulate the nanomaterials being
used in available products?
A4. Strategic research is needed both on fundamental mechanisms of
action of nanomaterials in humans and the environment--which will help
predict the behavior of new nanomaterials and develop new understanding
of what makes them harmful--and on specific nanomaterials in commerce.
But without a clear strategy, there will be no coordination of these
complementary approaches, and no hope of making systematic progress.
This is the situation we find ourselves in now.
In my analysis of the research portfolio last year, it was clear
that a bottom-up approach to EHS research (i.e., one where the
researchers dictate the agenda) has led to a preponderance of
scientifically interesting studies of questionable relevance, and major
gaps in the research portfolio for addressing commercially relevant
materials and significant routes of exposure. For instance, much
research has focused on carbon nanotubes and inhalation exposure. Yet
relatively little research is being carried out on prevalent, although
perhaps less scientifically stimulating, materials like silver
nanoparticles, and other exposure routes such as ingestion.
The only way of redressing the balance is to complement bottom-up
driven research with a top-down strategy, that enables goal-oriented
targeted and exploratory research with the aim of providing relevant
answers that industry and regulators can use.
Q5. You and Dr. Denison call for ten percent or more of the Federal
Government's nanotechnology research and development budget be
dedicated to goal-oriented EHS research. As pointed out by Dr.
Denison's testimony, only 4.1 percent of NNI's 2008 budget is to be
spent on EHS R&D. Would you please elaborate on this and explain how
you came up with this 10 percent figure? Would the other panelists
please comment on this recommendation?
A5. As I argue in my testimony, research funding must be tied to a
research strategy, which will allow for a systematic allocation of
funds and the review of progress towards clear goals. Targeted research
goals arise from specific questions that need to be answered if we are
to develop safe ways of using the current generation of engineered
nanomaterials. In my July 2006 analysis,\14\ I evaluated how much it
would cost to address the most pressing questions and attained an
estimate of $50 million per year. In addition to this targeted
research, exploratory research (including basic research) is needed to
develop the knowledge needed to ask and address longer-term questions.
This research should still be goal-oriented, but its exploratory nature
precludes attaching definite dollar figures to the cost of generating
new knowledge. As an example, the goal of developing methods to predict
the toxicity of new engineered nanomaterials requires the generation of
new knowledge through exploratory research, but it is impossible to
tell how much this research will cost to yield results. Yet a line must
be drawn somewhere on how much funding will be allocated to such
research.
---------------------------------------------------------------------------
\14\ Maynard, A.D. (2006). Nanotechnology: A research strategy for
addressing risk, Project on Emerging Nanotechnologies, Woodrow Wilson
International Center for Scholars, Washington, DC.
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The figure of 10 percent of the NNI budget for both targeted and
exploratory EHS research will enable valuable research to proceed
without unduly biasing the funding portfolio towards risk-based
research. With less than 10 percent, exploratory research becomes
starved and thus prevents the generation of new knowledge essential to
tackling future problems. With more than 10 percent, it becomes hard to
justify EHS research funding to managing possible (and even
speculative) risks arising from associated nanotechnology research.
Assigning 10 percent of the nanotechnology R&D budget to risk
research also makes a number of very clear statements: risk research
and risk researchers have a credible and a critical role to play; the
Federal Government is dedicated to supporting the commercial
development of nanotechnology with the knowledge necessary to use it
safely; and the Federal Government are committed to a transparent and
accountable plan for ensuring the safe development of nanotechnology.
Questions submitted by Representative Ralph M. Hall
Q1. Please share your thoughts on the idea of establishing a separate
program office to oversee EHS research. Why is such an office needed
for nanomaterials versus other materials? What authorities would such
an office need to have? What are the possible pitfalls of such an
approach? How would you prevent the perception of adding another level
of federal bureaucracy to the mix? As an alternative to creating a new
office, how can we improve the mechanisms we currently have in place to
achieve the same goals?
A1. I have not suggested that a separate program office is needed to
oversee EHS research, but rather that leadership is needed (together
with a strategic plan, and the resources and means to implement it) to
ensure that the right research is done to underpin the development of
safe nanotechnologies--and to support the U.S. Government's significant
investment in nanotechnology research and development.
The current approach to ensuring the right research is done is
clearly not working. I demonstrated this in my testimony with the
example of carbon nanotubes--a material that anyone can purchase online
and use. The questions we need to answer in order to use this material
safely are not rocket science: Does exposure occur in the workplace?
How can we measure it? How toxic is the material? Does it behave like
asbestos? How much will be released into the environment? And so on.
Yet current research plans do not seem geared to addressing pressing
questions like these in a timely manner. The question is, therefore,
what does it take to fix the system?
In my written testimony, I make several recommendations on actions
that are needed if we are to provide industry, regulators and the
public with the answers they need to develop and use the products of
nanotechnology safely. From these recommendations, it is very clear
that leadership with authority is needed to enable research, oversight
and regulatory agencies to work within their respective authorities
toward the common goal of ensuring the safety of emerging
nanotechnologies. It is also clear that EHS research needs a champion--
a person who understands its relevance and value; a person who can
counter misconceptions that risk research is somehow a poor cousin of
basic and applications-focused research; and a person who understands
how risk research works.
Such leadership could reside within the current NNI structure. But
to be effective, this appointed person would need to be given authority
to engage agencies at the highest level in order to lead a coordinated
and strategic response to the challenges raised by emerging
nanotechnologies. This champion would also need the authority to
channel strategic research to addressing regulatory oversight issues.
Answers to Post-Hearing Questions
Responses by Richard A. Denison[1], Senior Scientist, Environmental
Defense
Introduction
Before addressing Subcommittee Members' specific questions,
Environmental Defense wishes first to elaborate on the recommendations
we offered in our testimony on changes needed for the NNI to
effectively identify and address the potential risks of nanoscale
materials, as our recommendations bear directly on many of these
questions. We also wish to address what we believe to be serious
mischaracterizations of our positions provided by two other witnesses
at the hearing. Finally, we describe a federal precedent and potential
model for restructuring the NNI. This model directly addresses our and
others' mounting concern that nanotechnology's potential risks are not
being sufficiently addressed because the same entity has been charged
with both promoting and providing oversight of this technology. The
restructuring we suggest would help to ensure that nanotechnology's
risk implications get the attention they need, even as federal
investment in nanotechnology development proceeds.
Our two main recommendations are as follows: First, we recommend
creating a new entity, or elevating an existing entity, with the
responsibility to develop and oversee a federal research strategy to
identify, assess, and address the potential risks of nanomaterials.
This entity should be provided with ample budgetary and independent
management authority and sufficient resources, and should have a core
public health and/or environmental mission. Second, we recommend
establishing a clearer and stronger separation in decision-making and
management between the parts of the Federal Government whose mission is
to help develop and advance nanotechnology, and those parts charged
with ensuring a thorough and objective examination of its potential
risks and taking steps needed to mitigate those risks.
Hearing witnesses Dr. Clayton Teague and Mr. Floyd Kvamme
inaccurately depicted Environmental Defense's recommendations in their
prepared statements and in response to Subcommittee Members' questions.
They repeatedly and incorrectly stated or implied that we and other
witnesses critical of their efforts (a) are calling for appointment of
an EHS research ``czar'' and (b) intend for EHS research to be
conducted in isolation (in a ``silo''), wholly removed from research on
nanotechnology applications. Neither is the case.
Environmental Defense is indeed very concerned about the NNI's
continuing lack of sufficient direction, leadership, and authority to
develop and implement an effective and coherent risk research strategy
across the Federal Government. This lack of focus is not the result of
happenstance, in our view, but rather it is embedded in the origins and
management structure of the NNI itself.
With apologies for the ``alphabet soup,'' note that the National
Nanotechnology Coordination Office (NNCO, headed by Dr. Teague) is
managed under the Nanoscale Science Engineering and Technology (NSET)
Subcommittee of the Committee on Technology (CoT), which is part of the
National Science and Technology Council (NSTC). The NSTC is advised by
the President's Council of Advisors on Science and Technology (PCAST,
co-chaired by Mr. Kvamme). PCAST has been designated as the National
Nanotechnology Advisory Panel (NNAP), which is charged with reviewing
the federal nanotechnology research and development program.
The core mission of all of these entities is the advancement of
technology in the U.S. The NNCO staff, the NSET and CoT chairs, and the
PCAST/NNAP membership are populated almost entirely with
technologists--individuals trained in materials sciences or with
technology development expertise and experience.[2] From a historical
perspective, this makeup is not surprising, as the NNI was created with
the primary aim of advancing nanotechnology. (Of the eleven areas of
activity delineated for the national nanotechnology program called for
under the 21st Century Nanotechnology Research and Development Act of
2003, only a small part of one of them addresses health or
environmental implications; the other ten focus on advancing
nanotechnology applications.[3])
Although the staffing and membership composition described above is
quite appropriate for the NNI's work to develop and promote
nanotechnology applications, it is entirely inappropriate when it comes
to addressing nanotechnology's implications--it potential risks.
Scientists trained and experienced in understanding health or
environmental risks, rather than technologists, need to direct and
implement the NNI's efforts to identify and address nanomaterial
hazards and exposure potential. Delivering the right expertise is
crucial, as is providing some distance from, and an effective
counterbalance to, the inevitable boosterism of technologists charged
with a promotional role.
The effect of the current imbalance is evident in the hearing
statements of technologists Mr. Kvamme and Dr. Teague, defending the
NNI's risk-related efforts. Even as they professed that the NNI is
serious about addressing nanotechnology's potential risks, both
witnesses claimed or implied that concerns about nanotechnology's risks
are overblown. In his written statement, Mr. Kvamme stated the
following:
``Already, research is shedding light on some of the questions
being asked. Specifically, a study at Purdue on the
environmental impact of manufactured nanoparticles on ordinary
soil showed no negative effects; Georgia Tech scientists are
doing similar work. Researchers at Dayton University are
working on the health and safety aspects of the use of
nanodiamonds as drug delivery vehicles with encouraging
results. University of Oregon chemists are looking at the use
of nanomaterials to clean up toxic groundwater contaminants
that have until now been difficult to remove. In vivo tests at
Rice University have found no immediate adverse health effects
from carbon nanotubes injected directly into the bloodstream
and that the liver seems to collect these materials effectively
for excretion.'' (emphases added)[4]
This ``summary'' of the available risk research on nanomaterials is
highly selective and biased, as it over-generalizes findings and
highlights only ``exonerative'' results while ignoring many other
studies that indicate potential concerns. It is also entirely at odds
with the far more balanced rendition of the facts provided by NNI
Agency health and environmental scientists.[5]
Dr. Teague, in response to a Subcommittee Member's question, stated
the following:
``A lot of the research that was done early on, even though it
was certainly not coordinated and from the Federal Government,
and I think that is why some of it did produce some very
premature results and a lot of wrong conclusions were drawn
from it. By the careful planning and by tapping into the depth
of experts within the Federal Government, and our collaboration
with others outside, I think that we have, by far, the best
approach to trying to carry out appropriate research in a
careful, deliberately planned way. If one doesn't do that, the
result is typically bad research and research that leads to
premature and often poor results, poor understanding and
leading to, I think, a lot of misleading conclusions that have
already been drawn there often, because the result was not
planned, not well-conducted.''[6]
While we certainly have no quarrel with the need for more and
better coordinated research, Dr. Teague's implication that only ``bad''
research has indicated the potential for risks again reflects a very
biased view of the available literature. It also is not indicative of
what any good health or environmental scientist in the field would
state to be the case.
Indeed, a review just published in Nanotoxicology found that the
``vast majority'' of nearly 430 journal papers reporting on toxicity
testing of various nanoparticles identified adverse effects in
laboratory animals or cell lines.[7]
What concerns Environmental Defense most about these statements,
however, is that senior NNI and PCAST members seem to believe it is
their role to downplay evidence that suggests that engineered
nanomaterials may pose risks to health or the environment.
The mechanism the NNI is using to address nanotechnology's
potential risks is the Interagency Working Group on Nanotechnology
Environmental and Health Implications (NEHI). NEHI's stated mission is
to:
provide for exchange of information among agencies
that support nanotechnology research and those responsible for
regulation and guidelines related to nanoproducts (defined as
engineered nanoscale materials, nanostructured materials or
nanotechnology-based devices, and their byproducts);
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
parties.[8]
Environmental Defense agrees with the importance and necessity of
such ``bottom-up'' functions of interagency information exchange,
facilitation, and communication, but we believe they are not enough to
produce and effectively implement a risk research strategy. We think
the record speaks for itself: a string of unmet promises to deliver the
strategy, and near-universal disappointment in the scope and quality of
the interim documents delivered to date by NEHI.[9]
We support retaining and continuing to use the ``bottom-up''
approach to gain input from the full range of agencies and individuals
with expertise in relevant fields. This approach needs to be
supplemented, however, with a ``top-down'' capacity, designating a
smaller group of senior health and environmental scientists with the
authority to direct and oversee both the EHS research budgets and
associated activities within and across NNI agencies. These scientists
should be drawn from NNI agencies with missions to protect human health
and/or the environment and related research capabilities. Whether
situated within the current NNI structure or outside of it, this
executive body needs to have decision-making authority that is
independent of those parts of NNI charged with advancing nanotechnology
development. (Our written testimony elaborates further on why this
separation of roles is needed.)
With regard to the claim of other witnesses that Environmental
Defense favors somehow isolating implications research from
applications research, we absolutely do not. We fully recognize both
the need for and the benefits of ``cross-fertilization,'' as well as
the importance of simultaneously pursuing and sharing the results, from
different lines of research. It would clearly be counterproductive to
obstruct such opportunities for synergism or to impede the free flow of
research ideas and results. Our point instead is that addressing risk
implications requires conducting research that is both intended and
directly targeted to answer specific risk-relevant questions. Such
research should also be undertaken and directed by--and judgments as to
its adequacy, quality and interpretation made by--scientists trained in
the health or environmental sciences who work at agencies charged with
the pursuit of health or environmental missions. It is equally
important that the specifics of the projects and amount of funding
spent on such research be transparently and clearly identified and
accounted for separate from applications research, some of which may
well yield findings relevant to understanding risk.
A federal precedent--and potential model--for our recommended approach
Our nation has faced similar situations in the past, when mounting
concern that a technology's potential risks received insufficient
attention because the same entity had been charged with both promoting
and providing oversight of that technology. The Atomic Energy
Commission (AEC), for example, first established by the Atomic Energy
Act of 1946, was explicitly assigned the functions of both encouraging
the use of nuclear power and regulating its safety. Concerns about this
dual charge grew among both proponents and critics of nuclear power,
coming to a head in the mid-1970s, when Congress abolished the AEC.
Congress then assigned the oversight functions of the AEC to a new
entity, the Nuclear Regulatory Commission (NRC), and shifted federal
nuclear energy research and development to the U.S. Department of
Energy (DOE).[10]
The NRC's mission and work specifically includes risk research:
``As part of its regulatory program, the NRC conducts an extensive
research program to provide independent information and expertise to
support its safety decision-making.''[11] This research is conducted
through the NRC's Office of Regulatory Research, which ``[p]rovides
leadership and plans, recommends, manages and implements programs of
nuclear regulatory research.'' The Office also engages in considerable
cooperative research with ``DOE and other federal agencies, the nuclear
power industry, U.S. universities, and international partners.''[12]
However, it operates and is managed independently, and the NRC has in
place extensive guidelines and procedures intended to assure it avoids
conflicts of interest (COI) that could arise from its use of DOE
laboratories for technical assistance and research,[13] or from its
hiring contractors who have also worked on or are competing for DOE
contracts.[14]
Hence--far from operating in a ``silo'' and being unable to take
advantage of the ``cross-fertilization'' arising from research
conducted on applications--the NRC has established an approach intended
to allow for safety research to be conducted in a manner that
transparently manages COI, while also maintaining its independent
decision-making. While we make no representation as to the NRC's
performance, we believe the Committee should seriously examine the NRC
example as a precedent and potential model for the kinds of changes
that may be needed to reform the NNI. Such reform would, in our view,
help to ensure that nanotechnology's risk implications get the
attention they need, even as federal investment in nanotechnology
development proceeds.
Our specific responses to Questions for the Record follow.
Questions submitted by Chairman Brian Baird
Q1. Dr. Maynard has suggested a mechanism for government to partner
with industry to fund environmental, health and safety (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. Do you
believe this would be a good model for developing a government/industry
research partnership for EHS research related to nanotechnology?
A1. We agree that the Health Effects Institute (HEI) provides a good
model for governing public-private research partnerships, for several
reasons. First, because the research findings have implications for
needed regulatory controls that may be controversial, it would be
beneficial to have an objective, scientifically excellent third party,
which neither makes nor is a stakeholder in policy-making (i.e., is
outside of government and the regulated industry), conduct such
research. Second, given the considerable technical demands of the
research, the HEI model--which employs the finest academic scientists
as research planners, performers and peer reviewers--will help assure
high-quality and credible research results. Third, situating this
research in a high-quality independent institution will help foster the
development of a focused and consistent research strategy in a way that
may be more difficult to achieve with multiple competing government
agencies. Finally, HEI employs a number of governance and operational
procedures to help ensure transparency, credibility and integrity in
its research; these include a commitment to release all research
results (positive or negative), reliance on governance and advice by
independent expert committees, and insulation of the review and release
process from sponsor influence.
Q2. The President's Council of Advisors on Science and Technology
(PCAST) was assigned by the President to serve as the statutorily
created outside advisory committee for the National Nanotechnology
Initiative. How useful is PCAST as a means for private sector
organizations to provide input to the planning and prioritization
process for EHS research under the NNI? Are there other mechanisms
available for stakeholders to have a voice in this process?
A2. As noted in our Introduction, PCAST, like the NNI itself, has as
its core mission the advancement of technology in the U.S. Not
surprisingly, PCAST's membership is therefore made up almost entirely
of technologists--individuals trained in materials sciences or with
expertise and experience in the area of technology development.[15]
Only three of the 36 PCAST members have health science or environmental
science expertise, and none has a risk science background. This mission
and composition, while appropriate for overseeing NNI's primary goals
related to developing and promoting nanotechnology applications, are in
appropriate when it comes to overseeing or judging how well the NNI is
addressing nanotechnology's implications--its potential risks.
Scientists trained and with extensive experience in understanding
health or environmental risks--not technologists--need to oversee and
advise NNI's efforts to identify and address nanomaterial hazards and
exposure potential. In our view, PCAST's ability to effectively execute
its assigned advisory tasks is impeded by the same problem we have
identified within the NNI itself: insufficient separation between the
promotional and oversight roles it is being expected to play.
In addition to this structural or compositional constraint, the
only mechanism PCAST seems to have developed for gaining outside
input--its Nanotechnology Technical Advisory Group (NTAG)--operates
virtually entirely out of sight. No description of the NTAG--its
members, its mission or charge, its operating guidelines, whether or
when it meets--is available on the PCAST website.[16] (In the interest
of full disclosure, Environmental Defense was extended but declined an
invitation to join the NTAG primarily because we were concerned that it
appears to operate largely out of public view.) This approach is in
marked contrast to the manner in which federal advisory committees are
structured and operate, pursuant to the Federal Advisory Committee Act
(FACA).
Q3. Dr. Maynard suggested the need for an individual to be designated
to take a leadership role for EHS research under the NNI. Do you agree
with this recommendation, and if so, how would you define the
characteristics and functions of this leadership role and how could the
proposal be implemented?
A3. We agree with the need for more centralized and independent
leadership and increased decision-making authority sufficient to direct
and oversee federal nanotechnology risk research, although we think
that designation of a small group of experienced individuals with a
somewhat diverse set of backgrounds and expertise in health and
environmental fields, rather than a single individual, may be
preferable. In our Introduction, we have described in some detail the
characteristics, functions and authorities such an entity would need to
effectively direct a federal risk research program. We have also
suggested that the Nuclear Regulatory Commission and its Office of
Nuclear Regulatory Research provide both a precedent and potential
model. Most important, such an executive body needs to have decision-
making authority that is independent of those parts of NNI charged with
advancing nanotechnology development.
Q4. One of the key aspects of carrying out EHS research is to have
agreed terminology and standards for characterization of nanomaterials.
a. Is this getting sufficient attention under the NNI? What is
the role of NIST in this area?
b. Is there a role for NNI to provide direct assistance to
nanotechnology companies, particularly small companies, to help
them characterize new nanomaterials, which will thereby assist
the companies in assessing the potential environmental and
health risks of the new materials?
A4a,b. While deciding on terminology and standards for characterization
has proven challenging both domestically and internationally, we
believe the NNI is devoting sufficient attention to these important
matters. Because terminology and standards for characterization must be
agreed upon by a variety of industry sectors, academic researchers, and
government bodies in different countries, there is only so much the NNI
can do to help the parties come to agreement. The National Institute of
Standards and Technology (NIST) has an important role to play in both
helping to set the standards and then developing and making available
reference materials for those standards. To our knowledge, NIST is
adequately engaged in these processes.
The Federal Government, through entities such as NIST and the
Nanomaterial Characterization Laboratory of the National Cancer
Institute, has been assisting both private sector and academic groups
with nanomaterials characterization. This is indeed an important and
useful role for the government to play, and the NNI should encourage
its member agencies to assist with characterization. The NNI itself
does not have the facilities to carry this out.
Questions submitted by Representative Vernon J. Ehlers
Q1. On the issue of stovepiping EHS research versus integrating it
into all research, do all current NNI grants currently include and EHS
component? If not, should they? Why or why not?
A1. The choice need not be between either incorporating an EHS
component into every research grant or stovepiping risk research into a
completely separate program. Environmental Defense does not believe it
makes sense to compel all researchers to add EHS research questions
into their projects, as--many of them may lack the relevant EHS
expertise. Rather, there ought to be a mechanism to ensure that
federally funded investigators pursuing basic or applications-oriented
research projects, which may provide insight into EHS questions (e.g.,
how nanomaterials interact with biologic systems), at least share their
findings with EHS researchers. They should also coordinate their
studies wherever possible (e.g., by conducting testing on the same
materials, utilizing the same reference materials or methods for
nanomaterial characterization).
As described in our Introduction, maximizing research coordination
and sharing of results among investigators conducting applications and
EHS implications research is highly beneficial and should be
encouraged. However, in addressing EHS implications, it is essential to
conduct research that is both intended and targeted to answer specific
risk-relevant questions. Scientists trained in the health or
environmental sciences who work at agencies charged with the pursuit of
health or environmental missions should undertake and direct this
research, and they should be the judges of its adequacy, quality and
interpretation. It is equally important that the specifics of the
projects and amounts spent on such EHS-targeted research be
transparently and clearly identified and accounted for separate from
applications research, even while fully acknowledging that some
applications research will yield findings relevant to understanding
risk.
Questions submitted by Representative Daniel Lipinski
Q1. Much of the EHS research to date has focused on exotic materials
with unrealistic exposure scenarios. While that is useful in
establishing information on an ``upper bound'' of the hazard, the
context is rarely communicated and it creates fear. What is critical is
that we make sure nano-enabled products are as safe or safer than what
we use today.
A1. We will address the question of ``upper bound hazard'' and
``unrealistic exposure scenarios'' under the related Question 4 below.
We do not agree that current EHS research on nanomaterials is
focusing on exotic materials. Most studies to date have focused on a
range of engineered nanomaterials that are either already in commerce
in significant amounts (e.g., titanium dioxide) or are now subject to
considerable research interest and poised to enter commerce in the near
future (e.g., carbon nanotubes). Some less common engineered
nanomaterials (e.g., quantum dots) are confined mostly to biomedical
research applications, but they are also being examined for use in a
broader range of applications (e.g., photovoltaic cells, LED
displays).[17]
Q1a. As I understand it, the hazard of a nanomaterial often depends
upon much more than the size and type of material, but also surface
properties, purity, etc. that relate to how it is made. How is the
toxicology work underway controlling for this? Are researchers using
standardized, well characterized materials? If not, how can we make use
of the research findings?
A1a. There is currently substantial variation in the degree and quality
of physico-chemical characterization performed on nanomaterials used in
toxicology studies.[18] The questioner is correct in suggesting that
the results of studies with poor characterization are of limited use.
Efforts to develop a scientific consensus are underway both
domestically and internationally, and the government laboratories are
setting a high standard for physicochemical characterization in their
own work. The development of international voluntary standards and
characterization requirements for publication in scientific journals
are both underway. Lastly, NIST and its international counterparts are
developing and promoting the use of standardized reference
nanomaterials. All of these efforts will improve the credibility and
usefulness of research results.
One obstacle to sharing characterization data is the fact that
manufacturers frequently consider such information to be Confidential
Business Information (CBI), which greatly impedes the ability of the
government, nanomaterial users, third-party researchers, and the public
to independently conduct adequate toxicity testing or interpret the
results. Ultimately, fully addressing the characterization issue will
require both an understanding of the types of information that are most
important for nanomaterials, as well as an agreement on what
information needs to be released to strike the right balance between
the need to sufficiently inform and to protect legitimate CBI.
Q2. It seems that most of the early uses of nanotechnology and
nanomaterials are for existing products and processes, many of which
are far from ideal from a health and environmental safety perspective.
What is being done to systematically compare the risks and benefits of
the nanoscale alternative against the conventional approach in use
today so that we accelerate the substitution of nanomaterials where
they are superior (e.g., when replacing a known toxin)?
A2. We agree that most current nanomaterial applications represent
incremental modifications of existing products and processes. We are
not aware of evidence or analysis, however, indicating that such
modifications have typically yielded any significant health or
environmental benefits over the processes and products they are
intended to replace. Indeed, most of the nanomaterialcontaining
products introduced onto the market to date have been intended to
provide other consumer benefits (e.g., stain resistance, scratch
resistance, strength enhancement, etc.), not to provide direct health
or environmental benefits or replace of a specific toxic chemical.
(Some producers may argue that the slew of recently introduced
nanosilver-containing products claiming antimicrobial activity provide
health benefits, but that assertion is far from established, in our
view, and could easily be offset by the harm they could cause to
beneficial microbes.) Nonetheless, there is no question that
considerable nanotechnology research and development is underway that
is intended to deliver products and processes that offer health or
environmental benefits. Nanotechnology holds significant promise in
this regard.
Determining whether and to what extent risks are reduced and
environmental or health benefits are realized is complex. Virtually all
experts agree that a systematic comparison will require considering the
full life cycles of the materials being compared, and that much of the
information needed to perform such comparisons may be unavailable or
difficult to compile. In many cases there may also be tradeoffs:
reduced energy consumption of a nano-enabled product during use might
be offset by increased production energy, for example.
Proponents of Green Chemistry are already mounting efforts to
ensure that its principles[19] are fully understood and applied by
developers of nanomaterials.[20] While it cannot be assumed that nano-
enabled products and processes will be inherently safer or yield health
or environmental benefits, the potential for these outcomes exists and
will be more likely to be realized through conscious design decisions.
Q3. The discussion around nanomaterials tends to focus on
``engineered'' nanomaterials which are roughly defined as those that
are purposefully created. However, the volume of naturally occurring
and ultrafine particles produced by combustion, as well as those used
as fillers in rubber tires or plastics is many orders of magnitude
greater than the newly engineered nanomaterials. What are we doing to
ensure that we leverage the body of EHS knowledge on these particles?
Are we missing the forest from the trees by emphasizing only
``engineered nanomaterials''? What efforts are there to assess the
comparative hazard posed by engineered nanomaterials against incidental
or naturally occurring nanomaterials?
A3. Newly engineered nanomaterials have both similarities and major
differences with natural or incidental combustion particles and
industrial ultrafine particles that have been around for decades or
longer. Several points need to be made. First, there should be no
assumption that non-engineered nanoparticles to which we are exposed,
or even engineered nanoparticles that have been in use for some time,
are ``safe.'' It is precisely our recognition that inhaled ultra-fine
combustion particles can traverse the lungs and cause damage not only
to the lungs but also elsewhere in the body (including to the
cardiovascular system) that prompted much of the initial concern about
engineered nanomaterials. The considerable literature and methods
available on ultrafine combustion particles are indeed being used
extensively to inform our efforts to understand the potential risks of
engineered nanomaterials.
Second, in many cases, little or no testing of even large-volume
``existing'' engineered nanomaterials has been required as a condition
to remain on the market, and for some of these so-called ``legacy''
nanomaterials, very few studies have been conducted. We would welcome
greater scrutiny of such materials, as well as newer engineered
nanomaterials, as well as comparisons among them.
Third, while it may be viewed as inequitable to hold newly
engineered nanomaterials to a higher threshold of safety than older
engineered nanomaterials, it would be an even more serious mistake to
fail to ascertain the potential toxicity of newly engineered
nanomaterials out of a belief that exposures will never be significant
compared to more familiar materials. Some nanomaterials are being
considered for use or already used in applications that will widely
disperse them in the environment. For example, EPA's Office of Air and
Radiation is evaluating an application for use of nano cerium oxide as
a fuel additive. This application is eerily reminiscent of our
experience with leaded gasoline, where initial assumptions that the
lead would never be released from motor vehicle tailpipes in sufficient
quantities to cause meaningful exposure or harm turned out disastrously
wrong. We should not repeat this mistake with insufficiently tested
nanoparticle fuel additives.
Samsung's washing machines, which claim to infuse nanosilver
particles into the washwater[21] (which then go down the drain), raised
objections from operators of municipal wastewater treatment facilities,
who were concerned about potential environmental effects of the
resulting wastewater treatment plant influents and effluents, given
that silver exhibits significant ecotoxicity.[22] Other nanomaterial
applications already on the market entail direct human exposure, most
notably sunscreens and cosmetics; the latter are not subject to any
pre-market review despite the certainty of human exposure.[23]
Fourth, the precise and highly homogeneous composition of most
engineered nanomaterials, and their intended use in specific
applications, could well lead to exposures of a wholly different nature
and magnitude than those associated with natural or incidental
nanomaterials.
Q4. To what extent is the toxicity research relevant to ``real world''
situations? To what extent are federally funded efforts using the
routes of exposure or formulations that emulate the nanomaterials being
used in available products?
A4. This question, like the preface to Mr. Lipinski's questions, is
essentially asking whether the laboratory conditions used in toxicity
testing realistically simulate conditions under which actual exposures
occur.
There are important scientific and policy justifications for the
approaches used to characterize the potential hazards of a substance,
independent of how or in what form someone might be exposed to it.
First, hazard characterization is intentionally conducted independent
of exposure characterization (which are typically then combined to
characterize risk); the former is used to identify the inherent hazards
of a material, while the latter step is when factors affecting the
nature and extent of exposure--e.g., form of the material, likely dose,
etc.--are taken into account.
Second, the goal of hazard identification is to characterize the
full extent of potential adverse affects that could be associated with
exposure to a substance across an entire population. The exposed
population will exhibit a range of responses even to the same exposure.
In order to ensure that the most susceptible or vulnerable members of
society are protected, hazard identification must be able to identify
upper bound effects.
Third, toxicologists' obvious need to rely on animal rather than
human studies requires, for sound scientific reasons, that they employ
what the lay person may think are ``unrealistic'' exposure scenarios.
Consider the very high doses typically used in animal studies. Certain
adverse health effects, such as malignant tumors, are typically
relatively infrequent events. Under ``realistic'' exposures, an effect
seen in a human population at a frequency, say, of one in ten thousand
to one in a million, would nevertheless be considered to occur at a
high incidence.
Given that it is unrealistic and unethical to use ten thousand or a
million laboratory animals in a study, we must rely on high-dose
exposures to increase the chances that we will observe these rare
events, should they be associated with the chemical being tested, in a
much smaller number of laboratory animals, within a reasonable time
span. We can then extrapolate the observed effects to predict what
would occur in humans at much lower doses or over longer periods of
time.
This is the risk-based approach to public health protection that
has evolved over the last 60 years. Laboratory techniques have been
developed to provide useful information for predicting toxicity in the
``real world.'' While the resulting information is not perfect, and
examples of inaccuracies are available, overall the information
generated using validated, standardized laboratory tests allows
scientists and policymakers to make informed decisions about the
relative safety of different materials. All of these challenges
inherent in developing a basis for predicting the effects of real world
exposures apply equally to nanomaterials. They are among the reasons we
are calling for more federal investment in, and a more strategic
approach to, nanomaterial risk research.
With regard to our ability to know or predict what real world
exposures will be, it is important to first recognize the complexity in
defining what constitutes the ``real world'' for a class of materials
like nanomaterials, the fate and behavior of which are presently poorly
understood. Many nanomaterials are likely to take multiple forms when
one considers the full value chain or life cycle, from production
through end use and disposal or post-use management. At each stage, the
potential for releases into the environment or exposures to workers,
consumers or the public are possible. Clearly, there is no single
``real world'' situation.
Seeking to limit testing at this early stage to only certain routes
of exposure or certain formulations rests on the questionable
assumption that we know exactly how these materials are produced, used
and disposed of, now and for the foreseeable future. Most of this
information is not available, and is almost certain to change. Before
C60 fullerenes (``buckyballs'') started showing up in skin creams
offered for sale, few would have ever predicted such a use or the
associated routes of exposure. Under our current regulatory system,
except in limited circumstances, even new nanomaterials can be produced
and used in any number of ways without the producer or user having to
inform the government or gain its approval. There is essentially no
tracking of the production and use of nanomaterials. This is another
reason why it is so important to gain an understanding of the inherent
hazard of a material, which is relevant no matter how it may be used or
encounter people or the environment.
It is also premature to assume we know or can predict how
nanomaterials behave in the body or the environment. As just one
example, consider the conventional wisdom has been that, once released
to the environment, nanomaterials would always aggregate and lose their
``nano-ness.'' This assumption is already proving to be wrong. Because
aggregation reduces or interferes with functionality and performance,
developers of these materials are finding ways to modify or treat
nanomaterials to better maintain them in a dispersed state. And recent
studies of carbon nanotubes have revealed that mixing them with natural
river water actually leads to a stable suspension of individual CNTs,
due to their interaction with humic acids present in the water.[24]
Q5. You and Dr. Maynard call for ten percent or more of the Federal
Government's nanotechnology research and development budget be
dedicated to goal-oriented EHS research. As pointed out in Dr.
Denison's testimony, only 4.1 percent of NNI's 2008 budget is to be
spent on EHS R&D. Would you please elaborate on this and explain how
you came up with this 10 percent figure? Would the other panelists
please comment on this recommendation?
A5. Our call to devote at least 10 percent of the Federal R&D
nanotechnology budget to direct EHS research for the foreseeable future
is based on an assessment of the scope, magnitude and complexity of the
needed research.[25] It is also informed by reference to a number of
analogous or related cost benchmarks, which are briefly noted below.
Our full analysis and associated documentation is included here as
Attachment 1; we prepared this analysis at the request of the National
Academies' Committee to Review the National Nanotechnology Initiative.
Benchmarks we used to derive the minimum 10 percent figure include
the following:
Government and non-government experts' assessments of
the costs of conducting the needed research--including basic
material characterization, development of the needed
infrastructure (e.g., methods, tools, instrumentation), and
assessment of risks in specific exposure settings (e.g.,
workplaces). Each of these tasks by itself is estimated to
require at least a major fraction of the 10 percent EHS
investment we call for.
Actual testing costs for identifying the hazard
potential of conventional chemicals, which indicate the
potential for testing costs per substance to extend into the
millions of dollars.
The budget--averaging $60 million annually--for a
roughly analogous research program to characterize the risks of
airborne particulate matter (PM), which EPA undertook based on
a strategy developed and overseen by the National Academies'
Board on Environmental Studies and Toxicology (BEST) between
1998 and 2004. As noted by BEST, this budget covered only a
portion of EPA's and the Nation's research needs to understand
the risks of airborne PM. This task, while complex, is
considerably more restricted in scope than what is expected to
be needed to assess potential risks of nanomaterials.
Q6. You mentioned in your testimony that over the past two years
scientists at several NNI agencies and at NNI itself have published
documents describing how little we know about nanomaterials' potential
hazards and exposures and how much work will be needed both to address
these gaps and to adequately assess risks. Yet everyday new
nanotechnologies are entering the marketplace. Would you like to
comment further on this finding? Would the other panelists care to
address this issue?
A6. My written statement addresses this issue in considerable detail,
and provides examples of the agencies' recognition of the magnitude of
the research and regulatory task at hand, contrasted with the rather
tepid actions being taken by those same agencies. These responses
illustrate the growing disconnect between what most stakeholders--
industry included--believe government should be doing in the face of
nanotechnology's rapid commercialization, and what it is actually
doing. This situation is at or near the point putting at risk the
public's confidence in both government and industry's ability or
willingness to responsibly address the development of this technology.
That, in turn, puts public acceptance--and the success--of
nanotechnology itself at risk.
Questions submitted by Representative Ralph M. Hall
Q1. Please share your thoughts on the idea of establishing a separate
program office to oversee EHS research. Why is such an office needed
for nanomaterials versus other materials? What authorities would such
an office need to have? What are the possible pitfalls of such an
approach? How would you prevent the perception of adding another level
of federal bureaucracy to the mix? As an alternative to creating a new
office, how can we improve the mechanisms we currently have in place to
achieve the same goals?
A1. The Introduction to this document addresses these questions in
detail.
Endnotes
1. My colleagues Drs. John Balbus and Caroline Baier-Anderson
assisted in preparing our answers to these questions for the record.
2. See www.nano.gov/html/about/nnco.html (NNCO); www.nano.gov/html/
about/nsetmembers.html (NSET); www.ostp.gov/nstc/html/
G5-committees.html#cot (CoT); and www.ostp.gov/PCAST/membership2.html
(PCAST). Only three of the 36 members of PCAST have a health science or
environmental science expertise, and none has a risk science
background.
3. See Section 2(b) of the Act, available at
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=108G5-congG5-publicG5-laws&docid=f:publ153.108
4. Statement of Mr. Floyd Kvamme, Co-Chair of the President's Council
of Advisors on Science and Technology, House Science Committee hearing
held on 10/31/07, page 2, available at democrats.science.house.gov/
Media/File/Commdocs/hearings/2007/research/31oct/Kvamme--testimony.pdf
5. For example, see: U.S. Food and Drug Administration,
Nanotechnology: A Report of the U.S. Food and Drug Administration
Nanotechnology Task Force, July 25, 2007, at www.fda.gov/
nanotechnology/taskforce/report2007.pdf; and U.S. Environmental
Protection Agency, Nanotechnology White Paper, February 2007, at
www.epa.gov/osa/nanotech.htm; National Institute for Occupational
Safety and Health, Strategic Plan for NIOSH Nanotechnology Research:
Filling the Knowledge Gaps, at www.cdc.gov/niosh/topics/nanotech/
stratG5-planINTRO.html
6. Transcribed from the webcast of the hearing, starting at
approximately one hour 29 minutes, available at science.edgeboss.net/
real/science/scitech07/103107.smi.
7. See Hansen, Steffen Foss, Larsen, Britt H., Olsen, Stig I. and
Baun, Anders, ``Categorization framework to aid hazard identification
of nanomaterials,'' Nanotoxicology, published online November 13, 2007.
8. See www.nano.gov/html/society/NEHI.htm
9. See testimony of non-government witnesses at the Committee's
hearings held on November 17, 2005 (science.house.gov/publications/
hearingsG5-markupsG5-details.aspx?NewsID=979); September 21, 2006
(science.house.gov/publications/
hearingsG5-markupsG5-details.aspx?NewsID=1186); and October 31, 2007
(science.house.gov/publications/
hearingsG5-markupsG5-details.aspx?NewsID=2021).
10. See ``NRC--Regulator of Nuclear Safety'' (www.nrc.gov/reading-rm/
doc-collections/nuregs/brochures/br0164/r4/) and ``Our History''
(www.nrc.gov/about-nrc/history.html) on the NRC's website.
11. See ``Regulatory Research'' (www.nrc.gov/about-nrc/history.html)
on the NRC's website.
12. See webpage for the Office at www.nrc.gov/about-nrc/organization/
resfuncdesc.html
13. See NRC memoranda titled ``Organizational Conflict of Interest
Regarding Department of Energy Laboratories'' dated January 6, 1998
(www.nrc.gov/reading-rm/doc-collections/commission/secys/1998/secy1998-
003/1998-003scy.html) and February 5, 1999 (www.nrc.gov/reading-rm/doc-
collections/commission/secys/1999/secy1999-043/1999-043scy.html).
14. See NRC memorandum titled ``Memorandum Report: Audit of NRC
Oversight of Its Federally Funded Research and Development Center,''
May 28, 2002 (www.nrc.gov/reading-rm/doc-collections/insp-gen/2002/02a-
011.pdf).
15. See www.ostp.gov/PCAST/membership2.html
16. This situation with the NTAG is in partial contrast to PCAST
itself, whose members and meeting agendas are posted at ostp.gov/pcast/
pcast.html
17. See, for example, Evident Technologies, the self-described
``leader in quantum dot product development'' (www.evidenttech.com/
applications.html).
18. One review just published in Nanotoxicology of nearly 430
nanoparticle toxicology papers found that, while the vast majority
showed evidence of adverse effects, there was also a serious lack of
characterization of the tested materials. See Hansen et al., 2007, op.
cit.
19. See ``12 Principles of Green Chemistry,'' www.epa.gov/
greenchemistry/pubs/principles.html, originally developed by Paul
Anastas and John Warner, Green Chemistry: Theory and Practice (Oxford
University Press: New York, 1998).
20. See, e.g., Paul Anastas and Julie Zimmerman (2007). ``Green
Nanotechnology: Why We Need a Green Nano Award & How to Make it
Happen.'' Washington, DC: Project on Emerging Nanotechnologies, Woodrow
Wilson International Center for Scholars, at www.nanotechproject.org/
fileG5-download/206; and other information at www.nanotechproject.org/
tags?tag=green
21. See ww2.samsung.co.za/silvernano/silvernano/washingmachine.html
22. See letter dated January 26, 2006 to Jim Jones, Director, EPA
Office of Pesticide Programs, from Chuck Weir, Chair, Tri-TAC (a
technical advisory group for Publicly Owned Treatment Works (POTWs)
jointly sponsored by the California Association of Sanitation Agencies,
the California Water Environment Association, and the League of
California Cities), at www.tritac.org/documents/letters/
2006G5-01G5-27G5-EPAG5-SamsungG5-SilverG5-Wash.pdf
23. Sunscreens qualify as over-the-counter (OTC) drugs, and as such
are required by FDA to meet more extensive requirements than are
cosmetics, though considerably fewer than for prescription drugs. With
respect to pre-market approval, if a new active ingredient is used in a
sunscreen, some testing is required for both efficacy and dermal
effects before such a product can be marketed. Use of an already
reviewed active ingredient does not require such approval. One point of
remaining ambiguity, however, is the extent to which FDA will consider
nano versions of active ingredients they have already reviewed in their
larger forms to be new active ingredients. See U.S. Food and Drug
Administration, 2007, op. cit.
24. Hyung H, Fortner J.D., Hughes J.B., Kim J. 2007. Natural organic
matter stabilizes carbon nanotubes in the aqueous phase. Environ. Sci.
Technol. 41(1):179-184.
25. In addition to the information and sources provided in Attachment
1, more recent reports by federal agencies have elaborated further on
the broad scope of research needed. See reference in Endnote 5.
Attachment 1
A proposal to increase federal funding of nanotechnology risk research
to at least $100 million annually
Richard A. Denison, Ph.D., Senior Scientist[1]
Environmental Defense
April 2005
Environmental Defense has called for the Federal Government to
dedicate at least $100 million annually, sustained for a period of at
least several years, to research directly related to elucidating the
health and environmental risks of nanotechnology.[2] This document
summarizes our reasoning and support for calling for such an outlay.
There is, of course, no single ``magic number'' nor a precise means
to determine the right dollar figure, given the wide-ranging set of
research issues needing to be addressed and the significant associated
uncertainty as to the anticipated results. Nevertheless, we believe
that the amount we propose represents a reasonable, lower-bound
estimate of what is needed.
Below we first provide some context appropriate to consider in
assessing both the need for and costs of risk-related research on
nanomaterials. We then describe the major complexities involved in
assessing these risks and the broad scope of research needed to address
them. Finally, we provide a number of benchmarks that we believe
strongly support our proposal for spending at least $100 million
annually nanotechnology risk research. These benchmarks include:
experts' assessments of the expected research costs; hazard testing
costs for conventional chemicals; and EPA budgets for airborne
particulate matter risk research.
Context for judging risk research spending
In our view, both the public and private sectors' best interests
are served by an investment to identify and manage potential
nanotechnology risks now, rather than to pay later to remediate
resulting harms. History demonstrates that embracing a technology
without a careful assessment and control of its risks can be extremely
costly from both human and financial perspectives. The failure to
sufficiently consider the adverse effects of using lead in paint,
plumbing, and gasoline has resulted in widespread health problems that
continue to this day, not to mention extremely high remediation costs.
Asbestos is another example where enormous sums of money were spent by
private companies for remediation, litigation, and compensation, even
beyond that spent by the public sector to alleviate harm to human
health and the environment. Standard & Poor's has estimated that the
total cost of liability for asbestos-related losses could reach $200
billion.[3]
Initial research raises serious concerns that nanomaterials have
the potential to pose significant health and environmental risks. The
limited data now available demonstrate the potential for some
nanomaterials to be both persistent and mobile in the environment and
in living organisms; to cross the blood-brain barrier; and to be
capable of damaging brain, lung and skin tissue.[4]
These initial studies only highlight how little is known about the
health and environmental effects of engineered nanomaterials. Despite
the uncertainty, the rapid development of nanomaterial applications is
outpacing efforts to understand their implications--let alone ensure
their safety. Thousands of tons of nanomaterials are already being
produced each year,[5] and hundreds of products incorporating
nanomaterials are already on the market.[6] The global market for
nanotechnology products is expected to reach at least $1 trillion over
the next decade.[7] Given the length of time it will take to develop an
adequate understanding of the potential risks posed by a wide variety
of nanomaterials, and to apply this knowledge to inform appropriate
regulation, it is imperative that we dedicate substantial funding for
comprehensive risk research programs now.
The National Nanotechnology Coordination Office (NNCO) estimates
that fiscal year 2004 spending for environmental and health
implications research stood at only $8.5 million, less than one percent
of the total NNI budget.[8] Since then, such spending appears to be
rising somewhat: Requested funding for FY 2006 from federal agencies
under the NNI for health and environmental research totals $38.5
million, just under four percent of the total FY 2006 nanotechnology
development budget for these agencies of $1.05 billion.[9] While an
annual expenditure of $100 million represents an additional significant
increase over the current level, it is still a small fraction of the
more than $1 billion now being directed annually towards nanotechnology
development through the National Nanotechnology Initiative (NNI).
Moreover, it is a modest investment compared to the potential benefits
of risk avoidance and to the $1 trillion or more that nanotechnology is
projected to provide to the world economy by 2015.[10]
Complexity of defining nanomaterial risks
There is broad agreement among stakeholders that addressing the
potential risks of nanotechnology will be an unusually complex task.
Despite its name, nanotechnology is anything but singular; it is a
potentially limitless collection of technologies and associated
materials. The sheer diversity of potential materials and
applications--which is a source of nanotechnology's enormous promise--
also poses major challenges with respect to characterizing potential
risks. Nanotechnology entails:
many fundamentally different types of materials
(e.g., metal oxides, quantum dots, carbon nanotubes), and
hundreds or thousands of potential variants of each;
many novel properties potentially relevant to risk
(e.g., size, structure, reactivity, surface chemistry,
electrical and magnetic properties)
many potential types of applications (e.g., fixed in
a matrix vs. freely available, captive vs. dispersive use);
many categories and types of uses (e.g., medical
devices, pharmaceuticals, environmental remediation, and
consumer products ranging from cosmetics to electronics);
multiple points of potential release and exposure
over the full life cycle of a given material/application (e.g.,
during production, use, disposal);
multiple potential means of release (e.g., in
emissions, in wastes, from products);
multiple potential routes of exposure (e.g.,
inhalation, dermal, oral);
multiple potentially exposed populations (e.g.,
workers, consumers as well as public); and
potential to cause environmental as well as human
health-related impacts.
Scope of needed research
Even before the research that will allow hazards and exposures to
be quantified, a number of more fundamental needs must be addressed. We
currently lack a good understanding of which specific properties will
determine or are otherwise relevant to nanomaterials' risk potential.
Many of the methods, protocols and tools needed to characterize
nanomaterials, or to detect and measure their presence in a variety of
settings (e.g., workplace environment, human body, environmental media)
are still in a very early stage of development.
Nor is it clear the extent to which we can rely on our existing
knowledge about conventional chemicals to predict risks of
nanomaterials. The defining character of nanotechnology--the emergence
of wholly novel properties when materials are reduced to or assembled
at the nanoscale--carries with it the potential for novel risks and
even novel mechanisms of toxicity that cannot be predicted from the
properties and behavior of their bulk counterparts. By their very
nature many nanomaterials are more reactive per unit mass than their
conventional counterparts. For example, aluminum in the form used in
many applications, such as the ubiquitous soda can, is prized because
of its lack of reactivity, but it becomes highly explosive in nano-
form--hence its potential use as a rocket fuel catalyst.
Moreover, we already know that even extremely subtle manipulations
of a nanomaterial can dramatically alter its properties and behavior:
Tiny differences in the diameters of otherwise identical quantum dots
can alter the wavelength of the light they fluoresce; slight changes in
the degree of twist in a carbon nanotube can affect its electrical
transmission properties. We have yet to develop the means to
sufficiently characterize or systematically describe such subtle
structural changes--a clear prerequisite to being able to consistently
and rigorously apply and interpret the results of toxicological
testing. And only then can we begin to assess the extent to which such
subtle structural changes may affect the toxicity of a material--or the
extent to which such a property is stable or may be transformed in the
environment or the human body.
Until these threshold questions about nanomaterials' potential
risks are answered, it is unclear whether or to what extent we will be
able to rely on methods widely used to reduce the amount of traditional
toxicological testing needed to characterize conventional chemicals:
the ability to identify ``model'' materials, which upon
characterization could serve as a basis for extrapolation to ``like''
materials.
Among the types of risk research needed are the following:
Material characterization (in manufactured form(s),
during use, in emissions, in wastes, in products; in
environmental media, in organisms)
Biological fate (extent and rate of absorption,
distribution, metabolism, elimination)
Environmental fate and transport (persistence,
distribution among media, transformation)
Acute and chronic toxicity (related to both human and
ecological health).
For each of these areas, existing testing and assessment methods
and protocols need to be re-examined to determine the extent to which
they can be modified to account for nanomaterials' novel
characteristics or need to be supplemented with new methods. Similar
challenges will arise with respect to methods and technologies for
sampling, analysis and monitoring, all of which will be needed to
detect nanomaterials and their transformation products in living
systems and in various environmental media.
Benchmarks for risk research spending
Our view that significantly more needs to be spent on
nanotechnology risk research is informed and supported by: a) other
experts' assessments, b) our knowledge of testing costs associated with
hazard characterization programs for conventional chemicals, and c) the
research budgets recommended for and expended on a roughly analogous
risk characterization effort, namely EPA's research on risks of
airborne particulate matter. A summary of these various information
sources is provided below.
Experts' assessments:
Experts from a variety of fields have declared that
NNI's current funding for nanotechnology risk research needs to
be significantly increased. Invited experts to a workshop
sponsored by the Nanoscale Science Engineering, Science and
Technology Subcommittee (NSET) of the NNI, held in September
2004, called for at least a 10-fold increase in federal
spending on nanotechnology risk-related research, relative to
the approximately $10 million spent in FY 2004.[11]
At that same workshop, a representative of the
Nanotechnology Initiative at the National Institute for
Occupational Safety and Health (NIOSH) provided an estimate of
the investment needed just to begin to address workplace safety
issues--which accounts for only one of the numerous settings
where release and exposure to nanomaterials may occur. That
estimate, which is based on an internal analysis conducted by
NIOSH researchers, is that an investment of $10-20 million per
year for at least 10 years will be needed--assuming the funds
are able to be directed at targeted research to address
specific predetermined issues. The representative further
indicated that the investment necessary to identify the issues
to target and to more broadly address nanotechnology
implications in the workplace as the technology matures will be
significantly larger.[12] (NIOSH's current funding level for
this research is considerably lower, $2-3 million per year. In
2004, NIOSH initiated a five-year program to assess the
toxicity of ultrafine and nanoparticles, funded at about $1.7
million in FY 2004 and about $2.3 million in FY 2005.[13]
According to NNI, NIOSH has requested $3.1 million for FY 2006
for this type of work.[14])
At a briefing held on March 22, 2005, to preview the
findings of an upcoming report by the President's Council of
Advisors on Science and Technology (PCAST) that has been
charged with reviewing the NNI, John H. Marburger III, Science
Adviser to the President and chief of the White House Office of
Science and Technology Policy, noted that the toxicity studies
now underway are ``a drop in the bucket compared to what needs
to be done.''[15]
The chemical industry has also concluded that
nanotechnology risk research should be highly prioritized and
highly funded relative to other activities by the NNI. In a
nanotechnology development roadmap requested by the NNI, the
industry identifies an essential need to increase our
``understanding of the fundamental scientific principles
operating at the nanoscale, including interdependent structure-
property relationships.'' The roadmap highlights as critical
research needs the following:
development of characterization tools,
including real-time characterization methods and tools
and the associated infrastructure for their development
and use; and
environment, health and safety, including
assessment of human health and environmental impact
hazards, determination of exposure potentials for
nanosized materials, and handling guidelines for
operations involving nanomaterials.
The report calls for sustained research in these areas over
twenty years, and assigns its top or high priority ranking to
each of the subtopics under these key elements. While actual
dollar figures are not provided, the report indicates that two
of these subtopics--development of real-time characterization
methods and tools, and assessment of human health and
environmental impact hazards--will require a level of
cumulative R&D investment that is the highest of any assigned
to the priority research requirements.
Finally, other expert comments on nanotechnology risk
research needs and costs indicate that even setting up the
initial infrastructure for adequate risk research will involve
significant resources. The United Kingdom's Royal Society and
Royal Academy of Engineering, in its seminal July 2004 report,
Nanoscience and nanotechnologies: Opportunities and
uncertainties, calls for the UK government to devote
5-6 million ($9.5-11.3 million) per annum for 10
years just to do its part to develop the methodologies and
instrumentation needed to set the stage for actual testing of
nanomaterials.[16]
Hazard endpoint testing costs:
There are several estimates available from chemical hazard
assessment programs that can be used as context for providing at least
a lower bound on the costs of testing a nanomaterial for hazardous
properties. These costs are for the testing of a conventional chemical
for an assortment of hazard (toxicity plus environmental fate)
endpoints of concern; notably, they do not include costs associated
with assessing exposure, which is also needed to assess risk.
It must be noted that these estimates provide only a very rough
means of extrapolating to the anticipated costs of hazard testing for a
given nanomaterial. A definition of what constitutes the needed set of
such endpoints sufficient to characterize hazard has yet to be defined.
Moreover, the number of different nanomaterials requiring testing is
another major unknown, but could be very large.
Below we discuss several available hazard testing cost estimates.
At one end of the spectrum is the so-called Screening
Information Data Set (SIDS), developed by the Chemicals Program
of the Organization for Economic Cooperation and Development
(OECD), which consists of about 20 data elements and--as its
name indicates--represents the minimum hazard information
considered necessary to screen chemicals in order to set
priorities for further scrutiny. SIDS focuses primarily on
short-term toxicity to mammals (as models for human toxicity)
and aquatic species (as a subset of indicators of potential
ecological toxicity). The U.S. Environmental Protection Agency,
which employs the SIDS in its High Production Volume (HPV)
Challenge,[17] estimates the cost of producing a full set of
SIDS data at $250,000 per chemical,[18] which is generally
consistent with an industry estimate of up to $275,000 per
chemical.[19] While SIDS is useful in setting priorities for
further action among conventional chemicals, the information it
provides is too limited to be sufficient to characterize the
risks posed by nanomaterials.
Testing cost estimates have been prepared in a
Business Impact Assessment document prepared for the European
Commission's Enterprise Directorate in support of the European
Union's chemical policy proposal called REACH (for
Registration, Evaluation and Authorization of Chemicals). REACH
proposes different levels of testing that depend primarily on
the production tonnage of a chemical. At the lowest production
volumes, a base set of test data--roughly equivalent to the
SIDS discussed above--would be required, the generation of
which is estimated to cost -151,700 (about $198,000). The most
extensive test battery applicable to the highest-volume
substances--and considered generally sufficient to inform a
full risk assessment--is estimated to cost -1,664,260 (about
$2,170,000).[20]
An even more extensive test battery (and perhaps a
more appropriate one for characterization of many
nanomaterials, at least initially) is that required of
pesticides under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA). This hazard-only test battery consists
of up to 100 individual data elements,[21] with the actual
requirements varying by factors such as use and volume of use.
When supplemented with detailed exposure information, EPA
generally considers this dataset sufficient to conduct a risk
assessment for a pesticide. An upper estimate of $10 million
per chemical for testing costs has been indicated by the
Agricultural Research Service for a pesticide proposed for
major food crop use, with costs for most pesticides being
``significantly less.''[22]
Recommended and actual EPA research budgets for risks of airborne
particulate matter:
As an additional benchmark for judging the appropriate level of
federal expenditure for nanomaterial risk research, we considered the
recommended and actual budgets for EPA research conducted over the past
several years on risks posed by airborne particulate matter (PM). In
1998, at the request of EPA, a committee of the Board on Environmental
Studies and Toxicology (BEST) of the National Research Council assessed
the state of research in this arena and additional needs, setting out a
13-year research agenda and associated recommended budget.[23] In 2004,
in the fourth report in its series, the committee looked back over the
research actually conducted and the associated budget expended by EPA
in the six years since its first report.[24]
We recognize, of course, the substantial differences between the
nature of, state of knowledge concerning, and risk-related research
needs for, airborne particulate matter (PM) and nanomaterials. Even in
1998, it was already clear that airborne PM exacts an enormous toll in
terms of human morbidity and mortality--clearly not the case with
nanomaterials, although we believe there is an opportunity through
proactive research and action to identify and avoid such risks. Our aim
here is not at all to claim any direct analogy between the two classes
of materials or the magnitude of their risks, but rather to utilize the
careful assessment done of the scope of research needed to assess risk.
If anything, the scope of needed research on nanomaterials is
considerably broader--and hence likely to cost more--than is the case
for airborne PM. Our reasoning is as follows. Airborne PM is a complex
mixture of relatively well-characterized chemicals produced by a
discrete (though highly diffuse) set of sources, to which exposure
occurs through a single route, inhalation. In contrast, nanomaterials:
are comprised of many entirely novel classes of
materials;
will be applied and used in ways that will create the
potential for release and exposure through many more pathways
(e.g., oral, dermal; via drinking water);
in addition to being present in air emissions, may be
present in wastes, water discharges and a wide array of
products;
through incorporation into products, may result in
exposure of consumers, as well as the general public and
workers; and
pose potential environmental as well as human health
risks that need to be considered.
Hence--independent of the ultimate magnitude of risk identified--
the assessment of that risk is likely to be considerably more involved
and costly for nanomaterials than for airborne PM.
The research agenda and budget for airborne PM recommended by NRC
in 1998 called for EPA to spend $40-60 million annually for the first
six years, and declining amounts thereafter, from $31 million in year
seven to 15 million in year 13. The NRC noted explicitly that its
recommended budgets should not be interpreted as sufficient to
encompass all of the airborne PM risk research needed to be conducted
by EPA or the Nation as a whole.[25]
Actual EPA expenditures during the first six years of the research
program (FY 1998-2003) were relatively similar to the recommended
amounts, as reported by NRC in its 2004 report:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The NRC's 2004 report, which represents a ``mid-course'' review of
EPA's airborne PM research, found that the allocated money had been
well spent, noting rapid progress in some areas, slower in others, and
with much work remaining to be done.
Given that addressing the potential risks of nanomaterials will
very likely entail considerably greater complexity than is the case for
airborne PM, we believe the NRC's assessment of research needs and
associated budget needs for airborne PM risk-related research strongly
supports our call for the Federal Government to be devoting at least
$100 million annually over a number of years to address the major
unknowns and uncertainties associated with the burgeoning field of
nanotechnology.
Conclusion
The rapid commercialization of nanotechnology, coupled with the
clear risk potential of at least certain nanomaterials demonstrated in
initial studies, lends urgency to the need for the Federal Government
to direct more of its major investment in nanotechnology development
toward research aimed at identifying the potential risks and the means
to address them. There is a remarkable degree of agreement among
experts and stakeholders from a range of perspectives on both the need
and the urgency. There is also considerable agreement that assessing
these risks will be a complex task, given the range of materials and
potential applications involved and the current lack of knowledge and
experience with such materials. A broad scope of research will be
needed, first to identify the key characteristics of nanomaterials
relating to hazard and exposure; second, to adapt existing or develop
new testing methods; and third, to actually assess the magnitude of
hazard and exposure potential of specific nanomaterials.
We have also provided a number of benchmarks, which taken together
strongly support our call for the Federal Government to spend at least
$100 million annually on a sustained basis to fund research directly
related to understanding the potential health and environmental risks
of nanotechnology:
Experts' assessments of the costs of conducting the
needed research--including basic material characterization,
development of the needed infrastructure (e.g., methods, tools,
instrumentation) and assessment of risks in specific exposure
settings (e.g., workplaces). Each of these tasks by itself is
estimated to require at least a major fraction of the $100
million investment we call for.
Actual testing costs for identifying hazard potential
for conventional chemicals, which indicate the potential for
testing costs per substance to extend into the millions of
dollars.
The recommended and actual EPA research budgets for
characterizing the risks of airborne particulate matter, which
have totaled at least half of the amount we have proposed be
devoted to risk research on nanomaterials. As made clear by the
National Research Council in recommending these amounts, they
cover only a portion of EPA's and the Nation's needs for
research to understand the risks of airborne PM. While this
task is complex, it is considerably more restricted in scope
than what is expected to be needed to assess potential risks of
nanomaterials.
Federal initiatives on nanotechnology to date have done a great job
in accentuating and accelerating the enormous potential benefits of
nanomaterials. To date, however, federal agencies have yet to come to
terms with their equally critical role in identifying, managing and
ideally avoiding the potential downsides. A far better balance between
these two roles must be struck if nanotechnology is to deliver on its
promise without delivering unintended and unforeseen adverse
consequences.
Endnotes
1. Environmental Defense staff members Dr. John Balbus, Scott Walsh
and Karen Florini reviewed and provided substantial input into this
paper.
2. See Environmental Defense's written statement submitted to the
National Academies' Committee to Review the National Nanotechnology
Initiative at its March 24-25, 2005 Workshop on Standards for
Responsible Development of Nanotechnology, Washington DC; and letter
dated November 15, 2004 from Environmental Defense to Dr. Mihail Roco,
Chair, NSTC Subcommittee on Nanoscale Science, Engineering and
Technology (also attached to our written statement).
3. Standard & Poor's, Insurance: Property-Casualty Industry Survey,
July 15, 2004.
4. To assist the Committee, we attached a bibliography of references
and associated abstracts of risk-related research studies on
nanomaterials to our written statement provided to the Committee's at
its March 24-25, 2005 workshop reviewing the National Nanotechnology
Initiative.
5. See The Royal Society and the Royal Academy of Engineering,
Nanoscience and nanotechnologies: Opportunities and uncertainties,
London, July 2004, pp. 26-7, available online at www.nanotec.org.uk/
finalReport.htm. This estimate is provided for the 2003-2004 timeframe,
with rapidly escalating quantities projected thereafter.
6. See, for example, an unofficial list of nanomaterial-containing
products compiled by EPA as of July 2004, posted by the ETC Group
online at www.etcgroup.org/documents/nanoproductsG5-EPA.pdf; and a
description of current nanotechnology applications at www.nanotech-
now.com/current-uses.htm
7. See, for example, Lux Research, Sizing Nanotechnology's Value
Chain, October 2004, summary available online at
www.luxresearchinc.com/press/RELEASEG5-SizingReport.pdf ``Sales of
products incorporating emerging nanotechnology will rise from less than
0.1 percent of global manufacturing output today to 15 percent in 2014,
totaling $2.6 trillion.'' Also see National Science Foundation,
Societal Implications of Nanoscience and Nanotechnology, March 2001, p.
3, available online at www.wtec.org/loyola/nano/
NSET.Societal.Implications/nanosi.pdf ``. . .projected total worldwide
market size of over $1 trillion annually in 10 to 15 years. . .''
8. E. Clayton Teague, Responsible Development of Nanotechnology,
National Nanotechnology Coordination Office, April 2, 2004, available
online at www.technology.gov/OTPolicy/Nano/04/0402G5-Teague-
Infocast.pdf
9. National Science and Technology Council, Nanoscale Science,
Engineering and Technology Subcommittee of the Committee on Technology,
The National Nanotechnology Initiative: Research and Development
Leading to a Revolution in Technology and Industry: Supplement to the
President's FY 2006 Budget, March 2005, p. 38.
10. See endnote 7.
11. Phibbs, P., Daily Environment Report, 9/13/04, p. A-3, ``Federal
Government Urged to Boost Spending on Managing Risks Posed by
Nanotechnology,'' quoting experts invited to NSET's Research Directions
II workshop held in Washington, DC on 9/8-9/04.
12. Phibbs, P., ibid., quoting NIOSH scientist Andrew Maynard's
statement at NSET's Research Directions II workshop held in Washington,
DC on 9/8-9/04; and A. Maynard, personal communication, 4-20-05.
13. See National Nanotechnology Initiative, ``NNI Environment and
Health Safety Research,'' available online at www.nano.gov/html/facts/
EHS.htm
14. National Science and Technology Council, op. cit.
15. R. Weiss, ``Nanotech Is Booming Biggest in U.S., Report Says,''
Washington Post, March 28, 2005, p. A6, available online at
www.washingtonpost.com/wp-dyn/articles/A5221-2005Mar27.html
16. The Royal Society and the Royal Academy of Engineering, op. cit.,
p. 48.
17. See EPA's website for the U.S. HPV Challenge, www.epa.gov/chemrtk/
volchall.htm
18. See www.epa.gov/chemrtk/hpvq&a.pdf
19. See the American Chemistry Council's summary of the U.S. HPV
Challenge, online at memberexchange.americanchemistry.com/randt.nsf/
unid/nnar-4dfn3h
20. Risk & Policy Analysts Ltd, Revised Business Impact Assessment for
the Consultation Document, Working Paper 4, prepared for the European
Commission Enterprise Directorate-General, October 2003, Annex 1,
available online at www.rpaltd.co.uk/tools/downloads/reports/
reachrevisedbia.pdf Figures cited here assume that all listed tests are
required to be conducted, that none of the tests have previously been
conducted, and that no estimation techniques are allowed as a
substitute for testing.
21. Requirements are summarized at www.epa.gov/pesticides/regulating/
data.htm. Regulations specifying testing requirements are at 40 CFR
Part 158.
22. See ``EPA and Pesticide Registration Issues,'' USDA Agricultural
Research Service, available online at www.ars.usda.gov/is/np/mba/jan97/
epa.htm
23. Board on Environmental Studies and Toxicology, Research Priorities
for Airborne Particulate Matter: I. Immediate Priorities and a Long-
Range Research Portfolio, Committee on Research Priorities for Airborne
Particulate Matter, National Research Council, 1998, available online
at books.nap.edu/catalog/6131.html
24. Board on Environmental Studies and Toxicology, Research Priorities
for Airborne Particulate Matter: IV. Continuing Research Progress,
Committee on Research Priorities for Airborne Particulate Matter,
National Research Council, 2004, available online at books.nap.edu/
catalog/10957.html
25. Board on Environmental Studies and Toxicology, 1998, op. cit.,
Table 5.1, page 101. Amounts include research management, including
research planning, budgeting, oversight, review, and dissemination,
cumulatively estimated by the committee at 10 percent of project costs.
26. Board on Environmental Studies and Toxicology, 2004, op. cit.,
Table S-1, page 6.
Answers to Post-Hearing Questions
Responses by Paul D. Ziegler, Chairman, American Chemistry Council
Nanotechnology Panel
Questions submitted by Chairman Brian Baird
Q1. What do you see as the relative roles of the government and
industry related to research on environmental, health and safety (EHS)
aspects of nanotechnology?
A1. The Panel believes that the Federal Government and industry each
have distinct but interrelated roles in EHS research pertinent to
nanotechnology. The government has the primary role of identifying and
conducting basic EHS research. The Federal Government is plainly in the
best position to identify and coordinate government-funded research and
the multi-disciplinary expertise of the many participating agencies
engaged in the EHS aspects of nanotechnology. Federal research is
essential to providing the underlying methods and tools critical to
developing a fundamental understanding of nanoscale materials and
nanotechnologies. These methods and tools can be used by all
nanotechnology producers and users to fulfill their role in the
responsible development of nanotechnology. Industry also has several
critically important roles. First, industry should assist with and
comment upon the government's identification of research priorities as
industry is well-positioned to help inform the government's
understanding of which nanotechnology product platforms are nearing
commercialization or are commercially important. Together, the
government, industry, and other stakeholders can identify research
priorities that will best correlate with real world realities and
challenges. Second, once equipped with the tools and methods critical
to developing an understanding of nanomaterials, industry is best able
to discharge its responsibility of assuming the primary role of
characterizing the EHS implications of specific types of nanoscale
materials or technologies that enable specific types of manufactured
products.
Q2. You note in your testimony that industry's role in developing
research priorities to date has been ``largely restricted to passive
review of decisions already made.'' Do you have recommendations on how
to address this? Does industry have a voice through the outside
advisory process for the NNI that is currently handled by the
President's Council of Advisors on Science and Technology (PCAST)?
A2. The Panel believes that industry's role in the identification and
communication of research priorities could be given better expression
if industry were engaged earlier in the process. While PCAST provides
some limited opportunity for the expression of stakeholder views in
this area, it is not clear how industry's participation in PCAST (and
comment upon various National Nanotechnology Coordination Office (NNCO)
Nanotechnology Environmental Health Implications (NEHI) research
prioritization initiatives) actually translate into the identification
of research priorities. Industry's role traditionally has been one of
passive comment on the product of a deliberative process in which it is
not engaged. The Panel believes that the product of this process would
be substantively enhanced and more reflective of industry's significant
expertise in this area if industry were more substantively engaged in
the deliberative process itself, as opposed merely to commenting upon
the result of that process.
Q3. Through what mechanisms could government and industry work more
collaboratively to address risk-research needs for nanotechnology? How
does the American Chemistry Council's Nanotechnology Panel coordinate
with federal activities?
A3. There are multiple mechanisms that facilitate collaboration between
the government and industry to address effectively risk-research needs
pertinent to nanotechnology. First, and as noted above, the Panel
believes it could add significant value if it were more substantively
engaged earlier in the deliberative process in identifying research
priorities. Second, the Panel is supportive of public-private
partnerships that enable both the government and industry
collaboratively to fund strategically important research in targeted
EHS areas. Third, the Panel has been very active in supporting the
concept of and helping to build the foundational elements of the U.S.
Environmental Protection Agency's (EPA) voluntary Nanoscale Materials
Stewardship Program (NMSP). The Panel participated in the National
Pollution Prevention Toxics Advisory Committee (NPPTAC) as a member of
the Ad Hoc Work Group on Nanoscale Materials, and has consistently
supported EPA's efforts to design and implement a voluntary program
designed to collect and generate information and data on nanoscale
materials. The Panel is also engaging in extensive outreach to other
stakeholders to help ensure the NMSP, once commenced, is successful and
attracts robust participation. The Panel also has signed-on to multiple
letters to Congress expressing the views of diverse stakeholders
including industry, researchers, and non-government organizations,
urging greater funding for EHS nanotechnology research and the funding
of a National Academies' Board of Environmental Studies and Toxicology
(BEST) initiative to develop and monitor implementation of a
comprehensive, prioritized EHS nanotechnology research roadmap for all
federal agencies. These letters are attached for your information and
review.
Q4. Dr. Maynard has 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. Do you believe this would be a good model for
developing a government/industry research partnership for EHS research
related to nanotechnology?
A4. The Panel believes that the Health Effects Institute (HEI) model is
one of several models that may potentially serve as a suitable model
for structuring government/industry research partnerships. The Panel is
engaged with other stakeholders in identifying suitable models based on
existing public-private partnership models. The Panel believes, however
that the process of identifying a suitable model is an iterative one.
More discussion is needed to identify the unique aspects of EHS
nanotechnology research needs before the elements of existing models,
including the HEI model, the Foundation for the National Institutes of
Health model, and other relevant models, can be assessed to ensure the
appropriate elements of a construct suitable to nanotechnology EHS
research are identified. Once this foundational work is completed,
stakeholders will be better able to build a model appropriate for EHS
nanotechnology public-private partnerships. The Panel is open to
considering all appropriate models, but believes that it is premature
now to conclude that any one existing model, including the HEI model,
is appropriate for EHS nanotechnology research purposes.
Q5. The President's Council of Advisors on Science and Technology
(PCAST) was assigned by the President to serve as the statutorily
created outside advisory committee for the National Nanotechnology
Initiative. How useful is PCAST as a means for private sector
organizations to provide input to the planning and prioritization
process for EHS research under the NNI? Are there other mechanisms
available for stakeholders to have a voice in this process?
A5. PCAST is, of necessity, very high-level. As such, it cannot be
expected to deal explicitly with research needs at a useful level of
detail. PCAST has sought external advice from stakeholders on several
occasions. The pathway to more industry involvement may be elsewhere,
as discussed in the response to Question 1. If desired, PCAST could be
augmented with industry representatives with nanotechnology expertise.
Q6. One of the key aspects of carrying out EHS research is to have
agreed terminology and standards for characterization of nanomaterials.
Q6a. Is this getting sufficient attention under the NNI? What is the
role of NIST in this area?
A6a. As best as the Panel can discern, NNI's role in terminology and
standards development has been expressed principally, if not
exclusively, in participating in the ANSI TAG and ISO 229 standards
development process. The Panel welcomes NNI's participation, and
believes that it is a critical partner in these important standards
setting initiatives. The Panel urges NIST and other agencies, as
appropriate, to become more engaged in initiatives intended to
prioritize, discuss, and help define and resolve morphology issues.
Q6b. Is there a role for NNI to provide direct assistance to
nanotechnology companies, particularly small companies, to help them
characterize new nanomaterials, which will thereby assist the companies
in assessing the potential environmental and health risks of the new
materials?
A6b. The Panel believes there is considerable merit in the suggestion
that NNI has a role in providing nanotechnology companies assistance in
characterizing nanomaterials with a view toward better identifying,
characterizing, and mitigating potential environmental and health risks
posed by nanoscale materials. The Panel would be interested in working
with NNI and other interested stakeholders in exploring how best NNI
could provide such assistance.
Questions submitted by Representative Vernon J. Ehlers
Q1. How does the chemical industry deal with new technology
uncertainty in the development of new products?
A1. The chemical industry has a well documented and distinguished
history of addressing proactively and thoroughly the implications of
new technology. All Panel member companies support and promote the safe
use and manufacture of products and applications of nanotechnology, as
well as any new technology, consistent with the Responsible Care
Program. Responsible Care is a global initiative of the international
chemical industry that is practiced currently in 52 countries, and has
been for over two decades. Participating entities share a common
commitment to advancing the safe and secure management of chemical
products and processes. Specific Responsible Care practices may vary
from country to country as they are determined by each country's laws
and national industry association. Participating in Responsible Care
is mandatory for ACC member companies, all of which have made CEO-level
commitments to uphold these program elements: measuring and publicly
reporting performance; implementing the Responsible Care Security Code;
applying the modern Responsible Care management system to achieve and
verify results, and obtaining independent certification that a
management system is in place and functions according to professional
standards.
Since 1988, ACC members have significantly improved their
environmental, health, safety, and security performance through the
Responsible Care Program. This commitment requires a third-party
certified management system that incorporates the following product
stewardship elements: ensure that health, safety, security, and
environment and resource conservation are considered for all new and
existing products and processes; provide information on health, safety,
security, and environmental risks and pursue protective measures for
employees, the public, and other key stakeholders; and support
education and research on the potential health, safety, environmental
effects of its products and processes. More information on the
Responsible Care Program is available at http://
www.responsiblecare.com.
The Panel has also prepared and conducted a survey on practices
followed by Panel member companies who participated in the survey. In
addition to workplace practices, the Panel survey collected information
on potential exposures (which were found to be exceedingly trivial),
confirmed the existence and implementation of exposure control programs
for nanomaterials handling, and related information pertinent to
nanomaterials use and risk mitigation measures used in the workplace.
The summary of this survey is available at http://
www.americanchemistry.com/nanotechnology.
Q2. On the issue of stovepiping EHS research versus integrating it
into all research, do all current NNI grants currently include an EHS
component? If not, should they? Why or why not?
A2. To the best of the Panel's information and belief, not all NNI
grants include an EHS component. The Panel believes that while not all
NNI grants may be explicitly relevant to EHS issues, all NNI grants
should include a component that explicitly seeks consideration of the
EHS implications of the actions contemplated under the grant.
Questions submitted by Representative Daniel Lipinski
Q1. Much of the EHS research to date has focused on exotic materials
with unrealistic exposure scenarios. While that is useful in
establishing information on an ``upper bound'' of the hazard, the
context is rarely communicated and it creates fear. What is critical is
that we make sure nano-enabled products are as a safe or safer than
what we use today.
As I understand it, the hazard of a nanomaterial often depends
upon much more than the size and type of material, but also surface
properties, purity, etc. that relate to how it is made. How is the
toxicology work underway controlling for this? Are researchers using
standardized, well characterized materials? If not, how can we make use
of the research findings?
A1. The Panel strongly advocates that all physical/chemical
considerations be included in toxicology studies. As you may know,
several prominent national and international symposia and workgroups
convened over the past several years have strongly suggested that
certain physical characteristics of study substances must be determined
and reported by investigators conducting toxicological studies on
nanomaterials. One set of recommendations published by Oberdoerster et
al., 2005 in Particle and Fibre Toxicology,\1\ strongly suggests
specific physical properties of nanomaterials, including median size,
size distribution, zeta potential, surface chemistry, surface
topography, shape, etc., be characterized in conjunction with any
investigation of their potential hazards. The Panel strongly suspects
that research findings presented on nanomaterials that are not well
characterized along the lines noted above may well distort the hazard
potential of nanomaterials to the point of invalidating the findings.
Research findings can be utilized to the maximum by ensuring that the
subject materials are well characterized along the lines outlined
above.
---------------------------------------------------------------------------
\1\ Oberdorster G., Maynard A., Donaldson K., Castranova V.,
Fitzpatrick J., Ausman K., Carter J., Karn B., Kreyling W., Lai D.,
Olin S., Monteiro-Riviere N., Warheit D., Yang H., Principles for
characterizing the potential human health effects from exposure to
nanomaterials: elements of a screening strategy, Part Fibre Toxicol
Oct. 6;2:8.
Q2. It seems that most of the early uses of nanotechnology and
nanomaterials are for existing products and processes, many of which
are far from ideal from a health and environmental safety perspective.
What is being done to systematically compare the risks and benefits of
the nanoscale alternative against the conventional approach in use
today so that we accelerate the substitution of nanomaterials where
---------------------------------------------------------------------------
they are superior (e.g., when replacing a known toxin)?
A2. The Panel does not necessarily agree with your statement that
``many'' early uses of nanotechnology are ``far from ideal from a
health and environmental safety perspective.'' That said, you raise a
good point about the need to develop strong risk/benefit principles and
practices to help ensure that the substitution of macro-scale materials
with nanoscale materials reaps EHS benefits. The Panel is a supporter
of lifecycle analyses (LCA) approaches, and believes that the
application of well defined LCA tools and programs will assist
innovators and others in assessing the comparative benefits of
nanoscale materials over their macroscale counterparts. LCA for
nanomaterials includes the assessment of potential risk throughout the
product's life cycle or planned life cycle. LCA considerations include
considerations from material sourcing, through production and use, to
end-of-life disposal or recycling. LCA considerations should also
include how the material's properties, hazards, and exposures may
change during the material's life cycle (for example, because of
physical interactions during manufacturing or use, or from chemical
changes that may occur as it breaks down after disposal).
EPA's Design for the Environment (DfE) has been a leader in
identifying the pollution prevention opportunities offered by
nanotechnology. EPA recently convened a symposium, Pollution Prevention
Through Nanotechnology, http://www.epa.gov/oppt/nano/nanopconfinfo.htm,
in which many applications of nanoscale materials and structures were
identified as having compelling pollution prevention benefits. The
Panel supports continued research in LCA and related areas.
Q3. The discussion around nanomaterials tends to focus on
``engineered'' nanomaterials which are roughly defined as those that
are purposefully created. However, the volume of naturally occurring
and ultrafine particles produced by combustion, as well as those used
as fillers in rubber tires or plastics is many orders of magnitude
greater than the newly engineered nanomaterials. What are we doing to
ensure that we leverage the body of EHS knowledge on these particles?
Are we missing the forest from the trees by emphasizing only
``engineered nanomaterials''? What efforts are there to assess the
comparative hazard posed by engineered nanomaterials against incidental
or naturally occurring nanomaterials?
A3. We concur that the volume of naturally occurring nanoscale
materials and those produced through combustion products dwarf the
volume of engineered nanomaterials. A key difference between engineered
and non-engineered materials is that non-engineered materials may be
poorly defined in a variety of ways including size and purity. Any EHS
impacts are difficult to attribute to a particular property. Many
engineered nanomaterials can be well defined using available tools
making it easier to correlate potential EHS impacts to specific
properties. Using existing LCA information from naturally occurring
nanomaterials or nanomaterials that are produced incidentally is
accomplished through ``bridging.''
Q4. To what extent is the toxicity research relevant to ``real world''
situations? To what extent are federally funded efforts using the
routes of exposure or formulations that emulate the nanomaterials being
used in available products?
A4. The Panel agrees with the implicit concern in this question, that
being there may be a disconnect between ongoing federal research and
near-term research needs relevant ``to `real world' situations,'' or at
the least concerned that we lack a high degree of confidence that there
is a correlation between ongoing research and research results that
serve real world situations. It is because of this concern the Panel
has urged Congress, as set forth in the attached letters, to consider
funding the NAS/BEST to prepare and implement a comprehensive federal
EHS nanotechnology research roadmap.
Questions submitted by Representative Ralph M. Hall
Q1. It is our understanding that responsible manufacturers and users
of nanomaterials, including presumably some of your members, are
generating information about their properties that could be relevant to
understanding their biological and environmental behavior. How can that
information be shared so that risk assessment and risk management in
general can be improved and so that developers can design more benign
materials and avoid pitfalls?
A1. The Panel intends to share information through its participation in
the EPA NMSP. An noted above, the Panel has been a strong and
consistent supporter of the NMSP, and believes that Panel members and
many other stakeholders will participate in this important voluntary
program. Additionally, industry is encouraging all OECD participating
countries to help develop an EHS research database as part of the
ongoing efforts of the OECD's Working Party on Nanomaterials Steering
Group (SG) 1 project. The objective of SG 1 is to develop a global
resource that identifies research projects that address environmental,
human health, and safety issues associated with manufactured
nanomaterials. The database will include projects that are planned,
underway, or completed, and build upon the database of the Woodrow
Wilson International Center for Scholars: Nanotechnology Health and
Environmental Implications: An Inventory of Current Research.
Industry is required to inform users of the hazards of any product,
whether or not they are nanoscale materials, on Material Safety Data
Sheets and labels as required by OSHA's Hazard Communication Standard.
We are also required to inform EPA of any previously unknown
Unreasonable Risks under the requirements of TSCA Section 8(e) for
industrial chemicals and under FIFRA Section 6(a)(2) for pesticides.
Q2. Are companies holding back on the development of nanotechnology
products because of a lack of regulations? Do you feel that actual
nanotechnology products are being mislabeled in order to stem public
concern?
A2. The Panel is unaware of any of its members ``holding back'' on
nanotechnology innovation due to the perceived ``lack of regulations.''
Panel members companies and many other business stakeholders are well
aware of the panoply of federal and State regulations that apply to the
manufacture of products, including the products of nanotechnology. The
Panel thus believes that the perception that there is a ``lack of
regulations'' is a misperception. The Panel is unaware of any specific
products that are being ``mislabeled'' to stem public concern.