[Senate Hearing 109-1101]
[From the U.S. Government Publishing Office]
S. Hrg. 109-1101
DEVELOPMENTS IN NANOTECHNOLOGY
=======================================================================
HEARING
before the
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
FEBRUARY 15, 2006
__________
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
TED STEVENS, Alaska, Chairman
JOHN McCAIN, Arizona DANIEL K. INOUYE, Hawaii, Co-
CONRAD BURNS, Montana Chairman
TRENT LOTT, Mississippi JOHN D. ROCKEFELLER IV, West
KAY BAILEY HUTCHISON, Texas Virginia
OLYMPIA J. SNOWE, Maine JOHN F. KERRY, Massachusetts
GORDON H. SMITH, Oregon BYRON L. DORGAN, North Dakota
JOHN ENSIGN, Nevada BARBARA BOXER, California
GEORGE ALLEN, Virginia BILL NELSON, Florida
JOHN E. SUNUNU, New Hampshire MARIA CANTWELL, Washington
JIM DeMINT, South Carolina FRANK R. LAUTENBERG, New Jersey
DAVID VITTER, Louisiana E. BENJAMIN NELSON, Nebraska
MARK PRYOR, Arkansas
Lisa J. Sutherland, Republican Staff Director
Christine Drager Kurth, Republican Deputy Staff Director
Kenneth R. Nahigian, Republican Chief Counsel
Margaret L. Cummisky, Democratic Staff Director and Chief Counsel
Samuel E. Whitehorn, Democratic Deputy Staff Director and General
Counsel
Lila Harper Helms, Democratic Policy Director
C O N T E N T S
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Page
Hearing held on February 15, 2006................................ 1
Statement of Senator Allen....................................... 25
Statement of Senator Ensign...................................... 2
Prepared statement........................................... 3
Statement of Senator Kerry....................................... 30
Statement of Senator Pryor....................................... 27
Statement of Senator Smith....................................... 29
Statement of Senator Stevens..................................... 1
Prepared statement........................................... 1
Prepared statement of Senator Inouye......................... 1
Witnesses
Buckius, Dr. Richard O., Acting Assistant Director for
Engineering, National Science Foundation....................... 10
Prepared statement........................................... 12
Davies, Dr. J. Clarence (Terry), Senior Advisor, Project on
Emerging Nanotechnologies, Woodrow Wilson International Center
for Scholars; Senior Fellow, Resources for the Future.......... 68
Prepared statement........................................... 70
Davis, Mark E., Ph.D., Professor of Chemical Engineering,
Caltech; Member of the Comprehensive Cancer Center, City of
Hope........................................................... 63
Prepared statement........................................... 65
Gotcher, Alan, Ph.D., President/CEO, Altair Nanotechnologies,
Inc............................................................ 31
Prepared statement........................................... 33
Hylton, Dr. Todd L., Director, Center for Advanced Materials and
Nanotechnology, Science Applications International Corporation. 39
Prepared statement........................................... 42
Linares, Bryant R., President/CEO, Apollo Diamond, Inc........... 57
Prepared statement........................................... 59
Schloss, Jeffery, Ph.D., Program Director, Division of Extramural
Research, National Human Genome Research Institute; Co-Chair,
National Institutes of Health Nanomedicine Roadmap Initiative,
National Institutes of Health, Department of Health and Human
Services....................................................... 15
Prepared statement........................................... 17
Swager, Timothy M., Ph.D., Professor of Chemistry, Massachusetts
Institute of Technology (MIT); on behalf of the Institute for
Soldier Nanotechnologies (ISN)................................. 45
Prepared statement........................................... 47
Teague, Dr. E. Clayton, Director, National Nanotechnology
Coordination Office............................................ 3
Prepared statement........................................... 5
Appendix
Response to written questions submitted by Hon. Gordon H. Smith
to:
Dr. Richard O. Buckius....................................... 85
Dr. J. Clarence (Terry) Davies............................... 88
Mark E. Davis, Ph.D.......................................... 89
Alan Gotcher, Ph.D........................................... 90
Dr. Todd L. Hylton........................................... 91
Bryant R. Linares............................................ 89
Jeffery Schloss, Ph.D........................................ 86
Timothy M. Swager, Ph.D...................................... 89
Dr. E. Clayton Teague........................................ 83
DEVELOPMENTS IN NANOTECHNOLOGY
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WEDNESDAY, FEBRUARY 15, 2006
U.S. Senate,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Committee met, pursuant to notice, at 2:40 p.m. in room
SD-562, Dirksen Senate Office Building, Hon. Ted Stevens,
Chairman of the Committee, presiding.
OPENING STATEMENT OF HON. TED STEVENS,
U.S. SENATOR FROM ALASKA
The Chairman. I'm sorry to be a little late. We appreciate
your being here. I do not know how many others will join us. I
am going to put my statement in the record.
[The prepared statements of Senator Stevens and Senator
Inouye follow:]
Prepared Statement of Hon. Ted Stevens, U.S. Senator from Alaska
Nanotechnology is a revolutionary science, one that has the
potential to change and improve many facets of our lives.
From the creation of more precise methods of targeting and treating
cancer, to stronger body armor for our soldiers in the line of attack,
to consumer products like straighter flying golf balls or better
sunscreen, nanotechnology's potential engenders excitement, intrigue,
and substantial benefits to society as a whole.
As with any technological and scientific progress, certain
obstacles and challenges abound. For starters, how does one efficiently
produce anything in quantity when the raw material is only one one-
thousandth the width of a human hair? Or, do nanoparticles differ to
such an extent from their larger counterparts in the physical world
that their properties exhibit unknown or unstable characteristics?
These questions lie at the heart of what we hope to examine today. In
other words, what is the status of developments in the nanotech field
and how will further progress in this area of science impact our
everyday lives?
Because we are here in a Senate hearing room, it is only natural
for us also to consider what the proper role of government is in
responding to nanotechnology's tremendous promise. We want to avoid
stifling this technology before beneficial applications have the
opportunity to successfully enter the market. We also want to protect
all consumers who are the eventual end-users of these scientific
achievements. Because, after all, if a nanoproduct is not safe, all the
potential in the world would not justify its use.
We welcome two very distinguished panels of witnesses today. Our
witnesses come from diverse backgrounds, and we look forward to hearing
their perspectives on developments in the field of nanotechnology. We
hope to take away some of their wisdom regarding the most appropriate
paths to follow in this area of science.
______
Prepared Statement of Hon. Daniel K. Inouye, U.S. Senator from Hawaii
Nanotechnology is the science of very small things that have very
big potential. Like information technology, nanotechnology is not an
end in itself. Rather, it has the potential to change fundamentally the
way we make products from airplanes to pharmaceuticals.
Nanotechnology holds great promise, but to secure that promise, we
need to understand the long-term effects of exposure to nano-engineered
particles. What, if any, impact do they have on human health?
Researchers are trying to answer this question as we speak.
Despite this uncertainty, companies are already marketing a wide
range of products that utilize nanotechnology, from stain-resistant
clothing to clear sunscreen.
The question is, are we doing enough to learn about the long-term
effects of nano-engineered products? Are we making the right decisions
about research funding and prudent regulation?
According to Mr. Davies' colleagues at the Wilson Center, the
answer is no. Only $39 million of the government's $1.3 billion annual
investment in nanotechnology research has been directed toward
environmental, health, and safety research and development. Little of
that is dedicated to long-term exposure studies.
In what could be a fortuitous coincidence, the Senate is currently
considering legislation that addresses the consequences of asbestos
exposure. As many of us recall, asbestos was once well-regarded. We
knew very little about its effect on human health before its widespread
use. We now know it can be deadly to those exposed to it.
With nanotechnology, history must be our guide, and our experience
with asbestos provides an important lesson. If we do not learn from it,
Congress could very well be considering legislation 30 years from now
to address the ill-effects of nano-engineered products.
Like the other members of this committee, I am excited about
nanotechnology's enormous potential, and I look forward to hearing
about the advancements in this field. I also hope that our witnesses
can help us understand how we can make choices that will allow this
industry to grow safely and responsibly.
The Chairman. I think everyone realizes that we are dealing
with a very evolutionary science, and we are trying to improve
our knowledge of what it is and what is going on and what is
the progress--what has the progress been so far, and what
obstacles and challenges are involved.
So, I'll yield to my friend here, who was here ahead of me.
Senator Ensign, do you have an opening statement?
STATEMENT OF HON. JOHN ENSIGN,
U.S. SENATOR FROM NEVADA
Senator Ensign. Yes, Mr. Chairman. I'll keep it very brief,
because I know we have nine witnesses today and we want to hear
as much as we can, especially with all the witnesses we had
this morning. We did not get nearly as much time to hear from
them as we wanted to.
In the second panel, I'm very excited to have a Nevadan
here, Dr. Allan Gotcher. Dr. Gotcher will be discussing his
efforts to develop a nanotechnology business. He is the
President and Chief Executive Officer of Altair
Nanotechnologies, in Reno, Nevada. I think the importance of
this hearing is that nanotechnology is such an exciting field
with so many potential applications. But I know that people
have raised a lot of concerns about the safety of
nanotechnology. We have to be careful, but we also have to make
sure that we do not squelch innovation. In addition, although
we must monitor potential health problems related to
nanotechnology, I think that we have to proceed very carefully
and slowly as we are looking at potentially regulating an
incredible field of science and technology. The potential
benefits from nanotechnology are so incredible that we have to
be careful, exactly what we do as policymakers. With that in
mind, I look forward to hearing from the witnesses on both of
our panels.
[The prepared statement of Senator Ensign follows:]
Prepared Statement of Hon. John Ensign, U.S. Senator from Nevada
Thank you, Chairman Stevens, for holding a hearing on this exciting
topic.
With 9 witnesses set to testify, I will try to keep my opening
remarks brief. I look forward to hearing from all of our witnesses this
afternoon and, in particular, I would like to extend a hearty welcome
to a fellow Nevadan, Dr. Alan Gotcher. Dr. Gotcher will be discussing
his efforts to develop a nanotechnology business, Altair
Nanotechnologies, Inc., out in Reno.
Nanotechnology has the potential to positively impact so many
aspects of our lives that it is helpful for this committee to explore
where we have been, where we are, and where we are going with
nanotechnology.
Nanotechnology can assist humans in very serious ways, from
improving the treatment of life-threatening diseases like cancer and
diabetes, to assisting our men and women in the armed forces to detect
explosive devices.
In addition, nanotechnology can help provide simple pleasures like
facilitating the creation of improved sports equipment and chocolate
chewing gum.
Nanotechnology has already demonstrated that it will be
increasingly relevant in society for a long time to come.
As scientists, universities, and businesses continue their efforts
to use nanotechnology in a broad number of fields, we as policymakers
in Washington need to be careful as we examine what role we should
play.
While nanotechnology has tremendous potential to improve our daily
lives, we need to make sure that we are adequately addressing the
potential safety concerns that are raised by this dynamic field of
development. I look forward to hearing more on this topic from today's
witnesses.
At the same time, we need to be cautious about introducing
additional regulation that could unintentionally squelch the positive
innovation that is occurring in the field.
Thank you again, Mr. Chairman.
The Chairman. Well, thank you very much.
We have two panels this afternoon. The first panel has
three witnesses: Dr. E. Clayton Teague, Director of the
National Nanotechnology Coordination Office; Dr. Richard
Buckius, Assistant Director for Engineering at the National
Science Foundation; and Dr. Jeffrey Schloss, the Co-Chairman of
the Nanomedicine Roadmap Initiative at the National Institutes
of Health.
We look forward to hearing your testimony. We will print
your statements in the record in full. Because of the subject
matter, I am not going to place a time limit on you, but I hope
you'll realize that there is a second panel behind you of six
other people that we would like to listen to this afternoon.
So, Dr. Teague, would you start it off, please?
STATEMENT OF DR. E. CLAYTON TEAGUE, DIRECTOR,
NATIONAL NANOTECHNOLOGY COORDINATION OFFICE
Dr. Teague. Good afternoon, and thank you, sir.
Chairman Stevens and other distinguished members of the
Committee who are present, I'm honored to have this opportunity
to speak with you today about developments in nanotechnology;
in particular, the role of the National Nanotechnology
Initiative. My primary message today is that, with your
support, the NNI has been, and will continue to be, a major
driver for the responsible development of nanotechnology in the
United States and the world.
The NNI is now in its sixth year, and it is a highly
collaborative program among 25 Federal agencies, 13 of which
have budgets for nanotechnology R&D. Because of the NNI,
Federal agencies have initiated major new nanotechnology R&D
activities that support national goals in their agency
missions. There is an extensive and growing infrastructure of
nanotechnology research centers and user-facilities that have
been put in place. The 25 participating agencies are--and I
have emphasized--they are working together very harmoniously to
maximize the effectiveness of their individual and collective
investments through communication, coordination, and actual
joint programs.
As called for by you and your fellow legislators, the
President's Council of Advisors on Science and Technology, in
its role as the National Nanotechnology Advisory Panel,
recently reviewed the first 5 years of the NNI. Overall, they
gave the NNI high marks for advancing foundational knowledge,
for promoting technology transfer for commercial and public
benefit, and taking steps to address societal concerns. They
also concluded that the money the U.S. is investing in
nanotechnology is money very well spent.
With a Federal investment of over $1 billion a year and
over 4,000 active R&D projects, the U.S. is the world leader in
nanotechnology development. With only one-quarter of the total
international funding in nanotechnology, U.S. researchers are
the leading producers of nanotechnology patents and publish
over half of the nanotechnology papers in the key high-impact
journals worldwide.
The NNI has also been effective in using these funds to
support the movement of scientific discoveries from the lab to
the marketplace. More than 160 companies supported by Small
Business Innovation Research grants are now producing
nanotechnology products or providing related commercial
services. Since 2001, some 600 new ``pure-play''--totally
nanotechnology--companies have been formed in the United
States.
Technology transfer, in this vein, is also promoted by the
creation of a large geographically distributed network of
research facilities. The NNI has established more than 50
nanotechnology research and education centers. I've provided a
list of these centers along with my written testimony. These
include more than a dozen user-facilities that are open to all
researchers from academia and from industry.
I'd like now to take just a moment to explain a little bit
about why spending a billion dollars of taxpayers' money each
year in nanotechnology R&D is justified.
This slide shows some of the major application areas for
nanotechnology. In each of the areas that are shown--and this
is just a sampling of the many areas that nanotechnology will
impact--this transformational technology promises to overcome
what people sometimes call ``brick walls'' to the advancement
by conventional approaches. In medicine and health, for
example, targeted treatments for cancer with minimal or no
side-effects. In information technology, devices that are
``beyond silicon,'' a phrase that's used in the industry, and
will allow us to stay on the path of Moore's Law. In energy
production, revolutionary high-efficiency, low-cost solar
cells. In materials science, achievement of atom-by-atom design
of materials. In food, water, and the environment, effective
remediation methods for Superfund sites and membranes to
produce pure water, free even of viruses. In instrumentation,
microscopes that can image the 3D--three dimensional--locations
of atoms and the nanostructure on the time-scale of chemical
reactions.
Along with all these advances in technology, in line with
your comments, the United States has also pioneered
environmental health and safety research, leading the world in
this area. This research has been directed at implications of
engineered nanoscale materials, and the U.S. is the world's
leader in funding this work. Another vital element of the NNI
is research directed at the societal aspects of nanotechnology
development, as well as education and public outreach.
Among the challenges ahead are, certainly, strong
competition from other countries, an issue with both economic
and national security implications. While recognizing this, we
are working to cooperate with other countries on research
related to safety and societal impacts and on setting standards
for this field.
In these brief remarks today, I hope I've been able to
communicate that the NNI has been a major driver for
nanotechnology in the U.S. and the world. All the members of
the NNI, the agency members and representatives, see tremendous
opportunity ahead and realize that we've got much work that
remains to be done. We have now in place a vigorous program
underway to launch a new era in this science and technology,
thanks to the support of this administration and this Congress.
With your continued support, the NNI will bring us closer to
achieving some of our greatest national and societal goals.
Thank you, and I'll look forward to your questions.
[The prepared statement of Dr. Teague follows:]
Prepared Statement of Dr. E. Clayton Teague, Director,
National Nanotechnology Coordination Office
Chairman Stevens, Co-Chairman Inouye, and distinguished members of
the Committee, I'm honored to have the opportunity to speak with you on
behalf of the Nanoscale Science, Engineering, and Technology (NSET)
Subcommittee of the President's National Science and Technology
Council, which coordinates the National Nanotechnology Initiative
(NNI). My subject is developments in nanotechnology--in particular, the
role of the National Nanotechnology Initiative (NNI) in driving the
responsible development and application of nanotechnology. That is my
primary message today--that the NNI has been and continues to be the
major driver for developments and applications of nanotechnology in the
U.S. and the world.
The NNI--now in its sixth year--is a highly successful,
collaborative, cross-cutting program among 25 Federal agencies: 13
agencies involved in the NNI R&D budget and 12 others with missions
related to advances in nanotechnology (see list below). For a
description of the vision, goals, organization, and management of the
initiative, I would direct you to the NNI Strategic Plan provided along
with this written testimony. Because of the NNI: (1) Federal agencies
have initiated major new programs and efforts in nanotechnology
research, development, and applications that expand knowledge and
understanding, address broad national goals, and support the agencies'
missions; (2) an extensive infrastructure of focused centers of
excellence in nanotechnology and nanotechnology user facilities has
been established and continues to grow; and (3) the 25 participating
agencies are working together to maximize the effectiveness of their
individual and collective investment through communication,
coordination, and joint programs.
As called for by you and your fellow legislators, the President's
Council of Advisors on Science and Technology (PCAST), in its role as
the National Nanotechnology Advisory Panel, recently reviewed the first
5 years of the NNI. In its report, which is provided along with this
written testimony, PCAST concludes that our activities already have
paid significant dividends, such as ``advancing foundational knowledge,
promoting technology transfer for commercial and public benefit,
developing an infrastructure of user facilities and instrumentation,
and taking steps to address societal concerns.'' PCAST members believe
the NNI ``appears well positioned to maintain United States leadership
going forward,'' that ``the money the U.S. is investing in
nanotechnology is money very well spent,'' and that ``continued robust
funding is important for the Nation's long-term economic well-being and
national security.''
With a total Federal investment of more than $1 billion per year,
the U.S. is the acknowledged world leader in nanotechnology R&D as
evidenced by research output measured by patents and publications. With
only one quarter of the total international funding in nanotechnology,
U.S. researchers are the leading producers of nanotechnology patents
and publish over half of the nanotechnology papers in high-impact
journals worldwide.
The investment of such funds must lead to commercialization,
however, in order to contribute to our economy. The NNI has also been
effective in moving science from the bench to products in the
marketplace. The U.S. leads in the number of nanotechnology-based
start-up companies, many of which have received Federal support. More
than 160 companies supported by Small Business Innovation Research
grants are now producing nanotechnology-based products or providing
related commercial services. Many of these are among the 600 ``pure
play'' nanotechnology companies formed in the United States since 2001,
identified in a recent survey by Small Times Media.
Technology transfer is also promoted by the creation of a large,
geographically distributed network of research facilities. The NNI has
established more than 50 nanotechnology research and education centers
at universities and government laboratories, including more than a
dozen user-facilities that are open to all researchers, including those
from industry. Such broad access facilitates collaborations between
government, business, and university partners. (See the attached list
of all centers and user facilities established by the agencies
participating in the NNI.)
I'd like to take a moment to explain why the Federal Government is
investing over $1 billion in nanotechnology R&D each year.
Nanotechnology incorporates science, engineering, and technology at the
nanometer scale. Technically, a nanometer is a millionth of a
millimeter; I find it useful to think of a nanometer in terms of the
thickness of a sheet of paper--100,000 nanometers. At this scale,
properties of materials can differ markedly from those of individual
atoms and molecules or of bulk matter. By putting these unique
properties to work, scientists are developing highly beneficial
products in medicine, energy, electronics, materials, and other areas.
Nanoscale control over the structure of materials and their properties
is already leading to a variety of innovative technologies and is
expected to impact virtually all industry sectors as an ``enabling'' or
``key'' technology. Some examples of impact areas are shown in the
figure below.
To focus on one of these areas, consider an example of how
nanotechnology could transform our economy and enhance our national
security. Sunlight is by far the largest of all carbon-neutral energy
sources. More energy from sunlight strikes the Earth in 1 hour than all
the energy consumed on the planet in a year. Sunlight has long been
seen as a compelling solution to our need for clean, abundant sources
of energy in the future. It is readily available, secure from
geopolitical tension, and can reduce the impact of energy use on our
environment. This great promise has long been recognized. But cost and
low-efficiency issues have stood in the way of harnessing this energy--
problems that are largely due to materials limitations. Nanotechnology
allows us to design materials with combinations of properties not found
in previously available materials. Photovoltaic cells formed from
quantum dots--nanometer-sized particles of semiconductor materials--
have been engineered to absorb and convert energy from multiple parts
of sunlight's spectrum to electricity, yielding devices with
significantly higher efficiency than those currently in use.
Today, the cost of producing electricity from photovoltaic cells is
between two and five times that from conventional systems. With new
materials and devices for energy conversion, transmission, and storage,
this price differential could be bridged and make photovoltaic cell
production of electricity competitive with that of conventional
systems.
Another vital element of the NNI is research directed at
environmental, health, and safety (EHS) impacts. The U.S. is the world
leader in funding EHS research on the implications of engineered
nanoscale materials. Further, the Federal Government has been
coordinating research activity in this area since 2003, when the
National Toxicology Program began a new program on several engineered
nanoscale materials and the Nanotechnology Environmental and Health
Implications (NEHI) Working Group was formed within the NSET
Subcommittee. NEHI brings together representatives from some 24
agencies that support nanotechnology research or that have regulatory
responsibilities to exchange information and to identify, prioritize,
and implement research needed to support regulatory decisionmaking
processes. Through the efforts of the NEHI Working Group, regulatory
agencies have been proactively engaged with each other and the research
agencies, leading to earlier awareness of relevant issues and expedited
activities to address them. In addition, those agencies that are
primarily focused on research have a greater appreciation for the
issues confronted by the regulatory bodies.
My colleague Dr. Buckius will report on NSF's support of programs
aimed at improving nanotechnology education at all ages, including
through informal venues, such as science museums. NSF is also to be
commended for the creation, in the Fall of 2005, of the Network for
Nanotechnology in Society. That network will engage economists, social
scientists, and non-scientists in looking at how nanotechnology could
impact society economically, socially, legally, and how nanotechnology
fits into the ethical dialogue on potential outcomes of emerging
technologies. Engaging various publics in discussions regarding
nanotechnology development is another function of this network.
Because technological innovation is a global phenomenon,
international cooperation and coordination on many of the pre-
competitive and noncompetitive aspects of nanotechnology will encourage
development to occur in a responsible and beneficial manner. The United
States takes the position that all countries will benefit from
cooperating and coordinating efforts in many of the formative areas of
nanotechnology R&D, such as technical norms and standards; intellectual
property rights; environment, health, and safety; and education. In
2005, the NSET Subcommittee created an informal working group on Global
Issues in Nanotechnology, whose purpose is to develop, coordinate, and
support U.S. Government international activities related to
nanotechnology.
The GIN working group has supported numerous international
activities in the past year, including those involving the Organization
for Economic Co-operation and Development (OECD). At an October 2005
meeting of the OECD Committee for Scientific and Technological Policy
(CSTP, within the Science, Technology and Industry Directorate), the
U.S. proposed the creation of a Working Party on Nanotechnology. This
new Working Party would provide an international governmental forum to
help OECD Member States and Observers more effectively utilize their
nanotechnology R&D investments in furtherance of the CSTP goals of
stimulating science and innovation, enhancing economic growth,
providing societal benefits, and promoting innovation through
international science and technology cooperation. In parallel,
following a workshop hosted by the United States on the safety of
manufactured nanomaterials, a proposal has been made to create within
the OECD Environmental Directorate a working group focused on EHS risk
assessment and management of nanomaterials.
A critical aspect of protecting health and the environment are
standardized tools and methods for measuring and monitoring exposure;
developing standardized methods for characterizing properties of
personal protective equipment, etc. Accordingly, the International
Organization for Standardization (ISO) established in late 2005 the
Nanotechnologies Technical Committee. The Working Group on Health,
Safety, and Environmental Aspects of Nanotechnologies under the
Technical Committee will be led by the U.S. I was privileged to lead
the U.S. delegation to the ISO inaugural nanotechnology-related meeting
and also chair the American National Standards Institute (ANSI)-
accredited U.S. Technical Advisory Group (TAG) for nanotechnology
standards.
The U.S. delegation to that ISO meeting submitted the National
Institute for Occupational Safety and Health document on ``Approaches
to Safe Nanotechnology'' to the ANSI TAG for consideration as a
possible work item. Following further development and approval of the
draft by the ANSI TAG, the document will be put forth to the ISO
Working Group as a draft work item toward an ISO Technical Report. Once
approved by the ISO Technical Committee, the document will be issued as
an ISO Technical Report, an informational document available for use by
all countries.
The work of the NNI has been broad. Still, there are challenges
ahead. Among them is strong competition from other countries and
regions, particularly the EU, Japan, and China, an issue with both
economic and national security implications, and also for retaining our
finest scientists.
I hope I have been able to communicate that the NNI has been a
major driver for developments and applications of nanotechnology in the
U.S. and the world. The NNI leadership sees tremendous opportunity
ahead and fully realizes that much work remains to be done. We have a
vigorous program underway to launch a new era in science and technology
in the U.S., thanks to the support of the Administration and Congress.
With continued support the NNI will advance discoveries in medicine,
energy, security, and other areas that will bring us closer to
achieving some of our greatest national and societal goals.
List of Federal Agencies Participating in the NNI During 2006
Federal Agencies With Budgets Dedicated to Nanotechnology Research and
Development
Department of Agriculture, Cooperative State Research, Education,
and Extension Service (USDA/CSREES)
Department of Agriculture, Forest Service (USDA/FS)
Department of Defense (DOD)
Department of Energy (DOE)
Department of Homeland Security (DHS)
Department of Justice (DOJ)
Department of Transportation (DOT)
Environmental Protection Agency (EPA)
National Aeronautics and Space Administration (NASA)
National Institute of Standards and Technology (NIST, Department
of Commerce)
National Institute for Occupational Safety and Health (NIOSH,
Department of Health and Human Services/Centers for Disease Control and
Prevention)
National Institutes of Health (NIH, Department of Health and Human
Services)
National Science Foundation (NSF)
Other Participating Agencies
Bureau of Industry and Security (BIS, Department of Commerce)
Consumer Product Safety Commission (CPSC)
Department of Education (DOEd)
Department of Labor (DOL)
Department of State (DOS)
Department of the Treasury (DOTreas)
Food and Drug Administration (FDA, Department of Health and Human
Services)
International Trade Commission (ITC)
Intelligence Technology Innovation Center, representing the
Intelligence Community (IC)
Nuclear Regulatory Commission (NRC)
Technology Administration (TA, Department of Commerce)
U.S. Patent and Trademark Office (USPTO, Department of Commerce)
National Nanotechnology Initiative Infrastructure: Centers, Networks and
User Facilities
(February 2006)
------------------------------------------------------------------------
NNI Center, Network, or User
Facility Agency Host Institution
------------------------------------------------------------------------
Institute for Nanoscience DOD Naval Research Lab
Institute for Soldier DOD Massachusetts
Nanotechnologies Institute of
Technology
Nanoscience Innovation in DOD U California-Santa
Defense Barbara
Functional Nanomaterials (pre- DOE Brookhaven National
operations) Lab
Integrated Nanotechnologies DOE Sandia and Los Alamos
(pre-operations) National Labs
Molecular Foundry (pre- DOE Lawrence Berkeley
operations) National Lab
Nanophase Materials Sciences DOE Oak Ridge National
Lab
Nanoscale Materials (pre- DOE Argonne National Lab
operations)
Biologically Inspired Materials NASA Princeton U
Institute
Cell Mimetic Space Exploration NASA U California-Los
Angeles
Intelligent BioNanomaterials & NASA Texas A&M
Structures for Aerospace
Vehicles
Nanoelectronics & Computing NASA Purdue
Engineering Cellular Control: NIH U California-San
Synthetic Signaling and Francisco
Motility Systems
NanoMedicine Center for NIH Columbia U
Mechanical Biology
National Center for Design of NIH U Illinois Urbana-
Biomimetic Nanoconductors Champaign
Protein Folding Machinery NIH Baylor College of
Medicine
Cancer Nanotechnology NIH/NCI U. North Carolina
Excellence
Cancer Nanotechnology NIH/NCI Massachusetts
Excellence Institute of
Technology/Harvard U
Nanomaterials for Cancer NIH/NCI Northwestern U
Diagnostics and Therapeutics
Nanosystems Biology Cancer NIH/NCI California Institute
Center of Technology
Nanotechnology Characterization NIH/NCI NCI Frederick
Laboratory
Nanotechnology Excellence NIH/NCI Stanford U
Focused on Therapy Response
Nanotechnology for Treatment, NIH/NCI U California-San
Understanding, and Monitoring Diego
of Cancer
Personalized and Predictive NIH/NCI Emory U/Georgia
Oncology Institute of
Technology
The Siteman Center of Cancer NIH/NCI Washington U
Nanotechnology Excellence
Integrated Nanosystems for NIH/NHLBI Washington U
Diagnosis and Therapy
Nanotechnology: Detection & NIH/NHLBI Emory U
Analysis of Plaque Formation
Nanotherapy for Vulnerable NIH/NHLBI Burnham Institute
Plaque
Translational Program of NIH/NHLBI Massachusetts General
Excellence in Nanotechnology Hospital
Nanoscale Science and NIST NIST/Gaithersburg
Technology
Affordable Nanoengineering of NSF Ohio State U
Polymer Biomedical Devices
Directed Assembly of NSF Rensselaer
Nanostructures Polytechnic
Institute
Electron Transport in Molecular NSF Columbia U
Nanostructures
Extreme Ultraviolet Science and NSF Colorado State U
Technology
High-Rate Nanomanufacturing NSF Northeastern U
Integrated Nanomechanical NSF U California-Berkeley
Systems
Integrated Nanopatterning & NSF Northwestern U
Detection
Learning & Teaching in NSF Northwestern U
Nanoscale Science &
Engineering
Molecular Function at NanoBio NSF U Pennsylvania
Interface
Nanobiotechnology NSF Cornell U
Nanoscale Chemical-Electrical- NSF U Illinois Urbana-
Mechanical Manufacturing Champaign
Systems
Nanoscale Systems & Their NSF Harvard U
Device Applications
Nanoscale Systems in NSF Cornell U
Information Technologies
Nanoscience in Biological & NSF Rice U
Environmental Engineering
Nanotechnology Computational NSF Purdue and others
Network
National Nanotechnology NSF Cornell U and others
Infrastructure Network
Network for Informal Science NSF Museum Of Science-
Education at the Nanoscale Boston and others
Network for Nanotechnology in NSF Arizona State U, U
Society California-Santa
Barbara, and others
Network of Materials Research NSF Various
Science and Engineering
Centers
Oklahoma Nano Net NSF Oklahoma U, Oklahoma
State U and others
Probing the Nanoscale NSF Stanford U
Scalable & Integrated NSF U California-Los
Nanomanufacturing Angeles
Templated Synthesis & Assembly NSF U Wisconsin-Madison
at the Nanoscale
------------------------------------------------------------------------
The Chairman. Thank you very much.
Dr. Buckius?
STATEMENT OF DR. RICHARD O. BUCKIUS,
ACTING ASSISTANT DIRECTOR FOR ENGINEERING,
NATIONAL SCIENCE FOUNDATION
Dr. Buckius. Thank you, Chairman Stevens and distinguished
members of the Committee.
My name is Richard Buckius. I'm the Acting Assistant
Director of the National Science Foundation, for Engineering.
And I'm very pleased to be here today to discuss NSF's strong
commitment to fundamental academic research in the area of
nanoscale science and technology.
Before I begin, though, I want to thank you for the ongoing
support of basic research. This support will help ensure our
Nation's leadership in innovation in an increasingly
competitive world.
Nanotechnology is our next great frontier in science and
engineering. By tailoring molecules and manipulating individual
atoms, we now have the ability to be able to design materials,
medicines, and machines at the smallest, most fundamental
level. This is an amazing capability, and it will have a
profound and lasting impact on our quality-of-life.
In the early stages of--nanotechnology referred to simply
as passive materials, such as nanoparticles found in composites
materials and even paints. Today nanotechnologies are passive
systems and active nanostructures, such as thin, nanoscale
transisters and commercial electronics and the LEDs used in
some traffic lights. As our ability to create new materials and
technology increases, we can expect to see complete nanosystems
with complex three-dimensional structures that will have the
ability to perform multiple functions. NSF's unique
contribution to the enterprise is its support of fundamental
academic research and education through individual
investigators and interdisciplinary groups.
Since the inception of NNI, NSF's investments have led to
significant accomplishments, and I'd like to highlight a few.
NSF has created an interdisciplinary nanotechnology
research community through support of the individuals, as well
as the groups, as well as a variety of programs in training and
education. Within NSF's total FY07 investment in the
nanotechnology initiative of $373 million, $65 million will be
allocated to support these new interdisciplinary research
teams.
NSF has established two user networks, the Network for
Computational Nanotechnology and the National Nanotechnology
Infrastructure Network.
Recently, NSF has established three other additional
networks with national outreach addressing education and
nanotechnology's societal dimensions; and let me just list
these: The Nanoscale Center for Learning and Technology will
reach out to a million students in all 50 States over the next
5 years. The Nanoscale Informal Science Education Network,
along with others in the next 5 years, will develop
approximately a hundred nanoscale science and technology museum
exhibits. And, also, the Network for Nanotechnology in Society
will address both the short- and long-term societal
implications of nanotechnology.
In the first 5 years of the initiative, the National
Science Foundation investment for fundamental research
supporting environmental health and safety aspects of
nanotechnology is approximately $82 million, or about 7 percent
of NSF's nanoscale science and engineering investment. The
support for research in nanomanufacturing and small-business
innovative research has increased in funding and is helping
industrial growth. The growth is clearly demonstrated by three
nanomanufacturing centers which will advance our ability to
integrate reliable, cost-effective manufacturing of nanoscale
materials, devices, and systems.
I'd like to conclude with just a few examples of how this
fundamental academic research is paying off.
The first is a group of researchers at the University of
Kentucky who have demonstrated the potential to build membranes
from billions of aligned nanotubes. The idea here is that
nanotubes have an interior that is approximately friction-free,
allowing the fluids to flow at more than 100,000 times than
what would be expected in normal situations. Filters based upon
these highly-efficient nanotubes may one day contribute to the
purification of products ranging from industrial chemicals to
pharmaceuticals to dairy products.
Another exciting example has been developed by the research
at Northwestern in the University's Nanoscale Science and
Engineering Center. They've developed a rapid and simple test
to both diagnose HIV infection in patients and monitor the
disease progression. This nanotechnology approach is capable of
detecting proteins associated with HIV at concentrations
several orders of magnitude smaller than was possible before
with current technology.
I think you can see that even though we're just beginning
to scratch the surface of this powerful new field, we have
already witnessed remarkable achievements and the promise of
great things to come. The United States currently is the world
leader in nanotechnology, I'd claim, and it is a strategic area
for NSF.
We seek your continued encouragement and support, and thank
you for the opportunity to provide these remarks.
[The prepared statement of Dr. Buckius follows:]
Prepared Statement of Dr. Richard O. Buckius, Acting Assistant Director
for Engineering, National Science Foundation
Advancing the Frontiers of Nanotechnology Through Fundamental
Academic Research
Chairman Stevens, Co-Chairman Inouye, and distinguished members of
the Committee, my name is Richard Buckius, and I am the Acting
Assistant Director of the National Science Foundation for Engineering.
I am pleased to be here today to discuss the NSF's strong commitment to
fundamental academic research in the area of nanoscale science and
technology.
Before I begin, I wish to express my thanks for your ongoing
support for basic research, which is absolutely necessary to ensure our
Nation's leadership in innovation in an increasingly competitive world.
Nanotechnology is truly our next great frontier in science and
engineering, and it represents an entirely new realm of technological
capabilities. By tailoring molecules and even manipulating individual
atoms, scientists and engineers now have the ability to design
materials, medicines, electronics, and machines at the tiniest, most
fundamental level.
This is an amazing capability, and it will have profound and
lasting impact on our industry and economy, our national and homeland
security, and our commitment to sustain the quality of life for all
through advances in areas such as affordable healthcare and reliable
energy.
In its earliest stages, nanotechnology referred simply to passive
materials, such as nanoparticles found in composite materials and
paint. We are now moving beyond passive systems and are beginning to
see active nanostuctures, such as sub-100-nm transistors in commercial
electronics and the LEDs used in traffic lights. As our ability to
create new materials and technologies increases over the next decades,
we can expect to see complete nanosystems with complex three-
dimensional structures and the ability to respond and perform multiple
functions.
Currently, U.S. industry and government agencies are working
individually and collectively to enable these important developments.
NSF, however, has a clearly defined yet vitally important role to play
in this enterprise. Our focus is on fundamental science and engineering
research and education. This research is supported primarily through
grants to individuals and teams at our Nation's academic institutions.
One successful mechanism is through the NSF's support of
interdisciplinary research teams and centers. These group awards
related to nanoscale science and engineering are incredibly effective
in helping advance our understanding of the nanoscale because they
encourage collaborative and synergistic research.
These grants enable faculty-level scientists and engineers from
diverse fields to come together as teams to conduct frontier, nanoscale
research. Their efforts have been particularly fruitful because
nanoscale research and education are inherently interdisciplinary
pursuits, often combining elements of chemistry, biology,
manufacturing, physics, optics and photonics, and nearly every other
field of basic science. By fostering this type of research, NSF is able
to accelerate innovation in this burgeoning field.
Within NSF's total FY 2007 investment for the National
Nanotechnology Initiative of $373 million, $65 million will be
allocated to support such interdisciplinary research teams.
Since the inception of the National Nanotechnology Initiative (NNI)
in FY 2001, NSF investments have led to significant accomplishments.
NSF has created an interdisciplinary nanotechnology research
community through support for large and small research groups
and individual investigators, as well as a variety of programs
for training and education. For example:
-- NSF supports approximately 3,000 active R&D projects.
-- NSF has founded 24 centers, networks, and user facilities
(nearly half of the total created by the entire NNI).
-- NSF has educated or trained about 10,000 students and
teachers in nanotechnology in 2005 alone.
Two user networks established by NSF, the Network on
Computational Nanotechnology (established in 2002) and the
National Nanotechnology Infrastructure Network (established in
2003) have attracted over 12,000 academic, industry, and
government users in 2005:
-- The Network for Computational Nanotechnology has a mission
to connect theory, experiment, and computation to address the
challenges in nanotechnology through new algorithms,
approaches, and software tools with capabilities not yet
available commercially.
-- The National Nanotechnology Infrastructure Network (an
outgrowth of the National Nanotechnology Users Network) broadly
supports nanotechnology activities by providing users across
the Nation access to leading-edge fabrication and
characterization tools and instruments in support of nanoscale
science and engineering research. In addition, this effort
seeks to develop and maintain advanced research infrastructure,
contribute to the education and training of a new workforce
skilled in nanotechnology and the latest laboratory techniques,
conduct outreach to the science and engineering communities,
and explore the social and ethical implications of
nanotechnology.
The NSF has established recently three other NSF networks
with national outreach addressing education and societal
dimensions:
-- The Nanoscale Center for Learning and Teaching aims to reach
one million students in all 50 states in the next 5 years.
-- The Nanoscale Informal Science Education network will
develop, among others, about 100 nanoscale science and
technology museum sites in the next 5 years.
-- The Network on Nanotechnology in Society was established in
September 2005, with four nodes at the Arizona State
University, University of California at Santa Barbara,
University of South Carolina, and Harvard University. The
Network will address both short-term and long-term societal
implications of nanotechnology, as well as public engagement.
NSF has funded a research theme on nanoscale processes in
the environment since FY 2001. In the first 5 years of NNI, the
NSF investment for fundamental research supporting
environmental, health, and safety aspects of nanotechnology is
about $82 million, or 7 percent of the NSF nanoscale science
and engineering investment. Research has addressed the sources
of nanoparticles and nanostructured materials in the
environment (in air, water, soil, biosystems, and work
environment), as well as the nonclinical biological
implications. The safety of manufacturing nanomaterials is
investigated in four NSF centers/networks.
The support for research in nanomanufacturing and Small
Business Innovative Research has seen increases in funding and
is helping industrial growth. More than 200 small businesses
with a total budget of approximately $60 million have received
support from NSF since 2001. This growth is clearly
demonstrated in three NSF nanomanufacturing centers, which will
advance our ability to integrate reliable, cost-effective
manufacturing of nanoscale materials, structures, devices, and
systems.
The NSF investment in nanotechnology is further leveraged and
augmented through partnering among academic, industry, and state and
local government organizations; today there are over 20 nanotechnology-
related regional alliances and associations. An important example of
this is the International Institute for Nanotechnology (IIN) at
Northwestern University in Illinois. With support from NSF, NIH, DOE,
and NASA, this institute has developed partnerships with the State of
Illinois, the City of Chicago, and private foundations to create a new
kind of science-and-technology-driven regional coalition. With $300
million in funding for nanotechnology research, educational programs,
and infrastructure, IIN has established a large pre-competitive
nanoscale science and engineering platform for developing applications,
demonstrating manufacturability, and training skilled researchers.
To conclude my remarks, let me quickly share with you two examples
of how this fundamental academic research is paying off.
First, researchers at the University of Kentucky have predicted
that membranes can be made from billions of aligned carbon nanotubes.
The nanotubes have interiors that are nearly friction free, allowing
some fluids to flow through them 100,000 times faster than we would
normally expect. Filters based on these highly efficient nanotubes may
one day contribute to the purification of products ranging from
industrial chemicals and pharmaceuticals to dairy products.
Next, researchers at Northwestern University's Nanoscale Science
and Engineering Center in Chicago have developed a rapid and simple
test to both diagnose HIV infection in patients, and monitor disease
progression. This nanotechnology approach is capable of detecting a
protein associated with HIV at concentrations several orders of
magnitude smaller than is possible with current technology.
As you can see, even though we are just beginning to scratch the
surface of this powerful new field of science and engineering, we have
already witnessed remarkable achievements that promise great things to
come.
The United States currently is the world leader in nanotechnology,
and that offers tremendous advantages as the field grows and matures
over the next decade. The current vision for the U.S. investment in
nanotechnology has proven remarkably fruitful. We realize that
nanoscale science and technology represent a major opportunity for the
Nation. It is a strategic area for NSF, and we seek your continued
encouragement and support.
National Science Foundation Nanotechnology Centers and Networks
------------------------------------------------------------------------
------------------------------------------------------------------------
Nanoscale Science and Engineering Centers (NSECs)
------------------------------------------------------------------------
Columbia University Center for Electron Transport in
Molecular Nanostructures
Cornell University Center for Nanoscale Systems
Rensselaer Polytechnic Institute Center for Directed Assembly of
Nanostructures
Harvard University Science for Nanoscale Systems and
their Device Applications
Northwestern University Institute for Nanotechnology
Rice University Center for Biological and
Environmental Nanotechnology
University of California, Los Center for Scalable and Integrated
Angeles Nanomanufacturing
University of Illinois at Urbana- Center for Nanoscale Chemical,
Champaign Electrical, Mechanical, and
Manufacturing Systems
University of California at Berkeley Center for Integrated
Nanomechanical Systems
Northeastern University Center for High-Rate
Nanomanufacturing
Ohio State University Center for Affordable
Nanoengineering
University of Pennsylvania Center for Molecular Function at
the Nanoscale
Stanford University Center for Probing the Nanoscale
University of Wisconsin Center for Templated Synthesis and
Assembly at the Nanoscale
Arizona State University Nanotechnology in Society Network
University of California, Santa
Barbara
University of Southern California
Harvard University
------------------------------------------------------------------------
Centers From the Nanoscale Science and Engineering Education
Solicitation
------------------------------------------------------------------------
Northwestern University Nanotechnology Center for Learning
and Teaching
Boston Museum of Science Nanoscale Informal Science
Education
------------------------------------------------------------------------
NSF Networks and Centers That Complement the NSECs
------------------------------------------------------------------------
Cornell University National Nanotechnology
Infrastructure Network
Purdue University Network for Computational
Nanotechnology
Cornell University STC: The Nanobiotechnology Center
------------------------------------------------------------------------
The Chairman. Thank you very much.
Our next witness is Dr. Jeffrey Schloss, Co-Chair of the
Nanomedicine Roadmap Initiative at NIH.
STATEMENT OF JEFFERY SCHLOSS, Ph.D., PROGRAM
DIRECTOR, DIVISION OF EXTRAMURAL RESEARCH,
NATIONAL HUMAN GENOME RESEARCH INSTITUTE; CO-CHAIR, NATIONAL
INSTITUTES OF HEALTH NANOMEDICINE ROADMAP INITIATIVE, NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Schloss. Thank you, Senator Stevens and distinguished
members, for the opportunity to come and describe to you----
The Chairman. Would you pull that microphone over and be
sure to press the button?
Dr. Schloss. Thank you. It's on, thank you--for the
opportunity to speak with you about a few examples of some of
the medical applications of nanotechnology, also to describe
the Nanomedicine Roadmap Initiative, and then, finally, to
close with a description of some of our recent activities and
the ways in which NIH funds nanoscience and nanotechnology
research.
This is an example of a very recently published study on
the hearts of rats in which an attempt was made to mimic a
heart defect--a loss of blood circulation to a region of the
heart. That's shown here in this region. The study shows that
by delivering a protein factor that has been attached to a
nanofiber that's made of protein--quite an innocuous substance,
the same kinds of proteins that are found in our body--one can
reduce the death of the cells in the heart, reduce the size of
the injury, and increase the ability of the heart muscle cells
to contract.
In the first figure, they're showing that, for quite a long
time, even out to 2 weeks, in the presence of this factor that
has been attached to these nanofibers, there is a biological
effect of the material. The figure at the bottom shows the
increased contractility. The difference between the first and
second bars is the loss of ability of the heart muscle cells to
contract as a result of the experimental myocardial infarction.
And then, here at the end is shown the effect of treating with
this factor in the presence of the nanofibers, retaining the
majority of the normal contractility. The last figure shows--I
won't go through the details--a decrease in the cell death that
results from the injury.
This is very recently published, and shows hugely
intriguing possibilities. Of course, it's research. We don't
know yet all of the answers about this. I want to stress that
the material that's being used to make the nanofiber is benign.
It's protein. And it's a study that's being led by a physician
who is board certified in cardiovascular disease and internal
medicine. That means that issues of biocompatibility are very
bright on the radar screen.
Another study, out of the University of Michigan, shows
that nanoparticle targeting of anticancer drugs improves the
therapeutic response, in an animal-model system of human
epithelial cancer. This uses a very small particle, less than 5
nanometers, that has been designed with several functions, one
of which is the anticancer drug, another is a molecule that
directs this particle to bind very specifically to cancer
cells, and the third is to help monitor the experiments--it has
a fluorescent label, so a pathologist can see where the
particle is going. This study showed improved therapeutic
response over what would be obtained by using the drug by
itself.
The point here is that you can target these particles to
the location of the cancer. This means you dramatically reduce
the body-burden of the drug, which would otherwise be used at
higher concentration and therefore be very toxic.
The Nanomedicine Roadmap Initiative is part of a much
larger effort, the NIH Roadmap for Medical Research, that is
trying to bridge across the NIH organizationally, given that we
have 27 Institutes and Centers, each with its own mission and
budget. It is bridging organizationally, and from basic
research to applications, and across scientific disciplines.
The Nanomedicine Roadmap Initiative itself is trying to create
both a conceptual and a literal interface between biology and
medicine. It does this by starting out with study of the
physical and chemical properties of molecules in the cell--
which are nanomachines. We will build an understanding, from an
engineering perspective, of what's going on in the cell, and
then use the knowledge about how the cells works, and also the
knowledge that we gained in building the tools to make the
measurements, to actually build medical treatment devices.
I'm going to very quickly give you an example of one of the
centers that was recently awarded, that takes the view of
biology as having parts out of which one builds devices that
assemble into functional systems. This study uses an actin-
based motility system, about which we already know quite a lot,
to build programmable systems that incorporate guidance
circuits and force-generation into systems that can be used for
search and delivery, searching for problems in the body and
delivering therapeutics.
The three examples I've given you all reflect different
levels of control of the nanotechnology systems--passive,
multifunctional, and active.
And finally, I'll close just by summarizing several of the
ways in which NIH supports this kind of research through
programs that are focused on engineering approaches to solving
biological problems, some of which are specifically for
nanotechnology. We take very seriously the ideas of
investigators, who propose their best ideas to the NIH, to
apply them to a variety of important medical problems. And
finally, several of the institutes have now launched their own
programs explicitly in nanotechnology. These include--I need to
very quickly summarize a characterization laboratory within the
NCI Alliance for Nanotechnology Cancer program, and several
programs within the National Institute of Environmental Health
Sciences, to address the safety- and health-related issues.
Thank you very much for the opportunity present this
material, and I look forward to your questions.
[The prepared statement of Dr. Schloss follows:]
Prepared Statement of Jeffery Schloss, Ph.D., Program Director,
Division of Extramural Research, National Human Genome Research
Institute; Co-Chair, National Institutes of Health Nanomedicine Roadmap
Initiative, National Institutes of Health, Department of Health and
Human Services
I am Jeffery Schloss, a Program Director in the Division of
Extramural Research at the National Human Genome Research Institute, a
component of the National Institutes of Health (NIH) of the Department
of Health and Human Services, with responsibility for DNA sequencing
technology development. I have served as an NIH representative to the
National Nanotechnology Initiative (NNI) even before it became a formal
Federal initiative. And I am Co-Chair of the NIH Nanomedicine Roadmap
Initiative, which I shall discuss below. I appreciate the opportunity
to provide an overview of the Nanomedicine Initiative and nanoscience
and nanotechnology research at the NIH.
Each of the twenty-seven Institutes and Centers (ICs) at NIH funds
nanotechnology research to improve the quality of life for countless
Americans.
Scientific Opportunities
Nanotechnology has the potential to radically change the study of
basic biological mechanisms, as well as to significantly improve the
prevention, detection, diagnosis, and treatment of diseases. One key to
this potential is that nanotechnology operates at the same scale as
biological processes, offering an entirely unique vantage point from
which to view and manipulate fundamental biological pathways and
processes. Most other technologies require the study of large numbers
of molecules purified away from the cells and tissues in which they
usually function; nanotechnology offers ways to study how individual
molecules work inside of cells.
The most immediate near-term benefits envisioned for the use of
nanotechnology in medicine arise because of novel properties of
materials, and the ability to prepare and control materials properties
with greater precision and complexity than can be achieved by other
methods.
For example, early-stage proof-of-principle studies have been
accomplished for most of the elements of a system, made of chemical
subunits known as dendrimers, in which nanoparticles can be targeted to
cancer cells wherever they may be in the body, bind exclusively to the
cancer cells in that region, and deliver both an imaging agent to allow
the physician to observe the cancer location, and a therapeutic agent
to reduce or destroy the cancer. Further, the particle can be triggered
to disintegrate upon release of the therapeutic agent, into harmless
chemical subunits that no longer have the characteristics of the
nanoparticle and are readily cleared from the body. These device
concepts can also be applied to other conditions, such as acute
vascular injury and inflammation, and can also be achieved by building
nanoparticles using materials other than dendrimers. Such particles can
also be programmed to sense molecular and physiological signals, and
activate the imaging agent, or release the therapeutic agent, only
under specified molecular circumstances. These strategies should
dramatically reduce side-effects of drugs by delivering them only when
and where in the body they are needed. The name ``smart'' nanoparticle
is therefore apt.
Metallic nanoparticles have been used in several ways for
experiments on imaging and therapy. Quantum dots (i.e., nanoscale
crystalline fluorescent semiconductors) that absorb and emit colors of
light that can penetrate body tissues have been used in animal
experiments to demonstrate the potential to allow doctors to see, from
outside the body, the exact location of certain tumors that occur near
the body surface. Even though toxicity was not detected in these
studies, the possibility that some of the particles used could be toxic
has led to research on the permanence of the coatings and research on
particles with the same optical properties but that are composed of
non-toxic materials. A second type of metallic nanoparticle can be
delivered specifically to tumor locations and heated by the application
of colors of light that penetrate the skin, resulting in local heating
to destroy tumor cells but not the surrounding healthy cells. Yet other
metal particles are already in use to enhance magnetic resonance
imaging, providing sharper images than previously possible with other
MRI imaging agents.
For tissue repair, several different materials are being tested for
their ability to form nanofibers that mimic natural structures that
surround cells (extracellular matrix) in the body. Such materials could
be injected at sites of injury caused by trauma or syndrome-associated
degeneration, to provide both a physical substrate and the molecular
signals needed to stimulate and support tissue healing. For example,
versions of these materials are being tested to support the growth of
bone, muscle, and nervous tissue.
While the examples above describe use of nanomaterials inside the
body, nanotechnology is also being used to produce sensors for use in
the research or clinical laboratory, or possibly implanted in the body.
These sensors have exquisite sensitivity and selectivity. Based on
nanomaterials such as carbon nanotubes or silicon nanowires, whose
electrical properties change depending on the materials bound to their
surface, sensors have been developed that can detect very small amounts
of material, such as biosignatures for infection or disease, in complex
mixtures such as blood or saliva. These electrically-activated sensors
could be deployed in simple, cost-effective devices that could record
several different measurements at once from a very small patient
sample.
The scientific research is thus proceeding at a good pace. But
there is a difference between a successful experiment and a robust
device or medical treatment that functions in real-life situations, can
pass all regulatory requirements, and be cost-effectively manufactured,
commercialized and adopted. The next few years will be very important
in establishing the reality of the early vision.
NIH Support for Nanotechnology Research
The opportunities transcend the mission of any single NIH IC.
Therefore, trans-NIH grant solicitations were developed by the NIH
Bioengineering Consortium (BECON; www.becon.nih.gov), in which all of
the ICs participate, and have resulted in funding of dozens of research
grants to colleges, universities, research institutions, and small
businesses. Since 1999, BECON initiatives have been reaching out to
teams of physical scientists, biologists, and clinicians to apply
state-of-the-art nanotechnologies that are emerging from research in
non-biological disciplines, to solving important problems in biology
and medicine, ranging from understanding the mechanisms of disease, to
developing novel diagnostic and therapeutic methods. To stimulate those
collaborations and explore opportunities, BECON hosted a nanotechnology
symposium in 2000 that was attended by over 600 scientists and
engineers, and NIH co-hosted with the National Science Foundation (NSF)
and other agencies participating in the National Nanotechnology
Initiative, a workshop on Nanobiotechnology in 2003.
In addition to support through BECON initiatives, much of the
support for nanoscience and nanotechnology research is provided by the
NIH ICs in response to various other initiatives that are focused on
solving specific biomedical problems, and to investigator-initiated
grant applications. In many such cases, the programmatic rationale is
to develop understanding of biomedical phenomena or the causes of
disease or to develop specific diagnostics or therapeutics, and the
particular scientific approach chosen by the investigators to achieve
the goals incorporates nanotechnology.
Recently, several institutes have developed explicit nanotechnology
programs that are central to achieving their missions.
NHLBI Programs of Excellence in Nanotechnology
The National Heart, Lung, and Blood Institute has initiated
Programs of Excellence in Nanotechnology (PENs). Its goal is to create
multidisciplinary teams capable of developing and applying
nanotechnology and nanoscience solutions to the diagnosis and treatment
of cardiovascular, pulmonary, hematopoietic, and sleep disorders. To
accomplish this goal the centers will conduct research on causes and
treatments for these diseases, train investigators to apply
nanotechnology to this set of problems, and actively disseminate their
results. Four center awards were made beginning in FY 2005,
representing a five-year funding commitment of $53 million.
NCI Alliance for Nanotechnology in Cancer
The largest single nanotechnology program at NIH is the National
Cancer Institute's (NCI) Alliance for Nanotechnology in Cancer. These
activities are integrated with existing NCI programs and resources. The
Alliance currently supports eight Centers of Cancer Nanotechnology
Excellence (CCNEs) to serve as hubs to develop and apply nanotechnology
devices and systems to the diagnosis, prevention, and treatment of
cancer. Examples of the goals of the centers include: the development
of smart, multifunctional, all-in-one platform capable of targeting
tumors and delivering therapeutics; and development and validation of
tools for early detection and stratification of cancer through rapid
and quantitative measurement of panels of serum- and tissue-based
biomarkers.
The Alliance also awarded twelve cancer nanotechnology platform
development partnerships. Further, it is supporting the education,
training, and career development of graduate, post-doctoral, and mid-
career investigators for multi-disciplinary nano-oncology research
through fellowship grants and, with NSF, institutionally-based awards.
NCI also is engaged in outreach and communication via its publications
and website (nano.cancer.gov) about nanotechnology research and
development as it relates to cancer and other biomedical applications,
including the full spectrum of societal issues attending the
development of nanobiotechnology.
Finally, NCI is actively supporting environmental, health, and
safety research relevant to the cancer mission, particularly through
the Nanotechnology Characterization Laboratory (NCL). The NCL will
provide critical infrastructure for studies supporting decisionmaking
about the implications of nanotechnology-based products. It will
develop a characterization cascade to characterize nanoparticles'
physical attributes, their in vitro biological properties, and their in
vivo compatibility using animal models, from the perspective of
intentional exposure (i.e., medical application or delivery). This will
enable nanotechnology-based strategies to rapidly and safely transition
to clinical applications. The work also will provide a framework for
regulatory decisions by the Food and Drug Administration (FDA)
concerning the testing and approval of nanoscale cancer diagnostics,
imaging agents, and therapeutics. To achieve these goals, the NCL is
conducted in collaboration with FDA and the National Institute of
Standards and Technology at the Department of Commerce. Overall, the
NCI Alliance for Nanotechnology in Cancer represents a five-year
funding commitment of $144 million beginning in FY 2005.
NIEHS National Toxicology Program and Collaboration
The National Toxicology Program (NTP) is a partnership of the
National Institute of Environmental Health Sciences (NIEHS) with the
National Institute for Occupational Safety and Health (NIOSH) at the
Centers for Disease Control and Prevention, and the National Center for
Toxicological Research (NCTR) of FDA. NTP's research program to address
potential human health hazards from unintentional exposure associated
with the manufacture and use of nanoscale materials includes
investigation of toxicology of nanoscale materials of current or
projected commercial importance. The overall goal is to understand
critical physical and chemical properties that affect biocompatibility,
so in the future nanomaterials can be designed to minimize adverse
health and safety issues. Most of the funding for this NTP activity is
contributed by NIEHS. The NCTR contributes the use of state-of-the-art
capabilities of its NTP Phototoxicology Center. Studies are currently
underway examining the absorption, biological fate, and potential
toxicity of quantum dots; metal oxides used in sunscreens; and selected
carbon-based materials (fullerenes, carbon nanotubes) following
application to the skin, or exposure by inhalation or oral ingestion.
The NTP and the NCI NCL programs are coordinated to ensure the most
efficient development of nanoscale cancer therapeutics that are both
safe and effective.
Additionally, NIEHS is participating with the Environmental
Protection Agency, NIOSH and NSF in funding a joint solicitation to
investigate environmental and human health effects of manufactured
nanomaterials. NIEHS will fund research on the routes of human
exposure, toxicology, biotransformation, and bioavailability of
nanomaterials. These partner agencies are currently designing the next
phase of this solicitation and are in dialogue with the Science
Directorate of the European Commission to explore the possibility of a
joint U.S.-E.C. research solicitation.
NIH Nanomedicine Roadmap Initiative
The cross-cutting nature of this technology is exemplified by its
inclusion in the NIH Roadmap for Biomedical Research, a program that
began in 2002, to identify major opportunities and gaps in biomedical
research that no single IC at NIH could tackle alone, but that the
agency as a whole must address to have the greatest impact on the
progress of medical research. The Nanomedicine Roadmap Initiative
(nihroadmap.nih.gov/nanomedicine/) is a component of the ``New Pathways
to Discovery Theme'' of the Roadmap (the other themes are ``Research
Teams of the Future'' and ``Re-Engineering the Clinical Research
Enterprise''). All of the NIH ICs collectively support and are
responsible for the implementation of all of the Roadmap initiatives.
The Nanomedicine Initiative is envisioned as a ten-year program
whose eventual goal is to manipulate precisely cellular processes by
repairing or building new structures in cells, to prevent and treat
disease and repair damaged tissue. In the near-term, interdisciplinary
research teams are assembling to devise new methods to study problems
in cell biology and biophysics. Those efforts will enable measurement
of a host of parameters we cannot measure inside of cells today. This
new information will lead to better prediction of the behavior of
subcellular assemblies of molecules, and of cells themselves. In
combining the knowledge gained from new insights into how biomolecules
work and from building the tools that made those measurements possible,
research teams can then design new strategies to build molecular-scale
tools for disease or injury intervention. Unlike conventional medicine,
the approaches taken here should enable interventions to be made with
greater precision, much earlier in the course of disease or tissue
degeneration, and at a more fundamental level for repair of tissue
damage caused by trauma.
In a sense, the goal of the Nanomedicine Roadmap Initiative is to
use quantitative approaches to understand, from an engineering
perspective, the design of biomolecular structural and functional
pathways, and to use that information to design and build functional
biocompatible molecular tools to ``dial'' the body's systems back into
``normal'' operating ranges after function has been perturbed by
disease. One might think of this in context of the way in which we can
design and build a functioning electromechanical system, such as the
heating and cooling system in your house. We know how to draw it out on
paper--which electrical parts and controls, and motors, and valves and
structures are needed--and when we build according to those plans, it
actually works. We want to be able to understand biology at the
molecular and system level, in the way in which we understand the parts
and logic of an engineered system. If we can do that, we should be able
to precisely repair or replace parts and keep the system operating
normally, at the fundamental level at which the system operates,
namely, its molecular systems.
The teams that will carry out this initiative consist of people
with deep knowledge of biology and physiology, physics, chemistry, math
and computation, engineering, and clinical medicine. Even though the
first few years require basic biology research, the choice and design
of experimental approaches are directed by the need to solve clinical
problems. These are extremely challenging problems, and great
breakthroughs are needed if we are to be successful in achieving our
goals within the projected timeframe. Therefore, NIH is willing to take
risks and is working closely with the funded investigators to use the
funds and the intellectual resources of the entire network of
investigators to meet those challenges.
Nanotechnology is key to the Nanomedicine Roadmap Initiative in
several aspects. First and most obvious, nanotechnologies critically
enable us to measure things that we have been unable to measure in the
past, to ``fill in the blanks'' in the equations we need to understand
and to predict how biomolecules work. Those biomolecules are
nanostructures, and if we are to be able to touch and measure them with
precision, without destroying them and their ability to operate, we
will need to employ biocompatible nanotechnologies. Second, successful
creation of measurement tools informs the development of manipulation
tools for biomolecular repair of cells or subcellular assemblies. And
third, in the process of fulfilling goals that are central to the
mission of the NIH, we gain knowledge of the design of biological
systems that nature has produced over millions of years. That knowledge
of system design can be used by scientists and technologists who are
working outside of the biomedical realm, to develop novel strategies to
solve their own engineering problems, whether in computers,
transportation, energy, or national security. In this way, the
Nanomedicine Roadmap Initiative will give back in full measure to the
physical scientists and engineers who developed the earliest ideas from
which the National Nanotechnology Initiative was formulated.
To fulfill these goals, the Nanomedicine Initiative is establishing
a network of highly-interactive centers around the Nation. The first
four centers were established in FY 2005 with a $6 million investment.
The initial centers are:
Center for Protein Folding Machinery, Wah Chiu, Baylor
College of Medicine.
National Center for the Design of Biomimetic Nanoconductors,
Eric Jakobsson, University of Illinois, Urbana-Champaign.
Engineering Cellular Control: Synthetic Signaling and
Motility Systems, Wendell Lim, University of California, San
Francisco.
Nanomedicine Center for Mechanical Biology, Michael Sheetz,
Columbia University, New York.
While this list shows only the names of the team leaders and their
home institutions, the teams include distinguished and experienced
investigators, and bright new investigators, at institutions across the
Nation and internationally. To exemplify the program, the themes of two
centers are briefly described.
The first project is the Center for Protein Folding Machinery.
Proteins are synthesized in cells as linear structures. These proteins
must fold in very precise ways to achieve the correct shape required
for their function. While a few proteins can fold by themselves, most
require the action of other proteins in cells, called molecular
chaperonins. The Center will study the mechanisms by which chaperonins
select and fold specific proteins, and will use that information to
develop chaperonins that can trap misfolded proteins or prevent folding
(and therefore activity) of proteins that should not be present in a
particular type of cell. This is important because protein misfolding
is implicated in several neurodegenerative diseases, such as
Huntington's disease and Alzheimer's disease. Some other diseases
involve the accumulation of proteins that are normally not present or
are present only at very low levels (e.g., cancer), so the Center will
develop specific adapters to control the interaction of the proteins
with the folding machinery. Additional goals include designing novel
chaperonins that can be used to deliver drugs in the body, or to be
used during the processing of protein-based pharmaceuticals, to ensure
correct folding and activity.
Another project, the Engineering Cellular Control center, will
endeavor to develop ``smart'' cells or cell-like devices that have some
of the properties of normal immune cells. They would be relatively
simple systems (compared to real cells) that are programmed to detect a
lesion (e.g., injury) or threat (e.g., infection or cancer cell), then
move to that site in the body and respond precisely with a controlled
action such as releasing a therapeutic agent or mediating recruitment
of the body's own immune system.
The focus of each center is distinct and complementary to the
others, and their discoveries will apply to many tissues and diseases.
NIH Participation in the National Nanotechnology Initiative
NIH activities in the development of nanotechnology for biology and
medicine are coordinated with those of other Federal agencies through
its active participation in the NNI. A highlight of that activity is
the active participation of NIH staff in the planning and development
activities conducted through working groups on issues such as
environmental and health implications, public engagement, and global
issues.
For example, NIH is participating actively in the Public Engagement
working group. This group is developing the first stages of an ongoing
commitment to engage the public in discourse about societal issues
related to emerging nanotechnologies. A broad range of stakeholders,
including people from universities, industry, and civic- and community-
based organizations, will be involved in this process.
Conclusion
The NIH is fully engaged in a wide variety of nanoscience and
nanotechnology research and development activities to achieve short-
and long-term advances to reduce the burden of disease and disability.
Peer-reviewed research support has been growing substantially since the
initiation of the NNI, as has participation of NIH staff in the full
range of NNI activities. The NIH is fully committed to continuing these
activities in ways that capture maximum benefit for improving the
health of the American people and individuals around the world.
The Chairman. Thank you very much, all of you, for coming.
Let me say, we are each going to have a round of 5 minutes,
and then we'll call the next panel. But can you tell us, Dr.
Teague, who started the National Nanotechnology Initiative and
what challenges do you have that pose obstacles that you
confront to your continued advancement in your area?
Dr. Teague. Well, the National Nanotechnology Initiative
has its roots in some terrific efforts started by a group out
of several of the agencies, one of whom is here today, Dr.
Michael--Mihail Roco--Mike Roco, as we refer to him. We just
recently awarded him a plaque to recognize his leadership as
the Chair of the Nanoscale Science, Engineering, and Technology
Subcommittee. He is one of the--we say, one of the fathers of
the NNI, and served as one of the major driving forces of the
NNI. There were a number of others.
They had--they pulled together, first, an Interagency
Working Group on Nanotechnology. My understanding is that they
worked for several years before the NNI was proposed as an
Initiative under the previous Administration. Following the
movement then--it was formed in late 2000--the Initiative
actually were kicked-off in late 2000. Moving on from there, in
late 2003 we had the 21st Century Nanotechnology R&D Act, for
which many of you, including Senator Allen here, was a big part
of moving that forward. I--we could go quite a long time. The
NNI has a long and very distinguished history as to how it came
about. It really was a ground-up effort on the part of several
representatives from the major agencies--Department of Defense,
NIH, and others. Dr. Jeff Schloss was also a part of that
initial Working Group on Nanotechnology. So there was a good
groundswell to form this and to seize the opportunity that
nanotechnology offered for our country, and, indeed, for the
world.
In terms of the second part of your question, the
challenges that we face ahead of us, I think that one of the
real challenges--there are several that I would want to
discuss--one is international competition. The United States is
not the only country in the world that has realized the
tremendous potential of nanotechnology for economic growth, for
national security, for improvement of our overall health. So, I
think we need to be very much aware, very keenly aware, of the
competition as it's building in the world.
The EU, if you take all the countries in the EU, their
investment already likely equals, or maybe even is beginning to
exceed, the U.S. investment in nanotechnology, as far as public
investment.
The Chairman. Were any of you involved in Norm Augustine's
report we received on the problems of the growing disparity in
education? The report is called ``Rising Above the Gathering
Storm.'' Were any of you involved in that? NSF was, weren't
they?
Dr. Buckius. I mean, I personally wasn't, but, yes, NSF was
involved, from the point of view----
The Chairman. Well, I just wonder, has the role of
technology been examined, as far as this education gap is
concerned in our country? I notice every one of you has a
doctorate.
Dr. Teague. Yes. Well, certainly, the----
[Laughter.]
The Chairman. No, I'm serious now. We're asked to try and
enlarge--we've got an Initiative here called PACE--we're asked
to enlarge the monies that are available to teach another
generation of scientists, engineers, and medical people. Is
this something that bothers you, as far as this area is
concerned, nanotechnology, the lack of enough funds to educate
the coming generations to keep up with the world?
Dr. Buckius. I have a two-pronged answer. From the point of
view of engineering, which is where the ``Gathering Storm''
makes a very large point, engineering education is an important
issue, and is--and we agree with the ``Gathering Storm's''
recommendations. We, in engineering at NSF, are investing, I
consider, a lot of money into educational activities in the
engineering field, particular--not in general from the point of
view of all of education. So, our investment in engineering
education is significant, because it is a problem. We have--we
drop off too fast from the freshman class to the graduating
class. So, from the--now you come to nanotechnology. If you
read the testimony, there are a couple of points in there.
We've started to fund nanoscience learning centers and teaching
centers, for exactly the same point, to make sure that we have
a population that understands nanotechnology. So, yes, we are
investing.
Dr. Teague. Yes. I'd like to just add one----
The Chairman. Well, I'm going to live within my limits,
Doctors. I've got to tell you, we have meetings after this
hearing, so I want to make sure everyone has time. But I do
hope that you will keep in touch with us. And I think maybe we
ought to have what I call a listening session sometime, sit
around with you guys and kick the ball back and forth and
understand further what is occurring in this important field.
Senator Ensign?
Senator Ensign. Thank you, Mr. Chairman.
There are several proposals out there. Chairman Stevens
just mentioned the PACE proposal. Senator Lieberman and I
introduced the National Innovation Act. The exciting
development is that people are talking about innovation and
competitiveness issues now. And people are looking at
nanotechnology and other sciences as a competitiveness issue
for the United States. The United States is in competition with
other parts of the world. The National Institutes of Health
received a doubling of funding over the last several years. Now
we are considering doing the same thing for the National
Science Foundation. We must ensure that support for the
physical sciences keeps up with the funding that we have
provided to support research in the life sciences. Supporting
basic research is a fundamental role for the Federal
Government, and nanotechnology is a great example of why basic
research is important for the Federal Government to fund,
because nobody else has the resources required to conduct this
research.
Dr. Teague, because nanotechnology covers such a wide
spectrum of scientific disciplines, could you address how the
Coordinating Office effectively uses one single plan to
administer this multi-agency Initiative?
Dr. Teague. Well, in terms of how we work, my office serves
as a support for the Nanoscale Science, Engineering, and
Technology Subcommittee. We also work very closely with the
Office of Science and Technology Policy, liaison with them. Our
support and, I think, the primary coordinating, management, and
reporting aspects of the overall initiative, is done through
this subcommittee, in the NSET Subcommittee. This subcommittee
has been meeting monthly for the last 5 years.
And, as I mentioned in my testimony, through a lot of
communication and coordination and full joint programs among
the agencies, a lot of that coordination that you're talking
about does actually--takes place very effectively. If you
noticed, I bolded the words ``working together'' in the slide
that I presented. And as I've said several times, that as I
look at my job--I've been in it now for about 3 years--one of
the things that I was most impressed with finding out while
working with the--these 24 agencies was--I guess it shouldn't
be too surprising--that the people that worked in those
agencies are truly dedicated to the missions of their agencies.
The people in Defense, they're really dedicated to defense, and
so on.
But the other part of it is that they are beginning to work
together in this particular area of nanotechnology. Because all
of them realize that, while it is important that they
accomplish their missions, I think, more and more, they're
realizing that it is essential that they coordinate their
efforts among the agencies to be as effective as they can in
moving forward with their programs.
Probably the most concrete way in which this joint activity
is manifest is in literal joint solicitations, where about four
or five agencies would come together and agree upon one
specific area that they would like to issue a solicitation in.
The most recent one was led by the Environmental Protection
Agency, but it also had cooperation from the National Science
Foundation, from the National Institute for Occupational Safety
and Health, and the National Institute of Environmental Health
Sciences, to try to study the environmental, health, and safety
aspects of engineered nanoparticles for the environment. One
solicitation went out, proposals came in, and then each of the
agencies chose the ones that were most appropriate for their
individual agencies.
That's just a few examples of how they work together. It's
workshops conducted jointly, as I say, many different meetings.
We have working groups that are underneath that subcommittee
that address various aspects of the work that we do. And----
Senator Ensign. Dr. Teague, thank you for your answer. I
only have about a minute left, so----
Dr. Teague. OK.
Senator Ensign.--let me just ask Dr. Buckius a quick
question on how NSF is going to maximize. You know, you have
limited funds. Obviously, every agency would love more funds.
And, you know, additional funding makes things a little easier,
but with limited funds how do you maximize the potential
research that is being done? How do you pick those projects
that are the most worthy and where you think you are going to
get the most bang for the buck?
Dr. Buckius. Well, let me start off by saying that NSF
invests in the intelligence of the research community, period.
That's just the way it works. We obtain proposals that have
absolutely great ideas and, as you've noted, just aren't able
to fund them. We use the merit review process, so peers review
proposals, they assess the quality, they assess and make
recommendations on which ones are the great ideas, and then we
try to fund as many of those as we can. And in the case of the
nano area, because we have generated a very strong community
now, I'd argue that the proposals are just absolutely superb,
and we're doing our best to make sure that we get the money in
the hands of the best ideas.
Senator Ensign. Just one last comment, Mr. Chairman. Many
people, especially from NIH, are familiar with Michael Milken,
the Prostate Cancer Foundation, some of the work that the
Foundation has done, and the way that the Foundation has
awarded its grants with both younger researchers and innovation
in mind. And I have spoken to Mr. Milken about some of the ways
that we can reform how we do things up here. Sometimes the
groups that get funding, do so because they are very good at
writing grant proposals. I think that, especially in a field
like nanotechnology, that entails such exciting research, we
have to make sure that we are encouraging innovative young
researchers to go into these fields instead of other fields.
Thank you, Mr. Chairman.
The Chairman. Thank you.
Our next--Senator Allen?
STATEMENT OF HON. GEORGE ALLEN,
U.S. SENATOR FROM VIRGINIA
Senator Allen. Thank you, Mr. Chairman, for holding this
hearing. And we have some outstanding witnesses on both panels.
Senator Wyden and I, back in 2002, actually had the first
hearing on this, and on the issue of nanotechnology, the
competitiveness, where we were. It is the next transformative
economic revolution. It is going to affect, and it is
affecting, as Senator Ensign mentioned, in a variety of ways,
so many different sectors, from microelectronics to materials
engineering to the life sciences, health sciences. We had a
hearing, by the way, this morning in the Energy Committee, and
I was discussing with one gentleman, one of our witnesses, how
solar photovoltaics now, or solar power, with nanotechnology
you have can have shingles that actually look nice rather than
they, you know, look like you have a sliding glass door on your
roof----
[Laughter.]
Senator Allen.--for solar power. And there are a variety of
ways that this is improving our lives. I love the medical and
life sciences aspects of it. In fact, what we passed through
this committee, Senator Wyden and I, in the bipartisan effort,
was really in this nanotech initiative. We called it the 21st
Century Nanotechnology Research and Development Act. But the
practical matter is, it's the biggest investment in basic
science since the space program back in the 1960s. Dr. Rocco
here is really the founder of a lot of it, if you want to know
who is a key leader; and Dr. Teague and Buckius and Dr.
Schloss, are all important, as well.
In our briefing--let me point this out--the briefing from
the Committee, it has different types of research. And I'm one
who's very competitive. And one of the--the key impetus and why
the President was so strongly behind this and the funding of
it, and actually focusing more in the Department of Energy, out
of all the different Federal agencies, is to get collaboration
with the private sector, with the--with college and
universities, regional initiatives, which we'll hear about in
the second panel. But I was over in China, and Senator Ensign
and I, and Senator Lieberman and others, care about how we're
falling behind in--with engineers and so forth. But I was at a
facility in China, near Beijing, and they're--they were like--
for carbon nanotubes, which are the basis of materials
engineering--they wanted to get the best scientists in the
world there. They're like George Steinbrenner, they were just
going to get the best, and whatever it cost to get them.
Now, the Chinese investment in nanotechnology is clearly
rapidly increasing. They are focused, it seems to me, on the
materials engineering aspect of it. Do you find, Dr. Teague,
that the funding that we have provided, and the President has
initiated, now and in the future, to be adequate for us to
continue--the education, the innovation, and development to
continue?
Dr. Teague. Probably if you ask anyone who's in the field,
they would like to see the funding keep increasing, certainly
at something like the rate that it has increased over the past
years. Certainly, the funding that we currently have in the
President's request for 2007 is, like, $1.2 billion. This
request will meet many of the research needs and many of the
research areas that we're expecting ahead of us.
One thing that I would point out, to go back to Chairman
Stevens' question earlier on, is that--and yours, as well, just
now--is that probably there's no field that has been
established, in terms of science and technology, that offers as
great an opportunity to attract young people into science and
technology as nanotechnology does. It has many wonderful things
that attract people, particularly young people, into it, the
promise of being so beneficial to health, to the environment,
and to the world, that it, I think, is a very attractive field
for many people.
Senator Allen. Count on us--we even created a Nano Caucus
to try to educate more Senators on nanotechnology. Let me ask
Dr. Buckius--huh?
Senator Smith. It's a pretty small caucus.
[Laughter.]
Senator Allen. Yes, it's--there are not many members, but
it's not \1/100\th of the width of the human hair; it's bigger
than that.
[Laughter.]
Senator Allen. At any--Dr. Buckius--I only have a minute
left--the United States, as I understand it, holds about 60
percent of the worldwide nanotechnology patents. Our patents,
though--and this is the information I've received--have
actually decreased in 2005. Do you have an explanation as to
why there are fewer nanotechnology patents, or nanotech
application patents?
Dr. Buckius. I have a conjecture, only.
Senator Allen. Conjecture, please.
Dr. Buckius. If you take a look at that curve, it was a
rapidly increasing curve. OK? And when it got to 2004, there,
it just flattened off, from the point of view of patents. And,
as you know, the patenting process is an investment of many
years. And so, I'm not sure that that individual-year drop-off
is an indication of a long-term trend; it might simply be the
way the patents were coming into the system and how long it
takes. We'll have to probably wait and see what happens in 2006
and 2007 to see how that curve changes. It's still very
productive, though. I mean, if you take a look at the quantity
of patents that are generated by NSF funding in this area, it
really is--it--the documentation shows that we're way out
there, from the point of view of comparisons with other
agencies and other activities that do patents. So, I think
we're in good shape. I think we have to wait and see what 2006
and 2007 is going to bring.
Senator Allen. Thank you very much. Thank you, all three.
The Chairman. Thank you.
Senator Pryor?
STATEMENT OF HON. MARK PRYOR,
U.S. SENATOR FROM ARKANSAS
Senator Pryor. Thank you, Mr. Chairman.
And I'm a big supporter of nanotechnology. In fact, one of
the things we've done in our State, which is a relatively small
state, is, we have done a nanotechnology alliance with our
universities and some businesses there. And they try to reach
out regionally and nationally and try to pool resources and do
things like that.
Let me ask this question. I am a very big supporter of
nanotechnology. I think it has a very bright future. But I do
think that we need to be careful when it comes to the possible
environmental hazards with nanotechnology, health hazards,
human safety hazards, et cetera. So, I would like to get all
your thoughts, just whoever wants to take it, on whether we're
spending enough money when we do research--whether we're
spending enough money, or whether we have a close enough eye on
the potential problems that might come from nanotechnology.
Because I think once we build those safeguards in, we ought to
really do our very, very best to make sure that we're the world
leader in nanotechnology. But I think America and the world
would like to see those safeguards.
So, who wants to take that?
Dr. Schloss. Well, I can start off by saying that we
completely agree with you that these are essential issues to
address, and to address effectively. I don't know exactly how
one decides what's the right amount of money to spend. I think
what we want to do is approach the science as quickly as we
can, but in a very effective way. We are able to base a lot of
the studies of engineered nanomaterials on our knowledge of
other kinds of particles, including natural nanomaterials. So,
what we're doing now, through several different efforts, is
building cascades of characterization of nanomaterials so that
we can really understand: What are the physical attributes? How
do these materials act in biological systems in glass, in test
systems? And how do they act in animal studies? We're building
on the knowledge we have, but these are difficult materials to
work with and to characterize. A number of studies have been
published that actually are somewhat misleading, because there
was other stuff in there that wasn't the material that people
thought was being tested.
Senator Pryor. OK. I just hope that we, as a Nation, do
think through all the ramifications of this. And then, like I
said, I think once we feel like we have that under control, we
need to really be aggressive in this area.
With regard to the universities doing research--Dr.
Buckius, I'll ask you this--it would--I would think that the
universities around the country are very, very important
partners in nanotechnology research. Are they pretty much the
backbone of the research that's being done in this area?
Dr. Buckius. From NSF's perspective, yes.
Senator Pryor. OK. I think that that's good. I just think
that they're very innovative, and they can do great things.
Let me also ask this. The Consumer Product Safety
Commission, are they involved in the National Nanotechnology
Initiative at all? Do they have a seat at the table, so to
speak? And do you have someone there who's a consumer advocate?
Dr. Teague. Yes. We--on the NSET Subcommittee that I
mentioned earlier, we do have a representative from the
Consumer Product Safety Commission as an ongoing member of both
the main subcommittee and also an active member of our
Environmental Health and Implications Working Group. So, we do
have someone who is an advocate and keeps us very much aware of
the concerns for ensuring safety for our consumer products.
Senator Pryor. From your perspective, at least--I know you
can't speak for them--but does the Consumer Product Safety
Commission, from your perspective, have enough staff and enough
expertise to be competent, I guess, to opine on things like
that?
Dr. Teague. Certainly, in terms of the representative that
we interact with, I would say that he is a--in terms of
competency, without any question, he's a competent scientist in
our area and, I think, certainly represents his organization
very carefully, and the interests of the Consumer Product
Safety Commission, very effectively.
Senator Pryor. OK, thank you.
Mr. Chairman, the last thing I had, really, is more of an
observation, and that is, I think nanotechnology potentially
could be the next industrial revolution. Really, it has a ton
of potential to do great things, long term. And just a very
simple example would be these incandescent light bulbs right
here. Supposedly, you guys tell me--you all are the experts on
this--but, supposedly, about 90 percent of the energy that's
used in these light bulbs don't go to make light, they go to
make heat.
And so, in a way--even though Thomas Edison was a genius
and all that, in a way these are very efficient--inefficient
ways to light a room, because not only do you have to use too
much energy to do it, but, also, you're, in effect, heating the
room, and then you have to have a system to cool the room at
the same time, so you're really using way too much energy in
order to do that. But with nanotechnology, supposedly you can
now make nanolights that--are either ready for the marketplace,
or will be very shortly, because I know the University of
Arkansas has been involved in some of that--but you can make
nanolights that can save a--well, can heat this--I mean, can
light this room at the same level, for a fraction of the
energy, and you don't have the heating problem that these bulbs
cause.
So, this has applications really across the board that can
help our economy so much, and my understanding is the FY07
budget that the President sent over a few days ago has a very
small cut in nanoresearch, and I want to double-check that and
track that down, but I may want to work with some of the
Committee members here to see if we can't restore that to the
funding level that it has been in years past.
Thank you.
The Chairman. Very astute observation, my friend.
Senator Smith?
STATEMENT OF HON. GORDON H. SMITH,
U.S. SENATOR FROM OREGON
Senator Smith. Thank you, Mr. Chairman. And thanks to our
witnesses for being here for this very, very important hearing
and topic. When you contemplate that in the coming years this
is likely to be a one-trillion-dollar industry, it certainly
behooves us, as a Nation and as academia, to get a headstart.
I'm also, like Senator Pryor, proud of my state. We've had
the same kind of coming together of higher education and
different industries, under an entity called ONAMI, which
brings together commercial and academic nanotechnology.
I'm also very grateful, and want to state publicly, I
appreciated the President's including nanotechnology in his
budget for 2007, and specifically the establishment of an
Institute for Nanotechnology within the State of Oregon.
I'm wondering if there is more we ought to be doing to
provide the seed capital and, particularly, the link between
the classroom, the science, and commerce. In that possibility,
I have introduced a bill, called the Nanoscience to
Commercialization Institutes Act, which would establish, I'm
sure, in each of your states, these kinds of institutes to help
make this transition. It establishes up to eight Nanoscience
Commercialization Institutes. And the goal of each institute is
to apply nanotechnology research to commercial goods or
services--specifically, in industries including energy,
electronics, agriculture, medicine, textiles, and
transportation--and to achieve their full commercial
realization.
Any comments on that? Is this--would this be helpful? Is
this needed? Will this happen, just on its own?
Dr. Teague. Well, I don't think anything like that happens
on its own. I think it certainly needs to be driven. And I
think some of those would be--sounds like it would be a very
effective means of trying to aid in commercialization. I would
point out that, within the agencies now participating in the
NNI, through the Small Business Innovation Research program,
certainly the degree to which the discoveries have been
transitioned into commercialization has been quite successful
and has received strong support through that program. We did a
study of the amount of funding that had gone into
nanotechnology from the SBIR grants, and it's something upwards
of $500 million over the last 5 years has gone to SBIR
programs, the SBIR grants, for nanotechnology development and
to do the commercialization of some of the ideas coming out of
the laboratory.
Also, I would mention that we have been, just recently,
interacting quite a bit with the Department of Labor and the
Department of Education, as well as the ongoing activities from
the National Science Foundation, to look into workforce issues,
training issues relative to equipping people to move into this
new field and to do the commercialization.
But this sounds like it might well bridge both the
education, training, and, to some degree, the actual moving of
nanotechnology from the laboratory to commercialization. We are
very conscious of the need for this to happen, and have been
trying to take some appropriate steps to work in this
direction, as well.
Senator Smith. Well on the basis of your recommendation,
I'll recommend it to my colleagues, to become joint sponsors of
this. Thank heavens for law school, huh?
Thank you, gentlemen, very much.
Thank you, Mr. Chairman.
The Chairman. Thank you very much.
We will print my statement and the statement of the Co-
Chairman at the beginning of this hearing.
Thank you very much, gentlemen. We appreciate your keeping
in touch with us, and we would welcome your comments at any
time to assist in this initiative.
Dr. Teague. We would welcome the chance to sit down with
you, as you indicated in your remarks.
The Chairman. We do that once in a while, Doctor. It is
off-the-record. We explore the subject to see if we really
understand what is going on. It's helpful. We will try to do
that.
The next panel is Dr. Alan Gotcher, President and Chief
Executive Officer of Altair Nanotechnologies; Dr. Todd Hylton,
Director of the Center for Advanced Materials and
Nanotechnology at Science Applications International
Corporation; Dr. Mark Davis, Professor of Chemical Engineering
at the California Institute of Technology; Dr. Clarence Davies,
Senior Advisor, Project on Emerging Nanotechnologies at the
Woodrow Wilson Center; and Dr. Timothy Swager, Professor of
Chemistry, the head of the Chemistry department at the
Massachusetts Institute of Technology.
If you would, please. Thank you very much, gentlemen.
We have been joined by Senator Kerry, who would like to
introduce Dr. Swager, I believe.
STATEMENT OF HON. JOHN F. KERRY,
U.S. SENATOR FROM MASSACHUSETTS
Senator Kerry. Mr. Chairman, I--thank you, I wasn't really
going to so much introduce them as both welcome Dr. Swager,
from MIT--we're delighted with the work that's being done
there; obviously, I'm very proud of what's happened--and, also,
Bryant Linares, from Apollo Diamond. Very, very happy to have
both to them here, and everybody.
This is a subject--Mr. Chairman, thank you for having this
hearing--this is, as everybody on this committee knows, an area
of extraordinary promise. And given the fact that, since World
War II, I think something like 75 percent of the productivity
increases in the United States have been driven by technology
advances, this is our future. So, I wish that the budget
weren't being cut this year for it. There's about a $24 million
cut, I think, in the budget, at this moment. Hopefully, we all
can address that as we go forward.
But I welcome all of the witnesses on this panel. And thank
you very much, Mr. Chairman, for having this important hearing.
I'm told that it is possible that the worldwide market in this
field could be as much as $700 billion, some people say, by
about 2008. And the--therefore, the possibilities, beyond the
sort of lightness of materials and strength of those materials
and all the other advances that we could gain through it are
just mind-boggling, to say the least. So, we look forward to
your testimony today.
And thank you, Mr. Chairman, for putting the Committee's
focus on this.
The Chairman. Thank you very much.
Let us proceed and just go through, from left to right. We
will be pleased to have your statements. All of your statements
that were prepared will be in the record. And if you have them
on CD, we'll take them and print them directly. But we hope
that you can hold your statements to a reasonable period. As I
said before, I do not want to cut you all off. The whole panel
has doctorate degrees, and I think we ought to sit and listen,
rather than ask questions.
Dr. Gotcher?
STATEMENT OF ALAN GOTCHER, Ph.D., PRESIDENT/CEO, ALTAIR
NANOTECHNOLOGIES, INC.
Dr. Gotcher. I'd like to thank you, Chairman Stevens, for
your leadership on this issue and for holding this hearing. I'd
also like to thank Senator Ensign for his support in ensuring
Nevada is a leader and a strong supporter of nanotechnology.
I'm Alan Gotcher, President and Chief Executive Officer of
Altair Nanotechnologies. Previously, I was the Senior Vice
President of Manufacturing and Technology, and Chief Technical
Officer at Avery Dennison, a $5 billion company, where I
managed corporate research, product development, and
manufacturing.
I led the development and commercialization of several
hundred-million-dollar new product platforms. I was, and still
am, a serial inventor and entrepreneur.
Altair Nanotechnologies, or Altairnano, is a small, rapidly
growing company where innovative nanomaterials are created and
commercialized into a wide diversity of globally competitive
products. We are a Nevada-based company publicly traded on
NASDAQ. We have about 60 employees located in Reno, Nevada, and
Anderson, Indiana.
Our twin missions are to create innovative products, such
as green batteries for fully electric vehicles, or drug
therapies for renal failure in humans and animals, that can
benefit our society as a whole, and then to ensure that those
products are safe. Because we take product stewardship
seriously, we are currently gathering data to measure the
impact of our nanomaterials and manufacturing processes on the
health and safety of our employees and the environment. We do
this to protect the environment and to provide sustainable
economic benefits to our shareholders.
Here's the view of nanotechnology from the trenches. The
hyperbole surrounding this technology is significant, but the
potential is real. It can truly change our lives in many
fundamental and positive ways. We're already beginning to see
some of those changes. Almost half of the U.S. consumption of
imported oil comes from dependence on the internal combustion
engine used in cars and trucks. Nanotechnology may provide
significant new products that can break that dependence and win
the quest for a practical alternative-energy vehicle. Those
vehicles of the future are just several years down the road. At
Altairnano, our innovative nanostructured electrode materials
enable realistic production of vehicles unlike any that are
available today. Imagine a fully electric six-passenger car, or
full-size pickup trucks, operating on batteries that can offer
conventional acceleration and cruising speeds. These batteries
will provide a driving range of at least 200 miles and a
recharge time of just a few minutes, under 6. These batteries
are more than twice the life cycle of comparable batteries
today, able to power a vehicle for more than 100,000 miles
without replacement, batteries that will be affordable,
inherently safe, and environmentally friendly. Even sooner,
imagine plug-in hybrid electric vehicles that can be charged
rapidly at home, at work, providing gas mileage dramatically
better than similar vehicles today.
At companies such as ours, environmental stewardship is
obligatory. We are strongly committed to that principle, both
in our manufacturing processes and in the applications of our
products. Our product portfolio includes ion exchange and
photocatalytic materials for cleaner water, biochemical sensors
for environmental monitoring and homeland security,
photocatalytic materials for indoor air purification, and, as I
mentioned previously, a new generation of ``green'' battery
technology. We're seeking partnerships with the Government in
this pursuit, as illustrated by a collaboration that we
initiated with the National Institute on Occupational Safety
and Health.
We ask, from Congress--our two separate thrusts--the first
focus on continued funding to U.S. companies for basic and
applied R&D. Priority spending would be on alternative energy
and life sciences. The former would be for commercially-
interesting nanomaterials and systems solutions to replace or
decrease the use of internal combustion engines. The latter,
life sciences, would be for nanotechnology that could help
investigate, monitor, and treat cancer and cardiovascular
disease; thus, improving the quality of life and decreasing the
cost of healthcare.
The second thrust would provide increased Federal funding
for environmental health and safety research and development.
What is needed is a broad initiative aimed at establishing
empirical data and models for the predictability of
environmental health and safety risks of commercially-
interesting nanomaterials. Included must be inducements for
private-sector companies to engage in this research initiative.
Yesterday, Altairnano cosigned a letter to the Senate
Appropriations Committee urging just this sort of research
initiative. As the letter notes, ``Myriad applications of
nanomaterials, which can exhibit a range of novel or enhanced
properties, can hold great promise, but much more needs to be
known about their potential risks.'' Other signatories include
large and small business, environmental groups, and
nongovernment organizations. It's not often that these diverse
groups find themselves on the same page. While I recognize that
this committee does not handle appropriations, this letter may
be of interest to your members. With the Chairman's permission,
I ask that it be included in the record of today's hearing.
Thank you for the opportunity to speak here today. I'd be
pleased to answer any questions later.
[The prepared statement of Dr. Gotcher follows:]
Prepared Statement of Alan Gotcher, Ph.D., President/CEO,
Altair Nanotechnologies, Inc.
I thank Chairman Stevens and Co-Chairman Inouye for their
leadership in holding this hearing on the Developments in
Nanotechnology in the U.S. Further, I would like to thank Senator
Ensign for his support to ensure that Nevada is a nanotechnology
leader.
I am Alan Gotcher, President and CEO of Altair Nanotechnologies,
Inc. Altair (Altairnano), based in Reno, Nevada, is a leading supplier
and innovator of advanced ceramic nanomaterial technology. Previously,
I was Senior Vice President of Manufacturing and Technology and CTO at
Avery Dennison, where I managed R&D, product development, manufacturing
and lead the development and commercialization of several hundred-
million-dollar new product platforms. I am also an inventor and
entrepreneur.
The hyperbole surrounding nanotechnology is significant. And yet
the potential of the technology is real. I wish to take this
opportunity to address three core issues:
1. The State of the Technology: How it Looks From the Trenches
Nanotechnology can truly change our lives in many fundamental and
positive ways. We have barely scratched the surface of what the science
of nanotechnology might be capable. Today I will tell you how two of
Altairnano's platforms--its Lithium-ion nano battery initiative and its
chem/bio sensors--are on the verge of changing our reality.
2. The Responsible Commercialization of Nanotech Products: Altairnano
as Steward
As this infant industry grows, we--like the chemical industry
before us--must learn how to be good stewards of our environment. I
will briefly outline our corporate commitment to product and
environmental stewardship, and what we are doing to ensure that our
products and manufacturing processes are safe.
3. The Role of the Federal Government: Ensuring the Global
Competitiveness of the U.S. Nanotechnology Industry
All members of our national science and engineering establishment
need to come together and partner with people in the nano industry in
order to ensure that nanotechnology is researched and developed
properly from the beginning. This will require a major commitment of
Federal resources, which will be an investment in our country's future
competitiveness.
1. The State of the Technology: How it Looks From the Trenches
As I said earlier, the hyperbole about nanotechnology is
tremendous, but the potential for this technology to change our lives
in many fundamental and positive ways is real. To illustrate that
point, I offer two examples of exciting technology that Altairnano has
developed and is currently in the process of commercializing. In each
instance, the Altairnano materials--specifically due to their ``nano-
ness''--provide revolutionary characteristics that are desired by the
marketplace. In addition to stimulating significant national economic
activity, these development programs at Altairnano will serve to
protect and improve the environment.
My first example is Altairnano's advanced, rechargeable Lithium-ion
(Li-ion) nano battery. This product is a response to the increasing
need and demand for more affordable, less-environmentally damaging
energy sources. Consider the factors that are driving this demand:
Pollutants emitted by conventional cars and trucks are
making the air we breath increasingly unhealthy. (Recognizing
this danger, many states are looking to follow California's
lead by requiring low- and zero-emission vehicles.)
Nearly half our consumption of imported oil comes from a
dependence on conventional cars and trucks with internal
combustion engines.
We need to win the quest for the production of a practical
alternative-energy vehicle.
The solution? Altairnano has created an innovative, rechargeable
Li-ion battery that will enable realistic production of a vehicle
unlike any available today. Imagine a fully electric six-passenger car
or full-size pickup truck operating on batteries that offer
conventional acceleration and cruising speed. Imagine batteries with a
range of 200 miles--and with a recharge time of just several minutes.
And imagine batteries with twice the lifecycle of anything comparable
today--powering a vehicle for more than 100,000 miles.
Just last week, we produced and tested our first batch of Li-ion
battery cells, utilizing the company's nano-structured electrode
materials, at our Anderson facility just north of Indianapolis,
Indiana.
Unprecedented Battery Performance
Testing has revealed that they perform at 90 percent of capacity at
-22 degrees, Fahrenheit. Conventional Li-ion batteries and the nickel-
metal hydride batteries used in hybrid electric vehicles become either
sluggish or unable to charge at temperatures below freezing. In
addition, unlike conventional Li-on batteries that risk spontaneous and
catastrophic failure at temperatures above 266 degrees, the safety
threshold for Altairnano's nano-structured lithium titanate spinel
electrodes is 480 degrees, an important consideration for such extreme
environments as aerospace and military applications. And, unlike
current Li-ion batteries that contain hazardous chemicals and
materials, the Altairnano battery designs and materials are
intrinsically safe because they do not contain any toxic materials.
This also makes them recyclable without any special needs.
As this performance shows, the infrastructure now exists for the
creation of a high-performance, all-electric vehicle. This technology
could be rapidly adopted by American automobile manufacturers, and is
just around the corner. We are already in negotiations with top
automobile, truck and bus manufacturers. Similarly, our technology is
being evaluated by major manufacturers of hand-held power tools. Just
imagine a power tool with twice the power of today's 18- to 20-volt
tools at the same price point, and one that can be fully recharged
while the worker grabs a cup of coffee. That, also, is coming soon.
Chemical/Biological Sensors for National Security
My second example of how Altairnano's unique materials can change
our world relates to national security. We have been collaborating with
the Universities of Western Michigan and Nevada-Las Vegas to develop
chem/bio sensor arrays capable of detecting the presence of a wide
spectrum of potential explosives, chem/bio weapons and illegal drugs.
These arrays, made possible by Titanium Dioxide (TiO2) base
technology unique to Altairnano, have been successful beyond our
wildest expectations. Not only are they capable of sensing the presence
of low levels of potential explosive and chem/bio hazards, they're also
able to report this information to a local display or a remote
monitoring station.
With the help of scientists and engineers at Genesis Air
Technologies, we have also learned how to use these and similar
materials to destroy target chem/bio agents introduced into, for
example, a building's HVAC system. The application of this technology
can provide protection against most airborne health or environmental
hazards. These materials are now being incorporated and tested by
Genesis Air in systems designed for ``smart'' buildings. Clean, safe
air with a built-in early-alert system in the case of adverse action:
It's within sight, thanks to nanotechnology.
2. Responsible Commercialization of Nanotech Products: Altairnano as
Steward
Altairnano is strongly committed to a position of good stewardship.
This includes concern for the safety and welfare of our employees, our
customers and strategic partners. Employees and consumers should be
shielded from exposure to nanoparticles at every point along a product
lifecycle. That is why we are dedicated to creating ``safe'' products--
safe for individuals and safe for the environment.
Altairnano-NIOSH-University of Nevada Collaboration
Since the Fall of 2005, Altairnano has been working closely with
scientists at NIOSH and the University of Nevada-Reno to monitor air
quality in our Reno facilities. Ultimately, the two goals of this
program are to ensure minimal--or zero--worker exposure to fine and
ultrafine materials in the workplace, and to establish the basis (a
series of standard operation procedures or best practices) for a
responsible employee health monitoring system. Regarding the former,
preliminary findings show that Altairnano's particulate aggregates are
of a size that would not likely harm either the environment, employees
or consumers.
As for the latter, if this collaboration results in the creation of
new best practices for the safe handling and monitoring of
nanoparticles, these practices will be broadly disseminated through
scientific talks and publications. Hopefully, this collaboration will
also serve as a template for similar future efforts within the
industry.
Altairnano & University of California-Santa Barbara (UCSB)
We are committed to this explicit goal: There must be little or no
direct worker exposure to nanoparticles at the manufacturing site, and
there must be virtually no downstream-worker or consumer exposure to
free nanoparticles throughout the manufacture, use, and normal disposal
of products incorporating these nanomaterials.
We will be collaborating with UCSB chemists, and materials,
biological and environmental scientists to evaluate the intrinsic
health hazard of our materials. Based on the data available in the
literature and from our own testing programs, we believe the materials
we are using in our products and platforms are generally recognized as
safe at normal levels of exposure. Our goal in this collaboration is to
learn under what conditions--if any--these materials might pose health
or environmental hazards. We will simultaneously be investigating how
to modify the composition, surface functionality or morphology of our
materials so that they concurrently provide superior performance and
inherently low-to-zero health risk.
The Altairnano Lithium-ion battery mentioned earlier is just one of
several Altairnano products and initiatives that are ``green.'' The EPA
recently suggested six foci for improving environmental sustainability.
Our R&D pipeline is already devoted to addressing these four:
Sustaining water resources--Some of our products remove
contaminants like arsenic, promote photo-oxidation of microbes
and dangerous organics, and inhibit algal growth.
Generating clean energy--We improve the manufacture of high-
efficiency photo-voltaics and rechargeable, high-performance
``green'' batteries.
Sustaining clean and healthy air--Our photocatalytic systems
can be added to building HVAC systems.
Using materials carefully and shift to environmentally
preferable materials--We're achieving that through development
of green products (e.g., Altairnano's innovative Li-ion
battery) and manufacturing processes that do not use hazardous
solvents.
3. Role of the Federal Government: Ensuring Global Competitiveness of
the U.S. Industry
The needs of our society require continued funding to U.S.
nanotechnology companies for basic and applied R&D, including priority
spending in:
Alternative energy, for commercially-interesting nano-
materials and system solutions to replace or decrease the use
of internal combustion engines.
Life Sciences--For nano-materials and methods to
investigate, monitor and treat cancers and cardio-vascular
diseases to improve quality of life and decrease the cost of
care.
Additionally, the Altairnano safety partnerships outlined earlier
are examples of the first step in the type of research still needed to
fill in the gaps about nanotechnology. The list of gaps in our
knowledge base--connecting characteristics of one type of nanoparticle
or another to potential environment, health or safety risks--is very
long.
The U.S. is at a critical point in the development of this infant
industry. If we go the route of seeking better answers and
understanding of the various families/classes of nanomaterials before
imposing government regulation, it could lead to greater benefits to
the consumers and the environment through dramatic changes within
widely diverse industries.
Taking the other road--regulation first, without research--could
lead to a disquieting moratorium on all future nano-research and
development in the U.S., with great cost to our economy. There are some
who feel that nanotechnology will require new regulatory legislation--
for example, a recent report by Terence Davies with the Woodrow Wilson
International Center for Scholars/The Pew Charitable Trusts Project on
Emerging Nanotechnologies.
But much of this concern is founded on sparse and sometimes
conflicting data. If anything is clear, it is that there is no single
prototypical ``nanoparticle.'' Asbestos-like fibrous nanotubes and
toxic-metal containing quantum dots are not good surrogates for all
nanomaterials. To fall into a ``one-size-fits-all'' approach to
nanotechnology is irresponsible and counter-productive. There are no
clear and comprehensive data available to let us really assess the
general risk of the wide range of nanomaterials under consideration
and/or development.
Many of the cognizant Federal funding and regulatory agencies--such
as the National Institutes of Health (NIH), the National Cancer
Institute (NCI), the Food and Drug Administration, EPA and NIOSH--
recognize this reality and are working hard to understand the
underlying science and to develop quantitative data and models to
quantitatively assess risks.
What Altairnano asks from Congress is the following:
A broad, government-funded initiative (similar to the Human
Genome project) with the goal of establishing broad empirical
data and models for the predictability of the environment,
health and safety risks of commercially-interesting
nanomaterials.
Today, we lack data to say what characteristics or properties of a
nanomaterial make it potentially harmful. Nor are there sufficient
models to predict how the characteristics of materials change upon
exposure to the environment, to transport, or bioaccumulation for most
of the types of nanomaterials being developed.
While industry, academic, and government scientists continue to
vigorously explore nanotechnology's potential applications in a wide
variety of fields, including groundwater cleanup and cancer therapy,
research on nanotechnology's potential health and environmental
implications has failed to keep up. Federal funding for programs to
develop appropriate EHS data for use in responsible regulation of
nanotechnology is critical. EHS types of R&D comprise less than 4
percent of the core National Nanotechnology Initiative funding for
materials and applications R&D. So much more needs to be done.
Federal research dollars are essential to supporting the creation
of methods and tools critical to developing a fundamental understanding
of the risk potential of nanomaterials and nanotechnologies. A
metrology and modeling infrastructure would help producers and users of
nanomaterials to fulfill their responsibility to identify potential
risks of their own materials and applications. With increased Federal
funding, our society will be in a stronger position to address such
risk while these materials are still in an early stage of development
and commercialization. An early and open examination of the potential
risks of a new product or technology is critical to responsible product
development and technology application.
Others have presented the data gaps and modeling needs, and have
priced such a program at the $0.5 billion to $1 billion range over the
next five to 8 years. And, to be very clear, this would not be a
program aimed at elucidating the connection of structure-function
relationships of certain nanomaterials to performance enhancements in
specific applications. Nor should it have a materials discovery thrust.
For a national prioritization of EHS research needs, we need to
convene a dialogue of all informed stakeholders to assess what is
known, what technologies are available, and what capabilities need to
be developed.
Once the needs are prioritized--once we have a roadmap--we can then
form teams and consortia, and attack the highest-priority problems.
Hopefully a strong Federal participation (including staff at NIST, NIH,
NCI, EPA, NIOSH, etc.) and substantial Federal funding will ensure that
what we learn is broadly shared across our entire nanotech enterprise.
Private-sector participation is also critical. But participation by
and Federal funding to for-profit companies has to be acceptable as a
trade-off for their participation, and the sharing of results. Federal
investment and participation in developing the underlying EHS
metrologies, models and methodologies will dramatically accelerate the
realization of the economic potential promised by nanotechnology. This
would be an investment that will raise all boats.
I would like to ask you think back just 10 years. Take a minute to
revisit the history of the gene chip. In 1994, it was just a dream--a
concept that might have utility in clinical diagnostics. The government
made a coherent suite of tailored investments in the mid-1990s--less
than $200 million of government funding invested in industry-led R&D
activities engaging over 100 companies, universities and national
laboratories. With the help of that funding, by 2001 we had an infant
gene-chip industry, with widespread use in academic and medical
research labs and a changing view of what the technology could do. By
2005, gene-chip sales had reached nearly $1 billion and micro- and
nano-arrays are now a core tool of modern drug development, as well as
powerful diagnostics. Now, healthcare professionals can't imagine
modern medicine without the presence of the gene chip.
This is an excellent example of how the right types of investments
at the right time in history can make all the difference. Federal
investment into nanotechnology EHS research today could lead nano along
similar time and economic development trajectories.
Inducements for Private-Sector Companies to Engage in That Research
Project, Within a Framework That Is as Open and Accessible as
Possible
Neither academia nor the Federal Government is going to be able to
develop the requisite knowledge-base without the help of private
industry--especially not without technology start-ups and small
materials development companies. Smaller, independent companies like
ours are the ones that will ultimately bring the majority of new
nanomaterials into the marketplace. These types of companies not only
provide insight into the types of materials to which workers, consumers
and the environment will soon be exposed, they also provide a window on
manufacturing processes and waste streams.
It is in our Nation's best interest to have them involved, in order
to get this right, and to get it right from the start.
To ensure the participation of smaller nanomaterials companies,
reimbursement for their participation in such programs is crucial.
Unfortunately, most of the NNI funding mentioned earlier goes to
Federal agencies, like NIH and EPA, which do not generally fund
companies. If funding is provided, it's limited to materials-discovery
R&D. Even the NIOSH and NIEHS components of the joint STAR grants are
limited to the modest funding of $133,000 per year.
Open Source Infrastructure
Beyond the absence of company participation in most of the current
nanomaterials EHS research, there is a fundamental problem with our
collective approach to ensuring the responsible development of
nanotechnology.
Most large chemical companies involved in nanotechnology have
established safety programs and diverse product pipelines. They know
what to do, but will wait until specific materials and product concepts
have passed through multiple developmental-stage gates prior to
undertaking any substantive EHS studies. Even then, the methods used
and results will remain proprietary. Because new metrologies and
predictive models need to be developed for nanoparticles and materials,
this business-as-usual approach is highly inefficient, and will create
a few winners and many losers.
What we need are Federal R&D programs geared toward bringing
companies and academics together to develop a suite of metrology tools
and predictive models that will be accessible to and usable by all.
This is a critical point in history. Five years ago it was too early in
the lifecycle of nanotechnology for such a bold plan. Five years from
now, it could be too late for us to catch up with advances made by
competing nations.
Regulatory Mentoring
Many smaller nanotechnology companies have no prior experience with
worker safety or regulatory compliance programs, and are fearful of
``big government's stick.'' Regulatory agency staffers need to
establish informational outreach programs that make it easy to ``do it
right'' from day one. Programs that encourage mentorship from larger,
established chemical companies in the same materials or applications
space would be especially useful.
Altairnano, and companies like us, need to be able to know that we
can approach these Federal agencies and get helpful guidance for moving
forward. Because we are investing shareholder monies in our R&D and
product development programs, we also need to know that evolving
regulations will be predictable and based on sound science--not
political expedience.
One suggestion would be to fund regularly held workshops that
gather scientists, technologists and engineers from large and small
companies, academic and government research labs, and legal advisors
and regulators to discuss application- or materials-specific
regulations and appropriate regulatory pathways from product concept to
market entry and beyond.
A Transparent and Consistent Regulatory Environment That Is Truly Data
Driven
I believe we can all agree that there is insufficient quantitative
data to inform the development or application of any new regulatory
activities. And, anything we attempt to put in place today would likely
prove to be an imperfect solution that might be a greater drag on
economic development than no regulation at all. There seem to be two
common concerns: There is no clear central point of contact and control
for nanotechnology, and the number of new materials being developed
would swamp the system
I would like to propose a solution that I believe would be embraced
by both large and small nanomaterials companies. Let's create a portal
to a unified governance committee that operates in a manner analogous
to the FDA.
While holding regulatory authority, the FDA is probably one of the
single most powerful drivers of economic development throughout the
medical industry. The agency staff helps innovators and inventors at
early stages of product and process development by teaching them what
they need to know and do to comply with the appropriate regulatory
framework. The staff provides a way for the innovator's product ideas
and work to come up to speed on new technologies as they arise, a
single point-of-contact and control, constant and transparent
processes, strong outreach and advocacy.
The approval process is also a staged process. For example, in
developing a new drug, one might evaluate (at the sub-gram level of
manufacture) tens of thousands of molecules before striking the handful
of potential leads that the company considers commercially relevant. It
is only at this point that manufacture is scaled up to tens or hundreds
of grams and animal trials are undertaken. Only those lead candidates
that pass initial animal trials are submitted for limited evaluation
for safety (Phase I Clinical Trials).
Essentially, what this means is that only one in many compounds are
presented to the FDA for regulatory approval. Clearly, it is at this
point that the analogy between development of nanomaterials and
therapeutic drugs breaks down. But my point is that there are examples
that demonstrate responsible and effective regulatory oversight without
imposition of unreasonable burden to the innovators. From a corporate-
governance perspective, having an established and rigorous regulatory
pathway to market enables innovators to know that they are acting in
good faith as product stewards.
Support Math and Science Education at All Levels
We all have seen the numbers from the National Science Foundation--
while 70,000 Ph.D. engineers are graduating from universities in China
and 35,000 from universities in India, there are fewer than 10,000
engineering graduates from universities in the U.S. Plus, many of the
U.S. graduates are foreign nationals, many of whom return home with the
benefits of their education. This is a national crisis.
For Altairnano, it is also a company crisis. It is extremely
difficult for us to recruit science and engineering students from the
University of Nevada-Reno. There just are not enough students in the
pipeline to go around. Nanotech--the ``sexy'' science of the 21st
century--might be the catalyst needed to stimulate renewed interest in
math and science in American students, from K through graduate school.
One approach would be to fund the development of curricula, in
coordination with scientists and engineers from local/regional
nanotechnology companies, and focused on, perhaps, grades five and six,
junior high, and high school.
Another approach could be to fund scholarships to nanoscience camps
for students at the junior high and high school levels. A third
approach could be to provide scholarships for students enrolling in
nanotechnology programs at undergraduate and graduate levels--including
curricula focused on nanomaterials and nanochemistry, nanobiology, and
nano-environmental engineering. All of these programs should include a
component devoted to considerations of public policy issues affecting
nanotechnology.
Thank you for the opportunity to speak here today. I will be
pleased to try to answer any questions that you might have.
______
[Individually addressed copies of this letter were sent to
all members of the Senate and House Appropriations Committees]
February 14, 2006
Dear Senator:
The undersigned organizations strongly urge you to significantly
increase appropriations directed to research on the health and
environmental implications of nanotechnology. Although the National
Nanotechnology Initiative (NNI) has an annual budget of more than $1
billion, health and environmental implications research currently
accounts for less than 4 percent of that amount ($38.5 million for
FY06).
Nanotechnology, the design and manipulation of materials at the
molecular and atomic scale, is one of the most exciting fields in high
technology--one that could revolutionize the way our society
manufactures products, produces energy, and treats diseases. Myriad
applications of nanomaterials, which can exhibit a range of novel or
enhanced properties, hold great promise, but much more needs to be
known about their potential risks.
While industry, academic, and government scientists continue to
vigorously explore nanotechnology's potential applications in a wide
variety of fields, such as groundwater cleanup and cancer therapy,
research on nanotechnology's potential health and environmental
implications has failed to keep up. Federal research is essential to
providing the underlying methods and tools critical to developing a
fundamental understanding of the risk potential of nanomaterials and
nanotechnologies--methods and tools that all producers and users can
then use to fulfill their appropriate responsibility to identify
potential risks of their own materials and applications. With increased
Federal funding, our society will be in a stronger position to address
such risks while these materials are still in an early stage of
development and commercialization. An early and open examination of the
potential risks of a new product or technology is critical to
responsible product development and technology application.
We appreciate your consideration of this request. For further
information, please contact Mr. Terry Medley, Global Director,
Corporate Regulatory Affairs, DuPont, at (302) 773-3191, or Ms. Karen
Florini, Senior Attorney, Environmental Defense, at (202) 387-3500.
Sincerely,
Air Products & Chemicals, Inc.
Altair Nanotechnologies Inc.
BASF Corporation
Carbon Nanotechnologies, Inc.
Degussa
DuPont
Environmental Defense
Foresight Nanotech Institute
Houston Advanced Research Center
Lux Research, Inc.
NanoBusiness Alliance
Natural Resources Defense Council
PPG Industries, Inc.
Rohm and Haas Company
Union of Concerned Scientists
The Chairman. Thank you.
All of the statements you have, and attachments, will be
printed in the record.
Dr. Hylton?
STATEMENT OF DR. TODD L. HYLTON, DIRECTOR, CENTER
FOR ADVANCED MATERIALS AND NANOTECHNOLOGY,
SCIENCE APPLICATIONS INTERNATIONAL CORPORATION
Dr. Hylton. Chairman Stevens and distinguished members of
the Committee, I want to thank you for inviting me to testify
on developments in nanotechnology. It is a subject that's near
and dear to my heart.
I have spent my entire career working to transition
nanotechnologies from the research laboratory to products.
Trained as an applied physicist, my career includes work for
large and small technology companies working variously in the
fields of semiconductors, magnetic storage, sensing, equipment,
and defense.
I am currently employed by Science Applications
International Corporation, in McLean, Virginia, where I manage
a group of scientists and engineers providing nanotechnology
development and transition services to government and
commercial clients.
Nanotechnology is not an isolated technical innovation.
Rather, nanotechnology is a convergence of emerging
capabilities from the physical, chemical, and biological
sciences dealing with the manipulation and design of matter at
the nanometer scale. I believe that the term ``nanotechnology''
ultimately will be recognized as an era of innovation, lasting
throughout most of this century, that transforms human
existence with profundity and scope never before seen.
In the past 2 decades, I have observed a seemingly
inexorable displacement of the technology industries in this
country. For example, most of the newest semiconductor and
display manufacturing facilities are being located offshore. In
large part, this transformation is a consequence of global
competition, technology access, and a general leveling of the
quality of life across the world. From a global humanitarian
perspective, this transformation is long overdue, and I believe
it will continue unabated.
From a national perspective, however, we must maintain
leadership in the commercialization of new technologies, as
this leadership will be the material basis of our economic
prosperity and our global leadership.
My testimony today focuses on the challenges of
transitioning nanotechnologies from the research laboratories
to commercialization. Because of the inherent complexities
associated with nanotechnologies, many of the most valuable of
these transitions will be extremely difficult. In addition to
its basic research investment, I propose that the country
consider investment in a new means to effectively commercialize
nanotechnologies.
I'm going to refer now to a chart which is contained within
the materials that you have in front of you, committee members,
but which is not projected.
The first chart. I illustrate--in the first chart, I
illustrate a typical technology transition process in the
United States today. Basic research at universities and
research laboratories results in the creation of novel
technical capabilities whose applicability is generally poorly
understood. A small fraction of these capabilities are absorbed
by a small company, which invests in the transition of that
capability into a commercially-viable concept. A larger company
then generally enters to provide late-stage product development
and market access. The critical portion of the transition
process is borne by the small company and its investors.
Prior to the emergence of this model, the prevalent model
involved very large, very profitable companies transitioning
internally funded basic research into new products. This older
model became obsolete with the advent of increased domestic
competition and the emergence of similarly powerful foreign
competitors. By virtue of evolving global competition and
investor sentiments, the current model, featuring small
companies and venture capital investors, is now under stress.
The current technology transition model poses three major
challenges for nanotechnology commercialization.
The first challenge is that the technology transition
process is very long, often exceeding 10 years, because the
technical breadth and complexity inherent in most
nanotechnologies. Research institutions and large companies
typically cannot support a technology transition effort
exceeding 2 years. Venture capitalists are typically
uninterested in investments exceeding 5 years. And very, very
few small companies can sustain a decade-long transition
process.
The second challenge is access to intellectual property,
which initially may be distributed among various research
institutions and which freedom to employ is required for
successful commercialization.
The third challenge is access to, or existence of,
supporting hardware infrastructure--for example, prototype
manufacturing--to demonstrate product scalability and cost.
Referring now to the second chart, I illustrate an
alternative technology transition model intended to address
these challenges. The critical piece is the creation of public/
private organizations dedicated to the technology--dedicated to
technology transition in a specific industry segment that
coordinate and serve a large array of research institutions, a
consortium of small and large technology companies, and public
economic development organizations nationwide. At the interface
with the research institutions, the new organization provides a
conduit for intellectual property to the business consortium.
At the interface with the established industry, which is
mostly large companies, the new organization provides well-
developed technologies and a new--and new product opportunities
and receives financial support and product-development
resources and market guidance.
At the interface with small technology companies, the new
organization provides business, technical, and infrastructure-
related services and receives product-development resources.
And at the interface with the private sector--with the
public sector, excuse me, the organization provides economic-
development opportunities and receives assistance for
participating businesses.
Public funding for the new organization would be used to
establish and maintain core staff and facilities, while
participating businesses and research institutions would
contribute technical staff, as needed.
The many challenges of establishing such an organization
notwithstanding, the advantages of such an approach include
sufficient longevity to address the length of the technology
transition process, a comprehensive approach to access and
employ the intellectual property assets of the Nation, and,
thereby, to maximize the value of the national investment in
basic research in nanotechnology, a means to effectively share
expensive infrastructure, such as prototype manufacturing
capabilities, a means to target markets through the market
leaders, a large reduction in risk for private investors and
entrepreneurs, thereby generating greater private investment
and more new-company starts, a coordination of regional
economic development resources nationwide, and, finally, a
competitive posture that does not attempt to select winners in
the marketplace.
I propose that the country consider the creation of a
network of these technology transition organizations, each with
a specific industry focus, many of which have already been
discussed, things such as energy, medical devices, medical
therapeutics, and computing. This network would closely
parallel the research activity sponsored by the National
Nanotechnology Initiative and would seek to capitalize on the
research that it supports.
Last, I would like to comment on the often-heard statement
that we need to educate more scientists and engineers in the
United States. The unstated assumption behind this assumption--
behind this statement is that, by educating more scientists and
engineers, we will be able to maintain our leadership in
technical innovation and technology-based economic development.
I would like to point out that the career of the technical
professional generally parallels the transition of new
technologies. In response to our recent difficulties in
transitioning new technology and the corresponding dearth of
career opportunities, the best and brightest students in the
U.S. increasingly, and, I think, correctly, select other
professions. When the opportunities return, the U.S. students
will return, as well.
Thank you very much for the opportunity to testify today.
[The prepared statement of Dr. Hylton follows:]
Prepared Statement of Dr. Todd L. Hylton, Director, Center for Advanced
Materials and Nanotechnology, Science Applications International
Corporation
Chairman Stevens, Senator Inouye, members of the Committee, I want
to thank you for inviting me to testify on developments in
nanotechnology, a subject near and dear to my heart. I have spent my
entire career working to transition nanotechnologies from the research
laboratory to products. Trained as an applied physicist, my career
includes work for large and small technology companies working
variously in the fields of semiconductors, magnetic storage, sensing
equipment, and defense. I am currently employed by Science Applications
International Corporation in McLean, Virginia, where I manage a group
of scientists and engineers providing nanotechnology development and
transition services to government and commercial clients.
Nanotechnology is not an isolated technical innovation; rather,
nanotechnology is a convergence of emerging capabilities from the
physical, chemical and biological sciences dealing with the
manipulation and design of matter at the nanometer scale. I believe
that the term nanotechnology ultimately will be recognized as an era of
innovation lasting throughout most of this century that transformed
human existence with profundity and scope never before seen.
In the past two decades I have observed a seemingly inexorable
displacement of the technology industries in this country. For example,
most of the newest semiconductor and display manufacturing facilities
are being located offshore. In large part this transformation is a
consequence of global competition, technology access, and a general
leveling of the quality of life across the world. From a global
humanitarian perspective this transformation is long overdue, and I
believe it will continue unabated. From a national perspective,
however, we must maintain leadership in the commercialization of new
technologies, as this leadership will be the material basis of our
economic prosperity and our global leadership. My testimony today
focuses on the challenges of transitioning nanotechnologies from the
research laboratories to commercialization. Because of the inherent
complexities associated with nanotechnologies, many of the most
valuable of these transitions will be extremely difficult. In addition
to its basic research investment, I propose that the country consider
investment in a new means to effectively commercialize
nanotechnologies.
Referring now to Chart 1, I illustrate a typical technology
transition process in the United States today. Basic research at
universities and research laboratories results in the creation of novel
technical capabilities whose applicability is generally poorly
understood. A very small fraction of these capabilities are absorbed by
a small company, which invests in the transition of that capability
into a commercially-viable concept. A larger company then enters to
provide late-stage product development and market access. The critical
portion of the transition process is borne by the small company and its
investors. Prior to the emergence of the current model, the prevalent
model involved very large, very profitable companies transitioning
internally-funded basic research into new products. This older model
became obsolete with the advent of increased domestic competition and
the emergence of similarly powerful foreign competitors. By virtue of
evolving global competition and investor sentiments, the current model
featuring small companies and venture capital investors is now under
stress.
The current technology transition model poses three major
challenges for nanotechnology commercialization. The first challenge is
that the technology transition process is very long, often exceeding 10
years, because of the technical breadth and complexity inherent in most
nanotechnologies. Research institutions and large companies typically
cannot support a technology transition effort exceeding 2 years;
venture capitalists are typically uninterested in investments exceeding
5 years; and very, very few small companies can sustain a decade-long
transition. The second challenge is access to intellectual property,
which initially may be distributed among various research institutions
and which freedom to employ is required for successful
commercialization. The third challenge is access to (or existence of)
supporting hardware infrastructure, for example prototype manufacturing
to demonstrate product scalability and cost.
Referring now to Chart 2, I illustrate an alternative technology
transition model intended to address these challenges. The critical
piece is the creation of public-private organizations dedicated to
technology transition in a specific industry segment that coordinate
and serve a large array of research institutions, a consortium of large
and small technology companies, and public economic development
organizations nationwide. At the interface with the research
institutions, the new organization provides a conduit for intellectual
property to the business consortium. At the interface with the
established industry (mostly large companies), the new organization
provides well-developed technologies and new product opportunities and
receives financial support, product development resources, and market
guidance. At the interface with small technology companies, the new
organization provides business, technical and infrastructure-related
services and receives product development resources. At the interface
with the public sector, the organization provides economic development
opportunities and receives assistance for participating businesses.
Public funding for the new organization is used to establish and
maintain core staff and facilities, while participating businesses and
research institutions contribute technical staff. The many challenges
of establishing such an organization notwithstanding, the advantages of
such an approach include:
sufficient longevity to address the length of the technology
transition process;
a comprehensive approach to access and employ the
intellectual property assets of the Nation and, thereby, to
maximize the value of the national investment in basic research
in nanotechnology;
a means to effectively share expensive infrastructure such
as prototype manufacturing capabilities;
a means to target markets through the market leaders;
a large reduction in risk for private investors and
entrepreneurs, thereby generating greater private investment
and more new-company starts;
a coordination of regional economic development resources
nationwide; and
a competitive posture that does not attempt to select
winners in the marketplace.
I propose that the country consider the creation of a network of
these technology transition organizations, each with an industry focus
such as, for example, energy conversion (e.g., solar, thermal), energy
storage (e.g., batteries, hydrogen), agriculture, medical diagnostics
and devices, medical therapeutics, high-speed electronics, flexible
electronics, and high-strength materials. This network would closely
parallel the research activities sponsored by the National
Nanotechnology Initiative and would seek to capitalize on the research
that it supports.
Lastly, I would like to comment on the often heard statement that
we need to educate more scientists and engineers in the United States.
The unstated assumption behind this statement is that by educating more
scientists and engineers we will be able maintain our leadership in
technical innovation and technology-based economic development. I would
like to point out that the career of the technical professional
generally parallels the transition of new technologies. In response to
our recent difficulties in transitioning new technology and the
corresponding dearth of career opportunities, the best and brightest
students in the U.S. increasingly (and correctly) select other
professions. When the opportunities return, the U.S. students will
return, as well.
Chart 3
Functions of the Technology Transition Organization
Intellectual Property Coordination
Product Development Infrastructure
Small Business Services
Participant Relationship Management
Technical Development Coordination
Economic Development Coordination
Market Strategy Coordination and Roadmapping
Chart 4
Potential Industry Focused Technology Transition Organizations
Energy conversion (e.g., solar, thermal)
Energy storage (e.g., batteries, hydrogen)
Agriculture
Medical diagnostics and devices
Medical therapeutics
High speed electronics
Flexible electronics
High strength materials
The Focuses of the Technology Transition Organizations
should parallel the investments of the National Nanotechnology
Initiative
The Chairman. Thank you very much, Doctor.
Our next witness is Dr. Timothy Swager, Professor of
Chemistry at MIT.
STATEMENT OF TIMOTHY M. SWAGER, Ph.D.,
PROFESSOR OF CHEMISTRY, MASSACHUSETTS INSTITUTE OF
TECHNOLOGY (MIT); ON BEHALF OF THE INSTITUTE FOR
SOLDIER NANOTECHNOLOGIES (ISN)
Dr. Swager. Thank you, Chairman Stevens, for the invitation
to be here. And thank you, Senator Kerry, for----
The Chairman. I might say, it is a courtesy of the Chair to
call on witnesses who have home state Senators up here. So, I
apologize to the rest of you, but----
Dr. Swager. OK. Thank you for the introduction. I
appreciate it.
I'm a Professor of Chemistry at MIT, and representing today
the Institute for Soldier Nanotechnologies, which is an Army-
funded research center.
The Institute for Soldier Nanotechnologies is dedicated to
the development of nano-enabled technologies to protect
dismounted soldiers. The ISN mission is to increase
capabilities by simultaneously decreasing the weight soldiers
must carry. Present-day soldiers, like the one shown in this
picture from Iraq, often carry in excess of 100 pounds of
equipment, which reduces their effectiveness and survivability
in the field.
The Chairman. I'll tell you, Doctor, when they appeared
here, we added it up, and they weighed more than I do.
[Laughter.]
The Chairman. The stuff that they were carrying weighed
more than I do.
Dr. Swager. It's impressive how resilient these soldiers
are.
Our vision is to design, from the ground up, a new
battlesuit with a number of integrated systems that
automatically activate on on-demand, much in the same way as
airbags deploy in automobiles. It will include sensing
subsystems to detect chemical and biological threats, as well
as perform physiological monitoring. It will provide mechanical
performance enhancements, integrated power, and informational
systems.
Nanotechnology will help us integrate these many functions
into the uniform. One materials platform we envision is the
fabric of the uniform itself, wherein a diversity of functional
nanocoatings will be developed which provide massive new
capability to the soldier, with an insignificant increase in
weight.
The ISN has over 30 research projects, but today I will
focus on only two examples of new sensory systems for enhanced
situational awareness.
New nanostructured optical fibers have been developed to
detect specific kinds of light, such as that coming from a
targeting laser. These fibers are produced by a drawing process
and contain metal electrodes interfaced with semiconductors.
When illuminated with light, electrical currents are generated
between the metal electrodes. The optical fibers display
selected responses to different colors of light due to a
photonic coating. Grids of fibers can be used to determine the
point of illumination, and extensions of this technology will
eventually be able to tell a soldier the direction from which
the light originated.
We are also developing networks of photonic molecular wires
for the detection of explosives. These materials are electronic
plastics that absorb and emit light, and have high sensitivity
to explosives like TNT. These materials have the unusual
ability to self-amplify their own sensory responses due to
transport of energy packets through the network. This process
behaves similar to a string of holiday lights, wherein only one
light need be broken to cause the entire system to become dark.
In a similar way, one molecule of TNT can produce a massively
amplified response.
To transition our technologies to the military, the ISN
works with partner companies, both large and small, distributed
throughout the United States. MIT has licensed our explosive-
detection technology, to Nomadics, a small company based in
Oklahoma, also with a site in Massachusetts, which has
developed ultrasensitive explosive detectors. I am a paid
consultant for Nomadics and actively assist them in extending
this technology.
The Nomadics sensor, known as Fido TM, one of
which I have brought with me here today, detects vapors of
explosives as they pass through a capillary tube. I also have a
capillary that is coated with our molecular wires.
The Chairman. I don't think they saw that. Hold that up----
Dr. Swager. It's just a small capillary that has a
nanocoating of our electronic polymer inside. You can't even
see it. It's what I call a definition of very-high-value
material. These systems can detect explosive vapors at
distances more than 2 meters away from the source. Only trained
dogs are capable of similar detection limits; and, hence, Fido
TM represents a new capability for our soldiers.
Fido TM sensors are undergoing evaluation in
Iraq, both as handheld systems and on robotic platforms. I show
here Fido TM mounted on a PackBot, which is a
robotic platform developed by iRobot. As shown in the
photograph, this integrated system can be used at checkpoints
for vehicle interrogation at safe distances. It can also be
used for investigating potential roadside bombs and in
identifying individuals who have recently handled explosives.
The feedback from the soldiers has been very promising.
Thank you.
[The prepared statement of Dr. Swager follows:]
Prepared Statement of Timothy M. Swager, Ph.D., Professor of Chemistry,
Massachusetts Institute of Technology (MIT); on behalf of the Institute
for Soldier Nanotechnologies (ISN)
(Slide 1)
The Institute for Soldier Nanotechnologies (ISN) is dedicated to
the development of nano-enabled technologies to protect dismounted
soldiers. The ISN mission is to increase capabilities while
simultaneously decreasing the weight soldiers must carry. Present day
soldiers, like the one shown in this picture from Iraq, often carry in
excess of 100 pounds of equipment, which reduces their effectiveness
and survivability in the field.
(Slide 2-3)
Our vision is to design from the ground up a new battlesuit with a
number of integrated systems that activate automatically on-demand,
much in the same way as airbags deploy in automobiles. It will include
sensing subsystems to detect chemical and biological threats as well as
perform physiological monitoring. It will further provide mechanical
performance enhancements, integrated power, and informational systems.
(Slide 4)
Nanotechnology will help us to integrate these many functions into
the uniform. One materials platform we envision is the fabric of the
uniform itself wherein a diversity of functional nanocoatings will be
developed which provide massive new capability to the soldier with an
insignificant increase in weight. The ISN has over 30 active research
projects, but today I will focus on two examples of new sensory systems
for enhanced situational awareness.
(Slide 5)
New nanostructured optical fibers have been developed to detect
specific kinds of light such as that coming from targeting lasers.
These fibers are produced by a drawing process and contain metal
electrodes interfaced with semiconductors. When illuminated with light,
electrical currents are generated between the electrodes.
(Slide 6)
The optical fibers display selective responses to different colors
of light due to a photonic coating. Grids of fibers can be used to
determine the point of illumination, and extensions of this technology
will eventually be able to tell a soldier the direction from which the
light originated.
(Slide 7)
We have also developed networks of photonic molecular wires for the
detection of explosives. These materials are electronic plastics that
absorb and emit light and have a high sensitivity to explosives like
TNT. These materials have the unusual ability to self-amplify their own
sensory responses due to the transport of energy packets throughout the
network. This process behaves similarly to a string of holiday lights
wherein only one light need be broken to cause the entire system to
become dark. In a similar way one molecule of TNT can provide a
massively amplified response.
(Slide 8)
To transition our technologies to the military, the ISN works with
partner companies, both large and small, distributed throughout the
United States. MIT has licensed our explosives detection technology to
Nomadics, a small company based in Oklahoma, which has developed ultra-
sensitive explosive detectors. I am a paid consultant of Nomadics and
actively assist them in extending this technology.
(Slide 9)
The Nomadics sensor, known as Fido TM, detects vapors of
explosives as they pass through a capillary containing a nanocoating of
our electronic plastic. These systems can detect explosive vapors at
distances more than 2 meters away from the source. Only trained dogs
are capable of similar detection limits, and hence Fido TM
represents an important new capability for our soldiers.
(Slide 10)
Fido TM sensors have been fielded in Iraq both as hand
held systems and on robotic platforms. I show here Fido TM
mounted on a PackBot, which is a robotic platform developed by iRobot.
As shown in the photograph, this integrated system can be used at
checkpoints for vehicle interrogation at safe distances. It can also be
used for investigating potential roadside bombs and identifying
individuals who have recently handled explosives. The feedback from
soldiers has been very promising.
The Chairman. Tremendous.
Mr. Bryant Linares, President and Chief Executive Officer
of Apollo Diamond, Incorporated.
STATEMENT OF BRYANT R. LINARES, PRESIDENT/CEO,
APOLLO DIAMOND, INC.
Mr. Linares. Thank you. I would like to thank Chairman Ted
Stevens, Co-Chairman Daniel Inouye, and our Senator from my
home State of Massachusetts, John Kerry, for the opportunity to
testify before this committee.
My name is Bryant Linares. I'm the CEO and President of
Apollo Diamond, and a representative of the NanoBusiness
Alliance.
I'm here today to tell you that the philosophers and
alchemists of Ancient Greece actually had it wrong trying to
turn lead into gold. They should have been trying to turn
carbon into diamonds.
At Apollo Diamond, we're using nanotechnology production
principles to grow one of the most coveted and desired
materials known to mankind: diamond. I have a couple of
diamonds. This is a 1-carat diamond that we've grown at Apollo
Diamond, here. And Jason Mulvihill, from the subcommittee, is--
staff--has some diamonds to show you, Senators. And we all do
this--we do this atom by atom from ordinary carbon.
Diamond is an extremely useful material. It is the hardest
material known to man. It is one of our planet's best
electrical insulators; and it transmits the entire spectrum of
light through it. Equally amazing and important is that diamond
is totally biocompatible with the body's chemistry. Diamonds
will lead to advanced applications in a wide range of fields,
from computing to communications to medicine. And yet,
diamonds' usage today has really been limited to jewelry, on
the high end, and cutting and grinding applications, on the
industrial end. The reason for this is simple. Current supplies
of diamond, either from mines or from traditional industrial
sources, do not provide diamond in a form, purity, or cost that
allows its superior characteristics to translate into highly
useful technical and commercial applications. Nanotechnology
promises to change the availability of high-quality diamond and
allow us to unleash the potential of this highly useful
material.
At Apollo Diamond, we're using nanotechnology to control
atoms and molecules so that we can produce diamond in a
prepared medium of carbon gas. We are able to produce real-
world sized diamonds, 5 carats and larger, that are purer than
the finest mine diamonds. This process, we call culturing. It
produces diamonds that are 100 percent real diamond. They are
optically, chemically, and physically identical to diamonds
mined from the Earth. They differ from mined diamonds only in
the following three respects. Apollo diamonds are ultrapure,
they are large--we're in the process of developing capabilities
to grow these into 4-inch wafer sizes suitable for
semiconductors and optics--they are cost-effective for the use
in electronics, similar to the cost of other high-grade
semiconductor materials.
These features are what will make diamond useful for high-
tech applications. They were also the prerequisite material
characteristics for silicon, which has powered our country's
high-tech boom over the last 30 years. Diamond is now the
beginning of a similar 50-year growth curve, in which we will
see it used in every corner of our society, courtesy of
nanotechnology manufacturing techniques.
Apollo plans to use gem diamond sales to fund its
commercialization of its technology initiatives, which makes us
very unique, that we have a commercial application early in our
product's lifecycle. However, most nanotechnology start-ups
face tremendous challenges taking their technology from the lab
to the store shelves.
While there is money for research and for companies that
are almost ready to sell products, the rest of the
commercialization process lies in the--what's called the
``Valley of Death.'' And this is the period, between initial
research and the final commercialization, where investment
money is limited. Start-up companies need financing. If America
is going to maintain its leadership position in the global
nanotechnology race, government must help create incentives to
invest in nanotechnology commercialization. This will lead to a
whole range of high-quality new jobs and new products spread
across almost every industry, reduce our Nation's
independence--dependence on foreign oil, generate positive
effects for our environment and human health.
We have four recommendations for the Federal Government.
First, level the playing field by creating incentives for
nanotech commercialization. This will ensure that the private
sector takes full advantage of Federal investments in
infrastructure development to date. Second, develop policy that
creates export and trade controls that maintain access to
global markets. Avoid export controls in nanotechnology, except
where they have national security impact. Combat foreign
interference with domestic trade institutions to ensure that we
are able to develop sound business platforms for foreign trade
here domestically. Third, address environmental health and
safety implications of nanotechnology using existing regulatory
structures. We believe that existing laws can, and should, be
updated to address nanotechnology, rather than creating new
laws. We must ensure that there are appropriate safeguards
without diminishing our competitive advantage through--under
regulations that can strangle small businesses like Apollo.
Finally, encourage U.S. students to enter science and
engineering programs, and develop policies that encourage
foreign graduates to stay in the United States.
In summary, we feel fortunate to live in the United States
and to have the ability to develop a world-leading diamond
technology platform here, domestically. With the right
nurturing, we can develop a large diamond-based electronics and
optics industry right here at home. American nanotechnology
companies are making breakthroughs that could develop into
full-fledged U.S.-based industries, but in order to realize
this potential, we need to ensure that we are effectively
competing with the rest of the world.
Nanotechnology has the opportunity to profoundly improve
our quality of life, increase our national security, provide
good-paying, high-tech domestic jobs for our citizens. We are
on the verge of a large wave of positive change. Let's make
sure it stays here in the United States.
Thank you for the opportunity to address this Committee.
[The prepared statement of Mr. Linares follows:]
Prepared Statement of Bryant R. Linares, President/CEO,
Apollo Diamond, Inc.
As the President and Chief Executive Officer of Apollo Diamond,
Inc., I would like to thank Chairman Ted Stevens, Co-Chairman Daniel
Inouye, and our Senator from my home State of Massachusetts, John
Kerry, for the opportunity to testify before this committee.
The Potential of Nanotechnology
The National Nanotechnology Initiative defines nanotechnology as
the understanding and control of matter at dimensions of roughly 1 to
100 nanometers (for comparison, a sheet of notebook paper is about
100,000 nanometers thick) and exploiting the unique phenomena that
occur at that scale to enable novel applications. Market impact
estimates for nanotechnology have reached as high as $1 trillion by
2015.
At Apollo Diamond we are now using nanotechnology production
principles to grow one of the most coveted and desired materials known
to mankind, diamond.
The Need for Diamond
Diamonds have long been desired not just because of their beauty in
a necklace or an engagement ring, but also for their utility as an
extreme material that surpasses all other known materials in its
physical ability.
Diamond's physical properties are truly amazing: diamonds are the
hardest material known to man, they are known to be our planet's best
electrical insulator, they can pass heat through their structure faster
than any other known substance, they offer minimal expansion through
large temperature variations, they are inert to most chemical and
radioactive environments, and they are optically transmissive through
the infrared, visible and ultraviolet spectrums of light. Yet, equally
amazing and important, they are also totally biocompatible with the
body's chemistry.
Diamond is a material of the highest utility, yet its use has been
limited to gem jewelry applications on the high end and cutting/
grinding applications on the industrial end. The reason for this is
simple: current supplies of diamond, either from the mine or from other
conventional diamond sources, do not provide diamond in a form, purity
or cost that allows its superlative physical characteristics to
translate into useful high-technology and commercial applications.
The Defense Advanced Research Projects Agency (DARPA) has kept an
early eye on diamond's development over the years because of the
tremendous promise of the material's performance. In a Naval Research
Lab/DARPA analysis on various semiconductor materials, diamond was
shown to have a performance potential 100,000 times greater than that
of silicon and hundreds of times that of the then state-of-the-art
semiconductor materials gallium nitride and silicon carbide. The
prospect of discovering a path to make such diamond material, however,
appeared so daunting that the United States basically gave up all
government-funded research on diamond's fundamental materials
development in the mid-1990s.
The Nanotechnology Solution
At Apollo Diamond, we are using nanotechnology manufacturing
processes (i.e., controlling atoms and molecules) to reproduce diamond
on an atomic level, while producing real-world sized diamonds (i.e., 5+
carat crystals) that have the purity of the finest diamond crystals
found in mines. This process is called ``culturing,'' the growth of
diamond through a prepared medium.
The Apollo process produces diamonds that are 100 percent real
diamond. They are optically, chemically and physically identical to
diamonds mined from the Earth. They differ from earth-mined diamonds
only in the following respects. Apollo Diamonds have:
1. Costs similar to other semiconductor materials (when in
wafer form);
2. Large sizes heading toward super sizes (4 inch wafers); and
3. Ultra purity.
These three features of cost, size and consistent purity are the
hallmarks of an industrialized materials platform and were
prerequisites for another fundamental high-utility material that has
powered our country's high-tech boom over the last thirty years:
silicon. Diamond is now at the beginning of a similar fifty-year growth
curve, in which we will see it used in every corner of our society,
courtesy of nanotechnology manufacturing techniques.
Nanotechnology manufacturing techniques in essence let us to do two
things: (a) control the diamond material at the nano scale to create an
exact copy of a high-quality natural diamond; and (b) impart (if we so
choose) nano scale features in the body of the diamond or on the
surface of the diamond that can be electrically, optically or
biologically activated.
In our diamond growth chamber, thin slivers of diamond (diamond
seeds) are placed on a pedestal. Purified gas is introduced into the
growth chamber and super-heated, stripping the carbon atoms away from
other impurities. The plasma gas of superheated carbon atoms envelops
the diamond seeds and begins the deposition of individual carbon atoms
on top of the seed diamond in the growth chamber. By maintaining this
process the diamond grows literally atom by atom. A pure, perfect
diamond crystal forms from what was previously gas.
Through the selective introduction of other atoms (such as boron or
nitrogen) into the pure carbon-based diamond, nano/atomic scale
features can be imparted into the interior of the diamond or on its
surface. These features and their consistent, engineered placement
connect the potential of the diamond to the full utility of the
material's promise. Consistent manufacturing, over large areas, with
controlled impurity content create the platform for semiconductor,
optical, and life science applications.
There is enormous opportunity for diamond to shape our world in the
same way that other blockbuster materials technologies like silicon
have done. Diamond is poised to be the materials platform of choice for
many advanced semiconductor, optical and life science applications that
will radically change the world.
The Commercialization Path
The culture of entrepreneurship is critical to innovation in the
nanotechnology sector. Apollo Diamond is an excellent example of this.
Like many high-potential, fast-growing American technology companies,
Apollo Diamond is a start-up company with twenty full-time employees.
The company was started in a garage but has its roots in the success of
the previous technology companies started and sold by its founders. Our
company places the good fortune of its success squarely on the fertile
ground of the United States capital system, the work ethic and
ingenuity of our American employees, and a band of 300 dedicated angel
investors who want to see this diamond technology stay domestic and
morph into a globally dominant business. This intersection of business
propellant only happens in the United States and we are truly
fortunate!
Apollo Diamond's Unique Approach to Commercialization
Materials technologies are time-consuming and capital-intensive to
commercialize. Fortunately, Apollo was able to leverage some unique
capabilities and opportunities that most semiconductor materials
science companies cannot access. First, the founders were commercially
successful in other technology ventures and could fund the preliminary
growth of the company despite lack of government funding. Second, and
more importantly for Apollo, it was the early business opportunity to
commercialize Apollo diamonds as gemstones that gave the company the
business strategy it needed to develop this difficult technology. The
gemstone opportunity is truly unique for a new materials technology
because it represents an extremely large market opportunity early in
the lifecycle of the product. Gem quality diamonds make up a $60
billion global market at the retail level and an $11 billion market at
wholesale.
Furthermore, a precedent had already been set in the gemstone
business with the introduction of cultured pearls early in the 1900s,
which essentially allowed the introduction of cultured pearls into what
was then a totally natural pearl market. Cultured pearls now represent
over 90 percent of the cultured pearl business as natural pearls have
become scarcer on a per capita basis because of environmental
sustainability issues surrounding pearl diving.
Enter the cultured diamond! Despite the fear in the diamond
industry surrounding the introduction of a competing product, the
cultured diamond actually makes the industry healthier. Diamonds remain
robust as a product category by allowing consumers to purchase larger,
more perfect diamonds than they were previously able to afford, opening
new markets while allowing mined diamonds to grow in value. A gem
market commensurately allows a technology company like Apollo to
attract investments which require early commercialization, while
building for the larger, long-term technology play.
The opportunity is large. As in other areas, the United States has
the opportunity to thrive in this emerging multi-billion dollar market.
But, the stakes are high and we cannot take victory for granted. As a
fundamental technology, we can not afford to hold anything less than a
commanding lead. A national effort in diamond will lead to a whole
range of technology sector jobs and allow our country to maintain our
lead in the applications spin-offs from diamond technology that will
directly affect our Nation's strategic capabilities.
Industry Challenges
Innovation is the key to America retaining its competitiveness in
nanotechnology. The source of innovation in America is our distinctive
culture of entrepreneurship. This culture and its advantages, however,
have come under increasing pressure in recent time. Investors want
quick returns and the private and public-market sector do not want to
invest in research or development. This comes at a time when foreign
governments are directly supporting product focused R&D in their
companies.
Although there are seemingly many new technology start-ups every
year in the United States, these startups need risk capital to bring
innovations to market. The period between a company's formation and its
achieving positive cashflow, known as the ``Valley of Death,'' is
particularly acute for new technologies including nanotechnology start-
ups. Start-ups are most vulnerable during this time. Apollo is ending
this phase with early stage revenues starting from gemstone sales which
will ideally in turn support further technology development. To get
here, however Apollo required investments in ``platform'' development
and capital support to make the fundamental breakthroughs in basic
research that power our product.
From our perspective, we see that the U.S. has the opportunity to
seed a large diamond-based electronics and optics industry here. The
industry can give us leadership in a number of areas including electric
power controls, high-speed wireless, water purification and bio-medical
sensors for life science applications. These products could profoundly
improve our quality of life, increase our national security and provide
well-paying high-tech, domestic jobs. We are however under competitive
threat from a declining local capital environment and growing foreign
subsidies for our competitors. Leveling this playing field by
encouraging investments in research and development will ensure that we
are not in the nanotech race just to play, but that we are going to
win.
Policy Recommendations
We recommend that the U.S. Government:
Level the playing field by creating incentives for
commercially-focused nanotech R&D. This will ensure that the
private-sector takes full advantage of the Federal investments
in infrastructure development to date. We believe that a focus
on commercialization will show an increased rate in new start-
up development, successful companies and a good return on
investment.
Engage the environmental, health and safety implications of
nanotechnology using the existing infrastructure and Acts for
materials regulation. We believe that the existing laws can and
should be updated to reflect nanotech rather than creating a
new law. The question is how we ensure that there are
appropriate safeguards without diminishing our competitive
advantage through undue regulations. We believe that when
answering this question we must make sure we consider
engineered nanomaterials in the context of other, known
materials rather than as a separate class.
Encourage U.S. students to enter science and engineering
graduate programs and developing policies that encourage
foreign graduates to stay in the United States. In the near-
term, we must continue to attract and retain the best
technological minds from around the world. In the medium- to
long-term, we must redevelop a pool of skilled domestic talent
that has always been a cornerstone of U.S. industry.
Develop policy that creates export and trade controls that
do not restrict access to global markets. Support free and open
trade and avoid export controls on nanotechnology except where
they have a clear, direct, and material national security
impact relative to existing non nanotechnology based
alternatives. Commensurately, ensuring that foreign competitors
do not unduly access and influence institutions such as the
Federal Trade Commission or other governing bodies would ensure
that we are able to develop sound domestic business as a
platform for foreign trade.
In summary, we feel fortunate to be in the United States and have
had the benefits of our system to fund a world-leading diamond
technology like the one we have at Apollo Diamond. With the right
nurturing, we collectively have the opportunity to seed a large
diamond-based electronics and optics industry here in the United States
similar to the silicon-based renaissance that happened in the 1960s and
1970s with silicon-based integrated circuit technologies. As Wired
Magazine stated, a ``New Diamond Age'' is upon us where we will see
diamond in every aspect of our society including electric power
controls, high-speed wireless, water purification and bio-medical
sensors for life science applications. These products have the
opportunity to profoundly improve our quality of life, increase our
national security and provide good-paying, high-tech, domestic jobs for
our citizens. We are on the verge of a large wave of positive change,
let's make sure it stays here in the United States.
Thank you.
Senator Allen. Mr. Chairman?
The Chairman. Yes, sir?
Senator Allen. Just for a point of clarification, may I
ask, do you own the intellectual property to the manufacturing
of these nano----
Mr. Linares. Yes, we do.
Senator Allen.--diamonds? You do.
Mr. Linares. Yes, we do.
Senator Allen. Thank you.
The Chairman. Our next witness, Dr. Mark Davis, Professor
of Chemical Engineering, at Caltech.
STATEMENT OF MARK E. DAVIS, Ph.D., PROFESSOR OF
CHEMICAL ENGINEERING, CALTECH; MEMBER OF THE
COMPREHENSIVE CANCER CENTER, CITY OF HOPE
Dr. Davis. Mr. Chairman and Committee Members, thank you
for the opportunity to speak to you today.
My objective is to tell you all about the excitement around
nanoparticles used in medicines, and how they might be able to
revolutionize the treatment of cancer.
The summary points from my written testimony are that not
all nanoparticles are alike, that nanoparticles that are made
for injection into humans for therapeutics are well-designed
and rigorously tested before they are injected into humans;
these nanoparticle therapeutics, as I will try to show you,
have the potential to change the way cancer is treated; and
that the regulatory processes for these high benefit-to-risk
ratio nanomedicines are working and constantly evolving, both
from a scientific and regulatory point of view.
Now, there has been great progress in understanding cancer,
but there is still a great need to try to reduce the number of
deaths due to cancer. And the ultimate cause of death in most
cancer patients is drug-resistant metastatic cancer. What does
that mean? That means that you have tumors disseminated through
your body that no longer respond to chemotherapeutic
treatments. And it's actually this state that nanoparticles
have an opportunity to attack, precisely because of their
unique properties.
Here, I show a picture of nanoparticles. These particles
contain polymers that are carrying therapeutic agents; and
they're in the size of about 100 nanometers. And what that
means is, they're very small. And, being small, they can
circulate through your blood for a long period of time, access
tumors throughout your body, and penetrate into the tumors. And
we, and others, have shown that when you're in this size range
between 50 and 100 nanometers, you can actually enter cells to
bring in the drug that would normally be resistant to the
molecule itself. So, it's an access plus also a treatment to
drug resistant cells, that's important with that size.
Now, although these are small, relative to particles you
can see with your eye, and feel, they're large, relative to
molecules. A molecule is about one nanometer in size. And so,
when you have a 100-nanometer particle, you can really carry a
lot of drug molecules with it. So, in addition to the access,
you can carry a big payload.
Now, let me illustrate how that can work. I hope we've all
seen fireflies; and the back of a firefly lights up. And that's
a protein that gives off that light. We can take the gene for
that protein, put it in cancer cells; and so, we can follow
those cancer cells through animals, because they light up. What
I've shown you here is a series of images of a mouse where
we've put human cancer cells in; and where you see the color in
the white fur is actually where the tumors are. In the top
sequence of days that you see there, there are three treatments
at--where the stars are, of the normal chemotherapeutic drugs
used in its optimum conditions. And this is one that's
commercially used in patients. What you see is that the tumors
start to shrink, but they ultimately come back in multiple
locations and ultimately cause the death of the animal.
On the bottom panel, we've given a nanoparticle with--
holding essentially the same drug, at one-tenth the amount of
drug going into the animal, which can then access, very
efficiently, these tumors. As you can see, those tumors are
eradicated, and they stay away. And the animal lives a long
life and dies of old age. These principles are--I show you
today in animals--actually being tested in humans right now in
early clinical trials.
So, there's an amazing excitement, but also caution,
because of safety. But what I want to make clear to you today
is, nanoparticles in medicine are not new. There have been
nanoparticles in humans used for therapeutics for at least 25
years now. And there's a history of safety with these. In fact,
the safety profile of these nanomedicines are actually better
than the drugs that they're carrying when they're used alone.
The features of these medicines that are really exploited
are not only the size, but the surface properties. And it's the
control of those properties that's important to these
nanomedicines and doesn't happen when you get environmental
exposures to nanoparticles. It's this control and then all of
the regulatory safety issues that we have to go through, first
in animals and in humans, before these are released to the
public that make this different than other areas of
nanoparticles.
So, to conclude, where's the future and what are the
challenges?
Well, in the future, these newer nanoparticles are only
going to get better. They're going to get more uniform in size
and surface properties, which will make them more effective,
and also we'll be able to make them more definable from their
safety profiles. And, in fact, this year alone, for the first
time, new nanomedicines that were designed from first
principles are reaching the clinic.
These new particles are going to have greater
functionality, in the sense that they're going to be ``smart.''
They can recognize what's going on and do their functions only
when they're in the right place to do them.
We'll also have, simultaneously, imaging in therapeutic
particles so that we can go into a patient and make sure that
the target of the disease is in the patient before you treat
the patient. And so, in a way, this is one aspect of
personalized medicine.
Now, what are the challenges? These are complex particles.
They have many components. And so, their costs are going to be
high. Also, we--any new medicine has long regulatory pathways.
And in this space here, there are many, many intellectual
property issues that have to be resolved to be able to make a
functioning particle. Also, because of these regulatory issues,
there are long times for approval, which turn into being very
capital-intensive. These are really the rate-limiting steps to
getting these medicines through to the public. So, because of
those time-scales and so forth, if we're to get these medicines
to the public in the next 10 years, they either have to exist
today or in the very near future to be able to get it to them
in the next few years.
Thank you very much.
[The prepared statement of Dr. Davis follows:]
Prepared Statement of Mark E. Davis, Ph.D., Professor of Chemical
Engineering, Caltech; Member of the Comprehensive Cancer Center, City
of Hope
Mr. Chairman and members of the Committee, thank you for the
opportunity to testify at this hearing. Since the early 1980s, I have
been working in areas of science and technology that are now classified
as nanoscience/nanotechnology. My objective today is to present the
potential of nanoparticles for use as therapeutics to treat human
disease. In particular, I wish to convey the excitement over what these
new medicines could mean to the diagnosis and treatment of metastatic
cancer. Additionally, I want to emphasize that not all nanoparticles
are the same: those created for the purpose of injection into humans
for therapeutic purposes are well designed and rigorously tested for
safety offer a tremendous benefit-to-risk ratio for the treatment of
cancer, unlike nanoparticles that enter the body from environmental
exposure.
Numerous diseases occur throughout the human body, and systemic
imaging and therapy are necessary to treat and eradicate them.
Metastatic cancer, for one, is a particularly important disseminated
disease requiring such an approach, because treatment-resistant
metastases (tumors located throughout the body that are not the primary
tumor or site of the cancer) ultimately are the cause of death in most
cancer patients. Detection and treatment of systemic diseases present
numerous challenges, since humans possess a variety of defense
mechanisms against the foreign agents that must be inserted into the
body for imaging and therapy. Additionally, systemically-delivered
agents need to reach all their intended tissue and cellular targets to
be effective. These features and many others make the creation of
systemic imaging and therapeutic agents a daunting task.
Nanoscaled materials typically have properties not manifested
either in larger particles with the same composition or in individual
molecules, a distinguishing feature of great significance. While this
motivation has driven nanoscience and technology in physics and
engineering, it is not the main reason that nanoparticles are useful
for systemic applications in the human body. Nanoparticles in the body
behave differently compared with larger particles, not because of any
fundamental difference in physical or chemical properties, but instead
because the small size of a nanoparticle allows it access to sites that
larger particles cannot reach.
To achieve systemic localization, medicines must at some point
enter the circulatory system for dissemination throughout the body.
Molecular medicines that are typically 1 nm in size are quickly removed
from the body by the kidneys. In order to stop this fast elimination,
nanoparticles must be larger than 10 nm in diameter. Thus, an advantage
of nanoparticle medicines over molecular medicines is that they can
remain in circulation for longer times and provide for extended length
of therapy (in addition to the enhanced localizations). Through careful
experimentation, we and others have shown that nanoparticles can access
tumors from the circulatory system and move throughout them if they are
``well designed,'' and have sizes in the 50-100 nm range (Hu-Lieskovan
et al., 2005 and Kim et al., 2006). By ``well designed'', I mean the
surface of the particles are carefully controlled as the surface
properties of the nanoparticles can greatly influence their behavior in
humans (Chen et al., 2005). It is the purposeful control of size and
surface properties of nanoparticle medicines that distinguishes them
from other types of nanoparticles.
Nanoparticles for imaging and therapy will be of size 10-100 nm and
are composites of polymers and other organic materials and the
therapeutic/image agents. These particles are typically spherical and
they are seven orders of magnitude smaller than a soccer ball. That is,
the increase in size from the nanoparticles to the size of a soccer
ball is the same increase in size as going from the size of a soccer
ball to the size of the Earth. While these nanoparticles are small
compared to other particles, they are large compared to molecules. For
example, the size of a molecule (ca. 1 nm) to the size of a 100 nm
nanoparticle is analogous to the size relationship between a soccer
ball and the Goodyear blimp (think about how many soccer balls could be
held in the blimp). This size allows nanoparticles to have a variety of
features and functions that are not possible with molecules. It is
precisely these features and functions that can be exploited to create
nanoparticle medicines.
What particular features will be exploited when nanoparticles are
used for systemic imaging and therapy? First, control over size and
surface properties allows access to locations that are either denied to
larger entities or difficult to reach in significant quantities with
smaller entities such as molecule therapeutics because of rapid loss
from the body (renal clearance). Additionally, if the drug or imaging
agent needs entrance into the cell, nanoparticles can be engineered so
that they can be internalized. There are at least two important
consequences of this feature. Nanoparticles can be used to attack
intracellular disease targets. Many of these intracellular targets have
been known for some time but have been considered un-drugable. Also,
nanoparticles can be designed to release a significant portion of their
``payload'' when they enter cells, and this feature can be very
advantageous. For example, many anticancer drugs lose their
effectiveness when tumors become resistant owing to surface proteins
that deny entrance to the drug molecules. Nanoparticles internalize
into cells in ways that bypass the surface proteins, and can thus
facilitate new therapies using existing drugs that, administered alone,
would be ineffective. This capability of nanoparticles may provide
whole new treatment methodologies for cancer patients.
These attributes lead to a second feature of nanoparticles that
makes them useful for systemic imaging and therapy: their ability to
perform multiple functions, since the particles are large enough to
accommodate numerous components within the same particle. Multiple
agents can be assembled into individual nanoparticles (multiple
therapeutic agents, multiple imaging agents, and their combinations),
making it possible, for example, to combine small molecular
chemotherapeutic agents with other types of agents to simultaneously
attack cancer at multiple pathways.
A third feature important for systemic imaging and therapy is the
large number of atoms contained in a nanoparticle relative to that
contained in a molecule (think of the soccer balls in the blimp). The
nanoparticle thus delivers a greater ``package'' of material, and this
increased payload size can help enhance the signal for imaging or
provide a localized ``bolus'' of drug. One can imagine nanoparticle
imaging agents that provide information on intracellular targets. The
molecular target of the disease could be verified to exist in a patient
prior to treatment, and since the observation was made via a
nanoparticle with the same size and surface properties as the
therapeutic particle, the therapy would be expected to reach the
target. This combination will allow personalized medicine in the sense
that treatment does not have to be administered until the target is
known actually to be present in the patient. Also, follow-up imaging
can be performed to verify that the target has been reached and that
the therapy is working.
While there is tremendous excitement over the potential of
nanopaticles for cancer imaging and therapy, there are also words of
caution about their safety appearing in the literature. Concerns about
nanoparticle toxicity are legitimate since not much is known about how
these entities behave in humans. The size and surface properties of
nanoparticles give them access to locations that were not previously
available with larger particles, and the size of properly designed
nanoparticles can affect their localization. Studies in this area
suggest that more investigation is needed in order to define the
biocompatibility of nanoparticles in humans. On the one hand, there are
examples where nanoparticles have no detrimental effects (silica coated
magnetic 50 nm particles: Kim et al., 2006), and, on the other hand,
examples where they do (carbon nanotubes: Salvador-Morales et al.,
2006). As expected, the size and surface properties of nanoparticles
dictate their behavior, and much more data are necessary to develop a
fundamental understanding of the structure-property relationships.
However, one must consider the benefit-to-risk ratio for the intended
application when assessing the biocompatibility of nanoparticles. In
cancer, this ratio is very high and therapeutic agents in current use
are not without their own safety risk profile. In fact, current
nanoparticle medicines have superior safety profiles to the drugs that
they are carrying. Also, in order to use a nanoparticle in humans, they
must pass rigorous and lengthy regulatory processes prior to approval.
Nanoparticle medicines and imaging agents already have a history of
use in humans. Commercial therapeutics and imaging agents such as
AmBisome (liposomal amphotericin B), SMANCS (synthetic polymer-drug
conjugate), Abraxane (albumin-paclitaxel nanoparticle), and Feridex
(dextran-iron oxide nanoparticle for MRI) are just a few of the
nanoparticulate drugs and imaging agents currently available for human
use. Some of these nanoparticles are in the 10-100 nm range (AmBisome
has an average size of 60-90 nm, Feridex an average size of
approximately 30 nm), while others are not (Abraxane has an average
size of 130 nm). Other nanoparticulate materials such as the polymer-
drug conjugate XYOTAX (polygutamate-paclitaxel) are in late-stage
clinical trials. Thus there is at least a 25-year history of using
nanoparticles in medicine (AmBisome being the first and used in
clinical trials in the 1980s). These commercial nanoparticles have gone
through rigorous toxicity testing for regulatory approvals and have
years of experience in humans. This increasing store of information
provides an initial understanding of how nanoparticles can exist and
function in the body. Although each new nanostructure will need to be
tested individually, there is reason to believe that nanoparticles can
be used as effective systemic medicines and imaging agents. As more
biocompatibility data become available, a further understanding of how
to tune size and surface properties to provide safety will permit the
creation of new, more effective nanomedicines for systemic use.
Since nanoparticles already exist as commercial medicines and
imaging agents, what might be expected in the future? To begin, control
over the size distribution and surface properties will see great
improvements. Although average sizes of commercial nanoparticulate
medicines and imaging agents fall within the range 10-150 nm, the
distribution in size (that is, the spread of values about the average)
and the consequent variation of surface properties are quite large for
each product. Newer nanoparticles will be much more uniform in their
size and surface properties than current ones, and this uniformity
should translate into more effective medicines and imaging agents with
better definable biocompatibilities. Additionally, nanoparticles will
become ``smart'' in the sense that they will be able to take cues from
their local environment to activate functions at specified times and
locations. Early examples of this phenomenon already exist for
nanoparticles designed to sense their entrance into cells and trigger
the release of therapeutic agents (Davis et al., 2004).
There is no doubt that these types of nanoparticles will exist in
the future. Current nanoparticle medicines and imaging agents provide
initial support for low toxicity with properly designed nanoparticles,
and significant advancements in nanoparticle uniformity will further
improve this situation. As newer and more complex nanoparticle systems
appear, better methodologies to define biocompatibility will need to be
developed, especially those that can assess intracellular
biocompatibility. A significant remaining question is whether complex
nanoparticle agents for imaging and therapy will be commercially-viable
in the face of numerous impediments to their development and
implementation. These complex, multifunctional nanoparticles will be
expensive to produce, and issues regarding scale-up and cGMP production
are not often discussed. The multi-component nature of the
nanoparticles also renders their manufacture and regulatory approval
very difficult. Beyond the cost of development itself, intellectual
property costs can be very high as well, because each of the many
components needed to create the nanoparticle might require multiple
licenses. Given these high barriers to commercialization, some
excellent medical nanoscience will doubtless never attain clinical or
commercial status, and those products that do win approval will likely
be expensive. Finally, we must recognize that the time-frame for
regulatory approval is sufficiently long that new nanomedicines of the
next 10 to 15 years--if they are to be realized--must already exist and
be in some stage of research or development, or else be invented within
the next few years. If advanced nanomedicines are to reach the public
within 10 or 15 years, there must be a significant effort underway in
their discovery and development today because of lengthy approval
processes.
References
Chen, M.Y., Hoffer, A., Morrison, P.F., Hamilton, J.F., Hughes, J.,
Schlageter, K.D., Lee, J., Kelly, B.R. and Oldfield, E.H. (2005)
Surface properties, more than size, limiting convective distribution of
virus-sized particles and viruses in the central nervous system. J.
Neurosurg. 103, 311-319.
Davis, M.E., Pun, S.P., Bellocq, N.C., Reineke, T.M., Popielarski,
S.R., Mishra, S. and Heidel, J.H. (2004) Self-Assembling Nucleic Acid
Delivery Vehicles via Linear, Water-Soluble, Cyclodextrin-Containing
Polymers. Curr. Med. Chem. 11, 179-197.
Hu-Lieskovan, S., Heidel, J.D., Bartlett, D.W., Davis, M.E. and
Triche, T.J. (2005) Sequence-Specific Knockdown of EWS-FLI1 by
Targeted, Nonviral Delivery of Small Interfering RNA Inhibits Tumor
Growth in a Murine Model of Metastatic Ewing's Sarcoma. Cancer Res. 65,
8984-8992.
Kim, J.S., Yoon, T.J., Yu, K.N., Kim, B.G., Park, S.J., Kim, H.W.,
Lee, K.H., Park, S.B., Lee, J.K. and Cho, M.H. (2006) Toxicity and
Tissue Distribution of Magnetic Nanoparticles in Mice. Toxicol. Sci.
89, 338-347.
Nomura, T., Koreeda, N., Yamashita, F., Takakura, Y. and Hashida,
M. (1998) Effect of particle size and charge on the disposition of
lipid carriers after intratumoral injection into tissue-isolated
tumors. Pharm. Res. 15, 128-132.
Popielarski, S.R., Hu-Lieskovan, S., French, S.W., Triche, T.J. and
Davis, M.E. (2005) A Nanoparticle-Based Model Delivery System to Guide
the Rational Design of Gene Delivery to the Liver, 2. In Vitro and In
Vivo Uptake Results. Bioconj. Chem. 16, 1071-1080.
Salvador-Morales, C., Flahaut, E., Sim, E., Sloan, J., Green,
M.L.H. and Sim, R.B. (2006) Complement activation and protein
adsorption by carbon nanotubes. Mol. Immunol. 43, 193-201.
The Chairman. Thank you, Doctor.
Our last witness is Dr. Clarence Davies, Senior Advisor to
the Project on Emerging Nanotechnologies at Woodrow Wilson
International Center.
Dr. Davies?
STATEMENT OF DR. J. CLARENCE (TERRY) DAVIES, SENIOR
ADVISOR, PROJECT ON EMERGING NANOTECHNOLOGIES,
WOODROW WILSON INTERNATIONAL CENTER FOR
SCHOLARS; SENIOR FELLOW, RESOURCES FOR THE FUTURE
Dr. Davies. Thank you, Mr. Chairman.
My name is J. Clarence Davies. I am Senior Advisor to the
Project on Emerging Nanotechnologies at the Woodrow Wilson
International Center for Scholars, and a Senior Fellow at
Resources for the Future. However, my testimony represents my
personal views, and not the views of any of these
organizations.
The Project on Emerging Nanotechnologies asked me to
examine the strengths and weaknesses of the current U.S.
regulatory system in relation to nanotechnology. My report,
``Managing the Effects of Nanotechnology,'' is the subject of
my testimony. And I gather that will be included in the hearing
record, Mr. Chairman.
It is a critical time for nanotechnology. It can offer
solutions to many of the most serious problems our society
faces, as you have heard from many of the other witnesses
today. However, we currently know little about its short- and
long-term effects on human health or the environment. The
public's views of nanotechnology remain----
The Chairman. Can you all hear him back there? I don't
think they can hear you. Pull that mike up a little bit closer.
Thank you.
Dr. Davies. That better?
The Chairman. Yes.
Dr. Davies. OK.
The Chairman. Thank you.
Dr. Davies. The public's views of nanotechnology remain
unformed. Most people have never heard of nanotechnology. We
now have a unique opportunity to get it right, to introduce a
major new technology without incurring significant public
opposition, and without gambling with the health of citizens,
workers, consumers, or the environment.
A lot depends on our ability to get it right. If we fail,
we run a double risk. First, a risk of unanticipated harm to
health and the environment. Second, a risk of public rejection
of the technology. Our past experiences with agricultural
biotechnology, nuclear power, and asbestos, for example,
illustrate how tragic either of these risks could be. Industry,
as well as the general public, has a big stake in ensuring that
nanotechnology is developed responsibly from the start.
Adequate government oversight of nanotechnology is an
essential part of getting it right. The Federal agencies have
maintained that they have adequate statutory authority to deal
with nanotechnology. The analysis in my report clearly shows
that the existing regulatory structure for nanotechnology is
not adequate. Some programs, like FDA's oversight of drugs, are
OK, as Dr. Davis has commented, but the regulatory structure as
a whole suffers from three types of problems: gaps in statutory
authority, inadequate resources, and a poor fit between some of
the regulatory programs and the characteristics of
nanotechnology.
The Chairman. What was that, the third one?
Dr. Davies. A poor fit between some of the regulatory
programs and the characteristics of the technology. In other
words, the definitions in the laws and, you know, the way the
program is oriented don't fit very well.
The gaps in statutory authority are most obvious with
respect to two of the most common uses of nanomaterials,
cosmetics and consumer products. In both cases, there is
essentially no statutory authority to review the health and
safety of these products. In both areas, there is a large
potential for human exposure.
Originally, I did not believe that new legislation would be
necessary; however, given the shortcomings of the existing
system, I now believe that it is in everyone's interest to
start thinking about a new law. The existing laws cannot
provide protection for the public or offer a predictable
marketplace for nanotechnology businesses and investors. No
amount of coordination or patching will fix this problem.
One of the frequent reactions that I got to the report
after its release was, shouldn't we wait for more information
before we regulate? Waiting for more information is a
reasonable and valid option in the scientific world; however,
in the policy world, waiting for more information is not
delaying a decision, it is making a decision. It is making a
decision to not do something. Put another way, our policy
choice is not between acting or waiting for more information,
it is between reviewing products for their health and safety or
allowing people to be exposed to products without any
government oversight of their effects.
Do we need more scientific information to help us evaluate
the health and safety of nanoproducts? Absolutely. And I
support the kinds of initiatives that Dr. Gotcher talked about
in his testimony.
Is there reason now to believe that some nanoproducts could
have adverse effects? Yes, for reasons that I outlined in my
written testimony and also in a scientific review article which
I have submitted for the record.
We might not need regulation if all companies were good
product stewards, just as we would not need criminal laws if
all people were angels. Unfortunately, there are bad actors in
the corporate world, and all companies face pressures not to
invest money in so-called nonproductive efforts, like testing
for health and environmental effects. It is in a firm's
interest to test products for acute, immediate adverse effects,
but when it comes to testing for chronic effects, like cancer
immunogenesis, or to testing for environmental effects, it can
be tempting for companies to not test their products.
The greatest threat to the future of nanotechnology and to
nano-based businesses is not regulation, but a collapse in
public confidence. A dialogue among interested parties,
including industry, environmental and consumer groups, and
government agencies can, I think, arrive at a reasonable
regulatory approach that does not unduly inhibit technological
innovation. This dialogue needs to start now. We cannot afford
to lose the opportunity to get it right.
Thank you, Mr. Chairman.
[The prepared statement of Dr. Davies follows:]
Prepared Statement of Dr. J. Clarence (Terry) Davies, Senior Advisor,
Project on Emerging Nanotechnologies, Woodrow Wilson International
Center for Scholars; Senior Fellow, Resources for the Future
I would like to thank Chairman Ted Stevens, Co-Chairman Daniel
Inouye, and the members of the Senate Commerce, Science, and
Transportation Committee for holding this hearing on developments in
nanotechnology. I appreciate the opportunity to appear here before you
today.
My name is J. Clarence (Terry) Davies. I am a Senior Advisor to the
Project on Emerging Nanotechnologies at the Woodrow Wilson
International Center for Scholars and a Senior Fellow at Resources for
the Future. However, my testimony represents my personal views and not
those of the Project on Emerging Technologies, the Wilson Center, or
Resources for the Future.
Last summer, the Project on Emerging Nanotechnologies asked me to
examine the strengths and weaknesses of the current U.S. regulatory
system in relation to nanotechnology. My report, ``Managing the Effects
of Nanotechnology,'' is the subject of my testimony today. I request
the Committee's permission to include the report as part of the hearing
record.
I was asked to do the study because I have spent more than 40 years
as an analyst and participant in environmental policy. I have a Ph.D.
in American Government from Columbia University, and have been on the
faculties of Bowdoin College and Princeton University. I have worked in
the Federal Government at three different times, most recently as
Assistant Administrator for Policy at the Environmental Protection
Agency (EPA) in the George H.W. Bush Administration. In 1970, as a
consultant to the President's Advisory Council on Executive
Organization, I co-authored the plan that created EPA.
I have served on a number of committees of the National Academy of
Sciences, chaired the Academy's Committee on Decision Making for
Chemicals in the Environment, and in 2000 I was elected a Fellow of the
American Association for the Advancement of Science for my
contributions to the use of science and environmental policy analysis.
When I began the study for the Project on Emerging
Nanotechnologies, I spent several months focusing on the applications
and implications of nanotechnology. As I learned more, I was impressed
by what a critical time this is for the development of this marvelous
technology. Nanotechnology is still very new and it is full of promise.
It may offer solutions to many of the most serious problems our society
faces. It offers the hope of significant breakthroughs in areas such as
medicine, clean energy and water, environmental remediation, and green
manufacturing. However, we currently know little about the short- and
long-term effects of nanotechnology on human health or the environment.
Additionally, the public's views of nanotechnology remain largely
unformed. The vast majority of people have never heard of
nanotechnology, though it is anticipated that they will learn about the
technology as applications emerge and as products enter the market. For
this reason, we now have a unique opportunity ``to get it right''--to
introduce a major new technology without incurring significant public
opposition and without gambling with the health of citizens, workers,
consumers, or the environment.
A lot depends on our ability to ``get it right.'' If we fail, we
run a double risk. First, we run the risk of unanticipated harm to
health and the environment. Second, we run the risk of public rejection
of the technology. Our past experiences--with agricultural
biotechnology, nuclear power, and asbestos, just to name a few--
illustrate how tragic either of these scenarios could be. Industry, as
well as the general public, has a big stake in ensuring that
nanotechnology is developed responsibly from the start.
Adequate government oversight of nanotechnology is an essential
part of ``getting it right.'' The public does not trust industry to
regulate itself. Past experience, as well as surveys and focus groups,
show that if the public does not think that the government is
exercising adequate regulatory oversight of a potentially hazardous new
technology then it will mistrust and likely reject that technology. If
this happens, literally billions of dollars of investment by government
and industry in nanotechnology research and development may be
jeopardized.
To date, the National Nanotechnology Coordinating Office (NNCO) has
maintained that the Federal agencies have adequate statutory authority
to deal with nanotechnology. Dr. E. Clayton Teague, Director of the
NNCO, has said that: ``Until we have good, solid, scientifically
validated information that would indicate significant inadequacies in
existing regulatory authorities, additional regulations would just be
unnecessarily burdensome.'' \1\ This is an insufficient response to the
challenge, and, I believe, misleading to both the public and industry.
By overstating the case for regulatory adequacy, one shifts risks onto
corporate investors, shareholders, and the exposed public.
---------------------------------------------------------------------------
\1\ Susan R. Morrissey, ``Managing Nanotechnology: Report Evaluates
Ability of US Regulatory Framework to Govern Engineered
Nanomaterials,'' Chemical & Engineering News, Volume 84, Number 5,
January 30, 2006, p. 34.
---------------------------------------------------------------------------
The analysis in my report clearly shows that the existing
regulatory structure for nanotechnology is not adequate. It suffers
from three types of problems: (1) gaps in statutory authority, (2)
inadequate resources, and (3) a poor fit between some of the regulatory
programs and the characteristics of nanotechnology.
(1) The gaps in statutory authority are most obvious with respect
to two of the most common uses of nanomaterials--cosmetics and consumer
products. In both cases, there is essentially no statutory authority to
review the health and safety of these products. In both cases, the
principle is caveat emptor--let the buyer beware. In both areas, there
is large potential for human exposure to nanomaterials. A wide variety
of nano-based consumer products have already begun to enter the market
as sporting goods, clothing, cleaning materials, and kitchen
appliances. Similarly, nano-based cosmetic products already range from
skin creams to spray-on foot deodorizers, all with significant exposure
potential (dermal, inhalation, and ingestion) and little publicly-
available risk data.
A more subtle set of statutory problems relates to the Toxic
Substances Control Act (TSCA), which many have suggested as the primary
law that should be used to regulate nanotechnology. TSCA is a very weak
law for reasons that I describe in the report. One weakness is
particularly important in relation to nanotechnology. TSCA implicitly
assumes that if there is no information on the risk of a chemical then
there is no risk. In other words, the law acts as a significant
disincentive to generating information on possible risks of a chemical.
This is exactly the opposite of what is needed. A major reason to
adequately regulate nanotechnology is to provide an incentive for
generating information. There is an interaction between regulation and
information. A certain amount of information is needed to make
regulation work, but regulation, properly crafted, can provide an
important incentive to produce health and safety information.
(2) All of the Federal regulatory programs suffer from a shortage
of resources. This shortage of resources is not only related to funding
levels. There is also a shortage of personnel--particularly individuals
with the appropriate expertise to deal with nanotechnology. For some of
the programs most relevant to nanotechnology the deficiency is so great
that it raises doubts about whether the program can function at all. In
1980, The Occupational Safety and Health Administration (OSHA) had
2,950 employees, a number that was inadequate for its responsibilities
then. Today, with a greatly expanded economy and workforce, OSHA has
2,208 employees, approximately 25 percent fewer. The Consumer Product
Safety Commission (CPSC) has, since its creation, suffered from both
statutory and resource problems. Today CPSC has half the staff that it
had in 1980. Statutory authority without the resources for
implementation will not lead to adequate oversight. This committee
should ask for a more detailed accounting of available resources
[including personnel (FTEs) and research dollars] dedicated
specifically to nanotechnology oversight in key agencies (EPA, FDA,
OSHA, CPSC, and the U.S. Department of Agriculture).
(3) None of the health and environment laws were drafted with
nanotechnology in mind, and fitting nanotechnology into the existing
statutory framework can be problematic. For example, many of the
environmental statutes are based on an assumption that there is a
direct relationship between quantity or volume on one hand and degree
of risk on the other. This relationship does not hold for most
nanomaterials.
In the near-term, we will have to make do with current laws and
programs. My report discusses adjustments to existing laws. It also
discusses voluntary programs that can be used in the near-term. Though
voluntary programs have been put forth as an interim solution, they are
not a solution over the long-term.
Voluntary programs tend to leave out the firms that most need to be
regulated. Such programs also lack both transparency and accountability
and thus do not contribute to public confidence in the regulatory
system.
When I began working on the report, I did not believe that new
legislation would be necessary. However, given all of the shortcomings
of the existing system, I now believe that it is in everyone's interest
to start thinking about what a new law might look like. The existing
laws are not adequate. They cannot provide protection for the public,
or offer a predictable marketplace for nanotechnology businesses and
investors. No amount of coordination or patching is likely to fix the
problem.
The report devotes a whole chapter to what a new law might contain.
However, the details are less important than getting the major
interested parties talking about what needs to be done. Such a dialogue
depends on recognizing the shortcomings of the existing regulatory
framework. All-out defense of the status quo does not serve the
interests of public safety or technological innovation. If
nanotechnology is to reach its full potential, then the problems that I
raise in my report need to be faced.
Since its release in January 2006, the report has attracted a good
deal of attention. I have frequently been asked three questions which
are worth briefly addressing here:
1. Is there any reason to believe that there are any adverse
effects from nanotechnology?
2. Can't industry be trusted to test new products since it is
in its best interest to do so?
3. Don't we need to wait for more information before we can
regulate nanotechnology?
(1) Adverse effects: I am not a toxicologist, and I do not have the
qualifications to address in depth the potential adverse effects of
nanotechnology. However, there are three reasons to believe that such
effects are likely. First, every technology of the scope of
nanotechnology has had adverse effects. The idea that nanotechnology
could be completely innocuous flies in the face of what we have learned
over many years of dealing with technological innovation.
Second, many decades of studying exposure to fine particles--in the
workplace and the environment in general--have shown that inhaling fine
(and possible nanometer-sized) particles can be harmful. Third, on-
going research into the health implications of engineered nanomaterials
raises many questions and concerns. For instance, we know that:
Nanometer-scale particles behave differently from larger
sized particles in the lungs--possibly moving to other organs
in the body;
The surface of some nano-structured particles is associated
with toxicity--rather than the more usually measured mass
concentration; and
Conventional toxicity tests do not seem to work well with
nanomaterials such as carbon nanotubes.
My report references several summaries of the results of these
tests. \2\
---------------------------------------------------------------------------
\2\ Additionally, see: Gunter Oberdorster, Eva Oberdorster, Jan
Oberdorster. ``Nanotoxicology: An Emerging Discipline Evolving for
Studies of Ultrafine Particles,'' Environmental Health Perspectives,
July 2005, 113(7): 823-839; The Royal Society and The Royal Academy of
Engineering. Nanoscience and Nanotechnologies, London, U.K., The Royal
Society and The Royal Academy of Engineering, 2004; and Tracy Hampton.
``Nanotechnology Safety,'' JAMA 294(20): 2564-2564.
---------------------------------------------------------------------------
The debate over how safe nanotechnology is, and how risk should be
governed, must be conducted in the knowledge that nanotechnologies--or
the specific applications of nanotechnology--are diverse. Some will
present a far greater risk to health and the environment than others.
For example, a review article, which I also ask permission to
submit for the record, notes that nanomaterials and products which
present the greatest risk to human health are those that can both get
into the body and possess a nanostructure that is associated with toxic
effects. These include unbound nanometer-diameter particles (in
powders, aerosols and liquid suspensions); agglomerates and aggregates
of nanometer-diameter particles, and particles produced as
nanotechnology products degrade or are machined in some way. \3\
---------------------------------------------------------------------------
\3\ Andrew D. Maynard and Eileen D. Kuempel. ``Airborne
Nanostructured Particles And Occupational Health,'' Journal of
Nanoparticle Research, 2005 7: 587-614.
---------------------------------------------------------------------------
Overall, the current state-of-knowledge on nanotechnology and risk
does not provide definite answers to how harmful nanotechnologies are.
Rather, it raises red flags concerning some materials and products, and
enables us to start asking important questions. Now that we can begin
to ask the right questions, it should be possible to develop
scientifically sound, rational and responsible approaches to
understanding and managing the possible impacts of nanotechnology on
health.
(2) Voluntary testing. It is in the interest of most manufacturers
to do some tests of their products. A number of companies have a
reputation of exceeding current regulatory requirements in regards to
product testing, and no manufacturer wants its customers or workers to
be adversely affected by its products. However, testing, when done, is
largely for short-term acute effects and not for long-term effects,
such as cancer, mutagenesis, and environmental effects. Testing for
long-term health and environmental effects can be expensive and, if
there is some adverse effect, it is unlikely that the effect will ever
be associated with the particular product. Thus it can be tempting not
to do such testing, if not required.
(3) Information and regulation. We do need more information before
an adequate oversight system can succeed. But it is not too early to
start thinking and talking about the outlines of such a system. It is
not too early because nanotechnology products are being commercialized
now, and the regulatory system must deal with them. A survey by EmTech
Research of companies working in the field of nanotechnology has
identified approximately 80 nanotechnology consumer products, and over
600 nanotechnology-based raw materials, intermediate components and
industrial equipment items that are used by manufacturers. \4\ Experts
at the Project on Emerging Nanotechnologies believe that the number of
nanotechnology consumer products on the market worldwide is actually
larger than the EmTech data suggest.
---------------------------------------------------------------------------
\4\ U.S. Environmental Protection Agency, External Review Draft
Nanotechnology White Paper, December 2, 2005, p. 14.
---------------------------------------------------------------------------
Furthermore, it also is not too early to start thinking and talking
about an oversight system because knowing what a regulatory structure
will look like can provide important guidance about what information is
needed. Given the realities of the legislative process, it could be
years before new legislation is enacted. The process of discussing a
better system can itself help generate agreement about what needs to be
done, and help foster international harmonization, research, and public
participation.
We will never have all the information we want, but now is the time
to begin putting in place an oversight system to utilize the available
information and encourage the generation of more.
My report is intended to help advance a powerful and beneficial new
technology while at the same time ensuring that it does not produce
avoidable adverse effects. These twin goals are mutually compatible. In
reality, they are inseparable. If we do not create a system that can
adequately review nanotechnology products for potential adverse
effects, we not only may endanger human health and the environment, we
will also endanger the future of the technology itself.
The Financial Times last year in an editorial, ``Nurturing
Nanotech'' said: ``No one wants to strangle a fast-expanding young
industry with regulations. The Internet illustrates the benefits of
allowing an exciting new technology to explode in a virtually
unregulated environment. But some promising new fields are likely to
grow better inside a well-constructed regulatory framework, either
because they are exceptionally sensitive in moral and ethical terms or
because they pose a potential hazard to health and the environment.
Nanotechnology comes clearly into the latter category.'' \5\ I agree.
---------------------------------------------------------------------------
\5\ ``Nurturing Nanotech,'' The Financial Times. February 26, 2005.
---------------------------------------------------------------------------
Existing laws and regulatory programs are inadequate for dealing
with the possible adverse effects of nanotechnology. Failure to develop
a better system could leave the public unprotected, the government
struggling to apply existing laws to a technology for which they were
not designed, and industry exposed to the possibility of public
backlash, loss of markets, and potential financial liabilities.
Nanotechnology holds great promise for a better life. If it is to
fulfill this promise, we must openly face the issues of whether the
technology has adverse effects, what these effects are, and what kind
of a regulatory system can prevent adverse effects from occurring.
The greatest threat to the future of nanotechnology and to
nanotechnology-based businesses is not regulation but a collapse in
public confidence. Based on polling and focus groups, I believe that
the public will hold both government and industry to a higher standard
of safety for nanotechnology than it has for any previous technology.
\6\ Citizens are both more sophisticated and more suspicious of new
technologies and will be largely intolerant if adverse effects occur.
If a problem develops and public confidence collapses, it will be
impossible to go back and argue that the existing system of statutes
was adequate. There will be great public pressure to do something. We
will not have the time to undertake the careful deliberation and
consultation with stakeholders that can take place now. We will have
lost the opportunity to ``get it right.''
---------------------------------------------------------------------------
\6\ See Jane Macoubrie. Informed Public Perceptions of
Nanotechnology and Trust in Government. Washington, D.C.: Woodrow
Wilson International Center for Scholars, 2005. Available at http://
www.wilsoncenter.org/news/docs/macoubriereport1.pdf;
Nanotechnology: Views of the General Public. London, U.K.: BMRB
Social Research, January 2004, BMRB/45/1001-666. Available at
www.nanotec.org.U.K./Market%20Research.pdf; and Andrew Laing. ``A
Report on Canadian and American News Media Coverage of Nanotechnology
Issues'' in First Impressions: Understanding Public Views on Emerging
Technologies. Ottawa, Canada: Canadian Biotechnology Secretariat, 2005.
Available at http://www.biostrategy.gc.ca/english/View.asp?x=802.
The Chairman. Well, thank you very much.
You really hit the area that I was going to ask about,
harder than I intended to hit it. We have on the floor, as you
know--well, it is not in the floor now. It missed staying on
the floor by one vote last night on asbestos. The problems of
whether any of these new substances or new combination of
substances--am I using the right words?--could cause us
problems of exposure, contamination, diseases, or not. Who is
going to look into that? Dr. Davies, you sort of indicate we
don't have enough basic law to deal with that. Have you written
anything on that, in particular?
Dr. Davies. On the need for further research or on the gaps
in the laws?
The Chairman. On gaps in the law.
Dr. Davies. Yes. I mean, the best example is cosmetics,
which are being--nanomaterials are being widely used now in
face creams, hair lotions, foot deodorants, a whole range of
cosmetic products. They are not tested--or, I mean, so far as
we know, they are not tested for their effects, or at least
there is certainly no public requirement that they be tested.
There is no governmental review of those products for their
safety or their environmental effects. So, that's--you know,
that's the kind of gap that I'm talking about.
There are whole other areas of--Dr. Davis talked about FDA
review of drugs and so on--which I think are fine, which are
functioning, you know, reasonably well now, and, you know, I
wouldn't tamper with at all. But there are large gaps, in terms
of the statutory authority, and there are also major resource
problems. There was an earlier question, I think by Senator
Pryor, about the resources for the Consumer Product Safety
Commission. The Consumer Product Safety Commission has slightly
over 400 people, total staff. That's 50 percent down from what
it was in 1980. And in 1980 it didn't have anywhere the staff
it needed to keep track of consumer products. So, that's the
kind of resource problem that I'm talking about.
The Chairman. Well, I was told last night that the last
time asbestos was really utilized in our industry was around
1970, but the exposure continues for years, as we found in
schools and other places around the world. It's a very serious
subject, I think. We are getting into newly developed
substances, in effect, either manmade or at least isolated by
man, that might have the potential for contamination or
exposure leading to difficulty. I think it is something that we
ought to explore with you further, Dr. Davies. It may send
shudders up and down the back of people, like Dr. Gotcher here,
but who is going to think about the delay that might come from
such a review to determine whether exposure--whether there is
an environmental potential for such contamination for the
future, or cause of illness in the future? I think it is
something we ought to explore.
I do want to thank all of you for your testimony, and I
think you probably testified more about the real application of
some of these nanotechnologies. What challenges did you really
face as you developed these new concepts, particularly in the
battery area?
Dr. Gotcher. Well, I think I'd like to address your
question about health and safety, just for a moment, if I may.
The Chairman. Sure.
Dr. Gotcher. The asbestos issue is a severe issue. But what
happened there was, a lot of material was mined and
incorporated into products before any health or safety work was
done at all. And I think in the nanomaterial world----
The Chairman. There was a war going on, Doctor.
Dr. Gotcher. Well, absolutely. But, I think, in the
nanomaterials, I think a number of us are trying to react much
more responsibly and look at the health and safety impact of
these materials before they're widely used, before millions of
pounds are used in products. And so, I think we're trying to
address some of the concerns that Dr. Davies is raising.
Now, with respect to batteries, our materials are used
inside of a product, they're encapsulated in materials. And so,
the nanomaterials are not readily available to the environment.
The Chairman. Let me back up and tell you about a pit in
Alaska, where they went back and excavated all of the residue
of rehabilitated and reprocessed materials. A man took old
batteries, and he combined pieces of them and made new types of
batteries. And he lined a pit with some substance, thinking it
was enough protection, and he put batteries that he had gotten
for several years in that pit. It was found that there was
leaching out of that pit, chemicals that had been blended
together by virtue of his disposal, and it became a Superfund
site.
Now, what about your batteries? What happens when they
dispose of them?
Dr. Gotcher. Well, our materials are much more
environmentally friendly. There are no caustics, no acids, no
lead, no chromates, no cadmium, and no hazardous metals at all.
And our anticipation is that these batteries will be
recyclable. So, what we're trying to do is look ahead, and
learn from the past, and develop an attitude to bring new
products to market with this product stewardship concept in
mind that has been used in the chemical industry for decades.
The Chairman. You use a lithium ion, don't you?
Dr. Gotcher. That's correct.
The Chairman. Can that be reprocessed?
Dr. Gotcher. Yes, it can.
The Chairman. Is there any danger, if it is not?
Dr. Gotcher. Not that we're aware of. In fact, lithium, in
small quantities, is considered to be a favorable metal to have
in your body. It's actually used as a positive drug to treat
depression, in low quantities.
The Chairman. Well, my time is almost running out. I would
like to have any comment from any of you who would like to make
one on the following question: Is there anything here that we
should do in the near future that we have not done with regard
to this new whole concept in nanotechnology? I am talking about
Congress. I have Dr. Davies' concept about reviewing the laws,
but do you have any gaps in the legal processes or the
availability of assistance that you think we should know about?
Dr. Davies. Yes, absolutely. I mean, I--as I say, things
like cosmetics, many kinds of consumers products have gaps,
which the Congress should address. Also, with respect to the
resource shortages, which I think are very acute in the
regulatory process, or among regulatory programs, I think this
committee, or a committee of the Senate, could request from the
regulatory agencies what resources they do have available to
deal with the health and safety consequences. And just as a
starting point----
The Chairman. Let me go to Dr. Hylton, and then I have got
to move on. Doctor, you looked like you wanted to say
something.
Dr. Hylton. So, my comment about nanotechnologies and
environmental health and safety is much along the lines that
they're--they may be hazardous materials, and we should think
of them as hazardous materials, not necessarily because they're
nanotechnology, but because they're new and we don't know what
they do yet. So, we've dealt with hazardous materials for a
long, long time, and sometimes in not very smart ways, the
examples of which, or some of which, were just mentioned. So, I
think--but it's an immensely complicated problem. I think it
would be--it would be very difficult to come up with a piece of
legislation that could address all of the risks associated with
nanotechnology. So, I think one approach might be to employ a
team of experts to identify where the hotspots are--cosmetics
being one example, perhaps--where there might be risks that are
large in comparison to the current usage of the materials, or
the anticipated usage of the materials in the near future, and
then attack those one by one. Because I think attacking them
will require a different approach in each case.
The Chairman. Very well. I thank you.
Senator Ensign?
Senator Ensign. Thank you, Mr. Chairman.
With such a diverse panel with different ideas, it is hard
to know where to begin questioning. But, let me try to address
it this way. First of all, Dr. Hylton--is it Hylton or----
Dr. Hylton. It's Hylton.
Senator Ensign. Hylton, OK. Dr. Hylton, regarding the model
that you have drawn up to try to get products to market via
more public/private partnerships, I was just mentioning to
Senator Allen, that I could foresee potential future problems.
We even hear criticisms now, and we do not have these centers
set up. For instance, when the government conducts basic
research on drugs, and then the drug companies take a product
to market, we get criticized, because people wonder why the
government does not get funds in return for its investment. How
do you foresee answering criticisms that this would happen? You
know those kind of criticisms would occur in a situation like
that. The product is developed out of government-funded basic
research, then somebody takes the product and makes a gazillion
dollars out of it. Does the government get any benefit, other
than a stronger economy from that? How do you address this
issue?
Dr. Hylton. I guess I would say two things, the most
obvious benefit being the economic one, which you brought up.
Senator Ensign. Sure.
Dr. Hylton. We get more--public invests money, we get taxes
for it in return.
I think, however, if we could--we could level the playing
field to a great deal--a great deal if we had organizations
such as the ones that I suggested, because they would make it--
they would make intellectual-property access, for example, much
easier to a much larger group of people. I think it's partly a
problem of transparency. There's a--if many more people could
see the opportunities, many more people would take the leap and
start a new company or invest in a new product or so forth. So,
it's partly one of providing transparency, and also by
providing, I think, critical pieces of infrastructure--that
maybe only very rich organizations could afford--to smaller
organizations will also help to level the playing field there.
So, I guess that would be my comment there, about why an
organization--that's how you might respond to a criticism such
as that.
Senator Ensign. Interesting idea. I think that the health
issue related to nanotechnology is something that should be a
concern. Dr. Gotcher, I am very proud of the efforts that you
and your company are making to address health concerns. I think
that is very responsible. A company should be applauded when
they are doing that right up front. And, based on what the
trial lawyers do to companies, I think it is actually a smart
business move, because, as you have seen, the reason we are
trying to fix the asbestos problem is because of the huge
potential liabilities. If there turns out to be problems with
nanotechnology, trial lawyers will exploit it. So, it is a
smart move on your part to behave so responsibly up front.
In addition, I just want to point out the difficulty in
this. Dr. Davies, I appreciate the concerns you raised in your
testimony. How do we balance the importance of safety with the
danger of over-regulating, and trying to be too safe. Over-
regulation can stop products coming to market that may save
hundreds of thousands of lives a year. You know, this balancing
act is so difficult. I once heard an illustrative and analogous
hypothetical--if we had OSHA around when the Wright Brothers
were developing the first airplane an OSHA regulator might have
looked at what the Wright Brothers were doing and said ``Wait a
second. You're going to take this thing up into the air, where
man has never been before, and you're going to have employees,
potentially, on this thing, test pilots. But how are we going
to ensure safety on this thing? I don't think we can go for
this.'' I'm just saying that we may never have been able to
break into the heavens if we regulated the wrong way. And you
could seriously impede progress if you regulated product after
product after product in this overly burdensome manner.
I think, that it is sometimes very beneficial when the
Congress is so slow to act that we actually allow products to
evolve into their final versions before we can actually act and
over-regulate. And so, I want to make sure that, as we move
forward in the nanotechnology field, that we all consider the
related issue of global competitiveness. We are worried about
being competitive in the world, and we want to ensure that safe
nanotechnology products are made here in America, not China. I
don't think, the Chinese are going to be nearly as worried
about safety. If we over-regulate, and, because of that
burdensome activity, the costs are too high to do the research
in this country and to take the risk here in this country, we
will drive innovative nanotech productions to China and to
India and to other places in the world that have less
burdensome regulations. Nanotechnology research is going to
occur. Whether it happens in the United States or not, it is
going to happen. And that is why we have to be very, very
careful as we're going forward to make sure that nanotech
research continues to occur in the United States.
I want to applaud everybody here. You know, you all
provided excellent, excellent oral testimony. And your written
testimonies are very good. And regarding the diamonds, I just
want to know, are those diamonds going to be available
commercially? And if so, what will the cost of such diamonds
be?
[Laughter.]
Mr. Linares. We're actually starting to sell some diamonds
now----
Senator Ensign. What are the comparable prices for your
diamonds versus diamonds extracted from the Earth? I'm actually
thinking about this from a competitive perspective, as well,
because right now the diamond market is totally dominated by
such a small number of people in the world. And, obviously, if
your diamonds are true diamonds, it could really become a
competitive market for the United States.
Mr. Linares. Sure, absolutely. The opportunity is huge. The
global retail market for diamonds is $60 billion. It's large.
And we're looking for the right value proposition right now.
The analogy that we use is cultured diamond, and these are 100
percent real diamond in every respect to a mined diamond,
except that we culture them. It's like the cultured pearl.
Senator Ensign. Right.
Mr. Linares. So, we see the markets starting to mimic each
other over time. So, we're starting to sell, right now,
privately, and expect to move into a commercial venue toward
the end of this year.
Senator Ensign. I think we could spend a lot of time
discussing the issues raised by members on both panels. I think
that having more listening sessions that this committee has had
earlier is a great idea, because the complexity of these issues
is so great. And to have such listening sessions on a little
more informal setting, I think, would be very, very helpful,
Mr. Chairman.
So, thank you.
The Chairman. It's one thing to have a hearing, but it's
another thing to ask people to just come by and talk. So, I
don't know, do you all have a national association of any kind?
Is there a national association of people involved with
nanotechnologies?
Mr. Linares. Yes, absolutely. There's the NanoBusiness
Alliance.
Voice. The NanoBusiness Alliance. In fact, we have about--
--
The Chairman. I'm wondering--things that these guys are
members of. That's what I'm talking about. Is--we've got to
find--to answer your question, we've got to find sometime when
these people will be in town, anyway, and ask them to give us a
little bit of their time.
Dr. Allen?
[Laughter.]
Senator Allen. Thank you, Dr. Chairman Stevens.
[Laughter.]
Senator Allen. I have very much enjoyed listening to all
these applications and--of what I said in the beginning, being
such a multifaceted discipline, from the microelectronics to
the life science and health sciences, which I think will be
really the great applications of the future, where you kill the
cancerous cells without this shotgun-blast approach of killing
healthy and bad cells together. I think that we'll look,
someday in the future, back at chemotherapy and these sort of
approaches differently, maybe the way we look at leeches in
medicine. But much--it's just targeted to kill the cancerous
cells. And then, the materials engineering, where--which
really, as a practical matter, has the most application
commercially right now.
What we are doing, as a country, with this nanotechnology
initiative, is to fund this collaboration that people have been
talking about, whether it's the Department of Energy, the
Department of Defense with some of these applications, NASA and
a lot of the things that we learned from space in the past are
being made applicable today, the engines, the energy aspects of
it, the lighter, stronger materials that'll be made out of
nanomaterials, the area--in EPA, there are some ways for
environmental cleanups. And so, while we need to be concerned,
as we always are, about health and safety, what Mr. Linares
said is, we do have the protocols, the principles of safe
workplaces, clean rooms. If your diamonds are going to be used
as a substitute for silica for microelectronics, or microchips,
semiconductor chips, those rooms are as clean as possible. It's
probably more dangerous to be drinking this water here, with
the dust from the carpet and all the rest, than what are in
those working places. Dr. Gotcher, in his company there in
Nevada--it's just fantastic. And there are others like that.
There's a Luna Innovations, in Virginia, which are making--
manufacturing these Trimetaspheres, which will have all sorts
of applications; and they're in the old tobacco warehouse
district in Danville, Virginia. That's at--almost a symbol of
the transformation of old industry, loss of textile jobs,
tobacco's gone down, and now there's something there for the
future.
What we need to do, Mr. Chairman, is make sure that our tax
policies, our regulatory policies--which need to be
reasonable--there's nothing wrong with reasonable regulations,
but they need to be science-based. In this area, just like what
happened with genetically modified crops or seeds, if people do
not know--are not sufficiently conversant, they can be
frightened, unnecessarily frightened. Genetically modified
organisms are no more than, really, hybrid crops. No one cared
about hybrid crops. But, because they didn't know about it,
we've seen the problems we've had with the Europeans. And it is
important that Senators are conversant and the American people
are conversant. So, then we make the right decisions so that we
don't cutoff what is really a transformative part of our
economy and making sure that that intellectual property is
owned here in this country from creative inventors, innovators,
scientists, technologists, and materials engineers, for
example.
So, I have about a minute or two minutes left, but what--if
each and every one of you all just said, number one, would be
the number-one thing that the government, your government, can
do to make sure that we're preeminent in this multifaceted
field, just--I just want number-one thing from each and every
one of you, starting with you, Dr. Gotcher.
Dr. Gotcher. I'd say the one thing that weighs on my mind
is the cost to do the last two steps of commercializing a
product. It takes the most people, and it's the most costly.
And it isn't risk-free. Many people think the invention is the
most difficult part. And, frankly, that's the easiest step.
It's the last two or three steps in the commercialization as
you scale-up that, I think, concerns me most about----
Senator Allen. What----
Dr. Gotcher.--the competitive----
Senator Allen. OK, what should government do, if we can,
anything, on that?
Dr. Gotcher. What I would ask is that the government help
mentor and help fund the last step or two of the
commercialization process. Share the risk, share the funds, and
share the reward.
Senator Allen. Hopefully, the National Nanotechnology
Initiative, with the peer review, can determine which ones to
fund, because there are not enough funds for every single one
of them.
Dr. Gotcher. I think that's an excellent idea.
Senator Allen. Dr. Hylton?
Dr. Hylton. Along the same lines. I would say, more
generally, to focus on this problem of transitioning the
technologies. I think we are institutionally handicapped, in
that we don't have an appropriate institution in place that can
do the thing that needs to be done. The small companies
struggle with various parts. He mentioned the late-stage part.
Getting the company off the ground is another hard thing to do,
as well. It's just that--I've done it, and I know he's past it,
so--but all of the stages are difficult. And I think they're
going to be really, especially difficult in nanotechnologies.
And if we don't go and solve that problem, we risk, I guess,
several things. We risk that other countries that figure it out
before we do can take advantage not only of their research, but
also of ours, because the information is public, generally
speaking. And I think we will also miss, I think, sort of the
next wave, the next industrial revolution if we don't solve
that problem.
Senator Allen. Well, you've worked in a collaborative way
in Virginia, Maryland, and D.C., together in this Chesapeake
Initiative. And those are universities, the----
Dr. Hylton. Correct.
Senator Allen.--private-sector, and the government. Are
those not helpful ways that others may wish to emulate, as far
as that development----
Dr. Hylton. I----
Senator Allen.--structure of a company and what they need
to--what these scientists need?
Dr. Hylton. I would be happy to share the--those findings--
that report is relatively recently completed. I'd be happy to
share it with others who would be interested. But, yes, it does
attempt to address many of those issues.
Senator Allen. Thank you, Dr. Hylton.
Dr. Davis?
Dr. Davis. In medicine, everything funnels through the FDA.
Senator Allen. Right.
Dr. Davis. So, I would request that the FDA continue to get
resources so that they can evolve to evaluate these new
medicines properly and help speed the processes through.
Senator Allen. Good advice. We hear that a lot. Thank you.
Dr. Davies?
Dr. Davies. I'd just make the point that, in terms of
competitiveness, the health and safety is an important element
of competitiveness, and that a product that causes adverse
health effects or causes adverse environmental effects is not
going to be competitive for long in the modern world.
Senator Allen. Dr. Swager?
Dr. Swager. Yes, I'd make a comment that's specific to
national security and military issues. I think there's a
tendency right now to over-regulate universities in terms of
asking for censorship of publications and restricting what
students can work on a project. MIT's taken a very firm stand
on this. And for me to get money to do explosives detection
these days--I won't go into it here, but it is very difficult,
because the Department of Homeland Security can't fund me.
The Chairman. Senator Inouye and I also Co-Chair the
Defense Appropriations Committee. We will talk to them.
Dr. Swager. Some of the agencies actually have policies
which are not consistent with universities and what we do. I
think that we really need a free and open network, in terms of
our research. Our goal is to educate the world. And I think one
of the things we do best, as Americans, is, we run faster, we
innovate--we work harder, and we innovate more than the rest of
the world. If we get attenuated on that because of security
issues, I think it'll be a problem.
Senator Allen. Thank you.
Mr. Linares?
Mr. Linares. Thank you. I would recommend that the Federal
Government fund fundamental research into diamond-based
semiconductor and optics for the----
[Laughter.]
Mr. Linares.--obviously, directly, but I was too specific.
Specifically, materials development and devices. And there are
two specific areas there. The Air Force and Navy have a direct
need for immune--systems that are immune from electrical
interference, essentially, from directed energy weapons, and
for--the Army has specific needs for high-energy laser systems
for things like remote mine detonation and potentially knocking
down certain missiles. And those require fundamental
developments in--largely in material and specific device
development.
Senator Allen. Thank you. Thank you, and good luck next
Valentine's Day with your diamonds----
[Laughter.]
Mr. Linares. Thank you.
Senator Allen.--and anniversaries.
Thank you, Mr. Chairman.
The Chairman. Well, thank you very much.
Mr. Linares, I think you ought to talk to DARPA, at the
Defense Department.
I'm pleased to say that the staff tells me that the
NanoBusiness Alliance will be up here on Capitol Hill tomorrow,
and they're holding a staff briefing on nano in this building
for staff. So, we thank you very much for that.
We thank you all for taking the time. I think you're in one
of the most fascinating areas of the developing technology base
that we have, and we want to keep up with you and try to
understand what you're doing, as much as possible, and to be of
as much help as we can. So, we will try, sometime, to see if we
can find a way to--not inconvenience you--to find a way when
you could come back and just have some conversations with our
people about--here in this committee--what's going on and what
we could do, and what we shouldn't do.
But, Dr. Swager, in our--with other hats that Senator
Inouye and I wear, your briefing, in terms of what you're
doing, in terms of protection of our people wearing uniforms,
just is overwhelming. I'd like to see you come back to the
Defense Subcommittee soon and tell us more about that.
Dr. Swager. I'd like to do that, thank you.
The Chairman. Thank you very much.
We thank you very much for your patience and your
contribution. We hope to see you again soon. Thank you all very
much.
[Whereupon, at 4:40 p.m., the hearing was adjourned.]
A P P E N D I X
Response to Written Questions Submitted by Hon. Gordon H. Smith to
Dr. E. Clayton Teague
Question 1. Nanotechnology is an emerging technology in which many
countries around the globe are making significant investments and
advancements. What steps are necessary for the United States to be the
world leader in nanotechnology in the long run?
Answer. U.S. leadership in nanotechnology is at the heart of the
National Nanotechnology Initiative (NNI). The strategy for realizing
the benefits of nanotechnology and sustaining U.S. leadership is
detailed in the NNI Strategic Plan released in 2004, \1\ and was
developed with input from academic, industry, and government experts.
The plan identifies four overarching goals for the initiative. Progress
toward these goals will go a long way toward sustaining U.S. leadership
in this important emerging area. The goals are:
---------------------------------------------------------------------------
\1\ Available at http://www.nano.gov/NNI_Strategic_Plan_2004.pdf.
1. Maintain a world-class research and development (R&D)
program aimed at realizing the full potential of
---------------------------------------------------------------------------
nanotechnology.
2. Facilitate transfer of new technologies into products for
economic growth, jobs, and other public benefit.
3. Develop educational resources, a skilled workforce, and the
supporting infrastructure and tools to advance nanotechnology.
4. Support responsible development of nanotechnology.
The ability to be a world leader in nanotechnology is underpinned
by a healthy innovation ecosystem in which discoveries can be made and
ideas can flourish. The President's American Competitiveness Initiative
(ACI), announced in the 2006 State of the Union address, proposes a
comprehensive approach to strengthening this ecosystem, targeting
policies and programs in the areas of research and development (R&D),
math and science education, high-skilled immigration, and workforce
training. A primary role of the Federal Government in fostering
innovation is sustaining strong support for basic research. As such,
the centerpiece of the ACI is a commitment to double, over 10 years,
funding for the most critical basic research in the physical sciences;
funding for this nanotechnology research is an important component of
this commitment.
Within this overall framework, here are five Federal specific areas
that will be important to maintaining U.S. leadership in nanotechnology
in the long run:
Basic research. Continued strong Federal support for nanotechnology
research, especially in the physical sciences, across the Federal R&D
enterprise. At the same time, agencies that fund R&D should make
nanotechnology research a priority. At the Federal level, the United
States invests approximately one quarter of the amount spent by
governments worldwide; Japan and the European nations combined each
spend a similar amount. Although the United States leads all nations in
the level of funding for nanotechnology research, other nations are
growing their own programs in this emerging area. Investment in basic
research today will fuel innovation and American competitiveness in the
future.
Infrastructure. Continued strong support for the advanced
infrastructure of facilities and instrumentation that is necessary in
order to perform nanotechnology research. Researchers need access to
costly equipment necessary to fabricate and characterize nanoscale
materials and devices. User facilities and research centers
specifically aimed at supporting nanoscale science and engineering
research are supported by many of the NNI agencies, including the
National Science Foundation, the Department of Energy, the National
Cancer Institute, and the National Institutes for Standards and
Technology. The United States investment in this area has been crucial
to enabling cutting-edge research and support for maintenance and
operations will sustain this valuable resource. In addition, research
is needed to develop the next-generation tools and instruments that
will continue to allow advances to take place going forward.
Technology transfer. Support for transitioning the results of
research from the laboratory to the marketplace, including by creating
an environment in which entrepreneurial activity can thrive. Generally,
the challenges associated with transitioning the results of
nanotechnology research are not unique or specific to nanotechnology.
Therefore, existing mechanisms and authorities (e.g., those provided
for by the Bayh-Dole and Stevenson-Wydler Acts, Small Business
Innovation Research (SBIR) and Small Business Technology Transfer
(STTR) and other technology transfer statutes) can and should be
utilized. In addition, making permanent and modernizing the Research
and Experimentation (R&E) tax credit will strengthen incentives for
private-sector investment in nanotechnology commercialization.
Specific actions by the NNI to promote technology transfer and
commercialization include the following:
Utilizing the SBIR and STTR programs to fund development of
new applications of nanotechnology in small companies.
Increasing support for research on environmental, health,
and safety (EHS) aspects of nanotechnology to allow industry,
regulatory agencies, and others to assess and manage risks
associated with nanotechnology.
Strengthening of expertise and structures within the U.S.
Patent and Trademark Office to improve the ability of U.S.
inventors and businesses to protect intellectual property
related to nanotechnology.
Working with the U.S. Patent and Trademark Office as they
strengthen the protection of intellectual property through
continued work on the cross-referencing of nanotechnology-
related patents and in-depth technical training of patent
examiners on the state-of-the-art in nanotechnology.
Facilitation of communication with and among local, state,
and regional nanotechnology economic development initiatives,
e.g., through workshops such as those organized in 2003 and
2005.
Standards for materials and processes. In industries where
materials and components are manufactured by one business and
integrated into products by another, standards are vital to business-
to-business commerce. Standards also allow consumers to know what they
are buying and allow regulators to establish guidelines for safe
practices. Already, a number of U.S. standards developers are engaged
in the development of nanotechnology standards and, following an
inquiry by OSTP Director John Marburger, the American Nationals
Standards Institute (ANSI) has established a Nanotechnology Standards
Panel to coordinate U.S. activities in international standards forums,
including the International Organization for Standards (ISO). The NNI
supports the ANSI-led efforts and the Director of the National
Nanotechnology Coordination Office (NNCO) currently chairs the ANSI-
accredited Technical Advisory Group, which represents the United States
at the ISO Technical Committee on Nanotechnologies (TC 229). In
addition, the U.S. leads the subgroup under TC 229 on standards for
health, environment, and safety of nanotechnology.
Communication with stakeholders. It is important to educate the
public about nanotechnology and the steps being taken both to realize
its potential benefits and to assess and manage, or even avoid, risks.
Stakeholders include the business, research, policymaking, and investor
communities, as well as the general public. In general, research
results are communicated to the scientific and technical community
through scientific publications, conferences, and workshops (a number
of which are supported by NNI agencies). To promote communication with
the broader public, the NNI, through the NNCO, maintains a website with
regularly updated information about nanotechnology and NNI programs, as
well as link to agency-specific information (e.g., workplace safety
information at the National Institute for Occupational Safety and
Health). The NNCO acts as a portal for questions about the NNI and
nanotechnology, and works proactively to communicate with the science
reporters at major media outlets. Finally, the NNCO has conducted
meetings to plan for public engagement as called for in the 21st
Century Nanotechnology Research and Development Act.
As the agencies make progress in the areas outlined above so as to
advance nanotechnology for government needs and for U.S. economic and
societal benefit, it is important to bear in mind that the United
States is not the only nation investing in nanotechnology for the
future. New knowledge and innovative ideas are being created around the
world and Federal agencies that support nanotechnology R&D and that
have needs that can be addressed by nanotechnology solutions should be
informed about activities taking place elsewhere. Advances in
nanotechnology in the United States will be expedited by working
cooperatively in areas of nanotechnology research that are pre-
competitive or noncompetitive, such as research on environmental and
health implications and research to promote the incorporation of U.S.
standards and concepts into international standards.
To assess U.S. global performance in nanotechnology, the NNI,
through the interagency Nanoscale Science, Engineering, and Technology
(NSET) Subcommittee of the National Science and Technology Council,
tracks activities internationally, including investments, scientific
publications, and patent activities. The NSET Subcommittee also
provides input and feedback to U.S. representatives to international
bodies that are considering nanotechnology, such as the ISO and other
standards developers, the Organization of Economic Cooperation and
Development (OECD), and the Wassenaar organization.
The NNI, through the activities of the participating agencies, the
interagency NSET Subcommittee and its subgroups, and the National
Nanotechnology Coordination Office is working to address the areas
outlined above. In its review of the NNI released in 2005, \2\ the
President's Council of Advisors on Science and Technology (PCAST)
concluded that ``the United States is the acknowledged leader in
nanotechnology R&D,'' and that the NNI is well managed. PCAST goes on
to caution that the U.S. lead in nanotechnology is under increasing
competitive pressure from other nations. While encouraging efforts by
the NNI to facilitate technology transfer, the PCAST report emphasizes
that the primary focus is on supporting and coordinating a broad,
multidisciplinary program of world-class basic research.
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\2\ See full PCAST at http://www.ostp.gov/pcast/
PCASTreportFINAL.pdf.
Question 1a. What are other countries doing that we could learn
from?
Answer. As the first of its kind, the NNI is the model for
nanotechnology programs in many other countries. Yet each country or
region has adapted the U.S. approach to its needs and strengths.
Notably, a number of countries have elected to focus research around
one or more particular areas of application, such as materials science,
biomedicine, or electronics. The members of the NSET Subcommittee
representing the diverse Federal agencies participating in the NNI have
considered such an ``application-driven'' strategy and continue to
support the current broad program of basic research at the level of the
initiative as a whole. Individual mission-oriented agencies, such as
the Department of Defense, Department of Energy, and the National
Institutes of Health, is the level at which application-driven
nanotechnology research is and should be organized.
The NNI has established a Global Issues in Nanotechnology Working
Group under the NSET Subcommittee. One objective of the Working Group
is to track international activities related to nanotechnology. The
Working Group reports to the Subcommittee, thereby providing
information about ``lessons learned'' from around the world to the
Subcommittee as it manages the initiative and periodically reviews the
U.S. strategy for the Federal nanotechnology R&D program.
______
Response to Written Question Submitted by Hon. Gordon H. Smith to
Dr. Richard O. Buckius
Question. Do you support the concept of my legislation, S. 1908 the
Nanoscience to Commercialization Institutes Act, that emphasizes
commercialization of nanotechnology? What more should be done to
promote the commercialization of nanotechnology?
Answer. NSF cannot comment on provisions in legislation that do not
affect the agency. The long-term objectives of this Nation's broad
initiatives in nanotechnology--as contained in the National
Nanotechnology Initiative (NNI)--focus on building a foundation of
fundamental research to understand nanoscale concepts, and to apply
novel principles to the most promising opportunities in measuring and
manipulating matter on the nanoscale. Another objective is ensuring
that U.S. institutions have access to a full range of nano-facilities,
enabling access to nanotechnology education, and catalyzing the
creation of new commercial markets that depend on three-dimensional
nanostructures. These are intended to facilitate the transfer of new
technologies into products for economic growth, jobs, and other public
benefit. The promise of nanotechnology resides in controlling the
atomic and molecular realm, where new principles and possibilities
emerge. This is a fundamental distinction between nanotechnology and
micro-technology. Additionally, a comprehensive peer-review process
should be carried out by expert groups to select any potential
awardees.
To facilitate the commercialization of nanotechnology and bring
discovery to innovation, NSF supports and maintains strong partnerships
with industry, national laboratories, and international centers of
excellence. This support includes investments in 16 Nanoscale Science
and Engineering Centers, and grants for nanoscale research through the
Small Business Innovation Research (SBIR) program and the Small
Business Technology Transfer (STTR) program.
______
Response to Written Questions Submitted by Hon. Gordon H. Smith to
Jeffery Schloss, Ph.D.
Question 1. The potential applications of nanotechnology to
diagnose and treat cancer are remarkable. Do you have any
recommendations on how we can further support advancements in this
area?
Answer. Nanotechnology does indeed encompass a wide range of
materials and techniques that are being applied to a remarkable range
of cancer problems, including:
Early imaging agents and diagnostics that will allow
clinicians to detect cancer in its earliest, most easily
treatable, presymptomatic stage;
Systems that will provide real-time assessments of
therapeutic and surgical efficacy for accelerating clinical
translation;
Multifunctional, targeted devices capable of bypassing
biological barriers to deliver multiple therapeutic agents at
high local concentrations, with physiologically appropriate
timing, directly to cancer cells and those tissues in the
microenvironment that play a critical role in the growth and
metastasis of cancer;
Agents capable of monitoring predictive molecular changes
and preventing precancerous cells from becoming malignant;
Surveillance systems that will detect mutations that may
trigger the cancer process and genetic markers that indicate a
predisposition for cancer;
Novel methods for managing the symptoms of cancer that
adversely impact quality of life; and
Research tools that will enable investigators to quickly
identify new targets for clinical development and predict drug
resistance.
The National Cancer Institute's Alliance for Nanotechnology in
Cancer (http://nano.cancer.gov) is developing more effective
interventions to accelerate progress against cancer in the next decade.
New nanotechnology-based therapeutic delivery systems could
significantly enhance the efficacy and tolerability of cancer
treatments, immediately benefiting cancer patients. The Alliance is
also leveraging nanotechnology as a catalyst to build the
multidisciplinary teams that are the future of biomedical research and
molecular, personalized medicine. In addition, NCI's close
collaboration with the FDA through the Interagency Oncology Task Force
(IOTF) and the Alliance's Nanotechnology Characterization Laboratory
will help to ensure that the science needed to inform the review of
these new products keeps pace with the research. This is a crucial step
in ensuring that the critical pathway to clinical application is well-
defined for these novel technologies.
In short, advancements in applying nanotechnology to the diagnosis
and treatment of cancer can be further supported along the following
lines:
Facilitate team science with integration into clinical
oncology to accelerate matching of key cancer problems with
cutting-edge nanotechnology-based solutions.
Foster development of standards and informatics to more
effectively integrate researchers and clinicians across
disciplines and sectors.
Establish the general clinical development pathway that
includes characterization of materials and biological responses
to encourage researchers to pursue nanotechnology therapeutic
development through to commercialization and broad application.
Remove barriers to cross-licensing of nanotechnology
platforms that will be needed to develop integrated components
for diagnostics in particular.
Support research through user facilities to enhance
uniformity of materials and improve nanotechnology platform
manufacturing capabilities and quality assurance/quality
control measures.
Support additional research toward understanding fundamental
interactions of biological components (nucleic acids, proteins)
and a wide range of nanomaterials to address practical problems
such as biocompatibility/biofouling, aggregation, and
overcoming biological barriers.
Distinguish environmental (incidental) and medical
(intentional) toxicological issues, and quantify and clarify
the risk-benefit ratio for novel nanotechnology applications in
comparison to current standards of care.
For more information: The NCI Alliance for Nanotechnology in Cancer
website http://nano.cancer.gov provides comprehensive information on
the program and on current nanotech advances relevant to cancer.
Question 2. To what extent have other countries made advances in
nanomedicine?
Answer. Based on information available through the National
Nanotechnology Coordination Office (NNCO), below is some information on
what other counties are doing in the area of nanomedicine.
Europe
The European Science Foundation has identified (ESF Scientific
Forward Look on Nanomedicine, 2004) needs and opportunities, and the
trans-European ability to achieve significant advances, in the
following areas:
nanomaterials and nanodevices for drug delivery (including
an emphasis on scale-up manufacturing and materials
characterization); the goal is to realize clinical benefit by
2010. Substantial potential exists for direct targeting of
specific diseases and transport across biological barriers.
multiplex sensing of complex analytes in vitro for tissue
engineering, regenerative medicine and complex diagnostics
(application by 2015). Scaffolds for tissue regeneration.
externally controlled. multifunctional, mobile devices for
combined diagnostics and drug delivery (application by 2015).
The subsequent generation of devices would be bioresponsive or
autonomously controlled. To realize these opportunities, a
better understanding of potential toxicological and
environmental implications of these materials is needed, as are
risk management strategies. Effective communication among
workers from multiple fields in academia, industry and
regulatory bodies will facilitate development, and clinical and
regulatory evaluation, of products. Multidisciplinary education
from undergraduate through graduate and professional levels is
needed to support rapid development and clinical application of
the field. The level of preparedness to exploit emerging
nanomedical technologies was seen as a weakness to be
addressed. Better information needs to be conveyed to the
public, politicians and policymakers.
In late 2004, about 40 nanotechnology-related products were
reported as being in clinical testing or use for medical applications
with emphasis on treating cancer and infections (including HIV/AIDS and
STDs), and included examples for mitigation of hereditary or
degenerative diseases and side-effects of chemotherapy. More than 30
European companies were involved in nanomedicine product development.
Asia
Japan, one of the non-U.S. countries with the largest
nanotechnology investment ( $780M overall nanotechnology investment in
FY 2005), includes both nanotechnology/materials and life sciences
among four S&T high priorities (the others being information technology
and environmental sciences). (Second-ranked areas include energy,
manufacturing technology, social infrastructure, and ``frontier-
sciences.) It is difficult to know with precision how the
nanotechnology and life sciences interests overlap. One sees credible
reports in the scientific literature and in news releases in areas
similar to those of interest in the U.S., including use of
nanotechnologies for medical imaging, diagnosis of disease signatures,
and drug delivery.
Bionanotechnology is China's second largest nano-related funding
target after nanomaterials. China anticipates a very strong market in
pharmaceuticals, medical devices, etc., and has invested in industry
with specific focus on biomedical materials. For example, a Chinese
company announced last year a patent on a biodegradable nanosilicon
material for drug delivery, with early intended applications for
treatment of liver cancer.
Taiwan supports activities in nanobiotechnology basic science
contributing to imaging and detection, manipulation of DNA and genes,
and drug delivery and treatment of disease. The relatively small
investment is focused on developing products with strong commercial
potential.
Singapore has a focus on nanobiotechnology and nanomedicine, and
has built a dedicated research facility called Biopolis. Scientists in
Singapore have reported progress in developing materials for drug
delivery and tissue engineering, and efficient batteries for diagnostic
and implantable devices. Alliances have been established for
nanomedicine research with U.S. institutions such as the University of
Washington and MIT.
The size of Korea's activity in this area is difficult to separate
from other S&T activities. One sees reports on nanobiomaterials for use
in tissue repair, drug delivery and medical diagnostics.
______
Response to Written Question Submitted by Hon. Gordon H. Smith to
Dr. J. Clarence (Terry) Davies
Question. Nanotechnology is an emerging technology with a short
history, specifically in the area of regulation and health and safety
issues. How do you propose we move forward in advancing this technology
without stifling this industry and preventing its benefits from
reaching the marketplace?
Answer. The future of nanotechnology depends on striking a balance
between over-regulation and under-regulation. The former can stifle
innovation and technological progress. The latter can turn the public
against the technology and similarly stifle innovation and
technological progress. We need to start talking about how to strike
the necessary balance.
In a discussion sponsored by the Senate Committee on Environment
and Public Works, I proposed 15 initiatives that the Congress can take
now to encourage the development of nanotechnology. They are as
follows:
Research
1. Amend Nanotech R&D Act (117 Stat. 1923) to require separate
strategic plan for health and environmental research.
2. Under NNI, establish separate pot of money (5-10 percent of
agency nano budgets), distributed by OMB and OSTP for filling
gaps identified in H&E plan.
3. Create a Nanotechnology Effects Institute, modeled after the
Health Effects Institute (EPA and auto industry), jointly
funded by government and industry.
4. Commission GAO or Library of Congress, working with State
Department and U.S. embassies, to do a report on what other
countries are doing with respect to nano R&D, effects research,
and regulation.
5. Commission a study, funded through NSF, on the economic
impacts of nano in the U.S. over the next decade.
6. Conduct a hearing on how to encourage ``green''
nanotechnology.
7. Provide funding (through NSF) to develop and distribute a
layman's primer on nano.
Management
8. Amend Nanotech R&D Act to establish an interagency
Nanotechnology Regulatory Coordinating Committee.
9. Commission a GAO study of what resources (Dollars, FTEs,
expertise) Federal agencies are currently devoting to nano
health and safety.
10. Fund NIOSH/OSHA to: (1) examine existing worker protection
practices in nano-manufacturing; (2) evaluate the adequacy of
such practices; and (3) promulgate best practices.
11. Amend the Food, Drug and Cosmetic Act to provide pre-market
approval of cosmetics. (Limit to products containing
nanomaterials if politically necessary.)
12. Amend the Toxic Substances Control Act to allow EPA to
require additional data for nanoproducts with human exposure.
13. Start stakeholders' dialogue on nano management/oversight
needs.
14. Start House/Senate dialogue on management/oversight needs.
15. Commission a study by Library of Congress or GAO
(cooperating with Consumer Product Safety Commission, FDA, and
Federal Trade Commission) on labeling of nano products.
I would be happy to discuss any or all of the above items with your
committee.
Response to Written Questions Submitted by Hon. Gordon H. Smith to
Mark E. Davis, Ph.D.
Question 1. Are we on the verge of witnessing a revolution in the
way we treat and cure disease?
Answer. Yes. Many factors are contributing to this revolution but a
specific example is now the ability to attack diseases at their genetic
level.
Question 1a. Are other countries making advances in this area?
Answer. Yes. As expected because of the huge societal and economic
impacts, many countries throughout the world are making large
investments in new therapeutics that are taking advantage of the new
breakthroughs in science/engineering and understandings of the
molecular basis of disease.
Question 1b. What are other countries doing, if anything, that we
could learn from?
Answer. I believe that the most difficult step on the route to
bringing new therapeutics to the public is getting them through
clinical trials for approval. It is lengthy and costly. However, it is
necessary to provide for public safety. While the FDA is doing a good
job in my opinion, the European regulatory agencies have adopted a
better strategy for life-threatening diseases. They allow biological
markers to be used to test the effectiveness of a new drug rather than
having to wait for a survival say in a cancer trial. This automatically
allows companies to go after types of cancers that would take long
times to determine survival. Because of economic reasons, companies
tend to go to diseases where the trials can be done in a reasonable
timeframe and therefore trials in Europe can be performed on disease
states that would not be done in the U.S. While the FDA is moving
toward the concept of molecular markers, there is still a large
difference in what can be used as trial end-points in Europe vs. the
U.S. This will certainly not favor trials of new revolutionary drugs in
the U.S. because they tend to all attack molecular targets of disease
for which molecular markers can be developed. Additionally, the U.S.
Patent Office is very problematic. The inconsistencies in what is
allowed and not allowed is causing significant issues for
commercialization of new drugs. My own experiences with the U.S. Patent
Office (I have 35 U.S. patents) has taught me that it is an
organization that needs dramatic change. Other countries have
variations on how Intellectual Property is handled and I not able to
recommend a particular country that I would single out who is
performing well. I just believe that the U.S. Office is a real problem
at this time.
Question 2. Do you have specific examples of institutions that are
not in compliance with Title IX?
Answer. No.
______
Response to Written Questions Submitted by Hon. Gordon H. Smith to
Bryant R. Linares
Question 1. What specific barriers do entrepreneurs like yourself
experience in advancing commercialization on nanoscience research?
Answer. There is a great time-lag between getting from the discover
phase, through research and development to finishing with a
commercialized product. In the case of Apollo Diamond, this time-frame
has lasted for over ten (10) years. Funding is very difficult in the
early phases and relies (from a small company perspective) on mainly
government funds. Any research funding however is sketchy and may be
out of phase to the specific technology that is being developed. In our
case, we relied mainly on private funds from investors. This is a
difficult process and adds extreme risk to the early stage company.
In summary adequate funding is the main barrier to thorough
commercialization.
Question 1a. What can be done to benefit entrepreneurs in this
field?
Answer. Better sources of funding and support infrastructures to
connect small businesses with good technologies with large companies
getting government funding and government institutions.
Apollo Diamond supports the Nanoscience to Commercialization
Institutes Act.
______
Response to Written Question Submitted by Hon. Gordon H. Smith to
Timothy M. Swager, Ph.D.
Question. How has collaboration with industry made a difference in
attaining your institute's objectives?
Answer. The Institute for Soldier Nanotechnologies (ISN) at the
Massachusetts Institute of Technology (MIT) considers the collaboration
with industry to be a critical underpinning that is essential for our
continued success. One obvious advantage of engaging industry is the
fact that MIT is a university and hence is not able to manufacture. The
ISN has a portfolio of activities at different levels of scientific and
technological maturity. Companies actively engaged in the ISN can best
identify opportunities for transitioning technologies at an early stage
to the Army. The most successful transition thus far have been in the
area of sensors that can detect bombs based upon an explosives vapor
signature. A small company, Nomadics Inc. of Stillwater, OK, was
responsible for this transition. Multiple other transitions in
materials for protection from ballistic impacts and optical sensors are
anticipated in the future. Companies understand that the ISN has
established creditability with the Army. Hence, companies are becoming
more willing to help to underwrite part of the ISN and will help us to
expand our program in the future.
______
Response to Written Questions Submitted by Hon. Gordon H. Smith to
Alan Gotcher, Ph.D.
Question 1. What impediments do you face in achieving your business
goals relating to nanotechnology?
Question 1a. Do you believe more can be done to support the
commercialization of nanoscience research?
Answer. In the development of any new technology the coordinated
roles of industry and government are critical to world leadership in
the sector. In general industry's role is to marry scientific
development with exploiting market opportunities for the new
technology, while government's role is to provide funding that
accelerates time to market, ensure a regulatory environment that
removes impediments to market, and fund educational establishments to
provide a skilled pool of scientists.
With regard to nanotechnology we believe the U.S. Government should
work with industry to ensure the global competitiveness of the U.S.
nanotechnology industry by focusing on the following key areas:
1. Funding that accelerates time to market. Two specific areas
are critical to the development of commercial nanotechnology.
The first is judicious, continuing funding of programs in
segments critical to our society--life sciences, nanomaterial
manufacturing technology and alternative energy. By
appropriately funding basic and applied R&D in U.S.
nanotechnology companies we can ensure we stay in a world
leadership position. A further area for funding is providing a
national infrastructure for the testing and analysis of new
materials. Frequently innovators are unable to afford the
leading-edge analytical equipment required to ensure rapid time
to market. Examples of these are very high resolution
transmission electron microscopes.
2. Ensure an appropriate regulatory environment. The U.S. is at
a critical point in the development of this infant industry. If
we go the route of seeking better answers and understanding of
the various families/classes of nanomaterials before imposing
government regulation, it could lead to greater benefits to the
consumers and the environment through dramatic changes within
widely diverse industries. Taking the other road--regulation
first, without research--could lead to a disquieting moratorium
on all future nano-research and development in the U.S., with
great cost to our economy. There are some who feel that
nanotechnology will require new regulatory legislation--for
example, a recent report by Dr. Clarence Davies with the
Woodrow Wilson International Center for Scholars/The Pew
Charitable Trusts Project on Emerging Nanotechnologies. But
much of this concern is founded on sparse and sometimes
conflicting data. If anything is clear, it is that there is no
single prototypical ``nanoparticle.'' Asbestos-like fibrous
nanotubes and toxic-metal containing quantum dots are not good
surrogates for all nanomaterials. To fall into a ``one-size-
fits-all'' approach to nanotechnology is irresponsible and
counter-productive. There are no clear and comprehensive data
available to let us really assess the general risk of the wide
range of nanomaterials under consideration and/or development.
Many of the cognizant Federal funding and regulatory agencies--
such as the National Institutes of Health (NIH), the National
Cancer Institute (NCI), the Food and Drug Administration, EPA
and NIOSH--recognize this reality and are working hard to
understand the underlying science and to develop quantitative
data and models to quantitatively assess risks. What is needed
is a broad, government-funded initiative (similar to the Human
Genome project) with the goal of establishing broad empirical
data and models for the predictability of the environment,
health and safety risks of commercially-interesting
nanomaterials.
3. Supply of educated personnel. We all have seen the numbers
from the National Science Foundation--while 70,000 Ph.D.
engineers are graduating from universities in China and 35,000
from universities in India, there are fewer than 10,000
engineering graduates from universities in the U.S. Plus, many
of the U.S. graduates are foreign nationals, many of whom
return home with the benefits of their education. This is a
national crisis. For Altairnano, it is also a company crisis.
It is extremely difficult for us to recruit science and
engineering students from the University of Nevada-Reno. There
just are not enough students in the pipeline to go around.
Nanotech--the ``sexy'' science of the 21st century--might be
the catalyst needed to stimulate renewed interest in math and
science in American students, from K through graduate school.
One approach would be to fund the development of curricula, in
coordination with scientists and engineers from local/regional
nanotechnology companies, and focused on, perhaps, grades five
and six, junior high, and high school. Another approach could
be to fund scholarships to nanoscience camps for students at
the junior high and high school levels. A third approach could
be to provide scholarships for students enrolling in
nanotechnology programs at undergraduate and graduate levels--
including curricula focused on nanomaterials and nanochemistry,
nanobiology, and nano-environmental engineering. All of these
programs should include a component devoted to considerations
of public policy issues affecting nanotechnology.
Question 1b. Do you support the concept of my legislation, S. 1908,
the Nanoscience of Commercialization Institutes Act, that emphasizes
commercialization of nanotechnology?
Answer. We believe that more needs to be done to harness the
potential of nanotechnology for the U.S. economy. Currently specific
programs are funded by individual government departments, often as
collaborative projects between academia and industry. These are, in
general, excellent programs and Altairnano is grateful for the support
it has received under these fundings, often leading to new commercial
opportunities such as our battery program. However the programs are
silos and need to be self-contained from a funding perspective.
A key missing component to this funding allocation model is that
there is fundamental infrastructure that is not getting built which
would significantly help each project. Examples of this include state-
of-the-art analytic equipment such as transmission electron
microscopes. This type of equipment is too expensive to justify either
for an individual project or for an entrepreneurial industrial partner.
Although only occasional access would be required, when the equipment
is used it would provide invaluable insight to the materials being
investigated and could save unnecessary additional experimental work
and time to market delays.
We support the concept of S. 1908, that is the establishment of
centers of nanoscience excellence. We believe the greatest contribution
that these centers could make to the progress of nanotechnology would
be to provide regional centers of nanoscience infrastructure. These
centers would provide shared access to a range of analytic and
experimental equipment key to nanotechnology. They would also naturally
act as centers for information exchange and potentially technical
recruitment.
______
Response to Written Questions Submitted by Hon. Gordon H. Smith to
Dr. Todd L. Hylton
Question 1. Do you believe that more can be done to support
commercialization of nanoscience research?
Answer. I strongly believe that more can be done to support
commercialization of nanoscience research. The country has to date
invested well and wisely in support of basic research, but many of the
commercial benefits of this research will not be realized without
effective support of commercialization. Because of the complexities
associated with nanotechnologies, conventional commercialization paths
are not likely to be as effective as they have been with other recent
technology transformations (e.g., the Internet and telecommunications).
In addition to the impact on the U.S. economy, effective
commercialization of nanotechnologies promises to address many of the
most pressing problems facing humanity today (in energy, healthcare and
national security) and, thereby, to dramatically improve the quality of
life worldwide. The principal problem to be addressed is to effectively
coordinate the many academic, national laboratory, small and large
technology businesses, capital investors, and public-sector support
organizations along selected high-value market opportunities. I believe
that this coordination should be led by public-private partnerships
focused in these high-value market/application areas. The U.S.
Government should sponsor the creation of these partnerships and
sustain support for them for a significant period of time. In
proportion to the benefit that would be derived, the investment needed
from the U.S. Government is very small.
Question 1a. Would you support public-private partnerships to
promote the application of research to commercialization?
Answer. As stated in my response to Question 1, I strongly support
this concept and believe that it is the best way to enhance
nanotechnology commercialization.
Question 1b. Do you support the concept of my legislation, S. 1908,
the Nanosciences to Commercialization Institutes Act that emphasizes
commercialization of nanotechnology?
Answer. I was very pleased to read the S. 1908. It clearly
recognizes the challenges and importance of nanotechnology
commercialization. I would offer, however, the following comments on
the measure that I believe will make it more effective in its intended
purpose.
1. Because nanotechnologies are so complicated and because of
the substantial amount of time that will be required to
implement the type of organization required of the Institutes,
I believe that 3 years is an inadequate period of support. I
recommend 5 years as a minimum.
2. My concept of such an Institute would include the following
minimal set of personnel. The role of this staff is to build
and sustain a national partnership of universities, research
laboratories, capital investors, regional economic development
organizations and small and large technology businesses. I
believe that the $1.5M/yr maximum allocation is approximately
$1M too low to support such a staff.
a. Director (1)
b. Intellectual Property expert or attorney (1)
c. Technical specialists (2)
d. Business services specialists (2)
e. Economic development specialist (1)
f. Communications/liaison staff (2)
g. Administrative staff (1)
3. While it may be advantageous from a technical resource
perspective to locate the Institutes in the vicinity of
universities or national laboratories, I strongly recommend
that the Institutes be managed by (impartial) technology
businesses with expertise in technology commercialization.
Universities and national laboratories do not have the
appropriate experience or backgrounds in commercialization to
manage these Institutes effectively. These managing businesses
should be held accountable for the results and replaced as
necessary to continue the mission. Also, I believe that a
strong affiliation with a single university or government
laboratory would unavoidably give the Institutes strong biases
and discourage the participation of other similar institutions.
The result would be much smaller, more regional efforts that do
not draw upon the resources and investment in nanotechnology
nationwide.
4. The Institutes should strive to continually increase
private-sector support and correspondingly decrease public-
sector support. At the end of the public-support period, the
successful Institutes will be self-sustaining privately-funded
organizations playing a role similar to that played by Sematech
in the microelectronics industry.
5. I recommend that there be two energy institutes--one focused
on conventional sources (e.g., fossil, bio, nuclear) and one
focused on renewable sources (e.g., solar, fuel cells,
hydrogen).
The comments and opinions described here are derived largely from
my testimony of 15 February 2006. A key piece of that testimony
describes what I call a ``Technology Transitions Organization,'' which
corresponds closely to the ``Institutes'' in S. 1908. Here I insert two
charts from that testimony illustrating the function of that
organization for your ease of reference. I believe that these ideas in
these charts are highly relevant to the underlying purpose of S. 1908.
I appreciate the opportunity to be of service in this matter.
Please contact me if I can be of further assistance.*
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* Charts attached to questions are printed on pg. 44.
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