Research On Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation Under The National Nanotechnology Initiative

RESEARCH ON ENVIRONMENTAL AND
SAFETY IMPACTS OF NANOTECHNOLOGY:

CURRENT STATUS OF PLANNING AND
IMPLEMENTATION UNDER THE NATIONAL
NANOTECHNOLOGY INITIATIVE
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. 11069

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

WASHINGTON
38534PS
2008
For sale by the Superintendent of Documents, U.S. Government Printing Office

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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
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
WILLIAMS Republican Professional Staff Member
MELE
MEGHAN HOUSEWRIGHT Research Assistant
(II)
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CONTENTS
October 31, 2007
Page
Witness List .............................................................................................................

Hearing Charter ......................................................................................................
2
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 ....................................................................................
Written Statement ............................................................................................
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 ...............................................
Prepared Statement by Representative Daniel Lipinski, Member, Subcommittee on Research and Science Education, Committee on Science and
Technology, U.S. House of Representatives .......................................................
8
9
10
11
12
Witnesses:
Dr. E. Clayton Teague, Director, National Nanotechnology Coordination Office
(NNCO)
Oral Statement .................................................................................................
Biography ..........................................................................................................
Mr. E. Floyd Kvamme, Co-Chair, Presidents Council of Advisors on Science
and Technology
Oral Statement .................................................................................................
Biography ..........................................................................................................
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 .................................................................................................
Biography ..........................................................................................................
Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for Scholars,
Washington, D.C.
Oral Statement .................................................................................................
Biography ..........................................................................................................
Dr. Richard A. Denison, Senior Scientist, Environmental Defense
Oral Statement .................................................................................................
Biography ..........................................................................................................
Mr. Paul D. Ziegler, Chairman, American Chemistry Council Nanotechnology
Panel
Oral Statement .................................................................................................
Biography ..........................................................................................................
12
14
24
25
27
28
29
31
35
36
37
57
57
59
66
71
73
77
(III)
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IV
Page
Discussion .................................................................................................................
78
Appendix: Answers to Post-Hearing Questions

Dr. E. Clayton Teague, Director, National Nanotechnology Coordination Office
(NNCO) .................................................................................................................
Mr. E. Floyd Kvamme, Co-Chair, Presidents Council of Advisors on Science
and Technology .....................................................................................................
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. Andrew D. Maynard, Chief Science Advisor, Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for Scholars,
Washington, D.C. .................................................................................................
Dr. Richard A. Denison, Senior Scientist, Environmental Defense .....................
Mr. Paul D. Ziegler, Chairman, American Chemistry Council Nanotechnology
Panel .....................................................................................................................
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104
108
110
117
136
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RESEARCH ON ENVIRONMENTAL AND SAFETY

IMPACTS OF NANOTECHNOLOGY: CURRENT
STATUS OF PLANNING AND IMPLEMENTATION
UNDER
THE
NATIONAL
NANOTECHNOLOGY INITIATIVE
WEDNESDAY, OCTOBER 31, 2007
SUBCOMMITTEE
HOUSE OF REPRESENTATIVES,
RESEARCH AND SCIENCE EDUCATION,
COMMITTEE ON SCIENCE AND TECHNOLOGY,
Washington, DC.
ON
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.
(1)
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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. 108153) 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 Presidents 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. 108153).
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
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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
3001 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.
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 publics 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.
The Presidents 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 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
One of the NEHI Working Groups 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 reports release, the Chairman and Ranking
Member stressed the urgency 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 pre1 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 (NTSR06003) (hereafter cited as Taking Action).
3 Lux Research, Sizing Nanotechnologys Value Chain, October 2004.
4 Matthew Nordan testimony, Science Committee hearing, September 21, 2006, Serial No.
10963.
5 Terms of Reference, Nanotechnology Environmental and Health Implications Working Group
Nanoscale Science, Engineering, and Technology Subcommittee Committee on Technology;
March, 2005.
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vious 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. 10934], 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. 10963]. 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 nongovernment 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. 108153). 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:
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Research Plan for Environmental and Safety Implications of Nanotechnology

At the Science Committees 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.
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
6 Clayton
Teague testimony, Science Committee hearing, November 17, 2005, Serial No. 109
34.
7 http://www.nano.gov/
PrioritizationEHSResearchNeedsEngineeredNanoscaleMaterials.pdf
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priorities. No estimate is given for a date for completion of this EHS research program assessment and strategy document.
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?
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?
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Chairman BAIRD. This mornings 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 Committees 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 Committees November 2005 hearing, the Administrations 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 Committees 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 re-
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port 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 Centers 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 todays 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 todays
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 mornings 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 Committees 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 issuesor 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.
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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 initiatives 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 Committees November 2005
hearing, the Administrations 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 Committees 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 laterthis past Augustan 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 marketplacethe number of such products has doubled to 500 over the
past year according to surveys by the Wilson Centers 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 todays 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 doesnt somehow impinge on the
seriousness of the topic were 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 longterm 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
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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, todays 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, todays 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.
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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 weeks 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 onehalf 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 Presidents 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
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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 agencys 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 groups 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 documents 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.
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NNIs growing portfolio of EHS research is leveraged through collaborations among multi-disciplinary research groups, with industries, NGOs, 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 Presidents 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 nations 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.
I have been asked to describe the NNIs approach to prioritizing and addressing
EHS research related to nanotechnology. Our approachour strategyconsists 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 gov1 See Table 6 in the NNI Supplement to the Presidents FY 2008 Budget, http://
www.nano.gov/NNI08Budget.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.
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ernment 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) Subcommittees
Nanotechnology Environmental Health Implications (NEHI) Working Group serves
centrally and effectively to coordinate the planning and implementation of the U.S.
Governments 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 Groups 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
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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 NNIs 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 NNIs 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 oneIdentify 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.
Step twoPrioritize 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 threeObtain 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 Presidents
2006 Budget. For example, some research in the PCA for Instrumentation Research,
Metrology, and Standards was found to be highly relevant.
Step fourAnalyze 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 NNIs 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.
2 http://www.nano.gov/NNI
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NEHIs 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
OMBs call for data on research in the five categories of the NNI Research Needs
Document is provided in Appendix B.
Step fiveProvide research strategy document as guidance:
The single most important outcome of this process is the creation of a sciencebased 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
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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 NNIs 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 issuessomething that industry has asked us to provide.
We expect industry-created research plans will address in greater detail important industry needsespecially 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 NIHs 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
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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 NIOSHs 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 cannotand should notgo 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 nanotechnologyrelated 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 OECDs 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:
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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 nonmember 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
Presidents 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 NNI3 was complimentary of the NNIs 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.
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.
3 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, http://

books.nap.edu/openbook.php?recordid=11752&page=92
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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, FDAs 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 NCLs charter is to conduct safety testing of nanomaterials intended for medical applications;
it is a resource available to investigators in academia, industry, and government
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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 NCLs
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 OECDs Working Party on Nanotechnology
and Working Party on Manufactured Nanomaterials (WPMN), including
leadership of the WPMNs 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 NISTNEHI
interactions include:
2005 Advanced Technology Program Project: Development of 2 and 3Dimensional 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
NISTs 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
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have addressed the interaction of engineered nanomaterials with biological systems
and in international dialogue on nanotechnology health and safety issues.
National Science Foundation (NSF): NSFs 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 NSFEPA MOU and their joint support for the establishment of a Center
for Environmental Implications of Nanotechnology.
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Appendix B
Initial Analysis of OMBs 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, budg-
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et 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 1970s, 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 Societys 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
IR100 Industrial Research and Development Award for his work.
Chairman BAIRD. Mr. Kvamme.

STATEMENT OF MR. E. FLOYD KVAMME, CO-CHAIR, PRESIDENTS 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 Presidents
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.
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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
materials specific characteristics and intended application.
Federal investment in nanoscale science and engineering research remains money well spent. PCASTs 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 NNIs
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 wellthought-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
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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 CoChair of the Presidents 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 Subcommittees 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 materials specific characteristics and intended application.
Federal investment in nanoscale science and engineering research remains
money well spent. PCASTs 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 societalfrom nano advances. To do so, there also needs to be investment in research for understanding and overcomingthat is, managing or designing
outthe 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
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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 riskbenefit 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 nonEHS 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 K12 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 possiblehopefully
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 Semi-
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conductor, 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.
ICONs 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 couldnt 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
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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 nanotechnologys 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 cant 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 actu-
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ally 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
NNIs 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 nanotechnologys
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 Governments 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 objectivessuch as the development of predictive models for nanomaterials 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
nanotechnologys 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 extractwithin a few
yearsconsensus answers to key questions in this research area. These developments would create confidence that were on a path towards understanding
nanotechnologys 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 multistakeholder, 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.
ICONs 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 environ-
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mentally 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 nanotechnologys 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 nanoEHS research among the agencies; while risk research is not as clearly connected
to NSFs 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 bioinformaticsdisciplines 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
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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 didnt 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 cant 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 NNIs planning process.
Engage external stakeholders in developing Grand Challenges for NanoEHS Research
The NEHIs 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 (20002003) 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 planningand 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 nanoEHS 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
(nanotechnologys 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 nanotechnologys 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 vol-
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untary 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 NNIs 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 activitiesto 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. Finallyand most problematicstandards 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 simulationswill 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 were on a path towards understanding nanotechnologys risks, and
keep the pipeline for nanotechnology innovation flowing.
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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 nanomaterialsi.e., how they behave rather than what they are made ofto 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 organismsincluding oxidative stress, inflammation and immune response, protein misfolding, apoptosis and necrosis, genotoxicity and mutagenicity, and developmental effectsand 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 communitys 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
(BES0646107) 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 Bachelors 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 Societys 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 Nations first
Nanoscience and Engineering Centers funded by the National Science Foundation.
One of CBENs primary areas of interest is the application of nanotechnology to the
environment.
Colvin has received numerous accolades for her teaching abilities, including Phi
Beta Kappas Teaching Prize for 19981999 and the Camille Dreyfus Teacher Scholar Award in 2002. In 2002, she was also named one of Discover Magazines 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?
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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. Im 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
Vickis 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 manufacturers 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 coauthors. 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 governments 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
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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 theyre 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 Governments 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 1990s 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
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agency on the Nanoscale Science, Engineering and Technology (NSET) Subcommittee of the National Science and Technology Council (NSTC), and was CoChair 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 nonpartisan, 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.
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 Governments 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 Governments 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 fundingan
estimated $95 million in fiscal year 2008should 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,
1 For
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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 themnew 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.
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 nave to assume that twentieth century assumptions and approaches are up to the task of protecting health and the
2 Maynard, A.D., Aitken, R.J., Butz, T., Colvin, V., Donaldson, K., Oberdo
rster, 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 444:267269.
3 Oberdo
rster, G., Stone, V. and Donaldson, K. (2007). Toxicology of nanoparticles: A historical
perspective. Nanotoxicology 1:225.
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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
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 materials
chemical makeup alone.6
An ability to penetrate to parts of the body and the environment that are inaccessible to non-nanomaterials.7
The emergence of physical and chemical properties that are not directly predictable from individual atoms, or the bulk material.8
A possible ability to interfere with living systems including DNA and proteins
that are naturally nanoscale.9
An association with diseases not conventionally associated with exposure to
non-nanomaterials.10
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 nonexistent 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.
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. 51:112.
6 Oberdo
rster, G., Gelein, R.M., Ferin, J. and Weiss, B. (1995). Association of particulate air
pollution and acute mortality: involvement of ultrafine particles? Inhal. Toxicol. 7:111124.
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. 114:11721178.
8 Preining, O. (1998). The physical nature of very, very small particles and its impact on their
behavior. J. Aerosol Sci. 29:481495.
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
10 Mills, N.L., To
rnqvist, 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. 357:10751082.
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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 committeeor working groupprovide 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 committees 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 involvedboth national and
internationalin 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
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by the NEHI group in 200611 (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.
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.
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:
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 marketsthe
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.
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 Gov11 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.
13 Maynard, A.D. (2006). Nanotechnology: A research strategy for addressing risk. Woodrow
Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington,
DC.
14 See supra note 2.
15 Niche
Manufacturing
Flagship.
http://www.csiro.au/org/
NicheManufacturingFlagshipOverview.html. Accessed October 19, 2007.
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ernment; 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 goalsincluding 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 longterm 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 Health18 also has been successful in developing effective publicprivate 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.
Irrespective of which model is the best suited for nanotechnology, the need is urgent to develop such partnerships as part of the governments strategy to address
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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nanotechnology risks. Nanotechnologies are being commercialized rapidlygoing
from $50 billion in manufactured goods in 200620 to a projected $2.6 trillion in
nanotechnology-enabled manufactured goods by 2014or 15 percent of total manufactured goods globally.21 And knowledge about possible risks is simply not keeping
pace with consumer and industrial applications.
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.
But beyond the $50 million figure, further investment in exploratory research is
needed to identify the questions we havent thought of yet. It isnt possible to place
a firm figure on how much should be spent here, but a useful rule of thumband
one that others have advocatedis to ensure that at least 10 percent of the Federal
Governments 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 millionallowing 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
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 Report: Investment Overview and Market Research
for Nanotechnology. 4th edition, volume 1. Lux Research Inc., New York, NY.
23 See also: supra note 13.
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in exploratory research that is directly relevant to identifying and reducing potential
nanotechnology risks in the workplace.24
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 Governments actions match up to what is needed?
While I argue later that the Federal Governments 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
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.
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
24 NIOSH (2007). Progress towards safe nanotechnology in the workplace, National Institute
for Occupational Safety and Health, Washington, DC.
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.
26 U.S. Congress (2003). 21st Century Nanotechnology Research and Development Act (Public
Law 108153), 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.
28 Ferin, J., Oberdo
rster, 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. 21:381384.
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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
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 successfulif sparsely fundedresearch portfolio spanning
exploratory to applied studies.35 The NSF recognized the need to develop a sciencebased 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 Programa 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 agencys 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 risksand how to tackle the resulting challenges.
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:
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 HSLs 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.
34 EPA (2007). U.S. Environmental Protection Agency Nanotechnology White Paper, Environmental Protection Agency, Washington, DC. EPA 100/B07/001. February.
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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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
EPAs paper led Barnaby Federa leading journalist with the New York Times
to write an article with the headline EPA to Nanotech: Size Doesnt 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.
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
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 governments 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.
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 NIOSHs activities
and other agencies was underlined by the agency commenting publicly on EPA
plans to regulate engineered nanomaterialsrather 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
documenta document that NIH representatives had contributed to!44 And the recently announced Center for Environmental Implications of Nanotechnologya joint
39 EPA (2007). TSCA Inventory Status of Nanoscale SubstancesGeneral Approach, Environmental Protection Agency, Washington DC.
40 Feder, B. (2007). EPA to Nanotech: Size Doesnt 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.
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/.
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, EPAHQOPPT20040122. 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/ehspriorities/comments/. Accessed
October 25, 2007.
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venture between EPA and NSFdoes not seem to be part of any coordinated crossagency plan.45
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 NEHIs tardy response to repeated calls for action from Congress over the
past two years. Yet when economic interests, peoples health and the environment
are on the line, to claim its 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 frameworkand 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. NEHIs 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.
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.
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!
45 See
2007.
46 See
47 See
48 See
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http://www.nsf.gov/funding/pgmsumm.jsp?pimsid=503124. Accessed October 25,

supra note 11.
supra note 12.
supra note 13.
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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 progressagencies 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 doesnt fit within a particular agencys 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 crossdisciplinary 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 nanotechnologiesand 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
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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 million49less 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.
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 agencys 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 ineffectiveno 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
risksand how to avoid themnew 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 executiona 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, times a wasting. 50 The stakes are too high for the Federal Government not to take appropriate action now.
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
49 NSET (2007). The National Nanotechnology Initiative. Research and Development Leading
to a Revolution in Technology and Industry. Supplement to the Presidents FY 2008 Budget,
Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology,
National Science and Technology Council, Washington, DC.
50 Congressman Sherwood Boehlert (RNY) opening statement for nanotechnology hearing.
September 21, 2006. http://gop.science.house.gov/hearings/full06/Sept%2021/sbopening.pdf.
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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 200651 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.
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!
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 graphitethe same substance used to form pencil leads. Yet research has shown carbon nanotubes to be
51 See
52 See
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supra note 13.
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potentially hazardous in ways we dont 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 itsafely?
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.
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.
Overall, it is possible to find research being carried out within each of the twentyfive 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 possiblethis 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.
But beyond this figure, there is a need for further investment in exploratory research that will identify the questions we havent thought of yet. It isnt possible
to place a firm figure on how much should be spent here, but a useful rule of
thumband one that others have advocatedis to ensure that at least 10 percent
of the Federal Governments 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 millionallowing 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
53 Cheap Tubes, Inc. http://www.cheaptubesinc.com/. Accessed October 19, 2007. Purchased
materials are accompanied by detailedif currently out-datedinformation on published hazard
studies. Yet the supplied manufacturers safety data sheet continues to list the material as
graphite, in the absence of clear guidance from regulatory authorities.
54 Nanotechnology health and environmental implications. An inventory of current research.
http://www.nanotechproject.org/18 Accessed October 14, 2007.
56 See also: supra note 13.
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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
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
Governments 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 milliona shortfall of $27.5 million!59
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 designwealthy 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 millionan increase of
over one and a half times NIOSHs 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.
57 See
supra note 24.

58 NSET (2007). The National Nanotechnology Initiative. Research and Development Leading
to a Revolution in Technology and Industry. Supplement to the Presidents FY 2008 Budget,
Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology,
National Science and Technology Council, Washington, DC.
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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 agencys 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.
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 welldefined 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
nanotechnologiesin 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 goaland in a timely mannerthen 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 NNIs goalsand the terms under which it operateswill 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
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;
60 See
supra note 12.

Working Group on Nanotechnology Environmental and Health Implications
(NEHI WG). http://www.nano.gov/html/society/NEHI.html. Accessed October 14, 2007.
61 Interagency
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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 crossagency 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
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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 strategymerely 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 longterm 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.
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BIOGRAPHY
FOR
ANDREW D. MAYNARD
Dr. Andrew Maynard is the Chief Science Advisor to the Project on Emerging
Nanotechnologiesan 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 wellknown 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 cochaired 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.
Governments 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 Presidents 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 NGOs 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 Governments 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
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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 lions 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 Defenses 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 slow-
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ing 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 nanotechnologys 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
NNIs 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:
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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 latters 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 nanotechnologys potential applications in a wide variety of fields, such as
groundwater cleanup and cancer therapy, research on nanotechnologys 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 nanotechnologiesmethods 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]
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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
NNIs 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 moreat least 10
percentof 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
NNIs 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 NNIs 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
PENs 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 lions 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 capacitybuilding and research agenda should be viewed as an investment that will facilitate
the responsible development of emerging nanotechnologies.
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Need for a comprehensive federal risk research strategyand 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 1Identify 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 Defenses comments on this document are attached
to this testimony.
Step 2Further 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 3Evaluate in greater detail the current NNI EHS research portfolio.
Step 4Perform a gap analysis of the NNI EHS research compared to
prioritized needs.
Step 5Coordinate and facilitate among the NNI agencies research programs
to address priorities.
Step 6Establish 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 Defenses 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 twofold. 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
nanotechnologys implications. The conflict manifests itself in the continuing budget
disparity I have already discussed. It is also apparent in NNIs 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
whats 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
nanotechnologys 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.
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For example, the FDA Nanotechnology Task Forces 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 isor needsto 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
agoexcept 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 Agencys
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.
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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/
stratplanINTRO.html; and National Nanotechnology Initiative, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials,
September 2006, at www.nano.gov/NNIEHSresearchneeds.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/5067nanoappropsLetter.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/6015Approps
2007NASLetter.pdf
8. The National Nanotechnology Initiative: Research and Development Leading to
a Revolution in Technology and Industry, Supplement to the Presidents FY 2008
Budget, Tables 2 (p. 7) and 6 (p. 11), at www.nano.gov/NNI08Budget.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, Lets Get Nanotech Right, Wall Street
Journal, June 14, 2005, p. B2, at www.environmentaldefense.org/documents/
5177OpEdWSJ050614.pdf That same month, the American Chemistry Councils 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/4857ACC-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 NNIs 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/filedownload/77
12. NNI, 2006, op. cit.
13. National Nanotechnology Initiative, Prioritization of Environmental, Health and
Safety Research Needs for Engineered Nanoscale MaterialsAn Interim Document
for
Public
Comment,
at
www.nano.gov/
PrioritizationEHSResearchNeedsEngineeredNanoscaleMaterials.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
SubstancesGeneral 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
EPAs National Pollution Prevention & Toxics Advisory Committee (NPPTAC)
is at www.epa.gov/oppt/npptac/pubs/nanowgover viewdocument20051125.pdf
Environmental Defenses comments on both of EPAs recent proposals are at
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www.environmentaldefense.org/documents/7010EDWrittenCommentson
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
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Attachment 1
BIOGRAPHY
FOR
RICHARD A. DENISON
Dr. Denison is a Senior Scientist in Environmental Defenses 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 Defenses 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 Californias Green Chemistry Initiative. Until recently, he was a member of the National Pollution Prevention and Toxics Advisory Committee (NPPTAC), which advises EPAs toxics office. Dr. Denison is part of Environmental Defenses 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.
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Attachment 2
ENVIRONMENTAL DEFENSE COMMENTS1 ON:

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 Initiatives 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 Initiatives 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
1 These comments are available online at www.nano.gov/html/meetings/ehs/uploads/
200701310752EDcommentsonNNIEHSResearchNeedsFI NAL.doc
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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 routesmethods 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)
b)
c)
d)
Improve understanding of process design and engineering controls

Develop green design techniques
Determine product life cycles and potential impact on EHS
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:
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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.
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.
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.
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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 nanomaterialcontaining 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.
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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 toxicityeffects 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 exposureexamined 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 EPAs 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 Institutes Nanotechnology Characterization Laboratorys 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,
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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 highquality, 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.
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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 EPAs 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 Gordons invitation
to address the House Committee on Science and Technology on the role of the National Nanotechnology Initiative (NNI) in planning and implementing the environ-
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mental, 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 peoples 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 Nations economy. It is one of the Nations 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 Nations 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 ACCs 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.
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 Groups 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 Groups 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;
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.
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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 industrys research
experience prior to making final research priority recommendations. To date,
industrys role has been largely restricted to passive review of decisions already made. Industrys 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 Developments (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
nanomaterialsair, 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 nanomaterialsbasic 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 #3Nanomaterials 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
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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 Groups 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 510 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
ACCs Nanotechnology Panel member companies are committed to support and actively promote the safe manufacture and use of the products of nanotechnology, consistent with the ACCs Responsible Care programa 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
EPAs 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.
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BIOGRAPHY
FOR
PAUL D. ZIEGLER
Education
1984Program for Executives, Carnegie Mellon University
1976Master of Science in Hygiene, University of Pittsburgh, Graduate School of
Public Health
1973Master of Public Health in Environmental Health, University of Pittsburgh,
Graduate School of Public Health
1968Bachelor of Science in Pre-Med (Biology/Chemistry), Lincoln Memorial University, Harrogate, Tennessee
Professional Experience
April 1, 2007Present
Retired/Consultant
October 2003April 1, 2007 (Retired this date)
Global Director Product Compliance Assurance, PPG Industries, Inc. Report to
Global Director EHS, serving all PPG SBUs. Globally this position is responsible
for reviewing and assessing product/process related risk, of PPGs 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 SBUs and keep the appropriate levels of management informed.
October 1999October 2003
Global Director Product Stewardship, PPG Industries, Inc. Report to Corporate
Vice President EHS, serving 16 SBUs 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 SBUs 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 SBUs, utilizing outside counsel/technical consultants as appropriate, develop GMP/GLP documents and participate in various inspections.
Member of a number of standing committeesEHS Leadership; Management Development/Talent Review; Salary Review; Quality Council; European EHS Council;
Acquisition/Divestiture Committee; Customs/NAFTA Steering Committee.
April 1987October 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 prod-
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ucts 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 1986March 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.
1984June 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.
19761984
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.
19741975
Product Manager/Noise Pollution Specialist with USC Incorporated, an environmental/engineering consulting firm in Pittsburgh, Pennsylvania.
19731974
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 cant ask someone to prove the
negative. It cant 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
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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 dont 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 EHSrelated 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
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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 collaboratorswe 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 questioningI 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
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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 dont 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 dont 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 dont
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
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rapid agreement on how they are going to do this researchjust
the toolsI think can be done fairly quickly and doesnt 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 cant 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 arent, 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 developingwhat did you
call ita 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
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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 werent there are actually some of the tools of bioinformaticsthe 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 dont 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 examplethere are many othersof 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
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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
bodys 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
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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 cant 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 cant yet identify which ones are going to be those problems because we dont 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 were 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 Alzheimers 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 arent 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
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setting up some czar for EHS. I dont think that will be an informed approach.
Chairman BAIRD. The gentlemans 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. Kvammes 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 doesnt get through this mysterious blood-brain barrier. I
havent 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 towe 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 dont 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.
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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 dont 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
dont 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
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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 dont 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 dont 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 tofive 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.
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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 Governments 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 dont 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 cant 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
dont 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 dont understand how risk science works; and to solve that, you
have got to have somebody in leadership that understands the riskbased issues, the oversight issues, and the regulatory issues. If you
dont 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
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no one agency, I dont 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 doesnt 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. Colvins 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,
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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 naturaloccurring 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 arenasyou know, I live in Houston, Texas,
and when the hurricanes head to us, there are all these predictive
models. But they dont 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 doesnt 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 dont 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
doesnt 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 10,000100,000 atomsbut 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 mod-
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eling toxicologynow 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 buts 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 childrens 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 morethere 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?
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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
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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.]
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Appendix:
ANSWERS
TO
POST-HEARING QUESTIONS
(95)
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ANSWERS
TO
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 OECDs 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 NNIs 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 sev-
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eral 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 nanotechnologys
development engineered nanomaterials typically are proprietary. Second, while the
HEI model is based on joint efforts between one agency and one industrial sector
(EPAprimarily, 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 NNIs 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;
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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 80118013 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 1213, 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 longerterm, 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 Presidents 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?
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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 Presidents 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. EPAs, 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 (inhouse) 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 EPAs ORD
to the National Toxicology Program and the NIOSH nanomaterials health effects
lead scientists to visit ORDs 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 ORDs intramural nanomaterials health effects research:
NIOSH scientists are collaborating with ORDs 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 EPAs 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 inhouse 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 becauseif for no other reasonthe agencies participated
in its development and have a commitment to it. Call it buy-in or ownership, if you
will, but its 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?
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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 NNIs 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 FDAs 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 nanomaterialsstable materials
for which the chemical and physical properties are rigorously characterized to verify
the composition or properties of their productsare being developed to overcome
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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 EPAs 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 NTPs 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 nanotechnologythe capacity to reduce pollution
through the redesign of industrial processes and the replacement of toxic solvents,
poisonous metals, and corrosive chemicals with less hazardous nanomaterialsis
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. EPAs recent Pollution Prevention through
Nanotechnology Conference (held September 2526, 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 oc-
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curring 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. EPAs 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.
EPAs 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 EPAs Particulate Matter research program is linking particulate health effects from
ultrafine particles generated from the combustion of fossil fuels. EPAs Particulate Matter research will provide potentially important information regarding the dosimetry/translocation, hazard identification, and health effects of inadvertently produced ultrafine particles.
NIOSHs 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,
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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 TC229.
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.
Nanotechnologyspecific 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 biosystemsfrom 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
nanotubesnot from material-specific toxic effects.
Appropriate prioritization of the Federal Governments 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.
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ANSWERS
TO
Responses by E. Floyd Kvamme, Co-Chair, Presidents Council of Advisors on Science

and Technology
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. PCASTs 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 agencys 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 PCASTs 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 NNIs
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
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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
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.
this area?
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.
do all current NNI grants currently include and EHS component? If not, should
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 com-
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ponent. 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.
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
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 Halls question, each generation of tests will improve our knowledge of what input parameters are critical
to understanding outcomes of tests.
A2. Risk vs. benefit comparisons occur on an application-specific basis (e.g., sunscreens, nanocrystalline formulations of approved drugs). To my knowledge, this
process doesnt differ from the normal process of evaluating new and improved approaches for any application, whether they are nano-enabled or not.
However, the volume of naturally occurring and ultra-fine particles produced by
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.
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,
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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.
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ANSWERS
TO
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.
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 Presidents 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?
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
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?
fear. What is critical is that we make sure nano enabled products are as safe
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nanomaterials?
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?
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ANSWERS
TO
Responses by Andrew D. Maynard, Chief Science Advisor, Project on Emerging

Nanotechnologies, Woodrow Wilson International Center for Scholars, Washington, D.C.
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 multistakeholder 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.
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 cross1 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/B07/001. February.
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agency EHS research program, as well as the respect of researchers and decisionmakers 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.
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 processwhether undertaken by the NAS or another organizationwould 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 placeresearch 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 NISTs 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.
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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.
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.
The current research portfolio is not prioritized to address and manage the impact
of these materialsor 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 datawhile inconclusivesuggests 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 neededas 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 endof-life impacts. Such an approach is fundamental to a strategic research program,
and yet it is not in evidence.
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
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).
8 Maynard, A.D., R.J. Aitken, et al. (2006). Safe handling of nanotechnology. Nature
444(16):267269.
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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 researchimplying 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 Foundationfunded 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.
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.
more than the size and type of material, but also surface properties, purity, etc.,
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.
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
9 Niche
Manufacturing
Flagship.
Available
at:
http://www.csiro.au/org/
NicheManufacturingFlagshipOverview.html (accessed October 19, 2007).
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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.
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 Commissions Nano &
Converging Science and Technologies Unit, EPAs 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 agencys National Center for Environmental Research is funding grants
for research in green nanotechnology.
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.
nanomaterials which are roughly defined as those that are purposely created.
However, the volume of naturally occurring and ultra-fine particles produced by
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.
10 Schmidt, K. (2007). Green nanotechnology: Its easier than you think. PEN 08. Washington, DC, Woodrow Wilson International Center for Scholars, Project on Emerging
Nanotechnologies. Available at: http://www.nanotechproject.org/filedownload/187 (accessed
November 15, 2007).
11 Dahl, J.A., B.L.S. Maddux, and J.E. Hutchison. 2007. Toward Greener Nanosynthesis.
Chem. Rev. 107(6):22282269.
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 23, 2006. Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, and European Commission. Available at: http://
www.nanotechproject.org/fileG5download/168 (accessed November 15, 2007).
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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 neededregardless of
how the technologies or the materials are classifiedis 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.
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.
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 environmentwhich will help predict the behavior of new nanomaterials and develop new understanding of what makes them
harmfuland 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 Governments
nanotechnology research and development budget be dedicated to goal-oriented
EHS research. As pointed out by Dr. Denisons testimony, only 4.1 percent of
NNIs 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.
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 re13 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)
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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search 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.
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 nanotechnologiesand to support the U.S. Governments 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 championa 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.
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ANSWERS
TO
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
nanotechnologys 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
nanotechnologys 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 Defenses 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 NNIs 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 Presidents 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 technologistsindividuals 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 NNIs work to develop and promote nanotechnology applications,
it is entirely inappropriate when it comes to addressing nanotechnologys implicationsit potential risks. Scientists trained and experienced in understanding health
or environmental risks, rather than technologists, need to direct and implement the
NNIs 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.
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The effect of the current imbalance is evident in the hearing statements of technologists Mr. Kvamme and Dr. Teague, defending the NNIs risk-related efforts.
Even as they professed that the NNI is serious about addressing nanotechnologys
potential risks, both witnesses claimed or implied that concerns about
nanotechnologys 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 Members 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 doesnt 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. Teagues 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 nanotechnologys potential risks is
the Interagency Working Group on Nanotechnology Environmental and Health Implications (NEHI). NEHIs 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 bottomup functions of interagency information exchange, facilitation, and communication,
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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 byand judgments as
to its adequacy, quality and interpretation made byscientists 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 precedentand potential modelfor our recommended approach
Our nation has faced similar situations in the past, when mounting concern that
a technologys 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 NRCs 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 NRCs 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]
Hencefar from operating in a silo and being unable to take advantage of the
cross-fertilization arising from research conducted on applicationsthe 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 NRCs 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 nanotechnologys risk implications get the attention they need, even as federal investment in nanotechnology development proceeds.
Our specific responses to Questions for the Record follow.
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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 modelwhich employs the
finest academic scientists as research planners, performers and peer reviewerswill
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.
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, PCASTs membership is therefore made up almost entirely of technologistsindividuals 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 NNIs 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 nanotechnologys implicationsits potential risks. Scientists trained and with extensive experience in understanding health or environmental risksnot technologistsneed to oversee and advise NNIs efforts to identify and address nanomaterial hazards and exposure potential. In our view, PCASTs 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 inputits Nanotechnology
Technical Advisory Group (NTAG)operates virtually entirely out of sight. No description of the NTAGits members, its mission or charge, its operating guidelines,
whether or when it meetsis 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
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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 decisionmaking authority that is independent of those parts of NNI charged with advancing
nanotechnology development.
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
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.
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, asmany 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.
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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
A1a. There is currently substantial variation in the degree and quality of physicochemical 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, thirdparty 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.
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 com-
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pared, 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.
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, EPAs 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.
Samsungs 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.
A4. This question, like the preface to Mr. Lipinskis questions, is essentially asking
whether the laboratory conditions used in toxicity testing realistically simulate conditions under which actual exposures occur.
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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
exposuree.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]
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Q5. You and Dr. Maynard call for ten percent or more of the Federal Governments
nanotechnology research and development budget be dedicated to goal-oriented
EHS research. As pointed out in Dr. Denisons testimony, only 4.1 percent of
NNIs 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 researchincluding 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 budgetaveraging $60 million annuallyfor 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 EPAs and the Nations 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 stakeholdersindustry includedbelieve government should be doing in the
face of nanotechnologys rapid commercialization, and what it is actually doing. This
situation is at or near the point putting at risk the publics confidence in both government and industrys ability or willingness to responsibly address the development of this technology. That, in turn, puts public acceptanceand the success
of nanotechnology itself at risk.
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.
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2. See www.nano.gov/html/about/nnco.html (NNCO); www.nano.gov/html/
about/nsetmembers.html
(NSET);
www.ostp.gov/nstc/html/
G5committees.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=108G5congG5publicG5laws&docid=f:publ153.108
4. Statement of Mr. Floyd Kvamme, Co-Chair of the Presidents 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/Kvammetestimony.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/
stratG5planINTRO.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 Committees hearings held on
November
17,
2005
(science.house.gov/publications/
hearingsG5markupsG5details.aspx?NewsID=979); September 21, 2006
hearingsG5markupsG5details.aspx?NewsID=1186); and October 31, 2007
hearingsG5markupsG5details.aspx?NewsID=2021).
10. See NRCRegulator of Nuclear Safety (www.nrc.gov/reading-rm/doc-collections/nuregs/brochures/br0164/r4/) and Our History (www.nrc.gov/aboutnrc/history.html) on the NRCs website.
11. See Regulatory Research (www.nrc.gov/about-nrc/history.html) on the NRCs
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/readingrm/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 Cen-
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21.
22.
23.
24.
25.
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ter for Scholars, at www.nanotechproject.org/fileG5download/206; and other

information at www.nanotechproject.org/tags?tag=green
See ww2.samsung.co.za/silvernano/silvernano/washingmachine.html
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/2006G501G527G5EPAG5SamsungG5SilverG5Wash.pdf
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.
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):179184.
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.
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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 & Poors 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
implicationslet 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).
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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
applicationswhich is a source of nanotechnologys enormous promisealso 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
nanotechnologythe emergence of wholly novel properties when materials are reduced to or assembled at the nanoscalecarries 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 nanoformhence 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 materialor 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.
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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 EPAs 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 NNIs 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 issueswhich 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 $1020 million per year for at least 10 years will be neededassuming 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] (NIOSHs current funding level for this research
is considerably lower, $23 million per year. In 2004, NIOSH initiated a fiveyear 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 Presidents 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:
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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 subtopicsdevelopment of real-time characterization
methods and tools, and assessment of human health and environmental impact hazardswill 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 Kingdoms 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 56 million ($9.511.3 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 andas its name indicatesrepresents 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 Commissions Enterprise Directorate in
support of the European Unions 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 dataroughly
equivalent to the SIDS discussed abovewould 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 substancesand considered generally sufficient to inform a full risk assessmentis 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
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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 mortalityclearly 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 broaderand hence likely to cost morethan 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.
Henceindependent of the ultimate magnitude of risk identifiedthe 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 $4060 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
19982003) were relatively similar to the recommended amounts, as reported by
NRC in its 2004 report:
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The NRCs 2004 report, which represents a mid-course review of EPAs 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
NRCs 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 researchincluding 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 EPAs and the Nations 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.
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2. See Environmental Defenses written statement submitted to the National
Academies Committee to Review the National Nanotechnology Initiative at its
March 2425, 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 & Poors, 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 Committees at its March 2425, 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 20032004 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/nanoproductsG5EPA.pdf;
and
a
description
of
current
nanotechnology applications at www.nanotech-now.com/current-uses.htm
7. See, for example, Lux Research, Sizing Nanotechnologys Value Chain, October
2004,
summary
available
online
at
www.luxresearchinc.com/press/
RELEASEG5SizingReport.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/04/0402G5Teague-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 Presidents 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 NSETs Research Directions II workshop held in Washington,
DC on 9/89/04.
12. Phibbs, P., ibid., quoting NIOSH scientist Andrew Maynards statement at
NSETs Research Directions II workshop held in Washington, DC on 9/89/04;
and A. Maynard, personal communication, 42005.
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 EPAs 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 Councils 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
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21.
22.
23.
24.
25.
26.
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tests have previously been conducted, and that no estimation techniques are allowed as a substitute for testing.
Requirements are summarized at www.epa.gov/pesticides/regulating/data.htm.
Regulations specifying testing requirements are at 40 CFR Part 158.
See EPA and Pesticide Registration Issues, USDA Agricultural Research Service, available online at www.ars.usda.gov/is/np/mba/jan97/epa.htm
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
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
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.
Board on Environmental Studies and Toxicology, 2004, op. cit., Table S1, page
6.
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ANSWERS
Responses by Paul D.
Nanotechnology Panel
TO
Ziegler,
Chairman,
American
Chemistry
Council

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
governments identification of research priorities as industry is well-positioned to
help inform the governments 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 industrys 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 Presidents Council of Advisors on Science and Technology (PCAST)?
A2. The Panel believes that industrys 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 industrys 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. Industrys 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 industrys 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 Councils 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 Agencys (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 EPAs 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 exten-
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sive 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.
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.
this area?
A6a. As best as the Panel can discern, NNIs 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 NNIs
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.
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.
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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 countrys 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.
A2. To the best of the Panels 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.
fear. What is critical is that we make sure nano-enabled products are as a safe
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
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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.
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
products 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 materials properties, hazards, and exposures may change during the materials 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).
EPAs 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.
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.
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
1 Oberdo
rster 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.
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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.
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 OECDs 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 OSHAs 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.
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Research On Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation Under The National Nanotechnology Initiative

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RESEARCH ON ENVIRONMENTAL AND

SAFETY IMPACTS OF NANOTECHNOLOGY:

SUBCOMMITTEE ON RESEARCH AND SCIENCE

COMMITTEE ON SCIENCE AND

Serial No. 11069

U.S. GOVERNMENT PRINTING OFFICE

For sale by the Superintendent of Documents, U.S. Government Printing Office

14:35 Feb 06, 2008

COMMITTEE ON SCIENCE AND TECHNOLOGY

HON. BRIAN BAIRD, Washington, Chairman

14:35 Feb 06, 2008

Witness List .............................................................................................................

14:35 Feb 06, 2008

Appendix: Answers to Post-Hearing Questions

14:35 Feb 06, 2008